Case DescriptionCase Type: Whistleblower/ Qui Tam
Company: DePuy Orthopaedics
Sanford Heisler Sharp brought whistleblower claims on behalf of Dr. Antoni Nargol and Dr. David Langton, two physicians and researchers who were first to uncover that medical-device company DePuy Orthopaedics manufactured and sold large numbers of defective hip implants to the government. Based on their experience and their clinical practice, the physicians ascertained that DePuy’s Pinnacle metal-on-metal hip implants were failing at an unreasonably high rate. Further research revealed that DePuy’s manufacturing processes were producing metal liners (the prosthetic replacement for a hip socket) that did not meet FDA-required specifications 50.41% of the time, and that the metal head (the prosthetic replacement for the ball at the top of the leg) did not meet FDA-required specifications 14.93% of the time. The physicians also determined that DePuy was likewise manufacturing two metal parts within the metal head out of specification.
Manufacturing precisely to specification is particularly important for hip implants, because when a device does not meet specifications, the metal pieces may come into contact and discharge metal into the patient’s bloodstream, causing tumor-like reactions in the patient’s tissue and requiring further surgery. Based on the discovery of these defects the physicians concluded that rather than manufacturing safe hip implants, DePuy was producing devices that were substantially more likely to harm patients and selling them to physicians who would, in turn, seek reimbursement from government health insurance programs, such as Medicare and Medicaid.
Sanford Heisler Sharp filed a whistleblower suit on behalf of Drs. Nargol and Langton in 2012 in the United States District Court for the District of Massachusetts alleging that the Government had been defrauded of the benefit of its bargain. The whistleblowers alleged that rather than paying for safe and effective hip implants that would help patients, the government had instead unwittingly been paying for surgeries that would implant defective devices causing patients harm and costing the government money in the process. In 2016, the United States District Court for the District of Massachusetts dismissed the lawsuit, but in July 2017, the United States Court of Appeals for the First Circuit reversed the District Court’s ruling. The Court of Appeals determined that the Sanford Heisler Sharp and Drs. Nargol and Langton had a valid claim that should proceed. It stated that Drs. Nargol and Langton should be able to pursue their claim that Defendants had “palmed off latently defective versions of its FDA-approved product on unsuspecting doctors who sought government reimbursement for the defective products.” The Court continued, “over a five-year period, several thousand Medicare and Medicaid recipients received what their doctors understood to be Pinnacle [metal-on-metal] device implants; that more than half of those implants fell outside the specifications approved by the FDA; and that the latency of the defect was such that doctors would have had no reason not to submit claims for reimbursement for noncompliant devices.”
The case is among the first to successfully allege that a medical-device manufacturer may be held liable for selling the government defectively manufactured medical devices. Sanford Heisler Sharp’s victory on appeal represents a major victory both for Drs. Nargol and Langton and for whistleblowers nationwide.
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