Accutane Isotretinoin

Though initially developed as a chemotherapy drug, isotretinoin was discovered to be quite effective in treating severe acne (including cystic or nodular acne). This synthetic form of Vitamin A was so effective at treating severe acne, that it was quickly marketed as a treatment for common acne. Isotretinoin has been marketed under the following brand names: Accutane, Amnesteem, Claravis, and Sotret.

The United States Food and Drug Administration (FDA) issued a lot of information about the risks of Accutane. On March 28, 2007, the FDA issued the following statement, “The U.S. Food & Drug Administration (FDA) is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online.  Isotretinoin is a drug approved for the treatment of severe recalcitrant nodular acne that does not respond to antibiotics. Improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use. The Web page,, will be positioned as a search result on Google and other search engines when a consumer initiates an online search for the drug under any one of its four names (Isotretinoin is sold under the brand name of Accutane and in generic versions called Amnesteem, Claravis, and Sotret.) The web page warns that the drug “should only be taken under the close supervision” of a physician or a pharmacist, and provides links to helpful information, including ways to check that drugs purchased online come from legitimate pharmacies.

Unfortunately… “On October 3, 2018, the New Jersey Supreme Court granted pharmaceutical companies two significant legal victories in the Accutane multi-county litigation (“MCL”), which consolidated 532 product-liability from plaintiffs in forty-five jurisdictions.  In re Accutane Litig. 2018 N.J. LEXIS 1187 (N.J. Oct. 3, 2018).  First, the Court held in its choice-of-law analysis that New Jersey’s relationship to the claims was more significant than those of the other 44 jurisdictions, and New Jersey’s Product Liability Act’s (“PLA”) provisions on the adequacy of warning labels should, therefore, apply.  Second, the Court held plaintiffs who seek to overcome the presumption of adequacy attached to a FDA-approved drug label must present clear and convincing evidence that the manufacturer knew or should have known of a causal association between the drug and “a clinically significant hazard.”” (

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