Medtronic, Inc. has agreed to pay $22 million to settle Infuse liability claims with 950 claimants. That averages out to about $23, 000 per case.
Medtronic Settles Some Infuse Lawsuits for $22 Million
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The announcement on May 6, 2014, stated that approximately 750 filed cases brought by approximately 1, 200 individual plaintiffs remain pending in various courts throughout the U.S. The majority of these cases are still in the early procedural stages and none have resulted in a finding of liability against Medtronic. As previously disclosed in Medtronic`s SEC filings, certain law firms have advised the company that they may bring a large number of similar claims against the company in the future. The company estimates those law firms represent approximately 2, 600 additional unfiled claimants.
Potential Liability
If there are over 3, 000 remaining and potential unfiled claimants and the benchmark is $23, 000 per claim, Medtronic could be on the hook for another $77 million.
Earlier this month, on the eve of trial and after several days of pretrial motions, a California trial judge entered summary judgment in favor of Medtronic in the first Infuse case scheduled to go to trial.
The Allegations
As we have previously reported, most of the lawsuits include allegations that Medtronic improperly promoted off-label uses of Infuse. Plaintiff’s lawyers are trying to prove those allegations by presenting testimony of former Medtronic employees regarding off-label promotion in a shareholder derivative action, undisclosed payments to opinion leaders, letters from U.S. Senators regarding promotion and marketing of Infuse, the June 1, 2011 issue of The Spine Journal and the October 25, 2012 U.S. Senate Committee on Finance “Report on Medtronic’s Manipulation of the Infuse Studies and Close Financial Ties with Researchers.”
No Admission of Liability
A company statement said the settlement agreement is a compromise of disputed claims and is not in any way an admission of liability or validity of any defense in the litigation by Medtronic. The company continues to stand behind the product, which has been utilized in more than one million patients since it was approved more than ten years ago, and will vigorously defend the product and company actions in the remaining cases.
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Discussion
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?
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.
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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