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Judge Upholds $8.3 Million DePuy ASR Verdict

depuy asr recallIn March 2013, a California jury awarded plaintiff Loren Kransky $8.34 million in damages from injuries he allegedly sustained after being implanted with the DePuy ASR hip replacement device. Kransky claimed that after his surgery in 2007, he suffered serious hip replacement complications, including pain, trouble walking, and metal contamination.

After the trial was over, manufacturer DePuy Orthopaedics, a subsidiary of Johnson & Johnson, argued that the jury’s finding was unjustified, and asked Judge J. Stephen Czuleger to grant a new trial. Yet on May 24, 2013, Judge Czuleger ruled that there was sufficient evidence that the DePuy ASR was defectively designed, and that the company failed to provide adequate warnings about the risks—and upheld the March verdict for the plaintiff.

DePuy faces another about 11,000 DePuy ASR lawsuits, with plaintiffs making similar claims about the company’s failure to provide adequate warnings.

Reports of problems with DePuy ASR

The FDA approved the DePuy ASR for sale in August 2005. The device was not proven safe in clinical trials, however, but achieved clearance through the 510(k) fast-track process, which required only that the manufacturer prove the product significantly similar to others already on the market.

One of many metal-on-metal hip implants on the market, the DePuy ASR was designed to give patients a longer lasting, more durable option in hip replacements. By 2007, however, the FDA had received over 100 reports of problems linked to the device, and by 2008, that number had climbed to over 300.

It wasn’t until March 2010, however, that DePuy started to disclose some of the concerning information about the ASR. They sent a letter to doctors that month warning them of the increased failure rate associated with the device, and admitted that it also seemed to be causing a higher than expected revision rate in patients.

Company implements voluntary DePuy ASR recall

On July 27, 2010, the FDA announced a nationwide DePuy ASR recall. On August 25, 2010, DePuy confirmed the recall, and stated that in the first five years after implantation, about 13 percent of patients who had received the device needed revision surgery—a unacceptably high rate. On August 26, 2010, the company issued a worldwide DePuy ASR recall for all components associated with the total hip replacement system and the hip resurfacing system.

Following the recall, many patients began to come forward to file DePuy ASR lawsuits. They claimed that DePuy was aware of the problems with the ASR long before they initiated the recall, yet continued to sell the device anyway, putting many patients at unnecessary risk.

Status of DePuy ASR lawsuits

While Kranksy’s DePuy hip lawsuit was the first to go to trial, a second case was heard in an Illinois state court soon afterwards. That lawsuit resulted in a verdict for DePuy, but thousands of lawsuits are still pending.

In December 2010, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federal DePuy ASR lawsuits into the Northern District of Ohio. The first bellwether cases there are scheduled to go to trial later this year (2013). Lawsuits have also been centralized at the state level in New Jersey and California.