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Accutane Lawsuit

Accutane is an acne treatment created by Hoffman La Roche, a United States drug manufacturer. It is a synthetic form of Vitamin A that is made to alleviate severe acne symptoms. The La Roche Group is a leading pharmaceutical manufacturer bringing in $1.2 billion annually just for sales of Accutane.

About Accutane

Accutane appears in other prescription forms under the following names: Amnesteem, Claravis, Decutan, Istane, Sotret, Ratane, Raccutane, and the generic Isotretinoin. Accutane was originally only meant for the treatment of severe acne but it has been found that dermatologists have prescribed the drug for mild cases that should never have been prescribed the drug as the risks far outweighed the benefits. By inhibiting oil gland and cell growth and reproduction, Accutane can clear up most patients’ acne in several months. It was depletes the body of molecules that hold water which help to keep skin, eyes, scalp, and joints well lubricated.

Side Effects

The way Accutane effectively treats acne causes side effects such as weak skin, Alopecia, depression, suicidal tendencies, birth defects, miscarriages, back pain, joint pain, dry mucus membranes, pink eye, dryness of the eye, vision problems, ringing in the ear, psychosis, liver damage, anaphylaxis, erectile dysfunction, aggressive behavior, bone loss, heart attack, stroke, seizures, lowered white blood cell count, inflammatory bowel disease, and allergic vasculitis. This has sparked much controversy over the drug and caused many lawsuits against medical professionals and Hoffman La Roche as well.

FDA Response

The FDA has required a black box warning be put on all containers of Accutane, warning of all risk associated with taking Accutane. This has caused a New Jersey appeals court to not hold Hoffman La Roche accountable for birth defects caused by its product because the company has been diligent in warning patients and providers of the risks of the medication. Federal courts also ruled in favor of Hoffman La Roche in a case between Adam Mason, a man who suffered severe inflammatory bowel disease after taking Accutane. This caused him to have most of his colon removed. The courts ruled in favor of Hoffman La Roche because Mason could not produce the deceptive warning label he claimed he received.

Accutane and Pregnancy

Women who have taken Accutane should have had to meet the iPLEDGE requirements approved by the FDA, making sure they understood the possibility of severe birth defects or possibility of miscarriage before taking the drug. Providers would have had to warn female patients of all this and inform them that they should not pregnant while taking the drug. If female patients did conceive while taking Accutane, they should have been warned to discontinue use and keep in contact with a medical professional who is experienced with reproductive toxicity. Women who were not warned of this have legitimate grievances against either their medical provider who prescribed them Accutane, or Hoffman La Roche.

Legal Responsibility

Health care providers can be held responsible if they do not inform patients of the side effects of Accutane. It is a responsibility of a provider to make certain patients are well aware of all side effects before taking a drug or else they could be considered as acting negligent.

Consumers who were prescribed Accutane before Hoffman La Roche warned those outside the company of widespread serious risks of taking the drug are generally successful in court rulings. The New Jersey Superior Court awarded several million to three people claiming that Accutane caused their inflammatory bowel disease. Inflammatory bowel disease can include Crohn’s Disease and Ulcerative Colitis and can seriously affect a patient’s quality of life and health.

In 2009, Hoffman La Roche discontinued the manufacture of Accutane citing their dwindling market share of the acne medication because of widespread generic brands. The medication that was introduced in 1982 has since treated over 13 million patients.

If you or a loved one has experienced serious side effects or health complications with Accutane, fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.