Articles Tagged with Bayer

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Woman in pain with Essure birth control device
Bayer’s Essure birth control device is coming off the market, thanks to a public campaign aimed at raising awareness about its dangers. After years of silence, in which women were told that their pain wasn’t real, and years of incident reports that went unheeded, the U.S. Food and Drug Administration (FDA) finally agreed that Bayer needed to do more to warn patients about the risks of the birth control device.

Now that women are making informed decisions, use of the birth control device has dropped off so precipitously that Bayer is ending its production. Let’s look at what Essure is and why it’s so dangerous.

The Essure Birth Control Implant

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Xarelto Trial Verdict
Today, a jury in Philadelphia awarded approximately 28 million dollars to a woman who suffered serious gastrointestional bleeding after taking the blood-thinning drug Xarelto. It was a huge win for the plaintiff, Lynn Hartman. Ms. Hartman took Xarelto for over a year to treat atrial fibrillation. She suffered internal bleeding and was eventually hospitalized. She needed four blood transfusions. According to court documents, the internal bleeding eventually stopped, and Ms. Hartman was taken off the medication. After she stopped taking Xarelto and switched to another blood-thinner, she had no further internal bleeding.

Ms. Hartman sued Bayer Healthcare Pharmaceuticals, Janssen Pharmceuticals, and parent company Johnson & Johnson. Her primary claim was that the defendants failed to provide adequate warning of the bleeding risks associated with taking Xarelto.

One important witness for the plaintiff at trial was David Kessler, the former Commissioner of the Food and Drug Administration. Kessler testified that he believed the warning label on Xarelto was inadequate and lacked important information regarding the specific risks of internal bleeding.

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Jury Verdict in First Xarelto Bellwether Trial

More than 18,000 lawsuits have been filed against the drug manufacturers of Xarelto over internal bleeding injuries. Two weeks ago the first bellwether case in the Xarelto multidistrict litigation was tried to a jury in Louisiana. On May 3, 2017, that jury rendered a verdict in favor of Bayer Healthcare Pharmaceuticals, Janssen Pharmaceuticals, and parent company Johnson & Johnson. After a seven day trial, the jury found in favor of defendants on one narrow issue: that the plaintiff did not prove his claim that the drug makers failed to give adequate instructions to the physician on the safe use of Xarelto; specifically, the plaintiff argued that drug makers failed to give instructions to doctors about the need to perform a blood-clotting test on Xarelto patients before prescribing the drug.

Although a setback for the plaintiffs, this narrow decision makes me confident there is “plenty of game left” in the overall Xarelto litigation. I do not believe the Boudreaux case adequately represents so many of the remaining claims against Bayer, Janssen, and J&J.

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XareltoYou’ve probably seen the commercials. The most vivid to me was the one with Arnold Palmer, Kevin Nealon, and Brian Vickers. They are playing a round of golf and speaking to each other in shockingly sophisticated ways about the many benefits and occasional side effects of the drug Xarelto. These guys sound like pharmacists or physicians, not athletes and comedians. It is a perfect example of direct-to-consumer pharmaceutical marketing.

Xarelto quickly became a blockbuster drug when it hit the market in 2011. Xarelto (or rivaroxaban) was approved for sale by the FDA in July 2011. It was supposed to represent the next major advancement in blood thinning (anti-coagulant) medication. Xarelto was developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anti-coagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. The patients Xarelto was intended to help were those with atrial fibrillation (or irregular heartbeat), who were a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE and DVT and atrial fibrillation.

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