Health Care Practitioner Liability Associated with Accutane Distribution

While the majority of medical malpractice claims are associated with negligent surgical procedures, patients have brought successful medical malpractice claims based on non-surgical procedures, such as those resulting from dermatologic-related injuries.  In order to prevail on a medical malpractice claim, a patient injured by a negligently performed dermatological procedure must show that the treating dermatologist departed from accepted standards of care, and that the dermatologist's negligence caused the patient's injury. 

 

Dermatologists, along with other health care practitioners, may also face liability for failing to warn a patient regarding dangerous side effects from medication.  Accutane, a medication intended to treat severe acne, is one such medication.  However, unlike most medications, with Accutane, health care providers are expected to do much more than merely warn patients of Accutane's side effects.

 

Risks of Congenital Defects

The basic elements of Accutane are developed naturally in all individuals as a derivative of vitamin A.  However, supplementing the body's natural occurrence of Accutane poses a risk to fetuses and is also under investigation for possible links to depression and suicide.  Even small doses of Accutane during the first few weeks of pregnancy have been known to cause life-threatening congenital abnormalities. 

 

The dangers of Accutane, also known under its generic name, Isotretinoin, were known prior to its FDA approval in 1982. Consequently, it was given an "X" rating by the Food and Drug Administration (FDA), indicating that pregnant women must avoid using it at all costs.  In 1988, when it became clear that many women were continuing to use Accutane while pregnant despite warnings, the manufacturer, Hoffman-La Roche (Roche), created the Accutane Pregnancy Prevention Program (PPP) to discourage pregnant women from using Accutane.  Along with instituting PPP, which involved sending special materials to physicians to be given to and explained to patients, Roche set up a toll-free number, distributed contraception information in numerous languages and offered to finance family planning counseling.  Nevertheless, a study conducted regarding the nine years following the PPP's introduction demonstrated that many women continued to take Accutane while pregnant.

 

In 2002, to provide additional safeguards against birth defects, Roche and the FDA introduced a program called the System to Manage Accutane Related Teratogenicity (SMART).  As a result of SMART, in order to obtain Accutane, female patients must agree to follow strict guidelines, including the following:

• Take two pregnancy tests showing negative results (tests to be provided by Roche)
• Agree to use two forms of contraception one month prior to, during and following Accutane treatment
• Sign a patient / information consent form after reading cautionary materials
• Be informed of the purpose and significance of the "Accutane survey," a survey to test the effectiveness of the SMART program

Male patients must also be informed by health care practitioners of the risks associated with Accutane.  Specifically, male patients must be cautioned not to share Accutane with anyone and refrain from donating blood during Accutane treatment.

 

Additional Action to Protect Patients and Fetuses

Despite the strict requirements under SMART, the number of pregnancies of women on Accutane did not improve, prompting the FDA to consider an additional program to protect against such pregnancies. Although all of the details of the program have not been disclosed to the public, experts anticipate that the FDA will require patients and associated health care practitioners to enroll in a central registry.  Many believe that such action will severely restrict the use of Accutane, while at the same time reduce birth defects.

 

Health Care Practitioner Liability

Based on the above distribution requirements, if a dermatologist or other health care practitioner fails to comply with the SMART requirements and prescribes Accutane to a pregnant woman, the prescribing physician may be liable for medical malpractice.  Similarly, such practitioners may also be subject to liability if a male patient is not sufficiently warned of the dangers and consequently shares the treatment with a female who gives birth to an infant with Accutane-caused birth abnormalities.

 

Isotretinoin and the Canadian / U.S. Drug Import Debate

In 2004, the debate with respect to allowing U.S. residents to take advantage of lower medicine costs available in Canada became increasingly prominent due to election-year politics.  Officials against allowing U.S. residents to use such medications have cited the dangers of counterfeit drugs as the primary reason.  However, in January 2004, the dangers of Accutane added a new element to the debate when the FDA and other U.S. officials intercepted a cache of medications being imported from Canada, including a Canadian version of Accutane.  U.S. health officials have since expressed concern that medications imported from Canada, such as Accutane and other heavily restricted medications, may be distributed to patients, subverting efforts to avoid related complications.