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J&J, Bayer ordered to pay $28 million in first Xarelto loss

By Jef Feeley Bloomberg News 

WILMINGTON, Del. — Johnson & Johnson and Bayer AG are responsible for a woman’s injuries tied to the blood-thinning drug Xarelto and must pay almost $28 million in damages, jurors concluded in the companies’ first loss at a trial over the medicine.

Lynn Hartman said she took Xarelto, sold by J&J’s Janssen Pharmaceuticals unit, for more than a year before being hospitalized in 2014 with gastrointestinal bleeding she blamed on the drug. A Philadelphia jury on Tuesday ordered J&J and Bayer, which jointly developed the product, to pay $1.8 million in actual damages and $26 million in punitive damages, one of Hartman’s lawyers said after the verdict.

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Johnson & Johnson and Bayer won the first three cases to come to trial in federal courts in Louisiana and Mississippi, after juries found the drug was safe and the companies properly warned about Xarelto’s bleeding risks. Plaintiffs had pinned their hopes on winning in state court in Philadelphia, which is known for having plaintiff-friendly juries. The companies still face more than 20,000 Xarelto suits.

“The plaintiffs needed to put a win on the board to keep these other cases alive,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia. “Otherwise, the rest of the cases may have been seen as having little value.”

J&J and Bayer officials said Tuesday they’d appeal the jury’s finding that Xarelto posed a health risk. Xarelto’s labeling “has always warned of bleeding events” and provided information doctors need to make proper “treatment decisions,” Sarah Freeman, a Janssen spokeswoman, said by e-mail.

“Bayer stands behind the safety and efficacy of Xarelto and believes there is no basis in fact or law for the verdict, including the punitive award,” Chris Loder, a Bayer spokesman, said in an e-mailed statement.

The companies still face more than 20,000 patient suits over Xarelto, which has been linked to at least 370 deaths, according to US Food and Drug Administration reports. The number of Xarelto suits has grown by 27 percent this year, J&J said in an SEC filing.

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The drug is Bayer’s top-selling product, generating $3.2 billion in sales last year and $2.5 billion in 2015 for the Leverkusen, Germany-based pharmaceutical company. Xarelto is J&J’s third-largest seller, bringing in $2.3 billion in 2016 as the New Brunswick, N.J., company seeks to replace revenue from its Remicade arthritis treatment, which lost patent protection a year ago.

Xarelto belongs to a class of drugs aimed at replacing Bristol-Myers Squibb Co.’s Coumadin, which has thinned patients’ blood since the 1960s. Other new thinners include Pradaxa made by Boehringer Ingelheim GmbH, a German company that paid $650 million in 2014 to settle thousands of suits claiming it hid the medicine’s bleeding risks.

“Xarelto is the worst in class of the new blood thinners,” Michael Weinkowitz, a Philadelphia attorney who represents Hartman, said Tuesday in an e-mailed statement. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.”

Hartman, 75, argued she had to have four blood transfusions to counteract Xarelto’s bleed-out effects, which caused her pain and worry. She switched to another blood thinner and hasn’t had similar problems, according to court filings.

During the trial, ex-FDA chief David Kessler told the Philadelphia Common Pleas Court jury the companies’ Xarelto warning labels understated the drug’s bleeding risks and didn’t warn doctors that some patients would be at higher risks for bleed outs.