The Seventh Circuit taught us recently that the letter “A” is a powerful thing. Of course, we already knew that a well-placed A can convert the ordinary (“typical”) into the extraordinary (“atypical”), the melodic (“tonal”) into the dissonant (“atonal”), and the virtuous (“moral”) into the indifferent (“amoral”).  Adding a single A to a Scrabble board can result in a seriously high-value word, provided you can manage to place it on a triple word score appended to a word that already has high value letters, like H or Y, or if you are really lucky, X.

For today, A stands for “Abbreviated”—as in Abbreviated New Drug Application, or ANDA. It’s important because the Seventh Circuit held in Guilbeau v. Pfizer, Inc., No. 17-2056, 2018 WL 476343 (7th Cir. Jan. 19, 2018), that implied preemption of a failure-to-warn claim under Pliva v. Mensing depends not on a drug’s colloquial description as “generic” or “brand name,” but rather on the nature of the drug’s approval process.  If a drug is approved through an ANDA, federal regulation of drug labeling preempts state-law failure to warn claims—even if the drug is technically the “Reference Listed Drug.”

This ruling makes perfect sense, and here is how it works. In Guilbeau, the plaintiffs alleged that manufacturers of a testosterone replacement therapy product called Depo-T failed adequately to warn regarding cardiovascular events. Id. at *1.  Depo-T, however, had a slightly unusual regulatory history.  When a manufacturer applies for drug approval under an ANDA, it has to demonstrate that the drug has the same active ingredients, effects, and labeling as a predecessor drug that the FDA has already approved. Id. at *2.  The predecessor drug is called the Reference Listed Drug. Id.

The Reference Listed Drug is usually the innovator product, approved through the NDA process and often referred to as a “brand-name” drug. The ANDA drug is often called “generic.”  If, however, an original innovator drug has been discontinued, the FDA can designate the remaining market-leading drug to take its place as the Reference Listed Drug. Id. Something like that (but not exactly) happened to Depo-T.  Because of unique circumstances surrounding the timing of the drug’s approval, the FDA classified Depo-T as an ANDA-approved drug, but the product also was designated the Reference Listed Drug for its kind of testosterone injection. Id. at *4.

So which is it? “Generic” or “brand name”?  It turns out those terms are neither useful nor dispositive when applying implied preemption.  Or, as the Seventh Circuit observed, “These colloquial terms are not quite precise enough for our purposes in this case.” Id.  The relevant distinction is NDA-approved versus ANDA-approved.  That distinction determines whether a drug manufacturer can unilaterally update its labeling through the changes being effected (or “CBE”) process and thus potentially lose the protection of implied preemption recognized in Pliva v. Mensing.  The Seventh Circuit explained it this way:

[D]espite potentially confusing references to brand-name and generic drugs—recall that the relevant FDA terms are NDA-approved and ANDA-approved—Mensing itself unambiguously refers to the lines drawn in the drug approval process as determining access to the CBE regulation. Mensing concludes that while NDA holders may use the CBE regulation to add warnings, ANDA holders (like [the manufacturer] here) may not. . . .

Despite their occasional use of these terms, the Supreme Court, Congress, and the FDA all agree that the meaningful difference is found in approval process classifications, not shorthand terms like brand-name and generic.

Id. at *6. The key point for the Seventh Circuit was that the CBE regulation is unavailable for products approved through the ANDA process.  And that goes for every ANDA product, even if it is the Reference Listed Drug—like Depo-T.  Because ANDA product manufacturers cannot change their labels unilaterally, it is impossible to change a label in response to state tort law without violating the federal duty of “sameness” that applies to all ANDA products.  That is Pliva v. Mensing implied preemption. Id. at **4-5.

The Guilbeau plaintiffs tried to avoid preemption by arguing that, because Depo-T was itself the Reference Listed Drug, the manufacturer’s duty was to have labeling the same as its own labeling.  According to the plaintiffs, that means the manufacturer could change the label all it wanted to and it would still be the “same” as itself. Id. at *5.  We appreciate the metaphysical nature of this argument:  How can something ever be different from itself?  But the answer is pretty easy.  The duty of “sameness” means that ANDA holders must match the labeling for the Reference Listed Drug as approved by the FDA, “not whatever the RLD’s manufacturer currently thinks would be best.”  Id. at *7.  In other words, “The statutes, the regulations, and the Mensing opinion do not draw the distinction plaintiffs advocate:  a difference in abilities and responsibilities between RLD ANDA holders and other ANDA holders.” Id.

In the end, ANDA drugs that are also Reference Listed Drugs are subject to a “duty of sameness indistinguishable from that of all other ANDA drugs.” Id. at *8.  They all must show that their labeling is the same as the approved labeling. Id. Thus, because Depo-T’s manufacturer “may not unilaterally change the FDA-approved language on Depo-T’s label,” a lawsuit under state law that seeks damages for the manufacturer’s failure to do so is preempted by federal law. Id.

One more important note: The Seventh Circuit held that the plaintiffs were not entitled to conduct further discovery.  The district court decided this case on a motion to dismiss, and because “preemption is a legal question for determination by courts . . . , discovery of facts may not be as vital to this inquiry as it could be to others.” Id. at *10.  With recent opinions from the Third Circuit and Ninth Circuit treating preemption as a factual issue on which discovery might be appropriate (discussed here  and here), the Seventh Circuit’s holding on discovery is most welcome.  Preemption can and should be decided on the pleadings in many instances, including the circumstances presented here.  The district court in Guilbeau correctly did exactly that, and the Seventh Circuit gave the order an A grade.

Today is the birthday of Gilbert O’Sullivan, who scored a hit back in 1972 with “Alone Again, Naturally,” the saddest song we can think of this side of Albinoni’s Adagio.  That is fitting, given our postscript.


December 1 is also the birthday of Sarah Silverman and Bette Midler, two women who consistently bring smiles, so we’ll discuss a good case out of the Eleventh Circuit, though probably not good enough to crack our upcoming top ten list.  In Tsavaris v. Pfizer, Inc., 2017 WL 5593488 (11th Cir. Nov. 21, 2017), the plaintiff claimed that she developed breast cancer after ingesting a generic version of a hormone replacement drug.  She sued both the brand and generic manufacturers.  We don’t know what happened regarding the brand manufacturer (they should certainly have secured a dismissal), but we know that the district court dismissed the claims against the generic manufacturer on preemption grounds well-established in the Mensing and Bartlett SCOTUS decisions and the Guarino Eleventh Circuit decision.  The district court entered final judgment for the defendant.


The plaintiff filed an amended complaint against the generic manufacturer, asserting that she would not have been harmed had the manufacturer not “failed in its federally mandated duty” under 21 U.S.C. section 355 to notify the FDA of certain scientific studies relevant to the cancer risk.  The district court denied the amendment on both procedural and substantive grounds, and the Eleventh Circuit affirmed, holding that the district court had not abused its discretion.  The procedural grounds were enough to bar the amendment: the plaintiff identified no newly-discovered evidence or manifest error of law, as required by Federal Rule of Civil Procedure 59(e).  That is all well and good.


But it is the substantive decision that is more interesting to us.  The plaintiff was complaining of a violation of a federal reporting duty owed to a federal agency, not to her.  More specifically, she premised her complaint on a provision of the federal Drug Price Competition and Patent Term Restoration Act that requires companies to submit “data relating to clinical experience and other data or information … about the safety, effectiveness, or labeling of its drug” to the FDA.  Because the plaintiff was seeking “to enforce a duty owed to a federal agency and her cause of action would not exist in the absence of that duty, her proposed second amended complaint is preempted.”


The Tsavaris decision was not selected by the Eleventh Circuit for publication in the Federal Reporter, perhaps because this was a pro se appeal.  But the proposed amended complaint was drafted “with the assistance of counsel,” and is fairly typical of the way some plaintiff lawyers seek to evade preemption.  Thus, the Eleventh Circuit’s finding that the amendment would have been futile provides some comfort to practitioners on the right side of the v.


We mourn the passing earlier this week of beloved Reed Smith colleague Chuck Pagliotti.  Chuck was what all of us in the legal profession should aspire to be – a problem solver.  Chuck was a genius when it came to fixing messes we made on our computers, iPhones, or anything else that could occasionally baffle us.  He always did so with patience and a smile.  We shared a love for anything relating to Star Wars.  Chuck was a sweet, gentle soul. Our grief exceeds our poor power of expression.



The Ninth Circuit filed a preemption opinion the other day that should help prevent the “foodification” of medical device litigation. That made-up word refers to the wasteful food-related class action litigation that has somewhat thrived in California.  The template is familiar:  Opportunistic plaintiffs’ lawyers find some aspect of food labeling that they claim is misleading—e.g., that a product is “wholesome” or “natural”—and they recruit a plaintiff to say that he or she would not have purchased the food or would have paid less for it had truth been told.  We wrote more than two years ago about a class action claiming that Hershey chocolates made misleading “healthy diet claims.”  Who would possibly rely on “healthy diet claims” for chocolate treats?  That class action obviously had no legs, but others have gotten by.

Attempts to extend this business model to medical devices have failed, and one reason is federal preemption. That is our takeaway from DeBons v. Globus Medical, Inc., No. 14-5645, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), where the Ninth Circuit affirmed the district court’s order dismissing a putative class action involving bone putty, an allograft tissue product that the FDA regulates as a medical device. See the district court’s dismissal order, DeBons v. Globus Medical, Inc., No. 2:13-cv-08518, 2014 WL 12495351 (C.D. Cal. Aug. 8, 2014).  Taking a page from the food playbook, the plaintiff claimed that the device was “not in fact FDA approved,” which we take to mean that product was “cleared” through the 510k process rather than formally “approved.”  He alleged therefore that “had made it known that the product was not FDA approved,” he would not have paid for it. Id. at *1.  He asserted a raft of consumer fraud claims, including a claim under California’s broadly written Unfair Competition Law, and purported to represent a class of other bone putty patients. Id. Bear in mind that the plaintiff alleged no surgical complication; the device evidently worked just fine.  This was strictly a play for a price refund.

Here is where it gets interesting. The main reason why medical device class actions are so rare these days is that medical treatment unavoidably presents individualized issues, making class treatment impossible.  Another reason is Section 337(a) of the FDCA, which gives the FDA exclusive authority to enforce the Act’s provisions.  This provision impliedly preempts any private action right of action filed because a device manufacturer’s conduct allegedly violates the FDCA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  When combined with the Medical Device Amendments’ express preemption provision, would-be plaintiffs face the “narrow gap” between implied preemption and express preemption on which we often comment (such as here). On the one hand, the MDA’s express preemption provision bars states from enforcing requirements “different from or in addition to” federal requirements.  21 U.S.C. § 360k(a).  On the other hand, private litigants cannot enforce the FDCA.  A plaintiff therefore “must be suing for conduct that violates the FDCA (or else his claim is expressly preempted . . . ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” DeBons, 2016 WL 43463171, at *1 (quoting Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013)).

Continue Reading Another Reason Why Medical Device Class Actions Don’t Work