British Lawmaker Suggests Criminal Charges be Filed against DePuy Execs for Concealing Safety Data on ASR Metal-on-Metal Hip ImplantFeb 4, 2013
At least one member of the British Parliament believes that a criminal inquiry may be necessary if it’s proven that DePuy Orthopaedics knowingly marketed its ASR metal-on-metal hip implant as safe and effective in the U.K., even after surgeons had warned of its defects there and the company’s own data showed that it was defective.
According to a report from U.K.’s The Telegraph news source, the Labour Party Member of Parliament Andrew Miller believes that criminal, not civil, charges may be necessary against executives at DePuy, a division of Johnson & Johnson, for failing to warn of the problems associated with the failed ASR metal-on-metal hip implant.
Miller says that one leading British surgeon had his warnings to the company ignored when he speculated that there were problems associated with the ASR hip implant he and others had used on patients. He told the source that one surgeon had sent several emails to executives at DePuy indicating that patients were “suffering” because of the defects associated with the ASR metal-on-metal device.
That information combined with data disclosed during a trial in the U.S. last week that showed internal information at DePuy indicated that the ASR hip implant was prone to an early-failure rate as high as 40 percent. DePuy never shared that information with the public, including British regulators, and continued to market the hip implant as safe and effective to thousands of Britons.
The ASR hip implant was introduced to the U.K. market two years before its release in the U.S., in 2003. From then until the time of its worldwide recall in August 2010, the DePuy ASR hip implant was given to more than 10,000 people in the U.K. During its time on the market, DePuy officials became well aware of the problems plaguing its safety profile, including several warnings from surgeons who complained that many of their patients had suffered painful complications caused by the hip implant.
The Telegraph reports that one British surgeon, David Beverland, began emailing executives with DePuy starting in 2006 about problems he was noticing among his patients fitted with the ASR metal-on-metal hip implant, specifically the pain caused by the joint loosening and the accumulation of toxic metals cobalt and chromium caused by the metal components of the device rubbing together and shedding metallic particles into a person’s body, leading to tissue and organ damage and increased pain and suffering.
Beverland wrote to DePuy exec Graham Isaac in 2006 and in 2007 and eventually said he’d stop using the company’s device because too many of his patients were experiencing problems with it that required an inordinate amount of revision surgeries. Isaac testified last week in a U.S. court regarding his knowledge of the problems that plagued the ASR device during its time on the market.
Miller has been joined in his fight against DePuy by Tory Party MP David Tredinnick, who said he’d raise the issue through his role with the Parliament’s Health Committee and its Science and Technology Committee.