J&J Announces Plans to Halt Sales of All-Metal Hips in August as Number of DePuy Pinnacle Hip Replacement Lawsuits Surpasses 4,000
Johnson & Johnson, the world’s biggest healthcare product manufacturer, has announced its plans to stop selling the metal Ultamet liner component of an implant at the center of over 4,000 DePuy hip replacement lawsuits at the end of August, Bloomberg.com reports.
According to the article posted May 17, 2013, the company says its decision to discontinue sales of the Ultamet Metal-on-Metal Articulation and the Complete Ceramic-on-Metal Acetabular Hip System on August 31, 2013, was fueled by lower demand for metal-on-metal hips, which as a class have been associated with early failure rates. In turn, this has led to the filing of more DePuy Pinnacle hip replacement lawsuits in a multidistrict litigation (MDL) underway in the U.S. District Court, Northern District of Texas.
As of May 1, 2013, court records indicated there were 4,087 claims over the Ultamet liner pending in the proceeding.
Did Metal Hip Sales Plummet Because of DePuy Pinnacle Hip Replacement Lawsuits?
Sales of Metal-on-metal hips in the U.S. and Europe plunged from 20 percent of the market in 2007 to less than 2 percent last year, according to the article, which also said the halt on sales of related products through 2014 will hopefully simplify and streamline offerings from the manufacturer. According to the company, this action was not prompted by concerns over safety and effectiveness, however, and does not signify a recall.
“We won’t have any metal-on-metal or ceramic-on metal hips any longer,” confirmed a spokeswoman for DePuy Orthopaedics. “We’ve seen, for example, a 90 percent decline in metal-on-metal sales industrywide in the U.S. and Europe since 2007. There’s really not a viable market for these bearing combinations anymore.”
Discontinuing its sales of metal-on-metal hips may be a smart move for DePuy if and when The U.S. Food and Drug Administration’s proposed regulations for approving this class of devices go into effect. Announced in January 2013, the agency spoke of new rules that would require all metal hip manufacturers to submit all designs for premarket approval, where they would undergo rigorous testing for safety and effectiveness. In April 2013, 11,000 consumers signed a letter from Consumers Union urging the agency to put these new regulations into action.
This would make the devices ineligible to receive clearance through the agency’s 510(k) process, which allows a product to enter the market if its maker can prove it is substantially to one that has already been approved.
DePuy hip replacement lawsuits point out that the metal Ultamet liner of the Pinnacle hip was cleared in 2005 via the FDA’s 510(k) program.
Starting the Process of Filing a DePuy Pinnacle Hip Replacement Lawsuit
In taking your first steps toward filing a claim against DePuy after suffering complications that may include metal ion poisoning (known as metallosis), pain and swelling and infection, it is in your best interest to contact a lawyer at Bernstein Liebhard LLP. Call the Firm at (877) 779-1414.