United States: A Banner Week For Buckman Preemption

Last Updated: September 2 2016
Article by James Beck

There used to be a TV show called "That Was the Week That Was." It was a satirical look at the news of the prior week, but perhaps it's most lasting accomplishment was to launch David Frost's career. Without an ounce of satire, however, we have to say that the business week of August 15 through 19, 2016 was a heck of a week for implied preemption utilizing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). We've already blogged about the Ninth Circuit's decision in DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), which invoked Buckman preemption to affirm dismissal of a consumer protection class action that was seeking to recover based on allegations that a medical device wasn't properly "approved" (but rather cleared under §510(k)) by the FDA.

But DeBons was only one part of that week's Buckman hat trick.

On the same day, the Fifth Circuit got into the act, affirming a preemption-based dismissal of another medical device product liability suit in Estes v. Lanx, Inc., ___ F. Appx. ___, 2016 WL 4375644 (5th Cir. Aug. 16, 2016). We've already blogged about favorable district court results in the Estes case three times. The Fifth Circuit affirmed all of them. Estes involved a spinal fixation system anchored with bone screws, some of which broke under the intense pressures of holding the human body upright. The screws were explanted and replaced, but "neither the hospital nor [defendant] retained" them. Id. at *1.

Plaintiff first screamed "spoliation" – he lost. Id. ("we find no basis for disturbing the district court's finding of no bad faith").

Unable to establish a conventional defect without the product, plaintiff tried "fraudulent concealment" instead. That's where his claim collided with Buckman. The alleged "fraud" involved how the defendant allegedly presented the device to the FDA:

[Plaintiff's] claim for fraudulent concealment was premised on the allegation that by submitting component-based applications (rather than a single application) for 510(k) approval for the [device] system, [defendant] violated the Federal Food, Drug, and Cosmetic Act ("FDCA").

Estes, 2016 WL 4375644, at *2. Buckman, of course, famously held that there can't be a private right of action for enforcing FDCA violations, and this claim plainly failed the Buckman preemption test because it could not exist without the FDCA – since there wouldn't have been an FDA application process at all unless statute existed. Id. (plaintiff's "claim is based on the allegation that the system lacked, to use his words, 'the requisite FDA approval'"; thus, it 'exist[s] solely by virtue of the FDCA disclosure requirements'") (citation and quotation marks omitted).

Our non-preemption Estes post praised a discovery ruling that refused to require production of documents about other devices that the defendant made that were never prescribed for, or used by, the plaintiff. The Fifth Circuit affirmed that as well:

[Plaintiff] also sought all consumer complaints for any [a different] device. . . . To the extent this discovery would even matter with the dismissal of the fraudulent concealment claim that we have just affirmed, we conclude that the trial court did not abuse its discretion in denying the discovery request.


Two days later, Elliott v. Sandoz, Inc., 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016), completed the week's Buckman Trifecta. Elliott involved a generic drug, so the plaintiff's immediate problem was to gin up some sort of claim that stood a prayer of getting around Mensing/Bartlett preemption. This particular drug was approved only as a "last resort" for patients suffering from a life-threatening condition. However, since the physician prescribed it off-label for a non-life-threatening condition, plaintiff made off-label promotion allegations against the both the defendant and the manufacturer of the branded reference drug (not a defendant). 2016 WL 4398407, at *2.

Plaintiff also alleged that the defendant (indeed, any seller of this drug) had to supply pharmacies with FDA-mandated "Medication Guidelines," which were in turn supposed to be given directly to patients by pharmacies. Id. Plaintiff claimed that the defendant didn't supply enough of these guides, the decedent (this was a wrongful death case) never received it, and wouldn't have taken the drug if he had, because of the off-label use issue – that is, that the decedent would not have followed his doctor's prescription. Id.

These allegations in Elliott formed the basis for warning and fraudulent marketing claims. Also included throughout the complaint were vague allegations that the defendant failed to warn "physicians" generally about the risks of off-label use. No go. Buckman, combined with TwIqbal, did them in.

First, Buckman. Plaintiff was trying for the hypothetical "parallel claim" exception to generic drug preemption, alluded to in Bartlett, footnote 4 (we discussed that in more detail here). Plaintiff argued that the medication-guide-based claims were "parallel" claims – alleging conduct violative both of state and federal law − and thus were not preempted.


In her attempt to run away from Mensing/Bartlett, plaintiff ran headlong into Buckman.

The court finds the argument in favor of preemption is persuasive. Plaintiff seeks to sue Defendant for an alleged violation of federal law and regulations − that is, Defendant's failure to provide the Medication Guide. The duty of Defendant to provide Medication Guides to pharmacies . . . arises solely under federal law. See 21 C.F.R. §208.24(b). Even if Mensing and its progeny do not apply in this case (which is doubtful because Plaintiff is ultimately arguing a "failure to communicate" theory . . .), Plaintiff's claim that Defendant was negligent for failing to provide Medication Guides to Decedent is preempted by section 337(a).

2016 WL 4398407, at *6 (other citations and quotations omitted). Section 337(a), of course, is the foundation of Buckman preemption. "The Supreme Court has held that 'that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions." Id. at *5 (quoting Buckman, 531 U.S. at 349 n.4 (which, in turn, cites §337(a)).

Nor could plaintiff point to any analogous state-law duty. A medication guide goes to the plaintiff-patient. The learned intermediary rule (adopted in Alabama, like everywhere else) bars warning claims based on direct-to-patient allegations. Id. at *6-7 ("the manufacturer has no further duty to warn the patient directly") (citation and quotation marks omitted) (emphasis original). TwIqbal then nailed plaintiff's "conclusory statement" that the defendant failed to warn "physicians." Id. at *7.

Nor did plaintiff's warning claims plausibly allege causation. Employing judicial notice, the court observed that multiple companies manufactured this generic drug, id., and the prescribing physician could have relied on any (or indeed, none) of their warnings. Id. ("any one of the [manufacturers] may (or may not) have influenced or warned [the prescriber] (adequately or inadequately) concerning off-label use of [the drug]"). Finally, since plaintiff couldn't plead enough to satisfy TwIqbal, she certainly couldn't plead fraud-based claims with the specificity needed to satisfy Fed. R. Civ. P. 9(b). Id. at *8 (allegations were "quintessential examples of the 'naked assertion[s] devoid of further enhancement'") (citation omitted).

That makes three nifty Buckman-based wins – two of them appellate – in one week. Keep up the good work.

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

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