http://www.law.stanford.edu/library/special/B147727.DOCFiled 8/9/01
CERTIFIED FOR PARTIAL PUBLICATION*
IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA
SECOND APPELLATE DISTRICT
DIVISION ONE
CONSUMER CAUSE, INC., Plaintiff and Appellant, v.SMILECARE
et al., Defendants and Respondents. B147727 (Los
Angeles County Super. Ct. No. BC225511)
APPEAL from a judgment and an order of the Superior Court of
Los Angeles County, Aurelio Munoz, Judge. Judgment reversed; order
affirmed.
Law Offices of Morse Mehrban and Morse Mehrban for Plaintiff
and Appellant.
Bill Lockyer, Attorney General, Richard M. Frank, Chief
Assistant Attorney General, Theodora Berger, Senior Assistant
Attorney General, Craig Thompson, Supervising Deputy Attorney
General, Edward G. Weil and Susan S. Fiering, Deputy Attorneys
General, for the State of California as Amicus Curiae on behalf of
Plaintiff and Appellant.
Stradling Yocca Carlson & Rauth, Randall J. Sherman and Adym
W. Rygmyr for Defendants and Respondents.
Plaintiff filed this action, alleging a violation of the Safe
Drinking Water and Toxic Enforcement Act of 1986, commonly known as
Proposition 65. Plaintiff alleged that defendants, providers of
dental care, violated the act by failing to warn employees and
patients that standard amalgam fillings, also called "silver
fillings," contain mercury and mercury compounds, which are
reproductive toxins. The trial court granted defendants' motion for
summary judgment, which was based on an affirmative defense.
We conclude that the trial court misapplied the burden of
producing evidence in granting the motion. Defendants had an initial
burden of production to make a prima facie showing that the
affirmative defense applied. Because defendants made no such
showing, the burden did not shift to plaintiff to raise a triable
issue. Accordingly, we reverse.
THE DENTAL AMALGAM CONTROVERSY
Concern over the use of silver fillings is nothing new. "In
dental offices around the world, cavities are treated by drilling
holes in patients' teeth and filling the abscesses with a compound
known as dental amalgam filling. Also known as 'silver fillings,'
dental amalgam is composed of a mixture of 45 to 52 percent mercury,
35 percent silver, and varying portions of copper, zinc and tin.
Mercury, a heavy metal, is used in the amalgam mixture because,
although it is liquid in its free state, when combined with other
metals, it forms a paste that hardens within minutes and provides the
mixture with strength and cohesiveness. Overall, amalgam is a
popular material for filling cavities because it is strong, durable,
and relatively inexpensive. Amalgam is used in about half of the 200
million cavity filling procedures performed annually, while the other
half of cavity fillings are done with such materials as gold,
ceramics and plastics.
"The modern dental amalgam was introduced in 1812 by British
chemist Joseph Bell as a silver paste, which was a combination of
coins and mercury. In the United States during the 1800s, however,
[the] concern of the American Society of Dental Surgeons regarding
possible mercury toxicity led to mercury usage becoming an issue of
malpractice. In addition, all Society members were forced to sign an
oath not to use mercury containing materials. Nonetheless, use of
mercury fillings increased, because it offered dentists an economic
advantage[,] and because the fillings were simple to use and durable
in the mouth. By 1856, the American Society of Dental Surgeons was
forced to disband due to dwindling membership caused by the debate
over the mercury filling issue. In its place rose the American
Dental Association . . . , which was founded by dentists who
advocated silver amalgam mercury use in dentistry. [] . . . [] . . .
"Over the past few years, several studies have reported that
dental amalgam fillings continuously leak small amounts of mercury
into the oral cavity. . . . Vaporization of the mercury from dental
fillings is further intensified by chewing, tooth brushing and
consumption of hot liquids. After mastication or tooth brushing, it
takes almost ninety minutes for the rate of mercury vaporization to
decline to pre chewing level. In addition, a greater number of
fillings over a larger chewing surface area lead to even higher
levels of mercury.
"[S]tudies have demonstrated that brushing filled teeth increases the
level of mercury vapor in expired air, and that when exposed to
mercury, individuals inhale and absorb as much as 80 percent of the
vapors. Even human autopsy evidence has indicated that brain and
kidney tissues contain significantly higher amounts of mercury in
individuals with mercury fillings, and the concentration of mercury
in the brain of subjects with mercury fillings correlate[s] directly
with the number of fillings present.
"Recent experimentation on sheep and monkeys suggests that dental
mercury accumulates in all tissues on the adult and is at its highest
level in the kidney and liver. In fact, human studies have recently
shown an association between urinary mercury excretion and the
presence of mercury fillings. These results corroborate the results
of human autopsy studies. Of particular interest, is the potential
effect of mercury fillings on the unborn child. In studies where
fillings were installed in the teeth of pregnant sheep, mercury
amalgam was shown to cross the placenta and accumulate in the
developing fetus within two days of the filling's installation. The
mercury was found at the highest level in the fetal liver and the
mother's milk, suggesting an additional form of transmission to
newborns.
"During the past two decades, more concerns have been raised about
possible adverse medical side effects from the mercury in dental
amalgam fillings. It has been suggested that mercury exposure is
responsible for a wide variety of systemic ill effects in some
patients, including immune suppression, neurotoxicity, renal
impairment, obstetric complications, multiple sclerosis and
conditional symptoms such as headache, fatigue and depression."
(Miller, Mercury Amalgam Fillings: Human and Environmental Issues
Facing the Dental Profession (1996) 1 DePaul J. Health Care L. 355,
355-359, fns. omitted.)
"Very young children are more sensitive to mercury than adults.
Mercury in the mother's body passes to the fetus and may accumulate
there. It can also can pass to a nursing infant through breast
milk. However, the benefits of breast feeding may be greater than
the possible adverse effects of mercury in breast milk.
"Mercury's harmful effects that may be passed from the mother to the
fetus include brain damage, mental retardation, incoordination,
blindness, seizures, and inability to speak. Children poisoned by
mercury may develop problems [with] their nervous and digestive
systems, and kidney damage." (Agency for Toxic Substances and
Disease Registry (April 1999) Chemical Abstracts Service No. 7439 97
6, <http://www.atsdr.cdc.gov/tfacts46.html> [as of August 8, 2001].)
One report, which summarizes the findings of 229 studies, surveys,
and papers, has concluded: "Mercury from amalgam in pregnant women
crosses the placenta and appears in amniotic fluid and fetal blood,
liver, and pituitary gland within 2 days of placement . . . . Mercury
is often stored in breast milk and [in] the fetus at much higher
levels than that in the mother's tissues . . . . The highest level is
in the pituitary gland of the fetus which affects development of the
endocrine, immune, and reproductive systems." (Dental Amalgam
Scientific Facts (Windham, edit.), Part II, No. 19, citations
omitted, <http://www.web-light.nl/AMALGAM/EN/frame_r.html> [as of
August 8, 2001].) "The level of mercury in the brain tissue of the
fetus, new born, and young children is directly proportional to the
number of amalgam surfaces in the mother's mouth." (Id., No.
18.) "Mercury has an effect on the fetal nervous system at levels
far below that considered toxic in adults, and background [levels] of
mercury in mothers correlate significantly with incidence of birth
defects and still births . . . ." (Id., Part III, No. 16.)
But dental amalgam is not without its supporters. The American
Dental Association (ADA) has long approved its use. As recently as
May 11, 2001, the ADA issued a "Statement on Dental Amalgam,"
saying: "Dental amalgam (silver filling) is considered a safe,
affordable and durable material that has been used to restore the
teeth of more than 100 million Americans. It contains a mixture of
metals such as silver, copper and tin, in addition to mercury, which
chemically binds these components into a hard, stable and safe
substance. Dental amalgam has been used for more than 150 years and,
during that time, has established an extensively reviewed record of
safety and effectiveness.
"Issued in late 1997, the FDI World Dental Federation and the World
Health Organization consensus statement on dental amalgam stated, 'No
controlled studies have been published demonstrating systemic adverse
effects from amalgam restorations.' The document also states that,
aside from rare instances of local side effects of allergic
reactions, 'the small amount of mercury released from amalgam
restorations, especially during placement and removal, has not been
shown to cause any . . . adverse health effects.'
"The ADA's Council on Scientific Affairs' 1998 report on its review
of the recent scientific literature on amalgam states: 'The Council
concludes that, based on available scientific information, amalgam
continues to be a safe and effective restorative material.' The
Council's report also states, 'There currently appears to be no
justification for discontinuing the use of dental amalgam.' . . .
"The U.S. Public Health Service issued a report in 1993 stating there
is no health reason not to use amalgam, except in the extremely rare
case of the patient who is allergic to a component of amalgam. This
supports the findings of the Food and Drug Administration, the
National Institutes of Health Technology Assessment Conference and
the National Institute of Dental and Craniofacial Research, that
dental amalgam is a safe and effective restorative material. In
addition, in 1991, Consumer Reports noted, 'Given their solid track
record . . . amalgam fillings are still your best bet.'
"In 1991, the U.S. Food and Drug Administration's Dental Products
Panel found no valid data to demonstrate clinical harm to patients
from amalgams or that having them removed would prevent adverse
health effects or reverse the course of existing diseases. The U.S.
Public Health Service found in 1993 'no persuasive reason to believe
that avoiding amalgams or having them removed will have a beneficial
effect on health.' In fact, it is inadvisable to have amalgams
removed unnecessarily because it can cause structural damage to
healthy teeth.
"The ADA supports ongoing research in the development of new
materials that it hopes will someday prove to be as safe and
effective as dental amalgam. However, the ADA continues to believe
that amalgam is a valuable, viable and safe choice for dental
patients and concurs with the findings of the U.S. Public Health
Service that amalgam has 'continuing value in maintaining oral
health.'" (Am. Dental Assn., Statement on Dental Amalgam (May 11,
2001) <http://www.ada.org/prof/prac/issues/statements/ amalgam.html>
[as of August 8, 2001].)
The State of California has classified mercury and mercury compounds
as reproductive toxins since July 1, 1990. (Cal. Code Regs., tit.
22, § 12000, subd. (c)(1), p. 182, col. 2.) "Mercury is a highly
toxic metal that is more dangerous than lead, cadmium and arsenic in
relation to its effect on the body." (Leading Edge Research Group,
Mercury Amalgam: Contamination of Human Neurophysiology (1996)
<http://www.trufax.org/mercury/merc1.html> [as of August 8, 2001];
accord, Note, Up in Smoke: The Need for International Regulation of
Hazardous Waste Incineration (1994) 29 Tex. Internat. L.J. 257, 264
[highly toxic substances include mercury and high level radioactive
waste; less toxic substances include arsenic, lead, copper, and
zinc].)
In short, a wealth of information exists on both sides of the dental
amalgam controversy, much of it on the Internet. (Compare "The
Dental Amalgam Issue" [opposing use of silver fillings]
<http://www.amalgam.org> [as of August 8, 2001] with "Possible Health
Effects and Dental Amalgam" [supporting use of silver fillings]
<http://www.odont.lu.se/ projects/NBHW/amalgam.html> [as of August 8,
2001].
PROPOSITION 65
The Safe Drinking Water and Toxic Enforcement Act of 1986
(the Act) was passed as an initiative, Proposition 65, by a vote of
the people on November 4, 1986. It is codified in the Health and
Safety Code (§§ 25249.5-25249.13). The Act is intended to deter
businesses from contaminating sources of drinking water and to
require businesses to warn individuals about carcinogens and
reproductive toxins to which they are exposed through consumer
transactions, employment, and the environment. (Cal. Code Regs.,
tit. 22, § 12601, subds. (b), (c).) Because "Proposition 65 [is] a
remedial statute intended to protect the public . . . [w]e construe
the statute broadly to accomplish that protective purpose." (People
ex rel. Lungren v. Superior Court (1996) 14 Cal.4th 294, 314.)
Section 1 of Proposition 65 states:
"'The people of California find that hazardous chemicals pose
a serious potential threat to their health and well being, that state
government agencies have failed to provide them with adequate
protection, and that these failures have been serious enough to lead
to investigations by federal agencies of the administration of
California's toxic protection programs. The people therefore declare
their rights:
"'(a) To protect themselves and the water they drink against
chemicals that cause cancer, birth defects, or other reproductive
harm.
"'(b) To be informed about exposures to chemicals that cause cancer,
birth defects, or other reproductive harm.
"'(c) To secure strict enforcement of the laws controlling hazardous
chemicals and deter actions that threaten public health and safety.
"'(d) To shift the cost of hazardous waste cleanups more onto
offenders and less onto law abiding taxpayers. [] . . .'"
(Historical and Statutory Notes, 40C West's Ann. Health & Saf. Code
(1999 ed.) foll. § 25249.5, pp. 279-280.)
The present case concerns reproductive toxins that cause
adverse "developmental" effects. (See Cal. Code Regs., tit. 22, §
12000, subd. (c)(1), p. 182, col. 2.) Under the Act, the Governor is
required to publish, at least once a year, a list of chemicals known
to the state to cause reproductive toxicity. (Health & Safety Code,
§ 25249.8, subd. (a); all further section references are to the
Health and Safety Code unless otherwise indicated.)
A chemical is "known to the state to cause . . . reproductive
toxicity . . . if in the opinion of the state's qualified experts it
has been clearly shown through scientifically valid testing according
to generally accepted principles to cause . . . reproductive
toxicity, or if a body considered to be authoritative by such experts
has formally identified it as causing . . . reproductive toxicity, or
if an agency of the state or federal government has formally required
it to be labeled or identified as causing . . . reproductive
toxicity." (§ 25249.8, subd. (b).) The list of chemicals known to
the state to cause reproductive toxicity includes mercury and mercury
compounds (hereafter mercury). (Cal. Code Regs., tit. 22, § 12000,
subd. (c)(1), p. 182, col. 2.)
One of the Act's principal sections states that "[n]o 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 . . . ." (§ 25249.6, italics added.)
The term "person" includes individuals and various entities.
(§ 25249.11, subd. (a).) The phrase "[p]erson in the course of doing
business" does not include certain public entities or an employer
with fewer than 10 employees. (§ 25249.11, subd. (b); see § 25249.5.)
"'Knowingly' refers only to knowledge of the fact that a
discharge of, release of, or exposure to a chemical listed . . . [as
a reproductive toxin] is occurring." (Cal. Code Regs., tit. 22, §
12201, subd. (d).) In general, "[n]o knowledge that the discharge,
release or exposure is unlawful is required." (Ibid.)
The term "expose" means "to cause to ingest, inhale, contact
via body surfaces or otherwise come into contact with a chemical."
(Cal. Code Regs., tit. 22, § 12201, subd. (f).) "An individual may
come into contact with a chemical through water, air, food, consumer
products and any other environmental exposure as well as occupational
or workplace exposures." (Ibid.)
The "level in question" means "the chemical concentration of
a listed chemical for the exposure in question." (Cal. Code Regs.,
tit. 22, § 12821, subd. (a).)
The Act's warning requirement (§ 25249.6) is subject to
statutory exemptions, one of which applies to "[a]n exposure for
which the person responsible can show that the exposure . . . will
have no observable effect assuming exposure at one thousand (1,000)
times the level in question for substances known to the state to
cause reproductive toxicity . . . ." (§ 25249.10, subd. (c), italics
added (hereafter "exposure exemption").) "In any action brought to
enforce [the warning requirement,] the burden of showing that an
exposure meets the criteria of this subdivision shall be on the
defendant." (Ibid., italics added.)
Thus, if a provider of dental care knowingly and intentionally
exposes employees and patients to mercury without a warning, it has
the burden of showing that an exposure 1,000 times the level in
question will not cause any observable reproductive harm. (The
exposure exemption is not the only exemption under the Act (see §
25249.10, subds. (a), (b)), but the others are not applicable.)
The Act is enforced in accordance with regulations
promulgated by the Office of Environmental Health Hazard Assessment,
the primary agency that implements the Act. (See Cal. Code Regs.,
tit. 22, §§ 12301, 12302, 12305; id., appen. foll. § 12903, p. 199.)
Under the regulations, a defendant can seek the protection of the
exposure exemption by providing specified data about the effect of a
reproductive toxin. In particular, a defendant must establish: (1)
the "no observable effect level," or "NOEL," which is the "maximum
dose level at which a chemical has no observable reproductive effect"
(Cal. Code Regs., tit, 22, § 12801, subd. (c)); and (2) the level of
exposure in question.
A. Maximum Dose Level
The calculation of the NOEL involves a highly technical,
scientific inquiry. "The determination of whether a level of
exposure to a chemical known to the state to cause reproductive
toxicity has no observable effect [at 1,000 times the level in
question] shall be based on evidence and standards of comparable
scientific validity to the evidence and standards which form the
scientific basis for the listing of a chemical as known to the state
to cause reproductive toxicity." (Cal. Code Regs., tit. 22, § 12801,
subd. (a).) While other evidence and standards are permitted
(ibid.), a defendant must still perform a "quantitative risk
assessment" regardless of the type of evidence or standard used (Cal.
Code Regs., tit. 22, §§ 12801, subds. (a), (b)(1), 12803; see also
id., §§ 12801, subd. (b)(2), 12805).
A quantitative risk assessment determines the maximum dose
level having no observable reproductive effect, assuming an exposure
1,000 times the level in question. (§ 25249.10, subd. (c); Cal. Code
Regs., tit. 22, §§ 12801, subd. (b)(1), 12803.) The assessment has
to be based on studies producing the reproductive effect that
provided the basis for listing the substance as a reproductive toxin
in the first place. (Cal. Code Regs., tit. 22, § 12803, subd. (a)
(1).) The NOEL must be the highest dose level that results in no
observable reproductive effect. (Ibid.) The quality and suitability
of any epidemiological data must be examined in deciding whether the
data is appropriate. (Id., subd. (a)(2).) Any comparative animal
studies must satisfy generally accepted scientific principles. (Id.,
subd. (a)(3).) The NOEL must be based on the most sensitive study of
sufficient quality (id., subd. (a)(4)), and must be converted into a
milligram per day dose level by multiplying the NOEL by an assumed
human body weight - 70 kilograms for a male, 58 kilograms for a
female (id., subd. (b)).
B. Level of Exposure
"The exposure in question includes the exposure for which the
person in the course of doing business is responsible . . . ."
(Ibid.) The level of exposure to a reproductive toxin "shall be
determined by multiplying the level in question (stated in terms of a
concentration of a chemical in a given medium) times the reasonably
anticipated rate of exposure for an individual to a given medium.
The reasonably anticipated rate of exposure shall be based on the
pattern and duration of exposure that is relevant to the reproductive
effect which provided the basis for the determination that a chemical
is known to the state to cause reproductive toxicity." (Cal. Code
Regs., tit. 22, § 12821, subd. (b).)
"For exposures to consumer products, the level of exposure shall be
calculated using the reasonably anticipated rate of intake or
exposure for average users of the consumer product, and not on a per
capita basis for the general population. The rate of intake or
exposure shall be based on data for use of a general category or
categories of consumer products . . . ." (Cal. Code Regs., tit. 22,
§ 12821, subd. (c)(2).)
The level of exposure is also based on certain assumptions about
people in general, including the amount of air they breathe, the
amount of water they drink, and their life expectancy. (Cal. Code
Regs., tit. 22, §§ 12821, subd. (c)(1), 12721, subd. (d).) For an
exposure to a fetus, a nine month gestation period is used. (Ibid.)
C. Determination of Exemption
A defendant is exempt from warning others about a
reproductive toxin if the level of exposure in question is 1,000
times below than the NOEL. If the defendant is not exempt, it must
provide a warning that is "reasonably calculated, considering the
alternative methods available under the circumstances, to make the
warning message available to the individual prior to exposure."
(Cal. Code Regs., tit. 22, § 12601, subd. (a).) The warning "may be
provided by general methods such as labels on consumer products,
inclusion of notices in mailings to water customers, posting of
notices, placing notices in public news media, and the like, provided
that the warning accomplished is clear and reasonable." (§ 25249.11,
subd. (f).)
PROCEDURAL HISTORY
On February 28, 2000, Consumer Cause, Inc., filed this action
on behalf of the general public, naming Community Dental Services,
Inc., and SmileCare as defendants. Subsequently, Consumer Cause
filed a first amended complaint, alleging that defendants had
violated the Act (§ 25249.6) and the California unfair competition
law (Bus. & Prof. Code, § 17200 et seq.).
More specifically, Consumer Cause alleged that defendants had
violated the Act by exposing employees and patients to amalgam
fillings containing mercury - a reproductive toxin - without
providing the requisite warning. (See Cal. Code Regs., tit. 22, §
12000, subd. (c)(1), p. 182, col. 2.) The amended complaint did not
contain any allegations concerning whether defendants came within the
exposure exemption. As a second cause of action, Consumer Cause
alleged that defendants' violations of the Act also violated the
prohibition on unlawful business acts and practices under the unfair
competition law. (See Bus. & Prof. Code, § 17200.)
Defendants filed an answer, alleging as an affirmative
defense that their "actions were permissible pursuant to California
Health & Safety Code § 25249.10(c)[, i.e., the exposure exemption]."
Shortly after answering the complaint, defendants filed a motion for
summary judgment, which relied on two categories of evidence: (1)
Consumer Cause's discovery responses, which admitted that Consumer
Cause did not have any evidence to dispute the applicability of the
exposure exemption; and (2) the declaration of a dentist, Dr. Louis
Amendola, who stated that standard amalgam fillings contain trace
amounts of mercury. Dr. Amendola also said that silver fillings have
been used safely in the United States for 150 years and are approved
by the ADA. In their moving papers, defendants admitted that, for
purposes of summary judgment, they use amalgam fillings containing
mercury.
In opposition, Consumer Cause argued that the warning
exemption was an affirmative defense and that defendants had the
burden of making a prima facie showing that the defense applied.
Consumer Cause asserted that, because defendants had not made such a
showing, the motion should be denied.
By order dated January 16, 2001, the trial court granted
summary judgment. On the same day, the trial court entered judgment
in defendants' favor. Consumer Cause filed a timely appeal.
DISCUSSION
We first address the evidentiary burdens applicable to a
defense motion for summary judgment in a Proposition 65 case where
the defendant invokes the exposure exemption to the warning
requirement (§§ 25249.10, subd. (c), 25249.6). We then apply those
burdens to the summary judgment motion in this case. Finally, we
turn to the remedy available on Consumer Cause's claim under the
unfair competition law.
A. The Burden on Summary Judgment
Defendants rely on our decision in Leslie G. v. Perry
Associates (1996) 43 Cal.App.4th 472, where we stated: "Under the
current version of the summary judgment statute, a moving defendant
need not support his motion with affirmative evidence negating an
essential element of the responding party's case. Instead, the
moving defendant may (through factually vague discovery responses or
otherwise) point to the absence of evidence to support the
plaintiff's case. When that is done, the burden shifts to the
plaintiff to present evidence showing there is a triable issue of
material fact. If the plaintiff is unable to meet her burden of
proof regarding an essential element of her case, all other facts are
rendered immaterial." (Id. at p. 482, second italics added.)
We have also stated that a 1993 amendment to the summary
judgment statute (Code Civ. Proc., § 437c, as amended by Stats. 1993,
ch. 276, § 1, pp. 1969-1974) "changed our state court procedure
dramatically, from one where a moving defendant was required to
present affirmative evidence conclusively negating an element of the
plaintiff's case . . . to one where the defendant can satisfy its
evidentiary burden by proof of the plaintiff's inability to prove its
own case (by evidence in the form of the plaintiff's factually vague
discovery responses)." (Certain Underwriters at Lloyd's of London v.
Superior Court (1997) 56 Cal.App.4th 952, 959, italics in original.)
But defendants fail to appreciate that their motion for
summary judgment did not seek to negate an element of Consumer
Cause's claims, conclusively or otherwise. Rather, the motion was
based on an affirmative defense, i.e., exposure to mercury had no
observable reproductive effect at 1,000 times the level of in
question. (See § 25249.10, subd. (c).)
By statute, "[a]ny party may move for summary judgment in any
action or proceeding if it is contended that the action has no merit
or that there is no defense to the action or proceeding." (Code Civ.
Proc., § 437c, subd. (a), italics added.) "A cause of action has no
merit if either of the following exists: [] (1) One or more of the
elements of the cause of action cannot be separately established,
even if that element is separately pleaded. (2) A defendant
establishes an affirmative defense to that cause of action." (Id.,
subds. (n)(1), (2), italics added.) "A defendant . . . has met his
or her burden of showing that a cause of action has no merit if that
party has shown that one or more elements of the cause of action,
even if not separately pleaded, cannot be established, or that there
is a complete defense to that cause of action. Once the
defendant . . . has met that burden, the burden shifts to the
plaintiff . . . to show that a triable issue of one or more material
facts exists as to that cause of action or a defense thereto." (Id.,
subd. (o)(2), italics added.)
"The burden on a defendant moving for summary judgment based
upon the assertion of an affirmative defense is [different] than the
burden to show [that] one or more elements of the plaintiff's cause
of action cannot be established. Instead of merely submitting
evidence to negate a single element of the plaintiff's cause of
action, or offering evidence such as vague or insufficient discovery
responses that the plaintiff does not have evidence to create an
issue of fact as to one or more elements of his or her
case . . . 'the defendant has the initial burden to show that
undisputed facts support each element of the affirmative
defense' . . . . If the defendant does not meet this burden, the
motion must be denied." (Anderson v. Metalclad Insulation Corp.
(1999) 72 Cal.App.4th 284, 289-290; accord, Weil & Brown, Cal.
Practice Guide: Civil Procedure Before Trial (The Rutter Group
2001) 10:241, 10:242, 10:246 to 10:249, pp. 10 77, 10 78, 10 83 to
10 85, rev. # 1, 2001.)
"'[T]here is no obligation on the opposing party (plaintiffs
here) to establish anything by affidavit unless and until the moving
party has by affidavit stated "'facts establishing every element [of
the affirmative defense] necessary to sustain a judgment in his
favor. . . .'"' . . . [] What this means . . . is that if an
affirmative defense has four elements, it does not suffice even if
the defendant produces overwhelming evidence as to three of those
elements. If the defendant fails to address the fourth element at
all or to produce substantial evidence supporting that element, the
trial court cannot properly grant summary judgment. Moreover, a
summary judgment granted in those circumstances would have to be
reversed, even if the plaintiff failed to introduce a scintilla of
evidence challenging that element." (Huynh v. Ingersoll Rand (1993)
16 Cal.App.4th 825, 830-831, citations omitted, second italics added,
bracketed material added in Huynh.)
As our Supreme Court recently explained: "From commencement
to conclusion, the party moving for summary judgment bears the burden
of persuasion that there is no triable issue of material fact and
that he is entitled to judgment as a matter of law. That is because
of the general principle that a party who seeks a court's action in
his favor bears the burden of persuasion thereon. . . . There is a
triable issue of material fact if, and only if, the evidence would
allow a reasonable trier of fact to find the underlying fact in favor
of the party opposing the motion in accordance with the applicable
standard of proof. . . ." (Aguilar v. Atlantic Richfield Co. (2001)
25 Cal.4th 826, 850 (Aguilar), citation and fn. omitted, italics
added.)
"[T]he party moving for summary judgment bears an initial
burden of production to make a prima facie showing of the
nonexistence of any triable issue of material fact; if he carries his
burden of production, he causes a shift, and the opposing party is
then subjected to a burden of production of his own to make a prima
facie showing of the existence of a triable issue of material
fact. . . . A prima facie showing is one that is sufficient to
support the position of the party in question.
"[The way in which] the parties moving for, and opposing,
summary judgment may each carry their burden of persuasion and/or
production depends on which [party] would bear what burden of proof
at trial." (Aguilar, supra, 25 Cal.4th at pp. 850-851, first italics
added.)
B. The Burden as Applied in this Case
We conclude that defendants' summary judgment motion should
have been denied. In their motion, defendants assumed, for the sake
of argument, that they had knowingly and intentionally exposed
employees and patients to mercury without providing a warning. They
relied on the exposure exemption - an affirmative defense - and
claimed that a warning was unnecessary.
Of course, at trial, a defendant raising an affirmative defense has
the burden of proving it. (Ramirez v. Yosemite Water Co. (1999) 20
Cal.4th 785, 794-795; Bertero v. National General Corp. (1974) 13
Cal.3d 43, 54; see § 25249.10, subd. (c).) Under the Act, a
defendant relying on the exposure exemption at trial would have to
establish the NOEL, the level of exposure in question, and,
ultimately, that the level of exposure was 1,000 times below the
NOEL. (§ 25249.10, subd. (c); Cal. Code Regs., tit. 22, §§ 12801,
subds. (a), (b)(1), (c), 12803.)
Therefore, at the summary judgment stage, the defendants in the
present case had an initial burden of production to make a prima
facie showing that their conduct came within the exposure exemption.
(See § 25249.10, subd. (c); Code Civ. Proc., § 437c, subds. (n)(2),
(o)(2); Anderson v. Metalclad Insulation Corp., supra, 72 Cal.App.4th
at pp. 289-290; Weil & Brown, Cal. Practice Guide: Civil Procedure
Before Trial, supra, 10:241, 10:242, 10:246 to 10:249, pp. 10 77, 10
78, 10 83 to 10 85, rev. # 1, 2001.) If they failed to meet that
burden, "the plaintiff need not make any showing at all." (Pepperell
v. Scottsdale Ins. Co. (1998) 62 Cal.App.4th 1045, 1054.)
Defendants contend that Dr. Amendola's declaration, together with
Consumer Cause's discovery responses, shifted the burden of
production to Consumer Cause. We disagree, as does the Attorney
General of the State of California.
In his amicus brief, filed in this appeal, the Attorney General
states: "Amicus Curiae, the People of the State of
California . . . , ex rel. Bill Lockyer, the Attorney General of the
State of California, file this amicus brief to urge the Court to
reverse the decision of the trial court granting summary
judgment . . . . [T]he trial court misconstrued the burden of proof
in a Proposition 65 action and the evidence necessary to meet that
burden of proof, and improperly dismissed plaintiff Consumer Cause,
Inc.'s claims. [] . . .
"The People file this brief because of their interest in this
matter. The Attorney General is constitutionally designated as
the 'chief law officer of the state' and has the constitutional duty
to ensure that state law is adequately enforced. . . . Under
Proposition 65, the Attorney General sues 'in the name of the People
of the State of California' . . . which signifies that the action is
an exercise of the sovereign power. . . . The Attorney General is the
only official permitted to sue on behalf of the People. As the
principal enforcer of Proposition 65, the Attorney General has a
significant interest in decisions interpreting the proper burden of
proof in a Proposition 65 action." (Italics added.)
1. Dr. Amendola's Declaration
In his declaration, Dr. Amendola stated that (1) standard dental
amalgam contains only a trace amount of mercury, (2) amalgam fillings
have been used safely throughout the country for 150 years, (3) the
ADA has approved the use of amalgam fillings, and (4) there is no
scientific evidence, to his knowledge, suggesting that amalgam
fillings cause any adverse physical effect with the exception of
allergic reactions in some people.
We find Dr. Amendola's declaration to be woefully inadequate in
several respects. It does not discuss or even mention the NOEL, the
level of exposure in question, or the relationship between the two.
In addition, Dr. Amendola's representation that amalgam fillings
are "safe" ignores the standards imposed by the Act. As the Attorney
General has stated in his amicus brief:
"[W]hat is at issue in the exemption is not the 'safety' of the
product causing the exposure, but rather whether the exposure is one
thousand times below the 'no observable effect' level. Thus, even
products, whose use is sanctioned by state and federal regulatory
agencies, may still require a Proposition 65 warning. [] . . .
[] . . .
"Nothing in the declaration [of Dr. Amendola] indicates that [he] is
a toxicologist or has any expertise in either risk assessment or
exposure assessment. . . . Even assuming that all of Dr. Amendola's
statements are true, Dr. Amendola said nothing about . . . the level
of exposure to mercury caused by dental amalgam, and nothing about
whether the exposure is one thousand times below the NOEL.
Furthermore, he could not have made such statements because of his
apparent lack of expertise."
We conclude that, because Dr. Amendola's declaration does not address
any of the relevant factors under the exposure exemption, it is not
entitled to any weight.
2. Consumer Cause's Discovery Responses
In moving for summary judgment, defendants also relied upon Consumer
Cause's responses to requests for admissions and special
interrogatories. The question, then, is whether Consumer Cause's
discovery responses - without any support from Dr. Amendola's
deficient declaration - shifted the burden of production to Consumer
Cause. We think not.
One of the requests for admissions stated: "Admit that exposure to
mercury at one thousand times the level you contend defendants have
exposed individuals to will have no observable effect on the
individuals." (Italics added.) Consumer Cause responded that,
despite a reasonable inquiry, it "lacks sufficient information or
knowledge to admit the matter. . . ." In responding to other
requests for admissions, Consumer Cause admitted that it did not have
any evidence that defendants' use of mercury had caused injury to
anyone, nor did it have evidence concerning the level of mercury to
which defendants had allegedly exposed individuals.
As for the interrogatories, special interrogatory No. 3 asked, "Do
you contend that exposure to mercury at one thousand times the level
you believe Defendants have exposed individuals to will result in
observable effects to the individual?" (Italics added.) Consumer
Cause answered, "No." The next interrogatory asked, "If your answer
to the [preceding interrogatory] is anything other than an
unqualified negative, IDENTIFY all facts in support of your response
thereto." Consumer Cause responded, "Not applicable."
Another interrogatory asked Consumer Cause to identify all
facts "regarding the level of mercury to which you claim Defendants
have exposed INDIVIDUALS." (Italics added.) Consumer Cause
stated: "Responding party has made no allegation regarding the level
of mercury to which defendants have exposed individuals. Therefore,
responding party is not in possession of such facts." (Italics
added.)
The two succeeding interrogatories asked Consumer Cause to identify
all documents and individuals, respectively, "regarding the level of
mercury to which you claim Defendants have exposed individuals."
(Italics added.) Consumer Cause's response to both interrogatories
stated: "Responding party has made no allegation regarding the level
of mercury to which defendants have exposed individuals. Therefore,
responding party is not in possession of such information." (Italics
added.)
The last interrogatory asked Consumer Cause to identify any injuries
attributed to defendants' conduct. Consumer Cause
replied, "Responding party has made no allegation regarding any
injuries to individuals attributable to defendants' conduct.
Therefore, responding party is not in possession of such
information." (Italics added.)
On an appeal from summary judgment, we do not examine the opposing
party's discovery responses in isolation. Where, as here, the trial
court has granted a defendant's motion for summary judgment, the
plaintiff's discovery responses are pertinent only if they are used
to support undisputed "facts" in the defendant's separate statement.
As we have previously stated: "[A]ll material facts must be set
forth in the separate statement. 'This is the Golden Rule of Summary
Adjudication: if it is not set forth in the separate statement, it
does not exist. Both the court and the opposing party are entitled
to have all the facts upon which the moving party bases its motion
plainly set forth in the separate statement.'" (United Community
Church v. Garcin (1991) 231 Cal.App.3d 327, 337, italics in original,
superseded by statute on another point, as stated in Certain
Underwriters at Lloyd's of London v. Superior Court, supra, 56
Cal.App.4th at p. 957, fn. 4; accord, Kim v. Sumitomo Bank (1993) 17
Cal.App.4th 974, 979.)
In their separate statement, defendants relied on Consumer Cause's
discovery responses in support of two allegedly undisputed facts:
(1) "Plaintiff has no evidence that defendants' alleged exposure of
individuals to mercury . . . will have an observable effect assuming
exposure at 1000 times the level used by defendants; and
(2) "Defendants' alleged exposure of individuals to mercury . . .
will have no observable effect assuming exposure at 1000 times the
level used by defendants."
In its responsive statement, Consumer Cause admitted that it had no
evidence indicating that defendants' exposure of individuals to
mercury would cause an observable effect at 1,000 times the level in
question. As to the second alleged fact, Consumer Cause
responded: "Disputed. Since defendants have not shown a complete
defense under Health & Safety Code section 25249.10, subdivision (c)
[, i.e., the exposure exemption], plaintiff has no evidentiary
burden. . . ."
We conclude that Consumer Cause's responses to defendants' separate
statement did not warrant summary judgment. Both of the alleged
facts concerned the applicability of defendants' affirmative defense,
as to which they had - but did not satisfy - the burden of production.
a. Consumer Cause's Lack of Evidence
Defendants had an initial burden to make a prima facie showing that
the exposure exemption applied. That showing, however, could not be
based on Consumer Cause's lack of evidence to disprove the
applicability of the defense. (See Anderson v. Metalclad Insulation
Corp., supra, 72 Cal.App.4th at pp. 289-290; Huynh v. Ingersoll Rand,
supra, 16 Cal.App.4th at pp. 830-831, Weil & Brown, Cal. Practice
Guide: Civil Procedure Before Trial, supra, 10:235 to 10:237, pp.
10 75 to 10 76, rev. # 1, 2001.) Defendants' contrary contention
puts the cart before the horse.
Consumer Cause did not have to offer any evidence disputing the
applicability of the exposure exemption until defendants made the
requisite initial showing. Were it otherwise, a defendant's initial
burden in moving for summary judgment on an affirmative defense would
be no burden at all - even though defendants would have the burden of
proof at trial. (See Ramirez v. Yosemite Water Co., supra, 20
Cal.4th at pp. 794-795; Bertero v. National Corp., supra, 13 Cal.3d
at p. 54.) "[I]t is not plaintiff's initial burden to disprove
affirmative defenses . . . asserted by the defendant." (Weil &
Brown, Cal. Practice Guide: Civil Procedure Before Trial, supra,
10:235, p. 10 75, rev. # 1, 2001.)
As stated, Dr. Amendola's declaration did not come close to making a
prima facie showing that defendants' conduct came within the exposure
exemption. As a result, the burden of production did not shift to
Consumer Cause, and its lack of evidence was of no consequence.
b. Consumer Cause's Contentions
"A summary judgment should not be based on tacit admissions or
fragmentary and equivocal concessions, which are contradicted by
other credible evidence." (Price v. Wells Fargo Bank (1989) 213
Cal.App.3d 465, 482; see id. at pp. 481-482; accord, Prilliman v.
United Air Lines, Inc. (1997) 53 Cal.App.4th 935, 961-962.) To
protect the interests of the party opposing summary judgment,
its "admissions[, if any,] should be . . . careful[ly] examin[ed] in
light of the entire record." (Mason v. Marriage & Family Center
(1991) 228 Cal.App.3d 537, 546, italics added; accord, Scheiding v.
Dinwiddie Construction Co. (1999) 69 Cal.App.4th 64, 78.)
Virtually all of the discovery propounded by defendants assumed that
Consumer Cause had formed an opinion or adopted a position regarding
the specific level of exposure to which individuals had actually been
exposed. That was an erroneous assumption, and, as such, it has no
legal significance.
Consumer Cause's discovery responses, viewed in light of the entire
record, did not contend or admit that defendants had exposed
individuals to a specific level of mercury. Instead, consistent with
its burden of proof under the Act, Consumer Cause simply alleged that
defendants had knowingly and intentionally exposed employees and
patients to mercury without a warning. That allegation -
unchallenged for purposes of summary judgment - put the burden on
defendants to make a prima facie showing that the level of exposure
was within the limits set by the Act: "In any action brought to
enforce [the warning requirement,] the burden of showing that an
exposure [is exempt] shall be on the defendant." (§ 25249.10, subd.
(c), italics added.)
Consumer Cause did not have to fund scientific studies or collect
medical data to establish the NOEL or to gauge the level of exposure
at defendants' offices. Nor did it have to hazard a guess. Under
the Act, defendants, not Consumer Cause, had to contend that the
exposure was at a specific level - 1,000 times below the NOEL. By
not alleging a specific level of exposure, Consumer Cause did not
concede the level to be 1,000 times below the NOEL. As stated in
Consumer Cause's separate statement, "[s]ince defendants have not
shown a complete defense under . . . [the exposure exemption],
plaintiff has no evidentiary burden. . . ." We cannot fault a party
for providing discovery responses that comport with its burden of
proof under the Act.
Thus, defendants did not satisfy their burden of production by
relying on Consumer Cause's lack of contentions. Indeed, at oral
argument, counsel for defendants agreed with that conclusion. He
stated that summary judgment was proper because it was based on both
Consumer Cause's discovery responses and Dr. Amendola's declaration.
During argument, the court referred to Consumer Cause's interrogatory
answers and asked defendants' counsel: "You are of the view that by
submitting their answers to your interrogatories, you have met your
burden of proof?" Counsel replied, "Well, not just that but the
declaration of Dr. Amendola . . . ." At another point, defense
counsel stated, "And so the combination of the declaration and the
interrogatory responses . . . justifies the summary judgment."
Also during argument, the court focused on Consumer Cause's negative
answer to special interrogatory No. 3, which asked: "Do you contend
that exposure to mercury at one thousand times the level you believe
Defendants have exposed individuals to will result in observable
effects to the individual?" (Italics added.) The court inquired of
defendants' counsel, "If the declaration, for whatever reason, is
inadequate in our view, is it your position that their answer to the
interrogatory is by itself sufficient to have met your burden of
proof, initially?" Defense counsel answered: "I would be forced to
say, no, and if that's all we came up with, then we would not be in a
position for summary judgment."
As we have already explained, Dr. Amendola's declaration is
entitled to no weight. And, as defendants correctly state, they
could not rely on Consumer Cause's discovery responses alone to
satisfy their burden of production. As a result, under defendants'
own theory of the case, summary judgment was improper. (See Browne
v. Superior Court (1940) 16 Cal.2d 593, 599 [counsel's concessions
and admissions at oral argument are binding]; Franklin v. Appel
(1992) 8 Cal.App.4th 875, 893, fn. 11 [same]; 9 Witkin, Cal.
Procedure (4th ed. 1997) Appeal, § 665(c), p. 698 [same].)
We note that, in responding to special interrogatory No. 3,
Consumer Cause was faced with a Hobson's choice. By answering "no" -
as it did - Consumer Cause stands accused of conceding defeat. But
had Consumer Cause answered "yes" and then stated, in the succeeding
interrogatories, that it had no facts, documents, or witnesses to
support its answer, it would be accused of making an unfounded
contention. Either way, defendants come out the winner.
However, as Consumer Cause has amply demonstrated, its interrogatory
answer, like its other discovery responses, was based on the premise
that it had made no allegation regarding the specific level of
mercury to which individuals had been exposed. The answer to special
interrogatory No. 3 conceded nothing because it was consistent with
Consumer Cause's burden of proof under the Act. Thus, "[i]n this
case [Consumer Cause's] explanation of [its] response to the
interrogatory, viewed in light of the whole record, is
[satisfactory]." (Mason v. Marriage & Family Center, supra, 228
Cal.App.3d at p. 546.)
The Attorney General agrees, stating in his amicus brief: "The
Dental Defendants further based their argument on the fact that, in
discovery, Consumer Cause stated that it lacked information about the
level of exposure to mercury from dental amalgam, had no contention
that exposure to mercury at one thousand times the level in question
would result in observable effects, and had no evidence that
defendants caused injury by exposing individuals to mercury.
[] . . . [T]he trial court granted summary judgment . . . and
dismissed the action. . . . [T]his ruling is in error and should be
reversed. [] . . . [] . . .
"[T]he elements of the [exposure] exemption to be proved by the
Dental Defendants are detailed and specific. . . . [T]he exemption
does not involve showing that the chemical is 'safe,' or has not
caused harm to individuals, or is recommended by various agencies.
Rather, the Dental Defendants were required (1) to present evidence
to prove the NOEL for mercury, (2) to present evidence to prove the
exposure to mercury from dental amalgam, and (3) to prove that the
exposure to mercury from dental amalgam was one thousand times below
the NOEL.
"As is evident from the record, the Dental Defendants failed to
submit evidence to meet even a single element of the exemption. They
did not perform a quantitative risk assessment and did not provide
any evidence whatsoever that established the NOEL for mercury. The
only evidence relied on, the one page declaration of [Dr. Amendola],
says nothing about the NOEL for mercury . . . . [] . . . []
"Consumer cause met its burden of alleging the elements of its prima
facie case - that the Dental Defendants knowingly and intentionally
exposed individuals to mercury, a listed reproductive toxin, without
providing a warning. The Dental Defendants did not challenge this
prima facie case. Instead, they asserted an affirmative defense and
argued that the exposure met the [statutory] exemption . . . because
it was one thousand times below the NOEL.
"[T]he Dental Defendants failed to introduce even a shred of evidence
to prove any element of this affirmative defense. Thus, contrary to
the arguments presented by the Dental Defendants, Consumer Cause had
no further burden and was not required to provide any evidence to
refute the defense.
"Furthermore, it is irrelevant that Consumer Cause admitted in
discovery that it [(1)] had no contention about the level of exposure
to mercury from dental amalgam, and [(2)] had no contention that
exposure at one thousand times the level in question would result in
observable effects. While it is correct that a moving party may
obtain summary judgment if it proves that the plaintiff has no
evidence concerning an 'essential element' of its case . . . ,
neither of these [two] issues were elements of Consumer Cause's prima
facie case. Consumer Cause was only required to prove a knowing and
intentional exposure without a warning. . . . It did so. It was not
required to have contentions or to present evidence about the NOEL or
the exposure level, until the Dental Defendants met their own burden
of presenting evidence . . . that the exposure to mercury from dental
amalgam is one thousand times below the NOEL for mercury. . . . Since
the Dental Defendants failed to establish the elements of the
exemption, Consumer Cause had no further burden in presenting its
case." (Italics in original, citations and fn. omitted.)
In sum, defendants failed to make an adequate showing that the
exposure exemption applied. It follows that the burden of production
did not shift to Consumer Cause to raise a disputed issue with
respect to the exemption. Thus, this is not a case where "[the]
party moving for summary judgment . . . would prevail at trial
without submission of any issue of material fact to a trier of fact
for determination . . . ." (Aguilar, supra, 25 Cal.4th at p. 855.)
Regardless of the evidence that Consumer Cause could, or did, offer,
the lack of evidence submitted by defendants was fatal to summary
judgment.
C. Unfair Competition Law
At the pleading stage, the trial court granted defendants'
motion to strike Consumer Cause's prayer for restitution under the
unfair competition law (UCL). We find no error.
Consumer Cause relies on defendants' alleged violation of the
Act to support its claim under the UCL. There is nothing wrong in
that.
"Section 17200 of the Business and Professions Code broadly
defines 'unfair competition' as, inter alia, any 'unlawful, unfair or
fraudulent business [act or] practice . . . .' 'Unlawful business
activity' proscribed under section 17200 includes '"anything that can
properly be called a business practice and that at the same time is
forbidden by law."' . . . '[I]n essence, an action based on Business
and Professions Code section 17200 to redress an unlawful business
practice "borrows" violations of other laws and treats these
violations, when committed pursuant to business activity, as unlawful
practices independently actionable under section 17200 et seq. and
subject to the distinct remedies provided thereunder.'" (Farmers
Ins. Exchange v. Superior Court (1992) 2 Cal.4th 377, 383.)
The UCL states that "[t]he [trial] court may make such orders or
judgments . . . as may be necessary to restore to any person in
interest any money or property, real or personal, which may have been
acquired by means of such unfair competition." (Bus. & Prof. Code, §
17203.) This provision authorizes the trial court to order a
defendant to make restitution. (See Kraus v. Trinity Management
Services, Inc. (2000) 23 Cal.4th 116, 128-129.)
In the complaint, Consumer Cause asserted that it was bringing this
action "on behalf of the general public." But restitution under the
UCL is limited to the "victims" of the defendant's unlawful business
practice or act. (See Stop Youth Addiction, Inc. v. Lucky Stores,
Inc. (1998) 17 Cal.4th 553, 581-584 [conc. opn. of Baxter, J.].)
Consumer Cause does not contend that it fell victim to defendants'
alleged misconduct or that every member of the general public has
been harmed. Perhaps Consumer Cause sought to establish a "fluid
recovery fund" on behalf of nonparties who could later make a claim
against the fund and be paid. But that attempt, too, is foreclosed.
(See Kraus v. Trinity Management Services, Inc., supra, 23 Cal.4th at
pp. 126-131, 137.)
Consumer Cause was therefore not entitled to restitution under the
UCL.
DISPOSITION
The judgment is reversed and the order striking plaintiff's
prayer for restitution is affirmed. Plaintiff is entitled to costs
on appeal.
CERTIFIED FOR PARTIAL PUBLICATION.
MALLANO, J.
I concur:
SPENCER, P. J.
VOGEL (Miriam A.), J., dissenting.
According to the majority opinion, lawsuits under Proposition
65 can be filed and prosecuted by any person against any business
based on bare allegations of a violation unsupported by any evidence
of an actual violation -- or even a good faith belief that a
defendant is using an unsafe amount of a chemical known by the state
to cause cancer or reproductive toxicity. Unconcerned about the
practical effect of their decision, and undeterred by a plaintiff's
admission that it has no evidence at all to suggest that the
defendant is using an unsafe level of any listed chemical, my
colleagues have endorsed and encouraged a form of judicial extortion.
Here is how it works (it certainly appears to be what was done in
this case). Pick a dentist or doctor, any dentist or doctor (but
preferably one with a deep pocket). Visit the dentist's or doctor's
office. If you don't see Proposition 65 warning signs on the walls
or counters, go to the nearest courthouse, file a complaint, allege a
failure to warn, and ask for $2,500 for each day the dentist or
doctor has failed to give the required warnings. Don't be concerned
when the dentist or doctor answers and alleges as an affirmative
defense that he is exempt from the warning requirements because he
uses only trace amounts of the chemical, and certainly not enough so
that anyone's exposure to the chemical is 1,000 times the level that
will result in an observable effect. Don't worry when the dentist or
doctor sends you some interrogatories and requests for admissions --
go ahead and admit that you have no evidence about the level of the
chemical he uses (and thus no reason to believe that he is in
violation of the law), and admit that you do not contend that
exposure at the level used by the dentist or doctor will result in
any observable effect.
The dentist or doctor won't be able to get out of the case by
a motion for summary judgment based on your admissions. Instead,
he'll have to commission an "assessment" to prove that his level of
use is safe, and he will have to pay for the kind of "assessment"
done by the State of California when it determines that a chemical
should be added to the Proposition 65 list. How many thousands of
dollars will that cost? I don't know, but I do know that, whatever
the cost, the end product will not guaranty a judgment for the
defense. What's a dentist or doctor to do? Settle with the
plaintiff, of course. Save the cost of the assessment. Save the
legal fees. Get rid of the case.
I'm not making this up. My colleagues did. And they can't
blame the electorate or the Legislature. Although the statute
presumes that warnings are required whenever a listed chemical is
used, and although the burden is on the defendant to prove that he is
entitled to rely on the exemption from the warning requirement when
only safe amounts of a listed chemical are used, the statutory scheme
has another requirement ignored by my colleagues -- that, to survive
summary judgment, the plaintiff must have at least a good faith
belief that the defendant is using an unsafe amount of a listed
chemical.
As the following discussion will show, the result reached by
the majority is just plain wrong.
A.
Consumer Cause's First Amended Complaint: Reduced to its
essence, the first amended complaint alleges that SmileCare, while
filling teeth and removing old fillings, has knowingly and
intentionally exposed its patients and employees to "amalgams contain
[ing] mercury and mercury compounds" known to the state to cause
reproductive (developmental) toxicity without "first giving clear and
reasonable warning" to SmileCare's patients and employees. (Health &
Saf. Code, § 25249.6; Cal. Code Regs., tit. 22, § 12000(b), (c).)
Implicit in this allegation is the assumption that SmileCare is
obligated by law to give "reasonable warning" to its patients and
employees.
SmileCare's Answer to the First Amended Complaint: SmileCare
generally denied Consumer Cause's allegations and alleged as an
affirmative defense that its "actions were permissible" under section
25249.10, subdivision (c).
B.
1. The Statutory Exemption
Subdivision (c) of section 25249.10 provides that warnings
are not required when "the person responsible can show that the
exposure poses no significant risk assuming lifetime exposure at the
level in question for substances known to the state to cause cancer,
and that the exposure will have no observable effect assuming
exposure at [1,000] times the level in question for substances known
to the state to cause reproductive toxicity . . . . In any action
brought to enforce [the warning requirement], the burden of showing
that an exposure meets the criteria of this subdivision shall be on
the defendant." (Italics added.) The parties agree that, as to
substances known by the state to cause reproductive toxicity,
warnings are required when the exposure is to an amount sufficient to
have an observable effect assuming exposure at 1,000 times the level
in question.
2. The Regulations Governing the Exemption
In the context of this case, the "level in question" means the
chemical concentration of mercury for the "exposure in question."
The "exposure in question" includes the exposure for which SmileCare
is responsible, and does not include exposure to mercury from any
other source or product. (Reg. § 12821(a).) The "level of exposure"
to mercury is determined by "multiplying the level in question
(stated in terms of a concentration of a chemical in a given medium)
times the reasonably anticipated rate of exposure for an individual
to a given medium. The reasonably anticipated rate of exposure shall
be based on the pattern and duration of exposure that is relevant to
the reproductive effect which provided the basis for the
determination that a chemical is known to the state to cause
reproductive toxicity. . . ." (Reg. § 12821(b).)
Unless more specific and scientifically appropriate data are
available, specified "assumptions" are used "to calculate the
reasonably anticipated rate of exposure" to mercury. (Reg. § 12821
(c).) By way of example, for an exposure reasonably expected to
affect "the conceptus (embryo or fetus), the gestation period for the
exposed conceptus is nine months." (Regs. §§ 12821(c)(1), 12721(d)(2)
(B).) By way of another example, "[w]here a maternal exposure to a
listed reproductive toxicant has an effect on the conceptus (embryo
or fetus), the level of exposure shall be based on the reasonably
anticipated rate of exposure for the mother during the nine-month
gestation period." (Reg. § 12821(c)(3).)
"The determination of whether a level of exposure to
[mercury] has no observable effect [for purposes of determining that
warnings are not required] shall be based on evidence and standards
of comparable scientific validity to the evidence and standards which
form the scientific basis for the listing of a chemical known to the
state to cause reproductive toxicity. Nothing in [the regulations
covering "observable effect levels"] shall preclude a person from
using evidence, standards, assessment methodologies, principles,
assumptions or levels not described in [these regulations] to
establish that a level of exposure has no observable effect at . . .
1,000[] times the level in question." (Reg. § 12801(a), italics
added.) Since mercury is not included in any of the regulations that
identify the levels at which chemicals have no observable effect, it
appears that a "quantitative risk assessment" is the anticipated
method to determine the level of exposure that has no observable
effect. (Regs. §§ 12801-12821.) The "quantitative risk assessment"
must be "based on evidence and standards of comparable scientific
validity to the evidence and standards which form the scientific
basis for listing the chemical as known to the state to cause
reproductive toxicity." (Reg. § 12803(a).) Four pages of squint-
print explain how and by whom a chemical gets on the list in the
first place. (Regs. §§ 12301-12306.)
This is the way the "observable effect level" is explained in
Appendix A to the Regulations: For reproductive toxicants, "a
warning is not required if the business can demonstrate that the
exposure will produce no observable effect, even at 1,000 times the
level in question. In other words, the level of exposure must be
below the 'no observable effect level (NOEL),' divided by a 1,000-
fold safety or uncertainty factor. The 'no observable effect level'
is the highest dose level which has not been associated with an
observable adverse reproductive or developmental effect." (Regs.
App. A.)
3. The Attorney General's Explanation of the Regulations
This is the way the Attorney General puts it in his amicus
brief: "The regulations . . . give substance to the . . . exemption
and provide guidance for determining whether a level of exposure to a
listed chemical has 'no observable effect' for purposes of the
exemption. This is a highly technical, scientific inquiry, and is
not the same as presenting anecdotal evidence that a product
is 'safe' under some other standard. Thus, in order for the
defendant to meet the exemption, it must first calculate the 'no
observable effect' level ('NOEL'). The regulations define the NOEL
as the 'maximum dose level at which a chemical has no observable
reproductive effect' . . . , and provide a methodology for
calculating the NOEL that is deemed sufficient to meet the regulatory
requirements: [Fn. omitted.]
"1. The defendant must perform a quantitative risk
assessment that meets the standards described in [the regulations] to
determine the maximum dose level having no observable effect assuming
exposure at [1,000] times the level in question.
"2. The quantitative risk assessment must be based on
studies producing the reproductive effect which provides the basis
for the listing. Where multiple studies exist, the NOEL must be
calculated from the studies which produce the lowest NOEL. The NOEL
is the highest dose level which results in no observable
effect, 'expressed in milligrams of chemical per kilogram of
bodyweight per day.' [Citation.]
"3. If the assessment is based on epidemiological data,
it must be evaluated for quality and suitability of data to determine
whether it is an appropriate basis for assessment. [Citation.]
"4. If the assessment is based on animal bioassay
studies, the studies must meet the generally accepted scientific
principles relating to experimental protocol, manner of exposure,
temporal exposure pattern, duration, etc. [Citation.]
"5. The NOEL must be based on the most sensitive study of
sufficient quality. [Citation.]
"6. The NOEL must be converted to a milligram (or
microgram) per day dose level by multiplying the assumed human body
weight by the NOEL. [Citation.]
"Once the defendant has established the NOEL consistent with
the regulations, the defendant must then complete the second portion
of the risk assessment and prove, through competent scientific
evidence, the individual's daily exposure to the listed substance
from the product at issue. Again, this is a highly technical,
scientific determination. [The Regulations state] that the level of
exposure 'shall be determined by multiplying the level in question
(stated in terms of a concentration of a chemical in a given medium)
times the reasonably anticipated rate of exposure for an individual
to a given medium.' [Citation.] Certain assumptions are to be used
in calculating the reasonably anticipated rate of exposure.
[Citation.] These include assumptions about the amount of air that
people breathe, the amount of water they drink, the normal gestation
period, etc. [Citation.] The regulatory assumptions must be used
unless 'more specific and scientifically appropriate data are
available.' [Citation.]
"At the conclusion of this quantitative risk assessment
process, the defendant will have calculated the NOEL and the exposure
in question, and can determine whether the exposure in question is
[1,000] times below the NOEL and therefore does not require a warning.
"While the regulations specifically state that they are not
exclusive, and nothing prohibits a person from using alternative
evidence, standards, assessment, methodologies, principles,
assumptions or levels to prove that a level of exposure is [1,000]
times below the NOEL [citation], the statute makes clear that the
question is not one of anecdotal 'safety,' but one of hard science,
requiring both the calculation of a NOEL and an exposure level. In
performing these calculations, the party advancing the evidence must
rely on 'evidence and standards of comparable scientific validity to
the evidence and standards which form the scientific basis for the
listing of such chemical. [Citation.] Thus, the ability to deviate
from the regulatory method for calculating the NOEL and the exposure
is limited." (Most italics added.)
C.
The Requests for Admissions: SmileCare propounded four
requests for admissions to Consumer Cause, two of which were answered
with admissions. As a result, Consumer Cause has admitted (1) that
Consumer Cause "has no evidence that [SmileCare] caused injury to any
individuals by exposing individuals to mercury," and (2) that
Consumer Cause "has no evidence concerning the level of mercury to
which [SmileCare] allegedly exposed individuals."
The Interrogatories: SmileCare propounded eight special
interrogatories to Consumer Cause. Some were answered, others were
not. As relevant, these are the questions and answers:
"Do you contend that exposure to mercury at [1,000] times the
level you believe [SmileCare has] exposed individuals to will result
in observable effects to the individuals?" Consumer Cause's answer
was "No."
When asked to "[i]dentify all facts[, documents, and
individuals with information] regarding the level of mercury to which
[Consumer Cause] claim[s that SmileCare has] exposed individuals,"
Consumer Cause responded with a statement that it had "made no
allegation regarding the level of mercury to which [SmileCare has]
exposed individuals. Therefore, [Consumer Cause] is not in
possession of such facts."
D.
SmileCare's Motion for Summary Judgment and Separate
Statement. SmileCare moved for summary judgment on the ground that
it is exempt from the warning requirements, as admitted by Consumer
Cause in its responses to SmileCare's requests for admissions and
interrogatories. More specifically, SmileCare relied on Consumer
Cause's answer to the interrogatory that asked, "Do you contend that
exposure to mercury at [1,000] times the level you believe [SmileCare
has] exposed individuals to will result in observable effects to the
individuals?" As noted above, Consumer Cause answered, "No." The
interrogatory and the answer are cited in SmileCare's separate
statement in support of the admitted fact and the logical conclusion -
- that Consumer Cause's failure to contend that SmileCare's use of
mercury results in observable effects means that SmileCare is not
required to give any Proposition 65 warnings. In its opposition to
SmileCare's motion, Consumer Cause simply ignored its discovery
responses. In its responding separate statement, Consumer Cause
admitted that it had no evidence to suggest that SmileCare's use of
mercury results in observable effects assuming exposure at 1,000
times the level it is used by SmileCare, and disputed the issue
solely on the ground that (in Consumer Cause's view) SmileCare had
not met its burden of proof.
The majority finds it significant that SmileCare concedes its
use of mercury and concedes that it has not presented scientific
proof that its use of mercury does not result in observable effects
assuming exposure at 1,000 times the level it is used. My colleagues
miss the point. SmileCare's position is that, assuming its use of a
listed chemical, it is exempt from the warning requirements because
Consumer Cause does not contend otherwise. Since Consumer Cause
admitted in response to SmileCare's interrogatory that it does not
contend "that exposure to mercury at [1,000] times the level
[Consumer Cause] believe[s SmileCare has] exposed individuals to will
result in observable effects to the individuals," SmileCare's
affirmative defense -- that it is entitled to rely on the "observable
effects" exemption -- is not disputed.
1.
I agree generally with the majority's statement of the burden
of proof rule in the context of this case. Simply put, when a
defendant moves for summary judgment based upon an affirmative
defense, the defendant has the initial burden of production -- that
is, to make a prima facie showing in support of its affirmative
defense, which can be done with declarations, admissions, answers to
interrogatories, other discovery responses, and matters about which
judicial notice can be taken. Once that is done, the burden shifts
to the plaintiff to present evidence sufficient to create a triable
issue of fact as to the affirmative defense relied on by the
defendant. (Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826,
849-855.)
I part company with my colleagues when it comes to the
application of these rules to this case. In my view, SmileCare met
its burden. It presented the declaration of Louis J. Amendola,
D.D.S., attesting to the fact that SmileCare uses standard dental
amalgams with "trace amounts of mercury," the most widely used
fillings in the United States for 150 years, fillings that are
approved and recommended as safe by the American Dental Association.
SmileCare also presented Consumer Cause's discovery responses in
which Consumer Cause admitted (1) that it had no evidence concerning
the level of mercury to which SmileCare exposed anyone and (2) that
it does not contend that exposure to mercury at 1,000 times the level
used by SmileCare will result in observable effects to the
individuals. In my view, these are admissions that SmileCare is
exempt under subdivision (c) of section 25249.10 -- because it is
undisputed that the exposure at issue will have no observable effect
assuming exposure at 1,000 times the level in question.
With that showing, I believe the burden shifted to Consumer
Cause to present some evidence showing at least a reasonable belief
that the level used by SmileCare does have an observable effect
assuming exposure at 1,000 times the level in question. I am not
suggesting that, contrary to section 25249.10, subdivision (c), the
burden is on a plaintiff to show that the levels of exposure are
sufficiently high to require warnings. (§ 25249.10, subd. (c) [in
any action brought to enforce the warning requirement, "the burden of
showing that an exposure [is exempt] shall be on the defendant"].)
But I am most definitely suggesting that, before putting every random
dentist and doctor in California to the extraordinary expense
involved in preparing the "assessment" required to prevail in this
kind of lawsuit, we ought to require something more than the
plaintiff's naked assertion of an absolute right to engage in this
kind of litigation.
2.
The statute and the regulations support this approach.
Regulation 12801(a) (which says the determination whether a level of
exposure to mercury has no observable effect shall be based on
evidence and standards of comparable scientific validity to the
evidence and standards which form the scientific basis for the
listing of a chemical known to the state to cause reproductive
toxicity) also provides that nothing in the regulations covering
observable effect levels precludes a person from using evidence or
assumptions other than those described in the regulations to
establish that a level of exposure has no observable effect at 1,000
times the level in question. Here, for purposes of summary judgment,
SmileCare has used Consumer Cause's admissions that it does not
contend that the level of exposure at 1,000 times the exposure in
question will result in observable effects, and that it has no
evidence concerning the levels at issue as evidence corroborating the
dentist's testimony that only trace amounts are used. The
assumption, for purposes of summary judgment, ought to be that
Consumer Cause has no reasonable belief that SmileCare has violated
the letter or the spirit of Proposition 65.
The "notice" requirements lend further support to my
interpretation of this statutory scheme. Section 25249.7,
subdivision (d)(1), permits any person acting in the public interest
to bring an action to enforce the warning requirements -- provided
that notice has first been given to the Attorney General and other
prosecutors with jurisdiction. Regulation section 12903 sets out the
specific content of the required notice, including (in this context)
the route of exposure by which exposure is alleged to occur (e.g., by
inhalation, ingestion, dermal contact), the name of the consumer
product or service, and the identity of the regulated chemical. But
the notice need not contain "the level of exposure to the chemical in
question or the "specific admissible evidence by which the person
providing the notice will attempt to prove the violation." (Reg. §
12903(b)(4)(B)-(C), emphasis added.) Quite plainly, the electorate
and the rulemakers assume that, at some point in these proceedings,
it is the plaintiff who must, at a minimum, attempt to prove the
violation. Given that fact, I believe that, based on the showing
made by SmileCare in support of its motion for summary judgment,
Consumer Cause's inability to say that it has so much as a good faith
belief that SmileCare is not exempt requires an affirmance of the
summary judgment granted by the trial court.
To conclude otherwise is to give Consumer Cause the right to
pick its defendants out of a hat and, without even a suspicion of
liability, require them to prove that they are not violating the law -
- that is, to shoot holes in the side of a barn, then draw circles
around them. Since that result will do nothing more than line
Consumer Cause's pockets with money extorted from dentists and others
who will then be forced to raise their fees, I cannot believe that
was the voters' intent when Proposition 65 was adopted.
I would affirm the summary judgment.
VOGEL (MIRIAM
A.), J.