Accutane Lawsuits

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What is Accutane?

Accutane® (isotretinoin or roaccutane) is considered by many dermatologists to be the strongest, most effective weapon against persistent, severe acne. A derivative of Vitamin A, the drug works by reducing the skin's production of oil. It's typically prescribed in cases of serious, scarring acne that have not responded to other treatments, including the long-term use of antibiotics and antibiotic creams. Users say it's worked "miracles" by curing stubborn and painful breakouts of severe cystic acne.

As a business venture, Accutane® has been a major money-maker for its manufacturer, pharmaceutical giant Hoffman-La Roche (Roche), which introduced the drug, with U.S. Food and Drug Administration (FDA) approval, in 1982. But the number of prescriptions is currently down in the United States, most likely because of public concern regarding the serious side effects associated with taking the drug.

What are the Risks Associated With Accutane?

There are multiple known, serious risks associated with taking Accutane®. Among the more serious complications are:

• Miscarriages, birth defects, premature births, and deaths in babies whose mothers take the drug while they are pregnant
• Depression, suicidal thoughts, and suicide attempts
• Clinical hepatitis and liver damage
• Inflammatory bowel disease, ulcerative colitis, Crohn's Disease, and rectal bleeding
• Spontaneous osteoporosis, decrease in bone density, bone fractures, delay in healing of bone fractures, and muscle weakness
• Decreased night vision
• Temporary or permanent hearing loss.

Additionally, some people taking Accutane® have temporarily developed high cholesterol and other blood fats. Other users have had serious allergic reactions to the drug.

Less serious side effects include:

• Headaches
• Chapped lips
• Dry skin
• Dry eyes
• Temporarily thinning hair
• Dry nasal passages leading to mild nosebleeds.

Because of the number of side effects directly related to Accutane®, the FDA requires all potential users of the drug to sign a consent form. Since 1996, pharmacists have been required to give users a detailed warning brochure called a Medication Guide. Only two other drugs, Thalidomide and Mifeprex, have required a Medication Guide.

What Link is There Between Accutane and Birth Defects? There is an extremely high risk of severe birth defects if a woman becomes pregnant while taking Accutane®. Because of the high risk of birth defects, the Accutane® label includes the following warning:

Accutane must not be used by female patients who are or may become pregnant.

In an effort to further minimize fetal exposure, the FDA has restricted the marketing of Accutane® and its generic formulations to a special distribution program called iPledge^TM. This system replaces a less restrictive system called the System to Manage Accutane-Related Teratogenicity (SMART) program, which was instituted by Roche and the FDA in 2002--20 years after the drug was first approved for use. iPledge^TM, which becomes effective on December 31, 2005, requires doctors, patients, and pharmacies to register in the iPledge^TMprogram in order to prescribe, receive, or dispense Accutane® or any comparable form of isotretinoin, including Amnesteem®, Claravis®, and Sotret®.

The million-dollar question in lawsuits claiming that Roche is liable for birth defects caused by Accutane® is when the company actually knew that the drug was dangerous for pregnant women and their embryos. Roche did try to reduce fetal exposure by instituting a Pregnancy Prevention Program in 1998, but that program failed since the number of women who got pregnant while taking Accutane® increased. The SMART program, instituted by the company with the FDA's approval in 2002, also failed to protect pregnant women and their unborn children. The iPledge^TMprogram, while more rigorous, raises questions about medical privacy and limits on the FDA's regulatory authority.

What Link is There Between Accutane and Suicide?

Accutane® has also been linked to serious mental health problems, including depression and suicide attempts. Public awareness of this risk increased after Michigan Congressman Bart Stupak's son committed suicide in May 2000 while taking the drug.

Although Roche denies the connection between Accutane® and an increased risk of suicide, several lawsuits have been filed on behalf of Accutane®-related suicide victims. Congressman Stupak's interest in the issue has brought several important facts to light. For example, in 1997 when the FDA initiated discussions with Roche concerning reports of serious psychiatric disorders associated with Accutane®, the company neglected to disclose that the French equivalent of the FDA had ordered Roche to add "suicide attempt" to the Accutane® warning label earlier that year. In fact, while the FDA was prodding Roche to strengthen warnings of Accutane's risks of "depression, psychosis and, rarely, suicidal ideation, suicide attempts and suicide," the company was marketing Accutane® as an effective treatment of severe acne that minimized negative psychosocial effects such as depression and poor self-esteem. Roche did not stop this marketing tactic until after receiving a warning letter from the FDA in March 1998.

The Accutane® warning label was changed to reflect the full psychiatric warnings on May 1, 2000. The FDA, meanwhile, continues to assess reports of suicide and suicide attempts associated with the use of the drug.

Who Can File an Accutane Lawsuit?

If you have suffered a Accutane®-related injury, or if you are a close family member of someone who died as a result of taking Accutane®, you may be able to file an Accutane® lawsuit.

How Do I File an Accutane Claim?

When choosing a lawyer, you should look for someone who has experience dealing with Accutane® lawsuits. After all, Roche has legal experts defending it against Accutane® claims that are similar to yours. You should find a lawyer with proven experience in the field, someone who has the resources and contacts to deal with your case quickly and efficiently.

An experienced lawyer will be able to advise you about your options, including whether you should file an individual lawsuit or opt for a class action. Your lawyer may be able to advise you about your chances of success and give you an idea of how much compensation you can reasonably hope to recover. Once you have selected a lawyer, you will need to provide information regarding:

• When and how long you took Accutane®, as well as the dosage
• What type of Accutane®-related injury you suffered, when the injury occurred, and whether you were taking Accutane® at the time
• Whether you sought medical or psychological help for your symptoms

The more information you provide your lawyer, the better chance he or she will have of preparing a solid Accutane® case for you. As your case develops, your lawyer will be able to advise you about accepting an out-of-court settlement, if one is offered, or if you should go to trial.

How Can I Report a Serious Side Effect With Accutane to the FDA?

If you're aware of a serious adverse reaction to Accutane®, the FDA encourages you to make a MedWatch report (click on "How to Report") or call 1-800-FDA-1088.

More Information

Articles

- More information on the topics of drug and medical devices, class actions
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Web Links

- Accutane® from the FDA, including historical information and a copy of the
Medication Guide
- iPledge^TMprogram, or call 1-866-495-0654
- DEA "Consumer Alert!" concerning buying drugs online
- Drug and Medical Devices Lawyers
- Class Action or Products Liability message boards for more help