Stanford Law School - Robert Crown Law Library

Filed 4/15/04

IN THE SUPREME COURT OF CALIFORNIA

PAUL DOWHAL,
Plaintiff and Appellant,
S109306
v.
) Ct.App.
1/5
A094460
SMITHKLINE BEECHAM CONSUMER )
HEALTHCARE et al.,
San
Francisco
County
Defendants and Respondents. )
Super. Ct. No. 305893

Plaintiff filed this action to challenge the failure of defendants to place
health warnings mandated by California’s Proposition 65 on products containing
nicotine sold over the counter as aids to stop smoking. The trial court granted
summary judgment to defendants, ruling that in this setting the requirements of
Proposition 65 were impliedly preempted by the federal Food, Drug, and Cosmetic
Act (FDCA) (21 U.S.C. § 301 et seq.). The Court of Appeal reversed; we granted
review.
We conclude: (1) Notwithstanding language in the FDCA exempting
Proposition 65 from the preemptive effect of the federal act, when the warning
mandated by California law directly conflicts with the one that the federal Food
and Drug Administration (FDA) requires, the federal requirement prevails; (2) this
is a case of direct conflict; and (3) the FDA has authority to prohibit use of the
Proposition 65 warning, even though that warning is literally truthful, if the FDA
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concludes that it would have the effect of misleading consumers. We therefore
reverse the judgment of the Court of Appeal.
I. FACTUAL AND PROCEDURAL BACKGROUND
On November 4, 1986, the voters of this state enacted Proposition 65 as an
initiative measure. Proposition 65 added section 25249.6 to the Health and Safety
Code: “No person in the course of doing business shall knowingly and
intentionally expose any individual to a chemical known to the state to cause . . .
reproductive toxicity without first giving clear and reasonable warning to such
individual . . . .” This provision does not apply, however, to “[a]n exposure for
which federal law governs warning in a manner that preempts state authority.”
(Health & Saf. Code, § 25249.10.)
The regulations adopted to implement Health and Safety Code section
25249.6 state that the required warning “must clearly communicate that the
chemical in question is known to the state to cause . . . birth defects or other
reproductive harm.” (Cal. Code Regs., tit. 22, § 12601, subd. (a).) The
regulations also describe optional “safe harbor” warnings that are deemed to be
clear and reasonable. (Id., § 12601, subd. (b).) One of the “safe harbor” warnings
reads: “WARNING: This product contains a chemical known to the State of
California to cause birth defects or other reproductive harm.” (Id., § 12601, subd.
(b)(4)(B).) The warning may be communicated through product labeling, point-
of-sale signs, or public advertising. (Id., § 12601, subd. (b)(1)(A)-(C).)
On April 1, 1990, the State of California listed nicotine as a chemical
known to cause reproductive toxicity. (Cal. Code Regs., tit. 22, § 12000(c).) This
listing was based on the then current determination by the FDA that because of the
dangerous consequences of fetal nicotine exposure, nicotine delivery products
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should be rated in “Category X” – not for use by pregnant women.1
Consequently, to conform to Proposition 65, defendants’ products must carry a
warning that “this product contains nicotine, a chemical known to the state of
California to cause reproductive harm,” or words to that effect.
The FDA, however, has never permitted defendants to use the Proposition
65 warning. The FDA’s currently approved warning does not state that nicotine
can cause reproductive harm. It requires the product label to state: “If you are
pregnant or breast-feeding, only use this medicine on the advice of your health
care provider. Smoking can seriously harm your child. Try to stop smoking
without using any nicotine replacement medicine. This medicine is believed to be
safer than smoking. However, the risks to your child from this medicine are not
fully known.” The difference between the two warnings is the focus of this case.
The FDCA prohibits a drug manufacturer from marketing a new drug
unless the FDA has approved the drug as both safe and effective for its intended
use. (21 U.S.C. § 355.) In addition to scientific and experimental data, a new
drug application must include a proposed label. (21 U.S.C. § 355(b)(1)(F).) If the
FDA determines that the labeling is false or misleading in any way, the drug is
deemed “misbranded,” and the FDA will reject the application for approval of the
drug. (21 U.S.C. § 352(a).) Once an application has been approved, any change
in the labeling requires a supplement to the application and approval by the FDA,
either before or after the change. (21 C.F.R. §§ 314.70, 314.71 (2003).)

1
In 1992 the FDA reclassified nicotine delivery products, placing them in
categories C and D, which permits use by pregnant women with a doctor’s
prescription.

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The issue here is whether California’s Proposition 65 requirements are
preempted by the FDA regulation, or preserved by the savings clause, section
379r(d)(2), of the Food and Drug Administration Modernization Act of 1997
(Modernization Act) (Pub. L. No. 105-115 (Nov. 21, 1997) 111 Stat. 2296).
Section 379r(a) establishes the preemptive effective of federal regulation; it states
in part: “[N]o State or political subdivision of a State may establish or continue in
effect any requirement -- [¶] . . . . (2) that is different from or in addition to, or
that is otherwise not identical with, a requirement under this chapter . . . .” The
Modernization Act, however, contained a savings clause designed specifically to
preserve Proposition 65. It provides: “This section shall not apply to a State
requirement adopted by a State public initiative or referendum enacted prior to
September 1, 1997.” (21 U.S.C. § 379r(d)(2).) Proposition 65 is the only state
enactment that falls within the savings clause.
Defendants here manufacture, market, and distribute products, such as gum
and patches, that are designed to help people quit smoking through nicotine
replacement therapy (NRT).2 Originally, the products were available only by
prescription. In 1993, defendants sought FDA approval to sell them over the
counter. Defendants’ application presented a complex labeling issue because the
products contain nicotine, a substance that if taken by a pregnant woman could
cause harm to the fetus. On the other hand, the purpose of the products is to help

2
Defendants are GlaxoSmithKline Consumer Healthcare, LP (formerly
SmithKline Beecham Consumer Healthcare), which markets Nicorette and
NicoDerm CQ; McNeil Consumer Products Company and Pharmacia & Upjohn,
Inc., which have marketed Nicotrol; Aventis Pharmaceuticals Inc., which is
involved in the packaging of NicoDerm CQ; Alza Corporation, which
manufactures NicoDerm CQ, and Costco Wholesale Corporation, Lucky Stores,
Inc., Rite Aid Corporation, Safeway, Inc., and Walgreen Co., which retail
Nicorette, NicoDerm CQ, and/or Nicotrol.
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individuals stop smoking, and smoking is even more dangerous to the fetus,
because it may deliver more nicotine than the NRT products, and also exposes the
smoker to carbon monoxide and other harmful chemicals. As the chairman of the
FDA’s Nonprescription Drugs Advisory Committee stated: “This is one of the
few instances where we have a product that has come before this committee that I
would like lots of people to use, that I think we are underusing. . . . [¶] So we
want to make sure that we are not introducing barriers that would prevent people
from using them, and what is worse, somebody continuing to smoke or not calling
their physician and talking with him. . . . [¶] I think, at least as I am interpreting
the sense of the committee is that let’s be real careful on something we want
people to use more of that we don’t introduce barriers that would reduce their
willingness to use the product.” (FDA Nonprescription Drugs Advisory Meeting
(Apr. 19, 1996), pp. 169-170.)
Partly in an effort to balance these competing concerns, the products
underwent an unusually long approval process. As of 1996, the labels for the
original Nicorette, Nicoderm, and Nicotrol prescription products carried a required
warning: “Nicotine in any form may cause harm to your unborn baby.” (This is
the warning required for prescription drugs containing nicotine in 1996.) But
when the FDA approved over-the-counter sales in 1996, the FDA advised
defendants that their products could carry the following pregnancy warning:
“Nicotine can increase your baby’s heart rate; . . . if you are pregnant or nursing a
baby, seek the advice of a health professional before using this product.”3 Failure

3
The warnings for the various products differ in some minor respects. No
party to this appeal contends the differences are relevant for purposes of this
appeal.
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to label the products “exactly as requested,” the FDA warned producers, “may
render the product mislabeled.”
In January 1997, defendant McNeil asked the FDA for permission to
change the label for its product Nicotrol to add the Proposition 65 “safe harbor”
warning: “This product contains nicotine, a chemical known to the State of
California to cause birth defects or other reproductive harm.” The FDA denied the
request, telling McNeil it “[m]ust use the labeling that was approved at the time of
. . . approval.”
The California Attorney General, however, determined in a letter issued
July 10, 1998, that the “increased heart rate” warning did not comply with
Proposition 65, because it failed to warn that nicotine can “harm” the fetus, and
suggested that nicotine only posed a narrow risk of an increased fetal heart rate
“when the true risks appear to be significantly broader and more serious.”
In August 1999, after the enactment of the Modernization Act, plaintiff
Paul Dowhal, acting on behalf of the public, filed the complaint here. Plaintiff
alleged defendants violated Health and Safety Code section 25249.6 because they
placed products containing nicotine into the “stream of commerce” without the
pregnancy warning required by Proposition 65. Plaintiff also alleged that by
failing to provide an adequate warning, defendants committed an unfair business
practice in violation of Business and Professions Code section 17200 et seq. He
asked for an injunction barring defendants from offering their products for sale in
California without providing an adequate Proposition 65 warning.
In November 1999, while this case was pending, the FDA granted
permission to Novartis Consumer Health Care, Inc. (Novartis) to sell an NRT
product called Habitrol. (Novartis is not a party to this case.) Although Habitrol
is identical to some of defendants’ products in nicotine content, indication for use,
and method of administration, the FDA approved Novartis’s warning to
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consumers: “Nicotine, whether from smoking or medication, can harm your
baby.”
When defendant SmithKline learned about the Habitrol pregnancy warning,
it asked the FDA whether it should change its warning. The FDA responded that
it was “reviewing its position as it relates to the warnings of nicotine products
concerning pregnancy and breast feeding.” In May 2000, defendants SmithKline
and McNeil each wrote to the FDA, again pointing out that Habitrol carried a
different pregnancy warning than their products and that they faced litigation over
the adequacy of their warning. In June 2000, the FDA responded to SmithKline
that while the FDA was reviewing its position on the pregnancy warning,
SmithKline should continue to “use the current warning.”
On July 11, 2000, counsel for SmithKline wrote to the FDA seeking
confirmation about the pregnancy warning that was required. The FDA responded
by letter 10 days later, stating that the products “must” carry the pregnancy
warning that had been specified when they were approved.
In March 2001, the FDA sent a letter to SmithKline stating that even
though Habitrol carried a different warning, the instructions concerning
defendants’ products remained unchanged: “The agency is currently reviewing its
position regarding the pregnancy/nursing warning on [over-the-counter] nicotine
replacement products. [¶] . . . As we have stated previously, until the agency’s
review is complete, all sponsors of [over-the-counter] nicotine replacement
products should continue to use the pregnancy/nursing warning that was approved
by the agency as part of their [new drug approval]. Any additional or modified
warning may render the product misbranded.” (Italics added.)
While defendants were working with the FDA in an effort to clarify their
obligation to warn, plaintiff moved for summary adjudication. Defendants filed a
cross-motion for summary judgment, arguing that federal law preempted any
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obligation to warn under Proposition 65. The trial court denied plaintiff’s motion,
granted defendants’ motion, and entered judgment for defendants. Plaintiff
appealed.
While this appeal was pending, the FDA responded to a citizen’s petition
that plaintiff had filed with the agency on August 2, 2000. In a letter to plaintiff
mailed August 17, 2001 (hereafter sometimes referred to as the August 17 letter)4,
the FDA reviewed the medical literature, and said it would “grant [plaintiff’s]
request for a consistent pregnancy warning for all [over-the-counter] NRT drug
products that clearly and reasonably communicates all of the known harm and
conveys the relative reproductive harm of smoking, use of NRT drug products,
and total abstinence from nicotine.” The FDA denied plaintiff’s request to require
a warning on all NRT drug products similar to the “can harm your baby” warning
on Habitrol. That warning, the FDA asserted, “overstates what is actually known
about nicotine and its effect on the unborn child.” It also rejected a proposal to
use a label similar to that required for prescription drugs on the ground that the
warning to doctors was “not easily translated into consumer friendly language.”
The FDA agreed that the “can increase your baby’s heart rate” warning was
insufficient, because it might lead consumers to believe that this was the only
possible effect of nicotine. It proposed, instead, that all nicotine replacement

4
On October 4, 2001, plaintiff and defendants filed a joint request asking the
Court of Appeal to take judicial notice of the August 17 letter. The Court of
Appeal exercised its discretion to grant judicial notice, so this letter is now part of
the record on appeal. The August 17 letter is attached as an appendix to this
opinion.

Because plaintiff’s action seeks injunctive relief, an appellate court can take
into account events occurring after the trial court judgment. (See Fisher v. City of
Berkeley (1984) 37 Cal.3d 644, 654, fn. 3 [changes in the law]; Reserve Insurance
Co. v. Pisciotta (1982) 30 Cal.3d 800, 813 [new facts not in dispute].)
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products, including the products at issue and Habitrol, bear the uniform pregnancy
warning quoted earlier in this opinion. (Ante, at p. 3.) This warning advised
pregnant women to consult their health care provider, recommended that they try
to stop smoking without using an NRT product, and told them that the medical
risks to their child from the product were not fully known.
The Court of Appeal majority here reversed the judgment of the trial court.
It concluded that the savings clause in the Modernization Act precluded federal
preemption of Proposition 65 warnings, even if there was a direct conflict between
those warnings and FDA requirements. The concurring opinion found no conflict
between Proposition 65 and the FDA requirements on three grounds: (1) a truthful
Proposition 65 label would not conflict with the policy of the FDCA; (2) the
informal letters from the FDA to defendants were insufficient to create a
preemptive federal policy; and (3) Proposition 65 warnings need not be placed on
the package, but could be posted elsewhere where consumers could see them.
We granted defendants’ petition for review.

II. DOES THE MODERNIZATION ACT PRECLUDE CONFLICT

PREEMPTION?
The supremacy clause of article VI of the United States Constitution grants
Congress the power to preempt state law. State law that conflicts with a federal
statute is “ ‘without effect.’ ” (Cipollone v. Liggett Group, Inc. (1992) 505 U.S.
504, 516 (Cipollone), quoting Maryland v. Louisiana (1981) 451 U.S. 725, 746.)
It is equally well established that “[c]onsideration of issues arising under the
Supremacy Clause ‘start[s] with the assumption that the historic police powers of
the States [are] not to be superseded by . . . Federal Act unless that [is] the clear
and manifest purpose of Congress.’ ” (Cipollone, at p. 516.) Thus, “ ‘ “[t]he
purpose of Congress is the ultimate touchstone” ’ of pre-emption analysis.” (Ibid.)
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The United States Supreme Court has explained that federal preemption
arises in three circumstances: “First, Congress can define explicitly the extent to
which its enactments pre-empt state law. [Citation.] Pre-emption fundamentally
is a question of congressional intent, [citation] and when Congress has made its
intent known through explicit statutory language, the courts’ task is an easy one.
[¶] Second, in the absence of explicit statutory language, state law is pre-empted
where it regulates conduct in a field that Congress intended the Federal
Government to occupy exclusively. Such an intent may be inferred from a
‘scheme of federal regulation . . . so pervasive as to make reasonable the inference
that Congress left no room for the States to supplement it,’ or where an Act of
Congress ‘touch[es] a field in which the federal interest is so dominant that the
federal system will be assumed to preclude enforcement of state laws on the same
subject.’ [Citation.] Although this Court has not hesitated to draw an inference of
field pre-emption where it is supported by the federal statutory and regulatory
schemes, it has emphasized: ‘Where . . . the field which Congress is said to have
pre-empted’ includes areas that have ‘been traditionally occupied by the States,’
congressional intent to supersede state laws must be ‘ “clear and manifest.” ’
[Citations.] [¶] Finally, state law is pre-empted to the extent that it actually
conflicts with federal law. Thus, the Court has found pre-emption where it is
impossible for a private party to comply with both state and federal requirements,
[citation] or where state law ‘stands as an obstacle to the accomplishment and
execution of the full purposes and objectives of Congress.’ ” (English v. General
Electric Co. (1990) 496 U.S. 72, 78-79, fn. omitted; see Crosby v. National
Foreign Trade Council (2000) 530 U.S. 363, 372-373; Olszewski v. Scripps
Health (2003) 30 Cal.4th 798, 814.)
The first and second forms of preemption are inapplicable here. The
savings clause in the Modernization Act demonstrates both that Congress did not
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expressly preempt California law, and that it did not occupy the field of labeling of
over-the-counter drugs. Thus the issue here concerns the third form of
preemption, referred to as “conflict preemption.”
Congress has the power to preclude conflict preemption, allowing states to
enforce laws even if those laws are in direct conflict with federal law or frustrate
the purpose of federal law. (Geier v. American Honda Motor Co., Inc. (2000) 529
U.S. 861, 872 [Geier].) The Court of Appeal here, relying on the language of the
Modernization Act, concluded that Congress had so exercised its power.
The Modernization Act, in 21 United States Code section 379r(a), prohibits
states from enacting “any requirement . . . that is different from or in addition to,
or that is not identical with, a requirement under this chapter.” Section 379r(d)(2)
then provides that section 379r does not apply to certain state initiative measures;
Proposition 65 comes within this exemption. From this language the Court of
Appeal reasoned that California may establish requirements different from, and
thus in conflict with, the FDA requirements.
A Proposition 65 requirement, however, may be “different from, in addition
to, or . . . not identical” (21 U.S.C. § 379r(a)) to an FDA requirement without
actually conflicting with the federal requirement. Here, for example, if the FDA
had simply required the warning that “[n]icotine can increase your baby’s heart
rate,” but had not prohibited other warnings, a Proposition 65 warning that
nicotine “is known . . . to cause birth defects or other reproductive harm” (Cal.
Code Regs., tit. 22, § 12601, subd. (a)) would not conflict with the federal
requirement. The product label could simply contain both warnings. Thus,
contrary to the Court of Appeal’s view, recognizing conflict preemption would not
nullify the savings clause of section 379r.
The United States Supreme Court’s decision in Geier, supra, 529 U.S. 861,
established a strong presumption that Congress does not ordinarily intend to bar
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conflict preemption. The issue in that case was whether the 1984 version of the
Federal Motor Vehicle Safety Standard promulgated by the Department of
Transportation relating to airbags preempted a state common law tort action
alleging that the defendant manufacturer should have equipped its car with
airbags. The federal standard provided for a variety of passive restraints and a
gradual phasing-in of airbags. It was based in part on the Transportation
Department’s fear of a consumer backlash if it were to require airbags on all cars
at that time.
The controlling statute in Geier, supra, 529 U.S. 861, like the statute in the
case here, prohibited states from establishing standards not identical to federal
standards. (15 U.S.C. former § 1392(d).) It further provided, however, that
“compliance with” a federal safety standard “does not exempt any person from
any liability under common law.” (15 U.S.C. former § 1397(k).) The United
States Supreme Court held that this savings clause removed tort actions from the
scope of the express preemption clause, but did not foreclose conflict preemption.
(Geier, supra, 529 U.S. at p. 869.)
The high court went on to say: “Nothing in the language of the savings
clause suggests an intent to save state-law actions that conflict with federal
regulations. The words ‘compliance’ and ‘does not exempt’ [citation] sound as if
they simply bar a special kind of defense, namely, a defense that compliance with
a federal standard automatically exempts a defendant from state law whether the
Federal Government meant that standard to be an absolute requirement or only a
minimum one. [Citation.] It is difficult to understand why Congress would have
insisted on a compliance with-federal-regulation precondition to the provision’s
applicability had it wished the Act to ‘save’ all state-law tort actions, regardless of
their potential threat to the objectives of federal safety standards promulgated
under that Act.” (Geier, supra, 529 U.S. at pp. 869-870.)
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Geier also gave “some weight” to the Department of Transportation’s
conclusion that allowing tort suits against manufacturers who had complied with
the department’s airbag rules would stand as an obstacle to the accomplishment of
federal objectives. (Geier, supra, 529 U.S. at p. 883.) It explained its deference to
the department’s conclusion: “Congress has delegated to DOT authority to
implement the statute; the subject matter is technical; and the relevant history and
background are complex and extensive. The agency is likely to have a thorough
understanding of its own regulation and its objectives and is ‘uniquely qualified’
to comprehend the likely impact of state requirements.” (Ibid.)
Geier concluded that the savings clause in that case preserved state tort law
only when the federal regulation was intended to provide a minimum standard, not
when it was intended to establish an absolute standard. Plaintiff here seeks to
confine Geier by pointing to differences between the savings clause at issue in
Geier and the savings clause in the Modernization Act. He notes also the
difference between preempting a common law tort action, as was involved in
Geier, and preempting a state regulation. But later cases confirm that Geier is not
a narrow holding limited to automobile safety standards; instead it established a
general rule upholding conflict preemption even if the applicable federal law
contains a savings clause. (See Sprietsma v. Mercury Marine (2002) 537 U.S. 51,
63; Buckman Co. v. Plaintiffs’ Legal Comm. (2001) 531 U.S. 341, 352.) The
United States Supreme Court has never interpreted a savings clause so broadly as
to permit a state enactment to conflict with a federal regulation scheme.5

5
Oxygenated Fuels Ass’n., Inc. v. Davis (9th Cir. 2003) 331 F.3d 665, held
that the Clean Air Act (42 U.S.C. § 7401 et seq.) did not preempt a conflicting
California regulation (Cal. Code Regs., tit. 13, § 2262.6 (2003)) prohibiting use of
the gasoline additive MTBE. That decision was not based on the savings clause in
the federal statute (42 U.S.C. § 7545 (c)(4) (B)), which did not apply to the

(footnote continued on next page)
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The language of the Modernization Act’s savings clause does not express
an intention to preclude all conflict preemption. The legislative history suggests
an intent to preclude conflict preemption in pursuit of national uniform labeling.6
In light of that language, history, and the principles established by Geier, supra,
529 U.S. 861 and other United States Supreme Court decisions, we conclude that
the savings clause of 21 United States Code section 397r(d)(2), does not entirely
exclude conflict preemption.
We do not, however, go as far as the United States Attorney General urges
in his amicus curiae brief and hold that the savings clause, by nullifying the
preemptive effect of 21 United States Code section 397(a), left the law of implied
preemption, so far as Proposition 65 is concerned, as if neither were enacted.
Such an interpretation would allow the FDA to pursue a goal of national
uniformity in warnings, and to further that goal by preempting all Proposition 65
warnings. Section 397r(a) and (d)(2), however, establish that a Proposition 65
warning cannot be preempted solely because it is not identical with the federal
requirement. If the FDA’s directive here prohibiting nonidentical labels is to be

(footnote continued from previous page)

California regulation, but on evidence that Congress did not intend to preempt
such state regulation.
6
During the floor debate on the Modernization Act, Senator Barbara Boxer
stated: “I want to thank Senators Gregg and Jeffords for working with me to
ensure that California’s proposition 65 will not be preempted by the uniformity
provisions of this bill . . . Proposition 65 has successfully reduced toxic
contaminants in a number of consumer products sold in California and it has even
led the FDA to adopt more stringent standards for some consumer products . . . .
So I am very pleased that the FDA reform bill now being debated will exempt
California’s proposition 65.” (Remarks of Sen. Boxer, 143 Cong. Rec. S9811,
S9843 (Sept. 24, 1997). “Such statements . . . can provide evidence of Congress’
intent.” (Brock v. Pierce County (1986) 476 U.S. 253, 263.)
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sustained, it must be on a basis relevant to consumer health, and not because the
Proposition 65 label would frustrate the FDA’s policy favoring national
uniformity.

III. IS THERE A DIRECT CONFLICT BETWEEN THE WARNING
REQUIRED BY PROPOSITION 65 AND THE ORDERS OF THE
FDA?
The language required by the FDA’s August 17, 2001, letter is not
necessarily inconsistent with a Proposition 65 warning to consumers that
defendants’ products contain nicotine, a chemical known to cause reproductive
harm. The apparent conflict arises from the FDA’s insistence that defendants
must use the warning it has promulgated unless they have data to support a
different warning. The FDA has rejected plaintiff’s claim that his data justify a
different warning, and defendants do not claim to have any additional data. Thus,
if a defendant were to add a warning to its label advising that nicotine can cause
fetal harm, it would violate the FDA’s determination and would risk legal
sanctions.
Plaintiff contends, however, that the FDA action is not sufficiently definite
and authoritative to create a conflict with state law. Before August 17, 2001, the
FDA had regularly sent letters instructing defendants not to add any additional
warnings to the FDA-approved warning, and cautioning them that adding such
additional warnings might render the product misbranded. Some letters advised
the recipient that the matter was still under consideration. But amicus curiae
United States Attorney General, on behalf of the FDA, acknowledges: “Before its
disposition of Dowhal’s citizen petition [by the August 17, 2001, letter], FDA had
not issued definitive advice concerning whether use of Dowhal’s proposed
warning labeling would render Defendants’ products misbranded under the
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FDCA.” The FDA takes the position that its August 17 letter was the first
definitive ruling on the subject.
The FDA’s August 17 letter specifically rejected plaintiff’s proposed “can
harm your baby” warning. (Aug. 17, 2001, letter, p. 8.) It did not expressly reject
all possible Proposition 65 warnings. It announced, however, that the FDA had
developed “a uniform warning that manufacturers . . . will be requested to
implement.” (Id. at p. 5.) Rejecting all earlier warnings, including both the “fetal
heart rate” warning used by defendants and the “can harm your baby” warning
used on Habitrol, the FDA said that the label should instead tell the buyer to
consult her health care provider for advice. Manufacturers were requested to
submit a supplement changing their warning to conform to the warning in the
August 17 letter. (Id. at pp. 7-8.)
Plaintiff argues that the FDA’s August 17 letter did not establish a required
federal warning, but merely “requested” defendants to submit supplements. But
the term “requested” appears to be simply a matter of courtesy; it is apparent from
the tenor of the letter that it imposes a duty on defendants. A company cannot use
warnings the FDA considers misleading simply because it chooses not to comply
with an FDA request to submit the forms required to change its warnings to the
one adopted by the FDA.
Plaintiff and his amici curiae point to language in the FDA’s August 17
letter stating that “[a]ny other warnings proposed by the sponsor must be
supported by data,” as showing that defendants are not required to use warnings
identical to the FDA warning. But this is standard language that appears, or is
implied, in all FDA labeling decisions. A company is always free to change its
label, after notifying the FDA, if it has new data showing the former warning was
inappropriate. (See 21 C.F.R. § 314.70 (2003).) The possibility that new data
may justify a change in the warning does not invalidate the approval of the
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existing warning; that warning continues to be binding until the new data emerge
and a change is requested.
Plaintiff and his amici curiae point out that the FDA’s August 17 letter has
not been published in the Federal Register. There is no requirement, however, that
it be so published to be effective. Congress was undoubtedly aware that one
common means of FDA regulation is to publish rulings through letters to the
parties requesting the rulings. When Congress granted preemptive effect to FDA
regulation as to all state regulation except Proposition 65 regulation, it probably
had in mind regulation through FDA advisory letters.
In
Geier, supra, 529 U.S. 861, the United States Supreme Court gave
preemptive effect to a federal policy expressed in less formal manner than the
FDA policy here. Rejecting a contention that formal notice-and-comment
rulemaking should be required before an agency’s action has preemptive force, the
high court found federal policy to be sufficiently definite as to create a conflict
when that policy was set out only in comments of the Department of
Transportation accompanying its revision of the airbag rules and in statements in
the Solicitor General’s brief submitted on the agency’s behalf. (Id. at pp. 883-
884.)
Plaintiff here contends that although the FDA has rejected several proposed
labels based on Proposition 65, defendants cannot prevail on their motion for
summary judgment unless all possible Proposition 65 labels would conflict with
the FDA’s determination. (See Dental Amalgam Mfrs. & Distributors v. Stratton
(9th Cir. 1996) 92 F.3d 807, 810; Chemical Specialties Mfrs. Ass’n, Inc. v. Allenby
(9th Cir. 1992) 958 F.2d 941, 943; People ex rel. Lungren v. Cotter & Co. (1997)
53 Cal.App.4th 1373, 1393.) The FDA seeks to prohibit any warning not identical
to its own, but the absence of identical language is not enough to justify
preemption, since the savings clause specifically allows state regulations that are
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“different from . . . [or] otherwise not identical” to FDA requirements. (21 U.S.C.
§ 379r(a)(2).) In this case, however, any warning that conformed in substance to
the FDA’s warning would not comply with Health and Safety Code section
25249.6 because it would not provide clear and reasonable warning to the
consumer that the product contained a chemical “known . . . to cause . . .
reproductive toxicity.” Thus, the FDA determination has effectively barred all
warnings on labels that comply with Proposition 65.
Finally, plaintiff and his amici curiae point out that Proposition 65 warnings
need not appear on labels; warnings can also be conveyed through point-of-sale
notices or public advertising. (Cal. Code Regs., tit. 22, § 12601.) Because the
FDA regulates only product labeling, they contend that a Proposition 65 warning
conveyed through other means cannot be preempted.
The FDA’s ruling, however, reflects the concern that Proposition 65
warnings on product labels might lead pregnant women to believe that NRT
products were as dangerous as smoking, or nearly so, and thus discourage the
women from stopping smoking. Warnings through point-of-sale posters or public
advertising could have the same effect of frustrating the purpose of the federal
policy. Conflict preemption does not require a direct contradiction between state
and federal law; the state law is preempted if state law “ ‘stands as an obstacle to
the accomplishment and execution of the full purposes and objectives of
Congress.’ ” (English v. General Electric Co., supra, 496 U.S. at p. 79.)
We conclude that the FDA’s August 17, 2001, letter established a federal
policy prohibiting defendants from giving consumers any warning other than the
one approved by the FDA in that letter, and that the use of a Proposition 65
warning would conflict with that policy.

18

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IV. CAN THE FDA PROHIBIT DEFENDANTS FROM USING A
TRUTHFUL WARNING?
Plaintiff contends that his proposed warning advising pregnant women that
defendants’ products contain nicotine which “can harm your baby” -- or words to
that effect -- is truthful. He argues that the enforcement authority of the FDA is
limited to prohibiting “adulterated or misbranded” products (21 U.S.C. § 331(a)),
and that a truthful warning cannot render a product “misbranded.” He points out
that not only California, but also the United States Surgeon General and the
Environmental Protection Agency (EPA) list nicotine as a chemical harmful to the
fetus. (See Reducing Tobacco Use, A Report of the Surgeon General (2000) at
p. 118; 40 C.F.R. § 372.65 (2003) [EPA determination].) Defendants dispute the
point, arguing that the evidence is insufficient to show that nicotine can harm the
fetus.
The FDA’s August 17, 2001, letter sets out its views on the effect of
nicotine on the fetus. Because of the FDA’s scientific expertise and long
administrative experience, these views are entitled to judicial deference. (Serono
Laboratories, Inc. v. Shalala (D.C. Cir. 1998) 158 F.3d 1313, 1320; see Geier,
supra, 529 U.S. at p. 883.) But a close reading of that letter shows that the FDA is
aware that nicotine may endanger the fetus.
The August 17 letter states: “Although some of the pharmacologic effects
of NRT products on the mother and unborn child are known, the full range of
compliance or risks to the unborn child are not fully known. . . . NRT drug
products have not been tested in pregnant women . . . Extrapolating from the
animal data on nicotine exposure and considering the smoking data in humans, the
agency believes that chronic nicotine exposure may represent some risk in humans
for embryo-fetal lethality, but likely presents little risk for teratogenic or adverse
development effects. . . . While smoking has clearly been associated with fetal
19

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harm, the contribution of nicotine has not been clearly delineated. There are
numerous other constitutants of cigarette smoke that may be major contributing
factors to the harm caused by smoking. There continue to be unanswered
questions involving the clinical pharmacology and toxicology of NRT use during
pregnancy in humans and additional research should be conducted to answer those
questions.” (Aug. 17, 2001, letter, p. 4.)
The FDA’s August 17 letter recognized that its approved warning to
doctors for prescription products containing nicotine states: “It is presumed that
[the product] can cause fetal harm when administered to pregnant women.” (Aug.
17 letter at p. 3.) But the FDA explains: “This labeling was intended to provide
doctors with information to help them make treatment recommendations to their
patients. The complexity of the data regarding exposure to nicotine during
pregnancy and the relative risks of smoking versus use of NRT products are not
easily translated into consumer friendly language on an OTC package.” (Aug. 17
letter at pp. 3-4.)
The August 17 letter rejected the proposal that defendants’ products use the
“can harm your baby” warning approved for Habitrol. It said that this warning
“overstates what is known about nicotine and its effect on the unborn child. The
words ‘can harm’ may suggest to consumers that harm will occur in most, if not
all, pregnant women who use NRT products. . . . The ‘Harm your baby’ warning
may lead some consumers simply to continue smoking after failed attempts at
abstinence because they will be resigned to the belief that use of NRT drug
products are just as harmful as smoking.” (Aug. 17 letter at p. 5.)
Contrary to defendants’ contention, the FDA’s August 17, 2001, letter and
its summary of the evidence do not show that the FDA considers the evidence
insufficient to show that nicotine can harm the fetus. The letter notes both that the
effect of nicotine on the fetus is not fully understood, and that it has not been
20

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shown that defendants’ products are harmful. But it does not dispute that the
nicotine in defendants’ products is a potential hazard to the fetus, even though the
risks to the unborn child “are not fully known.” (Aug. 17 letter at p. 8, italics
added.) The FDA’s objection to labels warning that nicotine “can” harm the baby
is not that they are false, but that consumers may give too much weight to the
warnings and decide to continue smoking instead of using an NRT product to stop
smoking.
But even though it is probably true that the nicotine in defendants’ products
can cause reproductive harm, the FDA has authority to prohibit truthful statements
on a product label if they are “misleading” (21 U.S.C. § 321(n), § 352(a); see
United States v. Watkins (9th Cir. 2002) 278 F.3d 961, 967), or if they are not
stated in “such manner and form, as are necessary for the protection of users.” (21
U.S.C. § 352(f).) There are numerous examples involving product descriptions.
For example, in United States v. Ninety-five Barrels of Vinegar (1924) 265 U.S.
438, the label on the vinegar said it was made from apples. It was, but it was
made from dehydrated apples and was different from vinegar made from fresh
apples. The United States Supreme Court found the vinegar to be misbranded,
observing that deception “may result from the use of statements not technically
false or which may be literally true.” (Id. at p. 444.) In United States v. An
Article of Food, Etc. (E.D.N.Y. 1974) 377 F.Supp. 746, the district court found the
label of Manischewitz’s Diet-Thin matzos misleading because they contained the
same number of calories as Manischewitz’s plain matzos. The opinion observed:
“Even a technically accurate description of a food or drug’s content may violate
21 U.S.C. § 343 if the description is misleading in other respects.” (Id. at p. 749.)
In United States v. An Article of Food (8th Cir. 1973) 482 F.2d 581, the
government did “not challenge the factual accuracy of the Nuclomin label; rather
it claims the label is misleading to the public because some of the ingredients are
21

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either not needed in human nutrition or are included in such insignificant amounts
as to be valueless.” (Id. at p. 582.) The federal appellate court held that even
though the Nuclomin label was technically accurate, it was misleading, and the
product was subject to seizure. (Id. at p. 584.)
A truthful warning can be misleading or fail to communicate the facts
necessary for the protection of users. This court discussed that concern in Carlin
v. Superior Court (1996) 13 Cal.4th 1104, a product liability action in which the
plaintiff claimed that the FDA-approved warning for Halcion, a prescription drug,
was inadequate because it failed to warn of certain dangers. Quoting Finn v. G.D.
Searle & Co. (1984) 35 Cal.3d 691, 701, Justice Mosk’s majority opinion noted:
“[E]xperience suggest[s] that if every report of a possible risk, no matter how
speculative, conjectural, or tentative, imposed an affirmative duty to give some
warning, a manufacturer would be required to inundate physicians
indiscriminately with notice of any and every hint of danger, thereby inevitably
diluting the force of any specific warning given.” (Carlin v. Superior Court,
supra, at p. 1115; see Walsh & Klein, The Conflicting Objectives of Federal and
State Tort Law Drug Regulation (1986) 41 Food Drug Cosm. L. J. 171, 182.) The
concurring and dissenting opinion expanded on this problem. It noted that even if
scientific evidence supports the existence of a risk, a warning is not necessarily
appropriate: “The problems of overwarning are exacerbated if warnings must be
given even as to very remote risks . . . .” (Carlin v. Superior Court, supra, 13
Cal.4th at p. 1126 (conc. & dis. opn. of Kennard, J.).) “Against the benefits that
may be gained by a warning must be balanced the dangers of overwarning and of
less meaningful warnings crowding out necessary warnings, the problems of
remote risks, and the seriousness of the possible harm to the consumer.” (Id. at
p. 1133.)
22

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The New Jersey Supreme Court in R.F. v. Abbott Laboratories (N.J. 2000)
745 A.2d 1174, in holding that an FDA regulation preempted state law on the duty
to warn, reasoned that the FDA could prohibit a truthful warning. The FDA label
for donated blood specified a test to determine whether the blood was
contaminated with HIV, and established a cutoff point requiring rejection of blood
scoring above a certain value. The plaintiff suggested that the FDA label should
also require retesting of marginal samples that fell within 10 percent of the cutoff
point. The FDA rejected this suggestion, and plaintiff unfortunately was infected
with donated blood that fell within this 10 percent range. The court rejected
plaintiff’s challenge to the FDA regulation, relying on FDA findings that (1) there
was no scientific evidence that borderline samples were more likely to be false-
negative than samples falling well below the borderline, so retesting of borderline
samples would not find many cases of contamination; and (2) blood banks would
be likely to throw out donations falling in the borderline range instead of incurring
the expense of retesting, a consequence that would imperil the nation’s blood
supply. (See id. at p. 1180.)
The New Jersey Supreme Court emphasized that deciding upon a warning
may involve balancing of competing interests. (R.F. v. Abbott Laboratories,
supra, 745 A.2d at p. 1180.) “The FDA’s active involvement at every step of the
test’s development, approval, and use in the field, reflected the risk-utility analysis
undertaken by the FDA to address significant public policy considerations. [¶]
[T]he FDA’s mandate directing Abbot not to provide for retesting of samples near
the cutoff . . . remained in force as part of a conscious ongoing risk-benefit
analysis by the FDA in managing a public health crisis.” (Id. at p. 1192.)
Plaintiff here disputes the proposition that the FDA can undertake a risk-
utility analysis in formulating an appropriate label. He relies on the United States
Supreme Court decisions in Food and Drug Admin. v. Brown & Williamson
23

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Tobacco Corp. (2000) 529 U.S. 120 (Brown & Williamson) and Thompson v.
Western States Medical Center (2002) 535 U.S. 357 (Western States Medical
Center).
Brown & Williamson concerned whether the FDA could classify tobacco as
a drug and regulate it accordingly. The majority held that Congress had precluded
FDA regulation. One basis for this conclusion was that if the FDA followed its
own reasoning and analysis, it would have to conclude that tobacco was unsafe
and ban its distribution – an action that would frustrate congressional acts
regulating the growing and marketing of tobacco. (Brown & Williamson, supra,
529 U.S. at p. 142.)
In response to that argument, the FDA contended that even though tobacco
was unsafe and had no therapeutic purpose, the FDA could balance other
considerations, such as the risk of creating a black market for cigarettes, and
impose something less than an outright ban. The high court disagreed: “Section
352 (j) focuses on the dangers to the consumer from use of the product, not those
stemming from the agency’s remedial measures. . . . [¶] The FDA, consistent
with the FDCA, may clearly regulate many ‘dangerous’ products without banning
them. Indeed, virtually every drug or device poses dangers under certain
conditions. What the FDA may not do is conclude that a drug or device cannot be
used safely for any therapeutic purpose and yet, at the same time, allow that
product to remain on the market.” (Brown & Williamson, supra, 529 U. S. at
pp. 141-142.)
Thereafter,
in
Western States Medical Center, supra, 535 U.S. 357, the
United States Supreme Court held that a provision of the Modernization Act
prohibiting the advertising of compounded drugs violated the First Amendment to
the federal Constitution. The FDA sought to justify the challenged provision on
the ground that it was necessary to prevent unnecessary prescription of
24

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compounded drugs. The court described this argument as “paternalistic” (id. at
p. 375), and said the FDA’s “concern amounts to a fear that people would make
bad decisions if given truthful information about compounded drugs.” (Id. at
p. 374.) The high court went on to say: “We have previously rejected the notion
that the Government has an interest in preventing the dissemination of truthful
commercial information in order to prevent members of the public from making
bad decisions with the information.” (Id. at p. 374, citing Virginia State Bd. of
Pharmacy v. Virginia Citizens Consumer Counsel, Inc. (1976) 425 U.S. 748, 769
[state statute barring advertising of prescription drug prices violates First
Amendment].)
Both cases cited by plaintiff raise issues distinct from those here. This case
does not involve the marketing of an unsafe product as in Brown & Williamson,
supra, 529 U.S. 120, and unlike Western States Medical Center, supra, 535 U.S.
357, it presents no constitutional issues. There is no question but that the FDA has
jurisdiction to regulate the labeling of defendants’ products, and that its rulings are
valid and preemptive as to products sold in every state, subject only to the savings
clause in 21 United States Code section 379r(d)(2).
The United States Supreme Court described the reasoning underlying the
FDA arguments in Brown & Williamson, supra, 529 U.S. 120, and Western States
Medical Center, supra, 535 U.S. 357, as “paternalistic.” The same can be said of
the FDA’s reasoning here. But we do not know of any statute or constitutional
provision that precludes the FDA from taking this approach to regulation of
nonprescription drugs. In formulating the label for a product to be marketed – as
distinguished from a decision whether or not to permit the product to be marketed
– the FDA must take into account the effect of proposed labels on the consumer.
Whether a label is potentially misleading or incomprehensible is essentially a
judgment of how the consumer will respond to the language of the label. As we
25

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have noted, a truthful warning of an uncertain or remote danger may mislead the
consumer into misjudging the dangers stemming from use of the product, and
consequently making a medically unwise decision. The authority of the FDA, we
conclude, extends to barring warnings that are misleading in this fashion.
Although there is reason to believe that nicotine can cause reproductive
harm, plaintiff has offered no qualitative assessment of this risk. The mere
existence of the risk, however, is not necessarily enough to justify a warning; the
risk of harm may be so remote that it is outweighed by the greater risk that a
warning will scare consumers into foregoing use of a product that in most cases
will be to their benefit. The FDA has so determined in this case, and we find no
basis to question the FDA’s expert determination.
The United States Attorney General, as amicus curiae for defendants, goes
further and argues that every FDA labeling decision involves balancing all
relevant considerations relating to the precise wording of the label, and that
consequently any nonidentical state warning would constitute misbranding. That
argument would nullify the savings clause in the Modernization Act, which plainly
permits Proposition 65 warnings that differ from the FDA warnings. As
defendants point out, this is an unusual case; in most cases FDA warnings and
Proposition 65 warnings would serve the same purpose – informing the consumer
of the risks involved in use of the product – and differences in wording would not
call for federal preemption. Here, however, the FDA warning serves a nuanced
goal – to inform pregnant women of the risks of NRT products, but in a way that
will not lead some women, overly concerned about those risks, to continue
smoking. This creates a conflict with the state’s more single-minded goal of
informing the consumer of the risks. That policy conflict justifies federal
preemption here.
26

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DISPOSITION
The judgment of the Court of Appeal is reversed.
KENNARD,
ACTING
C.
J.
WE CONCUR:

WERDEGAR, J.
CHIN, J.
BROWN, J.
MORENO, J.
SCOTLAND, J.*
SEPULVEDA, J.**

*
Presiding Justice of the Court of Appeal, Third Appellate District, assigned
by the Acting Chief Justice pursuant to article VI, section 6 of the California
Constitution.
**
Associate Justice of the Court of Appeal, First Appellate District, Division
Four, assigned by the Acting Chief Justice pursuant to article VI, section 6 of the
California Constitution.
27

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See last page for addresses and telephone numbers for counsel who argued in Supreme Court.

Name of Opinion Dowhal v. Smithkline Beecham Healthcare
_________________________________________________________________________________

Unpublished Opinion

Original Appeal
Original Proceeding
Review Granted XXX 100 Cal.App.4th 8
Rehearing Granted

__________________________________________________________________________________

Opinion No.

S109306
Date Filed: April 15, 2004
__________________________________________________________________________________

Court:

Superior
County: San Francisco
Judge: David A. Garcia

__________________________________________________________________________________

Attorneys for Appellant:

Lexington Law Group, Eric S. Somers, Mark N. Todzo, Todd E. Robins and Howard J. Hirsch for Plaintiff
and Appellant.

Bill Lockyer, Attorney General, Manuel M. Medeiros, State Solicitor General, Richard M. Frank, Chief
Assistant Attorney General, Theodora Berger, Assistant Attorney General, Craig C. Thompson, Edward G.
Weil, Dennis Ragen and Susan S. Fiering, Deputy Attorneys General, for the People as Amicus Curiae on
behalf of Plaintiff and Appellant.

Environmental Law Foundation, James R. Wheaton, Iryna A. Kwasny; Public Citizen Litigation Group,
Allison M. Zieve and Brian Wolfman for Public Citizen as Amicus Curiae on behalf of Plaintiff and
Appellant.

__________________________________________________________________________________

Attorneys for Respondent:

Morrison & Foerster, James P. Bennett, Michèle B. Corash, Maria Chedid and Brooks M. Beard for
Defendants and Respondents GlaxoSmithKlineConsumer Healthcare, Alza Corp., Aventis Pharmaceuticals,
Inc., Costco Wholesale Corp., Lucky Stores, Inc., Rite Aid Corp., Safeway Inc., and Walgreen Co.

Livingston & Mattesich Law Group, Livingston & Mattesich Law Corporation, Gene Livingston and
Matthew J. Goldman for Defendant and Respondent McNeil Consumer Products Company.

Crosby, Heafey, Roach & May, Reed Smith Crosby Heafey, John E. Dittoe and Paul D. Fogel for
Defendant and Respondent Pharmacia & Upjohn Company.

28

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Page 2 - counsel continued - S109306

Attorneys for Respondent:

Covington & Burling, Steven J. Rosenbaum and Darren D. Cooke for the Consumer Healthcare Products
Association, the Cosmetic Toiletry and Fragrance Association, the Grocery Manufacturers of America and
the Pharmaceutical Research and Manufacturers of America as Amici Curiae on behalf of Defendants and
Respondents.

Catherine I. Hanson, Astrid Meghrigian and Hans P. Lee for California Medical Association as Amicus
Curiae on behalf of Defendants and Respondents.

Robert D. McCallum, Jr., and Peter D. Keisler, Assistant Attorneys General, David W. Shapiro and Kevin
V. Ryan, United States Attorneys, Barbara L. Herwig, Douglas Letter, Peter R. Maier; Daniel E. Troy,
Lynn Whipkey Mehler and Heidi P. Forster for United States of America as Amicus Curiae on behalf of
Defendants and Respondents.

29

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Counsel who argued in Supreme Court (not intended for publication with opinion):

Mark N. Todzo
Lexington Law Group
1627 Irving Street
San Francisco, CA 94122
(415) 759-4111

Susan S. Fiering
Deputy Attorney General
1515 Clay Street, Suite 2000
Oakland, CA 94612-0550
(510) 622-2142

James P. Bennett
Morrison & Foerster
425 Market Street
San Francisco, CA 94105
(415) 268-7000

Peter R. Maier
U.S. Department of Justice
Civil Division, Room 9012
601 D Street N.W.
Washington D.C. 20530-0001
(202) 514-3585

30

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Opinion Information

Date:	Docket Number:
Thu, 04/15/2004	S109306

Disposition
Apr 15 2004	Opinion: Reversed

Dockets
Aug 21 2002	Petition for review filed   by counsel for respondents (Smithkline Beecham Consumer Healthcare, etc. et al.)
Aug 22 2002	Record requested
Aug 27 2002	Received Court of Appeal record   file jacket/briefs/box
Sep 10 2002	Answer to petition for review filed   by counsel for appellant (Paul Dowhal).
Sep 23 2002	Received letter from:   counsel for appellant {Paul Dowhal) in response to letters in support of petition for review.
Sep 27 2002	Received letter from:   counsel for respondents (GlaxoSmithKline Consumer Healthcare et al.) dated 9/27/02 responding to appellants letter received 9/23/02.
Oct 11 2002	Time extended to grant or deny review   To November 19, 2002.
Oct 21 2002	Note: Mail returned and re-sent   to attorney Paul D. Fogel. (Order filed 10/11/02)
Oct 23 2002	Petition for Review Granted (civil case)   George, CJ., was recused and did not participate. Votes: Kennard, Baxter, Werdegar, Chin, Brown and Moreno, JJ.
Oct 23 2002	Letter sent to counsel re:   certification of interest and form.
Nov 5 2002	Request for extension of time filed   respondents asking to Jan. 21, 2003 to file opening brief on the merits.
Nov 7 2002	Extension of time granted   On application of respondent and good cause appearing, it is ordered that the time to serve and file the opening brief on the merits is extended to and including Jan. 21, 2003.
Nov 8 2002	Certification of interested entities or persons filed   by counsel for appellant (Paul A. Dowhal).
Nov 12 2002	Letter sent to counsel re:   certification of interest and form sent to counsel Paul Fogel & Gene Livingston (for respondent).
Nov 12 2002	Letter sent to counsel re:   second request for certification of interest and form sent to counsel Michele B. Corash (for respondent).
Nov 25 2002	Certification of interested entities or persons filed   by counsel for respondents (SmithKline Beecham Consumer Healthcare etc., et al.).
Jan 21 2003	Opening brief on the merits filed   by counsel for respondents (GlaxoSmithKline Consumer Healthcare et al.).
Jan 24 2003	Request for extension of time filed   by counsel for appellant requesting to April 15, 2003 to file answer brief. (granted - order being prepared)
Jan 28 2003	Extension of time granted   On application of appellant and good cause appearing, it is ordered that the time to serve and file the answer brief on the merits is extended to and including April 15, 2003.
Feb 3 2003	Notice of substitution of counsel received   by counsel for respondent Pharmacia & Upjohn Company. The firm of Crosby, Heafey, Roach & May merged with Reed Smith LLP. The combined firm is now known as Reed Smith Crosby Heafey LLP.
Apr 15 2003	Answer brief on the merits filed   by counsel for appellant (Paul Dowhal).
Apr 16 2003	Request for extension of time filed   by counsel for respondents (GlaxoSmithKline Consumer Healthcare et al.) requesting to June 13, 2003 to file reply brief on the merits. (granted - order being prepared)
Apr 18 2003	Extension of time granted   On application of respondents and good cause appearing, it is ordered that the time to serve and file the reply brief on the merits is extended to and including June 13, 2003.
Jun 16 2003	Filed:   Defendants' application for permission to exceed word limit for reply brief.
Jun 16 2003	Received:   oversized reply brief on the merits from counsel for defendants/respondents. (40k)
Jun 19 2003	Reply brief filed (case fully briefed)   with permission by counsel for respondents (GlaxoSmithKline Consumer Healthcare et al.).
Jul 14 2003	Received application to file Amicus Curiae Brief   Public Citizen in support of appellant.
Jul 14 2003	Amicus Curiae Brief filed by:   Attorney General in support of appellant (Paul A. Dowhal). Answer due by any party within 20 days.
Jul 17 2003	Request for extension of time filed   Respondents requesting a 60 day extension to Oct. 2, 2003 to file a consolidated answer to amicus curiae briefs in support of appellant. (ok to grant -order being prepared.)
Jul 21 2003	Received application to file amicus curiae brief; with brief   from counsel for the United States Dept. of Justice on behalf of the United States of America in support of respondents. (Holding application & ac brief. Counsel advised to submit an application to appear as counsel pro hac vice and be associated with an active member of the State Bar of Calif.. Application should be here by 7/24/03.)
Jul 21 2003	Received application to file Amicus Curiae Brief   by The Consumer Healthcare Products Assoc. et al. in support of respondents.
Jul 21 2003	Received application to file Amicus Curiae Brief   by the California Medical Assocation in support of respondents.
Jul 24 2003	Permission to file amicus curiae brief granted   Public Citizen
Jul 24 2003	Amicus Curiae Brief filed by:   The application of Public Citizen for permission to file an amicus curiae brief in support of appellant is hereby granted.
Jul 24 2003	Permission to file amicus curiae brief granted   California Medical Assocation
Jul 24 2003	Amicus Curiae Brief filed by:   The application of California Medical Association for permission to file an amicus curiae brief in support of respondent is hereby granted. Answer due by any party within 20 days.
Jul 24 2003	Permission to file amicus curiae brief granted   Consumer Healthcare Products Association et al.
Jul 24 2003	Amicus Curiae Brief filed by:   The application of the Consumer Healthcare Products Association, the Cosmetic, Toiletry and Fragrance Association, the Grocery Manufacturers of America, and the Pharmaceutical Research and Manufacturers of America for permission to file an amicus curiae brief in support of respondents is hereby granted. Answer due by any party within 20 days.
Jul 24 2003	Extension of time granted   On application of respondents and good cause appearing, it is ordered that the time to serve and file answer briefs or a consolidated answer to amicus curiae briefs in support of appellant is extended to and including October 2, 2003.
Jul 24 2003	Application to appear as counsel pro hac vice (granted case)   Application of Douglas N. Letter for admission pro hac vice to appear on behalf of amicus curiae The United States of America. (Counsel to send amended proof of service. State Bar not served.)
Jul 28 2003	Request for extension of time filed   appellant requesting to Oct. 2, 2003 to file answer briefs to amicus briefs supporting respondent. (granted - order being prepared)
Jul 29 2003	Received document entitled:   Amended Proof of Service from Douglas Letter confirming that copy of Application to Appear As Counsel Pro Hac Vice was served on State Bar.
Jul 31 2003	Application to appear as counsel pro hac vice granted   The application of Douglas N. Letter of the District of Columbia for admission pro hac vice to appear on behalf of an amicus is hereby granted.
Jul 31 2003	Permission to file amicus curiae brief granted   United States of America
Jul 31 2003	Amicus Curiae Brief filed by:   The application of the United States of America for permission to file an amicus curiae brief in support of respondents is hereby granted. Answer due by any party within 20 days.
Aug 4 2003	Extension of time granted   Appellant may file a single, consolidated reply to any amicus briefs on behalf of respondents on or before October 2, 2003. Respondents may file a single, consolidated reply to any amicus briefs on behalf of appellant on or before October 2, 2003. This order supersedes all previous orders setting the dates when replies to briefs of amici are due.
Aug 18 2003	Filed:   Letter from Mr. Peter R. Maier (co-counsel for amicus United States of America) dated 8-04-2003, notifying the court that he anticipates filing an application to appear as counsel pro hac vice
Sep 8 2003	Application to appear as counsel pro hac vice (granted case)   Application of Peter R. Maier for admission pro hac vice to appear on behalf of amicus curiae The United States of America.
Sep 9 2003	Application to appear as counsel pro hac vice granted   The application of Peter R. Maier of the District of Columbia for admission pro hac vice to appear on behalf of amicus is hereby granted.
Sep 10 2003	Additional issues ordered   In responding to the amicus briefs, the parties should address the following matter: If (1) it is true that nicotine is a chemical known to cause reproductive harm, but (2) placing a truthful warning label to this effect on defendants' products might discourage pregnant women from using those products to stop smoking, and thus do more harm than good, does the Food and Drug Administration have authority to prohibit defendants from using such a label? Does its authority depend on whether the product, so labeled, would be considered 'misbranded?' This order does not preclude the parties from discussing other issues raised in the briefs of amici.
Sep 17 2003	Request for extension of time filed   By counsel for Respondents {Smithkline Beecham Cinsumer Health Care et al.,} requesting a 14-day extension to October 16, 2003 to file Respondent's consolidated response to AC Briefs.
Sep 18 2003	Filed document entitled:   Substituted amicus curiae brief of the United Stated of America in support of respondents. The substituted briefs add Ms. Herwig's (CA State Bar member) name on the cover and signature page only. No other changes from those filed initially.
Sep 24 2003	Extension of time denied   Respondents' request for extension of time to file Consolidated Response to AC Briefs.
Oct 2 2003	Response to amicus curiae brief filed   by counsel for appellant (Paul Dowhal). Reply to amicus briefs filed on behalf of respondents.
Oct 3 2003	Response to amicus curiae brief filed   By Respondents' {GlaxoSmithkline Consumer Healthcare, Alza Corp. et al.,} to AC Briefs filed by the Attorney General and by Public Citizen./ 40(K).
Oct 3 2003	Request for judicial notice filed (in non-AA proceeding)   By counsel for Respondents {Glaxosmithkline Consumer Healthcare et al.,}.
Oct 14 2003	Opposition filed   Plaintiff/Appellant's Opposition to Defendants' Motion for Judicial Notice
Jan 14 2004	Case ordered on calendar   Monday, February 9, 2004 @ 1:30pm (Sacramento)
Jan 16 2004	Filed:   Request of A/C (Attorney General on behalf of the People) for perm to participate in oral argument.
Jan 22 2004	Order filed   The request to allocate to A/C People of the State of California, ex rel. Bill Lockyer, Attorney General, 10 minutes of appellant's 30-minute allotted time for oral argument is granted.
Jan 23 2004	Filed:   Request for resp to allocate oral argument time to A/C USof A
Jan 30 2004	Received letter from:   Respondents {GlaxoSmithKline Consumer Healthcare, Alza Corp., et al.,} to bring to the Court's attention a recent case decided by 2 DCA.
Jan 30 2004	Order filed   Permission granted for two counsel to argue on behalf of resp. SmithKline
Jan 30 2004	Order filed   permission granted for resp SmithKline to allot 10 min oral argument time to A/C U.S.A.
Feb 3 2004	Request for judicial notice granted   The request of defendants for judicial notice of the July 30, 2003 Food and Drug Administration letter is granted.
Feb 9 2004	Cause argued and submitted
Apr 15 2004	Opinion filed: Judgment reversed   Opinion by Kennard, Acting C.J. -- joined by Werdegar, Chin, Brown, Moreno, Scotland (CA 3 assigned ) & Sepulveda (CA 1/4 assinged) JJ.
May 19 2004	Remittitur issued (civil case)
May 20 2004	Received:   Receipt for remittitur CA 1/5.

Briefs
Jan 21 2003	Opening brief on the merits filed
Apr 15 2003	Answer brief on the merits filed
Jun 19 2003	Reply brief filed (case fully briefed)
Jul 14 2003	Amicus Curiae Brief filed by:
Jul 24 2003	Amicus Curiae Brief filed by:
Jul 24 2003	Amicus Curiae Brief filed by:
Jul 24 2003	Amicus Curiae Brief filed by:
Jul 31 2003	Amicus Curiae Brief filed by:
Oct 2 2003	Response to amicus curiae brief filed
Oct 3 2003	Response to amicus curiae brief filed

If you'd like to submit a brief document to be included for this opinion, please submit an e-mail to the SCOCAL website