Trejo v. Johnson & Johnson

Filed 6/30/17
CERTIFIED FOR PUBLICATION
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
SECOND APPELLATE DISTRICT
DIVISION FOUR
CHRISTOPHER TREJO, B238339
Plaintiff and Respondent, (Los Angeles County
Super. Ct. No. YC058023)
v.
JOHNSON & JOHNSON et al.,
Defendants and Appellants.
APPEAL from a judgment of the Superior Court of Los Angeles County,
Robert H. O‘Brien, Judge. Reversed and remanded.
Law Offices of Brian D. Witzer, Inc., Brian D. Witzer, Jeffrey E. Zinder
and Michael P. Manapol for Plaintiff and Respondent.
Butler, Snow, O‘Mara, Stevens & Cannada, Kari L. Sutherland;
Drinker Biddle & Reath, Thomas W. Pulliam, Jr., Vernon I. Zvoleff, Alan J.
Lazarus, Kenneth P. Conour, Benjamin J. Holl; O‘Melveny & Myers, Catalina
J. Vergara and Charles C. Lifland for Defendants and Appellants.
After taking Motrin, an over-the-counter ibuprofen medication
manufactured and sold by McNeil Consumer Healthcare (McNeil), plaintiff
Christopher Trejo suffered a reaction in the form of a rare skin disease,
Stevens-Johnson Syndrome, and the more severe variant, Toxic Epidermal
Necrolysis (collectively SJS/TEN).1 He sued McNeil and its corporate parent,
Johnson & Johnson, on various theories of products liability, four of which
went to trial: strict liability failure to warn and negligent failure to warn,
based on defendants‘ failure to include the symptoms of SJS/TEN (skin
reddening, rash, and blisters) on Motrin‘s warning label, and strict liability
design defect and negligent design defect, based on McNeil‘s failure to sell an
allegedly safer product, dexibuprofen (an isomer or component of ibuprofen)
rather than ibuoprofen.
Returning a special verdict, the jury found McNeil liable for negligent
failure to warn (but not for strict liability failure to warn), negligent design
defect, and strict liability design defect under the consumer expectation test
(but not under the risk-benefit test). The jury found Johnson & Johnson
1 This is one of a number of SJS/TEN cases being brought against
defendants, with varying results. (See, e.g., Robinson v. McNeil Consumer
Healthcare (7th Cir. 2010) 615 F.3d 861 (Robinson) [affirming judgment in
favor of defendants]; Lofton v. McNeil Consumer & Specialty Pharmaceuticals
(5th Cir. 2012) 672 F.3d 372 [affirming summary judgment in favor of
defendants because federal law preempted Texas tort law regarding failure to
warn cases]; Reckis v. Johnson & Johnson (Mass. 2015) 28 N.E.3d 445[affirming judgment in favor of plaintiff] (Reckis); Batoh v. McNeil-PPC, Inc.
(D.Conn. 2016) 167 F.Supp.3d 296 (Batoh) [granting defendants‘ summary
judgment motion]; Wolfe v. McNeil-PPC, Inc. (E.D.Pa. 2011) 773 F.Supp.2d
561 (Wolfe) [denying defendants‘ summary judgment motion on plaintiff‘s
failure to warn claim and granting their motion on plaintiff‘s claims for
negligent failure to test, negligent marketing, negligent defective design, and
strict liability manufacturing, design defect and misrepresentation].)
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liable for strict liability design defect on a consumer expectation theory (but
not on a risk-benefit theory), and not liable on plaintiff‘s other claims.
In this appeal by defendants, we hold that the jury‘s verdict finding
McNeil liable for negligent failure to warn must be reversed because it is
fatally inconsistent with the verdict finding McNeil not liable for strict
liability failure to warn. Accordingly, we reverse the negligent failure to
warn verdict, and remand for a new trial on the claims against McNeil for
negligent and strict liability failure to warn. We also conclude that the
negligent failure to warn special verdict was defective on a second ground:
the failure to include the necessary question whether a reasonable
manufacturer under the same or similar circumstances would have warned of
the danger (an issue we consider because there might be a retrial).
Further, we hold that the verdicts against McNeil for negligent and
strict liability design defect, as well as against Johnson & Johnson for strict
liability design defect, must be reversed, because the design defect claims
were based on a theory—failure to sell dexibuprofen—that is impliedly
preempted by the United States Supreme Court‘s decision in Mutual
Pharmaceutical Co., Inc. v. Bartlett (2013) __ U.S. __, 133 S.Ct. 2466, 2473
(Bartlett). We also conclude that the strict liability design defect verdicts
must be reversed on a second ground: the jury found McNeil and Johnson
and Johnson liable solely under the consumer expectation test, but that test
does not apply when, as here, the question of design defect involves complex
questions of feasibility, practicality, risk, and benefit beyond the common
knowledge of jurors. Accordingly, we reverse the verdicts finding McNeil
liable for negligent and strict liability design defect, and finding Johnson and
Johnson liable for strict liability design defect. Because plaintiff‘s negligent
and strict liability design defect claims are preempted, and because the only
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theory of strict liability design defect found by the jury (the consumer
expectation test) does not apply, none of plaintiff‘s design defect claims can be
retried.
Therefore, the ultimate disposition is that the judgment as to McNeil
and Johnson and Johnson is reversed, and the case is remanded for retrial on
the sole remaining claims in the case: those against McNeil for negligent and
strict liability failure to warn.
FACTUAL AND PROCEDURAL BACKGROUND
I. Factual Background
A. Ibuprofen
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID). It was
approved by the Food and Drug Administration (FDA or agency) for
prescription use in the United States to treat arthritis and pain in 1974, and
for over-the-counter (OTC) use in 1984. Both prescription and OTC ibuprofen
are composed of the same ingredient, differing only in the dosage amounts.
In 2006, the FDA estimated that approximately 29 million prescriptions for
ibuprofen were dispensed per year, and that OTC ibuprofen had
approximately 100 million users per year.
There are many different OTC ibuprofen products, both generic and
brand name, sold by various companies. They all have the same labeling,
regardless of the manufacturer. Motrin is a brand name ibuprofen product.
McNeil acquired the right to produce Motrin from the Upjohn Manufacturing
Company before the events giving rise to this action. In 1994, the FDA
approved McNeil‘s application for OTC ibuprofen gelcaps, concluding ―the
drug is safe and effective for use as recommended in the submitted labeling.‖
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Regarding the risk of SJS and TEN from taking ibuprofen, in 1989, the
FDA provided McNeil with a medical officer review informing the company
that, in 1982, 10 billion doses of ibuprofen were used worldwide, and that
SJS was an adverse reaction reported with ibuprofen products at a rate of
less than one percent. The labeling approved by the FDA in the 1980‘s for
prescription ibuprofen contained a reference to SJS and TEN as possible
adverse events. However, the FDA-approved label for OTC ibuprofen did not
refer to SJS, TEN, skin reddening, rash or blisters. The labels differed
because prescription labeling is intended for use by physicians, while OTC
labeling is aimed at consumers.
The warning label on the bottle of OTC Motrin plaintiff took in October
2005 included the following FDA-approved warnings and instructions:
―Warnings
―Allergy alert: Ibuprofen may cause a severe allergic reaction which
may include:
―• hives • facial swelling • asthma (wheezing) • shock . . .
―Do not use if you have ever had an allergic reaction to any other pain
reliever/fever reducer. . . .
―Stop use and ask a doctor if
―• an allergic reaction occurs. Seek medical help right away.
―• pain gets worse or lasts more than 10 days
―• fever gets worse or lasts more than 3 days
―• stomach pain or upset gets worse or lasts
―• redness or swelling is present in the painful area
―• any new symptoms appear‖
The label did not include specific warnings about skin reddening, rash,
and blisters as possible allergic reactions. According to McNeil, the FDA did
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not require such a specific warning for OTC products prior to 2005 because
the warning to seek medical help if any new symptoms appeared was a
broader warning that included these symptoms. McNeil did not seek
permission from the FDA to add SJS or TEN to its OTC labels. On one
occasion before 2005, it had asked the FDA for permission to change the
allergy alert language, but the agency advised it not to do so.
In July 2005, the FDA made a ―class label change,‖ directing McNeil
and other manufacturers of OTC ibuprofen products to change their labels
within six months to add three additional symptoms—skin reddening, rash,
and blisters. McNeil made the requested changes to its labels.
B. Plaintiff’s Use of Motrin
Plaintiff was born in November 1988 and lived in Honduras with his
grandmother, great-grandmother, and sister. His mother, Naara Silver, lived
in the United States with her husband and other children and occasionally
sent plaintiff care packages that included OTC medication. In 2005, Silver
purchased OTC Motrin and sent it to plaintiff. She had never purchased
Motrin before, but she wanted her grandmother to try it for her arthritis
pain. Silver testified that she would not have bought Motrin had she known
of the possibility of blisters because her grandmother was elderly and had
delicate skin.
In October 2005, plaintiff experienced aches and soreness in his legs
after a strenuous soccer practice. Plaintiff took half a tablet of aspirin and
took a nap. Plaintiff took aspirin for two days because he continued to feel
sore and very warm, but he stopped taking it after reading the label‘s
warning about Reye‘s Syndrome.
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Plaintiff continued to experience fever and muscle pain. He found
Motrin in the medicine cabinet and read the label because he had never
taken it before. After seeing that Motrin would treat pain and fever, plaintiff
took one pill and felt better. However, his symptoms returned after a four-
hour nap, so he took another Motrin and slept through the night. The
following morning, he was warm and his legs hurt, so he took a third Motrin
and continued to take it for two more days. When he awakened on the second
day, he noticed blisters in his mouth. One of the blisters broke and started
bleeding, so he asked his grandmother to take him to the doctor. He did not
take any more Motrin.
Plaintiff testified that if there had been a warning about blisters on
Motrin‘s label, he would not have taken it because he knew that blisters were
painful and could lead to an infection. He also testified that a warning about
skin reddening and rash would have convinced him not to take Motrin
because he was a teenager and would not have wanted blisters or rash on his
face. He acknowledged that he read the label, which included warnings
about hives and facial swelling, and he took the Motrin even though he
understood that facial swelling would affect his appearance.
Plaintiff was hospitalized in Honduras for about 10 days until
November 4, 2005, when he was transferred to Shriners Hospital for
Children in Galveston, Texas. When plaintiff arrived in Texas, he had
blisters or open wounds over most of his body. He was treated for TEN and
discharged on November 27, 2005.
C. SJS/TEN
The disease from which plaintiff suffered, SJS/TEN, is a rare disease,
thought to be an allergic reaction to a drug. SJS and TEN are part of the
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same disease spectrum, differing only in severity.2 The initial signs of
SJS/TEN include fever, malaise, redness of the skin, rash, and blisters,
known as non-specific symptoms. The early symptoms last several days
before the disease fully develops. Because various drugs may be taken to
treat the early, non-specific symptoms, it is difficult to determine the cause of
SJS and TEN.
At trial, one of plaintiff‘s experts, Roger Salisbury, opined that
plaintiff‘s TEN was caused by the Motrin he consumed and not by any
environmental factors. Another plaintiff‘s expert, Randall Tackett, testified
that he did not believe the aspirin and Tylenol that plaintiff consumed
contributed to his disease. He stated that TEN is referred to as an
idiosyncratic side effect that can occur at a dosage even lower than the
minimum recommended dosage. Tackett described the mechanism by which
he believed ibuprofen caused plaintiff‘s TEN, explaining that NSAIDs affect a
chemical in the body related to inflammation, leading to an immune system
process and a reaction affecting a chemical compound known as tumor
necrosis factor.
D. FDA Safety Review and Citizen’s Petition
In early 2005, the FDA undertook a comprehensive safety review of
NSAIDs, including ibuprofen. In February 2005, Salisbury, Tackett and
several experts involved in other Motrin litigation, submitted a Citizen‘s
Petition to the FDA and McNeil, asserting that the label on OTC Motrin
should contain a warning about SJS and TEN. Salisbury asked the FDA to
2 Generally, the diagnosis is SJS when less than 10 percent of the body
surface area is affected, SJS/TEN when 10 to 30 percent is affected, and TEN
when more than 30 percent of the body is affected.
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conduct a risk assessment of SJS/TEN, to investigate whether manufacturers
had withheld ―critical safety information regarding the risks of SJS and TEN
associated with ibuprofen products,‖ and to require manufacturers to add
warnings of SJS/TEN to their labeling.
The FDA responded to the petition in a detailed letter dated June 22,
2006. The agency explained that in April 2005, it issued a press release, a
public health advisory, and a decision memo explaining the risks of NSAID
products but emphasizing the need for a wide variety of NSAID options. The
agency decided to ask prescription NSAID manufacturers to change their
labels to include additional warnings about SJS/TEN. As to OTC NSAIDs,
the FDA decided to warn consumers about the risks of severe skin reactions
but did not believe it was useful to use the terms ―SJS‖ and ―TEN‖ because
most consumers are not familiar with those terms. The agency thus decided
to add warnings about skin reddening, rash, and blisters to OTC NSAID
labels.
The FDA disputed Salisbury‘s estimate that there are 49-60 per million
cases of SJS per year, stating instead that there are 1.2 to 6 per million cases
of SJS per year and 0.4 to 1.2 per million of TEN per year. The agency‘s
estimate was based on its review of the Adverse Event Report System
database, which revealed 88 cases from 1975 through March 2005, of which
49 were possibly related to the use of ibuprofen. Given that ―there are
approximately 29 million prescriptions dispensed per year in the U.S. retail
setting for prescription single-ingredient ibuprofen . . . and probably more
than 100 million users of OTC ibuprofen per year,‖ the FDA concluded that
the risk of SJS/TEN was much lower than Salisbury had asserted.
The FDA further disputed Salisbury‘s assertion that the mortality rate
for SJS was 5 to 30 percent and 80 percent for TEN. Instead, the agency
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asserted that SJS was fatal in 5 percent of cases and TEN in 30 percent of
cases. Salisbury acknowledged at trial that the mortality rate for TEN
patients at his burn center was actually 30 percent or lower, not 80 percent.
In response to the petition‘s assertion that manufacturers withheld
safety information about SJS/TEN, the FDA stated that Salisbury provided
no evidence, and the FDA had no evidence of undisclosed safety information.
Salisbury acknowledged at trial that he was not aware of any adverse event
report received by McNeil that it failed to report to the FDA.
The FDA disagreed with Salisbury‘s statement that the agency should
―reconsider the OTC status of the pediatric formulation of ibuprofen‖ because
―the incidence of SJS or TEN is not as great as cited.‖ The agency further
explained that ―the overall benefit versus risk profile for ibuprofen products
remains very favorable when they are used according to the labeled
instructions. It is in the interest of the public health to maintain in the
pediatric OTC market a range of therapeutic options for the short-term relief
of pain.‖
E. Dexibuprofen as an Alternative to Ibuprofen
Tackett testified that dexibuprofen, an isomer or component of
ibuprofen, ―appears to be a safer product‖ with fewer side effects than
ibuprofen. He believed that defendants should have withdrawn ibuprofen
and marketed dexibuprofen instead, even though the FDA has not approved
dexibuprofen for sale in the United States. Tackett testified that when the
FDA denied an application to market dexibuprofen, it was not due to a safety
issue but because it ―had not been put forward as a prescription drug first,
which is the usual way things . . . go from prescription to over the counter.‖
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Tackett opined that, unlike dexibuprofen, Motrin contained a
component called racemic ibuprofen that contributed to SJS/TEN, and that
dexibuprofen was not associated with SJS/TEN. However, a prescription
label for dexibuprofen, which was sold outside the United States, contained a
warning for SJS/TEN. Tackett acknowledged that dexibuprofen use was
much lower than ibuprofen, which had been used several billion times.
II. Procedural History
A jury trial commenced in August 2011 on plaintiff‘s claim that he
developed SJS/TEN as a result of taking Motrin. He alleged claims for strict
liability failure to warn, negligent failure to warn, negligent design defect,
and strict liability design defect based on the consumer expectation test and
the risk-benefit test.3
The jury found McNeil liable for negligent failure to warn, strict
liability design defect under the consumer expectation test, and negligent
design defect. As to Johnson & Johnson, the jury found in favor of plaintiff
only on his strict liability design defect claim under the consumer expectation
test. The jury awarded plaintiff $11,401,220 in economic damages,
$21,166,660 in non-economic damages, $6,833,330 in punitive damages
against McNeil, and $8,791,670 in punitive damages against Johnson &
Johnson.
After polling the jurors on their verdicts, the trial court asked if there
was any reason why the jury should not be discharged. Defense counsel
3 In January 2011, we denied defendants‘ petition for writ of mandate
challenging the trial court‘s order denying their motion for summary
adjudication of issues regarding punitive damages. (See Johnson & Johnson
v. Superior Court (2011) 192 Cal.App.4th 757.)
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stated, ―Other than about the verdict being fatally inconsistent.‖ The court
replied, ―Anything else. Other than that.‖ Defense counsel said no, and the
court discharged the jury. The court subsequently asked counsel to put their
objections on the record, which they did, arguing that the verdicts on
negligent and strict liability failure to warn were fatally inconsistent. As
later explained in the trial court‘s order denying defendants‘ motion for new
trial, defendants raised the issue of inconsistent verdicts in an unreported
chambers discussion before the jury was discharged, but the court did not
find the verdicts to be inconsistent. Defendants timely appealed from the
judgment.
DISCUSSION
I. Inconsistent Verdicts on Negligent and Strict Liability Failure to Warn
By special verdict, the jury found McNeil liable on plaintiff‘s claim for
negligent failure to warn, but not liable on plaintiff‘s claim for strict liability
failure to warn. McNeil contends that the verdicts are inconsistent, and that
therefore the verdict of liability on the negligence theory must be set aside.
For the reasons explained below, we agree.4
4 Plaintiff contends that McNeil forfeited this contention by failing to
object before the jury was discharged and ask the court to have the jury
reconvene under Code of Civil Procedure section 619 to correct the
inconsistency. We disagree. First, no objection was required to preserve the
claim. (Lambert v. General Motors (1998) 67 Cal.App.4th 1179, 1182
(Lambert) [no objection to preserve the issue of inconsistent verdicts for
review]; see Morris v. McCauley’s Quality Transmission Service (1976) 60
Cal.App.3d 964, 972 [inconsistent verdict defect ―is not waived by failure to
call it to the attention of the trial court prior to discharging the jury‖].)
Second, in any event, McNeil raised the issue in the trial court. According to
the trial court‘s denial of the motion for new trial, defense counsel raised the
issue in an unreported conference in chambers before the jury was
discharged, but the court found no inconsistency in the verdicts. Then, on the
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A. Inconsistency in Special Verdicts
―‗―The inconsistent verdict rule is based upon the fundamental
proposition that a factfinder may not make inconsistent determinations of
fact based on the same evidence. . . .‖ [Citations.] An inconsistent verdict
may arise from an inconsistency between or among answers within a special
verdict [citation] or irreconcilable findings. [Citation.] Where there is an
inconsistency between or among answers within a special verdict, both or all
the questions are equally against the law. [Citation.] The appellate court is
not permitted to choose between inconsistent answers.‘ [Citation.]‖ (Oxford
v. Foster Wheeler LLC (2009) 177 Cal.App.4th 700, 716 (Oxford).)
―The proper remedy for an inconsistent special verdict is a new trial.
[Citation.]‖ (Singh v. Southland Stone, U.S.A., Inc. (2010) 186 Cal.App.4th
338, 358 (Singh).) ―A court reviewing a special verdict does not infer findings
in favor of the prevailing party [citation], and there is no presumption in
favor of upholding a special verdict when the inconsistency is between two
questions in a special verdict. [Citation.]‖ (Zagami, Inc. v. James A. Crone,
Inc. (2008) 160 Cal.App.4th 1083, 1092 (Zagami).) The standard of review for
inconsistency in a special verdict is de novo.5 (Cumbre, Inc. v. State Comp.
Ins. Fund (2010) 189 Cal.App.4th 1381, 1388.)
record, after polling the jury, the trial court asked if there was any reason
why the jury should not be discharged. Defense counsel stated, ―Other than
about the verdict being fatally inconsistent.‖ Finally, after the jury was
discharged, the court asked counsel to put their objections to the verdict on
the record, which they did. In short, the issue was not forfeited.
5 Plaintiff asserts that ―A jury‘s ‗verdict will stand unless the facts found
by the jury in answer to special interrogatories are so clearly antagonistic to
it as to be absolutely irreconcilable, the conflict being such as to be beyond
the possibility of being removed by any evidence admissible under the
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B. Products Liability Failure to Warn
Products liability may be premised upon a theory of design defect,
manufacturing defect, or failure to warn. (Anderson v. Owens–Corning
Fiberglas Corp. (1991) 53 Cal.3d 987, 995 (Anderson).) ―[A] plaintiff may
seek recovery in a ‗products liability case‘ either ‗on the theory of strict
liability in tort or on the theory of negligence.‘ [Citations.] The rules of
products liability ‗focus responsibility for defects, whether negligently or
nonnegligently caused, on the manufacturer of the completed product.‘
[Citation.] Thus, under either a negligence or a strict liability theory of
products liability, to recover from a manufacturer, a plaintiff must prove that
a defect caused injury. [Citations.] Under a negligence theory, a plaintiff
must also prove ‗an additional element, namely, that the defect in the product
was due to negligence of the defendant.‘ [Citations.]‖ (Merrill v. Navegar,
Inc. (2001) 26 Cal.4th 465, 478-479 (Merrill); Brown v. Superior Court (1988)
44 Cal.3d 1049, 1056 (Brown) [―Strict liability differs from negligence in that
it eliminates the necessity for the injured party to prove that the
issues,‘‖ quoting Lowen v. Finnila (1940) 15 Cal.2d 502, 504. However, this
standard applies when a special finding is alleged to be inconsistent with a
general verdict, not when special verdict findings are inconsistent with other
special verdict findings—a fact made obvious in portions of the quoted
sentence plaintiff omits. The rule that ―a verdict should not be modified ‗if
there is any ―possibility of reconciliation under any possible application of the
evidence and instructions‖‘ . . . [¶] applies only to inconsistencies between
general and special verdicts, and inconsistencies between special findings
rendered in support of a general verdict.‖ (Mendoza v. Club Car, Inc. (2000)
81 Cal.App.4th 287, 302-303.) ―With a special verdict, unlike a general
verdict or a general verdict with special findings, a reviewing court will not
infer findings to support the verdict.‖ (Singh, supra, 186 Cal.App.4th at p.
358.)
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manufacturer of the product which caused injury was negligent.‖].)
―‗Ordinarily, strict liability, which was developed to ease a claimant‘s burden
of proof, requires proof of fewer elements than negligence, making a positive
verdict on the latter difficult to explain if strict liability cannot be found.‘‖ (1
Owen & Davis on Prod. Liab. (4th ed. 2016) § 5:29, fn. 25.)
The failure to warn theory of products liability is based on the premise
that ―‗a product, although faultlessly made, may nevertheless be deemed
―defective‖ under the rule and subject the supplier thereof to strict liability if
it is unreasonably dangerous to place the product in the hands of a user
without a suitable warning and the product is supplied and no warning is
given.‘ [Citation.]‖ (Anderson, supra, 53 Cal.3d at pp. 995-996.) ―Whether
the absence of a warning makes a product defective involves several factors,
including a consumer‘s normal expectations of how a product will perform;
degrees of simplicity or complication in its operation or use; the nature and
magnitude of the danger to which the user is exposed; the likelihood of injury;
and the feasibility and beneficial effect of including such a warning.
[Citation.]‖ (Oxford, supra, 177 Cal.App.4th at p. 717.)
C. The Jury’s Verdicts
In the present case, the evidentiary basis of plaintiff‘s failure to warn
theory for both strict liability and negligence was that OTC Motrin was
defective because its warning label did not include the potential side effects of
skin reddening, rash and blisters. In returning a special verdict finding
McNeil not liable on a theory of strict liability failure to warn, the jury found
that OTC Motrin had ―potential risks, side effects and/or allergic reactions
that were known or knowable through the use of scientific knowledge
available at the time of manufacture, distribution or use by Christopher
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Trejo,‖ that ―ordinary consumers [would not] have recognized the potential
risks, side effects and/or allergic reactions,‖ and that ―McNeil fail[ed] to
adequately warn or instruct of [sic] the potential risks, side effects and/or
allergic reactions.‖ But in response to question 6 on verdict form, the jury
answered ―no‖ to the query: ―Did the potential risks, side effects, and/or
allergic reactions present a substantial danger when the OTC Motrin is used
or misused in an intended or reasonably foreseeable way?‖6 This ―no‖
6 The jury‘s full findings on strict liability and negligent failure to warn
were as follows:
―(Strict Liability—Failure to Warn)
―1. Did Defendant McNeil manufacture, distribute and/or sell over-the-
counter (‗OTC‘) Motrin? [¶] Yes 12 No 0 . . .
―2a. Did Defendant Johnson & Johnson receive a direct financial benefit
from the sale of OTC Motrin? [¶] Yes 12 No 0 . . .
―2b. Was Defendant Johnson & Johnson an integral part of the marketing
enterprise such that its conduct was a necessary factor in bringing OTC
Motrin to the consumer market? [¶] Yes 12 No 0 . . .
―2c. Did Defendant Johnson & Johnson have control over, or a substantial
ability to influence, the marketing of OTC Motrin? [¶] Yes 12 No 0 . . .
―3. Did OTC Motrin have potential risks, side effects and/or allergic reactions
that were known or knowable through the use of scientific knowledge
available at the time of manufacture, distribution or use by Christopher
Trejo? [¶] Yes 12 No 0 . . .
―4. Would ordinary consumers have recognized the potential risks, side
effects and/or allergic reactions? [¶] Yes 1 No 11. . .
―5(a) Did McNeil fail to adequately warn or instruct of the potential risks,
side effects and/or allergic reactions? [¶] Yes 10 No 2 . . .
―5(b) Did Johnson & Johnson fail to adequately warn or instruct of the
potential risks, side effects and/or allergic reactions associated with OTC
Motrin? [¶] Yes 2 No 10 . . .
―6. Did the potential risks, side effects, and/or allergic reactions present a
substantial danger when the OTC Motrin is used or misused in an intended
or reasonably foreseeable way? [¶] Yes 2 No 10
―If you answered ‗Yes‘ to Question 6, please answer Question 7. If you
answered ‗No,‘ please skip to Question 8.
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response—i.e., that OTC had no potential risks that caused a substantial
danger when used in a foreseeable way—compelled a verdict in McNeil‘s
favor, because under the jury instructions for strict liability, OTC Motrin
lacked adequate warnings only if it ―had potential risks/side effects/allergic
reactions that were known or knowable by the use of scientific knowledge
available at the time of manufacture/distribution/sale,‖ and if those reactions
―presented a substantial danger when the Motrin is used or misused in an
intended or reasonably foreseeable way.‖7 (Italics added.)
―7. Was the lack of sufficient warnings or instructions a substantial factor in
causing harm to Plaintiff? [¶] Yes __ No __ . . .
―(Negligence—Failure to Warn)
―8. Did Defendant know or should it reasonably have known that OTC
Motrin was dangerous or was likely to be dangerous when used in a
reasonably foreseeable manner?
Defendant McNeil Yes 10 No 2 . . .
Defendant Johnson & Johnson Yes 10 No 2
―If you answered ‗Yes‘ to either part of Question 8, please answer Question 9
as to that Defendant or Defendants. Otherwise, please proceed to Question
11.
―9. Did Defendant know or should it reasonably have known that users
would not realize the danger?
Defendant McNeil Yes 10 No 2 . . .
Defendant Johnson & Johnson Yes 10 No 2
―If you answered ‗Yes‘ to either part of Question 9, please answer Question 10
as to that Defendant or Defendants. Otherwise, please skip to Question 11.
―10. Was Defendant‘s failure to warn a substantial factor in causing harm to
Christopher Trejo?
Defendant McNeil Yes 9 No 3 . . .
Defendant Johnson & Johnson Yes 1 No 11.‖
7 We note that the verdict form for strict liability failure to warn
presented the elements of the claim in a different order than the strict
liability jury instruction, CACI No. 1205, and the sample verdict form for
CACI No. 1205 provided by the Judicial Council. CACI No. 1205 and VF-
1205, as well as the verdict form proposed by defendants, ask whether the
potential risks present a substantial danger before asking whether the
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By contrast, the jury found McNeil liable on plaintiff‘s cause of action
for negligent failure to warn. In returning that special verdict, the jury found
(in response to question 8) that McNeil knew or ―should . . . reasonably have
known that OTC Motrin was dangerous or was likely to be dangerous when
used in a reasonably foreseeable manner.‖ The jury also concluded that
McNeil knew or ―should . . . reasonably have known that users would not
realize the danger,‖ and McNeil‘s ―failure to warn [was] a substantial factor
in causing harm to [plaintiff].‖ These findings compelled a verdict for
plaintiff on the negligent failure to warn claim, because under the jury
instructions for that claim, McNeil was liable if it ―knew or reasonably should
have known that the Motrin was dangerous or was likely to be dangerous
when used or misused in a reasonably foreseeable manner,‖ but failed to
warn of the danger under circumstances in which a reasonable manufacturer
would have warned.
Considering that both the strict liability and negligence theories were
premised on a single alleged defect—failure to warn of potential skin
reddening, rash and blisters—the jury‘s findings meant, in substance, that
McNeil was not strictly liable for failure to warn of those possible reactions
because they created no substantial danger, but was liable for negligent
failure to warn because those possible reactions were, or were likely to be,
dangerous. As we next explain, we conclude that these verdicts are fatally
inconsistent. (See Oxford, supra, 177 Cal.App.4th at p. 720 [―a finding of
negligent failure to warn is logically and legally inconsistent with the jury‘s
defendant failed to adequately warn of the potential risks. Placing the
special verdict questions in that order is more logical than the verdict form
here, because if the potential risks do not present a substantial danger, there
is no need to warn under strict liability principles.
18
finding [in favor of defendants] on plaintiffs‘ strict products liability failure to
warn‖]; Valentine v. Baxter Healthcare Corp. (1999) 68 Cal.App.4th 1467,
1483 (Valentine) [―the manufacturer‘s strict liability duty to warn is greater
than its duty under negligence, and thus negligence requires a greater
showing by plaintiffs‖]; Lambert, supra, 67 Cal.App.4th at pp. 1185-1186
[jury‘s finding of negligent design inconsistent with its finding of no strict
liability design defect].)
D. The Verdicts are Inconsistent
The decision in Valentine, supra, 68 Cal.App.4th 1467 is particularly
instructive, and virtually indistinguishable in all pertinent aspects from the
present case. As here relevant, the plaintiff in Valentine sued a
manufacturer of silicone gel breast implants for strict liability and negligent
failure to warn, based on the manufacturer‘s failure to warn her physician
(and through him, her) that the migration or bleeding of silicone from
implants might cause disease. The case was tried twice. The first jury
returned a special verdict for the defense on the plaintiff‘s strict liability
failure to warn claim, but deadlocked on negligent failure to warn. After the
declaration of a mistrial, the negligent failure to warn claim was tried to a
second jury. That jury deadlocked as well, and the trial court directed a
defense verdict on that claim.
On appeal, the appellate court considered whether ―the defense verdict
in the first trial on strict liability failure to warn subsume[d] the cause of
action for negligent failure to warn so that the court presiding over the
second trial was within its authority to direct a defense judgment on that
19
negligence count.‖8 (Valentine, supra, 68 Cal.App.4th at p. 1471.) The court
concluded that the defense verdict on strict liability failure to warn mandated
a defense verdict on negligent failure to warn as well.
For strict liability failure to warn, the jury in Valentine was instructed
in part that ―‗[a] product is defective if the use of the product in a manner
that is reasonably foreseeable by the defendant involves a substantial danger
that would not be readily recognized by the ordinary user of the product and
the manufacturer knows or should have known of the danger but fails to give
adequate warning of such danger. . . . A manufacturer has a duty to provide
an adequate warning to the user on how to use the product if a reasonably
foreseeable use of the product involves a substantial danger of which the
manufacturer is either aware or should be aware, and that would not be
recognized by the ordinary user.‖ (Valentine, supra, 68 Cal.App.4th at p.
1481.)
For negligent failure to warn, the jury was instructed that a supplier
who ―‗knows or has reason to know [the product] is dangerous or is likely to
be dangerous for the use for which it is supplied, has a duty to use reasonable
care to give warning of the dangerous condition of the product or of facts
which make it likely to be dangerous to those who the supplier would expect
to use the product or to be endangered by its probable use, if the supplier has
reason to believe that they will not realize its dangerous condition.‘‖
(Valentine, supra, 68 Cal.App.4th at pp. 1481-1482.)
8 Plaintiff contends that Valentine is inapplicable because the court there
was not deciding whether two special verdicts were inconsistent. However,
the different procedural posture is immaterial. The issue decided by
Valentine was the same as that raised here: whether a jury‘s finding of no
strict liability failure to warn foreclosed a finding of negligent failure to warn.
(Valentine, supra, 68 Cal.App.4th at pp. 1480-1481.)
20
Under these instructions (as pertinent here),9 the appellate court held
that the defense verdict in the first trial on plaintiff‘s strict liability failure to
warn claim ―disposed of any liability for failure to warn,‖ because ―the strict
liability definition of defective product, coupled with instructions on the strict
liability duty to warn physicians of the potential risks or side effects of
silicone breast implants that were ‗known or knowable,‘ more than subsumed
the elements of duty to warn set forth in the negligence instructions.‖
(Valentine, supra, 68 Cal.App.4th at p. 1482.)
The court explained: ―The [trial] court defined a product as defective if
its use involved a substantial danger that would not be readily recognized by
the ordinary user and the manufacturer knows/should have known of the
danger but fails to warn. Under the negligence warning instructions, the
manufacturer was charged with knowing/having reason to know that the
product is dangerous or likely to be dangerous for its intended use.‖
(Valentine, supra, 68 Cal.App.4th at p. 1482.) The appellate court found no
―real difference between a warning to ordinary users about a product use that
involves a substantial danger, and a warning about a product that is
dangerous or likely to be dangerous for its intended use. The former warning
[applicable for strict liability] centers on the term ‗use.‘ A product whose use
involves a substantial danger may or may not harm any particular user. The
latter warning [applicable for negligence] centers on (1) the dangerous
condition of the product, or (2) facts likely to make the product dangerous.
9 The court also considered claims that the strict liability instructions did
not adequately convey that the duty to warn was a continuing duty
(Valentine, supra, 68 Cal.App.4th at p. 1482) and that the instructions failed
to convey that an ordinary user included someone highly susceptible to
autoimmune disease (id. at p. 1483). As these issues are not relevant here,
we do not discuss them.
21
Again, under the ‗likely‘ prong, the product may or may not harm any
particular user. As a practical matter then, the difference in the two concepts
is so small as to make no difference.‖ (Id. at pp. 1482-1483.)
Similarly, the court reasoned that ―the finding of the [first] jury [for
strict liability purposes] that the implants were not defective due to Baxter‘s
[the manufacturer‘s] failure to warn included the finding that Baxter
discharged its duty to warn of potential risks or side effects which were
‗known or knowable . . . .‘ The manufacturer‘s duty, per strict liability
instructions, to warn of potential risks and side effects envelopes a broader
set of risk factors than the duty, per negligence instructions, to warn of facts
which make the product ‗likely to be dangerous‘ for its intended use. A
‗potential‘ risk is one ‗existing in possibility‘ or ‗capable of development into
actuality,‘ while a product ‗likely‘ to be dangerous will ‗in all probability‘ or
‗probably‘ be dangerous. Stated differently, if Baxter adequately warned of
potential risks and side effects [a necessary conclusion of the verdict finding
it not liable on a strict liability theory], it of necessity warned of facts likely to
render the product dangerous to the user [for negligence purposes]. But
conversely, one could discharge the duty to warn of likely risks [for
negligence purposes] without discharging the duty to warn of potential risks
[for strict liability purposes]. In sum, the manufacturer‘s strict liability duty
to warn is greater than its duty under negligence, and thus negligence
requires a greater showing by plaintiffs.‖ (Valentine, supra, 68 Cal.App.4th
at p. 1483, fns. omitted.)
The court also concluded ―the ‗known or knowable in light of‘ language
in the strict liability instruction at a minimum encompasses the ‗knows or
has reason to know‘ language in the negligence instruction. Under a
negligence standard, a reasonable manufacturer would not be charged with
22
knowing more than what would come to light from the prevailing scientific
and medical knowledge. . . . ‗Negligence law in a failure-to-warn case
requires a plaintiff to prove that a manufacturer or distributor did not warn
of a particular risk for reasons which fell below the acceptable standard of
care, i.e., what a reasonably prudent manufacturer would have known and
warned about. Strict liability is not concerned with the standard of due care
or the reasonableness of a manufacturer‘s conduct. The rules of strict
liability require a plaintiff to prove only that the defendant did not
adequately warn of a particular risk that was known or knowable in light of
the generally recognized and prevailing best scientific and medical knowledge
available at the time of manufacture and distribution. Thus, in strict
liability, as opposed to negligence, the reasonableness of the defendant‘s
failure to warn is immaterial.‘‖ (Valentine, supra, 68 Cal.App.4th at pp.
1483-1484.) In short, the court concluded that ―a jury finding of no strict
liability for failure to warn . . . cannot admit a companion finding for
negligent failure to warn.‖ (Id. at p. 1484.)
In the present case, the jury was instructed on substantially the same
principles as in Valentine.10 In Valentine, the jury instructions required a
finding of negligent failure to warn if the defendant manufacturer knew or
had reason to know that the product ―‗is dangerous or is likely to be
dangerous for the use for which it is supplied,‘‖ and failed to meet the ―‗duty
10 Plaintiff contends that Valentine does not apply because the jury
instructions in Valentine differ from the jury findings here. However,
plaintiff compares the jury instructions in Valentine with the jury‘s findings
here, rather than the instructions given here, which is not an apt comparison.
We compare the jury instructions to the instructions here. The jury
instructions are similar and are, in fact, identical as to the salient requisite
elements.
23
to use reasonable care to give warning of the dangerous condition of the
product or of facts which make it likely to be dangerous . . . if the supplier has
reason to believe that [expected users] will not realize its dangerous
condition.‘‖ (Valentine, supra, 68 Cal.App.4th at p. 1482.) Similarly, in the
present case, to return a verdict for plaintiff on the negligent failure to warn,
the jury was instructed in relevant part it had to find that ―McNeil knew or
reasonably should have known that the Motrin was dangerous or was likely
to be dangerous when used or misused in a reasonably foreseeable manner,‖
that ―McNeil knew or reasonably should have known that users would not
realize the danger,‖ that ―McNeil failed to adequately warn of the danger or
instruct on the safe use of Motrin,‖ and that ―a reasonable manufacturer . . .
under the same or similar circumstances would have warned of the danger or
instructed on the safe use of Motrin.‖11 These instructions track the
principles of the negligent failure to warn instructions in Valentine—in both
11 The instruction on negligent failure to warn was CACI No. 1222,
modified to address plaintiff‘s claim, as follows: ―[P]laintiff claims that
Johnson & Johnson and/or McNeil was negligent by not using reasonable
care to warn or instruct about the Motrin‘s dangerous condition or about facts
that make Motrin likely to be dangerous. To establish this claim, [plaintiff]
must prove all of the following: [¶] 1. That Johnson & Johnson and/or
McNeil manufactured, distributed, or sold Motrin; [¶] 2. That Johnson &
Johnson and/or McNeil knew or reasonably should have known that the
Motrin was dangerous or was likely to be dangerous when used or misused in
a reasonably foreseeable manner; [¶] 3. That Johnson & Johnson and/or
McNeil knew or reasonably should have known that users would not realize
the danger; [¶] 4. That Johnson & Johnson and/or McNeil failed to
adequately warn of the danger or instruct on the safe use of Motrin; [¶] 5.
That a reasonable manufacturer, distributor, or seller under the same or
similar circumstances would have warned of the danger or instructed on the
safe use of Motrin; [¶] 6. That plaintiff was harmed by Motrin; and [¶] 7.
That Johnson & Johnson and/or McNeil‘s failure to warn or instruct was a
substantial factor in causing [plaintiff]‘s harm.‖
24
cases, ―the manufacturer was charged with knowing/having reason to know
that the product is dangerous or likely to be dangerous for its intended use,‖
and required to warn of that actual or likely danger. (Ibid.)
On the other hand, for strict liability in Valentine, the jury instructions
permitted a finding of liability if ―use [of the product] involved a substantial
danger that would not be readily recognized by the ordinary user and the
manufacturer knows/should have known of the danger but fails to warn.‖
(Valentine, supra, 68 Cal.App.4th at p. 1482.) The same concept was
conveyed to the jury in the present case: the jury was instructed OTC Motrin
lacked adequate warnings if it ―had potential risks/side effects/allergic
reactions that were known or knowable by the use of scientific knowledge
available at the time of manufacture/distribution/sale,‖ ―the potential
risks/side effects/allergic reactions presented a substantial danger when the
Motrin is used or misused in an intended or reasonably foreseeable way,‖
―ordinary consumers would not have recognized the potential risks/side
effects/allergic reactions,‖ and ―McNeil failed to adequately warn or
instruct of [sic] the potential risks/side effects/allergic reactions.12 Thus, the
instructions in the present case, as in Valentine, conveyed that strict liability
12 The instruction on strict liability failure to warn was CACI No. 1205,
modified to address plaintiff‘s claim, as follows: ―Plaintiff claims that the
Motrin [product] lacked sufficient [instructions] [or] [warning of potential
[risks/side effects/allergic reactions]]. To establish this claim, [plaintiff] must
prove all of the following: [¶] That [Johnson & Johnson] and/or McNeil
[manufactured/distributed/sold] the [product]; [¶] That the [product] had
potential [risks/side effects/allergic reactions] that were [known] [or]
[knowable by the use of scientific knowledge available] at the time of
[manufacture/distribution/sale]; [¶] 3. That the potential [risks/side
effects/allergic reactions] presented a substantial danger when the Motrin is
used or misused in an intended or reasonably foreseeable way; [¶] 4. That
ordinary consumers would not have recognized the potential [risks/side
effects/allergic reactions]; [¶] 5. That [Johnson & Johnson] and/or McNeil
25
depends on finding that the manufacturer failed to warn of potential risks
from an intended use of the product that creates substantial danger.
Given that the jury here was instructed on the same principles as in
Valentine, the same conclusions necessarily flow from the jury‘s finding in its
strict liability verdict that ―the potential risks, side effects, and/or allergic
reactions‖ of OTC Motrin—skin reddening, rash and blisters—did not
―present a substantial danger when the OTC Motrin is used or misused in an
intended or reasonably foreseeable way.‖ As in Valentine: (1) the strict
liability instructions ―more than subsumed the elements of duty to warn set
forth in the negligence instructions‖ (Valentine, supra, 68 Cal.App.4th at p.
1482); (2) under the instructions, there is no ―real difference between a
warning to ordinary users about a product use that involves a substantial
danger, and a warning about a product that is dangerous or likely to be
dangerous for its intended use‖ (ibid.); (3) McNeil‘s duty under the strict
liability instructions ―to warn of potential risks and side effects envelope[d] a
broader set of risk factors than the duty, [under the] negligence instructions,
to warn of facts which make the product ‗likely to be dangerous‘ for its
intended use‖ (id. at p. 1483); (4) the reference in the strict liability
instructions here to ―potential risks . . . that were known or knowable by the
use of scientific knowledge‖ encompasses the concept in the negligence
instructions of risks McNeil ―knew or reasonably should have known‖; and
(5) for all these reasons, the jury‘s finding that McNeil was not liable under a
failed to adequately warn [or instruct] of the potential [risks/side
effects/allergic reactions]; [¶] 6. That [plaintiff] was harmed; and [¶] 7.
That the lack of sufficient [instructions] [or] [warnings] was a substantial
factor in causing [plaintiff]‘s harm.‖
26
strict liability theory ―disposed of any liability for failure to warn‖ on a
negligence theory. (Id. at p. 1482.)
If there were any doubt that the verdicts are inconsistent, that doubt is
put to rest by the decision in Oxford, supra, 177 Cal.App.4th 700. There, the
plaintiffs sued the manufacturer of ship boilers that contained asbestos,
alleging products liability causes of action for strict liability failure to warn
and design defect, as well as a general negligence claim. (Id. at p. 704.) The
jury returned a special verdict that found the defendant not liable for strict
liability failure to warn and design defect, but a general verdict for plaintiff
on the negligence claim, without any specification of the factual basis of
negligence. (Id. at p. 706.) The Court of Appeal reversed the general
negligence verdict as being irreconcilable on the evidence and instructions
with the special verdict on strict liability failure to warn.13 (Id. at pp. 721-
722.)
The court reasoned that in finding no strict liability for failure to warn,
the jury ―found explicitly that under California products liability law the
boilers were not defective with respect to warnings. Consequently the finding
13 Because the inconsistency was between a general and special verdict,
the court did not apply the standard applicable to inconsistency between
special verdicts (the situation in the present case), but the more lenient rule
applicable to inconsistencies between the special and general verdicts.
―General and special verdicts are deemed inconsistent when they are ‗beyond
possibility of reconciliation under any possible application of the evidence and
instructions.‘ [Citations.] ‗If any conclusions could be drawn thereunder
which would explain the apparent conflict, the jury will be deemed to have
drawn them.‘ [Citation.] Where the jury‘s findings are so inconsistent that
they are incapable of being reconciled and it is impossible to tell how a
material issue is determined, the decision is ‗―against law‖‘ within the
meaning of Code of Civil Procedure section 657. [Citation.]‖] (Oxford, supra,
177 Cal.App.4th at p. 716.)
27
of negligence can be reconciled [with the finding of no liability for strict
liability failure to warn] only if the record reveals some other basis on which
the jury, under the court‘s instructions, could have found defendant to have
been negligent.‖ (Oxford, supra, 177 Cal.App.4th at p. 719.) The court thus
examined ―the precise instructions that were given and the particular
evidence that was before the jury‖ to determine whether the jury‘s finding of
negligence was supportable under a theory other than negligent failure to
warn. (Id. at p. 718.) The court concluded that the only other possible theory
of negligence supported by the evidence (negligent testing) was inconsistent
with the jury‘s verdict for the defendant on the design defect claim, and thus
could not support a negligence verdict. Ruling out that and any other
potential basis for negligence, the court concluded that ―a finding of negligent
failure to warn is logically and legally inconsistent with the jury‘s finding on
plaintiffs‘ strict products liability failure to warn.‖ (Id. at p. 720; see id. at p.
721 [―the jury necessarily found that defendant did not fail to provide
adequate warnings when it found against plaintiffs on the products liability
failure to warn claim‖].) Because the jury‘s verdicts were inconsistent, the
court reversed and remanded for a new trial. (Id. at p. 722.)
In the present case, unlike Oxford, plaintiff did not pursue a general
negligence claim based on different factual bases, but rather a specific claim
of negligent failure to warn based on a single factual basis—the failure to
include warnings of skin reddening, rash, and blisters. Further, the jury
returned a special verdict, not a general verdict. Thus, we need not ask
whether the jury‘s finding of negligence can be supported on some factual
basis other than failure to warn; we know it cannot. Under these
circumstances, as in Oxford, the jury‘s finding of negligent failure to warn
was ―logically and legally inconsistent‖ with the finding of no strict products
28
liability failure to warn. (Oxford, supra, 177 Cal.App.4th at p. 720; accord
Werner v. Upjohn Co., Inc. (4th Cir. 1980) 628 F.2d 848, 860 [jury verdicts
―obviously inconsistent‖ where ―[t]he effect of the jury verdict on negligence
was to find that Upjohn failed to use due care to give an adequate warning of
the propensities of the drug marketed, and, in the same breath, the verdict on
strict liability found that the drug marketed with such an inadequate
warning was not unreasonably dangerous‖].)14
Plaintiff argues that the verdicts should stand, because ―negligence and
strict products liability are not identical doctrines.‖ (Oxford, supra, 177
Cal.App.4th at p. 718.) True enough—the two theories of products liability
are not identical. In Carlin v. Superior Court (1996) 13 Cal.4th 1104(Carlin), the California Supreme Court explained the difference between
strict liability failure to warn and negligent failure to warn, stating that,
unlike negligent failure to warn, ―‗[s]trict liability is not concerned with the
standard of due care or the reasonableness of a manufacturer‘s conduct. . . .‘
14 Though it did not involve failure to warn, the decision in Lambert,
supra, 67 Cal.App.4th 1179, is to the same effect regarding the preclusive
effect of a defense verdict on strict liability. In Lambert, the plaintiff, who
was injured in an accident in which the Chevrolet Blazer he was driving
rolled over, sued General Motors, alleging that the design of the Blazer was
defective on both a strict liability and negligence theory. In answer to the
first question in the special verdict, which related to the theory of strict
liability, the jury found no ―defect in the design‖ of the Blazer. (Id. at p.
1182.) But in response to the fifth question, which related to the negligence
claim, the jury found that ―General Motors [was] negligent in the design of‖
the Blazer. (Ibid.) The Court of Appeal set aside the negligence finding as
inconsistent with the finding of no design defect on the strict liability claim.
The court noted that the only evidence of negligence presented by plaintiff
was of negligent design. In that context, the court held that ―[i]f the design of
the [vehicle] was not defective, [the defendant] could not be deemed
negligent.‖ (Id. at p. 1186.) Because the special verdict was ―fatally
inconsistent,‖ the court reversed and remanded for a new trial. (Ibid.)
29
[Citation.]‖ (Id. at p. 1112.) The court gave examples illustrating that a
manufacturer could be held liable under strict liability principles even if its
failure to warn conformed to industry-wide practices and thus was not
negligent. (Id. at pp. 1112-1113.) The court did not, however, indicate that a
manufacturer could be held liable for negligent failure to warn despite being
found not liable for strict liability failure to warn. Indeed, as illustrated by
Valentine and Oxford, this cannot be so where, as here, only one viable
factual basis supports both theories.
Plaintiff also argues that the verdicts are not inconsistent because the
term ―danger‖ in the negligence instructions and in question 8 of the
negligence special verdict referred to a different type of danger than
―substantial danger‖ as referred to in the strict liability instructions and in
question 6 of the strict liability verdict. According to plaintiff, ―substantial
danger‖ for strict liability is a quantitative danger and refers to how rare the
disease is, while ―danger‖ for negligence purposes is a qualitative danger and
refers to how severe the disease is. Thus, in plaintiff‘s view, the jury could
have concluded for strict liability that the risk of skin reddening, rash and
blisters from SJS/TEN was not a substantial danger because it was such a
rare reaction, but at the same time concluded for negligence that such a
reaction was a danger because of its severity. To support this supposed
dichotomy, plaintiff relies on Cavers v. Cushman Motor Sales, Inc. (1979) 95
Cal.App.3d 338 (Cavers).
In Cavers, the court rejected the plaintiff‘s challenge to a jury
instruction on strict liability failure to warn, which gave guidance on the
concept of substantial danger: ―‗Whether a danger is substantial or
insubstantial must be determined from the evidence and measured in the
light of several criteria none of which is totally controlling including the
30
potential injurious consequences of such danger, the likelihood that injury
might result, the quality and extent of danger to which the user is exposed,
and whether a danger is latent or patent (patent means apparent and latent
is its antonym).‘‖ (Cavers, supra, 95 Cal.App.3d at p. 349.) Plaintiff quotes
Cavers for the proposition that ―the term ‗substantial danger‘ embraces
several criteria, ‗none of which is totally controlling.‘‖
For several reasons, plaintiff‘s attempt to draw a quantitative-
qualitative distinction between ―substantial danger‖ and ―danger‖ fails.
First, the jury instruction on negligence itself defeats the claim that ―danger‖
for negligence purposes referred to a qualitative danger, that is, the severity
of the potential reaction. Under the instructions, liability was premised on
McNeil‘s failure to warn of reactions that were ―dangerous or . . . likely to be
dangerous,‖ not reactions based on their severity. Second, in the present
case, defendants requested a jury instruction modeled on Cavers to aid in
defining substantial danger for strict liability: ―In determining whether a
danger is substantial, you may consider several factors, including the
likelihood that harm will occur and the nature of that harm.‖ However, the
trial court declined to give the instruction, instead relying on CACI No. 1205,
which does not include an explanation of the term ―substantial danger.‖
Thus, the jury was never instructed on factors to weigh in determining
whether the potential risks of OTC Motrin posed a substantial danger.
Third, plaintiff relies on Cavers for the proposition that ―the term
‗substantial danger‘ embraces several criteria, ‗none of which is totally
controlling.‘‖ But even if this concept had been explained to the jury, it
directly contradicts plaintiff‘s argument on appeal that ―substantial danger‖
in the strict liability failure to warn instructions and verdict refers only to a
singular type of danger—a quantitative danger, meaning how rare SJS/TEN
31
is. Fourth, as we have noted, under the reasoning of Valentine, there is no
―real difference between a warning to ordinary users about a product use that
involves a substantial danger, and a warning about a product that is
dangerous or likely to be dangerous for its intended use.‖ (Valentine, supra,
68 Cal.App.4th at p. 1482.) Indeed, in the instant case, the jury was not
instructed that there was any such quantitative-qualitative distinction
between ―substantial danger‖ and ―danger.‖ In short, plaintiff‘s portrayal of
the findings on strict liability and negligence as consistent based on
distinguishing types of danger is unsupportable. The jury‘s special verdict on
negligent failure to warn is fatally inconsistent with its verdict on strict
liability failure to warn and must be reversed.15
II. Failure to Include Question on Duty to Warn
Although we reverse the verdict on negligent failure to warn as
inconsistent with the verdict on strict liability failure to warn, in the event of
a retrial, we also consider defendants‘ contention that the special verdict for
negligent failure to warn was defective for failing to include an essential
element: whether a reasonable manufacturer under the same or similar
circumstances would have warned of the danger. We agree that the verdict
form was defective.
―‗[A] special verdict is that by which the jury find the facts only, leaving
the judgment to the Court. The special verdict must present the conclusions
of fact as established by the evidence, and not the evidence to prove them;
and those conclusions of fact must be so presented as that nothing shall
15 Because we reverse the negligent failure to warn verdict, we do not
address defendants‘ argument that the failure to warn of skin reddening,
rash, and blisters did not cause plaintiff‘s injuries.
32
remain to the Court but to draw from them conclusions of law.‘ (Code Civ.
Proc., § 624.) [¶] . . . ‗A special verdict is ―fatally defective‖ if it does not
allow the jury to resolve every controverted issue. [Citations.]‘ [Citation.]‖
(Taylor v. Nabors Drilling USA, LP (2014) 222 Cal.App.4th 1228, 1240.)
Defendants‘ proposed verdict form for negligent failure to warn
included the following question: ―Would a reasonable manufacturer,
distributor or seller under the same or similar circumstances have warned of
the danger of or instructed on the safe use of OTC Motrin.‖16 The trial court
believed that the question was unnecessary because the instruction on
negligent failure to warn included this element. Plaintiff opposed the
proposed question, and the court did not include the question on the verdict
form. We conclude that because this question resolves a necessary element of
a negligent failure to warn claim, it was error to exclude it from the special
verdict.
On appeal, plaintiff contends that the special verdict form did require
the jury to consider appellants‘ duty to warn, despite the omission of the
question. He cites question 5(a), under the Strict Liability - Failure to Warn
portion of the special verdict form: ―Did McNeil fail to adequately warn or
instruct of the potential risks, side effects and/or allergic reactions?‖ He also
cites question 10, under the Negligence—Failure to Warn portion of the form:
―Was [McNeil‘s] failure to warn a substantial factor in causing harm to
[plaintiff]?‖ He contends that the jury‘s findings on these questions
sufficiently answer whether a reasonable manufacturer would have provided
the warning. Plaintiff further argues that the jury instruction on a
16 This question is taken from the standard CACI verdict form of
negligent failure to warn, VF-1205.
33
reasonable manufacturer‘s duty to warn rendered it unnecessary to include
the question on the verdict form. None of these contentions is meritorious.
First, question 5(a), regarding strict liability failure to warn, is
irrelevant to whether the special verdict form omitted an element as to
negligent failure to warn. ―‗Negligence law in a failure-to-warn case requires
a plaintiff to prove that a manufacturer or distributor did not warn of a
particular risk for reasons which fell below the acceptable standard of care,
i.e., what a reasonably prudent manufacturer would have known and warned
about. Strict liability is not concerned with the standard of due care or the
reasonableness of a manufacturer‘s conduct.‘‖ (Carlin, supra, 13 Cal.4th at p.
1112.) Thus, the question defendants wanted included in the special verdict
form—whether a reasonable manufacturer under the same or similar
circumstances would have given a warning—is an essential inquiry in the
negligent failure to warn claim. (See CACI No. 1222.) The question
regarding strict liability failure to warn does not address this element of
negligent failure to warn.
Second, question 10, asking whether McNeil‘s failure to warn was a
substantial factor in causing plaintiff harm, deals with causation and does
not address whether a reasonable manufacturer would have included a
warning about skin reddening, rash, and blisters. The question defendants
contend was erroneously omitted from the verdict form is not whether their
failure to warn caused plaintiff harm, but whether a reasonable
manufacturer would have provided the warning, because that is a necessary
element to prove liability for negligent failure to warn.
Third, that the jury instruction on negligent failure to warn defined a
reasonable manufacturer‘s duty to warn did not obviate the necessity of
including that required element in the special verdict. ―A jury instruction
34
alone does not constitute a finding. Nor does the fact that the evidence might
support such a finding constitute a finding.‖ (Myers Building Industries, Ltd.
v. Interface Technology, Inc. (1993) 13 Cal.App.4th 949, 961; see also Fuller-
Austin Insulation Co. v. Highlands Ins. Co. (2006) 135 Cal.App.4th 958, 1005
(Fuller-Austin) [―despite instructions asking the jury to consider the issue of
the settlement‘s reasonableness, the special verdict did not require the jury to
make any finding on the issue of reasonableness‖].) ―‗―The jury must resolve
all of the ultimate facts presented to it in the special verdict, so that ‗nothing
shall remain to the court but to draw from them conclusions of law.‘
[Citation.]‖‘‖ (Vanderpol v. Starr (2011) 194 Cal.App.4th 385, 396.) Because
the essential basis of a negligence failure to warn claim is that the
manufacturer did not warn of a particular risk that ―‗a reasonably prudent
manufacturer would have known and warned about,‘‖ (Carlin, supra, 13
Cal.4th at p. 1112) the verdict form should have included this question.
Plaintiff relies on Amerigraphics, Inc. v. Mercury Casualty Co. (2010)
182 Cal.App.4th 1538 (Amerigraphics), disapproved on another ground in
Nickerson v. Stonebridge Life Ins. Co. (2016) 63 Cal.4th 363, 377, fn. 2, to
argue that the omission of this element was immaterial. There, the court
rejected the defendant‘s argument that the punitive damages were not
supported by the special verdict because the jury did not separately award
damages for bad faith, which were ―an absolute predicate‖ for a punitive
damages award. (Id. at p. 1557.) The court reasoned that the jury‘s special
finding that the defendant breached its obligation of good faith and fair
dealing ―necessarily included the finding that [the plaintiff] had been
damaged by [the defendant‘s] conduct.‖ (Id. at p. 1558.)
Amerigraphics is distinguishable. Unlike Amerigraphics, the jury‘s
findings here regarding strict liability to warn and causation do not
35
―necessarily include[]‖ a finding regarding whether a reasonable
manufacturer would have added a warning about skin reddening, rash, and
blisters to an ibuprofen product. (Amerigraphics, supra, 182 Cal.App.4th at
p. 1558.) As discussed above, the questions relied on by plaintiff (questions
5(a) and 10) do not address the duty to warn.
Instead, the situation here is similar to Fuller-Austin and Saxena v.
Goffney (2008) 159 Cal.App.4th 316 (Saxena). In Fuller-Austin, insurance
companies that were not parties to the insured‘s bankruptcy proceedings
sought to show that the bankruptcy settlement was not reasonable. Although
the jury was instructed to consider the settlement‘s reasonableness, the
special verdict form did not include a question concerning reasonableness.
The jury found that the insured was not guilty of inequitable misconduct in
entering into the settlement. (Fuller-Austin, supra, 135 Cal.App.4th at p.
1005.) However, ―the jury‘s finding that [the insured] was not guilty of
inequitable misconduct did not answer the distinctly different question of
whether the [settlement] was unreasonable. [Citation.]‖ (Id. at p. 1006.)
Because the special verdict did not ask the jury to resolve the controverted
issue of reasonableness, the court found the verdict to be ―fatally defective‖
and reversed and remanded for retrial. (Id. at pp. 1006-1007.)
Similarly, in Saxena, the court reversed a special verdict that did not
require the jury to make a finding on the plaintiff‘s battery claim. (Saxena,
supra, 159 Cal.App.4th at p. 326.) The special verdict form asked the jury
whether the defendant doctor performed a procedure without ―informed
consent,‖ but ―did not require the jury to answer the separate and distinct
question of whether [the defendant] performed the procedure with ‗no
consent‘ at all.‖ (Ibid.)
36
Similar to Fuller-Austin and Saxena, whether a reasonable ibuprofen
manufacturer would have added a warning about skin reddening, rash, and
blisters was a controverted issue not addressed by the special verdict form.
As in Fuller-Austin, the defective verdict ―affords an additional basis for
reversal‖ of the jury‘s negligent failure to warn findings. (Fuller-Austin,
supra, 135 Cal.App.4th at p. 1006.)
At oral argument, plaintiff argued that under Babcock v. Omansky
(1973) 31 Cal.App.3d 625 (Babcock), disapproved on another point in Canal-
Randolph Anaheim, Inc. v. Wilkoski (1978) 78 Cal.App.3d 477, 485-486, the
failure to include a question in the special verdict form asking whether a
reasonable manufacturer of ibuprofen under the same or similar
circumstances would have given a warning was not fatal to the special
verdict. Babcock is inapposite.
In Babcock, as here relevant, the plaintiffs sued defendant Leon for
recovery on four promissory notes and sought to void Leon‘s conveyances of
certain property to his wife as fraudulent. In turn, Leon cross-complained,
contending that he was induced to enter the promissory notes by fraud and
seeking damages. (Babcock, supra, 31 Cal.App.3d at p. 628.) After the jury
found Leon liable on the promissory notes, and found the property
conveyances to be fraudulent, he appealed. (Ibid.)
According to the appellate opinion, the jury was presented with ―special
verdicts (in response to pertinent interrogatories).‖ (Babcock, supra, 31
Cal.App.3d at p. 628.) However, regarding Leon‘s cross-complaint, the
verdict form did not ask questions relating to each element of fraud, but
rather simply whether Leon was induced to enter the loan agreement
resulting in the promissory note ―‗by reason of any fraud on the part‘‖ of the
plaintiffs. To that question, the jury responded no. (Id. at p. 630.) Similarly,
37
regarding plaintiffs‘ claim challenging Leon‘s property conveyances, the jury
was asked simply whether the conveyances were ―‗fraudulent‘‖ as to
plaintiffs. To that question, the jury answered yes. (Ibid.)
On appeal, Leon contended that the judgment was void because in
these two findings, the jury made conclusions of law, not fact. As to the first
finding, Leon argued that the verdict should have asked the jury to make
findings on each element of fraud. The court disagreed: ―Although, as
pointed out by Leon, the court in its own motion instructed the jury on all
such elements . . . , we do not believe that a cumbersome interrogatory
embracing each of the several elements was necessarily required. Said the
court in McCloud v. Roy Riegels Chemicals, 20 Cal.App.3d 928, 936-937,
‗Parties should have one chance (by request for special verdict forms) to have
a jury‘s fact finding pinpointed.‘ Leon was apparently satisfied with the
pinpointing form of this first interrogatory at the trial of the cause—the
record is devoid of any showing that he objected thereto; having failed to do
so below, any error inherent therein is waived. [Citations.] Furthermore, as
noted by Witkin, ‗The questions submitted in special issues must call for
ultimate facts, not for evidentiary facts or conclusions of law.‘ [Citation.] As
applied to the point here under discussion such view is consistent with
decisional law commencing with Hick v. Thomas, 90 Cal. 289, that a finding
as to fraud may be couched in general terms. [Citations.]‖ (Babcock, supra,
31 Cal.App.3d at p. 630.) On the same reasoning, the court upheld the jury‘s
second finding. (Id. at p. 631.)
For several reasons, Babcock is of no aid to plaintiff. First, despite the
appellate court‘s description of the verdict as a special verdict, the jury‘s
findings at issue were in the nature of a general verdict (one in which
findings on all issues are implied) rather than a special verdict (in which
38
express findings are made on each ultimate fact essential to the claim). (See
Markow v. Rosner (2016) 3 Cal.App.5th 1027, 1047.) Thus, we question its
precedential value in judging the sufficiency of a true special verdict. Second,
assuming Babcock’s reasoning can apply to a special verdict, unlike
defendant Leon in Babcock, McNeil specifically objected to omitting from the
special verdict a question regarding whether a reasonable manufacturer in
the same or similar circumstances would have given a warning. Thus, the
argument was not forfeited.
Third, to the extent Babcock‘s reasoning may apply to a special verdict,
it does not apply here. In Babcock, the jury was asked to find in general
terms the ―ultimate fact‖ whether fraud occurred. Because the question was
so phrased, the appellate court could conclude that the verdict form
permitted the jury to resolve every controverted issue regarding fraud under
the jury instructions. But in the present case, the jury was not asked
generally to find whether McNeil was negligent. The jury was asked to make
findings on specific elements of the negligence cause of action—all elements
except the fundamental question, which was contested at trial, whether a
reasonable manufacturer in the same or similar circumstances would have
warned of the danger. In that circumstance, the verdict was clearly defective,
because it cannot be inferred from the findings made by the jury that it
resolved that controverted issue. ―‗―‗The requirement that the jury must
resolve every controverted issue is one of the recognized pitfalls of special
verdicts. ―[T]he possibility of a defective or incomplete special verdict, or
possibly no verdict at all, is much greater than with a general verdict that is
tested by special findings . . . .‖ [Citation.]‘ [Citation.]‖‘ ‗A special verdict is
―fatally defective‖ if it does not allow the jury to resolve every controverted
issue.‘‖ (J.P. v. Carlsbad Unified School Dist. (2014) 232 Cal.App.4th 323,
39
338.) In short, whereas in Babcock, ―a cumbersome interrogatory embracing
each of the several elements [of fraud] was [not] necessarily required‖ (31
Cal.App.3d at p. 630), questions regarding each element of negligence were
required here.
On remand, therefore, any special verdict form for negligent failure to
warn must include a question regarding whether a reasonable manufacturer
under the same or similar circumstances would have given a warning.
III. Design Defect Claims
In addition to his strict liability and negligent failure to warn theories
at trial, plaintiff also sought recovery for design defect on strict liability and
negligence theories. The alleged design defect for both claims was that
defendants should have withdrawn Motrin from the market and sold
dexibuprofen, an isomer or component of ibuprofen, instead.17 On the
negligent design defect claim, the jury found McNeil liable, and Johnson &
Johnson not liable. On the strict liability design defect claim, the jury found
both McNeil and Johnson and Johnson liable under the consumer expectation
test, but not under the risk-benefit test.
On appeal, defendants contend that under Ramirez v. Plough, Inc.
(1993) 6 Cal.4th 539 (Ramirez), plaintiff‘s design defect claim is preempted as
a matter of law because the FDA approved OTC Motrin as safe and effective
and approved the warning label. They also contend that under Brown, supra,
44 Cal.3d 1049, a nonprescription drug manufacturer cannot be held strictly
17 Plaintiff contends that this design defect claim also relied on the theory
that Motrin‘s design was defective for its failure to warn of skin reddening,
rash, and blisters. However, as we explain, infra, the jury was not instructed
on that theory of design defect, plaintiff did not argue it, and the verdict
form did not refer to it.
40
liable for a design defect. We disagree with defendants‘ interpretation of
Ramirez and Brown. However, we conclude that plaintiff‘s design defect
claim—that defendants should have withdrawn OTC Motrin and sold
dexibuprofen instead—is preempted by the analysis of the United States
Supreme Court in Bartlett, supra, 133 S.Ct. 2466. We also agree with
defendants that the trial court erred in instructing the jury on the consumer
expectation test.
A. Design Defect Defined
―A design defect exists when the product is built in accordance with its
intended specifications, but the design itself is inherently defective.
[Citation.]‖ (Chavez v. Glock, Inc. (2012) 207 Cal.App.4th 1283, 1303
(Chavez).) ―‗A product . . . is defective in design when the foreseeable risks of
harm posed by the product could have been reduced or avoided by the
adoption of a reasonable alternative design by the seller or other distributor.‘‖
(Morson v. Superior Court (2001) 90 Cal.App.4th 775, 786 (Morson), quoting
Restatement Third of Torts, Products Liability, § 2.)
―‗[T]he Supreme Court [has] recognized two tests for proving design
defect. The ―consumer expectation test‖ permits a plaintiff to prove design
defect by demonstrating that ―the product failed to perform as safely as an
ordinary consumer would expect when used in an intended or reasonably
foreseeable manner.‖ [Citation.] . . . [¶] ‗The second test for design defect is
known as the ―risk-benefit test.‖ Under this test, products that meet
ordinary consumer expectations nevertheless may be defective if the design
embodies an ―‗excessive preventable danger.‘‖ [Citations.]‘‖ (Chavez, supra,
207 Cal.App.4th at p. 1303.)
41
B. Ramirez
In Ramirez, supra, the plaintiff alleged that he suffered Reye‘s
syndrome as a reaction to OTC children‘s aspirin, and sued the manufacturer
for products liability based (as here relevant) on the manufacturer‘s failure to
withdraw the aspirin from the market.18 (6 Cal.4th at p. 555; see O’Neill v.
Novartis Consumer Health, Inc. (2007) 147 Cal.App.4th 1388, 1393 (O’Neill)
[describing the plaintiff‘s theories of liability].) Affirming the trial court‘s
grant of summary adjudication of this claim (as part of the trial court‘s grant
of summary judgment), the California Supreme Court held, ―as a matter of
law, . . . defendant may not be held liable for failing to withdraw its product
from the market in early 1986, when plaintiff‘s mother purchased and used
it. . . . Although devastating, Reye‘s syndrome was then and remains now a
rare and poorly understood illness. A few scientific studies had shown an
association between aspirin and Reye‘s syndrome, but the methodology of
those studies had been questioned and the FDA had determined that further
studies were needed to confirm or disprove the association. Pending
completion of those studies, the FDA concluded that product warnings were
an adequate public safety measure. Although the FDA‘s conclusion is not
binding on us, we think it deserves serious consideration. Plaintiff has
submitted nothing that causes us to doubt the FDA‘s judgment in this matter
that in early 1986 aspirin could be considered a reasonably safe product for
18 Ramirez is better known for its rejection of the plaintiff‘s claim that the
manufacturer should have used an additional Spanish-language warning,
instead of ―adopt[ing] the legislative/regulatory standard of care that
mandates nonprescription drug package warnings in English only.‖
(Ramirez, supra, 6 Cal.4th at p. 555.) That issue is not relevant to the
instant case.
42
administration to children, when distributed with appropriate warnings.‖
(Ramirez, supra, 6 Cal.4th at p. 556.)
Defendants argue that Ramirez bars plaintiff‘s design defect claim
because ibuprofen is approved by the FDA. However, Ramirez did not hold
that the FDA‘s approval preempts all state law claims, but only that the
FDA‘s judgment ―deserves serious consideration.‖ (Ramirez, supra, 6 Cal.4th
at p. 556; see also O’Neill, supra, 147 Cal.App.4th at p. 1396 [―the
government agency in our case, the FDA, is the regulatory body charged with
protecting the public health by ensuring that drugs are safe and effective.
[Citations.] While the FDA‘s standards and decisions do not immunize a
drug manufacturer from liability, they are nevertheless entitled to ‗serious
consideration‘ on the issue of the safety of [the drug] at the time of appellants‘
injuries.‖].) The Supreme Court upheld the summary adjudication rejecting
the claim that the manufacturer should have stopped selling children‘s
aspirin, because the plaintiff had ―submitted nothing‖—in context, meaning
no evidence sufficient to raise a triable issue of material fact—that caused
the court to doubt the FDA‘s conclusion that children‘s aspirin was safe with
appropriate warnings. (Ramirez, supra, 6 Cal.4th at p. 556.)
Here, defendant‘s appeal is not from a grant of summary judgment, but
rather from a jury verdict. Unlike the standard of review in Ramirez,
therefore, which was de novo, our review is circumscribed by the rules
governing an appeal from a judgment following a jury verdict, including the
substantial evidence rule. In the present case, plaintiff did present to the
jury evidence tending to contradict the FDA‘s conclusion concerning the
safety of OTC Motrin. Much of plaintiff‘s case was directed to proving that
OTC Motrin was unsafe without a label warning of skin reddening, rash and
blisters. Moreover, Tackett testified that dexibuprofen is an isomer or
43
component of ibuprofen, and ―appears to be a safer product‖ with fewer side
effects than ibuprofen. Although the FDA denied an application to market
dexibuprofen, that denial was not due to a safety issue, but rather to the
failure to ―put [the drug] forward as a prescription drug first, which is the
usual way things . . . go from prescription to over the counter.‖ Tackett
further testified that, unlike dexibuprofen, Motrin contained a component
called racemic ibuprofen that contributed to SJS/TEN, and that dexibuprofen
was not associated with SJS/TEN.
On this record, it is not for this court to declare, as a matter of law, that
a jury could not disagree with the FDA‘s conclusions. The reasoning of
Ramirez simply does not govern this case.
C. Brown
We likewise disagree that Brown, supra, 44 Cal.3d 1049, immunized
defendants, who manufacture and distribute a nonprescription medication,
from plaintiff‘s design defect claim. Brown held that ―a manufacturer is not
strictly liable for injuries caused by a prescription drug so long as the drug
was properly prepared and accompanied by warnings of its dangerous
propensities that were either known or reasonably scientifically knowable at
the time of distribution.‖ (Id. at p. 1069.) The court noted that prescription
drug manufacturers could still be liable for ―for manufacturing defects, as
well as under general principles of negligence, and for failure to warn of
known or reasonably knowable side effects.‖ (Id. at p. 1069, fn. 12; see
Garrett v. Howmedica Osteonics Corp. (2013) 214 Cal. App. 4th 173, 182-183
(Garrett) [explaining Brown].)
The court‘s decision was based on the determination that neither of the
two tests for strict liability design defect—consumer expectation and risk-
44
benefit—should be applied to a prescription drug manufacturer. As for the
consumer expectation test, the court reasoned that, assuming the
manufacturer provided sufficient warnings to the prescribing physician, the
manufacturer should have no strict liability for the physician‘s failure to
convey them: ―While the ‗ordinary consumer‘ may have a reasonable
expectation that a product such as a machine he purchases will operate safely
when used as intended, a patient‘s expectations regarding the effects of such
a drug are those related to him by his physician, to whom the manufacturer
directs the warnings regarding the drug‘s properties. The manufacturer
cannot be held liable if it has provided appropriate warnings and the doctor
fails in his duty to transmit these warnings to the patient or if the patient
relies on inaccurate information from others regarding side effects of the
drug.‖ (Brown, supra, 44 Cal.3d at pp. 1061-1062, fn. omitted.)
As for the risk benefit analysis, the court conceded that the rationale of
strict liability (to deter manufacturers from marketing unsafe products and
to pass the cost of injury to all consumers, who will pay a higher price for the
product because of a manufacturer‘s increased insurance burden) ―could
justify application of the doctrine to the manufacturers of prescription drugs.
It is indisputable, as plaintiff contends, that the risk of injury from such
drugs is unavoidable, that a consumer may be helpless to protect himself
from serious harm caused by them, and that, like other products, the cost of
insuring against strict liability can be passed on by the producer to the
consumer who buys the item. Moreover, . . . in some cases additional testing
of drugs before they are marketed might reveal dangerous side effects,
resulting in a safer product.‖ (Brown, supra, 44 Cal.3d at p. 1063.)
Nonetheless, the court concluded that public policy weighed in favor of
precluding imposition of strict liability on manufacturers of prescription
45
drugs. The court observed that unlike non-medical products for which
manufacturers had been held strictly liable in the past, which were
―product[s] used to make work easier or to provide pleasure,‖ prescription
drugs ―may be necessary to alleviate pain and suffering or to sustain life.
Moreover, unlike other important medical products (wheelchairs, for
example), harm to some users from prescription drugs is unavoidable.
Because of these distinctions, the broader public interest in the availability of
drugs at an affordable price must be considered in deciding the appropriate
standard of liability for injuries resulting from their use. [¶] Perhaps a drug
might be made safer if it was withheld from the market until scientific skill
and knowledge advanced to the point at which additional dangerous side
effects would be revealed. But in most cases such a delay in marketing new
drugs—added to the delay required to obtain approval for release of the
product from the Food and Drug Administration—would not serve the public
welfare. Public policy favors the development and marketing of beneficial
new drugs, even though some risks, perhaps serious ones, might accompany
their introduction, because drugs can save lives and reduce pain and
suffering. [¶] If drug manufacturers were subject to strict liability, they
might be reluctant to undertake research programs to develop some
pharmaceuticals that would prove beneficial or to distribute others that are
available to be marketed, because of the fear of large adverse monetary
judgments. Further, the additional expense of insuring against such
liability—assuming insurance would be available—and of research programs
to reveal possible dangers not detectable by available scientific methods could
place the cost of medication beyond the reach of those who need it most.‖
(Brown, supra, 44 Cal.3d at p. 1063.)
46
Relying on the public policy concerns expressed by Brown, courts have
applied its exemption from strict liability design defect claims to
manufacturers of a limited range of other products, including implanted
prescription medical products (Hufft v. Horowitz (1992) 4 Cal.App.4th 8, 11 [a
penile prosthesis]; Plenger v. Alza Corp. (1992) 11 Cal.App.4th 349, 357-361
[intrauterine device]), and implanted medical devices that, although not
prescription devices, are available only through the services of a physician
(Artiglio v. Superior Court (1994) 22 Cal.App.4th 1388, 1395-1397 (Artiglio)
[breast implants]; Garrett, supra, 214 Cal.App.4th at pp. 183-185 [implanted
prosthetic device]). Relying on Artiglio and Garrett, which extended Brown to
nonprescription devices, defendants contend that Brown should apply to OTC
drugs as well.
We disagree that the rationale of Brown extends that far. A necessary
predicate of Brown’s public policy analysis, and that of Artiglio and Garrett, is
intervention of a physician between the manufacturer and the patient. As
recognized in Artiglio, ―all of the drugs considered in Brown and following
cases were stipulated, or assumed to be, available only by ‗prescription.‘ The
conclusion is that the imposition of the condition of ‗prescription‘ provides
insulation between the manufacturer and the user such as to warrant
elimination of the consumer protections afforded by strict liability. We find
the same to be true of medical prostheses, at least as to those in the category
of devices available only through the services of a physician.‖ (Artiglio,
supra, 22 Cal.App.4th at p. 1397.) Similarly, Garrett held that ―[t]he public
interest in the development, availability and affordability of implanted
medical devices justifies an exemption from design defect strict products
liability for all implanted medical devices that are available only through the
services of a physician. [Citations.]‖ (Garrett, supra, 214 Cal.App.4th at p.
47
184, italics added.) By contrast, OTC Motrin is meant to be taken orally by
the typical consumer, without the services of a physician. Thus, OTC Motrin
is distinguishable from prescription drugs as discussed in Brown, and from
the nonprescription medical devices as discussed in Artiglio and Garrett. We
have found no cases, and defendants have provided none, that extend Brown
to OTC drugs as a class, and we decline to do so.19 (See Rodriguez v. Superior
Court (1990) 221 Cal.App.3d 1371, 1373 [declining plaintiff‘s request to
conclude that Brown’s holding ―abolishing strict liability for the manufacture
of a prescription drug, should not be extended to cases of certain
nonprescription medications‖].)
D. Federal Preemption
Although neither Ramirez nor Brown preempts plaintiff‘s claim, we
conclude that plaintiff‘s design defect claim that defendants should have
withdrawn Motrin from the market is preempted by the impossibility
preemption analysis of the United States Supreme Court in Bartlett, supra,___ U.S. ___, 133 S.Ct. 2466, which held, in pertinent part, that a
manufacturer may not be required to stop selling a product in order to avoid
a state products liability claim. (Id. at p. 2477.)
In his supplemental brief, plaintiff concedes that his ―risk/benefit
design-defect claim premised on the defendants‘ failure to use an
19 (See Michael M. Walsh, Testing Liability: While Brown v. Superior
Court Remains A Foundational Case in Medical Products Litigation,
Attempts to Expand Its Reach Have Not Always Been Successful, L.A. Law.,
September 2014, at p. 26 [explaining that ―there remain efforts to expand
Brown‘s protection against design defect claims to a widening scope of
medical products. The most likely candidates for this include nonprescription
drugs and medical products that, while not implanted, interact with the
human body.‖].)
48
alternative active ingredient in Motrin is preempted‖ under Bartlett.20 He
argues, however, that his design defect claim was based not only on
defendants‘ failure to sell dexibuprofen, but also on their failure to warn of
the symptoms of SJS/TEN, and he concludes that his consumer expectation
design defect claim and his negligent design defect claim are not preempted
under Bartlett.
For reasons we explain below, we conclude that the record does not
support plaintiff‘s contention that the jury based its design defect finding on
a failure to warn theory. We agree with plaintiff that his claim that
defendants should have sold dexibuprofen instead of ibuprofen is preempted
under Bartlett. We further conclude that the consumer expectation test was
not properly applied in these circumstances.
1. Plaintiff’s Design Defect Claim
Plaintiff‘s contention that his design defect claim was based in part on
the theory of failure to warn is not supported by the record. He did not argue
his design defect claim to the jury under a failure to warn theory, but under
the theory that dexibuprofen was a safer product that defendants should
have sold. Nor was the jury instructed to find design defect by the failure to
20 Plaintiff concedes, on the one hand, that his design defect claim is
barred to the extent that it relied on defendants‘ failure to use dexibuprofen
instead of ibuprofen in Motrin. On the other hand, he asserts that he did not
argue that defendants ―should have withdrawn Motrin from the marketplace,
or should have never sold it in the first place.‖ This argument is merely a
matter of semantics. No matter how plaintiff words his argument, the claim
that defendants failed to sell dexibuprofen instead of ibuprofen requires the
claim that defendants should have withdrawn Motrin from the market
because defendants could not have changed the active ingredient of Motrin
without undergoing an entirely new FDA drug application process. (21
U.S.C. § 355(a); 21 C.F.R. § 314.70(b)(2)(i).)
49
warn. Rather, the jury was instructed separately on the design defect and
failure to warn claims, and the design defect instructions did not refer to the
warning label as a consideration.
Plaintiff relies on the negligence instruction on design defect, which
instructed the jury to ―balance what Johnson & Johnson and/or McNeil knew
or should have known about the likelihood and severity of potential harm
from the product against the burden of taking safety measures to reduce or
avoid the harm.‖ However, this instruction does not refer to the warning
label as a consideration in the balancing test, and we cannot infer that the
jury understood the instruction in this manner, in particular because the
instructions distinguished between design defect and failure to warn.
Plaintiff also relies on the jury‘s finding of negligent failure to warn to
support his contention that the negligent design defect verdict was based on
the failure to warn. However, the jury‘s special verdict on negligent design
defect did not refer to the warning label at all, and we cannot infer such a
finding. (See Zagami, supra, 160 Cal.App.4th at p. 1092 [―A court reviewing
a special verdict does not infer findings in favor of the prevailing party.‖].)
Moreover, even if we could infer that the jury relied on the negligent failure
to warn finding in considering the design defect claim, we already have
determined that the negligent failure to warn verdict is fatally inconsistent
with the strict liability failure to warn verdict, and that inconsistency would
vitiate a finding of negligent design defect on a failure to warn theory. The
jury‘s negligent failure to warn finding accordingly cannot be relied upon to
support the negligent design defect verdict.21
21 After oral argument, plaintiff filed a letter brief reiterating his
argument that he did rely on the failure to warn theory to support his design
defect claim. As discussed above, we disagree. Even if the record supported
plaintiff‘s contention, the negligent failure to warn verdict is fatally
50
2. General Principles of Federal Preemption
Having concluded that plaintiff‘s design defect claim was based on the
theory that defendants should have sold dexibuprofen instead of ibuprofen,
we conclude that this claim is preempted under Bartlett. We begin with an
overview of federal preemption principles in the pharmaceuticals context.
―Under the supremacy clause of the United States Constitution, ‗[w]hen
a state statute, administrative rule, or common-law cause of action conflicts
with a federal statute, it is axiomatic that the state law is without effect.
[Citations.]‘ [Citation.] ‗In determining whether federal law preempts state
law, a court‘s task is to discern congressional intent. [Citation.] Congress‘s
express intent in this regard will be found when Congress explicitly states
that it is preempting state authority. [Citation.] Congress‘s implied intent to
preempt is found (i) when it is clear that Congress intended, by
comprehensive legislation, to occupy the entire field of regulation, leaving no
room for the states to supplement federal law [citation]; (ii) when compliance
with both federal and state regulations is an impossibility [citation]; or (iii)
when state law ―stands as an obstacle to the accomplishment and execution
of the full purposes and objectives of Congress.‖ [Citations.]‘ [Citations.] In
addition, federal agency regulation with the force of law can preempt
conflicting state requirements. [Citations.]‖ (Eckler v. Neutrogena Corp.
(2015) 238 Cal.App.4th 433, 447-448 (Eckler).) ―Even in the absence of an
express pre-emption provision, the Court has found state law to be impliedly
inconsistent with the strict liability failure to warn verdict. The failure to
warn accordingly cannot be relied upon to support the design defect claim.
Moreover, plaintiff‘s contention is that the warning label is relevant to the
consumer expectation test. As explained below, we conclude that the
consumer expectation test does not apply in these circumstances.
51
pre-empted where it is ‗impossible for a private party to comply with both
state and federal requirements.‘ [Citations.]‖ (Bartlett, supra, 133 S.Ct. at p.
2473; see also PLIVA, Inc. v. Mensing (2011) 564 U.S. 604, 618 (Mensing)
[―[S]tate and federal law conflict where it is ‗impossible for a private party to
comply with both state and federal requirements.‘‖].)
Preemption of state product liability suits regarding OTC drugs is
addressed by 21 United States Code section (U.S.C. § ) 379r, which is
entitled, ―National Uniformity for Nonprescription Drugs and Preemption for
Labeling or Packing of Cosmetics.‖ The statute ―authorizes the FDA to
regulate, among other things, the ingredients and labeling of nonprescription,
over-the-counter (OTC) drugs . . . . Section 751 of the FDCA [Federal Food,
Drug, and Cosmetic Act], codified at 21 United States Code section 379r(a),
specifically prohibits state requirements that are not identical with federal
requirements: ‗no State . . . may establish or continue in effect any
requirement—[¶] (1) that relates to the regulation of a drug . . . and [¶] (2)
that is different from or in addition to, or that is otherwise not identical with,
a requirement under this chapter . . . .‘‖ (Eckler, supra, 238 Cal.App.4th at p.
439, fn. omitted.) However, a savings clause in the statute provides that
―Nothing in this section shall be construed to modify or otherwise affect any
action or the liability of any person under the product liability law of any
State.‖ (21 U.S.C. § 379r(e), italics added.) Courts are divided about the
scope of this savings clause.
In Hunt v. McNeil Consumer Healthcare (E.D.La. 2014) 6 F.Supp.3d
694 (Hunt), the federal district court concluded that federal law did not
preempt a state inadequate warning claim involving a nonprescription drug,
Children‘s Motrin. The court quoted the savings clause in 21 U.S.C. § 379r(e)
and concluded that this subdivision showed ―Congress‘ intent to preserve
52
state-law product liability actions with respect to non-prescription drugs
. . . .‖ (Id. at p. 699.)
The Supreme Judicial Court of Massachusetts came to the opposite
conclusion in Reckis, supra, 471 Mass. 272 [28 N.E.3d 445, 456], which
addressed a failure to warn claim by a plaintiff who contracted TEN after
ingesting Children‘s Motrin. The court rejected the plaintiff‘s argument that
conflict preemption was ―irrelevant‖ because of the savings clause in 21
U.S.C. § 379r. (Id. at p. 284 [28 N.E.3d at p. 455].) The court explained that,
―by its terms, the § 379r(e) savings clause frames its exemption from
preemption with a reference to § 379r itself and, as a result, must be read in
the context of § 379r as a whole and specifically the express preemption
provision set out in § 379r(a). The savings or exemption from preemption
provided by § 379r(e), however, does not extend beyond the provisions of
§ 379r, and in particular does not preclude ‗the ordinary working of conflict
pre-emption principles.‘ [Citation.] That is, even if the savings clause in
§ 379r(e) ‗removes tort actions from the scope of [an] express pre-emption
clause‘ such as § 379r(a), the savings clause ‗does not foreclose . . . the
possibility that a federal [law] will pre-empt a state common-law tort action
with which it conflicts‘ [citation] . . . .‖ (Ibid. [28 N.E.3d at p. 456, fn.
omitted].)
The federal district court in Batoh, supra, 167 F.Supp.3d 296, relied on
Reckis in holding that 21 U.S.C. § 379r(e) did not save the plaintiff‘s failure to
warn claim regarding OTC Motrin. (Id. at p. 316, fn. 15.) The court reasoned
that ―the statute at issue, which states that ‗[n]othing in this section shall be
construed to modify or otherwise affect any action or the liability of any
person under the product liability law of any State,‘ 21 U.S.C. § 379r(e)
(italics added), does not foreclose the possibility that conflict preemption may
53
arise from other sources of federal law.‖ (Ibid.; see also National Federation
of the Blind v. United Airlines, Inc. (9th Cir. 2012) 813 F.3d 718, 731 [―the
inclusion of either a saving clause or an express preemption clause within a
statutory scheme does not foreclose the application of ordinary implied
preemption principles‖].)
Our colleagues in Division Seven similarly stated regarding the FDCA
that, ―‗even where the express preemption provision in [21 U.S.C. § 379r] is
not applicable, implied preemption may arise [citation].‘ [Citation.]‖ (Eckler,
supra, 238 Cal.App.4th at p. 443.) Because the savings clause expressly
refers to ―this section‖—that is, 21 U.S.C. § 379r(e)—we disagree with Hunt
and instead agree with Eckler, Reckis, and Batoh that the savings clause does
not foreclose the possibility that conflict preemption may arise from federal
sources other than 21 U.S.C. § 379r. We therefore examine whether
impossibility preemption applies. We conclude that it does under Bartlett.
3. Bartlett’s Holding
The plaintiff in Bartlett asserted a New Hampshire design defect claim
against the manufacturer of a generic prescription NSAID (sulindac) after
she contracted SJS/TEN. New Hampshire design defect law relied on the
risk-utility test, under which ―‗a product is defective as designed if the
magnitude of the danger outweighs the utility of the product.‘ [Citation.]‖
(Bartlett, supra, 133 S.Ct. at p. 2474.) The Supreme Court reasoned that ―[i]n
the drug context, either increasing the ‗usefulness‘ of a product or reducing
its ‗risk of danger‘ would require redesigning the drug: A drug‘s usefulness
and its risk of danger are both direct results of its chemical design and, most
saliently, its active ingredients. [Citation.]‖ (Id. at p. 2475.) The Court
concluded that it was impossible to redesign the drug at issue because if the
54
manufacturer were to change the composition of the drug, it would be
required to file a new drug application with the FDA, and the drug was
―chemically incapable of being redesigned‖ because it was essentially ―‗a one-
molecule drug.‘‖ (Ibid.)
Pertinent to the case before us, Bartlett rejected the appellate court‘s
reasoning that the manufacturer ―could escape the impossibility of complying
with both its federal- and state-law duties by ‗choos[ing] not to make [the
drug] at all.‘ [Citation.]‖ (Bartlett, supra, 133 S.Ct. at p. 2477.) The Court
explained: ―We reject this ‗stop-selling‘ rationale as incompatible with our
pre-emption jurisprudence. Our pre-emption cases presume that an actor
seeking to satisfy both his federal- and state-law obligations is not required to
cease acting altogether in order to avoid liability. Indeed, if the option of
ceasing to act defeated a claim of impossibility, impossibility pre-emption
would be ‗all but meaningless.‘ [Citation.] [¶] The incoherence of the stop-
selling theory becomes plain when viewed through the lens of our previous
cases. In every instance in which the Court has found impossibility pre-
emption, the ‗direct conflict‘ between federal- and state-law duties could
easily have been avoided if the regulated actor had simply ceased acting.‖
(Ibid.)
―Given the impossibility of redesigning sulindac, the only way for [the
manufacturer] to ameliorate the drug‘s ‗risk-utility‘ profile—and thus to
escape liability—was to strengthen ‗the presence and efficacy of [sulindac‘s]
warning‘ in such a way that the warning ‗avoid[ed] an unreasonable risk of
harm from hidden dangers or from foreseeable uses.‘ [Citations.]‖ (Bartlett,
supra, 133 S.Ct. at p. 2475.) Because the manufacturer was prevented by
federal law from changing the warning label, ―federal law prohibited [the
manufacturer] from taking the remedial action required to avoid liability
55
under New Hampshire law.‖22 (Id. at p. 2476.) The plaintiff‘s design defect
claim accordingly was preempted by federal law. (Id. at p. 2470.)
4. Bartlett’s Application to OTC Drugs
Bartlett concerned generic prescription drugs, not OTC drugs, and the
Court noted the difference, stating that ―the FDCA‘s treatment of
prescription drugs includes neither an express pre-emption clause (as in the
vaccine context, 42 U.S.C. § 300aa–22(b)(1)), nor an express non-pre-emption
clause (as in the over-the-counter drug context, 21 U.S.C. §§ 379r(e), 379s(d)).
In the absence of that sort of ‗explicit‘ expression of congressional intent, we
are left to divine Congress‘ will from the duties the statute imposes.‖
(Bartlett, supra, 133 S.Ct. at p. 2480.) Because Bartlett drew a distinction
between prescription drugs and OTC drugs, lower courts are divided about
whether Bartlett‘s preemption analysis applies to OTC drugs. (See Brown v.
Johnson & Johnson (E.D.Pa. 2014) 64 F.Supp.3d 717, 721 [―The Supreme
Court has not addressed whether federal law can preempt state law design
defect claims brought against manufacturers of brand-name or non-
prescription drugs.‖]; Hunt, supra, 6 F.Supp.3d at p. 703 [―The scope of the
Bartlett holding has been the subject of much debate among lower courts.‖].)
We conclude that Bartlett‘s reasoning is not limited to prescription drugs.
22 Generic drug manufacturers are not free to strengthen drug label
warnings under 21 C.F.R. § 314.70, the FDA‘s ―changes being effected‖ (CBE)
regulation, which permits a brand name prescription drug manufacturer to
strengthen a warning label while waiting for FDA approval of the change.
(Wyeth v. Levine (2009) 555 U.S. 555, 558-559; Mensing, supra, 564 U.S. at
pp. 613-615.) The CBE regulations do not apply to generic prescription drug
labels, which are required by federal law to be identical to brand name labels.
(Mensing, supra, 564 U.S. at pp. 613-615.)
56
In Brown v. Johnson & Johnson, supra, the federal district court
concluded that Bartlett‘s holding did not extend to manufacturers of non-
prescription drugs and therefore rejected the defendants‘ argument that
federal law preempted the plaintiffs‘ claim that Children‘s Motrin was
defectively designed. (Brown v. Johnson & Johnson, supra, 64 F.Supp.3d at
p. 721; see also Hunt, supra, 6 F.Supp.3d at p. 704 [concluding the plaintiff‘s
design defect claim regarding a non-prescription drug was not preempted
under Bartlett].)
Batoh disagreed with the conclusions of Brown v. Johnson & Johnson,
supra, 64 F.Supp.3d at page 721, and Hunt, supra, 6 F.Supp.3d at page 704,
that Bartlett is limited to manufacturers of generic prescription drugs.
(Batoh, supra, 167 F.Supp.3d at p. 321, fn. 19.) The court reasoned that the
―non-preemption clause‖ in 21 U.S.C. § 379r(e) ―only limits the scope of the
express preemption clause in § 379r(a). It does not purport to limit the
preemptive effect of other sources of federal law, including FDA regulations,
that conflict with state law requirements.‖ (Ibid.) The court thus relied on
Bartlett to hold that federal law preempted the plaintiff‘s ―claim that
Defendants could have altered the chemical composition of Motrin‖ by selling
dexibuprofen instead of ibuprofen. (Id. at p. 322.)
Consistent with our conclusion that the savings clause in 21 U.S.C.
§ 379r(e) does not prevent the applicability of ordinary preemption principles
in the nonprescription drug context, we agree with Batoh that Bartlett‘s
holding is not limited to prescription drugs.
5. Impossibility Preemption Analysis
In determining whether impossibility preemption applies, we begin
with the manufacturer‘s duties under state law. (See Bartlett, supra, 133
57
S.Ct. at p. 2473 [―We begin by identifying [the manufacturers‘] duties under
state law.‖].) As stated above, ―A design defect exists when the product is
built in accordance with its intended specifications, but the design itself is
inherently defective. [Citation.]‖ (Chavez, supra, 207 Cal.App.4th at p.
1303.) ―[A] product may be found defective in design if the plaintiff
demonstrates that the product failed to perform as safely as an ordinary
consumer would expect when used in an intended or reasonably foreseeable
manner.‖ (Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 429.) A
product also ―‗may be found defective in design, even if it satisfies ordinary
consumer expectations, if through hindsight the jury determines that the
product‘s design embodies ―excessive preventable danger,‖ or, in other words,
if the jury finds that the risk of danger inherent in the challenged design
outweighs the benefits of such design. [Citations.]‘ [Citation.]‖ (Soule v.
General Motors Corp. (1994) 8 Cal.4th 548, 562 (Soule).)
Under plaintiff‘s theory, the design of Motrin was inherently defective
because defendants used ibuprofen instead of dexibuprofen. However, federal
law prohibited defendants from changing the design of Motrin by selling
dexibuprofen without prior FDA approval.23 Defendants accordingly could
not have avoided design defect liability without violating federal law.
―FDA regulations provide that once a drug, whether generic or brand-
name, is approved, the manufacturer is prohibited from making any major
changes to the ‗qualitative or quantitative formulation of the drug product
. . . .‘ [Citation.]‖ (Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. (6th
Cir. 2015) 808 F.3d 281, 298 (Yates); see also 21 U.S.C. § 355(a) [―No person
shall introduce or deliver for introduction into interstate commerce any new
23 It is undisputed that dexibuprofen has not been approved by the FDA.
58
drug, unless an approval of an application filed pursuant to subsection (b) or
(j) of this section is effective with respect to such drug.‖]; Bartlett, supra, 133
S.Ct. at p. 2470 [―Under the [FDCA], drug manufacturers must gain approval
from the [FDA] before marketing any drug in interstate commerce. [21
U.S.C.] § 355(a).‖].)
According to Tackett‘s testimony in the present case, dexibuprofen is an
isomer or component of ibuprofen. 21 C.F.R. section 310.3(h)(1) provides that
―The newness of a drug may arise by reason (among other reasons) of: [¶] (1)
The newness for drug use of any substance which composes such drug, in
whole or in part, whether it be an active substance or a menstruum,
excipient, carrier, coating, or other component.‖ Dexibuprofen therefore
would be a new drug, requiring a new drug application. (See Kanter v.
Warner-Lambert Co. (2002) 99 Cal.App.4th 780, 784-785 [―Under the [FDCA]
(21 U.S.C. § 301 et seq.), a drug manufacturer is prohibited from marketing a
new drug unless the FDA has approved the drug as both safe and effective for
its intended use. [Fn. omitted.] [Citations.] [¶] A manufacturer seeking
approval of a new drug must submit a detailed new drug application in
accordance with the requirements of the FDCA and related regulations
promulgated by the FDA. [Citations.]‖]; Upjohn Mfg. Co. v. Schweiker (6th
Cir. 1982) 681 F.2d 480, 481–482 [describing the new drug application
process Upjohn complied with in order to market ibuprofen as Motrin].)
In light of the statutes and regulations regarding new drug applications
and preventing changes to drugs already approved by the FDA, defendants
could not have ―unilaterally changed the active ingredient of Motrin from
ibuprofen to dexibuprofen to satisfy their state law duty‖ without violating
federal law. (Batoh, supra, 167 F.Supp.3d at p. 322.) ―Because it would have
been impossible for Defendants to comply both with any state law duty to
59
substitute dexibuprofen for ibuprofen and with federal requirements, federal
law preempts [the] claim that Defendants should have altered the chemical
composition of Motrin.‖ (Ibid.; see also Wolfe, supra, 773 F.Supp.2d at p. 572
[granting the manufacturers‘ summary judgment motion as to a strict
liability defective design claim regarding Children‘s Motrin because ―[t]here
exists no FDA-approved alternative form of ibuprofen, meaning there is no
available alternative design of the drug for defendants to adopt‖]; Yates,
supra, 808 F.3d at p. 298 [―to the extent [the plaintiff] argues that defendants
should have altered the formulation of ORTHO EVRA® after the FDA had
approved the patch, we find this claim clearly preempted‖]; Rheinfrank v.
Abbott Laboratories, Inc. (S.D. Ohio 2015) 137 F.Supp.3d 1035, 1040–1041
[concluding that the plaintiffs‘ argument that the defendants could sell a
different drug or ―tweak the [drug‘s] molecule to make it safer‖ was
preempted, reasoning that ―[c]reating an alternative design would require
changing the composition of an FDA-approved drug, which is prohibited by
federal law‖]; Booker v. Johnson & Johnson (N.D. Ohio 2014) 54 F.Supp.3d
868, 875 [relying on Bartlett to conclude the plaintiff‘s design defect claim
regarding a birth control patch under the risk-utility test was preempted
because ―it was impossible for the Defendants to comply with both its state-
law duty to alter the composition of the drug, and its federal-law duty not to
alter an FDA-approved design‖].)
Thus, under federal law—including 21 U.S.C. § 355, 21 C.F.R. §§ 310.3and 314.70, and Bartlett—defendants could not unilaterally change the
chemical composition of Motrin from ibuprofen to dexibuprofen in order to
satisfy consumer expectations or to increase the benefits or decrease the risks
of Motrin. Nor could they be required to stop selling Motrin in order to avoid
60
state liability. (Bartlett, supra, 133 S.Ct. at p. 2477.) Plaintiff‘s design defect
claim accordingly is preempted.
In his supplemental brief, plaintiff argues that Bartlett does not
preempt his design defect claims because defendants could have strengthened
the warning label without FDA approval. He cites the following language in
Bartlett: ―In cases where it is impossible—in fact or by law—to alter a
product‘s design (and thus to increase the product‘s ‗usefulness‘ or decrease
its ‗risk of danger‘), the duty to render a product ‗reasonably safe‘ boils down
to a duty to ensure ‗the presence and efficacy of a warning to avoid an
unreasonable risk of harm from hidden dangers or from foreseeable uses.‘
[Citation.]‖ (Bartlett, supra, 133 S.Ct. at p. 2480.) Bartlett, however, was
applying New Hampshire law and thus was quoting from a New Hampshire
state court case.24
Plaintiff‘s argument fails for several reasons. Most importantly, as
discussed above, there is no indication in the record that the jury was
instructed to or did consider the warning label in determining plaintiff‘s
design defect claim. To the contrary, plaintiff‘s design defect claim was based
24 The risk-utility inquiry under New Hampshire law was based on three
factors: ―‗the usefulness and desirability of the product to the public as a
whole, whether the risk of danger could have been reduced without
significantly affecting either the product‘s effectiveness or manufacturing
cost, and the presence and efficacy of a warning to avoid an unreasonable risk
of harm from hidden dangers or from foreseeable uses.‘ [Citations.]‖
(Bartlett, supra, 133 S.Ct. at p. 2475.) Under California‘s risk-benefit test,
the considerations include ―‗the gravity of the danger posed by the challenged
design, the likelihood that such danger would occur, the mechanical
feasibility of a safer alternative design, the financial cost of an improved
design, and the adverse consequences to the product and to the consumer
that would result from an alternative design. [Citations.]‘ [Citation.]‖
(Soule, supra, 8 Cal.4th at p. 562.)
61
on his dexibuprofen argument. Furthermore, the language plaintiff relies on
deals with New Hampshire‘s risk-utility test, which focused on three factors,
including ―‗the presence and efficacy of a warning.‘‖ (Bartlett, supra, 133
S.Ct. at p. 2475.) Here, not only are we applying California law, but the jury
found in favor of defendants under the risk-benefit test.25
For the foregoing reasons, we conclude that plaintiff‘s design defect
claim is preempted under Bartlett.
E. Consumer Expectation Test
Defendants argue that the trial court erred in instructing the jury on
the consumer expectation test for design defect. We agree. ―We review de
novo claims of instructional error. [Citation.]‖ (Romine v. Johnson Controls,
Inc. (2014) 224 Cal.App.4th 990, 1000 (Romine).)
25 Plaintiff relies on language in Fraser v. Wyeth, Inc. (D. Conn. 2014) 992
F.Supp.2d 68, 88 (Fraser) stating that ―evidence of Wyeth‘s marketing,
advertising, and ghost-writing efforts was relevant to Plaintiffs‘ strict
liability claim under the modified consumer expectation test.‖ However,
Fraser applied a modified consumer expectation test, which ―‗incorporat[ed]
risk-utility factors into the ordinary consumer expectation analysis.‘‖ (Id. at
p. 83.) Because the jury here found in favor of defendants under the risk-
benefit test, Fraser does not support plaintiff‘s contention. Similarly, Hansen
v. Sunnyside Products, Inc. (1997) 55 Cal.App.4th 1497 (Hansen) does not
help plaintiff because that case held ―that product label warnings are
relevant in determining whether a product has a design defect under the
risk/benefit test,‖ not the consumer expectation test. (Id. at p. 1501, italics
added.) Also unlike here, in Hansen, ―defense counsel argued to the jurors
that in determining whether there was a design defect under the risk/benefit
test (inquiring whether the risk of harm outweighed the benefits of the
product), they could consider the warning label as part of the product.‖ (Id.
at p. 1504.) Here, the failure to warn was presented to the jury as a separate
cause of action, and the jury was instructed separately on the claims and
made findings separately.
62
―[T]he consumer expectations test is reserved for cases in which the
everyday experience of the product‘s users permits a conclusion that the
product‘s design violated minimum safety assumptions, and is thus defective
regardless of expert opinion about the merits of the design.‖ (Soule, supra, 8
Cal.4th at p. 567.) ―‗The critical question, in assessing the applicability of the
consumer expectation test, is not whether the product, when considered in
isolation, is beyond the ordinary knowledge of the consumer, but whether the
product, in the context of the facts and circumstances of its failure, is one
about which the ordinary consumers can form minimum safety expectations.‘‖
(Pannu v. Land Rover North America, Inc. (2011) 191 Cal.App.4th 1298,
1311–1312.) ―[W]hen the ultimate issue of design defect calls for a careful
assessment of feasibility, practicality, risk, and benefit, the case should not
be resolved simply on the basis of ordinary consumer expectations [because]
‗. . . in many instances it is simply impossible to eliminate the balancing or
weighing of competing considerations in determining whether a product is
defectively designed or not. . . .‘ [Citation.]‖ (Soule, supra, 8 Cal.4th at pp.
562–563.)
In order to establish a design defect under the consumer expectation
test when a ―‗―product is one within the common experience of ordinary
consumers,‖‘‖ the plaintiff must ―‗―provide[] evidence concerning (1) his or her
use of the product; (2) the circumstances surrounding the injury; and (3) the
objective features of the product which are relevant to an evaluation of its
safety.‖ [Citation.] The test is that of a hypothetical reasonable consumer,
not the expectation of the particular plaintiff in the case.‘‖ (Mansur v. Ford
Motor Co. (2011) 197 Cal.App.4th 1365, 1375 (Mansur).)
In Mansur, the court affirmed the trial court‘s decision not to instruct
the jury on the consumer expectation test in the plaintiffs‘ design defect
63
action following the rollover of their vehicle. (Mansur, supra, 197
Cal.App.4th at p. 1368.) The plaintiffs satisfied their burden of presenting
evidence of their use of the product and the circumstances surrounding the
injury. (Id. at pp. 1375-1376.) However, as to the objective features, they
presented evidence only of the vehicle‘s marketing and handling, as well as of
the lack of warning about rollovers. The court concluded that this evidence
failed to ―show the vehicle‘s objective features in such a way that a jury could
understand why the roof crushed in . . . . Since Plaintiffs did not present
sufficient evidence about the objective features of the product, which are
relevant to an evaluation of its safety, we conclude the trial court correctly
denied the consumer expectations instruction.‖ (Id. at p. 1378.)
In Soule, the plaintiff sued the manufacturer of her car after she was
injured in an accident, alleging that the defective design of the car caused her
injuries. The California Supreme Court held that the jury should not have
been instructed on the consumer expectation test because the plaintiff‘s
―theory of design defect was one of technical and mechanical detail. It sought
to examine the precise behavior of several obscure components of her car
under the complex circumstances of a particular accident.‖ (Soule, supra, 8
Cal.4th at p. 570.) The court further reasoned that ―ordinary experience and
understanding [would not] inform such a consumer how safely an
automobile‘s design should perform under the esoteric circumstances of the
collision at issue here,‖ pointing out that expert testimony was required to
explain the ―complicated design considerations‖ at issue.26 (Ibid.)
26 The court subsequently held that the instructional error was harmless
because it was ―not reasonably probable defendant would have obtained a
more favorable result in its absence. [Citations.]‖ (Soule, supra, 8 Cal.4th at
p. 570.)
64
Similarly, in Morson, supra, the court held that the consumer
expectation test did not apply to the plaintiffs‘ design defect claim against
manufacturers of latex gloves. (Morson, supra, 90 Cal.App.4th at p. 779.)
The plaintiffs contended that they had sensitivities to latex that worsened
from their usage of the gloves. Morson recognized the difficulty of
―reconciling products liability law that has developed in the context of
merchandise, such as soda bottles and automobiles, with the body of
knowledge that deals with medical and allergic conditions and their genesis.‖
(Id. at p. 791.) Because ―the alleged circumstances of the product‘s failure
involve technical and mechanical details about the operation of the
manufacturing process, and then the effect of the product upon an individual
plaintiff‘s health,‖ the consumer expectation test did not apply. (Id. at p.
792.)
Morson explained that ―[t]he clear trend of authority allows for the
application of scientific understanding and analysis in the products liability
context, and this is particularly so where there are allegations of allergic
and/or idiosyncratic reactions to the product that is allegedly defective in
design. The complex nature of the design defects alleged here requires such
scientific resources to achieve a just resolution of the controversy by the
finder of fact.‖ (Morson, supra, 90 Cal.App.4th at p. 795.) Because expert
testimony was ―essential to assist the finder of fact in understanding the pros
and cons of‖ the design defect claim, Morson concluded that the alleged
design defects of the latex gloves could not correctly be evaluated under the
consumer expectation test. (Id. at pp. 793, 795.)
The court in Pruitt v. General Motors Corp. (1999) 72 Cal.App.4th 1480(Pruitt) held the consumer expectation test did not apply despite the
plaintiff‘s testimony that she did not expect the air bag to injure her during a
65
low-speed collision. The court explained that ―[m]inimum safety standards
for air bags are not within the common knowledge of lay jurors. Jurors are in
need of expert testimony to evaluate the risks and benefits of the challenged
design. Even [plaintiff‘s] own expert testified that in designing air bags there
are tradeoffs involving complex technical issues.‖ (Id. at pp. 1483-1484.)
Plaintiff here contends that the consumer expectation test applies
because the ordinary consumer does not expect to contract SJS/TEN from
taking OTC Motrin. However, it could be said that any injury from the
intended or foreseeable use of a product is not expected by the ordinary
consumer. If this were the end of the inquiry, the consumer expectation test
always would apply and every product would be found to have a design
defect. (See Soule, supra, 8 Cal.4th at p. 568, fn. 5 [―we have consistently
held that manufacturers are not insurers of their products; they are liable in
tort only when ‗defects‘ in their products cause injury.‖].)
As the court in Morson explained, ―Plaintiffs view the product as a
simple one that can give rise to simple consumer expectations of safety that
have nothing to do with the chemical composition of the material from which
the product is manufactured, or any other design characteristics for which
specialized knowledge is required for understanding or taking appropriate
precautions. [¶] However, the protective or barrier function of the latex
gloves, on which the Plaintiffs‘ safety argument is mainly premised, is not
their only characteristic. These gloves are made of a particular material
through a particular manufacturing process. The effect of this material and
these processes may well be to create in their users many degrees of allergic
reactions. Understanding and assessing responsibility for such allergic
reactions is a matter that is driven by the science of the manufacturing and
preparation procedures, as well as the medical aspects of an individual‘s
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allergic reactions to various substances.‖ (Morson, supra, 90 Cal.App.4th at
p. 793.)
Soule, Morson, Mansur and Pruitt indicate that the consumer
expectation test does not apply merely because the consumer states that he
or she did not expect to be injured by the product. As in those cases, the
design defect claim here involves ―technical and mechanical detail‖ (Soule,
supra, 8 Cal.4th at p. 570) and testimony regarding the ―medical aspects of
an individual‘s . . . reactions to various substances.‖ (Morson, supra, 90
Cal.App.4th at p. 793.) Because ―the ultimate issue of design defect calls for
a careful assessment of feasibility, practicality, risk, and benefit,‖ the
consumer expectation test does not apply here. (Soule, supra, 8 Cal.4th at p.
562.)
The need in this case for expert testimony about the risks and benefits
of Motrin‘s design is highlighted by the fact that the trial court repeatedly
sustained objections and admonished plaintiff‘s counsel not to allow expert
testimony related to the consumer expectation test. ―‗[E]xpert witnesses may
not be used to demonstrate what an ordinary consumer would or should
expect,‘ because the idea behind the consumer expectations test is that the
lay jurors have common knowledge about the product‘s basic safety.
[Citation.] Using expert testimony to demonstrate common knowledge would
be inappropriate (Evid. Code, § 801, subd. (a)), ‗and would invite
circumvention of the rule that the risks and benefits of a challenged design
must be carefully balanced whenever the issue of design defect goes beyond
the common experience of the product‘s users.‘‖ (Mansur, supra, 197
Cal.App.4th at p. 1375; see Stephen v. Ford Motor Co. (2005) 134 Cal.App.4th
1363, 1370, fn. 6 [―The consumer expectation test applies only when the
defect can be determined by common knowledge regarding minimum safety
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expectations, not where (as here) an expert must balance the benefits of
design against the risk of danger.‖].) Instead, the plaintiff should ―present
pertinent nonexpert testimony related to the features of the [product], which
would allow a trier of fact to evaluate the safety of the [product‘s features].‖
(Mansur, supra, 197 Cal.App.4th at p. 1379.)
It cannot reasonably be disputed that contracting SJS/TEN after taking
OTC Motrin is an ―idiosyncratic reaction[]‖ to the drug, which the FDA
estimated is used approximately 100 million times per year in the United
States. (Morson, supra, 90 Cal.App.4th at p. 795.) Indeed, when Tackett was
explaining the physiological mechanism by which he believed ibuprofen
caused plaintiff‘s TEN, he stated that TEN is referred to as an ―idiosyncratic‖
side effect. (See Robinson, supra, 615 F.3d at p. 868 [―The prevalence of TEN
from all causes is estimated to be only between .4 and 1.2 cases per million
users of the drug, and what fraction of that slight probability is due to
ibuprofen is unknown and may be zero‖].) Because SJS/TEN is an unusual
reaction, expert testimony was required to explain plaintiff‘s theory of how
Motrin caused his injury.
―That causation for a plaintiff‘s injuries was proved through expert
testimony does not mean that an ordinary consumer would be unable to form
assumptions about the product‘s safety. [Citations.]‖ (Romine, supra, 224
Cal.App.4th at p. 1004.) Nonetheless, ―‗in many instances it is simply
impossible to eliminate the balancing or weighing of competing
considerations in determining whether a product is defectively designed or
not. . . .‘ [Citation.]‖ (Soule, supra, 8 Cal.4th at pp. 562–563.) The
circumstances of Motrin‘s failure involve technical details and expert
testimony regarding ―the effect of the product upon an individual plaintiff‘s
health‖ (Morson, supra, 90 Cal.App.4th at p. 792), and the ultimate question
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of whether Motrin was defectively designed ―calls for a careful assessment of
feasibility, practicality, risk, and benefit‖ (Soule, supra, 8 Cal.4th at p. 562).
Accordingly, we conclude that the consumer expectation test should not have
been applied here.27
DISPOSITION
We summarize our holdings as follows:
(1) The jury‘s finding that McNeil was not liable for strict liability
failure to warn is fatally inconsistent with its finding that McNeil was liable
for negligent failure to warn.
(2) The special verdict form for negligent failure to warn was defective
for failing to include the element of whether a reasonable manufacturer
under the same or similar circumstances would have warned of the danger.
27 Because we conclude the case must be retried, we do not address
defendants‘ argument that the negligent design defect finding against McNeil
is inconsistent with the finding in favor of defendants on the risk-benefit test.
We note, however, that our Supreme Court has stated that, ―in a products
liability action based on negligence in the design of a product ‗placed on the
market,‘ the test of negligent design ‗involves a balancing of the likelihood of
harm to be expected from a machine with a given design and the gravity of
harm if it happens against the burden of the precaution which would be
effective to avoid the harm.‘ [Citation.] . . . Thus, ‗most of the evidentiary
matters‘ relevant to applying the risk/benefit test in strict liability cases ‗are
similar to the issues typically presented in a negligent design case.‘‖ (Merrill,
supra, 26 Cal.4th at pp. 479–480.) Nor do we need to address Johnson &
Johnson‘s argument that the finding in plaintiff‘s favor on his strict liability
design defect claim is not supported by the evidence. We also do not address
defendants‘ arguments regarding punitive damages and plaintiff‘s counsel‘s
alleged misconduct. (See Lambert, supra, 67 Cal.App.4th at p. 1186 [―Having
determined that the verdict is fatally inconsistent and must be reversed, we
do not need to address the multitude of evidentiary and misconduct issues
raised by General Motors. The proper disposition, in our view, is to remand
for a new trial.‖].)
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(3) Plaintiff‘s negligent and strict liability design defect claims, which
were based on defendants‘ failure to sell dexibuprofen instead of ibuprofen,
are preempted under federal law.
(4) The consumer expectation test of design defect does not apply
when, as here, the question of design defect involves complex questions of
feasibility, practicality, risk, and benefit beyond the common knowledge of
jurors.
As to both McNeil and Johnson and Johnson, the judgment is reversed.
As to McNeil alone, the case is remanded for retrial on plaintiff‘s claims for
negligent and strict liability failure to warn. The parties shall bear their own
costs on appeal.
CERTIFIED FOR PUBLICATION
WILLHITE, J.
We concur:
EPSTEIN, P. J.
COLLINS, J.
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