Accutane, a Vitamin A synthetic drug, was developed by Hoffman La Roche for the treatment of severe acne, as it was found to be quick and effective in clearing skin with results seen in a matter of months.
Acting as an oil gland inhibitor, it also stymied cell reproduction and growth, depleting the skin – as well as other parts of the body – of moisture. While this treatment was originally approved for more extreme acne, many doctors prescribed the medication for milder skin irritations, allowing for potential side effects that could possibly outweigh the benefits.
Accutane created 1.2 billion dollars worth of sales for Hoffman La Roche annually.
Legal Action Against Accutane
Many lawsuits have been filed against Hoffman La Roche and the medical professionals prescribing the drug due to patients’ alleged lack of information about a variety of unreported side effects and health risks that the plaintiffs claimed against Accutane.
These side effects include:
- pain in the back and joints,
- suicidal tendencies and depression,
- miscarriages and birth defects,
- weakened skin,
- dry mucous membranes,
- aggressive behavior,
- heart attack,
- vision problems,
- including pink eye and excessive dryness,
- allergic vasculitis,
- inflammatory bowel disease,
- erectile dysfunction,
- bone loss,
- lowered white blood cell count,
- ringing in the ear
- and liver damage.
The FDA responded by issuing a warning label for Accutane packaging and marketing, explaining the associated risks with taking the controversial medication.
Because of this black box notification, an appeals court in New Jersey found in favor of Hoffman La Roche, maintaining that the company had done enough to inform the patients of the risks involved.
Hoffman La Roche also won a case in federal court brought against the company by a prescribed Accutane user, who had part of his colon removed after a severe bout of inflammatory bowel disease that he alleged was caused by the medication.
Complications with Pregnancy
Accutane should not be taken by pregnant women, and those women who do take it have to meet the FDA approved requirements of iPLEDGE, a risk management program to protect the fetus from the drug Isotretinoin, the generic form of Accutane.
This is to ensure that patients understand the birth defect and miscarriage risks, before taking the medication. Besides Isotretinoin, Accutane is also prescribed under the names Amnesteem, Claravis, Decutan, Istane, Sotret, Ratane and Raccutane.
If conception occurred after taking any of these prescribed drugs, the patient should have been instructed to stop using this medication and seek medical attention for toxicity. If this warning did not transpire, these women may have a justifiable legal case.
When a person is not warned of a drug’s known health risks, the attending medical professional can be held accountable for any negative outcome.
This could be considered negligence, as a doctor did not pass along pertinent information to his patient, even though he was aware of the potential dangers involved. Court rulings for those who began taking Accutane before Hoffman La Roche implemented its warning system are usually positive for the plaintiff.
Three people, citing Accutane as the cause of their Inflammatory Bowel Disease – which has been known to lead to Crohn’s Disease or Ulcerative Colitis – were awarded several million dollars by the New Jersey Superior Court.
Although Hoffman La Roche discontinued the manufacturing of Accutane in 2009 – claiming profit loss brought about by generic brands – 13 million people have been treated with the drug.
If you or someone you know has been burdened with health complications or negative side effects due to the use of Accutane, you should consider seeking immediate legal representation.