Twelve years ago, drug maker Bayer recalled its cholesterol drug Baycol because patients taking it disproportionately developed a deadly muscle disorder called rhabdomyolysis. Thousands of pharmaceutical injury lawsuits alleged that Bayer knew about the drug’s problems long before its 2001 recall, which was requested by the FDA after at least 31 deaths in the U.S. alone were attributed to Baycol. Much of that litigation is now settled, so I was interested to see a related whistleblower lawsuit decided by our own Eighth U.S. Circuit Court of Appeals. In Simpson v. Bayer Healthcare et al., former Bayer employee Laurie Simpson alleged that Bayer defrauded the federal government through marketing and sale of the drug to Medicare and Medicaid programs and Department of Defense contracts. The Eighth Circuit permitted the claims as to the Defense contracts.
Rhabdomyolysis is caused by severe muscle damage, with muscle breakdown products entering the bloodstream. High enough levels of those products can be harmful to the kidneys and even lead to kidney failure. Symptoms include brown urine, muscle pains, vomiting and confusion. By now, doctors know that statins, the drug family that Baycol belonged to, pose a risk of rhabdomyolysis; Baycol itself had a much higher risk than its cousins. Simpson’s lawsuit, filed in 2006, alleges that Bayer knew about the rhabdomyolysis risk before the FDA took action, but downplayed it in marketing. She also alleged that Bayer misrepresented Baycol’s comparative efficacy and paid kickbacks to doctors for prescribing it. This defrauded Medicare and Medicaid via reimbursements, she claimed, as well as the Defense Department health organizations. The district court granted Bayer’s motion to dismiss, agreeing that she hadn’t cited representative enough false claims.
The Eighth Circuit upheld that ruling as to the Medicare and Medicaid programs, but reversed as to the Defense contracts. Simpson’s allegations about the Defense contracts said Bayer falsely induced the government to enter into purchase contracts in January and February of 2001 The Eighth said a claim alleging fraud in the inducement of a government contract does focus on statements made at the outset—contrary to the district court’s reasoning. Supreme Court cases and the legislative history both support this position, the court noted. And Simpson’s Defense allegations sufficiently identify the basics of the alleged fraud, it said. However, it upheld dismissal of the Medicare/Medicaid claims, saying there was no direct contractual relationship between the government and Bayer, and Simpson didn’t include specific false claims or representative examples in her claim.
I’m pleased to see that this whistleblower is going forward with at least some of her dangerous drug claims. State attorneys general and federal attorneys sometimes sue drug makers for defrauding the federal government when the drug has been proven unsafe and the drug maker has covered it up—just like here. Private individuals with insider knowledge, like Simpson, ought to be able to make similar claims. After all, the federal government has a clear interest in being notified about fraud that costs large amounts of taxpayer money. And all of us have an interest in learning as soon as possible about cover-ups of unsafe prescription drugs, which continue despite millions in payments in pharmaceutical liability lawsuits like this.
If you believe you were hurt by a drug that was supposed to make you feel better, you should call Carey, Danis & Lowe today to discuss your rights and your legal options. To learn more or set up a free consultation, call us today at 1-877-678-3400 or send us a message online.
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