A federal judge threw out a New Jersey woman’s chance at punitive damages from Mentor Corp., finding that Food & Drug Administration approval pre-empts states’ rules on medical device company liability.
Judge Clay Land of the U.S. District Court for Middle Georgia ruled that Geraldine Doria is not entitled to punitive damages in her lawsuit against the company, which made the ObTape transobturator vaginal sling until March 2006.
The device was designed to provide support to the vaginal wall, reinforcing the muscles that control the flow of urine, for women suffering from stress urinary incontinence. But unlike other, similar devices, the Mentor product was not made of woven material, meaning it could block nutrients and oxygen, potentially causing severe pain, vaginal extrusions, urinary tract erosion and infection.
Doria’s complaint, from which was stricken an initial claim that Mentor misled the FDA when it sought approval for the device, states that she experienced significant mental and physical pain after a surgeon implanted her with the device Feb. 4, 2005. The device caused “erosion of her internal bodily tissue, including her vaginal wall … and painful infections,” according to the complaint, and eventually had to be surgically removed.
Land’s ruling effectively guts her case, as the parties in the suit already agreed to strike the fraud accusation from the lawsuit.
Perhaps more importantly, the case falls under New Jersey’s Products Liability Act, under which “punitive damages generally are not permitted in product liability actions regarding medical devices approved by the federal Food & Drug Administration,” Land wrote.
And even though the NJPLA contains an exception “where the product manufacturer knowingly withheld or misrepresented information” to the FDA during the approval process, “a New Jersey appellate court has ruled that the exception is preempted by federal law, and that punitive damages are not available under the NJPLA,” he wrote.
In February 2008, the U.S. Supreme Court decided in Riegel v. Medtronic, Inc. (PDF) that a clause in the Medical Device Amendments of 1976 “bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration.”
But that pro-pre-emption ruling would be undone by the Medical Device Safety Act now working its way through Congress. The bill is designed to restore patients’ ability to sue device makers in state courts, regardless of existing federal law.