putative falsity about medical test not material to labs, but maybe to doctors

Quidel Corp. v. Siemens Medical Solutions USA, Inc., No.
16-cv-3059-BAS-AGS, 2019 WL 5320390 (S.D. Cal. Oct. 21, 2019)
A pair of opinions shows the importance of (1) defining the
market and (2) being able to show materiality.
The parties compete in the market for assays (blood tests)
used for measuring thyroid stimulating immunoglobins, which can aid in the
detection of Graves’ disease. There are two relevant types of assays: (1) TSH
receptor antibody (TRAb) assays, which detect both stimulating and blocking
thyroid immunoglobins (TSI and TBI) and (2) TSI only assays.  Quidel entered the market first with Thyretain,
advertised as a “TSI only” assay that produces a positive (qualitative) result
if TSI is detected. Siemens entered with Immulite, using Thyretain as the
predicate device for their 510(k) application to the FDA.
While Thyretain is a bioassay, Immulite is an immunoassay
that Siemens says may be measured “in a ‘semi-quantitative’ manner, depicting
the concentration of TSI in a sample, rather than just a binary ‘qualitative’
result.”
Quidel argued that, as an immunoassay, Immulite didn’t
distinguish between stimulating or blocking antibodies, and thus detects TBI as
well as TSI. After Quidel’s protest, Siemens dropped the “TSI only” claim, but
Quidel argued it suffered damages: out of four US laboratories, two switched to
Immulite.
The court found that “TSI only” was not ambiguous,
especially in context and given the advertising targeted to sophisticated
consumers. Siemens argued that it wasn’t false because its statements were
always made in conjunction with a claim of 98% specificity (where the remaining
2% apparently might come from detecting TBI). Given conflicting expert
testimony over whether Immulite actually detected TSI only, there was a
question of fact.
However, there was no question of fact on materiality to
laboratories. The evidence showed that the two labs that switched didn’t rely
on Siemens’s advertising.  A
representative for one lab testified that the decision about whether or not to
adopt the new assay “involved months of discussion and deliberation,” including
“a review of the relevant literature” and “a validation study” after FDA
approval. Ultimately, the lab concluded that Immulite “was a superior assay for
use in the laboratory.” The witness testified that he didn’t remember any press
releases or statements on Siemens’s website; his lab “is not guided by
manufactures’ sales and marketing collaterals on a website.”  The other lab rep testified similarly. He
testified that he understands that when vendors give him papers regarding the
product, “they’re likely to provide [him] only papers that are positive for
their test.” He found this lawsuit to be “frivolous” and “personally offensive”
because it assumes that his lab doesn’t “do a very, very rigorous job of
vetting our assays and that we can be swayed by marketing.” Based on this
testimony, the court found that it wasn’t enough to show that the labs reviewed
the allegedly false statements; that didn’t show that the statements “had any
material impact on their decision-making process.”
The fact that the labs now believed that Immulite detects
TSI only (and advertised same on their own websites) didn’t mean that the false
advertising drove that belief, which could have come from internal testing. Nor
did the fact that TSI-only capability was an inherent/core chracteristic of the
product make it material given the other evidence. “No matter what the false
advertising pertains to, if the customer is not likely to be influenced by the
statement, it is not material.”
Matters were different with respect to doctors. A jury could
find that doctors were relevant purchasers; there was evidence on both sides.
Siemens’s employee testified that it previously contracted a marketing agency
to conduct a marketing campaign aimed at clinicians because “it’s really
important to educate the physicians…[b]ecause if they don’t order the test,
then there’s…no point of having it in the laboratory.” A lab director also
testified that the clinicians are “substantially” in charge of deciding which
type of assay to run. testified the clinicians “have the capability of and ask
for [the assay] by name…and in some circumstances they will specify.” And a
Siemens representative received an email from a doctor who asked if IMMULITE
“is specific to TSI or if it potentially can detect TBI’s directed towards the
N-terminal part of the thyroid receptor.” “This shows the physicians are aware
of the details of the test, and therefore may be interested in how the product
is marketed.”  However, a different
Quidel expert stated that at her institution, “when a TSI is ordered [by a
clinician], there is no indication on the report of which assay (Roche,
Thyretain, Immulite, etc.) was utilized” and the physician only receives the
results from the test, i.e. the measurement of TSI.
The court also partially rejected Siemens’s unclean hands
defense.  That Quidel was allegedly
billing the tests wrongly was unrelated to the misconduct here now that the
labs were out of the case. However, that Quidel’s Thyretain also allegedly
detected TBI and that the presence of TBI could “interfere with Thyretain’s
measurement of TSI, and result in a false ‘negative’ reading” was related, and
there was a genuine issue of material fact on the question. Even if the
misconduct occurred and was related, it had to be balanced against the wrong at
issue, which couldn’t be done at this stage of the case.
Quidel Corp. v. Siemens Medical Solutions USA, Inc., No.
16-cv-3059-BAS-AGS, 2019 WL 5328730 (S.D. Cal. Oct. 21, 2019)
Here, the court denies Siemens’s motion to exclude
plaintiff’s survey expert’s report/testimony. Mr. Ezell surveyed “physicians
that specialize in endocrinology and who, as part of their practice, order
assay tests to assist in patient diagnosis.” He showed test and control
materials:

They were asked screening questions and then about whether
Immulite does or doesn’t detect TSI only, in both closed- and open-ended
questions. They were then asked whether they were likely to order both a TSI
only and TRAb assay, and why. The expert concluded that approximately 67.42% of
the relevant universe was likely to be misled or deceived by the message that IMMULITE
is a TSI assay, detects TSI only, or is not a TRAb assay (assuming, as he
should given his role in the litigation, that these statements are false).
As noted above, doctors could be relevant purchasers. “This
is not a situation where all physicians blindly use whatever assay the
laboratory happens to carry, with no input into what assay they use on
patients. Given the conflicting testimony, it is possible the physicians’
opinions regarding the products are relevant and their opinions could be
influenced by marketing or website information.”
Criticisms of the questions as ambiguous also failed—it was
for the jury to decide whether it was troubling that Ezell used the terms “TSI
only” and “TRAb assay” in the survey without defining the terms. So too for
whether the questions led and biased the respondents, which goes weight rather
than admissibility. “Surveys can be admitted even if they contain ‘highly
suggestive’ questions, as long as the survey is ‘conducted according to
accepted principles and [is] relevant.’”  Nor was the control group excerpt biased
because it used “gratuitous language.” The differences between test and control
stimulus were “not so great that they predetermined the result of the survey,”
and this argument was for the jury.  (To
me, very much a nonexpert, the control statement seems self-contradictory: a
test that does not differentiate, but nonetheless detects TSI only at 98.5%
specificity?)  Nor did it matter that
counsel drafted the control statement; Ezell reviewed it and agreed it was
appropriate. That differs from surveys “entirely designed and conducted by
counsel ‘who is not qualified to design or interpret surveys.’” (Citing McCarthy:
“Attorney cooperation with the survey professional in designing the survey is
essential to produce relevant and usable data.”).  Disputes over whether control group answers
were properly coded as not confused, allegedly resulting in nearly 25%
confusion in the control group, were also for the jury.

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