A federal judge in Georgia reversed his decision to throw out a New Jersey woman’s chance at punitive damages from Mentor Corp., sending the case back to the Garden State.
Judge Clay Land of the U.S. District Court for Middle Georgia initially 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. Land found that Food & Drug Administration approval preempts states’ rules on medical device company liability.
In August, the judge decided that under New Jersey’s Products Liability Act, “punitive damages generally are not permitted in product liability actions regarding medical devices approved by the federal Food & Drug Administration.”
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.
But in a Nov. 24 ruling, Land vacated his order denying punitive damages, after Doria claimed “ObTape was approved by the FDA within the meaning of the NJPLA’s punitive damages provision,” according to court documents. Doria asserted that the New Jersey statute is limited to devices cleared under the FDA’s pre-market approval process and that the watchdog agency recognizes as safe and effective.
“Plaintiff contends that ObTape is neither because it went through the FDA’s pre-market notification process, which is different than the pre-market approval process, and because the FDA has not recognized ObTape as safe and effective,” Land wrote. “The resolution of this issue depends on an interpretation of New Jersey law. Because Mentor’s motion to dismiss the punitive damages claim is not dispositive of the case, the Court concludes that the question whether ObTape is covered by the punitive damages provision of the NJPLA should be reserved for the New Jersey court.”
Mentor’s ObTape 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 original 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.