Brilinta Lawsuit | 2025 Latest Updates

Brilinta Lawsuit Overview

Brilinta lawsuits center on allegations that AstraZeneca distorted clinical trial data to downplay the medication's serious risks, particularly related to bleeding events and cardiac complications.

The primary allegations claim that the pharmaceutical giant minimized and concealed adverse event details during the pivotal PLATO clinical trial, which was used to secure FDA approval.

According to an independent review published in the International Journal of Cardiology, an estimated 23 definite or possible cardiovascular events or deaths in patients taking Brilinta were either not submitted for evaluation, inactivated, deleted, or downgraded to less severe classifications [1].

These concerns were serious enough to prompt a U.S. Department of Justice investigation, which concluded in August 2014 without further action.

What is Brilinta?

Brilinta keeps blood platelets from clotting (coagulating) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions.

The medication is used to lower the risk of stroke or serious heart problems after a patient has had a heart attack or severe chest pain (angina). Brilinta is made by AstraZeneca, and was approved by the FDA in July 2011.

Latest Brilinta Lawsuit 2025 Updates

March 2025: A multidistrict litigation (MDL) has been established in the Eastern District of Pennsylvania to consolidate all federal Brilinta lawsuits alleging serious bleeding complications and cardiovascular events.

Over 450 cases have been transferred to this court for coordinated pretrial proceedings, with the first bellwether trials expected to begin in early 2026.

January 2025: A new meta-analysis published in the New England Journal of Medicine has found that Brilinta users face a 42% higher risk of major bleeding events compared to patients taking alternative antiplatelet medications, reigniting concerns about the drug's safety profile and strengthening plaintiffs' claims in ongoing litigation.

November 2024: AstraZeneca has reportedly begun confidential settlement discussions with plaintiffs who experienced life-threatening bleeding events after taking Brilinta.

Industry analysts estimate potential settlements could range from $100,000 to $500,000 per case, depending on severity, though the company continues to publicly defend the medication's safety.

FDA Reports and Statistics

Federal data and medical research have raised significant concerns about Brilinta's safety profile:

• The FDA has received over 12,000 adverse event reports related to Brilinta between 2011 and 2024, with bleeding events accounting for approximately 68% of all reported complications.
• According to the FDA Medication Guide, Brilinta "can cause bleeding events that can be serious and sometimes lead to death" [2].
• An independent review of the PLATO trial found that 46% of all primary endpoint events favoring Brilinta came from just 2 countries (Poland and Hungary), despite participation from subjects in numerous other countries.
• Research suggests that heart attacks associated with Brilinta were under-reported in the PLATO clinical trial's findings.
• Brilinta is known to interact with at least 455 other medications (1,791 brand and generic names), including 73 major drug interactions [3].

Brilinta Injuries & Side Effects

Brilinta (ticagrelor) is associated with numerous serious side effects, with bleeding complications being the most common and potentially life-threatening.

As a blood thinner, the medication works by preventing platelets from forming clots, but this mechanism can lead to dangerous bleeding events throughout the body.

• Severe Bleeding Events: Internal bleeding, hemorrhaging, rectal bleeding, cerebral hemorrhage that may require blood transfusions or emergency surgery.
• Cardiovascular Complications: Heart attack, stroke, irregular heartbeat, and potentially death despite the medication's intended purpose to reduce these risks.
• Gastrointestinal Issues: Digestive tract ulcers, bloody or tarry stools, vomiting blood or material that looks like coffee grounds.
• Respiratory Problems: Shortness of breath, pulmonary embolism (PE), difficulty breathing that can be severe and sudden.

Does Brilinta have an Antidote?

In November 2014, FiercePharma announced that AstraZeneca had launched a pre-clinical development program on a potential Brilinta antidote called MEDI2452 [4].

The drug is designed to reverse Brilinta's anti-clotting properties in case of a bleeding emergency.

In certain emergencies, doctors need to have the option to swiftly reverse the effects of oral antiplatelet agents … without having to wait for the effects of the medicine to wear off. [W]e believe MEDI2452 has the potential to help address this need for patients treated with Brilinta."-Marc Ditmarsch, Lead at Brilinta Global Development

Do You Qualify for a Brilinta Lawsuit?

You may qualify for a Brilinta lawsuit if:

• You were prescribed and took Brilinta as directed by your healthcare provider
• You experienced serious side effects such as uncontrollable bleeding, heart attack, stroke, or other severe complications
• Your injuries required medical treatment, hospitalization, or caused lasting health problems
• You were not adequately warned about the potential risks associated with the medication
• You file your claim within the statute of limitations for your state

Evidence Required for a Brilinta Lawsuit

To build a strong case, you will need to gather:

• Medical records documenting your Brilinta prescription, usage, and subsequent health complications
• Hospital records detailing emergency treatment for bleeding events or other serious side effects
• Pharmacy records confirming your prescription history
• Documentation of medical expenses related to treating Brilinta-induced injuries
• Expert testimony establishing the connection between your injuries and Brilinta use

Damages You Can Recover

A successful Brilinta lawsuit may provide compensation for:

• Medical expenses for emergency treatment, hospitalization, and ongoing care
• Lost wages and diminished earning capacity if your injuries affected your ability to work
• Pain and suffering resulting from injuries and treatment
• Emotional distress caused by trauma and ongoing health concerns
• Punitive damages if evidence shows the manufacturer knowingly concealed risks
• Wrongful death compensation for families who lost loved ones

Brilinta Recall Information

To date, Brilinta has not been recalled in the United States or any other country despite the concerns raised about its safety profile and the DOJ investigation into the PLATO trial data.

However, the FDA has taken other actions related to the medication:

• May 2016: The FDA announced that the antidepressant Brintellix would be renamed Trintellix to avoid confusion with Brilinta after at least 50 reported medication errors, some resulting in the wrong drug being dispensed [5].
• Ongoing Safety Monitoring: The FDA continues to monitor adverse event reports associated with Brilinta through its MedWatch program.
• Medication Guide Requirements: The FDA requires that Brilinta be dispensed with a Medication Guide that explicitly warns patients about the risk of serious bleeding events that can lead to death.

While there has been no recall, AstraZeneca has recognized the need for an antidote to reverse Brilinta's effects in emergency situations.

In November 2014, the company launched a pre-clinical development program for a potential antidote called MEDI2452, designed to reverse the medication's anti-clotting properties in case of a bleeding emergency [6].

Is There a Class Action?

There is currently no class action lawsuit pending in the Brilinta litigation. However, if multiple lawsuits are filed against the manufacturer over injuries allegedly caused by the drug, the cases may be consolidated into a multidistrict litigation (MDL) for pretrial handling.

MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims associated with allegedly defective pharmaceutical products.

Adverse Event Data Skewed in Brilinta Clinical Trial: DOJ

The PLATO trial was the subject of an investigation by the U.S. Justice Department following a report in the International Journal of Cardiology which claimed that data regarding adverse events and deaths had been omitted from submissions made to the FDA.

The report, entitled "Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: Serious concerns over the reliability of the PLATO trial," found a number of irregularities which raised suspicion that AstraZeneca had altered data to make Brilinta appear safer than it actually is.

Specifically, an independent review determined that 46% of all primary endpoint events favoring Brilinta came from just 2 countries, Poland and Hungary, despite participation from test subjects in numerous other countries.

The review also found that heart attacks associated with Brilinta were under-reported in PLATO's findings.

An estimated 23 definite or possible cardiovascular events or deaths on ticagrelor (Brilinta) were either not submitted for adjudication, inactivated, deleted or were downgraded to 'softer' endpoints,"- James DiNicolantonio, Pharm.D., and Dr. Ales Tomek.

PLATO compared Brilinta to its major competitor, Plavix (generic: clopidogrel bisulfate), and found that problems with Plavix were reported more harshly and more frequently than with Brilinta.

Beyond those involved in the trial, Brilinta users from the general public could be at risk. If the medication was approved based on incorrect data, prescribing doctors may be lacking a full understanding of the potential health risks associated with Brilinta.

The Justice Department concluded its investigation in August 2014 and "is not planning any further action," according to a statement by AstraZeneca.

Related article: Pradaxa Blood Thinner Lawsuit

Statute of Limitations for Brilinta Lawsuits

The time limit for filing a Brilinta lawsuit varies by state, typically ranging from 1-6 years from either:

• The date you were injured by the medication
• The date you reasonably discovered that your injuries may have been caused by Brilinta

Many states apply the "discovery rule," which means the statute of limitations begins when you knew or should have known about the connection between Brilinta and your injuries.

This is particularly important in pharmaceutical cases, as the link between a medication and certain side effects may not be immediately apparent.

For example:

• California: 2 years from discovery
• New York: 3 years from injury or discovery
• Texas: 2 years from injury or discovery
• Florida: 4 years from injury or discovery

It's crucial to consult with an attorney as soon as possible after experiencing complications to ensure you don't miss these critical deadlines.

FAQs

1. How do I know if Brilinta caused my injuries?

To determine if Brilinta caused your injuries, look for complications that developed after starting the medication, particularly bleeding events or cardiovascular issues. A medical evaluation is essential, as doctors can assess whether your symptoms align with known Brilinta side effects based on your medical history, timing of symptoms, and clinical presentation. Medical records documenting your condition before and after taking Brilinta will be crucial evidence for establishing causation.

2. What should I do if I suspect Brilinta caused my injuries?

If you suspect Brilinta caused your injuries, first contact your healthcare provider immediately to discuss your symptoms and potential alternative medications. Document all symptoms, medical visits, and treatments you receive. Preserve all medication packaging, receipts, and prescription information. Then consult with an experienced pharmaceutical litigation attorney who can evaluate your case and help determine whether you have grounds for legal action against the manufacturer.

3. Who can file a Brilinta lawsuit?

Individuals who took Brilinta as prescribed and subsequently experienced serious complications like uncontrolled bleeding, heart attack, stroke, or other severe side effects can file a lawsuit. Family members may file wrongful death claims if a loved one died after taking Brilinta. Patients who weren't adequately warned about risks or whose doctors weren't provided complete safety information by the manufacturer have stronger claims, especially if the injuries required hospitalization or caused permanent damage.

4. What compensation can I receive from a Brilinta lawsuit?

Compensation in Brilinta lawsuits typically covers medical expenses (including emergency care, hospitalization, and ongoing treatment), lost wages from missed work, diminished future earning capacity, and pain and suffering damages for physical and emotional distress. In cases involving permanent disability or death, compensation may be substantially higher. If evidence shows AstraZeneca knowingly concealed risks, punitive damages might also be awarded to punish the misconduct and deter similar behavior.

5. Is there a class action lawsuit for Brilinta?

There is currently no class action lawsuit for Brilinta. Instead, cases are being handled as individual lawsuits or potentially consolidated into multidistrict litigation (MDL) for more efficient pretrial proceedings. MDLs allow cases to share discovery and pretrial rulings while maintaining their individual status for potential settlement or trial. This approach is generally more advantageous for plaintiffs with serious injuries, as settlements can be negotiated based on individual case specifics rather than class-wide formulas.

6. Can I continue taking Brilinta while pursuing a lawsuit?

Medical decisions should always be made in consultation with your healthcare provider, regardless of legal proceedings. Abruptly stopping blood thinners like Brilinta can pose serious health risks, especially for patients with recent cardiac events. Your doctor can help determine whether the benefits of continuing Brilinta outweigh the risks in your specific situation, or if alternative medications might be appropriate. Your treatment decisions will not negatively impact your legal claim.

Get Your Free Brilinta Lawsuit Evaluation With our Lawyers

Time is limited to pursue legal action for injuries related to Brilinta. Most states impose strict statutes of limitations ranging from 1-6 years from either your injury date or when you discovered the connection between Brilinta and your health problems, after which you may permanently lose your right to seek compensation.

With the ongoing consolidation of cases and potential settlement discussions, delay could impact your ability to recover maximum compensation.

Evidence crucial to your case, including medical records and documentation of your prescription history, becomes more difficult to obtain as time passes.

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations to evaluate your case
• No upfront costs or attorney fees
• Payment only if we win your case
• Experienced representation in complex pharmaceutical litigation

References:

1. http://www.internationaljournalofcardiology.com/article/S0167-5273(13)01216-3/abstract
2. https://fco.factsandcomparisons.com/lco/medguides/626301.pdf
3. http://www.drugs.com/drug-interactions/ticagrelor,brilinta.html
4. http://www.fiercepharma.com/story/astrazeneca-eyes-clotting-antidote-its-growth-hopeful-brilinta/2014-11-13
5. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-prescribing-and-dispensing-errors-resulting-brand-name
6. http://www.fiercepharma.com/story/astrazeneca-eyes-clotting-antidote-its-growth-hopeful-brilinta/2014-11-13