Just under two months ago, the Food and Drug Administration began recalling hip implants manufactured by DePuy Orthopedics, citing complaints it has received for more than two years about unusually high (and quick) failure rates of the implants requiring additional surgeries. Since, complaints about the recalled models have flooded in, leading some to predict that the total number of faulty hip surgeries could reach 12,000, and based on past faulty surgeries, lawyers have estimated that DePuy Orthopedics could be on the hook for more than $5 billion.
Government investigators are concerned that if the implant is not installed perfectly, the metal-on-metal models could send harmful metal shards into the blood stream and local tissue. The threat is so present that DePuy now recommends that patients immediately procure a blood test to determine whether they have abnormal levels of chromium and cobalt, which could lead to deafness and even heart disease.
Where did this start? And how did it spiral out of control? We decided to take a look at the recall timeline that has put DePuy Orthopedics at the center of hundreds of hip surgery lawsuits worldwide.
2005: The FDA approves DePuy’s ASR hip implant model for safe use in the United States after DePuy parent company Johnson & Johnson requests permission to skip clinical trials.
January 2008: The British equivalent of the FDA releases a report that finds “evidence of genetic damage in patients with certain metal hip implants,” and name checks DePuy.
2008: About 400 ASR patients complain about their implants to the FDA.
2009: Citing international complaints, DePuy takes its ASR models out of circulation in Australia.
January 2010: DePuy warns doctors of the early failure rate of their ASR models, and announces that it will phase out sales of the system.
March 2010: DePuy is criticized for its “silent recall” of the ASR models after the New York Times reports that an Australian report proves alarmingly high failure rates soon after surgery.
April 2010: The British version of the FDA releases a report citing additional complications associated with the ASR model, including a heightened risk of tumors.
June 2010: A Florida woman files the first lawsuit against DePuy, claiming that less than a year after her hip surgery, she experienced “extreme weakness in her hip and quadriceps.” When doctors replaced the implant, they found that it had categorically failed.
July 2010: The FDA announces that DePuy will recall the ASR model.
August 2010: DePuy parent company Johnson & Johnson announces its worldwide recall of the ASR Hip Resurfacing System and the ASR XL Acetabular System.
More than 100 lawsuits have already been filed on the state and federal level, reports the San Francisco Daily Journal, with personal injury lawyers expecting the total to expand to more than 4,000 lawsuits against DePuy and Johnson & Johnson. Preliminary discussions have indicated that San Francisco is on the short list of potential centers for the pending state and federal lawsuits. We will keep you updated with more information as it arises.
Photo credit: Cindy Funk