U.S. Supreme Court Will Rule On Preemption Of Generic Drug Design Defect Claim

U.S. Supreme Court Will Rule On Preemption Of Generic Drug Design Defect Claim

WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court on Nov. 30 said it will review a First Circuit U.S. Court of Appeals ruling that a defective design claim involving a generic drug is not preempted by federal law, placing in jeopardy a $21 million verdict for a New Hampshire woman who suffered burnlike injuries from generic sulindac (Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett, No. 12-142, U.S. Sup.).


The decision followed a Nov. 30 conference by the court to consider the petition for a writ of certiorari by Mutual Pharmaceutical Co. Inc.

Karen Bartlett was prescribed Clinoril, a prescription nonsteroidal anti-inflammatory drug to treat shoulder pain. The pharmacy dispensed sulindac, the generic version of Clinoril.

Bartlett subsequently developed Stevens-Johnson syndrome and toxic epidermal necrolysis, reactions that resulted in burnlike damage to 60 to 65 percent of her body. She spent 70 days in a hospital, including a burn unit, and suffered permanent tissue damage and near-blindness.

Design Defect Only Survived

Bartlett sued three defendants in New Hampshire state court. Mutual Pharmaceutical removed the case to the U.S. District Court for the District of New Hampshire.

Eventually, most of Bartlett's claims were dismissed by the court or by the plaintiff, and only the design defect claim remained against Mutual, the sole defendant at trial. Bartlett's failure-to-warn claim was dismissed because Bartlett's prescribing doctor testified that he had not read the warning label.

At trial, the sole theory of design defect was whether sulindac's risks outweighed its benefits, making it unreasonably dangerous to consumers, despite the fact that the Food and Drug Administration had never withdrawn Clinoril's designation as "safe and effective."

After a 14-day trial in 2009, a jury awarded Bartlett $21.06 million in compensatory damages. The court denied Mutual's motion for judgment as a matter of law or a new trial.

1st Circuit Affirms

Mutual appealed to the First Circuit U.S. Court of Appeals, but in May an appeals panel ruled that design defect claims are not preempted. The panel said generic drug manufacturers could avoid conflict between their duties under state court and under federal regulations for generic drugs by not making the drugs at issue.

The panel also said the Supreme Court should decide the issue and later granted Mutual's motion to stay entry of judgment pending the filing of a petition for a writ of certiorari.

In July, Mutual Pharmaceutical filed its petition. It argued that the First Circuit panel's decision is plainly at odds with the Supreme Court's generic drug preemption ruling in Pliva, Inc. v. Mensing (131 S. Ct. 2567 [2001] [enhanced version available to lexis.com subscribers]).

Opposition: No Circuit Conflict

In her Oct. 31 brief in opposition, Bartlett said the First Circuit's decision creates no conflict with other circuit courts. In addition, Bartlett said Mutual's petition does not present a question of recurring national importance.

Sulindac is not an essential drug, Bartlett said. District court cases cited by Mutual do not justify Supreme Court review, she said.

The First Circuit correctly concluded that compliance with federal and state law is not impossible in her case, Bartlett said, adding that New Hampshire law imposes strict, but not automatic, liability for unreasonably dangerous drugs.

Nothing in federal law precluded Mutual from complying with New Hampshire law, Bartlett said.

Pliva Inapplicable

Bartlett said Pliva involved a different state law duty - failure to warn - than the defective design claim in her case. The state law did not require Mutual to perform any act prohibited by federal law, she said.

In addition, Bartlett said New Hampshire law does not require Mutual to change the design of its drug.

Mutual is represented on the petition by Jay P. Lefkowitz of Kirkland & Ellis in New York and Michael W. McConnell, Michael D. Shumsky and John K. Crisham of Kirkland & Ellis in Washington.

Bartlett is represented by Keith M. Jensen of Jensen & Associates in Fort Worth, Texas, and Steven M. Gordon and Christine M. Craig of Shaheen & Gordon in Concord, N.H.

Amicus Counsel

Amicus curiae Morton Grove Pharmaceuticals Inc., Aurobindo Pharma USA Inc., Amneal Pharmaceuticals LLD, Teva Pharmaceuticals USA Inc., Impax Laboratories Inc. and Ranbaxy Pharmaceuticals Inc. are represented by Steffen N. Johnson, Scott H. Blackman and Andrew C. Nichols of Winston & Strawn in Washington and George C. Lombardi, W. Gordon Dobie, James F. Hurst, Maureen L. Rurka and William P. Ferranti of Winston & Strawn in Chicago.

Amicus Generic Pharmaceutical Association is represented by Ray M. Aragon of McKenna, Long & Aldridge in Washington and Clem C. Trischler and Jason M. Reefer of Pietragallo, Gordon, Alfano, Bosick & Raspanti in Pittsburgh.

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