False Claims Suit Against Bayer Is Still Kicking

     (CN) – A federal judge called for an eighth amended complaint from a former analyst who says that Bayer hid safety risks and got illegal kickbacks for off-label marketing.
     Laurie Simpson is the relator of the federal qui tam action in the District of New Jersey against Bayer, Bayer HealthCare Pharmaceuticals and Bayer HealthCare.
     She alleges that the 150-year-old pharmaceutical company concealed health risks and unlawfully marketed Avelox (moxifloxacin hydrochloride), an extremely powerful antibiotic, and Trasylol (aprotinin), which aims to reduce bleeding during complex surgery. For this promotion, the company allegedly received illegal kickbacks.
     Simpson, who held various marketing and analytical positions with Bayer from April 1998 through January 2005, says Bayer retaliated against her for expressing concerns about cholesterol drug Baycol, which led to numerous patient deaths and a multidistrict litigation.
     Bayer later allegedly downplayed the dangerous risks of Trasylol, “including hypersensitivity and anaphylaxis, heart attack, adverse graft patency and clotting, and renal dysfunction.”
     When Simpson complained that the company’s cardiac team meetings were “fraudulent, promotional in nature, involved kickbacks, violated Bayer’s corporate compliance policy, and were illegal,” she was excluded from the drug’s business planning process, the complaint states.
     She said Trasylol marketing director Stan Horton allegedly told Simpson in August 2004 that he needed a “supportive” market researcher, and that she was fired a month later.
     Though the company allegedly attributed her firing to a workforce reduction, she claims a less qualified employee assumed her role.
     The Food and Drug Administration asked Bayer to suspend marketing of Trasylol in 2007, and the product was recalled the next year, prompting hundreds to file suit.
     Simpson’s seventh amended complaint asserts 39 causes of action under the false claims acts of 21 states, the District of Columbia and New York City, as well as workplace retaliation and emotional distress claims.
     The government declined to intervene on Feb. 19, 2010, but filed a statement of interest in connection after Bayer filed its latest motion to dismiss in June.
     U.S. District Judge Jose Linares partially denied Bayer’s motion last week, holding that Simpson’s reactions amounted to more than mere “grumbling.”
     “Simpson spoke to her supervisors and members of Bayer’s senior management on multiple occasions to inform them that she believed the relevant marketing practices were illegal and that she refused to participate in or help cover up what she believe to be illegal marketing tactics, including kickbacks,” the unpublished ruling states. “Plaintiff also alleges that her discussions led to the involvement of in-house counsel. Simpson further alleges that as a result of those discussions, she was insulated from certain team activities and the business planning process, not given assignments or promotions for which she was qualified, and eventually terminated. In addition, plaintiff alleges that she was informed that her choice to stand up to Mr. Horton was behind Bayer’s decision to terminate her, notwithstanding that she warned Human Resources that her firing would be illegal. Accordingly, the court concludes that plaintiff sufficiently pleads a probable right to relief.”
     The court dismissed the state and local claims and those for misbranding and emotional distress, but gave Simpson 30 days to amend her suit for the eighth time.
     She is barred only from refilling her emotional distress claim, which was dismissed last week with prejudice.
     Bayer reported about $52 billion in sales in 2012.

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