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Pradaxa Lawsuit Update (MDL 2385): Recent Articles Raise Issue of Credibility with Company’s own Clinical Trial

The Hamilton Spectator found interest in lawsuits filed in July 2013 by Samuel Richardson of Castlewood, Va. and Billie Jean Benitez of Fair Oaks, Ca. While these are two plaintiffs amongst nearly 2,300 in the pending Multidistrict Litigation, In re: Pradaxa® (Dabigatran Etexilate) Products Liability Litigation (MDL 2385, Case No. 12-md-2385), who have filed cases against the manufacturers of Pradaxa, Boehringer Ingelheim (BI), these two lawsuits name three additional co-defendants — McMaster University, Hamilton Health Sciences (HHS) and their jointly operated Population Health Research Institute (PHRI).  PHRI conducted the only clinical trial to study the effects of Pradaxa®, which resulted in the drugs approval by the Food and Drug Administration (FDA) in October 2010.

According to The Hamilton Spectator, this clinical trial, RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy), involved 18,000 patients from 44 countries. Dr. Stuart Connolly, the head of cardiology and one of the lead authors of the trial, is quoted as calling RE-LY “a landmark trial” with “earth-shattering results”. However, Plaintiffs Richardson and Benitez allege the trial was inadequately designed and administered and failed to maintain adequate data. Their claims also allege PHRI and thereby Hamilton Health Sciences and McMaster, who jointly operate the research institute, assisted BI in getting Pradaxa®’s approval by gaining the company’s favor through their failure to report serious adverse events related to the drug.

In February 2010, the U.S. FDA denied BI’s application due to concerning issues in the data sets submitted. The Spectator reports that the FDA found errors in transcription, transposing and auditing. Like the plaintiffs in these lawsuits, the FDA looked into the adverse events the company reported — and what they found was a large discrepancy between the data provided by BI and that of the research company, HHS. However, only a few months later, the FDA accepted a newly submitted version of the same data sets from BI and PHRI and approved Pradaxa® to be sold in the U.S. market.

Roger Denton, Co-Lead Counsel for plaintiffs in the Pradaxa® MDL, said in an exclusive interview with The Hamilton Spectator, “It’s a public health issue…What goes on in these clinical trials in this litigation ought to be out in the public.”  He added, “Accurate reporting of the number and severity of adverse events is crucial in a clinical trial because those numbers have a vital bearing on whether the drug is deemed safe and effective.”

Also, after an announcement last month from the FDA that it would conduct a new safety assessment of Pradaxa®, the Institute for Safe Medication Practices (ISMP) is speaking out. Michael Cohen, President of ISMP, blogged recently that their January 2012 QuarterWatch report “detected a strong signal of a safety problem while monitoring serious adverse events reported to the FDA in the first months after the drug’s approval.” Cohen regresses to ISMP’s finding that anticoagulants were the leading drug safety risk in both 2011 and 2012, following Pradaxa®’s approval. He stresses the need for therapeutic options after citing a recent publication that showed data supported that the “150mg dose could produce a five-fold or more difference in the critical blood clotting function.”

Roger Denton and the Pharmaceutical Litigation Department at Schlichter, Bogard & Denton, LLP represent clients nationwide who have suffered serious and fatal injuries as a result of using the blood thinning medication Pradaxa®. Anyone who took Pradaxa® and suffered a severe internal bleeding event, such as gastrointestinal internal bleeding, may be eligible to file a federal case in the Pradaxa® MDL. The attorneys at Schlichter, Bogard & Denton, LLP are offering a free case review with no further obligation to those who have been injured, or those who lost loved ones, after suffering severe internal bleeding events after using 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.

The choice of a lawyer is an important decision and should not be based solely on advertisements. The cases discussed do not predict outcomes in future cases. Past results afford no guarantee of future results and every case is different and must be judged on its own merits.

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