Today is Boxing Day, when we, along with millions of other Americans, scamper off to the Mall to return those Christmas presents that just didn’t quite fit (physically or spiritually or aesthetically) our needs. So buh-bye jelly-of-the-month club (we’re diabetic), Hello Kitty lounge pants (wrong size), Three Stooges talking bottle-opener (we love hearing “nyuck, nyuck, nyuck” whilst popping the top off a Yuengling, and that’s why we already have one), and the boxed DVD set of all the episodes of Punky Brewster (like we said, we’re diabetic).
We wish we could take back some of the crummier cases we saw this year, and exchange them for something better. Luckily, something like that happened with one of the cases that made it onto last week’s Ten Worst list. We bemoaned Lefaivre v. KY Pharmaceuticals Co., 636 F.3d 935 (8th Cir. 2011), for permitting an improper private FDCA violation claim to go forward. More recently, a subsequent iteration from that litigation suggests the claims won’t go very far forward, because there is no ascertainable loss. In Polk v. KV Pharmaceuticals Co., 2011 WL 6257466 (E.D. Mo. Dec. 15, 2011), the same basic claim was dismissed pursuant to Fed. R. Civ. P. 12(b)(6). The plaintiffs filed a putative class action, alleging that they had used Metoprolol Succinate tablets, and had gotten less than they expected because the FDA found that the defendants were not in compliance with current good manufacturing practices. That FDA finding means that the tablets were “adulterated” within the meaning of 21 U.S.C. section 351(a)(2)(B).
The plaintiffs tried to rely on the Consent Decree entered into between the defendants and the FDA. But in the Consent Decree preamble the parties disclaimed liability, The plaintiffs argued that the disclaimer was “inconsequential” and that the findings in the Consent Decree provided evidence of liability. The court disagreed and concluded that the Consent Decree contained “only allegations that were neither admitted nor denied by Defendants as well as the express denial of liability by the Defendants.” 2011 WL 6257466 at *4. Therefore, the Consent Decree was evidence of nothing except that a settlement was reached between the defendants and the FDA. So far so good.
And it’s about to get better. The plaintiffs’ central claim is that the medication was worth less than what they paid for it, in light of the adulteration. But there was no evidence that the tablets posed any health risk to consumers. The court then followed the reasoning of Myers-Armstrong v. Actavis Totowa, LLC, 2009 WL 1082026 (N.D. Cal. April 22, 2009), a case we applauded here. Noncompliance with good manufacturing practices is insufficient in the face of no actual “manifestation of a defect that results in some injury or rational fear of injury” to state a cognizable claim. 2011 WL 6257466, quoting Myers-Armstrong. Put simply, there’s no evidence that “adulteration” equals ascertainable loss. Therefore, the claims under both the Missouri consumer protection statute and breach of warranty fail.
The Polk case is like finding another present under the tree after you thought you were all done. Or it’s like taking back that weird “The Scream” inflatable and exchanging it for something serviceable and solid, like a Yellow Submarine ice cube tray, or a nice, pro-defense ruling.