According to reports and company records, Johnson and Johnson received a letter from the Food and Drug Administration asking for additional safety data just weeks before the company decided to stop selling its DePuy ASR hip implant in 2009. The device, recalled in August 2010, has since been found to have a high rate of premature failure. The hip implants were expected to last for at least 15 years, but had been failing after only a few years of implantation. The DePuy implants are also being blamed for injuries in hundreds of lawsuits filed by personal injury attorneys. The injuries are the result of particles of metallic debris generated as the all-metal hip implant wears. About 93,000 patients had received the ASR hip implant during the eight years it was on the market.
In January, the FDA sent a warning letter to DePuy Orthopaedics Inc., a Johnson & Johnson subsidiary, regarding 14 devices that the company sold without pre-market clearance or FDA approval. The devices included DePuy hip systems and knee implants.
According to the letter, DePuy failed to comply with quality requirements, did not have adequate procedures to ensure the devices conformed to the user’s needs and did not have an adequate procedure to review complaints. DePuy also did not have a process in place for the employee in charge of nonconformance to be notified when a product was not in conformance.
The Philadelphia personal injury lawyers at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of personal injury lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a defective medical device, a negligent medical provider, or have endured any other type of personal injury, contact the personal injury lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.