Accutane Litigation History

Accutane, a medication used in treating serious cases of acne in which scarring may occur, has been the center of widespread litigation because of its dangerous side effects. Consequently, the drug has become the source of many lawsuits filed against the manufacturer and medical professionals who prescribed it by former consumers, who were totally unaware of the danger they were facing when they began using it.
 

About Accutane

Accutane, which is a synthetic variation of vitamin A, is also prescribed as Claravis, Amnesteem, Istane, Decutain, Ratane, Sotret, and Isotretinoin, which is the generic form. While it was originally intended to treat severe acne, some dermatologists have used it in treating even mild cases, which has compounded the problem. The drug produces the desired results after several months because it inhibits the oil gland, along with cell growth and cell reproduction. As a result, Accutane also depletes the body of essential molecules that retain water and assist in keeping the joint, skin, scalp and eyes well-lubricated.
 

Accutane’s Side Effects

Side effects include alopecia (hair loss), bone loss, weak skin, psychotic behavior, aggressive behavior, suicidal tendencies, depression, miscarriages, birth defects, joint pain, pink eye, vision problems, dry mucous membranes, ringing in the ears, liver damage, anaphylaxis (a severe allergic reaction), erectile dysfunction, stroke, heart attack, seizures, inflammatory bowel disease, and inflammation and damage to the blood vessels.
 

FDA Warnings

The Federal Drug Administration (FDA) now requires that a warning be placed on the drug’s containers to alert the public of the many risks related to it. As a result, a New Jersey appeals court did not hold the manufacturer, Hoffman-LaRoche, responsible for the birth defects caused by Accutane, ruling that it had fulfilled its obligation in informing both providers and patients of the risks involved in using the drug.
 

Potential Lawsuits

Any woman who has taken Accutane should have been asked to meet specific requirements that have been approved by the FDA – known as iPledge – which would have made the possibility of miscarriage or severe birth defects clear to them before they began taking the medication. Medical professionals also should have been required to provide their female patients with this information and warned them about becoming pregnant while they were taking the drug. Those who did become pregnant should have been urged to discontinue using it and consult a physician with experience in treating reproductive toxicity. Those who were not given this warning have a legitimate grievance against either their doctor, who presumably was negligent, or Roche itself.
 

Litigation History

In general, consumers who were given a prescription for Accutane (before the manufacturer made known to the public that a number of serious risks were associated with taking the drug) have succeeded in winning their cases in court. For example, three individuals who claimed that Accutane was the cause of their inflammatory bowel disease were awarded several million by the New Jersey Superior Court. Ulcerative colitis and Crone’s disease are two forms of inflammatory bowel disease that have a serious negative impact on a patient’s health and quality of life.
 

About the Manufacturer

Hoffman-LaRoche, Accutane’s manufacturer in the United States, belongs to “The LaRoche Group,” an international conglomerate that has affiliates in 150 countries and one of the largest pharmaceutical companies in the world. While it is one of the manufacturer’s top sellers and annual sales are estimated at $1.2 billion, Accutane is also one of three drugs currently being sold that are known to have the most side effects, leading to widespread litigation.

In 2009, Roche announced that it would no longer manufacture Accutane, claiming that the growth of the drug’s generic brands was causing the company to lose market share and citing no other reason for taking that step. The drug, which was introduced in 1982, has been used to treat more than 13 million patients since then. Accutane, a medication used in treating serious cases of acne in which scarring may occur, has been the center of widespread litigation because of its dangerous side effects. Consequently, the drug has become the source of many lawsuits filed against the manufacturer and medical professionals who prescribed it by former consumers, who were totally unaware of the danger they were facing when they began using it.