We’ve discussed before how we expect genetic testing of plaintiffs to become routine in prescription medical product liability litigation. The cost of such testing is constantly plummeting, even more steeply than would be predicted by Moore’s Law. We even proposed a rule of federal procedure to govern the conditions under which such testing could
Bexis recently attended the “Emerging Issues in Mass-Tort MDLs Conference” sponsored by Duke Law School (those of us from Philly remember Duke as part of “Black Saturday” back in 1979). Several panels discussed various issues relating to MDLs including using early, issue-specific fact sheets, which Bexis advocated be considered amended pleadings subject to Rule 8
Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On that same day, co-blogger Steve Boranian alerted Bexis to a new defense argument in asbestos/mesothelioma cases that also utilizes genomics – certain mutations in a gene called “BAP1” – to identify persons at greater risk of idiopathic (that is, not related to asbestos) mesothelioma. Here’s a link to that article. A verifiable alternative cause could be a game-changer for asbestos litigation. The statement we quoted back in 2009, uttered by the first person ever to have his genome individually sequenced, that “individual genes are just not very informative,” appears in the process of being disproven by ongoing scientific events.
Both items, as informative as they were on scientific facts, were rather short on the law. That’s where we come in. We thought we’d take a look at what law exists concerning the intersection of pharmacogenomics, personalized medicine, and prescription medical product liability litigation. We’ve touched on these issues back in 2011, when we blogged about Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), one of the first cases in which the plaintiff made allegations about pharmacogenomically-based risks. Back then we said:
The plaintiff is claiming that a drug is defective, not because of anything inherent in the drug itself, but solely because it is less effective (and therefore has a different risk-benefit profile) due to the plaintiff’s peculiar genetic makeup. Essentially, the allegations seek to impose a non-FDA-approved contraindication, using state law, based upon human genetic variability. With advances in computer technology making genetic testing exponentially cheaper and more detailed as times passes (see Moore’s law), more and more genetic variability in the efficacy of prescription drugs is bound to be discovered. Eventually – certainly within some of our lifetimes – we’ll be able to carry our entire individual genetic code around with us on a chip, should we so choose….
The complaint in Mills is a bare genetic susceptibility claim, frankly based on an allegation of “variant” genetic characteristics shared by only a minority of the population. In our view, unless and until – and only to the extent that – the FDA decides to assess drug approvals and contraindications on the basis of genetic subgrouping, this type of tort claim should not be recognized, because it is flatly contrary to the criteria by which the intended uses of drugs are currently determined. Claims such as in Mills, which are at loggerheads with FDA criteria for drug development, are precisely those with the most potential for making pharmaceutical manufacturers into “sitting ducks” for litigation, in this instance litigation based on extraneous genetic factors.
It may well be that the coming (and to some extent existing) revolution in genetically individualized medical therapy will require changes in how drugs are evaluated, labeled, etc., but this is a singularity-driven issue that needs to be addressed by the policy branches of our government, and not haphazardly in product liability litigation.
(Emphasis added).
We found the decision in Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), interesting for at least three reasons. First of all, it’s another TwIqbal dismissal, so it goes on our TwIqbal cheat sheet.
But what’s even more interesting is precisely what the plaintiff wasn’t able to plead.
A new lawsuit was filed in our favorite Judicial Hellhole, Madison County, Illinois, alleging that a pharmaceutical company failed to warn that African-Americans face an elevated risk of certain dermatological side-effects from Tegretol. At this point it’s merely a complaint. Anyone with a word processor and a check can file one, especially in Madison County.
J.C. McElveen, of Jones Day, submitted the following guest post, for which we thank him. As is always true of guest posts, our guest gets all the credit for what follows:
Relatively few legal cases have discussed the newly emergent field of genomics, but there is no shortage of discussion on the subject. In