Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon must face design defect claims in 37 of the 23,000 lawsuits filed against it over its pelvic mesh products, a federal judge in West Virginia ruled yesterday.
Ethicon asked Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia to grant summary judgment, arguing that the plaintiffs’ state design defect claims about its Tension-Free vaginal tape are preempted by federal law.
It’s the 4th time Goodwin has considered a preemption argument from Ethicon; in each of the prior instances the judge ruled against the company.
Yesterday Goodwin did it again, ruling that there is no conflict between state and federal law in the cases, which are part of the 70,000 cases spanning 3 multi-district litigations concerning pelvic mesh products from several manufacturers.
“Unlike the law imposing the duty of sameness for generics, there is no federal law prohibiting design changes to medical devices, particularly changes representing advances in safety. To the contrary, 1 of the purposes of the 510(k) exemption was ‘to ensure that improvements to existing devices can be rapidly introduced into the market.’ The law simply requires that manufacturers making a ‘significant change’ submit another 510(k) notification, which the FDA will clear if it determines the device is substantially equivalent to a device already on the market,” Goodwin wrote. “Again, this substantial equivalence determination does not directly conflict with the state law requirement that a product be reasonably safe.”