Pharmaceutical

Court documents show DePuy knew nearly 40 percent of its hip implants failed within 5 years

DePuy ASR hip recall 435x369 Court documents show DePuy knew nearly 40 percent of its hip implants failed within 5 yearsDocuments unsealed ahead of the first faulty hip implant lawsuit against Johnson & Johnson and DePuy Orthopedics to go to trial show that company executives knew in 2011 that its ASR metal hip implants would fail in nearly 40 percent of patients within five years, but withheld that information.

DePuy, a division of medical giant Johnson & Johnson, recalled its ASR XL Acetabular and ASR Hip Resurfacing Systems in August 2010 as evidence mounted that the hip devices, which consisted of a metal ball and metal cup, failed at unusually high rates. At the time of the recall, the devices had been implanted in some 93,000 people worldwide, including 37,000 people in the United States.

DePuy recalled the faulty devices after data from the National Joint Registry of England and Wales demonstrated for the first time that 13 percent of the ASR XL Acetabular system and 12 percent of the hip resurfacing implants failed within five years.

Traditionally, hip implants are supposed to last about 10-15 years, and metal-on-metal hip implants are designed to be even more durable than conventional implants made with plastic and ceramic components. According to the Wall Street Journal, DePuy has said that no more than 5 percent of hip implant patients should undergo revision surgery within five years.

In 2011, updated data from the U.K.’s Joint Registry showed that the DePuy’s ASR hip implants were failing in about a third of the patients who had them the longest. DePuy objected to those figures even when its own internal analysis mirrored the findings, the court documents show.

A Johnson & Johnson spokeswoman told the Wall Street Journal that the company will present evidence during the California trial showing that it “acted appropriately and responsibly” with its knowledge of the faulty hip devices.

Johnson and Johnson faces about 10,000 personal injury lawsuits involving the recalled hip devices. The California case was chosen as the first to be tried because its plaintiff, Loren Kransky, is battling cancer and may not live much longer, according to the New York Times.

Two thousand DePuy hip implant lawsuits have been consolidated in a California state court, while an additional 7,000 lawsuits have been consolidated for multidistrict litigation in United States District Court for the Northern District of Ohio, Western District, with Judge David Katz presiding.

The DePuy lawsuits represent one of largest and potentially costliest medical device failures in recent decades. Johnson & Johnson said last year that it took a special charge of $3 billion to help cover medical and legal costs stemming from its ASR implants.

Sources:

Wall Street Journal
New York Times