Report: FDA’s Pradaxa Drug Approval Process Substandard

A Kentucky Pradaxa attorney notes a report claiming the FDA overlooked many red flags during the Pradaxa approval process. Lawsuits allege that the blood thinning medication has led to serious side effects, including uncontrollable and often fatal bleeding. Affected patients may be eligible to seek compensation by filing a Kentucky Pradaxa lawsuit.

For more information, contact Attorney Group for Kentucky today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated Kentucky Pradaxa attorney who can assist you throughout the legal process.

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Report Follows $650 Million Pradaxa Lawsuits Settlement

The Project on Government Oversight’s (POGO) investigation into the approval process for the popular blood-thinning medication Pradaxa is raising significant concerns about whether today’s prescription drugs are properly regulated at the federal level. Among the red flags raised by the study, according to The Washington Post, is the fact that members of the U.S. Food and Drug Administration’s (FDA) drug review and approval committee had alleged vested interests in the pharmaceutical industry. Additionally, the agency approved the drug on the basis of one clinical trial and without a known antidote in existence to counteract possible uncontrollable bleeding.

Representatives for POGO believe the FDA overlooked these and other red flags as it worked to accommodate Pradaxa’s manufacturer, Boehringer Ingelheim, at the expense of American patients. While POGO’s claims are among the more recent concerns voiced publicly about Pradaxa, they aren’t the first. In 2014, Boehringer Ingelheim settled roughly 4,000 lawsuits claiming the company allegedly failed to properly disclose information about bleeding risks to the tune of more than $650 million, the news site reported.

How a Kentucky Pradaxa Attorney Can Help

Drug manufacturers have a duty to ensure their products are accompanied by full and accurate instructions and warnings to guide prescribing doctors and other health care providers in making treatment decisions. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

Patients who are injured by Pradaxa may be entitled to compensation for damages, including:

  • Medical expenses
  • The permanency of the injury
  • Pain, suffering, and mental anguish
  • Loss of income or ability to work

If a patient dies from complications after taking Pradaxa, family members may be entitled to compensation for the wrongful death of their loved one, including:

  • Conscious pain and suffering of a loved one prior to death
  • Pain, suffering, and mental anguish from the loss of a loved one
  • Funeral expenses

Patients who have suffered severe side effects after taking Pradaxa, as well as the families of those who have died as a result of complications with the drug, are encouraged to seek the advice of a Kentucky Pradaxa attorney to learn more about their rights and remedies.

The Time You Have to Pursue a Claim is Limited. Contact Us Today.

For more information, contact Attorney Group for Kentucky. You can fill out the form on this page, call us at the number listed at the top of the page, or email us at

When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.

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