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Xarelto 217 articles

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

Former FDA chief: Xarelto makers did not adequately warn of bleeding risks

Former Food and Drug Administration (FDA) Commissioner David Kessler told a Philadelphia jury that the warning labels on the blood thinner Xarelto did not give consumers or their doctors enough information about the risk of significant bleeding events using the drug posed. “They did not adequately notify physicians that some patients are at higher risk than other,” he said. “That’s what I believe.” Kessler testified for plaintiff Lynn Hartman during the first bellwether involving Xarelto side effects to go to trial in Philadelphia. Hartman sued Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer claiming the drug caused her to ... Read More

Judge orders deposition of Xarelto sales rep

A sales representatives for Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson, were ordered to undergo a midtrial deposition by a Pennsylvania state judge to determine whether she tried to sway a doctor’s testimony in an upcoming trial alleging Janssen’s blood thinner Xarelto caused a man’s internal bleeding. Attorneys for plaintiff Lynn Hartman asked the judge for the deposition after they became suspicious over the timing of the drug rep’s visit to the doctor before his deposition in April, and the fact that Janssen failed to disclose the contact until just weeks before the trial was to begin on ... Read More

Xarelto trial delayed over possible witness tampering

Opening statements in the first Xarelto side effects bellwether trial to be heard in the Philadelphia Court of Common Pleas were set to begin Monday, but were delayed due to a tussle between parties over the significance of a meeting between the plaintiff’s treating physician and a sales representative for Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, maker of Xarelto. Janssen’s attorneys said the meeting was a routine call between a drug rep and a doctor. But the plaintiff’s attorneys said it smelled more like the events that occurred with a witness in a bellwether trial involving DePuy Orthopedics’ hip implant, ... Read More

Xarelto trial begins this week in PA mass tort program

The first bellwether trial in a mass tort program in the Philadelphia County courts alleging the blood thinner Xarelto caused uncontrolled bleeding is scheduled to go to trial this week. The lawsuit was filed by Lynn Hartman of Indiana, who claimed she suffered gastrointestinal bleeding after taking Xarelto to prevent strokes related to her heart condition called paroxysmal atrial fibrillation. The bleeding injury landed her in the hospital for four days in June 2014, during which her doctors ordered her to stop taking Xarelto. Since then, she has suffered no additional internal bleeding. Hartman’s trial is one of 1,500 pending ... Read More

Lower dosage of Xarelto approved for prevention of recurrent VTE

The Food and Drug Administration (FDA) has approved a new lower dosage of Xarelto for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy. The new 10-milligram, once-daily dose was approved based on a review of data from the EINSTEIN CHOICE study, a Phase 3, double-blind study that showed that both the 10mg and 20mg doses of Xarelto worked better than 100mg of aspirin at reducing the risk of VTE after six months of standard anticoagulation. The study showed that the 10mg dose reduced VTE risk by 74 percent, and the 20mg dose ... Read More

FDA to decide on lower dose of Xarelto for VTE prevention

The Food and Drug Administration (FDA) is expected to decide this week whether it should include a 10-milligram, once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy for the blood thinner Xarelto. Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer were granted priority review for a supplemental New Drug Application for the new dosage earlier this year, which includes data from EINSTEIN CHOICE study, a Phase 3, double-blind, superiority study that showed that both 10mg and 20mg doses of Xarelto worked better than 100mg of aspirin at reducing the ... Read More