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A patient who has been injured by a prescription drug or medical device may sue the manufacturer on one or more theories of strict liability, negligence or breach of warranty, which often merge in an inadequacy-of-warning case. Sec. 402A of the Restatement (Second) of Torts imposes liability on the manufacturer of a product that is sold “in a defective condition unreasonably dangerous to the user or consumer,” regardless of whether the manufacturer “has exercised all possible care in the preparation and sale of his product.” When defending the strict liability claim, the manufacturer, however, generally relies on the Restatement (Second) of Torts, � 402A, Comment K, which deals with “unavoidably unsafe” products. Adopted in 1964, � 402A helped establish the doctrine of strict product liability. It adopted the basic rule that a consumer injured by a dangerous product can recovery from the manufacturer without proving fault. In a pharmaceutical/medical device context, � 402A provides, in part, that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs…. [S]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” A finding by the courts of an “unavoidably unsafe” product can relieve the manufacturer from strict liability for injury resulting from its use only if the product is properly manufactured and accompanied by adequate directions and warnings of the product’s inherent dangers. This is where the learned intermediary doctrine comes in. The learned intermediary doctrine provides that the manufacturer or supplier of a prescription drug or medical device has no legal duty to warn a consumer of the dangerous propensities as long as adequate warnings are provided to the prescribing physician. But in this era of patients taking more control over their health care while, at the same time, pharmaceutical companies are marketing directly to the consumer, the impact of the learned intermediary doctrine as an affirmative defense appears to be on the wane. [For a list of learned intermediary case law by states, see the related Practice Tool.] COURTS STRICT IN WARNING’S ADEQUACY Under the learned intermediary doctrine, which was first articulated in Sterling Drug v. Cornish, 370 F.2d 82 (8th Cir. 1966), a prescribing physician is deemed to act as a “learned intermediary” between the manufacturer and the consumer 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 (5th 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. Some courts have found that 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 (1st Dist. 1997). In that case, 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. More recently, in Anderson v. Sandoz Pharmaceuticals Corp., 77 F. Supp. 804 (S.D. Tex. 1999), the court denied defendant’s motion for summary judgment on the grounds that the manufacturer did not share all its available research and, therefore, the physician was unable to make an informed decision. The warning must be reasonable under the circumstances. Generally, that means that sufficient information must be provided to a physician who may have the least knowledge and experience with the drug or device. The warning also must accurately, clearly and consistently portray the risks involved. Martin v. Hacker, 83 N.Y.2d 1, 607 N.Y.S.2d 598, 628 N.E.2d 1308 (1993). Courts are divided as to whether the adequacy of a manufacturer’s warning is a question of fact to be determined by a jury or a question of law. Id., 83 N.Y.2d at 11. Expert testimony, in any event, is almost always necessary to establish the inadequacy of a warning. EXCEPTIONS TO THE DOCTRINE Over the years, the courts have found two broad exceptions to this rule or its inapplicability altogether under different factual scenarios. Some courts have refused to invoke the doctrine when a defendant manufacturer argues it complied with Food and Drug Administration patient labeling regulations, reasoning that such regulations do not define the bounds of a manufacturer’s duty to warn for state tort law purposes. Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997); see also MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65 (Mass. 1985), cert. denied, 474 U.S. 920 (1985); McEwen v. Ortho Pharmaceutical Corp., 270 Ore. 375, 528 P.2d 522 (Ore. 1974). The Edwardscourt relied on Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), in which the U.S. Supreme Court held that the FDA’s regulation of medical devices does not preclude state tort liability, noting that it has long been within the realm of the states, under their police powers, to protect the health and safety of their citizens. Another court held a manufacturer of oral contraceptives liable for its failure to comply with federal package insert warning requirements and that a duty to warn also ran directly to the patient-user. Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, modified, 532 F. Supp. 211 (E.D. Wisc. 1981). Bear in mind that, when responding to a new drug application, the FDA is entirely dependent on testing that is performed and reported by the sponsoring manufacturer. The FDA regulates the testing process, the study design, the method by which the design is carried out and data integrity. Still, there have been reports of incomplete compliance with FDA regulations and even coverups of adverse effects and event reports. Courts also have recognized another 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, which resulted in adverse medical consequences, were not deemed to be “learned” for purposes of the doctrine’s applicability and, therefore, were not capable of performing the risk/benefit analysis typically conducted by prescribing physicians. As early as 1977, the 5th U.S. Circuit Court of Appeals applied the mass immunization exception even to a private physician who administered a vaccine, because the physician’s office was run much like a public clinic. Givens v. Lederle, 556 F.2d 1341, 1345 (5th Cir. 1977). In those cases, the manufacturer’s duty to warn has been held to extend to the ultimate consumer. Davis v. Wyeth Laboratories Inc., 399 F.2d 121 (9th Cir. 1968); Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974). DUTY TO WARN EXTENDS DIRECTLY TO CONSUMER An extension of this theory is being applied by some courts in the area of elective medical devices and prescriptions that are marketed directly to the consumer, as in breast implant and IUD litigation. See Hill v. Searle Laboratories, 884 F.2d 1064 (8th Cir. 1989). In Perez v. Wyeth Laboratories Inc., 161 N.J. 1, 734 A.2d 1245 (1999), a case involving the contraceptive drug Norplant, 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 companies’ 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. Other courts, too, are finding that manufacturers that advertise prescription medication directly to consumers cannot properly invoke the learned intermediary doctrine. In dictum, the court in Garside v. Osco Drug, 764 F. Supp. 208, 211 n. 4 (D. Mass. 1991), rev’d, 976 F.2d 77 (1st Cir. 1992), said: “In an appropriate case, the advertising of a prescription drug to the consuming public may constitute a third exception to the learned intermediary rule. By advertising directly to the consuming public, the manufacturer bypasses the traditional patient-physician relationship, thus lessening the role of the ‘learned intermediary.’” Therefore, courts are not allowing the learned intermediary doctrine to become a shield for these direct-marketing manufacturers whose warnings are inadequate, that conceal product defects or that misrepresent product safety. RESTATEMENT (THIRD) OF TORTS The Restatement (Third) of Torts: Products Liability, adopted in 1997, changes the face of the learned intermediary doctrine. Repudiating a rule that permits plaintiffs to win by showing that the product failed to measure up to consumers’ reasonable expectations of safety, it, instead, adopts a risk/benefit balancing test. Sec. 6(c) states that a drug or medical device is defective if, at the time of sale or other distribution, it (1) contains a manufacturing defect, (2) is not reasonably safe due to defective design or (3) is not “reasonably safe due to inadequate instruction or warnings.” Sec. 6(d) addresses the informational obligations of drug manufacturers and provides:
A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided t (1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or (2) the patient when the manufacturer knows or has reason to know that health care provider will be in a position to reduce the risks of harm in accordance with the instructions or warnings.

Although it is up to the individual states to determine whether to adopt the new provision, they are free to retain � 402A of the Restatement (Second) if they choose. One of the acknowledged weaknesses of � 402A was that its authors did not focus on two critical areas in proving defect — defective design and defective warnings — but they still admit not dealing with the relatively new concept of pharmaceutical manufacturers marketing directing to consumers. At the very least, it appears that its editors have allowed for case law to resolve whether other exceptions should be recognized. Drugs and medical devices certainly can have a great social utility, but without proper and adequate testing and truthful and full disclosure, their practical benefits are compromised. Common sense and much of the common law tells us that the manufacturer of any product it knows or should know is dangerous is going to be held to an unequivocal duty to warn consumers of inherent or potential hazards and their adverse effects. Robert A. Clifford is a partner at Chicago’s Clifford Law Offices, a nationally renowned personal injury firm concentrating in medical negligence, product liability, aviation, transportation and wrongful death litigation. He is also vice chairman of the American Bar Association Section of Litigation. Telephone: (312) 899-9090.

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