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Pradaxa Lawsuit Update (MDL 2385): News Articles Report BI Altered Research Paper it Feared Would Harm Sales

What if a pharmaceutical company knew that its drug required frequent testing to reduce the potential danger to patients, yet hid that information? According to two recent news articles, the manufacturer of the anticoagulant drug Pradaxa may have done just that. The problem may start with “the fact that much of the research on drugs is performed by the drug makers themselves, who have a financial interest in ensuring their products are approved by regulators,” states the online news source in an article entitled Manufacturer Tried to Hide Results of Testing of Blood Thinner Implicated in 1,000 Deaths. Boehringer Ingelheim (BI) claims that one of the benefits of its drug, as opposed to the competing blood thinning medication warfarin, is that Pradaxa patients do not need regular blood monitoring. However, internal documents showing that such monitoring may reduce the risk to patients were recently unsealed in the Pradaxa Multidistrict Litigation entitled In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation (MDL 2385, Case No. 12-md-2385), pending in the United States District Court for the Southern District of Illinois.

According to a recent editorial published the British Medical Journal (BMJ), these internal documents showed that a research paper prepared by BI “clashed with a marketing claim that its new anticoagulant did not need monitoring”. The company’s research concluded that lower concentrations of the drug in a person’s plasma was “associated with a significantly increased risk of ischaemic stroke”, while higher levels were associated with a significantly increased risk of “major bleeding.” In other words, as described it, “some patients absorb too little of the drug to prevent strokes”, while others absorb “so much that they are at a higher risk for bleeding.”

As reported by BMJ, Boehringer Ingelheim executives were concerned that such a conclusion regarding monitoring undercut the corporate marketing strategy. One international project manager stated in an email that she could not believe “that the company would release the paper after spending a decade developing a drug with the ‘clearly defined target of no monitoring needs.’” She added, ‘This will make any defense of no monitoring to HA [health authorities] extremely difficult… and undermine our efforts to compete’” with other anticoagulants. A revised version of the paper was later published, but conclusions about blood monitoring had been removed.

Schlichter, Bogard & Denton, LLP are leaders in the national Pradaxa Multidistrict Litigation (MDL 2385) against the manufacturers of Pradaxa. Partner Roger Denton has been appointed by Chief Judge Herndon to serve as Plaintiffs’ Co-Lead Counsel in the Pradaxa MDL. Roger Denton and the Pharmaceutical Litigation Department at Schlichter, Bogard & Denton, LLP represent clients nationwide who have suffered serious and fatal bleeding events, such as gastrointestinal bleeding, as a result of using the blood thinning medication Pradaxa.

If you or a loved one has suffered injuries after using the blood thinning medication Pradaxa, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.

Schlichter, Bogard & Denton, LLP also welcomes the opportunity to work with other attorneys on these types of cases. Schlichter, Bogard & Denton, LLP is available to either handle these cases or work as co-counsel, so other attorneys with Pradaxa cases are invited to contact an attorney at the firm to explore this opportunity.


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