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. 

from Blogger http://ift.tt/2jKylUW

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