In a Matter of Weeks, Drugmakers Urge Alabama Court to Reconsider Generics Liability Ruling

Contributed by Natalie Blazer

Ever since the Supreme Court of Alabama handed down its controversial decision in Wyeth Inc. v. Weeks, No. 1101397 (Ala. Jan. 11, 2013) last month, it seems the pharmaceutical world has not stopped talking about it. As my colleague reported, the Weeks court held that a generic drug user could foreseeably rely on a brand-name drug warning and maintain a failure-to-warn claim against the brand-name manufacturer, even when the plaintiff did not ingest that manufacturer’s drug. The Supreme Court of Alabama joined only a handful of other courts in ruling this way, and was the first state supreme court to do so.

Because of the serious implications this ruling could have for drug manufacturers, particularly if other states follow Alabama’s lead, the defendants (supported by pharmaceutical industry groups) have sprung into action. On Monday, Pfizer Inc. and Schwarz Pharma Inc. urged Alabama’s highest court to throw out the Weeks decision. Several other organizations, including the U.S. Chamber of Commerce, filed amicus curiae briefs in support of the request.

In challenging Weeks, the drugmakers argued that in taking such an “extreme outlier position,” the majority misapprehended Pliva v. Mensing, 131 S.Ct. 2567, a 2011 decision that holds state-law failure-to-warn claims against generics manufacturers are preempted by federal law. The drugmakers’ brief argued that since Mensing, each of 16 courts other than the Alabama Supreme Court to consider so-called innovator liability has rejected the theory, including three federal appeals courts. In putting aside previous decisions in Alabama rejecting innovator liability, the Weeks majority pointed out that those rulings had come before Mensing.

In what turned out to be good timing for the drugmakers, the U.S. Food and Drug Administration confirmed earlier this month that it may effectively overrule Mensing by allowing generics makers to change their labeling. Thus, the drugmakers had the opportunity to argue in their brief that “rather than distorting settled law to saddle manufacturers with indefinite liability for their competitors’ products, the court should defer to the appropriate policymaking bodies.”

Finally, and not surprisingly, the drugmakers argued that the Weeks decision violates manufacturers’ due process rights by ignoring important Alabama tort law principles, such as the requirement that plaintiffs asserting that a defendant owed them a duty must show a relationship between the two entities, and that a defendant cannot be held liable for failure to warn of a product’s risks if the plaintiff cannot prove it manufactured the products.

Indeed, one key consequence if the Weeks decision stands is that plaintiffs will be able to survive a motion to dismiss and seek to hold a brand-name manufacturer liable for failure to warn even when product identification is impossible. This impact will be especially felt by brand-name manufacturers with small market share, who historically have enjoyed an exit strategy based on product identification. The end result, of course, will be more lawsuits filed against brand-name manufacturers, a reality that is fueling the industry backlash.

Ultimately the drugmakers are asking for the court to grant oral arguments if it won’t change its answer to the certified question, noting that “[i]f ever a case demanded oral argument, this one does.” In addition to the Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, the groups that filed amicus briefs were the Product Liability Advisory Council, the Business Council of Alabama, the Alabama Policy Institute and the Alabama Defense Lawyers Association. You can read Pfizer and Schwarz’s brief here.