Pradaxa Maker Gets $1.25M Verdict Overturned

Pradaxa Maker Gets $1.25M Verdict Overturned

Introduction

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.

Pradaxa (Dabigatran) is an oral anticoagulant prescribed to lower the chance of stroke for those suffering from atrial fibrillation (not caused by heart valve issues) and to treat blood clots in the veins of the legs (deep vein thrombosis) or lungs (pulmonary embolism) and reduce the risk of them occurring again. Pradaxa was introduced in the U.S. market in 2010, as an alternative to warfarin, after gaining approval from the U.S. Food and Drug Administration (FDA). The drug is manufactured and marketed by a European pharmaceutical giant, Boehringer Ingelheim Pharmaceuticals, Inc.

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.

In August 2012, MDL No. 2385 was created by the U.S. Judicial Panel on Multidistrict Litigation to be convened in the Southern District of Illinois and to be presided by Judge David R. Herndon. Nearly 21 legal actions were transferred to this MDL, and thousands of lawsuits continued to be filed touching the count of approximately 4,000.