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Home/Legal & Regulatory and Reimbursement/Stryker Settles Final Metal-on-Metal Hip Lawsuits
Legal & Regulatory and Reimbursement

Stryker Settles Final Metal-on-Metal Hip Lawsuits

May 16, 2017 2 min read Premium comments

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Stryker Settles Final Metal-on-Metal Hip Lawsuits
Photo creation by RRY Publications, LLC and Stryker
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Stryker Corporation is putting lawsuits over its Rejuvenate Modular-Neck hip stem and ABG II Modular-Neck hip stem in the rearview mirror.

On May 8, 2017, the company announced that 95% of additional registered eligible patients have enrolled in the Settlement Program under the Master Settlement Agreement announced in December 2016.

The 2016 Settlement Program follows an initial 2014 Settlement Program that covered patients who had a revision surgery prior to November 3, 2014. In that initial program, over 95% of eligible patients also enrolled.

At the end of 2014 Stryker and lawyers representing patients suing the company settled the claim for approximately $1.4 to $2.3 billion.

Stryker voluntarily conducted a worldwide recall of the products in July 2012. More than 20, 000 patients across the country received the implant. The first of the lawsuits against Stryker was filed a month after the recall.

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 stated that there are “unique risks” for metal-on-metal artificial hips and ordered manufacturers to conduct postmarket surveillance.

In November 2016. Wright Medical Technology, Inc. entered into settlement agreements with patients and insurance carriers over lawsuits resulting from claims over the company’s Conserve metal-on-metal hip implant.

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The agreements represent 1,292 individual claims for a total settlement of $240 million, or about $185,000 per claim.

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.

According to the New York Times, all-metal implants once accounted for about one of every three devices used in the estimated 250,000 hip replacement procedures that are performed annually in the U.S. Device companies stopped marketing the devices after evidence emerged that the metal components could rub together, creating tiny particles of metallic debris that could severely damage a patient’s tissue and muscle. Surgeons stopped using the devices in most cases.

Stryker company officials say the high participation rates in both the Stryker 2014 and 2016 Settlement Programs are a testament to the fair and efficient processes afforded to patients through both programs.

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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