Tuesday, December 05, 2017

Tick tick boom: Lyme-blocking claim avoids preliminary injunction

Merial, Inc. v. Zoetis, Inc., 2017 WL 4466471, No. 1:17-CV-1624 (N.D. Ga. Jun. 6, 2017)

Thorough discussions of the effect of disclaimers on literal falsity/misleadingness are rare, so this one is useful. Merial makes NexGard, flea-and-tick removal treatments; the latter was the first U.S. prescription monthly flea-and-tick medication for dogs that could be administered orally. Zoetis launched its own oral flea-and-tick product, Simparica. The parties’ products are only dispensed by licensed vets. 

Zoetis ran a TV ad with a display banner stating: “In a study, Simparica blocked Lyme disease transmission.” A disclosure continues: “In a study, Simparica killed >98% of deer ticks in existing infestations within 12 hours, while Lyme disease is typically transmitted in 24-48 hours. In another study, Simparica was shown to block Lyme transmission from deer ticks.”

A voice-over later states: “Studies show that at the end of the month, Simparica killed more ticks in less time than both Frontline and NexGard,” while an animated dog uses its back paws to kick dirt over boxes of Frontline Plus and NexGard.  The disclosure on screen: “Studies showed that at the end of the month, 24 hours after infestation, Simparica killed more deer ticks than Frontline and more Lone Star, Gulf Coast, brown dog, and deer ticks than NexGard.”

Merial alleged that the first claim relating to blocking Lyme disease is literally false because Simparica does not “block” Lyme disease, and that the second claim of killing ticks faster was literally false because the studies on which Zoetis relied didn’t demonstrate that at the end of the month Simparica kills “more ticks in less time” as compared to Frontline Plus and NexGard.

First, Merial argued that no study supports the conclusion that Simparica worked similar to a vaccine and could completely block Lyme disease itself. Rather, Simparica at most reduces opportunities for ticks carrying the Lyme disease-causing pathogen to bite dogs by killing the ticks themselves.  Zoetis responded that killing ticks effectively blocked the transmission of the disease-causing pathogen, which was sufficient, and that the “clarifying text” informed the interpretation of the ad.  Merial responded that the text was too small and difficult for consumers to read.

“A disclosure is adequate if it is actually communicated to consumers.”  Zoetis offered an affidavit that the disclosure was “compliant with network advertising guidelines, which means that the network compliance attorneys have ... confirmed that the [Clarifying Text is] on screen for a sufficient amount of time to be comprehensible by viewers.” Zoetis also offered evidence that it conducted testing and displayed the Clarifying Text for a sufficient length of time for a consumer to read the information. The court determined that it was appropriate to consider the disclosure as part of its falsity analysis, because the claim “primes the viewer to look to the Clarifying Text by stating ‘[i]n a study, Simparica blocked Lyme disease transmission,’” and the disclosure explains how Simparica blocked Lyme disease.  The disclosure was also part of the full context of the ad, especially because it appeared simultaneously with the ad, and Zoetis provided evidence that the text was sufficient to reach consumers.  For purposes of a preliminary injunction, Merial didn’t show that the disclosure should not be considered.

Merial then didn’t show that, taken together, the claims were likely literally false.  Merial argued that Zoetis’s studies didn’t actually test for Lyme disease; only one study tested for the presence of the pathogen; and only five to ten percent of dogs exposed to the pathogen exhibit symptoms of Lyme disease.  But the study that didn’t test for the pathogen still tested for deer ticks, which are the main vectors of Lyme disease in the United States, and the other study showed that the drug interfered with the pathogen.  Even without the disclosure, “block” wasn’t likely literally false, because “block” can mean to hinder/interpose an obstruction according to the dictionary, and the drug could arguably do that.  Zoetis’s interpretation was also reasonable because others use “block” in the same way, such as an NIH article, “Tick Talk: Block Tick Bites and Lyme Disease” that noted that “the best way to avoid Lyme and other tick-borne illnesses is to prevent tick bites in the first place.”  Also, in the context of the entire ad, which showed Simparica working by killing ticks before they transmit diseases, there was no claim that Simparica is a vaccine that acts directly on pathogens.

Merial’s challenge to the “faster killing” claims also failed at this stage.  Merial argued that, even if Simparica killed more ticks after twenty-four hours, the results were mixed on whether Simparica killed more ticks at eight or twelve hours. But the disclosure indicated that the 8/12 hour marks weren’t relevant, because it specified that “[s]tudies show that at the end of the month, 24 hours after infestation, Simparica killed more ticks” than Frontline Plus and NexGard.  Also, even on its own, the faster killing claim hadn’t been shown to be literally false.  Because the 8 and 12 hour marks were, on the whole, inconclusive as to which medicine killed more ticks, it was okay to look to the twenty-four hour mark (the only other mark tested) to determine who killed more ticks in less time. (The court also found that “killed more ticks in less time” could have multiple meanings, depending on when the kill rate was measured.)

Merial also argued that the Lyme Disease Claim wrongly went beyond the studies to claim that Simparica was superior to Frontline Plus and NexGard across all types of dogs, ticks, and geographies. The parties offered conflicting affidavits on whether studies mainly using Beagles and certain tick types could be used in support of broader claims, but that wasn’t enough at this stage. 

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