After years of pre-trail discovery and legal maneuvering, the first of the DePuy Lawsuit trials got underway Friday at California Superior Court in Los Angeles. The plaintiff, according to Bloomberg News (1/25/13), has not only suffered from elevated levels of cobalt in his blood, the California resident has already endured a DePuy hip implant replacement. It was reported that plaintiff Loren Kransky might have died from cobalt poisoning had he not facilitated the replacement of the faulty DePuy ASR XL device. Tragically, Kransky’s case was chosen as the first to go to trial because, according to The New York Times (1/22/13), he also has cancer and is at risk of dying before his trial comes to a close.
The DePuy hip implant is one of a family of metal-on-metal devices that served as a departure from the more traditional artificial hips fashioned from plastic and ceramic. The all-metal devices were hailed as superior to more traditional designs, with the expectation the new devices would last longer than the heretofore standard for implant life ??" about 15 years.
The opposite has been true. Failure rates of the DePuy ASR hip have been identified as being as high as 40 percent. The action of metal working against metal has been seen to release metal particles into the soft tissue surrounding the joint, causing swelling and fluid build-up ??" and even the breakdown of muscle tissue. Even more serious is the release of metal ions into the bloodstream at levels far higher than is considered safe, according to experts.
Pharmaceutical giant Johnson & Johnson (J&J), which is the parent company under which DePuy Orthopaedics operates, offered to replace any failed DePuy hip implant following a formal Hip Replacement Recall in 2010. It is not known if the company also offered compensation for pain, suffering and the inconvenience of a second surgical procedure to correct the failed DePuy ASR so soon (for many, in terms of months or a few short years) following the initial procedure. Due to the expected robustness of the all-metal hips, the new-age devices were favored for younger, more active patients. To that end, many hip replacement patients still gainfully employed due to their younger age would be spending additional time off the job in order to go through a second convalescence, potentially jeopardizing finances or a career.
An orthopedic surgeon featured in a video posted at consumer reports.org required revision surgery to replace a failed DePuy ASR. Still practicing today and living an active lifestyle, the doctor opted for the metal-on-metal DePuy hip due to the expected lifecycle of the device. His reality, however, was anything but. The surgeon is now doing just fine with a plastic and ceramic implant.
While undertaking a vigorous defense in the first bellwether trial that started January 25, Bloomberg News cited sources as claiming J&J offered to pay more than $200,000 per case for most of the lawsuits, which now number over 10,000 so far... Were plaintiffs to accept the terms, the deal would have cost the juggernaut in excess of $2 billion. In a telling sidebar, The New York Times (1/22/13) reported that Johnson & Johnson took a $3 billion special charge in 2012 related primarily to legal and medical costs associated with the failed DePuy ASR.
As for the DePuy lawsuit launched by plaintiff Kransky, The Los Angeles Times (1/25/13) reports that DePuy may have received its first reports pertaining to the potential ill-health of their device as early as June 2005, when an Irish marketing official contacted DePuy over grave concerns about the failure rate of the DePuy ASR devices. Exactly one year later, a doctor stationed in the Netherlands and a key opinion leader in his field referenced significant failure of the DePuy ASR, announcing he had abandoned further use of the device.
On opening day of the trial, a DePuy lawyer acting for the defense claimed the now-vilified ASR was carefully researched and tested before going to market. However, under current guidelines of the US Food and Drug Administration (FDA), manufacturers introducing a new product that remains substantially similar to devices already on the market and performing successfully can skip the more rigorous testing required of a brand-new device with a unique design.
Meantime, new documents contained in court records recently unsealed reveal that an internal analysis conducted by Johnson & Johnson mere months after the DePuy ASR was recalled in mid-2010 estimated the all-metal devices would fail within five years in close to 40 percent of the patients who received them.
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Johnson & Johnson, it has been reported, also projects the problematic DePuy ASR will fail in thousands more patients in the coming couple of years, suggesting not only additional revision surgeries, but potentially more lawsuits.
This past September, a regulatory finding from Johnson & Johnson revealed 10,100 lawsuits. Of those, 7,240 were pending as consolidated cases in federal court in Toledo. More than 2,000 DePuy Hip Replacement cases have been filed in California state court located at San Francisco.
Based on J&J’s own projections, those numbers are about to climb in the debacle that is the DePuy hip implant…