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Home/Legal & Regulatory and Reimbursement/DePuy (J&J) Whistleblower Action Dismissed
Legal & Regulatory and Reimbursement

DePuy (J&J) Whistleblower Action Dismissed

December 28, 2021 1 min read Premium comments

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Chief United States Magistrate Judge Page Kelley in the United States District Court for the District of Massachusetts has affirmed a motion to dismiss in a whistleblower action filed by two UK orthopedic surgeons—Antoni Nargol, FRCS and David Langton, MRCS.

The lawsuit has been ongoing for nearly a decade. In 2012, Dr. Nargol and Dr. Langton brought an action under the False Claims Act. The action was filed against DePuy Orthopaedics, Inc., DePuy, Inc., and Johnson & Johnson Services, Inc. (collectively “DePuy”).

The surgeons claimed that, per the memorandum and order, “over a five-year period, DePuy illegally promoted and sold a significant number of Pinnacle devices that fell outside FDA-approved manufacturing specifications.” This caused “false claims to be submitted to Medicare and Medicaid.”

One of the main issues in the current matter arose from Dr. Nargol’s and Dr. Langton’s involvement in other litigation. Both previously served as experts and consultants in litigation that involved the Pinnacle device at issue.

As experts and consultants in the other litigation, Dr. Nargol and Dr. Langton had access to confidential information. The confidential information was “subject to protective orders.” During the course of the whistleblower litigation, issues arose regarding the surgeons’ “past disclosure of confidential information.”

Earlier this year, DePuy filed a motion to dismiss and strike which the court dismissed. DePuy then filed a motion for reconsideration. It argued, in part, that the surgeons “were unable to point to a public source of information” regarding some of the information at issue.

In the order affirming DePuy’s motion, Judge Kelley said that, “Not only have relators [Dr. Nargol and Dr. Langton] violated those orders, but they have done so repeatedly over the course of this nearly decade-long litigation, evidencing a pattern of disregarding orders from this and other courts.”

Judge Kelley continued, “Repeated attempts by this court and others to hold relators [Dr. Nargol and Dr. Langton] to their obligations have proven futile, making dismissal the most appropriate sanction, particularly when the court cannot trust that the remaining allegations of the second amended complaint are untainted.”

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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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