Pradaxa Lawsuits

Pradaxa’s manufacturer, Boehringer Ingelheim Pharmaceuticals, was the defendant in thousands of lawsuits. The bulk of the claims were settled in 2014 with the remainder settling in November 2020.

After the initial 2014 settlement, lawyers filed additional lawsuits in state court in Connecticut where Boehringer Ingelheiconnecticutm Pharmaceuticals’ U.S. headquarters is located. The claims in the more recent cases were similar or identical to the thousands of previous lawsuits.

Patients who experienced severe internal bleeding and their surviving family members claimed their injuries were the result of taking Boehringer Ingelheim’s dabigatran-based anticoagulant. Pradaxa is linked to dangerous side effects, including uncontrollable bleeding.

Plaintiffs also claimed that marketing campaigns pushed the idea that the medicine was easy to take and didn’t require monitoring. But internal company documents showed that employees tried to quash a research paper, allegedly fearing it would lead to a blood test requirement.

Bellwether Trials in Connecticut

The first three Connecticut bellwether trials concluded in March, May and October 2018. All yielded jury verdicts in favor of the defendant. An additional bellwether in May 2019, Roberto v. Boehringer Ingelheim, however, ended with a verdict in favor of the plaintiff.

Bellwether trials can give the parties involved in a lawsuit an idea of how the rest of the cases may proceed. Bellwether results are not a guarantee of how individual cases will go, however.

Mary Boone’s doctor prescribed Pradaxa to lower her risk of stroke from atrial fibrillation. She died from uncontrolled bleeding. Similarly in Mary Lou Gallam’s lawsuit, documents indicate she experienced major bleeding after her doctor prescribed Pradaxa for atrial fibrillation in 2011. William Bedsole also says in his lawsuitthat he was prescribed the drug around Nov. 29, 2010, for atrial fibrillation. He experienced a severe internal bleed eight months after taking Pradaxa and was hospitalized for three days.

In court documents for Boone’s case, defendant Boehringer Ingelheim argued that the drug’s warnings were adequate, maintaining that Boone’s doctor understood the risks. Jurors in Bedsole, Boone and Gallam’s cases all found in favor of the defendant. An appeal of the Boone verdict ended with the court upholding the original verdict.

In May 2019, Roberto v. Boehringer Ingelheim, ended in the first loss for the drugmaker. While the jury awarded Eugene Roberto $542,464 in compensatory damages, the judge only awarded $1 in punitive damages because expert testimony did not warrant more damages.

Knight v. Boehringer Ingelheim

Though not one of the Connecticut bellwethers, another notable trial was the case of Betty Knight. According to the lawsuit, she died while taking Pradaxa.

In October 2018 a West Virginia federal jury awarded $1.25 million to Knight’s family. One million of that award was for punitive damages. However, the verdict was reversed on appeal in 2021.

Why Did People File Pradaxa Lawsuits?

According to one lawsuit, from October 2010 until the end of March 2011, American doctors wrote approximately 272,119 prescriptions for Pradaxa. During that time, there were 932 Pradaxa-associated serious adverse event reports filed with the U.S. Food and Drug Administration, including at least 120 deaths and more than 500 reports of severe, life-threatening bleeding.

The lawsuit adds that from April 1, 2011 until the end of June 2011, there were another 856 adverse event reports filed with the FDA involving the drug. These included at least 117 deaths and more than 510 reports of severe, life-threatening bleeding.

Injuries Named in Pradaxa Lawsuits

More than 540 people who took Pradaxa died in 2011. Thousands of other people reported serious complications, including life-threatening bleeding that was difficult to reverse. Lawsuits say the drug causes a higher rate of life-threatening bleeds than the strokes or systemic embolisms it is intended to prevent.

Pradaxa is effective only if dosed properly for individual patients. Lawsuits assert that there is no accurate test to check drug levels.

The FDA approved Pradaxa in 2010. Boehringer Ingelheim sold the drug for five years without a bleeding remedy.

Pradaxa lawsuits say Boehringer Ingelheim developed a bleeding remedy in 2010. But the company didn’t seek approval for the remedy until Feb. 19, 2015. The FDA first approved Praxbind, a fast-acting Pradaxa antidote, in October 2015.

Company Accused of Deceptive Marketing

Pradaxa lawsuits further claim Boehringer Ingelheim misled patients and their doctors about Pradaxa’s risks and benefits. Patients say the company endangered the public through deceptive marketing practices. Lawsuits claim the manufacturer didn’t adequately label the drug.

The complaints allege the company made massive profits while hundreds of patients died and thousands experienced serious injuries. In fiscal year 2011, Pradaxa sales around the world surpassed $1 billion, lawsuits say, giving the drug what the industry deems “blockbuster” status.

Federal Settlement

Boehringer Ingelheim announced a Pradaxa settlement plan on May 28, 2014. It said it would pay $650 million to settle 4,100 lawsuits that were pending at the time.

“We are pleased that today’s settlement will bring justice and financial assistance to those hurt while taking Pradaxa,” Mikal Watts, a member of the 27-lawyer Plaintiffs’ Steering Committee, said in a statement. “We are proud of the settlement we have achieved, congratulate the company on doing the right thing, and look forward to distributing these funds to our clients as expeditiously as possible.”

Boehringer Ingelheim Denied Wrongdoing

In agreeing to the settlement, the company denied any wrongdoing. Boehringer Ingelheim maintained that the plaintiffs’ claims “lacked merit.” People are no longer able to file these lawsuits in federal court as a result of the settlement.

“We continue to stand resolutely behind Pradaxa and believed from the outset that the plaintiffs’ claims lacked any merit,” Andreas Neumann, head of the legal department and general counsel for Boehringer Ingelheim worldwide, said in a statement.

“Notwithstanding our strong belief that we would prevail in these lawsuits, this settlement allows our company to avoid the distraction and uncertainty of protracted litigation over years and years.”

Federal Judge Closed Consolidated Action

Before the settlement, people filed thousands of cases in federal court. A judicial panel consolidated most of the lawsuits into a multidistrict litigation. A judge in the U.S. District Court for the Southern District of Illinois managed the Pradaxa MDL.

U.S. District Court Judge David Herndon planned to conduct four trials. The trials were to happen between August 2014 and February 2015.

Herndon selected the cases to help attorneys determine the effectiveness of their arguments. Two were wrongful death lawsuits. Two blamed the drug for severe injuries.

But the trials never started. Boehringer Ingelheim settled the cases instead. Herndon closed the MDL in December 2017 after the last case was resolved.