August 31, 2012

First Three DePuy Cases settled by Johnson & Johnson for over $600,000



The DePuy metal-on-metal hip implant, approved by the FDA a mere seven years ago—has been inundated with over 8,000 lawsuits claiming the implant is inherently defective and can lead to costly and painful revision surgery as well as a myriad of other serious health issues. DePuy initially claimed the failure rate of the ASR metal hip implant to be between 4-5%. When DePuy voluntarily recalled the implant in 2010, they upgraded the failure rate to approximately 12% within the first five years. Studies independent of DePuy or Johnson & Johnson place the failure rate of the ASR metal implant at 50% within six years and 80% within eight years. These staggering numbers almost guarantee that this particular metal-on-metal hip implant will fail at some point in the majority of recipients.

Nearly a hundred thousand ASR devices were implanted worldwide prior to the recall with nearly forty thousand in the United States alone. The propensity of the implant to loosen and detach as well as the thousands of reports regarding adverse health effects from high levels of chromium and cobalt have led to over 6,000 lawsuits filed in federal court an another 2,000 filed at the state level in Maryland, California, Nevada and other states. Johnson & Johnson recently settled three Nevada cases for $600,000—an amount considered to be at the low end of the expected $200,000-$500,000 to settle each case.

These three lawsuits were expected to go to trial in late 2012 and came from three women, all over the age of sixty, whose surgeries were performed by the same surgeon. Each woman had no choice but to undergo revision surgery—a procedure which is not only extremely painful, but can require months of recuperation and time away from work. One of the women reported excessive amounts of damage to the surrounding hip bone as a direct result of the implant yet Johnson & Johnson countered that the implants were not responsible for any of the developing life-threatening illnesses. The research regarding the potential of chromium and cobalt in the bloodstream to cause serious and life-threatening illnesses is sadly lacking at this point in time.

It is expected that when all DePuy cases are fully resolved the amount Johnson & Johnson will be liable for will exceed $2 billion dollars although the company has set aside approximately three billion in anticipation of additional lawsuits. Three state trials coming from Maryland will be the first to see the inside of a courtroom this January should they not reach a settlement agreement prior to that date. The first consolidated federal trials are expected to begin in March or April of 2013. A representative for Johnson & Johnson stated in January that they have spent over $800 million dollars on the recall for the ASR during the past two years. The representative declined to estimate the current product liability costs.

DePuy’s metal-on-metal hip implant has dealt with multiple design flaws in addition to its potential to cause metal toxicity health problems when the metal ball and cup rub against one another during normal everyday activity. This friction causes small metal ions to shear off, lodging in the surrounding tissues or entering the bloodstream. Those metal shavings often lead to serious infection, inflammation of the joints and metal poisoning.  Neurological, kidney, cardiovascular and thyroid problems have been seen in those patients with the all-metal hip implant as well as destruction of the soft tissue surrounding the implant. When the implant fails, it can be very difficult to obtain a successful revision surgery due to the dead tissue.  This leaves patients who believed their implant was safe with multiple physical problems. While not medically documented, many recipients of the metal implant have reported such symptoms as dizziness, the inability to distinguish between sweet and salty foods, memory loss, skin disorders, gastrointestinal problems, loss of balance, nerve damage and impaired liver function.

Although the metal-on-metal hip implants are considered much more durable than the metal-on-ceramic or metal-on-polyethylene implants fewer surgeons are choosing to use the all-metal implants due to the surrounding controversy. In fact, the use of metal-on-metal implants has dropped from an all-time high of about 40% to less than 10% since the recall and subsequent FDA warnings. Many of the lawsuits currently filed against DePuy and Johnson & Johnson claim there was little or no warning regarding the potential dangers of the implant. The total lack of adequate warning and concern for the health of implant patients will likely end up costing Johnson & Johnson several billion dollars--yet the health cost to recipients cannot be quantified in dollars.

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