This case arose in 2007, when Thomas Lamere, who had been implanted 19 years earlier with a heart valve manufactured by St. Jude Medical, suddenly died because the valve fractured. Expert analysis indicated that the valve broke because of a manufacturing defect – tiny cracks in the coating on the valve. Mr. Lamere’s wife sued for wrongful death in Minnesota, where St. Jude is located. St. Jude claimed that the applicable statute of limitations had expired and that the Medical Device Amendments (MDA), a federal law under which the heart valve had been approved for marketing by the FDA, precluded a lawsuit based on a manufacturing defect unless the plaintiff could point to a specific federal standard violated in the manufacturing of the device. The trial court rejected the statute of limitations defense but held that the manufacturing defect was preempted by the MDA. Ms. Lamere appealed, and Public Citizen joined in representing her before the Minnesota appellate courts. Our brief argues that the MDA does not preclude lawsuits that do not challenge the FDA’s approval of a device but merely assert that a particular specimen of the device had manufacturing flaws not called for in its design. We also argue that St. Jude’s statute of limitations defense, which it continues to advance, is not supported by Minnesota law and would have the effect of barring a claim before the plaintiff was even injured. The case has been briefed and argued and is awaiting decision.