What is the Impact of Recent FDA Report on Pradaxa Bleeding Risk?

On November 2, 2012 the FDA issued a Drug Safety Communication report update addressing the risk of serious bleeding among new users of Pradaxa. On its face, the FDA appeared to conclude that the rates for uncontrolled bleeding events among Pradaxa users were the same as other blood thinner medications, most notably warfarin (Coumadin). Thus headlines suggested the report was a critical blow to plaintiffs’ claims in the MDL pending before Judge David R. Herndon in the U.S. District Court, Southern District of Illinois (MDL No. 2385, Pradaxa Product Liability Litigation). A closer look analysis reveals that this is not necessarily the case.

Before the 2010 release of Pradaxa by drug maker Boehringer Ingelheim Pharmaceuticals, Coumadin was the standard blood thinner prescribed in the US. Boehringer Ingelheim marketed Pradaxa as a safer, more effective and easier to administer alternative. One fact that was not highlighted in such advertising was that Pradaxa was also much more expensive than Coumadin and thus, potentially much more profitable. Indeed, the average annual cost of Pradaxa use was $3,000 compared to $200 for Coumadin. Plaintiffs contend that the manufacturer put product safety well behind such potential profits.

The recent FDA study did serve to buttress one basis of liability in the Pradaxa litigation. A significant difference between Pradaxa and Coumadin is that, unlike Coumadin, there is no antidote to counteract the effects of Pradaxa as an anti-coagulant. Thus, any unexpected bleeding event which may occur while a patient is taking Pradaxa (such as from a fall) has the potential to be fatal. In contrast, Coumadin has a simple antidote, Vitamin K, which allows the body to resume producing blood clotting material in the event of a bleed. Thus, although the bleeding rates may be similar for both drugs, Plaintiffs contend that Pradaxa is much more hazardous because the potential for catastrophic injury is much greater.

Boehringer Ingelheim contends that there is a methodology to remove the drug from a patient’s system in the event of a bleed: dialysis. However, while technically possible, it is clearly impractical as it is highly unlikely most patients who experience catastrophic and uncontrolled bleeding will have access to or the time to be connected to a dialysis machine.

It is important to note that despite the FDA report on the similarity of adverse bleeding events between the two drugs, the report does not necessarily cause irreparable harm to plaintiffs’ claims in the litigation. The Observational Medical Outcomes Project, a non-profit entity originally formed by the FDA, PhRMA, and the Foundation for NIH specifically to identify reliable methods for analyzing health data, has criticized the FDA’s use of unadjusted incidence rate ratios as a basis for its recent conclusions (the FDA reviewed health insurance claims and hospital data). Thus, as with any study, it remains critical for attorneys to scrutinize the sample population the FDA considered, and compare that population to the particular Plaintiffs and adverse event claims at issue in the individual cases.

Meanwhile, the litigation presses onward at a brisk pace under Judge Herndon. Discovery for the first bellwether trial is expected to conclude by Oct. 31, 2013, and the first trial is scheduled to commence in August 2014.
VERDICT: Case Pending
COURT: U.S. District Court of Illinois, Southern District

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