510(k); Pathway for Safer drugs or Recipe for Disaster

Recent medical disasters such as the DePuy ASR, DePuy Pinnacle, and transvaginal mesh cases have revealed that medical devices were approved for use without adequate clinical data based on a grandfathering type provision in the FDA called a 510(k) process, where a new device that is cleared as "substantially equivalent" as a previously approved device [...]

June 3rd, 2013|DePuy Hip Replacement, Drug and Medical Device Litigation, Transvaginal Mesh|Comments Off on 510(k); Pathway for Safer drugs or Recipe for Disaster

J&J’s DePuy Unit Abandons Pinnacle and All Metal Hip Implants

On May 16, 2013, in what many health advocates feel is a long overdue move, J&J’s DePuy Orthopedic unit announced it was stopping the manufacture of all metal replacement hips.  In August 2010 the unit recalled the DePuy ASR in the face of mounting evidence of high failure rates but continued to sell the all [...]

May 17th, 2013|DePuy Hip Replacement, Drug and Medical Device Litigation|Comments Off on J&J’s DePuy Unit Abandons Pinnacle and All Metal Hip Implants