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Pliva, Inc. v. Mensing: Consumers Lose Right to Pursue Justice for Injury Caused by Generics

Here’s a communication I received as a member of the Leaders Forum for the American Association for Justice.


Dear Colleagues,

As a Leaders Forum member, you are among the first to receive the latest update on the work of the Center for Constitutional Litigation.

In this last year since the Supreme Court of the United States ruled in Pliva, Inc. v. Mensing, the Center for Constitutional Litigation has worked on a number of cases that challenge the reach of that decision. As you know, in Mensing, the court ruled 5-4 that in most cases generic drug makers cannot be sued for failure to warn. The Court held that it was impossible for the generic manufacturers to comply with federal law—which requires generic labels to match brand-name labels—and state law—which may require a stronger warning.

In particular, among other issues, CCL is arguing that “impossibility preemption” does not apply to design defect cases. At this point, among the courts, there is a difference in opinion.

Thank you for your dedication and support of AAJ as a member of Leaders Forum.


Mensing Does Not Preempt…

In the case of Bartlett v. Mutual Pharm. Co., Inc., the U.S. Court of Appeals for the First Circuit ruled that the Supreme Court’s decision in Mensing did not preempt state law design defect claims against the generic drug manufacturer.

In this case, CCL worked with the New Hampshire Association for Justice and filed an amicus brief in support of the plaintiff who used a drug called sulindac, which blinded her and caused much of her skin to burn off. The doctor had prescribed the brand name version of this non-steroidal anti-inflammatory drug, but the pharmacy dispensed the generic form, sulindac.

At trial, the district court told the jury that in order to find for the plaintiff, it must find that “sulindac’s design was in a defective condition unreasonably dangerous to consumers.” The jury decided in favor of the plaintiff and awarded her $21 million.

In his opinion for the court, Judge Michael Boudin wrote that, “…it is up to the Supreme Court to decide whether [Mensing’s] exception is to be enlarged to include design defect claims. 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.”

Mensing Does Preempt…

One of the courts that concluded differently is the U.S. District Court, Eastern District of Kentucky. In a joint motion to dismiss filed by multiple defendants in In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, Judge Danny C. Reeves ruled that the Mensing decision applies to design defect and failure-to-warn claims.

One of the most compelling arguments for preserving these cases is that the clients took a generic form (propoxyphene) of Darvon/Darvocet which has been pulled off the market. The removal of the drug from the market bolsters the design defect argument that the drug’s risks outweighed its limited benefits.

CCL Senior Litigation Counsel, Lou Bograd, will handle the appeal of this ruling to the Sixth Circuit. Briefing in the Court of Appeals is scheduled to begin in August.

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