Accutane (isotretinoin) is a popular prescription acne medication manufactured by Hoffmann-La Roche Ltd. Since Accutane went on the market in 1982, the drug has been the target of hundreds of lawsuits in federal and state courts. Plaintiffs in these cases claimed their use of Accutane led to severe birth defects, suicidal thoughts and actions, and inflammatory bowel disease (IBD).
Although Hoffmann-La Roche pulled Accutane from the U.S. market in 2009, isotretinoin is still available in the generic form. Read on to learn more about Accutane, the claims made in these product liability lawsuits, and the status of Accutane litigation. (For answers to basic questions about defective product liability claims, see Nolo's Product Liability FAQ.)
What Is Accutane?
Accutane is the brand name for the generic drug isotretinoin. Approved by the FDA in 1982 to treat severe recalcitrant nodular acne that is unresponsive to traditional treatments such as antibiotics, Accutane is also prescribed to treat other skin conditions and some types of cancer. Accutane was once a bestseller for manufacturer Hoffmann-La Roche Ltd. But in June 2009 the company stopped selling Accutane in the U.S., citing decreased sales due to generic competitors and the cost of defending itself against personal injury lawsuits. Generic forms of isotretinoin can still be purchased under the names Amnesteem, Claravis, and Sotret.
Side Effects of Accutane
The majority of plaintiffs in the Accutane lawsuits claimed they suffered one of three serious side effects through their Accutane use:
- severe birth defects, including abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands
- serious mental health problems, including depression, psychosis (loss of contact with reality), violent behavior, suicidal thoughts or actions, and
- inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis -- symptoms of which include abdominal pain, cramping, rectal bleeding, and severe diarrhea.
A myriad of other possible serious side effects are associated with Accutane, including severe skin reactions, pancreatitis, elevated triglycerides, liver damage, bone growth retardation and other bone problems, impaired vision and hearing, and more.
FDA Black Box Warning for Birth Defects
The FDA classifies Accutane as a "Category X" drug, effectively prohibiting the use of the drug by pregnant women. Despite the warning on the drug's label, reports of babies born with severe birth defects to women who had taken Accutane started just months after the drug's approval -- nine months after approval, to be exact -- and continued thereafter.
Starting in 1985, the FDA required Hoffmann-La Roche to use a black box warning on the package inserts of Accutane. A black box warning -- so named because of the black border surrounding the text -- notifies consumers that a drug may have serious, adverse side effects. It is the strongest warning the FDA can require. The required FDA black box warning for Accutane states that:
- Accutane must not be used by female patients who are or may become pregnant.
- There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time.
The iPLEDGE Program
Because babies with severe birth defects continued to be born to mothers who had taken Accutane during their pregnancies, as of 2006 the FDA requires women taking isotretinoin to participate in the iPLEDGE program. This program aims to eliminate fetal exposure to the drug. Under iPLEDGE, access to isotretinoin is severely restricted for women who can become pregnant, including young women who have not started having menstrual periods and women who have had their tubes tied. Women taking the drug must take pregnancy tests each month, use two forms of contraception, and log certain information into a government database before receiving their 30-day supply of isotretinoin each month.
Accutane and Suicide
In 1998, Hoffmann-La Roche amended Accutane's warning label to include suicide attempts as a possible side effect. By then, the FDA and the drug maker had received 170 reports of suicide, suicide attempts, or suicidal ideation (suicidal thoughts) in patients taking Accutane.
Whether Accutane actually causes suicide attempts in its users is a question that remains unresolved. Accutane ranks among the top ten drugs in the FDA's database with respect to depression and suicide attempts. However, the number of reported cases of depression and suicide among Accutane users is no greater than that in the general population.
Legal Claims in Accutane Lawsuits
Typically, people who have been injured by a pharmaceutical medication bring a defective product liability lawsuit against the drug's manufacturers and marketers. In the Accutane product liability lawsuits, plaintiffs argue that Accutane causes one of three unreasonably dangerous side effects: severe birth defects, serious mental health problems leading to suicide, or IBD. Plaintiffs also argue that Hoffmann-La Roche did not adequately warn doctors and patients of these potential side effects. (To learn more about legal claims in defective product lawsuits involving pharmaceutical drugs, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)
Legal Defenses in Accutane Cases
Drug manufacturers almost always mount a vigorous defense when they are sued under product liability laws. Often, they challenge plaintiffs' claims by arguing that either the drug is not dangerous or the plaintiffs' injuries were caused by something other than the drug.
In the Accutane cases that have gone to trial, Hoffmann-La Roche has made the following arguments:
- The causes of plaintiffs' injuries are unknown.
- Plaintiffs' injuries were not caused by their Accutane use.
- There is no reliable scientific evidence that Accutane causes IBD or suicide.
- The company provided adequate warnings about the drug's side effects to doctors and patients.
Status of Accutane Litigation
In 2004, the federal claims against Hoffmann-La Roche over Accutane were consolidated in multidistrict litigation in a Florida court. In multidistrict litigation (MDL), cases involving similar issues of fact are transferred to one court for pretrial and discovery proceedings (the process where each side finds out everything they can about the other side's case). Once that process is finished, attorneys try the cases in the court where the case was originally filed or in the MDL court. (To learn more about multidistrict litigation, see Nolo's article Multidistrict Litigation (MDL) for Drug Lawsuits and Other Cases.)
Many of the lawsuits over Accutane were filed in New Jersey state court because Hoffmann-La Roche is located in New Jersey. In 2005, New Jersey's Supreme Court designated all existing and future statewide lawsuits involving Accutane as a mass tort. Most Accutane cases were transferred to Atlantic County to be managed and heard before a single judge.
Since 2007, Hoffmann-La Roche has lost six Accutane jury trials alleging the drug causes IBD, although at least one of the verdicts was overturned by an appellate court. The awards in these cases ranged from $2.6 million to $25.16 million.
The legal and medical issues in Accutane cases are sophisticated and complex. Depending on the specifics of 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 Accutane). 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 in choosing a good personal injury attorney, read Nolo's article Finding a Personal Injury Lawyer. Or go straight to Nolo's Lawyer Directory for a list of personal injury attorneys in your area.