Accutane (isotretinoin) lawsuits link the acne medication to birth defects, suicide, and inflammatory bowel disease (IBD).
Accutane (isotretinoin, a popular acne medication manufactured by the Hoffmann-La Roche company, hit the market in 1982. Since it’s release the drug has been the target of hundreds of lawsuits in federal and state courts. Plaintiffs in these cases are claiming that their use of Accutane led to severe birth defects, suicidal thoughts, and actions, plus inflammatory bowel disease (IBD).
Hoffmann-La Roche did pull Accutane from the U.S. market in 2009, although the generic form, isotretinoin is still available. To learn more about Accutane, the claims made in these product liability lawsuits, and the status of Accutane litigation.
What Is Accutane?
Approved by the FDA in 1982 to treat severe recalcitrant nodular acne that is unresponsive to traditional treatments such as antibiotics, Accutane, generic drug isotretinoin, Accutane is also prescribed to treat other skin conditions and some types of cancer. At one point Accutane was a bestseller for manufacturer Hoffmann-La Roche Ltd. But in June 2009 the company stopped selling Accutane in the U.S., due to decreased sales thanks in part 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.
What are the Side Effects of Accutane?
The majority of plaintiffs that filed Accutane lawsuits claimed that they suffered one of three serious side effects through their time spent taking their prescribed doses of Accutane:
- 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.
These of course are not the only three side effects encountered. Other possible serious side effects that are associated with Accutane, include 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 Accutane & Birth Defects
Accutane is a “Category X” drug according to the FDA, thus it is effectively prohibited to use 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. To be more precise, nine months after the approval of Accutane, the cases started 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, (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 as follows:
- “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.”
2006 FDA iPledge Program
Due to babies continuing to be born with severe birth defects continued, mothers who had taken Accutane during their pregnancies, women were required women to participate in the iPLEDGE program. This program was instated in 200 by the FDA and was aimed 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. Those women taking the drug must have to pledge to do three things:
- take pregnancy tests each month
- use two forms of contraception
- log particular information into a government database before receiving their 30-day supply of isotretinoin each month
Accutane and Suicide
Hoffmann-La Roche amended Accutane’s warning label in 1989 to include suicide attempts as a possible side effect. At that point, the FDA and the drug maker had received 170 reports of suicide, suicide attempts, or suicidal thoughts in patients taking Accutane.
Did Accutane actually cause suicide attempts in its users? That is a question that is still unresolved, but Accutane does rank among the top ten drugs in the FDA’s database with respect to depression and suicide attempts. To date, the number of reported cases of depression and suicide among Accutane users is no greater than that in the general population.
What is the Status of the Accutane Lawsuits?
A New Jersey Appeals Court ruling will reinstate several thousand Accutane lawsuits, which were previously dismissed after the lower court wrongly determined that expert testimony linking the acne drug to an increased risk of Crohn’s disease was inadequate. In an opinion (PDF) issued by the Superior Court of New Jersey Appellate Division, it was found that the trial judge exceeded his authority when he excluded testimony from plaintiffs’ expert witnesses on gastroenterology and epidemiology, reviving 2,174 cases that were previously dismissed. According to the ruling, Atlantic County Superior Court Judge Nelson Johnson incorrectly determined that the plaintiffs’ expert witnesses were not using the best science when they called into question the findings of epidemiological studies brought forth by the defense.
More than 6,700 people filed product liability lawsuits against Roche, alleging that the drug maker failed to adequately warn about the risk of Accutane side effects. Several early bellwether trials in the litigation resulted in multi-million dollar damage jury awards for instances of IBD from Accutane. However, Roche has continued to challenge those verdicts on appeal. Thousands of those cases were dismissed in February 2015, following on the admissibility of expert testimony to support the Accutane Crohn’s disease lawsuits.
The appeals court disagreed with the Judges ruling stating:
“The trial court took too narrow a view in determining whether the experts were using accepted scientific methodologies to analyze the evidence, and improperly determined the weight and credibility of the experts’ testimony,” the three-judge panel said in their decision. “Among other things, the judge inappropriately condemned the experts for relying on relevant scientific evidence other than epidemiological studies, despite their plausible explanations for doing so. Consequently, we conclude that the trial court mistakenly exercised discretion in barring the experts’ testimony.”
As of Today the cases have been reinstated and remanded back to New Jersey’s Atlantic County court.
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