United States District Court, S.D. California
ORDER: (1) GRANTING IN PART AND DENYING IN PART
DEFENDANTS' MOTION FOR SUMMARY JUDGMENT; AND (2) DENYING
PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT [ECF NOS. 138,
Cynthia Bashant United States District Judge.
three years of litigation, this case has reached the summary
judgment stage, and both parties seek summary judgment in
their favor. Defendants Siemens Medical Solutions USA, Inc.
and Siemens Healthcare Diagnostics Inc. move for summary
judgment on all claims, (“Def. Mot., ” ECF No.
138), and Plaintiff Quidel Corporation moves for summary
judgment on the element of falsity. (“Pl. Mot., ”
ECF No. 145.) Both motions are opposed, (“Pl.
Opp'n, ” ECF No. 169; “Def. Opp'n,
” ECF No. 166). The Court finds the Motions suitable for
determination on the papers and without oral argument. Civ.
L. R. 7.1(d)(1). For the reasons stated below, the Court
GRANTS IN PART Defendants' Motion and
DENIES Plaintiff's Motion.
case revolves around two competing assays (blood tests) used
for measuring thyroid stimulating immunoglobins, which can
aid in the detection of Graves' disease. Graves'
disease is an immune system disorder that leads to the
overproduction of thyroid hormones. Generally, there are two
types of assays available to aid in the diagnosis of
Graves' disease: (1) TSH receptor antibody (TRAb) assays
and (2) TSI only assays. TRAb assays detect both stimulating
and blocking thyroid immunoglobins (also known as
“TSI” and “TBI”), while TSI only
assays detect only stimulating immunoglobins.
entered the market first, and in 2008 submitted its product,
Thyretain TSI Reporter BioAssay (“Thyretain”),
for FDA approval. (See Exhibit 4 to Declaration of
Erik Haas, ECF No. 140-1.) The FDA cleared Thyretain in 2009.
Plaintiff advertises Thyretain as a “TSI only”
assay. (Exhibit 1 to Declaration of Erik Haas, ECF No. 140,
at 210:6-10.) According to Plaintiff, “Thyretain is a
cell-based assay that measures the functional activity of TSH
receptor antibodies and returns a positive result when TSI
bind to the stimulating epitope of the TSH receptor.”
(Pl. Opp'n at 2 (emphasis omitted).) If TSI is detected,
this is a positive result, and a light is emitted. This is
known as a qualitative result.
entered the market in 2012 with their product IMMULITE, using
Thyretain as the predicate device for their 510(k)
application to the FDA. (Exhibit 5 to Declaration of T. Kevin
Roosevelt, ECF No. 171, at 4.) In applying to the FDA,
Defendants acknowledged that Plaintiff's product was
“the only FDA-cleared TSI assay on the market at this
time” while other approved TRAb assays “detect
both stimulating and blocking thyroid antibodies” and
had inferior “specificity for Graves'
disease.” (Id.) While Thyretain is a bioassay,
IMMULITE is an immunoassay. (Def. Mot. 4; Pl. Mot. 4.)
According to Defendants, IMMULITE “uses a novel
‘bridge' technology which links the receptors that
bind with TSI to signal receptors. Those signal receptors in
turn emit light that may be measured in a
‘semi-quantitative' manner, depicting the
concentration of TSI in a sample, rather than just a binary
‘qualitative' result.” (Def. Mot. at 4.)
crux of this matter lies in Defendants' advertising of
IMMULITE. In Plaintiff's opinion, IMMULITE, as an
immunoassay, “measures the binding of antibodies to the
TSH receptor without discrimination, ” meaning it does
not distinguish between stimulating or blocking antibodies.
(Pl. Opp'n at 3.) Plaintiff argues IMMULITE “has
the potential to and actually does detect blocking
antibodies.” (Id. at 3.) However, Defendants
advertised IMMULITE as a “TSI only” assay (i.e.
one that does distinguish between stimulating and blocking
proclaiming of IMMULITE to be an assay that detects TSI only
is undisputed. In its de novo request to the FDA, Defendants
classified IMMULITE as an assay that “measures
stimulating immunoglobins only.” (Exhibit U to
Declaration of T. Kevin Roosevelt, ECF No. 147; see
also Exhibit 29 to Declaration of T. Kevin Roosevelt,
ECF No. 169-1 (Defendants' 510(k) Premarket Notification:
“TRAb assays measure both [TBI and TSI] quantitatively
without distinguishing between the two, whereas the IMMULITE
2000 TSI measures stimulating immunoglobins only.”)).
After the FDA cleared the product, Defendants sent out
information to potential customers on the product, saying
IMMULITE “utilizes recombinant human TSH receptors
(hTSHR) for the specific detection of thyroid stimulating
autoantibodies.” (Exhibit 23 to Declaration of T. Kevin
Roosevelt, ECF No. 171.) Defendants distinguished IMMULITE
from “TSHR autoantibody (TRAb) assays [which] do not
distinguish between TSI and TBI.” (Id.).
Similar statements appeared on Defendants' website.
(See, e.g., Exhibit T to Declaration of T. Kevin
Roosevelt, ECF No. 147-3, at 51:3-10 (testimony regarding
Defendants' website in May 2016).)
advertised IMMULITE as “TSI only” for a few
months. (Def. Mot. at 7-8.) When Plaintiff protested this
advertising, Defendants dropped the “TSI only”
claim. (Id.) Plaintiff argues that advertising
IMMULITE in this way was false and has caused Plaintiff
damages. Specifically, before IMMULITE entered the market,
Quidel had four U.S. customers, which were four laboratories,
two of which were LabCorp and Sonic. LabCorp and Sonic since
have switched to using IMMULITE. (Id. at 12.)
Whether these two customers (and others) considered or were
deceived by Defendants' advertising in making the
decision to switch is an issue in this case.
judgment is appropriate under Rule 56(c) where the moving
party demonstrates the absence of a genuine issue of material
fact and entitlement to judgment as a matter of law.
See Fed. R. Civ. P. 56(c); Celotex Corp. v.
Catrett, 477 U.S. 317, 322 (1986). A fact is material
when, under the governing substantive law, it could affect
the outcome of the case. Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248 (1986). A dispute about a
material fact is genuine if “the evidence is such that
a reasonable jury could return a verdict for the nonmoving
seeking summary judgment always bears the initial burden of
establishing the absence of a genuine issue of material fact.
Celotex, 477 U.S. at 323. The moving party can
satisfy this burden in two ways: (1) by presenting evidence
that negates an essential element of the nonmoving
party's case; or (2) by demonstrating that the nonmoving
party failed to make a showing sufficient to establish an
element essential to that party's case on which that
party will bear the burden of proof at trial. Id. at
322-23. “Disputes over irrelevant or unnecessary facts
will not preclude a grant of summary judgment.”
T.W. Elec. Serv., Inc. v. Pac. Elec. Contractors
Ass'n, 809 F.2d 626, 630 (9th Cir. 1987).
moving party fails to discharge this initial burden, summary
judgment must be denied, and the court need not consider the
nonmoving party's evidence. Adickes v. S.H. Kress
& Co., 398 U.S. 144, 159-60 (1970). If the moving
party meets this initial burden, however, the nonmoving party
cannot defeat summary judgment merely by demonstrating
“that there is some metaphysical doubt as to the
material facts.” Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 586 (1986); Triton
Energy Corp. v. Square D Co., 68 F.3d 1216, 1221 (9th
Cir. 1995) (“The mere existence of a scintilla of
evidence in support of the non-moving party's position is
not sufficient.” (citing Anderson, 477 U.S. at
242, 252)). Rather, the nonmoving party must “go beyond
the pleadings” and by “the depositions, answers
to interrogatories, and admissions on file, ” designate
“specific facts showing that there is a genuine issue
for trial.” Celotex, 477 U.S. at 324 (quoting
Fed.R.Civ.P. 56(e)). Such admissions may be presented in
testimony of a party's own witnesses through
declarations. See Fed. R. Civ. Pro. 56(c)(4).
making this determination, the court must view all inferences
drawn from the underlying facts in the light most favorable
to the nonmoving party. See Matsushita, 475 U.S. at
587. “Credibility determinations, the weighing of the
evidence, and the drawing of legitimate inferences from the
facts are jury functions, not those of a judge, [when] he [or
she] is ruling on a motion for summary judgment.”
Anderson, 477 U.S. at 255.
MOTION FOR SUMMARY JUDGMENT
move for summary judgment on Plaintiff's Lanham Act false
advertising claims (section 43(a)), unfair competition claims
(Cal. Bus. & Prof. Code § 17200), and False
Advertising Law claims (Cal. Bus. & Prof. Code §
17500). Defendants argue they should be granted
judgment on various grounds: (1) Defendants' advertising
is not false or deceptive; (2) the message in the advertising
is immaterial and did not cause injury to Plaintiff; and (3)
Plaintiff's unclean hands bar its claims.
(1) that the IMMULITE Assay detects TSI only, (2) that the
IMMULITE Assay is a “TSI assay” that detects TSI
only, and (3) that TRAb assays are distinguishable from the
IMMULITE Assay, while failing to disclose that the IMMULITE
Assay is substantially similar to TRAb assays that fail to
differentiate between stimulating and blocking antibodies.
(First Amended Complaint, ECF No. 12, ¶ 24.) These can
be summed up to one overarching statement: IMMULITE detects
same legal standard applies to all three of Plaintiff's
causes of action. The elements of a Lanham Act § 43(a)
false advertising claim are:
(1) a false statement of fact by the defendant in a
commercial advertisement about its own or another's
product; (2) the statement actually deceived or has the
tendency to deceive a substantial segment of its audience;
(3) the deception is material, in that it is likely to
influence the purchasing decision; (4) the defendant caused
its false statement to enter interstate commerce; and (5) the
plaintiff has been or is likely to be injured as a result of
the false statement, either by direct diversion of sales from
itself to defendant or by a lessening of the goodwill
associated with its products Southland Sod Farms v.
Stover Seed Co., 108 F.3d 1134, 1139 (9th Cir. 1997).
Claims pursuant to California Business and Professions Code
section 17200 and section 17500 are “substantially
congruent” to claims made under the Lanham Act.
Cleary v. News Corp., 30 F.3d 1255, 1262-63 (9th
Cir. 1994) (citing Academy of Motion Picture Arts &
Scis. v. Creative House Promotions, Inc., 944 F.2d 1446,
1457 (9th Cir. 1991)); JHP Pharm., Ltd. Liab. Co. v.
Hospira, Inc., 52 F.Supp.3d 992, 997 n.4 (C.D. Cal.
the first element, statements can be “literally false,
either on [their] . . . face or by necessary implication,
” or “literally true but likely to mislead or
confuse consumers.” Southland Sod Farms, 108
F.3d at 1139. When evaluating whether a claim is ...