S.Y. Tan, MD, JD

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. Should a prescription drug or medical device lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. 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 An example is the cardiovascular deaths caused by Vioxx, a nonsteroidal, anti-inflammatory drug that was withdrawn in 2004.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. Should a prescription drug or medical device lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. 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. Should a prescription drug or medical device lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. 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: 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. Congress and state legislatures have enacted laws to ensure the confidentiality of medical peer review, incident reports, and patient safety work products. 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. Congress and state legislatures have enacted laws to ensure the confidentiality of medical peer review, incident reports, and patient safety work products. 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. Congress and state legislatures have enacted laws to ensure the confidentiality of medical peer review, incident reports, and patient safety work products. 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: 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. The law requires that a professional acts reasonably with the knowledge, skill, and judgment ordinarily possessed by fellow members in good standing. For the medical profession, this duty of due care springs from the doctor-patient relationship, 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. The law requires that a professional acts reasonably with the knowledge, skill, and judgment ordinarily possessed by fellow members in good standing. For the medical profession, this duty of due care springs from the doctor-patient relationship, 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. The law requires that a professional acts reasonably with the knowledge, skill, and judgment ordinarily possessed by fellow members in good standing. For the medical profession, this duty of due care springs from the doctor-patient relationship, 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: 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. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations, or limitation period. 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. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations, or limitation period. 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. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations, or limitation period. 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: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?

A. CAM practitioners are just as likely as medical doctors to be sued.

B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.

C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.

D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.

E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.

Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.

CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.

More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.

CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.

In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.

Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.

For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.

In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.¹ In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.²

However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.³ The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.

The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.

Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.⁴ And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.⁵ The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.

Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.

In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.⁶ Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.

Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.

In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.⁷

The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.

In general, a physician may employ several legal defenses to avert liability following an adverse event.

One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.

A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.⁸ The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.

The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.

A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.

When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It 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. Wengel v. Herfert, 473 N.W.2d 741 (1991).

2. Salazar v. Ehmann, 505 P.2d 387 (1972).

3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).

4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).

5. Wallman v. Kelley, 976 P.2d 330 (1998).

6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).

7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).

8. Schneider v. Revici, 817 F. 2d 987 (1987).

Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?

A. CAM practitioners are just as likely as medical doctors to be sued.

B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.

C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.

D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.

E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.

Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.

CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.

More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.

CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.

In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.

Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.

For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.

In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.¹ In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.²

However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.³ The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.

The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.

Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.⁴ And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.⁵ The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.

Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.

In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.⁶ Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.

Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.

In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.⁷

The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.

In general, a physician may employ several legal defenses to avert liability following an adverse event.

One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.

A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.⁸ The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.

The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.

A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.

When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It 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. Wengel v. Herfert, 473 N.W.2d 741 (1991).

2. Salazar v. Ehmann, 505 P.2d 387 (1972).

3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).

4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).

5. Wallman v. Kelley, 976 P.2d 330 (1998).

6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).

7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).

8. Schneider v. Revici, 817 F. 2d 987 (1987).

Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?

A. CAM practitioners are just as likely as medical doctors to be sued.

B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.

C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.

D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.

E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.

Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.

CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.

More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.

CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.

In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.

Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.

For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.

In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.¹ In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.²

However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.³ The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.

The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.

Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.⁴ And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.⁵ The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.

Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.

In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.⁶ Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.

Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.

In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.⁷

The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.

In general, a physician may employ several legal defenses to avert liability following an adverse event.

One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.

A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.⁸ The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.

The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.

A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.

When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
 

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It 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. Wengel v. Herfert, 473 N.W.2d 741 (1991).

2. Salazar v. Ehmann, 505 P.2d 387 (1972).

3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).

4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).

5. Wallman v. Kelley, 976 P.2d 330 (1998).

6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).

7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).

8. Schneider v. Revici, 817 F. 2d 987 (1987).

Question: Regarding medical care aboard cruise ships, which of the following is incorrect?

A. It is difficult to prove negligence because of jurisdictional issues.

B. The American College of Emergency Physicians has published practice guidelines.

C. Cruise line owners are immune from liability under the Barbetta rule.

D. The Franza decision may be a game changer.

E. Lawsuits are on the increase.

Answer: A. More and more people are cruising, with the number of passengers on North American lines reaching nearly 18 million in 2017, about one-third out of Florida. Medical illnesses and accidents predictably occur at sea, and unfortunately, substandard and negligent care occasionally follows some of these mishaps.

However, up until recently, courts have immunized cruise line owners from legal liability by relying on the so-called Barbetta rule, which is based on historical notions of limited resources at sea and the impossibility of exerting control over the conduct of a ship’s health care providers.

A 2007 Florida case is illustrative. The doctor aboard a Carnival cruise ship failed to diagnose acute appendicitis in a 14-year-old girl who had complained of several days of abdominal symptoms. As a result, the patient ruptured her appendix, and this eventually resulted in sterility. The parents sued the cruise line, which denied liability because the doctor was not an employee, a fact specifically disclosed in the cruise ticket.

Although the doctor’s contract stated that he was an independent contractor, the District Court of Appeal of Florida reasoned that, in a claim based on agency, it is the right of control rather than actual control itself that matters.

It therefore held that: “for purposes of fulfilling cruise line’s duty to exercise reasonable care, the ship’s doctor is an agent of cruise line whose negligence should be imputed to cruise line ... regardless of the contractual status ascribed to the doctor” and to the extent cruise ticket sought to limit cruise line’s liability for negligence of doctor, it was invalid.

However, the Florida Supreme Court quashed this decision, because federal maritime law has historically protected shipowners from liability flowing from the medical negligence of shipboard physicians.¹

The Barbetta rule was named after a 1988 case in which Florence L. Barbetta suffered serious medical complications during a Mexican cruise out of Florida. The ship’s doctor was alleged to have been negligent for his failure to diagnose diabetes.² The lower court dismissed the case, and the appellate court affirmed.

The appellate court noted that an impressive number of courts from many jurisdictions have, for almost 100 years, followed the same basic rule: If the doctor is negligent in treating a passenger, that negligence will not be imputed to the carrier unless the carrier itself was negligent in hiring the doctor.

Citing approvingly from another case, the appellate court noted: “[A] shipping company is not in the business of providing medical services to passengers; it does not possess the expertise requisite to supervise a physician or surgeon carried on board a ship as a convenience to passengers. A ship is not a floating hospital; a ship’s physician is an independent medical expert engaged on the basis of his professional qualifications and carried on board a ship for the convenience of passengers, who are free to contract with him for any medical services they may require.”

However, courts now appear ready to jettison this rule.

In the 2014 case of Franza v. Royal Caribbean Cruises, Ltd., a passenger fell and hit his head while his ship was at port in Bermuda.³ He died several days later, allegedly because of negligence and delay by the ship’s medical staff. The lower courts barred the lawsuit, based on Barbetta, but on appeal, the 11th Circuit Court reversed. It rejected the historical justifications for immunizing shipowners from liability, concluding that past reasons were no longer applicable to modern-day cruise ships.

The court wrote: “Here, the roots of the Barbetta rule snake back to a wholly different world. Instead of 19th-century steamships, we now confront state-of-the-art cruise ships that house thousands of people and operate as floating cities complete with well-stocked modern infirmaries and urgent-care centers. In place of independent doctors and nurses, we must now acknowledge that medical professionals routinely work for corporate masters. And whereas ships historically went ‘off the grid’ when they set sail, modern technology enables distant ships to communicate instantaneously with the mainland in meaningful ways.”

However, the injured person must still prove that the doctor or nurse was acting as a ship employee rather than an independent contractor. Some of the factors to be considered include whether the cruise line advertised its medical center or medical staff to passengers, whether it retained the right to hire and fire medical staff, and methods of payment.

This 2014 11th Circuit Court ruling has particular impact on Florida, because the state’s federal court system falls within its jurisdiction, and many cruise lines – such as Carnival, Celebrity, Disney, Norwegian, Royal Caribbean, and Silversea Cruises – are headquartered in Florida. Because most ocean liners hire medical professionals who are foreign nationals, seeking legal remedy against the individuals can be difficult.

As a result, suing the cruise line directly can serve as the simplest way to obtain compensation. Some major cruise lines have already seen an increase in personal injury lawsuits. According to Bloomberg Law, there were 164 such federal injury suits in 2016, 188 in 2017, and 83 cases in just the first 3 months of 2018.

The popular press recently highlighted the latest example of medical malpractice at sea. A cruise worker was awarded $3.34 million after a young, inexperienced doctor prescribed a large dose of intravenous promethazine for nausea. Instead of using 6.25 mg, the usual dose, he prescribed 25 mg, which was inadvertently injected into the ulnar artery. The caustic drug, known to injure vascular walls, caused severe damage with extravasation, and tissue swelling, ending in compartment syndrome.

Furthermore, he had to wait 24 hours before arriving in port for treatment. By then, his arm was gangrenous and had to be amputated. The defense had argued unsuccessfully that the plaintiff had a venous anomaly to account for the injury.⁴

These changes in the law augur well for the cruising public. The Franza decision puts cruise line owners on notice that they no longer enjoy blanket immunity, and will be held responsible for the negligence of their health care providers. Hopefully, this will ensure a more uniform and adequate standard of care.

The American College of Emergency Physicians has published specific guidelines regarding medical standards aboard cruise ships. In addition to having established medical policies and procedures, and a dedicated medical emergency telephone number, they must have at least one doctor available 24/7 to provide emergency medical care and maintain certain equipment on board, such as pulse oximeters, cardiac monitors, defibrillators, an EKG device, as well as a laboratory.

Norwegian Cruise Line has taken a step further: It recently installed the capability to consult in real time with the Cleveland Clinic for diagnostic and treatment advice.
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Carlisle v. Carnival Corporation, et al., 953 So.2d 461, 2007.

2. Barbetta v. S/S Bermuda Star, 848 F.2d 1364 (5th Cir. 1988).

3. Franza v. Royal Caribbean Cruises Ltd., 772 F.3d 1225 (11th Cir. 2014).

4. Loncar v. NCL Bahamas, International Center for Dispute Resolution, Case # 01-16-0004-3640, June 13, 2018.

Question: Regarding medical care aboard cruise ships, which of the following is incorrect?

A. It is difficult to prove negligence because of jurisdictional issues.

B. The American College of Emergency Physicians has published practice guidelines.

C. Cruise line owners are immune from liability under the Barbetta rule.

D. The Franza decision may be a game changer.

E. Lawsuits are on the increase.

Answer: A. More and more people are cruising, with the number of passengers on North American lines reaching nearly 18 million in 2017, about one-third out of Florida. Medical illnesses and accidents predictably occur at sea, and unfortunately, substandard and negligent care occasionally follows some of these mishaps.

However, up until recently, courts have immunized cruise line owners from legal liability by relying on the so-called Barbetta rule, which is based on historical notions of limited resources at sea and the impossibility of exerting control over the conduct of a ship’s health care providers.

A 2007 Florida case is illustrative. The doctor aboard a Carnival cruise ship failed to diagnose acute appendicitis in a 14-year-old girl who had complained of several days of abdominal symptoms. As a result, the patient ruptured her appendix, and this eventually resulted in sterility. The parents sued the cruise line, which denied liability because the doctor was not an employee, a fact specifically disclosed in the cruise ticket.

Although the doctor’s contract stated that he was an independent contractor, the District Court of Appeal of Florida reasoned that, in a claim based on agency, it is the right of control rather than actual control itself that matters.

It therefore held that: “for purposes of fulfilling cruise line’s duty to exercise reasonable care, the ship’s doctor is an agent of cruise line whose negligence should be imputed to cruise line ... regardless of the contractual status ascribed to the doctor” and to the extent cruise ticket sought to limit cruise line’s liability for negligence of doctor, it was invalid.

However, the Florida Supreme Court quashed this decision, because federal maritime law has historically protected shipowners from liability flowing from the medical negligence of shipboard physicians.¹

The Barbetta rule was named after a 1988 case in which Florence L. Barbetta suffered serious medical complications during a Mexican cruise out of Florida. The ship’s doctor was alleged to have been negligent for his failure to diagnose diabetes.² The lower court dismissed the case, and the appellate court affirmed.

The appellate court noted that an impressive number of courts from many jurisdictions have, for almost 100 years, followed the same basic rule: If the doctor is negligent in treating a passenger, that negligence will not be imputed to the carrier unless the carrier itself was negligent in hiring the doctor.

Citing approvingly from another case, the appellate court noted: “[A] shipping company is not in the business of providing medical services to passengers; it does not possess the expertise requisite to supervise a physician or surgeon carried on board a ship as a convenience to passengers. A ship is not a floating hospital; a ship’s physician is an independent medical expert engaged on the basis of his professional qualifications and carried on board a ship for the convenience of passengers, who are free to contract with him for any medical services they may require.”

However, courts now appear ready to jettison this rule.

In the 2014 case of Franza v. Royal Caribbean Cruises, Ltd., a passenger fell and hit his head while his ship was at port in Bermuda.³ He died several days later, allegedly because of negligence and delay by the ship’s medical staff. The lower courts barred the lawsuit, based on Barbetta, but on appeal, the 11th Circuit Court reversed. It rejected the historical justifications for immunizing shipowners from liability, concluding that past reasons were no longer applicable to modern-day cruise ships.

The court wrote: “Here, the roots of the Barbetta rule snake back to a wholly different world. Instead of 19th-century steamships, we now confront state-of-the-art cruise ships that house thousands of people and operate as floating cities complete with well-stocked modern infirmaries and urgent-care centers. In place of independent doctors and nurses, we must now acknowledge that medical professionals routinely work for corporate masters. And whereas ships historically went ‘off the grid’ when they set sail, modern technology enables distant ships to communicate instantaneously with the mainland in meaningful ways.”

However, the injured person must still prove that the doctor or nurse was acting as a ship employee rather than an independent contractor. Some of the factors to be considered include whether the cruise line advertised its medical center or medical staff to passengers, whether it retained the right to hire and fire medical staff, and methods of payment.

This 2014 11th Circuit Court ruling has particular impact on Florida, because the state’s federal court system falls within its jurisdiction, and many cruise lines – such as Carnival, Celebrity, Disney, Norwegian, Royal Caribbean, and Silversea Cruises – are headquartered in Florida. Because most ocean liners hire medical professionals who are foreign nationals, seeking legal remedy against the individuals can be difficult.

As a result, suing the cruise line directly can serve as the simplest way to obtain compensation. Some major cruise lines have already seen an increase in personal injury lawsuits. According to Bloomberg Law, there were 164 such federal injury suits in 2016, 188 in 2017, and 83 cases in just the first 3 months of 2018.

The popular press recently highlighted the latest example of medical malpractice at sea. A cruise worker was awarded $3.34 million after a young, inexperienced doctor prescribed a large dose of intravenous promethazine for nausea. Instead of using 6.25 mg, the usual dose, he prescribed 25 mg, which was inadvertently injected into the ulnar artery. The caustic drug, known to injure vascular walls, caused severe damage with extravasation, and tissue swelling, ending in compartment syndrome.

Furthermore, he had to wait 24 hours before arriving in port for treatment. By then, his arm was gangrenous and had to be amputated. The defense had argued unsuccessfully that the plaintiff had a venous anomaly to account for the injury.⁴

These changes in the law augur well for the cruising public. The Franza decision puts cruise line owners on notice that they no longer enjoy blanket immunity, and will be held responsible for the negligence of their health care providers. Hopefully, this will ensure a more uniform and adequate standard of care.

The American College of Emergency Physicians has published specific guidelines regarding medical standards aboard cruise ships. In addition to having established medical policies and procedures, and a dedicated medical emergency telephone number, they must have at least one doctor available 24/7 to provide emergency medical care and maintain certain equipment on board, such as pulse oximeters, cardiac monitors, defibrillators, an EKG device, as well as a laboratory.

Norwegian Cruise Line has taken a step further: It recently installed the capability to consult in real time with the Cleveland Clinic for diagnostic and treatment advice.
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Carlisle v. Carnival Corporation, et al., 953 So.2d 461, 2007.

2. Barbetta v. S/S Bermuda Star, 848 F.2d 1364 (5th Cir. 1988).

3. Franza v. Royal Caribbean Cruises Ltd., 772 F.3d 1225 (11th Cir. 2014).

4. Loncar v. NCL Bahamas, International Center for Dispute Resolution, Case # 01-16-0004-3640, June 13, 2018.

Question: Regarding medical care aboard cruise ships, which of the following is incorrect?

A. It is difficult to prove negligence because of jurisdictional issues.

B. The American College of Emergency Physicians has published practice guidelines.

C. Cruise line owners are immune from liability under the Barbetta rule.

D. The Franza decision may be a game changer.

E. Lawsuits are on the increase.

Answer: A. More and more people are cruising, with the number of passengers on North American lines reaching nearly 18 million in 2017, about one-third out of Florida. Medical illnesses and accidents predictably occur at sea, and unfortunately, substandard and negligent care occasionally follows some of these mishaps.

However, up until recently, courts have immunized cruise line owners from legal liability by relying on the so-called Barbetta rule, which is based on historical notions of limited resources at sea and the impossibility of exerting control over the conduct of a ship’s health care providers.

A 2007 Florida case is illustrative. The doctor aboard a Carnival cruise ship failed to diagnose acute appendicitis in a 14-year-old girl who had complained of several days of abdominal symptoms. As a result, the patient ruptured her appendix, and this eventually resulted in sterility. The parents sued the cruise line, which denied liability because the doctor was not an employee, a fact specifically disclosed in the cruise ticket.

Although the doctor’s contract stated that he was an independent contractor, the District Court of Appeal of Florida reasoned that, in a claim based on agency, it is the right of control rather than actual control itself that matters.

It therefore held that: “for purposes of fulfilling cruise line’s duty to exercise reasonable care, the ship’s doctor is an agent of cruise line whose negligence should be imputed to cruise line ... regardless of the contractual status ascribed to the doctor” and to the extent cruise ticket sought to limit cruise line’s liability for negligence of doctor, it was invalid.

However, the Florida Supreme Court quashed this decision, because federal maritime law has historically protected shipowners from liability flowing from the medical negligence of shipboard physicians.¹

The Barbetta rule was named after a 1988 case in which Florence L. Barbetta suffered serious medical complications during a Mexican cruise out of Florida. The ship’s doctor was alleged to have been negligent for his failure to diagnose diabetes.² The lower court dismissed the case, and the appellate court affirmed.

The appellate court noted that an impressive number of courts from many jurisdictions have, for almost 100 years, followed the same basic rule: If the doctor is negligent in treating a passenger, that negligence will not be imputed to the carrier unless the carrier itself was negligent in hiring the doctor.

Citing approvingly from another case, the appellate court noted: “[A] shipping company is not in the business of providing medical services to passengers; it does not possess the expertise requisite to supervise a physician or surgeon carried on board a ship as a convenience to passengers. A ship is not a floating hospital; a ship’s physician is an independent medical expert engaged on the basis of his professional qualifications and carried on board a ship for the convenience of passengers, who are free to contract with him for any medical services they may require.”

However, courts now appear ready to jettison this rule.

In the 2014 case of Franza v. Royal Caribbean Cruises, Ltd., a passenger fell and hit his head while his ship was at port in Bermuda.³ He died several days later, allegedly because of negligence and delay by the ship’s medical staff. The lower courts barred the lawsuit, based on Barbetta, but on appeal, the 11th Circuit Court reversed. It rejected the historical justifications for immunizing shipowners from liability, concluding that past reasons were no longer applicable to modern-day cruise ships.

The court wrote: “Here, the roots of the Barbetta rule snake back to a wholly different world. Instead of 19th-century steamships, we now confront state-of-the-art cruise ships that house thousands of people and operate as floating cities complete with well-stocked modern infirmaries and urgent-care centers. In place of independent doctors and nurses, we must now acknowledge that medical professionals routinely work for corporate masters. And whereas ships historically went ‘off the grid’ when they set sail, modern technology enables distant ships to communicate instantaneously with the mainland in meaningful ways.”

However, the injured person must still prove that the doctor or nurse was acting as a ship employee rather than an independent contractor. Some of the factors to be considered include whether the cruise line advertised its medical center or medical staff to passengers, whether it retained the right to hire and fire medical staff, and methods of payment.

This 2014 11th Circuit Court ruling has particular impact on Florida, because the state’s federal court system falls within its jurisdiction, and many cruise lines – such as Carnival, Celebrity, Disney, Norwegian, Royal Caribbean, and Silversea Cruises – are headquartered in Florida. Because most ocean liners hire medical professionals who are foreign nationals, seeking legal remedy against the individuals can be difficult.

As a result, suing the cruise line directly can serve as the simplest way to obtain compensation. Some major cruise lines have already seen an increase in personal injury lawsuits. According to Bloomberg Law, there were 164 such federal injury suits in 2016, 188 in 2017, and 83 cases in just the first 3 months of 2018.

The popular press recently highlighted the latest example of medical malpractice at sea. A cruise worker was awarded $3.34 million after a young, inexperienced doctor prescribed a large dose of intravenous promethazine for nausea. Instead of using 6.25 mg, the usual dose, he prescribed 25 mg, which was inadvertently injected into the ulnar artery. The caustic drug, known to injure vascular walls, caused severe damage with extravasation, and tissue swelling, ending in compartment syndrome.

Furthermore, he had to wait 24 hours before arriving in port for treatment. By then, his arm was gangrenous and had to be amputated. The defense had argued unsuccessfully that the plaintiff had a venous anomaly to account for the injury.⁴

These changes in the law augur well for the cruising public. The Franza decision puts cruise line owners on notice that they no longer enjoy blanket immunity, and will be held responsible for the negligence of their health care providers. Hopefully, this will ensure a more uniform and adequate standard of care.

The American College of Emergency Physicians has published specific guidelines regarding medical standards aboard cruise ships. In addition to having established medical policies and procedures, and a dedicated medical emergency telephone number, they must have at least one doctor available 24/7 to provide emergency medical care and maintain certain equipment on board, such as pulse oximeters, cardiac monitors, defibrillators, an EKG device, as well as a laboratory.

Norwegian Cruise Line has taken a step further: It recently installed the capability to consult in real time with the Cleveland Clinic for diagnostic and treatment advice.
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Carlisle v. Carnival Corporation, et al., 953 So.2d 461, 2007.

2. Barbetta v. S/S Bermuda Star, 848 F.2d 1364 (5th Cir. 1988).

3. Franza v. Royal Caribbean Cruises Ltd., 772 F.3d 1225 (11th Cir. 2014).

4. Loncar v. NCL Bahamas, International Center for Dispute Resolution, Case # 01-16-0004-3640, June 13, 2018.

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

Question: Which of the following regarding medical trainee liability is best?

A. Trainees are commonly named as codefendants with their attending physician in a medical malpractice lawsuit.

B. “From a culture of blame to a culture of safety” is a rallying cry against poor work conditions.

C. House officers are always judged by a lower standard, because they are not fully qualified.

D. A, B, and C are correct.

E. A and C are correct.

Answer: A. A recent case of trainee liability in the United Kingdom resulted in criminal prosecution followed by the trainee being struck off the medical register.¹ Dr. Hadiza Bawa-Garba, a pediatric trainee in the U.K. National Health Service, was prosecuted in a court of law and found guilty of manslaughter by gross negligence for the septic death of a 6-year-old boy with Down syndrome. The General Medical Council (GMC), the U.K. medical regulatory agency, voted to take away her license. The decision aroused the ire of physicians worldwide, who noted the poor supervision and undue pressures she was under.

In August 2018, the U.K. Court of Appeal noted that the general clinical competency of Dr. Bawa-Garba was never at issue, and that “the risk of her clinical practice suddenly and without explanation falling below the standards expected on any given day is no higher than for any other reasonably competent doctor.” It reversed the expulsion order and reinstated the 1-year suspension recommended by the Medical Practitioners Tribunal.

Even as the GMC accepted this appellate decision and had convened a commission to look into criminal negligence, it nonetheless received heavy criticism for having overreacted – and for its failure to speak out more forcefully to support those practicing under oppressive conditions.

For example, the Doctors’ Association UK said the GMC had shown it could not be trusted to be objective and nonpunitive. The case, it noted, had “united the medical profession in fear and outrage,” whereby “a pediatrician in training ... a highly regarded doctor, with a previously unblemished record, [was] convicted of [the criminal offence of] gross negligence manslaughter for judgments made whilst doing the jobs of several doctors at once, covering six wards across four floors, responding to numerous pediatric emergencies, without a functioning IT system, and in the absence of a consultant [senior physician], all when just returning from 14 months of maternity leave.”

The Royal College of Pediatrics and Child Health said it had “previously flagged the importance of fostering a culture of supporting doctors to learn from their mistakes, rather than one which seeks to blame.” And the British Medical Association said, “lessons must be learned from this case, which raises wider issues about the multiple factors that affect patient safety in an NHS under extreme pressure, rather than narrowly focusing only on individuals.”²

The fiasco surrounding the Dr. Bawa-Garba case will hopefully result in action similar to that following the seminal report that medical errors account for nearly 100,000 annual hospital deaths in the United States. That study was not restricted to house staff mistakes, but involved multiple hospitals and hospital staff members. It spawned a nationwide reappraisal of how to approach medical errors, and it spurred the Institute of Medicine to recommend that the profession shift “from a culture of blame to a culture of safety.”³

Criminal prosecution in the United States is decidedly rare in death or injury occurring during the course of patient care – for either trainees or attending physicians. A malpractice lawsuit would have been a far more likely outcome had the Dr. Bawa-Garba case taken place in the United States.

Lawsuits against U.S. house staff are not rare, and resident physicians are regularly joined as codefendants with their supervisors, who may be medical school faculty or community practitioners admitting to “team care.” Regulatory actions are typically directed against fully licensed physicians, rather than the trainees. Instead, the director of the training program itself would take corrective action against an errant resident, if warranted, which can range from a warning to outright dismissal from the program.

How is negligence law applied to a trainee? Should it demand the same standard of care as it would a fully qualified attending physician?⁴ Surprisingly, the courts are split on this question. Some have favored using a dual standard of conduct, with trainees being held to a lower standard.

This was articulated in Rush v. Akron General Hospital, which involved a patient who had fallen through a glass door. The patient suffered several lacerations to his shoulder, which the intern treated. However, when two remaining pieces of glass were later discovered in the area of injury, the patient sued the intern for negligence.

The court dismissed the claim, finding that the intern had practiced with the skill and care of his peers of similar training. “It would be unreasonable to exact from an intern, doing emergency work in a hospital, that high degree of skill which is impliedly possessed by a physician and surgeon in the general practice of his profession, with an extensive and constant practice in hospitals and the community,” the court noted.⁵

However, not all courts have embraced this dual standard of review. The New Jersey Superior Court held that licensed residents should be judged by a standard applicable to a general practitioner, because any reduction in the standard of care would set a problematic precedent.⁶ In that case, the residents allegedly failed to reinsert a nasogastric tube, which caused the patient to aspirate.

And in Pratt v. Stein, a second-year resident was judged by an even higher standard – that of a specialist – after he had allegedly administered a toxic dose of neomycin to a postoperative patient, which resulted in deafness. Although the lower court had ruled that the resident should be held to the standard of an ordinary physician, the Pennsylvania appellate court disagreed, reasoning that “a resident should be held to the standard of a specialist when the resident is acting within his field of specialty. In our estimation, this is a sound conclusion. A resident is already a physician who has chosen to specialize, and thus possesses a higher degree of knowledge and skill in the chosen specialty than does the nonspecialist.”⁷

However, a subsequent decision from the same jurisdiction suggests a retreat from this unrealistic standard.

An orthopedic resident allegedly applied a cast with insufficient padding to the broken wrist of a patient. The plaintiff claimed this led to soft-tissue infection with Staphylococcus aureus, with complicating septicemia, staphylococcal endocarditis, and eventual death.

The court held that the resident’s standard of care should be “higher than that for general practitioners but less than that for fully trained orthopedic specialists. ... To require a resident to meet the same standard of care as fully trained specialists would be unrealistic. A resident may have had only days or weeks of training in the specialized residency program; a specialist, on the other hand, will have completed the residency program and may also have had years of experience in the specialized field. If we were to require the resident to exercise the same degree of skill and training as the specialist, we would, in effect, be requiring the resident to do the impossible.”⁸
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Saurabh Jha, “To Err Is Homicide in Britain: The Case of Hadiza Bawa-Garba.” The Health Care Blog, Jan. 30, 2018.

2. “‘Lessons Must Be Learned’: UK Societies on Bawa-Garba Ruling.” Medscape, Aug. 14, 2018.

3. “To Err is Human: Building a Safer Health System.” Institute of Medicine, National Academies Press, Washington D.C., 1999.

4. JAMA. 2004 Sep 1;292(9):1051-6.

5. Rush v. Akron General Hospital, 171 N.E.2d 378 (Ohio Ct. App. 1987).

6. Clark v. University Hospital, 914 A.2d 838 (N.J. Super. 2006).

7. Pratt v. Stein, 444 A.2d 674 (Pa. Super. 1980).

8. Jistarri v. Nappi, 549 A.2d 210 (Pa. Super. 1988).

QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.

Which of the following statements is incorrect?

A. These are all examples of product liability.

B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.

C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.

D. It is now harder to include multiple plaintiffs in a class-action lawsuit.

E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.



ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.¹ DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.

The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”² Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.

At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.

Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.

The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.

Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.

In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.³ He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.

2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.

3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).

4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.

5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.

6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).

QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.

Which of the following statements is incorrect?

A. These are all examples of product liability.

B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.

C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.

D. It is now harder to include multiple plaintiffs in a class-action lawsuit.

E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.



ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.¹ DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.

The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”² Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.

At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.

Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.

The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.

Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.

In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.³ He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.

2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.

3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).

4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.

5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.

6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).

QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.

Which of the following statements is incorrect?

A. These are all examples of product liability.

B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.

C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.

D. It is now harder to include multiple plaintiffs in a class-action lawsuit.

E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.



ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.¹ DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.

The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”² Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.

At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.

Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.

The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.

Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.

In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.³ He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.

2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.

3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).

4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.

5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.

6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).

Question: Which of the following statements regarding the law on evidence is incorrect?

A. Expert testimony is always needed to establish the applicable standard of care in a negligence lawsuit.

B. According to the Federal Rules of Evidence, a witness may be qualified as an expert based on knowledge, skill, experience, training, or education.

C. It is the judge, not the jury, who determines whether a witness is admissible as an expert.

D. Expert testimony is a requirement in medical malpractice lawsuits, unless a plaintiff can successfully invoke the res ipsa loquitur doctrine.

E. Only a few states have enacted statutes specifying that an expert must be in the same specialty as the defendant, and in some cases, a nonphysician such as a nurse or pharmacist may be allowed to testify.

Answer: A. Under the tort of negligence, a defendant’s conduct is measured by what is expected of the reasonable person – the man on the street. The jury can usually decide on its own, without the aid of an expert, what that level of care ought to be. However, in medical malpractice lawsuits, the law requires an expert to testify to the requisite standard of care, as this determination is believed to be beyond the scope of the layperson.

An exception, rarely invoked, is the res ipsa loquitur doctrine, where “the thing speaks for itself.” There, an expert is not necessary because of common knowledge, e.g., when a surgeon inadvertently leaves a sponge or instrument inside a body cavity.

Whether one is admitted as an expert is within the sole discretion of the judge, who is guided by the Federal Rules of Evidence. Typically, an expert is in the same medical specialty, but there are instances of professionals of unlike specialties qualifying as experts. Examples include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores.

We had previously reviewed the law governing expert medical testimony in these columns.¹ However, three recent cases awaiting final adjudication caught our attention, as they raise important and serious legal issues.

The first frontally suggests that jury members may rely on their own notion of what constitutes an appropriate standard of care. Although it is established law in Maryland that expert testimony is required to set that standard in medical malpractice litigation, the recent Maryland case of Armacost v. Davis appeared to modify this principle, leading to a plaintiff verdict.²

The facts involved a neurosurgeon’s anterior cervical discectomy and fusion surgery, which was complicated by a pinpoint opening at the end of the incision. This eventually developed into a MRSA abscess. In his lawsuit, the plaintiff alleged that surgery was neither medically necessary nor appropriate, that there was no proper informed consent, and that the diagnosis of his postoperative infection was delayed.

A pivotal part of the trial centered on a Baltimore county judge’s instructions to the jury that it could consider what a layperson would deem reasonable standard of care. Moreover, the judge refused to modify the jury instructions when the doctor-defendant objected and asked that the standard of care be measured by the expectations for a neurosurgeon. The jury returned a verdict in favor of the plaintiff in the amount of $329,000.

Upon appeal, the Court of Special Appeals of Maryland ruled that the jury instructions were improper and therefore ordered a new trial. It held: “Medical malpractice claims are not general negligence claims, and so jury instructions on general negligence, although correct statements of Maryland law, are not supported by the facts of a case centered on the allegedly negligent conduct of a physician. Accordingly, we hold that the trial court erred in giving general negligence instructions in a medical malpractice case.”

The case is now before Maryland’s highest court, the Court of Appeals of Maryland, which is expected to uphold this decision and reject the reasonable person (instead of reasonable doctor) standard used by the lower court.

The second case deals with whether a jury in a medical liability trial may be prejudiced if they hear four medical experts testify for the physician and just one expert testify for the plaintiff. In Shallow v. Follwell, the defendant doctor performed a laparoscopic hernia repair, which was complicated by bowel perforation, atrial fibrillation, sepsis, and death.³

At trial, plaintiffs produced one expert witness, whereas Dr. Follwell had four, with expertise in cardiology, critical care, vascular surgery, and colorectal surgery. The trial court judge instructed the jury not to give weight to the number of experts on either side, and based on the testimony, the jury found that Dr. Follwell did not cause the perforated bowel or the patient’s death.

However, on appeal, the Missouri Court of Appeals overturned the verdict after finding that the trial court erred in allowing “unfairly cumulative and prejudicial repetition of certain expert opinions.” The Missouri Supreme Court is currently being asked to render a final opinion on the matter. In its supporting brief, the American Medical Association’s Litigation Center is urging the high court to “ensure that Missouri trial judges are empowered to safeguard the use of sound science in their courtrooms,” and that “given the highly specialized nature of medicine today, multiple experts may be required to ensure a jury has a proper understanding of the relevant medical science.”⁴

The third case addresses whether trial judges can suppress expert witness testimony attesting that a known complication of a medical procedure can occur absent any negligence.

The case involved a laparoscopic hysterectomy performed by a gynecologist. The patient’s bowel was perforated during the procedure.⁵ Expert witnesses from both sides testified about bowel perforation and professional standards, and the trial court allowed the defendant’s expert to state that such an injury was a commonplace risk even if surgery was performed properly.

The plaintiff objected to this testimony; but the trial judge overruled the plaintiff’s objection, and the jury found in favor of the gynecologist. Upon appeal, the Pennsylvania Superior Court reversed, concluding that the defendant’s expert testimony was irrelevant and misleading, and immaterial to the issue of whether the defendant’s treatment met the standard of care. It held that the evidence was inadmissible and ordered a new trial. The case is now before the Pennsylvania Supreme Court.

The foregoing three cases are yet to be finally adjudicated, but controversies in these and similar issues can be expected to continue. Expert testimony is dispositive at trial, and both sides rely heavily on it. Little wonder malpractice litigation is frequently framed as a “battle of the experts.”
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Internal Medicine News, “Expert medical testimony,” Sept. 9, 2010; “Qualifying as an expert,” Jan. 2, 2015; “Dispensing with expert testimony,” April 19, 2016.

2. Armacost v. Davis, 175 A.3d 150 (Ct. App. Md, 2017).

3. Shallow v. Follwell, (No. ED103811, Mo. App., Eastern Dist., Div. 4, 2017).

4. Henry TA, “Is it OK to have 4-to-1 expert ratio in medical liability case?” AMA Wire, June 22, 2018.

5. Mitchell v. Shikora, 161 A.3d 970 (Pa. Super. 2017).

Question: Which of the following statements regarding the law on evidence is incorrect?

A. Expert testimony is always needed to establish the applicable standard of care in a negligence lawsuit.

B. According to the Federal Rules of Evidence, a witness may be qualified as an expert based on knowledge, skill, experience, training, or education.

C. It is the judge, not the jury, who determines whether a witness is admissible as an expert.

D. Expert testimony is a requirement in medical malpractice lawsuits, unless a plaintiff can successfully invoke the res ipsa loquitur doctrine.

E. Only a few states have enacted statutes specifying that an expert must be in the same specialty as the defendant, and in some cases, a nonphysician such as a nurse or pharmacist may be allowed to testify.

Answer: A. Under the tort of negligence, a defendant’s conduct is measured by what is expected of the reasonable person – the man on the street. The jury can usually decide on its own, without the aid of an expert, what that level of care ought to be. However, in medical malpractice lawsuits, the law requires an expert to testify to the requisite standard of care, as this determination is believed to be beyond the scope of the layperson.

An exception, rarely invoked, is the res ipsa loquitur doctrine, where “the thing speaks for itself.” There, an expert is not necessary because of common knowledge, e.g., when a surgeon inadvertently leaves a sponge or instrument inside a body cavity.

Whether one is admitted as an expert is within the sole discretion of the judge, who is guided by the Federal Rules of Evidence. Typically, an expert is in the same medical specialty, but there are instances of professionals of unlike specialties qualifying as experts. Examples include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores.

We had previously reviewed the law governing expert medical testimony in these columns.¹ However, three recent cases awaiting final adjudication caught our attention, as they raise important and serious legal issues.

The first frontally suggests that jury members may rely on their own notion of what constitutes an appropriate standard of care. Although it is established law in Maryland that expert testimony is required to set that standard in medical malpractice litigation, the recent Maryland case of Armacost v. Davis appeared to modify this principle, leading to a plaintiff verdict.²

The facts involved a neurosurgeon’s anterior cervical discectomy and fusion surgery, which was complicated by a pinpoint opening at the end of the incision. This eventually developed into a MRSA abscess. In his lawsuit, the plaintiff alleged that surgery was neither medically necessary nor appropriate, that there was no proper informed consent, and that the diagnosis of his postoperative infection was delayed.

A pivotal part of the trial centered on a Baltimore county judge’s instructions to the jury that it could consider what a layperson would deem reasonable standard of care. Moreover, the judge refused to modify the jury instructions when the doctor-defendant objected and asked that the standard of care be measured by the expectations for a neurosurgeon. The jury returned a verdict in favor of the plaintiff in the amount of $329,000.

Upon appeal, the Court of Special Appeals of Maryland ruled that the jury instructions were improper and therefore ordered a new trial. It held: “Medical malpractice claims are not general negligence claims, and so jury instructions on general negligence, although correct statements of Maryland law, are not supported by the facts of a case centered on the allegedly negligent conduct of a physician. Accordingly, we hold that the trial court erred in giving general negligence instructions in a medical malpractice case.”

The case is now before Maryland’s highest court, the Court of Appeals of Maryland, which is expected to uphold this decision and reject the reasonable person (instead of reasonable doctor) standard used by the lower court.

The second case deals with whether a jury in a medical liability trial may be prejudiced if they hear four medical experts testify for the physician and just one expert testify for the plaintiff. In Shallow v. Follwell, the defendant doctor performed a laparoscopic hernia repair, which was complicated by bowel perforation, atrial fibrillation, sepsis, and death.³

At trial, plaintiffs produced one expert witness, whereas Dr. Follwell had four, with expertise in cardiology, critical care, vascular surgery, and colorectal surgery. The trial court judge instructed the jury not to give weight to the number of experts on either side, and based on the testimony, the jury found that Dr. Follwell did not cause the perforated bowel or the patient’s death.

However, on appeal, the Missouri Court of Appeals overturned the verdict after finding that the trial court erred in allowing “unfairly cumulative and prejudicial repetition of certain expert opinions.” The Missouri Supreme Court is currently being asked to render a final opinion on the matter. In its supporting brief, the American Medical Association’s Litigation Center is urging the high court to “ensure that Missouri trial judges are empowered to safeguard the use of sound science in their courtrooms,” and that “given the highly specialized nature of medicine today, multiple experts may be required to ensure a jury has a proper understanding of the relevant medical science.”⁴

The third case addresses whether trial judges can suppress expert witness testimony attesting that a known complication of a medical procedure can occur absent any negligence.

The case involved a laparoscopic hysterectomy performed by a gynecologist. The patient’s bowel was perforated during the procedure.⁵ Expert witnesses from both sides testified about bowel perforation and professional standards, and the trial court allowed the defendant’s expert to state that such an injury was a commonplace risk even if surgery was performed properly.

The plaintiff objected to this testimony; but the trial judge overruled the plaintiff’s objection, and the jury found in favor of the gynecologist. Upon appeal, the Pennsylvania Superior Court reversed, concluding that the defendant’s expert testimony was irrelevant and misleading, and immaterial to the issue of whether the defendant’s treatment met the standard of care. It held that the evidence was inadmissible and ordered a new trial. The case is now before the Pennsylvania Supreme Court.

The foregoing three cases are yet to be finally adjudicated, but controversies in these and similar issues can be expected to continue. Expert testimony is dispositive at trial, and both sides rely heavily on it. Little wonder malpractice litigation is frequently framed as a “battle of the experts.”
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Internal Medicine News, “Expert medical testimony,” Sept. 9, 2010; “Qualifying as an expert,” Jan. 2, 2015; “Dispensing with expert testimony,” April 19, 2016.

2. Armacost v. Davis, 175 A.3d 150 (Ct. App. Md, 2017).

3. Shallow v. Follwell, (No. ED103811, Mo. App., Eastern Dist., Div. 4, 2017).

4. Henry TA, “Is it OK to have 4-to-1 expert ratio in medical liability case?” AMA Wire, June 22, 2018.

5. Mitchell v. Shikora, 161 A.3d 970 (Pa. Super. 2017).

Question: Which of the following statements regarding the law on evidence is incorrect?

A. Expert testimony is always needed to establish the applicable standard of care in a negligence lawsuit.

B. According to the Federal Rules of Evidence, a witness may be qualified as an expert based on knowledge, skill, experience, training, or education.

C. It is the judge, not the jury, who determines whether a witness is admissible as an expert.

D. Expert testimony is a requirement in medical malpractice lawsuits, unless a plaintiff can successfully invoke the res ipsa loquitur doctrine.

E. Only a few states have enacted statutes specifying that an expert must be in the same specialty as the defendant, and in some cases, a nonphysician such as a nurse or pharmacist may be allowed to testify.

Answer: A. Under the tort of negligence, a defendant’s conduct is measured by what is expected of the reasonable person – the man on the street. The jury can usually decide on its own, without the aid of an expert, what that level of care ought to be. However, in medical malpractice lawsuits, the law requires an expert to testify to the requisite standard of care, as this determination is believed to be beyond the scope of the layperson.

An exception, rarely invoked, is the res ipsa loquitur doctrine, where “the thing speaks for itself.” There, an expert is not necessary because of common knowledge, e.g., when a surgeon inadvertently leaves a sponge or instrument inside a body cavity.

Whether one is admitted as an expert is within the sole discretion of the judge, who is guided by the Federal Rules of Evidence. Typically, an expert is in the same medical specialty, but there are instances of professionals of unlike specialties qualifying as experts. Examples include a nephrologist testifying against a urologist, an infectious disease specialist offering an expert opinion in a stroke case, a pharmacist testifying on the issue of a medication side effect, and a nurse on bedsores.

We had previously reviewed the law governing expert medical testimony in these columns.¹ However, three recent cases awaiting final adjudication caught our attention, as they raise important and serious legal issues.

The first frontally suggests that jury members may rely on their own notion of what constitutes an appropriate standard of care. Although it is established law in Maryland that expert testimony is required to set that standard in medical malpractice litigation, the recent Maryland case of Armacost v. Davis appeared to modify this principle, leading to a plaintiff verdict.²

The facts involved a neurosurgeon’s anterior cervical discectomy and fusion surgery, which was complicated by a pinpoint opening at the end of the incision. This eventually developed into a MRSA abscess. In his lawsuit, the plaintiff alleged that surgery was neither medically necessary nor appropriate, that there was no proper informed consent, and that the diagnosis of his postoperative infection was delayed.

A pivotal part of the trial centered on a Baltimore county judge’s instructions to the jury that it could consider what a layperson would deem reasonable standard of care. Moreover, the judge refused to modify the jury instructions when the doctor-defendant objected and asked that the standard of care be measured by the expectations for a neurosurgeon. The jury returned a verdict in favor of the plaintiff in the amount of $329,000.

Upon appeal, the Court of Special Appeals of Maryland ruled that the jury instructions were improper and therefore ordered a new trial. It held: “Medical malpractice claims are not general negligence claims, and so jury instructions on general negligence, although correct statements of Maryland law, are not supported by the facts of a case centered on the allegedly negligent conduct of a physician. Accordingly, we hold that the trial court erred in giving general negligence instructions in a medical malpractice case.”

The case is now before Maryland’s highest court, the Court of Appeals of Maryland, which is expected to uphold this decision and reject the reasonable person (instead of reasonable doctor) standard used by the lower court.

The second case deals with whether a jury in a medical liability trial may be prejudiced if they hear four medical experts testify for the physician and just one expert testify for the plaintiff. In Shallow v. Follwell, the defendant doctor performed a laparoscopic hernia repair, which was complicated by bowel perforation, atrial fibrillation, sepsis, and death.³

At trial, plaintiffs produced one expert witness, whereas Dr. Follwell had four, with expertise in cardiology, critical care, vascular surgery, and colorectal surgery. The trial court judge instructed the jury not to give weight to the number of experts on either side, and based on the testimony, the jury found that Dr. Follwell did not cause the perforated bowel or the patient’s death.

However, on appeal, the Missouri Court of Appeals overturned the verdict after finding that the trial court erred in allowing “unfairly cumulative and prejudicial repetition of certain expert opinions.” The Missouri Supreme Court is currently being asked to render a final opinion on the matter. In its supporting brief, the American Medical Association’s Litigation Center is urging the high court to “ensure that Missouri trial judges are empowered to safeguard the use of sound science in their courtrooms,” and that “given the highly specialized nature of medicine today, multiple experts may be required to ensure a jury has a proper understanding of the relevant medical science.”⁴

The third case addresses whether trial judges can suppress expert witness testimony attesting that a known complication of a medical procedure can occur absent any negligence.

The case involved a laparoscopic hysterectomy performed by a gynecologist. The patient’s bowel was perforated during the procedure.⁵ Expert witnesses from both sides testified about bowel perforation and professional standards, and the trial court allowed the defendant’s expert to state that such an injury was a commonplace risk even if surgery was performed properly.

The plaintiff objected to this testimony; but the trial judge overruled the plaintiff’s objection, and the jury found in favor of the gynecologist. Upon appeal, the Pennsylvania Superior Court reversed, concluding that the defendant’s expert testimony was irrelevant and misleading, and immaterial to the issue of whether the defendant’s treatment met the standard of care. It held that the evidence was inadmissible and ordered a new trial. The case is now before the Pennsylvania Supreme Court.

The foregoing three cases are yet to be finally adjudicated, but controversies in these and similar issues can be expected to continue. Expert testimony is dispositive at trial, and both sides rely heavily on it. Little wonder malpractice litigation is frequently framed as a “battle of the experts.”
 

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. For additional information, readers may contact the author at siang@hawaii.edu.

References

1. Internal Medicine News, “Expert medical testimony,” Sept. 9, 2010; “Qualifying as an expert,” Jan. 2, 2015; “Dispensing with expert testimony,” April 19, 2016.

2. Armacost v. Davis, 175 A.3d 150 (Ct. App. Md, 2017).

3. Shallow v. Follwell, (No. ED103811, Mo. App., Eastern Dist., Div. 4, 2017).

4. Henry TA, “Is it OK to have 4-to-1 expert ratio in medical liability case?” AMA Wire, June 22, 2018.

5. Mitchell v. Shikora, 161 A.3d 970 (Pa. Super. 2017).