Report: Pradaxa Manufacturer Failed to Report Fatal Bleeding Risks

Posted by in

Drug manufacturer Boehringer Ingelheim – a company that has faced a flood of product liability lawsuits in recent years – may have deliberately failed to report that its popular blood thinner, Pradaxa, had the potential to cause serious and possibly fatal bleeds, according to a recent article in Tech Times.

As the news outlet reports, a study published in BMJ (formerly British Medical Journal) suggests that Boehringer Ingelheim marketed the drug – also called dabigatran – as one that requires less blood plasma monitoring than older blood thinners such as Coumadin. Pradaxa is widely used to reduce the risk of strokes for patients with atrial fibrillation, a heart condition.

Canadian researchers analyzed the company’s data to see whether more frequent testing could have reduced the number of adverse outcomes from Pradaxa, including extreme gastrointestinal bleeding and cerebral hemorrhages.

They found that up to 40 percent of all severe bleeds and patient deaths could have been prevented with better monitoring. Pradaxa is especially dangerous because there is no antidote if a complication occurs. By contrast, reactions to competing drug warfarin can be reduced with Vitamin K.

In a statement, Boehringer Ingelheim disputed the results, and maintained that Pradaxa had been developed and marketed responsibly.

Manufacturer Accused of ‘Failure to Warn’ Patients

In May, Boehringer Ingelheim agreed to pay $650 million to 4,000 patients and families to end state and federal litigation about adverse outcomes related to Pradaxa use. However, the company stood by the drug and said in a press release that it agreed to settle because it wanted to end the “distraction” and “uncertainty” of ongoing litigation.

Claims against Boehringer Ingelheim about Pradaxa fall under an area of law known as product liability. In these cases, an injured party files suit against a company, manufacturer, distributor or other entity with allegations that the party negligently designed, manufactured or marketed a dangerous or defective product. One of the more common product liability claims alleges that the manufacturer is liable due to its “failure to warn” consumers of known risks.  Many of the Pradaxa cases fall under the “failure to warn” heading.

Plaintiffs in Pradaxa cases often allege that the company:

  • Represented Pradaxa as a safer alternative to Coumadin (also called warfarin), which has been the go-to blood thinner for physicians for years
  • Erroneously marketed Pradaxa as a drug that needed less monitoring by doctors
  • Did not tell regulators that Pradaxa had the potential to cause serious bleeds.
  • Failed to warn consumers of the dangers associated with the medication
  • Did not provide information about treatment methods for a bad outcome
  • Failed to properly label the drug at certain periods.

Consumers have the basic right to believe that the drugs that they are prescribed are safe, and any known risks are duly communicated to healthcare providers so that information can be used in turn as providers evaluate and recommend various courses of treatment to their patients.

Even though there is no way to prevent an adverse outcome in every patient, a manufacturer who knowingly fails to warn approval agencies such as the U.S. Food and Drug Administration (FDA) of life-threatening dangers should be held accountable.

Leave a Reply

Your email address will not be published. Required fields are marked *