Deepthy Kishore, Test at Your Own Risk: Your Genetic Report Card and the Direct-to-consumer Duty to Secure Informed Consent

• Publication year: 2010

TEST AT YOUR OWN RISK: YOUR GENETIC REPORT CARD AND THE DIRECT-TO-CONSUMER DUTY TO SECURE INFORMED CONSENT

Deepthy Kishore

ABSTRACT

On June 26, 2000, President Bill Clinton and Prime Minister Tony Blair announced that new gene sequencing techniques had accelerated the progress of the Human Genome Project; for the first time ever, scientists had completed a "rough draft" of the human genome. The announcement inspired a worldwide debate about cloning and genetic engineering, prompting both public curiosity and fierce debate about the nebulous science of predicting one's lifespan and assessing the likelihood for developing disease. A host of companies, some of which market their services over the Internet, have since made genetic testing available directly to consumers.

The emergence of direct-to-consumer (DTC) genetic testing raises important questions about how best to protect consumers from misinterpreting the meaning of their genetic makeup and has sparked discussion about how much and what kind of information a company should disclose to adequately warn consumers of the risks of undergoing genetic testing. Moreover, recent news events suggest that the Food and Drug Administration (FDA) will soon attempt to regulate DTC genetic testing: In May 2010, CVS drugstores and sixty thousand Walgreens drugstores suspended their plans to sell genetic test kits after the FDA announced that it would investigate DTC genetic testing companies.

Selling access to individual genetic information has transposed the physician-patient relationship into a company-consumer context, calling for a novel examination of how consumer and patient protections overlap and where federal regulation ends and tort law begins. This Comment applies principles of products liability and informed consent to the context of genetic testing to argue that tort liability, rather than greater regulation of genetic tests, is the best way to protect consumers of DTC genetic testing. This Comment demonstrates that without professional assistance, consumers risk misinterpreting the meaning of their genetic test results and may even be driven to take drastic actions based on that information. Thus, it asserts that where genetic testing services are marketed directly to consumers, the required level of disclosure should be the same as that under the doctrine of informed consent: Courts should impose a duty on companies engaged in DTC genetic testing to provide complete warnings, akin to the warnings physicians must provide patients in accordance with informed consent. The ultimate goal of the duty of disclosure proposed by this Comment is to protect and promote the autonomy of the consumer-patient.

INTRODUCTION ............................................................................................ 1556

I. MEDICAL TESTS IN A REGULATORY VACUUM: THE

COMMERCIALIZATION OF GENETICS ................................................ 1561

A. The "Medical Services" Quandary of Direct-to-Consumer

Genetic Testing ......................................................................... 1562

1. The Competing Goals of Consumerism and the Need to

Protect Patients from Harm ............................................... 1563

2. Genetic Testing Services and the "Practice of Medicine" . 1564

B. Federal Regulations Are Necessary but Insufficient to Protect

Consumers ................................................................................ 1568

C. The Solution: "Regulation" Through Tort Liability ................ 1572

II. INFORMED CONSENT AND AUTONOMY ............................................ 1576

A. The Legal Doctrine of Informed Consent ................................. 1577

B. Autonomy as the Foundation of Informed Consent .................. 1581

C. "Adequate Disclosure" and Informed Consent Are "Two

Sides of the Same Coin" ........................................................... 1582

D. The Patient-Based Standard as a Consumer-Based Standard . 1584

III. WHEN THE CONSUMER'S AUTONOMY IS DIMINISHED ..................... 1587

A. Diminished Autonomy Through Misunderstanding .................. 1588

B. Diminished Consumer Autonomy Through Aggressive

Advertising ................................................................................ 1590

C. The Solution: The Doctrine of Informed Consent ..................... 1593

IV. THE DIRECT-TO-CONSUMER DUTY TO SECURE INFORMED

CONSENT .......................................................................................... 1595

A. Direct-to-Consumer Genetic Testing and Informed Consent for HIV Testing ......................................................................... 1596

B. The Greater Duty of Disclosure for Elective Procedures ........ 1600

C. The Analogous Duty to Warn in Products Liability and What

It Means for Direct-to-Consumer Genetic Testing ................... 1601

1. When the Physician's Role Is Attenuated, Courts Have

Placed the Duty to Warn on the Drug Manufacturer ......... 1601

2. DTC Genetic Testing Companies Are in the Superior Position to Inform Consumers of the Risks of Genetic Testing Services .................................................................. 1606

CONCLUSION ................................................................................................ 1609

INTRODUCTION

In medical genetics, we have seen first hand in the faces of expectant mothers undergoing prenatal testing or in the families of patients with rare disorders, the power of information to disrupt emotions and lives.¹

-James P. Evans & Robert C. Green

I know no safe depository of the ultimate powers of the society but the people themselves; and if we think them not enlightened enough to exercise their control with a wholesome discretion, the remedy is not to take it from them but to inform their discretion by education.²

-Thomas Jefferson

On September 30, 2008, the American actress Christina Applegate appeared on The Oprah Winfrey Show to explain to millions of viewers her dramatic decision to have both her breasts removed as a result of information she received from a genetic test.³Applegate made her decision after an MRI and biopsy detected early-stage cancer in her left breast, and subsequent genetic testing revealed that she had inherited BRCA, the "breast cancer gene."⁴Fearful that her other breast was also at risk because of her genetic predisposition, Applegate decided to undergo a double mastectomy.⁵"I'm clear. Absolutely 100 percent clear and clean,"⁶she assured viewers on Good

Morning America, and "I'm definitely not going to die from breast cancer."⁷

Her preemptive strike against recurring breast cancer was not without emotional costs: "I cry at least once a day about it because it's hard to overlook it when you're standing there in the mirror."⁸

Imagine that a twenty-seven-year-old graduate student, Sarah,⁹watches the show. Having seen her mother survive breast cancer, she is especially vulnerable to suggestions that she might develop it herself.¹⁰Applegate's plight inspires her to undergo genetic testing, and a quick Google search reveals that she can order a whole-genome scan for $499; a doctor's authorization is not required.¹¹Sarah mails the company her saliva sample, and just days later it sends her a report informing her that she has inherited a gene variant that gives her a 60%-90% chance of developing breast cancer.¹²

Her obsession with her high risk grows, and she searches constantly for a lump in her breast. She avoids her family members to prevent them from worrying about her and is haunted by memories of chemotherapy appointments that aged her mother.¹³She is overwhelmed with a sense of doom and confused about her numerical odds-what does it mean to have a 10%-40% chance of never developing breast cancer? Should she undergo a mammogram every year? Every few months? Should she see an oncologist to discuss her fears? A plastic surgeon to remove her breasts?

This hypothetical demonstrates why consumers should be apprised of the implications and possible impact of genetic test results before purchasing such services.¹⁴If Sarah had been aware of the emotional risks in advance of receiving information about her genetic makeup, would she have wanted to learn of her genetic risks? At the time she ordered the genetic scan, Sarah did not realize that receiving information about her genetic susceptibilities could give rise to difficult decisions about how to manage her risk for breast cancer,¹⁵or that it might cause her significant anxiety regarding the genetic makeup of her family members and future children.¹⁶She did not anticipate the distress that might accompany "inconclusive" results.¹⁷Nor did she expect to discover that Applegate's assurances were not exactly correct-a double mastectomy significantly decreases the chances of later developing breast cancer but does not guarantee prevention.¹⁸Had she sought genetic counseling before ordering the test, Sarah might have benefited from such disclosures.¹⁹

However, the direct-to-consumer genetic testing company has no legal responsibility to provide her with any such information.²⁰

Fortunately, Sarah can pursue prophylactic surgery or other treatments²¹to reduce her risk for developing breast cancer. But other consumers may learn that no clinical interventions are available to address their particular genetic risks, and they may experience severe emotional distress as a result.²²For example, would a consumer agree to purchase a genetic testing service if she were to know in advance that she may learn of a high risk for developing

Alzheimer's disease, for which there is currently no cure or preventative treatment?²³

Prenatal genetic tests are of particular concern because consumers might use the information from the tests to decide whether to terminate a pregnancy.²⁴In many states consumers can order such tests without a physician's authorization and at an affordable price.²⁵One company, Counsyl, sells a testing service that can determine whether...