First DePuy ASR Trial Begins as FDA Proposes Stricter Reviews of Metal-on-Metal Hip Implants

As the first DePuy ASR hip trial began in a California State Court in Los Angeles, Defendant, Johnson & Johnson (“J&J”) was reeling from the Food & Drug Administration’s proposal that manufacturers of metal-on-metal hip implants submit affirmative scientific evidence that the devices are safe and effective. Previously, manufacturers like J&J were allowed to market the implants under much less stringent guidelines that did not require submission of such safety and effectiveness data.

The FDA’s proposal was in response to more than 100 studies demonstrating that metal-on-metal hip implants posed risks over and above those risks found generally in hip replacement surgery. These additional risks include the release of metal particles around the hip joint and into the bloodstream, which could damage the bone and soft tissue surrounding the joint and cause symptoms or illnesses in other parts of the body. Lawyers for plaintiffs claiming injuries from metal-on-metal hip replacements contend that patients not only experienced tissue death around the joint, but also suffered immobilizing pain, dislocations, fractures and toxic blood infections as a result of defective implants.

The FDA also issued a safety communication to healthcare providers to be aware of the signs of metal ion adverse reactions in patients with metal-on-metal hip replacements.

As of late 2012, J&J faced over 10,000 lawsuits. Approximately three-quarters of those cases are consolidated in the U.S. District Court, Northern District of Ohio (Toledo, Ohio), while another 2,000 are pending in California State Court in San Francisco.

During the trials of these cases, it is anticipated that J&J will be forced to confront its own internal review, which indicated that J&J predicted a 37% hip-failure rate for its product within only 4.6 years of implantation. This revelation is nearly three times what J&J had previously publicly stated was the potential failure rate that would likely require revision surgery. Although at the time it recalled its ASR hip product, J&J indicated a 13% failure rate, the British Orthopaedic Association and British Hip Society countered that their preliminary data suggested the failure rate in the UK to be closer to an astounding 49%.

The first ASR implant trial began in California Superior Court, Los Angeles County, on January 25. The case, Kransky v. DePuy, involves 65-year-old former corrections officer, Loren Kransky, who received a DePuy hip implant in 2007 that required replacement by 2012. Kransky contends that he suffered exposure to heavy metal poisoning originating from the prosthetic hip. J&J has denied the allegations, and blames Kransky’s illness on his long history of smoking, exposure to Agent Orange in Vietnam, and other health complications including kidney disease and coronary artery disease.

Counsel for Kransky contends that J&J’s DePuy unit knew about design defects with the ASR hip replacement, but hid them from surgeons utilizing their product. The defects included the design of the ASR cup, in which the metal ball of the hip would rotate. Because the cup was shallower than other cups, the joint was prone to scrapping and wear, leading to the release of toxic debris—cobalt and chromium ions—into the bloodstream. A former DePuy Product Manager admitted that DePuy never told surgeons that the failure rate of the ASR implants requiring revision surgeries was eight times that of other manufacturers of similar metal-on-metal implants. He testified that J&J elected not to redesign the ASR cup because of financial and business reasons.

It was reported that Plaintiff’s toxicologist testified that Kransky’s blood exhibited metal ions in his bloodstream that were seven to eight times higher than exposure levels set by the California Poison Control Department. Metal toxicity can cause not only local damage to the tissue surrounding the metal component, but also systemic damage, which can affect the central nervous system.

This first bellwether trial is being closely watched around the country.

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