United States: Guest Post – Generically Speaking – "Sameness" Creates Sanctuary From State Law Liability

Last Updated: June 5 2018
Article by James Beck

Today's guest post is by Reed Smith associate Devin Griffin. It's about preemption in a generic drug case, something that has become so routine that, other than add cases to our generic preemption scorecard, we rarely feel the need to discuss them. But Devin's case is better than most, and thus worthy of individual discussion. However, in the end, the plaintiff is out of court, as is usually the case. Everything preempted save "failure to update," which was TwIqballed for lacking any factual basis. As always, our guest posters are 100% responsible for their posts, deserving of all the credit and any blame. Take it away Devin.


When writing a blog post, there is an inevitable (and often tedious) brainstorming process that one must go through before coming to a final conclusion about how to present the relevant information. For this post, I found myself tasked with writing about a highly favorable generic drug case that hails out of the Southern District of Florida. Sounds easy enough, right? Well, not entirely. Five minutes into my brainstorming process, and a few Google searches later, I found myself in a veritable research rabbit hole. My initial search of "Puns about Florida" led me to a few chuckle-worthy jokes, but none that the DDL Blog would share with its readers in this age of political correctness.

After my preliminary brainstorming, I paused to think "how can I tie any of this into my post?" Should I take the "Florida: God's Waiting Room" angle and make a pun about how the DDL Blog would like to breathe new life into this Southern District of Florida generic drug decision from December of 2017—a decision that is particularly blog-worthy for its clear-cut analysis of products liability causes of action as applied to generic drug manufacturers? No ... much too crass. Or I can take the angle of "There are many bad things to come out of Florida" (i.e., the trend of bath-salt induced cannibalism) "but this case is certainly not one of them." No ... much too morbid. Or I can make a pun about how the Blog's readers are likely reading this post, about a delightfully refreshing Southern District of Florida decision, while enjoying some of Florida's finest OJ? No.

Instead, I decided to present this case to you with no angles, no fun-facts, no themes to tie in throughout. I followed the lead of the Southern District of Florida, which took a direct approach when it found in favor of the generic pharmaceutical manufacturer on the basis of federal preemption.

In Allbright v. Teva Pharms. USA, Inc., 290 F. Supp. 3d 1321 (S.D. Fla. 2017), the Southern District of Florida decided a Motion to Dismiss filed by a generic drug manufacturer. Plaintiff asserted the usual causes of action—strict liability design defect, strict liability failure to warn, and negligence. Id. at *1. Ultimately, the Southern District of Florida dismissed them all, providing a useful roadmap of generic preemption.

After providing us with a law school refresher on the various types of preemption, id. at *3, Allbright then applied the two implied preemption presumptions that blog readers have come to know and detest since Wyeth v. Levine, 555 U.S. 555 (2009): (1) that the police powers of the States were not to be superseded by federal preemption unless that was the clear and manifest purpose of Congress, and (2) that "the purpose of Congress is the ultimate touchstone in every case ... such that any preemption provision and [the] surrounding statutory framework[] ... provide [the] primary guide for discerning Congressional intent" regarding the scope of preemption. Id. (internal citations omitted).

Then, Allbright turned to the attributes of generic drugs that support preemption. Generic drug manufacturers can forego the New Drug Approval process "by demonstrating equivalence to a drug that has already undergone clinical trials and been approved by the FDA." Id. at *4 (citing 21 U.S.C. § 355(j)(2)(A)). Once a generic drug has been approved through an ANDA, the generic manufacturer has a "duty of sameness" requiring that a generic manufacturer simply bear the verbatim identical label of its brand-name bioequivalent. Id. To maintain this identity, a generic manufacturer does not have the authority to unilaterally change its generic drug's label, design, or formulation—to do so would be in violation of its federal duty of sameness. Id.

This "sameness" mostly removes generic manufacturers from the realm of product liability law. First, claims against generic manufacturers for failure to warn or design defect are preempted. Id. at *5-6. When a plaintiff brings a failure to warn claim against a generic manufacturer, the plaintiff is demanding that the generic manufacturer should have changed or enhanced the approved warning label in some way to deviate from what appears on the brand-name counterpart drug label. To meet both that state law duty and the federal duty of sameness would be impossible, thus the generic manufacturer's federal law duty of "sameness" trumps. Id. Ditto for why state law design defect claims are preempted as to generic manufacturers. Id.

There remains one particular instance where federal and state law requirements for generic manufacturers would not conflict. Id. at *6-7. Where a generic manufacturer fails to update its label, meaning the label is no longer the same as its brand-name counterpart, the manufacturer can be subject to state law liability if that failure to update is also a failure to warn under state law. Id. A failure to update claim does not claim that warnings stronger than the brand-name drug were required . Id. Instead, failure to update claims allege that the generic manufacturer failed to maintain sameness. Id. In this situation, the generic manufacturer's federal and state law duties are congruent, not conflicting. Id.

Ultimately, ( as is often the case) the duty to update claim failed anyway. While the claim was cognizable, in the abstract, Plaintiff's evidentiary support for this claim was "sparse at best." Id. Plaintiff failed to present sufficient evidence to substantiate her allegation that the generic manufacturer failed to update its drug label consistent with the brand name label, and thus Plaintiff could not withstand the generic manufacturer's Motion to Dismiss. Id.

One more win for generic manufacturers in the preemption wars. One more case for the Blog's generic preemption scorecard.

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

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James Beck
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