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Less than 24 hours after Loraine Franklin fell on the kitchen floor of her Georgetown home, she was dead.
It was December 29, 2011, and Franklin's daughters say today that, had Franklin, 80, not been prescribed a blood thinner called Pradaxa, she'd have lived to see the new year and subsequently celebrate her 60th wedding anniversary.
Instead, they say, the fall caused a blow to her head, which caused an intracranial hemorrhage, which doctors at the hospital could not stop. All the doctors could do, the daughters say, is make Franklin as comfortable as possible as her speech became slurred and the blood pooled in her skull.
Like hundreds of thousands of others with a heart condition called atrial fibrillation, which raises the risk of stroke, Franklin had been told of the benefits of the recently FDA-approved Pradaxa over its comparatively ancient counterpart, Coumadin. What she hadn't been told about, according to her daughters, was Pradaxa's most significant drawback: There is no effective reversal agent for a traumatic bleeding event.
Had Franklin been taking Coumadin — as she had years before — she would have left the hospital with a headache and a slight concussion, her daughters say. With Coumadin, doctors have a variety of ways to keep a patient from bleeding to death. Instead, according to Franklin's daughters, Pradaxa turned a simple fall into a death sentence.
Which is why Franklin's daughters are suing Pradaxa's German manufacturer, Boehringer Ingelheim, in federal court. They say the company did not adequately warn doctors and patients of the lack of an antidote. They're just two of dozens of clients represented by the Texas law firm Watts Guerra Craft, whose mass-tort team opened the floodgates by filing the first Pradaxa-related cases in November 2011.
The timing coincided with Boehringer's announcement that it had recorded 260 Pradaxa-related fatal bleeding events worldwide between March 2009 and October 2011. The FDA followed suit by announcing a post-market safety review. Regulators in Japan had already asked Boehringer to issue "Dear Doctor" letters to health-care professionals warning of the bleeding risk, and Australian regulators issued a safety advisory as well.
However, the FDA, per its announcement, "continues to believe that Pradaxa provides an important health benefit when used as directed," and Boehringer representatives told the Houston Press that 260 recorded deaths are not outside the parameters of a major clinical trial that the FDA and its global counterparts relied on in approving the drug in the first place. Company representatives also say the risks were not hidden or minimized.
Pradaxa has been a boon to Boehringer's bottom line. But if Loraine Franklin's daughters get their way, the drug will be off the market — just not soon enough for their mother.