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Drug giants sued for mismarketing of widely used drug

Janssen Pharma and Bayer have come under fire for improperly marketing a drug that has been linked to serious internal bleeding issues for some patients

Xarelto is an anti-coagulant drug made by Janssen Pharmaceuticals and Bayer Corp. — both of which are now being sued for a products liability claim regarding the substance. Virginia G. Stuntebeck is filing a suit against the makers of the drug as she alleges that the drug caused severe internal and gastrointestinal bleeding after being prescribed to her for atrial fibrillation — the fibrillation of the muscles of the atria of the heart, a common type of arrhythmia. Xarelto has been primarily used to reduce the risk of, and/or treat, stroke and systemic embolism in patients with atrial fibrillation.

Stuntebeck’s lawsuit claims that the drug makers marketed a “one size fits all” drug, but was mismarketed to patients as such, and many patients were put at risk because of the misinformation delivered by physicians. Risks were not made clear for serious and fatal bleeding, and the marketing for the drug further indicated that it was easier to use than other drugs because of its lack of required monitoring for internal bleeding once the patient takes the drug.

Negligence, products liability, breach of implied and express warranties, fraud, violation of consumer protection laws, unreasonable marketing, and unreasonable failure to remove the drug from the market are all counts of the plaintiff’s lawsuit. As the mismarketing of the drug is one of the key points at the heart of the lawsuit, reports quote the plaintiff’s complaint, which claims that Janssen and Bayer “fervently marketed Xarelto using print advertisements, online marketing on their website, and video advertisements with no regard to the accuracy and repercussions of their misleading advertising in favor of increasing sales.”

130,000 prescriptions for Xarelto were written in the first three months of 2012.

Drugwatch has described the similar dangerous qualities between Xarelto and a drug that has come under serious fire in the U.S. for creating similar potentially fatal bleeding in patients: Pradaxa. 200 lawsuits have been filed by victims and families of victims as a result of hundreds of deaths and thousands of injuries as a result of taking Pradaxa as prescribed.

And this is not the first time, of course, that Bayer has been involved in major lawsuits for some of its drugs. 2013’s debacle over the birth control pills Yasmin and Yaz involving Bayer AG resulted in the U.S. Federal Circuit invalidating the company’s patent on Yaz. Bayer had been involved in millions of dollars of settlement claims for patients that suffered gallbladder injuries as a result of taking the birth control pills.


Further reading:

IP: Can personalized medicine survive Prometheus?

Pfizer agrees to pay $491 million in drug suit

FDA rule would allow generic drugmakers to update labels

Contributing Author

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Juliana Kenny

Juliana Kenny is a contributor to, covering a range of topics including patent litigation, conflict mineral laws, executive compensation, and antitrust regulation. Juliana earned B.A.s...

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