Court Opinion

ID: 4711066
Source: CourtListenerOpinion
Date Created: 2021-08-12 00:36:33.243814+00
Date Added: 2024-06-11T08:07:06.671568
License: Public Domain

Madsen, J.
(dissenting) — The majority has adopted, verbatim, the Court of Appeals’ analysis regarding plaintiffs strict liability claim for failure to adequately warn of the dangers of Theo-Dur.4 Unfortunately, both the majority and the Court of Appeals fail to recognize that while application of the comment k exception to Restatement (Second) op Torts § 402A (1965) depends upon adequate warnings having been given, the adequacy of warnings is not measured by comment k, but is instead measured by the strict liability standard of § 402A. Rogers v. Miles Labs., 116 Wn.2d 195, 802 P.2d 1346 (1991) contains language supporting the majority. However, the analysis in Rogers was founded on a California Supreme Court decision which the California Court subsequently explained did not hold that comment k alters the § 402A rule of strict liability when the claim is failure to adequately warn. Rogers is, thus, inconsistent with the California law it purports to follow. It is also inconsistent with the court’s holding that a failure to warn claim is a strict liability claim.
Three types of product defects may give rise to a strict liability claim against a product’s manufacturer: a flaw in *180the manufacturing process; a defect in design; or a failure to warn of dangers in the use of a product which renders an otherwise reasonably safe product dangerous. American Law of Products Liability 3d § 17:3, at 12 (1987). Under the Restatement (Second) of Torts § 402A, a manufacturer is strictly liable for either a defective condition in the product arising from design or manufacture, or a failure to give adequate warning of the risks associated with use of the product. Id. Washington adopted the rule of strict liability embodied in § 402A. Ulmer v. Ford Motor Co., 75 Wn.2d 522, 531-32, 452 P.2d 729 (1969). In Little v. PPG Indus., 92 Wn.2d 118, 120, 594 P.2d 911 (1979), this court made it clear that the rule of strict liability in Washington encompasses claims of failure to warn. The focus of inquiry in a failure to warn claim is on the warning itself and the reasonable expectations of the consumer. Id. at 122. The adequacy of the warning, in most cases, is a jury question. Id. at 123. In strict liability, as opposed to negligence, the reasonableness of the defendant’s failure to warn is immatérial. Id. at 122.
The sole claim in the case before us is that the manufacturer, Key Pharmaceuticals, failed to adequately warn of the risks involved in using Theo-Dur. The trial court found that the prescription drug in this case, Theo-Dur, fell within the exception to § 402A’s strict liability standard embodied in comment k. The court then concluded that the rule of strict liability does not apply to a product encompassed by comment k.
The majority, by adopting the Court of Appeals opinion, agrees with the trial court, finding Rogers, 116 Wn.2d 195, dispositive on the question of "whether comment k should apply to shield a manufacturer from strict liability when it fails to adequately warn of the dangers of its product.” Majority at 168. The majority concludes that the Rogers court "rejected the argument that, where a manufacturer has not met its duty to warn, it would be strictly liable.” Majority at 168. I agree with the majority that Rogers indeed considered the question and reached the attributed *181conclusion. I strongly disagree, however, with the majority’s conclusion that Rogers either establishes binding precedent or makes good sense.
The starting place in the analysis must be Restatement (Second) of Torts § 402A, which sets forth a strict liability rule relating to defective products. Section 402A, comment k, establishes an exception to that rule in the very limited circumstance in which a product cannot be made safe for its ordinary and intended use, such as in the case of some drugs. Where the prerequisites of comment k are met, a manufacturer of such an unavoidably unsafe product may be liable only in negligence for injuries proximately caused by the qualifying product. The rationale underlying the exception is the recognition that certain products are incapable of being made safe for their intended and ordinary use, but the marketing of such products is justified despite the medically recognizable risk because of the social utility of having the product available. Provided that such products "are properly prepared and marketed, and proper warning is given” a manufacturer of a product falling within the ambit of comment k will not be strictly liable for the consequences of using the product merely because it has undertaken to supply the public with an apparently useful and desirable product, attended with a known, but apparently reasonable, risk. Restatement (Second) of Torts § 402A, cmt. k (emphasis added). Such a product "properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” Restatement (Second) of Torts § 402A, cmt. k (some emphasis added).
By its express terms, comment k protection from strict liability is not available to a manufacturer who fails to adequately warn. Comment k does not state whether the adequacy of its required warning is measured under a negligence or strict liability standard. This is so because the comment is intended to apply to a claim of design defect and assumes that adequate warnings were given. Adequate warnings are a predicate to application of com*182ment k, but the adequacy of those warnings is not governed by comment k. Rather, warnings are measured under the rule set forth in § 402A, and the exception to that rule, outlined in comment k, applies only after the trier of fact determines whether the known or knowable risk was disclosed. Under Little v. PPG Industries, 92 Wn.2d 118, the reasonableness of the defendant’s failure to warn is immaterial. Instead, the manufacturer is strictly liable for its failure to adequately warn, measured by the reasonable expectations of the ordinary consumer, or the reasonable expectations of a learned intermediary.
In Rogers, this court departed from Washington precedent regarding failure to warn, stating that "[i]f the manufacturer of an unavoidably unsafe product fails to provide an adequate warning, it has been negligent—but it is liable in negligence and not in strict liability.” Rogers, 116 Wn.2d at 207.
Initially, it is important to recognize that the plaintiff in Rogers did not claim that the warning in that case was inadequate. Thus, the adequacy of warnings under comment k was not before that court. Rogers came to this court on a certification from the federal district court. The plaintiff in that case argued that the blood product, factor IX concentrates, manufactured by the defendants, was contaminated with human immunodeficiency virus (HIV) antibodies and the plaintiff was injured as a result. The plaintiff claimed that the defendant manufacturer should be held strictly liable under Washington law because the blood shield statute (RCW 70.54.120) excluded for-profit transactions from its protection. The federal court asked:
Whether, in Washington, the doctrine of strict liability is applicable to a for-profit pharmaceutical company for injuries allegedly resulting from the processing and supplying of blood products contaminated with HIV, the virus causing AIDS, where those blood products were derived from plasma obtained from compensated donors?
Rogers, 116 Wn.2d at 197 (emphasis added). At that time, *183Washington’s blood shield statute provided immunity from strict liability for individuals and corporations dealing in blood products. The statute expressly provided, however, that its protection did not extend to "any transaction in which the donor receives compensation.” RCW 70.54.120. The parties agreed that the defendants in Rogers compensated their donors. The plaintiffs argued that because the defendants compensated donors, and thus fell outside the immunity of RCW 70.54.120, the defendants were held to answer in strict liability.
To answer the certified question, the court first considered whether the Legislature intended the manufacturer of blood products which compensated its donors be held to a strict liability standard by excluding compensated donor transactions from protection under RCW 70.54.120. The Rogers court declined to make a distinction based on for-profit status and concluded that exclusion of for-profit transactions from the statute did not dictate a strict liability standard be applied to the defendant manufacturer. The court then went on to discuss whether the manufacturer could be held strictly liable under the common law. In its analysis under common law, the Rogers court acknowledged that Washington had adopted a theory of strict liability as applied to manufacturers in Ulmer, 75 Wn.2d 522. It then noted that exceptions had been made to this rule and specifically adopted comment k of the Restatement (Second) of Torts § 402A as the "applicable rule in Washington for blood and blood products.” Rogers, 116 Wn.2d at 197.
The claim by the plaintiff in Rogers related to the defect in the product, contamination, not to a failure to warn of the risk of contamination. By its terms, comment k rejects a strict liability standard for claims of design defect when the product is accompanied by adequate warnings and the product is free of manufacturing flaw. Although the plaintiff argued neither manufacturing flaw nor inadequate warnings, Rogers nevertheless went on to make additional gratuitous observations regarding any possible issues based on the defendants’ duty to warn stating:
*184It might be argued that, in order fully to resolve the question whether strict liability applies, we must also resolve whether defendants met their duty to warn under comment k. The argument would be that if defendants did not qualify for the comment k exception, then the overall rule—strict liability— would apply.
Rogers, 116 Wn.2d at 207 (emphasis added). Justice Callow, writing for the majority, was correct—it could have been argued that the failure to adequately warn would deprive the manufacturer of comment k protection and thus render it strictly liable under the common law. It is clear, however, that neither the question nor the argument were before the court in Rogers. As the Rogers court said "as plaintiffs’ negligence claims are still before the federal court, any issues regarding defendants’ duty to warn should be resolved by that court.” Id. Contrary to the conclusion reached by the Court of Appeals and the majority, Rogers is simply not binding authority on the issues in this case.
More importantly, whether dicta or not, Rogers wrongly applied comment k and Washington law. Exemption from strict liability under comment k is expressly limited to products accompanied by adequate warnings. Stated another way—adequate warnings are a predicate to application of comment k by the express terms of the comment. When the Rogers court eliminated the requirement of adequate warnings as a prerequisite to immunity from strict liability, it is unclear whether the court intended to read the express requirement of adequate warnings out of comment k or whether the court was reversing Washington case law, beginning with Little v. PPG Industries, which established strict liability as the standard for failure to warn. In either case, Rogers went astray.
To understand where Rogers went wrong it is helpful to recognize that the source of the Rogers pronouncement was Brown v. Superior Court, 44 Cal. 3d 1049, 751 P.2d 470, 245 Cal. Rptr. 412 (1988). In the passage quoted by Rogers from the Brown decision the California Supreme Court noted that
*185theré is a general consensus that, although [comment k] purports to explain the strict liability doctrine, in fact the principle it states is based on negligence. That is, comment k would impose liability on a drug manufacturer only if it failed to warn of a defect of which it either knew or should have known.
Rogers, 116 Wn.2d at 207 (quoting Brown, 44 Cal. 3d at 1059). Since Brown was decided, the California Supreme Court has had occasion to. explain its holding in that case. In Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d 987, 810 P.2d 549, 281 Cal. Rptr. 528 (1991) the California high court explained:
The procedural posture of Brown . . . required us to address . . . the plaintiffs contention that a manufacturer’s strict liability for failure to warn should extend to "unknowable” risks of harm. The trial court had ruled before trial that the defendants could not be held strictly liable for an alleged design defect in the drug at issue but could be held strictly liable for their failure to warn of the drug’s known or knowable side effects. This pretrial ruling in Brown, insofar as it recognized strict liability for failure to warn of known or knowable side effects, was not questioned by the plaintiff on appeal. Instead, the plaintiff wanted the appellate court to extend the ruling to "unknowable” risks. The Court of Appeal affirmed the trial court’s ruling. We did the same.
Id. at 999 (emphasis added). Moreover, the Anderson court included the Brown decision in its list of cases which supported its conclusion that "knowledge [or knowability] is also a component of strict liability for failure to warn.” Id. at 1000. Thus, the court made clear in Anderson that Brown did not abrogate a rule of strict liability for failure to warn.
The rule articulated by the California Supreme Court in Anderson is followed by many courts which have considered whether comment k alters the rule of strict liability under § 402A when the claim is failing to adequately warn. See Jackson v. Nestle-Beich, Inc., 147 Ill. 2d 408, 589 N.E.2d 547 (1992) (unavoidably unsafe product subject to *186strict liability due to absence of warning of the unavoidable risk of injury posed by product); Niemiera v. Schneider, 114 N.J. 550, 555 A.2d 1112 (1989) (comment k immunity does not eliminate strict liability for failure to provide a proper warning); Borel v. Fibreboard Paper Prods. Corp., 493 F.2d 1076 (5th Cir. 1973) (court correctly instructed on strict liability in failure to warn claim involving unavoidably unsafe product under comment k), cert. denied, 419 U.S. 869 (1974); Alman Bros. Farms & Feed Mill, Inc. v. Diamond Lab., Inc., 437 F.2d 1295 (5th Cir. 1971) (failure to give complete disclosure of the existence and extent of risk involved in use of product deprived product of comment k exemption); Filler v. Rayex Corp. 435 F.2d 336 (7th Cir. 1970) (exception to strict liability under comment k applies only when product accompanied by proper warning); Davis v. Wyeth Lab., Inc., 399 F.2d 121 (9th Cir. 1968) (failure to warn of risk that reasonable consumer would want to know rendered warning defective under comment k and product subject to strict liability); but see Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (1996) (reading comment j and k together to hold manufacturer liable only in negligence for failure to warn).
A few courts have found that where liability is based on failure to warn, strict liability and negligence are equivalent. See Martin v. Hacker, 83 N.Y.2d 1, 628 N.E.2d 1308, 607 N.Y.S.2d 598 (1993); Savina v. Sterling Drug, Inc., 247 Kan. 105, 795 P.2d 915, 928 (1990). As the court in Savina explained,
in all warning cases—even if the plaintiff or the court claims to analyze failure to warn or inadequacy of warning in the context of a strict products liability claim—the tests actually applied condition imposition of liability on the defendant’s having actually or constructively known of the risk that triggers the warning.
Savina, 247 Kan. at 121-22 (quoting Johnson v. American Cyanamid Co., 239 Kan. 279, 286-87, 718 P.2d 1318 (1986)).
While it may be true that there is an aspect of negligence *187in a failure to warn claim, i.e., whether the risks were known or knowable, there is a crucial departure in a failure to warn claim from a traditional negligent standard: the reasonableness of the manufacturer’s conduct in deciding whether to warn is immaterial under a strict liability-theory. The California Supreme Court succinctly stated the difference between negligent failure to warn and strict liability failure to warn:
Negligence law in a failure-to-warn case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care .... Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer’s conduct. The rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. Thus, in strict liability, as opposed to negligence, the reasonableness of the defendant’s failure to warn is immaterial.
Anderson, 53 Cal. 3d at 1002-03.
In addition to the express language of comment k requiring adequate warnings as a prerequisite to immunity from strict liability, the theoretical underpinnings of that exclusion support a rule of strict liability for defects in warnings. Considering the usefulness of certain products which are unavoidably unsafe by nature, relieving the manufacturer of such products from strict liability, which would otherwise attach to a product which cannot be made safe even for its intended use, may be justified. The risk of using a product which cannot be made safe then shifts to the user. When the risk of use is shifted, however, it must be a risk which is fully appreciated. The consumer is in no position to know these risks and thus, comment k requires the manufacturer to adequately warn and properly manufacture such products to justify the reduced liability for placing an unavoidably unsafe product into the stream *188of commerce. As the court in Borel v. Fibreboard Paper Prods. Corp., 493 F.2d 1076 (5th Cir. 1973) stated:
[T]he decision to market [an unavoidably unsafe] product requires a balancing of the product’s utility against its known or foreseeable danger. But, as comment k makes clear, even when such balancing leads to the conclusion that marketing is justified, the seller still has a responsibility to inform the user or consumer of the risk of harm. The failure to give adequate warnings in these circumstances renders the product unreasonably dangerous. The rationale for this rule is that the user or consumer is entitled to make his own choice as to whether the product’s utility or benefits justify exposing himself to the risk of harm. Thus, a true choice situation arises, and a duty to warn attaches, whenever a reasonable man would want to be informed of the risk in order to decide whether to expose himself to it.
Id. at 1089 (emphasis added).
In the present case, Key Pharmaceuticals did not deny that it knew about the relationship between fevers or viral illnesses but argued that the information was not clinically reliable and that it would have been irresponsible for the drug company to warn of risks that were not proved to be legitimate risks. Considering the defendant’s admissions, the proper question for the jury was whether the warning given by defendant Key Pharmaceuticals was adequate, measured by the reasonable expectations of a consumer or learned intermediary. Instead, the jury was instructed to determine the reasonableness of the defendant’s failure to warn. Under Washington law the reasonableness of the defendant’s action is irrelevant. If the warning was not adequate then Key Pharmaceuticals is liable. The Court of Appeals should be reversed and this case remanded for a new trial. The jury should be instructed that the adequacy of the manufacturer’s warnings are to be measured under Washington’s strict liability test set forth in Little, 92 Wn.2d 118, and its progeny.
*189Johnson, Alexander, and Sanders, JJ., concur with Madsen, J.

Rather than cite to the Court of Appeals’ decision, however, I refer to the majority as I discuss my disagreements with the Court of Appeals’ analysis of that issue.