Instead Of Revealing ASR Failure Rates, DePuy Phased Out Hip Implants
A March 22, 2012 article published in the New York Times revealed that Johnson & Johnson executives chose to phase out its ASR hip implants instead of providing the U.S. Food and Drug Administration (“FDA”) with additional data on the safety of the devices in order to receive market approval. In August 2009, the FDA sent DePuy a confidential letter notifying the company that it was rejecting its application to sell its ASR resurfacing hip system in the United States. DePuy used a “sister version” (which had received FDA approval in 2005) of the device in the U.S. and abroad for traditional total hip replacement surgery. The New York Times obtained the confidential letter via the Freedom of Information Act. In the nonapprovable letter, the FDA cited high ASR failure rates as well as “high concentration of metal ions” in patients who received the devices. Agency reviewers noted that they found the high concentration of metal ions “concerning,” and observed that other countries found that the devices performed “somewhat more poorly” in comparison to the data submitted by DePuy.
According to the New York Times, DePuy executives responded to the letter by ceasing production of ASR implants and selling off its existing stocks. “We are almost out of ASR, and the few doctors still using ASR are threatening to leave DePuy anyhow,” a company executive wrote in an e-mail in May 2010. The company did not disclose the issues raised by the FDA to doctors or patients. Instead, the company simply encouraged orthopedic surgeons to use other models of hip replacements manufactured by DePuy.
Alarmingly High ASR Failure Rates Lead To Worldwide ASR Total Hip Recall And ASR Hip Resurfacing Recall
DePuy executives continued to maintain that their decision to phase out the hip implant was based on declining product sales and not safety concerns over the ASR failure rates or the FDA’s decision to deny approval. However, in August 2010, DePuy issued a worldwide voluntary hip implant recall of all variations of its ASR hip implants after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who received a DePuy ASR hip replacement had to undergo revision surgery within five years of implantation. The ASR hip replacement recall affected approximately 93,000 patients worldwide, although it is unknown how many patients received the ASR resurfacing system after the FDA denied its approval. If DePuy had issued an ASR total hip recall and ASR hip resurfacing hip recall earlier, many individuals could have been spared the dangerous complications associated with the defective devices.
ASR Failure Rates Lead To Surge Of Hip Replacement Lawsuits
Since the ASR hip recall, thousands of lawsuits have been filed by patients who were affected by the ASR total hip recall and the ASR hip resurfacing recall. If you received a DePuy metal-on-metal hip implant, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. The lawyers at Bernstein Liebhard LLP are actively filing cases on behalf of individuals who received the recalled ASR hip implants.
Contact a lawyer today for a free case review, and to learn about your legal rights and options.