Monday, June 18, 2012

Pradaxa Litigation: Lawsuits on the Horizon



This article will continue the discussion held by a group of attorneys during a recent Pradaxa litigation seminar. The discussion centered primarily around venue although cause of action and filing were also discussed. Boehringer’s primary American base is in Connecticut which is also the home of large numbers of insurance companies. This can lead to extremely tough jury pools and is something to consider when discussing alternative venues. Missouri could be a consideration, however Boehringer carried out their clinical trial in Missouri. Thus far, federal filings have been in Kentucky, Louisiana and Tennessee although Connecticut may well be the natural choice. Texas, Michigan and the 11th circuit court in general should be avoided, and while there is no particular rush to this case, it’s important to be prepared. A caution to the attorneys was not to file prematurely in the hopes of being lead counsel.

Strict Liability in Pradaxa Litigation

Strict liability will not be a problem since it is clear that the risks of Pradaxa outweigh the benefits. Warfarin has been around practically forever, and while there are certainly downsides to the drug there is also a ready antidote in the event of excessive bleeding. Boehringer exhibited a complete and total failure to warn and didn’t even tell doctors for a full year and a half that these bleeds could not be reversed. It was not until January when Boehringer grudgingly admitted there was no reversal agent, and even at this juncture they have still not fully warned about GI bleeds or that some populations are more at risk than others. Although the label for Pradaxa does mention bleeding risks, it is still clearly inadequate. It is believed that the science will prove there are fewer life-threatening bleeds with Warfarin, and that Warfarin causes fewer bleeds. Yet even in the face of these scientific facts, Warfarin carries a black box label regarding bleeding risk while Pradaxa does not, proving strict liability in the failure to warn and inadequate warning labels. 

Prescribing Physicians vs. ER Doctors

While prescribers may still be touting Pradaxa as the greatest thing since sliced bread, ER doctors have a different take. Prescribing physicians point to the fact there is no blood testing, no dietary restrictions—basically one size fits all. The New England Journal of Medicine featured letters written by four ER doctors about the dangers of Pradaxa. These doctors were not paid experts rather were offering unsolicited opinions regarding the cases they see of patients who come into the ER experiencing uncontrollable bleeding who are currently taking Pradaxa. These doctors state that their hands are literally tied—the patient is bleeding out and there is absolutely nothing they can do about it.

These ER doctors see multiple complications with Pradaxa patients. One of the doctors detailed a particular patient, a woman in Texas who was an elderly retired school teacher. She had a small cut and was unable to stop the bleeding. By the time the EMS arrived they said the scene looked like a bloodbath yet they were unable to determine where precisely the bleeding was coming from. This Texas woman died shortly after arriving at the hospital, and all the doctors found was a small puncture wound on her ankle. It is clear that Pradaxa is hardly the miracle drug its manufacturers claimed and that many more details will be coming out regarding the adverse effects of the drug.
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