SEE CONCURRING AND DISSENTING OPINION

Filed 12/21/17

IN THE SUPREME COURT OF CALIFORNIA

T.H., a Minor, etc., et al., )

)

Plaintiffs and Appellants, )

) S233898

v. )

) Ct.App. 4/1 D067839

NOVARTIS PHARMACEUTICALS )

CORPORATION, )

) San Diego County

Defendant and Respondent. ) Super. Ct. No. 37-2013-00070440-

) CU-MM-CTL

____________________________________)

Under California law, a brand-name drug manufacturer has a duty to warn 

of known or reasonably knowable adverse effects arising from an individual’s use 

of its drug. (See Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65.) In this 

case, we examine whether — and if so, under what circumstances — a brandname drug manufacturer may be sued under a theory of “warning label” liability 

when the warning label for its drug was alleged to be deficient, but the plaintiffs 

were injured by exposure to a generic bioequivalent drug bearing the brand-name 

drug’s warning label. 

Plaintiffs’ mother, J.H., was prescribed terbutaline, a generic form of the 

brand-name drug Brethine, to suppress premature labor during her pregnancy. 

Plaintiffs T.H. and C.H. were born full term, but were diagnosed with 

developmental delays at three years of age and autism by the time they turned five. 

Through their father as guardian ad litem, the minors allege that those responsible 
2

for the terbutaline label knew or should have known — based on studies of the 

drug’s effects in rats and in humans — that the drug posed a serious risk to fetal 

brain development. They further allege that the drug’s label unreasonably failed 

to include a warning about this risk.

Federal law explicitly conveys to the brand-name manufacturer — and only 

that manufacturer — the responsibility to provide an adequate warning label for 

both generic terbutaline and its brand-name equivalent, Brethine. As explained in 

more detail below, only the brand-name drug manufacturer has unilateral authority 

to modify the drug’s label by adding to or strengthening a warning. Generic drug 

manufacturers are required to follow the brand-name manufacturer’s label to the 

letter. Accordingly, the manufacturer of Brethine controlled both the form and 

content of the terbutaline warning label. 

Plaintiffs brought suit against defendant Novartis Pharmaceuticals 

Corporation (Novartis), which manufactured Brethine until December 2001, and 

aaiPharma Inc. (aaiPharma), which purchased the rights to and manufactured 

Brethine thereafter — using the same label Novartis had used — when plaintiffs’ 

mother was prescribed the generic bioequivalent in 2007. Plaintiffs claim that 

Novartis knew or should have known that its warning label failed to alert pregnant 

women or their physicians to the risk Brethine posed to fetal brain development; 

that manufacturers of terbutaline were compelled by federal law to include 

Brethine’s deficient label on their own products; that it was foreseeable Novartis’s 

successor (aaiPharma) would not change or update Brethine’s deficient label; and 

that in reliance on the deficient warning label, plaintiffs’ mother was prescribed 

terbutaline, which adversely affected plaintiffs’ developing brains in utero. What 

Novartis asserts in response is that its duty to provide a safe and adequate warning 

label for Brethine did not encompass those who were prescribed terbutaline in 

reliance on the Brethine label. Novartis further contends that any such duty should 
3

not extend to those who were exposed to terbutaline after Novartis ceased 

manufacturing Brethine and sold its rights in the drug to aaiPharma. 

Such contentions, and the case in which they arise, reach us at a very early 

stage in the litigation. In reviewing a demurrer, we ask only whether the plaintiff 

has alleged — or could allege — sufficient facts to state a cause of action against 

the defendant. (Schifando v. City of Los Angeles (2003) 31 Cal.4th 1074, 1081.) 

In our view, plaintiffs have indeed shown that they could allege a cause of action 

against Novartis for warning label liability. Because the same warning label must 

appear on the brand-name drug as well as its generic bioequivalent, a brand-name 

drug manufacturer owes a duty of reasonable care in ensuring that the label 

includes appropriate warnings, regardless of whether the end user has been 

dispensed the brand-name drug or its generic bioequivalent. If the person exposed 

to the generic drug can reasonably allege that the brand-name drug manufacturer’s 

failure to update its warning label foreseeably and proximately caused physical 

injury, then the brand-name manufacturer’s liability for its own negligence does 

not automatically terminate merely because the brand-name manufacturer 

transferred its rights in the brand-name drug to a successor manufacturer. We 

therefore affirm the Court of Appeal, which had directed the trial court to enter an 

order sustaining Novartis’s demurrer with leave to amend plaintiffs’ negligence 

and negligent misrepresentation causes of action.

I. BACKGROUND

From a certain perspective, the claim underlying this lawsuit is quite 

straightforward. Plaintiffs T.H and C.H., who are fraternal twins, sued defendant 

Novartis for negligence and negligent misrepresentation arising from Novartis’s 

failure to warn of the risks of Brethine, an asthma drug sometimes prescribed 

“off label” to stop or slow preterm labor. Plaintiffs allege that Novartis knew or 
4

should have known that Brethine carried a substantial risk of causing 

developmental and neurological damage to the fetus, yet failed to warn of this risk. 

What removes this case from the realm of the ordinary is that plaintiffs’ 

mother was never prescribed Brethine. Rather, she — like many pregnant women 

experiencing premature labor — was prescribed terbutaline sulfate (terbutaline), 

the generic bioequivalent drug. Moreover, Novartis stopped manufacturing 

Brethine and sold all rights to the drug in 2001, six years before plaintiffs’ injury. 

During the period it was the brand-name manufacturer, however, Novartis had the 

legal duty to disclose Brethine’s known and reasonably knowable risks in the 

drug’s warning label. All generic manufacturers, in turn, had a specific legal 

responsibility regarding the label: to ensure the terbutaline label was identical to 

the Brethine label. We therefore examine plaintiffs’ allegations against the 

backdrop of the distinctive legal framework governing labeling for brand-name 

and generic pharmaceuticals. 

On review of a demurrer, we accept as true all properly pleaded facts. 

(Shirk v. Vista Unified School Dist. (2007) 42 Cal.4th 201, 205.) Where particular 

facts are set out below, they are those alleged in plaintiffs’ first amended 

complaint. 

A. Federal Regulation of Drug Labeling

The Food, Drug, and Cosmetic Act (FDCA; 21 U.S.C. § 301 et seq.) 

prohibits the marketing of a new brand-name drug unless the manufacturer has 

submitted a new drug application (NDA) and the Food and Drug Administration 

(FDA) has approved the drug as safe and effective for its intended use. (21 U.S.C. 

§ 355(a).) The NDA must include an exemplar of the drug’s proposed label (21 

U.S.C. § 355(b)(1)(F)) describing the drug’s indications and usage, 
5

contraindications, warnings and precautions, and adverse reactions. (21 C.F.R. 

§ 201.56(e)(1).) 

In 1984, Congress enacted the Hatch-Waxman Act. (98 Stat. 1585, 1585-

1597, codified as amended at 21 U.S.C. § 355.) This statute allows a prospective 

generic drug manufacturer to file an abbreviated new drug application (ANDA) 

asserting the generic drug’s bioequivalence to an existing listed drug that has 

already been approved by the FDA. (PLIVA, Inc. v. Mensing (2011) 564 U.S. 604, 

612 (PLIVA), citing 21 U.S.C. § 355(j).) Such an application is typically filed as 

the brand-name drug’s patent is about to expire. The streamlined application 

relieves the generic manufacturer of the need to duplicate the clinical trials 

previously submitted for the equivalent brand-name drug. (Ibid.) The generic 

manufacturer must nonetheless “show that the labeling proposed for the new drug 

is the same as the labeling approved for the listed drug.” (21 U.S.C. 

§ 355(j)(2)(A)(v).) 

So under the federal scheme, “brand-name and generic drug manufacturers 

have different federal drug labeling duties.” (PLIVA, supra, 564 U.S. at p. 613.) 

It is the brand-name manufacturer that bears responsibility for the accuracy and 

adequacy of its label “as long as the drug is on the market.” (Wyeth v. Levine

(2009) 555 U.S. 555, 570-571 (Wyeth).) The generic manufacturer, on the other 

hand, is responsible only for “an ongoing federal duty of ‘sameness’ ” — that is, 

ensuring that its warning label is the same as the brand-name manufacturer’s. 

(PLIVA, at p. 613.) 

FDA regulations require the brand-name drug manufacturer to update the 

warning label “as soon as there is reasonable evidence of an association of a 

serious hazard with a drug; a causal relationship need not have been proved.” (21 

C.F.R. § 201.80(e); cf. id., § 314.80(b) [NDA holder “must promptly review all 

adverse drug experience information obtained or otherwise received by the 
6

applicant from any source”].) A specific warning is required if the drug is 

commonly prescribed for a disease or condition, even when the drug has not yet 

been approved for that use, where “such usage is associated with serious risk or 

hazard.” (Id., § 201.80(e).) Any manufacturer of the drug at issue may request a 

change in the label by submitting a “prior approval supplement” to the FDA, 

which decides whether to approve the requested change in the warning label. (21 

C.F.R. § 314.70(b)(2)(v); FDA, Abbreviated New Drug Application Regulations, 

57 Fed.Reg. 17950, 17961 (Apr. 28, 1992).) But a brand-name drug 

manufacturer, unlike a generic manufacturer, may unilaterally update a label, 

without waiting for FDA preapproval, “[t]o add or strengthen a contraindication, 

warning, precaution, or adverse reaction” under the “changes being effected” 

(CBE-0) regulation. (21 C.F.R. § 314.70(c)(6)(iii)(A); see Wyeth, supra, 555 U.S. 

at p. 568.) By contrast, a generic manufacturer may use the CBE-0 regulation 

only to conform its label to an updated brand-name label. (PLIVA, supra, 564 

U.S. at p. 614.) 

Because federal regulations preclude generic manufacturers from 

unilaterally altering the warning labels on their drugs (PLIVA, supra, 564 U.S. at 

p. 617), federal law preempts state tort claims against generic manufacturers for 

failure to provide adequate warnings. (Id. at p. 609.) State tort claims against a 

brand-name manufacturer based on a failure to warn, however, are not preempted. 

(Id. at p. 625.) 

B. Terbutaline, Brethine, and Novartis

Terbutaline is a beta-adrenergic agonist, acting upon the beta2 receptors in 

smooth muscle tissue and causing muscles to relax. The drug was originally 

developed by Draco, a Swedish company, and released for use as a bronchodilator 

to treat asthma. In 1974, the FDA approved terbutaline as a treatment for asthma 
7

in the United States. Astra AB (and later, AstraZeneca LP) licensed the right to 

manufacture and market terbutaline in its oral form to Ciba-Geigy (a predecessor 

to Novartis) under the brand name Brethine. Novartis owned the NDA for 

Brethine until 2001. 

In 1976, a Swedish physician with ties to Draco published the results of a 

small study indicating that terbutaline was safe and effective as a tocolytic — a 

drug to suppress premature labor in pregnant women — on the theory that the drug 

could relax uterine smooth muscle tissue. Terbutaline subsequently gained wide 

acceptance as a tocolytic, but neither Novartis nor any other manufacturer sought 

FDA approval for this off-label use.1 Later studies cast doubt on the safety and 

efficacy of terbutaline as a tocolytic. 

In 1978, a study published in the British Journal of Obstetrics and 

Gynaecology questioned the validity and conclusions of the original Swedish 

report. According to plaintiffs’ complaint, the British study warned that the 

benefits of this class of drugs on preterm labor was “ ‘not yet established,’ ” that 

the evidence was “ ‘too scanty to make conclusions about side effects possible,’ ” 

and that other data suggested “ ‘that labor inhibitors are potentially dangerous.’ ” 

A year later, a study published in the American Journal of Obstetrics and 

Gynecology reported adverse effects in both the pregnant mother and in the fetus 

following terbutaline exposure. 

A team of American clinical investigators in 1982 sought to replicate the 

results of the 1976 Swedish study. They could not. In fact, the investigators were 

 

1 Physicians may, in their professional judgment, prescribe a drug for a 

purpose other than that for which it has been approved by the FDA. (Buckman 

Co. v. Plaintiffs’ Leg. Com. (2001) 531 U.S. 341, 351, fn. 5 [“ ‘Off-label use is 

widespread in the medical community’ ”].) 
8

unable to find any benefit among the pregnant mothers who had been prescribed 

terbutaline as compared to those who received a placebo. A 1984 study published 

in the Journal of Reproductive Medicine similarly failed to confirm any benefits. 

In 1985, Dr. Theodore Slotkin and a team of Duke University Medical 

Center researchers found that a single dose of terbutaline given to pregnant rats 

interfered with an enzyme necessary for neuronal development in the fetal brain. 

Dr. Slotkin’s study showed that terbutaline can cross the placenta and fetal brain 

barrier in sufficient quantities to affect brain development. Other studies in the 

1980s revealed that children born to mothers who had received a different betaadrenergic agonist had poorer academic achievement and were more likely to have 

impairments in vision and language development than children born to mothers 

who did not receive such treatment. 

In 1989 and 1990, Dr. Slotkin published studies showing that terbutaline 

may interfere with the fetus’s neurobehavioral development, presumably through 

its effects on receptors in the fetal cerebellum. Shortly thereafter, in 1992, 

scientists from the University of Texas undertook a comprehensive and critical 

evaluation of the literature relating to terbutaline and concluded, in a study 

published in the American Journal of Obstetrics and Gynecology, that the drug 

had not been shown to arrest preterm labor and that chronic exposure may 

adversely affect the fetus. A 1995 meta-analysis by researchers from the 

University of Pennsylvania likewise concluded that the relevant literature did not 

support the claimed benefit from maintenance tocolytic therapy. The American 

College of Obstetricians and Gynecologists (ACOG) subsequently issued a 

“Technical Bulletin on Preterm Labor” to its more than 40,000 members, which 

noted the asserted benefit from maintenance tocolytic therapy lacked any 

evidentiary basis and warned that the potential risks of such therapy, to both the 

mother and the fetus, were well documented. ACOG’s bulletin stated that the risk 
9

associated with beta-mimetic agents (such as terbutaline) appeared greater than 

that associated with other tocolytic agents. In 1997, the FDA’s Associate 

Commissioner for Health Affairs issued a “Dear Colleague” letter, which endorsed 

ACOG’s assessment of the benefits and dangers of long-term tocolytic therapy. 

In 2001, the German Central Institute of Mental Health issued a report 

concluding that children whose mothers had received beta-agonist tocolysis had a 

significantly higher rate of psychiatric disorders and psychopathology, and that 

such children scored lower on psychometric tests of cognitive development. Dr. 

Slotkin’s Duke team released another study in October 2001, which revealed that 

beta2 receptors in the fetal brain, unlike those in mature brains, do not desensitize 

when exposed to continuous doses of terbutaline. Instead, the fetal receptors 

intensify their sensitivity to terbutaline and thus increase their response to the drug 

as the dosage increases (and the brain develops). 

Over the years, researchers developed –– and companies brought to market 

–– newer and more effective bronchodilators and other asthma treatments. 

Novartis continued to manufacture and distribute Brethine with the intention that it 

be used as a tocolytic. By 2001, nearly half of all prescriptions for terbutaline 

were for tocolysis, even though the drug was never approved by the FDA for that 

purpose. In December 2001, Novartis transferred the NDA for Brethine to 

NeoSan Pharmaceuticals Inc., a wholly owned subsidiary of aaiPharma. 

C. The Facts Underlying This Lawsuit

On September 5, 2007, plaintiffs’ mother, J.H., was hospitalized because of 

concerns about premature labor. She was prescribed terbutaline, to be 

administered every six hours, and was discharged on September 25, 2007. While 

in the hospital, J.H. received a generic version that was manufactured by Lehigh 

Valley Technologies, Inc.; after discharge, she received a generic version that was 
10

manufactured by Global Pharmaceuticals. J.H. continued taking terbutaline as 

directed until plaintiffs were born on October 9, 2007. Plaintiffs appeared to be 

normal until their pediatrician, during a routine checkup in December 2010, 

reported that the twins may have developmental delays. Despite specialized 

treatment for both children, a pediatric neurologist diagnosed them with autism in 

August 2012. 

Plaintiffs’ first amended complaint alleges that terbutaline passed through 

the placenta and the blood-brain barrier. As a result, plaintiffs contend, terbutaline 

caused them to suffer severe and permanent neurologic injuries, including an 

inability to speak and significant limitations and abnormalities in their motor 

skills. Plaintiffs further allege that Novartis knew or should have known that 

terbutaline was of questionable efficacy as a tocolytic agent, that terbutaline 

carried serious risks of side effects for newborns whose mothers received the drug 

during pregnancy, and that federal law required Novartis to report this information 

to the FDA and to update the warning label — something Novartis could have 

done unilaterally. (See 21 C.F.R. § 314.70(c)(6)(iii)(A).) Instead, Novartis falsely 

represented that terbutaline was safe and effective and would not cause serious 

side effects in newborns, and it intended for pregnant mothers and their physicians 

to rely on these representations. The complaint asserted causes of action for 

negligence and negligent misrepresentation, as well as strict liability, intentional 

misrepresentation, concealment, and medical negligence. 

To support and place in factual context their negligence cause of action, 

plaintiffs made a variety of specific allegations regarding Novartis. They alleged 

that Novartis had a duty to update the label to warn of the drug’s effects on fetal 

development, that Novartis knew or should have known of these effects, that 

J.H.’s physicians prescribed her terbutaline because of their erroneous belief that 

terbutaline was safe to use as a tocolytic, that plaintiffs suffered neurological 
11

damage as a result of their exposure to terbutaline in utero, and that plaintiffs’ 

injuries were foreseeable. Meanwhile, plaintiffs’ negligent misrepresentation 

cause of action alleged that Novartis falsely represented that terbutaline was safe 

to use as a tocolytic, that Novartis had no reasonable basis for believing terbutaline 

was safe to use as a tocolytic, that Novartis intended for pregnant mothers and 

their physicians to rely on their false representations concerning the drug’s safety 

as a tocolytic agent, that J.H. and her physicians relied on Novartis’s 

representations, that plaintiffs suffered neurological damage as a result of their 

exposure to terbutaline in utero, and that plaintiffs’ injuries were foreseeable. 

Novartis’s core assertion in its demurrer was that it had no duty to 

plaintiffs. To justify its position, the company offered two overarching rationales: 

It did not manufacture the terbutaline ingested by their mother; and it had 

transferred the Brethine NDA to another company in December 2001, nearly six 

years before plaintiffs’ mother was prescribed terbutaline. In addition, Novartis 

argued that plaintiffs had failed to identify with specificity any misrepresentation 

by Novartis or allege that plaintiffs had relied on any such misrepresentation. In 

opposition to the demurrer, plaintiffs responded that Novartis had a duty to warn 

about the drug’s effects on fetal development during the period it owned the NDA 

and manufactured Brethine; that the six-year gap between Novartis’s divestiture of 

the NDA and plaintiffs’ in utero exposure is relevant to causation (and not the 

existence of the duty); and that the first amended complaint adequately pleaded the 

misrepresentations with specificity, given that the specific misrepresentations are 

more likely to be within Novartis’s knowledge, and adequately pleaded reliance on 

those misrepresentations. 

The trial court sustained the demurrer without leave to amend. It concluded 

that Novartis owed plaintiffs no duty as a matter of law relating to claims arising 

from terbutaline exposure in 2007. Agreeing with Novartis, the court also found 
12

that the fraud-based claims suffered from a lack of specificity and that this defect 

could not be remedied by allegations about Novartis’s conduct prior to the 2001 

NDA divestiture.

The Court of Appeal reversed and directed that the order sustaining the 

demurrer be modified to grant plaintiffs leave to amend their causes of action for 

negligence and negligent misrepresentation. The appellate court reasoned that if 

plaintiffs could allege that Novartis failed to warn about fetal risks it knew or 

should have known were associated with terbutaline when used as a maintenance 

tocolytic prior to its divestiture of the brand-name drug in 2001, that the warning 

would have remained on the label in 2007 had Novartis added a suitable warning 

to the label before divestiture in 2001, and that their mother’s physician would not 

have prescribed terbutaline as a maintenance tocolytic had the drug been properly 

labeled, then their claims for negligence and negligent misrepresentation can 

survive demurrer. 

We granted Novartis’s petition for review to decide the existence and scope 

of warning label liability for brand-name drug manufacturers under California law. 

II. DISCUSSION

The sole issue before us is whether the demurrer should have been 

sustained with respect to the negligence and negligent misrepresentation claims on 

the ground that Novartis owed no duty of care to plaintiffs. In reviewing an order 

sustaining a demurrer, we examine the operative complaint de novo to determine 

whether it alleges facts sufficient to state a cause of action under any legal theory. 

(Lee v. Hanley (2015) 61 Cal.4th 1225, 1230.) Where the demurrer was sustained 

without leave to amend, we consider whether the plaintiff could cure the defect by 

an amendment. The plaintiff bears the burden of proving an amendment could 

cure the defect. (Blank v. Kirwan (1985) 39 Cal.3d 311, 318.) 
13

The gist of plaintiffs’ warning label liability claim is that Novartis 

negligently failed to warn about the drug’s risk to fetal brain development. They 

contend that the deficient label foreseeably and proximately caused harm not only 

to the children of women who were prescribed Brethine, but also to the children of 

women who were prescribed its generic bioequivalent, which was legally required 

to — and did — bear the same deficient label. Among other things, plaintiffs rely 

on section 311 of the Restatement Second of Torts (section 311), which addresses 

negligent misrepresentation involving physical harm. Under section 311(1), 

“[o]ne who negligently gives false information to another is subject to liability for 

physical harm caused by action taken by the other in reasonable reliance upon 

such information, where such harm results [¶] . . . [¶] to such third persons as the 

actor should expect to be put in peril by the action taken.” 

Section 311’s theory of liability is intended to be “somewhat broader” than 

that for mere pecuniary loss. (Rest.2d Torts, § 311, com. a.) It “finds particular 

application where it is a part of the actor’s business or profession to give 

information upon which the safety of the recipient or a third person depends.” 

(Id., § 311, com. b; see also Prosser, Misrepresentation and Third Persons (1966) 

19 Vand. L.Rev. 231, 254 [explaining that one has a duty not to make a false 

representation to “[t]hose to whom a public duty is found to have been created by 

statute, or pursuant to a statute . . . [and to] [t]hose members of a group or class 

whom he has special reason to expect to be influenced by the representation”].) 

This court applied and followed section 311 in Randi W. v. Muroc Joint Unified 

School Dist. (1997) 14 Cal.4th 1066 (Randi W.). There, we concluded that a 

school district’s negligent misrepresentations about a former employee in a letter 

of recommendation could render the school district liable for the employee’s 

molestation of a third person — a student at the employee’s new school — even 

though the student had no special relationship with the former school district and 
14

never received the misleading information. (Id. at p. 1081.) In accordance with 

the Restatement, we held “that the writer of a letter of recommendation owes to 

third persons a duty not to misrepresent the facts in describing the qualifications 

and character of a former employee, if making these misrepresentations would 

present a substantial, foreseeable risk of physical injury to the third persons.” 

(Ibid.) Plaintiffs urge us to hold, in similar fashion, that a brand-name drug 

manufacturer owes a duty to third persons not to misrepresent the safety of its 

drug, if making those misrepresentations would present a substantial, foreseeable 

risk of physical injury to those third persons. 

Duty is indeed the cornerstone of every negligence claim. In California, the 

general rule governing duty is codified in Civil Code section 1714, subdivision 

(a): “Everyone is responsible . . . for an injury occasioned to another by his or her 

want of ordinary care or skill in the management of his or her property or person 

. . . .” Thus, “each person has a duty to use ordinary care and ‘is liable for injuries 

caused by his failure to exercise reasonable care in the circumstances . . . .’ ” 

(Parsons v. Crown Disposal Co. (1997) 15 Cal.4th 456, 472.) Whether a party has 

a duty of care in a particular case is a question of law for the court, which we 

review independently on appeal. (Kesner v. Superior Court (2016) 1 Cal.5th 

1132, 1142 (Kesner).) 

The conclusion that a duty exists in a particular case “ ‘is not sacrosanct in 

itself, but only an expression of the sum total of those considerations of policy 

which lead the law to say that the particular plaintiff is entitled to protection.’ ” 

(Dillon v. Legg (1968) 68 Cal.2d 728, 734, quoting Prosser, Law of Torts (3d ed. 

1964) pp. 332-333.) We invoke the concept of duty to limit “ ‘ “ ‘the otherwise 

potentially infinite liability which would follow from every negligent act,’ ” ’ ” yet 

we do so only where public policy clearly supports (or a statutory provision 

establishes) an exception to the general rule of Civil Code section 1714. (Kesner, 
15

supra, 1 Cal.5th at p. 1143.) When considering whether to depart from the general 

rule, we balance a number of considerations, including “the foreseeability of harm 

to the plaintiff, the degree of certainty that the plaintiff suffered injury, the 

closeness of the connection between the defendant’s conduct and the injury 

suffered, the moral blame attached to the defendant’s conduct, the policy of 

preventing future harm, the extent of the burden to the defendant and 

consequences to the community of imposing a duty to exercise care with resulting 

liability for breach, and the availability, cost, and prevalence of insurance for the 

risk involved.” (Rowland v. Christian (1968) 69 Cal.2d 108, 113 (Rowland).) 

In the context of prescription drugs, a manufacturer’s duty is to warn 

physicians about the risks known or reasonably known to the manufacturer. 

(Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1112 (Carlin); see generally 

Finn v. G.D. Searle & Co. (1984) 35 Cal.3d 691, 699-700.) The manufacturer has 

no duty to warn of risks that are “merely speculative or conjectural, or so remote 

and insignificant as to be negligible.” (Carlin, at p. 1116.) If the manufacturer 

provides an adequate warning to the prescribing physician, the manufacturer need 

not communicate a warning directly to the patient who uses the drug. (Ibid.) 

In this case, plaintiffs allege that the terbutaline label failed to warn about 

the risks to fetal brain development and falsely represented that the drug was safe 

for use by pregnant women. They further claim that Novartis’s control over the 

Brethine label rendered it responsible for any deficiencies in the terbutaline label, 

given that generic drug manufacturers are legally obligated to use the label crafted 

by the brand-name drug manufacturer. Novartis contends that it owed no duty to 

plaintiffs to update or maintain an accurate label because (1) it did not 

manufacture the terbutaline that caused plaintiffs’ injuries; and (2) it had divested 

ownership of Brethine, the name-brand drug, several years before plaintiffs’ 

mother was prescribed terbutaline. 
16

To determine whether to create an exception to a brand-name drug 

manufacturer’s duty to warn, we balance the constellation of factors set out in 

Rowland, supra, 69 Cal.2d at page 113. Three of those factors — foreseeability, 

the certainty of the injury, and the closeness of the connection between the 

plaintiff and the defendant — address the foreseeability of the relevant injury. 

(Kesner, supra, 1 Cal.5th at p. 1145.) The remaining four — moral blame, the 

policy of preventing future harm, the burden on the defendant and the general 

public, and the availability of insurance — focus on the public policy justifications 

for or against carving out an exception to the general duty in this category of 

cases. (Ibid.) Our task is to determine whether a brand-name manufacturer owes 

a duty of ordinary care to those who may be injured by deficiencies in its warning 

label, not whether Novartis acted reasonably under the particular circumstances 

here. (See Cabral v. Ralphs Grocery Co. (2011) 51 Cal.4th 764, 772-774 

(Cabral).) 

A. Whether Plaintiffs Exposed to the Generic Bioequivalent Drug Can 

Assert Warning Label Liability Against Novartis, the Brand-name Drug 

Manufacturer 

The first case to recognize warning label liability was Conte v. Wyeth, Inc.

(2008) 168 Cal.App.4th 89 (Conte). In Conte the court concluded that a brandname drug manufacturer’s common law duty of care when warning of the dangers 

of its drug extended not only to consumers of the brand-name drug, “but also to 

those whose doctors foreseeably rely on the name-brand manufacturer’s product 

information when prescribing a medication, even if the prescription is filled with 

the generic version of the prescribed drug.” (Id. at p. 94.) The Court of Appeal’s 

holding predated by more than two years the United States Supreme Court’s ruling 

that federal law requires generic drug manufacturers to conform their warning 

label to the label used by the brand-name manufacturer (PLIVA, supra, 564 U.S. at 
17

p. 613), and its analysis referenced some — but not all — of the Rowland factors. 

(Conte, at pp. 105-107.) 

Only a handful of courts have followed Conte. (See, e.g., Dolin v. 

SmithKline Beecham Corp. (N.D.Ill. 2014) 62 F.Supp.3d 705; Chatman v. Pfizer, 

Inc. (S.D.Miss. 2013) 960 F.Supp.2d 641, 654; Kellogg v. Wyeth, Inc. (D.Vt. 

2010) 762 F.Supp.2d 694, 704; Wyeth, Inc. v. Weeks (Ala. 2014) 159 So.3d 649 

(Weeks).) But our careful review of the federal regulatory scheme and analysis of 

all the Rowland factors persuades us that a brand-name drug manufacturer has the 

duty under California law to warn of the risks about which it knew or reasonably 

should have known, regardless of whether the consumer is prescribed the brandname drug or its generic “bioequivalent.” (See 21 U.S.C. § 355(j)(2)(A)(iv).) 

1. Foreseeability and related factors

In determining whether to create an exception to the general statutory duty 

of care, the “major” (Cabral, supra, 51 Cal.4th at p. 771, fn. 2), and ultimately 

“most important” (Kesner, supra, 1 Cal.5th at p. 1145), consideration under 

California law is the foreseeability of physical harm. Novartis could reasonably 

have foreseen that deficiencies in its Brethine label could mislead physicians about 

the safety of terbutaline, Brethine’s generic bioequivalent, which was legally 

required to bear an identical label. 

A brand-name pharmaceutical manufacturer has a duty under federal law to 

draft, update, and maintain the warning label so that it provides adequate warning 

of the drug’s potentially dangerous effects. (21 U.S.C. § 352(f)(2).) The FDA, as 

part of its premarket review process, must approve the text of the proposed label. 

(21 U.S.C. § 355; Wyeth, supra, 555 U.S. at p. 568.) Although the brand-name 

manufacturer generally must obtain FDA approval before making any change to 

the label, this category of manufacturers may use the “changes being effected” 
18

(CBE-0) regulation (21 C.F.R. § 314.70(c)(3)) to “add or strengthen a 

contraindication, warning, precaution, or adverse reaction” immediately upon 

filing a supplemental application, without waiting for FDA approval. (Id., 

§ 314.70(c)(6)(iii)(A).) 

The duty for a manufacturer of generic drugs, on the other hand, is to 

ensure that its warning label is identical to the label of the brand-name drug. 

(PLIVA, supra, 564 U.S. at p. 613.) In other words, generic manufacturers “have 

an ongoing federal duty of ‘sameness.’ ” (Ibid.) A generic manufacturer may use 

the CBE-0 regulation to change its label only to match a revised brand-name label 

or otherwise comply with FDA instructions. (Id. at p. 614.)

What a brand-name manufacturer thus knows to a legal certainty is that any 

deficiencies in the label for its drug will be perpetuated in the label for its generic 

bioequivalent. A brand-name manufacturer will also be aware that although the 

warnings communicated in its drug label are designed for physicians — and are 

intended to influence a physician’s decision whether to prescribe the drug (see 

Stevens v. Parke, Davis & Co., supra, 9 Cal.3d at pp. 64-65) — it is often the 

pharmacist who actually decides whether the patient receives the brand-name drug 

or its generic bioequivalent. (Bus. & Prof. Code, § 4073.) Moreover, many 

insurance companies require the substitution of a generic drug for the brand-name 

drug as a matter of course, unless the physician justifies use of the branded drug. 

(PLIVA, supra, 564 U.S. at p. 628, fn. 2 (dis. opn. of Sotomayor, J.).) 

Accordingly, it is entirely foreseeable that the warnings included (or not included) 

on the brand-name drug label would influence the dispensing of the generic drug, 

either because the generic is substituted by the pharmacist or the insurance 

company after the physician has prescribed the brand-name drug, or because the 

warning label on the generic drug is legally required to be identical to the label on 
19

the brand-name drug. (Conte, supra, 168 Cal.App.4th at p. 105; accord, Weeks, 

supra, 159 So.3d at p. 670.)

Under the second Rowland factor, we assess the degree of certainty that the 

plaintiff suffered injury. This factor, too, strengthens the case for finding a duty of 

care in these circumstances. Plaintiffs allege that they suffer from global 

neurological impairment, including autism and pervasive developmental delays. 

These are indisputably injuries and are compensable under the law. (See Kesner, 

supra, 1 Cal.5th at p. 1148.)

The third Rowland factor implicates the closeness of the connection 

between the defendant’s conduct and the plaintiff’s injury. The label for a generic 

drug is (and must be) the same as the label for the brand-name drug, so any 

deficiency in the brand-name label will be reflected in the generic label. Plaintiffs 

allege that the deficient Brethine label led their mother’s physician to prescribe 

terbutaline, which caused their neurological injuries. This scenario describes a 

close connection between Novartis’s allegedly negligent conduct and plaintiffs’ 

injuries. 

Novartis, meanwhile, relies on O’Neil v. Crane Co. (2012) 53 Cal.4th 335 

(O’Neil). This is a case we can distinguish. There, a naval seaman developed 

mesothelioma caused by asbestos exposure. Following his death, his family filed 

a wrongful death action asserting strict liability and negligence claims against 

several defendants, including the manufacturers of valves and pumps that were 

used in warships. (Id. at p. 346.) At the close of evidence, the defendant 

manufacturers moved for nonsuit, pointing out the plaintiffs’ failure to show that 

the decedent had been exposed to asbestos from any of their products. Plaintiffs 

responded that even if the decedent was never exposed to asbestos from the 

defendants’ products themselves, it was foreseeable that the defendants’ valves 

and pumps would need to be replaced with new asbestos-containing components, 
20

and that asbestos could be released into the air during the repair and replacement 

process. (Ibid.) In reinstating the trial court’s judgment of nonsuit, we invoked 

the Rowland factors and noted, in particular, that the connection between the 

defendant manufacturers’ conduct and the decedent’s injury was “extremely 

remote” (id. at p. 365): Although component parts of the defendants’ valves and 

pumps had been replaced “during routine maintenance” (id. at p. 344), the 

decedent did not begin to work in the vicinity of these valves and pumps until 

more than 20 years after they were installed — and did not suffer an injury for 

another 40 years. In addition, the defendant manufacturers did not produce, sell, 

or supply any of the asbestos-containing products that could have caused his 

mesothelioma. Because the defendants’ asserted misconduct, according to the 

plaintiffs, was simply that they failed to warn about the potential dangers in 

replacement parts sold by other manufacturers — and there was “no reason to 

think a product manufacturer [would] be able to exert any control over the safety 

of replacement parts or companion products made by other companies” — we 

found that the connection between the alleged misconduct and the injury was too 

“attenuate[d]” to warrant imposition of a duty of care. (Id. at p. 365.) 

Here, by contrast, federal regulations granted the brand-name drug 

manufacturer — and no other manufacturer — control over the active ingredients 

in the generic drug and the content of the warnings included in the generic’s 

label.2 In addition, the temporal connection between Novartis’s allegedly 

 

2 The FDA has been considering for some time a rule that would effectively 

abrogate PLIVA and enable generic drug manufacturers to update a drug’s warning

label unilaterally, even if the brand-name manufacturer had not yet done so. (See 

FDA, Supplemental Applications Proposing Labeling Changes for Approved 

Drugs and Biological Products, 78 Fed.Reg. 67985 (Nov. 13, 2013); see Dept. of 

Health and Human Services, Regulatory Agenda, 82 Fed.Reg. 40277, 40279 (Aug. 

24, 2017).) If adopted, the new rule “would create parity between NDA holders 
21

negligent conduct, on the one hand, and plaintiffs’ exposure to harm and 

subsequent injury, on the other, is much closer than was the case in O’Neil. 

2. Considerations of public policy

Foreseeability alone, however, is not sufficient to justify a duty of care in 

every instance. (Erlich v. Menezes (1999) 21 Cal.4th 543, 552.) We will not 

recognize a duty of care even as to foreseeable injuries “where the social utility of 

the activity concerned is so great, and avoidance of the injuries so burdensome to 

society, as to outweigh the compensatory and cost-internalization values of 

negligence liability.” (Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 502.) 

Novartis contends that the circumstances here present such an exceptional case. 

We disagree. 

Time and again we have recognized how “ ‘[t]he overall policy of 

preventing future harm is ordinarily served, in tort law, by imposing the costs of 

negligent conduct upon those responsible.’ ” (Kesner, supra, 1 Cal.5th at p. 1150, 

quoting Cabral, supra, 51 Cal.4th at p. 781.) A brand-name drug manufacturer is 

not only in the best position to warn of a drug’s harmful effects (Sindell v. Abbott 

Laboratories (1980) 26 Cal.3d 588, 611): It is also the only manufacturer with the 

unilateral authority under federal law to issue such a warning for the brand-name 

drug or its generic bioequivalent. Although federal regulations impose a 

continuing duty on the brand-name manufacturer to update and maintain an 

 

and ANDA holders with respect to submission of CBE-0 supplements for safetyrelated labeling changes based on newly acquired information” (78 Fed.Reg., 

supra, at p. 67989) and may conceivably justify reweighing of the Rowland factors 

and some reconsideration of the brand-name manufacturer’s duty in this category 

of cases. 
22

adequate warning label (see 21 C.F.R. § 201.80(e)), a brand-name manufacturer’s 

incentive to comply with that duty declines once the patent expires and generic 

manufacturers enter the market, since the market share for the brand-name drug at 

that point “may drop substantially.” (78 Fed.Reg., supra, at p. 67988 [“Among 

drugs for which a generic version is available, approximately 94 percent are 

dispensed as a generic”].) The possibility that any consumer injured by a deficient 

drug label, including those who were dispensed the generic bioequivalent drug, 

could assert a claim of warning label liability restores the brand-name 

manufacturer’s incentive to update the warning label with the latest safety 

information, even as the brand-name drug’s market share declines. 

If the policy of preventing harm has special relevance to any particular 

endeavor, surely prescription drug labeling is one. (Sindell v. Abbott 

Laboratories, supra, 26 Cal.3d at p. 611.) A substantial body of state law serves 

to protect California consumers from the dangers posed by false, misleading, and 

inadequate labeling of prescription medications. (See, e.g., Bus. & Prof. Code, 

§§ 4070-4078.) The United States Supreme Court, too, has recognized the pivotal 

role of state tort actions “as a complementary form of drug regulation” with 

respect to drug labeling. (Wyeth, supra, 555 U.S. at p. 578; see id. at p. 579 

[“State tort suits uncover unknown drug hazards and provide incentives for drug 

manufacturers to disclose safety risks promptly. They also serve a distinct 

compensatory function that may motivate injured persons to come forward with 

information. Failure-to-warn actions, in particular, lend force to the FDCA’s 

premise that manufacturers, not the FDA, bear primary responsibility for their 

drug labeling at all times”]; accord, Stevens v. Parke, Davis & Co., supra, 9 Cal.3d 

at p. 65 [recognizing that federal warning-label regulations alone may be 

insufficient to protect patient safety].)
23

The brand-name drug manufacturer is the only entity with the unilateral 

ability to strengthen the warning label. So a duty of care on behalf of all those 

who consume the brand-name drug or its bioequivalent ensures that the brandname manufacturer has sufficient incentive to prevent a known or reasonably 

knowable harm. In O’Neil, by contrast, we found “no reason” to believe that the 

defendant valve and pump manufacturers would have any control over the safety 

of other companies’ replacement parts or companion products (or even the Navy’s 

purchasing choices or specifications). (O’Neil, supra, 53 Cal.4th at p. 365.) Our 

no-duty conclusion also rested explicitly on the fact that the replacement parts’ 

“dangerous feature” — i.e., the asbestos — “was not integral to the product’s 

design.” (Id. at p. 343.) Here, on the other hand, the brand-name drug 

manufacturer exercised complete control over the contents of the generic drug 

label at the time of its alleged negligence, and the generic drug was legally 

required to be the brand-name drug’s bioequivalent. We therefore conclude that 

warning label liability is likely to be effective in reducing the risk of harm to those 

who are prescribed (or are exposed to) the brand-name drug or its generic 

bioequivalent. 

Against the public interest in preventing harm, we must balance the 

defendant’s burden and the consequences to the community of imposing a duty of 

care. The burden that matters, though, is not the cost of compensating individuals 

for injuries that the defendant has actually and foreseeably caused. As we recently 

explained in Kesner, “shielding tortfeasors from the full magnitude of their 

liability for past wrongs is not a proper consideration in determining the existence 

of a duty. Rather, our duty analysis is forward-looking, and the most relevant 

burden is the cost to the defendants of upholding, not violating, the duty of 

ordinary care.” (Kesner, supra, 1 Cal.5th at p. 1152.) 
24

Strictly speaking, then, the burden on brand-name drug manufacturers of 

satisfying a common law duty of care to those who are prescribed the generic 

version of the drug is zero. Brand-name manufacturers already have a continuing 

duty to warn of potential risks “as soon as there is reasonable evidence of an 

association of a serious hazard with a drug; a causal relationship need not have 

been proved.” (21 C.F.R. § 201.80(e).) A brand-name manufacturer’s burden to 

maintain an adequate warning label persists without regard to the happenstance 

that a given prescription for a brand-name drug may — because of insurance 

company cost-savings rules (Meijer, Inc. v. Warner Chilcott Holdings Co. III Ltd. 

(D.D.C. 2007) 246 F.R.D. 293, 297), or a pharmacist’s discretion (Bus. & Prof. 

Code, § 4073, subd. (c)) — be filled with a generic bioequivalent. And where the 

brand-name manufacturer provides an adequate label, then it necessarily has also 

fulfilled its duty with respect to the generic bioequivalent. 

Novartis complains that unless the ordinary duty of care is narrowed, the 

brand-name drug manufacturer would end up an insurer for the entire market. 

This would occur, Novartis contends, even though the brand-name manufacturer 

may hold only a small fraction of the combined sales of the brand-name drug and 

its generic bioequivalent. We disagree. A brand-name drug manufacturer would 

not be liable where, for example, the injury arose from a defect in the 

manufacturing process of the generic drug (see, e.g., Fisher v. Pelstring (D.S.C. 

2012) 817 F.Supp.2d 791, 818), the generic manufacturer failed to conform its 

label to the brand-name drug’s label (Fulgenzi v. PLIVA, Inc. (6th Cir. 2013) 711 

F.3d 578, 582, 584; Huck v. Wyeth, Inc. (Iowa 2014) 850 N.W.2d 353, 356 (plur. 

opn. of Waterman, J.)), or the generic manufacturer was promoting a use that was 

inconsistent with the FDA-approved label (Arters v. Sandoz, Inc. (S.D. Ohio 2013) 

921 F.Supp.2d 813, 819-820). Under warning label liability, the brand-name drug 

manufacturer is liable only in a narrow circumstance — when deficiencies in its 
25

own label foreseeably and proximately caused injury. If instead tort law simply 

carved out those who were given the generic bioequivalent from obtaining 

otherwise available compensation for injuries attributable to the brand-name drug 

manufacturer’s defective warning label, then consumers would insist on the brandname drug over the cheaper bioequivalent, inflating health costs with no 

corresponding increase in safety and in contradiction to the stated federal policy of 

making low-cost generic drugs more available. (See H.R.Rep. No. 98-857, 2d 

Sess., p. 14 (1984), reprinted in 1984 U.S. Code Cong. & Admin. News, p. 2647.) 

Novartis nonetheless predicts that unless we carve out an exception for 

those taking generic drugs, warning label liability will lead to overwarning — i.e., 

inclusion of a slew of speculative risks in the warning label — which would dilute 

the effectiveness of any individual warning. But why this would occur is far from 

clear. To recognize that the duty of care includes all those who would foreseeably 

be affected by a deficient brand-name drug label merely preserves the brand-name 

manufacturer’s duty as it existed when its patent excluded all competitors from the 

market. Nor has Novartis identified any surge in overwarning since 2008, when 

Conte recognized warning label liability. (Cf. Carlin, supra, 13 Cal.4th at p. 1116, 

fn. 6 [“[T]here is no evidence that any such [overwarning] problem has emerged 

or that patients have suffered any detriment, despite the fact that strict liability has 

long been the rule in California”].) Plaintiffs further suggest that the 

consequences of overwarning on physicians’ prescription decisions is uncertain 

(Steven Garber, RAND Institute for Civil Justice, Economic Effects of Product 

Liability and Other Litigation Involving the Safety and Effectiveness of 

Pharmaceuticals (2013) p. xiv [“That claim is controversial within the medical 

community, and there is no direct empirical evidence about it”]) and, in any event, 

can be solved through the FDA’s power to reject a labeling change it deems 

unnecessary or counterproductive. (See Wyeth, supra, 555 U.S. at p. 571.) 
26

Novartis cautions that warning label liability could perversely incentivize a 

brand-name manufacturer to withdraw its drug from the market, rather than expose 

itself to the risk of suit by those who — in reliance on the brand-name 

manufacturer’s label — were prescribed the generic bioequivalent and suffered 

injury. Yet Novartis fails to explain why brand-name manufacturers would find it 

economically advantageous to withdraw drugs from the market rather than simply 

modify the warning labels to include the newly discovered risks. Nor does it offer 

any evidence that brand-name manufacturers have accelerated their withdrawal 

from the market in the nine years since Conte was decided. Moreover, a brandname drug manufacturer cannot avoid its duty to update and maintain its warning 

label simply by unilaterally exiting the market. Under FDA regulations, a brandname drug manufacturer’s duty to update and maintain the warning label 

continues, even if the brand-name drug has been withdrawn from the market, until 

the FDA (having assured itself that the drug is safe, effective, and correctly 

labeled) withdraws approval of the NDA. (21 C.F.R. § 314.150(a)(2), (b)(3) & 

(c); FDA, supra, 78 Fed.Reg. at p. 67993.) A brand-name manufacturer that 

sought to exit the market but was unsure whether the FDA would determine that 

the drug was withdrawn “for reasons other than effectiveness or safety” thus 

would presumably go ahead and update the label. (Lasker et al., Taking the 

“Product” Out of Product Liability: Litigation Risks and Business Implications 

of Innovator and Co-promoter Liability (July 2015) 82 Def. Counsel J. 295, 306.) 

Novartis complains next that it is unfair to subject a brand-name drug 

manufacturer to liability for harm caused by a competitor’s product — a product 

from which the brand-name manufacturer derives no revenues or profit. But the 

plaintiffs’ claim here is not that terbutaline is defectively designed or inherently 

dangerous. It is that terbutaline’s warning label failed to mention the risk to fetal 

brain development, and that Novartis was responsible for the deficient label. So 
27

the alleged fault here lies with Novartis, not with its generic competitors. The 

brand-name drug manufacturer’s burden to adequately label its drug as a means of 

ensuring adequate warnings for the generic bioequivalent is more than offset by 

the substantial benefits federal law confers on the brand-name manufacturer: a 

monopoly over the market for the life of the patent, which can be extended for the 

time consumed by FDA review of the NDA (see 35 U.S.C. §§ 154, 156(a), (c)); an 

additional five-year exclusivity period if the brand-name drug contains a new 

chemical entity or an additional three years for a new use of a previously approved 

drug (see 21 U.S.C. § 355(c)(3)(E); 21 C.F.R. § 314.108(b)(2), (4), (5)); and the 

higher prices the brand-name drug can continue to command even after the 

exclusivity period expires. (See Conte, supra, 168 Cal.App.4th at p. 110.) 

Because federal law bundles –– and indeed, only makes available –– those 

benefits along with the responsibility to maintain an adequate warning label, it is 

as logical as it is reasonable for state common law to ensure the brand-name 

manufacturer holds up its end of the deal. (See Wyeth, supra, 555 U.S. at pp. 578-

579; see generally Struve, The FDA and the Tort System: Postmarketing 

Surveillance, Compensation, and the Role of Litigation (2005) 5 Yale J. Health 

Pol’y L. & Ethics 587, 605-606 [“The problem of insufficient resources persists, 

as does the [structural] concern that the FDA may be loath to move swiftly to 

address emerging safety issues”].) The public interest in adequate drug warnings, 

in short, is just as acute when the brand-name drug manufacturer has an effective 

monopoly over the warning label as it was when the brand-name manufacturer 

had a monopoly over the entire market for the drug. (See Wyeth, supra, 555 U.S. 

at p. 571 [noting that federal regulations “plac[e] responsibility for postmarketing 

surveillance on the manufacturer”].)

We are equally unpersuaded by Novartis’s contention that warning label 

liability would stifle innovation by substantially raising drug costs and chilling the 
28

development and marketing of new drugs. The logic buttressing this argument is 

far from self-evident. Warnings about a product’s efficacy or danger may indeed 

risk diminishing its value to the manufacturer. Less obvious is the manufacturer’s 

response to this predicament. One might just as easily assert that a drug company, 

after adding a new warning, will be incentivized to develop new and safer 

alternatives to the drug so that it can recapture the market for treatment of that 

disease. (See Carlin, supra, 13 Cal.4th at p. 1117.) 

Indeed, the pharmaceutical industry raised a similar objection in Carlin to 

the imposition of strict liability for the failure to warn about the known or 

reasonably scientifically knowable dangers of a drug. We found “no clear or 

sufficient basis for concluding that research and development will inevitably 

decrease” as a consequence of imposing liability for failure to warn of known or 

knowable risks (Carlin, supra, 13 Cal.4th at p. 1117) — nor has Novartis offered 

any evidence that drug innovation has declined in the 21 years since Carlin was 

decided. Carlin therefore saw “no reason to depart from our conclusion . . . that 

the manufacturer should bear the costs, in terms of preventable injury or death, of 

its own failure to provide adequate warnings of known or reasonably scientifically 

knowable risks.” (Ibid.) 

The same is true here. When it comes to choosing whether the cost of an 

injury involving prescription medication should be borne by an innocent plaintiff 

or a negligent defendant, our case law has routinely held that the latter should bear 

the cost. (Sindell v. Abbott Laboratories, supra, 26 Cal.3d at pp. 610-611.) A 

brand-name drug manufacturer is in the best position to discover and cure 

deficiencies in its warning label, to bear the cost of injury resulting from its failure 

to update and maintain the warning label, to insure against the risk of liability, and 

to spread any increased cost widely among the public. (Id. at p. 611.) After all, 

the fault (if any) for a deficient label lies with the brand-name manufacturer alone. 
29

(Cf. Groll v. Shell Oil Co. (1983) 148 Cal.App.3d 444, 449 [manufacturer of bulk 

fuel owed no duty to the ultimate consumer where the manufacturer provided 

adequate warnings to the distributor, “who subsequently packages, labels and 

markets the product,” and the manufacturer thus “did not have the ability to 

prepare the warning”].) The balance of preventing harm and avoiding an undue 

burden on drug manufacturers and the public generally thus tips in favor of 

warning label liability. 

Neither of the two remaining Rowland factors weighs in favor of an 

exception to the general duty of care. To wit: Significant moral blame attaches 

where a brand-name drug manufacturer fails to warn about the unsafe effects of its 

drug, when those effects are known or reasonably should have been known to the 

manufacturer. (See Peterson v. San Francisco Community College Dist. (1984) 36 

Cal.3d 799, 814.) Blameworthiness would not depend on whether the pregnant 

woman, in reliance on the brand-name drug manufacturer’s label, was dispensed 

the brand-name drug or its generic bioequivalent. Even those women who were 

prescribed the brand-name drug may nonetheless have received the generic 

version, either because the insurance company required it or because the 

pharmacist chose it. Moreover, both the pregnant woman and her physician would 

have relied on the brand-name drug manufacturer to warn of any serious hazards 

that were “associated” with the drug. (21 C.F.R. § 201.80(e).) Indeed, under 

federal law, no other manufacturer could have advised them of the drug’s risks. In 

these circumstances, potential plaintiffs — the unborn — would be “particularly 

powerless,” while the defendant brand-name drug manufacturer would have the 

best information about the drug’s risks. (Kesner, supra, 1 Cal.5th at p. 1151.) 

Although we declared in O’Neil that “little moral blame can attach to a 

failure to warn about dangerous aspects of other manufacturers’ products and 

replacement parts” (O’Neil, supra, 53 Cal.4th at p. 365), the context of that 
30

statement was a situation in which the valve and pump manufacturers had no 

control or influence over the design, manufacturing, or safety of those parts; the 

warning attached to them; or the consumer’s decision whether to purchase such 

products. (Ibid.) Here, by contrast, the brand-name manufacturer legally 

controlled the label on the generic bioequivalent drug, and thus had significant 

influence on the decision whether to prescribe it.

Finally, Novartis offers no reason why a brand-name drug manufacturer 

would be unable to insure against the risk of warning label liability. Presumably, a 

brand-name manufacturer already insures against the risk of liability arising from 

a deficient warning label when a drug is introduced and the manufacturer has a 

monopoly over that market. It is far from clear why the brand-name drug 

manufacturer’s exposure would become fatally uncertain merely because the 

brand-name manufacturer is sharing the market with generic manufacturers. (Cf. 

O’Neil, supra, 53 Cal.4th at p. 365 [“it is doubtful that manufacturers could insure 

against the ‘unknowable risks and hazards’ lurking in every product that could 

possibly be used with or in the manufacturer’s product”].) 

3. Out-of-state authorities 

Novartis (and its amici curiae) rely in substantial part on what they call the 

“overwhelming” majority of courts that have declined to recognize warning label 

liability owed to those who were prescribed a generic version of the drug in 

reliance on the brand-name drug label. Although the decisions of our sister states 

and the lower federal courts may be instructive to the extent we find their analysis 

persuasive, they are neither binding nor controlling on matters of state law. 

(People v. Gonzales and Soliz (2011) 52 Cal.4th 254, 296.) We have respectfully 

considered the authorities cited by Novartis. We do not find them persuasive in 

analyzing California law. 
31

The “ ‘leading case’ ” (Strayhorn v. Wyeth Pharms., Inc. (6th Cir. 2013) 

737 F.3d 378, 401) for the proposition that a brand-name drug manufacturer owes 

no duty to warn patients who were dispensed the generic bioequivalent is Foster v. 

American Home Products Corp. (4th Cir. 1994) 29 F.3d 165 (Foster) — so we 

examine that case in some detail. In Foster, the decedent’s pediatrician prescribed 

Phenergan, a brand-name antihistamine manufactured by the defendant which was 

sometimes used to treat colic. The pharmacist substituted promethazine, a generic 

bioequivalent. After being given promethazine several times over the next few 

days, six-week-old Brandy was found dead in her crib. A pediatrician specializing 

in sudden infant death syndrome at the University of Maryland opined that 

Brandy’s death was caused by promethazine. (Id. at pp. 167-168.) The district 

court found the plaintiffs (Brandy’s parents) had stated a claim for negligent 

misrepresentation, despite the fact that the defendant had not manufactured the 

drug ingested by Brandy, but subsequently granted summary judgment because of 

the plaintiffs’ failure to demonstrate that their pediatrician had relied on the 

defendant’s representations. When the plaintiffs appealed the grant of summary 

judgment and the defendant cross-appealed the district court’s initial 

determination that a negligent misrepresentation claim could lie against the brandname manufacturer for harm arising from the generic drug, the Fourth Circuit 

sustained the cross-appeal. (Ibid.) 

Foster reasoned first that the negligent misrepresentation cause of action 

was in essence a claim of product liability, but “without meeting the requirements 

[Maryland] law imposes in products liability actions” — i.e., “that the defendant 

manufactured the product at issue.” (Foster, supra, 29 F.3d at p. 168.) The court 

next addressed the peculiarities of the regulated pharmaceutical market, under 

which “any representations [the defendant] makes when advertising Phenergan 

also apply to generic promethazine”; a warning “will simply not be made” if the 
32

brand-name manufacturer does not issue one; and a patient who is prescribed 

Phenergan “may actually receive generic promethazine.” (Id. at p. 169.) In 

rejecting liability nonetheless, the Foster court assumed that although generic 

manufacturers “must include the same labeling information as the equivalent name 

brand drug, they are also permitted to add or strengthen warnings and delete 

misleading statements on labels, even without prior FDA approval. . . . 

Manufacturers of generic drugs, like all other manufacturers, are responsible for 

the representations they make regarding their products.” (Id. at p. 170.) The court 

also concluded that “to impose a duty in the circumstances of this case would be to 

stretch the concept of foreseeability too far” under Maryland law, which had 

recognized the tort of negligent misrepresentation only where “ ‘one party has the 

right to rely for information upon the other, and the other giving the information 

owes a duty to give it with care.’ ” (Id. at p. 171.) In the court’s view, no such 

relationship could ever exist because Brandy “was injured by a product that [the 

defendant] did not manufacture.” (Ibid.)

At the core of the Foster court’s analysis is an erroneous assumption: that 

generic drug manufacturers may “add or strengthen warnings and delete 

misleading statements on labels, even without prior FDA approval,” and that they 

can be sued for their failure to do so. (Foster, supra, 29 F.3d at p. 170.) In reality, 

generic drug manufacturers are legally obligated to conform their drug label to the 

brand-name manufacturer’s label (PLIVA, supra, 564 U.S. at p. 613) and, so long 

as they fulfill their “duty of ‘sameness’ ” (ibid.), cannot be sued in tort for 

deficiencies in the label. (See id. at p. 624.) Fortunately, the Fourth Circuit has 

since recognized its error. Despite its categorical rejection of any duty in Foster,

the court recently certified to the Supreme Court of Appeals of West Virginia the 

question “Whether West Virginia law permits a claim of failure to warn and 

negligent misrepresentation against a branded drug manufacturer when the drug 
33

ingested was produced by a generic manufacturer.” (McNair v. Johnson & 

Johnson Corp. (4th Cir. May 30, 2017, No. 15-1806) 2017 WL 2333843, *1.)3 

Even on its own terms, though, Foster’s reasoning proves unhelpful in 

construing California law, and finds no support in it. First, California law does not 

conflate negligent misrepresentation and strict liability in the manner Foster

believed was true of Maryland law. (Conte, supra, 168 Cal.App.4th at p. 108.) 

Under our state’s law, there is no per se requirement in negligent 

misrepresentation actions that the misrepresentation be made by the product 

manufacturer. Consider Hanberry v. Hearst Corp. (1969) 276 Cal.App.2d 680, 

where the plaintiff alleged that defective shoes caused her injuries. (Id. at p. 682.) 

The Court of Appeal allowed the negligent misrepresentation claims to go forward 

against a nonmanufacturer — the publisher of Good Housekeeping magazine, 

 

3 There is a sad coda to Foster. The Fourth Circuit’s ruling relieved the 

brand-name manufacturer of any duty to warn of known or knowable risks of the 

drug when a plaintiff had been given the generic equivalent — and (contrary to 

Foster’s key assumption) the generic manufacturer had no ability to deviate from 

the brand-name manufacturer’s label. As a result, it took until 2000 –– six years 

after Foster was decided –– for the FDA to modify the warning to recommend that 

promethazine not be given to children younger than two years old. (Starke et al., 

Boxed Warning Added to Promethazine Labeling for Pediatric Use (2005) 352 

New Eng. J. Med. 2653, 2653.) Four years thereafter, following further review of 

all adverse events that had been reported, the FDA added a boxed warning — the 

strongest type of warning (21 C.F.R. § 201.57(c)(1)) — stating that the drug 

should not be given to children younger than two years old because of the 

potential for fatal respiratory depression. (Starke et al., supra, at p. 2653; Rostron, 

Prescription for Fairness: A New Approach to Tort Liability of Brand-name and 

Generic Drug Manufacturers (2011) 60 Duke L.J. 1123, 1146-1147.) This 

example underscores the reality that the FDA depends heavily on the brand-name 

drug manufacturer exercising its own unilateral ability to strengthen its warning 

label. (Wyeth, supra, 555 U.S. at p. 579; see generally Weeks, supra, 159 So.3d at 

p. 676 [“The FDA has limited resources to monitor the approximately 11,000 

drugs on the market”].) Yet Foster’s rule seriously undermines the brand-name 

manufacturer’s incentive to do so. 
34

which had given the shoes its renowned seal of approval. (Id. at p. 683.) This seal 

appeared not only in the pages of its own magazine, but was used by the shoe 

manufacturer in its advertising as well as on the product and its packaging. (Ibid.) 

The court acknowledged that the defendant publisher was neither the seller nor the 

manufacturer of the shoes, but nonetheless recognized a duty of care because of 

the allegations that the publisher “held itself out as a disinterested third party 

which had examined the shoes, found them satisfactory, and gave its 

endorsement”; and the plaintiff reasonably relied on the endorsement and 

“purchased the shoes because of [it].” (Id. at pp. 686, 683.) As to the plaintiff’s 

claim under strict liability, however, the court affirmed the trial court’s dismissal 

— declining to extend strict liability “to a general endorser who makes no 

representation it has examined or tested each item marketed.” (Id. at p. 688; see 

also Conte, supra, 168 Cal.App.4th at pp. 101-102 [similarly distinguishing 

between strict liability and negligent misrepresentation theories].)4 

 

4 Novartis suggests that we recently conflated strict liability and negligence 

in Webb v. Special Electric Co., Inc. (2016) 63 Cal.4th 167 when we observed that 

“ ‘there is little functional difference between the two theories in the failure to 

warn context.’ ” (Id. at p. 187.) Not so. Webb’s observation was merely that the 

sophisticated user and sophisticated intermediary defenses applied to both theories 

of liability. (Ibid.) We did not categorically alter our longstanding recognition 

that “California law recognizes the differences between negligence and strict 

liability causes of action.” (Johnson v. American Standard , Inc. (2008) 43 Cal.4th 

56, 71; see Saller v. Crown Cork & Seal Co., Inc. (2010) 187 Cal.App.4th 1220, 

1239 [“ ‘Negligence and strict products liability are separate and distinct bases for 

liability that do not automatically collapse into each other because the plaintiff 

might allege both when a product warning contributes to her injury’ ”].) 

O’Neil did not erase the distinction between strict liability and negligence, 

either. Far from conflating the two theories, we said simply that “[t]he same 

policy considerations that militate against imposing strict liability in this situation

apply with equal force in the context of negligence.” (O’Neil, supra, 53 Cal.4th at 

p. 366, italics added.) As we have demonstrated above, O’Neil is soundly 

distinguishable from the situation here. 
35

Second, California law places greater weight on the element of 

foreseeability in the duty analysis than does Maryland law. Indeed, this state 

treats foreseeability as “[t]he most important factor” (Kesner, supra, 1 Cal.5th at 

p. 1145), and we do not narrowly circumscribe the kinds of relationships that must 

exist between the plaintiff and the defendant as a predicate to imposing a duty on 

the defendant to prevent injuries arising from its own conduct. (Id. at p. 1163; see 

Randi W., supra, 14 Cal.4th at p. 1077 [one who negligently provides false 

information to another can owe a duty of care to a third person “who did not 

receive the information and who has no special relationship with the provider”].)5 

By contrast, Foster found that a “duty . . . arises” under Maryland law only “when 

there is ‘such a relation that one party has the right to rely for information upon the 

other, and the other giving the information owes a duty to give it with care.’ ” 

(Foster, supra, 29 F.3d at p. 171, quoting Weisman v. Connors (Md. 1988) 540

A.2d 783, 790.) Foster then summarily concluded that “[t]here is no such 

relationship between the parties to this case, as Brandy Foster was injured by a 

product that [defendant] did not manufacture.” (Foster, at p. 171.) Even this 

explanation, though, seems to overlook the fact that there is never a direct 

relationship between a prescription drug manufacturer and the ultimate consumer. 

A consumer may obtain a prescription medication only through the physician as a 

 

5 We therefore do not find persuasive those out-of-state cases discounting the 

role of foreseeability (see, e.g., Huck v. Wyeth, Inc., supra, 850 N.W.2d at p. 376 

(plur. opn. of Waterman, J.) [“ ‘foreseeability should not enter into the duty 

calculus’ ”]) or requiring the existence of a specific type of relationship between 

the plaintiff and the defendant (see, e.g., Moretti v. Wyeth, Inc. (9th Cir. 2014) 579 

Fed. Appx. 563, 564 [construing negligent misrepresentation, under Nevada law, 

to “ ‘require[], at a minimum, some form of relationship between the parties’ ”]; 

Schrock v. Wyeth, Inc. (10th Cir. 2013) 727 F.3d 1273, 1282 [“Oklahoma courts 

have also required a relationship between the defendant company and the product 

at issue for other theories of liability, including negligence”]). 
36

learned intermediary. (See Carlin, supra, 13 Cal.4th at pp. 1116, 1126.) A 

physician, in turn, typically relies on the drug’s warning label, the contents of 

which (regardless of whether the medication ultimately dispensed is the brandname or generic bioequivalent) are controlled by the brand-name manufacturer. It 

is difficult to understand why the relationship between the brand-name 

manufacturer and the physician must be deemed to evaporate simply because an 

insurance company or pharmacist subsequently decides to dispense a generic 

version of the drug that bears the warning label crafted by the brand-name 

manufacturer. 

Third, in one crucial respect, Foster is like the vast majority of the out-ofstate cases on which Novartis relies: it arose in federal court under diversity 

jurisdiction. Federal courts sitting in diversity are “extremely cautious” about 

recognizing innovative theories under state law (Combs v. Int’l Ins. Co. (6th Cir. 

2004) 354 F.3d 568, 578) and are bound to “apply the applicable state law as it 

now exists.” (Foster, supra, 29 F.3d at p. 171; see generally Gluck, Intersystemic 

Statutory Interpretation: Methodology as “Law” and the Erie Doctrine (2011) 

120 Yale L.J. 1898, 1939 [federal courts “pick the narrowest possible answer, 

usually the one that does the least to change the status quo, regardless of its 

predictions of what the state court would do”].) Because only a handful of 

jurisdictions have adopted the duty recognized in Conte, supra, and followed by 

the Court of Appeal here, it is not surprising that federal courts have been reluctant 

to interpret the law of various states to embrace it. But the task of this court is not 

to “ ‘opt for the interpretation that restricts liability, rather than expands it’ ” until 

someone else tells us otherwise. (Travelers Indem. Co. v. Dammann & Co., Inc.

(3d Cir. 2010) 594 F.3d 238, 253; see also Germain v. Teva Pharmaceuticals, 

USA, Inc. (In re Darvocet, Darvon, & Propoxyphene Products Litigation) (6th Cir. 

2014) 756 F.3d 917, 937 [“federal courts must be cautious”].) It is instead 
37

emphatically the province of this court to declare what the law is. By contrast, 

Novartis’s collection of federal decisions merely attempt to predict the law of 

other states, while operating under a presumption against expanding liability. (See 

Schrock v. Wyeth, Inc., supra, 727 F.3d at p. 1290 [“As a federal court . . . we have 

limited authority to correct this potential injustice. It is for the state courts, rather 

than this panel, to engage in the delicate policy considerations predicate to the 

expansion of the scope of state tort law”].) They are of little use in discharging 

our task.

We likewise discount decisions from those jurisdictions that differ from 

California by categorically excluding from liability certain defendants (see, e.g., 

Huck v. Wyeth, Inc., supra, 850 N.W.2d at p. 371 (plur. opn. of Waterman, J.) 

[“the tort of negligent misrepresentation does not apply to sellers of products but 

rather is limited to those in the business or profession of supplying information for 

the guidance of others”]) or certain injuries (see, e.g., Flynn v. American Home 

Products Corp. (Minn.Ct.App. 2001) 627 N.W.2d 342, 351 [“the Minnesota 

Supreme Court has recognized negligent misrepresentation involving damages 

only for pecuniary loss, and has expressly declined to recognize the tort of 

negligent misrepresentation involving the risk of physical harm”]) from the tort of 

negligent misrepresentation. And we find unhelpful the views of those 

jurisdictions that (federal courts predict) will recharacterize under their product 

liability act or similar rule all claims against a product manufacturer, no matter the 

theory, as product liability actions, which can be asserted only against the 

manufacturer of the product. (See, e.g., Germain, supra, 756 F.3d at pp. 941-954 

[construing the laws of Arkansas, Connecticut, Florida, Georgia, Illinois, 

Kentucky, Louisiana, Maryland, Mississippi, Nebraska, New York, North 

Carolina, Ohio, Texas, Washington, and West Virginia]; Phelps v. Wyeth, Inc.

(D.Or. 2012) 857 F.Supp.2d 1114, 1121 [Oregon law]; Stanley v. Wyeth, Inc.
38

(La.Ct.App. 2008) 991 So.2d 31, 33-34 [noting the “numerous cases where the 

negligent misrepresentation claims were . . . preempted by . . . a state’s enactment 

of products liability law”].) 

At core, what Novartis seems to want is more than just an exception to the 

general duty of care applicable in California — an exception constructed to avoid 

liability where a biologically equivalent product is sold and the warning label used 

is required by federal law to be the label that the brand-name manufacturer 

controls. Perhaps because there is no logical basis to justify such an exception, 

Novartis instead seeks a more categorical result, though one no easier to justify —

i.e., an unequivocal declaration that California law relieves a manufacturer of any 

failure-to-warn liability relating to another manufacturer’s products. True: An 

exception to California’s general duty of care is ordinarily applicable to relieve a 

manufacturer of the duty to warn consumers about a product’s risks where the 

product is that of another manufacturer. (O’Neil, supra, 53 Cal.4th at pp. 364-

366.) For good reason: A product manufacturer ordinarily will have no control 

over the design or safety of another manufacturer’s product, the other 

manufacturer’s use of dangerous materials, or any warnings the other 

manufacturer might place on the product. (Id. at pp. 350, 365.) Nor would there 

be any reason to think that a manufacturer has the ability to influence a customer’s 

decision to buy another manufacturer’s product. (Id. at p. 365.) Without such 

predicate connections between one manufacturer and another, it would be difficult, 

if not impossible, for a manufacturer to foresee the dangers lurking in the 

seemingly limitless number of other products that might be used with or in its 

product. (Ibid.) But prescription drug markets are different. They present the 

unusual situation where one entity’s misrepresentations about its own product 

foreseeably and legally “contributed substantially to the harm” caused by another 

entity’s product (i.e., the generic drug bearing the warning label drafted by the 
39

brand-name manufacturer). (O’Neil, at p. 362.) That key circumstance 

distinguishes the situation here from those involving the general run of products. 

The negligence causes of action are potentially viable because of the 

allegedly deficient representations in Novartis’s warning label. Novartis is not 

being sued for dangers inherent in the generic terbutaline manufactured by some 

other entity. Nor do plaintiffs claim that any product manufactured by Novartis 

caused them harm. They claim instead that allegedly deficient representations and 

omissions in Novartis’s warning label caused them harm. The fact that Novartis 

also manufactured a product is extrinsic to the analysis and does not insulate it 

from liability for its alleged misrepresentations. (See Conte, supra, 168 

Cal.App.4th at pp. 109-110; accord, Weeks, supra, 159 So.3d at p. 672 [“the [tort] 

claims are not based on the manufacturing of the product but instead allege that 

the label — drafted by the brand-name manufacturer and required by federal law 

to be replicated verbatim on the generic version of the medication — failed to 

warn”].) 

B. Whether Warning Label Liability Was Extinguished as a Matter of Law 

When Novartis Divested Ownership of Brethine

We have determined that Novartis owed a duty of care to those who were 

prescribed Brethine or its generic bioequivalent in reliance on Novartis’s warning 

label. Novartis claims that the demurrer should nonetheless be sustained without 

leave to amend on the ground that it sold the Brethine NDA to aaiPharma in 2001 

and no longer had control over its warning label in 2007, when plaintiffs’ mother 

was prescribed terbutaline. So we now consider whether Novartis should be 

relieved of all liability for its allegedly negligent failure to update the label as a 

matter of law, despite the fact that aaiPharma continued using the label Novartis 

had crafted. 
40

Plaintiffs fault Novartis. But they do not claim the company was 

responsible for any negligent acts or omissions after the transfer of ownership. 

After all, under FDA regulations, only the current NDA holder has the authority to 

unilaterally modify the drug’s warning label. Plaintiffs claim instead that they 

were harmed by Novartis’s failure to update the label prior to transferring the 

NDA to aaiPharma, in that aaiPharma continued to use the same warning label 

until at least 2007, when their mother was prescribed terbutaline. In effect, 

plaintiffs claim that the Brethine warning label was deficient at the time Novartis 

transferred the NDA –– and it was reasonably foreseeable that it would remain 

deficient, given the incentives facing any successor manufacturer. 

To address this aspect of plaintiffs’ claim, we must determine whether to 

recognize an exception to a brand-name manufacturer’s duty to warn. Is a brandname drug manufacturer’s duty to warn extinguished simply because the 

deficiency in the label caused the injured plaintiff to be exposed to the drug after

the manufacturer had transferred the NDA to a successor? Foreseeablity of harm 

is the touchstone of our duty analysis. (Kesner, supra, 1 Cal.5th at p. 1148.) 

Plaintiffs allege (or claim they can allege) that Novartis negligently provided 

inaccurate and incomplete warnings about the safety of its drug, that it was 

foreseeable the new NDA holder (aaiPharma) would continue to use Novartis’s 

warning label without modification, that their mother’s physician relied on the 

deficient warning label drafted by Novartis and reiterated by aaiPharma in 

prescribing terbutaline, and that they were harmed in utero by the terbutaline 

ingested by their pregnant mother. Whether aaiPharma would also be liable for 

any deficiencies in its warning label should not, in plaintiffs’ view, automatically 

negate Novartis’s culpability. 
41

1. Foreseeability and related factors

We explained above why it was foreseeable that Novartis’s failure to 

update the Brethine warning label could affect fetuses exposed to the generic 

version of the drug in utero. And there is no dispute that plaintiffs have alleged 

injury. Although Novartis was no longer responsible for updating the warning 

label at the time plaintiffs’ mother was prescribed the drug, aaiPharma was using 

the same label it had inherited from Novartis. According to plaintiffs, neither 

NDA holder had sufficient financial incentive to update the label: Nearly half of 

all prescriptions for Brethine or its generic equivalent were to slow preterm labor. 

Under the circumstances, it was certainly foreseeable that aaiPharma would be no 

more conscientious about updating the warning label than Novartis allegedly had 

been.

Novartis contends the connection between its alleged negligence and 

plaintiffs’ injury was extremely remote, as it had ceased producing the drug six 

years before the injury. But it is not clear why liability should turn on Novartis’s 

role in the manufacturing process. What warning label liability stems from is 

Novartis’s failure to warn about a drug’s risks, not its production of a defective 

drug. The complaint alleges that Novartis and aaiPharma were concurrent 

tortfeasors whose liability stemmed from failure to warn, because each negligently 

failed to update the warning label. 

We agree that Novartis’s failure to update the warning label could 

foreseeably cause harm to plaintiffs. Under the circumstances arising from the 

federal regulatory regime for prescription drugs, a successor manufacturer’s 

negligent failure to update the warning label is foreseeable. According to federal 

regulatory rules, a successor brand-name drug manufacturer has no choice but to 

use the former manufacturer’s warning label — or a warning label at least as 

strong as the one used by the previous brand-name manufacturer — unless 
42

directed otherwise by the FDA. (Wyeth, supra, 555 U.S. at p. 568 [“Generally 

speaking, a manufacturer may only change a drug label after the FDA approves a 

supplemental application”]; see 21 C.F.R. §§ 314.70(b)(2)(v), (c)(6)(iii), 

314.72(b).) Unlike other product manufacturers (cf. conc. & dis. opn., post, at pp. 

2-3), a brand-name drug manufacturer knows that, without FDA action, a 

successor manufacturer will produce a drug identical to the original in ingredients 

and design, and bearing an identical warning label (or a label that is at least as 

strong as the one used by the former manufacturer). (Cf. Cadlo v. Owens-Illinois, 

Inc. (2004) 125 Cal.App.4th 513, 516 [affirming summary judgment in favor of a 

former asbestos insulation manufacturer where there was no evidence the 

manufacturer “had an actual connection with the design, manufacture or 

distribution” of the product causing harm]; id. at p. 520 [distinguishing cases 

where “the maker of the misrepresentation reasonably foresaw that the 

intermediary would repeat the misrepresentation to another person”].)6 Because 

nearly half of all terbutaline prescriptions at the time of sale were written to 

prevent premature labor, it was also reasonably foreseeable that aaiPharma would 

be reluctant to add warnings about the risks to fetal brain development. In sum, a 

successor drug manufacturer’s negligent conduct can be “ ‘derivative of [the 

brand-name drug manufacturer’s] allegedly negligent conduct’ ” and thus 

foreseeable. (Kesner, supra, 1 Cal.5th at p. 1148.) 

 

6 Nor can the concurring and dissenting opinion derive any support from the 

scattering of federal district court cases involving a challenge to the adequacy of a 

medical device label. Federal law preempts state tort actions based on deficient 

warnings for medical devices. (Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 

329; cf. Wyeth, supra, 555 U.S. at p. 574 [“despite its 1976 enactment of an 

express pre-emption provision for medical devices, [citation], Congress has not 

enacted such a provision for prescription drugs”].) 
43

Novartis highlights the six years that elapsed between its surrender of the 

NDA for the drug at issue in this case and the decision to prescribe terbutaline to 

plaintiffs’ mother. Yet the gap between the transfer of this particular NDA and the 

time at which plaintiffs’ mother was prescribed terbutaline does not bear on the 

question of duty, “which must be addressed at a higher level of generality.” 

(Kesner, supra, 1 Cal.5th at p. 1158.) In determining whether to create an 

exception to a brand-name drug manufacturer’s duty of care, we do not evaluate 

“ ‘whether a particular plaintiff’s injury was reasonably foreseeable in light of a 

particular defendant’s conduct,’ ” but “ ‘whether the category of negligent 

conduct at issue is sufficiently likely to result in the kind of harm experienced that 

liability may appropriately be imposed . . . .’ ” (Cabral, supra, 51 Cal.4th at p. 

772.) So the relevant inquiry is whether a successor drug manufacturer is 

sufficiently likely to continue using the warning label it inherited from the prior 

brand-name manufacturer, even when that label was deficient at the time the NDA 

was transferred. 

It is true enough that a successor drug manufacturer has an obligation, 

under state as well as federal law, to ensure adequacy of the warning label. But 

the scenario at issue here implicates whether a successor drug manufacturer is 

sufficiently likely –– as a matter of law –– to modify the warning label when the 

brand-name manufacturer, which labored under an identical obligation, 

negligently failed to do so. In such circumstances, it is at least plausible that a 

successor manufacturer may choose to undertake only a cursory investigation of 

the medical literature, on the assumption that the prior manufacturer must have 

done a more thorough inquiry during the period that it was responsible for 

maintaining the warning label. This option will seem especially attractive when 

the prior manufacturer has greater resources or expertise than its successor. A 

successor manufacturer may also undertake an adequate inquiry but make no 
44

changes to the label in close cases, partially or entirely trusting the judgment of the 

prior manufacturer. Or a successor manufacturer, like the prior manufacturer, may 

fear an adequate warning would damage the market share for the drug and balance 

its lost revenue and potential exposure in the same way as the prior manufacturer. 

Indeed, plaintiffs claim that neither NDA holder wanted to jeopardize Brethine’s 

use as a tocolytic, which accounted for almost half of the drug’s market share. 

Any or all of these factors could explain why a drug’s warning label may prove 

“stickier” than what is optimal to protect public safety at a reasonable cost, and 

why a successor drug manufacturer would not be categorically distinguishable 

from the prior manufacturer in its likelihood of being conscientious about its 

obligations to disclose relevant risks. 

Under the “general” rule, “ ‘ “every person has a right to presume that 

every other person will perform his duty and obey the law.” ’ ” (Webb v. Special 

Electric Co., Inc., supra, 63 Cal.4th at p. 191.) But we have never allowed a 

defendant to excuse its own negligence as a matter of law simply by asserting that 

someone else should have picked up the slack and discharged the duty at issue. 

(See Stewart v. Cox (1961) 55 Cal.2d 857, 864 [“The fact that a third person does 

not perform his duty to protect the plaintiff from harm, either because he makes no 

effort or through his negligence does not succeed, is not a superseding cause”].) 

Nor have we permitted a negligent actor to evade liability simply because another 

party may also be liable for a similar tort. (See, e.g., Beacon Residential 

Community Assn. v. Skidmore, Owings & Merrill LLP (2014) 59 Cal.4th 568, 583 

(Beacon); accord, Humble Oil & Refining Co. v. Martin (Tex. 1949) 222 S.W.2d 

995, 1001 [“there is a distinction between the general axiom that a person is not 

bound to anticipate the negligence of others and the idea that one may always 

discharge a duty of due care to the public by relying on performance by another of 

the same duty owed by the latter”].) So while “ ‘[a] person who, himself, is 
45

exercising ordinary care, has a right to assume that others, too, will perform their 

duty under the law’ ” — and thus may not be negligent in failing to anticipate 

injury that results “ ‘ only from a violation of law or duty by another’ ” — the 

general rule does not apply when “ ‘it is reasonably apparent to one, or in the 

exercise of ordinary care would be apparent to him, that another is not going to 

perform his duty.’ ” (Stickel v. San Diego Elec. Ry. Co. (1948) 32 Cal.2d 157, 

166, first and second italics added; see id. at pp. 166-167 [“It is but a statement as 

to that common type of negligence, the unreasonable failure to observe what is 

going on about one, including the negligence of others. ‘One may not continue to 

assume that the law is being observed after knowing or having an opportunity, by 

the use of reasonable care, to know that it is not being observed’ ”]; Harris v. 

Johnson (1916) 174 Cal. 55, 58 [“ ‘The general rule . . . that every person has a 

right to presume that every person will perform his duty’ ” applies only “ ‘in the 

absence of reasonable ground to think otherwise’ ”].) Few if any entities would be 

in a position to know better that the law “ ‘is not being observed’ ” (Stickel, at p. 

167) than a brand-name drug manufacturer that itself had negligently failed to 

update the label. So the assumption underlying the brand-name drug 

manufacturer’s duty is not at all “that successor corporations will routinely ignore 

th[eir] duty.” (Conc. & dis. opn., post, at p. 5, italics added.) It’s that when a 

brand-name drug manufacturer has ignored its own duty, there is a risk that the 

successor manufacturer will adopt the same strategy. Under these circumstances, 

categorically justifying a manufacturer’s neglect of that risk requires heroic, and 

ultimately unreasonable, assumptions distinguishing an original brand-name 

manufacturer’s behavior from that of its successors. For these reasons, we find it 

reasonably foreseeable that a successor drug manufacturer could continue to use 

the same label it inherited, even when the label was deficient.
46

2. Considerations of public policy 

According to Novartis, the policy of preventing future harm would not be 

advanced by subjecting the brand-name drug manufacturer to liability after it has 

already divested itself of the drug and no longer has control over the warning 

label. But in examining the prevention of future harm, we undertake the duty 

analysis “look[ing] to the time when the duty was assertedly owed.” (Kesner, 

supra, 1 Cal.5th at p. 1150.) It is during the time Novartis owned the drug that 

both its legal duty and its power to discharge that duty converge. At that point, 

Novartis did have control over the warning label and could have modified it, 

without waiting for FDA approval, to warn of the risks to fetal brain development. 

Recognizing a brand-name drug manufacturer’s potential responsibility for 

injuries proximately caused by deficiencies in its warning label –– regardless of 

whether the injury occurred before or after divestment — provides a further 

incentive to the brand-name manufacturer to update the label as soon as it knows 

(or should have known) of the unwarned risks. Consider, on the other hand, the 

implications of allowing the brand-name manufacturer to shield itself from 

liability as soon as it transfers ownership to another manufacturer, as Novartis 

proposes. What such a rule would do is encourage an economically rational 

brand-name manufacturer to transfer the NDA, rather than add a warning to the 

label, since an updated label would diminish the utility (and thus the value) of the 

drug.7 Such a scenario obviously poses greater risks to consumer safety relative to 

the alternative. 

 

7 This case does not present the question, and we do not decide, whether a 

brand-name manufacturer would remain liable for deficiencies in its warning label 

when the FDA has formally withdrawn its approval of the NDA and has 

determined “that the drug was voluntarily withdrawn from sale for reasons other 

than effectiveness or safety.” (Lasker, supra, 82 Def. Counsel J. at p. 306; see 21 

C.F.R. § 314.150; 78 Fed.Reg., supra, at p. 67993.) 
47

Novartis counters with a different scenario. It claims that under plaintiffs’ 

regime, a successor brand-name drug manufacturer would have an incentive to 

maintain the identical label without change so that the former brand-name 

manufacturer would be forced to share in any liability. We are skeptical. When it 

is economically rational for the manufacturer to update the label, it will update the 

label –– regardless of the prospect that a prior manufacturer might share in the 

liability for its own negligent failure to update the label. Even in a marginal case, 

though, it does not seem especially likely that a successor drug manufacturer 

which knows or should know of an unwarned risk would choose to leave a 

warning label unchanged simply to preserve the possibility that –– if the label 

remained the same as under the former manufacturer –– the former manufacturer 

could be a codefendant in a future tort action. It seems implausible that a 

successor manufacturer would take that gamble if its proportional share of fault 

would be ever increasing as medical research became more confident about the 

link between the drug and some adverse effect. After all, the successor 

manufacturer could avoid liability altogether by updating the label to warn about 

the risk. 

The more substantial danger is that neither manufacturer will have 

sufficient incentive to update the label. Unless there is warning label liability, it 

will be economically rational in some circumstances for a brand-name 

manufacturer to offload the drug to a successor rather than update the warning 

label. And if the brand-name manufacturer fails to update the label to disclose a 

known or knowable risk, economic interests and simple inertia may lead the 

successor manufacturer to the same strategy. (See ante, at pp. 44-45.) The better 

rule is to provide appropriate incentives for the brand-name manufacturer to 

update the warning label at the earliest possible time, given that the successor 

manufacturer cannot remove any aspect of the warning without FDA approval. 
48

To determine how best to incentivize a drug manufacturer to provide 

prompt warnings, we turn to the very factors on which Novartis trains its attention: 

the extent of the duty’s burden on the defendant and the consequences to the 

community. Novartis complains first that plaintiffs’ proposed rule would lead to 

immeasurable and perpetual liability for brand-name drug manufacturers. This 

appears to be an overstatement. Only during the time it holds the NDA does the 

brand-name drug manufacturer have a duty of care. Although a breach of that 

duty can have enduring effects — effects that do not magically disappear merely 

because the brand-name manufacturer no longer holds the NDA — a plaintiff 

would still need to prove that the injury was foreseeable at the time the brandname manufacturer held the NDA, that the brand-name manufacturer’s deficient 

label proximately caused the injury, and that the prescribing physician relied on 

the brand-name manufacturer’s misrepresentations or omissions. The passage of 

time would naturally tend to undermine a plaintiff’s ability to prove that an injury 

was foreseeable at that earlier stage,8 that the physician actually relied on the 

defendant’s warning label, or that the defendant’s negligence proximately caused 

injury. (See Beacon, supra, 59 Cal.4th at p. 583.) An extended period of time 

also presupposes a lengthy latency period before an injury (or its connection to the 

drug) manifested itself, further complicating the showing of foreseeability, 

reliance, or causation. (Cf. PLIVA, supra, 564 U.S. at p. 625, fn. 9 [“the FDA 

 

8 Indeed, approximately half of the studies cited in the first amended 

complaint to demonstrate a link between terbutaline exposure in pregnancy and 

fetal brain development postdated Novartis’s sale to aaiPharma. To avoid the 

distortion caused by hindsight bias, trial courts should be careful to protect the jury 

from needlessly being exposed to or considering scientific studies connecting a 

drug to some harm where those studies postdate transfer of the NDA. 
49

informs us that ‘[a]s a practical matter, genuinely new information about drugs in 

long use . . . appears infrequently’ ”].) 

Yet the question before us involves neither causation nor these other 

elements of negligence. What role the six-year gap between Novartis’s transfer of 

the NDA to aaiPharma and plaintiffs’ exposure to terbutaline might play in 

plaintiffs’ ability to prove these remaining elements is beyond the scope of this 

proceeding. We granted review to decide only the threshold question of a brandname drug manufacturer’s duty of care and therefore have no occasion to address 

other arguments Novartis might advance to defeat liability. (See Kesner, supra, 1 

Cal.5th at p. 1157.)9 But we reject Novartis’s contention that a finding of duty 

will result in perpetual liability for brand-name drug manufacturers as well as the 

burden of a trial to address every claim of harm. Time’s effect on causation, while 

 

9 Recognizing a brand-name drug manufacturer’s duty of care in these 

circumstances does not prevent the manufacturer from arguing in a given case that 

it did not breach its duty given the scientific knowledge at the time; that its label 

could not have proximately caused the harm given the passage of time between the 

transfer of the NDA and the plaintiff’s exposure to the drug, as well as the 

successor’s exclusive responsibility for promoting the assertedly dangerous offlabel use of the drug (see Lyman v. Pfizer, Inc. (D.Vt. July 20, 2012, No. 2:09-CV262) 2012 WL 2970627, *17); or that its disclosure of the unwarned risks to the 

successor manufacturer severed any link between its own label and the harm. But 

our task here is not to decide whether there should be “an exception to the general 

duty of reasonable care on the facts of the particular case before us, but whether 

carving out an entire category of cases from that general duty rule is justified by 

clear considerations of policy.” (Cabral, supra, 51 Cal.4th at p. 772.)

The concurring and dissenting opinion finds “perhaps most troubling” the

court’s unwillingness to “predict” when the gap between transfer of the NDA and 

exposure to the drug will be so remote as to preclude a finding of proximate cause. 

(Conc. & dis. opn., post, at p. 9.) But neither party has briefed the issue of 

proximate cause, nor is proximate cause fairly encompassed within the issue 

presented –– indeed, the issue presented involves exclusively the tort law element 

of duty. Novartis remains free to contest the existence of proximate cause — as 

well as any of the other elements of negligence and negligent misrepresentation. 
50

ordinarily a question of fact, becomes a question of law “ ‘where the facts are such 

that the only reasonable conclusion is an absence of causation.’ ” (State Dept. of 

State Hospitals v. Superior Court (2015) 61 Cal.4th 339, 353; see id. at p. 357 

[sustaining demurrer where the theory of causation was “conjectural, depending 

on a long series of determinations”]; accord, Lyman v. Pfizer, Inc., supra, 2012 

WL 2970627 at p. *17 [affirming grant of summary judgment to a former brandname drug manufacturer on causation grounds].) Similarly, the question of breach 

can be decided as a matter of law where “no reasonable jury could find the 

defendant failed to act with reasonable prudence under the circumstances.” 

(Cabral, supra, 51 Cal.4th at p. 773.) The burden of a potential trial on a brandname drug manufacturer that, under the facts presented, acted unreasonably in 

failing to update the warning label before transferring the NDA — and whose 

negligence proximately caused harm to those exposed to the drug — is not a 

compelling justification for carving out an entire category of cases from the 

general duty of reasonable care. (See id. at p. 772.) 

Moreover, the greater the gap between transfer of the NDA and the 

plaintiffs’ exposure to the drug, the greater the likelihood that the NDA would 

have been transferred to yet another manufacturer, which would multiply the 

number of potential defendants available to share responsibility for damages. 

Because a defendant’s liability for noneconomic damages is not joint but several 

(Civ. Code, § 1431.2, subd. (a)), a negligent brand-name manufacturer would be 

liable for noneconomic damages only in an amount that was directly proportional 

to its percentage of fault. (Ibid.) 

Indeed, a brand-name manufacturer could entirely avoid the prospect of 

extended exposure by including an indemnification provision when it transferred 

ownership of the NDA. (See, e.g., Conte, supra, 168 Cal.App.4th at p. 95, fn. 1.) 

This might lower the sales price of the brand-name drug in the transaction, but not 
51

in any way that fails to reflect the true costs and benefits of being the NDA holder 

or that is unfair to the seller. Meanwhile, an indemnification provision may have 

the salutary effect of focusing both the seller and the purchaser, at a critical time, 

on the existence of any known or knowable risks not reflected in the warning 

label. And, as before, Novartis identifies no reason why it could not insure against 

the effects of any negligence related to the warning label for its drug. (See 

Vasilenko v. Grace Family Church (2017) 3 Cal.5th 1077, 1091.) Commercial 

general liability insurance policies cover injuries that accrue from multiple 

occurrences over a period of years (see Montrose Chemical Corp. v. Admiral Ins. 

Co. (1995) 10 Cal.4th 645), and tail coverage is available for injuries caused by 

the insured that did not manifest themselves until well after the manufacturer 

either sold the product or shut down its operations. (See State of California v. 

Continental Ins. Co. (2012) 55 Cal.4th 186, 195-196.) 

A somewhat analogous situation lay at the heart of a case the court 

addressed recently. In Centinela Freeman Emergency Medical Associates v. 

Health Net of California, Inc. (2016) 1 Cal.5th 994 (Centinela Freeman), we 

considered the circumstances under which a health care service plan could transfer 

its financial responsibility to pay for its enrollees’ emergency medical services to 

its contracting medical providers. Under state and federal law, licensed hospitals 

are required to provide emergency medical care to anyone, regardless of the 

patient’s ability to pay. A health care service plan, in turn, is required to 

reimburse a noncontracting emergency service provider for necessary services, but 

may delegate this responsibility to another entity, such as an individual practice 

association (IPA). (Id. at pp. 1000-1001.) The health care service plans in 

Centinela Freeman delegated their financial responsibility for emergency services 

to their contracting IPAs, which were (or became) financially insolvent and 

eventually went out of business. (Id. at p. 1001.) When the IPAs failed to 
52

reimburse the plaintiff emergency service providers for the care they had provided 

to enrollees of the defendant health care services plans, the plaintiffs sued the 

health plans for payment. (Ibid.) 

The defendant health care service plans made an argument that echoed what 

Novartis argues here: that they had lawfully transferred their legal responsibilities 

to another entity and had therefore terminated any duty of care. We unanimously 

rejected the argument that the delegation of financial responsibility to an IPA 

necessarily relieved the health care service plans of any obligation to pay for its 

enrollees’ covered emergency care. (Centinela Freeman, supra, 1 Cal.5th at p. 

1001-1002.) What we held instead was that a health care service plan owes 

certain duties to noncontracting emergency service providers: first, a duty at the 

outset not to delegate its financial responsibility to an IPA “that it knew or should 

have known would not be able to pay for emergency service and care provided to 

the health plan’s enrollees” (id. at p. 1002); and second, a duty not to continue or 

renew a delegation to an IPA “when it knows or should know that there can be no 

reasonable expectation that its delegate will be able to reimburse noncontracting 

emergency service providers for their covered claims.” (Ibid.) 

Centinela Freeman tends to undermine Novartis’s absolutist position that a 

lawful transfer of its duty to another entity necessarily terminated its liability for 

its own negligence. Under our ruling in Centinela Freeman, a health care service 

plan remains responsible for the costs of its enrollees’ emergency medical care, 

despite a lawful delegation of that financial responsibility, if the plan knows or 

should know the IPA would be unable to fulfill that financial responsibility. 

(Centinela Freeman, supra, 1 Cal.5th at pp. 1001-1002.) Here, we find that a 

brand-name drug manufacturer can be liable for the effects of its deficient warning 

label, despite transferring the NDA to a successor, if the harm is reasonably 

foreseeable and is proximately caused by the label. 
53

Novartis’s argument echoes the position we rejected in Centinela Freeman. 

Although some differences exist between these two scenarios, they do not 

undermine our conclusion that a brand-name drug manufacturer owes a duty to all 

those who may foreseeably and proximately be harmed by its deficient warning 

label. Unlike the duty we recognized in Centinela Freeman, warning label 

liability does not constitute a continuing duty of care. (See Centinela Freeman, 

supra, 1 Cal.5th at p. 1019 [“We agree that a health care service plan has a

continuing duty of care to noncontracting emergency service providers”].) The 

conduct giving rise to a brand-name drug manufacturer’s liability can occur only 

during the period that it holds the NDA. Negligent conduct during that period 

may have effects that extend beyond the transfer of the NDA, but a brand-name 

manufacturer is not subject to liability for any of its actions that occur after 

transfer of the NDA. Moreover, in this case, unlike in Centinela Freeman, we are 

analyzing a duty to prevent physical harm. Such a duty is broader than the duty to 

prevent pecuniary loss. (Rest.2d Torts § 311, com. a.) 

Novartis renews its claim that warning label liability would severely chill 

both the innovation and marketing of new drugs if imposed after the brand-name 

manufacturer exits the market. Yet once again, it offers neither evidence nor a 

persuasive rationale to support its contention –– and no reason for us to prefer 

some unknown increment of drug development over the urgent need to 

compensate a victim whose injury was foreseeably and proximately caused by a 

brand-name manufacturer’s negligence. (See Carlin, supra, 13 Cal.4th at p. 1117 

[“Upjohn offers no clear or sufficient basis for concluding that research and 

development will inevitably decrease” because of failure-to-warn claims]; id. at p.

1116, fn. 6 [discounting the risk of overwarning because of the lack of evidence]; 

cf. Kesner, supra, 1 Cal.5th at p. 1156 [noting the defendants “cite no evidence to 

suggest such [preventive] measures would have been unreasonably costly”].) 
54

After all, the duty imposed here merely reinforces the brand-name drug 

manufacturer’s existing duty to update and maintain the warning label. It does not 

require a brand-name drug manufacturer to do anything new. 

We explained earlier why significant moral blame attaches to the failure to 

warn about a drug’s risks when the brand-name drug manufacturer knew or should 

have known about those risks. The fact that the brand-name manufacturer has 

since exited the market does not alter the calculus. Under plaintiffs’ theory, the 

actionable conduct occurred while the manufacturer still had control over the 

warning label. Had Novartis updated the warning label before surrendering the 

NDA, the federal regulations make it very likely that the warning would have 

remained on the label in 2007. (See Wyeth, supra, 555 U.S. at p. 568.) Although 

it can be difficult to assess the full extent of moral blame before a factual record 

has been developed (Kesner, supra, 1 Cal.5th at p. 1151), concealment of a drug’s 

effects on the fetal brain for the purpose of preserving the drug’s share of the 

premature labor drug market and thus inflating the sales price of the NDA would 

be especially objectionable. So Novartis fails to show how “ ‘clear considerations 

of policy’ ” justify a categorical exception to the duty of care. (Kesner, supra, 1 

Cal.5th at p. 1144.) What the Rowland factors support instead is the conclusion 

that Novartis had a duty to warn about the potential risks of its drug, regardless of 

whether the consumer received the brand-name or generic bioequivalent, and that 

liability for the asserted breach of that duty did not end as a matter of law at the 

moment Novartis sold its rights to aaiPharma, an allegedly concurrent tortfeasor. 

A contrary rule would convey to Novartis and to similarly situated drug 

manufacturers the unjustified benefit of an exception to the general duty of care, 

incentivizing brand-name drug manufacturers that know or should know of 

unwarned risks to unload a problematic drug on another entity instead of 

modifying the drug’s warning label to include those hazards.
55

The concurring and dissenting opinion makes much of the fact that no other 

jurisdiction has yet recognized a brand-name drug manufacturer’s duty to maintain 

a warning label in these circumstances. The legal landscape was just as bare when 

the Court of Appeal recognized a brand-name drug manufacturer’s duty to 

consumers of the generic bioequivalent drug (see Conte, supra, 168 Cal.App.4th at 

p. 101) — a duty we unanimously affirm here. Rarely, if ever, do jurisdictions 

face precisely the same jurisprudential questions at the same time, nor is our 

system premised on the idea that law congeals across jurisdictions. To the 

contrary, the common law incorporates the possibility of change as a foundational 

premise: “[t]he law of torts is anything but static, and the limits of its 

development are never set. When it becomes clear that the plaintiff’s interests are 

entitled to legal protection against the conduct of the defendant, the mere fact that 

the claim is novel will not of itself operate as a bar to the remedy.” (Prosser & 

Keeton, Torts (5th ed. 1984) § 1, p. 4.) Indeed, even if we acknowledge the value 

of reducing uncertainty where possible, what is critical in common law 

adjudication is not that all jurisdictions rapidly converge on a particular 

understanding of tort liability. Instead a court must carefully weigh whether an 

existing rule should apply in a particular context under current conditions. 

Applying the Rowland factors to address that context, we conclude that brandname drug manufacturers owe a duty to those whose injuries are foreseeably and 

proximately caused by the manufacturer’s deficient warning label. 
56

III. CONCLUSION

We do not doubt the wisdom of crowds in some settings. But the value of 

an idea conveyed by or through a crowd depends not on how loudly it is 

proclaimed or how often it is repeated, but on its underlying merit relative to the 

specific issue at hand. Despite the impressive case authority Novartis has 

collected on its behalf, none of it purports to interpret California law. Yet it is 

California law that we must construe and apply in this case. 

In doing so, we find that brand-name drug manufacturers have a duty to use 

ordinary care in warning about the safety risks of their drugs, regardless of 

whether the injured party (in reliance on the brand-name manufacturer’s warning) 

was dispensed the brand-name or generic version of the drug. We also conclude 

that a brand-name manufacturer’s sale of the rights to a drug does not, as a matter 

of law, terminate its liability for injuries foreseeably and proximately caused by 

deficiencies present in the warning label prior to the sale. We therefore affirm the 

Court of Appeal. 

CUÉLLAR, J.

WE CONCUR:

CHIN, J.

LIU, J.

MAURO, J.*

 

* Associate Justice of the Court of Appeal, Third Appellate District, assigned 

by the Chief Justice pursuant to article VI, section 6 of the California Constitution.
1

CONCURRING AND DISSENTING OPINION BY CORRIGAN, J.

I accept the majority’s holding that a brand-name drug manufacturer’s duty 

to warn extends to consumers of a generic bioequivalent, but only because federal 

regulations currently require that generic drugs carry the same warning label as 

appears on the brand-name product. (See 21 C.F.R. § 314.94(a)(8)(iv); PLIVA, 

Inc. v. Mensing (2011) 564 U.S. 604, 613 (PLIVA).) This special feature of 

pharmaceutical law, which gives the brand-name manufacturer sole and complete 

control over the warning label, justifies making generic drugs an exception to our 

observation in O’Neil v. Crane Co. (2012) 53 Cal.4th 335, 342 (O’Neil) that a 

manufacturer is generally not liable for injuries caused by another manufacturer’s 

product.1

 

1 However, the pertinent regulations are now under review and subject to 

imminent change. In November 2013, the Food and Drug Administration (FDA) 

proposed rule changes that would allow generic drug makers to revise their 

product warning labels, and depart from the labeling of the brand-name drug, 

using the “changes being effected” process. (Supplemental Applications 

Proposing Labeling Changes for Approved Drugs and Biological Products, 78 

Fed.Reg. 67985 (Nov. 13, 2013) (Supplemental Applications).) In view of the 

Supreme Court’s preemption decisions, the FDA explained it sought to “create 

parity” between brand-name and generic manufacturers. (Id. at p. 67989.) 

Moreover, the change was needed to ensure postmarket safety surveillance, 

because the FDA had found that safety-related labeling changes are typically 

required many years after a drug’s initial approval, when generic versions are 

widely prescribed and the original brand-name manufacturer may have left the 

market. (Id. at p. 67988.) In 2015, the FDA reopened the comment period and 

scheduled a public meeting on the proposed rule change. (80 Fed.Reg. 8577 (Feb. 
2

The majority’s second holding, however, would extend indefinitely a drug 

manufacturer’s duty to warn the customers of its successor, even after sale of the 

product line. No special feature of FDA law or practice warrants this rule. 

Plaintiffs’ theory of “predecessor liability” represents a substantial and 

unprecedented expansion of tort duties. The majority cites no case holding a 

predecessor manufacturer liable for failing to warn about injuries caused by its 

successor’s product. Indeed, it appears that predecessor liability for failure to 

warn has never before been recognized by any court, in any jurisdiction. To the 

extent the theory has been raised, courts across the country have universally 

rejected it. 

For example, in the silicone breast implant litigation, some plaintiffs whose 

implants were manufactured by McGhan Medical Corporation (McGhan) sought 

to sue the Minnesota Mining and Manufacturing Company (3M) on the theory that 

3M was the original designer. (See, e.g., In re Minnesota Breast Implant 

Litigation (D.Minn. 1998) 36 F.Supp.2d 863, 873.) 3M had sold this product line 

to McGhan in 1984 after patients began complaining of problems. (Id. at p. 870.) 

In addition to rejecting strict liability claims, published federal decisions 

uniformly held that 3M had no negligence-based duty to warn about the risks of a 

product it no longer manufactured or supplied. (Id. at p. 874; see Christian v. 

Minnesota Min. & Mfg. Co. (D.Md. 2001) 126 F.Supp.2d 951, 958-959; 

McConkey v. McGhan Medical Corp. (E.D.Tenn. 2000) 144 F.Supp.2d 958, 963-

964.) Attempts to impose negligence liability on predecessor manufacturers have 

failed in other contexts as well. (See Cadlo v. Owens-Illinois, Inc. (2004) 125 

Cal.App.4th 513, 520-521 [asbestos insulation]; Potwora ex rel. Gray v. Grip

(N.J.Super.Ct.App.Div. 1999) 725 A.2d 697, 703-704 [motorcycle helmet]; Fricke 

 

18, 2015).) If this regulatory change is implemented, our decision to allow suits 

against brand-name manufacturers for injuries caused by generic equivalents will 

need to be reevaluated because the rationale supporting it will be largely, if not 

entirely, undermined. (See maj. opn. ante, at pp. 20-21, fn. 2.)
3

v. Owens-Corning Fiberglas Corp. (La.Ct.App. 1993) 618 So.2d 473, 474-475 

[vinegar].)

The majority insists pharmaceutical drugs are different from other products. 

However, both courts that have considered the issue have refused to extend tort 

liability to drug manufacturers after transfer of the product’s New Drug 

Application (NDA) to a successor company. In In re Darvocet, Darvon and 

Propoxyphene Products Liability Litigation (E.D.Ky. Mar. 7, 2012, MDL Docket 

No. 2226) 2012 WL 767595, plaintiffs who had taken painkillers containing 

propoxyphene sued the drug’s original manufacturer, Eli Lilly and Company 

(Lilly), for negligence and misrepresentation. Lilly had sold the NDA to another 

company in 2002 and stopped manufacturing the drug altogether in 2004. (Id. at 

p. *1.) The district court concluded Lilly had no liability for claims arising after 

the divestiture (id. at pp. *3, *9), and its decision was affirmed on appeal. (In re 

Darvocet, Darvon, and Propoxyphene Products (6th Cir. 2014) 756 F.3d 917, 

940-941.) Another federal court reached the same conclusion in Lyman v. Pfizer, 

Inc. (D.Vt. July 20, 2012, No. 2:09-cv-262) 2012 WL 2970627. Defendant Wyeth 

LLC (Wyeth) had sold its rights to the drug Reglan almost two years before the 

plaintiff took her first dose. (Id. at pp. *1, *5.) By that time, “Wyeth could not 

have delivered a stronger warning regarding the drug, or have changed its design 

in any way.” (Id. at p. *16). Assuming for sake of argument that Wyeth owed a 

legal duty to the customers of its successor and breached that duty by, among 

other things, failing to update Reglan’s label, the court concluded any negligence 

was too remote as a matter of law to be the proximate cause of the plaintiff’s 

injury. (Id. at p. *17.)

O’Neil, supra, 53 Cal.4th at pages 363-366, held that a manufacturer has no 

negligence-based duty to warn about the risks of another manufacturer’s product. 

There, we were addressing risks posed by replacement components used in and 

around the manufacturer’s product. Although it was foreseeable that the product’s 

original components would be replaced with asbestos-containing parts, we stressed 
4

that “ ‘foreseeability alone is not sufficient to create an independent tort duty.’ ” 

(Id. at p. 364.) Instead, weighing the other Rowland2 factors, we concluded strong 

policy considerations counseled against imposing a duty of care. (O’Neil, at 

pp. 364-365; see Taylor v. Elliott Turbomachinery Co. Inc. (2009) 171 

Cal.App.4th 564, 583.)

The majority attempts to distinguish O’Neil as applied to a brand-name 

manufacturer’s liability for generic bioequivalents. (See maj. opn. ante, at pp. 19-

20.) The distinction does not hold when applied to predecessor liability. In the 

generic drug context, public policy supports imposing a duty of care on brandname manufacturers because the brand-name manufacturer is the only party with 

the practical and legal ability to warn about product risks. Generic manufacturers 

cannot write their own labels. Their products are legally required to carry the 

same warnings as appear on their brand-name counterparts. (21 U.S.C. 

§ 355(j)(2)(A)(v), (4)(G); see PLIVA, supra, 564 U.S. at p. 613.) Placing a duty of 

care on brand-name manufacturers thus allocates the costs of compensating drugrelated injuries on the party that is best-situated to prevent the harm. (See Kesner 

v. Superior Court (2016) 1 Cal.5th 1132, 1153 (Kesner).) In the predecessor 

liability context, however, the opposite is true. Imposing a duty on predecessor 

manufacturers to warn about potential injuries that could result from successors’ 

products allocates costs to a party that has no ability to change the product’s 

labeling and thus no effective way to control the warnings given to consumers. 

After divestiture, only the successor manufacturer has the ability to warn its 

customers about hazards. (21 C.F.R. §§ 314.71(a), 314.72(a)(2).) The same 

considerations led this court to unanimously reject a duty of care in O’Neil. As we 

explained, “[t]here is no reason to think a product manufacturer will be able to 

exert any control over the safety of replacement parts or companion products made 

by other companies.” (O’Neil, supra, 53 Cal.4th at p. 365.) The O’Neil rule is 

 

2 Rowland v. Christian (1968) 69 Cal.2d 108.
5

consistent with the Restatement of Torts, which advocates liability for post-sale 

failure to warn only if the seller has the ability to identify and communicate 

effectively with those at risk. (Rest.3d Torts, Products Liability, § 10.)

When a drug manufacturer acquires a new product line, it assumes the 

responsibility to update the warning label if and when reasonable evidence 

demonstrates a link to a serious health hazard. (21 C.F.R. § 201.80(e).) 

Predecessor manufacturers have a right to presume successors will perform their 

duty and follow the law. (See Webb v. Special Electric Co., Inc. (2016) 63 Cal.4th 

167, 191; Harris v. Johnson (1916) 174 Cal. 55, 58.) The majority’s foreseeability 

analysis glosses over this important legal obligation, noting that the successor 

would have no financial incentive to make a labeling change. (See maj. opn. ante, 

at pp. 43-45.) However, the prospect of negative publicity, fines, and tort liability 

gives all manufacturers substantial reason to disclose the adverse effects of a drug 

they sell. Updating the warning label to disclose risks as they become known, and 

ensuring warnings remain adequate, is a drug manufacturer’s legal duty. (Wyeth v. 

Levine (2009) 555 U.S. 555, 570-571.) The majority’s assumption that successor 

corporations will routinely ignore this duty, simply because their predecessors 

may have done so, is unfounded. 

Moreover, the accumulation of scientific studies will often make the 

correlation with a health risk more clear over time. The majority’s analysis elides 

this important feature of pharmaceutical practice. Adverse effects from a drug 

typically appear first in anecdotal case reports. It can take several years for 

epidemiological studies, the gold standard for establishing causation, to be 

conducted and published. Indeed, a 2013 FDA study found that the “most critical 

safety-related label changes, boxed warnings and contraindications, occurred a 

median 10 and 13 years after drug approval (and the range spanned from 2 to 63 

years after approval).” (Lester et al., Evaluation of FDA Safety-related Drug 

Label Changes in 2010 (2013) 22 Pharmacoepidemiology & Drug Safety 302, 

304.) A connection to adverse effects that appears reasonably clear when a 
6

successor produces a drug may well have been more tenuous, perhaps not even 

rising to the FDA’s “reasonable evidence” standard, when it was the predecessor’s 

product. Scientific evidence may not demonstrate the link to a health risk until 

after divestiture. Yet, at that point there is little to nothing a predecessor 

manufacturer can do to warn about the harm.

This case demonstrates the point. The majority concedes that 

“approximately half” of the studies plaintiffs cite to show terbutaline’s impact on 

fetal brain development postdated Novartis’s sale of the product line. (Maj. opn. 

ante, at p. 48, fn. 8.) But this summary does not tell the full tale. A few rat studies 

in the 1980s showed that terbutaline could cross the placenta and affect fetal brain 

development, and effects in human children were beginning to be documented. 

But most of the early studies were focused on the drug’s effectiveness, or lack 

thereof, at preventing preterm labor. The first long-term study cited in plaintiffs’ 

complaint that demonstrates a potential impact on human development was 

published in 2001, the same year Novartis sold the Brethine NDA to aaiPharma. It 

is undisputed that after 2001 Novartis had no ability to change the drug’s warning 

label. Moreover, the scientific link between terbutaline and autism remains 

questionable. In 2011, four years after plaintiffs’ mother was given terbutaline 

and nearly 10 years after Novartis’s divestiture, the FDA reviewed the scientific 

literature investigating this link and concluded the studies did not constitute 

“ ‘positive evidence’ ” of a risk to fetal health. (Food & Drug Admin., letter to 

James P. Reichmann responding to citizen petition, Feb. 17, 2011, Docket No. 

FDA-2008-P-0358, p. 12.) 

I discuss these developments not to express a view on the merits of 

plaintiffs’ suit, but simply to point out that the scientific investigation of an alleged 

harmful effect takes time. Anecdotal case reports, in vivo studies, or animal 

studies that initially suggest an association are sometimes discredited by later 
7

epidemiological studies, which are more authoritative but take longer to conduct.3 

Yet the majority’s new duty rule makes it nearly imperative for manufacturers to 

issue warnings in advance of the science if they are selling a drug’s NDA. In the 

normal course, a responsible drug manufacturer can monitor scientific 

developments and work with the FDA to determine when additional warnings are 

warranted. It loses this ability after transferring the NDA to another company. By 

holding that such a manufacturer owes a duty to warn its successor’s customers 

even many years later, the majority creates an incentive for manufacturers to warn 

about every conceivable harm before transferring an NDA, lest their successors 

fail to include appropriate warnings when a risk is later validated.

It is certainly possible to foresee that a successor manufacturer will shirk its 

legal obligation to warn. That a harm is foreseeable does not necessarily mean we 

should recognize a duty of care, however. On “clear judicial days . . . a court can 

foresee forever.” (Thing v. La Chusa (1989) 48 Cal.3d 644, 668.) As the majority 

opinion recognizes, an analysis of the Rowland factors requires us to balance 

foreseeability against considerations of public policy. Several policy reasons 

strongly counsel against imposing a duty of care on predecessor companies to 

warn about risks in products manufactured and sold by their successors.

 

3 One example of tort liability leapfrogging scientific knowledge occurred in 

the Bendectin litigation. Several cases alleging the anti-nausea drug Bendectin 

caused birth defects went to trial in the 1980s, leading the manufacturer to 

withdraw the drug from the market. (Sanders, From Science to Evidence: The 

Testimony on Causation in the Bendectin Cases (1993) 46 Stan. L.Rev. 1, 4-7.) 

However, later scientific studies demonstrated the safety of Bendectin, and its 

active ingredient is now used in several over-the-counter medications. (Id. at 

pp. 9-10.) A similar phenomenon occurred in the early 1990s with breast 

implants. Despite little scientific evidence of an association, thousands of suits 

were filed across the country alleging silicone breast implants caused autoimmune 

disorders. (Bernstein, The Breast Implant Fiasco (1999) 87 Cal. L.Rev. 457, 477.) 

Eventually, several large-scale epidemiological studies conclusively refuted this 

proposition, finding no link between implants and systemic disease. (Id. at 

pp. 480-484.)
8

First, as noted, a predecessor manufacturer has no control over the 

successor’s product warnings. Only the current NDA holder has the power to 

change a drug’s warning label. (21 C.F.R. §§ 314.71(a), 314.72(a)(2).) The 

majority therefore imposes a duty of care that is impossible for predecessor 

companies to discharge. Although this result might increase compensation for 

claims of drug-related injury, it disserves the tort policy of deterring negligent 

behavior. As this court recently observed, the “goal of products liability law is not 

merely to spread risk but also ‘to “induce conduct that is capable of being 

performed.” ’ ” (Webb v. Special Electric Co., Inc., supra, 63 Cal.4th at p. 187.) 

Until today, a defendant’s ability to control product warnings has been understood, 

even taken for granted, as an essential prerequisite to imposing liability for failure 

to warn. Indeed, this very same logic underlies the Supreme Court’s preemption 

holding in PLIVA: It is unfair to subject generic manufacturers to failure-to-warn 

liability under state law when federal law gives them no ability to alter a drug’s 

warning label. (See PLIVA, supra, 564 U.S. at p. 624.) It is no answer to say that 

a predecessor need only ensure that its own warnings are complete and accurate. 

The immediate and efficient cause of plaintiffs’ alleged injury here was their 

mother’s ingestion of (a generic version of) aaiPharma’s drug. The warnings 

Novartis gave for the product it sold six years earlier are extremely remote from 

this event.

Second, the majority’s holding will likely encourage over-warning by drug 

manufacturers. Drug manufacturers are already under a duty to update their 

warning labels, and they already face the risk of suit from their own customers if 

they fail to comply with that duty. The knowledge that they will still be subject to 

liability years in the future, even after divesting a product line, might well cause 

companies to seek the FDA’s permission to add warnings about potential adverse 

effects that have only the barest support in evolving scientific literature. We have 

noted before that overabundant product warnings breed consumer disregard. (See, 

e.g., O’Neil, supra, 53 Cal.4th at p. 365.) Such a problem seems especially acute 
9

in the pharmaceutical drug context, where product inserts and advertising 

frequently include mind-numbing lists of potential side effects.

Third, the majority’s rule could conceivably have the perverse effect of 

diminishing successor corporations’ incentive to update labels as scientific 

evidence develops. Current product manufacturers already have a disincentive to 

add warnings that may lower their profits. By holding that predecessor companies 

must potentially share liability for injuries caused by a successor’s product, the 

court effectively reduces successor companies’ exposure to tort liability. Aware 

that the cost of tort suits can be shared with their predecessors, some successor 

companies may decide to delay or perhaps even forgo additional warnings.

Fourth, and perhaps most troubling, creating a broad duty of care to 

consumers of a successor’s product will expose pharmaceutical companies to 

liability in perpetuity. There is no logical stopping point for such a duty. The 

majority asserts that injuries will eventually become too remote for proximate 

causation to be established. It, however, declines to predict when that time might 

be reached and ventures no opinion about whether the six-year gap in this case is 

long enough. (But cf. Lyman v. Pfizer, Inc., supra, 2012 WL 2970627 at p. *17 

[finding any negligence of predecessor company too remote as a matter of law for 

a drug ingested less than two years after transfer of the NDA].) Without any 

limiting principles to guide the proximate cause analysis, the majority’s 

reassurance fails to reassure.

Absent some such limiting principle, a proximate cause inquiry cannot 

reliably prevent excessive liability because proximate cause is ordinarily a 

question of fact for the jury. (Lacy v. Pacific Gas & Electric Co. (1934) 220 Cal. 

97, 101.) The issue cannot be decided as a matter of law unless the only 

reasonable conclusion from the facts is an absence of causation. (State Dept. of 

State Hospitals v. Superior Court (2015) 61 Cal.4th 339, 353.) Thus, in all but the 

most extreme cases, predecessor liability claims are likely to reach a jury, with 

costly and unpredictable results. Duty, by contrast, is a question of law for the 
10

court to decide. (Cabral v. Ralphs Grocery Co. (2011) 51 Cal.4th 764, 770 

(Cabral).) This court has traditionally relied on duty rules to limit liability, even 

for foreseeable injuries. (E.g., Kesner, supra, 1 Cal.5th at pp. 1154-1155; O’Neil, 

supra, 53 Cal.4th at pp. 364-366; Parsons v. Crown Disposal Co. (1997) 15 

Cal.4th 456, 476-478.) In Kesner, for example, we limited the duty to prevent 

take-home asbestos exposure to members of the worker’s household, even though 

this limit excluded other individuals in close contact with the worker who would 

be foreseeably harmed. (Kesner, at pp. 1154-1155) This court has acknowledged 

the importance of limits to avoid potentially infinite expansions of tort duty. The 

majority’s opinion here proposes none.

Exposing drug manufacturers to broad liability with no predictable end 

point has the clear potential to destabilize the pharmaceutical industry and chill 

innovation. Although the majority contends no evidence has been presented to 

support this prediction (maj. opn. ante, at p. 53), we do not typically demand 

evidence on the Rowland factors. The Rowland analysis is inherently predictive, 

not evidence-based. (Cf. Cabral, supra, 51 Cal.4th at p. 772 [Rowland factors are 

evaluated at a broad level of generality and not tied to facts of a particular case].) 

It stands to reason that expanding a drug manufacturer’s exposure to tort liability 

will likely increase the drug’s price. It may also delay the release of new drugs or 

even keep some beneficial drugs off the market. “Public policy favors the 

development and marketing of beneficial new drugs, even though some risks, 

perhaps serious ones, might accompany their introduction, because drugs can save 

lives and reduce pain and suffering.” (Brown v. Superior Court (1988) 44 Cal.3d 

1049, 1063.) We have previously proceeded with caution in this area, recognizing 

this broad public interest in the availability of affordable drugs. (See, e.g., id. at 

pp. 1065-1066, 1069 [rejecting strict liability for injuries caused by prescription 

drugs].) The majority reverses this course. It imposes a more expansive, enduring 

liability on drug manufacturers than has been recognized elsewhere in tort law.
11

Fifth, there is no reason to think the majority’s predecessor liability holding 

will be limited to the pharmaceutical industry, or even to immediate predecessors. 

Despite its suggestion that pharmaceutical drugs are somehow different, the 

majority opinion identifies no specific feature of drug regulation that makes an 

extension of duty especially desirable or necessary in this context. What is now to 

stop users of any product from suing a former manufacturer, arguing it was 

foreseeable the successor would fail to update the product’s warnings? The path 

of least resistance for all successor companies is to continue the product warnings 

used by their predecessors. It will generally be against a successor’s financial 

interest to add warnings, no matter what the product. The majority’s rule thus 

opens the door to predecessor liability for all products. It is also unclear exactly 

how far back this liability would extend. Some amicus briefs advised that product 

line acquisitions are common in the pharmaceutical industry. If a product line has 

changed hands two or three times, do all of these manufacturers have a duty of 

care toward the eventual plaintiff? Apparently they do, given the majority’s 

remarks on joint and several liability. (See maj. opn. ante, at p. 50.) Again, 

however, this reasoning suggests no logical stopping point.

Sixth, it is not clear that an expanded duty of care is needed to prevent drug 

manufacturers from concealing risks when their product line is acquired. These 

transactions involve highly sophisticated parties, and acquiring companies can be 

expected to discover a drug’s known risks when conducting due diligence. 

Plaintiffs here never alleged that Novartis hid risks from aaiPharma. Moreover, 

the appropriate remedy for this wrong is not an overbroad duty rule, but a fraud or 

breach of contract lawsuit from the acquiring company. A lawsuit related to the 

acquisition offers a more immediate and effective deterrent than the prospect of 

future tort claims by the acquirer’s customers. Such an approach would make 

clear the duties of full disclosure and due diligence. It would also encourage 

successor companies to remain attentive to the evolving science relating to their 

acquisitions.
12

In discussing Centinela Freeman Emergency Medical Associates v. Health

Net of California, Inc. (2016) 1 Cal.5th 994 (Centinela Freeman), a completely 

distinguishable case, the majority implicitly assumes that drug companies 

commonly sell off product lines to undercapitalized entities in order to “unload” 

(maj. opn. ante, at p. 54) products found to be dangerous. It cites no evidence or 

authority for these assumptions. In contrast, we do know it is common for brandname manufacturers to stop selling a drug after their exclusivity period ends and 

generic competitors are allowed to enter the market. (See Supplemental 

Applications, supra, 78 Fed.Reg. at p. 67988; PLIVA, supra, 564 U.S. at p. 644 

(dis. opn. of Sotomayor, J.).) Because the brand-name drug’s market share 

inevitably declines with the entry of generic equivalents, these transactions may 

make good business sense and have nothing to do with the risks or benefits of the 

product itself. With respect to this case in particular, plaintiffs did not allege that 

Novartis hid health risks of terbutaline from aaiPharma or committed any 

wrongdoing in connection with the transfer of Brethine’s NDA. Nor is there a 

basis for speculating that Novartis deliberately sold Brethine to an 

undercapitalized company, or that such transactions are typical. Plaintiffs’ 

complaint includes no allegations to this effect, and aaiPharma’s bankruptcy did 

not occur until four years after the NDA transfer.4

The majority also suggests that an extended duty of care is needed because 

successor manufacturers may simply rely on their predecessor’s review of the 

medical literature or may trust their predecessor’s judgment of whether a warning 

 

4 Moreover, the court’s holding in Centinela Freeman included a scienter 

requirement, specifying that health care plans may be liable for negligent 

delegation of financial responsibility if they “knew or should have known” the 

transferee would not be able to pay. (Centinela Freeman, supra, 1 Cal.5th at 

pp. 1001-1002.) Yet the majority’s analysis here accords no such significance to 

details surrounding the transfer of an NDA. Novartis would be equally 

responsible under the majority’s duty rule if it had sold Brethine’s NDA to another 

multinational, highly capitalized company.
13

is required. (Maj. opn. ante, at p. 43.) This speculation rests on the mistaken 

assumption that due diligence is a static event, occurring only when an NDA is 

transferred. But, with the transfer, the new manufacturer assumes the sole and 

continuing responsibility to monitor the drug’s safety and labeling. (21 C.F.R. 

§ 314.72(b).) To fulfill this duty, the successor manufacturer must regularly 

monitor research developments as well as consumer feedback related to the drug. 

If the successor fails to update the drug’s warnings to include newly documented 

risks, it may face products liability suits from its customers. Predecessor liability 

is not necessary to give these injured customers a remedy. The majority’s holding 

is a solution in search of a problem.

Seventh, with respect to moral blame, the majority focuses too narrowly on 

the facts of this specific case. The broader question is what moral blame attaches 

to a manufacturer’s failure to warn its successor’s customers about a product 

defect. A predecessor manufacturer’s share of moral blame may well be lower 

than that of a successor company that fails to update warnings, especially if 

scientific knowledge has advanced over time to provide stronger evidence of the 

product’s link to an adverse effect.

Eighth, and finally, despite the majority’s blithe assurance that drug 

manufacturers can “entirely avoid” perpetual liability through insurance or 

indemnity agreements (maj. opn. ante, at p. 50), there is no precedent for coverage 

against claims arising from another company’s product. None of the cases cited in 

the majority opinion addressed this unusual scenario. While insurance might be 

available in theory, the policy would have to cover a potentially enormous future 

risk that the insured would have no ability to mitigate. At the very least, the 

coverage would be difficult to manage and extremely costly. Defining the covered 

events could also be difficult, given that the potential plaintiffs would have no 

relationship with the insured. Even if appropriate insurance does become 

available, the majority’s holding will require that pharmaceutical companies 

maintain it on all drugs for several years after they have stopped selling the 
14

products and realizing a profit. The high cost of insuring against the majority’s 

extension of the liability will almost certainly drive up the prices for prescription 

drugs.5

For all these reasons, although I join the majority’s decision to affirm Conte 

v. Wyeth, Inc. (2008) 168 Cal.App.4th 89, I dissent from its holding that 

predecessor manufacturers have a duty to warn their successors’ customers about 

risks of a product they no longer make or sell.

CORRIGAN, J.

WE CONCUR:

CANTIL-SAKAUYE, C. J.

KRUGER, J. 

 

5 Nor are indemnity agreements a satisfactory answer. After today’s holding, 

drug companies subject to suit in California will undoubtedly include indemnity 

provisions in all NDA transfer contracts. Such provisions could effectively put the 

burden of liability back where it rightfully belongs, i.e., on the actual manufacturer 

of the product used by the plaintiff. But they would not necessarily relieve the 

predecessor of all costs related to future claims. Indemnification rights may be 

capped or may exclude costs in defending the underlying lawsuits. There may 

also be costs if the predecessor must sue to enforce the indemnity agreement.
See last page for addresses and telephone numbers for counsel who argued in Supreme Court.

Name of Opinion T.H. v. Novartis Pharmaceuticals Corporation

__________________________________________________________________________________

Unpublished Opinion

Original Appeal

Original Proceeding

Review Granted XXX 245 Cal.App.4th 589

Rehearing Granted

__________________________________________________________________________________

Opinion No. S233898

Date Filed: December 21, 2017

__________________________________________________________________________________

Court: Superior

County: San Diego

Judge: Joan Marie Lewis

__________________________________________________________________________________

Counsel:

Public Justice, Leslie A. Brueckner; Thorsnes Bartolotta McGuire, Benjamin I. Siminou, Kevin F. Quinn 

and Charlynne I. Rejaian for Plaintiffs and Appellants.

Alan Charles Dell’Ario and Jeffrey R. White for Consumer Attorneys of California and American 

Association for Justice as Amici Curiae on behalf of Plaintiffs and Appellants.

Chavez & Gertler, Nance F. Becker; Public Citizen Litigation Group and Allison M. Zieve for Public

Citizen, Inc., as Amicus Curiae on behalf of Plaintiffs and Appellants.

William Alvarado Rivera for AARP and AARP Foundation as Amici Curiae on behalf of Plaintiffs and 

Appellants.

Hollingsworth, Eric G. Lasker, Joe G. Hollingsworth, Katharine R. Latimer; Morrison & Foerster, Erin M, 

Bosman and Julie Y. Park for Defendant and Respondent.

H. Sherman Joyce, Lauren Sheets Jarrell; Manufacturers’ Center for Legal Action, Linda E. Kelly, Patrick 

N. Forrest, Leland P. Frost; Shook, Hardy & Bacon, Phil Goldberg, Paul B. La Scala and Gabriel S. 

Spooner for National Association of Manufacturers and American Tort Reform Association as Amici 

Curiae on behalf of Defendant and Respondent.

Hugh F. Young, Jr.; Reed Smith, David E. Stanley and James M. Beck for Product Liability Advisory 

Council, Inc., as Amicus Curiae on behalf of Defendant and Respondent.

Gregory Herbers and Michelle Stilwell for Washington Legal Foundation as Amicus Curiae on behalf of 

Defendant and Respondent.

Martin S. Kaufman; Greenberg Traurig, Robert P. Charrow and Anna B. Laakmann for Atlantic Legal 

Foundation as Amicus Curiae on behalf of Defendant and Respondent.
Page 2 – counsel continued – S233898

Counsel:

Deborah J. La Fetra and Anastasia P. Boden for Pacific Legal Foundation as Amicus Curiae on behalf of 

Defendant and Respondent.

Covington & Burling, Jeffrey M. Davidson, Michael X. Imbroscio, Paul W. Schmidt and Gregory L. 

Halperin for Pharmaceutical Research and Manufacturers of America as Amicus Curiae on behalf of 

Defendant and Respondent.

Fred J. Hiestand for The Civil Justice Association of California as Amicus Curiae on behalf of Defendant 

and Respondent.

Williams & Connolly, Kannon K. Shanmugam, Allison Jones Rushing and Connor S. Sullivan for 

Chamber of Commerce of the United States of America as Amicus Curiae on behalf of Defendant and 

Respondent.

Haynes and Boone, Mary-Christine Sungaila and Polly Fohn for International Association of Defense 

Counsel and Federation of Defense & Corporate Counsel as Amici Curiae on behalf of Defendant and 

Respondent.

Shook, Hardy & Bacon and Alicia J. Donahue for Genentech, Inc., and California Life Sciences 

Association as Amici Curiae on behalf of Defendant and Respondent.
Counsel who argued in Supreme Court (not intended for publication with opinion):

Leslie A. Brueckner

Public Justice

555 12th Street, Suite 1230

Oakland, CA 94607

(510) 520-6205

Benjamin I. Siminou

Thorsnes Bartolotta McGuire

2550 Fifth Avenue, 11th Floor

San Diego, CA 92103

(619) 236-9363

Eric G. Lasker

Hollingsworth

1350 I Street NW

Washington, D.C. 20005

(202) 898-5800