Seroquel: Product Liability Claims

Seroquel, a drug used to treat schizophrenia and bipolar disorder, is the subject of recent lawsuits and a large government settlement.

By , Attorney (Northwestern University School of Law)

Seroquel (whose generic name is quetiapine fumarate) is an antipsychotic drug used to treat mental illnesses like schizophrenia and bipolar disorder. In the past few years, Seroquel has been the subject of more than 25,000 product liability lawsuits, including one brought by federal prosecutors. The federal litigation, and other lawsuits, alleged that AstraZeneca (Seroquel's manufacturer):

  • did not disclose certain side effects of the drug, and
  • encouraged doctors to prescribe the drug for treatments not approved by the U.S. Food and Drug Administration (FDA).

In April 2010, AstraZeneca paid $520 million to settle the federal government lawsuit. Thousands of other civil lawsuits continue on. Read on to learn about Seroquel and the claims made in these product liability lawsuits. (To learn about safety and legal issues related to other antipsychotic drugs, see Nolo's article Product Liability Claims Involving Antipsychotic Drugs.)

What Is Seroquel?

Seroquel is a prescription drug manufactured by AstraZeneca. Its active ingredient is quetiapine fumarate. The FDA has approved Seroquel to treat the following disorders.

  • Schizophrenia in adults and children age 13 or older. Schizophrenia is a psychotic disorder characterized by severely impaired thinking, emotions, and behaviors.
  • Bipolar disorder. This is a mood disorder (sometimes called manic-depression) that involves cycles of depression and elation (mania).
  • Depression associated with bipolar disorder.
  • Manic episodes associated with bipolar disorder in children ages 10 to 17.

Side Effects of Seroquel

Like other antipsychotic medications, Seroquel has numerous side effects. Some of the more serious effects include the following:

  • diabetes and high blood sugar
  • neuroleptic malignant syndrome (NMS) -- a life-threatening condition which causes fever, stiff muscles, irregular or fast heartbeat, change in blood pressure, problems with kidneys, and confusion, and
  • tardive dyskinesia (TDI) -- a neurological disorder that causes involuntary movement of the face and body.

Legal Claims in the Federal Lawsuit Against AstraZeneca

Typically, plaintiffs or government agencies bring defective product liability claims in lawsuits against drug manufacturers. In a product liability claim, plaintiffs argue that they were injured by a pharmaceutical drug because:

  • the drug caused unreasonably dangerous side-effects, and
  • the manufacturer, doctor, or pharmacy did not adequately warn the consumer (or prescribing physician) of these dangers. (To learn more about making a successful product liability claim, see Nolo's article Proving a Defective Product Liability Claim.)

In the federal litigation, the government focused on two aspects of AstraZeneca's failure to warn consumers and doctors about the dangers of the drug: marketing for unapproved uses of Seroquel and failure to disclose dangerous side effects. Let's take a closer look at these allegations.

Marketing Unapproved Uses of Seroquel

The federal lawsuit alleged that AstraZeneca aggressively marketed Seroquel for uses not approved by the FDA, including treating:

  • people with anger management issues
  • post-traumatic stress disorder
  • sleeplessness, and
  • children under the age of 10.

According to the lawsuit, AstraZeneca engaged in an illegal scheme to pay doctors to promote these off-market uses of Seroquel. Allegedly, AstraZeneca paid doctors to:

  • conduct studies regarding the unapproved uses
  • write articles (ghostwritten by AstraZeneca) promoting the unapproved uses, and
  • make presentations to other doctors regarding the unapproved uses.

Failing to Disclose Dangerous Side Effects of Seroquel

The federal lawsuit -- and numerous other civil lawsuits -- also alleged that AstraZeneca did not adequately warn prescribing doctors and consumers of the more serious risks associated with Seroquel use, including:

  • diabetes -- lawsuits point to data showing that patients taking Seroquel were over three times more likely to develop diabetes than patients taking certain other antipsychotic medications
  • rapid weight gain in children, and
  • possible death when used by elders with dementia.

Legal Defenses in Seroquel Cases

Drug manufacturers almost always mount a vigorous defense when sued under product liability laws. Often, they challenge plaintiffs' claims by arguing that (1) the drug is not dangerous and (2) plaintiffs' injuries were caused by something other than the drug.

For example, in Seroquel litigation, AstraZeneca has argued that Seroquel does not increase the risk of diabetes. Instead, says AstraZeneca, Seroquel users with diabetes either already had diabetes before taking the drug or had other health conditions that put them at high risk for developing diabetes.

Getting Help

The legal and medical issues in Seroquel cases are usually sophisticated and complex. Depending on your case, you may want to hire a lawyer who specializes in products liability litigation (or, even better, one who has experience with cases involving Seroquel or other antipsychotic medications). You may also consider joining an existing class action lawsuit, if there is one. (To learn more about class actions, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)

For help on choosing a good personal injury attorney, read Nolo's article Finding a Personal Injury Lawyer.

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