On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The defendant-appellant in the case, Mutual Pharmaceutical Company (“Mutual”) appealed from a decision of the U.S. Court of Appeals for the First Circuit, in Karen L. Bartlett v. Mutual Pharmaceutical Company, Inc., 678 F.3d 30 (1st Cir. 2012), where the Court found that the Federal, Food, Drug, and Cosmetic Act (“FDCA”) does not preclude a state law design defect claim against a generic drug manufacturer. You can find the documents in the case here.
Mutual is a Pennsylvania company that markets sulindac tablets, an anti-inflammatory drug. Sulindac tablets are the generic version of the brand-name drug Clinoril. Ms. Bartlett suffered permanent injuries after taking the sulindac tablets, and brought a design-defect lawsuit against Mutual pursuant to New Hampshire state law. The district court awarded compensatory damages to Ms. Bartlett. Mutual appealed, and the U.S. Court of Appeals for the First Circuit affirmed the district court’s decision. The Supreme Court granted certiorari on November 30, 2012.
Mutual markets the sulindac tablets under an Abbreviated New Drug Application (“ANDA”) that was approved by the U.S. Food and Drug Administration (“FDA”) in 1991. Unlike a New Drug Application (“NDA”), an ANDA does not require that a drug sponsor submit any preclinical or clinical testing data. All generic drugs under an ANDA, however, must be bioequivalent, or chemically identical, to an innovator drug already approved by an NDA.
Of primary focus in this case is whether states are allowed to impose liability on a generic drug manufacturer for a defective design. In a similar case, PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law precludes a state failure-to-warn claim against generic drug products because FDCA regulations require that a generic drug has the same label as the brand name drug. Since a generic drug manufacturer is not allowed to alter a drug’s label, the court found that a company would be unable to comply with the state duty to warn without violating federal law.
Mutual argues that Mensing is applicable to design-defect claims as well. According to Mutual, the FDCA requirement that a generic drug product be the bioequivalent of the brand name drug, with identical active ingredients, precludes any design-defect lawsuits targeting generic drugs.
Ms. Bartlett argues, and the First Circuit agreed, however, that Mensing is not applicable to design-defect claims. Previously, in Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court held that the FDCA does not preempt a state law failure-to-warn claim against a brand name drug. The First Circuit’s opinion explains that the later holding in Mensing only requires an exception for a failure-to-warn allegation against a generic drug. Additionally, according to the court, a generic drug manufacturer can avoid liability by not making the product if the risk outweighs the benefits to consumers.
In sum, the Supreme Court is not expected to issue an opinion in the case until June. If you have any questions about the requirements for generic drugs or the drug approval process, please contact us at email@example.com.