METAL-ON-METAL PINNACLE DEPUY FINALLY PULLED FROM MARKET
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By: Kelda Doherty
It is no surprise to our firm that Johnson & Johnson, the largest manufacturer of health care products in the world, has announced the discontinuation of their metal component Pinnacle hip device. This is re-encouraging confirmation for all the clients we are litigating for in state and federal courts around the country.
The device which contains metal-on-metal components was designed to be more durable and longer lasting than other hip replacement systems and be more suitable for a younger, active market. However, it has faced serious questioning as to its safety and effectiveness. Typically, hip replacement devices are to last 15 years before requiring replacement yet Johnson & Johnson devices have had high early failure rate with estimates detailing that 10% of Pinnacle implants will have failed in the next two years.
With over 3,300 lawsuits in the US alone, it is clear Pinnacle has an inherent problem with its construction. The metal-on-metal construction has shown to cause friction between its parts causing the release of tiny metal particles into the blood stream and surrounding tissue. The release of these metal ions can cause serious tissue damage, infection, having both short and long-term effects. Many who received the hip replacements have since developed a condition called metallosis, a form of blood poisoning and have experienced elevated levels of chromium and cobalt in the blood.
In January 2013 the Food and Drug Safety Agency (FDA) directed all companies producing metal-on-metal hip devices to carry out studies in order for the product to remain on the market. Metal-on-metal hip devices such as Pinnacle had previously been approved by a less thorough regulatory process.
Johnson & Johnson was also the producer of the previously recalled DePuy ASR hip replacement system for which they're facing 10,000 cases. The first of those trials was decided in Los Angeles on March 8,where it was ruled that the product was "defectively designed" and an $8.3 million verdict was given to the revision plaintiff. The controversy surrounding the hip devices could be the reason why the market for metal-on-metal implants has since plunged to less than 2% in 2012. A spokesperson for the company said that there was "not a viable market for these bearing combinations anymore" and that the decision to discontinue production was not related to the safety or effectiveness of its designs.