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New York Most Recent State to Challenge Validity of Learned Intermediary Rule

| May 19, 2009 | Pharmaceuticals

The learned intermediary rule, which roughly holds that a manufacturer (typically pharmaceuticals) satisfies their duty of care by providing a “learned intermediary” (usually a doctor) with all necessary information including risk of harm, because the learned intermediary will interact with the consumer and relay the risks.

The Rule has been challenged in a number of states with a wide ranging difference of opinion… And now it comes before New York.

I do not think I could state the justification for abolishing the rule any better than the sponsors of the bill, Brodsky and Weisenberg:

In 1997 the F.D.A. relaxed its guidelines for

direct-to-consumer advertisement of pharmaceuticals. Since that time,

there has been an onslaught of marketing in an attempt to influence a

patient’s choice of a drug. These efforts have become an essential

part of manufacturer’s marketing plans, resulting in an increase from

$843 million in 1997 to annual costs in the billions for print and

broadcast advertising. This change has also resulted in an increase in

the number of prescriptions written: fifteen months into the

relaxation of the guidelines, one heavily marketed drug saw an

increase in sales of more than one hundred times that of prescriptions

written prior to advertisement.

This controversial new marketing technique, opposed by the American

Medical Association, undermines the patient-physician relationship by

encouraging consumers to ask for advertised products by name. As

“patient choice” becomes an increasingly popular concept,

are being relegated to a passive role where, upon demand, the patient

receives a prescription for the advertised drug 73% of the time.

The purpose of the bill, as stated by the sponsors, echoing the opinion of all those who oppose the learned intermediary rule is:

To require that pharmaceutical

manufacturers who engage in direct-to-consumer advertising of

prescription drugs satisfactorily advise consumers of the risk

involved in the ordinary use of the prescription advertised. This bill

also requires that, in products liability actions, the adequacy of the

warning be a question of fact for the jury.

I applaud the New York assembly for challenging this rule and hope that it abolished. Such a doctrine may have been appropriate in 1966 when it was first raised in Sterling Drug v. Cornish, 370 F. 2d 82), but it is a dangerous doctrine today when pharmaceutical companies directly advertise their product to the public.