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Bayer 378 articles

Xarelto, Eliquis antidote review postponed

The Food and Drug Administration (FDA) has postponed its decision whether to approve an antidote to the blood thinners Xarelto and Eliquis, pushing the action date from early February to early May in order to consider additional information it had requested from the manufacturer. The news came as a blow not only to Portola Pharmaceuticals, maker of the antidote called AndexXa, but also to Eliquis’ Pfizer and Bristol-Myers Squibb, and Xarelto’s Johnson & Johnson and Bayer. “The agency has instituted an extension to allow more time for a thorough review of the information provided and to work with the company ... Read More

Bayer tries to skirt $28M Xarelto verdict

Bayer AG is trying to wiggle out of a $28 million verdict involving Xarelto side effects by saying the plaintiff’s legal team made xenophobic and offensive statements and tried associate the German company with Nazis in the minds of jurors. Bayer Healthcare Pharmaceuticals Inc., and Johnson & Johnson unit Janssen Pharmaceuticals cited an Instagram post by plaintiff Lynn Hartman’s legal team that used the hashtag “killinnazis,” and referenced “multiple inflammatory and xenophobic references” made during closing arguments. Hartman’s case is the latest to go to trial in the Xarelto mass tort program in Philadelphia County Court of Common Pleas where ... Read More

New guidance on controlling bleeding events with blood thinners

The American College of Cardiology (ACC) issued new guidance for managing major and minor bleeding events in patients taking oral blood thinners. The document is published in the Journal of the American College of Cardiology and compliments the 2017 ACC expert consensus decision pathway for management of anticoagulation in patients with atrial fibrillation. Atrial fibrillation is a common heart rhythm abnormality that increases the risk for strokes due to blood clots. Patients are generally treated with an oral anticoagulant such as the long-used warfarin, as well as newer blood thinners Pradaxa, Xarelto, Eliquis and Savaysa. These medications are designed to ... Read More

PA Xarelto trials focus on US bleeding risks

The first Xarelto side effects bellwether trial in a pool of about 1,500 pending in Philadelphia County Court of Common Pleas resulted in a $28 million verdict in favor of Lynn Hartman, who sued Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer alleging Xarelto caused her to bleed internally. The next trials in Philadelphia are scheduled for March, April, May and June. Apart from the cases pending in the Philadelphia mass tort program, another 18,000 lawsuits consolidated in a multidistrict litigation (MDL) in the Eastern District of Louisiana are pending. Three have been tried and fell in favor of ... Read More

$28M Xarelto verdict gives hope to others suing over side effects

The $28 million verdict against the makers of the blood thinner Xarelto for not adequately warning about bleeding risks is a reassuring sign to the near-20,000 cases pending across the country that they will see justice. But attorneys for drug makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer are expected to put up a fight as they try to worm their way out of the verdict during post-trial motions and a possible appeal to the Pennsylvania Superior Court. The case involved Lynn Hartman, who claimed she suffered gastrointestinal bleeding after taking Xarelto to treat atrial fibrillation. She was hospitalized for ... Read More

Plaintiff awarded $29M in latest Xarelto trial

A Philadelphia jury awarded an Indiana woman $29 million after finding that Johnson & Johnson’s Janssen Pharmaceuticals and Bayer did not adequately warn about bleeding risks with their blood thinner Xarelto. The case was brought by Lynn Hartman, who was prescribed Xarelto to treat a common heart rhythm abnormality called atrial fibrillation. In June 2014, she was hospitalized for suspected gastrointestinal bleeding. During her four-day hospital stay, she underwent multiple blood transfusions and was taken off Xarelto. Hartman’s attorneys presented studies showing the rate of major bleeding in U.S. patients taking Xarelto is 8.1 per year. The rate of major ... Read More

Lawyer accuses Xarelto makers of ‘fake news’

An attorney for a woman suing the makers of the blood thinner Xarelto in the first case to reach trial among about 1,500 in a mass tort program in the Philadelphia County Court of Common Pleas cried “fake news” during closing arguments Friday to convey how false information is being increasingly disseminated. “We live in a world today where it’s getting harder every day to tell that which is fact from that which is fake. It’s getting harder and harder to keep all that straight, and it happened right here in this courtroom,” the attorney told jurors. “Bayer comes from ... Read More

Jurors to decide fate in fourth Xarelto side effects trial

The fourth bellwether trial alleging bleeding risks with the blood thinner Xarelto came to a close Friday in the case of an Indiana woman who claims the drug caused her a serious gastrointestinal bleed. A Philadelphia jury is left to decide whether Xarelto makers, Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, failed to adequately warn patients and their doctors about Xarelto side effects. The trial involves the case of Lynn Hartman, who was prescribed Xarelto to treat her heart condition called atrial fibrillation. Months later, in June 2014, she was hospitalized for a suspected gastrointestinal bleed, losing about 40 percent of ... Read More

Witness-tampering testimony in Xarelto trial barred

Philadelphia Court of Common Pleas Judge Michael Erdos said he would not allow jurors in a trial involving alleged bleeding risks with the blood thinner Xarelto to hear any evidence about witness tampering – at least for now. Attorneys for plaintiff Lynn Hartman had raised concerns that sales representatives for Johnson & Johnson’s Janssen Pharmaceuticals, makers of Xarelto, had tried to influence a doctor scheduled to testify for the plaintiff. The physician, James Aldridge, provided a deposition that he did not believe Xarelto was the cause of Hartman’s bleeding injuries even though his own medical records listed Xarelto as the ... Read More

Xarelto makers fight FDA chief’s testimony

Johnson & Johnson’s Janssen Pharmaceuticals and Bayer are pushing back against a former Food and Drug Administration (FDA) chief who testified during a bellwether trial in Philadelphia Court of Common Pleas involving the drug companies’ blood thinner Xarelto that the drug companies “did not adequately notify physicians that some patients are at high risk (of bleeding) than others.” Former FDA Commissioner David Kessler was an expert witness in the case of Lynn Hartman, who sued the drug companies over Xarelto side effects. She claimed that she was hospitalized for four days in June 2014 just months after taking Xarelto to ... Read More