Pradaxa Federal Court Trial Win: $1.25 million verdict-with punitives of $1 million in death case

Betty Erelene Knight (Deceased), Claude R. Knight   vs. Boehringer Ingelheim Pharmaceuticals, Inc.  Docket No. 3:15-cv-06424; Judge Robert C. Chambers (United States District Court-Southern District of West Virginia)

(MASS TORT NEXUS MEDIA) A federal jury has awarded the family of a deceased West Virginia woman $1.25 million after finding that Boehringer Ingelheim failed to warn of risks associated with its blood thinner Pradaxa, causing her to suffer gastrointestinal bleeding.

The federal trial in Huntington, WV, (US District Court Southern District of West Virginia) awarded $250,000 in compensatory damages to the estate of Betty Erelene Knight and her husband Claude R. Knight, and added $1,000,000 more in punitive damages. The jury added the large punitive award after plaintiff counsel showed that Boehringer Ingelheim engaged in wanton and willful acts in handling of its blockbuster drug Pradaxa, primarily in failing to warn of the risks.

The October 17th plaintiffs’ verdict was the first trial win in the country against Boehringer Ingelheim the German drugmaker, showing that the blockbuster drug is dangerous. The Pradaxa defense team had won three earlier trials for the company, and this verdict on behalf of  the estate of Erelene Knight and her surviving spouse Claude, shows that juries can be convinced of the dangers including fatal risks related to Pradaxa. Mrs. Knight, who was in her 80’s passed away while taking Pradaxa.

She suffered from an irregular heartbeat, a condition that often leads to the development of blood clots, which can travel into the brain and cause a stroke. The plaintiff’s doctor stated that she was at “high risk of stroke.”

Prior to being prescribed Pradaxa, her doctors initially prescribed Coumadin, another prescription blood thinner. Because of the risk of uncontrolled bleeding with this particular drug, the victim required “frequent monitoring” which is what the Pradaxa marketing teams focused on, when meeting with doctors while marketing Pradaxa as a “safer alternative to Coumadin.”  Eventually, the victim grew weary of the inconvenience of such monitoring and learned about Pradaxa, which performs a similar function to Coumadin, from a television commercial.

Her doctor agreed to switch her to Pradaxa, and after about 18 months on the drug, she started to suffer from severe, uncontrolled internal bleeding. At one point she required surgery, which significantly weakened her and set into motion a decline in her health. Within several months of the surgery Erelene Knight passed away. Defense vigorously attempted to point the finger at other health conditions and place blame on anything besides Pradaxa, which failed as the punitive damage award of $1 million showed that the jury clearly saw that Boehringer Ingelheim knew the risks of Pradaxa, yet continued offering the drug without sufficient warnings.

The winning plaintiff trial team consisted of the Childers, Schlueter & Smith Firm and partner  Andy Childers, Neal Moskow of Ury & Moskow, LLC and Yvette Ferrer of Ferrer Poirot & Wansbrough. Congratulations to everyone, as the mass tort world looks forward to additional plaintiff verdicts in the many other Pradaxa cases pending in dockets around the country.

WHAT IS PRADAXA?

·        Pradaxa is an anticoagulant medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

·        The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.1

·        From approval in October 2010 through August 2012, a total of approximately 3.7 million Pradaxa prescriptions were dispensed, and approximately 725,000 patients received a dispensed prescription for Pradaxa from U.S. outpatient retail pharmacies.2

Rulings Prior to Trial

The estate’s lawsuit against Boehringer Ingelheim, focused on Pradaxa’s label, asserting claims that the company knew that “certain blood plasma concentrations of Pradaxa increased the risk of a major bleed without contributing any additional stroke prevention benefit.” This risk was actually disclosed on labels for Pradaxa in Europe, but not the United States at the time of the victim’s care. Boehringer also knew that patients should not take Pradaxa if they also use P-gp inhibitor drugs, which Erelene Knight did. And while the company later altered its label to include this information, it did not directly inform doctors of the risk.

Based on all this, the judge presiding over the case ruled the estate presented sufficient evidence to submit the question of liability for “failure to warn” to the jury. Defense protested that at the relevant time, Pradaxa contained a general warning that the drug “can cause serious and, sometimes, fatal bleeding.” But whether or not this was an “adequate” warning given what BI allegedly knew, but failed to disclose on the original U.S. label, will be for the jury to decide.

How the favorable verdict predicts future trial outcomes in not only Pradaxa cases currently pending around the country, but in the more than 25,000 Xarelto blood thinner cases that are filed in the Xarelto MDL 2592 litigation, see Mass Tort Nexus Briefcase XARELTO-(rivaroxaban)-MDL-2592-USDC-ED-Louisiana (Judge Eldon Fallon), and in the Philadelphia Court of Common Pleas, see XARELTO-Case-No-2349-in-Philadephia-Court-of-Common-Pleas–Complex-Litigation-(PA-State-Court). There are several bellwether trials set for the Philadelphia Xarelto cases in 2019, where Laura Feldman and Rosemary Pinto of the Philadelphi firm of Feldman & Pinto, will be co-lead counsel for the trial team.

Michael Brady Lunch will speak on the Pradaxa litigation as well as the status of Xarelto and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”

November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

For the most up to date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.

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