Kurin, Inc. v. Magnolia Medical Technol., Inc., 2020 WL
4049977, No. 18-cv-1060-L-LL (S.D. Cal. Jul. 20, 2020) 

A lot going on here in this false advertising case about
blood collection devices (one called Steripath); I will omit a lot of the contested
claims at issue. The most broadly interesting thing: the court rejects an
attempt to use a subject matter expert’s testimony to replace consumer survey
evidence of deception, even though the product is specialized/bought by
sophisticated entities (a situation where this technique has occasionally
worked). 

The proposed expert opinion was about whether the relevant consumers,
though generally familiar with FDA regulations, would have understood that “FDA
registered and listed” does not mean the same thing as “FDA approved” given the
regime applied to medical devices.  The opinion
was based on the  proposed expert’s
experience as an attorney representing medical device manufacturers before the
FDA.

Kurin argued that his opinion was admissible because he “has
25 years of experience regarding FDA compliance.” But the proposed expert had no
experience or expertise in market research or marketing and did not review any
market surveys to form his opinion; he only infrequently interacted with
purchasers of medical devices, and thus his opinion could not reliably be based
on his experience. Nor did he review any literature on the topic of “medical
device purchasers’ perception of statements about FDA regulatory status.”
Instead, he relied on two references to Steripath’s regulatory status in an
article and a presentation, although he didn’t know whether their authors would
be involved in purchasing such a device. 
His opinion was not admissible. 

Other notes: While health-related claims are often held to a
high standard, the court here found that certain statements were puffery. In
particular, Magnolia advertised that Steripath eliminates or “virtually
eliminates” false positive results. The evidence indicated that Magnolia could
substantiate a false positive rate below 1%. Under the circumstances, “virtually
eliminates” was puffery, as was the claim that “Steripath will
‘…significantly improve specimen integrity and the accuracy, consistency, and
predictability of critical laboratory tests.’ ” 

By contrast, the statement that “Steripath is the ‘only
vein-to-bottle closed blood culture collection system that is proven to
virtually eliminate preventable error of blood culture contamination and
false-positive results for sepsis’ ” was not puffery to the extent that
Magnolia contested whether Steripath was a “closed system.” (The claim still
failed based on proximate cause/harm issues.)

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