Judge Denies Pradaxa Makers Request to Hide Fraud

Patients who were allegedly hurt by the blood thinner Pradaxa scored a victory recently when a judge refused the manufacturers request to hide documents on previous allegations of fraud. Boehringer Ingelheim Pharmaceuticals, Inc., the maker of Pradaxa (Dabigatran), is being sued by more than 150 people in southern Illinois federal court. The patients and their families allege that Boehringer failed to warn them about the risk of unstoppable internal bleeding from Pradaxa. The January 18 court order denied Boehringers request to hide internal documents about illegal marketing and kickbacks for other drugs.

Eight years ago, a former Boehringer employee filed a whistleblower lawsuit alleging the company paid kickbacks to doctors for prescribing four of its drugs, and also made unwarranted, exaggerated and off-label claims about the drugs efficacy. While the whistleblower case was settled in October of 2012, the plaintiffs in the litigation over Pradaxa sought information about the case as part of an evaluation of Boehringers marketing practices. The judges decision orders Boehringer to turn over most of that information.

Boehringer is currently defending its blockbuster blood thinner Pradaxa in an MDL being handled by U.S. Chief Judge David Herdon. Pradaxa was once thought to be a better option than older blood thinners like Coumadin (warfarin), whose dosage must be carefully monitored. Coumadin also interacts with many common medicines and foods, which can require further dosage adjustments. As a result, patients must take inconvenient weekly blood tests and restrict their diets.

Pradaxa was touted to be the first in a new wave of blood thinners which do not require careful monitoring or dietary changes; however, Pradaxa has prompted concerns from doctors and patients alike that the drugs risks may outweigh its benefits. Pradaxa levels cannot be adequately monitored with blood testing, which is particularly worrisome for kidney patients who may have trouble filtering the drug out of their systems. An overdose of the drug can increase the patients risk for internal bleeding. To make matters worse, Pradaxa does not have an antidoteunlike older blood thinners like Coumadin. That means that when Pradaxa patients develop serious bleeding, theres almost no way to stop it.

The plaintiffs in the Illinois multi-district litigation (MDL) allege that they lost a loved one or suffered serious health problems because of uncontrolled bleeding they attribute to taking Pradaxa. In some cases, the patients did not present symptoms of internal bleeding immediately. In fact, theres some evidence that Pradaxa may cause bleeding in the stomach and intestines, particularly in patients over 75, because it contains an ingredient that may impair digestion.

The patients and families suing over Pradaxa allege Boehringer knew, or should have known, that the drug carried serious safety risks. According to the Philadelphia Inquirer, Pradaxa generated the most FDA reports of death or serious injury of any drug in 2011, with 542 deaths reported that year alone. The bleed-out reports have also caused drug regulators in other countries to require severe patient warnings. Patients who survived Pradaxa bleeding episodes and went on to file lawsuits often allege life-threatening internal bleeding events for which doctors had no effective means to treat.

The MDL over Pradaxa now includes more than 150 plaintiffs, and many more cases are pending in state courts. But if the FDA reports are any indication, hundreds of Americans suffer serious injuries from taking Pradaxa every year. Thats especially disturbing because Pradaxa is prescribed as a preventive measuremeaning that otherwise healthy people can suffer life-threatening harm from a side effect about which they were not properly warned. When drug manufacturers like Boehringer fail to warn patients about a serious health risk, they can and should be held legally liable for these injuries.

Author Bio:

Austin Tighe is a partner with Feazell & Tighe. Mr. Tighe is co-lead counsel in several consumer class action suits and focuses his practice on class actions, business and antitrust litigation, and personal injury matters.