Pharmaceutical

DePuy continued to make and sell faulty metal hip implants for months before recall

DePuy ASR hip recall 435x369 DePuy continued to make and sell faulty metal hip implants for months before recallDePuy Orthopedics and its parent company Johnson & Johnson knew in 2008 its ASR metal hip implants were failing early at unusually high rates, but they continued to make the devices for several more months before finally recalling them in August 2010, newly released court documents show.

The findings were contained in a number of pretrial depositions and internal company records unsealed before the scheduled start of the first trial over DePuy’s faulty implants on Friday. The case, which will be tried in California Superior Court in Los Angeles under Judge J. Stephen Czuleger. The trial will likely reveal a lot about what DePuy and Johnson & Johnson officials knew regarding the faulty ASR hip devices and how they handled the situation.

Other internal documents show that Johnson & Johnson conducted an analysis in 2011, which estimated its metal ASR implants would fail in 40 percent of patients within five years, but the company never disclosed those findings. Instead, Johnson & Johnson downplayed similar figures that came out of the National Joint Registry of England and Wales around the same time.

The faulty ASR XL Acetabular and Hip Resurfacing Systems were implanted in about 93,000 patients worldwide, including 37,000 Americans, before DePuy recalled them. Complaints about the devices often involve implant dislocation and bone fracturing, pain and swelling, and a myriad of problems associated with metallosis or metal poisoning, a condition caused by the buildup in the body of metal ions generated by the all-metal hips.

In some cases, the metallic ions were high enough to cause both acute and systemic illnesses in patients. Tissue and bone decay at the implant site are reported in are often found in some ASR implant patients, making revision surgeries trickier to implement and less likely to succeed.

According to the Wall Street Journal, the deposition of a DePuy official made pubic before Friday’s trial indicates Johnson & Johnson officials possessed clinical data in 2008 documenting “extreme” levels of metal ions in patients implanted with its ASR hip devices, compared to patients who received a hip implant from a competing firm.

Johnson & Johnson and DePuy face about 10,000 lawsuits filed by U.S. patients seeking damages for injuries allegedly caused by the recalled hips. About 2,000 of those lawsuits have been consolidated in a California state court while the bulk will be tried together in multidistrict litigation in an Ohio federal court.

Sources:

Wall Street Journal
New York Times