Earlier today, a jury ordered two pharmaceutical megacorporations - Johnson & Johnson and Bayer - to pay $28 million to Lynn Hartman and her husband due to internal bleeding and other complications related to using the blood thinner Xarelto.
Filed in the Philadelphia Court of Common Pleas, this Xarelto case is the first time that a jury has chosen to hold the two drug companies accountable for the extremely dangerous side effects of Xarelto, which can include severe bleeding and even death. All three previous trials ended in a win for the defense.
The Hartman Xarelto Case
In 2013, Lynn Hartman began taking Xarelto in an attempt to treat atrial fibrillation, a form of erratic heartbeat that can lead to strokes, heart attacks, pulmonary embolisms, and other health problems.
However, about a year after taking the blood thinner, Hartman began to experience severe gastrointestinal bleeding. She was hospitalized in 2014, but thankfully after being taken off the drug, she eventually recovered her health and stopped experiencing the bleeding problems.
In 2015, Hartman and her husband brought a Xarelto lawsuit against Janssen Pharmaceutical, a division of the multinational drug and consumer products company Johnson & Johnson that makes the anticoagulant. The couple, who live in Indiana, also sued Bayer, which markets the product alongside J&J.
The Hartmans' suit became the first in a state court to be tried as a bellwether trial. Bellwether trials often set precedents for similar cases and can signal to both companies and future plaintiffs the types of arguments that juries are likely to respond to.
The Hartmans had to wait more than two years from the time they filed their initial complaint to the trial itself. Once the trial was ready to start, they experienced yet another setback when it was discovered that the plaintiffs' doctor had allegedly met with a sales representative from Janssen Pharmaceuticals (a Johnson & Johnson division). After that meeting, the doctor changed his testimony, claiming that he was not aware of the gastrointestinal bleeding experienced by Lynn Hartman in 2014. As a result, the Hartman's lawyers requested that the doctor not be allowed to testify.
Later during the trial, however, the pharmaceutical companies were beset by a former commissioner of the U.S. Food & Drug Administration, who claimed that Xarelto's drug label was inadequate to warn patients of potential problems with the drug. Kessler had testified in previous Xarelto trials, as well.
Understanding the $28 Million Xarelto Verdict
Before the Hartman case, J&J and Bayer had won all three of the first federal court bellwether trials. Given that track record, the companies undoubtedly believed that they would win this state court trial as well, but as it happened, the jury sided with the plaintiff.
In total, the jury awarded the Hartmans $27.8 million. This compensation breaks down into:
- $1.8 million in compensatory damages
- $26 million in punitive damages
While the Hartmans could no doubt use the money to pay for medical bills and other expenses that have racked up during the trial, the money will likely continue to be tied up while the drug companies appeal the verdict. After the jury's decision, Chris Loder, a spokesperson for Bayer, stated, "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." The company has vowed to fight the verdict through appeals.
Given that there are more than 20,000 lawsuits against the companies - at least 18,500 in federal court and another 1,500 in the Philadelphia court where the Hartmans filed their claim - it's understandable why the drug companies will persist in their attempts to paint Xarelto as a legitimate medication.
However, there is more to it than just the cost of the trials and potential future payouts. Xarelto is Bayer's top-selling product, which has generated nearly $6 billion for the company in the last two years. And that's only a fraction of the total amount brought in to large pharmaceutical corporations from blood thinner drugs, which include Bristol-Myers Squibb's Coumadin as well as Pradaxa, manufactured by Boehringer Ingelheim. Severe internal bleeding injuries, however, have resulted in several waves of Pradaxa lawsuits and a $650 million settlement in 2014.
What Makes Xarelto So Dangerous
The reason that J&J and Bayer find themselves in their current predicament is that Xarelto does not have an "antidote" that will counteract the effects of the prescription medication. Patients who take other blood thinners like Coumadin can be given vitamin K to help the body resume its normal coagulation of blood. For individuals who take Xarelto, however, even a small cut or bruise can become extremely dangerous - or even deadly.
Because of this, Johnson & Johnson has found itself defending against thousands of lawsuits claiming that the company knew about the dangers of its drug but failed to warn patients. While it won a few early victories, this latest verdict could signal a change in the landscape. Whether that change endures for both the Hartmans and others who are still awaiting trial remains to be seen.