The recalled replacement hips manufactured by Johnson & Johnson/DePuy Orthopaedics did not become defective overnight. The evidence suggests that J&J has known for years that the products were defective. Key dates and events include the following:
2005: J&J/DePuy introduces the ASR hip replacement system in the United States after winning a “510(k) clearance” from the Food and Drug Administration (FDA). Such clearance meant that the product was given regulatory approval without having to go through clinical trials.
2008: A report to the Medicines and Healthcare products Regulatory Agency (MHRA; the British equivalent of the FDA) finds “evidence of genetic damage in patients with certain metal hip implants” (such as the ASR system).
2008: The FDA receives 400 complaints from or about patients who had ASR devices installed. 13% of ASR hip replacement patients require a second surgery to replace the device(s)—a much higher failure rate than the industry standard.
2009: DePuy voluntarily withdraws the ASR system from the Australian market.
2010: J&J/DePuy announces that it will phase out sales of the ASR hip replacement system by the end of the year. The companies send letters to doctors warning that data from the Australian Medical Device Registry show a higher than expected failure rate of the ASR system, especially in smaller patients or those with weak bones.
J&J/DePuy continue to sell the defective ASR even after being warned for years by surgeons of the device’s problems.
May 2010: The London Times reports that “[MHRA] announced an official review in April of some 40,000 hip replacements. Doctors are warning that metal debris originating from the defective implants can cause non-cancerous tumors, severe swelling and sinew damage.”
March 10, 2010: The New York Times reports that DePuy has warned doctors that its ASR system was failing patients within a few years after the replacement surgery, when such implants should typically be expected to last 15 or more years. To some this was considered a “silent” recall.
June 15, 2010: Kathleen Margunau, a Florida woman, files the first lawsuit against DePuy for harm caused by the ASR system. The suit, filed in federal court in Fort Myers, claims that Ms. Margunau received a DePuy ASR acetabular cup in March 2008 and began experiencing “extreme weakness in her hip and quadriceps” following surgery. Less than one year later, she required a second surgery, during which doctors, after removal of the hip implant, found that the device had catastrophically failed.
July 17, 2010: The FDA notifies the public that DePuy is recalling its ASR hip implant cups (FDA recalls nos. Z-2031 through Z-2059-2010).
August 26, 2010: J&J/DePuy issues a worldwide recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System. The decision is the result of a determination that the failure rate for both systems was over 12%.