Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics yesterday won the dismissal of a False Claims Act lawsuit brought by a pair of British surgeons over its since-discontinued Pinnacle metal-on-metal hip implant.
Drs. Antoni Nargol and David Langton sued in 2012, alleging that DePuy Orthopaedics committed fraud when it billed federal agencies for Pinnacle implantation procedures, because it knew of and concealed problems with the device.
Nargol, an early adopter of the Pinnacle MoM implant and a former member of DePuy’s Pinnacle user group, later became an expert witness for the plaintiffs in several product liability lawsuits brought over the Pinnacle device and another MoM hip implant, the DePuy ASR. Langton is a consultant for the FDA on failure rates for MoM devices and is also a plaintiffs’ witness in several MoM liability cases.
The doctors began reporting defects to DePuy in 2007 and, According to their complaint, “both the relators had personal experience in implanting the Pinnacle MoM device in their patients and began to alert defendants of the device’s defects in 2009,” after 2 years after they began reporting the problems to DePuy.
The lawsuit alleged that DePuy knew the revision rate for the Pinnacle MoM was 15%, not the 4-4.5% it reported to the FDA or the 0.1% rate it advertised to surgeons. But judge Dennis Saylor IV, of the U.S. District Court for Massachusetts, yesterday granted the company’s motion to dismiss the case, ruling that Nargol and Langton failed to link the alleged fraud with specific instances of false billing.
“Here, the [complaint] includes hundreds of paragraphs of allegations, covering dozens of pages, of claimed fraudulent activity by DePuy. That satisfies 1 of the components of an FCA claim, but it does not satisfy them all. As set forth below, the allegations as to specific claims for payment for the specific device actually at issue in this case are sparse indeed,” Saylor wrote.
“The [complaint] here fails to connect the multiple allegations of DePuy’s misrepresentations and omissions to any specific claims for payment. Nor does the [complaint] appear to identify a single physician who was a target of allegedly false DePuy marketing, identify a single physician who relied on that marketing, or identify a single physician who filed a false claim for the DePuy MoM device. The closest that the [complaint] comes to such specificity is ‘Dr. J.N.’ and ‘patient F.I.,’ but the [complaint] does not identify the specific representations or materials that the doctor received and relied upon, nor does it allege the specific DePuy device for which the doctor filed a claim,” the judge wrote. “Furthermore, the SAC’s unfocused and imprecise statistical evidence adds little to establish DePuy’s fraud beyond a mere possibility.”
Saylor also denied the doctors’ bid to allow a 3rd amended complaint, ruling that they’ve known since June 2015 at the latest of the complaint’s defects.
“Considerable time has passed since the filing of the original complaint and since the relators were put on notice of the defects in the complaint, and the relators have not demonstrated a legitimate reason for their neglect and delay. Accordingly, the relators’ request for leave to amend the SAC and file a third amended complaint will be denied,” Saylor wrote.
In October 2014, a Texas jury found for DePuy in the 1st product liability lawsuit to go to trial over the Pinnacle MoM.
In 2013, DePuy agreed to pay $2.5 billion to settle more than 7,000 lawsuits over the ASR devices, which it recalled in 2010.