United States: Non-News: Warnings Claims For A Generic Drug Preempted (Still)

Last Updated: November 15 2017
Article by Eric Alexander

We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it is useful to do not just a reality check but a date check. Stories on a social media stream come with a presumption of newness, but the date of the release of the story—once you find it—may make you stop reading because it is not news any more. You may even have read the old news when it was new and just got suckered back by the misimpression of novelty. A story about a new species of dinosaur, or even beetle, being discovered? We are clicking. Einstein's prediction of gravitational waves verified? Click—wait, we saw that way back in early 2016, and a Nobel Prize was awarded for that last month.

Generic drug preemption may not be as clickworthy as a "new" ankylosaur, but these decisions do still catch our attention. After Mensing, Bartlett and scores of published decisions preempting the vast majority of conceivable claims—or holding that state law does not recognize the claim the plaintiff would need to sidestep preemption—you might think that plaintiffs would stop pursuing these claims. Well, the nonsense that is innovator liability has not provided a viable alternative—although the plaintiffs keep trying (like here and here)—and courts have not yet resorted to Rule 11 for pursuing obviously preempted claims, so the plaintiffs keep trying. When Kious v. Teva Pharmaceuticals USA, Inc., No. 16-990-R, 2016 WL 9559038 (W.D. Okla. Dec. 8, 2016), popped up in our searches, we thought it might be new and newsworthy. It really was old news made to seem new because it had taken eleven months to get on Westlaw. The generic manufacturer defendant secured dismissal of the claims against it on preemption, but was there anything new, different or interesting about it? We think it is pretty much old hat, but that may be the point.

Kious involves a plaintiff who claims to have developed Stevens-Johnson Syndrome as the result of the use of a generic antibiotic, the label for which apparently matched that of the reference drug. The plaintiff sued the generic manufacturer, asserting standard state law claims, and a motion to dismiss the amended complaint followed. (He also sued the branded manufacturer, but that is not discussed in the opinion.) The court walked through each asserted claim, starting with design defect. Preemption of such claims is not really a question post-Bartlett, but the Tenth Circuit's decision in Schrock, discussed here, left no doubt that strict liability and negligence design claims fail. Id. at *2. Next up was the claim for manufacturing defect, which was really just a re-packaged claim for design defect. Plaintiff claimed "that every dose of azithromycin was defective because of its design and/or lack of adequate warnings," so he did not plead a manufacturing defect claim under Oklahoma law (and the design claim under a different label was still preempted). Id.

Next up were the warnings claims. Plaintiff did not allege a failure to update the generic label to mirror the reference drug's label, so Mensing's application should have been straightforward. Not so, claimed the plaintiff, because Mensing involved prescriptions written before the Food and Drug Administration Amendments Act of 2007, which established a procedure under which FDA could ask for a new label from a generic manufacturer if the reference drug was no marketed and there is new safety information. Even this argument, however, was not new, as courts like the Seventh Circuit had already rejected it. The Wagner decision (a lofty fifth place on last's year's best list) made clear that the FDAAA did not remove the prohibition against a generic drug manufacturer changing its label unilaterally. 2016 WL 9559038, *4. Kious went a step further—and we think this was actually novel—and noted that the FDA's proposed rule from 2013 to allow generic manufacturers to change their labels unilaterally in some situations supports preemption. "The proposed rule would be unnecessary if, as Plaintiff urges, the 2007 Amendments permitted unilateral labeling changes by generic manufacturer." Id. No news is good news, at least here, so warnings claims are still preempted.

The remaining claims were also dismissed. Express warranty claims are really preempted warnings claims and implied warranty claims were really preempted design claims or preempted warnings claims, depending on how construed. Again, the Schrock decision, also under Oklahoma law, determined the result. Id. at *5. For the claims of fraud, negligent misrepresentation, and negligent concealment, the court looked to the Eleventh Circuit's decision in Guarino for clear authority that these were simply another version of preempted warnings claims. Id. at **5-6. That was it for every claim plaintiff offered and, plaintiff did not get to amend again. Judgment for the defendant after only two strikes. Could it be that sanctions for asserting frivolous claims are next in such suits? That would be news, no matter when it happens.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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