Johnson & Johnson Defends Withdrawal of PMA for Rejected Hips
Los Angeles, CA, February 16, 2012 – The Johnson & Johnson Company is facing more criticism after a recent New York Times article revealed that the company continued to market a metal hip resurfacing system overseas, despite the fact that the FDA failed to approve the device. According to the Massachusetts Medical Devices Journal, a company spokesperson called the move a business decision.
Reportedly, the company had submitted an application for a metal hip resurfacing system that was similar to a metal hip replacement already being sold in the U.S. The company opted to withdraw its premarket approval application for the resurfacing system after receiving notice from the FDA that additional clinical data would be required in order to evaluate the device’s safety. According to the Times article, Johnson & Johnson continued to market the device to health professionals overseas but it is unclear whether the company disclosed the FDA’s nonapproval of the metal hips.
The withdrawal of the PMA came around the same time as health officials were questioning the safety of the device that was already on the market, the ASR hip, manufactured by the company’s DePuy Orthopaedics division. The ASR hip was approved under the FDA’s 510(k) system, which allows manufacturers to seek approval for a device without additional safety testing if they can prove that a substantially equivalent product is already on the market.
It is unclear how many patients may have received one of the rejected hips but it is believed that as many as 93,000 patients worldwide were implanted with one of the ASR hips. These devices have since been linked to a number of complications, including pain, swelling, loss of mobility and metallosis. Johnson & Johnson is currently facing numerous lawsuits from patients who claim they were injured by a DePuy hip.
Attorney Jeffrey Nadrich believes that there may be many more patients in the U.S. who are either unaware of the recall or have yet to experience complications caused by one of these devices. Patients who were injured after receiving a DePuy metal hip implant are encouraged to complete a MedWatch form by visiting the Food and Drug Administration’s website.
Nadrich & Cohen, LLP is offering confidential, no-cost consultations to patients across the country who believe they were harmed by a defective hip. Help is available by calling the firm’s injury hotline at 1-800-718-4658 or by completing an online case evaluation form at www.depuyhipreplacementlawyers.net.
Nadrich & Cohen LLP is a national law firm with offices in Los Angeles, Sacramento, San Diego and other cities throughout California specializing in handling mass tort actions and representing individuals in cases involving pharmaceutical companies and medical device manufacturers. The firm is committed to achieving the best outcome possible in every case and has recovered over $200 million in settlements on behalf of its clients.
In addition to handling DePuy and Zimmer hip claims, the firm is also investigating cases involving Yaz, Actos, Avandia, Fosamax, Paxil, Zoloft, Vaginal Mesh, Wright Conserve Hips, Stevens-Johnson Syndrome, Benzene, Reflex Sympathy Dystrophy, Fen Phen and PPH and Depakote. For more information, visit www.personalinjurylawcal.com.
National Client Intake Coordinator
Nadrich & Cohen LLP
12100 Wilshire Blvd.
Los Angeles, CA 90025
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