A federal judge in New Jersey has refused to reconsider his order allowing two False Claims Act (FCA) claims in a whistleblower’s long-running suit against Bayer Corp. for allegedly pushing off-label uses of heart surgery drug Trasylol. U.S. District Judge Jose L. Linares ruled that Bayer did not meet the “high standard” required for the court to reconsider its March order allowing two claims to survive the company’s motion to dismiss. Bayer had argued that the court “inadvertently missed” the company’s arguments that relator Laurie Simpson failed to show Bayer’s alleged misrepresentations concerning Trasylol constituted claims for government payment, and that the claims concerning the drug did not identify any false certification of compliance.
Bayer’s lawyers didn’t get very far with that type argument. The court’s opinion said that simply because the March ruling did not specifically address the arguments did not mean they were overlooked. I doubt that Judge Linares appreciated the argument. He said in his order:
To the contrary, this court carefully reviewed and considered each and every point in defendants’ submissions and ultimately decided that plaintiff had met its burden to survive defendants’ motion to dismiss.
Bayer had some success in its efforts to dismiss claims from the ninth amended complaint, filed by Ms. Simpson, but did not convince Judge Linares to drop two claims related to Trasylol. That has to be considered a victory for Simpson.
The U.S. Food and Drug Administration (FDA) had approved Trasylol for use in patients undergoing coronary artery bypass graft surgery using a cardiopulmonary bypass pump to prevent excess bleeding. Ms. Simpson, a former Bayer marketing employee, claimed the company misbranded Trasylol by promoting off-label uses of the drug, including use in valve replacement surgeries, surgeries involving pediatric patients, liver transplants and other medical scenarios. She also claims Bayer failed to update Trasylol’s label to provide safety information concerning off-label uses.
The claims that survived the motion to dismiss allege that Bayer’s conduct led to the submission of claims involving Trasylol uses that were not “reasonable and necessary” and therefore not covered under Medicare. Bayer argued that Ms. Simpson did not show that any use of Trasylol was material in claims for reimbursement and that she did not allege a false certification of compliance.
Judge Linares ruled in March that Ms. Simpson alleged facts “plausibly suggesting” that the uses were not medically accepted, and said it was “inappropriate” at that stage in litigation to dismiss the claims. A 10th amended complaint was filed in April. Judge Linares previously dismissed much of the Plaintiff’s case against Bayer last year, saying that violations of federal misbranding law alone are insufficient to trigger FCA liability. The case is in the U.S. District Court for the District of New Jersey.
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