Pradaxa Makers Admit to Withholding Data From FDA

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Documents have come to light that suggest that the makers of Pradaxa suppressed some of the scientific data they collected when developing the drug and did not submit it to the U.S. Food and Drug Administration. The information will be presented as evidence in hundreds of Pradaxa lawsuits filed by patients who were severely injured, or by family members of patients who died, from Pradaxa bleeding events.

Pradaxa is an anticoagulant, a type of drug designed to weaken the body’s ability to form blood clots. In some serious medical emergencies, a blood clot can lodge in vital blood vessels, blocking the supply of oxygen. In these cases, anticoagulants can dissolve clots and prevent additional damage. However, all anticoagulants carry the risk of uncontrollable bleeding. When a drug weakens a patient’s ability to form clots, the patient can bleed to death from even a minor wound.

Older generation anticoagulants, like Warfarin, have reversal agents. This means that if uncontrollable bleeding began, doctors could administer a reversal agent that could effectively “turn off” the drug’s effects. However, as various drug patents expired, drug companies began losing money, since they had to compete with generic anticoagulants. This created a motivation to develop new anticoagulants. However, the newer anticoagulants, like Pradaxa lack reversal agents.

The litigation against Boehringer Ingelheim, the Pradaxa drug maker, has taken the form of multidistrict litigation. An MDL, also called a “Mass Tort,” are a type of group lawsuit, similar to a class action lawsuit. While both are group lawsuits, there are a few differences. Generally, a Pradaxa class action lawsuit is created as a single legal action that other members can join onto if they have the same injury.

Mass Torts typically start as individual personal injury lawsuits filed across various jurisdictions. A process exists to combine and coordinate these individual lawsuits into a single MDL.

Both a Pradaxa class action lawsuit and the Pradaxa MDL can help the legal system and the parties involved save resources. It allows the plaintiffs to pool their expertise and finances to achieve greater potential success, making it more manageable for both the court and the defendant.

In the course of the Pradaxa mass tort lawsuits, it has been revealed that the Boehringer withheld certain data from federal regulators. Specifically, while the drug maker provided the FDA with raw data on the rate of uncontrollable bleeding and other complications, they withheld statistical analysis results.

In science, data often requires analysis and expert interpretation to make sense of it. Epidemiological data—information related to the health of large numbers of people—is particularly complicated, and often requires expert analysis to be understood. It is alleged that by withholding their analysis, the company obscured the risks associated with this drug.

The Pradaxa MDL is formally titled Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, filed in the U.S. District Court for the Southern District of Illinois.

Join a Free Pradaxa Class Action Lawsuit

If you or a loved one suffered from an uncontrollable bleeding incident after using Pradaxa, you’ve almost certainly been through a trying ordeal. But you need to remember that you still have rights, and there are steps that you can take to regain control over your situation. Start by visiting the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. There, you can enter information about your situation for a legal review by a trained expert with a background in this type of litigation.