Internal emails and confidential letters recently obtained by the New York Times reveal disturbing information about serious safety issues relating to the DePuy ASR hip implant. According to the article, the U.S. Food and Drug Administration raised legitimate concerns over the defective product design more than a year before hip manufacturer Johnson & Johnson officially issued a recall. Meanwhile, DePuy executives worked behind the scenes to quietly phase out the flawed hip until the entire inventory was depleted.
Our product liability attorneys at Pintas & Mullins recognize the serious potential for injury or death when drug manufacturers put profits ahead of patient safety. More than 93,000 patients around the world received the defective ASR metal-on-metal artificial hip device. The latest reports suggest that company executives knew of high failure rates associated with the device as early as 2009 but did not issue a recall until August 2010.
Newly released FDA documents show that the agency asked the company for additional safety information about the implant, citing blood tests of some patients who showed a high level of metal ions in their bloodstream. Just a few weeks later, the company decided to phase out the device inventory and sell the remaining stock. A company executive defended the decision, stating that slowing product sales rather than safety issues motivated the business plan.
Another confidential document that was not disclosed to doctors or patients until the recent New York Times report is an FDA letter that was sent to the company in 2009. The letter exposed serious problems with a resurfacing version of the implant that was being used abroad. The agency refused to approve the device for sale in the United States, because a number of patients reported high failure rates just a few years after implantation. However, the potential for harm remained because a similar version of the device, based on the same flawed metal-on-metal design, had been on the market since 2005. This version was cleared through a fast-track program that did not require extensive testing and clinical studies.
DePuy manufacturers finally issued a recall in August 2010, after 13 percent of the ASR hip implants were shown to fail within 5 years. The device was expected to last at least 15 years. In addition to early failure rates, patients also suffered debilitating injuries caused by shedding particles of metallic debris. This led to adverse reactions such as loss of mobility, hip pain, and metal toxicity.
When a product device manufacturer knows of a design flaw and fails to warn of the potential for harm, the company may face liability. In order to prove negligence, a patient must prove that the manufacturer owed the patient a duty of care, breached that duty, and caused injury. Here, DePuy manufacturers knew as early as 2009 that the ASR hip implant had obvious design flaws that caused patients serious injuries and forced them to undergo risky revision surgeries. Unfortunately, the company continued to sell the product for more than a year in order to avoid losing money on the rest of its flawed inventory.
Our defective device attorneys are deeply concerned that the ASR hip manufacturer knew or should have known of the risk of serious harm associated with its product, yet failed to warn patients. Tens of thousands of patients implanted with the defective device suffered permanent disabilities and other crippling injuries. Our DePuy hip implant lawyers are continuing to evaluate potential hip implant claims involving revision surgeries and serious injuries such as metal blood poisoning.