Tuesday, July 24, 2012

Accutane Warnings Adequate as a Matter of Law

This just in.  A federal MDL court in Florida has granted summary judgment in an Accutane case, holding that the drug's warnings with respect to inflammatory bowel disease ("IBD" - the same claims that have produced significant jury awards in certain other venues that shall remain nameless) are adequate as a matter of New York law.  The main holding:

Here, Defendants argue that [defendant's] extensive IBD warnings in place during the time Plaintiff used Accutane (in 2004) were adequate as a matter of law. The Court agrees. The Physician Package Insert plainly and prominently identified inflammatory bowel disease by name as a possible consequence of taking Accutane. This risk information appeared in the “WARNINGS” and “ADVERSE REACTIONS” sections of the insert. It also identified the common symptoms of IBD and instructed what should be done if those symptoms appeared. . . . Both independently and taken together, these formulations communicated the same essential message to prescribing physicians: IBD is a potential risk of Accutane.

In re Accutane Products Liability Litigation, MDL 1626, slip op. at 10 (M.D. Fla. July 24, 2012).  Once an adequate warning is given, the defendant's duty is complete.  "[Defendant] had no duty to warn Plaintiff directly or otherwise ensure that her prescribing physician conveyed appropriate warnings to her."  Id. at 11.

Moreover, under New York's "across the board" application of comment k, the adequate warning precludes design-related claims:
[U]nder New York law, an adequate warning bars design defect liability against the manufacturer. . . .  Although a prescription drug is by its nature an inherently unsafe product and would in the usual case impute strict liability to its manufacturer, a defense is provided against such liability when the drug is properly prepared, and accompanied by proper directions and warning.  Therefore, even though its side effects may cause injury, a prescribed drug, accompanied by adequate warnings, is not defective, nor is it unreasonably dangerous.

Slip op. at 11-12 (emphasis added) (quoting in part NY Court of Appeals decision).

This is why on this Blog we push removal before service and other means of obtaining federal subject matter jurisdiction.  There has yet to be a judicial hellhole in federal court.

Thanks to Mike Imbroscio at Covington for passing this gem along.