A Philadelphia jury awarded Lynn Hartman $27.8 million after finding drug manufacturers Johnson & Johnson and Bayer failed to warn about the dangers of their blood thinning drug Xarelto. The verdict includes $26 million in punitive damage, which juries award to plaintiffs when they believe the defendant acted egregiously. This bellwether case tried in Pennsylvania state court is the first loss for the pharmaceutical companies. Three other cases tried in federal courts ended with verdicts for the defense.
In all four trials, former FDA Commissioner Dr. David Kessler testified that the drug’s label did not adequately warn about the bleeding risk. Kessler also testified that Xarelto was approved by the FDA in 2011 based on a faulty study, the ROCKET-AF, which compared Xarelto to warfarin, the drug most commonly prescribed by doctors for decades.
The study seemed to have two intentional design flaws.
- A large number of the study’s participants were from Eastern Europe where warfarin is improperly prescribed. J&J and Bayer were aware that these participants were not getting the correct dose of medicine, causing warfarin patients to have comparable rates of stroke and hemorrhaging as those taking Xarelto.
- The British Medical Journal (BMJ) questioned the validity of the trail after their own investigation found that the blood clotting meter used in the study was defective and had been recalled by the FDA. The faulty readings caused some warfarin participants to take inappropriately high doses, increasing the risk of hemorrhaging and causing some injuries.
“It’s a clinically significant adverse event, it’s a demographic characteristic and it should be on the label.” Dr. David Kessler, former FDA commissioner under the first Bush and the Clinton administrations.
There were also allegations of witness tampering after Hartman’s doctor reversed his views shortly after a visit from a Janssen Pharmaceutical sale representative. Janssen is a subsidiary of J&J.
This win positively impacts more than 20,000 Xarelto lawsuits pending in state and federal courts, 1,500 of which are in the Philadelphia court that decided Hartman’s case.
Blood thinners are the most dangerous drugs on the market, according to a recent report published by the Institute for Safe Medication Practices (ISMP). Anticoagulants, such as Xarelto, warfarin, and Pradaxa, are most likely to require emergency room visits and half of all adverse events require hospitalization.
This class of drug accounted for roughly 22,000 severe injuries, including 3,000 death in 2016. Although it is estimated that number could be as much as 10 times higher since the FDA tracking system is reported voluntarily by patients and healthcare workers.
The FDA Adverse Events Reporting System (FAERS) on Xarelto shows:
- 68,000+ serious complications
- 14,000+ reports of gastrointestinal hemorrhage
- 370+ deaths
Even small injuries can be life-threatening to people who are taking a blood thinner. Xarelto, unlike other anticoagulants, is even more dangerous as it does not have an antidote. If you were to sustain a cut while taking warfarin, a vitamin K shot is given so the blood will begin clotting again. The antidote for Xarelto has not been approved by the FDA.
$28 Million Awarded to Indiana Couple in Xarelto Lawsuit Verdict, Consumer Safety News, December 5, 2017
Most Dangerous Drugs: Xarelto, Pradaxa and Other Blood Thinners, Consumer Safety, September 7, 2017
FDA Ignores Faulty Data in Approving Xarelto, Drug Safety News, February 5, 2016