Opinion ID: 161331
Heading Depth: 2
Heading Rank: 3

Heading: The Rebuttable Presumption under the Learned Intermediary Doctrine

Text: 20 Under Oklahoma law, the Ecks benefit from the development of a rebuttable presumption in their favor: 21 [w]here a consumer, whose injury the manufacturer should have reasonably foreseen, is injured by a product sold without a required warning, a rebuttable presumption will arise that the consumer would have read any warning provided by the manufacturer, and acted so as to minimize the risks. 22 Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1382 (Okla. 1974) (emphasis added) (quoting Reyes v. Wyeth Labs., 498 F.2d 1264, 1281 (5th Cir. 1974) (applying Texas law)). The manufacturer warns the consumer, who is the prescribing physician, who, in turn, acts as the learned intermediary. See Woulfe v. Eli Lilly & Co., 965 F. Supp. 1478, 1483 (E.D. Okla. 1997) (stating the Cunningham rebuttable presumption . . . applies equally to the situation of learned intermediaries). 23 In the duty to warn context, assuming that plaintiffs have established both duty and a failure to warn, plaintiffs must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided. Mazur v. Merck & Co., 742 F. Supp. 239, 262 (E.D. Pa. 1990); see Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992) (applying Mississippi law) (stating that to create a jury question, the evidence introduced must be of sufficient weight to establish, by the preponderance of the evidence, at least some reasonable likelihood that an adequate warning would have prevented the plaintiff from receiving the drug). To inform the prescribing physicians of the potential risks of an interaction during the concomitant use of acetaminophen and Dilantin, Mr. Eck proposed that the following warning should have been included on both products: 24 Phenytoin (generic name for Dilantin) may enhance the hepatoxicity of acetaminophen secondary to enzyme induction and glutathione depletion. Patients are advised to avoid concomitant use of acetaminophen and phenytoin. 25 Aplt's App. vol. III, doc. 31, at 2 (Dist. Ct. Order filed Jan. 18, 2000). 26 The district court apparently assumed without deciding that the Ecks demonstrated that the manufacturer failed to warn of a non-obvious risk about which it knew or should have known, pursuant to Cunningham. Because the adequacy of the proposed warning is irrelevant in light of Dr. Rogers' testimony discussed infra, we assume, for the limited purposes of this appeal, that the Ecks are correct in their assertion that the defendants failed to warn the prescribing physician of this risk. The Ecks thus receive the benefit of a rebuttable presumption that an adequate warning would have been read and heeded. Woulfe, 965 F. Supp. at 1483; cf. Van Buskirk, 760 F.2d at 493 (noting that defendant may defeat causation in a failure to warn case by discrediting plaintiffs' claims that . . . [the learned intermediary] . . . would have acted to avoid the injury). 27 Having established the presumption of causation-in-fact in the Ecks' favor, we must next determine whether the defendants, through the testimony of Drs. Rodgers and Newey, have rebutted this presumption. The defendants may rebut this presumption by establishing that although the prescribing physician would have read and heeded the warning or additional information, this would not have changed the prescribing physician's course of treatment. See Woulfe, 965 F. Supp. at 1485. The weight we afford to the physicians' testimony . . . depends on the substance of the evidence as well as the credibility and reliability of the treating physician[s]. Id. 28 Assuming the defendants successfully rebut this presumption, the burden shifts rather heavily back upon the Ecks. Our inquiry looks to whether the Ecks [came] forward with evidence sufficient to submit the case to a jury to determine if [defendants'] alleged inadequate warning[s] were a proximate cause of Mr. Eck's injuries. Id. at 1483; see also Garside, 976 F.2d at 81 (noting that once the presumption is rebutted, plaintiff must produce sufficient evidence to create a triable issue on the question of causation). To submit the case to a jury, the Ecks must either discredit the physicians' testimony or call into question the substance of the testimony, or otherwise demonstrate that the alleged failure to warn was the proximate cause of their injuries. Such a showing requires that the plaintiff demonstrate that the additional non-disclosed risk was sufficiently high that it would have changed the treating physician's decision to prescribe the product for the plaintiff. Thomas, 949 F.2d at 813 (applying Mississippi law); see also Woulfe, 965 F. Supp. at 1485-86; In re Norplant Contraceptive Prods. Liability Litig., 955 F. Supp. 700, 710 (E.D. Tex. 1997) (where physician was aware of dangers associated with drug and information that would have been provided in warning would not have changed his decision to prescribe drug, court held no causation), aff'd, 165 F.3d 374 (5th Cir. 1999).