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Artificial hip whistleblower suit reinstated

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A federal appeals court has reinstated a claim in a whistleblower suit that an artificial hip manufacturer “palmed off” a defective artificial hip on “unsuspecting” doctors.

Drs. Antoni Nargol and Robert Langton, who claim to be experts in hip replacement techniques and devices, filed an amended complaint in 2015 charging Warsaw, Indiana-based DePuy Inc. with violation of the False Claims Act, according to Wednesday’s ruling by the 1st U.S. Circuit Court of Appeals in Boston in United States, ex rel. Antoni Nargol and David Langton et al. v. DePuy Orthopaedics Inc.; DePuy Inc.; Johnson & Johnson Services Inc.

The False Claims Act is an 1863 law that provides that any person who knowingly submits, or causes the submission of, false claims to the government is liable, according to the U.S. Department of Justice.  Those who are found liable must pay a civil penalty of between $5,500 to $11,000 for each false claim and treble the amount of the government’s damages.

The doctors filed suit in U.S. District Court in Boston, charging both that DePuy made false statements in securing U.S. Food and Drug Administration approval for its “Pinnacle MoM” hip replacement device, and that it supplied doctors with “latently defective” versions of its FDA-approved product.  “MoM” stands for metal on metal, and refers to the material used in the device’s key components.

On appeal, a three-judge appeals court panel upheld dismissal of the FDA-related claim, but reinstated the second product defect claim.

The doctors alleged that over a five-year period, doctors had implanted the device on several thousand Medicare and Medicaid recipients and “more than half of those implants fell outside the specifications approved’” by the FDA, said the ruling.  

They charged the “latency of the defect was such that doctors would have had no reason not to submit claims for reimbursement for noncompliant devices,” said the ruling.

The doctors said the device had a five-year failure rate of nearly 15% compared with the five-year failure rate of 4.5% or lower claimed by DePuy, which was characteristic of, or superior to, the failure rates of other competing devices.

“In short, we have in this case a complaint that alleges the details of a fraudulent scheme with ‘reliable indicia that lead to a strong inference that claims were actually submitted’… for government reimbursement from the United States and from the state of New York,” said the ruling, in quoting an earlier case, and remanding the case for further proceedings.

The ruling says DePuy discontinued the device in 2013.

In June, a federal appeals court reinstated negligence and product liability claims against a medical device manufacturer by a patient whose hip replacement surgery had to be undone after complications arose.