Johnson and Johnson is selling more healthcare products than any company in the world, but it’s DePuy unit has recently garnered special attention for its all-metal hip implants. According to Jimmy Smith, a DePuy employee who oversaw a 2011 review of the design, the ASR hip implant used irrelevant controls while testing the product’s safety and effectiveness.
Smith’s testimony is just the beginning of 10,000 lawsuits against J&J. He says that the design team did its job, but that the job could have been done better. He wouldn’t go so far as to say that implant failures are caused by the design team’s safety standards.
Hip Implant Fails to Meet Advertised Expectations
Loren Kransky, a 65-year-old man from Montana who has suffered with a failed ASR hip, is one of many plaintiff’s suing J&J. His lawyer points out that the implant was marketed as a device that produced less debris than any metal-on-metal cup. This marketing, however, has not held up to scrutiny. In many cases, the implants’ failure has been caused by excessive cup wear.
Lawyers have already learned much about DePuy’s failures regarding the hip implant.
People living with the faulty devices have good reason to complain. Even Smith identified 13 areas where the team could have done a better job at detecting potential failures.
Some key components of the lawsuits point out that
- According to DePuy’s own analysis, 37 percent of the devices fail within 4.5 years
- Data from Australia shows that 44 percent of the hips fail after 7 years
- Even though the ASR has 10 cup sizes, only one was tested in DePuy’s lab
- The tests that DePuy performed only studied the implant at an optimal angle rather than those that surgeons often must use in real-world situations.
Hip Implant Could Cause Increased Cancer Risk
In addition to the obvious problems that a warped hip implant can cause, there is a possibility that the metal ion release could increase a person’s risk of getting cancer. This has been a complicated issue for both sides in the lawsuit. The FDA has not established a safety range for metal ion levels, making it difficult for DePuy or lawyers representing patients to adequately prove that the metal debris does or does not lead to negative health consequences.
The lawsuits, 2000 of which will be decided in California courts, could cost Johnson and Johnson billions of dollars.