The False Claims Act bars, among other things, unlawful kickbacks to physicians pertaining to any patient interaction to be subsequently billed to Medicare or Medicaid. The FCA also prohibits drug manufacturers from marketing or selling products in ways other than those approved by the FDA. Any deviation from the approved use or design, followed by a subsequent attempt for reimbursement, is considered a violation of the FCA.
In the case of LaCorte v. C.R. Bard Inc. et al, a whistleblower has come forward to accuse C.R. Bard of two violations: (1) marketing and manufacturing its central catheter product in a way contrary to its FDA approval, and; (2) offering physicians training at a reduced rate in exchange for their promise to recommend the product to patients.
The relator’s case was dismissed by a Louisiana federal District Court judge in March of this year after Bard successfully argued that the relator’s accusations were not backed by adequate evidence. In its opinion, the Court noted “[a]s presently pled, relator’s complaint seemingly asks the court to rely solely upon his professional medical opinion regarding the propriety of using defendants’ [catheters] to infer defendant’s bad faith regarding use of their products….This, however, the court cannot do.”
Background of the Parties
The relator in this case, Dr. William St. John LaCorte, is a New Orleans-based physician focusing primarily on the treatment and care of geriatric patients. LaCorte’s accusations centered around his suspicions that certain catheters manufactured by Bard, known as a peripherally-inserted central catheter, or PICC line, were offered in one diameter for approval and manufactured and marketed at a different diameter for physician and patient use.
Current Status of the Case
As mentioned above, LaCorte’s original complaint was dismissed under a procedural rule which allows for the dismissal of a civil claim if the plaintiff has not stated enough information in the Complaint to properly obtain relief. In other words, LaCorte did not provide the Court with enough evidence of improper marketing. LaCorte’s other FCA complaint stated that Bard offered doctors training below market rates, provided rebates and discounts for its product and encouraged nurses to use PICC lines when not medically necessary. The court similarly held that, without more, LaCorte is unable to prove “punishable wrongdoing” and could not sustain his FCA claims.
Earlier this month, LaCorte re-filed a complaint purporting to offer additional evidence to support his original FCA claims. Specifically, he added sections from the PICC line training manual, offered by Bard, demonstrating correct insertion with a PICC line sized too large for patient’s blood vessels. According to Bard, the complaint also contains “fifty-seven meaningless paragraphs which fail to provide any basis for a cause of action under the False Claims Act.”
LaCorte further expounds upon Bard’s alleged misrepresentations to the FDA by stating that Bard failed to disclose certain details pertaining to the correct catheter sizes when applying for its clearance.
Medical Fraud Could Result in Severe Patient Injury
One of LaCorte’s main concerns in his complaint was that use of a wrong-sized catheter, or use of an invasive PICC line when a more traditional peripheral IV is appropriate, could increase the risk of blood clots, patient injury or death. As the whistleblower, he stands to help eliminate these risks. If you are aware of suspicious practices at your place of employment, we encourage you to speak to a whistleblower attorney today.