FDA regulations do not preempt state law design defect claims against generic drug manufacturers, a three-judge panel of the First Circuit has held. The unanimous ruling affirmed a $21 million jury award to a New Hampshire woman who was injured by the generic anti-inflammatory drug sulindac. (Bartlett v. Mutual Pharm. Co., Inc., 2012 WL 1522004 (1st Cir. May 2, 2012).)
Defendant Mutual Pharmaceutical Co. had argued that the Supreme Court decision in Pliva, Inc. v. Mensing should extend to state law design defect claims against generic drugmakers because their products cannot differ from their brand-name equivalents. In Mensing, a divided Court last year held that FDA regulations preempt state law failure-to-warn claims over generic drug labeling.
The First Circuit concluded that Mensing did not apply to design defect claims, but the panel noted that whether it does was a “question of exceptional importance” that the Supreme Court should deliberate.
“Given the widespread use of generic drugs and the developing split in the lower courts, this issue needs a decisive answer from the only court that can supply it,” wrote Judge Michael Boudin, pointing out that the First Circuit’s opinion runs counter to other post-Mensing decisions.
In 2004, Karen Bartlett’s doctor prescribed the anti-inflammatory drug Clinoril for shoulder pain. When she filled the prescription at the pharmacy, she was given sulindac, the generic version manufactured by Mutual Pharmaceutical. Bartlett developed a reaction to the medication, involving severe burn-like injuries all over her body, that the manufacturer knew could happen.
Bartlett sued Mutual Pharmaceutical, making several claims against the generic drugmaker including failure to warn; all but the design defect claim were dismissed. She prevailed at trial. Mutual Pharmaceutical requested a new trial, insisting that not only was Bartlett’s claim preempted, but she presented insufficient evidence to support it. After the trial court denied the defendant’s motion for a new trial, Mutual Pharmaceutical appealed.
The First Circuit acknowledged that FDA regulations require generic drugs to have the same composition as the corresponding brand-name drugs. But Boudin noted that doesn’t mean generic manufacturers should not be liable for defective products. “While the generic maker has no choice as to label, the decision to make the drug and market it in New Hampshire is wholly its own,” he wrote.
Keith Jensen of Fort Worth, Texas, who represents Bartlett, said, “It would be an abomination of any fair interpretation of the laws as they presently exist to allow generic drug companies preemption on product defect claims. This has nothing to do with a failure-to-warn case and, therefore, nothing to do with the Mensing analysis.”
Louis Bograd, senior litigation counsel with the Center for Constitutional Litigation (CCL) in Washington, D.C., called the panel’s decision important, considering that so many Americans rely on generic drugs and are harmed by them. However, he said it is a limited exception to Mensing. “Clearly viable cases would be those in which the manufacturer marketed a generic drug that should never have been sold at all,” said Bograd, who was also counsel of record on an amicus brief that AAJ filed with the First Circuit in support of Bartlett.
Proving that a manufacturer should have ceased marketing a drug can be a difficult challenge for plaintiffs unless the FDA has already stepped in and ordered it to stop. Bograd mentioned propoxyphene, the generic version of the opioids Darvon and Darvocet, as one example of a drug pulled from the market because the risks outweighed the benefits. However, in March, the judge presiding over an MDL against makers of propoxyphene granted the defendants’ motion to dismiss the design defect claims against them, finding the claims to be preempted under Mensing. (In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig., 2012 WL 718618 (E.D. Ky. Mar. 5, 2012).)
CCL has since filed a supplemental authority letter with the presiding judge in the propoxyphene MDL, and enclosed a copy of the Bartlett decision. “We’re not telling the generic drug manufacturer to redesign their product,” said Bograd. “We’re saying they shouldn’t sell it in the first place.”
Bills have been introduced in the House and Senate that would address Mensing and authorize makers of generic drugs to update their labels. Last week, Senators Tom Harkin (D-Iowa), Patrick Leahy (D-Vt.), and Al Franken (D-Mass.) sent a letter to the FDA urging the agency to ensure that generic manufacturers are allowed to do so.