implied claims of FDA approval actionable under Lanham Act

Kurin, Inc. v. Magnolia Medical Technologies, Inc., 2019 WL
5422931, No.: 3:18-cv-1060-L-LL (S.D. Cal. Oct. 23, 2019)
Kurin developed the Kurin Lock, a “specimen diversion device
that reduces the risk of blood culture contamination and associated false
positive blood culture results.” Magnolia competes with Kurin, selling another
blood collection device, the Steripath, which launched before the Kurin Lock.
Kurin alleged that Magnolia’s representations that Steripath
is registered and listed as a Class I device and Steripath’s “Rx Only”
packaging falsely implied FDA review and approval.  Magnolia argued that this was a matter for the
FDA’s primary jurisdiction.
POM Wonderful explicitly noted “that analysis of
other types of labels, i.e. drug labeling, may be different than food and
beverage labeling due to statutory requirements.” And “actions in direct
conflict with an FDA policy choice are barred.” Still, consumer protection
justifies allowing Lanham Act claims in many circumstances.
The Lanham Act claim was precluded to the extent it relies
on allegations that the Steripath device was misclassified. “Congress placed
classification and re-classification of medical devices within the FDA’s
regulatory authority under the FDCA’s comprehensive regulatory scheme.”
By contrast, to the extent Kurin’s allegations merely implied
that the market or consumers has been misled by Magnolia’s representation that
the Steripath device was “listed and registered” as a Class I device, those
allegations remain.
Magnolia also argued that the FDCA requires Magnolia to
include the “Rx Only” statement on its device labeling, so it couldn’t be the
basis of a claim. The court disagreed: if the public was misled about the
implications the Lanham Act was triggered, even though “any remedial measures
involving the label [are] likely in the FDA’s domain.” However, the “Rx Only”
allegations were conclusory.

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