Philadelphia personal injury attorneys of Messa & Associates take issue with Johnson & Johnson’s business practices yet again. The pharmaceutical and medical device giant faces scrutiny once again, this time concerning their orthopaedics subsidiary, DePuy Orthopaedics Inc. It seems the company failed to get approval from regulators for the release of more than a dozen types of orthopedic devices. The U.S. Food and Drug Administration issued a warning letter to the company this week saying DePuy made 14 types of devices – from knee systems to hip systems – that didn’t receive pre-market clearance or approval from the FDA.
In addition to not getting approval, which increased the risk of personal injury to patients using the defective medical devices, the FDA said DePuy did not 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 failed to set up a procedure for the employee in charge of nonconformance to be notified when a product was not in conformance.
The FDA contends DePuy’s devices were not custom-made for specific patients, which would have made them exempt from the approval process, because after the devices were finished, they might have been available to other doctors.
Johnson & Johnson’s subsidiary companies have been involved in a number of recent FDA violation investigations. Last year, McNeil Consumer Healthcare closed one of its Tylenol plants after the company recalled millions of bottles of over-the-counter drugs because of several deficiencies in the manufacturing process. DePuy also has faced scrutiny for its hip-replacement device, the ASR XL Acetabular Hip Replacement System. The device is said to fail in about 13 percent of its patients. DePuy has issued a recall for the device.
The Philadelphia personal injury attorneys at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of New Jersey and Philadelphia personal injury attorneys 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 attorneys of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.