Seroquel: Product Liability and "Off-Label" Marketing Claims

Seroquel is an antipsychotic drug. The U.S. Food and Drug Administration (FDA) has approved Seroquel as a treatment for mental illnesses like schizophrenia and bipolar disorder. It it also prescribed for so-called "off-label" uses--for example, as a treatment for insomnia.

Seroquel's manufacturer faced government investigations and thousands of lawsuits in the late 2000s and early 2010s. These legal actions focused on Seroquel's side effects and on the company's marketing of the drug. The concerns that prompted these cases, and the company's response, remain important to understanding Seroquel's risks and benefits.

What Is Seroquel and What Conditions Does It Treat?

Seroquel is the brand name for the prescription drug quetiapine fumarate. It was developed by AstraZeneca and has been approved by the FDA to treat the following mental health 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.

It has also been prescribed for off-label uses, including as a treatment for sleep disorders and anxiety. "Off-label" means that a drug has been approved for certain uses, but is being prescribed in other ways. The FDA gives doctors discretion to prescribe drugs off label when they believe it is safe and medically appropriate. But the agency only vouches for a drug's safety and effectiveness when it is used in ways that the FDA has approved.

The Side Effects of Seroquel

Seroquel, like other antipsychotic medications, has numerous side effects. Some of Seroquel's more serious effects can include:

• high blood sugar;
• neuroleptic malignant syndrome (NMS), a life-threatening condition whose symptoms can include fever, irregular heartbeat, and confusion; and
• tardive dyskinesia (TDI), a neurological disorder that causes involuntary movement of the face and body.

Seroquel remains a commonly prescribed drug because the FDA and doctors believe its benefits outweigh these risks. But drug companies must warn consumers of the potential dangers of their medications, and doctors must be careful to only prescribe a drug when it is safe for the patient to take it.

Legal Claims Against the Manufacturer of Seroquel

AstraZeneca faced lawsuits and government investigations over allegations that it:

• did not disclose certain side effects of Seroquel, and
• encouraged doctors to prescribe the drug for off-label uses.

The lawsuits were product liability claims brought by consumers. In product liability cases involving prescription drugs, plaintiffs typically argue either that:

• the drug was unreasonably dangerous (whether or not the manufacturer knew it), or
• the manufacturer, doctor, or pharmacy did not adequately warn the consumer about a drug's known risks.

The government investigations focused both on:

• whether AstraZeneca adequately warned consumers about Seroquel's dangers, and
• whether AstraZeneca used improper methods to get doctors to prescribe the drug for off-label uses.

By the early 2010s AstraZeneca had paid hundreds of millions of dollars to resolve these legal matters.

Government Investigations Into AstraZeneca's Marketing of Seroquel

AstraZeneca faced investigations both by the federal government and dozens of state governments.

The federal government alleged that AstraZeneca aggressively marketed Seroquel for uses not approved by the FDA. This included promoting the drug for use by children under the age of 10, as well as marketing it as a treatment for:

• anger management issues
• post-traumatic stress disorder, and
• sleeplessness.

As we discussed above, it is not illegal to prescribe a drug for uses that are not FDA-approved. However, the government contended that AstraZeneca engaged in an illegal scheme to pay doctors to promote these off-label uses of Seroquel.

AstraZeneca allegedly paid doctors to:

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

In 2010 AstraZeneca paid a $510 million settlement to resolve these federal allegations.

In 2011 the company paid an additional $68 million to resolve similar allegations made by dozens of state governments.

Failing to Disclose Dangerous Side Effects of Seroquel

AstraZeneca also faced allegations that it did not adequately warn prescribing doctors and consumers of the more serious risks associated with Seroquel use. In particular, the company was sued by thousands of plaintiffs who said that they were not properly warned that using Seroquel would increase their risk of developing diabetes.

In 2010 the company paid a total of $198 million to 17,500 plaintiffs to resolve these diabetes-related claims.

Additional Warnings About Seroquel Side Effects

While In addition to investigations and lawsuits, Seroquel has also been subject to continuing regulation by the Food and Drug Administration. FDA regulation is usually a cooperative process, with the agency and drug companies reaching agreements about things like adding additional warnings to a drug's label. For example, in 2011 AstraZeneca agreed to an FDA request and began warning that Seroquel could cause a heart arrhythmia and even cardiac arrest if taken at the same time as certain other drugs.

Learn More About Pharmaceutical Drug Lawsuits

While the major lawsuits and government investigations into Seroquel have concluded, it's still important to understand your options if you believe you've been harmed by the drug. It may be helpful to read more about product liability claims involving antipsychotic drugs. Bear in mind that pharmaceutical companies vigorously defend themselves against lawsuits, including by arguing that a plaintiff was told of a drug's risks and chose to take it anyway.

This argument that a consumer knew the risks can be a particularly strong argument with a drug like Seroquel, which has been on the market for decades and comes with extensive warnings. So it's important to be realistic about the likelihood of succeeding with a lawsuit, and to consider speaking with a personal injury lawyer you trust about whether it makes sense to proceed.