The Cochran Firm Legal Blog

Back in 1995, one Andrew McCarrell, aged 23 at the time, began using Accutane, a drug for acne. He became ill and had to have five surgeries, one of which, in 1996, was to remove his colon. He had developed inflammatory bowel disease. Before he began taking Accutane, he was a college football player in robust health.

What is Accutane?

Accutane (Isotretinoin) is made by the Swiss pharmaceutical company, Roche Holding AG. It is a form of Vitamin A designed to reduce the amount of oil produced by the skin’s oil glands and to help the skin renew itself. Accutane is usually used for severe acne after other medications have failed to be effective. For most users, Accutane is highly effective and no further acne treatment is needed.

The company began selling Accutane in 1982 and over 13 million people began using it immediately. It can only be obtained by registering in a special program called iPLEDGE, where you sign statements saying that you understand Accutane’s dangers and that you agree to use birth control while you are on Accutane. Accutane can cause major birth defects and should not be taken by a pregnant woman. Pregnancy testing is required by the iPLEDGE program.

The Risks of Accutane

Accutane has been connected to birth defects and depression and more recently with a rare but very painful skin condition called Stevens-Johnson Syndrome (SJS). In SJS, the top skin layer dies and peels off, exposing the person to a severe risk of infection. The patient must be hospitalized in a burn unit for treatment. SJS is fatal in about three percent of cases.

Since Accutane works by inhibiting oil gland production, skin and mucous membranes over the entire body are affected. That gives rise to many side effects such as:

• Dry and itching skin
• Eye irritation
• Decreased night vision
• Increased sensitivity to the sun’s rays
• Dry nose and lips
• Intestinal and urinary problems

Most of the side effects are minor but in McCarrell’s case, the intestinal problems became major. He won a jury award in 2007 for $2.62 million but an appeals court overturned it and ordered a new trial.

The Sixth Accutane Jury Award

Yesterday, McCarrell won $25 million. He is the sixth Accutane user to win a jury award on the basis that Roche failed to warn users of the drug’s dangers (although one award, for $7.2 million has been overturned). Roche is facing about 1,000 other lawsuits and withdrew Accutane from the market in 2009.

McCarrell’s nine jurors deliberated for 3.5 hours to arrive at their decision. They also awarded McCarrell $159,000 to cover his past medical expenses. The jurors were not unanimous about whether Roche had failed to provide adequate warnings. Two of them regarded the warnings as adequate.

“It was all about the wording on the label,” said juror Vince Packer. “It didn’t give a clear-cut explanation as to what you can get by taking this drug. That’s my issue -- was it properly labeled?”

No doubt the labeling issue will be central in the remaining 1,000 or so lawsuits that remain to be tried.

If you have been harmed by a defective drug – whether defective in its medical effects or its labeling – you may have a valid claim. Please contact us if you would like to schedule a free case review. Our offices are nationwide for your convenience.

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