Supreme Court to Hear Generic Drug Lawsuit Over Design Defect:

Posted by T&G on January 10, 2012

Karen Bartlett brought an action in state court against drug manufacturer Mutual Pharmaceutical Company, asserting state-law strict products liability claims for failure to warn and defective design, as well as claims for negligence and fraud. After taking sulindac, the manufacturer's generic non-steroidal, anti-inflammatory drug ("NSAID") prescribed for pain, Ms. Bartlett developed Stevens-Johnson Syndrome ("SJS") and toxic epidermal necrolysis ("TEN").

As a result of these conditions, Ms. Bartlett was hospitalized for 70 days-50 of those days were spent in a burn unit. She had multiple surgeries and two major septic shock episodes that were allegedly caused by side effects of the generic drug, which left her permanently blinded and with burns covering 65 percent of her body. Following trial in December 2004, a jury determined that Mutual's sulindac medication was responsible for Ms. Bartlett's development of SJS and returned a $21 million verdict.

Mutual Pharmaceutical has maintained that it should not be liable for the allegedly defective design of the generic drug, arguing that they should be immune from liability, so long as the medication used the same warning label as the original brand-name version of the drug, which is marketed by Merck as Clinoril. The generic drug maker has argued that the controversial 2011 Supreme Court decision in Pliva v. Mensing establishes that the plaintiff's design defect claims should have been pre-empted by federal regulations for generic drug makers.

The First Circuit did not adopt the drug manufacturer's FDCA preemption argument in Bartlett and stated, "But although Mutual cannot legally make sulindac in another composition (nor is it apparent how it could alter a one-molecule drug anyway), it certainly can choose not to make the drug at all." However, the court did not resolve the entire preemption issue and concluded, "Whether and to what extent the FDCA preempts design defect claims against generic drug manufacturers is a question of exceptional importance that the Supreme Court has yet to decide." Bartlett v. Mutual Pharmaceutical Company, Inc., 678 F.3d 30, 37-38 (1st Cir. 2012). Indeed, in the upcoming months it seems the U.S. Supreme Court will decide.

On November 30, 2012, the U.S. Supreme Court granted certification of an appeal from the First Circuit to evaluated whether the lower court erred when it held that federal law does not pre-empt state law design defect claims involving generic drugs, as opposed to failure to warn claims addressed in Pliva. In other words, the U.S. Supreme Court has decided to review Ms. Bartlett's generic drug lawsuit and decide on the question of whether manufacturers can be held liable for selling dangerous and defectively designed generic medications. The Supreme Court granted certification in Bartlett with the following question presented:

Whether the First Circuit erred when it created a circuit split and held-in clear conflict with this Court's decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567(2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)-that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.

The bottom line: if a drug manufacturer realizes their label is insufficient but does not believe they can even propose a label change, they can simply stop selling the unsafe product.

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