Insufficient deviation from FDA label and lack of materiality doom false ad claims

Apotex Inc. v. Acorda Therapeutics, Inc., 2014 WL 5462547, No. 11 Civ. 8803 (S.D.N.Y. Oct. 23, 2014)
Zanaflex tablets and capsules (active ingredient tizanidine) are approved by the FDA to treat spasticity.  Somnolence is one of the most common side effects.  Apotex began selling a generic version of the tablets in 2004, and Acorda began selling Zanaflex capsules in 2005.  Tizanidine tablets and capsules aren’t bioequivalent when administered with food, and the differences might be clinically significant, including increased adverse events or delayed/faster onset of activity, for people switching between the two. Apotex sued Acorda for false advertising and related business torts. Acorda here won summary judgment.
The court began by noting that courts generally reject Lanham Act claims based on ads that merely repeat FDA-approved label information.  (Pom doesn’t even merit a mention.)  It then reviewed the various statements and images Apotex argued were false.
First, sales reps told doctors that Cmax (maximum blood concentration of a drug after dosing) was reduced when Zanaflex was taken with food.  But this was consistent with the FDA label, which said that  “the mean Cmax for the capsule when administered with food is approximately 2/3’s the Cmax for the tablet when administered with food.”
Second, sales reps told doctors that, when taken with food, Zanaflex capsules cause less somnolence than Zanaflex tablets.  The court rejected Acorda’s argument that these statements were unauthorized and isolated and thus couldn’t be the basis of liability, because they weren’t part of an organized campaign.  A reasonable juror could find otherwise.  Acorda also argued that a pharmaceutical company shouldn’t be held liable when it didn’t instruct the reps to make the statements and, after learning of them, reinforced company policy and made good faith compliance efforts.  That was a factual determination the court wasn’t willing to make on a summary judgment motion.
However, a reasonable juror couldn’t find these statements to be false.  Apotex argued that all it need to show was that the challenged statements weren’t supported by statistically significant evidence. When an ad explicitly or implicitly represents that its claims are test-backed, falsity can come from showing that the tests didn’t establish the proposition for which they were cited, including by showing that the tests weren’t sufficiently reliable.  But none of the statements about somnolence here were claims of test-proven superiority.  “At most, the statements suggest that, due to pharmacokinetic differences between the products, Zanaflex capsules cause less somnolence than Zanaflex tablets when taken with food.”  (Why wouldn’t reasonable doctors assume that there was actual evidence behind this, since the claim involves a scientific method of action?)  True, some of the challegned statements referred to a graph of pharmokinetic differences, but the graph seemed to be the one featured on the FDA label and there was no indication that the sales reps told doctors that the graph showed somnolence levels.  Encouraging doctors to draw an inference not directly supported by the graph was at most misleading, not false.  At most, Apotex showed lack of substantiation, not falsity.
Third, Acorda’s promotional materials said that taking Zanaflex tablets with food increases Cmax by 30%, whereas taking Zanaflex capsules with food decreases Cmax by 20%.  Again, this was consistent with the FDA-approved label; omitting “approximately” wasn’t enough to make the claim false. 
However, juxtaposing this claim with a graph of of mean tizanidine plasma concentration curves over time could create a literally false message, since mean plasma concentration over time is different from Cmax (the highest level, at whatever time it occurs).  Identifying the highest points on the graph as a “30% Increase for Tablets” and “20% Decrease for Capsules” unambiguously claimed that mean concentration increased that much/decreased that much when the drugs were taken with food.  However, the evidence suggested a much smaller increase/decrease of 13%/12%.  But falsity isn’t enough; there was no evidence that “misstating the extent to which food affects mean tizanidine plasma concentration was likely to influence consumers’ purchasing decisions.” Without materiality, summary judgment was appropriate.
Fourth, one promo piece claimed “Flexible Control in a Capsule,” images of the sun and moon, the words “day” and “night,” and information about “Important Pharmacokinetic Differences.” Apotex argued that this made a false claim that taking Zanaflex capsules with food reduces somnolence.  This was ambiguous at best: the brochure could be making a number of claims, such as that Zanaflex capsules relieve symptoms throughout the entire day, Zanaflex capsules release the drug in a controlled manner, or Zanaflex capsules allow for more effective treatment of spasticity over time.  And Apotex didn’t show misleadingness with extrinsic evidence.
Fifth, Acorda made statements about pharmacokinetic differences between Zanaflex capsules and tablets that differed from those on the FDA label, such as claiming unequivocally that effects and adverse events are related to plasma levels of tizanidine and calling the differences between capsules and tablets “important.”  But a claim isn’t literally false just because it exaggerates an FDA-approved statement.  There was no evidence allowing a reasonable juror to include that effects/adverse events weren’t related to plasma levels, that no important differences existed between the two forms, etc. Nor was there extrinsic evidence of consumer confusion.

This entry was posted in fda, http://schemas.google.com/blogger/2008/kind#post, preemption. Bookmark the permalink.

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