Last week, the law school at Arizona State University announced the news that it had been awarded a substantial grant aimed at research into personalized medicine—specifically, the liability issues that flow from it.
The almost-$900,000, three-year grant goes to a team led by Gary Marchant, a professor at the school. The grant was made by the National Institutes of Health’s National Human Genome Research Institute. His project’s title is “Liability in the Delivery of Personalized Medicine: Driver, Impediment, or Both?”
In the school’s press release, Professor Marchant is quoted:
“Liability is likely to be an increasingly important driver of personalized medicine, but it can be a double-edged sword. Our goal in this project is to first understand the dynamics and likely trajectory of liability in the field of personalized medicine. We then will try to shape liability impacts to be a positive rather than detrimental influence on the deployment of personalized medicine technologies and knowledge.”
If you read Arizona Attorney Magazine, you have read Gary’s work before. (Professor Gary Marchant is the ASU Lincoln Professor of Emerging Technologies, Law and Ethics at the Sandra Day O’Connor College of Law, and Faculty Director of the College of Law’s Center for Law, Science & Innovation.)
Gary’s collaboration with us at Arizona Attorney came in 2007, after he and I “met” on a national telephone conference on the topic of personalized medicine. Pleased to hear another Arizona voice on the conference call, I sent him an email while we all chatted. He followed up by graciously agreeing to write something on the topic for us.
The result was an October 2007 cover story on personalized medicine. In that article, he included a substantial portion on liability issues, so we may have gotten a preview of his study’s focus. Here is some of what he said then:
“One looming legal issue is the potential liability risks that PM may present for pharmaceutical manufacturers, genetic test providers and health care professionals. …
“All drug manufacturers now routinely collect genetic information of patients enrolled in pharmaceutical clinical studies. A manufacturer may face liability if these data show that certain genotypes are more susceptible to adverse side effects to a drug that is subsequently marketed without adequate genetic warnings. Drug manufacturers are legitimately concerned that genetic data of unknown or ambiguous significance at the time it is collected will be seen in hindsight by a jury in a product liability case many years later, relying on new evidence available at the time of trial, as evidence of a genetic susceptibility for which a warning should have been provided. Drug manufacturers are also concerned that pharmacogenomics will limit the sales of their new blockbuster drugs to specific genotypes within the population, and may be vulnerable to “failure to test” claims if they do not diligently investigate potential genetic susceptibilities to their drugs that may reduce their market by 50 percent or more. …
“Health care professionals are likely the most vulnerable to liability risks associated with PM. State-of-the-art diagnosis, prognosis and treatment of disease will increasingly rely on genetic characterization of the patient and his or her disease. Yet many doctors lack any training in genetics. And even those who have understanding lack the infrastructure and guidance needed to effectively use the pharmacogenomic information that is increasingly appearing on drug labels. … As the nation’s leading medical institutions implement new PM tests and knowledge as they emerge, the standard of care will shift rapidly, leaving many physicians behind. These doctors may increasingly face the risk of lawsuits if they fail to consider genetics adequately when prescribing a drug with known severe side effects or recommend the wrong course of treatment for a tumor with a genetic profile suggesting a different approach.”
Congratulations to Gary, and to the law school. We look forward to the results of the study, which should yield insights for policymakers and lawyers alike.Follow @azatty