Seroquel Lawsuits

Background information on Seroquel Lawsuits, settlements and litigation updates published between 2008 to 2013.

Seroquel Lawsuit Overview

Seroquel litigation centered on allegations that AstraZeneca failed to warn patients and healthcare providers about serious metabolic side effects associated with its blockbuster antipsychotic drug.

Originally approved to treat schizophrenia and bipolar disorder, Seroquel was later prescribed to millions of adults and children for off-label uses such as insomnia and anxiety. Over time, mounting evidence linked the medication to rapid weight gain, hyperglycemia, and type 2 diabetes, leading to widespread concern among regulators and medical professionals.

As adverse event reports and internal company documents surfaced, lawsuits were filed nationwide claiming AstraZeneca had concealed data showing that Seroquel could cause dangerous blood sugar spikes and other health complications. These cases were centralized in multidistrict litigation (MDL No. 1769) in the U.S. District Court for the Middle District of Florida, allowing coordinated discovery and pretrial proceedings.

Facing thousands of claims, AstraZeneca ultimately agreed to settlements resolving most of the lawsuits, paying roughly $600 million to more than 28,000 plaintiffs. The litigation became one of the largest pharmaceutical mass torts of its time, drawing attention to the marketing of atypical antipsychotics and their underreported risks of diabetes and metabolic disorders.

Seroquel Litigation Updates

February 26, 2008: Court Denies AstraZeneca’s Motion to Seal Seroquel Documents

A federal judge rejected AstraZeneca’s attempt to seal internal company documents related to Seroquel, ruling that the public had a right to access evidence concerning the drug’s safety and marketing practices. The decision allowed previously confidential materials to become part of the public record, increasing scrutiny of the antipsychotic’s link to diabetes.

April 14, 2008: Seroquel Litigation: 8,787 Lawsuits Filed Against AstraZeneca

By spring 2008, court filings revealed that nearly 8,800 product liability lawsuits had been filed against AstraZeneca over Seroquel side effects. Plaintiffs alleged that the company failed to warn about risks of weight gain and diabetes, while aggressively promoting the drug for off-label uses. The volume of claims underscored the scale of the litigation before the first trials even began.

June 4, 2008: Seroquel Problems Mount as First Trial Approaches

As the first Seroquel lawsuit neared trial, reports surfaced of thousands of claims alleging the drug caused users to develop diabetes and weight gain. Plaintiffs accused AstraZeneca of concealing risks and aggressively promoting the medication for unapproved uses, setting the stage for one of the largest pharmaceutical litigations of the decade.

June 10, 2009: Seroquel Diabetes Suit to Begin June 29

The first federal bellwether trial for Seroquel lawsuits was scheduled to begin at the end of June. The case was expected to test whether AstraZeneca could be held liable for failing to warn about diabetes risks associated with its blockbuster antipsychotic. Both sides prepared to present years of medical data and company research before the jury.

October 16, 2009: Seroquel Lawsuit Uncovers Efforts to Promote Drug for Off-Label Use

Discovery in ongoing litigation revealed AstraZeneca’s internal communications indicating plans to market Seroquel for unapproved psychiatric conditions. Plaintiffs alleged that the company’s off-label promotion led to widespread prescribing among patients who were not adequately warned about metabolic side effects. The revelations fueled public criticism and regulatory interest.

November 16, 2009: Delaware Judge Dismisses Seroquel Lawsuit

A Delaware state judge dismissed one of the Seroquel lawsuits, ruling that the plaintiff failed to establish causation between the medication and the alleged diabetes injury. The decision represented an early legal victory for AstraZeneca, though thousands of similar claims remained active in both state and federal courts.

June 17, 2010: AstraZeneca Seroquel Defense Costs Exceed $593 Million

Financial disclosures showed that AstraZeneca had spent nearly $600 million defending Seroquel-related litigation, including attorney fees and settlements. The mounting costs highlighted the scale of the legal battle as the company continued to deny wrongdoing and defend its marketing practices.

December 4, 2010: Generic Seroquel Blocked by U.S. Appeals Court

A federal appeals court upheld AstraZeneca’s patent rights, delaying the release of generic versions of Seroquel. The ruling preserved the company’s market exclusivity and revenue stream amid ongoing legal and regulatory pressures tied to the drug’s safety record.

April 27, 2010: Seroquel Settlement Reached with Federal Prosecutors

AstraZeneca agreed to pay $520 million to settle federal charges that it illegally promoted Seroquel for unapproved uses. The U.S. Department of Justice accused the company of misleading physicians about safety data and marketing the drug for conditions outside FDA approval. The settlement resolved one of the largest off-label marketing cases in history.

June 7, 2010: Seroquel Settlement Talks Ordered

The federal court overseeing Seroquel multidistrict litigation ordered both parties to enter mediation. The move was intended to explore potential global settlement options and reduce the massive backlog of individual diabetes injury claims. Negotiations began as trial preparations continued in parallel.

October 27, 2010: Two Seroquel Lawsuits in Delaware Dismissed

A Delaware judge dismissed two additional lawsuits, citing insufficient evidence that the drug directly caused plaintiffs’ diabetes. The rulings followed a trend of mixed outcomes in state and federal cases, reflecting challenges plaintiffs faced in proving causation.

January 31, 2011: AstraZeneca Reports Growing Seroquel Legal Costs

Company filings revealed that AstraZeneca’s cumulative Seroquel litigation expenses continued to climb, even as some settlements were reached. Analysts noted that the ongoing legal costs were eroding profits and casting uncertainty over future liability exposure.

May 24, 2011: Seroquel Diabetes Trial Under Way

One of the remaining bellwether trials began in federal court, where plaintiffs argued that AstraZeneca ignored early warning signs linking Seroquel to diabetes. The case tested whether jurors would accept internal company documents as evidence of negligence in risk communication.

July 13, 2011: AstraZeneca Wins First Seroquel Diabetes Lawsuit at Trial

A jury sided with AstraZeneca in the first diabetes-related Seroquel trial, finding that the company had adequately warned prescribers about potential side effects. The verdict represented a key defense win that influenced future settlement negotiations across the MDL.

October 22, 2011: Dismissal of Seroquel Diabetes Lawsuit Upheld on Appeal

A federal appeals court affirmed the dismissal of a Seroquel diabetes claim, reinforcing the defense’s argument that plaintiffs could not conclusively prove causation. The decision further limited the scope of viable pending lawsuits nationwide.

April 27, 2010: Settlement Over Seroquel Marketing Reached with U.S. Department of Justice

AstraZeneca formally finalized its $520 million agreement with federal prosecutors, resolving allegations that the company misled doctors and marketed Seroquel off-label for conditions like dementia and anxiety. The settlement also required compliance monitoring to prevent future violations.

May 5, 2011: Remand of Seroquel Lawsuits Requested

Plaintiffs’ attorneys asked the MDL panel to remand certain resolved or inactive Seroquel cases back to their home districts. The request aimed to expedite dismissals and settlements while preserving judicial resources. The motion came amid growing signs that the litigation was entering its final stages.

October 21, 2011: Thousands of Seroquel Lawsuits Should Be Remanded, Plaintiffs Argue

Lawyers representing plaintiffs urged the MDL judge to remand more than 10,000 remaining Seroquel cases to local courts for trial or closure. They contended that coordinated pretrial proceedings had been completed and centralized oversight was no longer necessary.

March 18, 2010: Settlement for Seroquel Lawsuits Reached in Some Cases

Reports indicated that AstraZeneca had reached partial settlements in certain Seroquel diabetes claims. The agreements covered plaintiffs with the strongest medical evidence of injury, suggesting that the company sought to limit exposure while continuing to contest weaker cases.

April 8, 2010: Seroquel Settlements Reached in Diabetes Lawsuits

Further progress was made toward resolution when AstraZeneca agreed to additional confidential settlements involving plaintiffs who developed diabetes after taking Seroquel. The developments suggested a broader settlement framework was taking shape behind the scenes.

September 29, 2010: 17,500 Seroquel Lawsuits Settled

AstraZeneca announced that it had resolved approximately 17,500 Seroquel claims through settlements totaling nearly $700 million. The resolution represented a major step toward ending the decade-long litigation and reducing pending caseloads in federal and state courts.

November 5, 2010: Seroquel Remand Vacated by Appeals Court

A federal appellate court vacated an earlier remand order in the Seroquel MDL, finding procedural errors in how certain cases were transferred back to state courts. The ruling temporarily slowed the final stages of litigation but did not affect ongoing settlement discussions.

July 29, 2011: AstraZeneca Reaches $68.5 Million Seroquel Settlement with States

AstraZeneca agreed to pay $68.5 million to resolve claims by 38 state attorneys general alleging deceptive marketing of Seroquel. The settlement closed out years of investigation into the company’s promotional tactics and required future compliance measures.

February 23, 2012: Nearly All Seroquel Lawsuits Settled Nationwide

By early 2012, AstraZeneca had resolved nearly all remaining Seroquel lawsuits through settlements, dismissals, or trial outcomes. The conclusion of the litigation ended one of the largest pharmaceutical mass torts of the 2000s, following billions in combined legal costs and penalties.

Seroquel Research and Reports

July 14, 2008: Zyprexa and Seroquel Side Effects Linked to Heart Disease

Medical researchers reported that users of antipsychotic medications like Seroquel and Zyprexa faced a higher risk of heart disease and sudden cardiac death. The findings raised renewed concerns about metabolic side effects such as obesity and elevated blood sugar, which were already associated with these drugs. Health experts urged closer monitoring for patients with cardiovascular risk factors.

October 30, 2008: FDA Requests Information on Once-Daily Seroquel Formulation

The U.S. Food and Drug Administration requested additional data from AstraZeneca regarding its application to market a once-daily version of Seroquel XR. Regulators sought clarification on safety concerns, particularly the drug’s potential to cause weight gain, diabetes, and cardiac complications. The request delayed approval as the agency continued to review post-marketing data.

December 2, 2008: Side Effects of Seroquel and Zyprexa Linked to Heart-Related Deaths

A new analysis found that atypical antipsychotics such as Seroquel and Zyprexa significantly increased the risk of fatal heart conditions, particularly among elderly patients. The study contributed to growing evidence that these medications posed serious cardiovascular dangers, prompting calls for stricter warning labels.

January 20, 2009: Seroquel Diabetes Side Effects Increase Risk by 389 Percent

Data published in a peer-reviewed medical journal indicated that patients using Seroquel had nearly four times the risk of developing type 2 diabetes compared to those on older antipsychotic drugs. Researchers cited metabolic disruptions and insulin resistance as key contributing factors. The findings further validated thousands of legal claims already pending against AstraZeneca.

February 10, 2009: Seroquel Diabetes Problems Kept from Doctors, Report Finds

An internal analysis revealed that AstraZeneca had known of elevated diabetes risks associated with Seroquel for years but failed to disclose the full extent to physicians. The report alleged that selective publication of study data minimized awareness of serious side effects. Medical experts criticized the lack of transparency and urged stronger regulatory oversight.

March 30, 2009: Seroquel Side Effects Lead to FDA Concerns

The FDA issued new warnings after receiving hundreds of adverse event reports linking Seroquel to diabetes and severe weight gain. Regulators cautioned prescribers to monitor blood sugar and lipid levels in patients taking the drug. The announcement intensified scrutiny of AstraZeneca’s marketing practices and post-approval safety monitoring.

July 14, 2009: Side Effects of Seroquel and Zyprexa for Children Under Review

Federal health officials launched an investigation into the use of Seroquel and Zyprexa among children and adolescents, following reports of dramatic weight gain and metabolic issues. Pediatric psychiatrists warned that the drugs were often prescribed off-label without adequate safety data. The review sought to determine whether additional restrictions were warranted.

September 15, 2009: Generic Schizophrenia Drug Carries Lower Death Risk Than Seroquel

A large-scale study comparing antipsychotic medications found that older generic drugs were linked to lower mortality rates than newer brand-name treatments like Seroquel. Researchers attributed the difference to metabolic complications and cardiac side effects associated with atypical antipsychotics. The findings reignited debate over the safety advantages of modern formulations.

February 2, 2010: Seroquel Diabetes Side Effects Data Withheld from U.S. Doctors

Documents obtained during litigation revealed that AstraZeneca shared more complete data about Seroquel’s diabetes risks with European regulators than with U.S. physicians. The disparity raised questions about whether the company selectively disclosed safety information to maintain sales in its largest market. The revelations fueled public criticism and legal scrutiny.

March 5, 2010: Seroquel Weight Gain Problems Hidden from Doctors

Medical experts accused AstraZeneca of downplaying Seroquel’s link to significant weight gain, citing internal correspondence indicating that unfavorable trial results were suppressed. The allegations reinforced claims that the company prioritized marketing over patient safety. Consumer advocates called for tougher penalties for selective disclosure of study data.

May 25, 2010: Zyprexa and Seroquel in Children Cause Dramatic Weight Gain, Studies Find

Clinical research confirmed that children and adolescents taking Seroquel or Zyprexa experienced extreme weight gain and metabolic disturbances within months of treatment. Pediatric specialists warned that the side effects could lead to lifelong health problems, including diabetes and heart disease. The studies prompted demands for stricter prescribing guidelines for minors.

June 22, 2010: Antipsychotics for Dementia Blamed for Deaths in Elderly Patients

Researchers linked Seroquel and other antipsychotic medications to thousands of premature deaths among elderly dementia patients. The findings intensified calls for black box warnings against off-label use in this population. Regulators later emphasized that the drugs were not approved for behavioral management in dementia care.

August 5, 2010: Zyprexa and Seroquel Side Effects in Children Require Urgent Review

A joint medical advisory committee urged further review of Seroquel and Zyprexa use among young patients, citing ongoing reports of rapid weight gain and hormonal imbalance. The panel recommended expanded post-marketing surveillance and better education for prescribers on metabolic monitoring protocols.

October 21, 2010: Seroquel Weight Gain Side Effects Suppressed in Company Research

Investigators uncovered evidence that AstraZeneca altered internal reports to understate Seroquel’s impact on weight gain. The suppressed findings showed significant metabolic disruption even at standard doses. The controversy deepened skepticism toward the company’s credibility and raised questions about pharmaceutical data transparency.

June 10, 2011: Ethics Violation Found Over Seroquel Weight Gain Statements

A review board concluded that AstraZeneca violated ethical standards by making misleading statements about Seroquel’s weight-related risks in marketing materials. The inquiry found that company representatives downplayed adverse data when communicating with healthcare providers. The ruling added to growing criticism of industry influence over medical information.

September 22, 2011: Suicide Risk Spurs Bill Limiting Seroquel Prescriptions in Military

A congressional report prompted legislation to restrict the use of Seroquel among U.S. military personnel after data suggested a link between the drug and increased suicide risk. Lawmakers called for comprehensive review of prescription practices within the Department of Defense. The measure highlighted concerns about psychiatric drug safety among active-duty service members.

November 18, 2011: Seroquel Approved for Depression in Europe

European regulators granted AstraZeneca approval to market Seroquel XR for major depressive disorder, expanding its use beyond schizophrenia and bipolar disorder. The decision came despite ongoing litigation and safety controversies in the United States. Critics warned that the expanded indication could expose more patients to serious side effects.

January 6, 2012: Study Finds Antipsychotic Drugs Increase Risk of Blood Clots

A population-based study published in BMJ found that users of antipsychotics such as Seroquel faced a significantly higher risk of developing venous thromboembolism. Researchers urged clinicians to weigh cardiovascular and clotting risks before prescribing. The findings added another layer of concern to the drug’s evolving safety profile.

July 17, 2013: Seroquel Heart Side Effects Warning Issued

Health officials issued updated warnings about the potential for Seroquel to cause irregular heartbeat and sudden cardiac death. The FDA recommended that physicians monitor cardiac function in patients with existing heart disease or electrolyte imbalances. The announcement marked one of the most serious safety advisories since the drug’s introduction.