CARLIN v. UPJOHN COMPANY (1995)

Where a plaintiff alleges that she has suffered harm from a prescription drug which its manufacturer marketed without providing adequate warnings as to the drug's known or scientifically knowable dangers, can she state a cause of action either in strict liability or in breach of warranty?   Relying mainly on Brown v. Superior Court (1988) 44 Cal.3d 1049, 245 Cal.Rptr. 412, 751 P.2d 470, the trial court ruled that these allegations will support only a negligence theory.   Because this ruling ignored the Supreme Court's subsequent holding in Anderson v. Owens–Corning Fiberglas Corp. (1991) 53 Cal.3d 987, 281 Cal.Rptr. 528, 810 P.2d 549, it was in error.

Petitioner and plaintiff Wilma Carlin seeks a writ of mandate following the trial court's sustaining of real party in interest The Upjohn Company's demurrer without leave to amend as to two causes of action in plaintiff's complaint.

As pertinent, in her first amended complaint plaintiff attempted to plead causes of action against Upjohn for strict liability and breach of warranty.   She alleged as to these causes of action that her physician prescribed Halcion, a drug manufactured and distributed for the treatment of insomnia by Upjohn, and that she took it from 1987 to 1992;  that Halcion is unavoidably unsafe because its use can cause emotional, physical and psychic instability, distress, and injuries;  that Halcion's dangerous propensities were known to Upjohn or were reasonably knowable scientifically at the time plaintiff received it;  that Upjohn failed properly to warn users of these dangerous propensities;  and that plaintiff sustained serious permanent physical, mental and emotional injuries as a proximate result of taking Halcion.   As to strict liability, plaintiff further alleged that Upjohn knew and intended that patients would rely on physicians to transmit warnings.   As to breach of warranty, plaintiff further alleged that Upjohn had made both express and implied warranties Halcion was fit for its intended use and of merchantable quality and that plaintiff had reasonably relied thereon.

Upjohn demurred to the first amended complaint, alleging as relevant that plaintiff had failed to state facts sufficient to constitute a cause of action for strict liability or breach of warranty.   Relying on Brown, supra, 44 Cal.3d at pages 1065–1067 and 1072, 245 Cal.Rptr. 412, 751 P.2d 470, Upjohn contended that under California law no cause of action for strict liability or breach of warranty can be stated against a prescription drug company based on failure to warn.

Plaintiff opposed the demurrer, arguing:  (1) Brown did not bar strict-liability or breach-of-warranty causes of action for failure to warn in prescription drug cases, and (2) to the extent Brown might be so interpreted, the Supreme Court had subsequently made clear in Anderson, supra, 53 Cal.3d at pages 998–100, 281 Cal.Rptr. 528, 810 P.2d 549, that such an interpretation of Brown is unwarranted.

After a hearing, the trial court issued a memorandum of decision sustaining Upjohn's demurrers without leave to amend as to strict liability and breach of warranty.   As to strict liability, the court cited Brown, supra, and Artiglio v. Superior Court (1994) 22 Cal.App.4th 1388, 27 Cal.Rptr.2d 589.   As to breach of warranty, the court cited only Brown.

The trial court thereafter issued an order in accordance with its memorandum of decision.

This writ petition followed.

DISCUSSION

 Since this petition comes to us following the sustaining of defendant's demurrer without leave to amend, we presume the truth of all well-pleaded factual allegations in the complaint and decide whether they state a cause of action.  (Blank v. Kirwan (1985) 39 Cal.3d 311, 318, 216 Cal.Rptr. 718, 703 P.2d 58.)

 If the trial court has deprived a party of an opportunity to plead a cause of action by wrongly sustaining a demurrer without leave to amend, and extraordinary relief may prevent a waste of judicial resources, mandamus will lie to compel the overruling of the demurrer.  (Coulter v. Superior Court (1978) 21 Cal.3d 144, 148, 145 Cal.Rptr. 534, 577 P.2d 669.)

A. Strict Liability

 There are commonly three types of product defects that may give rise to a claim that the manufacturer of the product should be liable in strict liability.   First, there may be a flaw in the manufacturing process, resulting in a product that differs from the manufacturer's intended result.   Second, there are products which are perfectly manufactured but are unsafe because of the absence of a safety device, i.e., a defect in design.   Third, there are products that are dangerous because they lack adequate warnings or instructions.  (Brown v. Superior Court, supra, 44 Cal.3d at p. 1057, 245 Cal.Rptr. 412, 751 P.2d 470.)

 In her memorandum of points and authorities filed in this court, plaintiff has stated that her claim for strict liability is premised upon the third category of product defect:  Upjohn's asserted failure to warn of dangerous propensities of Halcion that were known or scientifically knowable.   Accordingly, our discussion is necessarily circumscribed by the nature of plaintiff's claim.

We begin our analysis with Brown v. Superior Court, supra, 44 Cal.3d 1049, 245 Cal.Rptr. 412, 751 P.2d 470.   In Brown, the Supreme Court held that a drug manufacturer may not be held strictly liable for failure to warn of a drug's inherent risks where “it neither knew nor could have known by the application of scientific knowledge available at the time of distribution that the drug could produce the undesirable side effects suffered by the plaintiff.”  (44 Cal.3d at p. 1065, 245 Cal.Rptr. 412, 751 P.2d 470.)   Because the court found that strict liability might make drug companies reluctant to undertake the risk of developing and marketing beneficial new drugs, it adopted instead the test set out as follows in the Restatement Second of Torts, section 402A, comment 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․   Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous․   The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given ․, is not to be held to strict liability for unfortunate consequences attending their use․”  (Brown, supra, 44 Cal.3d at pp. 1058–1059, 1061, 1063–1066, 245 Cal.Rptr. 412, 751 P.2d 470.)   The court noted that comment k, though purporting to explain strict liability, in fact states a principle sounding in negligence;  furthermore, the test of comment k is distinguishable in particular from strict liability for failure to warn because comment k imposes liability only if the manufacturer knew or should have known of a drug's defect when the drug was distributed.  (Brown, supra, 44 Cal.3d at p. 1059 and fn. 4, 245 Cal.Rptr. 412, 751 P.2d 470.)   The court summarized its holding as follows:  “․ [A] manufacturer is not strictly liable for injuries caused by a prescription drug so long as the drug was properly prepared and accompanied by warnings of its dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution.”  (Brown, supra, 44 Cal.3d at p. 1069, 245 Cal.Rptr. 412, 751 P.2d 470, italics added.)   In a footnote, Brown added:  “Our conclusion does not mean, of course, that drug manufacturers are free of all liability for defective drugs.   They are subject to liability for manufacturing defects, as well as under general principles of negligence, and for failure to warn of known or reasonably knowable side effects.”  (Brown, supra, 44 Cal.3d at p. 1069, fn. 12, 245 Cal.Rptr. 412, 751 P.2d 470, italics added.)

The court also rejected the plaintiff's claims for breach of express and implied warranty, holding that they were barred for the same reason as her strict liability claims.  (Brown, supra, 44 Cal.3d at pp. 1071–1072, 245 Cal.Rptr. 412, 751 P.2d 470.)

Read in its entirety, Brown is uncertain with respect to whether a claim for strict liability against a drug manufacturer may be premised upon the manufacturer's failure to warn of defects that were known or reasonably knowable at the time of distribution.   The court's remarks with respect to comment k suggest such a theory of failure to warn would sound only in negligence.   However, other passages of the opinion, quoted above, suggest the strict liability door might still be open to a plaintiff who could allege the manufacturer failed to warn with knowledge or reason to know of the product's dangerousness.

This ambiguity was resolved in plaintiff's favor by Anderson v. Owens–Corning Fiberglas Corp., supra, 53 Cal.3d 987, 281 Cal.Rptr. 528, 810 P.2d 549.   In Anderson, the plaintiff raised a strict products liability claim against defendant asbestos manufacturers on theories including defendants' failure to warn of the risks of asbestos.   Defendants sought to introduce “state-of-the-art” scientific evidence that those risks were not known or reasonably knowable when plaintiff was exposed to asbestos.   The trial court first granted plaintiff's motion to exclude this evidence, then granted defendants' motion to bar plaintiff from proceeding on his failure-to-warn theory.   Following a jury verdict for defendants on plaintiff's remaining theories, plaintiff successfully moved for a new trial, contending he should be allowed to put on his failure-to-warn case even if defendants' state-of-the-art evidence was excluded.   The Court of Appeal upheld the new trial order and ruled that defendants' proposed evidence would be inadmissible because it would focus attention on the reasonableness of defendants' conduct, which the court deemed irrelevant to strict liability.  (53 Cal.3d at pp. 991–993, 281 Cal.Rptr. 528, 810 P.2d 549.)

The Supreme Court affirmed the judgment, but remanded the matter to the trial court with directions to admit defendant's state-of-the-art evidence on retrial.  (Anderson, supra, 53 Cal.3d at p. 1004, 281 Cal.Rptr. 528, 810 P.2d 549.)   This ruling was prompted by the majority's holding, contrary to the position of the Court of Appeal, that whether a product's risk was known or reasonably knowable to the defendant is a critical question for purposes of strict-liability failure to warn.

Surveying the development of strict liability for failure to warn in California law, the majority concluded that the weight of authority held “knowledge or knowability is a component of strict liability for failure to warn,” and approved this line of cases.  (Anderson, supra, 53 Cal.3d at p. 1000, 281 Cal.Rptr. 528, 810 P.2d 549.)   The majority specifically included Brown, supra, among the cases in this line—“if not directly, at least by implication.”  (Anderson, supra, 53 Cal.3d at p. 1000, 281 Cal.Rptr. 528, 810 P.2d 549.)   The majority then considered and rejected, without further reference to Brown, the objection that incorporating a requirement of knowledge or knowability of risk as an element of strict-liability failure to warn “improperly infuse[s] negligence concepts into strict liability cases.”   (Anderson, supra, 53 Cal.3d at p. 1000, 281 Cal.Rptr. 528, 810 P.2d 549.) ¹  In rejecting this objection, the majority spelled out what it saw as a crucial difference between “failure to warn in strict liability” and “failure to warn in negligence”:

“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, i.e., what a reasonably prudent 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 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, supra, 53 Cal.3d at pp. 1002–1003, 281 Cal.Rptr. 528, 810 P.2d 549, fn. omitted.)

Justice Mosk, the author of Brown, concurred in the result but dissented from the majority's reasoning.   He protested that the majority's analysis further blurred the formerly clear-cut distinctions between negligence and strict liability in California products liability law.  (Anderson, supra, 53 Cal.3d at pp. 1006–1007, 281 Cal.Rptr. 528, 810 P.2d 549.   He also complained that the majority had misconstrued Brown by failing to grasp that its holding “was based on a narrow public policy exception to strict products liability for prescription drugs, and for such drugs alone.”  (Anderson, supra, 53 Cal.3d at p. 1008, 281 Cal.Rptr. 528, 810 P.2d 549.)   Finally (as relevant), he suggested that the court ought to “consider the possibility of holding that failure-to-warn actions lie solely on a negligence theory.”   (Ibid.)

Upjohn asserts that Anderson does not “alter” the holding of Brown because “[t]he Anderson court addressed failure-to-warn principles applicable to products generally;  that is, products other than the pharmaceuticals that were singled out for special treatment in Brown. ”  (Italics added.)   The last quoted clause is a non sequitur.   Principles “applicable to products generally” necessarily apply to particular products, such as prescription drugs, unless expressly declared not to do so.   Anderson nowhere exempts prescription drugs from the principles of strict-liability failure to warn which it enunciates.   Indeed, as we have noted, Justice Mosk's concurring and dissenting opinion in Anderson reproaches the majority for failing to single out prescription drugs for special treatment.   (Anderson, supra, 53 Cal.3d at p. 1008, 281 Cal.Rptr. 528, 810 P.2d 549.)

Upjohn further asserts:  “The Anderson court's brief summary of the Brown holding does not remotely suggest that the court intended to modify—to any extent—the principles governing the liability of pharmaceutical manufacturers articulated in Brown.”  We do not view Anderson as a “modification” of Brown but rather as a clarification of Brown's inherent ambiguity with respect to the survival of a strict liability cause of action where the manufacturer fails to warn of a product defect that is known or reasonably knowable scientifically.

Finally, Upjohn cites several recent appellate opinions that supposedly show Brown 's continuing vitality on the question before us.  (Artiglio, supra, 22 Cal.App.4th 1388, 27 Cal.Rptr.2d 589;  Plenger v. Alza Corp. (1992) 11 Cal.App.4th 349, 13 Cal.Rptr.2d 811;  Hufft v. Horowitz (1992) 4 Cal.App.4th 8, 5 Cal.Rptr.2d 377.)   It is true that these opinions (all dealing with products liability actions for medical devices) rely on Brown, but none cites Brown for the proposition that liability for failure to warn in prescription drug cases can arise only out of negligence.

In Hufft and Plenger, the courts invoke Brown's discussion of the policy rationale justifying special treatment for drug manufacturers as to strict liability, then determine that this rationale applies equally to manufacturers of medical devices, and finally evaluate the facts before them as to whether the risks of the devices were known or knowable when defendants distributed them and whether defendants' warnings were adequate.  (Plenger, supra, 11 Cal.App.4th at pp. 357–362, 13 Cal.Rptr.2d 811;  Hufft, supra, 4 Cal.App.4th at pp. 13–24, 5 Cal.Rptr.2d 377.)  Hufft expressly construes Brown as preserving strict liability for failure to warn of known or knowable risks in cases of this type (Hufft, supra, 4 Cal.App.4th at p. 19, 5 Cal.Rptr.2d 377), and Plenger impliedly does so.  (Plenger, supra, 11 Cal.App.4th at pp. 360–361, 13 Cal.Rptr.2d 811.)

Artiglio, supra, does not address failure to warn;  it addresses only a claim of strict liability for an alleged design defect in a medical device.  (22 Cal.App.4th at pp. 1392–1397, 27 Cal.Rptr.2d 589.)   Thus it is not on point.

We conclude the trial court erred by sustaining Upjohn's demurrer to plaintiff's cause of action for strict liability for failure to warn.

B. Breach of warranty

 In Brown, the court rejected plaintiff's warranty claims as follows:  “Plaintiff's breach of warranty claims are inconsistent with our determination on the issue of strict liability for design defects.   We have concluded above that a manufacturer of prescription drugs is not strictly liable for injuries caused by such a defect that is neither known nor knowable at the time the drug is distributed.   To hold nevertheless that the manufacturer's representation, express or implied, that a drug may be prescribed for a particular condition amounts to a warranty that it is ‘fit’ for and will accomplish the purpose for which it is prescribed (Cal.U.Com.Code, §§ 2314, subd. (2)(c), 2313, subd. (1)(a)), and to allow an action for personal injury for the breach of such warranties, would obviously be incompatible with our determination regarding the scope of a drug manufacturer's liability for product defects.”  (Brown v. Superior Court, supra, 44 Cal.3d at p. 1072, 245 Cal.Rptr. 412, 751 P.2d 470.)

It is apparent that Brown 's preclusion of a warranty claim is a prophylactic rule.   It is designed to keep a plaintiff from pursuing a claim for breach of warranty where a claim for strict liability is barred.   In essence, Brown says to a plaintiff:  you cannot avoid my bar on strict liability by making an end run around the bar with a claim for breach of warranty.

Where, however, a plaintiff has a valid claim for strict liability, there is no longer any reason to bar an otherwise valid warranty claim.   Put differently, the preclusion of a warranty claim is no longer necessary to avoid an end run around the strict liability bar because the claim for strict liability is no longer barred.

Here, as we have noted, plaintiff has pled a viable strict liability claim.   For pleading purposes (the only issue before us now), plaintiff has therefore demonstrated she has a valid claim for strict liability.   Thus, for pleading purposes, there is no longer any basis to bar her claims for breach of warranty, which are properly pled.

The trial court therefore erroneously sustained the demurrer to the warranty cause of action.

DISPOSITION

Let a peremptory writ of mandate issue directing the trial court to vacate its order sustaining without leave to amend Upjohn's demurrer to plaintiff's causes of action for strict liability and breach of warranty and to enter a new order overruling Upjohn's demurrer to those causes of action.

FOOTNOTES

1.   The majority apparently did not read Brown as having taken this position.   In the majority's view, the question whether a defendant may be found strictly liable for failing to warn of known or knowable risks was not presented in Brown;  the only issue before the court as to failure to warn was whether a drug manufacturer may be found strictly liable for not warning of unknowable risks.  (Anderson, supra, 53 Cal.3d at p. 999, 281 Cal.Rptr. 528, 810 P.2d 549.)

SIMS, Associate Justice.

BLEASE, Acting P.J., and BROWN, J., concur.