Do I have an Accutane Case?
Do I have an Accutane Case?
Accutane, the brand name of the drug isotretinoin, was developed by Hoffman-La Roche Inc. (Roche) for the treatment of severe acne and was approved by the U.S. Food and Drug Administration (FDA) in 1982. Originally devised as a chemotherapy medication, researchers found that isotretinoin shrinks oil glands. The drug is a retinoid, meaning it is derived from vitamin A, and works by reducing sebum (an oily substance) production. Prior to the introduction of Accutane, patients suffering from severe nodular acne were typically prescribed antibiotics, which were only marginally effective. Upon its introduction, Accutane was hailed as a revolutionary acne treatment and in 2001, the FDA lauded the product as “the biggest breakthrough in acne drug treatment over the last 20 years.” It was also a breakthrough for Roche, which sold Accutane to approximately 13 million users since 1982 with yearly profits reaching up to $1.2 billion.
Accutane is indisputably an effective acne treatment, but from the time it was introduced, its relief of disfiguring acne has been shadowed by links to severe side effects including birth defects, suicide and depression, organ damage, and gastrointestinal disorders. Injured users began to seek Accutane lawsuit settlements from Roche, and the company eventually faced around 5,000 personal injury lawsuits. Citing the high cost of defending these suits, along with a dwindling market share caused by generic isotretinoin manufacturers, Roche withdrew Accutane from the U.S. market in June 2009.
Although many drugs on the market have dangerous, even deadly side effects, the ability of a pharmaceutical to cause harm is not itself grounds for a lawsuit. As long as a manufacturer provides sufficient warning of a drug’s danger, it cannot be held liable for injuries the drug causes. Furthermore, there must be evidence specifically linking a drug to the injury in question.
The link between Accutane and birth defects is extremely well-documented, but due to a “black box” warning on packaging and a strict government program (iPLEDGE) required for all female Accutane users, plaintiffs have not been successful when suing Roche over Accutane’s teratogenic properties. The same reasoning applies to Accutane and depression/suicide. In 1998 Roche added suicide attempts as a possible side effect on Accutane’s warning label. Just as important, there is no clear evidence linking the drug to suicide attempts. For these reasons, no plaintiff has successfully sued Roche on charges that Accutane negatively impacts mental health.
But one type of injury that Roche failed to provide sufficient warning about, at least according to several major court decisions, is gastrointestinal problems such as Inflammatory Bowel Disease (IBD) (including two major types of IBD: ulcerative colitis and Crohns’ disease). To date, Roche has been ordered to pay tens of millions of dollars in Accutane settlements to IBD sufferers, with individual awards ranging from $2.6 million to $25.16 million. Expert testimony (including that of gastroenterologist Dr. David Sachar) and scientific studies (including a study that found Accutane increases the risk of ulcerative colitis fourfold) have both supported verdicts rendered on behalf of plaintiffs.
Currently, a diagnosis of IBD is the cornerstone of a viable Accutane lawsuit. Any patient suffering from this chronic, painful disease is encouraged to contact the Rottenstein Law Group for a case evaluation. Although Roche has repeatedly stated there is no link between Accutane and IBD, scientific evidence indicates otherwise. With help from an RLG attorney, you can receive the compensation you need to be made whole again. Call 1 (888) 736-7262 or contact us online today to speak with an attorney.
Originally published here.
James Coltrane
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