No Way Around It: The Need for Federal “Permission and Assistance” Can Preempt a State Tort Duty

Note: Butler Snow represents companies that have been parties to cases referenced in this article. The information in this article derives solely from an analysis of the publicly reported decisions.

In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is supreme, it preempts that duty.[i]

In 2011, the U.S. Supreme Court extended this principle and held that, even absent a federal prohibition, federal law would preempt a state tort duty if federal “permission or assistance” were required before the defendant could comply with the state duty. In PLIVA, Inc. v. Mensing,[ii] the plaintiff challenged the accuracy of the label on a generic drug. Under federal law, the manufacturer could not change the label without the permission of the Food and Drug Administration (FDA). In an opinion by Justice Clarence Thomas, the Court not only found preemption but also rejected a claim that the manufacturer had a duty to ask for the change.

The test, the Court said, was whether the defendant could “independently do under federal law what state law requires of it,”[iii] and:

[W]hen a party cannot satisfy its state duties without the federal government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, the party cannot independently satisfy those state duties for preemption purposes.[iv]

The Court dismissed contentions about what the FDA might do if a change had been requested as mere “conjectures.”[v]

Since Mensing, parties have debated the reach of this doctrine. While the answers have not been uniform, in general they have been as follows:

  • Is it limited to generic drug cases? No.
  • Is it limited to FDA cases? No.
  • Can it be avoided by arguing that the defendant should have simply stopped selling the drug or device? No.
  • Can it be avoided by arguing the defendant had a duty to act differently when the defendant first sought permission to market the drug or device? No.

Here are some of the leading decisions on both sides:

“Special assistance and permission” preemption is not limited to generic drug cases.

As would be expected, defendants have successfully invoked “special assistance and permission” preemption in cases (like Mensing)that challenge the composition or labeling of a generic drug.

In Metz v. Wyeth LLC,[vi] the United States District Court for the Middle District of Florida held that any claim that a generic drug manufacturer “should have redesigned metoclopramide to alleviate the risks associated with its long-term use” as well as any claim that it “should have pulled the generic version … from the market,” were preempted.[vii]

In Strayhorn v. Wyeth Pharms., Inc.,[viii] the United States District Court for the Western District of Tennessee decisively stated, “Mensing means what it says: all failure-to-warn claims against generic drug manufacturers are preempted if generic manufacturers cannot independently alter their warning labels.”[ix]

But the courts have not stopped there. They have also applied the doctrine to brand-name drugs in rejecting design defect claims, i.e. claims that the manufacturer should have changed the formulation or dosage of the drug or made some other “major change” to the drug’s design.[x] Such a change requires FDA permission, even though it is not necessarily required to change brand-name labeling.

For example, in Yates v. Ortho-McNeil Pharm., Inc.,[xi] the Sixth Circuit determined that a plaintiff’s design defect claim was preempted when the plaintiff’s state law claim would have required the defendant (a brand-name manufacturer) to change the product’s design.[xii] The Sixth Circuit held that the plaintiff’s claim was “clearly preempted” because “[q]uite simply, federal law prohibited defendants from decreasing the dosage of estrogen post-approval.” In other words, any such design change would require the FDA’s permission.[xiii]

In Barcal v. EMD Serono, Inc.,[xiv] the United States District Court for the Northern District of Alabama found that the plaintiff’s design defect claims were preempted because once the FDA approved the formulation of the prescription fertility drug at issue, the manufacturer could not change the drug’s composition without the FDA’s prior approval (i.e., the FDA’s special permission and assistance).[xv]       

In Robinson on Behalf of T.R. v. Eli Lilly & Co.,[xvi] the plaintiff’s design defect claim was that “the chemical makeup of Prozac … created the risk suffered by T.R.” In other words, the plaintiff claimed the formula of Prozac itself was defective.[xvii] The United States District Court for the Eastern District of Kentucky found that the plaintiff’s design defect claims were preempted because “Eli Lilly could not have independently made such fundamental changes to Prozac’s formula.”[xviii]

At issue in Gustavsen v. Alcon Laboratories, Inc.[xix] was whether the defendants could be required by state law to design the dropper tips of the containers dispensing their respective prescription eye drops in such a way as to dispense smaller drops (i.e., to dispense less solution).[xx] The United States District Court for the District of Massachusetts determined that because changes to the size or shape of the dropper tip would be “major changes” under the applicable FDA regulations,[xxi] such changes would require preapproval by the FDA. In other words, once the original container or container closure system was approved by the FDA, additional changes to the container closure system could not be made without the FDA’s special permission and assistance.[xxii] See also Mutual Pharmaceutical Co., Inc. v. Bartlett: (“[o]nce a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product’”). [xxiii]

“Special permission and assistance” preemption is not limited to FDA cases.

Courts have applied this conflict preemption principle in cases that have nothing to do with the FDA or with drugs or devices, which reinforces the view that it is not confined to generic drug cases.

In Horsemen’s Benevolent & Protective Ass’n-Ohio Div. Inc. v. DeWine,[xxiv] the Sixth Circuit Court of Appeals examined whether an Ohio statute allowing racetracks to “secure authorization to simulcast races [for purposes of off-track wagering] even if they have not obtained consent from the horsemen’s group” was preempted by a federal statute requiring written consent of the horsemen’s group to off-track wagering.[xxv] Applying Mensing, the Sixth Circuit found that the state and federal laws “directly conflict[ed]” and, as a result, the Ohio statute was preempted.[xxvi]

In Sikkelee v. Precision Airmotive Corp.,[xxvii] the Third Circuit Court of Appeals vacated a summary judgment ruling based on “field preemption” but remanded the case so that the district court could consider the application of “traditional conflict preemption principles.”[xxviii] Field preemption applies when “federal law leaves no room for state regulation” and when Congress has expressed “a clear and manifest intent to supersede state law” in a certain field.[xxix] With respect to conflict preemption, the Third Circuit drew an analogy between the issuance of “type certificates” by the Federal Aviation Administration (FAA) under the Civil Aeronautics Act and Federal Aviation Act[xxx] and the FDA’s preapproval process for pharmaceutical labeling, as well as the preapproval process for certain medical devices under the Federal Food, Drug and Cosmetic Act.[xxxi]

The court noted that the FAA issues a type certificate when it has determined that a product is “properly designed and manufactured, performs properly, and meets the regulations and minimum standards prescribed under [49 U.S.C. §] 44701(a).”[xxxii]

Further, with respect to medical devices, the court noted that “just as aircraft manufacturers may not make major changes to or deviate from their type certificates without the FAA’s sign-off,” medical device manufacturers are required to obtain approval from the FDA before deviating from an FDA-approved design.[xxxiii] The court recognized that under these “analogous preapproval scheme[s] … where manufacturers are unable to simultaneously comply with both federal and state requirements, state law design defect claims are conflict preempted …”[xxxiv]

Finally, the court confirmed that, “[u]ltimately, where a party cannot ‘independently do under federal law what state law requires of it,’ the state law is conflict preempted.”[xxxv] On remand, the United States District Court for the Middle District of Pennsylvania granted the manufacturer’s motion for reconsideration and entered summary judgment in the manufacturer’s favor.[xxxvi]

On a further appeal, however, the Third Circuit reversed the portion of the district court’s summary judgment opinion finding Sikkelee’s claims to be conflict-preempted.[xxxvii] The Third Circuit found that the manufacturer could have and in fact did change the design set forth in the type certificate. Thus, it was not like the generic manufacturers in Mensing and Bartlett “who were unable to deviate from the brand-name manufacturers’ labels.”[xxxviii]

In BP America Inc. v. Chustz,[xxxix] the United States District Court for the Middle District of Louisiana applied “impossibility preemption” to a Louisiana state law cease and desist order requiring removal of orphaned anchors, finding it was impossible for BP to comply with both Louisiana law and a federal on-scene coordinator’s prohibition.[xl] In doing so, the court noted that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.”[xli]

In Backus v. General Mills Inc.,[xlii] the United States District Court for the Northern District of California found that the plaintiff’s claims regarding “the use of trans fats in the form of partially hydrogenated oil (PHO) in their baking mix products” were preempted where such claims “deal[t] with regulation of exactly the same products under both state and federal law and [sought] to render PHOs illegal before the compliance date despite the FDA’s intentional setting of the compliance date in June 2018.”[xliii]

Preemption cannot be avoided by arguing that the defendant should have stopped selling the drug or device.

In Bartlett, supra, the Court held that a state law failure-to-warn claim was preempted by federal law that prohibited generic manufacturers from making any unilateral changes to a drug’s label. It rejected a claim that the defendant could comply with state law and not violate federal law if it stopped the sale of the drug altogether:

We reject this “stop-selling” rationale as incompatible with our preemption jurisprudence. Our preemption cases presume that an actor seeking to satisfy both his federal and state obligations is not required to cease acting altogether in order to avoid liability.[xliv]

Preemption cannot be avoided by arguing that the defendant had a duty to act differently before the FDA granted permission to market the drug or device.

The Sixth Circuit in Yates followed Mensing and rejected the plaintiff’s argument that no federal law would have prohibited defendants from designing a different drug before FDA approval:

To imagine such a preapproval duty exists, we would have to speculate that had defendants designed [the drug] differently, the FDA would have approved the alternate design. Next, we would have to assume that [plaintiff] would have selected this method of birth control. Further yet, we would have to suppose that this alternate design would not have caused [plaintiff] to suffer a stroke. This is several steps too far … [T]he ultimate availability to [plaintiff] is contingent upon whether the FDA would approve that alternate design in the first place … Defendants could not have complied with whatever preapproval duty might exist without ultimately seeking the FDA’s approval prior to marketing [the drug], and certainly prior to [plaintiff’s] use of the drug.[xlv]

This was not enough, however, to convince the court in Guidry v. Janseen Pharms., Inc.[xlvi] There, the United States District Court for the Eastern District of Louisiana expressed a concern that adhering to Yates’s rejection of the “preapproval” design defect theory would effectively foreclose Louisiana plaintiffs from ever bringing a defective design claim against drug manufacturers.[xlvii] The court went on to embrace the “preapproval” theory, holding that pursuant to the Louisiana Products Liability Act:

Louisiana law imposes a duty on all manufacturers to consider feasible, alternative designs and reasonably weigh the risks and utility of the final product before it leaves the manufacturer’s control. Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval. Far from impossible, the two are complimentary, preferable and perhaps necessary to protect the public health and assure the safety, effectiveness and reliability of drugs.[xlviii]

On this basis, the court found that “in the narrow, pre-FDA approval context, the plaintiff’s defective design claim is not preempted by federal drug law.”[xlix]

The United States District Court for the Southern District of Indiana also declined to follow Yates. In Warren v. Boehringer Ingleheim Pharmaceuticals, Inc.,[l] the court expressed its belief that the Sixth Circuit’s impossibility preemption analysis was too “simple” and failed to interpret Mensing correctly. The court concluded:

[B]ecause the manufacturers have neither identified the specific state and federal duties at stake in this case, nor shown clear evidence that, if FDA approval of the state-mandated change is required, such approval would be withheld, the manufacturers are not now entitled to dismissal based on impossibility preemption.[li]

On the other hand, in Gustavsen v. Alcon Labs., Inc.,[lii] discussed supra, the United States District Court for the District of Massachusetts, examining Yates and Guidry, found “the Sixth Circuit’s conclusion in Yates more consistent with [Mensing] and Bartlett.” Following Yates, the court found:

As in Bartlett, defendants here could not have marketed droppers that complied with state consumer protection and unjust enrichment laws in the manner plaintiffs advocate without the FDA’s prior approval. It is irrelevant that the defendants could have designed an entirely different product before they sought approval, which may never have been granted. … Therefore the court concludes that plaintiff’s claims are preempted.[liii]

In short, “special assistance and permission” preemption is not limited to generic drug cases—or FDA cases for that matter. Nor can this preemption be avoided by arguing that the defendant should have stopped selling the drug or device, or that the defendant should have acted differently before the federal agency in question gave permission for the defendant to act. From a defendant’s perspective, there is great potential to use this somewhat narrow area of the law strategically.

[i] Riegel v. Medtronic, 552 U.S. 312 (2008).

[ii] PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).

[iii] Id. at 620.

[iv] Id. at 623-24.

[v] Id. at 621.

[vi] 872 F. Supp. 2d 1335 (M.D. Fla. 2012).

[vii] Id. at 1341.

[viii] 887 F. Supp. 2d 799 (W.D. Tenn. 2012).

[ix] Id. at 813.

[x] In the context of FDA-approved Class III devices, manufacturers—like generic drug manufacturers—cannot change the design of a device without the “special permission and assistance” of the FDA. However, in Fronczak v. Depuy Orthopaedics, Inc., 2014 WL 5175857, at *1 (M.D. Fla. Oct. 14, 2014), the United States District Court for the Middle District of Florida was persuaded by the plaintiff’s argument that “uncertainties exist as to the applicability of Mensing’s preemption with regard to the distributors of medical devices”—a category including the non-diverse defendant in the case. The device at issue was the Class III ASRTM XL artificial hip prosthesis. See 21 CFR 888.330 (Hip joint metal/metal semi constrained, with an uncemented acetabular component, prosthesis). The court noted that in resolving “uncertainties about the applicable law in favor of the plaintiff[,] … The plaintiff need not have a winning case; rather, the plaintiff need have only a possibility of stating a valid cause of action in order for the joinder to be legitimate.” Id. at *2. Ultimately, the court concluded that

The question of a generic drug manufacturer’s ability to simultaneously comply with both state law and specific federal regulations governing pharmaceuticals is not analogous to the question of a distributor of a brand name medical device’s ability to comply with both Florida law and federal regulations governing medical devices … [Indeed,] “[t]here is a marked difference between a duty requiring a drug manufacturer to physically change its federally approved label and a duty requiring a distributor to warn a third party of what the federally approved label or warning on file with the FDA says.”

Id. at 3 (quoting Zaremba v. Orthopedics, Inc., 2014 WL 3057400, at *4 n.2 (M.D. Fla. July 7, 2014)). As a result, the court “appl[ied] a presumption against the exercise of federal jurisdiction” and remanded the case.

Id. This reasoning seems directly contrary to Mensing’s refusal to engage in “conjecture” as to what the FDA might or might not do.

[xi] 808 F.3d 281 (6th Cir. 2015).

[xii] Id. at 298.

[xiii] Id. at 298-99.

[xiv] 2016 WL 1086028, at *4 (N.D. Ala. Mar. 21, 2016).

[xv] Id. at *4. See Chambers v. Boehringer Ingelheim Pharms., Inc., 2018 WL 849081, at *4-5 (M.D. Ga. Jan. 2, 2018), rev’d in part on other grounds, 2018 WL 847246 (M.D. Ga. Feb. 13, 2018) (finding plaintiff’s failure-to-warn claims that that would have required a 110-mg dose of Pradaxa in certain circumstances—a dose that has not been approved by the FDA—were preempted because any such dosage changes would have required the FDA’s approval).

[xvi] 2018 WL 4039701 (E.D. Ky. Aug. 23, 2018).

[xvii] Id. at *6.

[xviii] Id. See generally Barcal v. EMD Serono, Inc., 2016 WL 1086028, at *4 (N.D. Ala. Mar. 21, 2016) (finding plaintiff’s design defect claims to be preempted because, once the FDA approved the formulation of the prescription fertility drug at issue, the manufacturer could not change the drug’s composition without the FDA’s prior permission).

[xix] 272 F. Supp. 3d 241 (D. Mass. 2017).

[xx] Id. at 249-50.

[xxi] See id. at 250-51 (discussing “‘reporting categories’ for changes to previously approved drug products: major, moderate and minor”). See also 21 C.F.R. § 314.70(b)(2)(iii) (major changes requiring preapproval by the FDA include “[c]hanges that may affect drug substance or drug product sterility assurance, such as changes in the drug substance, drug product or component sterilization method(s) or an addition, deletion or substitution of steps in an aseptic processing operation”); Supplements and Other Changes to an Approved Application, 69 Fed. Reg. 18728, 18745 (April 8, 2004) (explaining that “[c]hanges in the container closure system, even if minimal, may affect the sterility assurance of the drug product and are a major change.”).

[xxii] See also Thompson v. Allergan USA, Inc., 993 F. Supp. 2d 1007, 1013-14 (E.D. Mo. 2014) (concluding “that reducing the amount of medicine in each [prescription eye drop] vial is a major change requiring prior FDA approval” and, accordingly, plaintiff’s claims were preempted).

[xxiii] 570 U.S. 472 (2013).

[xxiv] 666 F.3d 997 (6th Cir. 2012).

[xxv] Id. at 999-1000 (citing Ohio Rev. Code § 3769.089(G) and 15 U.S.C. § 3004(a)).

[xxvi] Id. at 1000-01.

[xxvii] 822 F.3d 680, 703-04 (3d Cir. 2016).

[xxviii] Id. at 708.

[xxix] Id. at 687-88.

[xxx] Id. at 683-84.

[xxxi] Id. at 702-04.

[xxxii] Id. at 684 (quoting 49 U.S.C. § 44704(a)(1)).

[xxxiii] Id. at 704.

[xxxiv] Id. at 702-03 (citing Bartlett, 570 U.S. at 480; Mensing, 564 U.S. at 618).

[xxxv] Id. at 703 (quoting Mensing, 564 U.S. at 620).

[xxxvi] See 268 F. Supp. 3d 660 (M.D. Pa. 2017).

[xxxvii] 907 F.3d 701, 714 (3d Cir. 2018).

[xxxviii] Id.

[xxxix] 33 F. Supp. 3d 676 (M.D. La. 2014).

[xl] Id. at 694, 699-700.

[xli] Id. at 684 (quoting Mensing, 564 U.S. at 620) (citing Levine, 555 U.S. at 573).

[xlii] 2018 WL 6460441 (N.D. Cal. Dec. 10, 2018).

[xliii] Id. at *1, *5.

[xliv] Id. at 487.

[xlv] Yates, 808 F.3d at 299-300.

[xlvi] 206 F. Supp. 3d 1187 (E.D. La. 2016). See also Mullins v. Ethicon, Inc., 147 F. Supp. 3d 478 (S.D.W. Va. 2015) (refusing to find preemption in medical device case on ground that FDA clearance is “unrelated” to a state safety requirement).

[xlvii] Id.

[xlviii] Id. at 1209.

[xlix] Id.

[l] 2017 WL 3970666 (S.D. Ind. Sept. 8, 2017).

[li] Id. at 15.

[lii] 272 F. Supp. 3d 241 (D. Mass. 2017).

[liii] Id. at 255 (internal citation omitted).