Medicolegal Issues

Is there liability if you don’t test for BRCA?

OBG Manag. 2021 March;33(3):39-46 | doi: 10.12788/obgm.0077

References

Sevilla C, Moatti JP, Reynier CJ, et al. Testing for BRCA1 mutations: a cost-effective analysis. Europ J Human Genetics. 2002;10:599-606.
Cotton V, Kirkpatrick D. Failure to recommend genetic counseling in breast cancer: is the next wave of medical professional liability lawsuits? Contemp OB/GYN. June 1, 2017.
Suryavanshi M, Kumar D, Panigrahi M, et al. Detection of false positive mutations in BRCA gene by next generation sequencing. Fam Cancer. 2017;16:311-317.
Black L, Knoppers B, Avard D, et al. Legal liability and the uncertain nature of risk prediction: the case of breast cancer risk prediction models. Public Health Genomics. 2012;15:335-340.
McClintock A, Gollab A, Laya M. Breast cancer risk assessment, a step-wise approach for primary care physicians on the front lines of shared decision making. Mayo Clin Proc. 2020;95:1268-1275.
National Cancer Institute. The Breast Cancer Risk Assessment Tool. https://bcrisktool.cancer.gov/. Accessed February 25, 2021.
Neff J, Richardson G, Phelps J. Legal liabilities associated with hereditary breast and ovarian cancers. J Reprod Med. 2020;65:227-230.
American College of Obstetricians and Gynecologists. Practice Bulletin No 182: hereditary breast and ovarian cancer syndrome. Obstet Gynecol. 2017;130:e110-e126.
Sá dos Reis C, Gremion I, and Meystre NR. Study of breast implants mammography examinations for identification of suitable image quality criteria. Insights Imaging. 2020;11:3.
Association for Molecular Pathology v Myriad Genetics, 569 U.S. 576 (2013).
Smith SR. The Supreme Court 2012-2013: dogs, DNA, and DOMA. Register Rep. 2013;39(Fall):26-33.
Bal BS. An introduction to medical malpractice in the United States. Clin Orthop Relat Res. 2009;467:339-347.
Helling v Carey, 83 Wn.2d 514, 519 P.2d 981 (1974).
The T.J. Hooper, 60 F.2d 737, 740 (2d Cir.1932), cert. denied 287 U.S. 662 (1932).
Fischer DA. Tort recovery for loss of a chance. Wake Forest L Rev. 2001;36:605-655.
Murphy BL, Ray-Zack MD, Reddy PN, et al. Breast cancer litigation in the 21st century. Ann Surg Oncol. 2018;25:2939- 2947.
Prince AE. Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease. J Law Biosci. 2015;2:365-395.
Marchant G, Barnes M, Evans JP, et al; LawSeq Liability Task Force. From genetics to genomics: facing the liability implications in clinical care. J Law Med Ethics. 2020;48:11-43.
Complaint, Held v Ambry Genetics Corp., No. 15-CV-8683, 2015 WL 6750024 (S.D.N.Y. Nov. 4, 2015); Order of Dismissal, Held v Ambry Genetics Corp., No. 15-CV-8683, (S.D.N.Y. Dec. 6, 2016).
Pederson HJ. Breast cancer risk assessment and treatment: current concepts in genetics and genomics. Contemp OB/ GYN. 2017; 62:A1-A4.
Pederson HJ. Who needs breast cancer genetics testing? OBG Manag. 2018;30:34-39.
Roberts JL, Foulkes A. Genetic duties. William Mary L Rev. 2020;62:143-212.
Thorogood A, Cook-Deegan R, Knoppers B. Public variant databases: liability? Genet Med. 2017;19:838–841.
Marchant G, Lindor R. Genomic malpractice: an emerging tide or gentle ripple? Food Drug Law J. 2018;73:1-37.
National Human Genome Research Institute. Genetic discrimination. https://www.genome.gov/about-genomics /policy-issues/Genetic-Discrimination. Updated September 16, 2020. Accessed February 25, 2021.
National Cancer Institute. BRCA mutations: cancer risk and genetic testing. https://www.cancer.gov/about-cancer /causes-prevention/genetics/brca-fact-sheet. Reviewed November 19, 2020. Accessed February 25, 2021.
National Cancer Institute. Genetics of breast and gynecologic cancers (PDQ®)–Health Professional Version. https://www .cancer.gov/types/breast/hp/breast-ovarian-genetics-pdq. Updated February 12, 2021. Accessed February 25, 2021.
Reed v Campagnolo, 630 A.2d 1145, 1152–54 (Md. 1993).
Munro v Regents of Univ. of Cal.,263 Cal. Rptr. 878, 885, 988 (1989).
AMA Council on Ethical and Judicial Affairs. AMA Code of Medical Ethics’ opinions on genetic testing. Opinion 2.131. 2009;11:683-685. https://journalofethics.ama-assn .org/article/ama-code-medical-ethics-opinions-genetictesting/2009-09.
Gilbar R, Barnoy S. Disclosing genetic test results to the patient’ relatives: how does the law influence clinical practice? J Law Technol Policy. 2019;125-168.
Song K. Warning third parties of genetic risks in the era of personalized medicine. U.C. Davis L Rev. 2016;49:1987-2018.
Tarasoff v Regents of the University of California, 551 P.2d 334, 131 Cal. Rptr. 14 (Cal. 1976).
Safer v Estate of Pack, 677 A.2d 1188 (N.J. App. 1996), cert. denied, 683 A.2d 1163 (N.J. 1996).
Pate v Threlkel, 661 So.2d 278 (Fla. 1995).
Rothstein MA. Liability issues in pharmacogenomics. Louisiana L Rev. 2005;66:117-124.
Marchant G, Lindor R. Personalized medicine and genetic malpractice. Genet Med. 2013;15:921-922.
Westbrook M. Transforming the physician’s standard of care in the context of whole genome sequencing technologies: finding guidance in best practice standards. Saint Louis U J Health Law Policy. 2015;9:111-148.

Was there liability in our example case?

The hypothetical case provided above suggests that there could be liability. Routine medical history by the primary care physician would have produced the fact that the patient’s mother, sister, and maternal grandmother had breast cancer. That would clearly have put her in a category of those who should have received genetic testing. Yet, she was not tested until after her cancer was found. From the limited facts we have, it appears that this timeline of events would have been outside accepted practice—and negligent. The case was not pursued by the patient, however, and this may represent the current state of liability for BRCA issues.

The extent of liability seems to be significant

Our discussion of liability suggests that there is significant potential for BRCA testing negligence within practice, and that the damages in these cases could be substantial. Yet the predicted “tsunami” of malpractice lawsuits related to genetic testing has not appeared.^36,37 One study of cases in the United States (through 2016) found a “slowly rising tide” of liability cases instead of a tsunami,²⁴ as the number of claims made was low. On the other hand, the payments where damages were awarded were an order of magnitude larger than other malpractice cases—a mean of $5.3 million and median of $2 million. This is compared with mean values in the range of $275,000 to $600,000 in other areas of malpractice.

The majority of the genetic malpractice cases involve prenatal and newborn testing, and diagnosis/susceptibility/pharmacogenomic accounting for about 25% of cases. In terms of type of errors claimed, approximately 50% were diagnostic-interpretation errors, 30% failure to offer testing, nearly 20% failure to return test results to the patients, and a few remaining cases of failure to properly treat in light of genetic testing.²⁴

Despite a few very large payments, however, the fact remains that there is a surprisingly low number of genetics malpractice cases. Gary Marchant and colleagues suggest that several reasons may account for this:

the clinical implementation of genetic science has been slower than expected
the lack of expertise of many physicians in genetic science
expert witnesses have sometimes been hard to find
the lack of understanding by plaintiffs’ attorneys of genetic malpractice
potential plaintiffs’ lack of understanding of the nature of genetic testing and the harms resulting from genetic negligence.^17,24,37

The tide is slowly coming in

By all appearances, there is every reason to think that genetic malpractice will be increasing, and that the recent past of much higher damages per claim paid in the genetics area will be part of that tide. The National Human Genome Research LawSeq project has suggested a number of useful ways of dealing with the liability issues.¹⁸ In addition to the BRCA issues that we have considered in this article for ObGyns, there are other critical issues of prenatal and newborn genetic testing.³⁸ But those are topics for another day. ●

References

Sevilla C, Moatti JP, Reynier CJ, et al. Testing for BRCA1 mutations: a cost-effective analysis. Europ J Human Genetics. 2002;10:599-606.
Cotton V, Kirkpatrick D. Failure to recommend genetic counseling in breast cancer: is the next wave of medical professional liability lawsuits? Contemp OB/GYN. June 1, 2017.
Suryavanshi M, Kumar D, Panigrahi M, et al. Detection of false positive mutations in BRCA gene by next generation sequencing. Fam Cancer. 2017;16:311-317.
Black L, Knoppers B, Avard D, et al. Legal liability and the uncertain nature of risk prediction: the case of breast cancer risk prediction models. Public Health Genomics. 2012;15:335-340.
McClintock A, Gollab A, Laya M. Breast cancer risk assessment, a step-wise approach for primary care physicians on the front lines of shared decision making. Mayo Clin Proc. 2020;95:1268-1275.
National Cancer Institute. The Breast Cancer Risk Assessment Tool. https://bcrisktool.cancer.gov/. Accessed February 25, 2021.
Neff J, Richardson G, Phelps J. Legal liabilities associated with hereditary breast and ovarian cancers. J Reprod Med. 2020;65:227-230.
American College of Obstetricians and Gynecologists. Practice Bulletin No 182: hereditary breast and ovarian cancer syndrome. Obstet Gynecol. 2017;130:e110-e126.
Sá dos Reis C, Gremion I, and Meystre NR. Study of breast implants mammography examinations for identification of suitable image quality criteria. Insights Imaging. 2020;11:3.
Association for Molecular Pathology v Myriad Genetics, 569 U.S. 576 (2013).
Smith SR. The Supreme Court 2012-2013: dogs, DNA, and DOMA. Register Rep. 2013;39(Fall):26-33.
Bal BS. An introduction to medical malpractice in the United States. Clin Orthop Relat Res. 2009;467:339-347.
Helling v Carey, 83 Wn.2d 514, 519 P.2d 981 (1974).
The T.J. Hooper, 60 F.2d 737, 740 (2d Cir.1932), cert. denied 287 U.S. 662 (1932).
Fischer DA. Tort recovery for loss of a chance. Wake Forest L Rev. 2001;36:605-655.
Murphy BL, Ray-Zack MD, Reddy PN, et al. Breast cancer litigation in the 21st century. Ann Surg Oncol. 2018;25:2939- 2947.
Prince AE. Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease. J Law Biosci. 2015;2:365-395.
Marchant G, Barnes M, Evans JP, et al; LawSeq Liability Task Force. From genetics to genomics: facing the liability implications in clinical care. J Law Med Ethics. 2020;48:11-43.
Complaint, Held v Ambry Genetics Corp., No. 15-CV-8683, 2015 WL 6750024 (S.D.N.Y. Nov. 4, 2015); Order of Dismissal, Held v Ambry Genetics Corp., No. 15-CV-8683, (S.D.N.Y. Dec. 6, 2016).
Pederson HJ. Breast cancer risk assessment and treatment: current concepts in genetics and genomics. Contemp OB/ GYN. 2017; 62:A1-A4.
Pederson HJ. Who needs breast cancer genetics testing? OBG Manag. 2018;30:34-39.
Roberts JL, Foulkes A. Genetic duties. William Mary L Rev. 2020;62:143-212.
Thorogood A, Cook-Deegan R, Knoppers B. Public variant databases: liability? Genet Med. 2017;19:838–841.
Marchant G, Lindor R. Genomic malpractice: an emerging tide or gentle ripple? Food Drug Law J. 2018;73:1-37.
National Human Genome Research Institute. Genetic discrimination. https://www.genome.gov/about-genomics /policy-issues/Genetic-Discrimination. Updated September 16, 2020. Accessed February 25, 2021.
National Cancer Institute. BRCA mutations: cancer risk and genetic testing. https://www.cancer.gov/about-cancer /causes-prevention/genetics/brca-fact-sheet. Reviewed November 19, 2020. Accessed February 25, 2021.
National Cancer Institute. Genetics of breast and gynecologic cancers (PDQ®)–Health Professional Version. https://www .cancer.gov/types/breast/hp/breast-ovarian-genetics-pdq. Updated February 12, 2021. Accessed February 25, 2021.
Reed v Campagnolo, 630 A.2d 1145, 1152–54 (Md. 1993).
Munro v Regents of Univ. of Cal.,263 Cal. Rptr. 878, 885, 988 (1989).
AMA Council on Ethical and Judicial Affairs. AMA Code of Medical Ethics’ opinions on genetic testing. Opinion 2.131. 2009;11:683-685. https://journalofethics.ama-assn .org/article/ama-code-medical-ethics-opinions-genetictesting/2009-09.
Gilbar R, Barnoy S. Disclosing genetic test results to the patient’ relatives: how does the law influence clinical practice? J Law Technol Policy. 2019;125-168.
Song K. Warning third parties of genetic risks in the era of personalized medicine. U.C. Davis L Rev. 2016;49:1987-2018.
Tarasoff v Regents of the University of California, 551 P.2d 334, 131 Cal. Rptr. 14 (Cal. 1976).
Safer v Estate of Pack, 677 A.2d 1188 (N.J. App. 1996), cert. denied, 683 A.2d 1163 (N.J. 1996).
Pate v Threlkel, 661 So.2d 278 (Fla. 1995).
Rothstein MA. Liability issues in pharmacogenomics. Louisiana L Rev. 2005;66:117-124.
Marchant G, Lindor R. Personalized medicine and genetic malpractice. Genet Med. 2013;15:921-922.
Westbrook M. Transforming the physician’s standard of care in the context of whole genome sequencing technologies: finding guidance in best practice standards. Saint Louis U J Health Law Policy. 2015;9:111-148.

Is there liability if you don’t test for BRCA?

References

Was there liability in our example case?

The extent of liability seems to be significant

The tide is slowly coming in

Pages

Recommended Reading