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Home/Legal & Regulatory and Reimbursement/Jury Awards Patient $8 Million in DePuy ASR Trial
Legal & Regulatory and Reimbursement

Jury Awards Patient $8 Million in DePuy ASR Trial

March 8, 2013 1 min read Premium comments

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Jury Awards Patient $8 Million in DePuy ASR Trial
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The jury in the DePuy Orthopaedic, Inc. ASR hip trial returned a mixed verdict on March 8, 2013, after a five week trial and has awarded Loren Kransky $8, 338, 000 in compensatory damages.

Kransky’s lawyers had asked jurors for $338, 000 in economic damages, $5 million in economic damages for pain and suffering, and up to $179 million in punitive damages.

According to published reports, the jury found that the ASR was defectively designed, but did not buy the argument that DePuy failed to adequately warn of the risks associated with the device.

“We believe ASR XL was properly designed, and that DePuy’s actions concerning the product were appropriate and responsible, ” said Lorie Gawreluk, a spokeswoman for DePuy in a written statement to OTW. “We plan to appeal the jury’s decision on design defect pending the outcome of post-trial motions. We believe we have a number of valid grounds for appeal, notably that the court didn’t let the company tell the jury about the Food and Drug Administration’s review and clearance of the device.”

“This is the first day of reckoning for DePuy, ” Brian Panish, one of Kransky’s lawyers reportedly said after the verdict. “We’ve learned a lot from this trial. We’ll get punitive damages in the next trial.”

One juror, David Vega, said after the verdict that “I wanted punitive damages” based on the evidence that DePuy found the problem and took so long to resolve it, according to a Bloomberg story.

With 10, 000 other lawsuits already filed against the company waiting in the wings, an $8 million price tag per case adds up to an astronomical $80 billion. The appeal regarding FDA clearance will weigh heavily on potential settlement discussions with other defendants. It’s unclear to us if DePuy’s appeal argument will rest on the federal preemption theory which protects companies against product liability lawsuits in state courts.

Last year, Johnson & Johnson, DePuy’s parent, took a $3-billion charge to cover costs related to the ASR hip recall, legal expenses and other related items. The company had already reportedly offered $200, 000 per case.

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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