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 11^th 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.

Author: Sullo & Sullo Attorneys

0 Comments

Categories: ImportedNumber of views: 1511

Tags: Pradaxa Litigation

Please login or register to post comments.

250,000 CLIENTS REPRESENTED

FREE CASE REVIEW

Full Name* Email* Telephone Number* Are You already a Client?* Type of Case* Tell Us About Your Case*

WARNING: Do not send any information in any email through this website if you consider the information confidential or privileged.

I understand that by submitting my contact information to Sullo & Sullo LLP for review, I consent to messages regarding this legal matter as well as marketing for other potential legal matters in the future without limitation at standard messaging and data rates unless terminated by me in writing. I further understand that my submission of any and all information in response to this website does NOT create a lawyer-client relationship between myself and Sullo & Sullo, LLP and/or its lawyers, and that any and all information submitted is NOT confidential or privileged. I further acknowledge that, unless Sullo & Sullo, LLP subsequently enters into an Attorney-Client relationship with me, any and all information I provide will NOT be treated as confidential or privileged, and any such information may be used against me and/or for the benefit of current or future clients of Sullo & Sullo, LLP. ...READ ENTIRE DISCLAIMER

Receive an Immediate Response

ANDREW SULLO IS A TOP 100 NATIONAL TRIAL LAWYER 2013 • 2014 • 2015 • 2016 • 2017 • 2018 • 2019

Obtener una Respuesta Inmediata

Andrew Sullo – 100 Mejores Abogados Nacional | 2013 • 2014 • 2015 • 2016 • 2017