DePuy hip implant lawyers at Pintas & Mullins Law Firm announce that the first of nearly 11,000 lawsuits has concluded with a jury award of $8.3 million. Jurors found that Johnson & Johnson’s DePuy was negligent in designing its defective metal-on-metal hip implant.
Loren “Bill” Kransky, 65, was implanted with the ASR XL hip implant in December 2007 and had it removed in February 2012 in a painful revision surgery. Kransky testified that he was in constant pain leading up to the surgery, was unable to walk, and believed that metal debris from the cobalt and chromium implant was poisoning him.
These claims are not without merit, as metal-on-metal hip implants were initially approved by the FDA in a special expedited process that did not require testing in humans. Traditional hip implants are made from plastic or ceramic and metal-on-metal implants were thought to last longer. Unfortunately, these implants generate high levels of metal ions that release into the body and bloodstream, often causing severe metallosis and premature failure.
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Metallosis, or metal poisoning, occurs when metal debris, usually cobalt and chromium, collects in the soft tissue. High levels of coabalt and chromium in the body can cause severe damage to the internal organs, as the immune system identifies the metal debris as foreign and starts attacking the organs and tissue where they have implanted. Metallosis can lead to the death of skin cells and necrosis, which is a serious skin condition.
Kransky experienced stabbing pain before the surgery, and was told by his doctors that something inside his body was poisoning him, most likely the DePuy implant. DePuy recalled nearly 95,000 of the implants in 2010, when more than 12% of them failed within five years. In 2012, 44% of the devices failed in Australian patients within seven years.
The trial lasted five weeks, and the next is expected to begin in Chicago in March 2013. Analysts are projecting that these lawsuits will cost Johnson & Johnson billions of dollars to resolve, and the company has reportedly already set aside more than $2 billion.
The lawsuits are alleging dislocations, infections, bone fractures, revision surgeries, and severe pain and suffering due to the defective design of the implants. As stated, DePuy did not test the devices in humans before they were placed onto global markets, which was made possible by the Medical Device Amendments of 1976. Lawmakers never officially classified how hip implants should be regulated, so the devices have remained in a sort of authoritarian limbo since the mid-1970s.
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In May 2011, the FDA requested that Johnson & Johnson, along with over 20 other metal-on-metal implant manufacturers, conduct post-market research regarding the risks of metallosis in these devices. Less than two years later, in February 2013, the FDA proposed that all-metal hip implants be taken off the market completely.
Manufacturers will have to submit pre-market approval applications before any metal implants can be placed back on the market. The deputy director of science at the FDA stated that he believes many manufacturers will use the results from the 2011 studies to satisfy these application requirements. If a manufacturer does not submit an application, or if the clinical results do not meet federal standards, it will have to stop selling the device. The FDA is also requiring that doctors closely monitor patients with the implants and recommend that anyone experiencing pain or other symptoms undergo testing to determine metallic ion levels.
Other metal-on-metal hip implants now subject to litigation include the Zimmer Durom Cup and Stryker’s Rejuvenate and Trident. With the help of a skilled defective hip implant attorney, compensation may be available to those who suffered serious injuries from the devices. Victims may be entitled to compensation for lost wages, medical bills, and pain and suffering, among other damages. Metal-on-metal hip implant lawyers at Pintas & Mullins Law Firm will continue to report on all verdicts and updates pertaining to defective implant litigation.