Last week, the 4th Circuit U.S. Court of Appeals in Richmond, Virginia, reversed a jury decision to award $1.25 million to the family of a now-deceased West Virginia woman alleging Boehringer Ingelheim's blood thinner Pradaxa for the woman's gastrointestinal bleeding.
According to the opinion dated January 6, the federal appellate panel ruled that the state-law fraud claims on which the jury held the drugmaker liable in 2018 are preempted by federal law.
The lawsuit was filed by the family of a woman who took Pradaxa for years, which allegedly resulted in her death after suffering from gastrointestinal bleeding and other complications. Her children accused the drugmaker of failing to adequately warn about the risks associated with taking the blood thinner.
A jury held the company responsible for the fraud claims and awarded the family $250,000 in compensatory damages and $1 million in punitive damages.
In the recent opinion, U.S. Circuit Judge Marvin Quattlebaum overturned the verdict stating that the company could not have unilaterally changed the drug's label to provide an adequate warning without approval from the U.S. Food and Drug Administration (FDA).
The family argued over the decision asserting that the label failed to warn patients with impaired kidney function to undergo blood testing to check Pradaxa concentration levels. However, Judge Quattlebaum said that as per FDA regulations, the company could only modify the labels based on "newly acquired information" about risks, and a study conducted after the FDA approved the drug did not constitute such information.
Last year, in November, Boehringer filed a brief in Connecticut Supreme Court indicating that it has reached a global settlement to resolve 2,935 lawsuits brought over by patients alleging failure to warn about the bleeding risks associated with the blood thinner. A status update concerning the settlement will be provided by August 2021, as noted by the drugmaker in the filing.