Opinion ID: 161331
Heading Depth: 2
Heading Rank: 2

Heading: Failure to Warn and the Learned Intermediary Doctrine

Text: 11 The Ecks contend that Warner-Lambert and Rugby, by failing to label their products with adequate warnings of Dilantin's propensity to interact with acetaminophen, placed defective and unreasonably dangerous products in the market place that caused Mr. Eck's liver failure. The Ecks also contend the defendants were negligent in the designing, testing, warning, and marketing of their products through their failure to provide adequate instructions or warnings and by misrepresenting the safety of their products when used in conjunction with one another. 12 To recover in a failure to warn case, a plaintiff must establish both cause-in-fact (that the product in question caused the injury) and proximate cause (that the manufacturer of the product breached a duty to warn of possible detrimental reactions). McKee v. Moore, 648 P.2d 21, 23-24 (Okla. 1982). To qualify as a proximate cause of the injury, the breach of a duty or failure to warn must be a substantial contributing factor in bringing about the harm in question. See Woolard v. JLG Indus. Inc., 210 F.3d 1158, 1172 (10th Cir. 2000) (applying Oklahoma law) (noting that a proximate cause is defined as one that, in the natural and continuous sequence, produces the plaintiff's injury and without which the injury would not have happened); Van Buskirk v. Carey Canadian Mines, Ltd., 760 F.2d 481, 492 (3d Cir. 1985) (applying Pennsylvania law) (internal quotation marks omitted). 13 Oklahoma's products liability law generally requires a manufacturer to warn consumers of danger associated with the use of its product to the extent the manufacturer knew or should have known of the danger. Edwards v. Basel Pharms., 933 P.2d 298, 300 (Okla. 1997). Certain products, including prescription drugs, are unavoidably unsafe products that cannot be made completely safe, but serve a public benefit. See id.; Restatement (Second) Torts 402A cmt. k (1965) (the Restatement). Oklahoma law recognizes that drug manufacturers cannot be strictly liable merely because of the dangerous propensities of such products. See Edwards, 933 P.2d at 300. Such products, if properly prepared, and accompanied by proper directions and warning[s, are] not defective, nor [are they] unreasonably dangerous. Restatement 402A cmt. k; Edwards, 933 P.2d at 300 (stating that the law regarding such products appears at Comment k of the Restatement). 14 Relying on Comment k, the Edwards court noted the exception to the manufacturer's duty to warn the ultimate consumer known as the learned intermediary doctrine: where a product is properly prepared and marketed and proper warning is given to the prescribing physicians, the manufacturer is shielded from liability. Edwards, 933 P.2d at 300. The reasoning behind this rule is that the doctor acts as a learned intermediary between the patient and the prescription drug manufacturer by assessing the medical risks in light of the patient's needs. Id. 15 The Edwards court adopted the rationale cited by the Kansas Supreme Court when it adopted the learned intermediary doctrine: 16 Where a product is available only on prescription or through the services of a physician, the physician acts as a 'learned intermediary' between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance upon that judgment. The physician decides what facts should be told to the patient. Thus, if the product is properly labeled and carries the necessary instructions and warnings to fully apprize the physician of the proper procedures for use and the dangers involved, the manufacturer may reasonably assume that the physician will exercise the informed judgment thereby gained in conjunction with his own independent learning, in the best interest of the patient. 17 Edwards, 833 P.2d at 300-01 (emphasis added) (quoting Wooderson v. Ortho Pharm. Corp., 681 P.2d 1038, 1052 (1984) (applying Kansas law)). This rationale applies to prescription drugs, because the patient may obtain the drug only through a physician's prescription, and the use of prescription drugs is generally monitored by a physician. Id. at 301; see also Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992) (applying Massachusetts law) (The rationale underlying the [learned intermediary doctrine] is that the prescribing physician, as the 'learned intermediary' standing between the manufacturer and consumer/patient, is generally in the best position to evaluate the potential risks and benefits of ingesting a certain drug and to advise the patient accordingly. Under this doctrine, the manufacturer's duty is fulfilled once it adequately warns the physician.). 18 Thus, in this case, the Ecks contend that Warner-Lambert had a duty to adequately warn Dr. Rodgers, the prescribing physician, and Rugby had a duty to adequately warn Dr. Newey, the treating physician, of the qualities and characteristics of Dilantin and acetaminophen and of potential risks associated with their concomitant use. 19