Tuesday, October 29, 2019

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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