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Home/Legal & Regulatory and Reimbursement/Wright Medical Reaches $240 Million Metal-on-Metal Hip Lawsuit Agreement
Legal & Regulatory and Reimbursement

Wright Medical Reaches $240 Million Metal-on-Metal Hip Lawsuit Agreement

November 7, 2016 2 min read Premium comments

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Wright Medical Reaches $240 Million Metal-on-Metal Hip Lawsuit Agreement
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Wright Medical Technology, Inc. has entered into settlement agreements with patients and insurance carriers over lawsuits resulting from claims over the company’s Conserve metal-on-metal hip implant.

The Master Settlement Agreement (MSA) with court-appointed lawyers represents 1, 292 individual claims for a total settlement of $240 million, or about $185, 000 per claim. Terms of the settlement with three of the company’s insurance carriers were not disclosed.

Outstanding Cases

As of September 25, 2016, the company estimates there were approximately 600 outstanding metal-on-metal hip revision claims that would not be included in the MSA settlement, including approximately 200 claims with an implant duration of more than eight years, approximately 300 claims subject to possible statute of limitations preclusion, approximately 30 claims outside this settlement group pending in U.S. courts, approximately 50 claims pending in non-U.S. courts, and approximately 20 claims that would be eligible for inclusion in the settlement but for the participation limitations contained in the MSA.

The company also estimates that there were approximately 700 outstanding metal-on-metal hip non-revision claims as of September 25, 2016. These non-revision cases are excluded from the MSA.

The settlement agreement requires that 95% of the plaintiffs opt-into the agreement. The MSA may be terminated by Wright Medical prior to any settlement disbursement if claimants holding greater than 5% of eligible claims in the Final Settlement Pool elect to “opt-out” of the settlement. No funding of any individual plaintiff settlement will occur until the 95% opt-in requirement has been satisfied or waived.

This settlement follows an $11 million federal jury award December 2015 to one of the plaintiffs in the first bellwether trial of Wright Medical consolidated cases.

Wright Medical sold its hip and knee implant business to China-based MicroPort Medical in 2013 for $290 million.

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Metal-on-Metal Hips

Metal-on-metal hips have been very controversial after foreign registries showed higher than normal failure rates. On May 6, 2011, the FDA ordered manufacturers of metal-on-metal hip devices to conduct postmarket surveillance.

Thousands of lawsuits have been filed around the country by patients who have alleged injury from their metal-on-metal hip implants made by various manufacturers. The multi-district cases, in addition to Wright Medical’s, include:

  • Zimmer Holding’s Durom Hip Cup (290 filed cases)
  • DePuy Orthopaedics, Inc.’s ASR Hip Implant (8, 858 filed cases)
  • DePuy Orthopaedics, Inc.’s Pinnacle Hip Implant (5, 153 filed cases)
  • Biomet, Inc.’s M2a Magnum Hip Implant (978 filed cases)

DePuy reached a multi-billion dollar settlement with patients implanted with the ASR implant.

Wright Medical President and CEO Robert Palmisano commented, “We are very pleased to have reached this settlement agreement, in particular the population of claims that the settlement covers as well as the required 95% opt-in rate for those claims. With this clarity, we will continue to focus on accelerating growth opportunities in the extremities and biologics markets. This settlement addresses approximately 85% of the known U.S. revision claims that do not have potential statute of limitations issues and removes a great deal of the uncertainty that has been associated with this litigation.”

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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