Originally studied in the 1960’s as a cancer treatment, researchers at Hoffman-La Roche accidentally discovered the benefits of 13-cis retinoic acid, or isotretinoin, in clearing up acne. It became evident that the teratogenic chemical was useless in treating cancer and the risks far outweighed the benefits as an acne treatment; therefore, research was largely abandoned. Despite knowledge of t
he birth defect causing properties of 13-cis retinoic acid, research was resumed when Dr. Frank Yoder and Dr. Gary Peck rediscovered it as a miracle cure for acne. The drug was eventually approved in 1982 by the FDA and distributed by Hoffman-La Roche as
Accutane, a treatment for severe acne. [1]
The history of Accutane since its release in 1982 is one spotted with litigation and controversy. There had been attempts at regulating the use of Accutane in pregnant women due to babies being born with serious birth defects, as well as litigation pertaining to suicidal tendencies and ideation in Accutane prescribed patients. [1] Almost unexpectedly, it would be the little known gastrointestinal issues linked to prior use of Accutane that would lead to the drug’s downfall. This article will discuss some of the toxic tort cases surrounding Accutane as well as some of the personal damages suffered from Accutane users. Attorney Michael Hook of Hook Bolton was the first to file an Accutane IBD suit in Florida of 2001. [2] By 2007, the first inflammatory bowel disease related toxic tort case against
Accutane producers (McCarrell vs. Hoffman-LaRoche) went to trial awarding the plaintiff $2.6 million for personal damages. [2] The decision was eventually appealed and reversed due to the defense being “unfairly restricted from presenting evidence to the jury about the number of people who had taken Accutane,” but upon a retrial the plaintiff, Andrew McCarrell, was awarded $25 million. [2]
In another case, a young girl who started taking Accutane at 12 was initially awarded $10.5 million. Kamie Kendall continued receiving courses of the drug from 1997 to 2003, when she was finally able to attribute her worsening ulcerative colitis diagnoses to her Accutane use. While defendants tried to argue that Kendall’s case was not timely filed, the New Jersey Supreme Court concluded that, given the circumstances, her claims were valid and indeed timely filed. [2] The original award amount of $10.5 million was overturned by a New Jersey Appellate Court, however Kamie Kendall did receive $1.5 million. [3]
By 2012, Hoffman-LaRoche was brought to court by two more plaintiffs suffering from ulcerative colitis; the plaintiffs were awarded $18 million. Since 2001, Hoffman-LaRoche has had to pay over $53 million in personal injury damages to Accutane patients suffering from IBD and Ulcerative Colitis. [4] Even though Hoffman-LaRoche stopped manufacturing Accutane in 2009, they continue being brought to litigation due to the late appearing nature of Accutane
related gastrointestinal issues.
References:
1. Babies, Blemishes and FDA: A History of Accutane Regulation in the United States; Green,
Julia; (http://dash.harvard.edu/handle/1/8963867); March 2002; Harvard Law School
2. Accutane litigation proliferate; Stephenson, Correy; Lawyers USA; Mar 7, 2012; The Dolan
Company
3. NJ jury orders drugmaker Roche to pay $1.5M at Accutane trial; Bloomberg News;
(http://www.nj.com/business/index.ssf/2014/03/nj_jury_orders_roche_to_pay_15m_in_accutane
_trial.html); March 11, 2014; New Jersey On-Line
4. Accutane Lawsuit; Unknown; (http://www.drugwatch.com/accutane/lawsuit.php); December
14, 2010; Drugwatch.com