The blood-thinning drug Brilinta has been linked to serious adverse events, including severe bleeding, heart attack, stroke, and death. A federal lawsuit alleges that clinical trial data was manipulated to downplay these risks.
Need a Texas Brilinta Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by severe side effects, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Brilinta Lawsuit Accuses AstraZeneca of Manipulating Study
Brilinta is a blood-thinning drug that was approved by the FDA in July 2011 for patients with acute coronary syndrome or a history of heart attacks. The manufacturer, AstraZeneca, gained approval based on the PLATO trial, an 18,000-patient study that found Brilinta patients had a lower risk of heart attacks, stroke, and death than patients on Plavix.
In February 2014, the Wall Street Journal reported that a federal lawsuit had been filed against AstraZeneca by Dr. Victor Serebruany, a medical professor at Johns Hopkins Hospital who said study data may have been manipulated.
In an FDA Medical Review, investigators found that 46% of the patients who had good outcomes on Brilinta came from just two countries — Poland and Hungary — which had more than double the number of patients from the United States and Canada combined.
In the part of the study based in the United States, results were opposite — patients on Brilinta had a 27% increased risk of heart attack, stroke, and vascular death.
However, the FDA blamed the increase on high-dose aspirin used by some patients on Brilinta, which may have interfered with how it worked. The label on Brilinta now carries a “Boxed Warning” that aspirin doses above 100-mg reduce the effectiveness of Brillinta and should be avoided.
Dr. Serebruany also alleged that serious adverse events were not reported to the FDA, which may have skewed data was in favor of Brilinta. For example:
“An estimated 23 definite or possible cardiovascular events or deaths on [Brilinta] were either not submitted for adjudication, inactivated, deleted or were downgraded to “softer” endpoints (this was not shown in the FDA review).”
In response to the lawsuit, the U.S. Department of Justice opened an investigation in October 2013. Just nine months later, the inquiry closed and AstraZeneca did not add warnings to the label.
What is the problem?
The Clark Firm, LLP is nationally recognized as a class action law firm, but our attorneys are not filing a Brilinta class action. Instead, we are filing individual lawsuits on behalf of people who were injured by bleeding or severe cardiovascular side effects.
About Class Actions
Class actions are designed to maximize efficiency when a large group of people have similar legal claims against the same defendant. Lawyers select a “class representative” and use that case to argue for compensation on behalf of everyone who joins the class action.
Why Our Law Firm is Filing Individual Lawsuits as Opposed to a Class Action
Any compensation awarded in a class action must be shared equally, after lawyers take a percentage. However, sometimes members have to accept “low-ball” settlements or higher attorneys’ fees that don’t leave much remaining.
Instead of a class action, our attorneys are filing individual lawsuits for people who were injured by defective medications. We specialize in holding pharmaceutical companies accountable for failing to warn about side effects. If you were injured by Brilinta, you may be eligible for compensation.
Need a Brilinta Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Brilinta lawyers for a free lawsuit review.