ST. LOUIS, Mo. – The U.S. Eighth Circuit Court of Appeals restored a whistleblower’s lawsuit against Bayer alleging the pharmaceutical giant fraudulently led the Department of Defense to into purchasing its drug Baycol, a cholesterol-lowering statin that had been linked to 31 deaths.
Laurie Simpson, former senior market research analyst for Bayer, filed her lawsuit in a federal court in Minneapolis under the False Claims Act, alleging that Bayer aggressively marketed Baycol in early 1998 to compete with other “cerivastation” drugs when it knew studies had found the drug to be less effective at lowering cholesterol than competing drugs when prescribed at the levels initially approved by the U.S. Food and Drug Administration (FDA).
Bayer sought and obtained approval from the FDA to market Baycol at higher dosage levels. Soon after, however, doctors reported that some patients had developed rhabdomyolysis, a rare but serious condition in which destroyed muscle cells are released into the blood stream. The risks of developing the muscle disorder climbed along with drug’s dosage levels, researchers found.
Ms. Simpson alleged that Bayer withheld this information from the Defense Department and others, and that had the government known the truth, it would not have contracted with Bayer or extended its contract to purchase Baycol.
U.S. District Judge Michael J. Davis tossed the lawsuit last year, saying that the whistleblower’s claims were not specific enough and failed to link the government’s decision to pay for Baycol to Bayer’s alleged fraud.
According to Ms. Simpson’s second amended complaint in November 2010, the Pentagon had a deal to purchase Baycol from Bayer that was potentially worth about $35.6 million.
According to Law 360, the appellate court reversed Judge Davis’ ruling, finding that Ms. Simpson’s complaint “properly alleges the government paid Bayer under the fraudulently induced contracts, as it claims approximately 400,000 Baycol prescriptions were filled in military treatment facilities between October 2000 and when the drug was pulled from the market, with the government shelling out at least $12 million during that time.”
Bayer withdrew Baycol from the market in August 2001.
“We fail to see how these allegations are insufficient to state a claim for relief under a theory of fraud-in-the-inducement,” the Eighth Circuit Court of Appeals wrote, remanding the case for further proceedings.