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‘Time lost is brain lost’
Question: Which of the following statements regarding “common knowledge” is correct?
A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.
B.
C. An expert is needed in the first place to establish whether something constitutes common knowledge.
D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.
E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.
Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.
Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.
The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.1 The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.
The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.2 In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.
There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”
Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.
Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.
However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).
2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.
Question: Which of the following statements regarding “common knowledge” is correct?
A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.
B.
C. An expert is needed in the first place to establish whether something constitutes common knowledge.
D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.
E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.
Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.
Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.
The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.1 The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.
The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.2 In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.
There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”
Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.
Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.
However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).
2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.
Question: Which of the following statements regarding “common knowledge” is correct?
A. In any negligence action absent common knowledge, expert testimony is then required to prove requisite standard of care and causation.
B.
C. An expert is needed in the first place to establish whether something constitutes common knowledge.
D. The jury is the one who determines whether a plaintiff can invoke the common knowledge exception.
E. An example of common knowledge in malpractice law is where a delay in stroke diagnosis results in loss of brain function.
Answer: B. The judge, not the jury or anyone else, makes the decision regarding res ipsa loquitur (the thing speaks for itself) or common knowledge, which exempts a plaintiff from producing an expert witness to testify as to the standard of care and causation. However, this is only true in actions arising out of professional negligence such as medical malpractice, whereas most common negligence actions – for example, slips and falls – do not require expert testimony.
Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony, while the plaintiff will typically be disqualified from playing this role because of the complexity of issues involved unless there is common knowledge. In general, courts are reluctant to grant this exception, which favors the plaintiff.
The best example of res ipsa loquitur is where a surgeon inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure. The factual circumstances of each case are critical to its outcome. For example, in a 2013 New York case, the plaintiff was barred from using the res doctrine.1 The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and retrieved it 2 months later. The plaintiff did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. However, the Court of Appeals reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard.
The Supreme Court of Kentucky recently rejected the use of common knowledge in a stroke case.2 In 2010, David Shackelford’s rheumatologist referred him to Paul Lewis, MD, an interventional radiologist, for a four-vessel cerebral angiogram to assist with diagnosing the cause of Mr. Shackelford’s chronic headaches. The procedure itself was uneventful, but while in the recovery room, Mr. Shackelford reported a frontal headache and scotoma, which resolved on its own. The headache improved with medication, and the patient experienced no other symptoms. There were no other visual changes, weakness, slurred speech, or facial palsies. Mr. Shackelford was discharged but had to return to the hospital the next morning via ambulance after becoming disoriented at his home. An MRI indicated multiple scattered small infarcts, and he was left with residual short-term memory loss and visual problems.
There was no allegation that the stroke itself was caused by negligence; rather, Mr. Shackelford alleged that the failure to examine and diagnose the stroke after the angiogram was negligent and caused injury greater than that which the stroke would have caused with earlier intervention. To support his claims, Mr. Shackelford’s expert, Michael David Khoury, MD, a vascular surgeon, criticized Dr. Lewis’s failure to examine Mr. Shackelford when his symptoms were consistent with a stroke. However, Dr. Khoury did not opine that Dr. Lewis could have limited the effects of the stroke through earlier intervention. When asked specifically whether he could state within a reasonable degree of medical probability that Dr. Lewis’s postprocedure care was a substantial factor in causing harm to Mr. Shackelford, Dr. Khoury responded that it was “impossible to tell.”
Based largely upon Dr. Khoury’s deposition testimony, the defendants successfully moved for summary judgment on the basis that the expert had failed to opine that the alleged negligence caused any injury to Mr. Shackelford. As a result, Mr. Shackelford could not prove an essential element of his medical malpractice claim. Defense expert Peter J. Pema, MD, a neuroradiologist, acknowledged the general proposition that strokes require timely diagnosis and treatment but did not provide an opinion on causation under the specific facts of this case. Another defense expert, Gregory Postal, MD, opined that Mr. Shackelford began to present symptoms of a stroke after leaving the hospital.
Notwithstanding the lower court’s ruling to summarily dismiss the case, the Court of Appeals found that, in this case, the issue of causation did not require expert medical testimony. It explained that given the ubiquity of information regarding stroke symptom identification and the necessity of prompt treatment, it had become common knowledge that “time lost is brain lost” as to timely medical intervention. In other words, a jury of laymen with this general knowledge could resolve the causation issue without the aid of expert testimony.
However, the Supreme Court of Kentucky held otherwise, writing: “We disagree with the Court of Appeals’ analysis. Although public service campaigns have increased public awareness and knowledge about stroke symptoms and timely intervention, that general information cannot provide the medical expertise necessary to evaluate this particular claim of medical malpractice. In other words, the question is not simply whether ‘time lost is brain lost.’ Rather, the specific facts and circumstances of this case play a significant role in determining whether the alleged negligent conduct was a substantial factor in Shackelford’s injuries, and to what extent. For example, as Dr. Lewis’s deposition testimony illustrates, a variety of factors influenced his diagnosis and treatment of Shackelford, including Shackelford’s medical history and history of cluster headaches; the common side effects of the angiogram procedure, including headache and scotoma; and the manner in which Shackelford’s headache and scotoma presented, as well as their timing. The complexities of these factors and how they affected Dr. Lewis’s evaluation of Shackelford may have also influenced the severity of the injury. These matters are clearly relevant to the determination of an alleged breach of the standard of care. Despite public perception about timely intervention, the average layperson cannot properly weigh such complex medical evidence without the aid of expert opinion. … To conclude otherwise is to drastically expand the res ipsa loquitor exception and to virtually eliminate the need for expert opinion evidence in similar medical malpractice actions that involve common or highly publicized conditions (e.g., stroke, heart attack, and even some cancers).”
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical or legal advice. The author published an earlier version of this topic in the April 19, 2016, issue of Internal Medicine News, available at https://www.mdedge.com/internalmedicine/law-medicine. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).
2. Lewis/Ashland Hospital v. Shackelford, Supreme Court of Kentucky, Opinion of the Court by Justice Keller, rendered August 29, 2019.
Labeling of medication warnings
Question: Which one of the following statements regarding medication warnings is incorrect?
A. The drug package “insert” or “label” contains, among other things, a drug’s pharmacology, indications, contraindications, risks and warnings.
B. The Physicians’ Desk Reference (PDR) is an annually updated drug compendium, which can be admitted into evidence as a learned treatise.
C. Drug labeling is a dual responsibility of the manufacturer and the Food and Drug Administration.
D. The FDA is solely responsible for a drug’s warnings and sets the absolute standard of care regarding side effects and complications.
E. State law can impose liability for negligent failure to warn even if the FDA has not included the warning in the drug’s label.
Answer: D. In medical products liability, injured plaintiffs frequently claim a failure to warn of known risks. An example is the cardiovascular deaths caused by Vioxx, a nonsteroidal, anti-inflammatory drug that was withdrawn in 2004. Other examples alleging failure to warn are Actos-associated bladder cancer and Baycol-related rhabdomyolysis. At the time of product approval, the FDA sets out the labeling that goes with each drug, and then makes periodic changes to reflect new indications, warnings and risks. The manufacturer has the prime responsibility for submitting all updated information, especially of augmented risks that come with field experience. In 2012, for example, the FDA mandated the revision of the labeling of Lipitor and other statins to warn of the increased risk of diabetes.
The drug manufacturer stands in the unique position as having the most detailed and up-to-date data and bears a serious responsibility to submit its full findings to the FDA, including its request for label change. Litigation over failure to warn of risks frequently turns on whether the drug manufacturer knew or should have known, had failed to inform the FDA, or whether the FDA itself had declined to make the changes, e.g., because of incomplete or premature data. Notwithstanding the FDA’s overarching federal status, a plaintiff may still attempt to use state tort law to hold a manufacturer liable should the federally approved labeling be silent on the matter.
Two U.S. Supreme Court cases sought to clarify the rules under which a drug manufacturer, when sued for failure to warn, may seek protection under its FDA-approved labeling. The first case involved Diana Levine, a Vermont musician and migraine sufferer, who lost her arm after the drug Phenergan, given by intravenous push, accidentally entered an artery and caused gangrene. Although the intravenous use of Phenergan is approved by the FDA and the risk of such use is clearly stated in the drug’s package insert, the lawsuit alleged that under state law, such a warning was inadequate and should have been strengthened to prohibit this mode of administration. A Vermont jury awarded damages of $6.7 million. On appeal, Wyeth, the defendant pharmaceutical company, maintained that its warning was appropriate, as it had been approved by the federal government through the FDA. It further argued that the drug’s package insert could not be unilaterally altered or modified without running afoul of federal regulations.
In a 6-3 decision,1 the U.S. Supreme Court ruled that the manufacturer was in fact at liberty to issue a more stringent warning, and FDA approval does not bar lawsuits. The Court opined that “Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Wyeth had argued that it was impossible for the company to provide additional warnings, since it was the FDA that made the sole determination of the nature and scope of a drug’s label. However, the court held that Wyeth never attempted to change the label to warn of the risk and failed to provide “clear” evidence that the FDA would have prevented it from changing its label. Without defining what constituted “clear” evidence, it rejected Wyeth’s broad assertion that unilaterally changing the Phenergan label would have violated federal law, which was based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.
In 2019, the landmark case of Merck Sharp & Dohme Corp v. Albrecht et al.2 reached the U.S. Supreme Court. This class-action suit involved more than 500 individuals who took Fosamax, an effective anti-resorptive drug for treating osteoporosis, and suffered atypical femoral fractures between 1999 and 2010. When the FDA first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculative risk of atypical femoral fractures. But stronger evidence connecting Fosamax to atypical fractures developed after 1995, prompting the FDA to add a warning in 2011. Merck argued that plaintiffs’ state-law failure-to-warn claims should be dismissed as preempted by federal law. It conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010 but believed the FDA would have rejected that attempt. In particular, it claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk of atypical femoral fractures. In short, Merck was relying on the legal doctrine of “impossibility preemption,” i.e., it was impossible to comply with both state law (adequate label warning of atypical fractures) and federal law (FDA control of warning labels). The plaintiffs’ position was that Merck’s proposed warning to the FDA had minimized the seriousness of the femoral fracture risk, characterizing them only as “stress fractures.”3
The Court’s earlier Levine decision had held that a state-law failure-to-warn claim is preempted where there is “clear” evidence the FDA would not have approved a label change. In the Albrecht decision, which also sided with the plaintiffs, the court indicated that “Clear evidence is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” The court also held that issues relating to presumption of impossibility are law-based, and thus it remains for the judge, not the jury, to make that determination.
Issuing timely warnings regarding medical products promotes patient safety, and the law appears to place the major onus on the manufacturer. Still, striking the proper balance is important. During oral arguments in Albrecht, Associate Justice Neil Gorsuch is said to have cautioned against “ ... incentives for companies to submit weakly supported label changes to the agency, knowing that when those label changes are rejected the companies will be free of further liability.” And as pointed out in the earlier cited Johnston article: “ ... a system that creates incentives for manufacturers to over-warn physicians and patients could harm patients by listing the important warnings of adverse effects among numerous less important warnings, which may discourage physicians and patients from choosing potentially useful drugs. On the other hand, a shift of responsibility for labeling to the FDA raises questions about whether the agency, which has resources that are dwarfed by the combined resources of industry, is necessarily capable to serve in this role ...”
Finally, this issue is more complex for devices because of the Medical Device Amendments Act of 1976 (MDA), which may preempt state-based lawsuits. In a claim brought after a Medtronic catheter ruptured in a patient’s coronary artery during heart surgery, the plaintiff alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The case was appealed to the U.S. Supreme Court. The court held that the MDA preempted petitioner’s common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.4 The court ruled that MDA created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wyeth v. Levine, 555 U.S. 2 (2009).
2. Merck, Sharp & Dohme Corp. v. Albrecht et al., 587 U. S. ____ (2019).
3. Johnston MC et al., A new Supreme Court ruling on drug liability. JAMA 2019;322(7):607-8.
4. Riegel v. Medtronic, 128 S. Ct. 999 (2008).
Question: Which one of the following statements regarding medication warnings is incorrect?
A. The drug package “insert” or “label” contains, among other things, a drug’s pharmacology, indications, contraindications, risks and warnings.
B. The Physicians’ Desk Reference (PDR) is an annually updated drug compendium, which can be admitted into evidence as a learned treatise.
C. Drug labeling is a dual responsibility of the manufacturer and the Food and Drug Administration.
D. The FDA is solely responsible for a drug’s warnings and sets the absolute standard of care regarding side effects and complications.
E. State law can impose liability for negligent failure to warn even if the FDA has not included the warning in the drug’s label.
Answer: D. In medical products liability, injured plaintiffs frequently claim a failure to warn of known risks. An example is the cardiovascular deaths caused by Vioxx, a nonsteroidal, anti-inflammatory drug that was withdrawn in 2004. Other examples alleging failure to warn are Actos-associated bladder cancer and Baycol-related rhabdomyolysis. At the time of product approval, the FDA sets out the labeling that goes with each drug, and then makes periodic changes to reflect new indications, warnings and risks. The manufacturer has the prime responsibility for submitting all updated information, especially of augmented risks that come with field experience. In 2012, for example, the FDA mandated the revision of the labeling of Lipitor and other statins to warn of the increased risk of diabetes.
The drug manufacturer stands in the unique position as having the most detailed and up-to-date data and bears a serious responsibility to submit its full findings to the FDA, including its request for label change. Litigation over failure to warn of risks frequently turns on whether the drug manufacturer knew or should have known, had failed to inform the FDA, or whether the FDA itself had declined to make the changes, e.g., because of incomplete or premature data. Notwithstanding the FDA’s overarching federal status, a plaintiff may still attempt to use state tort law to hold a manufacturer liable should the federally approved labeling be silent on the matter.
Two U.S. Supreme Court cases sought to clarify the rules under which a drug manufacturer, when sued for failure to warn, may seek protection under its FDA-approved labeling. The first case involved Diana Levine, a Vermont musician and migraine sufferer, who lost her arm after the drug Phenergan, given by intravenous push, accidentally entered an artery and caused gangrene. Although the intravenous use of Phenergan is approved by the FDA and the risk of such use is clearly stated in the drug’s package insert, the lawsuit alleged that under state law, such a warning was inadequate and should have been strengthened to prohibit this mode of administration. A Vermont jury awarded damages of $6.7 million. On appeal, Wyeth, the defendant pharmaceutical company, maintained that its warning was appropriate, as it had been approved by the federal government through the FDA. It further argued that the drug’s package insert could not be unilaterally altered or modified without running afoul of federal regulations.
In a 6-3 decision,1 the U.S. Supreme Court ruled that the manufacturer was in fact at liberty to issue a more stringent warning, and FDA approval does not bar lawsuits. The Court opined that “Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Wyeth had argued that it was impossible for the company to provide additional warnings, since it was the FDA that made the sole determination of the nature and scope of a drug’s label. However, the court held that Wyeth never attempted to change the label to warn of the risk and failed to provide “clear” evidence that the FDA would have prevented it from changing its label. Without defining what constituted “clear” evidence, it rejected Wyeth’s broad assertion that unilaterally changing the Phenergan label would have violated federal law, which was based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.
In 2019, the landmark case of Merck Sharp & Dohme Corp v. Albrecht et al.2 reached the U.S. Supreme Court. This class-action suit involved more than 500 individuals who took Fosamax, an effective anti-resorptive drug for treating osteoporosis, and suffered atypical femoral fractures between 1999 and 2010. When the FDA first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculative risk of atypical femoral fractures. But stronger evidence connecting Fosamax to atypical fractures developed after 1995, prompting the FDA to add a warning in 2011. Merck argued that plaintiffs’ state-law failure-to-warn claims should be dismissed as preempted by federal law. It conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010 but believed the FDA would have rejected that attempt. In particular, it claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk of atypical femoral fractures. In short, Merck was relying on the legal doctrine of “impossibility preemption,” i.e., it was impossible to comply with both state law (adequate label warning of atypical fractures) and federal law (FDA control of warning labels). The plaintiffs’ position was that Merck’s proposed warning to the FDA had minimized the seriousness of the femoral fracture risk, characterizing them only as “stress fractures.”3
The Court’s earlier Levine decision had held that a state-law failure-to-warn claim is preempted where there is “clear” evidence the FDA would not have approved a label change. In the Albrecht decision, which also sided with the plaintiffs, the court indicated that “Clear evidence is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” The court also held that issues relating to presumption of impossibility are law-based, and thus it remains for the judge, not the jury, to make that determination.
Issuing timely warnings regarding medical products promotes patient safety, and the law appears to place the major onus on the manufacturer. Still, striking the proper balance is important. During oral arguments in Albrecht, Associate Justice Neil Gorsuch is said to have cautioned against “ ... incentives for companies to submit weakly supported label changes to the agency, knowing that when those label changes are rejected the companies will be free of further liability.” And as pointed out in the earlier cited Johnston article: “ ... a system that creates incentives for manufacturers to over-warn physicians and patients could harm patients by listing the important warnings of adverse effects among numerous less important warnings, which may discourage physicians and patients from choosing potentially useful drugs. On the other hand, a shift of responsibility for labeling to the FDA raises questions about whether the agency, which has resources that are dwarfed by the combined resources of industry, is necessarily capable to serve in this role ...”
Finally, this issue is more complex for devices because of the Medical Device Amendments Act of 1976 (MDA), which may preempt state-based lawsuits. In a claim brought after a Medtronic catheter ruptured in a patient’s coronary artery during heart surgery, the plaintiff alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The case was appealed to the U.S. Supreme Court. The court held that the MDA preempted petitioner’s common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.4 The court ruled that MDA created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wyeth v. Levine, 555 U.S. 2 (2009).
2. Merck, Sharp & Dohme Corp. v. Albrecht et al., 587 U. S. ____ (2019).
3. Johnston MC et al., A new Supreme Court ruling on drug liability. JAMA 2019;322(7):607-8.
4. Riegel v. Medtronic, 128 S. Ct. 999 (2008).
Question: Which one of the following statements regarding medication warnings is incorrect?
A. The drug package “insert” or “label” contains, among other things, a drug’s pharmacology, indications, contraindications, risks and warnings.
B. The Physicians’ Desk Reference (PDR) is an annually updated drug compendium, which can be admitted into evidence as a learned treatise.
C. Drug labeling is a dual responsibility of the manufacturer and the Food and Drug Administration.
D. The FDA is solely responsible for a drug’s warnings and sets the absolute standard of care regarding side effects and complications.
E. State law can impose liability for negligent failure to warn even if the FDA has not included the warning in the drug’s label.
Answer: D. In medical products liability, injured plaintiffs frequently claim a failure to warn of known risks. An example is the cardiovascular deaths caused by Vioxx, a nonsteroidal, anti-inflammatory drug that was withdrawn in 2004. Other examples alleging failure to warn are Actos-associated bladder cancer and Baycol-related rhabdomyolysis. At the time of product approval, the FDA sets out the labeling that goes with each drug, and then makes periodic changes to reflect new indications, warnings and risks. The manufacturer has the prime responsibility for submitting all updated information, especially of augmented risks that come with field experience. In 2012, for example, the FDA mandated the revision of the labeling of Lipitor and other statins to warn of the increased risk of diabetes.
The drug manufacturer stands in the unique position as having the most detailed and up-to-date data and bears a serious responsibility to submit its full findings to the FDA, including its request for label change. Litigation over failure to warn of risks frequently turns on whether the drug manufacturer knew or should have known, had failed to inform the FDA, or whether the FDA itself had declined to make the changes, e.g., because of incomplete or premature data. Notwithstanding the FDA’s overarching federal status, a plaintiff may still attempt to use state tort law to hold a manufacturer liable should the federally approved labeling be silent on the matter.
Two U.S. Supreme Court cases sought to clarify the rules under which a drug manufacturer, when sued for failure to warn, may seek protection under its FDA-approved labeling. The first case involved Diana Levine, a Vermont musician and migraine sufferer, who lost her arm after the drug Phenergan, given by intravenous push, accidentally entered an artery and caused gangrene. Although the intravenous use of Phenergan is approved by the FDA and the risk of such use is clearly stated in the drug’s package insert, the lawsuit alleged that under state law, such a warning was inadequate and should have been strengthened to prohibit this mode of administration. A Vermont jury awarded damages of $6.7 million. On appeal, Wyeth, the defendant pharmaceutical company, maintained that its warning was appropriate, as it had been approved by the federal government through the FDA. It further argued that the drug’s package insert could not be unilaterally altered or modified without running afoul of federal regulations.
In a 6-3 decision,1 the U.S. Supreme Court ruled that the manufacturer was in fact at liberty to issue a more stringent warning, and FDA approval does not bar lawsuits. The Court opined that “Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Wyeth had argued that it was impossible for the company to provide additional warnings, since it was the FDA that made the sole determination of the nature and scope of a drug’s label. However, the court held that Wyeth never attempted to change the label to warn of the risk and failed to provide “clear” evidence that the FDA would have prevented it from changing its label. Without defining what constituted “clear” evidence, it rejected Wyeth’s broad assertion that unilaterally changing the Phenergan label would have violated federal law, which was based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.
In 2019, the landmark case of Merck Sharp & Dohme Corp v. Albrecht et al.2 reached the U.S. Supreme Court. This class-action suit involved more than 500 individuals who took Fosamax, an effective anti-resorptive drug for treating osteoporosis, and suffered atypical femoral fractures between 1999 and 2010. When the FDA first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculative risk of atypical femoral fractures. But stronger evidence connecting Fosamax to atypical fractures developed after 1995, prompting the FDA to add a warning in 2011. Merck argued that plaintiffs’ state-law failure-to-warn claims should be dismissed as preempted by federal law. It conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010 but believed the FDA would have rejected that attempt. In particular, it claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk of atypical femoral fractures. In short, Merck was relying on the legal doctrine of “impossibility preemption,” i.e., it was impossible to comply with both state law (adequate label warning of atypical fractures) and federal law (FDA control of warning labels). The plaintiffs’ position was that Merck’s proposed warning to the FDA had minimized the seriousness of the femoral fracture risk, characterizing them only as “stress fractures.”3
The Court’s earlier Levine decision had held that a state-law failure-to-warn claim is preempted where there is “clear” evidence the FDA would not have approved a label change. In the Albrecht decision, which also sided with the plaintiffs, the court indicated that “Clear evidence is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” The court also held that issues relating to presumption of impossibility are law-based, and thus it remains for the judge, not the jury, to make that determination.
Issuing timely warnings regarding medical products promotes patient safety, and the law appears to place the major onus on the manufacturer. Still, striking the proper balance is important. During oral arguments in Albrecht, Associate Justice Neil Gorsuch is said to have cautioned against “ ... incentives for companies to submit weakly supported label changes to the agency, knowing that when those label changes are rejected the companies will be free of further liability.” And as pointed out in the earlier cited Johnston article: “ ... a system that creates incentives for manufacturers to over-warn physicians and patients could harm patients by listing the important warnings of adverse effects among numerous less important warnings, which may discourage physicians and patients from choosing potentially useful drugs. On the other hand, a shift of responsibility for labeling to the FDA raises questions about whether the agency, which has resources that are dwarfed by the combined resources of industry, is necessarily capable to serve in this role ...”
Finally, this issue is more complex for devices because of the Medical Device Amendments Act of 1976 (MDA), which may preempt state-based lawsuits. In a claim brought after a Medtronic catheter ruptured in a patient’s coronary artery during heart surgery, the plaintiff alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The case was appealed to the U.S. Supreme Court. The court held that the MDA preempted petitioner’s common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.4 The court ruled that MDA created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes.
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wyeth v. Levine, 555 U.S. 2 (2009).
2. Merck, Sharp & Dohme Corp. v. Albrecht et al., 587 U. S. ____ (2019).
3. Johnston MC et al., A new Supreme Court ruling on drug liability. JAMA 2019;322(7):607-8.
4. Riegel v. Medtronic, 128 S. Ct. 999 (2008).
Don’t Take the Fall With Head Injuries
In the early morning hours of June 10, 2009, a 77-year-old man who had been undergoing chemotherapy for multiple myeloma took sleep medication. He then fell down a flight of stairs in his split-level home.
The patient sustained a laceration to his scalp but returned to bed and waited until later that morning to call his internist for an appointment. Later that day, the physician placed 11 sutures for the scalp laceration and performed a neurologic examination; he did not note any abnormalities. The patient complained of back pain, so the physician ordered a back x-ray, which revealed a TI2 fracture that had occurred from the fall. No further treatment was provided for the scalp injury, except removal of the stitches about a week later.
Six days after the fall and doctor visit, the patient’s condition began to deteriorate rapidly, with noted slurred speech and loss of consciousness. He was transported to an emergency department, where CT revealed a massive subdural hematoma. An immediate craniotomy was performed. However, on June 27, 2009, the patient died as a result of the brain bleed.
His estate filed suit against the physician and his practice, alleging medical malpractice and violations in the standard of care. The estate alleged that the standard of care required the physician to obtain a CT scan and that, had one been performed, it would have revealed a small subdural hematoma in time for it to have been successfully treated (ie, before the massive second related bleed). The estate’s theory of the case did not rest on the presentation of clinical symptoms. A medical expert who testified for the estate stated that the subdural hematoma began at the time of the fall.
The defense denied any violations in the standard of care. The physician contended that the patient had presented with no symptoms other than a head laceration, and there were no criteria for ordering CT. Further, the defense asserted that the patient was symptom free for 6 days post-fall. According to the defense, the patient experienced a sudden arterial bleed that was not caused by the fall and would not have been revealed on CT ordered at the time of initial presentation, because it did not occur until 6 days later.
VERDICT
After a 10-day trial and 25 minutes’ deliberation, the jury returned a defense verdict.
COMMENTARY
The 25-minute deliberation suggests that terms such as “bridging veins” and “shearing injury” were unlikely bandied about in the jury room. The jury was likely dismissive of the plaintiff’s claim owing to his cancer diagnosis, and perhaps rightly so. But if we eliminate the multiple myeloma diagnosis, the jury might have decided differently.
Continue to: The defendant physician...
The defendant physician did a good job of documenting a negative neurologic exam, which helped him convince the jury that the patient did not have any signs or symptoms when first evaluated. But in this patient, was imaging to rule out intracranial bleeding indicated?
As an oversimplification, we tend to think of intracranial hemorrhage in 2 varieties: the insidious and the bold. Subdural hematomas are stealthy, they are sneaky, and they prey on the old. They step out of the shadows to cause symptoms. They are the ninjas of intracranial hemorrhage. Beware.
Epidural hematomas and subarachnoid hemorrhage (SAH) are the opposite. They classically present with a sudden and severe symptom complex: with epidural hematoma, the loss of consciousness, lucid interval, and final loss of consciousness; with SAH, the “worst in your life” thunder-clap headache, which may be heralded by a sentinel headache.1 When manifesting this way, they are brash, direct, and unsubtle to the point of being obnoxious—the Steven Stifler of intracranial bleeding.
This generalization is made to highlight the potentially sneaky nature of subdural hemorrhage. There are circumstances in which the clinical presentation of epidural hematoma and SAH will be more challenging. The question here is whether a negative initial neurologic exam can adequately screen for a potentially stealthy subdural hematoma.
Subdural hemorrhage is caused by rapidly changing velocity that may stretch and tear small bridging veins.2,3 Subdural hematoma is more common in the elderly, those who abuse alcohol, and those with a prior history of head trauma.4 As the brain shrinks with age or atrophy, the subdural space enlarges and traversing veins are stretched to cover a wider distance—rendering them vulnerable to rupture.5 These structures may also weaken as a result of low cerebrospinal fluid (intracranial hypotension); as pressure decreases (eg, from a leak), the brain’s buoyancy is reduced, causing traction on anchoring and supporting structures (eg, bridging veins).5 Injury to bridging veins can even occur as a result of a coup-contrecoup mechanism in the absence of direct physical impact.6,7 Bottom line: the injury itself may be subtle, requiring an index of suspicion to make the diagnosis.
Continue to: The case patient was...
The case patient was elderly. He had a chronic malignancy and sustained a fall down the stairs. He was taking sleeping pills, which may have slowed reflexive protective mechanisms after he started to fall (resulting in greater force imparted to his head). Multiple myeloma can predispose a patient to coagulopathy, and we don’t know in this case if this patient’s multiple myeloma made him more susceptible to bleeding—but it certainly didn’t help.8 The patient’s age, the mechanism of injury, and the history of malignancy made this a setup for hemorrhage.
Interestingly, we are not given details about how the patient looked during his suture removal. We are told the time between the initial fall and deterioration was 6 days. Scalp sutures were removed “about a week later,” which was after the deterioration—so this can’t be correct. Removing scalp sutures after 5 days seems premature, but that is the only possibility if 6 days elapsed between the fall and the deterioration.
In short, these are difficult cases. If intracranial bleeding can be subtle and delayed, how can we be sure a patient is not experiencing a bleed? We can only apply the relevant standard of care using all the clinical information we have. The Canadian CT Head Rule and New Orleans Criteria are clinical tools designed to help providers determine when to image (see Table for details).9
Applying the Canadian CT Head Rule to the facts of this case, we would image the patient because he fell down a “flight” of stairs (which is > 5 stairs) and he is 77 years old (older than 65). The New Orleans Criteria require head CT for minor injury with any positive findings.9 Because the patient is older than 60, he would be scanned according this rule.
In this case, the tools indicate scanning would have been appropriate. The patient’s multiple myeloma might have further impelled a decision to image. However, the jury was persuaded that the defendant’s negative neurologic exam was reasonable under the circumstances. This was likely made possible by the physician’s good recordkeeping and demonstrated genuine concern for the patient’s well-being—as well as a differing viewpoint of the patient’s age and health status.
Continue to: Finally, a word about...
Finally, a word about falls and the elderly: We’ve all heard the 80s advertising catchphrase (which lives on as a present-day meme) “I’ve fallen, and I can’t get up!” The problem is, many don’t. It would be more clinically accurate to say, “I’ve fallen, and I’ll be hospitalized for an extended period of time, then transferred to a skilled nursing facility, but I won’t survive to discharge.” The reality is that falls kill, and the severity is underestimated.10 If it were a “brain-eating amoeba,” the media would be all over it. With falls, not so much. We tend to pay less attention.
Risk factors for a fall include postural hypotension; use of benzodiazepines or other sedative-hypnotic drugs; use of ≥ 4 medications; environmental hazards for tripping; impairment in balance and transfer skills; and gait impairment.11 Home setup also contributes—loose throw rugs, uneven carpet edges, cracked sidewalks, clutter and furniture, cables and wires and cords, oh my.
Do your older patients a favor by reinforcing fall risk. Instruct them to rise slowly from seated or recumbent positions; always consider central nervous system sedation and/or the coordination-hampering properties of medications, particularly in combination. Raise the issue of home safety. A brief 10-second comment from you may plant a seed in a family member’s head to do what you cannot: scan and make safe the patient’s living environment.
1. de Falco FA. Sentinel headache. Neurol Sci. 2004;25(suppl 3):S215-S217.
2. Miller JD, Nader R. Acute subdural hematoma from bridging vein rupture: a potential mechanism for growth. J Neurosurg. 2014;120(6):1378-1384.
3. Victor M, Ropper A. Craniocerebral trauma. In: Victor M, Ropper A, eds. Adams and Victor’s Principles of Neurology. 7th ed. New York, NY: McGraw-Hill; 2001:925.
4. McBridde W. Subdural hematoma in adults: etiology, clinical features, and diagnosis. UpToDate website. www.uptodate.com/contents/subdural-hematoma-in-adults-etiology-clinical-features-and-diagnosis? search=subdural%20hematoma. Published December 10, 2018. Accessed September 23, 2019.
5. US National Library of Medicine. Subdural hematoma. Medline Plus website. https://medlineplus.gov/ency/article/000713.htm. Accessed September 23, 2019.
6. Besenski N. Traumatic injuries: imaging of head injuries. Eur Radiol. 2002;12(6):1237-1252.
7. Mayer S, Rowland L. Head injury. In: Rowland L, ed. Merritt’s Neurology. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:401.
8. Saif MW, Allegra CJ, Greenberg B. Bleeding diathesis in multiple myeloma. J Hematother Stem Cell Res. 2001;10(5):657-660.
9. Stiell IG, Clement CM, Rowe BH, et al. Comparison of the Canadian CT Head Rule and the New Orleans Criteria in patients with minor head injury. JAMA. 2005;294(12):1511-1518.
10. Abdelrahman H, Almadani A, El-Menyar A, et al. Home-related falls: an underestimated mechanism of injury. J Family Community Med. 2018; 25(1):48-51.
11. Fuller GF. Falls in the elderly. Am Fam Physician. 2000;61(7):2159-2168.
In the early morning hours of June 10, 2009, a 77-year-old man who had been undergoing chemotherapy for multiple myeloma took sleep medication. He then fell down a flight of stairs in his split-level home.
The patient sustained a laceration to his scalp but returned to bed and waited until later that morning to call his internist for an appointment. Later that day, the physician placed 11 sutures for the scalp laceration and performed a neurologic examination; he did not note any abnormalities. The patient complained of back pain, so the physician ordered a back x-ray, which revealed a TI2 fracture that had occurred from the fall. No further treatment was provided for the scalp injury, except removal of the stitches about a week later.
Six days after the fall and doctor visit, the patient’s condition began to deteriorate rapidly, with noted slurred speech and loss of consciousness. He was transported to an emergency department, where CT revealed a massive subdural hematoma. An immediate craniotomy was performed. However, on June 27, 2009, the patient died as a result of the brain bleed.
His estate filed suit against the physician and his practice, alleging medical malpractice and violations in the standard of care. The estate alleged that the standard of care required the physician to obtain a CT scan and that, had one been performed, it would have revealed a small subdural hematoma in time for it to have been successfully treated (ie, before the massive second related bleed). The estate’s theory of the case did not rest on the presentation of clinical symptoms. A medical expert who testified for the estate stated that the subdural hematoma began at the time of the fall.
The defense denied any violations in the standard of care. The physician contended that the patient had presented with no symptoms other than a head laceration, and there were no criteria for ordering CT. Further, the defense asserted that the patient was symptom free for 6 days post-fall. According to the defense, the patient experienced a sudden arterial bleed that was not caused by the fall and would not have been revealed on CT ordered at the time of initial presentation, because it did not occur until 6 days later.
VERDICT
After a 10-day trial and 25 minutes’ deliberation, the jury returned a defense verdict.
COMMENTARY
The 25-minute deliberation suggests that terms such as “bridging veins” and “shearing injury” were unlikely bandied about in the jury room. The jury was likely dismissive of the plaintiff’s claim owing to his cancer diagnosis, and perhaps rightly so. But if we eliminate the multiple myeloma diagnosis, the jury might have decided differently.
Continue to: The defendant physician...
The defendant physician did a good job of documenting a negative neurologic exam, which helped him convince the jury that the patient did not have any signs or symptoms when first evaluated. But in this patient, was imaging to rule out intracranial bleeding indicated?
As an oversimplification, we tend to think of intracranial hemorrhage in 2 varieties: the insidious and the bold. Subdural hematomas are stealthy, they are sneaky, and they prey on the old. They step out of the shadows to cause symptoms. They are the ninjas of intracranial hemorrhage. Beware.
Epidural hematomas and subarachnoid hemorrhage (SAH) are the opposite. They classically present with a sudden and severe symptom complex: with epidural hematoma, the loss of consciousness, lucid interval, and final loss of consciousness; with SAH, the “worst in your life” thunder-clap headache, which may be heralded by a sentinel headache.1 When manifesting this way, they are brash, direct, and unsubtle to the point of being obnoxious—the Steven Stifler of intracranial bleeding.
This generalization is made to highlight the potentially sneaky nature of subdural hemorrhage. There are circumstances in which the clinical presentation of epidural hematoma and SAH will be more challenging. The question here is whether a negative initial neurologic exam can adequately screen for a potentially stealthy subdural hematoma.
Subdural hemorrhage is caused by rapidly changing velocity that may stretch and tear small bridging veins.2,3 Subdural hematoma is more common in the elderly, those who abuse alcohol, and those with a prior history of head trauma.4 As the brain shrinks with age or atrophy, the subdural space enlarges and traversing veins are stretched to cover a wider distance—rendering them vulnerable to rupture.5 These structures may also weaken as a result of low cerebrospinal fluid (intracranial hypotension); as pressure decreases (eg, from a leak), the brain’s buoyancy is reduced, causing traction on anchoring and supporting structures (eg, bridging veins).5 Injury to bridging veins can even occur as a result of a coup-contrecoup mechanism in the absence of direct physical impact.6,7 Bottom line: the injury itself may be subtle, requiring an index of suspicion to make the diagnosis.
Continue to: The case patient was...
The case patient was elderly. He had a chronic malignancy and sustained a fall down the stairs. He was taking sleeping pills, which may have slowed reflexive protective mechanisms after he started to fall (resulting in greater force imparted to his head). Multiple myeloma can predispose a patient to coagulopathy, and we don’t know in this case if this patient’s multiple myeloma made him more susceptible to bleeding—but it certainly didn’t help.8 The patient’s age, the mechanism of injury, and the history of malignancy made this a setup for hemorrhage.
Interestingly, we are not given details about how the patient looked during his suture removal. We are told the time between the initial fall and deterioration was 6 days. Scalp sutures were removed “about a week later,” which was after the deterioration—so this can’t be correct. Removing scalp sutures after 5 days seems premature, but that is the only possibility if 6 days elapsed between the fall and the deterioration.
In short, these are difficult cases. If intracranial bleeding can be subtle and delayed, how can we be sure a patient is not experiencing a bleed? We can only apply the relevant standard of care using all the clinical information we have. The Canadian CT Head Rule and New Orleans Criteria are clinical tools designed to help providers determine when to image (see Table for details).9
Applying the Canadian CT Head Rule to the facts of this case, we would image the patient because he fell down a “flight” of stairs (which is > 5 stairs) and he is 77 years old (older than 65). The New Orleans Criteria require head CT for minor injury with any positive findings.9 Because the patient is older than 60, he would be scanned according this rule.
In this case, the tools indicate scanning would have been appropriate. The patient’s multiple myeloma might have further impelled a decision to image. However, the jury was persuaded that the defendant’s negative neurologic exam was reasonable under the circumstances. This was likely made possible by the physician’s good recordkeeping and demonstrated genuine concern for the patient’s well-being—as well as a differing viewpoint of the patient’s age and health status.
Continue to: Finally, a word about...
Finally, a word about falls and the elderly: We’ve all heard the 80s advertising catchphrase (which lives on as a present-day meme) “I’ve fallen, and I can’t get up!” The problem is, many don’t. It would be more clinically accurate to say, “I’ve fallen, and I’ll be hospitalized for an extended period of time, then transferred to a skilled nursing facility, but I won’t survive to discharge.” The reality is that falls kill, and the severity is underestimated.10 If it were a “brain-eating amoeba,” the media would be all over it. With falls, not so much. We tend to pay less attention.
Risk factors for a fall include postural hypotension; use of benzodiazepines or other sedative-hypnotic drugs; use of ≥ 4 medications; environmental hazards for tripping; impairment in balance and transfer skills; and gait impairment.11 Home setup also contributes—loose throw rugs, uneven carpet edges, cracked sidewalks, clutter and furniture, cables and wires and cords, oh my.
Do your older patients a favor by reinforcing fall risk. Instruct them to rise slowly from seated or recumbent positions; always consider central nervous system sedation and/or the coordination-hampering properties of medications, particularly in combination. Raise the issue of home safety. A brief 10-second comment from you may plant a seed in a family member’s head to do what you cannot: scan and make safe the patient’s living environment.
In the early morning hours of June 10, 2009, a 77-year-old man who had been undergoing chemotherapy for multiple myeloma took sleep medication. He then fell down a flight of stairs in his split-level home.
The patient sustained a laceration to his scalp but returned to bed and waited until later that morning to call his internist for an appointment. Later that day, the physician placed 11 sutures for the scalp laceration and performed a neurologic examination; he did not note any abnormalities. The patient complained of back pain, so the physician ordered a back x-ray, which revealed a TI2 fracture that had occurred from the fall. No further treatment was provided for the scalp injury, except removal of the stitches about a week later.
Six days after the fall and doctor visit, the patient’s condition began to deteriorate rapidly, with noted slurred speech and loss of consciousness. He was transported to an emergency department, where CT revealed a massive subdural hematoma. An immediate craniotomy was performed. However, on June 27, 2009, the patient died as a result of the brain bleed.
His estate filed suit against the physician and his practice, alleging medical malpractice and violations in the standard of care. The estate alleged that the standard of care required the physician to obtain a CT scan and that, had one been performed, it would have revealed a small subdural hematoma in time for it to have been successfully treated (ie, before the massive second related bleed). The estate’s theory of the case did not rest on the presentation of clinical symptoms. A medical expert who testified for the estate stated that the subdural hematoma began at the time of the fall.
The defense denied any violations in the standard of care. The physician contended that the patient had presented with no symptoms other than a head laceration, and there were no criteria for ordering CT. Further, the defense asserted that the patient was symptom free for 6 days post-fall. According to the defense, the patient experienced a sudden arterial bleed that was not caused by the fall and would not have been revealed on CT ordered at the time of initial presentation, because it did not occur until 6 days later.
VERDICT
After a 10-day trial and 25 minutes’ deliberation, the jury returned a defense verdict.
COMMENTARY
The 25-minute deliberation suggests that terms such as “bridging veins” and “shearing injury” were unlikely bandied about in the jury room. The jury was likely dismissive of the plaintiff’s claim owing to his cancer diagnosis, and perhaps rightly so. But if we eliminate the multiple myeloma diagnosis, the jury might have decided differently.
Continue to: The defendant physician...
The defendant physician did a good job of documenting a negative neurologic exam, which helped him convince the jury that the patient did not have any signs or symptoms when first evaluated. But in this patient, was imaging to rule out intracranial bleeding indicated?
As an oversimplification, we tend to think of intracranial hemorrhage in 2 varieties: the insidious and the bold. Subdural hematomas are stealthy, they are sneaky, and they prey on the old. They step out of the shadows to cause symptoms. They are the ninjas of intracranial hemorrhage. Beware.
Epidural hematomas and subarachnoid hemorrhage (SAH) are the opposite. They classically present with a sudden and severe symptom complex: with epidural hematoma, the loss of consciousness, lucid interval, and final loss of consciousness; with SAH, the “worst in your life” thunder-clap headache, which may be heralded by a sentinel headache.1 When manifesting this way, they are brash, direct, and unsubtle to the point of being obnoxious—the Steven Stifler of intracranial bleeding.
This generalization is made to highlight the potentially sneaky nature of subdural hemorrhage. There are circumstances in which the clinical presentation of epidural hematoma and SAH will be more challenging. The question here is whether a negative initial neurologic exam can adequately screen for a potentially stealthy subdural hematoma.
Subdural hemorrhage is caused by rapidly changing velocity that may stretch and tear small bridging veins.2,3 Subdural hematoma is more common in the elderly, those who abuse alcohol, and those with a prior history of head trauma.4 As the brain shrinks with age or atrophy, the subdural space enlarges and traversing veins are stretched to cover a wider distance—rendering them vulnerable to rupture.5 These structures may also weaken as a result of low cerebrospinal fluid (intracranial hypotension); as pressure decreases (eg, from a leak), the brain’s buoyancy is reduced, causing traction on anchoring and supporting structures (eg, bridging veins).5 Injury to bridging veins can even occur as a result of a coup-contrecoup mechanism in the absence of direct physical impact.6,7 Bottom line: the injury itself may be subtle, requiring an index of suspicion to make the diagnosis.
Continue to: The case patient was...
The case patient was elderly. He had a chronic malignancy and sustained a fall down the stairs. He was taking sleeping pills, which may have slowed reflexive protective mechanisms after he started to fall (resulting in greater force imparted to his head). Multiple myeloma can predispose a patient to coagulopathy, and we don’t know in this case if this patient’s multiple myeloma made him more susceptible to bleeding—but it certainly didn’t help.8 The patient’s age, the mechanism of injury, and the history of malignancy made this a setup for hemorrhage.
Interestingly, we are not given details about how the patient looked during his suture removal. We are told the time between the initial fall and deterioration was 6 days. Scalp sutures were removed “about a week later,” which was after the deterioration—so this can’t be correct. Removing scalp sutures after 5 days seems premature, but that is the only possibility if 6 days elapsed between the fall and the deterioration.
In short, these are difficult cases. If intracranial bleeding can be subtle and delayed, how can we be sure a patient is not experiencing a bleed? We can only apply the relevant standard of care using all the clinical information we have. The Canadian CT Head Rule and New Orleans Criteria are clinical tools designed to help providers determine when to image (see Table for details).9
Applying the Canadian CT Head Rule to the facts of this case, we would image the patient because he fell down a “flight” of stairs (which is > 5 stairs) and he is 77 years old (older than 65). The New Orleans Criteria require head CT for minor injury with any positive findings.9 Because the patient is older than 60, he would be scanned according this rule.
In this case, the tools indicate scanning would have been appropriate. The patient’s multiple myeloma might have further impelled a decision to image. However, the jury was persuaded that the defendant’s negative neurologic exam was reasonable under the circumstances. This was likely made possible by the physician’s good recordkeeping and demonstrated genuine concern for the patient’s well-being—as well as a differing viewpoint of the patient’s age and health status.
Continue to: Finally, a word about...
Finally, a word about falls and the elderly: We’ve all heard the 80s advertising catchphrase (which lives on as a present-day meme) “I’ve fallen, and I can’t get up!” The problem is, many don’t. It would be more clinically accurate to say, “I’ve fallen, and I’ll be hospitalized for an extended period of time, then transferred to a skilled nursing facility, but I won’t survive to discharge.” The reality is that falls kill, and the severity is underestimated.10 If it were a “brain-eating amoeba,” the media would be all over it. With falls, not so much. We tend to pay less attention.
Risk factors for a fall include postural hypotension; use of benzodiazepines or other sedative-hypnotic drugs; use of ≥ 4 medications; environmental hazards for tripping; impairment in balance and transfer skills; and gait impairment.11 Home setup also contributes—loose throw rugs, uneven carpet edges, cracked sidewalks, clutter and furniture, cables and wires and cords, oh my.
Do your older patients a favor by reinforcing fall risk. Instruct them to rise slowly from seated or recumbent positions; always consider central nervous system sedation and/or the coordination-hampering properties of medications, particularly in combination. Raise the issue of home safety. A brief 10-second comment from you may plant a seed in a family member’s head to do what you cannot: scan and make safe the patient’s living environment.
1. de Falco FA. Sentinel headache. Neurol Sci. 2004;25(suppl 3):S215-S217.
2. Miller JD, Nader R. Acute subdural hematoma from bridging vein rupture: a potential mechanism for growth. J Neurosurg. 2014;120(6):1378-1384.
3. Victor M, Ropper A. Craniocerebral trauma. In: Victor M, Ropper A, eds. Adams and Victor’s Principles of Neurology. 7th ed. New York, NY: McGraw-Hill; 2001:925.
4. McBridde W. Subdural hematoma in adults: etiology, clinical features, and diagnosis. UpToDate website. www.uptodate.com/contents/subdural-hematoma-in-adults-etiology-clinical-features-and-diagnosis? search=subdural%20hematoma. Published December 10, 2018. Accessed September 23, 2019.
5. US National Library of Medicine. Subdural hematoma. Medline Plus website. https://medlineplus.gov/ency/article/000713.htm. Accessed September 23, 2019.
6. Besenski N. Traumatic injuries: imaging of head injuries. Eur Radiol. 2002;12(6):1237-1252.
7. Mayer S, Rowland L. Head injury. In: Rowland L, ed. Merritt’s Neurology. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:401.
8. Saif MW, Allegra CJ, Greenberg B. Bleeding diathesis in multiple myeloma. J Hematother Stem Cell Res. 2001;10(5):657-660.
9. Stiell IG, Clement CM, Rowe BH, et al. Comparison of the Canadian CT Head Rule and the New Orleans Criteria in patients with minor head injury. JAMA. 2005;294(12):1511-1518.
10. Abdelrahman H, Almadani A, El-Menyar A, et al. Home-related falls: an underestimated mechanism of injury. J Family Community Med. 2018; 25(1):48-51.
11. Fuller GF. Falls in the elderly. Am Fam Physician. 2000;61(7):2159-2168.
1. de Falco FA. Sentinel headache. Neurol Sci. 2004;25(suppl 3):S215-S217.
2. Miller JD, Nader R. Acute subdural hematoma from bridging vein rupture: a potential mechanism for growth. J Neurosurg. 2014;120(6):1378-1384.
3. Victor M, Ropper A. Craniocerebral trauma. In: Victor M, Ropper A, eds. Adams and Victor’s Principles of Neurology. 7th ed. New York, NY: McGraw-Hill; 2001:925.
4. McBridde W. Subdural hematoma in adults: etiology, clinical features, and diagnosis. UpToDate website. www.uptodate.com/contents/subdural-hematoma-in-adults-etiology-clinical-features-and-diagnosis? search=subdural%20hematoma. Published December 10, 2018. Accessed September 23, 2019.
5. US National Library of Medicine. Subdural hematoma. Medline Plus website. https://medlineplus.gov/ency/article/000713.htm. Accessed September 23, 2019.
6. Besenski N. Traumatic injuries: imaging of head injuries. Eur Radiol. 2002;12(6):1237-1252.
7. Mayer S, Rowland L. Head injury. In: Rowland L, ed. Merritt’s Neurology. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:401.
8. Saif MW, Allegra CJ, Greenberg B. Bleeding diathesis in multiple myeloma. J Hematother Stem Cell Res. 2001;10(5):657-660.
9. Stiell IG, Clement CM, Rowe BH, et al. Comparison of the Canadian CT Head Rule and the New Orleans Criteria in patients with minor head injury. JAMA. 2005;294(12):1511-1518.
10. Abdelrahman H, Almadani A, El-Menyar A, et al. Home-related falls: an underestimated mechanism of injury. J Family Community Med. 2018; 25(1):48-51.
11. Fuller GF. Falls in the elderly. Am Fam Physician. 2000;61(7):2159-2168.
Don’t Be a Maverick; Get a Wingman
A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.
The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.
The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).
On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.
In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.
The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.
The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.
Continue to: VERDICT
VERDICT
After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.
COMMENTARY
In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.
This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.
So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.
By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).1 Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.
Continue to: Generally, causation analysis...
Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.2
Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.
Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.
What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?
Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.
Continue to: This brings us to...
This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.
Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”5 In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”6
For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.
However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.
In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.7 This particularly involves specialty practices that perform certain procedures frequently.
Continue to: In this case...
In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?
In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.
One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”8
There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”
To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.
Continue to: In cases I've worked on...
In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.
As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.
There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.
This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.
Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”9 A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.
Continue to: IN SUMMARY
IN SUMMARY
Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—as they say on every police procedural you’ve ever watched, they can be used against you.
1. The Law Dictionary. What is proximate cause? https://thelawdictionary.org/proximate-cause. Accessed August 21, 2019.
2. Palsgraf v Long Island R.R. Co (248 NY 339, 162 NE 99 [1928]).
3. Stanford Health Care. Risks: our approach for ICD. https://stanfordhealthcare.org/medical-treatments/i/icd/risks.html. Accessed August 21, 2019.
4. Hofer D, Steffel J, Hürlimann D, et al. Long-term incidence of inappropriate shocks in patients with implantable cardioverter defibrillators in clinical practice—an underestimated complication? J Interv Card Electrophysiol. 2017;50(3):219-226.
5. Transcript: Obama pleads health care case. CNN.com. July 22, 2009. www.cnn.com/2009/POLITICS/07/22/transcript.obama. Accessed August 21, 2019.
6. The White House Office of the Press Secretary. Remarks by the President at Town Hall on Health Insurance Reform in Portsmouth, New Hampshire [press release]. August 11, 2009. https://obamawhitehouse.archives.gov/the-press-office/remarks-president-town-hall-health-insurance-reform-portsmouth-new-hampshire. Accessed August 21, 2019.
7. Maslow AH. The Psychology of Science: a Reconnaissance. New York, NY: Harper & Row; 1966:15.
8. Thornton Dep. 55:3-55:7, March 16, 2014, AR Cir No. CV-2012-640-2.
9. Arkansas Code Title 16. Practice, procedure, and courts § 16-55-206: standards for award of punitive damages. https://codes.findlaw.com/ar/title-16-practice-procedure-and-courts/ar-code-sect-16-55-206.html. Accessed August 21, 2019.
A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.
The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.
The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).
On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.
In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.
The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.
The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.
Continue to: VERDICT
VERDICT
After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.
COMMENTARY
In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.
This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.
So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.
By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).1 Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.
Continue to: Generally, causation analysis...
Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.2
Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.
Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.
What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?
Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.
Continue to: This brings us to...
This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.
Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”5 In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”6
For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.
However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.
In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.7 This particularly involves specialty practices that perform certain procedures frequently.
Continue to: In this case...
In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?
In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.
One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”8
There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”
To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.
Continue to: In cases I've worked on...
In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.
As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.
There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.
This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.
Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”9 A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.
Continue to: IN SUMMARY
IN SUMMARY
Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—as they say on every police procedural you’ve ever watched, they can be used against you.
A 39-year-old woman presented to an Arkansas cardiologist on February 12, 2010, with complaints of chest pain. The physician conducted an ankle-brachial index (ABI) test to measure the blood pressure in her lower extremity and interpreted it as less than 0.9%. He then ordered an echocardiogram to gauge the patient’s ejection fraction and interpreted the reading at 25%. Both measurements were below the normal average, which prompted the cardiologist to diagnose peripheral vascular disease and congestive heart failure.
The patient was eventually prescribed a course of cardiac medication and monitored over the ensuing months. On April 15, the cardiologist conducted a nuclear stress test; the computer-generated measurement of her ejection fraction was 50%, which the physician adjusted to 42%. In May, the patient underwent cardiac catheterization, which showed no lesions or blockages in the vessels. In the following months, the patient’s medication dosages were increased. On September 27, the cardiologist conducted another echocardiogram, which he read as 30%, and reaffirmed his diagnosis of congestive heart failure.
The physician continued to monitor the patient. On November 11, after being diagnosed with congestive heart failure, the patient was admitted to the hospital, where the cardiologist implanted an automated implantable cardioverter defibrillator (AICD).
On May 18, 2011, while running with her 2 daughters and a friend, the patient suddenly collapsed and experienced electrical currents coursing through her body (5 times). She was driven to a hospital, where it was determined that she did not go into cardiac arrest (which she suspected) but rather her defibrillator malfunctioned. The defibrillator was recalibrated to a higher setting, and she experienced no further issues.
In the ensuing years, the patient continued to follow up with her cardiologist. She eventually filed a lawsuit claiming that he had misdiagnosed congestive heart failure and unnecessarily implanted the AICD. Her experts in cardiology and cardiac electrophysiology testified that the defendant’s readings of the February 2010 ABI and echocardiogram results were incorrect; the ABIs were in fact .128 and .138 and the ejection fractions were 50% to 55% percent—in both instances, normal results. Furthermore, the September 2010 echocardiogram and another taken in February 2011, which showed little change from the first echocardiogram, were also normal, according to the experts.
The experts also opined that American College of Cardiology/American Heart Association guidelines state that a patient’s ejection fraction has to be less than 35% before a defibrillator is placed. Both experts concluded that the plaintiff did not have congestive heart failure and was therefore not a candidate for an AICD. The cardiac electrophysiology expert stated that to be a candidate, a patient must have an enlarged left ventricle—which plaintiff did not have. Moreover, none of the plaintiff’s physical findings were ever consistent with congestive heart failure: She did not have fluid in her lungs, as examinations always revealed clear lungs without congestion; there was no distention in her jugular veins; she did not experience sleep apnea; she did not lose consciousness; and she only experienced fatigue with exertion. The cardiology expert further faulted the defendant for failing to adjust the patient’s medication dosages to optimize her cardiac repair.
The defense maintained that the defendant’s treatment of the patient met the standard of care. According to the defense, the defendant’s judgment and interpretation of the patient’s ABI and echocardiogram results were medically sound and the defibrillator was necessary.
Continue to: VERDICT
VERDICT
After a 4-day trial and 3 hours of deliberation, the jury found that the defendant was liable and his actions were a factual cause of injury to plaintiff, who was awarded $1.75 million in damages.
COMMENTARY
In this case, the defendant cardiologist placed an AICD (also known as an implantable cardioverter defibrillator, or ICD). There was no allegation that the placement itself was negligent; rather, the claimed negligence was the decision to place it. But the plaintiff’s damages arise from the device’s malfunction—not the cardiologist’s decision to place it.
This case brings up an interesting issue of causation. As most of us know, medical malpractice plaintiffs must show (1) duty, (2) breach, (3) causation, and (4) harm. In law, there are 2 ways to think of causation: “but for” causation and “proximate” causation.
So-called “but for” causation is based on whether any causal relationship exists between an action and an outcome. For example, a drunk driver veers off the highway, through the breakdown lane, and strikes a tree, catching his car on fire. One minute later, a driver in the high-speed lane is captivated by the flaming vehicle, rubbernecks, fails to pay attention to traffic, and rear-ends the vehicle in front of him—injuring the driver of that car. Using “but for” causation, the drunk driver striking the tree “caused” the accident. If that had never happened, the second driver would never have been distracted, and if the driver wasn’t distracted, the second accident would not have occurred.
By contrast, “proximate” causation entails the immediate cause, which is foreseeable. Black’s Law defines proximate cause as “The result of a direct action and cause of loss to property that sets in motion a chain of events that is unbroken and causes damage, injury and destruction with no other interference” (emphasis added).1 Using a proximate causation analysis, the second driver’s negligent failure to pay attention to the road would be the proximate cause of the second crash.
Continue to: Generally, causation analysis...
Generally, causation analysis is limited to proximate cause on the basis that harm is reasonably foreseeable. A famous example is the case of Palsgraf v. Long Island Railroad.2
Mrs. Palsgraf was standing on a train platform. A man carrying an ordinary-looking package rushed to board a moving train, with help from 2 railroad employees (1 in the car and 1 on the platform). As the employees pushed and pulled the man aboard, the package fell onto the tracks. Unbeknownst to everyone but the package’s owner, it contained fireworks—which exploded when the rear wheels of the train ran over the package. The explosion caused a large standing scale to fall over and land on Mrs. Palsgraf, injuring her. This is what law professors live for.
Mrs. Palsgraf sued the railroad, arguing that if the employees had not negligently pushed and pulled the man, the package would not have fallen and would not have exploded, and the scale never would have fallen on her. Mrs. Palsgraf won her trial and won her first appeal. In a famous decision by a famous judge, the win was overturned on the basis that Mrs. Palsgraf’s injuries “were not a reasonably foreseeable consequence of any possible negligence by the railroad.” This case set a foundation of American law regarding reasonable foreseeability, both in terms of identifiable plaintiffs and expected danger.
What does a railroad accident have to do with medical malpractice? In the case described here, we had an arguably negligent medical decision to place the defibrillator. Then we had a malfunction of the device, which caused the plaintiff injury. Was it reasonably foreseeable that the device would malfunction and cause harm—and should the physician be on the hook for that?
Unlike the unforeseeable risk of knocking a simple package to the ground—which unexpectedly turned out to contain fireworks—the risk of device malfunction would be foreseeable. Why? Beyond the usual surgical risks of bleeding and infection, an ICD’s leads can dislodge, the device can fail, and devices can shock inappropriately (with younger patients at increased risk for inappropriate shocks).3,4 These risks are known, and it is highly likely the defendant cardiologist disclosed them on the consent form he asked the plaintiff to sign. The defense could not credibly argue that device malfunction was an unforeseeable risk. The malpractice here was the decision to place the ICD—and because placement wasn’t warranted in this patient, neither were the risks.
Continue to: This brings us to...
This brings us to the first malpractice trap: If you practice in a setting where a procedure is routinely offered, and that treatment has a billable cost, be cautious. Your decision-making can be made to appear driven by a profit motive. The lay public (including jurors) is suspicious of profit motive in medicine—a concept most clinicians find alien and repugnant.
Back in 2009, while outlining his rationale for the Affordable Care Act, President Obama made several statements that earned him swift rebuke from physician groups; I include them here not to incite political rants but to demonstrate the keen suspicion the public has for profit motives in clinical decision-making. On one occasion, he said, “Right now, doctors a lot of times are forced to make decisions based on the fee payment schedule. ... The doctor may look at the reimbursement system and say to himself, ‘You know what? I make a lot more money if I take this kid’s tonsils out.’”5 In another statement, while acknowledging that primary care providers offering preventive diabetes care make “a pittance,” Obama added, “But if that same [patient] ends up getting their foot amputated, that’s $30,000, $40,000, $50,000 immediately the surgeon is reimbursed.”6
For most clinicians, the idea of deciding on a course of treatment because it will be lucrative is an alien concept. Good clinicians base treatment on the accepted medical standard, and cost factors are a distant consideration if one at all.
However, if your practice involves a procedure or intervention that is a particularly lucrative billable event, do your part to play mental “devil’s advocate” and ensure that patients are genuinely in need of the treatment.
In some rare, bad (and usually highly publicized) cases, a procedure will be overused in a patently fraudulent way, which we all recognize is unethical and illegal. However, in other instances, a procedure may be overused because it is familiar and available. We’ve all heard the adage, “If all you have is a hammer, everything looks like a nail.” This “cute” expression holds some truth about the risk for cognitive bias based on the over-reliance on a familiar remedy.7 This particularly involves specialty practices that perform certain procedures frequently.
Continue to: In this case...
In this case, the plaintiff’s nuclear stress test showed an ejection fraction of 50%, which the defendant decreased to 42%. That is substantially different than the first ejection fraction of 25% and the second of 30% in a 39-year-old patient without any clinical signs of congestive heart failure. Did the defendant’s ability to offer an ICD color his appraisal of the patient’s cardiac function?
In closing arguments to the jury, the plaintiff’s attorney probably argued “this defendant behaved as if every human heart could be improved with a battery and wires.” Examine your practice to be sure you aren’t seeing nails where they don’t exist—because tomorrow, they will be the nails in the coffin of your career.
One thing missing from this case summary—but available via court records—is that the plaintiff claimed she had wanted a second opinion but was told she couldn’t have one: “I wanted a second opinion. And when I called [the defendant’s] office and asked ‘Could I have a second opinion,’ his nurse answered the phone and said that if I did get a second opinion, then I couldn’t come back.”8
There are a few aspects to discuss here, one of which is the second malpractice trap: viewing second opinions as an enemy. Most clinicians realize they are actually your friend. However, some providers are threatened by second opinions. It is as if they roll out of bed in the morning and consult the mirror to ask, “Who is the top cardiologist of them all?” and need the validation of that voice saying, “You, Dr. Smith—why of course, you!”
To that I say, forget the mirror, you egotistical so-and-so. Snow White will help protect you, your career, and most importantly, your patient. Allow the second opinion. In fact, integrate an expectation of the them into your practice style, to disarm any feelings of awkwardness, confrontation, or defensiveness. Think of the benefits: If Snow White validates your opinion, you have much stronger case that a course of treatment was indicated. Conversely, if Snow White arrives at a different opinion, she may have seen something you did not, and/or it may also relieve pressure from the patient to take an action with which you were only borderline comfortable.
Continue to: In cases I've worked on...
In cases I’ve worked on, I’ve seen some excellent surgeons who require a second opinion as a precondition to operating. This is particularly helpful when patient expectations are uncertain or there is a track record of unsuccessful interventions (eg, chronic back pain with multiple failed surgeries). Furthermore, a second opinion shows diligence, humility, and concern for the patient. It also gives you backup. As Top Gun taught us, there is no need to be a “maverick” when you can have a wingman.
As far as the alleged comment by the cardiologist’s nurse: We don’t know for certain if this actually happened—but if it did, it was unwarranted and foolish. Any jury would hear this and conclude the defendant (1) was an ass, (2) had something to hide, or (3) was guarding a profit source. Any way you slice it, this is bad for the patient and ultimately bad for the defendant. Make room in your practice for second opinions.
There was a legal fight regarding the admissibility of what the nurse had said. The defense filed a motion to prevent the plaintiff from telling the jury about the nurse’s statement, on the basis that the nurse’s statement was inadmissible hearsay. The court denied the motion, ruling that the cardiologist’s nurse was his agent and her words could be properly brought before the jury. The court found that the plaintiff relied on that statement in determining whether to have the ICD placed or obtain a second opinion.
This raises an interesting malpractice awareness point: If you are sued for malpractice, anything you had said to a patient, the patient’s family, or your coworkers will be admissible in court as a “party admission,” classified as either nonhearsay or a hearsay exception (assuming the statement was not made as part of a bona fide peer review, in which case it will likely be subject to peer review privilege). As seen in this case, this also applies to people acting as agents on your behalf. Be cautious of what you say and how you say it—and what your practice’s representatives are saying as well.
Interestingly, the jury found for the plaintiff in the amount of $1.75 million, but they declined to award punitive damages, which are designed to punish defendants rather than compensate the plaintiff. In Arkansas, the standard for punitive damages is tough; the plaintiff must “prove by clear and convincing evidence that the defendant knew or ought to have known, that their conduct would naturally and probably result in injury or damage and that they continued the conduct with malice or in reckless disregard of the consequences from which malice may be inferred.”9 A similar standard exists in most states. Because there were no punitive damages, we can infer the jury did not think the defendant implanted the ICD (for profit) knowing it wasn’t indicated.
Continue to: IN SUMMARY
IN SUMMARY
Consider foreseeable risks of practice interventions; be sure your practice is not on “autopilot,” recommending a common procedure or intervention too frequently. Don’t be threatened by second opinions; welcome them. And watch your words—as they say on every police procedural you’ve ever watched, they can be used against you.
1. The Law Dictionary. What is proximate cause? https://thelawdictionary.org/proximate-cause. Accessed August 21, 2019.
2. Palsgraf v Long Island R.R. Co (248 NY 339, 162 NE 99 [1928]).
3. Stanford Health Care. Risks: our approach for ICD. https://stanfordhealthcare.org/medical-treatments/i/icd/risks.html. Accessed August 21, 2019.
4. Hofer D, Steffel J, Hürlimann D, et al. Long-term incidence of inappropriate shocks in patients with implantable cardioverter defibrillators in clinical practice—an underestimated complication? J Interv Card Electrophysiol. 2017;50(3):219-226.
5. Transcript: Obama pleads health care case. CNN.com. July 22, 2009. www.cnn.com/2009/POLITICS/07/22/transcript.obama. Accessed August 21, 2019.
6. The White House Office of the Press Secretary. Remarks by the President at Town Hall on Health Insurance Reform in Portsmouth, New Hampshire [press release]. August 11, 2009. https://obamawhitehouse.archives.gov/the-press-office/remarks-president-town-hall-health-insurance-reform-portsmouth-new-hampshire. Accessed August 21, 2019.
7. Maslow AH. The Psychology of Science: a Reconnaissance. New York, NY: Harper & Row; 1966:15.
8. Thornton Dep. 55:3-55:7, March 16, 2014, AR Cir No. CV-2012-640-2.
9. Arkansas Code Title 16. Practice, procedure, and courts § 16-55-206: standards for award of punitive damages. https://codes.findlaw.com/ar/title-16-practice-procedure-and-courts/ar-code-sect-16-55-206.html. Accessed August 21, 2019.
1. The Law Dictionary. What is proximate cause? https://thelawdictionary.org/proximate-cause. Accessed August 21, 2019.
2. Palsgraf v Long Island R.R. Co (248 NY 339, 162 NE 99 [1928]).
3. Stanford Health Care. Risks: our approach for ICD. https://stanfordhealthcare.org/medical-treatments/i/icd/risks.html. Accessed August 21, 2019.
4. Hofer D, Steffel J, Hürlimann D, et al. Long-term incidence of inappropriate shocks in patients with implantable cardioverter defibrillators in clinical practice—an underestimated complication? J Interv Card Electrophysiol. 2017;50(3):219-226.
5. Transcript: Obama pleads health care case. CNN.com. July 22, 2009. www.cnn.com/2009/POLITICS/07/22/transcript.obama. Accessed August 21, 2019.
6. The White House Office of the Press Secretary. Remarks by the President at Town Hall on Health Insurance Reform in Portsmouth, New Hampshire [press release]. August 11, 2009. https://obamawhitehouse.archives.gov/the-press-office/remarks-president-town-hall-health-insurance-reform-portsmouth-new-hampshire. Accessed August 21, 2019.
7. Maslow AH. The Psychology of Science: a Reconnaissance. New York, NY: Harper & Row; 1966:15.
8. Thornton Dep. 55:3-55:7, March 16, 2014, AR Cir No. CV-2012-640-2.
9. Arkansas Code Title 16. Practice, procedure, and courts § 16-55-206: standards for award of punitive damages. https://codes.findlaw.com/ar/title-16-practice-procedure-and-courts/ar-code-sect-16-55-206.html. Accessed August 21, 2019.
Legal duty to nonpatients: Driving accidents
Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?
A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.
B. The pedestrian can sue Driver D for negligent driving.
C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.
D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.
E. All statements above are correct.
Answer: E. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.
Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.
The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,1 pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.2 The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.
Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled3 that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.4
In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,5 a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.
A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,6 a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.
2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).
3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).
4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).
5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).
6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).
Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?
A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.
B. The pedestrian can sue Driver D for negligent driving.
C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.
D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.
E. All statements above are correct.
Answer: E. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.
Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.
The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,1 pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.2 The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.
Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled3 that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.4
In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,5 a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.
A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,6 a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.
2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).
3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).
4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).
5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).
6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).
Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?
A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.
B. The pedestrian can sue Driver D for negligent driving.
C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.
D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.
E. All statements above are correct.
Answer: E. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.
Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.
The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,1 pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.2 The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.
Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled3 that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.4
In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,5 a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.
A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,6 a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.
2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).
3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).
4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).
5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).
6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).
Discovery of peer review and patient safety reports
Question: A patient died unexpectedly during hospitalization for a diabetic foot infection. The autopsy revealed the presence of a large saddle pulmonary embolus. The hospital’s peer review committee met to determine if care was suboptimal and whether prophylactic anticoagulation should have been used. When the attending doctor was subsequently sued for malpractice, the plaintiff’s attorney sought to subpoena all of the medical records, including the minutes of the peer review committee. Given this hypothetical scenario, which of the following can occur?
A. “Discovery” is the legal term given to the process during the pretrial phase for amassing relevant documents and other information.
B. A subpoena duces tecum, which is a court order for the production of relevant documents and one that should normally be obeyed, may be issued.
C. The hospital declines to hand over certain types of hospital records, such as peer review minutes, which in this case are statutorily protected from discovery.
D. The plaintiff attorney goes to the judge for an order to compel production and may or may not be successful.
E. All are correct.
Answer: E. Physicians and other participants regularly meet, under strict confidential conditions, to discuss adverse events that occur in their institution. Such records are protected from “discovery,” which is a pretrial procedure for collecting evidence in preparation for trial. The rationale for keeping these records beyond the reach of the discovery process is to encourage participants to engage in candid and free-rein analysis of adverse medical events so as to avoid future mishaps. If the content and nature of these discussions were freely available to parties in litigation, there would be a natural reluctance to express one’s viewpoints in a forthright manner.
Any given state’s statute on discovery requires careful reading because it could differ from another state’s directive – with important legal consequences. As an example, Hawaii’s statute1 contains several inclusions and exclusions and reads in part: “... the information and data protected shall include proceedings and records of a peer review committee, hospital quality assurance committee, or health care review organization that include recordings, transcripts, minutes, and summaries of meetings, conversations, notes, materials, or reports created for, by, or at the direction of a peer review committee, quality assurance committee, or a health care review organization when related to a medical error reporting system. ... Information and data protected from discovery shall not include incident reports, occurrence reports, statements, or similar reports that state facts concerning a specific situation and shall not include records made in the regular course of business by a hospital ... including patient medical records. Original sources of information ... shall not be construed as being immune from discovery ... merely because they were reviewed ... or were in fact submitted to, a health care review organization.”
Predictably, plaintiff attorneys in a medical malpractice lawsuit will attempt to discover information regarding adverse events, hoping to learn about potential errors and judgment lapses, and thus gain an advantage over the defendant doctor and/or hospital. Several recent court cases highlight the contentious nature regarding whether a particular hospital report is to be deemed discoverable. Organized medicine, led by the American Medical Association, has mounted a vigorous response in arguing against the release of peer review and patient safety documents.
The AMA2 recently weighed in on the case of Daley v. Teruel and Ingalls Memorial Hospital. In 2013, a renal failure patient died in an Illinois hospital from injuries that arose from prolonged hypoglycemia. She had received insulin, but when her blood glucose dropped to 16 mg/dl, the treatment team was not alerted and she was later found unresponsive with irreversible brain damage. The issue was whether incident reports from the case that were submitted to a certified PSO (patient safety organization) could be discovered. The Federal Patient Safety and Quality Improvement Act (PSQIA) had created PSOs to aggregate data from multiple sources to reduce adverse events and errors and improve medication safety.
An Illinois lower court ruled that, as part of the discovery process, the hospital had to turn over the report. However, the Illinois Appellate Court ruled in favor of the hospital, holding that the PSQIA protects the report because it is a “patient safety work product.”3 The AMA amicus brief had emphasized that Congress created a safeguarded patient safety process under the PSQIA to encourage hospitals to submit patient safety outcomes without fear of increased liability risk and that “these voluntarily created materials should be used for their intended purpose, not as a roadmap for litigation.”
New Jersey has also ruled against the discovery of a hospital’s self-critical report of a patient’s care, prepared in accordance with New Jersey’s Patient Safety Act.4 The plaintiff alleged that, when she reported to the emergency room at Chilton Medical Center complaining of persistent abdominal pain, fever, body aches, weakness, and a phlegmatic cough, she was incorrectly diagnosed as having pneumonia. In fact, she had appendicitis and a pelvic abscess. The New Jersey Supreme Court affirmed the panel’s order shielding the redacted document from discovery, but it reversed the judgment to the extent it ended the defendants’ discovery obligation with respect to this dispute, requiring instead that the lower court address, through current discovery rules, the proper balancing of interests between requesting and responding parties.
In a recent Michigan case,5 the trial court had earlier ruled that peer review documents at issue were in fact discoverable. Like similar statutes elsewhere, Michigan’s peer review privileges serve to encourage participation to improve on patient morbidity and mortality. The case centered on a court order compelling a Michigan hospital to release a physician’s credentialing file in a medical liability lawsuit on the narrow basis that the nondiscoverability privilege applied only to peer review deliberations and was inapplicable in the case. The trial judge had opined that, if all materials viewed by peer review committees were deemed undiscoverable, a hospital could never be held accountable for any negligent act within the purview of the committee. In its amicus brief in support of the hospital, the AMA argued that Michigan’s peer review privilege has historically spanned the bounds of the actual peer review process, and it countered that hospitals can be held liable – and are regularly held liable – without opening up these documents and that plaintiffs can use the same discovery mechanisms generally available to plaintiffs in other lawsuits.6 The case is currently under appeal.
In contrast, at least two state supreme courts have ruled to limit protections from discovery. The Florida Supreme Court has held that the federal law was intended to improve overall health care rather than to act as a shield to providers. In a case of alleged malpractice with severe neurological injuries, the court took a restrictive interpretation of the PSQIA as it relates to Florida’s risk-management and discovery laws, holding that patient safety work and related reports, when required by state law, do not come under the definition of patient safety work product and were therefore discoverable.7
The Pennsylvania Supreme Court has likewise ruled that documents generated by a hospital’s outside contractor are not protected from discovery under the state’s Peer Review Protection Act. It agreed with a lower-court ruling that Monongahela Valley Hospital could not claim privilege for a performance file on an emergency department physician employed by the hospital’s contractor University of Pittsburgh Medical Center Emergency Medicine.8 The case alleged that the plaintiff’s chest and back pain was misdiagnosed as reflux disease when in fact it was a myocardial infarct.
Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Hawaii Revised Statutes §624-25.5 (2012).
2. AMA fights to protect patient-safety work from legal discovery. AMA Morning Rounds. 2018 Aug 1.
3. Daley v. Teruel and Ingalls Memorial Hospital, 2018 Ill. App. LEXIS 440 (Ill. App. Ct. 2018).
4. Brugaletta v. Garcia, 190 A.3d 419 (NJ. 2018).
5. Dwyer v. Ascension Crittenton Hospital. Michigan Supreme Court SC: 158668, 919 N.W.2d 407 (Mi. 2018).
6. Appellate court case puts peer-review protections in danger. AMA Morning Rounds. 2019 Mar 29.
7. Charles v. Southern Baptist Hospital of Florida, Inc., 2017 Fla. LEXIS 231 (Fla. Jan. 31, 2017).
8. Reginelli v. Boggs, 2018 Pa. LEXIS 1503 (Pa. 2018).
Question: A patient died unexpectedly during hospitalization for a diabetic foot infection. The autopsy revealed the presence of a large saddle pulmonary embolus. The hospital’s peer review committee met to determine if care was suboptimal and whether prophylactic anticoagulation should have been used. When the attending doctor was subsequently sued for malpractice, the plaintiff’s attorney sought to subpoena all of the medical records, including the minutes of the peer review committee. Given this hypothetical scenario, which of the following can occur?
A. “Discovery” is the legal term given to the process during the pretrial phase for amassing relevant documents and other information.
B. A subpoena duces tecum, which is a court order for the production of relevant documents and one that should normally be obeyed, may be issued.
C. The hospital declines to hand over certain types of hospital records, such as peer review minutes, which in this case are statutorily protected from discovery.
D. The plaintiff attorney goes to the judge for an order to compel production and may or may not be successful.
E. All are correct.
Answer: E. Physicians and other participants regularly meet, under strict confidential conditions, to discuss adverse events that occur in their institution. Such records are protected from “discovery,” which is a pretrial procedure for collecting evidence in preparation for trial. The rationale for keeping these records beyond the reach of the discovery process is to encourage participants to engage in candid and free-rein analysis of adverse medical events so as to avoid future mishaps. If the content and nature of these discussions were freely available to parties in litigation, there would be a natural reluctance to express one’s viewpoints in a forthright manner.
Any given state’s statute on discovery requires careful reading because it could differ from another state’s directive – with important legal consequences. As an example, Hawaii’s statute1 contains several inclusions and exclusions and reads in part: “... the information and data protected shall include proceedings and records of a peer review committee, hospital quality assurance committee, or health care review organization that include recordings, transcripts, minutes, and summaries of meetings, conversations, notes, materials, or reports created for, by, or at the direction of a peer review committee, quality assurance committee, or a health care review organization when related to a medical error reporting system. ... Information and data protected from discovery shall not include incident reports, occurrence reports, statements, or similar reports that state facts concerning a specific situation and shall not include records made in the regular course of business by a hospital ... including patient medical records. Original sources of information ... shall not be construed as being immune from discovery ... merely because they were reviewed ... or were in fact submitted to, a health care review organization.”
Predictably, plaintiff attorneys in a medical malpractice lawsuit will attempt to discover information regarding adverse events, hoping to learn about potential errors and judgment lapses, and thus gain an advantage over the defendant doctor and/or hospital. Several recent court cases highlight the contentious nature regarding whether a particular hospital report is to be deemed discoverable. Organized medicine, led by the American Medical Association, has mounted a vigorous response in arguing against the release of peer review and patient safety documents.
The AMA2 recently weighed in on the case of Daley v. Teruel and Ingalls Memorial Hospital. In 2013, a renal failure patient died in an Illinois hospital from injuries that arose from prolonged hypoglycemia. She had received insulin, but when her blood glucose dropped to 16 mg/dl, the treatment team was not alerted and she was later found unresponsive with irreversible brain damage. The issue was whether incident reports from the case that were submitted to a certified PSO (patient safety organization) could be discovered. The Federal Patient Safety and Quality Improvement Act (PSQIA) had created PSOs to aggregate data from multiple sources to reduce adverse events and errors and improve medication safety.
An Illinois lower court ruled that, as part of the discovery process, the hospital had to turn over the report. However, the Illinois Appellate Court ruled in favor of the hospital, holding that the PSQIA protects the report because it is a “patient safety work product.”3 The AMA amicus brief had emphasized that Congress created a safeguarded patient safety process under the PSQIA to encourage hospitals to submit patient safety outcomes without fear of increased liability risk and that “these voluntarily created materials should be used for their intended purpose, not as a roadmap for litigation.”
New Jersey has also ruled against the discovery of a hospital’s self-critical report of a patient’s care, prepared in accordance with New Jersey’s Patient Safety Act.4 The plaintiff alleged that, when she reported to the emergency room at Chilton Medical Center complaining of persistent abdominal pain, fever, body aches, weakness, and a phlegmatic cough, she was incorrectly diagnosed as having pneumonia. In fact, she had appendicitis and a pelvic abscess. The New Jersey Supreme Court affirmed the panel’s order shielding the redacted document from discovery, but it reversed the judgment to the extent it ended the defendants’ discovery obligation with respect to this dispute, requiring instead that the lower court address, through current discovery rules, the proper balancing of interests between requesting and responding parties.
In a recent Michigan case,5 the trial court had earlier ruled that peer review documents at issue were in fact discoverable. Like similar statutes elsewhere, Michigan’s peer review privileges serve to encourage participation to improve on patient morbidity and mortality. The case centered on a court order compelling a Michigan hospital to release a physician’s credentialing file in a medical liability lawsuit on the narrow basis that the nondiscoverability privilege applied only to peer review deliberations and was inapplicable in the case. The trial judge had opined that, if all materials viewed by peer review committees were deemed undiscoverable, a hospital could never be held accountable for any negligent act within the purview of the committee. In its amicus brief in support of the hospital, the AMA argued that Michigan’s peer review privilege has historically spanned the bounds of the actual peer review process, and it countered that hospitals can be held liable – and are regularly held liable – without opening up these documents and that plaintiffs can use the same discovery mechanisms generally available to plaintiffs in other lawsuits.6 The case is currently under appeal.
In contrast, at least two state supreme courts have ruled to limit protections from discovery. The Florida Supreme Court has held that the federal law was intended to improve overall health care rather than to act as a shield to providers. In a case of alleged malpractice with severe neurological injuries, the court took a restrictive interpretation of the PSQIA as it relates to Florida’s risk-management and discovery laws, holding that patient safety work and related reports, when required by state law, do not come under the definition of patient safety work product and were therefore discoverable.7
The Pennsylvania Supreme Court has likewise ruled that documents generated by a hospital’s outside contractor are not protected from discovery under the state’s Peer Review Protection Act. It agreed with a lower-court ruling that Monongahela Valley Hospital could not claim privilege for a performance file on an emergency department physician employed by the hospital’s contractor University of Pittsburgh Medical Center Emergency Medicine.8 The case alleged that the plaintiff’s chest and back pain was misdiagnosed as reflux disease when in fact it was a myocardial infarct.
Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Hawaii Revised Statutes §624-25.5 (2012).
2. AMA fights to protect patient-safety work from legal discovery. AMA Morning Rounds. 2018 Aug 1.
3. Daley v. Teruel and Ingalls Memorial Hospital, 2018 Ill. App. LEXIS 440 (Ill. App. Ct. 2018).
4. Brugaletta v. Garcia, 190 A.3d 419 (NJ. 2018).
5. Dwyer v. Ascension Crittenton Hospital. Michigan Supreme Court SC: 158668, 919 N.W.2d 407 (Mi. 2018).
6. Appellate court case puts peer-review protections in danger. AMA Morning Rounds. 2019 Mar 29.
7. Charles v. Southern Baptist Hospital of Florida, Inc., 2017 Fla. LEXIS 231 (Fla. Jan. 31, 2017).
8. Reginelli v. Boggs, 2018 Pa. LEXIS 1503 (Pa. 2018).
Question: A patient died unexpectedly during hospitalization for a diabetic foot infection. The autopsy revealed the presence of a large saddle pulmonary embolus. The hospital’s peer review committee met to determine if care was suboptimal and whether prophylactic anticoagulation should have been used. When the attending doctor was subsequently sued for malpractice, the plaintiff’s attorney sought to subpoena all of the medical records, including the minutes of the peer review committee. Given this hypothetical scenario, which of the following can occur?
A. “Discovery” is the legal term given to the process during the pretrial phase for amassing relevant documents and other information.
B. A subpoena duces tecum, which is a court order for the production of relevant documents and one that should normally be obeyed, may be issued.
C. The hospital declines to hand over certain types of hospital records, such as peer review minutes, which in this case are statutorily protected from discovery.
D. The plaintiff attorney goes to the judge for an order to compel production and may or may not be successful.
E. All are correct.
Answer: E. Physicians and other participants regularly meet, under strict confidential conditions, to discuss adverse events that occur in their institution. Such records are protected from “discovery,” which is a pretrial procedure for collecting evidence in preparation for trial. The rationale for keeping these records beyond the reach of the discovery process is to encourage participants to engage in candid and free-rein analysis of adverse medical events so as to avoid future mishaps. If the content and nature of these discussions were freely available to parties in litigation, there would be a natural reluctance to express one’s viewpoints in a forthright manner.
Any given state’s statute on discovery requires careful reading because it could differ from another state’s directive – with important legal consequences. As an example, Hawaii’s statute1 contains several inclusions and exclusions and reads in part: “... the information and data protected shall include proceedings and records of a peer review committee, hospital quality assurance committee, or health care review organization that include recordings, transcripts, minutes, and summaries of meetings, conversations, notes, materials, or reports created for, by, or at the direction of a peer review committee, quality assurance committee, or a health care review organization when related to a medical error reporting system. ... Information and data protected from discovery shall not include incident reports, occurrence reports, statements, or similar reports that state facts concerning a specific situation and shall not include records made in the regular course of business by a hospital ... including patient medical records. Original sources of information ... shall not be construed as being immune from discovery ... merely because they were reviewed ... or were in fact submitted to, a health care review organization.”
Predictably, plaintiff attorneys in a medical malpractice lawsuit will attempt to discover information regarding adverse events, hoping to learn about potential errors and judgment lapses, and thus gain an advantage over the defendant doctor and/or hospital. Several recent court cases highlight the contentious nature regarding whether a particular hospital report is to be deemed discoverable. Organized medicine, led by the American Medical Association, has mounted a vigorous response in arguing against the release of peer review and patient safety documents.
The AMA2 recently weighed in on the case of Daley v. Teruel and Ingalls Memorial Hospital. In 2013, a renal failure patient died in an Illinois hospital from injuries that arose from prolonged hypoglycemia. She had received insulin, but when her blood glucose dropped to 16 mg/dl, the treatment team was not alerted and she was later found unresponsive with irreversible brain damage. The issue was whether incident reports from the case that were submitted to a certified PSO (patient safety organization) could be discovered. The Federal Patient Safety and Quality Improvement Act (PSQIA) had created PSOs to aggregate data from multiple sources to reduce adverse events and errors and improve medication safety.
An Illinois lower court ruled that, as part of the discovery process, the hospital had to turn over the report. However, the Illinois Appellate Court ruled in favor of the hospital, holding that the PSQIA protects the report because it is a “patient safety work product.”3 The AMA amicus brief had emphasized that Congress created a safeguarded patient safety process under the PSQIA to encourage hospitals to submit patient safety outcomes without fear of increased liability risk and that “these voluntarily created materials should be used for their intended purpose, not as a roadmap for litigation.”
New Jersey has also ruled against the discovery of a hospital’s self-critical report of a patient’s care, prepared in accordance with New Jersey’s Patient Safety Act.4 The plaintiff alleged that, when she reported to the emergency room at Chilton Medical Center complaining of persistent abdominal pain, fever, body aches, weakness, and a phlegmatic cough, she was incorrectly diagnosed as having pneumonia. In fact, she had appendicitis and a pelvic abscess. The New Jersey Supreme Court affirmed the panel’s order shielding the redacted document from discovery, but it reversed the judgment to the extent it ended the defendants’ discovery obligation with respect to this dispute, requiring instead that the lower court address, through current discovery rules, the proper balancing of interests between requesting and responding parties.
In a recent Michigan case,5 the trial court had earlier ruled that peer review documents at issue were in fact discoverable. Like similar statutes elsewhere, Michigan’s peer review privileges serve to encourage participation to improve on patient morbidity and mortality. The case centered on a court order compelling a Michigan hospital to release a physician’s credentialing file in a medical liability lawsuit on the narrow basis that the nondiscoverability privilege applied only to peer review deliberations and was inapplicable in the case. The trial judge had opined that, if all materials viewed by peer review committees were deemed undiscoverable, a hospital could never be held accountable for any negligent act within the purview of the committee. In its amicus brief in support of the hospital, the AMA argued that Michigan’s peer review privilege has historically spanned the bounds of the actual peer review process, and it countered that hospitals can be held liable – and are regularly held liable – without opening up these documents and that plaintiffs can use the same discovery mechanisms generally available to plaintiffs in other lawsuits.6 The case is currently under appeal.
In contrast, at least two state supreme courts have ruled to limit protections from discovery. The Florida Supreme Court has held that the federal law was intended to improve overall health care rather than to act as a shield to providers. In a case of alleged malpractice with severe neurological injuries, the court took a restrictive interpretation of the PSQIA as it relates to Florida’s risk-management and discovery laws, holding that patient safety work and related reports, when required by state law, do not come under the definition of patient safety work product and were therefore discoverable.7
The Pennsylvania Supreme Court has likewise ruled that documents generated by a hospital’s outside contractor are not protected from discovery under the state’s Peer Review Protection Act. It agreed with a lower-court ruling that Monongahela Valley Hospital could not claim privilege for a performance file on an emergency department physician employed by the hospital’s contractor University of Pittsburgh Medical Center Emergency Medicine.8 The case alleged that the plaintiff’s chest and back pain was misdiagnosed as reflux disease when in fact it was a myocardial infarct.
Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Hawaii Revised Statutes §624-25.5 (2012).
2. AMA fights to protect patient-safety work from legal discovery. AMA Morning Rounds. 2018 Aug 1.
3. Daley v. Teruel and Ingalls Memorial Hospital, 2018 Ill. App. LEXIS 440 (Ill. App. Ct. 2018).
4. Brugaletta v. Garcia, 190 A.3d 419 (NJ. 2018).
5. Dwyer v. Ascension Crittenton Hospital. Michigan Supreme Court SC: 158668, 919 N.W.2d 407 (Mi. 2018).
6. Appellate court case puts peer-review protections in danger. AMA Morning Rounds. 2019 Mar 29.
7. Charles v. Southern Baptist Hospital of Florida, Inc., 2017 Fla. LEXIS 231 (Fla. Jan. 31, 2017).
8. Reginelli v. Boggs, 2018 Pa. LEXIS 1503 (Pa. 2018).
Legal duty to nonpatients: Communicable diseases
Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?
A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”
B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.
C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.
D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.
E. All correct.
Answer: E. and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.1
Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,2 the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,3 a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.
A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,4 the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,5 a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.
Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”6 Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.
A recent case7 presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.
The AMA has filed an amicus brief in support of Dr. CC.8 It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”
References
1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).
2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).
3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).
4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).
5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).
6. California Health & Safety Code §121015 (a).
7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).
8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?
A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”
B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.
C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.
D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.
E. All correct.
Answer: E. and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.1
Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,2 the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,3 a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.
A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,4 the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,5 a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.
Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”6 Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.
A recent case7 presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.
The AMA has filed an amicus brief in support of Dr. CC.8 It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”
References
1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).
2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).
3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).
4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).
5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).
6. California Health & Safety Code §121015 (a).
7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).
8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
Question: Dr. X incorrectly informs his patient Y that he is HIV negative, when in fact he had tested positive. As a result, treatment was delayed for a year. In the meantime, Y infects his sexual partner Z, who is not Dr. X’s patient, and whom the doctor has never met. In a negligence lawsuit by Z against Dr. X, which of the following is best?
A. Legal duty is used as a filter to control the tide of litigation and to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class.”
B. Duty of care arises from the doctor-patient relationship and is usually owed to the patient and no one else.
C. Even if Dr. X were negligent, Z must first establish that the doctor owes her a duty of due care.
D. As a nonpatient “third party,” Z has the burden of convincing the court that she was a known, foreseeable victim of a serious condition and was in a special relationship.
E. All correct.
Answer: E. and is generally owed to the patient and to no one else. Allowing individuals outside the relationship, i.e., nonpatient third parties, a cause of action against the provider will unwisely expand the sphere of medical liability. Besides, an expansive view of legal duty may lead the provider to breach confidentiality or invite intrusive and/or irrelevant inquiries into a patient’s personal matters. Ascertaining whether a defendant owes a duty to a claimant is the first inquiry in the tort of negligence. To say there is no duty owed is to deny liability altogether, however obvious the breach or horrendous the foreseeable injuries. Thus, duty is used as a filter mechanism to reduce frivolous suits or otherwise control the tide of litigation, to prevent “liability in an indeterminate amount for an indeterminate time to an indeterminate class” as famously articulated in the 1928 Plasgraf case.1
Still, a health care provider can sometimes be found liable to one other than his or her immediate patient, notwithstanding the absence of a provider-patient relationship with that person. One such class of claims deals with communicable diseases. In Bradshaw v. Daniel,2 the Supreme Court of Tennessee held that a physician has a duty to inform a patient’s immediate family of the risk of an infectious disease such as Rocky Mountain spotted fever, although the condition itself is not contagious without a vector. In Shepard v. Redford Community Hospital,3 a lower court found no physician-patient relationship between the doctor and the patient’s son who died after contracting meningitis from his mother, who had the disease first, but was not warned of the risk of spreading it to family members. The appellate court reversed, finding liability and holding that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son.
A nonpatient can sue providers who have failed to advise their patients of the sexual transmissibility of conditions such as AIDS or hepatitis B. In DiMarco v. Lynch Homes-Chester County Inc.,4 the Supreme Court of Pennsylvania found liability where the physician’s failure to advise his patient to abstain from sexual activity for an appropriate period of time led to the sexual partner acquiring hepatitis B. The Court used a “foreseeable orbit of risk of harm” argument, stating: “If a third person is in that class of persons whose health is likely to be threatened by the patient … [she] has a cause of action … because the physician should recognize that the services rendered to the patient are necessary for the protection of the third person.” And in Reisner v. Regents of the University of California,5 a 12-year-old girl became infected with HIV after receiving tainted blood, but the defendant did not disclose the information in a timely manner. She died of AIDS at age seventeen, but not before infecting her sexual partner, who was the plaintiff in the case. The court held that a physician fulfills his duty only after he warns the patient of the risk to others, and that the lack of knowledge of the third party’s identity was immaterial.
Liability may be more likely in jurisdictions that impose a statutory duty on physicians to inform, counsel, or warn their patients or inform health authorities of conditions such as AIDS. California allows the attending physician to disclose to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer.”6 Although this statutory disclosure is permissive rather than mandatory, it may prove persuasive in any court’s deliberation over the “no-duty” defense argument.
A recent case7 presents an interesting fact-situation on the duty issue. Dr. CC incorrectly told his patient that he tested negative for a sexually transmissible disease (herpes), when in fact he had tested positive. His girlfriend, who was not Dr. CC’s patient, became infected and filed suit. The trial court dismissed, ruling that the doctor owed no duty to the girlfriend, because she was not his patient and therefore she had no “legally cognizable claim.” Connecticut’s highest court has recently heard oral arguments on appeal, and its decision is pending.
The AMA has filed an amicus brief in support of Dr. CC.8 It argues that Connecticut’s precedent mitigates against expansion of a provider’s duty to nonpatients and raises public policy concerns such as impact on malpractice insurance rates, patient care, and the ethics of patient confidentiality. The brief concluded that it was “… nearly impossible to articulate a bright-line rule of foreseeability … when, like here, the class of persons potentially exposed to injury from such care is so broad and cannot be readily identifiable at the time care is rendered.”
References
1. Palsgraf v. Long Island Railroad Co., 248 N.Y. 339, 162 N.E. 99 (1928).
2. Bradshaw v. Daniel, 854 S.W.2d 865 (Tenn. 1993).
3. Shepard v. Redford Community Hospital, 390 N.W.2d 239 (Mich. App. 1986).
4. DiMarco v. Lynch Homes-Chester County Inc., 583 A 2d 422 (Penn. 1990).
5. Reisner v. Regents of the University of California, 37 Cal Rptr 2d 518 (Cal App 2 Dist., 1995).
6. California Health & Safety Code §121015 (a).
7. Doe v. Cochran, 62 Conn L Rptr 33, 2016 (S.C. #19879).
8. What duties do physicians owe to non-patients? AMA News. 2018 Jul 13.
Dr. Tan is Emeritus Professor of Medicine and former Adjunct Professor of Law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
Statute of limitations in malpractice actions
Question: Regarding the statute of limitations, which of the following is incorrect?
A. The statute stipulates the time period from knowledge of injury to when a lawsuit must be filed, beyond which it will be forever barred.
B. This time period is usually 2 years but varies somewhat from jurisdiction to jurisdiction.
C. It starts to “run” when the cause of action accrues, i.e., when the claimant knew or should have known of the injury, not when the negligent act took place.
D. In the case of minors, disability, and concealment, the statute may be tolled, thereby giving the plaintiff more time to file his/her claim.
E. In some U.S. jurisdictions, the judge may exercise discretion and waive the statutory time period.
Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although there was a so-called “doctrine of laches” that foreclosed an action that had long lapsed. However, statutory changes in the law now require that complaints be brought in a timely manner so that the evidence remains fresh, accurate, and reliable. Another reason is to provide repose to the wrongdoer, i.e., relief from worrying for an indefinite period of time whether a lawsuit will be brought. It is 2 years for the tort of negligence in most jurisdictions, although states like California and Tennessee place a 1-year limit on medical malpractice claims under some circumstances. In England, actions for negligence-based personal injury have a limitation period of 3 years. Additionally, section 33 allows the court to use its discretion to extend this time period, something that is not available in other common law jurisdictions such as Singapore and the United States.
The statute of limitations does not start to run from the date of the negligent act or omission. For example, if there is a failure to timely diagnose and treat a cancerous condition and the patient suffers harm several years later, time starts to accrue from the date of discovering the injury, not the date of misdiagnosis. The term “discovery rule” defines the accrual period, which begins from the date the injury is discovered or should have been discovered if the party had exercised reasonable diligence. In cases of fraudulent concealment of a right of action, the statute may be tolled (halted) during the period of concealment. Tolling also may apply during legal disability.
In malpractice actions involving minors, the running of the time period may be tolled until the minor reaches a certain age, such as the age of majority, or by the minor’s 10th birthday (Hawaii law). Chaffin v. Nicosia1 dealt with such a situation. As the result of negligent forceps delivery, which injured the optic nerve, the plaintiff became blind in the right eye in early infancy. He brought suit when he was 22 years old. Indiana had two statutes on the issue, one requiring a malpractice suit to be brought within 2 years of the incident, and the other allowing a minor to sue no later than 2 years after reaching the age of 21. The Indiana Supreme Court allowed the case to go forward, reversing the lower court’s decision barring the action.
Courts are apt to closely scrutinize attempts to use the statute of limitations to prevent recovery as taking such actions could deprive the injured plaintiff of an otherwise legitimate claim. In one example, the defendants sought to dismiss the case (so-called motion for summary judgment) by arguing that the plaintiff filed suit some 32 months after she had developed Sheehan syndrome from postpartum hemorrhagic shock, and this exceeded the 2-year statute of limitations. The court ruled: “Since reasonable minds could differ as to when the injury and its operative cause should have been discovered by a reasonably diligent patient, the timeliness of the plaintiff’s claims should be decided by a jury and the motions for summary judgment will therefore be denied.”2
Two very recent cases are illustrative of litigation over statutes of limitations. In the first case, the District of Columbia’s highest court held that BKW, a patient-plaintiff, did not qualify for an extension and rejected his untimely suit against the hospital.3 The patient’s injuries stemmed from alleged unsuccessful venipunctures, and his complaint contained six causes of action, including negligent and intentional infliction of emotional distress and unnecessary pain, suffering, and bodily injury. In the District of Columbia, a plaintiff must serve the defendant with notice of intention to file suit (pre-suit notice) not less than 90 days prior to filing the action. The plaintiff must then file the complaint itself within the 3-year limitations period, with an extension allowed to take into account the 90-day pre-suit notice requirement. The case centered on the “within 90 days” requirement to trigger the statute of limitations extension. BKW, acting on one’s own behalf, conceded that the 3-year period applicable to his claims had lapsed, but because his complaint was filed “within 90 days” after the limitation period expired, it was eligible for an extension. The Court disagreed and dismissed the case, holding that to be eligible for the 90-day extension, a plaintiff must serve the pre-suit notice within 90 days before the limitation period expired.
The second case4 alleged malpractice in the care of a patient who died of anaphylaxis after a nurse infused him with iron dextran. The nurse had allegedly left the patient’s room too soon and did not adequately monitor his reaction to the drug. The patient was admitted to the hospital for removal of a colonic tumor and was to receive treatment for iron deficiency anemia. The nurse, identified in the chart as Agency Nurse RN 104, administered the prescribed intravenous 25-mg test-dose of iron dextran over a 5-minute period, but when the patient began having an anaphylactic-type allergic reaction, the nurse was allegedly not in the patient’s room. The plaintiff and her attorney attempted, on several occasions and without success, to discover the actual identity of the nurse from the hospital’s representatives. Consequently, the complaint designated the nurse as “Agency Nurse RN 104,” and the plaintiff did not provide the name of the nurse, even though doing so was legally required; the exclusion of the nurse’s name would have resulted in case dismissal since the statute of limitations had lapsed. However, the court ruled, “we are satisfied that plaintiff and her attorney acted with reasonable diligence in attempting – with no avail – to ascertain the true identity of “Agency Nurse RN 104” before filing suit and before the 2-year limitations statute ran ...”
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Portions of this article had been previously published in a 2010 issue of Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu
References
1. Chaffin v. Nicosia, 310 N.E.2d 867 (Ind. 1974).
2. Lomeo v. Davis, 53 Pa. D. & C. 4th 49 (Pa. Com. Pl. Jul 24, 2001).
3. Waugh v. Medstar Georgetown University Hospital, District of Columbia Court of Appeals No. 18-CV-329. Decided March 14, 2019.
4. Rosenberg v. Watts, Superior Court N.J. Appellate Div., Docket No. A-4525-16T4. Decided March 21, 2019.
Question: Regarding the statute of limitations, which of the following is incorrect?
A. The statute stipulates the time period from knowledge of injury to when a lawsuit must be filed, beyond which it will be forever barred.
B. This time period is usually 2 years but varies somewhat from jurisdiction to jurisdiction.
C. It starts to “run” when the cause of action accrues, i.e., when the claimant knew or should have known of the injury, not when the negligent act took place.
D. In the case of minors, disability, and concealment, the statute may be tolled, thereby giving the plaintiff more time to file his/her claim.
E. In some U.S. jurisdictions, the judge may exercise discretion and waive the statutory time period.
Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although there was a so-called “doctrine of laches” that foreclosed an action that had long lapsed. However, statutory changes in the law now require that complaints be brought in a timely manner so that the evidence remains fresh, accurate, and reliable. Another reason is to provide repose to the wrongdoer, i.e., relief from worrying for an indefinite period of time whether a lawsuit will be brought. It is 2 years for the tort of negligence in most jurisdictions, although states like California and Tennessee place a 1-year limit on medical malpractice claims under some circumstances. In England, actions for negligence-based personal injury have a limitation period of 3 years. Additionally, section 33 allows the court to use its discretion to extend this time period, something that is not available in other common law jurisdictions such as Singapore and the United States.
The statute of limitations does not start to run from the date of the negligent act or omission. For example, if there is a failure to timely diagnose and treat a cancerous condition and the patient suffers harm several years later, time starts to accrue from the date of discovering the injury, not the date of misdiagnosis. The term “discovery rule” defines the accrual period, which begins from the date the injury is discovered or should have been discovered if the party had exercised reasonable diligence. In cases of fraudulent concealment of a right of action, the statute may be tolled (halted) during the period of concealment. Tolling also may apply during legal disability.
In malpractice actions involving minors, the running of the time period may be tolled until the minor reaches a certain age, such as the age of majority, or by the minor’s 10th birthday (Hawaii law). Chaffin v. Nicosia1 dealt with such a situation. As the result of negligent forceps delivery, which injured the optic nerve, the plaintiff became blind in the right eye in early infancy. He brought suit when he was 22 years old. Indiana had two statutes on the issue, one requiring a malpractice suit to be brought within 2 years of the incident, and the other allowing a minor to sue no later than 2 years after reaching the age of 21. The Indiana Supreme Court allowed the case to go forward, reversing the lower court’s decision barring the action.
Courts are apt to closely scrutinize attempts to use the statute of limitations to prevent recovery as taking such actions could deprive the injured plaintiff of an otherwise legitimate claim. In one example, the defendants sought to dismiss the case (so-called motion for summary judgment) by arguing that the plaintiff filed suit some 32 months after she had developed Sheehan syndrome from postpartum hemorrhagic shock, and this exceeded the 2-year statute of limitations. The court ruled: “Since reasonable minds could differ as to when the injury and its operative cause should have been discovered by a reasonably diligent patient, the timeliness of the plaintiff’s claims should be decided by a jury and the motions for summary judgment will therefore be denied.”2
Two very recent cases are illustrative of litigation over statutes of limitations. In the first case, the District of Columbia’s highest court held that BKW, a patient-plaintiff, did not qualify for an extension and rejected his untimely suit against the hospital.3 The patient’s injuries stemmed from alleged unsuccessful venipunctures, and his complaint contained six causes of action, including negligent and intentional infliction of emotional distress and unnecessary pain, suffering, and bodily injury. In the District of Columbia, a plaintiff must serve the defendant with notice of intention to file suit (pre-suit notice) not less than 90 days prior to filing the action. The plaintiff must then file the complaint itself within the 3-year limitations period, with an extension allowed to take into account the 90-day pre-suit notice requirement. The case centered on the “within 90 days” requirement to trigger the statute of limitations extension. BKW, acting on one’s own behalf, conceded that the 3-year period applicable to his claims had lapsed, but because his complaint was filed “within 90 days” after the limitation period expired, it was eligible for an extension. The Court disagreed and dismissed the case, holding that to be eligible for the 90-day extension, a plaintiff must serve the pre-suit notice within 90 days before the limitation period expired.
The second case4 alleged malpractice in the care of a patient who died of anaphylaxis after a nurse infused him with iron dextran. The nurse had allegedly left the patient’s room too soon and did not adequately monitor his reaction to the drug. The patient was admitted to the hospital for removal of a colonic tumor and was to receive treatment for iron deficiency anemia. The nurse, identified in the chart as Agency Nurse RN 104, administered the prescribed intravenous 25-mg test-dose of iron dextran over a 5-minute period, but when the patient began having an anaphylactic-type allergic reaction, the nurse was allegedly not in the patient’s room. The plaintiff and her attorney attempted, on several occasions and without success, to discover the actual identity of the nurse from the hospital’s representatives. Consequently, the complaint designated the nurse as “Agency Nurse RN 104,” and the plaintiff did not provide the name of the nurse, even though doing so was legally required; the exclusion of the nurse’s name would have resulted in case dismissal since the statute of limitations had lapsed. However, the court ruled, “we are satisfied that plaintiff and her attorney acted with reasonable diligence in attempting – with no avail – to ascertain the true identity of “Agency Nurse RN 104” before filing suit and before the 2-year limitations statute ran ...”
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Portions of this article had been previously published in a 2010 issue of Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu
References
1. Chaffin v. Nicosia, 310 N.E.2d 867 (Ind. 1974).
2. Lomeo v. Davis, 53 Pa. D. & C. 4th 49 (Pa. Com. Pl. Jul 24, 2001).
3. Waugh v. Medstar Georgetown University Hospital, District of Columbia Court of Appeals No. 18-CV-329. Decided March 14, 2019.
4. Rosenberg v. Watts, Superior Court N.J. Appellate Div., Docket No. A-4525-16T4. Decided March 21, 2019.
Question: Regarding the statute of limitations, which of the following is incorrect?
A. The statute stipulates the time period from knowledge of injury to when a lawsuit must be filed, beyond which it will be forever barred.
B. This time period is usually 2 years but varies somewhat from jurisdiction to jurisdiction.
C. It starts to “run” when the cause of action accrues, i.e., when the claimant knew or should have known of the injury, not when the negligent act took place.
D. In the case of minors, disability, and concealment, the statute may be tolled, thereby giving the plaintiff more time to file his/her claim.
E. In some U.S. jurisdictions, the judge may exercise discretion and waive the statutory time period.
Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although there was a so-called “doctrine of laches” that foreclosed an action that had long lapsed. However, statutory changes in the law now require that complaints be brought in a timely manner so that the evidence remains fresh, accurate, and reliable. Another reason is to provide repose to the wrongdoer, i.e., relief from worrying for an indefinite period of time whether a lawsuit will be brought. It is 2 years for the tort of negligence in most jurisdictions, although states like California and Tennessee place a 1-year limit on medical malpractice claims under some circumstances. In England, actions for negligence-based personal injury have a limitation period of 3 years. Additionally, section 33 allows the court to use its discretion to extend this time period, something that is not available in other common law jurisdictions such as Singapore and the United States.
The statute of limitations does not start to run from the date of the negligent act or omission. For example, if there is a failure to timely diagnose and treat a cancerous condition and the patient suffers harm several years later, time starts to accrue from the date of discovering the injury, not the date of misdiagnosis. The term “discovery rule” defines the accrual period, which begins from the date the injury is discovered or should have been discovered if the party had exercised reasonable diligence. In cases of fraudulent concealment of a right of action, the statute may be tolled (halted) during the period of concealment. Tolling also may apply during legal disability.
In malpractice actions involving minors, the running of the time period may be tolled until the minor reaches a certain age, such as the age of majority, or by the minor’s 10th birthday (Hawaii law). Chaffin v. Nicosia1 dealt with such a situation. As the result of negligent forceps delivery, which injured the optic nerve, the plaintiff became blind in the right eye in early infancy. He brought suit when he was 22 years old. Indiana had two statutes on the issue, one requiring a malpractice suit to be brought within 2 years of the incident, and the other allowing a minor to sue no later than 2 years after reaching the age of 21. The Indiana Supreme Court allowed the case to go forward, reversing the lower court’s decision barring the action.
Courts are apt to closely scrutinize attempts to use the statute of limitations to prevent recovery as taking such actions could deprive the injured plaintiff of an otherwise legitimate claim. In one example, the defendants sought to dismiss the case (so-called motion for summary judgment) by arguing that the plaintiff filed suit some 32 months after she had developed Sheehan syndrome from postpartum hemorrhagic shock, and this exceeded the 2-year statute of limitations. The court ruled: “Since reasonable minds could differ as to when the injury and its operative cause should have been discovered by a reasonably diligent patient, the timeliness of the plaintiff’s claims should be decided by a jury and the motions for summary judgment will therefore be denied.”2
Two very recent cases are illustrative of litigation over statutes of limitations. In the first case, the District of Columbia’s highest court held that BKW, a patient-plaintiff, did not qualify for an extension and rejected his untimely suit against the hospital.3 The patient’s injuries stemmed from alleged unsuccessful venipunctures, and his complaint contained six causes of action, including negligent and intentional infliction of emotional distress and unnecessary pain, suffering, and bodily injury. In the District of Columbia, a plaintiff must serve the defendant with notice of intention to file suit (pre-suit notice) not less than 90 days prior to filing the action. The plaintiff must then file the complaint itself within the 3-year limitations period, with an extension allowed to take into account the 90-day pre-suit notice requirement. The case centered on the “within 90 days” requirement to trigger the statute of limitations extension. BKW, acting on one’s own behalf, conceded that the 3-year period applicable to his claims had lapsed, but because his complaint was filed “within 90 days” after the limitation period expired, it was eligible for an extension. The Court disagreed and dismissed the case, holding that to be eligible for the 90-day extension, a plaintiff must serve the pre-suit notice within 90 days before the limitation period expired.
The second case4 alleged malpractice in the care of a patient who died of anaphylaxis after a nurse infused him with iron dextran. The nurse had allegedly left the patient’s room too soon and did not adequately monitor his reaction to the drug. The patient was admitted to the hospital for removal of a colonic tumor and was to receive treatment for iron deficiency anemia. The nurse, identified in the chart as Agency Nurse RN 104, administered the prescribed intravenous 25-mg test-dose of iron dextran over a 5-minute period, but when the patient began having an anaphylactic-type allergic reaction, the nurse was allegedly not in the patient’s room. The plaintiff and her attorney attempted, on several occasions and without success, to discover the actual identity of the nurse from the hospital’s representatives. Consequently, the complaint designated the nurse as “Agency Nurse RN 104,” and the plaintiff did not provide the name of the nurse, even though doing so was legally required; the exclusion of the nurse’s name would have resulted in case dismissal since the statute of limitations had lapsed. However, the court ruled, “we are satisfied that plaintiff and her attorney acted with reasonable diligence in attempting – with no avail – to ascertain the true identity of “Agency Nurse RN 104” before filing suit and before the 2-year limitations statute ran ...”
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Portions of this article had been previously published in a 2010 issue of Internal Medicine News. For additional information, readers may contact the author at siang@hawaii.edu
References
1. Chaffin v. Nicosia, 310 N.E.2d 867 (Ind. 1974).
2. Lomeo v. Davis, 53 Pa. D. & C. 4th 49 (Pa. Com. Pl. Jul 24, 2001).
3. Waugh v. Medstar Georgetown University Hospital, District of Columbia Court of Appeals No. 18-CV-329. Decided March 14, 2019.
4. Rosenberg v. Watts, Superior Court N.J. Appellate Div., Docket No. A-4525-16T4. Decided March 21, 2019.
Good Notes Can Deter Litigation
At 11:15
While in the ED, the patient was examined and treated by a PA. At approximately 12:13
Given the lack of any positive pertinent findings, the PA irrigated the patient’s wounds and applied 1% lidocaine to all affected fingers so that pain would not mask any potential physical exam findings. He also used single-layer absorbable sutures to repair the injured digits. In addition, the PA tested the plaintiff for both distal interphalangeal (DIP) and proximal interphalangeal (PIP) flexion function and recorded normal results.
The PA discharged the patient from the ED at 5:56
The PA provided no further care or treatment to the patient following the visit to the hospital’s ED. However, the patient contended that he suffered an injury to the tendons of his right hand, which ultimately required several surgical procedures. He sued the hospital, the PA, the PA’s medical office, his supervising physician, and the physician who performed the later surgical procedures. The supervising physician and the surgeon were ultimately let out of the case by summary judgment motions. The hospital, which was named as a defendant under a respondeat superior theory, was also dismissed from the case when it was established that the PA was employed by his medical office and not by the hospital directly. The PA stipulated that he was within his course and scope of employment at the time he treated the plaintiff.
Continue to: Plaintiff's counsel contended...
Plaintiff’s counsel contended that the defendant PA was negligent in his examination and evaluation of the plaintiff’s digit lacerations and that he was negligent for failing to splint the plaintiff’s hand. Counsel also contended that the defendant was negligent for failing to refer the plaintiff to a hand surgeon (either directly or through the plaintiff’s primary care provider) and/or for failing to seek the assistance of his supervising physician, who was on site at the hospital’s ED and available for consultation.
Defense counsel argued that the defendant met the applicable standard of care at all times, in all aspects of his visit with the plaintiff in the early morning hours of September 1, 2014, and that there was nothing that he either did or did not do that was a substantial factor in causing the plaintiff’s alleged injuries and damages. The defendant claimed that upon his arrival at the patient’s bedside, the plaintiff verbally indicated to him that he could move his fingers (extension and flexion). He also claimed that he visualized the plaintiff moving his fingers while they were wrapped in the dressing that the plaintiff had placed on himself after the injury-producing event. However, the plaintiff disputed the defendant’s claim, denying ever being asked to extend and flex his fingers. The plaintiff also claimed that he never was able to make a full fist with his fingers on the night in question while in the ED, either by way of passive or active flexion.
Defense counsel noted that the defendant’s dictated ED note stated that the range of motion of all the plaintiff’s phalanges were normal, with no deficits, at all times while in the ED. The defendant testified about how he tested and evaluated the plaintiff’s DIP function. He also testified that he had the plaintiff lay his hand on the table, palm side up, and then laid his own hand across the plaintiff’s hand so as to isolate the DIP joint on each finger. He explained that he then had the plaintiff flex his fingers, which allowed him to determine whether there had been any kind of injury to the flexor digitorum profundus tendon (responsible for DIP function in the hand). The defendant claimed that he did the test for all the lacerated fingers and characterized them as active (as opposed to passive) flexion. Thus, he claimed that his physical exam findings were that the plaintiff had full range of motion (ROM) intact following the DIP function testing, which helped him conclude that the plaintiff did not have completely lacerated tendons as of that visit.
The defendant further explained that if the tendons were completely lacerated, the plaintiff would have had nonexistent DIP functioning on examination. The defendant testified that if he suspected a tendon laceration in a patient such as the plaintiff, his practice would be to notify his supervising physician in the ED and then either refer the patient to a primary care provider for an orthopedic hand surgeon referral or directly refer the patient to an orthopedic hand surgeon. He claimed that he took no such actions because there was no indication, from his perspective, that the plaintiff had suffered any tendon damage based on his physical exam findings, the plaintiff’s ability to make a fist, and the x-ray results.
Continue to: VERDICT
VERDICT
After a 5-day trial and 7 hours of deliberation, the jury found in favor of the defendants.
COMMENTARY
As human beings, we do a lot with our hands. They are vulnerable to injury, and misdiagnosis may result in life-altering debility. The impact is even greater when one’s livelihood requires fine dexterity. Thus, tendon lacerations are relatively common and must be managed properly.
In this case, we are told that the PA documented in his notes that the plaintiff had range of motion in all phalanges and no deficits. We are also told the defendant testified regarding his procedure for hand examination. But we are not told that his note included the details of his exam—and by inference, we have reason to suspect it did not.
You might think, “The jury found in favor of the defense, so why does this matter?” Because a well-documented chart may prevent liability.
If you wish to avoid lawsuits, it is helpful to understand how they originate: An aggrieved patient contacts a plaintiff’s lawyer, insists he or she has been wronged, and asks the lawyer to take the case. Often faced with the ticking clock of statute of limitations (the absolute deadline to file), plaintiff’s counsel will review whatever records are available (which may not be all of them), looking for perceived deficiencies of care. The case may also be reviewed by a medical professional (generally a physician) prior to filing; some states require an affidavit of merit—an attestation that there is just cause to bring the action.
Whether reviewed only by plaintiff’s counsel or with the aid of an expert, a well-documented medical record may prevent a case from being filed. Medical malpractice cases are a huge gamble for plaintiff firms: They are expensive, time consuming, difficult to litigate, document heavy, and technically complex—falling outside the experience of most lawyers. They are also less likely than other cases to be settled, thanks to National Practitioner Data Bank recording requirements and (in several states) automatic medical board inquiry for potential adverse action against a medical or nursing professional following settlement. Clinicians will often fight tooth and nail to avoid an adverse recording, hospital credentialing woes, and state investigation. A medical malpractice case can be a trap for both the clinician and the plaintiff’s attorney stuck with a bad case.
Continue to: In the early stages...
In the early stages of potential litigation, before a case is filed in court, do yourself a favor: Help plaintiff’s counsel realize it will be a losing case. You actually start the process much earlier, by conducting the proper exam and documenting lavishly. This is particularly important with specialty exams, such as the hand exam in this case.
Here, simply noting “positive ROM and distal CSM [circulation, sensation, and motion] intact” is inadequate. Why? Because it is a conclusion, not evidence of the specialty examination that was diligently performed. The mechanism of injury and initial presentation roused the clinician’s suspicions sufficiently to conduct a thorough hand examination—but the mechanics of the exam were not included, only conclusions. The trouble is, those conclusions may have been based on sound medical evidence or they may have been hastily and improvidently drawn. A plaintiff’s firm deciding whether to take this case doesn’t know but will bet on the latter.
The clinician testified he performed a detailed and thorough examination of the plaintiff’s hand. Had plaintiff’s counsel been confronted with the full details of the exam—which showed the defendant PA tested all the PIPs and DIPs by isolating each finger—early on, this case may never have been filed. Thus, conduct and document specialty exams fully. If you need a cheat sheet for exams you don’t do often, use one—that is still solid practice. If you don’t do many pelvic exams or mental status exams, make sure you aren’t missing anything. Practicing medicine is an open-book exam; if you need materials, use them.
Good documentation leads to good defense, and any good defense lawyer will recommend the Jerry Maguire rule: “Help me help you.” Solid records make a case easier to defend and win at all phases of litigation. Of course, this is not a universal cure that will prevent all lawsuits. But even if the case is filed, the strength of your records may have convinced stronger, more capable medical malpractice firms to turn it down. This is something of value: It is “you helping you” and potent proof that your human head weighs more than 8 lb.
IN SUMMARY
A well-documented chart may prevent liability by showcasing the strength of your care and preventing no-win lawsuits from being filed. Help the plaintiff’s attorney realize, early on, that he or she is facing a costly uphill battle. The key word is early, when the medical records are first reviewed—not 18 months later, when the attorney hears your testimony at deposition and realizes that he or she has invested time and sweat in a case only to learn that your care was fabulous. Showcase that fabulous care early and short circuit the whole process by detailing the substance of a key exam (not just conclusions) in the record. Detailed notes may spare you from a visit by a sheriff you don’t know holding papers you don’t want.
At 11:15
While in the ED, the patient was examined and treated by a PA. At approximately 12:13
Given the lack of any positive pertinent findings, the PA irrigated the patient’s wounds and applied 1% lidocaine to all affected fingers so that pain would not mask any potential physical exam findings. He also used single-layer absorbable sutures to repair the injured digits. In addition, the PA tested the plaintiff for both distal interphalangeal (DIP) and proximal interphalangeal (PIP) flexion function and recorded normal results.
The PA discharged the patient from the ED at 5:56
The PA provided no further care or treatment to the patient following the visit to the hospital’s ED. However, the patient contended that he suffered an injury to the tendons of his right hand, which ultimately required several surgical procedures. He sued the hospital, the PA, the PA’s medical office, his supervising physician, and the physician who performed the later surgical procedures. The supervising physician and the surgeon were ultimately let out of the case by summary judgment motions. The hospital, which was named as a defendant under a respondeat superior theory, was also dismissed from the case when it was established that the PA was employed by his medical office and not by the hospital directly. The PA stipulated that he was within his course and scope of employment at the time he treated the plaintiff.
Continue to: Plaintiff's counsel contended...
Plaintiff’s counsel contended that the defendant PA was negligent in his examination and evaluation of the plaintiff’s digit lacerations and that he was negligent for failing to splint the plaintiff’s hand. Counsel also contended that the defendant was negligent for failing to refer the plaintiff to a hand surgeon (either directly or through the plaintiff’s primary care provider) and/or for failing to seek the assistance of his supervising physician, who was on site at the hospital’s ED and available for consultation.
Defense counsel argued that the defendant met the applicable standard of care at all times, in all aspects of his visit with the plaintiff in the early morning hours of September 1, 2014, and that there was nothing that he either did or did not do that was a substantial factor in causing the plaintiff’s alleged injuries and damages. The defendant claimed that upon his arrival at the patient’s bedside, the plaintiff verbally indicated to him that he could move his fingers (extension and flexion). He also claimed that he visualized the plaintiff moving his fingers while they were wrapped in the dressing that the plaintiff had placed on himself after the injury-producing event. However, the plaintiff disputed the defendant’s claim, denying ever being asked to extend and flex his fingers. The plaintiff also claimed that he never was able to make a full fist with his fingers on the night in question while in the ED, either by way of passive or active flexion.
Defense counsel noted that the defendant’s dictated ED note stated that the range of motion of all the plaintiff’s phalanges were normal, with no deficits, at all times while in the ED. The defendant testified about how he tested and evaluated the plaintiff’s DIP function. He also testified that he had the plaintiff lay his hand on the table, palm side up, and then laid his own hand across the plaintiff’s hand so as to isolate the DIP joint on each finger. He explained that he then had the plaintiff flex his fingers, which allowed him to determine whether there had been any kind of injury to the flexor digitorum profundus tendon (responsible for DIP function in the hand). The defendant claimed that he did the test for all the lacerated fingers and characterized them as active (as opposed to passive) flexion. Thus, he claimed that his physical exam findings were that the plaintiff had full range of motion (ROM) intact following the DIP function testing, which helped him conclude that the plaintiff did not have completely lacerated tendons as of that visit.
The defendant further explained that if the tendons were completely lacerated, the plaintiff would have had nonexistent DIP functioning on examination. The defendant testified that if he suspected a tendon laceration in a patient such as the plaintiff, his practice would be to notify his supervising physician in the ED and then either refer the patient to a primary care provider for an orthopedic hand surgeon referral or directly refer the patient to an orthopedic hand surgeon. He claimed that he took no such actions because there was no indication, from his perspective, that the plaintiff had suffered any tendon damage based on his physical exam findings, the plaintiff’s ability to make a fist, and the x-ray results.
Continue to: VERDICT
VERDICT
After a 5-day trial and 7 hours of deliberation, the jury found in favor of the defendants.
COMMENTARY
As human beings, we do a lot with our hands. They are vulnerable to injury, and misdiagnosis may result in life-altering debility. The impact is even greater when one’s livelihood requires fine dexterity. Thus, tendon lacerations are relatively common and must be managed properly.
In this case, we are told that the PA documented in his notes that the plaintiff had range of motion in all phalanges and no deficits. We are also told the defendant testified regarding his procedure for hand examination. But we are not told that his note included the details of his exam—and by inference, we have reason to suspect it did not.
You might think, “The jury found in favor of the defense, so why does this matter?” Because a well-documented chart may prevent liability.
If you wish to avoid lawsuits, it is helpful to understand how they originate: An aggrieved patient contacts a plaintiff’s lawyer, insists he or she has been wronged, and asks the lawyer to take the case. Often faced with the ticking clock of statute of limitations (the absolute deadline to file), plaintiff’s counsel will review whatever records are available (which may not be all of them), looking for perceived deficiencies of care. The case may also be reviewed by a medical professional (generally a physician) prior to filing; some states require an affidavit of merit—an attestation that there is just cause to bring the action.
Whether reviewed only by plaintiff’s counsel or with the aid of an expert, a well-documented medical record may prevent a case from being filed. Medical malpractice cases are a huge gamble for plaintiff firms: They are expensive, time consuming, difficult to litigate, document heavy, and technically complex—falling outside the experience of most lawyers. They are also less likely than other cases to be settled, thanks to National Practitioner Data Bank recording requirements and (in several states) automatic medical board inquiry for potential adverse action against a medical or nursing professional following settlement. Clinicians will often fight tooth and nail to avoid an adverse recording, hospital credentialing woes, and state investigation. A medical malpractice case can be a trap for both the clinician and the plaintiff’s attorney stuck with a bad case.
Continue to: In the early stages...
In the early stages of potential litigation, before a case is filed in court, do yourself a favor: Help plaintiff’s counsel realize it will be a losing case. You actually start the process much earlier, by conducting the proper exam and documenting lavishly. This is particularly important with specialty exams, such as the hand exam in this case.
Here, simply noting “positive ROM and distal CSM [circulation, sensation, and motion] intact” is inadequate. Why? Because it is a conclusion, not evidence of the specialty examination that was diligently performed. The mechanism of injury and initial presentation roused the clinician’s suspicions sufficiently to conduct a thorough hand examination—but the mechanics of the exam were not included, only conclusions. The trouble is, those conclusions may have been based on sound medical evidence or they may have been hastily and improvidently drawn. A plaintiff’s firm deciding whether to take this case doesn’t know but will bet on the latter.
The clinician testified he performed a detailed and thorough examination of the plaintiff’s hand. Had plaintiff’s counsel been confronted with the full details of the exam—which showed the defendant PA tested all the PIPs and DIPs by isolating each finger—early on, this case may never have been filed. Thus, conduct and document specialty exams fully. If you need a cheat sheet for exams you don’t do often, use one—that is still solid practice. If you don’t do many pelvic exams or mental status exams, make sure you aren’t missing anything. Practicing medicine is an open-book exam; if you need materials, use them.
Good documentation leads to good defense, and any good defense lawyer will recommend the Jerry Maguire rule: “Help me help you.” Solid records make a case easier to defend and win at all phases of litigation. Of course, this is not a universal cure that will prevent all lawsuits. But even if the case is filed, the strength of your records may have convinced stronger, more capable medical malpractice firms to turn it down. This is something of value: It is “you helping you” and potent proof that your human head weighs more than 8 lb.
IN SUMMARY
A well-documented chart may prevent liability by showcasing the strength of your care and preventing no-win lawsuits from being filed. Help the plaintiff’s attorney realize, early on, that he or she is facing a costly uphill battle. The key word is early, when the medical records are first reviewed—not 18 months later, when the attorney hears your testimony at deposition and realizes that he or she has invested time and sweat in a case only to learn that your care was fabulous. Showcase that fabulous care early and short circuit the whole process by detailing the substance of a key exam (not just conclusions) in the record. Detailed notes may spare you from a visit by a sheriff you don’t know holding papers you don’t want.
At 11:15
While in the ED, the patient was examined and treated by a PA. At approximately 12:13
Given the lack of any positive pertinent findings, the PA irrigated the patient’s wounds and applied 1% lidocaine to all affected fingers so that pain would not mask any potential physical exam findings. He also used single-layer absorbable sutures to repair the injured digits. In addition, the PA tested the plaintiff for both distal interphalangeal (DIP) and proximal interphalangeal (PIP) flexion function and recorded normal results.
The PA discharged the patient from the ED at 5:56
The PA provided no further care or treatment to the patient following the visit to the hospital’s ED. However, the patient contended that he suffered an injury to the tendons of his right hand, which ultimately required several surgical procedures. He sued the hospital, the PA, the PA’s medical office, his supervising physician, and the physician who performed the later surgical procedures. The supervising physician and the surgeon were ultimately let out of the case by summary judgment motions. The hospital, which was named as a defendant under a respondeat superior theory, was also dismissed from the case when it was established that the PA was employed by his medical office and not by the hospital directly. The PA stipulated that he was within his course and scope of employment at the time he treated the plaintiff.
Continue to: Plaintiff's counsel contended...
Plaintiff’s counsel contended that the defendant PA was negligent in his examination and evaluation of the plaintiff’s digit lacerations and that he was negligent for failing to splint the plaintiff’s hand. Counsel also contended that the defendant was negligent for failing to refer the plaintiff to a hand surgeon (either directly or through the plaintiff’s primary care provider) and/or for failing to seek the assistance of his supervising physician, who was on site at the hospital’s ED and available for consultation.
Defense counsel argued that the defendant met the applicable standard of care at all times, in all aspects of his visit with the plaintiff in the early morning hours of September 1, 2014, and that there was nothing that he either did or did not do that was a substantial factor in causing the plaintiff’s alleged injuries and damages. The defendant claimed that upon his arrival at the patient’s bedside, the plaintiff verbally indicated to him that he could move his fingers (extension and flexion). He also claimed that he visualized the plaintiff moving his fingers while they were wrapped in the dressing that the plaintiff had placed on himself after the injury-producing event. However, the plaintiff disputed the defendant’s claim, denying ever being asked to extend and flex his fingers. The plaintiff also claimed that he never was able to make a full fist with his fingers on the night in question while in the ED, either by way of passive or active flexion.
Defense counsel noted that the defendant’s dictated ED note stated that the range of motion of all the plaintiff’s phalanges were normal, with no deficits, at all times while in the ED. The defendant testified about how he tested and evaluated the plaintiff’s DIP function. He also testified that he had the plaintiff lay his hand on the table, palm side up, and then laid his own hand across the plaintiff’s hand so as to isolate the DIP joint on each finger. He explained that he then had the plaintiff flex his fingers, which allowed him to determine whether there had been any kind of injury to the flexor digitorum profundus tendon (responsible for DIP function in the hand). The defendant claimed that he did the test for all the lacerated fingers and characterized them as active (as opposed to passive) flexion. Thus, he claimed that his physical exam findings were that the plaintiff had full range of motion (ROM) intact following the DIP function testing, which helped him conclude that the plaintiff did not have completely lacerated tendons as of that visit.
The defendant further explained that if the tendons were completely lacerated, the plaintiff would have had nonexistent DIP functioning on examination. The defendant testified that if he suspected a tendon laceration in a patient such as the plaintiff, his practice would be to notify his supervising physician in the ED and then either refer the patient to a primary care provider for an orthopedic hand surgeon referral or directly refer the patient to an orthopedic hand surgeon. He claimed that he took no such actions because there was no indication, from his perspective, that the plaintiff had suffered any tendon damage based on his physical exam findings, the plaintiff’s ability to make a fist, and the x-ray results.
Continue to: VERDICT
VERDICT
After a 5-day trial and 7 hours of deliberation, the jury found in favor of the defendants.
COMMENTARY
As human beings, we do a lot with our hands. They are vulnerable to injury, and misdiagnosis may result in life-altering debility. The impact is even greater when one’s livelihood requires fine dexterity. Thus, tendon lacerations are relatively common and must be managed properly.
In this case, we are told that the PA documented in his notes that the plaintiff had range of motion in all phalanges and no deficits. We are also told the defendant testified regarding his procedure for hand examination. But we are not told that his note included the details of his exam—and by inference, we have reason to suspect it did not.
You might think, “The jury found in favor of the defense, so why does this matter?” Because a well-documented chart may prevent liability.
If you wish to avoid lawsuits, it is helpful to understand how they originate: An aggrieved patient contacts a plaintiff’s lawyer, insists he or she has been wronged, and asks the lawyer to take the case. Often faced with the ticking clock of statute of limitations (the absolute deadline to file), plaintiff’s counsel will review whatever records are available (which may not be all of them), looking for perceived deficiencies of care. The case may also be reviewed by a medical professional (generally a physician) prior to filing; some states require an affidavit of merit—an attestation that there is just cause to bring the action.
Whether reviewed only by plaintiff’s counsel or with the aid of an expert, a well-documented medical record may prevent a case from being filed. Medical malpractice cases are a huge gamble for plaintiff firms: They are expensive, time consuming, difficult to litigate, document heavy, and technically complex—falling outside the experience of most lawyers. They are also less likely than other cases to be settled, thanks to National Practitioner Data Bank recording requirements and (in several states) automatic medical board inquiry for potential adverse action against a medical or nursing professional following settlement. Clinicians will often fight tooth and nail to avoid an adverse recording, hospital credentialing woes, and state investigation. A medical malpractice case can be a trap for both the clinician and the plaintiff’s attorney stuck with a bad case.
Continue to: In the early stages...
In the early stages of potential litigation, before a case is filed in court, do yourself a favor: Help plaintiff’s counsel realize it will be a losing case. You actually start the process much earlier, by conducting the proper exam and documenting lavishly. This is particularly important with specialty exams, such as the hand exam in this case.
Here, simply noting “positive ROM and distal CSM [circulation, sensation, and motion] intact” is inadequate. Why? Because it is a conclusion, not evidence of the specialty examination that was diligently performed. The mechanism of injury and initial presentation roused the clinician’s suspicions sufficiently to conduct a thorough hand examination—but the mechanics of the exam were not included, only conclusions. The trouble is, those conclusions may have been based on sound medical evidence or they may have been hastily and improvidently drawn. A plaintiff’s firm deciding whether to take this case doesn’t know but will bet on the latter.
The clinician testified he performed a detailed and thorough examination of the plaintiff’s hand. Had plaintiff’s counsel been confronted with the full details of the exam—which showed the defendant PA tested all the PIPs and DIPs by isolating each finger—early on, this case may never have been filed. Thus, conduct and document specialty exams fully. If you need a cheat sheet for exams you don’t do often, use one—that is still solid practice. If you don’t do many pelvic exams or mental status exams, make sure you aren’t missing anything. Practicing medicine is an open-book exam; if you need materials, use them.
Good documentation leads to good defense, and any good defense lawyer will recommend the Jerry Maguire rule: “Help me help you.” Solid records make a case easier to defend and win at all phases of litigation. Of course, this is not a universal cure that will prevent all lawsuits. But even if the case is filed, the strength of your records may have convinced stronger, more capable medical malpractice firms to turn it down. This is something of value: It is “you helping you” and potent proof that your human head weighs more than 8 lb.
IN SUMMARY
A well-documented chart may prevent liability by showcasing the strength of your care and preventing no-win lawsuits from being filed. Help the plaintiff’s attorney realize, early on, that he or she is facing a costly uphill battle. The key word is early, when the medical records are first reviewed—not 18 months later, when the attorney hears your testimony at deposition and realizes that he or she has invested time and sweat in a case only to learn that your care was fabulous. Showcase that fabulous care early and short circuit the whole process by detailing the substance of a key exam (not just conclusions) in the record. Detailed notes may spare you from a visit by a sheriff you don’t know holding papers you don’t want.
When Diet Is an Emergency
At age 35, a woman underwent Roux-en-Y gastric bypass surgery. About 1 month later, she began vomiting and became unable to keep down any food or liquids. She was admitted to the hospital.
Two days after her admission, a dietitian evaluated the patient and recommended that she receive total parenteral nutrition (TPN). However, the attending physician did not order TPN during the patient’s 12-day hospital stay. As a result, the patient experienced vitamin deficiencies, including low thiamine. The patient developed symptoms of neurologic complications but was discharged.
Within 1 week, she was readmitted with the same symptoms, as well as signs of delirium and reduced level of consciousness. Her mental state continued to decline, and she became comatose for a period of time.
The patient now has Wernicke encephalopathy, which she alleged was caused by a lack of thiamine. She has no short-term memory, is wheelchair bound, and lives in a nursing home.
VERDICT
The jury found in favor of the plaintiff, awarding her $14,285,505.86 in damages, including $133,202 for loss of past earning capacity, $888,429 for loss of earning capacity, and $13,263,874.86 for medical care expenses.
COMMENTARY
It is foolish to think of diet as ancillary to medicine. While we often consider the long-term health implications of diet—obesity, atherosclerosis—we may overlook the urgent and emergent conditions that can result from a patient’s diet.
A familiar example is hypoglycemia. We associate it with agents used to treat diabetes. But it also can occur in the context of renal failure, tumor, severe infection, alcohol, or starvation. Similarly, thiamine deficiency would be an obvious consideration in a patient who presented in a coma or with altered mental status. But, as this case shows, thiamine deficiency can sneak up on you.
Continue to: In this case...
In this case, the patient’s altered structural anatomy rendered her more susceptible to thiamine deficiency, which was ultimately found to be causally related to the physician’s failure to order TPN. This raises an important issue in the management of patients who have had bariatric procedures.
This plaintiff had Roux-en-Y gastric bypass, a significant procedure that short circuits a sizable portion of the stomach and about 75 to 100 cm of the small intestine. This surgery carries long-term risks including bowel obstruction, hernias, ulcers, dumping syndrome, low blood sugar, and malnutrition. The last of these can manifest as low levels of B12, folate, thiamine, iron, calcium, and vitamin D.
Roux-en-Y bypass requires adherence to dietary recommendations, lifelong vitamin/mineral supplementation, and follow-up compliance. Patients who have had bariatric procedures are at increased risk for complications—which also raise malpractice risks. Clinicians must be aware that patients who have had a bariatric procedure have altered anatomy. We must take steps to understand the nature of those alterations and how they impact the present clinical picture.
In this case, the altered anatomy in combination with the failure to order TPN resulted in Wernicke encephalopathy—a condition caused by a biochemical lesion that occurs after stores of B vitamin are exhausted. Classic Wernicke encephalopathy is advertised as a triad of ophthalmoplegia, ataxia, and confusion, but only 10% of patients will demonstrate a true triad.
Wernicke encephalopathy typically occurs in the setting of alcoholism. However, certain other conditions can cause it, including recurrent dialysis, uremia, hyperemesis, thyrotoxicosis, cancer, AIDS, and starvation. It may be caused by surgical GI changes (eg, gastric bypass and banding) and nonsurgical GI causes (eg, pancreatitis, liver dysfunction, chronic diarrhea, celiac disease, and Crohn disease).
Continue to: Prognosis depends on...
Prognosis depends on how quickly the condition is recognized. Prompt treatment can lead to cure. But treatment delays (or lack of treatment) give the disorder the opportunity to progress, and memory and learning impairment may not completely resolve. Mortality in those untreated is 10% to 20%. And 80% of untreated or undertreated patients will develop Korsakoff psychosis, with severe retrograde and anterograde amnesia, disorientation, and emotional changes.
These factors make Wernicke encephalopathy a medical malpractice risk. If the diagnosis is missed, the damage is clear, substantial, and irreversible—as seen in this unfortunate case. This plaintiff’s attorney had a dream of a closing argument to make: Her client will suffer the effects of brain damage, robbing her of her life, her memory, and her very personality. This damage could have been prevented—not through use of an experimental new procedure or an investigational drug, but through use of a simple and readily available vitamin.
Worse still, cases such as this can involve a punitive element. Jurors would be invited to conclude that treating clinicians ignored the patient and left her to starve in her own bed. Always act in the patient’s best interest—and be attuned to situations that may evolve into claims that the patient was abandoned, neglected, or ignored.
Finally, you must address anything in the patient’s written record that is contrary to your plan. The fact pattern makes clear that a nutritional evaluation was obtained 2 days after the plaintiff’s admission. The dietitian recommended TPN. The record is not clear on why the physician did not order it. If you plan to take an action at odds with a prior observation or recommendation, be sure to clearly explain the rationale supporting your course of treatment. If you perform a risk-benefit analysis that leads you to a different conclusion, document that in the record—preferably with a second opinion from another clinician who supports your decision to deviate from the recommendation.
IN SUMMARY
Nutrition can be critically important. Make sure you consider both short- and long-term consequences of nutritional deficiencies. Bariatric surgery patients have altered anatomy, so be cautious with them. Consider the possibility of thiamine encephalopathy—which can be devastating—when the setting is suggestive. And make sure that all recommendations from other clinicians recorded in the patient’s chart are acted on. If you select a course of treatment that departs from prior recommendation, make clear your risk-benefit analysis and consider obtaining a second opinion in support of your decision.
At age 35, a woman underwent Roux-en-Y gastric bypass surgery. About 1 month later, she began vomiting and became unable to keep down any food or liquids. She was admitted to the hospital.
Two days after her admission, a dietitian evaluated the patient and recommended that she receive total parenteral nutrition (TPN). However, the attending physician did not order TPN during the patient’s 12-day hospital stay. As a result, the patient experienced vitamin deficiencies, including low thiamine. The patient developed symptoms of neurologic complications but was discharged.
Within 1 week, she was readmitted with the same symptoms, as well as signs of delirium and reduced level of consciousness. Her mental state continued to decline, and she became comatose for a period of time.
The patient now has Wernicke encephalopathy, which she alleged was caused by a lack of thiamine. She has no short-term memory, is wheelchair bound, and lives in a nursing home.
VERDICT
The jury found in favor of the plaintiff, awarding her $14,285,505.86 in damages, including $133,202 for loss of past earning capacity, $888,429 for loss of earning capacity, and $13,263,874.86 for medical care expenses.
COMMENTARY
It is foolish to think of diet as ancillary to medicine. While we often consider the long-term health implications of diet—obesity, atherosclerosis—we may overlook the urgent and emergent conditions that can result from a patient’s diet.
A familiar example is hypoglycemia. We associate it with agents used to treat diabetes. But it also can occur in the context of renal failure, tumor, severe infection, alcohol, or starvation. Similarly, thiamine deficiency would be an obvious consideration in a patient who presented in a coma or with altered mental status. But, as this case shows, thiamine deficiency can sneak up on you.
Continue to: In this case...
In this case, the patient’s altered structural anatomy rendered her more susceptible to thiamine deficiency, which was ultimately found to be causally related to the physician’s failure to order TPN. This raises an important issue in the management of patients who have had bariatric procedures.
This plaintiff had Roux-en-Y gastric bypass, a significant procedure that short circuits a sizable portion of the stomach and about 75 to 100 cm of the small intestine. This surgery carries long-term risks including bowel obstruction, hernias, ulcers, dumping syndrome, low blood sugar, and malnutrition. The last of these can manifest as low levels of B12, folate, thiamine, iron, calcium, and vitamin D.
Roux-en-Y bypass requires adherence to dietary recommendations, lifelong vitamin/mineral supplementation, and follow-up compliance. Patients who have had bariatric procedures are at increased risk for complications—which also raise malpractice risks. Clinicians must be aware that patients who have had a bariatric procedure have altered anatomy. We must take steps to understand the nature of those alterations and how they impact the present clinical picture.
In this case, the altered anatomy in combination with the failure to order TPN resulted in Wernicke encephalopathy—a condition caused by a biochemical lesion that occurs after stores of B vitamin are exhausted. Classic Wernicke encephalopathy is advertised as a triad of ophthalmoplegia, ataxia, and confusion, but only 10% of patients will demonstrate a true triad.
Wernicke encephalopathy typically occurs in the setting of alcoholism. However, certain other conditions can cause it, including recurrent dialysis, uremia, hyperemesis, thyrotoxicosis, cancer, AIDS, and starvation. It may be caused by surgical GI changes (eg, gastric bypass and banding) and nonsurgical GI causes (eg, pancreatitis, liver dysfunction, chronic diarrhea, celiac disease, and Crohn disease).
Continue to: Prognosis depends on...
Prognosis depends on how quickly the condition is recognized. Prompt treatment can lead to cure. But treatment delays (or lack of treatment) give the disorder the opportunity to progress, and memory and learning impairment may not completely resolve. Mortality in those untreated is 10% to 20%. And 80% of untreated or undertreated patients will develop Korsakoff psychosis, with severe retrograde and anterograde amnesia, disorientation, and emotional changes.
These factors make Wernicke encephalopathy a medical malpractice risk. If the diagnosis is missed, the damage is clear, substantial, and irreversible—as seen in this unfortunate case. This plaintiff’s attorney had a dream of a closing argument to make: Her client will suffer the effects of brain damage, robbing her of her life, her memory, and her very personality. This damage could have been prevented—not through use of an experimental new procedure or an investigational drug, but through use of a simple and readily available vitamin.
Worse still, cases such as this can involve a punitive element. Jurors would be invited to conclude that treating clinicians ignored the patient and left her to starve in her own bed. Always act in the patient’s best interest—and be attuned to situations that may evolve into claims that the patient was abandoned, neglected, or ignored.
Finally, you must address anything in the patient’s written record that is contrary to your plan. The fact pattern makes clear that a nutritional evaluation was obtained 2 days after the plaintiff’s admission. The dietitian recommended TPN. The record is not clear on why the physician did not order it. If you plan to take an action at odds with a prior observation or recommendation, be sure to clearly explain the rationale supporting your course of treatment. If you perform a risk-benefit analysis that leads you to a different conclusion, document that in the record—preferably with a second opinion from another clinician who supports your decision to deviate from the recommendation.
IN SUMMARY
Nutrition can be critically important. Make sure you consider both short- and long-term consequences of nutritional deficiencies. Bariatric surgery patients have altered anatomy, so be cautious with them. Consider the possibility of thiamine encephalopathy—which can be devastating—when the setting is suggestive. And make sure that all recommendations from other clinicians recorded in the patient’s chart are acted on. If you select a course of treatment that departs from prior recommendation, make clear your risk-benefit analysis and consider obtaining a second opinion in support of your decision.
At age 35, a woman underwent Roux-en-Y gastric bypass surgery. About 1 month later, she began vomiting and became unable to keep down any food or liquids. She was admitted to the hospital.
Two days after her admission, a dietitian evaluated the patient and recommended that she receive total parenteral nutrition (TPN). However, the attending physician did not order TPN during the patient’s 12-day hospital stay. As a result, the patient experienced vitamin deficiencies, including low thiamine. The patient developed symptoms of neurologic complications but was discharged.
Within 1 week, she was readmitted with the same symptoms, as well as signs of delirium and reduced level of consciousness. Her mental state continued to decline, and she became comatose for a period of time.
The patient now has Wernicke encephalopathy, which she alleged was caused by a lack of thiamine. She has no short-term memory, is wheelchair bound, and lives in a nursing home.
VERDICT
The jury found in favor of the plaintiff, awarding her $14,285,505.86 in damages, including $133,202 for loss of past earning capacity, $888,429 for loss of earning capacity, and $13,263,874.86 for medical care expenses.
COMMENTARY
It is foolish to think of diet as ancillary to medicine. While we often consider the long-term health implications of diet—obesity, atherosclerosis—we may overlook the urgent and emergent conditions that can result from a patient’s diet.
A familiar example is hypoglycemia. We associate it with agents used to treat diabetes. But it also can occur in the context of renal failure, tumor, severe infection, alcohol, or starvation. Similarly, thiamine deficiency would be an obvious consideration in a patient who presented in a coma or with altered mental status. But, as this case shows, thiamine deficiency can sneak up on you.
Continue to: In this case...
In this case, the patient’s altered structural anatomy rendered her more susceptible to thiamine deficiency, which was ultimately found to be causally related to the physician’s failure to order TPN. This raises an important issue in the management of patients who have had bariatric procedures.
This plaintiff had Roux-en-Y gastric bypass, a significant procedure that short circuits a sizable portion of the stomach and about 75 to 100 cm of the small intestine. This surgery carries long-term risks including bowel obstruction, hernias, ulcers, dumping syndrome, low blood sugar, and malnutrition. The last of these can manifest as low levels of B12, folate, thiamine, iron, calcium, and vitamin D.
Roux-en-Y bypass requires adherence to dietary recommendations, lifelong vitamin/mineral supplementation, and follow-up compliance. Patients who have had bariatric procedures are at increased risk for complications—which also raise malpractice risks. Clinicians must be aware that patients who have had a bariatric procedure have altered anatomy. We must take steps to understand the nature of those alterations and how they impact the present clinical picture.
In this case, the altered anatomy in combination with the failure to order TPN resulted in Wernicke encephalopathy—a condition caused by a biochemical lesion that occurs after stores of B vitamin are exhausted. Classic Wernicke encephalopathy is advertised as a triad of ophthalmoplegia, ataxia, and confusion, but only 10% of patients will demonstrate a true triad.
Wernicke encephalopathy typically occurs in the setting of alcoholism. However, certain other conditions can cause it, including recurrent dialysis, uremia, hyperemesis, thyrotoxicosis, cancer, AIDS, and starvation. It may be caused by surgical GI changes (eg, gastric bypass and banding) and nonsurgical GI causes (eg, pancreatitis, liver dysfunction, chronic diarrhea, celiac disease, and Crohn disease).
Continue to: Prognosis depends on...
Prognosis depends on how quickly the condition is recognized. Prompt treatment can lead to cure. But treatment delays (or lack of treatment) give the disorder the opportunity to progress, and memory and learning impairment may not completely resolve. Mortality in those untreated is 10% to 20%. And 80% of untreated or undertreated patients will develop Korsakoff psychosis, with severe retrograde and anterograde amnesia, disorientation, and emotional changes.
These factors make Wernicke encephalopathy a medical malpractice risk. If the diagnosis is missed, the damage is clear, substantial, and irreversible—as seen in this unfortunate case. This plaintiff’s attorney had a dream of a closing argument to make: Her client will suffer the effects of brain damage, robbing her of her life, her memory, and her very personality. This damage could have been prevented—not through use of an experimental new procedure or an investigational drug, but through use of a simple and readily available vitamin.
Worse still, cases such as this can involve a punitive element. Jurors would be invited to conclude that treating clinicians ignored the patient and left her to starve in her own bed. Always act in the patient’s best interest—and be attuned to situations that may evolve into claims that the patient was abandoned, neglected, or ignored.
Finally, you must address anything in the patient’s written record that is contrary to your plan. The fact pattern makes clear that a nutritional evaluation was obtained 2 days after the plaintiff’s admission. The dietitian recommended TPN. The record is not clear on why the physician did not order it. If you plan to take an action at odds with a prior observation or recommendation, be sure to clearly explain the rationale supporting your course of treatment. If you perform a risk-benefit analysis that leads you to a different conclusion, document that in the record—preferably with a second opinion from another clinician who supports your decision to deviate from the recommendation.
IN SUMMARY
Nutrition can be critically important. Make sure you consider both short- and long-term consequences of nutritional deficiencies. Bariatric surgery patients have altered anatomy, so be cautious with them. Consider the possibility of thiamine encephalopathy—which can be devastating—when the setting is suggestive. And make sure that all recommendations from other clinicians recorded in the patient’s chart are acted on. If you select a course of treatment that departs from prior recommendation, make clear your risk-benefit analysis and consider obtaining a second opinion in support of your decision.