In a statement released by JNJ subsidiary DePuy Orthopaedics yesterday, the healthcare giant said it would halt all sales of its Ultamet metal-on-metal articulation and Complete ceramic-on-metal acetabular hip system because of lower physician adoption rates and a recent decision by the FDA to reclassify all metal-on-metal hip replacements.
Johnson & Johnson said the decision was not related to safety concerns, despite a string of high-profile recalls of metal-on-metal hips by DePuy and other orthopedic device makers.
"The decision to discontinue these products is not related to safety or efficacy, and is not a recall," company officials said in a prepared release. "Ultamet and Complete are backed by clinical data showing they are safe and effective options for patients who are candidates for hip replacement. As with all of our products, DePuy will continue to closely monitor the performance of Ultamet and Complete. DePuy reviews performance data from a variety of sources, including published and unpublished data from national joint registries, published literature, company-sponsored clinical trials and internal complaint data. This includes the FDA’s industry wide post-market surveillance of metal-on-metal hip systems."
DePuy officials said the company will discontinue other products over the next year and a half as it continues to "simplify and streamline DePuy’s portfolio by focusing on fewer, worldwide strategic product platforms that meet patient and clinician needs and ensure long-term growth."
Legal and regulatory scrutiny has honed in on MoM hips following the high-profile August 2010 recall of DePuy Orthopaedics’ ASR XL acetabular and ASR hip resurfacing systems. Johnson & Johnson pulled the devices off the market after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.
Some reports warned that 100s of 1,000s of patients may have also been exposed to toxic compounds from metal-on-metal implants, putting them at risk of developing cancer, cardiomyopathy, muscle and bone destruction and changes to their DNA.
Since then the controversy has ensnared device makers such Smith & Nephew (FTSE:SN, NYSE:SNN) and Biomet, with personal injury lawsuits piling up even against MoM hip implants that haven’t undergone a recall.
Johnson & Johnson paid as much as $600,000 to 3 patients in the 1st settled lawsuits accusing the company’s metal-on-metal implants of causing injuries.
A 2nd lawsuit, 1 of around 10,000 such cases in which patients have claimed that DePuy is liable for injuries related to the ASR XL hips, returned a $8.3 million verdict in favor of the plaintiff, Loren Kransky, who claimed the ASR XL implant was defectively designed.
That jury also dismissed claims that J&J failed to properly warn physicians about the risks of its metal hip implants and denied punitive damages.
The company has won some rounds in the court, however. In April, a Chicago jury ruled in favor of J&J, rejecting a patient’s claims that the company was liable for injuries she allegedly sustained after receiving an ASR implant.