Accutane Lawsuits

Accutane was a drug marketed by Roche Pharmaceuticals for the treatment of moderate to severe acne. Millions of people have taken Accutane since it was first introduced in the 1980s. However, there were many reports of side effects and dangerous adverse events. Accutane is no longer available, but generic versions are still available. 

Accutane users have reported Crohn’s disease, ulcerative colitis, and even suicidal thoughts. If you developed an illness after taking Accutane, talk to a personal injury attorney experienced with defective drug lawsuits about filing a lawsuit for damages. 

What Is Accutane?

Accutane is the brand name for isotretinoin. The drug was first developed by Hoffmann-La Roche in the 1960s. However, the company abandoned the drug because of a high risk of severe birth defects and abnormalities. Later, drug trials demonstrated it was successful as an acne drug. The U.S. Food and Drug Administration (FDA) approved the drug as an acne medication in 1982. 

Isotretinoin, or Sotret, is now marketed under several names, including Absorica, Claravis, Amnesteem, and Zenatane. Doctors prescribe isotretinoin to treat severe acne that does not respond to other treatments. 

Female patients have to go through regular screening to receive the prescription drug. The iPLEDGE program ensures pregnant women do not take isotretinoin. This includes getting pregnancy tests and using two forms of birth control while taking the drug. 

What Are the Side Effects of Accutane?

A black box warning, or boxed warning, refers to the highest safety-related warning on an FDA-approved drug. Accutane has a boxed warning, specifically for female patients who are pregnant or may become pregnant.

According to the approved warning label, there are several reported side effects of using Accutane. Side effects include: 

• Severe birth defects, premature birth, or miscarriage
• Depression, psychosis, and suicidal thoughts
• Gastrointestinal problems, including inflammatory bowel disease (IBD)
• Bone and muscle problems
• Hearing and vision problems
• Fat, cholesterol, and blood sugar problems
• Decreased red and white blood cells

The first thing you should do if you experience any of these serious side effects while taking Accutane is tell your health care provider. If you take legal action, it will be important to have evidence of your medical problems.

Did the FDA Recall Accutane?

The FDA never recalled Accutane. However, it did take extraordinary measures to limit availability for patients. The FDA required Accutane prescriptions to go through the iPLEDGE website. This included mandatory counseling for all patients, including male patients. Female patients of childbearing potential required multiple contraception methods and pregnancy test results. 

In 2002, Roche’s patent expired, and other companies began to offer generic versions. In 2009, Roche discontinued manufacturing and distributing Accutane. Isotretinoin continues to be available from other companies. Patients are still required to go through testing and screening to get the generic drug. 

What Is a Defective Drug Lawsuit?

A defective drug lawsuit is a type of product liability claim. Pharmaceutical companies are liable for putting out dangerous drugs on the market. Drug defect cases fall into three categories: 

• Design defects
• Manufacturing defects
• Failure to warn of dangerous side effects or reactions

Most Accutane-related product liability claims were based on a failure-to-warn claim. If the drug manufacturer fails to warn users about the risks and side effects of the drug, the drug maker is liable for damages. Product liability claims generally require a medical expert to testify about the lack of a proper warning that relates to your injuries. 

What Are Your Legal Rights After an Accutane Injury?

There have been thousands of Accutane cases filed against the company since the 1980s for marketing and selling a dangerous drug. Multidistrict litigation in Florida accounted for over 8,000 cases. However, the judge ultimately dismissed the failure-to-warn cases, finding the warning label was sufficient. 

Thousands more class-action cases were filed in New Jersey. However, the New Jersey Supreme Court eventually dismissed the failure-to-warn cases for similar reasons. 

You may face an uphill battle for any lawsuit that you file. The statute of limitations has expired for most claims, as the drug has been off the market since 2009. However, if a loved one suffered injuries after taking a generic version of isotretinoin, you can file a dangerous drug claim against the drug company. Contact an experienced defective drug lawyer for legal advice about your case.