Andriana Hansen was admitted to Mt. Sinai Hospital for stomach ulcer surgery in March, 1991. In preparation for surgery, a doctor inserted a catheter into Hansen’s jugular vein to allow the transfusion of blood and other fluids.

A connector that linked intravenous (I-V) tubing to Hansen’s catheter came apart, allowing air to enter Hansen’s brain, causing brain damage from which she later died. A jury awarded $18 million to Hansen’s estate against the I-V’s manufacturer, Baxter Healthcare Corp., for failure to warn and defective design.

On appeal, the general verdict was upheld since the court found sufficient evidence to sustain the defective design theory. Hansen v. Baxter Healthcare Corp., 309 Ill.App.3d 869, 723 N.E.2d 302 (1^st Dist. 1999).

The court, however, found that as a matter of law, Baxter had no duty to warn Mt. Sinai’s doctors about risks of which the doctors and medical community already were well-aware, relying upon the learned intermediary doctrine.

Under this doctrine, which apparently was first coined in Sterling Drug v. Cornish, 370 F.2d 82 (8^th Cir. 1966), a prescribing physician is deemed to act as a "learned intermediary" between the manufacturer and the consumer. The doctrine relieves drug and medical device manufacturers of a duty to warn a patient when the manufacturer has provided an adequate warning to the medical community.

The rationale of the learned intermediary doctrine is further explained in Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5^th Cir. 1974): Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities and side effects of the drug as well as the susceptibilities of the patient; in essence, weighing the benefits of any medication against its potential dangers.

Conversely, if the prescribing physician is not sufficiently warned, the doctor is not acting as a learned intermediary for the purpose of determining whether the warning was adequate.

Take, for instance, Proctor v. Davis, 291 Ill.App.3d 265, 682 N.E.2d 1203 (1^st Dist. 1997). There, the doctor injected a steroid into a patient’s eye to correct blurred vision and, instead, the patient suffered retinal detachment and blindness.

The court, on appeal, concluded that "an imbalance of information" existed between the manufacturer and physician because some of the literature available in the medical community generated by the manufacturer was misleading as to the safety and efficacy of the drug’s use.

Courts, however, have recognized a further exception to the learned intermediary doctrine, stemming from mass polio immunizations administered in the late 1960s and early 1970s.

In a series of decisions across the country, it was found that health care providers, who were administering the vaccines that resulted in adverse medical consequences, were not deemed to be "learned" for purposes of the doctrine’s applicability and, therefore, we not capable of performing the risk/benefit analysis typically conducted by prescribing physicians.

Although this common law doctrine serves generally as an exception to the rule that a failure to warn of a product’s dangerous propensities may serve as a basis for holding the manufacturer liable in tort, some pharmaceutical manufacturers have attempted to invoke the doctrine beyond its intended scope.

Defendant manufacturers have attempted to improperly apply the doctrine where the product is contaminated or where the manufacturer advertised directly to the consumer. Take, for instance, the recent case involving the contraceptive drug Norplant. Perez v. Wyeth Laboratories, Inc., 151 N.J.1, 734 A.2d 1245 (1999).

In a 5-2 decision, the New Jersey Supreme Court reversed the appellate court and found that companies that advertise their drugs directly to the public also must provide consumers with adequate warnings.

While recognizing "the profound public interest in developing new products for reproductive services" and the pharmaceutical company’s right to communicate directly with the public, the court held that where defendants engage in a massive advertising campaign directed at consumers, rather than doctors, a corresponding duty arises requiring the manufacturer to reliably warn of defects in the products.

Therefore, the learned intermediary doctrine cannot become a shield for these direct-marketing manufacturers whose warnings are inadequate, who conceal product defects or who misrepresent product safety.

Just what the impact of the recent findings in mapping the human genome will mean for drug manufacturers and the extent of their duty in dispensing medical information is yet to be determined.

What is known and accepted in jurisdictions throughout the country is that the pharmaceutical manufacturers can’t have it both ways: They can’t use the learned intermediary doctrine as a sword when it is to their advantage but also as a shield to avoid liability when warnings are inadequate.

They are always the party with the superior knowledge; and they should be held to that standard when dispensing information regarding medicines and medical products, whether it be to physicians or directly to consumers.