Bayer, J&J Fight Calls to Unify Blood-Thinner Death Suits

Updated on
Xarelto
By 2013, Xarelto had racked up more $2 billion in sales. Bayer produces the drug, and J&J owns the U.S. rights to the blood thinner. Source: Janssen Parmaceuticals Inc./AP Photo

Bayer AG and Johnson & Johnson are fighting calls to consolidate lawsuits over a blood-thinning drug blamed for causing some patients to bleed to death, a move that would make it easier for plaintiffs to prepare their cases.

Patients who took Xarelto accuse the drugmakers of downplaying the medicine’s bleeding risks and asked that the cases be gathered before U.S District Judge David Herndon in East St. Louis, Illinois, for pretrial information exchanges, according to court filings. Consumers contend 65 deaths have been linked to bleeding caused by the drug, which has no antidote, according to court filings.

Collecting the suits before a single judge could benefit both sides by saving them time and money. The judge would oversee the collection of documents and testimony about the drug’s development and performance to help attorneys prepare for trial.

Some lawyers for former Xarelto users and their families today asked a panel of federal judges in Charleston, South Carolina, to send Herndon 50 cases filed so far in 15 federal courts.

$650 Million Settlement

The push to consolidate the Xarelto cases follows a $650 million settlement of similar claims over Boehringer Ingelheim Gmbh’s blood thinner Pradaxa. Researchers linked Pradaxa to more than 500 users’ deaths, and the company wound up resolving more than 4,000 suits over the medicine. Herndon presided over the consolidation of the Pradaxa suits and the accord.

“If you have a judge already familiar with these blood-thinner suits, the cause of efficiency would be better served by sending the cases to him,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.

“We stand behind our product and will defend ourselves in the litigation,” Chris Loder, a U.S.-based spokesman for Bayer, said in an e-mailed statement.

Kristina Chang, a J&J spokeswoman, said that after three years on the U.S. market, “the benefit-risk profile of Xarelto remains favorable and consistent with the clinical trials.”

“All anticoagulants carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks,” Chang said in an e-mail.

New Jersey

In court filings, the companies urged the panel to rebuff the request to consolidate the Xarelto cases. If a consolidation is granted, however, J&J and Bayer want the case sent to a New Jersey federal court near their U.S. corporate offices.

“Several judges in New Jersey have the experience and docket capacity to handle these cases,” Bayer said in a Nov. 24 filing. The company said U.S. District Judge Freda Wolfson in Trenton already is presiding over two Xarelto cases.

Susan Sharko, a lawyer for J&J’s Janssen unit, touted New Jersey “as the only rationally based forum” for the Xarelto cases.

“Both companies are there, the executives are there and the other witnesses are there,” she added.

Roger Denton, a St. Louis-based lawyer who handled Pradaxa cases before Herndon, said the panel should focus on Herndon’s expertise with blood-thinner cases rather than the location of witnesses and documents.

‘Knows More’

“Judge Herndon knows more about this than anyone,” Denton told the panel today.

If Herndon isn’t available, other lawyers for Xarelto patients suggested the cases be sent to U.S. District Judge Eldon Fallon in New Orleans. Fallon oversaw the consolidation of suits against Merck & Co. over its withdrawn Vioxx painkiller that resulted in a $4.85 billion settlement in 2007.

U.S. regulators originally approved Xarelto in 2011 to prevent blood clots in patients undergoing knee and hip surgeries. The drug’s use has been extended to patients with irregular heartbeats and potentially deadly leg and lung blood clots.

Xarelto and Pradaxa belong to a class of drugs known as new oral anticoagulants, intended to replace for Bristol-Myers Squibb Co.’s Coumadin, used to thin stroke patients’ blood since the 1960s.

Xarelto was marketed as more effective at preventing strokes than Coumadin and easier to use, because Xarelto patients didn’t need frequent tests to monitor their blood-plasma levels.

$2 Billion

By 2013, Xarelto had racked up more $2 billion in sales. Bayer produces the drug, and J&J owns the U.S. rights to the blood thinner. That same year, U.S. regulators rejected the company’s request to expand the use of the drug to heart-surgery patients.

Xarelto’s U.S. sales generated $414 million for J&J in the third quarter of this year while Bayer’s sales in other markets generated $522.5 million over the same period, according to data compiled by Bloomberg.

Lawyers for Xarelto patients argue the companies didn’t properly test the blood thinner before putting it on the market, hid the fact the medicine had no antidote and overstated the drug’s effectiveness, according to court filings.

They said more than 1,000 reports of side effects were filed with the U.S. Food and Drug Administration by June 2012, including reports of at least 65 deaths, according to the filings.

‘Sheer Volume’

While the companies contend “this litigation is lawyer-driven, the sheer volume of reported serious adverse events shows their claim is simply not true,” lawyers for Kimberly West, a former Xarelto user who hemorrhaged while on the drug, said in a Nov. 4 filing.

Given the number of Xarelto side-effect reports, plaintiffs’ attorneys contend Bayer & J&J may face thousands of suits over the drug. The companies also face suits in state courts, including several in Pennsylvania.

The five federal judges on the Multidistrict Litigation Panel heard about a half hour of arguments today on whether and where the Xarelto cases should be consolidated.

Under the multidistrict-litigation system, suits filed in federal courts around the U.S. can be consolidated before a single judge for pretrial hearings.

Once pretrial information exchanges are done, the cases are sent back to the courts where they were filed for trials. Consolidation cuts expenses for both sides.

The case is Xarelto Products Liability Litigation, MDL No. 2592, U.S. Judicial Panel on Multidistrict Litigation.

Before it's here, it's on the Bloomberg Terminal. LEARN MORE