Accutane lawsuits and the 'learned intermediary doctrine'

October 1, 2006

Liability for failure to warn is transferred from the drug manufacturer to the treating physician. The sole exception to this doctrine is when the drug manufacturer relies on direct-to-consumer marketing.

Both he and his staff spend an enormous amount of time educating his patients as to the appropriate precautions surrounding the use of this drug. He has no difficulty complying with the increasing regulations associated with the use of oral retinoids because he firmly believes it would be a mistake for the Food and Drug Administration (FDA) to remove the drug from the market.

He and the drug's manufacturer have recently been sued by a patient with severe cystic acne for whom he prescribed oral retinoids some two years ago. As he was required to do, he warned the patient, a college student, that she must use two reliable forms of contraception, unless practicing abstinence, while on the drug. The patient, by written signature, acknowledged that she was aware of these warnings.

The patient sued both Dr. Acne and the drug manufacturer alleging that the warning to practice abstinence while on the drug was inadequate, since women of childbearing age were unlikely to remain abstinent. The manufacturer, by way of court, asked to be removed as a defendant. The court agreed, leaving Dr. Acne as the sole defendant. Dr. Acne does not understand. How could the manufacturer be discharged of any liability?

Flying solo

A recent New Jersey case addressed this very issue.

Debbie Banner sought treatment for severe acne and discussed the appropriateness of Accutane with her dermatologist. Her dermatologist complied with the Hoffman-La Roche-developed "Pregnancy Prevention Program." This, as well as the drug's package insert, mandated that patients use two forms of simultaneous birth control unless abstaining from sexual intercourse.

For religious reasons, Ms. Banner chose abstinence. However, she did not abide by this decision, became pregnant and refused to have an abortion. The baby was born profoundly disabled.

The Banners brought suit, alleging, among other issues, inadequacy of Hoffman-La Roche's warning regarding Accutane therapy and pregnancy risk. They argued that the manufacturer knew, or should have known, that women of childbearing age were unlikely to remain abstinent and, therefore, had a duty to warn Ms. Banner that abstinence alone was an unreliable form of pregnancy prevention. Hoffman-La Roche argued that the warning accompanying Accutane was adequate. The New Jersey court agreed with the company.

The issue in the New Jersey case centered on whether it was the manufacturer - or the physician - who had a duty to warn a patient about the risks of Accutane therapy and pregnancy. Ultimately, in releasing the manufacturer of liability, the court focused on the "learned intermediary doctrine." The doctrine states that a drug manufacturer generally fulfills its duty to warn the ultimate user (the patient) of its prescription drug's risks when it provides the physician with sufficient information about dangers associated with the drug.

When this doctrine applies, liability for failure to warn is transferred from the drug manufacturer to the treating physician. The sole exception to this doctrine is when the drug manufacturer relies on direct-to-consumer marketing. In the situation of direct-to-consumer marketing, the drug manufacturer must provide adequate warnings to both the physician and patient.

Ms. Banner asserted that Hoffman-La Roche advertised directly to intended consumers when the manufacturer supplied brochures to physicians, advertised in physician magazines and developed the Pregnancy Prevention Program. The court noted that physician brochures are not considered mass marketing materials. Furthermore, the court stated that the Pregnancy Prevention Program only memorialized the information communicated between physician and patient. The court found that Hoffman-La Roche's warnings were clear, unambiguous and adequate.

Because of the learned intermediary doctrine, Ms. Banner's dermatologist and Dr. Acne are left defending themselves without having the drug's manufacturer as a co-defendant.

Dr. Goldberg is the director of SkinLaser & Surgery Specialists of New York and New Jersey; director of Mohs surgery and laser research, Mt. Sinai School of Medicine; and adjunct professor of law, Fordham Law School.