Boehringer Ingelheim faces allegations that it failed to warn doctors about dangerous side effects of blood-thinning medication Pradaxa in two lawsuits in the Southern District of Florida. Courtesy photo.

Two Florida plaintiffs have filed federal lawsuits against Connecticut-based drug giant Boehringer Ingelheim Pharmaceuticals Inc., accusing it of over-promoting and misrepresenting Pradaxa, a blood-thinning medication that alleges causes internal bleeding.

Pradaxa is used to prevent blood clots and lower the risk of stroke for patients with irregular heartbeats.

But Berta Marquez, 74, and Edward Silverstein, 71, allege Pradaxa was the legal cause of episodes of uncontrollable bleeding that landed them in Hialeah and Delray Beach hospitals, respectively, for weeks. They seek damages for failure to warn, negligence and product liability.

Their complaints add to mounting litigation against Boehringer Ingelheim, which faces about 3,000 pending lawsuits in courts nationwide, but mainly in Connecticut.

Plaintiff attorneys C. Andrew Childers of Childers, Schlueter & Smith in Atlanta and Neal Moskow of Ury & Moskow in Fairfield, Connecticut, are co-national lead counsels for the litigation. They say they filed in Florida to avoid adding to the backlog.

"We've made a decision in the last several weeks that we will be filing more cases in federal courts and fewer in Connecticut state court," Moskow said. "There just aren't enough judges in Connecticut to try all the cases being filed."

Marquez and Silverstein's lawsuits claim Boehringer Ingelheim risked patient safety by touting Pradaxa as the first drug of its kind to require no monitoring, when in fact a blood test would have told doctors whether patient doses were too high or too low.

"They're marketing it as a one-size-fits-all drug, and the science that we've shown juries is that that's not true, and that there are people who are getting too much," Moskow said. "For those people, Pradaxa isn't the right drug."

Moskow said that if patients receive too much blood-thinning medication, even minor internal injuries could become a major bleed, especially in the gastrointestinal tract.

"Virtually everyone has little injuries in their intestines or in their stomach that, under normal circumstances, don't bleed," Moskow said. "But if you have too much of this drug in your system, it can cause even those very small injuries to bleed."

The lawsuit claims Boehringer Ingelheim failed to properly test Pradaxa and to warn doctors about the risk of bleeding. It implied the reason for that was "blockbuster" Pradaxa sales, which topped $1 billion in 2011.

According to the complaint, reports filed with the U.S. Food and Drug Administration suggest that Pradaxa was a factor in at least 120 deaths and 150 instances of life-threatening bleeding.

Boehringer Ingelheim has previously argued that federal law shields it from liability because the Food and Drug Administration has approved the Pradaxa label.

Company spokeswoman Lauren Murphy said, "Boehringer Ingelheim stands behind the safety and effectiveness of Pradaxa. Four previous court cases have reached the conclusion that the safety of Pradaxa is clearly reflected in its FDA-approved label."

Boehringer Ingelheim resolved about 4,000 lawsuits over Pradaxa with a $650 million settlement in 2014. The five cases tried since have produced a mixed bag, with two plaintiffs verdicts, one defense verdict and two mixed verdicts, where jurors found the defendant breached the standard of care but didn't award damages.

The major hurdle for plaintiffs, according to Moskow, is demonstrating that these cases aren't unavoidable effects of blood thinning medication, like, for example, patients with wounds that bleed more than they usually would.

"These are people who, because of the way the drug works, are getting too much in their system," Moskow said. "The company knows that there's a safe range, and we need to show that certain people are getting too much in their system so that they're at an excessive risk of bleeding."

U.S. District Judges Rodolfo Ruiz and Federico Moreno are scheduled to hear the Florida cases.

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