Genetic Testing Thriving, But Law Lags Behind

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genetic testing

By: Ryan Martin,

Genetic testing is a fast-growing area of medical technology, but in many respects the legal world has yet to match this pace.[1] These genetic tests can detect the likelihood of developing Celiac disease, Alzheimer’s, and various forms of cancer.[2] One of the most popular areas for genetic testing has been to detect gene mutations that lead to breast cancer. Although breast cancer rates have remained the same between 2005 to 2013, a recent study reported the rate of women receiving mastectomies increased 36 percent during that time.[3] Certainly this increase was partly aided by Angelina Jolie’s release of her own genetic breast cancer test subsequent double mastectomy.[4] However, this trend has shown a larger willingness to use genetic testing as a preventative health method. While this testing could save countless lives, it raises new concerns about medical malpractices cases, the privacy of one’s genetic data and how insurance companies can use this data.

Under traditional malpractice claims physicians are already at the risk for being sued for failure to: evaluate a lump, perform or analyze a mammogram, and perform or analyze a biopsy.[5] In these malpractice cases the proper care is to be determined by the then available facts which were or ought to have been known.[6] An action cannot succeed unless the diagnosis or error was made in a manner that did comply with the recognized standard of medical care by physicians in the same specialty, under the same or similar circumstances.[7] But what happens when different physicians are using different services to acquire these genetic tests, and what if it is publicized that certain tests contain serious flaws? Furthermore, if the results of a test turn out to be incorrect could a doctor be liable for having recommending that specific company?

Myriad Genetics has been the leader in genetic testing that identifies women who have an increased chance of developing breast cancer. This test detects dangerous forms of BRCA1 or BRCA2 genes that lead to a substantially higher risk for cancer.[8] If either of these genes is mutated a woman’s risk of developing breast cancer can soar to as high as 85 percent.[9] For years Myriad was the sole distributor of BRCA testing and made more than $2 billion from its BRCA tests.[10] However, the US Supreme Court overturned their patent which opened the door for other companies to begin offering the same test for significantly cheaper prices.[11]

As recently reported, Myriad is now advising that these other companies test have significant flaws and are missing these deadly mutations. Spokesman for Myriad, Ron Rogers, suggested that, “We don’t know how many people are affected, but we believe it’s hundreds of thousands.”[12] Clearly, Myriad has an interest in having its competitors have inferior test results but this raises unanswered questions as to what the recognized standard is in the field of genetic testing. As always, to reduce risk of malpractice suits, physicians should advise on any risks associated with genetic testing as well as any surgeries performed because of those results.

There is also the issue of what access someone’s family should have to their genetic results. There are currently no laws that say what a patient can or cannot do with their own genetic information.[13] However, what if that information could lead to a critical medical diagnosis in a child or sibling? Alternatively, someone who publicizes their genetic information—like Angelina Jolie—could be divulging genetic information of their family members. This raises privacy concerns and issues over who owns that information.[14]

The law has yet to catch up in the insurance realm as well. Typically, under the Genetic Information Nondiscrimination Act (GINA), health insurance companies are barred for denying coverage to people with a gene mutation.[15] However, the law does not encompass life insurance companies, long-term care, or disability insurance.[16] These insurers can ask about family history of disease and genetic information and are authorized to deny coverage if the person is deemed too risky.[17] While GINA applies at the federal level various states, such as CA, have passed legislation prohibiting discrimination based on genetic testing results.[18]

Ultimately, the world of technology is moving too fast for the legal world to keep pace. Courts must address this issues as they arise to give a sense of how genetic testing will be assessed in malpractice cases and state legislatures should take the lead to address the issues posed by genetic testing and insurance. Further information on genetic testing can be found here.

 

 

 

[1] See Genetic Testing Market Headed for Growth and Global Expansion by 2020 – Persistence Markey Research, medGadget, (Nov. 14, 2016), http://www.medgadget.com/2016/11/genetic-testing-market-headed-for-growth-and-global-expansion-by-2020-persistence-market-research.html.

[2] See id.

[3] See Gillian Mohney, Mastectomies Increased 36 Percent From 2005 to 2013, Report Finds, ABC News, (Feb. 22, 2016), http://abcnews.go.com/Health/mastectomies-increased-36-percent-2005-2013-report-finds/story?id=37116791.

[4] See Alexandra Sifferlin, Angelina Jolie’s Surgery May Have Doubled Genetic Testing Rates at One Clinic, TIME, (Sept. 2, 2014), http://time.com/3256718/angelina-jolie-genetic-testing/.

[5] See Medical Malpractice in Diagnosis and Treatment of Breast Cancer, 92 A.L.R.6th 379.

[6] See id.

[7] See id.

[8] See Sharon Begley, As revenue falls, a pioneer of cancer gene testing slams rivals with overblown claims, STAT, (Nov. 29, 2016), https://www.statnews.com/2016/11/29/brca-cancer-myriad-genetic-tests/.

[9] See Dr. Ian Shyaka, Breast cancer: Early detection is the key to survival, The NewTimes, (Nov. 14, 2016), http://www.newtimes.co.rw/section/article/2016-11-14/205322/

[10] See Begley, supra note 8.

[11] See Leo O’Connor, Experts Debate MDx Industry Impact of AMP v Myriad Three Years After Court’s Decision, genomeweb, (Nov. 15, 2016), https://www.genomeweb.com/business-news/experts-debate-mdx-industry-impact-amp-v-myriad-three-years-after-courts-decision

[12] See Begley, supra note 8.

[13] See Emily Mullin, Do your Family Members Have a Right to Your Genetic Code?, MIT Tech. Rev., (Nov. 22, 2016), https://www.technologyreview.com/s/602946/do-your-family-members-have-a-right-to-your-genetic-code/.

[14] See Privacy in Genomics, Nat’l Human Genome Research Inst., (Apr. 21, 2015), https://www.genome.gov/27561246/privacy-in-genomics/.

[15] Genetic Information Nondiscrimination Act of 2008, Pub. L. No. 110-233, 122 Stat. 881 (2008).

[16] See Christina Farr, If You Want Life Insurance, Think Twice Before Getting A Genetic Test, Fast Company, (Feb. 17, 2016), https://www.fastcompany.com/3055710/if-you-want-life-insurance-think-twice-before-getting-genetic-testing.

[17] See id.

[18] See id.

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