Seroquel Litigation May Cost AstraZeneca $1.2B in Legal Costs: Report

Litigation over Seroquel could cost AstraZeneca up to $1.2 billion in legal costs between thousands of plaintiffs’ failure-to-warn Seroquel lawsuits and government charges that the popular anti-psychotic drug was marketed illegally.

The ten-digit price tag for Seroquel litigation was estimated in a January 29 article in the Financial Times. The numbers include a $524 million settlement with the U.S. Attorney’s Office in Philadelphia over alleged off-label promotion of the drug, and the cost of battling about 10,000 Seroquel suits filed by 22,000 plaintiffs who claim that the drug maker failed to adequately warn users about potential side effects that may increase the risk of diabetes, weight gain, hyperglycemia and a rare movement disorder known as tardive dyskinesia.

To date, AstraZeneca has refused to settle Seroquel cases filed by individual users, indicating that they will defend all lawsuits. However, internal documents produced during the litigation suggest that the drug maker was aware of the potential weight-gain Seroquel side effects and continued to promote the drug as weight-neutral for years after clinical evidence demonstrated significant problems that could lead to diabetes and other injuries. The company has racked up $656 million in legal defense costs fighting the failure-to-warn lawsuits over Seroquel, but expects insurance to reimburse it for $521 million of that. However, with the cases are still being fought, the price tag will continue to climb.

All federal Seroquel lawsuits are consolidated for pretrial litigation in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida. In November, U.S. District Judge Anne Conway, who is presiding over the Seroquel MDL, ordered lawyers for both sides to met with a mediator to see if there is any possibility for a Seroquel settlement before as many as 6,000 cases are sent back to the districts where they were originally filed for trial.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism. Seroquel has been used by more than 19 million people worldwide.

In a quarterly report released in October, AstraZeneca noted that it had reached an agreement in principle to settle charges by the U.S. government that it was promoting Seroquel for uses not approved by FDA, which is illegal. While doctors may prescribe drugs to treat any ailment, regardless of their approved use, companies are not allowed to promote those drugs for uses other than those that have received federal approval. The settlement is estimated at about $524 million.

According to internal company documents uncovered through Seroquel litigation, off-label promotion of the drug has been a key marketing strategy for AstraZenca since at least 2000. During pretrial proceedings in lawsuits involving Seroquel filed by consumers who developed diabetes and other health problems after using the drugs, company papers were released that had the stated objective to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” even though treatment of bipolar disorders was not approved at the time.