In Victory For Device Industry, Supreme Court Favors PMA Pre-emption
This article was originally published in The Gray Sheet
In a ruling that is expected to shave the volume of lawsuits against device manufacturers, the Supreme Court held that FDA premarket approval should preclude patients from suing companies for personal injury in most cases
You may also be interested in...
A US House representative and two co-sponsors have reintroduced the Medical Device Safety Act, which would remove the defense against state product liability suits for premarket-approved devices from the Federal Food, Drug, and Cosmetic Act (FDCA).
The Utah Supreme Court is reviewing a case that could give device companies some protection from product liability suits. Industry heavyweights including AdvaMed and the Washington Legal Foundation have weighed in by filing briefs supporting defendant Wright Medical.
Public health organizations including the Facebook group ASHES/E-Sisters, and the National Center for Health Research, are pushing for wider distribution of and a big impact from the "The Bleeding Edge" Netflix documentary. They tell Medtech Insight that they will continued to lobby Congress and US FDA to put more safety regulations and protocols into place for devices.