ALABAMA UPDATE: Duty to Warn
August 15, 2014
Under Alabama law, a plaintiff claiming personal injury from a generic drug may have a cause of action for fraud or suppression against the drug company that manufactured the brand name drug. Does this mean that the Alabama Supreme Court has broken down traditional tort concepts of foreseeability and reliance, or flung open the product liability gates in non-pharmaceutical contexts? No, not at all.
In Wyeth, Inc., v. Danny Weeks and Vicki Weeks, the Supreme Court of Alabama (Special Term, 2014; 1101397) answered a certified question from the United States District Court for the Middle District of Alabama, Southern Division (Case No. 1:10 cv 602). On Application for Rehearing, Justice Bolin delivered the high court’s opinion. While creative litigants may cite this new Alabama case to extend duties to warn and to enlarge fraud causes of action against brand name manufacturers in personal injury cases stemming from another manufacturer’s generic equivalent product, Wyeth v. Weeks contains distinguishing features highly peculiar to the pharmaceutical world.
The Weekses asserted that Wyeth owed a duty to warn Danny Weeks’ physician concerning risks associated with a name brand medication; and that, as third-parties, the Weekses had the right to sue Wyeth when allegedly injured after taking a generic medication manufactured by a different company. Wyeth unsuccessfully argued that the claim really was just a products liability claim. Along the way, the Alabama Supreme court restated that the AEMLD does not subsume negligence or wantonness claims; and that fraudulent suppression likewise is a separate claim. In answering the question in favor of the Weekses, Alabama’s high court provided reasons that set this case apart from more commonplace duty to warn or product liability cases: the uniqueness of the pharmaceutical industry, with extensive FDA regulation and control; specific labeling rules; the learned¬intermediary doctrine; and the peculiar nature of weighing the benefits of life-saving medication against the risks of sometimes serious side-effects. These are not at issue when the products are machine guards, mascara and motor boats.
The Alabama Supreme Court made clear that this holding concerned “a product that, unlike any other product on the market, has unprecedented federal regulation. Nothing in this opinion suggests that a plaintiff can sue Black & Decker for injuries caused by a power tool manufactured by Skil based on labeling or otherwise.” And for the products liability practitioner, the high court articulated that the Weeks’ case was “premised upon liability not as a result of a defect in the product itself but as a result of statements made by the brand name manufacturer that Congress, through the FDA, has mandated be the same on the generic version of the brand name drug.” Therefore, non-pharmaceutical manufacturers of most consumer goods need not linger too long over this interesting case. Here is a link to see the full opinion:
https://acis.alabama.gov/displaydocs.cfm?no=598790&event=4510LWIH3
Danny Collier practices in Alabama and Mississippi, and can be reached at dcollier@lchclaw.com. Luther, Collier, Hodges & Cash, LLP's website is www.lchclaw.com.