Accutane Litigation

Since its FDA approval in 1982, the acne medication Accutane has received significant opposition. The drug is intended to treat severe recalcitrant nodular acne that does not respond to other traditional forms of treatment, including the use of antibiotics. However, there have been hundreds of lawsuits citing that the acne drug causes birth defects, thoughts of suicide, and inflammatory bowel disease.

While the manufacturer of Accutane, Hoffmann-La Roche Ltd. stopped selling Accutane in the US in 2009, the generic form of the drug, isotretinoin, is still available. Hoffmann-La Roche cited that decreased sales and profit-loss due to lawsuits led to the termination of Accutane production. Generic competitors still manufacture and sell isotretinoin under the names, Amnesteem, Sotret, and Claravis.

Side Effects

According to the lawsuits involving Accutane use, one of three serious side effects were cited by plaintiffs. The three major side effects of Accutane, include:

Severe mental health changes such as violent behavior, psychosis, depression, suicidal thoughts or actions.

Severe birth defects – abnormal formation of ears, skull, face, eyes, cardiovascular system, thymus, central nervous system, and parathyroid glands. Because of the serious risk of birth defects, most women are advised not to take isotretinoin. iPLEDGE is a program created by the FDA that requires women to adhere to specific terms if they plan to take isotretinoin. The terms of iPLEDGE include, taking a pregnancy test each month, using two forms of contraception, as well as use a federal database to log certain information before a monthly prescription of isotretinoin can be received.

Inflammatory bowel disease (IBD)Crohn’s disease has been cited. Symptoms of IBD include, cramping, bleeding of the rectum, severe diarrhea, and abdominal pain.

Other side effects often claimed, include: pancreatitis, severe skin reactions, high triglyceride count, bone problems, blurred vision, and liver damage.

Less serious side effects may include:

            Chapped lips
Itchy and dry skin
Dry nose, including minor nose bleeds
Temporary hair thinning
Urinary symptoms
Joint and muscle pains
Irritation and discomfort of the eyelids

Suicide and Accutane Use

As many as 170 reports of suicide or suicidal thoughts have been reported by Accutane users, however the connection between the drug and suicidal thoughts and actions has yet to confirmed. While the number of reported cases regarding depression and suicide for Accutane users is no higher than the number of reported cases within the general population, the FDA ranks Accutane in the top ten drugs related to suicide and severe depression.

Accutane Litigation Today

While Accutane is no longer sold by Hoffmann-La Roche, there are still lawsuits being brought against the company. Since 2007, six Accutane jury trials have led to awards as much as $25.16 million for users. Most cases against Hoffmann-La Roche were based out of New Jersey, where the Hoffman-La Roche is located. In 2005, the New Jersey Supreme Court ruled that all lawsuits involving Accutane in New Jersey fall under a mass tort.

Seek Legal Assistance

If you have used Accutane and you believe that you have suffered adverse reactions, seek a qualified products liability attorney. Lawsuits involving medical issues and prescription drugs are complex and should be handled with legal oversight. The attorneys at Big Horn Law are experienced in personal injury and product liability litigation, so give us a call to set up a consultation.


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