Two months ago, the Food and Drug Administration announced its recall of hip implants manufactured by DePuy Orthopedics, a division of Johnson & Johnson. Since, complaints about the recalled models have flooded in, leading some to predict that the total number of faulty hip surgeries could easily surpass 12,000.
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.
As investigators continue to probe DePuy’s liability in this hip surgery fiasco, government officials and reporters have insinuated that the recall resulted from more than a simple mistake. First of all, the F.D.A. accused DePuy of marketing an unapproved knee device and selling hip implants for purposes not approved by the agency.
Second, a North Carolina-based investigative reporting operation found that the F.D.A. approved the implants without clinical trials. As the ABC affiliate reports, “The company used a little-known regulation that allows a medical device to be approved if it’s similar to another device that’s already been tested.”
The DePuy debacle is a major setback for Johnson & Johnson, a longtime leader of the pharmaceutical industry. “All this makes it seem like it’s a pile-on time for J.&J.,” said William Trombetta of Philadelphia’s Saint Joseph’s University. “This is a company that was purer than Caesar’s wife, this was the gold standard, and all of a sudden it just seems like things are breaking down.”
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 continue skyrocketing. Based on a similar hip implant lawsuit settled in 2002, some attorneys expect these cases could be worth at least $5 billion. We will keep you updated with more information as it arises. [UPDATE: DePuy Orthopedics Lawsuits Move Forward]
Here’s a video describing the medical issues associated with DePuy’s faulty hip implants: