*1 Aug. S045912. [No. 1996.] CARLIN, Petitioner,
WILMA PEGGY COUNTY, THE SUPERIOR COURT OF SUTTER Responent; COMPANY, UPJOHN Real in Interest. Party *4 Counsel Deacon, Harbison,
Wilcoxen, Callahan, & B. Gary & Callahan Montgomery Callahan, Martin for Petitioner. S. Deacon and Judith Clark E. on behalf of Petitioner. L. Wilson as Amici Curiae L. Dunn and Gary
Joseph No appearance Respondent. Arnold, Detert, F. Healy, Moran & Michael
Todd W. Kingma, Sedgwick, Shook, Bacon, Baker, Jenkins, & Marie S. Kirk C. Hardy Frederick D. Real in Interest. E. Scheve for Party Woodbury Stephen *5 Hiestand, Powell, Hanson, Heafey, Fred E. Crosby, Catherine I. J. Marjorie Merksamer, Martin, Nielsen, Davis, C. Peter W. James Roach & May, Mueller, Merksamer, Parrinello, C. E. James Mueller & Steve John Naylor, Erbin, Dickson, Gross, Hall R. Marston and Carlson & Campillo, Gene in Interest. Party Amici Curiae on behalf of Real David R. Venderbush as Opinion whether we address the
MOSK,
question
C.
In thiscase
Acting
J.
a claim
can state
alleging
ingesting prescription
plaintiff
injury
of
for failure
warranty
for strict
and breach
the manufacturer
against
knowable dangerous
or reasonably scientifically
to warn about the known
We conclude that she can.
of its product.
propensities
Corp.
v. Owens-Corning Fiberglas
recent decision in Anderson
our
Ander
(hereafter
810 P.2d
Upjohn), failure to warn Anderson for cases involving standard under risks from drugs, known or knowable reasonably scientifically We only. for that industry and a new standard of adopt simple we affirm the judgment discern no sound basis for so. doing Accordingly, the Court of Appeal.
I. for (hereafter Carlin) Plaintiff Carlin an action brought Wilma Peggy sustained from she against injuries assertedly ingesting damages Upjohn Halcion, between which was for her by physician prescribed claimed, here, was She as relevant that strictly 1992. Upjohn liable and/or warn of failing “properly dangerous propensities prepare Halcion.” She “knew that Halcion alleged specifically Upjohn ...[,] took the was defective that those who were Halcion and prescribed mental, same would and did severe experience, experience, physical, emotional this knowledge, damages/injuries yet, notwithstanding [it] who and in willful and conscious of those safety despicably, disregard herein, were Halcion and of the without giving any prescribed plaintiff Halcion, notice of the defect to the purchasers placed persisted Halcion into the stream of commerce . . . .” She also claimed placing *6 was it liable for breach of She that Upjohn alleged “expressly warranty. that warranted to the and their health-care impliedly physicians patients Halcion was a for which it was intended and fit for the use prescription drug was of merchantable “was unfit and the fact that quality” despite product unsafe for of its known ingestion health-care by patients light propensity to, side-effects, to cause serious limited mental but not including, physical, and emotional to Halcion . . . .” injuries persons ingesting demurred, alia, to state facts inter that failed
Upjohn alleging, Carlin for breach of sufficient a cause of action for strict or liability constitute that, law, It no cause of action for strict warranty. under California argued or breach of can be stated a liability warranty against manufacturer The court sustained the based on failure warn. superior to amend. Carlin
demurrer as to those causes of action without leave an alternative for a writ of mandate. Court issued petitioned Appeal mandate; oral it issued a writ writ of after briefing argument, peremptory mandate, court to its order sustaining vacate directing superior for and breach of demurrer to the causes of action strict liability warranty and to enter a new order the demurrer. We review. overruling granted
II. contends the Court of erred in vacating Upjohn Appeal court’s order demurrer on Carlin’s cause of action for superior sustaining strict for failure to warn. It that California courts have liability argues “long refused to expand scope potential liability prescription pharmaceu so. In tical manufacturers traditional Not beyond negligence principles.” cases, we have a strict applied liability prior expressly repeatedly standard to manufacturers of for failure to warn of known We reaffirm knowable risks. those reasonably scientifically merely pre cedents here. Anderson, the general we summarized case law and outlined prior of strict been California courts for they by have
principles
applied
(Anderson,
994-1003.)
As
over three decades.
53 Cal.3d at
pp.
therein,
we
under our doctrine of strict
first announced
explained
liability,
Products,
Greenman v. Yuba Power
Inc.
We addressed the issue “whether actual knowledge, specifically constructive, is a of strict on the failure-to-wam component liability theory.” (Anderson, it is. “The 990.) 53 Cal.3d at We concluded that supra, p. courts, California either have to date required or by implication, expressly
1111 constructive, risk or before danger impos or of potential actual knowledge, (Id. 991.) that We affirmed for a failure to warn.” at p. strict ing liability that knowl well settled into the view majority “California is for failure to warn.” is a of strict liability or edge knowability component 1000.) (Id. at p. a manufacturer of Anderson involved an action against
Although asbestos, involving variety products, we relied on cases extensively our In we were guided by including prescription drugs. particular, prior Brown, we to extend decision in in which refused supra, to the failure to warn of risks that were unknown or unknow strict liability Brown], time distribution. “As we stated if a manufacturer able at the [in to that were known or knowable could not count on its risks limiting liability distribution, at the time of manufacture or it would be discouraged new and for fear that later ad improved products significant developing . . . vances in scientific would increase its manu knowledge liability. [A] is not so facturer liable for caused strictly injuries prescription drug as it was of its long accompanied by warnings properly prepared that were either known or knowable at dangerous propensities scientifically (Anderson, 999.) at We the time distribution.” concluded that the in Brown to all not to holding products, only applied sense are not to “Brown’s common limited prescription drugs: logic the extent to which rule Califor drugs. recognizing majority pervades cases, nia both Brown precedents nondrug clearly implied is also a knowledge for failure to warn in cases component 1000; (Id. other than cases.” at see also Vermeulen v. prescription drug Superior Court Cal.App.3d 805] [“We . . . do not Brown’s of the failure to warn issue to interpret analysis be limited to necessarily cases. The same rationale applies to other equally products.”].)1
We that the recognized knowledge knowability requirement failure to warn infuses some into strict cases. concepts and extensive reliance in Anderson on our rationale in Brown— express 1In view of our only prescription drugs—Justice which involved Anderson suggestion not Baxter’s (Dis. properly be “necessarily” applying prescription drugs understood as is unfounded. Baxter, J., post, asbestos, opn. Anderson involved a manufacturer of Although was, holding concerning application its of strict in failure-to-wam cases on its face, apply generally intended to products. to manufacturers of all To the extent that Justice Anderson, purports any support dissenting Baxter to find opinion unpersuasive. in the he is The Anderson disagreement expressed majority’s dissent with the conclusion that manufac generally only turers should be liable for failure to warn of known or knowable risks—as regardless opposed they for failure warn of risks of whether were known or only argued knowable—and that such apply a limited form of strict should (Anderson, 1005-1008, Mosk, J.) manufacturers. opn. Cal.3d at conc. & dis. but, considered, in Anderson majority rejected doing, they that approach. In so effect, Brown with to all manufacturers. adopted public policy regard rationale
(Anderson, Indeed, 1001.) 53 Cal.3d supra, at in the failure-to-wam context, strict is to some liability extent a of traditional hybrid strict liability however, doctrine. As we negligence “the explained, claim that a particular component ‘rings or ‘sounds in’ negligence has not precluded Indeed, its the context acceptance (Ibid.) of strict liability.” “the strict doctrine has liability incorporated some well-settled mies from the law of negligence has survived judicial that such challenges asserting incorpo- ration violates the (Id. 1002.) fundamental of the principles doctrine.” at Thus, Anderson, Brown, although following incorporated certain negligence warn, into the standard of strict concepts failure to it did not liability a test.2 thereby adopt simple negligence
“[Fjailure to warn in strict differs from failure to liability markedly warn in the context. law in a negligence Negligence failure-to-wam case requires that a plaintiff prove manufacturer or distributor did not warn of a risk for reasons which particular care, fell below the standard of acceptable i.e., what a reasonably manufacturer would have pmdent known and warned about. Strict is not concerned with the standard of due care or the reasonableness of a manufacturer’s conduct. The mies of strict liability require plaintiff that the prove only defendant did not warn adequately of a risk that was particular known or knowable in light generally recognized best prevailing scientific and medical available at knowledge Thus, the time of manufacture and distribution. in strict as liability, opposed to negligence, the reasonableness of the defendant’s failure to warn is immaterial. Stated another away, reasonably pmdent [‘JD manufacturer might decide that the reasonably risk of harm was such as not to require warning as, for if the example, manufacturer’s own showed a result testing contrary to that of others in the scientific Such a community. manufacturer might escape contrast, under under principles. strict liability principles manufacturer has no such the manufacturer is liable if leeway; it failed to give warning dangers were known to the scientific at the community time it manufactured or (Ander- distributed the product.” son, 1002-1003, Cal.3d at omitted.) fn. pp. a manufac- Similarly, turer could not escape under strict be- principles merely cause its failure to warn of a known or knowable reasonably scientifically support 2We found in Brown in the Restatement Second of adopted the standard we 402A, k, Torts section comment appears (Rest.2d which topic under the Liability.” “Strict Torts, 402A, k, 353-354.) com. We noted in Brown imposing § liability only if knew or should have known of a defect “sets forth a test which sounds in (Brown, negligence.” not, fn. Upjohn erroneously We did as contends, thereby Rather, establish that the standard simple negligence. for failure to warn is Anderson explains, merely that, we rejected a standard of imposing liability for unknown and unknowable risks, would be liability.” tantamount to “absolute *9 warnings of failing provide to an industry-wide practice risk conformed care.3 the standard of reasonable that constituted for strict standard liability behind our We explained policy “ case, ‘When, the risk in a qualitatively to warn as follows: particular failure on balance with as well as disability) quantitatively, of death or (e.g., major achieved, a true choice is such as to call for judgment, the end to be sought Thus, .’ medical or must be . . the warning personal, given. [Citation.] manufacturer acted as a reasonably prudent fact that a manufacturer warn, the manufacturer of liability not to while absolving deciding perhaps under strict will not negligence theory, preclude under the that, on the information if of fact concludes based the trier principles manufacturer, the manufacturer’s failure available to the scientifically (Anderson, supra, 53 Cal.3d rendered the unsafe to its users.” warn product Laboratories, Inc. 1003, added, (9th Cir. Wyeth Davis at italics quoting p. 121, to a manufacturer of 1968) F.2d strict liability 129-130 [applying drugs].) Anderson will and amici curiae place Upjohn argue applying in an because they manufacturers untenable prescription drugs position must with set the Food and Administration comply regulations by Drug FDA), warn (hereafter which them from with labeling drugs may preclude also contend that Anderson would result of certain side effects. ings They Neither claim withstands overlabeling pharmaceuticals. scrutiny.
We standard that a unpersuaded by Upjohn’s argument knowable for failure to warn about known or risks reasonably scientifically from is with regulatory inconsistent federal prescription drugs policy. Up concedes that FDA do not common law john regulations expressly preempt tort remedies for failure to the entire field of As warn occupy regulation. concluded, numerous courts have evinced no intention of Congress preempt Feld (See, state tort ing injuries prescription drugs. e.g., man v. Lederle Laboratories A.2d 125 N.J. 1192] Anderson, knowledge—i.e., 3In explained we that our definition of constructive what is “reasonably scientifically Second of Torts knowable”—is derived from the Restatement “ 402A, j, page knowledge ‘by applica section comment obtainable which refers to ” reasonable, (Anderson, developed foresight.’ tion of at human skill and Brown, 13; 1069.) knowledge fn. see 44 Cal.3d at The actual of the individual manufacturer, reasonably require even if prudent, is not the issue. We view the standard to field; obliged knowledge expert that the manufacturer held in the it is is and skill of an any keep presumed abreast of scientific discoveries to know the results of all such knowledge Brown Anderson require advances. We also note that both that the element Brown, must exist at the time of distribution. “a manufacturer’s knowl explained As we edge point should be measured at the time a because it is this is distributed (Brown, supra, fn. relinquishes control of the 44 Cal.3d at product.” controlling. Obviously, subsequently developed not be would scientific data the assertion that in the federal scheme to support find nothing
[“[W]e who literally comply and antibiotics of manufacturers tort injuries must be immune from state regulations] with [FDA (4th Co. Cyanamid Abbot v. American their Abbot caused products.”]; *10 1108, not law does 1112 A.L.R.Fed. 1988) 844 F.2d 107] [federal Cir. [98 warn, failure to despite common law of state preempt imposition FDA without changed “once cannot fact that labeling, approved, 239, Co., 1990) (E.D.Pa. 742 F.Supp. v. Merck & Inc. approval.”]; Mazur matter, FDA or for that with an suggestion, compliance 247 [“[M]ere order, law becomes irrele not mean that state tort or does regulation federal regula tort law is intended to supplement vant. . . . . . . State [50 _ Medtronic, _, .”]; (1996) 518 U.S. Inc. v. Lohr [135 tion . . . cf. Stevens, J.) 700, 725-726, [negli S.Ct. 116 (plur. opn. L.Ed.2d 2240] a medical to warn about risks of strict claims for failure gence federal regulations].) device were preempted by however, FDA are that regulations with Carlin’s argument, We disagree to warn. We law action for failure irrelevant in a common essentially Under liability. to warn is not absolute that strict for failure reiterate Anderson, was not liable for a risk that manufacturers are not strictly context, it is significant knowable. In this known or reasonably scientifically every about warning FDA manufacturers from that the precludes drug reaction; if there exists significant warn they only conceivable adverse may are also They specifically evidence of a health hazard. medical possible differences of opinion adverse reactions when warning precluded adverse reac with community regard potential exist within the medical shall 201.57(d) (e) (1996) warnings (See [requiring tions. 21 C.F.R. & § id., hazards, hazards]; 1.21(c)(1) not theoretical [prohib be of known § contraindications, precau the inclusion of iting differing opinions regarding reactions, labels].) tions, on adverse and other hazards drug warning product however, time, adverse to “describe serious At the same they required them, hazards, in use imposed by limitations safety reactions potential shall be taken if occur. The revised labeling that should be they steps of an association a soon as there is reasonable evidence include warning not have been a causal need of a serious hazard with a drug; relationship (Id., 201.57(e).) proved.” § inaction, cases, may not dispositive, FDA action or though appropriate a known or reason-
be admissible under Anderson to show whether risk was Sandoz-Wander, (Cf. Inc. knowable. ably scientifically Hatfield 1105, Ill.Dec. 464 N.E.2d [evidence Ill.App.3d 1109] [80 in as relevant evidence with FDA is admissible compliance requirements manufacturer tort on the issue a strict case whether a pharmaceutical Proctor v. Davis (1995) 275 Ill.App.3d warnings]; adequate failed provide [accord].) Similarly, 656 N.E.2d Ill.Dec. 29] was no “reasonably evidence to show that there could present distribution, because, the cause of at the time of knowable risk” scientifically to have been reasonably was too adverse effect speculative the alleged state-of-the-art research. a scientist conducting attributable to the drug risk Thus, based on an allegation particular claim is when plaintiff’s knowable,” arise as to what a an scientifically inquiry was “reasonably have known under the faith should scientist good reasonable operating Anderson, we do not the evidence. As we circumstances of emphasized context—for failure-to-wam altogether reject because some considerations reasonableness other any products—simply *11 (Anderson, supra, be 53 Cal.3d pp. sounding negligence may required. 1001-1002.)4
Moreover,
risk,
in the case of an
“known”
if state-of-the-art
alleged
the FDA
scientific data
was
disclosed to
alleged
fully
risk
concerning
determined,
review,
and it
after
that the
manufacturer was
pharmaceutical
to
was inconclusive or the risk
permitted
because the data
warn—e.g.,
was too
to
manufacturer
could
speculative
justify
warning—the
present
such evidence to
the FDA’s conclu
show that
cannot
apply;
was,
effect,
Feldman
(See
sion that there
no “known
controlling.
risk” is
Laboratories,
v. Lederle
supra,
We are also assertion that strict liabil- unpersuaded by Upjohn’s applying to claims of ity for failure to warn will result in manufac- injury inevitably turers with from inundating consumers of even risks warnings speculative 691, In Finn v. G. D. Searle & Co. 701 prescription drugs. 1147], 677 P.2d we addressed the Cal.Rptr. potential problems [200 risk, if overlabeling: that of a “[E]xperience suggests] every report possible tentative, no matter how or an affirmative speculative, conjectural, imposed to duty some a manufacturer would be to inundate give warning, required with notice hint of physicians indiscriminately every danger, of any reject suggestion dissenting by 4We opinion regulation of the the extensive to the rule in Anderson drug labeling require exception FDA of should us to create a new unique drug drug industry highly to pharmaceutical manufacturers. The fact is Moreover, regulated distinguish dissenting does not it from as the numerous other industries. concedes, opinion warning liability. approval particular the FDA’s of a is not determinative of adopted dissenting Nor have our courts the approach of the narrow line of cases cited opinion they merely gave which would insulate manufacturers for failure to warn if FDA- however, hold, here, approved warnings. very thing, It is a to as we do that a different pharmaceutical failing give warning not be it has been held liable for expressly precluded by the FDA giving. (See the force of thereby inevitably diluting any specific warning given.” Anderson, Finn.) 53 Cal.3d at citing application determinations whether theory failure-to-wam pharmaceuticals requires evidence established a causal link between an side effect available alleged and, should have been given, and a whether drug, any warning so, if whether the was These are issues fact warning involving, adequate. i.e., alia, art, the state of the what was known or concerning inter questions knowable of scientific medical reasonably application knowledge available at the time of manufacture and distribution the prescription drug. risk, involve whether the also necessarily questions concerning light They norms, scientific was more than merely conjec- of accepted speculative tural, or so remote and as insignificant negligible.5
Moreover, runs to in the case to warn drugs, duty Brown, (See, not to the 44 Cal.3d at physician, patient. e.g., Parke, 1061-1062; & Stevens v. Davis Co. the case of medical 507 P.2d 94 A.L.R.3d 1059] [“In ‘if has of a been
prescriptions, adequate warning potential dangers doctors, there is no manufacturer to insure that the given duty by reaches the doctor’s for whom the but warning prescribed.”]; patient Laboratories, Inc., see Davis v. F.2d at Wyeth supra, 399 [exception such,” where “was not but administered in prescription drug dispensed *12 Thus, mass immunization program].) pharmaceutical may not be of to medical a risk known commu- required provide warning (See nity. Plenger Corp. Cal.App.4th [13 Alza are aware of no which a manufac- Cal.Rptr.2d authority requires 811] [“We consumer, turer to warn of a risk which is known and readily apparent Davis, in this case the Proctor v. at physician.”]; Ill.App.3d 605-606 N.E.2d at manufacturer need not p. [pharmaceutical 31] of known risks to the medical provide warning community].)6 Nor does offer sound rationale for Upjohn any public policy departing from Anderson of manufacturers of concerning liability concurring dissenting opinion simply wrong asserting 5Justice Kennard’s in is that we impose prescription drug duty “every arguable would on manufacturers to warn of risk.” Kennard, J., post, (Conc. 1131.) opn. p. suggests and dis. Kennard at Justice also that liability costs prescription drugs of tort have been “excessive” in the case of such as the (Id. flu, 1127.) diphtheria-pertussis-tetanus, vaccines for swine polio. Perhaps at so. risk, a severe known But when a drug poses proportion vaccine or other albeit to a small patients, altering proof suggests it is how unclear the burden of for failure to warn as she deprive would reduce those costs—unless the inevitable would be to an innocent result injured person any remedy. 6Although conjectures physicians “may Justice Kennard that be overwhelmed excessive warnings” scientifically if manufacturers must warn of knowable risks under this known or (conc. Kennard, J., 1126), post, any standard opn. and dis. there is no evidence that detriment, problem such has emerged patients any despite or that the fact that have suffered liability long strict has been the rule in California. knowable scientifically of known or reasonably for failure to warn Thus, derived argument, purportedly risks. we unpersuaded Brown, be manufacturers of should prescription drugs in reasoning our because otherwise strict to warn liability duty they might from the exempt vac- and marketing drugs, including “cutting-edge refrain from developing (HIV)” virus and other diseases. human immunodeficiency cines to combat Brown, strict for design defects, Our which involved rationale defects, strict for unlike strict design inapplicable: manufacturers to failure to warn does not potentially subject have, not, have and could not discov- they flaws their products ered. manufacturers need warn of risks that are known or Drug actually knowable. reasonably scientifically offers no clear or sufficient basis for that research and concluding
Upjohn as a will decrease result inevitably imposing development risks; for failure to warn of known or knowable reasonably scientifically indeed, manufacturers to internalize the costs of to deter- requiring failing mine such risks instead increase the level of research into safe and may event, effective we see no reason to from our conclusion drugs. any depart costs, in Anderson that manufacturer should bear the terms of prevent- death, able of its own failure to injury adequate warnings provide known or knowable risks. As we observed: “What- reasonably scientifically manufacturer, ever from the reasonable view of the the user point must be either to refrain from product given option using at all or to use it in such as to minimize the product way degree danger.” (Anderson, supra, 53 Cal.3d at Anderson itself involved a Although asbestos, our nondrug, conclusion therein with force to applies equal pre- scription drugs.7
III. *13 also contends the Court of Upjohn that erred Appeal vacating court’s order demurrer on for superior sustaining Carlin’s cause of action unpersuaded by suggestion dissenting 7We are also opinion of the we create that should exception solely drug new for suggested manufacturers because some commentators have adequacy warnings law review articles question is a subset of the acceptability design product. Equally dissenting unpersuasive opinion’s the basic of a is the suggestion guided by that we should be the fact that some of these same commentators have and, indeed, proposed that the promulgated Restatement Third of Torts—which has not been only is stage—should still at the “tentative draft” adopt a “reasonableness” standard and any entirely abandon arguments might standard of strict for failure to warn. Both Anderson conceivably support reversing altogether—an approach dissenting that even the opinion rejects—but they here do support creating exceptions general not individual to a rule warn, e.g., only highly for failure to drug for manufacturers or for Indeed, regulated hardly clarify industries. it would common serve to law of patchwork types to create a of different of manufacturers. rules for different of action such cause any that Brown precludes It warranty. argues breach of Not so. drugs. manufacturers of warranty against for breach is not Brown, that “a manufacturer we held only nor defect that is neither known such a for caused injuries liable strictly that, an action is distributedand drug accordingly, the time the knowable at does not lie against drug for such unknown breach of warranty defect added.) italics That (Brown, 44 Cal.3d at manufacturers. warn, for failure to Carlin’s here. Like her claim is reasoning inapplicable warn of a known on failure to claim warranty premised breach of defect.8 knowable reasonably scientifically however, of a aspect that the “consumer expectation”
We emphasize, context, to the in the subject, prescription drug action is warranty breach of above, rule, concerning drug’s properties discussed warnings general (Brown, supra, rather than the patient. directed to the physician are properly the effects regarding 1061-1062 patient’s expectations [“[A] whom his are those related him by physician, drug prescription] [a regarding drug’s properties.”].) directs warnings the manufacturer “it is the Thus, for breach of warranty, ordinarily of liability purposes ‘the ordinary stands in the shoes of doctor who reality prescribing ” (1971) 17 (Carmichael v. Cal.App.3d consumer.’ Reitz 381].) IV. reasons, in this case the Court of Appeal these we conclude that
For court to Brown in the superior Anderson and directing correctly applied the causes of action for demurrer to vacate its order sustaining Upjohn’s we affirm Accordingly, judgment and breach of warranty. strict liability of the Court of Appeal. * J., J., (C. S.), J.,† concurred.
Werdegar, Spencer, Vogel The manufacture J., prescrip KENNARD, Concurring Dissenting. of the 20th has many tion a multibillion-dollar industry, provided drugs, strictly liable for could not be held 8Since Brown merely concluded that manufacturers risks, reject suitability of purport of unknown and unknowable it did failure to warn scientifically health risk. In view knowable warranty posed claims when a a known or manufacturers, we discern created for special exception our no should be conclusion that warranty. for breach of permitting plaintiff pursue her claim nothing “mischievous” about *14 Baxter, J., post, (See opn. at fn. dis. of One, District, Appellate Division *Presiding Appeal, the Court of Second Justice of VI, 6 of the California Acting pursuant to article section assigned by the Chief Justice Constitution. Four, District, Appellate Division †Presiding Appeal, Second Justice of the Court of VI, 6 of the California section assigned by Acting pursuant the Chief Justice to article Constitution. stories and success some its worst Because
century’s greatest tragedies. disease, life, cure have they pain, alleviate prolong been a benefit to But sometimes cause great society. prescription drugs effects, severe and side well as complications inflicting great anguish and even on temporary disability some individuals. permanent This court’s task in the case is to set present rules defining prescription manufacturers’ tort for caused their personal injuries by prod- ucts’ side effects. More task the is to determine under what particularly, a circumstances manufacturer should be held liable in tort for personal caused failure injury proximately a to warn about the damages by possibility of a particular drug complication. holds that manufacturer is majority liable tort warn, all
for about it which did not drug-related injuries that provided only the risk of was either or in injury known some manner actually scientifically dissent, ascertainable the manufacturer it the by when distributed In his drug. contrast, Justice by Baxter proposes that manufacturer be prescription drug held liable for failure to warn of if the possible drug-related injuries only drug succeeds in person injured that manufacturer’s proving decision not to warn was unreasonable.
I find neither approach entirely satisfactory. Combining what I view as the both, best features of I would hold that to establish a facie initially, prima case, a person on seeking damages a failure-to-wam drug-related injures theory need that the time of prove only distribution either learned, knew or should have through application commonly scientific accepted methods reasonably available of the technologies, harm; risk of I would particular but hold also after the that party seeking makes this recovery showing, manufacturer defend on basis considerations, it acted reasonably, in of all light relevant warning risk. particular I.
What standard of should when a consumer govern is aby injured properly manufactured but the dmg, manufacturer has not warned dmg’s association with the That is type suffered? the issue here. injury Because failure-to-wam caused injuries dmg part law, field of larger I products with a begin discussion development current state of law. body Under the common law as it existed before the development law, an consumer injured could recover under contractual
1120 law, of to who “stood recovery privity which limited those warranty is, the defective the of purchasers product. contract”—that immediate often, 96, 681.) All 1984) too (Prosser (5th & on Torts ed. Keeton § however, because had the they bought consumers lacked such privity prod from intermediaries such directly uct not from the manufacturer but the manufacturer erected yet Disclaimers of any warranty by retailers. (Ibid.) obstacle to recovery. another con consumers under injured
The
afforded
inadequacy
protection
tort
the
to
the
fault-based
existing
tract law
led
courts
extend
eventually
(MacPherson v. Buick
to the area of
products liability.
concept
1050]; see
Prosser &
Co.
This referred concept, products liability all others in chain to the manufacturer but to extending distribution, law. The Fall the Citadel (Prosser, became the ultimately 791, 791-805.) (Strict Consumer) (1966) 50 Minn. L.Rev. Liability to the when, in in the was first to this concept California embrace Products, (1963) 59 Cal.2d landmark case of Greenman v. Yuba Power Inc. 1049], “A this court held: 377 P.2d A.L.R.3d market, he on the is liable in tort when an article strictly places defects, to have a that it to be used without inspection proves knowing 62; (Id. human see generally, defect that causes injury being.” Prosser, Consumer), (Strict The Fall the Citadel Liability 803-805.) Minn. L.Rev. at “the of our pioneering
As this court has acknowledged, very purpose of proof in this was to relieve plaintiff problems efforts field Co., (Escola Bottling inherent Coca Cola pursuing negligence
1121 453, (Greenman v. concurring)) Cal.2d 461-462 J. (Traynor, warranty Products, Inc., remedies, 57, 63) Yuba Power 59 Cal.2d thereby injuries ‘to insure that the costs of from defective resulting borne by manufacturers . . . (Id; see Price v. Shell Oil Co. [1970] 2 245, 178, 722].)” (Cronin 251 466 P.2d v. J.B.E. Olson Cal.3d Cal.Rptr. [85 121, 433, 1153], (1972) 8 Cal.3d 133 501 P.2d Corp. Cal.Rptr. ellipses [104 Cronin.) 1965, then nationwide. In concept products liability spread prod- ALI) ucts was embraced (hereafter American Law Institute when it section 402A of the Restatement Second of Torts. That adopted section states that a seller of a in a defective condition “product [that is] to the user or consumer” is liable for unreasonably dangerous harm physical Torts, 402A, (Rest.2d caused 347-348.) product. Soon most § some jurisdictions form of strict for defective recognized products. Torts, (Prosser 99, & Keeton on § however;
Products
is not absolute
manufacturer is not
liability,
(See,
insurer of the
Anderson v.
product.
e.g.,
Owens-Corning Fiberglas
987,
(1991)
528,
53
Corp.
Cal.3d
1003-1004
549];
810 P.2d
Cal.Rptr.
[281.
380,
v. General
Daly
(1978)
Motors
20
Corp.
733
Cal.Rptr.
[144
1162].)
575 P.2d
A
must still
that the
plaintiff
was defective.
prove
product
“Strict
has been
invoked for three
of defects—manufactur
types
defects,
defects,
defects,’ i.e.,
ing
design
‘warning
inadequate warnings
(Anderson
or failures to warn.”
v. Owens-Corning Fiberglas
Corp., supra,
995;
Cal.3d at
see
(1978)
Barker v. Lull Engineering Co.
Courts and commentators have noted long that prescription drugs pose issues, unique products and that expansive liability drug-related medical developing marketing manufacturers from could deter injuries what later discussion of a draft of During of benefit to society. *17 Torts, of the Second of a member section of the Restatement became 402A because from section 402A that be drugs expressly exempted ALI proposed stifle research and on medical might products liability drugs imposing 1057-1058, Court, 44 Cal.3d at (Brown Superior testing. Prosser, was (1961).) In who 38 ALI 90-98 Dean response, Proc. quoting Torts, that the issue suggested Restatement Second of the the reporter 1058.) led to (44 Cal.3d at This with in a comment to section 402A. p. dealt Comment, (See K of k. Comment and comment drafting, the approval, be Protected? Liability: Prescription Drugs to Strict Should all Immunity 707, 736 beneficial nature of (1989) 26 Hous. L.Rev. [“the them from rules of reason for standard very excepting the drugs provides liability”].) strict k of of Torts recog-
Comment 402A the Restatement Second to section exces- nizes the risk to the interest significant public presented by imposing heading on Under the drugs. the manufacturer of sive used k observes that commonly unsafe comment “Unavoidably products,” beneficial, are of made entirely while often incapable being drugs, highly true in of new or many experimental safe. It then notes: “It is also particular which, time and for sufficient as to because of lack of opportunity even of be no of safety, medical there can assurance experience, perhaps marketing such as there is justifies but ingredients, experience purity (Rest.2d of the risk.” notwithstanding medically recognizable and use Torts, 402A, k, that 354.) It concludes that a manufacturer of drugs com. § it, is not to be with a “where the situation calls for warning are sold proper use, their to strict for unfortunate consequences attending held because undertaken with an he has public apparently merely supply reason- attended with a known but apparently useful and desirable product, (Ibid.) risk.” able the exact and meaning
Courts and have debated scope commentators (See, k Second Torts. e.g., to section 402A of Restatement comment Schwartz, and Meaning Policy Products: Unavoidably Clarifying Unsafe (1985) 42 L.Rev. 1139 various [discussing Behind Comment K Wash. & Lee Twerski, k]; & A Proposed of comment Henderson interpretations possible (1992) 77 (Second) Torts Revision Section 402A Restatement comment k for lack of clarity].) Cornell L.Rev. [criticizing it states court has that “in fact the principle This concluded [comment k] Court, (Brown v. 44 Cal.3d at on Superior based negligence.” of the standard k to section 402A of comment negligence-based of Torts recognition imposing Restatement Second reflects a on manufacturers of would harm the prescription drugs public interest medications that by discouraging development availability diseases, cure alleviate or sustain life. the words of pain suffering, Dean Prosser: “The industries argument potentially danger- producing harm, insurance, ous should make distribute it good by liability and add cost encounters reason for price product, pause, race, when we consider that two medical boons to the human greatest cortisone, effects, both have their side penicillin and that dangerous well have been deterred from companies might them.” producing selling (Prosser, (4th 1971) omitted.) Torts ed. fns. § *18 This concern—not to an impose excessively broad standard of on liability Thus, prescription drug manufacturers—continues the current tenta- today. tive draft of the Restatement Third of Torts contains a section special governing for products liability and medical devices. With prescription drugs defects, regard warning “(d) section 8 A provides: prescription drug medical device is not safe because of reasonably instructions or inadequate when (1) reasonable warnings instructions or fore- warnings regarding [^D seeable risks of harm or medical device posed by drug are not provided prescribing (Rest.3d other health care . . . .” Torts: Prod- providers ucts (Tent. Liability 1995) 210.)1 Draft No. Mar. § This court has in recent addressed years for defects” for liability “warning other than products (Anderson prescription drugs v. Fiber Owens-Corning glas Corp., 53 Cal.3d of whether risk known or [evidence knowable admissible in failure-to-wam case not involving prescription as well drugs]) liability (Brown prescription drug “design defects” Court, Superior 1049 [prescription drug manufacturers from strict exempt claims]). liability design defect But this court has not previously defined the elements necessary establish a manufacturer’s for failure to warn of a risk presented by prescription drug. summarize,
To or strict products law was developed compen- sate consumers defective injured by without so products expanding liability as to discourage manufacturers from developing marketing products beneficial to the General public. law principles products liability appro- accommodate priately these interests for most competing types products. 1The tentative draft of the may Restatement Third of part general Torts of a retrench products liability decade, however, ment of law. As one past commentator observes: “In the judicial further expansion products liability of tort and largely law has come to an end. ‘A new tort era’ has been entered that has been marked ‘the stabilization and contraction of doctrine,’ growth [tort] rather than its development. opinions Judicial products in the growing field reflect system affecting concerns that the the costs and availability (Schwartz, Impact adversely.” Liability the New Products Prescription Restatement on 399, 400, Products Drug 50 Food & L.J. brackets Schwartz, omitted.) fns. seen, standard of and a drugs require will be prescription
As for other from those used different allocation somewhat burden-of-proof case, nor the dissent has adequately the majority In this neither products. stake. interests at different consumer two accommodated II. manufac- a prescription the majority’s holding—that
At first glance, scientifi- reasonably that are “known or of those risks turer need warn ante, reasonable. A quite at p. 1109)—appears knowable” cally (maj. opn., look, however, on a manufacturer a the majority imposes reveals that close The sheer breadth of that exist. risk that any arguably to warn duty First, holding the majority’s fundamental interests. two public threatens duty recog- court has this overwaming previously in the problems will result Sec- in consumer nized, interest protection. undermining public thereby liability, to excessive ond, manufacturers by subjecting encouraging interest of the important public standard jeopardizes majority’s of beneficial affordability availability, the development, drugs. *19 or reasonably the “known phrase what the means majority by
To discern the majority its Throughout opinion, is no task. easy knowable” scientifically (see maj. that of the meaning phrase different descriptions itself gives id. at 1112 ante, p. community”]; to the scientific at 1108 opn., [“known knowl- and medical best scientific recognized prevailing ‘generally [“ ‘ 1113, ”]; obtainable “by fn. 3 [“knowledge available’ id. at p. edge ’ ”]; reasonable, ibid. skill and foresight” human developed application ”]; 1115 scientist operating id. at ‘true choice judgment’ [“reasonable [“ evidence”]; id. under the circumstances faith should have known good an side effect a casual link between alleged established at p. [“evidence ibid, of scientific by application and a drug”]; [“knowable available”]). and medical knowledge lead me to of “knowability” various characterizations
The majority’s “knowable,” even though risk to be considers a majority conclude that manufacturer, of distribution if the risk at the time known to the not actually The word identified. scientifically could have been reasonably had been or (Webster’s Collegiate New of a loss. “risk” means possibility simply 1018, suggest does (9th 1988) majority col. Because Dict. ed. the majority of loss is of any significance, that the of probability degree of harm with bare the identification of a possibility equates seemingly Thus, holding, under the majority’s and hence a warn. duty “knowability” reasonably has been or a risk once a drug plaintiff proves identified the scientific the manufacturer has community, could have been is otherwise to warn of whether regardless warning appropriate duty reasonable.2 that its conclusion is dictated our decisions in insists majority Court, 1049, v.
Brown v. 44 Cal.3d and Anderson Owens- Superior ante, 53 Cal.3d at Corning Fiberglas (Maj. 987. Corp., opn., pp. But, 1108-1109,1116-1117.) as Justice Baxter demonstrates in convincingly dissent, Baxter, J., (Dis. his is wrong. majority opn. post, 1153-1158.) this This court has not decided issue. previously view, too far my majority’s holding goes imposing liability, because it fails to involved in iden recognize complexity scientifically a risk as and in whether a tifying meaningful determining warning noted, As this court has of scientific evidence appropriate. quality “may (Finn certain.” v. G. D. Searle & Co. range extremely vague highly 870, 1147].) 677 P.2d Scientific [200 studies associations between them suggesting injuries may selves be as to the of their methods subjected legitimate question validity and the soundness of (See their conclusions. Inc. Plough, Ramirez 6 Cal.4th 863 P.2d 27 A.L.R.5th Cal.Rptr.2d 899] [explaining scientific studies an methodology showing association between had been aspirin Reye’s syndrome questioned, the Food and Administration had determined Drug that further studies to al., confirm or association were see disprove Foster et necessary]; generally, Phantom Risk: (1993).) Scientific Inference and the Law The majority’s standard that a apparent manufacturer is liable for prescription drug strictly failure to warn of “knowable” risk fails to any much less deal recognize, with, the of scientific complexity evaluations.
A possible result of such a standard is the destruction of the of viability any warnings. common sense if experience suggest every “[B]oth page 2On opinion, majority 1116 of its application states: “The of the failure-to-wam theory pharmaceuticals requires determinations whether available evidence established a any warning alleged causal link whether prescription drug, between an side effect and a should and, so, given, have been warning if whether adequate. was These are of fact issues alia, art, i.e., involving, questions concerning inter the state of the what or was known reasonably by application knowledge knowable of scientific and medical available at the time of manufacture drug. They and distribution of the prescription necessarily also involve risk, norms, questions concerning light whether accepted of scientific was more than insignificant (Italics negligible.” or so remote and as to be merely speculative conjectural, or added.) only majority These statements further obscure phrase what the means “known reasonably or scientifically portions quoted knowable.” The italicized of the sentences above yet way are either another expressing majority’s “knowability” duty of standard that the warn does not extend to unknowable risks or a concession that the standard of ante, (But maj. includes reasonableness opn., p. the manufacturer’s see at 1112 conduct. ”].) ‘the reasonableness [“ defendant’s is immaterial’ failure to warn 1126 tentative, risk, no matter how speculative, conjectural, of a possible
report would be some a manufacturer give warning, an affirmative duty imposed with notice of indiscriminately any to inundate physicians required hint the force of thereby inevitably diluting any specific every danger, link is relevant The of the causal thus strength warning given. [Citations.] all, and, if whether a should be at one is warning given both to the issue of Co., (Finn supra, what form it should take.” v. G. D. Searle & 35 required, 701.) Too broad a standard ineffective and even may prove Cal.3d at p. Inc., 553; (See v. 6 Cal.4th at Plough, supra, p. counterproductive. Ramirez al., Liability—Design Twerski et The Use and Abuse in Products Warnings 513-517; (1976) Comes 61 Cornell L.Rev. Litigation Age Defect Torts, on 686 much detail can Prosser & Keeton [“Too § A to be effective must be read and warning counterproductive. understood.”].) if must be
The are exacerbated overwaming warnings given problems risks, remote which manufacturers find necessary even as to very may would under the standard that the “Not vague majority adopts today. warnings they remote risk crowd out useful but warnings potentially such One cannot would also focus consumer attention on the tale fairy bogeyman. (Henderson & wolf without over the term.” cry price long paying Twerski, in Products Shell Failure Collapse Liability: Empty Doctrinal 318.) to Warn 65 N.Y.U. L.Rev. its would not result in standard
According majority, because the manufacturer’s consumers with too inundating many warnings, to warn runs to the rather than the and because there duty physician patient, ante, is no to warn of obvious duty dangers. (Maj. opn., true, states, It has as the that a majority prescription drug no to ensure that a reaches duty warning given physician patient. 45, Parke, (Stevens Davis & Co. 1059].) intermedi
P.2d A.L.R.3d But even the “learned physicians, aries,” this court has be overwhelmed excessive As warnings. that to recognized, suggest require both common sense and experience notice of any manufacturer “to inundate with physicians indiscriminately “the hint of dilutes force every danger” inevitably any specific 701; Co., (Finn D. & 35 Cal.3d at v. G. Searle warning given.” *21 contra, ante, And, 6.) at fn. maj. contrary majority’s opn., assertion, the absence of a to warn of known or obvious has duty dangers of the little the context of because few import prescription drugs, sophis ticated risks of could be considered obvious. potential prescription drugs to such manufacturers majority’s holding exposes drug prescription broad that and distribu- liability they restrict or the may development cease tion of and life-sustaining defeating strong public thereby lifesaving drugs, is an distinction important this observed: As court has interest. “[TJhere other such as construction machin and drugs products prescription between [citation], [citation], the [citations], a producers lawnmower perfume ery cases, In the is used product were liable. the latter of which held strictly the while in former it may work easier or to pleasure, make provide Moreover, life. unlike and or to sustain to alleviate necessary suffering pain (wheelchairs, harm to some example), other medical important products distinctions, these is unavoidable. Because from drugs users prescription of at an drugs price in the availability broader interest public the affordable the standard deciding be considered in appropriate must Court, (Brown their use.” v. resulting Superior supra, injuries from added.) prescription drugs italics This distinction between at p. (see of which the denies majority maj. other the products, legal significance ante, 5), at is rooted in law firmly fn. opn., v. Superior was the basis for this court’s unanimous decision Brown Court, 1063-1065.3 pages that
The concern voiced the courts and commentators legal repeatedly on the excessive manufacturers drug imposition prescription discourage life-sustaining lifesaving development availability founded, is well demonstrates. following as the discussion In the threat of was deterring drug because excessive tort flu manufacturers from a vaccine for swine needed to protect developing health, Act, enacted the under which the federal Swine Flu public Congress assumed the risk of lawsuits from associated government arising injuries 1113; 12, 1976) (Pub.L. the vaccine. §2, with No. 94-380 Stat. (Aug. Mais, & Franklin Tort Law and Mass Lessons Programs: Immunization from 769; the Polio and Flu see Brown Episodes Cal.L.Rev. Court, 44 Cal.3d at Superior 1983, Benedictin, antinauseant available pregnant
women, was withdrawn from the of insurance market because cost almost consumed the entire income and its from the sale price opinion, my suggesting 5 at page majority 3In footnote 1116 of its characterizes view as drug liability that the “costs” of excessive and asserts that it have been then my approach inevitable be to unclear how would reduce “those costs—unless result would injured person any my approach an innocent deprive remedy.” It is true under every person injured limiting of a would But the side effects recover. scope drugs, somewhat for failure to with prescription warn of risks associated do, people—those suffering as I would will best assure that millions other innocent debilitating or even prescription drugs fatal diseases—will have available to them that sustain Moreover, plaintiff requiring prove life or health. known or risk was knowable, reasonably scientifically majority’s holding too will innocent “deprive an injured person any remedy.” *22 1128 Court, (Brown v. over 300 Superior supra, increased percent.
had already 1064.) 44 at p. Cal.3d mid-1980’s, (DPT) the
In a of producer diphtheria-pertussis-tetanus the market because of “extreme its from product vaccine withdrew of to obtain continuing and the difficulty costs litigation exposure, Court, 1064, 44 at (Brown Superior supra, insurance.” adequate Health Before Subcom. on Compensation on Vaccine Hearing Injury quoting Commerce, of House Com. on 98th Energy Cong., the Environment 1986, 1984) 295.) there were two manufac 2d By Sess. (Sept. DPT still and its costs had risen marketing turers vaccine $11.40 $8 of which was from in 1982 to dose per 11 cents dose per Court, 44 (Brown Cal.3d at reserves. v. Superior for insurance ) insurance year unavailability prevented 1064. that same Incidentally, (Id. at p. to treat vision marketing problems. new ) 1065. had litigation
In threat of it was that the reported vaccine and with one manufacturer of the just polio left the United States measles, and rubella vaccine. of the combined mumps one manufacturer S16661, Heinz, (Oct. 1990).) Rec. SI6662 (Remarks of Sen. 136 Cong. for products More of too harsh a standard recently, imposition as a has been mentioned possible on manufacturers of drugs prescription the serious health to this combat impediment country’s ability public (See (AIDS). threat Syndrome gen- Immune Acquired Deficiency posed Arnold, Legal an AIDS Vaccine: Testing, Marketing erally, Developing, U. L.Rev. Pa. Concerns for Manufacturers To to warn of all scientifically manufacturers require prescription drug risks, holds, them to liability. excessive exposes knowable as majority Such disincentive on part creates exposure powerful medications, it is essential when manufacturers to develop especially of warn- inadequacy with the extensive joined liability exposure alleged (See, v. Ortho Pharmaceutical Corp. MacDonald ings given. e.g., that use of oral Mass. [adequacy warning N.E.2d 71] blood such vital organs cause abnormal contraceptive may clotting fact brain and that abnormal be fatal clotting may presented question Twerski, “stroke”]; & it did not the word see also Henderson because use Warn, Shell Failure to in Products Collapse Liability: Empty Doctrinal 318-319.) N.Y.U. L.Rev. short, majority subjects which the the broad standard of so manufacturers issue manufacturers cause *23 will be warnings important of the most the effectiveness that warnings many and interest in development the vital public and it jeopardizes negated, drugs. health-sustaining life- and availability rule, the dissent’s proposed advanced by interest is the latter Although consumer. on the injured a burden heavy too approach places dissent’s III. man- the view that prescription dissent expresses
Justice Baxter’s be based solely upon negli- to warn should for failure ufacturer’s liable for failure to manufacturer is Under that approach, gence principles. reasonable manufacturer establishes that a if the only plaintiff warn Baxter, J., (Dis. issued warnings. opn. would have similar circumstances 1988) 1147, 1162; Witkin, (9th ed. of Cal. Law see 6 Summary at post, pp. Torts, 56-58.) pp. § of negligent that the theories legal with the majority
The dissent agrees theories of are two different failure to warn failure to warn and strict liability conduct of a manufacturer’s looks to the reasonableness liability: negligence Baxter, J., at (Dis. post, considers it irrelevant. opn. while strict liability dissent, considerations 1157-1158.) the same policy According pp. Court, Superior that led this court in Brown v. with defects drug design apply standard for negligence prescription
adopt when, here, to warn of risks is a failure force defect alleged equal 1158.) (Dis. at with the drug. opn., post, associated First, it mentions four reasons for its conclusion. The dissent cites be warning may have concluded that a product’s several commentators Baxter, J., (Dis. opn. design. characterized as a subset of product’s Second, law 1158.) out that products at dissent points post, different legal drugs may require has always recognized prescription draft of the Restatement and that the tentative treatment than other products, its new standard into Third of Torts negligence principles incorporates (Dis. post, pp. liability. opn., manufacturer products prescription drug Third, 1160.) industry heavily it notes that 1159- one (FDA), and that and Administration the federal Food Drug regulated (Id. at drug warnings. functions is to evaluate of the FDA’s primary Fourth, of strict out that the 1161.) imposition the dissent points 1160- inhibit manufacturers would on for failure to warn (Id. at drugs. of essential marketing delay development the public the dissent preserves standard advocated lifesaving life-sustaining in the interest development availability if their manufacturers would liable because prescription drug *24 But would was the dissent’s not to warn unreasonable. approach decision under legal injured the afforded consumers protection weaken unnecessarily law. products outset, law objective
As mentioned at the a principal inherent in negli consumers of the problems proof to relieve injured is that were initially common law concepts and contractual warranty, gence (Ante, defective 1119 injured to consumers products. applied counter to this 1120.) The runs important goal. dissent’s approach failing was in negligent To manufacturer prove warn, the risk was have to establish not that only an consumer would injured valid, also, but that the risk was example, and scientifically appreciable render in to other as to it unreasonable sufficient relation risks magnitude remote, warn, that of the risk too under all that the was not not Thus, would have issued warning. circumstances a manufacturer prudent was the risk at issue have to show that the consumer would credible, but its relative severity also that scientifically probability to warn risks the decision not relation to other credible made scientifically unreasonable. con- the the
Having injured manufactured developed product sumer, one the rather than the consumer is the with superior Yet, scientific data. the standard negligence proposed access pertinent burden obtaining the dissent would saddle the consumer with the information. the relevant scientific evaluating addition, would consumer injured under dissent’s approach, there were no other factors have to that at time of distribution prove The other manufacturer’s decision not to warn reasonable. would make the harm, “a of the factors would involve seriousness balancing result, taking harm will and the burden involved in that the probability (Note, Failure to the Strict necessary precautions.” Formulating Liability 1509, 1512, omitted.) & fn. A manufac- Warn 49 Wash. Lee L.Rev. information, that turer that is with scientific requisite charged possessing and that the business of and marketing drugs, developing evaluating the FDA deals and on an basis with directly ongoing (1996), (see, 21 C.F.R. 201.57 e.g., and extent propriety warnings §§ is far situated to (1995), (1995), (1995)), et et 314 et better seq. seq. seq. whether address the to the reasonableness of decision issues relating consumer, does not warn of a risk. by comparison, An particular injured cannot reasonably have direct access to the relevant information and of proving burden necessary satisfy resources to have the expected negligence. standard, view, of a dissent adoption in my
Accordingly, advocates, underlying products the consumer protection goals undermines law.
IV. *25 above, strict As there are serious drawbacks majority’s explained of strict standard and the dissent’s Imposition approach. of development curtail the liability on manufacturers may prescription the manufac- to increase the cost to substantially beneficial society, consumer, the to and lead to turer and the the charged consequently price dissent, The so as to their effectiveness. negate issuance of many warnings hand, the consumer to that manu- prove on other an by requiring injured unreasonable, the failure to was would saddle facturer’s warn negligent short, an In the majority’s consumer with burden high proof. impossibly standard is too harsh towards the manufacturer while the dissent is too harsh towards the consumer. drugs, injured I an one the fairly intermediate that accommodates propose approach, Schwartz, (See and the Products competing policies. Prescription public Proposed (Third) Restatement Tenn. L.Rev. 1359 [pharmaceutical lives, to restore health should be reduce save and product’s ability pain, Unlike the balanced with its serious potential injuries].) producing I would on manufacturers for majority, not impose liability risk, their failure to warn of those risks arguable supported but every would be credible scientific evidence or that reasonable by upon inquiry dissent, the I would not credible scientific evidence. Unlike supported by to case consumer show as require part plaintiff’s plaintiff instead, I to the manufac- manufacturer acted would allocate unreasonably; turer the burden of that its decision not to warn was reasonable. proving stake, earlier,
As I discussed there two public competing policies side, one each On the distinct and consumer interest. advancing important there are the rise to the gave development products interests and to encour- law: consumers deficient by compensate injured side, there is manufacturers increase On other age product safety. which are life many interest in society’s drugs, affordable prescription the first serves lifesaving. holding partially sustaining majority’s but it does so these public liability, a broad standard policies by imposing by undermining by jeopardizing warnings given effectiveness of the beneficial availability ensuring development interest the public it weakens advances the latter policy, the dissent Although drugs. burden too onerous a on them consumers by imposing of injured protection an Thus, important the dissent sacrifice majority both of proof. important policy. of another equally the detriment policy a hybrid be achieved by of these important public policies A balance from strict liability the best features that borrows or intermediate approach would (1) The plaintiff has two steps: This approach well as negligence. that, at the facie case proving of establishing prima the burden have identi- evidence had credible scientifically of the drug, distribution time of been would have risk, the risk reasonable inquiry or that upon fied evidence; burden of proof then the credible scientifically identified warn was not to that its decision manufacturer to show shift to the would reasonable. court. of this decisions first I find guidance previous
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manufacturer to liability must benefits that bemay gained by warning the drug prescribed. Against the of less meaningful warnings be balanced overwaming dangers risks, and the out of remote warnings, crowding necessary problems But of the harm to consumer. requiring plaintiff seriousness possible force the warning that these of a would factors prove supported giving informa- relevant scientific obtain and evaluate all independently plaintiff readily information on factors. Because such bearing tion these also resources to analyze accessible to who lack the necessary plaintiffs, information, burden on it would too heavy and evaluate impose should been that a have warning given them require prove plaintiffs risks, factors risk in relation to other because of such as magnitude Therefore, harm, I the seriousness of and the harm. probability for the justification would shift to the burden of proving warn of consumer’s facie case. failure to the risk established prima Code, (See Evid. §§ burden, its have to that its failure
To the manufacturer would show satisfy *27 manufacturer, warn was in relation to risk. The to reasonable the identified instance, did a serious for could introduce evidence that the risk not pose health, remote, of was or relative severity threat that it that the number warn, risks that the association justified other a failure or scientific the risk was between and the weak. The manufacturer’s compliance would with as those of the FDA safety regulations statutes such product relevant, The true of be but not same is necessarily also controlling.5 standards relate to the reasonable- industry and extent practices they (See on ness of manufacturer’s decision not to warn. Prosser & Keeton Torts, 193-196.) supra, § may duty 4A manufacturer a to warn absence scientific have even of credible defined plaintiff evidence as here if the can that a reasonable manufacturer would establish warned. have agree majority prescription drug 5I with the cannot held liable for that a manufacturer be ante, issuing if it EDA. at precluded warning by (Maj. opn.,
failure warn was from a 4.) A contrary 1115 & fn. conclusion it would make would be unreasonable because compliance agree both federal I also with impossible. with and laws state majority regulations probative of that FDA and action or be admissible as inaction would (Id. whether a manufacturer should have warned of a risk. view, of allocation of the burden is appropriate given this my proof evaluating the relevant access to and superior capability manufacturer’s information; law of goal it furthers of products liability scientific also that burdens be too consumers from relieving evidentiary injured Co., (See Cal.3d at Engineering onerous. Barker Lull caused showing once a makes facie prima injury that [holding plaintiff that the burden should shift to the defendant to prove by product’s design, defective].) is not product this not. But it does strike a fair Is solution Perhaps attempt perfect? in- interests: consumers balance between two distinct public compensating encouraging and development prescrip- defective jured by products, of which are life sustaining lifesaving. tion drugs, many I now the facts of this case. turn to
V. Here, sued the Upjohn Company, Wilma Carlin defendant plaintiff Peggy Halcion, others, a drug caused by taking among injuries allegedly Plaintiff defendant physician. manufactured prescribed plaintiff’s of, among things, for the treatment other that Halcion intended alleges insomnia, 1992. she November ingested through and that emotional, inju- Halcion caused her physical, psychic She asserts that ries, known that the could defendant knew or should have cause these injuries. for strict liability to state causes action attempts complaint Hal
failure to and warn prepare dangerous propensities properly warn, cion, Citing and fraud. breach failure to warranty, negligence, Court, defendant manufacturer Brown v. Superior warranty, for strict and breach of demurred to the causes action against such causes action cannot maintained prescrip arguing defendant’s demurrer manufacturer. The trial court sustained tion drug and breach amend to causes of action for strict without leave to *28 Thereafter, a for the of granted plaintiff’s of Court warranty. Appeal petition demurrer, citing court the writ of mandate and directed the trial to overrule Fiberglas Corp., supra, this in v. Owens-Corning court’s decision Anderson drug as in a a permitting plaintiff of a of a failure to warn case to maintain a cause action in strict known or knowable risk. of termed “products cause action more
Although plaintiff’s properly warn,” to sufficient to contains allegations for failure her complaint law, sus- not be a demurrer a Under applicable demurrer. withstand cause of action. to sufficient constitute states facts if the complaint tained 311, Cal.Rptr. 39 Cal.3d v. Kirwan (See, Blank e.g., Here, knew defendant manufacturer 58].) alleged 703 P.2d plaintiff of at the time its dangerous Halcion’s propensities have known of should facie case. to a prima sufficient state These allegations distribution.
Conclusion standard of over the proper debate continuing available though the been framed as largely defects has warning Both the and the majority were strict liability negligence.
alternatives For framework. the from within that limited in case address issue dissent this however, above, framework must I am that the stated convinced the reasons just of that achieves a in order to craft a standard discarded resolution of competing public policies. other, the neither at the expense favors
My approach party Instead, strike a balance do. seeks to and the dissent majority my approach to compensation consumer interests: between two distinct quite providing consumer, and availability the the encouraging development injured drugs. affordable health- and life-sustaining prescription I liability, join I with the standard Although disagree majority’s which Appeal, the Court of majority’s affirming judgment disposition court order the demurrer and to enter directs trial to vacate its sustaining a new order the demurrer. overruling
TURNER, This caseinvolves the efforts J.,* Concurring Dissenting. of Brown v. Court justices faithfully holding Superior seven apply hereafter) (Brown, 751 P.2d 470] 1049 [245 Carlin, which first amended Wilma plaintiff, Peggy complaint defendant, warn of a known or failed to her alleges Upjohn Company, four filed this opinions knowable risk Halcion. The concerning an case in light matter involve effort Brown apply present Mosk, have come to since Justice with considerations which light warn form of failure to concurrence of six other a modified justices, applied with the strict tort 1988.1 agree liability principles prescription drugs to warn cause of action for failure has stated a majority plaintiff Halcion, I that the cause is risk further agree known question. claim. In that action for to warn is different from a negligence failure Five, Justice, District, assigned by *Presiding Appeal, Division Appellate Court of Second *29 VI, Constitution. Acting pursuant 6 of the California Chief Justice article section 1136 I with Justice Baxter’s
respect, respectfully disagree analysis plaintiff’s to warn of failure a a claim. known risk cause of action is merely with to warn of a known risk disagreement is that the failure My majority a for reasons that will be really is cause of action in strict theory Rather, a cause action for failure to disclose to physician explained. effect results in risk of known adverse side of a drug heightened not, of the courts of this but does the decisions potential responsibility given state, what has been described as strict tort liability. rise to give commonly Baxter, with insofar as he I am in Justice agreement though, complete to traditional concludes that a failure to warn of a knowable risk is subject including unavailability punitive damages. negligence principles I. Known Risks There are two reasons the failure of a manufacturer to be why ought First, the historical viewed as other than strict something liability. purposes to warn in the of strict tort have limited to a failure application Second, context. because of the inclusion of negligence manufacturer case, in a to warn there is no “strict” about anything failure longer concepts it to advise a tort manufacturer is to when fails subject drug. about the adverse side effects of a prescription plaintiff’s physician and Their Limited Liability A. The Historical Strict Tort Purposes of to Failure to Warn Known Cases Applicability Defect The doctrine of strict has its in the origins concurring opinion 24 (1944) v. Co. Bottling then Associate Justice Escola Coca Cola Traynor P.2d in which he a manu subjecting advocated 436] [150 facturer to “absolute when “an article that he has on liability” placed market, to have a that it is to be used without knowing inspection, proves causes to human This court Justice adopted defect that injury beings.” in Greenman language, without “absolute Traynor’s position, liability” Products, Yuba Power Inc. 59 Cal.2d 1049], “A P.2d 13 A.L.R.3d wherein it was stated: market, that it knowing liable tort when an article he on the strictly places defects, is to be used without to have a defect that inspection proves of strict causes to a human doctrine injury being.” purpose from defective was “to insure that the costs of injuries resulting on the are borne the manufacturers that such put products market rather than who injured persons powerless protect an (Id. themselves.” The doctrine also “to relieve injured served inherent in a negligence onerous burdens plaintiff many evidentiary (Barker cause of action.” v. Lull Co. Engineering
1137 443, 1].) 225, v. General Motors Daly A.L.R.3d P.2d 96 573 Cal.Rptr. [143 380, 725, noted 575 P.2d (1978) Cal.Rptr. 1162] 733 [144 20 Cal.3d Corp. liability.” the of “absolute was not liability” equivalent “strict that the term however, strict has liability inception, held: “From its In this court Daly, now, has been, As been liability. repeatedly is not absolute never become thereby the manufacturer does expressed, under strict (Ibid., original the user. insurer the safety product’s [Citations.]” of italics.) of tort the there three strict types potential
As noted
majority,
(1991) 53 Cal.3d
Owens-Corning Fiberglas Corp.
Anderson v.
liability.
hereafter),
987,
528,
Associate
(Anderson,
251 711 29 A.L.R.3d Cal.App.2d Cal.Rptr. [60 381]; Carmichael Cal.App.3d Reitz Brown, Torts, 402A, k, 353-354.) In this court held the com. Rest.2d § context, was no tort when risk there was strict prescription drug unknowable; “known or reasonably rather arose if the risk was liability only (Brown, at time distribution.” knowable scientifically Anderson, omitted.) In that the of strict theory at fn. this court noted been in the Courts of developed failure to warn had principally warnings that “a failure to culminating give adequate in the Appeal principle knew or strict when it or might subject a manufacturer distributor ensure warnings have known danger necessity should italics, (Anderson, and cases safe use.” original therein.) decisions cited Anderson noted that in the Court previous Appeal the factual of whether question that: the Courts of had not focused on Appeal in the or risks involved a manufacturer knew should have known or made such discussion because of the nature risk products, product should have of whether the manufacturer knew or unnecessary; issue had limited the was not at in those cases because plaintiffs known issue known; and known or should have been action risks which were obviously the issue or knowledge the failure of the Courts to discuss despite Appeal According such was an condition of knowability, liability. implicit of failure focus as a Anderson the was knowledge component aspect to be warned danger against to warn when issue was whether the cases, was knowledge was “unknowable.” In such the consensus *31 402A, in the to warn under section was factor obligation a knowability Torts, eliminating of because the of the Restatement Second j comment of into would have the effect strict turning knowledge component 997-998, (Anderson, 53 Cal.3d at pp. financial responsibility. absolute Co., Inc. E. de & 272 Cal.App.2d v. I. Du Pont Nemours Oakes citing v. Kaiser Foundation 650-651 Cal.Rptr. 709] [77 Christofferson (1971) A.L.R.3d Cal.App.3d Hospitals warn the of a manufacturer to of 292].) drug with the failure majority I agree to authority risk rise liability. foregoing clearly a known gives potential concerns, law, the in the Stare need for predictability so holds. decisis is from failure the manner in which different to subtle distinct yet this warn in the warrant of now well-established drug context acceptance However, in my come the Any Legislature. should from principle. change view, of a of warn known risk I conclude in the case a failure to of a manufacturer, confusing it both by effect of a a is drug side prescription to the label of “strict liability.” to continue unnecessary apply First, of of strict on a prescription neither the imposing purposes As noted served the issue is a known risk. manufacturer is when being above, “to insure that the a the doctrine of strict is of key purpose the from are borne manu by costs of defective injuries resulting products the injured on market rather than by facturers that such the put products (Greenman who are to themselves.” Yuba protect persons powerless Products, Inc., noted generally: 59 Cal.2d at Brown Power strict are reasons the underlying imposition fundamental “[T]he unsafe, and to from that are to deter manufacturers marketing products which consuming cost of from the to the plaintiff public, the spread injury the expense will for the to reflect increased higher product pay price its to liabili greater insurance to the manufacturer from resulting exposure 1062-1063.) the (44 Cal.3d at Brown also rejected imposition ty.” drugs design liability against prescription strict manufacturers risks, on interest grounds. defects and failure to warn of unknown public manufactures from strict liability principles exempting prescription circumstances, . that Brown “It is . . indisputable, under such stated: unavoidable, that be may is a consumer drugs risk from such injury that, them, and like to from serious harm caused himself helpless protect can be on passed cost of insuring other products, against Moreover, who item. ... some consumer producer buys reveal might additional before marketed drugs they cases testing effects, But there is an side in a safer dangerous resulting product. [<J0 such as and other products distinction between drugs important [citation], [citations], perfume [ci construction machinery lawnmower cases, In the latter tation], which liable. were producers strictly held while in the pleasure, work easier or provide is used make the product or to sustain life. suffering alleviate necessary pain it be former (wheelchairs, exam Moreover, medical unlike other important unavoidable. Because of drugs users harm some ple), at an distinctions, availability interest public broader these standard of deciding considered appropriate must be affordable price their use. *32 Perhaps might from resulting for [*][] liability injuries market until scientific skill was withheld from the made safer if it additional side effects to the at which dangerous advanced knowledge point in new delay marketing be revealed. in most cases such a would But of the to for release obtain drugs—added delay required approval from not serve the public the Food and Administration—would Drug product beneficial marketing Public favors the development welfare. policy ones, risks, serious might accompany new even some though perhaps drugs, introduction, suffer save lives and reduce pain their because can they might If were to strict liability, manufacturers ing. subject to to some develop pharmaceuticals reluctant undertake research programs to be that are available or to distribute others that would beneficial prove Further, marketed, monetary judgments. of the fear of adverse large because insur such liability—assuming the additional of insuring against expense to reveal possible ance would be available—and of research programs cost of methods could place not detectable available scientific dangers at (Brown, most.” supra, the reach of those who need it medication beyond court, from 1063.) This manufacturers p. by exempting to refusing strict under such circumstances and liability thereby “pre-allo indicates cate” the burden of the costs on the manufacturers prescription, to did it has determined that the benefits from society prescription drugs Strict warrant the of a doctrine of strict liability. imposition rather than the burden of the costs to the manufacturer necessity preallocated consumer, the risk was or unknown. even when known knew, i.e., Second, the defendant what by requiring plaintiff prove conduct, of the second on the defendant’s focusing primary purpose doctrine, of the onerous is “to relieve an injured many which plaintiff (Barker v. Lull in cause of action” burdens inherent evidentiary negligence Co., defeated. In 431), 20 at has been Engineering largely noted, Brown, that it differs from negligence this court “Strict liability that the manufacturer eliminates the injured prove necessity party on the It focusses not which caused was injury negligent. product itself, the manu and holds conduct of the manufacturer but on product at 44 Cal.3d (Brown, supra, facturer liable if the was defective.” product Further, Brown, was identified warn rule 1056.) the traditional failure to follows; from strict as “The test stated is to be distinguished comment k failure to identify both warn Although concepts for failure warn. k if the manufacturer liability only comment liability, imposes the basis of was the defect at time the sold or product have known of
knew or should was not issued why the reason the warning Under liability, distributed. irrelevant, even it knew nor could is liable if neither and manufacturer Thus, which the was of the defect about warning required. have known manufacturer, k, blameworthiness of the sets [focusing] on the comment while negligence, forth a test which sounds in imposition failure warn to the reason for such failure is consistent without regard caused with strict since whether the injury it asks product (Id. contained a defect. As several courts have fn. [Citation.]” “ noted, where the ‘concepts issue is a known or knowable risk law have of strict been into the doctrine amalgamated (Finn ....”’ v. G. D. & Co. Searle Reitz, 1147], P.2d Carmichael quoting *33 law, 988.) of strict at Under the doctrine liability California
Cal.App.3d in relieved defendant’s appropriate to plaintiff having prove negligence However, Co., 431.) (Barker at v. Lull Engineering supra, cases. effect of to defendant acted in prove practical plaintiff requiring risk, is of a known which riddled spite everyone agrees under a standard in the proof with is to burden negligence concepts, heighten plaintiff’s Further, where the for failure to warn context. unlike strict reason liability irrelevant, is to warn is mea- the failure manufacturer drug responsibility to have warned. sured what it knew and its blameworthiness for failing Thus, (Brown, 1059.) fundamental policies 44 Cal.3d at the two supra, are not the doctrine as set out in Greenman and its being behind progeny “strict to adhere to the fiction that there is liability” served. Continuing legal no in failure to warn cases in the context serves drug purpose prescription to and obscure segment other than add confusion to an already complex the law. bar and Brown
It has been that Anderson argued by portion area. is clear from both these have contributed to confusion this What with is that defendants’ and in accord Justice contrary to opinions position, case, failure in this at least to drug Mosk’s majority opinion which nor liability warn cases there is a standard” is neither strict “hybrid context of of failure warn prescrip- ordinary negligence. theory “strict it of defendant’s tion is not because liability” requires proof Brown, the an into what is known. After focus conduct and requires inquiry words, other and when it knew it. In on what the manufacturer knew fact on defendant’s conduct. unlike strict tort the focus is in liability, addition, out, Brown, on comment k to as Justice Baxter based points Torts, public policy section 402A of Restatement Second of recognized However, is not liability for prescription drugs. strict exception and Brown have made Anderson standards. ordinary negligence measured by warn into failure to cases negligence infusion of principles clear that the it strict did not doctrine of essence of the modifying very while in its cre- were inherent which erase fundamental policies completely into failure principles the infusion ation. another way, Stated but which was cases, liability” to warn which did not amount “strict quite did obliterate the completely not as not “ordinary negligence,” simple care for manufacturers standard of heightened behind policies maintaining (Anderson, 53 Cal.3d at supra, with risks 995-996 pp. known (Brown, manufacturers. manufacturer]) including [asbestos does not 44 Cal.3d at & fn. A 1069-1070 pp. decision As Anderson stated: “Our all for defective escape drugs. [in . for regarding liability did not affect the continued . . validity Brown] does ‘Our not known and knowable risks .... conclusion [in Brown] mean, course, are of all for defective manufacturers free defects, as well as drugs. subject manufacturing They under and for failure to warn of known or general negligence, principles 999-1000, (Anderson, knowable reasonably side effects.’” italics.) original liability, poten- defendant’s Accordingly, although tial other responsibility negligence. should be measured a standard than
B. Failure to Liability The Non-strict Nature Drug Manufacturer
Warn a Known Risk time, Whatever have been the of strict tort at one may liability concept made of defenses and modifications to this area law has emergence drug warn manufacturers other of a strictly than liable anything failing defect in a The burdens and available dangerous drug. plaintiff’s evidentiary a defenses render the to warn than matter for which something failure other a manufacturer For this court has may strictly recognized be liable. example, that if tort a strict acted in a liability comparatively negligent plaintiff fashion, the defendant’s financial can be diminished. (Safeway responsibility Stores, (1978) 21 Inc. v. Nest-Kart 579 441]; P.2d Daly v. General Motors Cal.3d at Corp., supra, Furthermore, notes, Administration if the Food and majority Drug risk, disclosure a no strict tort of even known there prohibits Moreover, ante, 1114-1115.) if known risk is liability.1 (Maj. opn., pp. remote, notes, as the there is no for failure to warn in the majority liability Drug against majority argues prohibition 1Insofar as the that a Food and Administration revealing liability complete a known or risk is a a strict tort cause of knowable not defense to action, government I respectfully disagree. lawfully precluded by If a manufacturer is risk, California, political advising the United States of of a America then subordinate Co., v. D. context. As this court noted Finn G. Searle & drug prescription “Moreover, both common sense and experi- 35 Cal.3d at page risk, that if no matter how every report possible speculative, ence suggest tentative, an affirmative some duty give warning, or conjectural, imposed would be to inundate a manufacturer required physicians indiscriminately hint of danger, thereby inevitably diluting with notice of any every on Given the limits foregoing force of any specific warning given.” risk, to warn of a known the potential manufacturer’s for failure liability form is strict in view. It can be characterized as my “hybrid” not But when all is said liability. financial “stricter” responsibility perhaps and done it not “strict” liability. is Risk
C. Conclusion Known Concerning does To I would that the term “strict liability” sum suggest up, to warn of a where a manufacturer fails define the scenario accurately modified known risk. This court’s rule articulated Brown and slightly Also, rule for drug from the of strict liability. deviates nature today for the manufacturers contravenes the fundamental purposes (Brown, Brown. well-stated reasons articulated in public policy it clear 1063-1064.) this court’s decisions have made Cal.3d at Finally, failing there is strict about the of a manufacturer nothing intertwined with warn of a known risk. The test of inextricably for the theory different from a negligence negligence concepts. Although Anderson, drug in Brown and reasons as well as expressed by majority measured in terms of what is no longer responsibility is otherwise known as strict tort liability.
II. Knowable Risks does not allege The fourth cause of action for failure to warn explicitly defendant of a knowable risk. to advise neglected plaintiff’s physician *35 herein as fourth cause of action “Plaintiff alleges: hereby incorporates full, in all of the contained in set forth though again allegations paragraphs 15-34, 1-14 and each Allegations of the General as well as paragraphs Defendants, them, First, and in the Second and Third Causes of Action. [U them, for drug each of on the market and offered sale placed Halcion, would be to health-care patients that Halcion knowing prescribed relied by their and that the would be used and/or upon by physicians, drug for, herein, amongst health-care as treatment patients, including plaintiff person entity, ought punish by tort manufacturer means of its laws Const., (U.S. art. obeys necessarily supremacy This is not an issue of the clause federal law. VI, 2), ought in the any it other state to follow cl. is a commonsense rule California agree Justice development respect, common law. I with Baxter. its In this
1143 herein, [‘JQ Halcion was defective At all times alleged insomnia. things, other known to and did cause use in that Halcion was unfit for its intended and/or to those health-care mental and emotional damages/injuries severe physical, herein, took it Halcion who for its prescribed including plaintiff patients, them, Defendants, [<JQ failed to warn and/or and each intended purpose. herein, health-care foreseeable patients, plaintiff warn adequately defective and/or unfit for its foresee reasonably that Halcion was particular, alleged and that Halcion contained the dangerous propensities able use However, cause of action reference the by herein.” the fourth incorporates is in the second cause of action claim. The claim negligence which defendant failed to advise allegations negligently plaintiff’s contains con adverse side effects Halcion. physician Liberally probable strued, form of the fourth cause of action the second alleges sufficiently failure to to advise physician warn potential liability—neglecting plaintiff’s Proc., 452;2 (Code Central Bank a knowable risk. Civ. King § 840, 771, 857]; v. Nevada Youngman 558 P.2d Cal.Rptr. [135 P.2d Dist. 244-245 Irrigation 462].) Brown, test of this court described the test for manufacturer’s for failure to subject warn of knowable risk as follows: “They defects, under liability manufacturing general as well as principles and for
negligence, failure to warn of known or knowable side reasonably (Brown, added.) 44 Cal.3d at fn. italics Anderson p. effects.” used various terms for describing drug liability for failing advise a tort of a knowable plaintiff’s adverse side effect of a physician Anderson used the tests for manufac prescription drug. following describing turer to warn of a failing knowable risk: “constructive knowl (Anderson, contexts edge” varying 53 Cal.3d at & fn. pp. 12, 1000); 997); “should (id. have known of the risks” at “knowability” p. 10, 999-1000, (id. 1003); (id. 998); at & fn. pp. 997 to know” at “ability p. “ (id. 999); knowable” know “reasonably scientifically ‘reasonably at ” 1000.) able side effects.’ at Anderson excluded from the scope {Id. strict tort failure to warn cases unknowable “scientifically dangerous (id. 995) at and utilized the word “unknowable” in several propensities” 998-999, 1002, 1003, (Id. contexts. fn. foregoing language also utilized forms in this case. repeatedly varying majority
I with disagree that there is a distinction plaintiff’s argument meaningful between the failure of a manufacturer to warn of a scientif- reasonably risk, knowable the test articulated ically quite rightly majority *36 pleading, 2Code of Civil Procedure section 452 for the states: “In the construction effect, construed, determining purpose allegations liberally its its with a view to must be justice substantial parties.” between the 1069, 12, Brown, footnote 44 Cal.3d at page in established where a reasonably creates a situation prudent whether such neglect there is no differently, meaning- Stated negligently. has acted of a knowable risk and ful failure to warn distinction between plaintiff’s Further, when to a jury the distinctions negligence presented theories. Hence, to warn of a I would hold that the failure ephemeral and confusing. Brown, risk, knowable as defined in is purely negligence.
The test of this court in Flowers v. Torrance was described negligence by 992, (1994) Memorial Center 8 Cal.4th Hospital Medical Cal.Rptr.2d [35 “ is conduct which falls below 884 P.2d as follows: ‘[N]egligence 142] of others unrea the standard established law for by against protection Torts, Thus, as a (Rest.2d sonable risk of harm.’ general proposition § to exercise the care that a of ordinary prudence one ‘is required person Because would exercise under the circumstances.’ application [Citations.] situational, this the amount of care deemed reasonable inherently principle case will while at the same time standard any vary, particular i.e., constant, due care commensurate with the risk conduct itself remains all relevant circumstances. the conduct into consideration by taking posed relation (Fn. omitted.) In the this court has identified the past, [Citations.]” between reasonable conduct and of medical care professionals ship making as follows: we do “Obviously require therapist, determination, exercise render a need therapist perfect performance; skill, care ordinarily ‘that reasonable degree knowledge, possessed and exercised members of under similar specialty] professional [that circumstances.’ Within the broad of reasonable range practice [Citations.] differ, and treatment which professional opinion judgment may is free to exercise his or her own best without judgment liability; therapist aided that he or she is insufficient proof, by hindsight, judged wrongly establish negligence.” (Tarasoff v. Regents University of California 1166].) 551 P.2d 83 A.L.R.3d These which involve an evaluation of the principles always unreasonableness of the tortfeasor’s conduct are well established potential tenets of In Crane California law. v. Smith 298 [144 Torts, 356], P.2d the Restatement First of this court held: “As relying upon involved, in all cases where a standard of conduct is the reasonable character of the care whether the interference with the actor’s own depends upon affairs is warranted the other’s The broad danger. concept underlying determination of reasonableness of conduct in tort law is stated as follows: ‘Where an act is one which a reasonable man would recognize involving another, a risk of harm to the risk is unreasonable and the act is if negligent the risk is of such as to as the what law magnitude outweigh regards of the act or of the is done.’ utility manner in which it particular [Citations.]”
1145 Torts, (Rest.2d the same analysis. of Torts adopted Second The Restatement Witkin, (9th 1988) accord, ed. 54-56; of Cal. Law Summary §291, pp. 750-751, Torts, 87-90.) §§ stated, law are permeated statements of negligence the foregoing
Simply reasonableness, and so is failure to warn the application principles a court in Brown articulated test risk. This in the context of knowable knowable side effects. to warn of reasonably for failure permitting liability conduct. If a manufac- That is the functional of negligent equivalent of a knowable turer does not warn a tort reasonably plaintiff’s physician scenario, adverse risk of conceivable such then in drug, virtually every of a failure would constitute the failure to warn risk negligence. Conversely, which is not would not be foresee- negligence any knowable reasonably able context. situation for her contention there is a only meaningful plaintiff posits to warn of a knowable risk
difference between and failure negligence theories involves an industry-wide extraordinarily hypothetical possible side effect of a to disclose an failing unreasonably dangerous practice She manufacturers could an argues industry-wide drug. adopt would of not side effects. This she reasons practice advising particular doubt, be defeat a claim. No an negligence industry-wide practice admissible as evidence of whether a or decisionmaker of ordi corporation would act in not as to the side nary prudence negligently advising dangerous (Bullis effects of a Pac. Bank drug. Security Nat. Cal.3d 642]; 582 P.2d 7 A.L.R.4th Perumean v. Wills [148 course, (1937) 8 96].) P.2d Of such evidence would not [67 be conclusive a matter of law as to the standard of care in the industry. Bank, 809; (Bullis v. Security City Pac. Nat. Polk v. Los However, 931].) 531-532 P.2d if the Angeles were the conduct would in unreasonably dangerous, virtually every fact, circumstance be a imaginable negligent jurors act. most would Moreover, known, offended such a if were practice. danger Brown',viz., manufacturer would be liable under the failure to first prong warn of a known risk. basis of
Finally, failing creating separate negligence warn of a knowable risk can create confusion reasonably scientifically Consider the confusion when read in among jurors. jurors experience they 3.11, room BAJI jury Nos. in which a test for provided, states; 9.00.7, which delineates failure to warn BAJI No. 3.11 principles. “One test that is whether or not was helpful determining person not, is to ask and answer the whether or if a negligent question person *38 the in the and of same possessed had been same situation ordinary prudence or that someone would have foreseen anticipated knowledge, [he] [or] [she] or of action or been as a result by [his] have might injured [her] [or] if and action or inaction If the to that the question ‘yes’, inaction. answer avoided, to be negli been then not avoid it would could have reasonably 9.00.7, No. which states in BAJI appears Similar gence.” language of the in a follows in is defective if the use manner “A part: product product that is the defendant involves a substantial by danger foreseeable reasonably that would not the user of the and recognized ordinary product be readily by of the but fails to the manufacturer knows or should have known danger, has a to duty of such manufacturer warning danger. give adequate [<J[][A to if an to the user on how use the a warning product provide adequate of the involves a danger foreseeable use substantial reasonably product aware, be either is or should would which the manufacturer aware be Jurors will confused readily by ordinary not be recognized user.]” foresee out where a would person when to sort attempting to an from failure warn of a manufacturer should danger anticipate injury a can become have known I have sat as and seen how jurors about. juror related concepts overwhelmed and by simple legal perplexed comparatively Plaintiff’s to distinguish negligence in written instructions. effort likely warn knowable risk is so ephemeral failure to of a in the it should be abro fact-finding confuse and confound those process, concerns articulated Justices gated particularly given public policy Kennard, J., ante, (Conc. at pp. Kennard Baxter. dis. opn. 1131-1132; Baxter, J., 1127-1129, 1146-1147.) dis. post, opn.
III. Conclusion as it reverses the I would affirm the Court insofar opinion Appeal leave of the demurer without sustaining order dismissal following amend.
BAXTER, I dissent. J. law, whether,
In under when this case we must determine California a a a on drug seeks manufacturer of a recovery against plaintiff “failure-to-wam” theory,
determined same strict apply under the generally principles instead, or, limited of all other must be products, manufacturers general negligence principles.
We a Court faced somewhat comparable issue in Brown Superior Brown, (Brown). 751 P.2d 470] that, court concluded considerations related light unique unanimous in the to the vital interest and reasonable public development, availability, when a seeks prescription drugs, plaintiff recovery against pricing manufacturer for an caused injury allegedly “design defect” in the manufacturer’s should not be based drug, *39 the same strict to manufac- design-defect upon principles applicable law, turers of other under California but instead should be limited We concluded that a ordinary negligence manufacturer principles. be held liable for an defect may when alleged design plaintiff establishes that the manufacturer was We negligent designing drug. held in Brown that a of a additionally manufacturer prescription drug may not be held liable for failure that strictly to warn of risks posed by were neither known nor knowable at time of the distribution scientifically Brown, however, of the Our drug. decision did not address the explicitly whether, with question scientifically risks that were either known or regard distribution, knowable the time of a manufacturer’s prescription drug for failure to warn could liability, properly premised upon as well as That is the before us in this case. upon negligence principles. issue
The holds that a majority be held prescription drug may liable, on strictly a failure-to-wam from the theory, injuries arising or ingestion use of dmgs, without consideration the reason- ableness conduct in that were furnishing warnings of manufacturer’s or given, no I warning. cannot subscribe to that result. For the reasons set below, forth I conclude that the same broad considerations that public policy Brown, led this court in to hold that the manufacturers of prescription dmgs injuries caused defec- by allegedly tively designed should dmgs properly be confined to negligence principles, limitation—i.e., also a similar support based solely upon negligence is principles—when recovery sought against manufac- prescription dmg Indeed, turer on a failure-to-wam that theory. conclusion is even more context, in the compelled failure-to-wam where the necessity furnishing warnings known or knowable or other risks of dangerous propensities harm posed by and the prescription dmg, content of such where warnings they required, and oftentimes heavily regulated dictated federal law. I Accordingly, would reverse the of the Court of judgment Appeal, which reached a conclusion. contrary
I Plaintiff’s first amended that defendant complaint alleges (complaint) Upjohn Company (Upjohn) manufactured a known as prescription dmg Halcion, insomnia, conditions; to be used for the treatment of other among emotional, its use cause unsafe in that was unavoidably Halcion distress, that these dan- and and injuries; instability, and psychic
physical, reasonably scientifically were either known Upjohn gerous propensities and ingested by plaintiff. Halcion was distributed the time that knowable at for Hal- obtained a further alleges plaintiff The complaint the time during period the ingested cion from physician result, sustained As a plaintiff proximate November 1992. through health, and suffered nervous system, strength, to her serious injuries action in to state causes of mental distress. complaint purports extreme warn of the and for failure to for defective (1) strict liability preparation Halcion, (2) knowable dangerous propensities known or scientifically warranties, fraud.1 implied breach of express negligence, *40 breach of in strict and causes of action demurred Upjohn action), maintaining other causes of warranties (among and implied express Brown, 1049, that, manufacturer exempt 44 Cal.3d a drug under supra, a failure to based warranty liability upon and breach of from strict liability a negligence to warn solely upon be held liable for failure warn and may amend both as without leave to court sustained demurrer trial theory. 1049, Brown, 44 Cal.3d supra, in strict liability, citing to the cause of action (1994) 22 1388 Cal.Rptr.2d Court Cal.App.4th [27 and Artiglio Superior for failure limiting liability Brown as construing dictum (containing 589] of action for breach and as to the cause warn to a negligence theory), warranties, motion for recon- Brown. After her citing implied express denied, or other for writ of mandate was filed a petition sideration plaintiff trial court’s to vacate the in the Court of seeking relief Appeal, appropriate order. and, full briefing alternative writ after
The Court of
issued an
Appeal
mandate,
trial court to
writ of
directing
issued a
argument,
peremptory
causes of action
demurrer to plaintiff’s
vacate its order sustaining Upjohn’s
new order overruling
and to enter a
for strict
and breach
warranty,
its
the Court Appeal
to those causes of action. In
opinion,
the demurrer
to whether a drug
in the Brown decision as
concluded that any ambiguity
an
on a
of strict
based
upon
manufacturer
be held liable
theory
may
a
was
risks of harm of drug,
to warn of known or knowable
asserted failure
decision in Anderson v.
in our
-Brown
resolved in
favor
post
plaintiff’s
528,
(1993)
Cal.Rptr.
1149 which the manufacturer be may failure to warn for claim is based upon liable. strictly held significance principles
We review to clarify scope granted Anderson, Brown, 53 Cal.3d and holdings to the issue of whether a prescription as they pertain or breach of held liable on theories of strict be or other risks of for failure to warn of the dangerous propensities warranty drug.2 harm posed
n The doctrine of strict without liability imposes legal responsibility, proof the manufacturer of a that is on the of negligence, upon product placed (Greenman market and a defect that causes v. Yuba have proves injury. Products, Power Inc. 59 Cal.2d 377 P.2d [27 1049].) it A.L.R.3d Strict differs from itself; focuses not conduct manufacturer but upon upon product need not that the manufacturer acted plaintiff unreasonably prove in order to but that the was defective. negligently prevail, product 413, 418, (Barker v. Lull Co. Engineering *41 443, 1].) 573 P.2d A.L.R.3d considerations Cal.Rptr. 96 policy the strict doctrine are underlying upon premised assumptions that the manufacturer can the recurrence of anticipate guard against hazards and that the cost of be to the injury may overwhelming person whereas the injured, manufacturer can insure the risk and distribute against (Brown, 1056.) the cost among consuming Cal.3d at public. supra, the doctrine of of Additionally, relieves an the “oner- injured plaintiff many (Barker ous burdens inherent in a evidentiary cause action.” v. Co., 431.) Lull Engineering 20 Cal. 3d at supra, As our cases strict be invoked for three past explain, liability may types defect, (1) defects: a where the injury-producing manufacturing product result; defect, deviates from the (2) manufacturer’s intended a where design either product fails to as an consumer would perform safely ordinary manner, when expect used or when reasonably foreseeable the risk of inherent in the danger the benefits of the design outweighs challenged defect, design; where the lacks “warning” product adequate Co., instructions or (Barker as to risks of warnings harm. Lull Engineering following organizations 2The have filed in support party briefs amicus curiae of real Reform; Upjohn: interest Association For California Tort California Chamber of Commerce Association; Association; and California Liability Manufacturers Product California Medical Council, Inc.; Advisory and Pharmaceutical Manufacturers of America. Research and 428-430.) 20 Cal.3d at the latter supra, pp. category, injured plaintiff defective, the manufacture or not that was but alleges, design product that the manufacturer failed to warn of in the use of its potential dangers If the could have been with product. injury prevented appropriate warnings, is deemed to render the the absence of such “defective” in warnings product of the law. v. S.S. Co. eyes (Midgley Kresge Cal.App.3d 217], cited.) 71-72 and cases defect, i.e., defect, As third this court’s regards category warning Anderson, recent decision in 53 Cal.3d decided five supra, after years Brown, our decision in concluded that under supra, gener- warn, ally of strict for failure to applicable a manufacturer principles be held any product liable for caused failure to strictly injuries provide of a or risks adequate warnings product’s dangerous propensities if such were known or knowable at the propensities scientifically time of (Anderson, 1003-1004.) distribution. 53 Cal.3d at Brown, before our decision in Long the drafters of the Restatement Second of Torts that because of fundamental recognized differences between and other it prescription drugs would products, contrary interest to manufacturers to public subject prescription drug generally applicable such far-reach- liability principles. Imposition would risk ing liability needed medical research and the stifling testing essential, beneficial, marketing but highly inherently dangerous drugs. k Comment to section 402A of the Restatement3 that the sellers of provides both established and experimental are from strict if drugs exempt are prepared properly accompanied by appropriate warnings (44 known risks. Cal.3d at Comment k states in full: “There are which, some state of human present knowledge, quite made safe for their incapable being intended and use. These are ordinary *42 common in especially the field of An is the drugs. outstanding example rabies, vaccine for the Pasteur treatment of which not leads to uncommonly serious and very when it is damaging Since consequences injected. death, disease itself invariably leads to a dreadful both the and the marketing use of the vaccine are fully justified, the unavoidable notwithstanding high degree risk which they involve. Such a product, properly prepared, defective, accompanied by directions and is not nor proper warnings, is it vaccines, unreasonably The same is true dangerous. other many drugs, Torts, 347-348, 3Section “(1) 402A of the pages provides part: Restatement Second of in One any product who sells in a dangerous defective condition unreasonably to the user or consumer property subject or to his physical thereby is harm caused to the consumer, (a) ultimate user or or to his property, engaged if the seller is in business of [<]Q selling (b) product, such a expected it is to and [1 does reach the user or consumer change without substantial in the in condition which it is sold.” like, of which for this reason cannot be sold very legally and the many or of a It is also true under except physicians, physician. which, new or as to because of lack many particular experimental drugs of time and for sufficient medical there can be no opportunity experience, such assurance of even of but safety, perhaps purity ingredients, as there is and use of the notwith- justifies marketing experience risk. The seller of such standing medically recognizable products, again marketed, with the they qualification properly prepared it, where the situation calls for is not to be held to warning given, proper use, for unfortunate their attending consequences merely because he has undertaken to with an useful and supply public apparently desirable attended with a known but reasonable product, risk.” apparently 353-354, (Id. at italics in pp. original.) Brown,
As we
44 Cal.3d at
comment k to
explained
page
section 402A of the Restatement Second of Torts has been
in the
adopted
overwhelming
that have
majority
jurisdictions
considered
issue of the
standard for
imposition
manufacturers for
liability upon prescription drug
from
injuries resulting
dangerous
and other risks of harm
propensities
emanating
(See,
prescription drug products.
e.g.,
v.
DeLuryea Winthrop
Laboratories,
(8th
222, 229;
1983)
etc.
Cir.
697 F.2d
v. Ortho
Lindsay
(2d
1980)
91;
Co.,
Pharmaceutical
Cir.
637 F.2d
Corp.
Werner v. Upjohn
(4th
848, 858;
Parke,
1980)
Inc.
Cir.
628 F.2d
Salmon
(4th
v.
Davis and Co.
1359, 1362;
1975)
Cir.
520 F.2d
(9th
1969)
Basko v. Sterling Drug, Inc.
Cir.
417, 426;
Smith,
416 F.2d
Stone v.
Kline
(Ala. 1984)
& French Lab.
1301, 1303-1304;
So.2d
Johnson v. American
Co.
Cyanamid
1318, 1323,
Kan.
55];
P.2d
66 A.L.R.4th
v.
Seley
[718
G.D. Searle 7 Co.
There is a
consensus that
general
the standard for
imposition
under comment k to section 402A of the Restatement Second of Torts is that
of negligence,
the conduct of the
focusing upon
manufacturer and whether
the manufacturer exercised reasonable care in
warning
potential dangers
of which it knew inor
the exercise of reasonable care should have known.
Laboratories,
(See
etc.,
DeLuryea Winthrop
the position the would field, and have by drug have a risk harm posed would foreseen McClellan, (See Strict Liability Drug warning. a reasonable provided for Products Liability, the An Excursion Injuries: Through Induced Maze of 1, 2.) 25 Rev. Dean Liability (1978) Wayne L. and Absolute Negligence summarized manufacturers drug earlier the liability prescription Prosser to hold the the courts have tended standard as follows: “Thus far under this testing drugs standard of care in and a high preparing in of evidence in but the absence and giving warning; unknown potentiality met, to hold the maker not been have refused they this standard has (4th 1971) (Prosser on Torts ed. p. for unforeseeable harm.” liable § omitted.) fiis. Brown, are not this held that manufacturers prescription court under the standard “design applicable, to strict for a subject defect” law, of other under our decision California to manufacturers
under
Co.,
(Brown,
44
Lull
In reaching other and because products, between drugs distinctions cause untoward side effects even drugs though properly in the broader interest public availability and carefully prepared, stan- deciding appropriate an affordable must considered price at (44 use. at from their Cal.3d dard of for injuries resulting defects would of strict liability design We determined that imposition and market- the undesirable consequence inhibiting development have at We of essential and beneficial medications affordable prices. ing highly safer if it withheld be made was drug might explained: “Perhaps at which until skill and advanced to knowledge point market scientific analyzed k and criticized numerous 4We observed “Comment has been Brown: disagreement scope meaning, as to its there is a commentators. While there is some doctrine, that, although purports explain it the strict general consensus fact Schwartz, Unavoidably negligence. (E.g., Products: principle it states is on based Unsafe (1985) Clarif1ying Meaning Policy & Lee L. Rev. Behind Comment K Wash. Kidwell, 1141; McClellan, 1, 2; Duty Injury Wayne L.Rev. Drug Induced 1377-1378; Merrill, Description A Model 53 Tex.L.Rev. Warn: Decision 1, 50.)” (Brown, supra, Drug Injuries (1973) Compensation Prescription Va.L.Rev. added.) italics *44 such revealed. But in most cases effects would be side dangerous additional obtain delay required new drugs—added in marketing a delay Administration the Food and Drug for release product approval the development welfare. Public favors serve the public policy —would not risks, even some though perhaps new drugs, of beneficial marketing introduction, can save ones, because drugs their serious might accompany were subject If manufacturers suffering, drug reduce pain lives and [f] to undertake research be reluctant programs to strict liability, they might beneficial or to distribute that would prove some pharmaceuticals develop marketed, adverse because of the fear large are available to be others that Further, such of insuring against the additional expense monetary judgments. be available—and of research programs insurance would liability—assuming methods available scientific not detectable by to reveal possible dangers it reach of those who need the cost of medication beyond could place 1063.) 44 Cal.3d at (Brown, most.” p. the consumers of
We also noted in Brown that other defects than the consumers of afforded greater protection against the Food and because the industry closely regulated by products, drug manufacture, Administration, which controls Drug actively testing, 12.) (44 Cal.3d at fit. marketing drugs. that, reasons,
We concluded in Brown for these standard Torts, embodied in comment k to section 402A of the Restatement Second rather than must principles liability, govern prescription drug of a manufacturer’s for caused the defective by design drug. injuries 1065.) (44 at We for breach held further that the claims plaintiff’s express implied warranty against drug were “inconsistent with our determination on the issue of strict defects,” and therefore the trial court’s disal- design upheld pretrial rulings the claims for breach of lowing warranty. {Id. Brown, court, as that case reached this procedural posture required address,
us to in addition to the of strict and breach question design defect, further contention that warranty plaintiff’s drug manufacturer could be held liable for failure to warn of unknowable strictly risks of harm. The trial court had made that the defendants rulings pretrial could be held liable for their failure to warn of the known or strictly drug’s effects, knowable side which on ruling was not defendants challenged Instead, the appeal. that the trial court had not far plaintiff argued gone enough sought a that a manufacturer could be held ruling strictly liable for failure to warn of risks in a even though inherent knew, manufacturer neither nor could known have application distribution, scientific available at the that the could knowledge time of *45 1154 effects. While recognizing split authority the undesirable side
produce issue, in view in we observed Brown that the majority products on the for in is that a manufacturer will be liable failure general cases liability of which the manufacturer had actual or constructive to warn of those risks (44 of the time the was distributed. Cal.3d at pp. knowledge product Brown, 1065-1066.) with the We therefore concluded in in accordance with the in cases and consistent view products liability generally, majority Torts, k to section 402A of the Restatement Second of rationale of comment manufacturer not be held liable for may strictly that a prescription drug (44 unknown or unknowable side effects. Cal.3d at p. failure to warn of 1066.)
Because of the nature of the and the issues raised on pretrial rulings appeal Brown, in we were not in that case 44 Cal.3d supra, directly presented with the issue before us in the case—whether a manu- precise present facturer should be to the same strict subject liability princi- failure-to-warn that are to manufacturers of other Our generally products. ples applicable however, in Brown did for failure to warn in opinion suggest, comment k to section 402A of context was prescription drug governed by Torts, footnote, and, in the Restatement Second of we acknowledged under comment k was distinct from analytically failure-to-wam liability of strict liability.5 general principles Brown,
Five after our decision in 44 Cal.3d this court supra, years whether, of strict was with the under presented question general principles held strictly to all a manufacturer could be liability applicable products, liable for a defect when the risk of harm as to which no warning “warning” known knowable at the time the had been was neither nor given scientifically Anderson, was distributed. In a case that product we clarified that in involved asbestos-related dmgs, injury, prescription cases a manufacturer not be held strictly products liability generally, unknowable liable for failure to of unknown or risks of harm. warn in Brown opinion explains, part: 4 of our in relevant “The test stated in comment 5Footnote distinguished Although concepts k is to be from strict for failure to warn. both identify liability, imposes liability only failure to warn as the basis of comment k if the product or should at the time the was sold or knew have known defect irrelevant, liability, why warning distributed. Under strict the reason was not issued is defect about the manufacturer is liable even if it neither knew nor could have known (Brown, warning required.” which the was Cal.3d at fn. Anderson, supra, below, explained fully subsequent As more this court’s decision in clear—contrary possible implication in 4 of the made it contained footnote Brown opinion—that liability principles, under strict for failure to warn even only upon scientifically can were either known or knowable at the time the be based risks that Nonetheless, of our Brown product opinion that this court was distributed. footnote reflects embodying understood the rationale of k as failure-to-wam essentially comment Brown together opinion subsequent standard. When read with the our discussion strongly endorsing drugs, k footnote 4 comment test manufacturers we were of the view in Brown that a suggests drag manufacturer’s governed by ordinary failure to warn would be negligence principles. a defendant in a issue Anderson was whether presented The precise action, based an failure to warn of a risk of upon alleged art”—i.e., harm, evidence of the “state of the evidence that the may present *46 risk was neither known nor knowable application particular (53 available at the time of manufacture or distribution. scientific knowledge 990.) Cal.3d at We determined in Anderson that such state-of-the-art in a action. In evidence was admissible properly products liability reaching conclusion, this we of decisional law a recognized body establishing of strict based manufacturer’s failure to warn of a theory liability upon known or knowable and product’s scientifically dangerous propensities, reviewed the discussion of in authorities in our Brown on the issue opinion of whether strict for failure to warn liability knowledge presupposes risk on the of the manufacturer. We concluded in Anderson that “Cali- part fornia is well settled into the view actual or majority knowledge, constructive, (53 is a for strict for failure to warn.” requisite liability at p. to the contention of
Contrary and the conclusion of the plaintiff majority case, in the I do not believe in present this court’s Anderson opinion properly be understood as that the failure-to-wam standard holding strict-liability generally applicable manufacturers of other products necessarily applies to manufacturers of prescription dmgs.
First, case, because Anderson was not a this drug court had no prescription occasion therein to consider or address the broader directly policy question of whether failure-to-wam strict should liability apply prescription did, however, manufacturers. We reliance on our earlier in place opinion Brown, case, 44 Cal.3d supra, in dmg reaffirming settled view that majority actual or “knowledge, constructive” is a requisite of strict component (Anderson, for failure to warn. 53 Cal.3d 1000.)6 consider, at p. But we did in not Anderson further simply much less reject, of Brown’s application important rationale—which led public policy Mosk, Brown, 6Justice who opinion authored the for in the court in Anderson and criticized the majority’s separately wrote reliance on Brown: “The [Ander majority rely extensively son] that Brown was They obviously on [Brown]. comprehend fail to public based on a narrow policy exception prescription drugs, drugs (at 1063) and for such declared in Brown emphatically alone. We that ‘there is an important prescription drugs distinction between products,’ and other and we elaborated on the reason for the policy distinction: ‘Public the development marketing favors risks, ones, drugs, though beneficial new even some perhaps might accompany serious their introduction, (Ibid.) drugs because can save lives and pain suffering.’ reduce We added public ‘the broader availability interest price at an affordable must be deciding considered in the appropriate injuries standard of resulting from their (Ibid.) use.’ majority [Anderson] in Brown holding analysis beyond stretch the all recognition they rely when injury] litigation on that case in involving products other [asbestos manufacturers from strict liability us in that case exempt prescription in the “broader interest” public in furtherance of the defects design ques- drugs—to specific of beneficial new marketing development should likewise exempt manufacturers tion of whether in failure-to-wam actions. from strict Second, decision Brown this court’s unanimous as already explained, under manufacturer’s liability, that a prescription drag we plainly suggested failure to Second of Torts for k to section 402A of the Restatement comment 4), warn, fn. (44 standard Cal.3d at aby negligence was governed between a marked distinction recognized whereas in Anderson we explicitly and failure to warn under failure to under a strict standard warn *47 the distinction Our observations in Anderson regarding standard. negligence actions bears closer and strict in failure-to-wam liability between negligence here. scrutiny context, observe that “in the failure-to-wam
The herein majority correctly traditional strict and liability is to some extent a of hybrid strict liability ante, 1112.) we In Anderson explained doctrine.” (Maj. p. negligence opn., or ‘sounds in’ negli- of’ ‘rings that “the claim that particular component (53 of strict liability.” its in the context has gence precluded acceptance Cal.3d at p. Anderson, Justice
In his
and
concurring
dissenting opinion
separate
liability
focus
strict products
Mosk elaborated on the point: “[T]he
[between
. . .
court has
has become blurred
the years.
negligence]
through
[T]his
strict
of
into
a number of
of the law
negligence
incorporated
principles
136, 145
(See,
v. McLean
8 Cal.3d
doctrine.
e.g., Luque
[104
443,
defense];
v. General
Daly
501 P.2d
of risk
Cal.Rptr.
[assumption
1163]
380,
725,
575 P.2d
[(1978)] 20 Cal.3d
736-737
Cal.Rptr.
Motors Corp.
[144
Co.,
20
supra,
Barker v. Lull Engineering
[comparative negligence];
1162]
413,
test];
(1988) 44
Cal.3d
432
Brown v.
Court
Superior
[risk-benefit
1049,
412,
a matter of policy,
1066
751 P.2d
470] [as
manufacturers].)”
standards not
drag
strict liability
applicable
Mosk, J.).)
(Anderson,
(conc.
53
dis.
Cal.3d at
1006
opn.
of our
states . . . have
courts of some
sister
Similarly,
permitted
“[t]he
strict
actions.
infusion of
into failure-to-wam
negligence
concepts
295,
1985)
(See,
(7th
v.
America
Cir.
752 F.2d
Corp.
Volvo
e.g., Gonzales
failure-to-
300
of reasonableness in strict [language
concepts
cases];
wam cases under
same as those
in negligence
Indiana law
applied
1973)
(5th Cir.
493 F.2d
Borel v. Fibreboard
Products
Paper
Corporation
Mosk,
(Anderson,
987,1008
(conc.
opn. of
prescription drugs.”
than
and dis.
J.).)
1157
Industries,
(Me.
law];
Inc.
1076,1088
Raymark
Bernier
under Texas
[same
factor];
534,
conduct is a
of defendant’s
1986) 516 A.2d
[reasonableness
N.J.
A.2d
385]
429 [479
v. Lederle Laboratories
Feldman
Co.,
(Minn. 1984) 346 N.W.2d
Inc.
[same];
Kelley
[strict
Bilotta v.
and see
concepts];
claims based on negligence
failure-to-wam
Twerski,
Liability:
in Products
Doctrinal Collapse
Henderson &
generally,
265, 271-273;
Rev.
(1990) 65 N.Y.U.L.
Shell Failure to Warn
The Empty
21;
Keeton,
fn.
(1988
The Law of Torts
supp.)
Prosser &
§
the Law Warnings
Label in
Liability
the Strict
Bromberg,
Mischief of
or harmful risks of its It is to that products. question I turn next.
Ill For the reasons hereafter I conclude that the same explained, important considerations public policy relating development, marketing, that led this court in Brown to conclude that availability prescription drugs (and of strict breach of principles warranty liability) generally defects” should not be applicable “design extended to manufacturers of prescription drugs, should as well to failure-to-wam I apply defects. would therefore hold this case that it is under that a solely negligence principles prescription drug held liable for failure to warn. *49 First, commentators, as several recognized by legal product’s “warning” be characterized as of may its overall and in part cases the design, many of the of is a of question adequacy subset the of the warnings question Twerski, (See, of the basic acceptability design. The Use and Abuse e.g., of Product in Warnings Products Liability—Design Comes Litigation Defect of warn, contrasting 7In liability negligent strict failure warn to with failure to we observed in Anderson that “a reasonably prudent might reasonably manufacturer decide of that the risk as, harm require warning example, was such as not to testing for if the manufacturer’s own contrary showed a result community. to that of others in the scientific Such a manufacturer contrast, might escape liability under principles. liability under strict principles the leeway; give warning manufacturer has no such the if is liable it failed to of dangers that were known to the scientific community the time it manufactured or distrib (53 1003.) product.” uted the Cal.3d at 500-501, 510.)8 the of consider- Many L.Rev. 61 Cornell Age are design equally applicable in of a defect involved the determination ations and, defect, specifi- a risk-utility balancing including ato “failure-to-wam” against design of warnings of the benefits balancing possible the cally, context, if the probability in the For example, prescription alternatives. is statistically new dmg side effects from a beneficial prescription of harmful all. remote, to them at Or arise whether warn against may question additional research instead on consideration of whether focus inquiry the need thereby obviating could to a safer reformulation dmg, lead Thus, and “the often warning design for any warnings. questions follows, then, that (Id. 524.) It to woven at p. inextricably together.” this court in to considerations led Brown extent important public policy for de- design manufacturers from strict liability exempt dmg prescription be same considerations should exempt prescription those fects, applied the known or strict to warn of manufacturers from dmg liability failure side effects associated with knowable risks harm harmful scientifically its products. above,
Second, in noted our Brown long Superior before decision Court, Restatement recognized drafters because between other dmgs of fundamental differences would contrary it interest products, public subject prescription manufacturers to because dmg generally principles applicable needed of such would risk medical imposition far-reaching liability stifling essential, beneficial, research but testing marketing highly I how this court Brown dangerous have inherently dmgs. explained concluded that warn context failure to k should be set forth in comment governed standard Torts, how, section 402A of the Restatement in a footnote to Second case, our in that we further reasoned that failure-to-wam opinion under k of strict comment was distinct from analytically general principles comment and that k in set liability, forth standard actuality incorpo- (Brown, rated fundamental 44 Cal.3d at concepts negligence. fn. tentative I note that related American Law Institute’s provisions draft of Third Torts the Restatement pertaining *50 have long buttress that the drafters of the Restatement conclusion my viewed, view, in dmg and continue to failure-to-wam liability (ante, 1150), 8As noted above that have addressed issue at courts prevented “warning” if have been injury by product defects have caused a could reasoned itself to render appropriate warnings, warnings with such deemed the absence of Co., (Midgley Kresge Cal.App.3d 55 product eyes in v. S.S. “defective” law. 71-72, cited.) and cases 1160 standard of Section 8 liability. a negligence application
cases as requiring draft, of Commercial or Distributor Seller “Liability entitled of that tentative Devices,” in and Medical provides by Drugs for Harm Caused Prescription because ... is not safe “(d) reasonably A drug pertinent part: (1) reasonable instructions or when warnings instructions inadequate [*][] ... drug of harm posed or risks regarding warnings foreseeable in who are a other health care providers and prescribing provided instructions or in accordance with the the risks of harm to reduce position 2, Mar. (Tent. Draft No. (Rest.3d Products Liability . . .” Torts: . warnings 8, 210, 13, added.) 1995) by incorporating concepts italics Clearly, § standard, drafters of into the new “foreseeability” “reasonableness” and sounding a standard of care intend to impose the new Restatement (See also drugs. actions involving prescription in failure-to-wam negligence 906, A.2d 200 545 (1988) & Co. 376 Pa.Super. Ellis v. Iron Chicago Bridge [ is not ‘strict’ from warnings liability arising inadequate 912-913] [“The manufacture, due to fault from a defect arising the same sense as liability with- dangerous is unreasonably of whether an object since a determination defective, involves necessarily and thus out adequate warnings, omitted.)].) (Fn. or foreseeability.” such as reasonableness principles context, exist- context, Third, as in the in the design-defect warning (FDA) provides Administration role of the federal Food Drug ence and from other drugs products, for distinguishing prescription a justification necessity is to evaluate the FDA’s functions because one of the primary manufacturers. drug by prescription adequacy warnings provided seen, Anderson, that generally product this court suggested as we have “if the under negligence principles might escape liability manufacturer to that of others in a result contrary own showed testing manufacturer’s (53 In the prescription Cal.3d at p. community.” scientific however, to decide to its own resources manufacturer is not left industry, Rather, FDA a warning. the risk of harm is such as require whether must be whether a warning provided, role in determining plays significant and, so, content of the warning.9 if the specific to prescription the FDA regulations applicable
It seems clear that
such as the presence
various factors
their
warnings,
accompanying
is,
course,
liability.
warning
not determinative
particular
approval
9The FDA’s
of a
1112,
(4th
1988)
1115
Cyanimid
(See
F.2d
American
Co.
Cir.
Abbott Abbott v.
(1st
1981)
Corp.
107];
Cir.
642 F.2d
Brochu v. Ortho Pharmaceutical
A.L.R.Fed.
1176, 1189].)
658;
A.2d
v. Lederle Laboratories
“[M]ere
1161 FDA has whether approval FDA requirement, of a prior approval or absence has been whether authorization or warning, for a particular been obtained all warning altogether—are highly of a furnishing to the forego obtained warn brought against for failure to actions determining liability relevant laws, of will necessity tort under state drug manufacturers prescription manufacturer’s individualized into the reasonableness of the require inquiry and the the requirements, with FDA warning in its efforts to comply conduct in the first instance.10 Concepts warnings of the need such foreseeability rooted in are fundamentally and “foreseeability” such as “reasonableness” them, and hold prescription To to instead doctrine. fail apply of risks of harm strictly liable warn failing manufacturers consideration of would effectively with their products, preclude associated of fault failure-to-wam relevant to the highly question evidence context. short, a basis for of FDA process provides existence regulatory of the manufacturers other products manufacturers
distinguishing drug scrutiny on market without such rigorous may placed and their contents by of the necessity accompanying warnings evaluation a federal regulatory agency. conducting standards in regulations professional with FDA or with or scientific comply reported tests FDA. that it 1 necessity labeling drugs, and prescription dispute 0There can be no that the (See, seq. regulated e.g., 21 301 et accompanying warnings, highly is a matter. U.S.C. § Food, id., Act]; Drug, regulations and Cosmetic [labeling promulgated under federal (m) [listing regulations spe [broadly defining “labeling”]; 21 201.57 C.F.R. § § id., 1.21(c) (1996) warnings governing labeling prescription drugs]; cifically [label § reactions, contraindications, possible risks of harm regarding precautions, adverse and other id., community]; medical opinion include within the not statements differences 201.57(e) potential safety [warnings adverse reactions and must include “serious § of an association of a hazards” and must be revised “as as there is reasonable evidence soon id., (italics added)]; 201.57(f)(6) (1996) [specific warning drug” serious with hazard § involved].) language pregnancy mandated where risks related to Moreover, recognized manufacturer should generally it has been that a regulations and state tort not be held liable where there is an between federal actual conflict i.e., (See, e.g., Feldman v. requirements, impossible comply law where it with both. is Laboratories, 1176, 1185.) authority line holds further
Lederle 592 A.2d One issued, warning could not FDA-approved where an or -mandated has and the manufacturer warning the manufacturer could change language approval, thereafter without FDA (See warnings. Hurley v. Lab. Div. failing not be LeDerle held liable for furnish additional 1179; 1988) & Cyanamid (5th Spychala v. G.D. Searle Co. Cir. 863 F.2d American Laboratories, 1024, 1033; (D.N.J. 1988) F.Supp. but see Feldman Lederle insulate warning A.2d does not FDA-approved of an [use harm, as the liability for to warn or risks of manufacturer from failure of known knowable approval labeling regulations prior FDA requirements, federal set minimum forth risks]; v. Ortho generally required warning of Brochu before known knowable Corp., supra, [same].) Pharmaceutical 642 F.2d 657-658 *52 Fourth, that manufacturers to a strict I believe prescription drug subjecting inhibiting for a risk of standard failure to warn would create liability is to and of new development drugs comparable the marketing delaying the contrary court in Brown was public risk that the determined standard, dangerous because of the inherently interest. Under a strict a manufacturer could risk astronomical of prescription drugs nature in accordance with though of harm even it acted for failure to warn risks Thus, even of care of a manufacturer. reasonably prudent standard high in reasonably refraining expending a has acted when manufacturer drug the availability that would have delayed additional time money strict liability of a new under principles increased the price drug, were in event a determined there could be held liable jury which could have been warning knowable risks of harm as to a scientifically to manufacturers of If a standard were prescrip- such legal applicable given. new drugs or market a manufacturer hesitate drugs, might develop tion unknown and unassess- because such less profitable products) (especially contrast, which to those situations in if is limited able liability. manufac- warnings, fails to act reasonably providing the manufacturer that, its best to ensure that a does its drug, turer developing marketing standards regulatory adhere to all of the high professional employees field, future confidence that the in the have applicable experts within a will remain drug it incurs as result of marketing reasonable, insurable limits. standard, under a some consumers prescription
Admittedly, from absence injuries resulting be denied for drugs may compensation reasonably knowable but scientifically of harm that were of risks warnings sold. a was known the manufacturer the time prescription not Brown, Nevertheless, conclude, that on balance I as did this court affordable, availability likely served by increasing better public cause strict liability by extending beneficial than highly prescription who injured action to those monetary compensation persons manufacturers. the reasonable actions despite
IV reasons, I conclude that For all of the foregoing risks to warn of the from failure injuries arising manufacturer’s standard, and be a negligence of harm should restricted posed by drug to warn under liable for failure should a manufacturer such *53 warranty.11 or breach liability implied theories strict sustained Upjohn’s I would find that the trial court properly Accordingly, of action for strict for to state causes to failure demurrer plaintiff’s complaint erred in that the Court of warranty, Appeal breach implied overturning ruling. 11Brown, 1071-1072, supra, pages plaintiff pursue a a Cal.3d at holds that cannot breach-of-warranty design-defect against drug manufacturer for the same prescription claim design-defect against a pursue prescription he or she cannot claim
reasons strict test,” drug expectation which is at the heart manufacturer. This is so because the “consumer Co., (see Engineering pp. at of a Barker v. Lull Cal.3d claim fitness, 429-430), analogous implied warranty of and the conceptually is to a claim of theory design-defect application of such to in the context actions 1071-1072, 1061-1062, 14.) (44 rejected was at and fn. Brown. majority merely holding regard by suggesting The seek to this Brown disavow Brown’s rejected warranty suitability arising design are “neither known claims from defects that ante, 1118.) is (Maj. nor the time at This opn., knowable at is distributed.” distinction, specious particularly appended when one considers the statement in footnote Brown, ignores, paragraph majority quoting majority but which is which the explains; holding plaintiff’s warranty “our is founded on the regarding breach claims subject inconsistency are not between such claims and our conclusion (Brown, design The to strict defects . . .” 44 Cal.3d at fn. . mischievous, applica- majority’s faulty reasoning particularly for it stands to revitalize the design bility arising in the warranty of breach of claims from known or knowable defects industry holding in Brown. prescription drug in direct contravention of our unanimous Brown, design-defect I do prescription drug same actions in applied For the reasons implied warranty adoption claim fitness would survive of Brown’s believe a of breach of an event, any parties to the in this are still rationale claims case. failure-to-warn broadly alleges pretrial stage litigation. complaint the defendants pleading in this and of impliedly expressly Halcion was fit its intended use warranted that effects, quality notwithstanding knowledge and there are merchantable their of its serious side way or other. As developed pleaded few facts in the claims one record substantiate the such, judgment of the extent it overturned the trial Appeal I would affirm the the Court of express sustaining alleging order breach of court’s the demurrer cause of action warranty.