May 17, 2019 Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing. As these questions become more pressing, now is the time to re-consider what ethical and regulatory safeguards should be implemented and discuss the many questions raised by advancements in consumer genetics. Presentation: Gary Marchant, Regent's Professor, Sandra Day O'Connor College of Law and Director, Center for Law, Science, and Innovation, Arizona State University (with Mark Barnes, Ellen W. Clayton, and Susan M. Wolf) - Liability Implications of Direct-to-Consumer Genetic Testing Learn more: https://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

1. Liability Implications of
Direct-to-Consumer Genetic Testing
Gary Marchant, Ph.D., J.D.
2019 Petrie-Flom Center Annual Conference on
Consuming Genetics:
Ethical and Legal Considerations of New Technologies
May 17, 2019

2. DTC Genetic Testing:
Lots of Testing,
….. And Lots of Errors

3. Source: Technology Review, 2019

6. Clinical Pharmacology & Therapeutics | VOLUME 95 NUMBER 6 | JUNE 2014

7. Liability?

8. Potential DTC Genetic Testing
Injuries That Could Create Liability
 Patient falsely tests positive for BRCA variant,
undergoes unnecessary prophylactic surgery
 Patient with family history of colon cancer falsely
tests negative for colon cancer variant; patient
reassured and takes no further action, develops
colon cancer 3 years later
 Patient receives erroneous results on warfarin
sensitivity; given wrong dose based on incorrect
DTC info, suffers serious bleeding or stroke
event

9. Two Liability Scenarios
1. DTC Company liable for erroneous
genetic test results
2. Personal physician of DTC customer
liable for mishandling genetic test
results

10. DTC Company

11. What is a DTC Genetic Testing
Company?
 Laboratory (non-provider)?
• Negligence
 Laboratory (health care provider)?
• Medical malpractice
 Product?
• Products liability

12. Restriction on Suing DTC
Company: Disclaimer (23andMe)
 “…this information is intended for informational
purposes only and for discussion with your physician
or other healthcare provider. As explained on our
website, 23andMe believes that (a) genetics is only part of
the picture of any individual's state of being, (b) the state
of the understanding of Genetic Information is rapidly
evolving and at any given time we only comprehend part of
the picture of the role of genetics, and (c) only a trained
physician or other health care provider can assess
your current state of health or disease, taking into
account many factors, including in some cases your
genetics as well as your current symptoms, if any.
Reliance on any information provided by 23andMe,
23andMe employees, others appearing on our website at
the invitation of 23andMe, or other visitors to our website
is solely at your own risk.”

13. Restriction on Suing DTC
Company: Arbitration (23andMe)
 “any disputes with 23andMe arising out of or relating to the
Agreement ("Disputes") shall be governed by California
law regardless of your country of origin or where you access
23andMe …. Any Disputes shall be resolved by final and
binding arbitration under the rules and auspices of the
American Arbitration Association, to be held in San Francisco,
California, in English, with a written decision stating legal
reasoning issued by the arbitrator(s) at either party's request,
and with arbitration costs and reasonable documented
attorneys' costs of both parties to be borne by the party that
ultimately loses.”

14. “Background: Customers of genetic testing service provider brought
putative class action against provider, asserting claims for unfair
business practices, breach of warranty, and misrepresentations about
the health benefits of provider's services.” N.D. Cal. “granted provider's
motion to compel arbitration pursuant to arbitration provision in provider's
terms of service agreement. Customers appealed.” Holdings:
“1 prevailing party clause in arbitration provision was not
substantively unconscionable;
2 forum selection clause in arbitration provision was not substantively
unconscionable;
3 arbitration provision's exemption for intellectual property disputes
was not substantively unconscionable;
4 provision establishing one-year limitations period did not render
arbitration provision unconscionable; and
5 unilateral modification provision did not render arbitration provision
unconscionable.
Affirmed.”

15. Physicians

16. Damned if You Don’t …
 Some physicians will apparently refuse to consider
a patient’s DTC genetic test results
 Not an unreasonable position
 clinical relevance of data is questionable
 most physicians lack expertise to evaluate genetic results
 no reimbursement for reviewing results
 But – if DTC records show significant actionable
genetic risk, physician could potentially be sued for
refusing to consider

17. Damned if You Do … (Part 1)
 Stroke patient is prescribed warfarin
 Patient shows physician DTC test results showing
variant suggesting much lower starting dose of
warfarin
 Insurer won’t pay for restesting of patient; doctor
doesn’t want to wait days for confirmatory
testing, so starts patient on lower dose
 Patient has stroke; turns out patient doesn’t have
the variant reported by DTC lab

19. Damned if You Do …
 Patient doesn’t meet current guidelines for BRCA
testing; gets DTC testing and finds out she has a
BRCA mutation
 Patient’s physician recommends retesting, but
patient’s insurer still won’t cover it, and patient
cannot afford to pay for retest
 Should physician assume that patient has BRCA
gene and recommend prophylactic surgery?

20. Downey v. Dunnington,
895 N.E.2d 271 (Ill.App. 4 Dist. 2008)
 Patient reported (incorrectly) that her mother and
sister had ovarian cancer and that her mother had
bilateral breast cancer
 Patient’s insurer wouldn’t cover BRCA testing
 Patient had bilateral prophylactic mastectomy
based on physician’s recommendation
 Later determined that patient did not have BRCA
mutation and was not at increased risk
 Patient sued physician for medical malpractice

21. Acknowledgements
 Co-authors:
 Mark Barnes, JD, LLM, Ropes & Gray LLP
 Ellen Wright Clayton, MD, JD, Vanderbilt
University Health Center
 Susan M. Wolf, JD, U. of Minnesota
 Funding:
 Funding for this work was provided by
NIH/NHGRI/NCI grant #1R01HG008605 on
“LawSeqSM: Building a Sound Legal
Foundation for Translation Genomics into
Clinical Application” (Wolf, Clayton, Lawrenz,
PIs). All views are those of the authors.