A Hartford Superior Court jury deliberated five hours Friday before finding Ridgefield-based Boehringer Ingelheim not liable for the severe internal bleeding a Florida man suffered after he used the relatively new blood thinner Pradaxa.
The verdict marks the third time this year a Connecticut jury has found in favor of the pharmaceutical company in such lawsuits. In one of the previous cases, plaintiffs said an 82-year-old woman’s death was caused by bleeding after taking Pradaxa. Covington & Burling and Shipman & Goodwin handled all three trials.
Boehringer Ingelheim’s Pradaxa was approved by the Food and Drug Administration in 2010. Before its approval, Warfarin, which was sold under the brand name Coumadin, was the only oral anticoagulant available in the United States for reducing stroke and systemic embolism in patients with atrial fibrillation.
The drugmaker agreed four years ago to pay about $650 million to resolve roughly 4,000 similar state and federal cases. Boehringer Ingelheim denied any wrongdoing in agreeing to the settlement and, at the time, said it was made to avoid lengthy litigation.
The latest case stems from a 2016 lawsuit brought by William Bedsole, who claimed the company failed to warn his doctor and other doctors about the risk associated with taking Pradaxa.
The jury found in favor of Boehringer Ingelheim after a three-week trial.
According to the court transcripts from opening statements, the plaintiffs claimed the drug was unsafely rushed to the market, while the defense argued that Pradaxa went through numerous tests and approvals.
Brian Perkins, an attorney for Bedsole and of counsel at Chicago-based Meyers & Flowers, told the jury, “This is a race to market. And, you’ll hear a lot of how Boehringer Ingelheim skipped steps to identify critical risks during their race to first. And, I’ll tell you, they won the race, but at the expense of patients like Mr. Bedsole.”
Labeling also became an issue during trial, Perkins said in his opening statement.
“One out of five patients who take Pradaxa are at a unnecessary risk of stroke or bleed[ing]. … And, nowhere in the label does it say anything about that,” Perkins said.
Speaking for Boehringer Ingelheim, Paul Schmidt, a partner with Covington, said in his opening statements that Pradaxa underwent studies for more than a decade.
“For a decade and a half, the studies, animal studies, test tube studies involving tens of thousands of patients, including the largest one of its kind ever conducted, Boehringer studied this medicine and shared its data with the FDA,” Schmidt said.
“After that approval, the company kept doing what you’d want them to do: They continued to study the medicine. We now have another decade, almost, of experience with this medicine,” he added.
Boehringer Ingelheim had four attorneys: Schmidt and Michael Imbroscio, both of Covington; Sharla Frost of Tucker Ellis; and Robert Simpson of Shipman & Goodwin.
Schmidt said, “We tried the case based on the benefits of the medicine and the strong warnings that were given and the jury seemed to agree with those facts.”
Lauren Murphy, associate director for communications for Boehringer Ingelheim’s cardiovascular portfolios, said the drugmaker “is committed to patient safety. We are gratified that three juries have rejected these claims and this lawsuit, thus confirming the important role that Pradaxa plays in improving patients’ lives.” Murphy declined to comment on any specific aspect of the trial.
In addition to Perkins, the plaintiffs were represented by Jonathan Mincieli, also of Meyers & Flowers; Ellen Presby of Nemeroff Law Firm; and Neal Moskow of Ury & Moskow. None of the attorneys responded to a request for comment Monday.