Accutane Lawsuit Guidelines

Since its approval in 1982, more than 16 million people worldwide have been prescribed Accutane to treat severe acne. Able to clear the skin of nearly 85 percent of the patients who applied it, Accutane (isotretinoin) was an extremely effective medication that quickly became a blockbuster. Roche Pharmaceuticals never warned of the medication’s risks including severe and chronic forms of gastrointestinal inflammation, psychiatric disorders, liver damage and birth defects.

More than 7,000 personal injury lawsuits have been filed against the manufacturer, holding them accountable for the harm many victims suffered. Our Law Firm has filed countless cases on behalf of clients who were injured or even died. Some plaintiffs received financial compensation of well over $25 million.

Medication Type: Acne

Injury: chronic forms of gastroinestinal inflammation, liver damage, birth defects.

Manufacturer:  Roche Pharmaceuticals

Total Cases: 7,000

Settlement Amounts: EST – $100,000 over $25,000,000

Bellwether Trial Start Date:        April 2017

See If You Qualify

What is Accutane?

Isotretinoin is a pharmaceutical compound which is closely related to Vitamin A. Accutane was initially developed as a chemotherapy agent used to treat skin cancer. However, since it acts by reducing the amount of oil released by sebaceous glands in your skin, researchers quickly found it could be effectively used to treat acne. The U.S. Food and Drug Administration (FDA) approved it to treat severe nodular acne after other medications such as the antibiotics proved to be ineffective. After a few years, though, Accutane was also adopted to treat even mild forms of acne.

After being hit by a storm of lawsuits, in 2009 Roche withdrew their patented form of isotretinoin from the market. However, generic brands of this drug are still available, such as Sotret, Decutan and Claravis.

The Danger of Birth Defects

Accutane has been used mostly by adolescents, an extremely vulnerable part of our society who always suffered from the most debilitating effects of acne. About half of the primary users of this medication are young women of childbearing age, who were never adequately warned that one of the most concerning side effects of isotretinoin was the risk of miscarriage and birth defects.

In twenty years since it reached the U.S. market, the FDA had received almost 200 reports of babies affected by serious malformations after their mothers used Accutane during pregnancy.

Other Accutane Side Effects

Other studies link Accutane with two severe forms of Inflammatory Bowel Disease (IBD): ulcerative colitis and Crohn’s disease. Long-term complications of these chronic gastrointestinal disorders require a partial or total removal of the colon with tremendously detrimental consequences to a patient’s quality of life. Some victims who later filed an Accutane lawsuit required a liver transplant after suffering from hepatic damage and cirrhosis. The FDA later added the infamous Black Box to warn about all these major adverse reactions associated with this drug, including an increased risk of psychiatric disorders such as suicidal behaviors and depression.

After extensive researches, in 1998, the Centers for Disease Control (CDC) sent a letter to the FDA recommending to withdraw the drug from the market since it was too dangerous.

The Accutane Multidistrict Litigation

The over 7,000 Accutane lawsuits filed so far have been consolidated in two Multidistrict Litigations (MDL). The first one MDL No. 1626 is held in the Middle District of Florida overseen by Judge James S. Moody. The second one is the multicounty litigation (MCL) No. 271 overseen by Judge Nelson C. Johnson in New Jersey.

Can I file a lawsuit if I took a generic version?

Between 1983 and 1988, the FDA sent several letters requiring Hoffman-LaRoche to update Accutane’s label to cover the full extent of its possible side effects. Even one of the scientists that discovered isotretinoin, Dr. Frank Yoder, tried to inform the public about the medication’s toxicity in 1983 by writing a letter to the Journal of American Medicine.

According to many attorneys, the pharmaceutical company already knew about the risk for IBD when the drug was released to the market. After a medication is approved and its patent expires, generic manufacturers can jump on the bandwagon and share their profits regardless of the purported dangers. However, if the original brand owner negligently designed or manufactured its product or failed to warn the public about its risks, it will be held legally responsible for any damage caused.

Previous Accutane Verdicts

Various juries required Roche to pay financial compensations to the victims of Accutane in excess of $53 million. In 2007, during the first trial, a New Jersey jury awarded Andrew McCarrell $2.5 million after the plaintiff claimed he had his colon surgically removed because of the drug’s consequences. The trial was held again in 2011 after Hoffman-LaRoche appealed the verdict, and a second jury increased his reward to $25 million. After the pharmaceutical company appealed again, however, his case was thrown out because the plaintiff waited too long to file the suit.

In 2008 Kamie Kendall was awarded $10.5 million in compensatory damages after she was diagnosed with ulcerative colitis. After Roche requested a retrial, the second jury confirmed that the company failed to warn the public about the danger of gastrointestinal disorders and granted the plaintiff a $1,5 million award.