Maryland Medical Law Report Legal news for the medical community
Johnson & Johnson and Bayer AG aren’t responsible for a Xarelto user’s internal bleeding, a jury found in the first trial over the blood-thinning drug.
J&J and Bayer didn’t defectively design Xarelto and didn’t mislead a Louisiana man and his doctors about the blood-thinning drug’s health risks, the federal jury in New Orleans found Wednesday.
The ruling was the first of more than 18,000 patient suits against J&J and Bayer, which jointly developed Xarelto, to come to trial. The companies face separate trials over three other Xarelto users’ claims in the next three months. Some users claim Bayer and J&J downplayed the medicine’s bleeding risks
“We never expected the struggle to be an easy one,” Gerald Meunier, a lawyer for Joseph Boudreaux, a part-time security guard in his 70s, said after the verdict. “We realize Bayer and Janssen have a lot of resources and a lot of motivation to protect Xarelto.”
The drug is Bayer’s top-selling product, generating $3.24 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 $2.29 billion in 2016 as the New Brunswick, New Jersey, company seeks to replace revenue from its Remicade arthritis treatment, which lost patent protection a year ago.
“The jury’s decision reflects the facts of this case and the appropriateness of the Xarelto prescribing information,” William Foster, a spokesman for J&J’s Janssen unit, said in an emailed statement.
Bayer officials said the jury’s finding affirms the safety of the blood thinner, used to prevent blood clots that can lead to fatal heart attacks and strokes.
‘Accurate’ label
The verdict shows the drug’s “FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine,” Chris Loder, a U.S.-based spokesman for the drugmaker, said in an emailed statement.
Xarelto belongs to a new class of drugs aimed at replacing Bristol-Myers Squibb Co.’s Coumadin, which has thinned patients’ blood since the 1960s. Some Xarelto users accuse J&J and Bayer of falsely marketing Xarelto as better than Coumadin because the companies said Xarelto patients didn’t need frequent blood tests.
Lawyers for Boudreaux and other former Xarelto patients stress the drug has no antidote, so it puts some users at high risk for bleeding out if they suffer an injury. Coumadin’s blood-thinning effects can be stemmed. J&J and Bayer officials should have warned consumers they could be tested to gauge their Xarelto bleed-out risk, patients’ attorneys claim.
J&J and Bayer counter the U.S. Food and Drug Administration’s finding that Xarelto is “safe and effective” for patients seeking to avoid clots buttresses their claims the drug doesn’t pose undue risks. They also say millions of users have taken the drug without suffering bleeding side effects.
The companies also dispute the validity of the safety test designed to gauge Xarelto users’ bleeding risks, saying in court filings that the test didn’t provide useful information to doctors.
The cases are Boudreaux v. Janssen, 14-cv-2720 and In RE Xarelto Products Liability Litigation, 14-MD-2592, U.S. District Court, Eastern District of Louisiana (New Orleans).
