Older case: placement of medical device on market isn't representation of FDA approval

Intra-Lock International, Inc. v. Choukroun, 2015 WL 11422285, No. 14-cv-80930 (S.D. Fla. May 4, 2015)

Old, but new in Westclip (why? It’s an algorithmic mystery), and presents an interesting fact pattern about FDA approval/the lack thereof and the relationship between that and the Lanham Act.  Intra-Lock made the IntraSpin System, used for drawing and centrifuging a dental patient’s blood. It had three different components: (1) blood collection material, (2) a centrifuge, and (3) a fabrication kit and instrumentation.  Defendants allegedly sold a “kit” of products substantially identical to the components that make up the system, which were then assembled by the target audience to create a competing system.  They also allegedly promoted the kit in the US, including with courses by Choukroun promoting the use of the competing device in various dental surgical procedures.

Intra-Lock pled that it had 510(k) pre-market clearance from the FDA, which classified its device a Class II medical device, or “automated blood cell separator,” while defendants deliberately skirted these requirements, instead representing to the FDA that two of the components were Class I medical devices, which are exempt from premarket notification procedures and other quality system regulations. This allegedly posed serious risks to consumers.

Defendants argued that Intra-Lock had unclean hands because it didn’t initially have pre-market clearance; until it obtained the clearance, it was selling nearly the exact same components in a manner similar to defendants’ marketing. That was exactly the conduct Intra-Lock now argued was false and misleading, which gave the court pause, but it proceeded to the merits anyway.

Anyway, Intra-Lock couldn’t identify any false or misleading statements—nothing on defendants’ websites and related materials mentioned “FDA anything.” “Merely because Defendants have opted to market their Competing Device in a fashion similar to Plaintiff, does not make any similarity to Plaintiff’s model a false representation.”  The claim that defendants’ system was “recognized around the world, from Nice to New York from Los Angeles to Shanghai, from Rangoon to Moscow, from Sao Paulo to Cape Town, Santiago to Zagreb” was mere puffery.  With reference to one of the components, a specific type of test tube, the website said that “[t]his tube is the only authorized at this moment.” But that didn’t specify FDA authorization and indeed could easily be read to mean that it was the only type that defendants authorized for use with their other components.  Finally, one defendant stated that one of the components, a centrifuge, was “FDA registered.”  But that was true.

A comment by Choukroun on a dentistry blog and conversations between Choukroun and Dr. Robert J. Miller weren’t commercial advertising or promotion.  Even considering them, Choukroun didn’t claim to have pre-market clearance; he expressed his opinion that “FDA approval” wasn’t required.

It wasn’t enough to claim that presence on the market falsely implied FDA approval.  Some “peculiar” type of marketing was required, such as a direct comparison to a product that had received pre-market clearance, along with evidence that this marketing implied FDA approval.  Intra-Lock lacked any consumer surveys.

Intra-Lock’s real complaint was that the device required pre-clearance, but it had complained to the FDA about that. “Absent misrepresentation, the mere fact that Defendants may be erroneously selling the Competing Device as a Class I device when it is more appropriately considered a Class II device, is a violation of the FDCA, not a violation of the Lanham Act.” Pom Wonderful was not to the contrary; that case applied “where a party has introduced literal falsehoods or other misrepresentations into commerce,” not here.