Defense Verdict in First Xarelto Bellwether Trial

A federal jury in Louisiana ruled that Johnson & Johnson and Bayer AG provided adequate instructions for the safe use of Xarelto to the doctors who prescribed it to the plaintiff, who suffered severe gastrointestinal bleeding and survived only because of several blood transfusions.

The defense verdict arrived in the first bellwether trial of the blood-thinning drug in In Re Xarelto Products Liability Litigation, U.S. District Court, Eastern District of Louisiana, No. 14-md-2592.

It was the first verdict in the first test case of 16,285 lawsuits, and it has no bearing on future trial outcomes. The plaintiff Joseph Boudreaux, Jr., age 75, of Lafourche Parish, Louisiana. He was prescribed Xarelto in 2014 for atrial fibrillation. He only took the drug for 21 days before he suffered severe gastrointestinal bleeding.

The drug is Bayer’s top-selling product, generating $3.24 billion in sales last year and $2.5 billion in 2015 for the German pharmaceutical company. Xarelto is J&J’s third-largest seller, bringing in $2.29 billion in 2016 as the New Brunswick, New Jersey.

Janssen is represented by Susan Sharko of Drinker Biddle & Reath LLP
Janssen was represented by Susan Sharko of Drinker Biddle & Reath LLP

Doctors sink plaintiff’s case

The fatal element for the plaintiff was that his doctor – cardiologist Dr. Kenneth Wong – testified that they stood by their decision to prescribe Xarelto.  Further, both doctors testified that they would have used a test to monitor anticoagulation, but only if it were FDA-approved. The defense argued that this test does not exist (although this claim is not accurate).

Xarelto advertised that its predecessor drug warfarin required testing and monitoring — and that Xarelto did not. The makers of Xarelto had to test the prothrombin time (PT)/international normalized ratio (INR) in their clinical trials, so a test does exist.

Accepting the defense argument that there was no approved test means that the makers of Xarelto put a product on the market for which testing/monitoring was needed — yet no test existed and the drug companies didn’t warn of this.

In the Boudreaux case, the defendants argued that the plaintiff was administered a different PT test which showed him in the normal range. Accordingly, the defense argued there is no causal connection between the plaintiffs’ injuries and the failure to warn, and the arguments are barred by the learned intermediary doctrine.

Janssen was represented by Susan Sharko of Drinker Biddle & Reath LLP and Richard Sarver and Celeste Coco-Ewing of Barrasso Usdin Kupperman Freeman & Sarver. Bayer’s attorneys are Beth Wilkinson of Wilkinson Walsh Eskovitz, David Dukes of  Nelson Mullins Riley & Scarborough and William Hoffman of Arnold & Porter Kaye Scholer LLP.

The defense succeeded in its argument that the drug label is legally adequate because it prominently warns of the risk of bleeding and the prescribing physicians testified that they were aware of that risk.

The defense succeeded in its argument that the drug label is legally adequate because it prominently warns of the risk of bleeding and the prescribing physicians testified that they were aware of that risk.

The plaintiff emphasized that there is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section.

The pharma companies face more bellwether trials in federal court presided over by US District Judge Eldon Fallon in New Orleans. :

  1. May 30, 2017 – Eastern District of Louisiana
  2. To Be Set in June 2017 – Southern District of Mississippi
  3. To Be Set in July 2017 – Northern District of Texas

Independently, the drug companies face 1,390 lawsuits over Xarelto in the Philadelphia Court of Common Pleas.

 

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