By Joseph Twarog, Esq.
On January 25, 2013, Judge James L. Graham of the Southern District of Ohio held the U.S. Supreme Court’s decision in Pliva v. Mensing preempted failure-to-warn claims brought under state law, but it did not preempt design defect claims.
Plaintiff Frederick Arter filed the lawsuit, Arters v. Sandoz, Docket No. 2:10-cv-00142, after suffering eye damage and permanent vision loss as a result of taking amiodarone, a generic drug. Specifically, Plaintiff alleged: (1) Defendant failed to warn the public of the significant risks associated with amiodarone; (2) amiodarone was unreasonably dangerous; and (3) Defendant improperly promoted the “off-label” use of the drug.
Defendant argued Plaintiff’s claims were all pre-empted by the Hatch-Waxman Act, which allows manufacturers of generic drugs to bypass the usual requirement of proving a drug is “safe and effective and that the proposed label is accurate and adequate.”1 Instead, generic drug manufacturers can use the cheaper, faster, “Abbreviated New Drug Application,” which only requires a showing that the drug is the bioequivalent of an existing approved drug.
In holding that the failure-to-warn claim was preempted, but the design defect claim was not, the Court reasoned that the design defect claim “rest[ed] on an alleged violation of an entirely different duty, not the duty to give a specific warning, but the duty to refrain from selling a product that is, according to state law, unreasonably dangerous.”2
This latest decision is in line with the First Circuit decision in Bartlett v. Mutual Pharmaceutical Company, where the First Circuit held state-law design defect claims were not preempted by the holding in Pliva v. Mensing. The Supreme Court will likely settle this issue when they review the First Circuit’s decision in Bartlett v. Mutual Pharmaceutical Company, which has just been granted certiorari.
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