Over 10,000 lawsuits have been filed against the company Johnson & Johnson for their distribution of the DePuy ASR hip implant, since a recall was issued in August 2010. The DePuy ASR hip implant has a metal on metal design, which means that a metal head rotates within a metal cup. This design causes metal debris, caused from the metal parts rubbing against each other, to be released into the surrounding tissue and cause medical problems. The failure occurs within five years of replacement.
When the recall was first issued, Johnson & Johnson stated that the failure rate was only about 13%, but after documents were released as part of the litigation, it was estimated that the failure rate of the DePuy ASR hip implant is as high as 37%. This means that one out of every eight DePuy ASR hip implants were failing within five years of replacement surgery.
There is currently a case going on in California against Johnson & Johnson for the marketing, manufacturing and sale of the defective DePuy ASR hip implants. It is being said that the company failed to properly warn the public, as well as healthcare professionals, about the risk of loosening and other complications that may develop shortly after hip replacement surgery.
In testimony in the current case being heard in California, a DePuy engineer testified that Johnson & Johnson only tested one angle of implantation and that the company failed to use the right engineering controls when trying to assess potential problems. The engineer further stated that the testing conducted failed to predict how much wear the hip implants would experience and how much they could loosen.
The FDA released a new guidance for metal on metal hip replacements in January of this year. Doctors were advised that metal on metal hip replacement systems should only be used if other artificial hip implants were not appropriate for the patient, and called on all manufacturers to prove that their implants are safe enough to stay on the market. Also, future metal on metal hip designs will have to undergo extensive human clinical trials before being made available for sale to the public.