How did this happen?

When a dangerous product causes harm to you or someone you care about, you naturally want to know how the terrible situation was allowed to come about. Manufacturers of consumer products are interested in making as much money as possible, like any company. But this can lead to corners being cut. And that can lead to injuries. So who keeps an eye on these companies? Who looks out for you?

In the United States, the federal Food and Drug Administration (FDA) is responsible for protecting public health by ensuring that human and veterinary drugs (including prescription and over-the-counter drugs), vaccines, medical devices, food, dietary supplements, cosmetics, and products that emit radiation are safe. Before a manufacturer may market a drug to the public, the drug must obtain FDA approval. The drug must got through a series of clinical trials that are intended to determine whether a drug is both safe and effective as a treatment for a condition or disease. It is important to note, however, that absolute safety is never guaranteed. The FDA merely determines that, overall, the benefits of a drug outweigh its risks.

Accutane is the brand name of the drug isotretinoin, which was developed and manufactured by Hoffman-LaRoche Inc./Roche Industries, Inc. (“Roche”). Accutane is prescribed to treat severe cases of acne. The several generic forms of the drug are sold under the names Amnesteem, Claravis, Clarus, Decutan, Izotek, Oratane, Sotret, and Roaccutane. Accutane received FDA approval in the United States in 1982. Between 1982 and 2009, Accutane was prescribed by doctors to more than 13 million patients.

In April 2008, in the first lawsuit involving Accutane, a court ordered Roche to pay a Florida man more than $10 million for his severe gastrointestinal health problems caused by Accutane. Similar cases followed in 2009 and 2010, with courts awarding money to patients who developed inflammatory bowel disease (IBD) after being prescribed Accutane. The courts found that Roche was blameworthy because it had failed to warn doctors and patients of the potential health risks of taking Accutane. Roche had not informed the FDA of the potential risk of IBD from Accutane either, which is why that agency was unable to warn doctors and patients of this dangerous side effect itself.

To date, Roche has paid $56 million to patients who were injured by Accutane. In June 2009, Roche ended sales of Accutane, in part because of the cost of defending lawsuits brought by injured patients.

If you’re suffering from any of the known side effects of Accutane, and you believe that your injuries have been caused by this dangerous drug, let the Rottenstein Law Group know. The knowledge, experience, and preparation of RLG’s lawyers will make seeking compensation for your pain as painless as possible. You’ve taken enough. We’ll take it from here.

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