Tuesday, July 21, 2020

expert can't substitute for survey evidence (at least w/o experience w/consumer reactions)

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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