Title: Stone v. Smith, Kline & French Lab.
Citation: 447 So. 2d 1301
Docket Number: N/A
State: Alabama
Issuer: Alabama Supreme Court
Date: March 9, 1984

447 So. 2d 1301 (1984)
Amy STONE and Glenn Stone
v.
SMITH, KLINE &amp; FRENCH LABORATORIES, et al.
82-695-CER.

Supreme Court of Alabama.
March 9, 1984.
Jack Drake of Drake, Knowles &amp; Pierce, Tuscaloosa, for appellants.
Lawrence B. Clark and Craig A. Alexander of Lange, Simpson, Robinson &amp; Somerville, Birmingham, for appellees.
Ted Taylor, Prattville, amicus curiae for appellants.
ADAMS, Justice.
Pursuant to Rule 18 of the Alabama Rules of Appellate Procedure, the United States Court of Appeals for the Eleventh Circuit has certified certain questions concerning the Alabama Extended Manufacturer's Liability Doctrine for resolution by this court. The certification opinion states:
I. STYLE OF THE CASE
II. STATEMENT OF THE FACTS
III. CERTIFIED QUESTIONS
CERTIFIED.
Plaintiffs-appellants object to both the district court's tacit finding as a matter of law that Thorazine, an ethical drug, is an "unavoidably unsafe product" as described in Comment k to Section 402A of the Restatement (Second) of Torts (1965),[1] and the predication of the first certified question on that finding. They assert that defendant-appellee should have been required to submit the question of whether Thorazine is "unavoidably unsafe" to the jury, as is ordinarily required when the defense of assumption of risk is raised under the Alabama Extended Manufacturer's Liability Doctrine. See Atkins v. American Motors Corp., 335 So. 2d 134, 143 (Ala.1976).
In response, defendant-appellee insists that it never raised the defense of assumption of risk in the trial court or on appeal, and that plaintiffs-appellants presented no facts from which the district court could conclude that Thorazine was not "unavoidably unsafe." Having carefully studied the record of this case and the briefs of the parties, we agree with these assertions of Smith, Kline &amp; French.
The district court rightly recognized the applicability of Comment k to Section 402A of the Restatement (Second) of Torts (1965), which we have said "retains its utility" under our modification of the Restatement's theory of strict liability, Atkins v. American Motors Corp., 335 So. 2d  at 143 n. 5, to the facts of this case. As has been noted, Comment k provides for drugs and vaccines an exception to the strict liability defined in Section 402A. L. Frumer and M. Friedman, 3 Products Liability § 33.02[4] (1983). Indeed, "[f]or adverse reactions to prescription drugs, section 402A does no more than codify the principles of negligence." R. Merrill, Compensation for Prescription Drug Injuries, 59 Va.L.Rev. 1, 50 (1973).[2]
*1304 The district court correctly held that under Comment k, the adequacy of a manufacturer's warning regarding dangerous conditions associated with the use of its product is not only relevant to establishing a defense of assumption of risk, but, "under the facts in this case, the issue of adequate warning pertains to the initial establishment of liability rather than constituting some type of affirmative defense." Stone v. Smith, Kline &amp; French Laboratories, CV 81-P-1146-W (N.D.Ala. July 7, 1982). In accordance with Comment k, the district court concluded, and we agree, that in the case of an "unavoidably unsafe" yet properly prepared prescription drug,[3] the adequacy of the accompanying warning determines whether the drug, as marketed, is defective, or unreasonably dangerous. Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1274 (5th Cir.1974), quoting Restatement (Second) of Torts § 402A comment k (1965). Thus, the adequacy of the warning issued by a drug manufacturer bears on whether a plaintiff has proved a prima facie case under the Alabama Extended Manufacturer's Liability Doctrine. See Casrell v. Altec Industries, Inc., 335 So. 2d  at 132; Atkins v. American Motors Corp., 335 So. 2d  at 141.
Inasmuch as the defense of assumption of risk is not at issue in this case, we see no need to address the second certified question. Therefore, we proceed to answer the third question.
Cholestatic jaundice is a risk known to attend the use of Thorazine, even though the jaundice occurs only in a small percentage of patients for whom the drug is prescribed. In seeking a determination of liability on the part of Smith, Kline &amp; French, plaintiffs-appellants have not indicated that they are prepared to prove that the risk is unreasonable, but only that it materialized in the course of Amy Stone's treatment with Thorazine.[4] They concede that Amy Stone's physician was adequately warned of the adverse side effects, including cholestatic jaundice, which sometimes accompany the use of Thorazine. Nevertheless, they contend that the warnings issued are of no consequence, because prescribing physicians cannot accurately predict which of their patients will develop jaundice as a result of treatment with Thorazine. In essence, they assert that Amy Stone's physician was incapable of making an informed choice to prescribe Thorazine, because he was unable to predict the occurrence of an adverse reaction. We disagree.
Plaintiffs-appellants misconceive the physician's role in prescribing ethical drugs, and the significance of a drug manufacturer's warnings in undertaking that responsibility. A proper understanding of that role has been articulated by the United States Court of Appeals for the Fifth Circuit as follows:
Reyes v. Wyeth Laboratories, 498 F.2d  at 1276. (Emphasis in original.) Accord, Timm v. Upjohn Co., 624 F.2d 536, 538 (5th Cir.1980). Based on this sound reasoning, which we adopt, we answer the third certified question in the affirmative.
QUESTIONS ANSWERED.
TORBERT, C.J., and MADDOX, FAULKNER, JONES, ALMON, SHORES and BEATTY, JJ., concur.
[1]  k. Unavoidably unsafe products. There 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. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.
[2]  Professor Merrill indicates that Comments j and k to Section 402A clearly retain the tort concept of fault in the context of "unavoidably unsafe" products such as drugs:

Although section 402A is commonly thought to impose liability without fault, in most prescription drug cases it does not. The requirement that the product be unreasonably dangerous, as amplified by comments j and k, produces essentially the same result as traditional negligence theory in cases of the manufacturer's alleged failure to provide adequate warnings.
59 Va.L.Rev. at 31. Thus, the Restatement's blueprint for the liability of drug manufacturers substantially comports with our remodeling of Section 402A in Casrell v. Altec Industries, Inc., 335 So. 2d 128 (Ala.1976), and Atkins v. American Motors Corp., 335 So. 2d 134 (Ala.1976). In both of those cases, this court declared that Alabama's version of extended manufacturer's liability is not a "no-fault" doctrine. Casrell v. Altec Industries, Inc., 335 So. 2d  at 132; Atkins v. American Motors Corp., 335 So. 2d  at 138-39.
[3]  Plaintiffs-appellants have not attempted to prove that the Thorazine administered to Amy Stone was improperly or negligently prepared.
[4]  In response to Smith, Kline &amp; French's motion for summary judgment, plaintiffs-appellants stated:

Plaintiffs admit that the physician of Amy Stone was so adequately warned. However, plaintiffs dispute the legal conclusion drawn from that fact by defendant. Plaintiffs' position is that Thorazine is unreasonably dangerous and defective, under Alabama law, because the drug causes a small percentage of users to develop cholestatic jaundice. There is no way for the prescribing physician to prevent the reaction once the drug is used. The only "treatment" for the reaction is to discontinue use of the drug. These facts make the drug defective.