As a pharmaceutical liability lawyer, I was very interested to read about a new series of lawsuits over potentially fatal side effects of the drug Praxada (dabigatran). According to an article from Bloomberg, Pradaxa’s manufacturer, the German company Boehringer Ingelheim, is facing at least 150 lawsuits in the United States alleging that it knew the drug could cause fatal bleeding and has no known antidote, but failed to disclose that information to patients. The article says Pradaxa, a blood thinner used to prevent strokes, has been linked to more than 500 deaths in two years, suggesting that more lawsuits could be on their way. Attorneys for plaintiffs in these cases say Boehringer could face thousands more lawsuits. Approved for U.S. sale in 2010, Pradaxa is still very profitable and has generated more than $1 billion in worldwide sales.
Pradaxa is prescribed as an alternative to the older blood thinner Coumadin (warfarin), for people who have a serious risk of strokes. Coumadin requires frequent blood tests to ensure the dosage is proper; Pradaxa does not, so it was welcomed as an alternative when it came to the United States in 2010. However, reports of safety problems began right away. In 2011, the U.S. Food and Drug Administration received 542 reports of deaths, and 3,781 other health incidents, related to Pradaxa. European, Japanese and New Zealander regulators have also reported deaths or bleeding incidents. Part of the problem is that unlike with older blood thinners, there is no known drug that reverses Pradaxa’s effects. As a result, patients can “bleed out,” or bleed to death internally, even under a doctor’s care.
One such patient in the U.S. was Barbara Jean Asher of Palm Springs, Calif., who was switched to Pradaxa from another blood thinner, intended to prevent a second stroke. After three months of using it as directed, Asher was rushed to a hospital with hemorrhaging doctors couldn’t stop. Her family is one of the more than 150 suing in federal court over Boehringer’s failure to warn patients about the risk of a bleed-out. Bloomberg says most of the federal suits have been filed in southern Illinois. The first such case is set for trial in March of 2014. An additional dozen or so are pending in state courts around the country. Boehringer says it believes it has acted responsibly in marketing Pradaxa, and points out that the FDA has not found a higher risk of bleeding from its drug than from older drugs.
As a dangerous drug attorney, I wonder if this claim doesn’t deliberately mislead the reader. It’s not the risk of bleeding at all that concerns the patients in this article—it’s the risk of uncontrolled bleeding that can’t be stopped with another drug. As one defective drug lawyer told Bloomberg, it’s not clear whether a drug with no antidote can be marketed as safer than older drugs. In fact, Coumadin requires frequent blood testing precisely to help patients avoid the risk of a life-threatening bleed-out. If the patients filing these claims are right that Boehringer knew about the risk and failed to disclose it, the company will be morally and legally responsible for any proven results of its failure. For patients pursuing lawsuits, that can include claims for wrongful death or unnecessary illness, all of the associated medical bills and more.
Based in St. Louis and southern Illinois, Carey, Danis & Lowe represents clients around the United States who were seriously injured or lost a loved one because of a drug they thought would make them feel better. To tell us your story and learn more about your legal options, call us today for a free consultation at 1-877-678-3400 or send us an email.
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