Defective Drugs: AccutaneAccutane is an acne medicine that hit the markets in the 1980s from manufacturer Roche Pharmaceuticals. It became a best-selling prescription drug for being hailed by dermatologists as a breakthrough treatment for patients suffering from severe acne. What does the drug do? Its chemical composition resembles retinoic acid, which is a compound derived from Vitamin A. The drug is for patients who do not respond to topical applications and standard antibiotic treatments and is used for patients with nodular acne. People who have nodular acne will likely display red, tender and swollen bumps under the skin, which can lead to permanent facial scarring and disfigurement when left untreated. Accutane treats the bumps by slowing the rate of chemical production that leads to skin breakouts.

This sounds great for patients suffering from severe acne, right? Well, pretty soon, Accutane was in the news for things other than being hailed by dermatologists as some miracle drug. Pretty soon, Accutane was being linked to serious side effects like birth defects, thoughts of suicide, depression and bowel disorders. These dangerous side effects affected thousands of patients over the past 30 years in various ways.


A year after the first prescriptions of Accutane were written in 1982, a baby was born with malformations after a pregnant woman took the drug during pregnancy. In 1983, two “Dear Doctor” letters were released. These are special communications that the FDA requires drug manufacturers to release if the drug label is not complete in covering the extent and severity of side effects. These letters alert physicians of the possibility of birth defects in infants when the drug is taken. From the years 1984 to 1988, even more of these letters were sent out.

For years to come, Accutane was seen as dangerous by more and more people. For instance, in 1983, Dr. Frank Yoder (one of the scientists involved in the discovery of Accutane) wrote a letter that informed the public of the possibility that Roche was not clear when alerting users of the toxicity associated with the drug. That same year, the health advocacy group Public Citizen petitioned the FDA to add warnings of birth defects to labels, which they did in 1985 by issuing a black-box warning to the drug. In 1988, furthermore, a pregnancy prevention program was put into place to decrease the amount of women getting pregnant while taking Accutane. This helped to decrease the percentage of women getting pregnant on Accutane, from 4 women per every 1,000 a year to less than 2 for every 1,000. The CDC also played a role in affirming the dangers of Accutane by publishing information on the fetal toxicity of the drug.

In June 2009, the number of adverse reports from the FDA and lawsuits from patients only continued to grow. This prompted Roche to stop manufacturing Accutane altogether. The company stated on the matter that it was an economic decision based on generic brands of the medication taking over the market, and it was also recalled in 11 other countries.

Accutane lawsuits coming in against Roche were not limited to bowel disease; no, they were also brought from patients and families of patients who have experienced side effects such as birth defects, depression, and suicide attempts. 7,000-plus lawsuits were filed against Roche over the debilitating side effects sustained by users. If you or a loved one have taken a drug that turned out to be defective and cause serious complications or injury, you may have a lawsuit as well. Call Welebir Law today to speak to your attorney about where you should head with your possible claim.


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