Bayer and J&J push back against consolidation of Xarelto suits

Bayer and Johnson & Johnson ($JNJ) are fighting a consolidation of lawsuits over their top-selling anticoagulant Xarelto, which patients say had more severe bleeding risks than the companies let on.

Patients who took Xarelto and their lawyers today will ask a panel of federal judges in Charleston, SC, to send 21 cases filed so far in 10 federal courts to U.S. District Judge David Herndon in East St. Louis, IL, for pretrial information exchanges, Bloomberg reports. Consolidating the cases for pretrial exchanges of evidence is a potential time and money saver, as one judge can oversee the collection of documents and testimony regarding the drug's performance.

J&J and Bayer are pushing the panel to reject plaintiffs' request for consolidation, but if one is granted, the companies want the case sent to a New Jersey federal court near their federal offices, according to court filings seen by Bloomberg.

Patients' lawyers argue that 65 deaths have been linked to bleeding caused by the drug, and that J&J and Bayer hid the fact that Xarelto has no antidote. But J&J and Bayer are standing by their product, maintaining that "the benefit-risk profile of Xarelto remains favorable and consistent with the clinical trials," J&J spokeswoman Kristina Chang told Bloomberg in an emailed statement. "All anticoagulants carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks," she said.

The push for consolidation comes on the heels of more legal drama surrounding new anticoagulants, as Boehringer Ingelheim in May agreed to shell out $650 million to wrap up 4,000 lawsuits claiming that its clot-fighting drug Pradaxa caused serious, sometimes fatal, bleeding in some patients. The German drugmaker said at the time that while it stood by its drug's safety, a settlement would allow it to avoid the cost and effort-drain of long-term litigation.

Meanwhile, J&J and Bayer are working hard to build a lead on the competition, as big names like Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) push their own next-generation anticoagulant therapies. A slew of recent indications in the U.S. and the EU have helped Xarelto bring in an eye-popping $1.09 billion through the first 9 months of the year. But J&J/Bayer faced a setback in February when the FDA gave the med a thumbs-down for treating acute coronary syndrome (ACS), a potentially lucrative designation as the malady accounts for some 1.1 million hospital admissions annually in the U.S.

- read the Bloomberg story

Special Report: Top 15 Drug Launch Superstars - Xarelto - Bayer and Johnson & Johnson

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