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Bayer 319 articles

Xarelto makers apply for new dosage


Janssen Research & Development, a unit of Johnson & Johnson, has submitted a supplemental new drug application to the Food and Drug Administration (FDA) updating the prescribing information for its blood thinner Xarelto. Janssen seeks to add a 10 mg dose to reduce patients’ risk of recurrent venous thromboembolism. Xarelto was approved by the FDA in 2011. Xarelto is currently prescribed in 20 or 15 mg once-daily doses for stroke prevention in atrial fibrillation, and 10 mg once-daily doses for blood clot prevention for 12 days in patients who recently underwent knee replacement surgery and 35 days in patients who ... Read More

Xarelto makers face wrongful death lawsuit


A woman has filed a wrongful death lawsuit against several drug companies alleging their jointly manufactured and marketed blood thinner Xarelto caused her husband to bleed to death, according to the Cook County Record. Julia Butler, independent executor of the estate of her husband Richard Butler, filed the complaint in the Cook County Circuit Court against Johnson & Johnson, its subsidiary Janssen Pharmaceuticals, Bayer AG, McNeil-PPC Inc., and Northwestern Memorial Hospital, alleging that negligence on the drug makers’ part led to her husband’s May 2015 death. According to her complaint, Richard Butler was prescribed Xarelto and as a result suffered ... Read More

First Xarelto trials are no indicator of final outcome


The first bellwether trial involving bleeding risks with the blood thinner Xarelto ended up as a win for the defendants, but mass tort consultant John Ray, in an editorial for Mass Tort Nexus said these early trials should not worry those suing Xarelto’s makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer. The first bellwether, which was tried just weeks ago, involved the case of Joseph Boudreaux, who claimed that he suffered serious internal bleeding after taking Xarelto to treat atrial fibrillation. Jurors found that the drug companies were not liable for his injuries. “The simple answer to the question, regarding the defense ... Read More

Xarelto cases will continue to be heard


Attorneys on both sides of the Xarelto bleeding risks litigation said that while the first bellwether trial fell in favor of the defense, it is unlikely to sway other consumers in the litigation to pull their cases. First consolidated in December 2014, more than 14,000 cases are pending in a massive multidistrict litigation (MDL) in Louisiana. Three more bellwethers are scheduled before the end of the year, with the next scheduled for later this month. Plaintiffs claim that Xarelto makers, Johnson & Johnson’s Janssen Pharmaceutials and Bayer, did not adequately warn of bleeding risks associated with use of the blood ... Read More

First Xarelto trial comes to an end


The first bellwether trial in a massive multidistrict litigation involving uncontrolled bleeding claims with the blood thinner Xarelto came to a close this week when a Louisiana federal jury found that the drugs’ makers were not guilty of failing to warn doctors that the medication could cause unstoppable bleeding events. The next bellwether trial is scheduled to begin in a matter of weeks as plaintiffs line up to have their day in court. Plaintiff Joseph Boudreaux filed his lawsuit against Xarelto makers Johnson & Johnson’s unit Janssen Pharmaceuticals and Bayer HealthCare Pharmaceuticals after allegedly taking Xarelto in January 2014 and, ... Read More

Bleeding often leads to heart-related death


Internal bleeding can cause heart attacks and is often listed as a cause of death on death certificates. Thus, bleeding should not be ruled out as a cause of death in patients who died while being treated with the blood thinner Xarelto, says Mass Tort consultant John Ray in an editorial for Mass Tort Nexus. “In our consulting practice at Mass tort Nexus we are often asked if the cause of death listed on a death certificate does not mention bleeding or ischemic stroke… – is that a fatal obstacle to finding a wrongful death case related to Xarelto, Pradaxa ... Read More

Xarelto patient regrets ever taking drug


Joseph Boudreaux says he regrets the day he started taking Xarelto. The blood thinner, manufactured by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, was designed to cut down Boudreaux’s risk of stroke due to a heart rhythm abnormality called atrial fibrillation. Instead, he claims the drug caused him to bleed internally, resulting in a week-long stay in the ICU, numerous blood transfusions, and several heart procedures. “I don’t want anybody else to suffer like I have from that drug,” he told Bloomberg. In 2014, he filed a lawsuit against the makers of Xarelto. He is now one of more than ... Read More

Attorney advertising questioned in Xarelto bellwether trial

drug ad

The first bellwether trial among more than 16,000 alleging bleeding risks with the blood thinner Xarelto began this week and early developments indicate that this isn’t your typical pharmaceutical case. Critics of plaintiffs attorney advertising are using Xarelto as an example that rules of professional conduct pertaining to attorney ads need to be changed. The effort is being led by tort reform groups like the U.S. Chamber of Commerce’s Institute for Legal Reform. House Judiciary Committee Chairman Bob Goodlatte, coauthor of a tort reform bill passed by the U.S. House of Representatives recently, also mentioned the Xarelto litigation in letters ... Read More

BA’s Birchfield heads up Xarelto litigation

Andy Birchfield

The first Xarelto bellwether trial in a massive multidistrict litigation (MDL) began this week with a familiar cast of characters from another notable pharmaceutical side effects case, the landmark Vioxx painkiller litigation, which resulted in a $4.85 billion settlement with Merck & Co. Inc. in 2007. The Vioxx litigation was before the same judge who is overseeing the Xarelto case, U.S. District Judge Eldon Fallon for the Eastern District of Louisiana. Andy Birchfield, head of the mass torts section of Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Alabama, was the co-lead attorney for plaintiffs in the Vioxx litigation. ... Read More

Judge limits expert testimony in upcoming Xarelto side effects trial


U.S. District Judge Eldon E. Fallon, overseeing more than 16,000 cases in a multidistrict litigation (MDL) involving Xarelto bleeding risks, ruled to exclude the drug makers’ expert testimony from Dr. James A. Reiffel. The expert presented by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer would have testified that patients taking Xarelto might have abruptly stopped taking the blood thinner due to attorney advertising. The first bellwether trial in the multidistrict litigation is scheduled to begin today. Both parties are arguing to limit or exclude expert testimony from the opposing sides. Judge Fallon agreed to allow experts for the defense to testify ... Read More