Carlin v. Superior Court

BAXTER, J.

I dissent.

In this case we must determine whether, under California law, when a plaintiff seeks recovery against a manufacturer of a prescription drug on a “failure-to-wam” theory, the liability of the drug manufacturer may be determined under the same strict liability principles that generally apply to the manufacturers of all other products, or, instead, must be limited to general negligence principles.

We faced a somewhat comparable issue in Brown v. Superior Court (1988) 44 Cal.3d 1049 [ 245 Cal.Rptr. 412 , 751 P.2d 470 ] (Brown). In Brown , a *1147 unanimous court concluded that, in light of the unique considerations related to the vital public interest in the development, availability, and reasonable pricing of prescription drugs, when a plaintiff seeks recovery against a prescription drug manufacturer for an injury allegedly caused by a “design defect” in the drug, the drug manufacturer’s liability should not be based upon the same strict liability design-defect principles applicable to manufacturers of other products under California law, but instead should be limited to ordinary negligence principles. We concluded that a drug manufacturer may be held liable for an alleged design defect only when the plaintiff establishes that the manufacturer was negligent in designing the drug. We additionally held in Brown that a manufacturer of a prescription drug may not be held strictly liable for failure to warn of risks posed by the drug that were neither known nor scientifically knowable at the time of the distribution of the drug. Our decision in Brown , however, did not explicitly address the question whether, with regard to risks that were either known or scientifically knowable at the time of distribution, a prescription drug manufacturer’s liability for failure to warn could properly be premised upon strict liability, as well as upon negligence principles. That is the issue before us in this case.

The majority holds that a prescription drug manufacturer may be held strictly liable, on a failure-to-wam theory, for injuries arising from the ingestion or use of prescription dmgs, without consideration of the reasonableness of the manufacturer’s conduct in furnishing the warnings that were given, or no warning. I cannot subscribe to that result. For the reasons set forth below, I conclude that the same broad public policy considerations that led this court in Brown, supra, 44 Cal.3d 1049 , to hold that the liability of manufacturers of prescription dmgs for injuries caused by allegedly defectively designed dmgs properly should be confined to negligence principles, also support a similar limitation—i.e., liability based solely upon negligence principles—when recovery is sought against a prescription dmg manufacturer on a failure-to-wam theory. Indeed, that conclusion is even more compelled in the failure-to-wam context, where the necessity of furnishing warnings of the known or knowable dangerous propensities or other risks of harm posed by a prescription dmg, and the content of such warnings where they are required, is heavily regulated and oftentimes dictated by federal law. Accordingly, I would reverse the judgment of the Court of Appeal, which reached a contrary conclusion.

I

Plaintiff’s first amended complaint (complaint) alleges that defendant Upjohn Company (Upjohn) manufactured a prescription dmg known as Halcion, to be used for the treatment of insomnia, among other conditions; *1148 that Halcion was unavoidably unsafe in that its use may cause emotional, physical, and psychic instability, distress, and injuries; and that these dangerous propensities were either known to Upjohn or reasonably scientifically knowable at the time that Halcion was distributed and ingested by plaintiff. The complaint further alleges that plaintiff obtained a prescription for Halcion from a physician and ingested the drug during the time period from 1987 through November 1992. As a proximate result, plaintiff sustained serious injuries to her health, strength, and nervous system, and suffered extreme mental distress. The complaint purports to state causes of action in (1) strict liability for defective preparation and for failure to warn of the known or scientifically knowable dangerous propensities of Halcion, (2) negligence, (3) breach of express and implied warranties, and (4) fraud. 1

Upjohn demurred to the causes of action in strict liability and breach of express and implied warranties (among other causes of action), maintaining that, under Brown, supra, 44 Cal.3d 1049 , a drug manufacturer is exempt from strict liability and breach of warranty liability based upon a failure to warn and may be held liable for failure to warn solely upon a negligence theory. The trial court sustained the demurrer without leave to amend both as to the cause of action in strict liability, citing Brown, supra, 44 Cal.3d 1049 , and Artiglio v. Superior Court (1994) 22 Cal.App.4th 1388 [ 27 Cal.Rptr.2d 589 ] (containing dictum construing Brown as limiting liability for failure to warn to a negligence theory), and as to the cause of action for breach of express and implied warranties, citing Brown. After her motion for reconsideration was denied, plaintiff filed a petition for writ of mandate or other appropriate relief in the Court of Appeal, seeking to vacate the trial court’s order.

The Court of Appeal issued an alternative writ and, after full briefing and argument, issued a peremptory writ of mandate, directing the trial court to vacate its order sustaining Upjohn’s demurrer to plaintiff’s causes of action for strict liability and breach of warranty, and to enter a new order overruling the demurrer to those causes of action. In its opinion, the Court of Appeal concluded that any ambiguity in the Brown decision as to whether a drug manufacturer may be held liable on a theory of strict liability based upon an asserted failure to warn of known or knowable risks of harm of a drug, was resolved in plaintiff’s favor in our post -Brown decision in Anderson v. Owens-Corning Fiberglas Corp. (1993) 53 Cal.3d 987 [ 281 Cal.Rptr. 528 , 810 P.2d 549 ] (Anderson). With respect to the cause of action for breach of warranty, the Court of Appeal concluded that such a claim against such a prescription drug manufacturer is not precluded under Brown to the extent *1149 the claim is based upon a failure to warn for which the manufacturer may be held strictly liable.

We granted review to clarify the scope and significance of the principles and holdings in Brown, supra, 44 Cal.3d 1049 , and Anderson, supra, 53 Cal.3d 987 , as they pertain to the issue of whether a prescription drug manufacturer may be held liable on theories of strict liability or breach of warranty for failure to warn of the dangerous propensities or other risks of harm posed by a prescription drug. 2

n

The doctrine of strict liability imposes legal responsibility, without proof of negligence, upon the manufacturer of a product that is placed on the market and proves to have a defect that causes injury. (Greenman v. Yuba Power Products, Inc. (1963) 59 Cal.2d 57, 62 [ 27 Cal.Rptr. 697 , 377 P.2d 897 , 13 A.L.R.3d 1049 ].) Strict liability differs from negligence in that it focuses not upon the conduct of the manufacturer but upon the product itself; the plaintiff need not prove that the manufacturer acted unreasonably or negligently in order to prevail, but only that the product was defective. (Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 418, 432 [ 143 Cal.Rptr. 225 , 573 P.2d 443 , 96 A.L.R.3d 1 ].) The policy considerations underlying the strict liability doctrine are premised upon the assumptions that the manufacturer can anticipate or guard against the recurrence of hazards and that the cost of injury may be overwhelming to the person injured, whereas the manufacturer can insure against the risk and distribute the cost among the consuming public. (Brown, supra, 44 Cal.3d at p. 1056 .) Additionally, the doctrine relieves an injured plaintiff of many of the “onerous evidentiary burdens inherent in a negligence cause of action.” (Barker v. Lull Engineering Co., supra, 20 Cal. 3d at p. 431 .)

As our past cases explain, strict liability may be invoked for three types of injury-producing defects: (1) a manufacturing defect, where the product deviates from the manufacturer’s intended result; (2) a design defect, where the product either fails to perform as safely as an ordinary consumer would expect when used in a reasonably foreseeable manner, or when the risk of danger inherent in the design outweighs the benefits of the challenged design; and (3) a “warning” defect, where the product lacks adequate instructions or warnings as to risks of harm. (Barker v. Lull Engineering Co., *1150 supra, 20 Cal.3d at pp. 428-430.) In the latter category, the injured plaintiff alleges, not that the manufacture or design of the product was defective, but that the manufacturer failed to warn of potential dangers in the use of its product. If the injury could have been prevented with appropriate warnings, the absence of such warnings is deemed to render the product “defective” in the eyes of the law. (Midgley v. S.S. Kresge Co. (1976) 55 Cal.App.3d 67, 71-72 [ 127 Cal.Rptr. 217 ], and cases cited.)

As regards the third category of defect, i.e., a warning defect, this court’s recent decision in Anderson, supra, 53 Cal.3d 987 , decided five years after our decision in Brown, supra, 44 Cal.3d 1049 , concluded that under generally applicable principles of strict liability for failure to warn, a manufacturer of any product may be held strictly liable for injuries caused by failure to provide adequate warnings of a product’s dangerous propensities or risks only if such propensities were known or scientifically knowable at the time of distribution. ( Anderson, supra, 53 Cal.3d at pp. 1003-1004.)

Long before our decision in Brown, supra, 44 Cal.3d 1049 , the drafters of the Restatement Second of Torts recognized that because of fundamental differences between prescription drugs and other products, it would be contrary to the public interest to subject prescription drug manufacturers to generally applicable strict liability principles. Imposition of such far-reaching liability would risk stifling needed medical research and the testing and marketing of essential, highly beneficial, but inherently dangerous drugs. Comment k to section 402A of the Restatement 3 provides that the sellers of both established and experimental drugs are exempt from strict liability if the drugs are prepared properly and accompanied by appropriate warnings of known risks. ( 44 Cal.3d at p. 354 .) Comment k states in full: “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 warnings, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, *1151 and the like, many of which for this very reason cannot be legally 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.” (Id. at pp. 353-354, italics in original.)

As we explained in Brown, supra, 44 Cal.3d at page 1059 , comment k to section 402A of the Restatement Second of Torts has been adopted in the overwhelming majority of jurisdictions that have considered the issue of the standard for imposition of liability upon prescription drug manufacturers for injuries resulting from dangerous propensities and other risks of harm emanating from prescription drug products. (See, e.g., DeLuryea v. Winthrop Laboratories, etc. (8th Cir. 1983) 697 F.2d 222, 229 ; Lindsay v. Ortho Pharmaceutical Corp. (2d Cir. 1980) 637 F.2d 87, 91 ; Werner v. Upjohn Co., Inc. (4th Cir. 1980) 628 F.2d 848, 858 ; Salmon v. Parke, Davis and Co. (4th Cir. 1975) 520 F.2d 1359, 1362 ; Basko v. Sterling Drug, Inc. (9th Cir. 1969) 416 F.2d 417, 426 ; Stone v. Smith, Kline & French Lab. (Ala. 1984) 447 So.2d 1301, 1303-1304 ; Johnson v. American Cyanamid Co. (1986) 239 Kan. 279 [ 718 P.2d 1318, 1323 , 66 A.L.R.4th 55 ]; Seley v. G.D. Searle 7 Co. (1981) 67 Ohio St.2d 192 [21 Ohio Ops.3d 121, 423 N.E.2d 831 ].) These courts as well as legal commentators have construed comment k as providing, in general, that a manufacturer of an unavoidably unsafe, but properly prepared, prescription drug shall not be held strictly liable to a consumer who has suffered injury as a result of ingesting that drug.

There is a general consensus that the standard for imposition of liability under comment k to section 402A of the Restatement Second of Torts is that of negligence, focusing upon the conduct of the manufacturer and whether the manufacturer exercised reasonable care in warning of potential dangers of which it knew or in the exercise of reasonable care should have known. (See DeLuryea v. Winthrop Laboratories, etc., supra, 697 F.2d at pp. 228-229; Lindsay v. Ortho Pharmaceutical Corp., supra, 637 F.2d at p. 91 ; Salmon v. Parke, Davis and Co., supra, 520 F.2d at p. 1362 ; Basko v. Sterling Drug, Inc., supra, 416 F.2d at pp. 425-426; Prosser & Keeton on Torts (5th ed. 1984) § 99, p. 697). Under a negligence standard, liability is imposed only where the evidence would support a finding that a reasonable person in *1152 the position of the manufacturer, held to the standard of an expert in the field, would have foreseen a risk of harm posed by the drug and would have provided a reasonable warning. (See McClellan, Strict Liability for Drug Induced Injuries: An Excursion Through the Maze of Products Liability, Negligence and Absolute Liability (1978) 25 Wayne L. Rev. 1 , 2.) Dean Prosser earlier summarized the liability of prescription drug manufacturers under this standard as follows: “Thus far the courts have tended to hold the manufacturer to a high standard of care in preparing and testing drugs of unknown potentiality and in giving warning; but in the absence of evidence that this standard has not been met, they have refused to hold the maker liable for unforeseeable harm.” (Prosser on Torts (4th ed. 1971) § 99, p. 661, fiis. omitted.)

In Brown, this court held that prescription drug manufacturers are not subject to strict liability for a “design defect” under the standard applicable, under California law, to manufacturers of other products under our decision in Barker v. Lull Engineering Co., supra, 20 Cal.3d 413. ( Brown, supra, 44 Cal.3d at pp. 1061-1065.) Adopting the standard under comment k to section 402A of die Restatement Second of Torts, which we characterized as being based upon negligence principles, 4 we held that a manufacturer is not strictly liable for injuries caused by a prescription drug so long as the drug was prepared properly and accompanied by warnings of those dangerous propensities that either were known or reasonably scientifically knowable at the time of distribution. (Id. at p. 1069.)

In reaching that conclusion, we reasoned that in light of fundamental distinctions between prescription drugs and other products, and because prescription drugs may cause untoward side effects even though properly and carefully prepared, the broader public interest in the availability of drugs at an affordable price must be considered in deciding the appropriate standard of liability for injuries resulting from their use. ( 44 Cal.3d at p. 1063 .) We determined that the imposition of strict liability for design defects would have the undesirable consequence of inhibiting the development and marketing of essential and highly beneficial medications at affordable prices. We explained: “Perhaps a drug might be made safer if it was withheld from the market until scientific skill and knowledge advanced to the point at which *1153 additional dangerous side effects would be revealed. But in most cases such a delay in marketing new drugs—added to the delay required to obtain approval for release of the product from the Food and Drug Administration —would not serve the public welfare. Public policy favors the development and marketing of beneficial new drugs, even though some risks, perhaps serious ones, might accompany their introduction, because drugs can save lives and reduce pain and suffering, [f] If drug manufacturers were subject to strict liability, they might be reluctant to undertake research programs to develop some pharmaceuticals that would prove beneficial or to distribute others that are available to be marketed, because of the fear of large adverse monetary judgments. Further, the additional expense of insuring against such liability—assuming insurance would be available—and of research programs to reveal possible dangers not detectable by available scientific methods could place the cost of medication beyond the reach of those who need it most.” (Brown, supra, 44 Cal.3d at p. 1063 .)

We also noted in Brown that the consumers of prescription drugs are afforded greater protection against defects than the consumers of other products, because the drug industry is closely regulated by the Food and Drug Administration, which actively controls the testing, manufacture, and marketing of drugs. ( 44 Cal.3d at p. 1069 , fit. 12.)

We concluded in Brown that, for these reasons, the negligence standard embodied in comment k to section 402A of the Restatement Second of Torts, rather than principles of strict liability, must govern a prescription drug manufacturer’s liability for injuries caused by the defective design of a drug. ( 44 Cal.3d at p. 1065 .) We held further that the plaintiff’s claims for breach of express or implied warranty against a prescription drug manufacturer were “inconsistent with our determination on the issue of strict liability for design defects,” and therefore upheld the trial court’s pretrial rulings disallowing the claims for breach of warranty. {Id. at p. 1072.)

The procedural posture of Brown, as that case reached this court, required us to address, in addition to the question of strict liability and breach of warranty for design defect, the plaintiff’s further contention that a drug manufacturer could be held strictly liable for failure to warn of unknowable risks of harm. The trial court had made pretrial rulings that the defendants could be held strictly liable for their failure to warn of the drug’s known or knowable side effects, which ruling was not challenged by defendants on appeal. Instead, the plaintiff argued that the trial court had not gone far enough and sought a ruling that a drug manufacturer could be held strictly liable for failure to warn of risks inherent in a drug even though the manufacturer neither knew, nor could have known by the application of scientific knowledge available at the time of distribution, that the drug could *1154 produce the undesirable side effects. While recognizing a split of authority on the issue, we observed in Brown that the majority view in products liability cases in general is that a manufacturer will be liable only for failure to warn of those risks of which the manufacturer had actual or constructive knowledge as of the time the product was distributed. (44 Cal.3d at pp. 1065-1066.) We therefore concluded in Brown, in accordance with the majority view in products liability cases generally, and consistent with the rationale of comment k to section 402A of the Restatement Second of Torts, that a prescription drug manufacturer may not be held strictly liable for failure to warn of unknown or unknowable side effects. ( 44 Cal.3d at p. 1066 .)

Because of the nature of the pretrial rulings and the issues raised on appeal in Brown, supra, 44 Cal.3d 1049 , we were not in that case directly presented with the precise issue before us in the present case—whether a drug manufacturer should be subject to the same strict liability failure-to-warn principles that are generally applicable to manufacturers of other products. Our opinion in Brown did suggest, however, that liability for failure to warn in the prescription drug context was governed by comment k to section 402A of the Restatement Second of Torts, and, in a footnote, we acknowledged that failure-to-wam liability under comment k was analytically distinct from general principles of strict liability. 5

Five years after our decision in Brown, supra, 44 Cal.3d 1049 , this court was presented with the question whether, under general principles of strict liability applicable to all products, a manufacturer could be held strictly liable for a “warning” defect when the risk of harm as to which no warning had been given was neither known nor scientifically knowable at the time the product was distributed. In Anderson, supra, 53 Cal.3d 987 , a case that involved asbestos-related injury, not prescription dmgs, we clarified that in products liability cases generally, a manufacturer may not be held strictly liable for failure to warn of unknown or unknowable risks of harm.

*1155 The precise issue presented in Anderson was whether a defendant in a products liability action, based upon an alleged failure to warn of a risk of harm, may present evidence of the “state of the art”—i.e., evidence that the particular risk was neither known nor knowable by the application of scientific knowledge available at the time of manufacture or distribution. ( 53 Cal.3d at p. 990 .) We determined in Anderson that such state-of-the-art evidence was properly admissible in a products liability action. In reaching this conclusion, we recognized the body of decisional law establishing a theory of strict liability based upon a manufacturer’s failure to warn of a product’s known or scientifically knowable dangerous propensities, and reviewed the discussion of authorities in our opinion in Brown on the issue of whether strict liability for failure to warn presupposes knowledge of the risk on the part of the manufacturer. We concluded in Anderson that “California is well settled into the majority view that knowledge, actual or constructive, is a requisite for strict liability for failure to warn.” ( 53 Cal.3d at p. 1000 .)

Contrary to the contention of plaintiff and the conclusion of the majority in the present case, I do not believe this court’s opinion in Anderson properly may be understood as holding that the failure-to-wam strict-liability standard generally applicable to manufacturers of other products necessarily applies to manufacturers of prescription dmgs.

First, because Anderson was not a prescription drug case, this court had no occasion therein to directly consider or address the broader policy question of whether failure-to-wam strict liability should apply to prescription drug manufacturers. We did, however, place reliance on our earlier opinion in Brown, supra, 44 Cal.3d 1049 , a prescription dmg case, in reaffirming the settled majority view that “knowledge, actual or constructive” is a requisite component of strict liability for failure to warn. (Anderson, supra, 53 Cal.3d at p. 1000 .) 6 But we simply did not in Anderson further consider, much less reject, application of Brown’s important public policy rationale—which led *1156 us in that case to exempt prescription drug manufacturers from strict liability for design defects in furtherance of the “broader public interest” in the development and marketing of beneficial new drugs—to the specific question of whether prescription drug manufacturers should likewise be exempt from strict liability in failure-to-wam actions.

Second, as already explained, in this court’s unanimous decision in Brown we plainly suggested that a prescription drag manufacturer’s liability, under comment k to section 402A of the Restatement Second of Torts for failure to warn, was governed by a negligence standard ( 44 Cal.3d at p. 1059, fn. 4 ), whereas in Anderson we explicitly recognized a marked distinction between failure to warn under a strict liability standard and failure to warn under a negligence standard. Our observations in Anderson regarding the distinction between negligence and strict liability in failure-to-wam actions bears closer scrutiny here.

The majority herein correctly observe that “in the failure-to-wam context, strict liability is to some extent a hybrid of traditional strict liability and negligence doctrine.” (Maj. opn., ante, at p. 1112.) In Anderson we explained that “the claim that a particular component ‘rings of’ or ‘sounds in’ negligence has not precluded its acceptance in the context of strict liability.” ( 53 Cal.3d at p. 1001 .)

In his separate concurring and dissenting opinion in Anderson , Justice Mosk elaborated on the point: “[T]he focus [between strict products liability and negligence] has become blurred through the years. . . . [T]his court has incorporated a number of principles of the law of negligence into strict liability doctrine. (See, e.g., Luque v. McLean (1972) 8 Cal.3d 136, 145 [ 104 Cal.Rptr. 443 , 501 P.2d 1163 ] [assumption of risk defense]; Daly v. General Motors Corp. [(1978)] 20 Cal.3d 725, 736-737 [ 144 Cal.Rptr. 380 , 575 P.2d 1162 ] [comparative negligence]; Barker v. Lull Engineering Co., supra, 20 Cal.3d 413, 432 [risk-benefit test]; Brown v. Superior Court (1988) 44 Cal.3d 1049, 1066 [ 245 Cal.Rptr. 412 , 751 P.2d 470 ] [as a matter of policy, strict liability standards not applicable to prescription drag manufacturers].)” (Anderson, supra, 53 Cal.3d at p. 1006 (conc. and dis. opn. of Mosk, J.).)

Similarly, “[t]he courts of some of our sister states . . . have permitted the infusion of negligence concepts into failure-to-wam strict liability actions. (See, e.g., Gonzales v. Volvo of America Corp. (7th Cir. 1985) 752 F.2d 295 , 300 [language and concepts of reasonableness in strict liability failure-towam cases under Indiana law same as those applied in negligence cases]; Borel v. Fibreboard Paper Products Corporation (5th Cir. 1973) 493 F.2d *1157 1076,1088 [same under Texas law]; Bernier v. Raymark Industries, Inc. (Me. 1986) 516 A.2d 534, 538 [reasonableness of defendant’s conduct is a factor]; Feldman v. Lederle Laboratories (1984) 97 N.J. 429 [ 479 A.2d 374, 385 ] [same]; Bilotta v. Kelley Co., Inc. (Minn. 1984) 346 N.W.2d 616, 622 [strict liability failure-to-wam claims based on negligence concepts]; and see generally, Henderson & Twerski, Doctrinal Collapse in Products Liability: The Empty Shell of Failure to Warn (1990) 65 N.Y.U.L. Rev. 265, 271-273; Prosser & Keeton, The Law of Torts (1988 supp.) § 99, p. 95, fn. 21; Bromberg, The Mischief of the Strict Liability Label in the Law of Warnings (1987) 17 Seton Hall L. Rev. 526 , 534-535.)” (Anderson, supra, 53 Cal.3d at p. 1007 (conc. and dis. opn. of Mosk, J.).)

In light of this state of the law, the question might reasonably be posed —has the melding of negligence concepts into strict liability doctrine in failure-to-wam cases obliterated all significant distinctions between the two theories of liability? If the answer is yes, then perhaps, as one justice of this court has suggested, “[w]e should consider the possibility of holding that failure-to-wam actions lie solely on a negligence theory. ‘[Although mixing negligence and strict liability concepts is often a game of semantics, the game has more than semantic impact—it breeds confusion and inevitably, bad law.’ (Henderson & Twerski, Doctrinal Collapse in Products Liability: The Empty Shell of Failure to Warn, supra, 65 N.Y.U.L. Rev. at p. 278.)” (Anderson, supra, 53 Cal.3d at p. 1008 (conc. and dis. opn. of Mosk, J.).)

To my mind, however, our opinion in Anderson answered the question —negligent failure to warn and strict-liability failure to warn remain analytically distinct theories of liability. Although there can be no doubt that this court, the courts of appeal, courts of our sister states, and many noted legal commentators and authorities, have long acknowledged the infusion of concepts of negligence into strict liability doctrine generally, and strict liability failure-to-wam actions specifically, in Anderson we nonetheless determined that “despite its roots in negligence, failure to warn in strict liability differs markedly from failure to warn in the negligence context.” (Anderson, supra, 53 Cal.3d at p. 1002 .) We went on to explain: “Negligence law in a failure-to-wam 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, i.e., what a reasonably pmdent manufacturer would have known and warned about. Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer’s conduct. The mies 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 *1158 strict liability, as opposed to negligence, the reasonableness of the defendant’s failure to warn is immaterial.” (Id. at pp. 1002-1003, fn. omitted.) 7

In sum, our decision in Anderson, supra, 53 Cal.3d 987 distinguished failure-to-wam actions sounding in negligence from failure-to-wam actions premised on strict liability, and found that although there is significant overlap between the elements of those two theories of liability, there remain marked differences as well. Anderson further holds that, as a general matter, although a manufacturer can be found strictly liable for failing to warn of the known or scientifically knowable risks of harm associated with its products, the reasonableness of the manufacturer’s conduct surrounding the giving of a particular warning, or no warning at all, is “immaterial” to a failure-towam action premised on strict liability. ( Anderson, supra, 53 Cal.3d at pp. 1002-1003.) Notably, what our opinion in Anderson did not do is address or resolve the broader public policy question of whether a prescription drug manufacturer should be exempt from strict liability for failing to warn of the dangerous propensities or harmful risks of its products. It is to that question that I turn next.

Ill

For the reasons hereafter explained, I conclude that the same important public policy considerations relating to the development, marketing, and availability of prescription drugs that led this court in Brown to conclude that principles of strict liability (and breach of warranty liability) generally applicable to “design defects” should not be extended to manufacturers of prescription drugs, should apply as well to failure-to-wam defects. I would therefore hold in this case that it is solely under negligence principles that a prescription drug manufacturer may be held liable for failure to warn.

First, as recognized by several legal commentators, a product’s “warning” may be characterized as part of its overall design, and in many cases the question of the adequacy of warnings is a subset of the question of the acceptability of the basic design. (See, e.g., Twerski, The Use and Abuse of Product Warnings in Products Liability—Design Defect Litigation Comes of *1159 Age (1976) 61 Cornell L.Rev. 495, 500-501, 510.) 8 Many of the considerations involved in the determination of a design defect are equally applicable to a “failure-to-wam” defect, including a risk-utility balancing and, specifically, the balancing of the benefits of possible warnings against design alternatives. For example, in the prescription drug context, if the probability of harmful side effects from a beneficial new prescription dmg is statistically remote, the question may arise whether to warn against them at all. Or the inquiry may instead focus on consideration of whether additional research could lead to a safer reformulation of the dmg, thereby obviating the need for any warnings. Thus, “the questions of warning and design are often inextricably woven together.” (Id. at p. 524.) It follows, then, that to the extent important public policy considerations led this court in Brown to exempt prescription dmg manufacturers from strict liability for design defects, those same considerations should be applied to exempt prescription dmg manufacturers from strict liability for failure to warn of the known or scientifically knowable risks of harm or harmful side effects associated with its products.

Second, as noted above, long before our decision in Brown v. Superior Court, supra, 44 Cal.3d 1049 , the drafters of the Restatement recognized that because of fundamental differences between prescription dmgs and other products, it would be contrary to the public interest to subject prescription dmg manufacturers to generally applicable strict liability principles because imposition of such far-reaching liability would risk stifling needed medical research and the testing and marketing of essential, highly beneficial, but inherently dangerous dmgs. I have explained how this court in Brown concluded that liability for failure to warn in the prescription drug context should be governed by the standard of liability set forth in comment k to section 402A of the Restatement Second of Torts, and how, in a footnote to our opinion in that case, we further reasoned that failure-to-wam liability under comment k was analytically distinct from general principles of strict liability, and that comment k in actuality set forth a standard that incorporated fundamental concepts of negligence. (Brown, supra, 44 Cal.3d at p. 1059, fn. 4 .)

I note that related provisions in the American Law Institute’s tentative draft of the Restatement Third of Torts pertaining to products liability buttress my conclusion that the drafters of the Restatement have long viewed, and continue to view, failure-to-wam liability in prescription dmg *1160 cases as requiring application of a negligence standard of liability. Section 8 of that tentative draft, entitled “Liability of Commercial Seller or Distributor for Harm Caused by Prescription Drugs and Medical Devices,” provides in pertinent part: “(d) A prescription drug ... is not reasonably safe because of inadequate instructions or warnings when [*][] (1) reasonable instructions or warnings regarding foreseeable risks of harm posed by the drug ... are not provided to prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings . . . .” (Rest.3d Torts: Products Liability (Tent. Draft No. 2, Mar. 13, 1995) § 8, p. 210, italics added.) Clearly, by incorporating concepts of “reasonableness” and “foreseeability” into the new standard, the drafters of the new Restatement intend to impose a standard of care sounding in negligence in failure-to-wam actions involving prescription drugs. (See also Ellis v. Chicago Bridge & Iron Co. (1988) 376 Pa.Super. 200 [ 545 A.2d 906, 912-913 ] [“The liability arising from inadequate warnings is not ‘strict’ in the same sense as liability arising from a defect due to fault in manufacture, since a determination of whether an object is unreasonably dangerous without adequate warnings, and thus defective, necessarily involves negligence principles such as reasonableness or foreseeability.” (Fn. omitted.)].)

Third, in the warning context, as in the design-defect context, the existence and role of the federal Food and Drug Administration (FDA) provides a justification for distinguishing prescription drugs from other products, because one of the FDA’s primary functions is to evaluate the necessity and adequacy of warnings provided by prescription drug manufacturers. In Anderson , as we have seen, this court suggested that generally a product manufacturer might escape liability under negligence principles “if the manufacturer’s own testing showed a result contrary to that of others in the scientific community.” ( 53 Cal.3d at p. 1003 .) In the prescription drug industry, however, a manufacturer is not left to its own resources to decide whether the risk of harm is such as to require a warning. Rather, the FDA plays a significant role in determining whether a warning must be provided, and, if so, the specific content of the warning. 9

It seems clear that the FDA regulations applicable to prescription drugs and their accompanying warnings, and various factors such as the presence *1161 or absence of a prior FDA approval requirement, whether FDA approval has been obtained for a particular warning, or whether authorization has been obtained to forego the furnishing of a warning altogether—are all highly relevant in determining liability in actions for failure to warn brought against prescription drug manufacturers under state tort laws, and of necessity will require inquiry into the reasonableness of the manufacturer’s individualized conduct in its efforts to comply with the FDA warning requirements, and the foreseeability of the need for such warnings in the first instance. 10 Concepts such as “reasonableness” and “foreseeability” are fundamentally rooted in negligence doctrine. To fail to apply them, and instead hold prescription drug manufacturers strictly liable for failing to warn of the risks of harm associated with their products, would effectively preclude consideration of evidence highly relevant to the question of fault in the failure-to-wam context.

In short, the existence of the FDA regulatory process provides a basis for distinguishing drug manufacturers from the manufacturers of other products that may be placed on the market without such rigorous scrutiny and evaluation of the necessity of accompanying warnings and their contents by a federal regulatory agency.

*1162 Fourth, I believe that subjecting prescription drug manufacturers to a strict liability standard for failure to warn would create a risk of inhibiting or delaying the development and marketing of new drugs that is comparable to the risk that the court in Brown determined was contrary to the public interest. Under a strict liability standard, because of the inherently dangerous nature of prescription drugs a manufacturer could risk astronomical liability for failure to warn of risks of harm even though it acted in accordance with the high standard of care of a reasonably prudent manufacturer. Thus, even when a drug manufacturer has acted reasonably in refraining from expending additional time and money that would have delayed the availability and increased the price of a new drug, under strict liability principles the manufacturer could be held liable in the event a jury determined there were scientifically knowable risks of harm as to which a warning could have been given. If such a legal standard were applicable to manufacturers of prescription drugs, a manufacturer might hesitate to develop or market new drugs (especially less profitable products) because of such unknown and unassessable liability. In contrast, if liability is limited to those situations in which the manufacturer fails to act reasonably in providing warnings, the manufacturer that, in developing and marketing a drug, does its best to ensure that its employees adhere to all of the high professional and regulatory standards applicable to experts in the field, may have confidence that the future liability it incurs as a result of marketing the drug will remain within reasonable, insurable limits.

Admittedly, under a negligence standard, some consumers of prescription drugs may be denied compensation for injuries resulting from the absence of warnings of risks of harm that were scientifically knowable but reasonably not known by the manufacturer at the time a prescription drug was sold. Nevertheless, I conclude, as did this court in Brown, that on balance the public is better served by increasing the likely availability of affordable, highly beneficial prescription drugs than by extending a strict liability cause of action for monetary compensation to those persons who are injured despite the reasonable actions of prescription drug manufacturers.

IV

For all of the foregoing reasons, I conclude that a prescription drug manufacturer’s liability for injuries arising from failure to warn of the risks of harm posed by a drug should be restricted to a negligence standard, and *1163 that such a manufacturer should not be liable for failure to warn under theories of strict liability or breach of implied warranty. 11

Accordingly, I would find that the trial court properly sustained Upjohn’s demurrer to plaintiff’s complaint for failure to state causes of action for strict liability or breach of implied warranty, and that the Court of Appeal erred in overturning that ruling.

The complaint also states causes of action for medical malpractice against defendants Valentino Andres, Jr., M.D., and Valentino Andres, Jr., M.D., Inc., a professional corporation.

The following organizations have filed briefs amicus curiae in support of real party in interest Upjohn: Association For California Tort Reform; California Chamber of Commerce and California Manufacturers Association; California Medical Association; Product Liability Advisory Council, Inc.; and Pharmaceutical Research and Manufacturers of America.

Section 402A of the Restatement Second of Torts, pages 347-348, provides in part: “(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if [<]Q (a) the seller is engaged in the business of selling such a product, and [1 (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.”

We observed in Brown: “Comment k has been analyzed and criticized by numerous commentators. While there is some disagreement as to its scope and meaning, there is a general consensus that, although it purports to explain the strict liability doctrine, in fact the principle it states is based on negligence. (E.g., Schwartz, Unavoidably Unsafe Products: Clarif1ying the Meaning and Policy Behind Comment K (1985) 42 Wash. & Lee L. Rev. 1139 , 1141; McClellan, Drug Induced Injury (1978) 25 Wayne L.Rev. 1, 2; Kidwell, The Duty to Warn: A Description of the Model of Decision (1975) 53 Tex.L.Rev. 1375, 1377-1378; Merrill, Compensation for Prescription Drug Injuries (1973) 59 Va.L.Rev. 1, 50.)” (Brown, supra, 44 Cal.3d at p. 1059 , italics added.)

Footnote 4 of our opinion in Brown explains, in relevant part: “The test stated in comment k is to be distinguished from strict liability for failure to warn. Although both concepts identify failure to warn as the basis of liability, comment k imposes liability only if the manufacturer knew or should have known of the defect at the time the product was sold or distributed. Under strict liability, the reason why the warning was not issued is irrelevant, and the manufacturer is liable even if it neither knew nor could have known of the defect about which the warning was required.” (Brown, supra, 44 Cal.3d at p. 1059, fn. 4 .)

As explained more fully below, this court’s subsequent decision in Anderson, supra, 53 Cal.3d 987 , made it clear—contrary to the possible implication contained in footnote 4 of the Brown opinion—that even under strict liability principles, strict liability for failure to warn can be based only upon risks that were either known or scientifically knowable at the time the product was distributed. Nonetheless, footnote 4 of our Brown opinion reflects that this court understood the rationale of comment k as essentially embodying a negligence failure-to-wam standard. When read together with the subsequent discussion in our opinion in Brown endorsing the comment k test for manufacturers of prescription drugs, footnote 4 strongly suggests we were of the view in Brown that a prescription drag manufacturer’s liability for failure to warn would be governed by ordinary negligence principles.

Justice Mosk, who authored the opinion for the court in Brown, supra, 44 Cal.3d 1049 , wrote separately in Anderson and criticized the majority’s reliance on Brown: “The [Anderson] majority rely extensively on [Brown]. They obviously fail to comprehend that Brown was based on a narrow public policy exception to strict products liability for prescription drugs, and for such drugs alone. We emphatically declared in Brown (at p. 1063) that ‘there is an important distinction between prescription drugs and other products,’ and we elaborated on the reason for the distinction: ‘Public policy favors the development and marketing of beneficial new drugs, even though some risks, perhaps serious ones, might accompany their introduction, because drugs can save lives and reduce pain and suffering.’ (Ibid.) We added that ‘the broader public interest in the availability of drugs at an affordable price must be considered in deciding the appropriate standard of liability from injuries resulting from their use.’ (Ibid.) The [Anderson] majority stretch the holding and the analysis in Brown beyond all recognition when they rely on that case in [asbestos injury] litigation involving products other *1156 than prescription drugs.” ( Anderson, supra, 53 Cal.3d 987,1008 (conc. and dis. opn. of Mosk, J.).)

In contrasting strict liability failure to warn with negligent failure to warn, we observed in Anderson that “a reasonably prudent manufacturer might reasonably decide that the risk of harm was such as not to require a warning as, for example, if the manufacturer’s own testing showed a result contrary to that of others in the scientific community. Such a manufacturer might escape liability under negligence principles. In contrast, under strict liability principles the manufacturer has no such leeway; the manufacturer is liable if it failed to give warning of dangers that were known to the scientific community at the time it manufactured or distributed the product.” ( 53 Cal.3d at p. 1003 .)

As noted above (ante, at p. 1150), courts that have addressed the issue of products liability “warning” defects have reasoned that if injury caused by a product could have been prevented with appropriate warnings, the absence of such warnings is itself deemed to render the product “defective” in the eyes of the law. (Midgley v. S.S. Kresge Co., supra, 55 Cal.App.3d at pp. 71-72, and cases cited.)

The FDA’s approval of a particular warning is, of course, not determinative of liability. (See Abbott by Abbott v. American Cyanimid Co. (4th Cir. 1988) 844 F.2d 1108 , 1112, 1115 [98 A.L.R.Fed. 107]; Brochu v. Ortho Pharmaceutical Corp. (1st Cir. 1981) 642 F.2d 652, 658 ; Feldman v. Lederle Laboratories (1991) 125 N.J. 117 [ 592 A.2d 1176, 1189 ].) “[M]ere compliance with regulations or directives as to warnings, such as those issued by the United States Food and Drug Administration .... may not be sufficient to immunize the manufacturer or supplier of the drug from liability. The warnings required by such agencies may be only minimal in nature and when the manufacturer or supplier knows of, or has reason to know of, greater dangers not included in the warning, its duty to warn may not be fulfilled.” (Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65 [ 107 Cal.Rptr. 45 , 507 P.2d 653 , 94 A.L.R.3d 1059 ].) A jury may still find a drug manufacturer negligent, for example, if it failed *1161 to comply with FDA regulations or with professional or scientific standards in conducting the tests that it reported to the FDA.

There can be no dispute that the labeling of prescription drugs, and the necessity of accompanying warnings, is a highly regulated matter. (See, e.g., 21 U.S.C. § 301 et seq. [labeling regulations promulgated under the federal Food, Drug, and Cosmetic Act]; id., § 321 (m) [broadly defining “labeling”]; 21 C.F.R. § 201.57 (1996) [listing regulations specifically governing labeling of prescription drugs]; id., § 1.21(c) (1996) [label warnings regarding contraindications, precautions, adverse reactions, and other possible risks of harm may not include statements of differences of opinion within the medical community]; id., § 201.57(e) (1996) [warnings must include “serious adverse reactions and potential safety hazards” and must be revised “as soon as there is reasonable evidence of an association of a serious hazard with a drug” (italics added)]; id., § 201.57(f)(6) (1996) [specific warning language mandated where risks related to pregnancy are involved].)

Moreover, it has generally been recognized that a prescription drug manufacturer should not be held liable where there is an actual conflict between federal regulations and state tort law requirements, i.e., where it is impossible to comply with both. (See, e.g., Feldman v. Lederle Laboratories, supra, 592 A.2d 1176, 1185 .) One line of authority holds further that where an FDA-approved or -mandated warning has issued, and the manufacturer could not thereafter change the language of the warning without FDA approval, the manufacturer could not be held liable for failing to furnish additional warnings. (See Hurley v. LeDerle Lab. Div. of American Cyanamid (5th Cir. 1988) 863 F.2d 1173, 1179 ; Spychala v. G.D. Searle & Co. (D.N.J. 1988) 705 F.Supp. 1024, 1033 ; but see Feldman v. Lederle Laboratories, supra, 592 A.2d at p. 1192 [use of an FDA-approved warning does not insulate prescription drug manufacturer from liability for failure to warn of known or knowable risks of harm, as the federal labeling regulations set forth only minimum requirements, and prior FDA approval is generally not required before warning of known or knowable risks]; Brochu v. Ortho Pharmaceutical Corp., supra, 642 F.2d 652, 657-658 [same].)

Brown, supra, 44 Cal.3d at pages 1071-1072, holds that a plaintiff cannot pursue a breach-of-warranty design-defect claim against a prescription drug manufacturer for the same reasons he or she cannot pursue a strict liability design-defect claim against a prescription drug manufacturer. This is so because the “consumer expectation test,” which is at the heart of a strict products liability claim (see Barker v. Lull Engineering Co., supra, 20 Cal.3d at pp. 429-430), is conceptually analogous to a claim of implied warranty of fitness, and the application of such theory of liability to design-defect actions in the prescription drug context was rejected in Brown. (44 Cal.3d at pp. 1061-1062, 1071-1072, and fn. 14.)

The majority seek to disavow Brown’s holding in this regard by suggesting Brown merely rejected the suitability of warranty claims arising from design defects that are “neither known nor knowable at the time the drug is distributed.” (Maj. opn., ante, at p. 1118.) This is a specious distinction, particularly when one considers the statement in the footnote appended to the paragraph the majority is quoting from Brown, which the majority ignores, but which explains; “our holding regarding plaintiff’s breach of warranty claims is founded on the inconsistency between such claims and our conclusion that prescription drugs are not subject to strict liability for design defects . . . .” (Brown, supra, 44 Cal.3d at p. 1072, fn. 14 .) The majority’s faulty reasoning is particularly mischievous, for it stands to revitalize the applicability of breach of warranty claims arising from known or knowable design defects in the prescription drug industry in direct contravention of our unanimous holding in Brown.

For the same reasons applied to prescription drug design-defect actions in Brown, I do not believe a claim of breach of an implied warranty of fitness would survive adoption of Brown’s rationale to the failure-to-warn claims in this case. In any event, the parties are still at the pretrial pleading stage in this litigation. The complaint broadly alleges the defendants impliedly and expressly warranted that the drug Halcion was fit for its intended use and of merchantable quality notwithstanding their knowledge of its serious side effects, and there are few facts developed in the record to substantiate the pleaded claims one way or the other. As such, I would affirm the judgment of the Court of Appeal to the extent it overturned the trial court’s order sustaining the demurrer to the cause of action alleging breach of express warranty.