On January 29, 2016, applying the learned intermediary doctrine, the Superior Court of New Jersey granted summary judgment in 31 cases involving the drug Accutane. See In re: Accutane Litigation, No. 271 (N.J. Super. Law Div. Jan. 29, 2016). The suits alleged that manufacturers and others of the drug Accutane failed to warn that taking the drug could lead to inflammatory bowel disease.
In granting summary judgment, the Accutane court emphasized that the learned intermediary doctrine describes a duty owed from the manufacturer of a drug to the physician, not the patient, and identified six public policy concerns supporting the doctrine:
“(1) Prescription medications require far more precaution than an over-the-counter (“OTC”) drug; they cannot be purchased without the sanction of a licensed health care professional, and may involve side effects peculiar to age, gender and personal health idiosyncrasies of the patient unconnected to the illness to be treated.
(2) Prescription drugs are often complex medications; a medical expert is needed to properly evaluate the proclivities of a drug as well as the vulnerabilities of the patient.
(3) As a practical matter, with a prescription drug, it is inconceivable that a manufacturer could fulfill its obligation of a warning sufficiently understandable by the average person, without a knowledgeable person advising the patient.
(4) The treating physician plays the role of the go-between to the full extent implied by that term. A physician’s ethics as well as the standards of medical care demand independent judgment – beyond the influence of the drug manufacturers – on the part of the doctor.
(5) Were patients to be provided all the technical information on the adverse effects possibly associated with the use of the drug, it’s unlikely they would evaluate it properly, and given their lack of learning, might take drugs they should not, or refuse a drug vital to curing an illness.
(6) Human nature is what it is, the common law acknowledges that, after the fact, upon diagnosis of a condition said to be associated with a medication, that the patient is likely to testify that she/he would never have taken the medication had they known then, what they know now.”
In re: Accutane Litigation, slip op. at 7. “Once a doctor determines that a medication accompanied by a warning approved by the FDA is suitable for the patient’s condition, then the drug manufacturer has no obligation to ensure how, or if, that warning is delivered to the patient.” Id. In cases where the doctrine applies, the adequacy of a warning must be assessed from the perspective of the physician, not the patient. In re: Accutane Litigation, slip op. at 9.
In granting summary judgment on 31 of the 32 cases before it, the court found that the treating physicians’ testimony was that either, “(a) a different warning would not have altered his or her decision to prescribe Accutane, nor the way in which he or she prescribed it; or (b) a different warning would likely have altered their discussions with patients but he physician still would have prescribed the medication to a willing patient.” (The court reserved deciding in one case pending the completion of the physician’s deposition.)
The full decision can be found here.