British MPs Seek Criminal Inquiry Into DePuy ASR Hip Device

British-MP-depuy-criminal-inquiryIn Britain, a criminal inquiry is being called for over toxic hip implants, namely the DePuy implants manufactured by Johnson & Johnson unit, DePuy Orthopaedics.

Despite a email warnings issued by a renowned British surgeon to a DePuy executive, said the Telegraph, DePuy continued to market its metal-on-metal hip implants. The Telegraph noted that DePuy’s own data allegedly revealed that a considerably high number of the hip devices—touted to last a lifetime—were failing in under three years.

Test found that the devices were likelier to fail when compared to other hip devices, yet DePuy continued to market the artificial hips to British patients, said the Telegraph; test results are believed to have been kept from the public and British regulators. Meanwhile, hundreds of patients in Britain have had to undergo dangerous and complex revision surgery to remove and replace the defective devices over so-called blood poisoning, said the Telegraph.

“If this is proven then it ought to be up to the regulator to contemplate involving the police so there is a criminal inquiry,” Andrew Miller, Labour MP for Ellesmere Port and Neston and chair of the Science and Technology Committee, said after reading the Telegraph’s disclosures. Miller described the information as “appalling,” adding that, “If a company would knowingly do this then where does the buck stop? I think it’s a question of a criminal inquiry rather than a civil one…. We need a very tight regulatory regime and what we should be saying to the NHS is to make sure that products that are being bought have been regulated and approved in Britain,” Miller added, referring to Britain’s National Health Service (NHS).

Miller added, said the Telegraph, that products used in Britain must be “rigorously tested to British standards and if there is any doubt they should not be bought.” David Tredinnick, Tory MP for Bosworth, also said: “There should be an investigation and I shall be raising this in the Health Committee and also in the Science and Technology Committee.”

The disclosure came as the first of some 10,000 lawsuits against DePuy over its metal-on-metal ASR hip device is being heard. According to the Telegraph, presented documents reveal that DePuy was continually warned about the impact of the device on British patients. More than 10,000 British patients have been implanted with the devices, which were launched in Britain in 2003. In August 2010, the device was globally recalled after some 93,000 patients were implanted with the ASR, about one-third in the United States.

News reports out of Britain and the U.S. reveal that, as far back as 2006, Dr. David Beverland, an orthopadic surgeon at Musgrave Park Hospital in Belfast, was writing to DePuy about problems with the device. Beverland, MD wrote to Graham Isaac, an engineer at DePuy, on May 15, 2006 saying, “Hi Graham, this is another patient with similar problems,” according to the Telegraph. The next year, Beverland told DePuy he would be ceasing his use of the device.

In his deposition, Isaac said he was not sure exactly why Beverland stopped using the ASR, said the Telegraph. Yet, in April 2008, after DePuy’s own tests revealed that its ASR product performed poorly against another type of hip replacement, Isaac wrote in an email that the data had the potential “to seriously affect our business,” according to the Telegraph. Isaac also wrote about metal ion levels between the two devices and wrote: “In essence, this shows that under certain conditions, ASR is susceptible to extreme metal—levels of metal ions.”

We’ve repeatedly written that research has linked metal-on-metal hip implant devices, such as the DePuy ASR, to a number of adverse events such as tissue necrosis, pain at the implant site that sometimes spreads to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid masses around the hip joint. The issue appears to be with the metal used in the construction of the implants, which was touted to last for at least two decades. More and more, reports and research indicate that some patients have required painful revision surgeries just two or three years after original implantation.

This entry was posted in Defective Medical Devices, Depuy, Metal Hip Implants. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.