The Supreme Court on Friday agreed to review an appeals court’s decision that generic drug manufacturers can face lawsuits over alleged problems in the design of drugs, regardless of federal protections against design-defect claims.
In early 2005, New Hampshire resident Karen Bartlett suffered a rare reaction to the generic anti-inflammatory drug sulindac that left her nearly blind and covered in burn-like lesions. She sued the drug’s maker, Mutual Pharmaceutical Co., for design defects under state law and subsequently won a $21 million jury award.
In its defense, Mutual argued that federal law preempts design defect claims, since it mandates that the labeling and design of generic and brand-name drugs be the same, an argument that echoed the Supreme Court’s June 2011 decision in Pliva Inc. v. Mensing.
But, on appeal, a three-judge panel of the 1st Circuit found that the Pliva ruling did not extend to design-defect claims, and upheld the award. In its decision, the court found that, although Mutual could not legally make an alternate version of the drug, it could “certainly choose not to make the drug at all,” and thus avoid a conflict with federal law.
Mutual, a unit of Japan’s Takeda Pharmaceutical Co., appealed the ruling in September, arguing that “the 1st Circuit’s opinion cannot be squared with Mensing, as every other appellate court has recognized and the 1st Circuit itself conceded.”
The Generic Pharmaceutical Association and a group of pharmaceutical companies have filed amicus briefs in support of Mutual. The court is expected to issue a decision by the end of June.
Read more at Thomson Reuters.
For more InsideCounsel coverage of the pharmaceutical industry, see: