As we have discussed before, the atrial fibrillation anticoagulation medication Pradaxa, which was meant as a safer alternative to warfarin (with supposedly the same ability to prevent strokes and systemic embolism), has a big problem: if a patient develops some type of serious bleeding or hemorrhaging, there’s no way to stop it.
Unlike warfarin / Coumadin, which can be reversed a number of ways (like a vitamin K shot), there’s no way to reverse the effects of Pradaxa. Emergency medicine physicians, neurosurgeons, and internal medicine specialists have been working frantically for months to come up with some sort of reversal procedure - trying everything from dialysis to injecting a cocktail of proteins - but nothing seems to work.
Dozens of patients who suffered uncontrollable gastrointestinal bleeding or brain hemorrhages have filed suit against the manufacturer of Pradaxa, Boehringer Ingelheim Pharmaceuticals, Inc. Roughly half of the federal cases are pending in the Southern District of Illinois, all of which are assigned to Chief United States District Judge David R. Herndon. Last week, Judge Herndon issued his first order, denying the pharmaceutical company’s motion to dismiss the cases, a significant victory for patients injured by Pradaxa.
As the Court recounted in its opinion:
In May 2011, the plaintiff’s physician prescribed the prescription drug Pradaxa for treatment of the plaintiff’s medically necessary blood thinning needs. Doc. 2 at ¶ 41. Pradaxa is a member of a class of anticoagulants known as direct thrombin inhibitors and is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (patients with atrial fibrillation have an increased risk of stroke). Id. at ¶ 11. Shortly after being prescribed Pradaxa, on or about July 7, 2011, the plaintiff suffered a severe gastrointestinal bleed causing her to be hospitalized for 5 days in St. Mary’s Hospital. Id. at ¶ 41. During this time, the plaintiff allegedly suffered from uncontrollable bleeding which was caused and/or worsened by her use of Pradaxa. Id. The Pradaxa prescribed to and ingested by the plaintiff was allegedly ‘designed, manufactured, marketed, advertised, distributed, promoted, labeled, tested and sold’ by BIPI. Id. at ¶ 10.
The plaintiff contends, inter alia, that despite being aware of certain safety risks associated with use of Pradaxa, BIPI failed to adequately warn or disclose information about such risks to the medical community and consumers. 5 See e.g., Id. at ¶¶ 18-22, 26 (a-m), 27. Specifically, the plaintiff contends that (1) BIPI failed to adequately warn or disclose information regarding the risk of serious and sometimes fatal irreversible bleeding events associated with the use of Pradaxa; (2) failed to warn or disclose information regarding the protocol, or lack thereof, for reducing the anticoagulation effects of Pradaxa in patients who experience a severe bleeding incident; (3) failed to provide adequate warnings and information regarding the increased risks of bleeding in certain patient populations; (4) failed to provide adequate warnings and information regarding the ability or need to assess certain factors in patients taking Pradaxa; and (5) failed to warn that patients taking Pradaxa are at an increased risk for excessive and/or uncontrollable bleeding. See e.g., Id. at ¶¶ 18, 20-22, 26 (a-m), 39. The plaintiff also contends that BIPI made affirmative misrepresentations regarding the efficacy, safety risk profile, and additional benefits of Pradaxa. See e.g., Id. at ¶¶ 14, 18, 20, 21. Finally, the plaintiff contends that BIPI failed to adequately research or investigate the safety profile of Pradaxa and failed to adequately research or investigate patient weight as a variable factor in establishing recommended dosages of Pradaxa. Id. at ¶ 26(c),(d).
Sellers v. Boehringer Ingelheim Pharms., Inc., 2012 U.S. Dist. LEXIS 102959, at *8-10 (S.D. Ill. July 25, 2012).
The key issue at this stage is whether the FDA-approved warning label for Pradaxa, which says that there is a risk of “serious and sometimes fatal bleeding,” was sufficient as a matter of law to preclude the plaintiffs from bringing any lawsuits. The judge held that the Pradaxa warning label failed to warn that “if a serious bleeding event occurs, there is no effective means for reversing the anticoagulation effects of Pradaxa,” and failed to warn about “the increased risk of excessive or uncontrolled bleeding in patients taking Pradaxa” as compared to warfarin. The judge did not conclude that either of those allegations were true or false, because that issue is not yet ripe, but rather just concluded that, if those allegations were true, the manufacturers of Pradaxa could be liable for failing to warn.
Those cases will thus move into discovery where they can obtain information about what Boehringer Ingelheim really knew about the risks of Pradaxa. In other news, the judicial panel on multidistrict litigation last week also heard arguments on a motion to create a single consolidated litigation for the cases. Consolidated litigation is different from a class action, because the cases are still filed individually and would be tried in a jury eventually, but it has many of the same benefits for plaintiffs, particularly in the ability of plaintiffs to use proof from one case in proving another case.