A Pennsylvania judge has overturned a $27 million jury verdict awarded to an Indiana couple, in one of the first of thousands of claims to go to trial against the makers of a popular blood-thinning drug. A Philadelphia jury had decided that Johnson & Johnson and Bayer AG failed to provide adequate warning of internal bleeding risks and other possible side effects of Xarelto, an anticoagulant that’s earned billions for its marketers in the past five years.
But the January 9 ruling
by Judge Michael Erdos reverses that decision, based on what the couple’s attorney has described as “a very narrow issue” having to do with the testimony of the plaintiff’s doctor.
Also known as rivaroxaban, Xarelto is a prescription drug used to prevent blood clots and reduce the risk of strokes in patients with an irregular heart beat or after knee or hip replacement surgery. First approved by the government in 2011, it’s been widely touted as an alternative to blood thinners such as warfarin, which require frequent blood monitoring. But thousands of patients say they’ve experienced internal bleeding, infections and other health complications from Xarelto, which was jointly developed by Bayer and Johnson & Johnson.
The $27.8 million verdict came December 5 in a case brought by Lynn Hartman, a 75-year-old woman who was hospitalized with severe gastrointestinal bleeding after she started taking Xarelto, which she’d been prescribed to treat her irregular heartbeat (atrial fibrillation). Hartman’s legal team told the jury that she had to have four blood transfusions after she started to bleed internally and that the problems stopped after she switched to a different blood thinner.
The jury awarded $1.8 million in compensatory damages and $26 million in punitive damages
to Hartman and her husband. The pharmaceutical companies denied any wrongdoing and filed a motion to have the verdict set aside. The companies had previously won three other trials over Xarelto in federal court, but more than 20,000 other claims have yet to go to trial. According to U.S. Food and Drug Administration reports
, the drug has been linked to at least 370 deaths.
Critics of Xarelto, including product liability lawyers who specialize in pursuing cases against drugs believed to be dangerous or defective, charge that the manufacturers have failed to sufficiently inform patients about possible side effects and that the drug is more challenging to administer safely than many patients realize. Proper dosages can be difficult to determine because of what they call the drug’s “narrow therapeutic index”— the margin between a supposedly “safe” dose and an excessive one — and the lack of required blood tests for monitoring its effects.
Many of the lawsuits concern bleeding in the gastrointestinal tract or in the brain, sometimes with fatal results. Some cite instances of brain hemorrhage or, in other cases, irreversible internal bleeding. They also allege an elevated risk of infection; with less blood clotting, wounds take longer to heal.
At Hartman’s trial, a former FDA commissioner told the jury that the warning labels for Xarelto understated its risks and didn’t provide enough information to doctors about patients who might be in more danger from use of the drug than others. Many patients don’t realize that there is no antidote that can instantly counteract the effects of the drug.
“Xarelto is the worst in class of the new blood thinners,” Hartman’s attorney said in a statement released to the press. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks.”
But according to news reports
, Erdos concluded that the plaintiffs hadn’t established whether Hartman’s doctor would still have prescribed Xarelto if she had taken a test measuring her blood’s ability to coagulate. In a statement Bayer expressed satisfaction with the judge's ruling and defended the warnings and safety information provided with Xarelto as more than adequate.
In addition to being prescribed for irregular heart beat, Xarelto has also been used in cases of deep vein thrombosis and pulmonary embolisms. It was Bayer’s best-selling drug in 2016, generating $3.4 billion in revenues, while Johnson & Johnson reported $2.2 billion from Xarelto sales. Patients who claim to have suffered adverse effects and their personal injury attorneys have called for tougher warnings, compensation for injuries, and the removal of the drug from the market, but the companies have not yet offered a settlement.
A few years ago, similar complaints involving the blood thinner Pradaxa (dabigatran) led to thousands of injury claims against the pharmaceutical company Boehringer Ingelheim. In 2014 the company settled 4000 lawsuits for $650 million while continuing to insist on the safety of the product. But according to the Institute for Safe Medication Practices, an organization that tracks drug safety, Pradaxa had been linked to more than a thousand deaths.
Pradaxa and Xarelto are among a new wave of blood thinners that have been represented as more convenient alternatives to long-established anticoagulant medications, such as warfarin, because they don’t require regular blood tests and dietary restrictions. But attorneys for patients who’ve experienced side effects of the new drugs say they have little or no advantage over warfarin in terms of safety, and that there are better ways to prevent blood clots in many cases — such as doctor-approved levels of aspirin or compression stockings.
If you or a loved one has suffered medical complications as a result of use of Xarelto, Pradaxa, or other prescribed drugs, you may be entitled to compensation. Defective pharmaceutical drugs and medical devices injure thousands of Americans each year. The product liability lawyers in Denver at Franklin D. Azar and Associates have helped thousands of Americans who have been harmed by defective pharmaceuticals and medical devices. We have been taking on large companies to help injured people for more than 30 years.
Our attorneys are currently investigating a wide range of possibly life-threatening side effects associated with Xarelto, Pradaxa, and Eliquis, including internal bleeding, infection following surgery, and hemorrhagic stroke (brain bleeding). Call us today for a consultation if you believe you have been injured by a defective drug or medical device. The consultation is free, and if there is no recovery, there is no fee.
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