Manufacturing Defect Claims Survive Preemption Analysis in Pa. Breast Implant Case

PITTSBURGH — A Pennsylvania federal judge has allowed manufacturing defect claims to proceed in a Mentor textured breast implant case, ruling they are not preempted by federal law because the plaintiff is not challenging the implants’ FDA-approved design, but rather Mentor Worldwide LLC’s execution of manufacturing.

In a July 26 order, Judge W. Scott Hardy of the U.S. District Court for the Western District of Pennsylvania also allowed the plaintiff to amend her negligence claim to the extent it accuses Mentor of failing to report adverse events to the FDA.

Christine McGee has a significant family history of breast cancer …