Boehringer to settle thousands of cases over Pradaxa blood thinner bleeding risk
11/10/20 REUTERS LEGAL 17:32:42
Copyright (c) 2020 Thomson Reuters
Nate Raymond
REUTERS LEGAL
November 10, 2020
A paramedic takes a blood sample for DNA testing from a resident looking for a relative missing during the eruption of Fuego volcano at the morgue in Escuintla, Guatemala, June 7, 2018. REUTERS/Luis Echeverria
Boehringer Ingelheim has reached an agreement to resolve thousands of lawsuits alleging that the drugmaker failed to warn patients about the bleeding risks of its blood thinner Pradaxa.
Boehringer, in a filing in Connecticut Supreme Court on Monday, said it had reached a global settlement to resolve 2,935 lawsuits nationwide against the drugmaker, almost all of which are pending in a state court in Hartford.
The drugmaker's lawyers, led by Covington & Burling's Paul Schmidt, and the plaintiffs' attorneys, as a result of the agreement, asked the state's top court to put on hold appeals of rulings the plaintiffs have said could doom the "vast majority" of cases.
"With the most recent favorable judicial rulings, Boehringer Ingelheim expects the Pradaxa litigation will be concluded in its entirety," Boehringer said in a statement. "Time and again, Pradaxa's benefits and established safety profile have been confirmed."
Boehringer separately asked the 4th U.S. Circuit Court of Appeals to stay its appeal of a $1.25 million jury award to the family of a woman who alleged it misrepresented the risks of Pradaxa, causing her to suffer gastrointestinal bleeding.
That court heard arguments in the case on Oct. 29. Boehringer said the family of Betty Knight, whose case in October 2018 became the first to result in a verdict against the company, would have the right to opt in to the settlement.
Terms of the settlement were not disclosed. Boehringer said the settlement's consummation was contingent on a process whereby certain participation thresholds for eligible claimants opting in to the deal must be met by May 5.
"We are pleased to have reached a comprehensive settlement that will provide compensation to thousands of injured Pradaxa patients," said C. Andrew Childers, a lawyer for the plaintiffs at Childers, Schlueter & Smith.
Pradaxa belongs to a new class of drugs designed to replace decades-old warfarin in preventing strokes in patients suffering from atrial fibrillation, or irregular heartbeat. The FDA approved it in 2010.
In 2014, Boehringer agreed to pay about $650 million to resolve about 4,000 Pradaxa product liability lawsuits largely pending in federal court. In five trials nationally to date, mostly in Connecticut, plaintiffs have won two and Boerhinger has won three.
The other plaintiff-side win besides the Knight case occurred in May 2019, when a Connecticut jury awarded $542,466 to Eugene Roberto, a New York man who alleged he suffered life-threatening bleeding after taking Pradaxa.
Hartford Superior Court Judge Carl Schuman in September 2019 upheld that verdict but said that one his claims was preempted by federal law.
That claim said Pradaxa's label failed to warn that doctors should monitor patients to ensure they stay within a therapeutic range of Pradaxa blood plasma concentration levels.
Schuman agreed with Boehringer that it had not acquired new information about risks not previously known by the Food and Drug Administration that would allow it to alter Pradaxa's label without the agency's approval.
The judge on similar grounds granted summary judgment in Boerhinger's favor in another case on the preemption issue, prompting an appeal to the Connecticut Supreme Court.
The case is Roberto v. Boehringer Ingelheim Pharmaceuticals Inc, et al, Connecticut Supreme Court, No. SC 20409.
For the plaintiffs: Neal Moskow of Ury Moskow, C. Andrew Childers of Childers Schlueter & Smith and Russell Abney of Ferrer Poirot Wansbrough Feller Daniel & Abney
For Boehringer: Paul Schmidt of Covington & Burling and Patrick Fahey of Shipman & Goodwin
(This story has been updated with comment from Boehringer and a lawyer for the plaintiffs.)
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