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.

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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.

7 Comments

  • AnnDecember 12, 2011 at 6:07 pm

    People who state they are able to function may not realize that all anti-psychotic drugs cause mental impairment. So, rather than addressing the root cause of mental issues, they damage the frontal lobe (chemical lobotomy) causing people to feel apathetic and indifferent, thus making them more submissive and less able to feel.

  • EricJune 19, 2010 at 7:21 pm

    I began treatment for bi-polar disorder with seroquel in 1997. Six month after my treatment. I was seen in the ER for acute pancrecitus. I sufferd with pancrecitus for nine years. I also developed weight gain. I was hospitalized with acute pancreicitus two or three time a year for the past 101/2 years. After finding out that seroquel was causing my acute pancrecitus. I was taken off the seroquel i[Show More]I began treatment for bi-polar disorder with seroquel in 1997. Six month after my treatment. I was seen in the ER for acute pancrecitus. I sufferd with pancrecitus for nine years. I also developed weight gain. I was hospitalized with acute pancreicitus two or three time a year for the past 101/2 years. After finding out that seroquel was causing my acute pancrecitus. I was taken off the seroquel in may of 2008. Since then, I was told I have developed type two diabetes. However, I have not sufferd from pancrecitus. I feel that If the maker of seroquel had been upfront about the side effects of seroquel. It could save me from alot of unnessary suffering.

  • NicoleMay 31, 2010 at 4:30 pm

    I have a friend who just lost her daughter on May /17/2010 and all indications are that she died after taking the drug Seroquel, she had gained a tremendous amount of weight.

  • SUSANFebruary 17, 2010 at 6:42 pm

    I am bipolar diabled veteran of the us navy after complaining for 25 years about back and body pain I started taking seroquel. I started having problems with my balance, falling losing my balance for no reason. I have stopped taking it, but I stil walk funny always off balance, almost to the point that people think I'm drunk. It has made my fibromyalgia 70% worse. I always have to be very careful [Show More]I am bipolar diabled veteran of the us navy after complaining for 25 years about back and body pain I started taking seroquel. I started having problems with my balance, falling losing my balance for no reason. I have stopped taking it, but I stil walk funny always off balance, almost to the point that people think I'm drunk. It has made my fibromyalgia 70% worse. I always have to be very careful trying to walk.

  • EmmaFebruary 13, 2010 at 10:13 pm

    I have developed Tardive Dyskenesia from taking neuroleptics including Seroquel. I am only 57, but am now unsteady on my feet, and have movement in my face, upper body, and arms, which worsens when I feel agitated. It's a double bind, because getting off the Seroquel could make it even worse. It's bad enough having bi-polar disorder, without having to fight drug side-effects I was never told ab[Show More]I have developed Tardive Dyskenesia from taking neuroleptics including Seroquel. I am only 57, but am now unsteady on my feet, and have movement in my face, upper body, and arms, which worsens when I feel agitated. It's a double bind, because getting off the Seroquel could make it even worse. It's bad enough having bi-polar disorder, without having to fight drug side-effects I was never told about.

  • GambleFebruary 7, 2010 at 5:15 am

    I battled over the fact that it created mental problems in a family member that were very disasterous to her well being plus we didn't find out she had a severe thyroid condition until we stopped the medication --it did create severe weight gain but that wasn't the really bad effect that it made her incoherant and totally out of touch with reality and quite a few serious trips to the hospital--tha[Show More]I battled over the fact that it created mental problems in a family member that were very disasterous to her well being plus we didn't find out she had a severe thyroid condition until we stopped the medication --it did create severe weight gain but that wasn't the really bad effect that it made her incoherant and totally out of touch with reality and quite a few serious trips to the hospital--thank God , she doesn't take it anymore and is almost a whole person plus a new doctor "zapped" her thyroid and she takes much more benevolent meds now. That stuff was making her "crazy" Her previous doctor was convinced "one size fits all" and that stuff almost ruined her. Not in a suing mode --just get the word to these doctors they need to review there medical research and take a more serious look at what they hand out---Rush Limbaugh anybody!!! Are they trying to make people into addicts at any cost for the almighty bucks or just plain lazy????

  • JamesFebruary 7, 2010 at 1:13 am

    This drug has done wonders for me. I am stable thanks to this drug. I no longer hear voices and I feel it is up to the doctor to deside who would benafit from this drug. I say to the lawmakers to leave AstraZeneca alone. You have no idea what it is to have a mental illness. Because of this drug I am able to funtion in everyday life. SO BACK OFF OF ASTRAZENECA!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!![Show More]This drug has done wonders for me. I am stable thanks to this drug. I no longer hear voices and I feel it is up to the doctor to deside who would benafit from this drug. I say to the lawmakers to leave AstraZeneca alone. You have no idea what it is to have a mental illness. Because of this drug I am able to funtion in everyday life. SO BACK OFF OF ASTRAZENECA!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

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