Judge: Teresa A. Beaudet, Case: BC665798, Date: 2022-10-03 Tentative Ruling
Case Number: BC665798 Hearing Date: October 3, 2022 Dept: 50
consumer advocacy group, inc., et al., Plaintiff, vs. gel spice company, inc., et al. Defendants. |
Case No.: |
BC665798 [c/w 19STCV24048] |
Hearing Date: |
October 3, 2022 |
|
Hearing Time: |
2:00 p.m. |
|
[TENTATIVE] ORDER
RE: PHASE
TWO COMBINED
MOTION FOR SUMMARY JUDGMENT OR, IN THE ALTERNATIVE SUMMARY ADJUDICATION BY
DEFENDANTS GEL SPICE CO., INC, BIG LOT STORES, INC., GROCERY OUTLET, INC. AND
TARGET CORPORATION ON STATUTORY AFFIRMATIVE DEFENSES ON THE MERITS (HSC 25249.10(c)) |
Background
Plaintiff Consumer Advocacy Group, Inc.
(“Plaintiff”) filed this Proposition 65 (“Prop 65”) action on June 20, 2017.
The operative Second Amended Complaint (“SAC”) was filed on January 19, 2021
against, inter alia, Gel Spice Company, Inc. (“Gel Spice”), Big Lots
Stores, Inc., Grocery Outlet, Inc., and Target Corporation (collectively, “Defendants”).
The SAC alleges ten causes of action for violations of Prop 65.
In the SAC, Plaintiff alleges that Defendants
exposed California consumers and users of ground cinnamon, ground cumin, ground
sage, ground cloves, poultry seasoning, garlic powder, and ground turmeric, which
Defendants manufactured, distributed, or sold, to lead, without first providing
any type of clear and reasonable warning of such to the exposed persons before
the time of exposure. (SAC, ¶¶ 49, 61, 72, 83, 93, 104, 115, 126, 137, 247.)
Plaintiff alleges that Defendants thereby violated Prop 65. (
On October 23, 2019, the Court issued an Order
consolidating this action with Consumer Advocacy Group, Inc. v. Viva Bargain
Center, Inc., et al. (Case No. 19STCV24048), in which one cause of
action is alleged for violations of Prop 65. In Consumer Advocacy Group, Inc. v. Viva Bargain Center, Inc., et al., Plaintiff alleges that the defendants (including Gel Spice) exposed California
consumers and users of ground sage, which defendants manufactured, distributed,
or sold, to lead and arsenic, without first providing any type of clear and
reasonable warning of such to the exposed persons before the time of exposure.
(Defendants’ RJN, Ex. D, Compl., ¶ 32.)
Defendants now move for an order granting summary judgment, or in the alternative, summary adjudication on each cause
of action, on the grounds that there is no triable issue of material fact with
respect to Plaintiff’s allegation that Defendants exposed California consumers
to lead and arsenic without warnings required under Prop 65. Plaintiff opposes.
Requests
for Judicial Notice
The
Court grants Defendants’ request for judicial notice in support of the motion
as to Exhibits A, B, C, D, G, H, I, J, K, L, M, N, O, and P. The Court denies
the request as to Exhibits E and F.
The Court grants
Plaintiff’s request for judicial notice in support of the opposition as to
Exhibits A, B, E, and F. The Court denies the request as to Exhibits C and D.
The
Court denies Defendants’ request for judicial notice filed in support of the
reply. The Court notes that “
Evidentiary
Objections
The Court rules on
the parties’ “Joint Statement Regarding Parties’ Respective Objections to
Evidence Related to Motions for Summary Judgment Re: ‘Merits’ Affirmative
Defenses” as follows:[1]
Plaintiff’s
Objections:
Objection No. 1 to Dr. Bloom’s Testimony: overruled
Objections to the Declaration of Dr. Barbara
Beck: overruled
Objection No. 1 to the Declaration of Barbara J.
Petersen: overruled
Objection
No. 2 to the Declaration of Barbara J. Petersen: overruled
Objection
No. 3 to the Declaration of Barbara J. Petersen: overruled
Objection
No. 4 to the Declaration of Barbara J. Petersen: overruled
Objection
No. 5 to the Declaration of Barbara J. Petersen: overruled
Objection
No. 6 to the Declaration of Barbara J. Petersen: overruled
Objection
No. 7 to the Declaration of Barbara J. Petersen: overruled
Objection
No. 1 to the Declaration of Carla Kagel: overruled
Objection
No. 1 to the Declaration of Dr. Chris Mackay: sustained as to ¶ 6, p.2, l. 28 -
p. 3, l. 1; otherwise overruled
Objection
No. 2 to the Declaration of Dr. Chis Mackay: sustained as to ¶ 8, ll. 1
starting with “Results” through l. 14 ending with “results;” otherwise overruled
Defendants’ Objections:
Objection No. 1 to
the Declaration of Paul Damian: overruled
Objection No. 2 to
the Declaration of Paul Damian: overruled
Objection No. 3 to
the Declaration of Paul Damian: overruled
Objection No. 4 to
the Declaration of Paul Damian: overruled
Objection No. 5 to
the Declaration of Paul Damian: overruled
Objection No. 6 to
the Declaration of Paul Damian: overruled
Objection No. 7 to the Declaration of Gagik
Melikyan: sustained as to paragraph 28, overruled as to the remainder.
Objection No. 8 to the Declaration of Gagik
Melikyan: overruled
Objection No. 9 to the Declaration of Gagik
Melikyan: sustained as to “USDA-affiliated website” and “the website appears to
be affiliated with the authoritative federal agency, i.e., USDA,” overruled as
to the remainder
Objection No. 10 to the Declaration of Stacia
DeSantis: overruled
Objection No. 11 to the Declaration of Stacia
DeSantis: overruled
Objection No. 12 to the Declaration of Walter
Meneses: overruled
Legal
Standard
“
The moving party bears the initial burden of production to
make a
prima facie showing that there are
no triable issues of material fact. (
When a defendant seeks summary judgment or summary
adjudication, he/she must show either (1) that one or more elements of the
cause of action cannot be established; or (2) that there is a complete defense
to that cause of action. (
Discussion
Defendants contend that warnings are not required for the
spice products at issue in this case because any exposures are below the Prop
65 “safe harbor” exemption.
“
“Lead has been
identified as a known carcinogen and reproductive toxin under Proposition 65.” (
“
Defendants assert that the spice products at issue in this
case (the “Spice Products”)[2] do
not exceed the “safe harbor” exemption to Prop 65’s warning requirement for
lead or arsenic, as the exposure to lead for any of the Spice Products is below
0.5 micrograms/day, and the exposure to inorganic
arsenic is below 0.1 micrograms/day.[3] Defendants
indicate that for lead, the
0.5 micrograms/day MADL for reproductive toxicity is lower than the 15
micrograms/day No
Significant Risk Level
(“NSRL”) for cancer. (Cal. Code Regs., tit. 27, §§
“Under
A.
Application
of the “Safe Harbor” Exemption for Lead
As to the level in question, Defendants’ expert Dr. Barbara J. Petersen
indicates that in calculating the level of lead or inorganic arsenic (or total
arsenic) in the Spice Products, she calculated the geometric mean and the
arithmetic mean of the combined Defendant and Plaintiff data sets. (Petersen
Decl., ¶ 24, Ex. B). Dr. Petersen prepared a spreadsheet identifying the
average lead and arsenic content levels in parts per million for the relevant
products, identified as both the arithmetic mean and geometric mean. (Petersen
Decl., ¶¶ 24, 42, Ex. B). As to the “
Dr. Petersen prepared a spreadsheet concerning the “estimated mean daily exposure to stated
chemical from consumption of Products (µg/day).” (Petersen Decl., ¶ 43, Ex. E). Dr.
Petersen determined that the average user’s calculated daily intake of lead
from the consumption of each of the Spice Products range from 0.002 micrograms
to 0.019 micrograms when calculated using the geometric mean and from 0.01 to
0.40 micrograms when calculated using the arithmetic mean, depending on the
product in question. (Defendants’ Undisputed Material Fact (“UMF”) No. 28;
Petersen Decl., ¶ 43, Ex. E.) Dr. Petersen determined that the “level of
exposure” of lead for each of the Spice Products is below the 0.5 microgram/day
warning threshold. (UMF No. 29). Defendants
assert that accordingly,
no Prop 65 warning is required. Based on the foregoing, the Court finds that
Defendants have met their burden as to their “safe harbor” defense with regard to the alleged lead
exposure.
In the opposition, Plaintiff submits the declaration of its expert, Dr.
Paul Damian,
who
asserts that the appropriate averaging time for lead exposure is one day, not a
30-day or
other
long-term average. (Damian Decl., p. 6:17-18; Damian Decl., ¶ 27.) Dr. Damian indicates
that “long-term averages are irrelevant and inappropriate when one is
attempting to evaluate for, and protect against, the potential for short term
(i.e. acute) developmental effects on the fetus, where very short (acute)
exposures occurring over a day or a few days may be sufficient to produce
adverse effects. Such averaging would mask potentially adverse spikes in lead
exposure occurring on a given day or just a few days...adverse effects of lead
on the neurologic development of the child can occur over much shorter exposure
time frames than 30 days.” (Damian Decl., ¶ 14.) Dr. Damian cites to a
California Attorney General letter dated March 3, 2008, providing that “[f]or a
reproductive toxicant such as lead, the usage on a given day is considered the
appropriate measure of exposure, not the long-term daily average.” (Damian
Decl., ¶ 17.)[4]
Dr. Damian indicates that his “Table 1” shows the calculated
daily intakes of lead associated with each of the Spice Products at issue,
conservatively assuming a single serving of each spice is consumed on a given
day of use and using Plaintiff’s lead concentrations. (Damian Decl., ¶ 28,
Table 1.)[5] Table
1 shows that, for all the spices except one of the sage products (Spice
Supreme), the lead MADL of 0.5 micrograms/day is exceeded based on a single
serving of spice on a given day of use. (Damian Decl., ¶ 28, Table 1.) Dr.
Damian indicates that this analysis conservatively assumes only a single
serving of spice in a meal on a given day, and if only two servings were
consumed on a single day, the “Spice Supreme” sage product would also exceed
the lead MADL based on even the lowest lead concentration. (Ibid.)
Defendants contend that Plaintiff’s “
“
But as Plaintiff notes, the Beech-Nut Court concluded that “
Defendants also cite to multiple new declarations in support
of their reply. For instance, Defendants cite to the reply declarations of
Barbara J. Petersen and Leila M. Barraj to support the assertion that Dr. Damian’s
first assessment is insufficient. (See Reply at p. 10:4-20.) As set
forth above, “
In addition to Dr. Damian’s
assessment discussed above, Plaintiff also asserts that Defendants’ analysis
ignores actual users of the Spice Products. Plaintiff notes that pursuant to
of exposure to a chemical listed as causing
reproductive toxicity, unless more specific and scientifically appropriate data
are available.”
Plaintiff indicates that based on a survey of South Asian and Middle
Eastern consumers in Los Angeles County, 95.6% of these individuals consumed
turmeric and 91% consumed it 4 or more times per
week. (Meneses Decl. ¶ 4, Ex. B.) Defendants note that this point only addresses turmeric, not the
other spices at issue in this case.[7] In
any event, Plaintiff’s subpopulations argument is only one of several arguments
raised by Plaintiff in support of its assertion that there are multiple triable
issues of material fact.
Based on the foregoing, the Court finds that Plaintiff has presented
sufficient evidence to raise a triable issue of material fact as to whether levels of lead in
the subject Spice Products fall within Prop 65’s regulatory “safe harbor.”
B.
Application
of the “Safe Harbor” Exemption for Arsenic
Defendants indicate that for arsenic exposure from sage, Dr. Petersen used the same
methodology used for lead. (Petersen Decl., ¶¶ 40-42). Dr. Petersen determined
that the average user’s calculated daily intake of inorganic arsenic from the
consumption of the ground sage product is 0.002 micrograms when calculated
using the geometric mean and 0.02 micrograms when calculated using the
arithmetic mean. (Petersen Decl., ¶ 43, Ex. E.) Dr. Petersen indicates that
while she relied upon the combined Defendant and Plaintiff data for her
conclusions, Plaintiff’s data alone also demonstrate an exposure well below the
regulatory safe harbor levels for inorganic arsenic in ground sage. (Petersen
Decl., ¶ 43.) Based on the foregoing, the Court finds that Defendants have met their
burden as to their “safe
harbor” defense with regard to the alleged arsenic exposure.
In the opposition, Plaintiff’s expert, Dr. Damian, indicates that the appropriate averaging time for
inorganic arsenic exposure is one day, not a 30-day or other
long-term average. (Damian Decl., p. 20:16-17.) Dr. Damian indicates that “[i]norganic
arsenic has been extensively studied as a teratogen in animals. Data from
animal studies demonstrate that arsenic can produce developmental toxicity,
including malformation, death, and growth retardation, in four species
(hamsters, mice, rats, rabbits). A characteristic pattern of malformations is
produced, and the developmental toxicity effects are dependent on dose, route,
and the day of gestation when exposure occurs.” (Damian Decl., ¶ 41.) He
thus asserts that because inorganic arsenic is a teratogen, a multi-day
averaging time is not appropriate and the exposure occurring on a given day of
use of the product is the correct basis for evaluating compliance. (Damian
Decl., ¶ 44.) Dr. Damian’s Table 1 shows the inorganic arsenic intake
based on a single serving of the subject sage product (the only product at
issue with regards to inorganic arsenic). (Damian Decl., ¶ 44, Table 1.) Dr.
Damian’s calculations resulted in an inorganic arsenic intake of 0.26
micrograms/day. (Damian Decl., ¶ 45, Table 1.)[8]
Based on the foregoing, the Court finds that Plaintiff has presented
sufficient evidence to raise a triable issue of material fact as to whether levels of inorganic
arsenic in the subject sage product fall within Prop 65’s regulatory “safe
harbor.”
C.
Toxicology
and Physiologically-Based
Pharmacokinetic Modeling
Defendants also assert that the Spice Products do not require a lead warning, as
demonstrated by “physiologically-based pharmacokinetic” (“PBPK”) modeling.
Defendants’ expert, Dr. Barbara
Beck, indicates that lead modeling has been used for many years to quantify the
impact of lead intake on blood lead, bone lead, and other tissues in the body to
assess risks from lead exposure, and to set permissible levels for lead in
environmental media, including food, water, air, and soil. (Beck Decl., ¶ 39.)
Dr. Beck
indicates that “modeling
was performed for a 25 year old male with a baseline lead intake of 0 [micrograms]/day
to compare the impact on blood lead and bone lead of the actual consumption
amounts and frequencies for the seven products at issue compared to daily
consumption at the [sic] of 0.5 [micrograms] MADL. In every instance, the
impact on blood lead and bone lead from the actual consumption patterns and
amounts of the products is less than the impact from daily consumption of the
0.5 [micrograms] MADL. Because blood lead model results are generally similar
for females as for males, and potential reproductive effects are associated
with higher blood lead levels in females than in males, my
conclusion is also applicable to females.” (Beck Decl., ¶ 53.) Dr. Beck indicates that “[c]onsidering
that even a one-time exposure event could result in some lead storage in bone
for long durations, with slow release of lead into the blood over time via
resorption, it would be appropriate to evaluate lead exposure (in terms of
resulting blood lead level) over a longer period of time such as 30 days or
more.” (Beck Decl., ¶ 28.)
Dr. Beck also indicates that she “conducted two separate
analyses based on 1) the arithmetic average mass of inorganic arsenic per
serving and arithmetic average frequency of consumption (based on the NPD
Group/Historical National Eating Trends® Survey data), and 2) the geometric
average mass of inorganic arsenic per serving and geometric average frequency
of consumption.” (Beck Decl., ¶ 72.) She indicates that for each analysis, the
average daily intake of inorganic arsenic fell below 0.1 [micrograms]/day.
(Beck Decl., ¶ 73, Ex. 8.)
In
the opposition, Plaintiff asserts that Defendants’
blood level modeling is inappropriate to rely upon when evaluating the alleged Prop
65 violations in this matter. Plaintiff’s expert, Gagik Melikyan, indicates
that Dr. Beck’s declaration is heavily based on lead blood level modeling in
human bodies called All-Ages Lead Model, or AALM. (Melikyan Decl., ¶ 47.) Dr. Melikyan asserts that modeling has never been a substitute for reliable
experimental studies, and results derived from modeling of any type are only
predictions, and not scientific facts. (Melikyan
Decl., ¶ 47.) Dr. Melikyan also asserts that in the modeling studies, Dr. Beck is using
the concept of “exposure frequency” or “intake frequency” that is analogous to the
concept of Eating Occasion (“EO”); and that the “EO” concept for assessment
purposes is scientifically inaccurate and ignores the published data on
metabolism of lead in human bodies. (Melikyan
Decl., ¶ 52.) Defendants cite to new evidence in support of the reply to
challenge Dr. Melikyan’s declaration. As set forth above, the general rule of motion practice is that new evidence is not
permitted with reply papers. (
In
addition, Plaintiff’s expert, Dr. Damian, asserts that blood lead modeling is
not relevant for evaluating Prop 65 compliance. (Damian Decl., p. 3:8.) He
asserts that the “measure of compliance with PROP65 is not based on the
resulting blood level of the chemical but on the intake of the chemical. In the
case of a chemical that is ingested, intake is simply the amount consumed, NOT
the amount that actually enters the blood.” (Damian Decl., ¶ 3.)
In light
of the foregoing, the Court finds that Plaintiff has presented sufficient
evidence to raise a triable issue of material fact as to whether levels of lead and arsenic in the
subject Spice Products fall within Prop 65’s regulatory “safe harbor.”
Conclusion
For the foregoing reasons, Defendants’ motion for summary
judgment or in the alternative, summary adjudication, is denied.
Defendants are ordered to provide notice of this ruling.
DATED: October 3, 2022 ________________________________
Hon. Teresa
A. Beaudet
Judge, Los
Angeles Superior Court
[1]The Court notes
that Plaintiff includes in the joint statement a number of “remaining
objections” as to the “legal” motion for summary judgment. The Court’s February
1, 2022 Order regarding the instant phase two motion on statutory affirmative
defenses on the merits provides, inter alia, “[i]if any material
objections remain unresolved, the parties are to set them forth in a joint
statement…” The February 1, 2022 Order only concerned the instant “merits”
motion. Thus, the Court disregards Plaintiff’s evidentiary objections
pertaining to the “legal” motion for summary judgment.
[2]As discussed
above, Plaintiff alleges that Defendants violated
Prop 65 with respect to the following spices:
ground cinnamon, ground cumin, ground sage, ground cloves, poultry seasoning,
garlic powder, and ground turmeric.
[3]Defendants indicate
that OEHHA developed, but never adopted, a Maximum Allowable
Dose Level (“MADL”) of 0.1 micrograms/day for inorganic arsenic. (Beck Decl., ¶ 57.) Plaintiff asserts that “OEHHA has not calculated an MADL, but Dr. Damian [Plaintiff’s expert]
has calculated an MADL of 0.01 [micrograms]/day for reproductive
toxicity…Defendants calculate an MADL for arsenic of 0.1 [micrograms]/day.”
(Opp’n at p. 11:20-22.)
[4] In addition, Plaintiff’s expert Stacia DeSantis
asserts that peer-reviewed research demonstrates that food “diaries” like NPD
NET (used by Defendants’ expert) do no correlate well with spice intake, and
specifically, that food diaries significantly underestimate spice intake.
(DeSantis Decl., ¶ 13.)
[5]Dr. Damian
indicates that a single serving of ¼ teaspoon was assumed for
the serving size, and that this is the amount of spice considered to represent
a typical serving size (amount consumed per eating occasion) by the Food and
Drug Administration. (Damian Decl., ¶ 28.)
[6]In addition, in Beech-Nut, the parties
“agreed that the ‘window of susceptibility for exposure to lead’ shall mean the
period of time during which exposure may cause a reproductive, including
developmental, effect,” and the plaintiff’s expert “admitted he had not seen
epidemiological literature that identified a window of susceptibility as
an interval shorter than either eight weeks or a single trimester.” (Environmental Law Foundation v. Beech-Nut Nutrition Corp.,
supra, 235 Cal.App.4th at p. 319.)
[7]In addition, Defendants assert in the reply that Plaintiff’s ethnic
subpopulation theory is inconsistent with Prop 65 regulations. As set forth in
the Court’s June 16, 2022 Order, Defendants previously moved for an order finding that (1) 27 Cal. Code Regs.
§ 25821(c)(2) governs the food exposure at issue; (2) 27 Cal Code Regs. §
25721(d)(2) does not apply to food exposure; and (3)
27 Cal. Code Regs. § 25721(d)(2)’s use of the
phrase “certain subpopulations in a geographic area” does not support using
ethnic subpopulations for exposure assessments either under sections 25721(d)(2) and 25821(c)(2), or any other
Prop 65 regulation. For the reasons set forth in the June 16, 2022 Order,
Defendants’ motion was denied.
[8]Dr. Damian indicates
that “[a]lthough OEHHA has not promulgated an MADL
for inorganic arsenic, I
have developed an MADL of 0.01 [micrograms]/day
using the same procedures required in the PROP65 regulations.” (Damian Decl., ¶
45.) In an event, the amount of 0.26 micrograms/day exceeds the 0.1
micrograms/day “safe harbor” level for inorganic arsenic used by Defendants in
the motion.