February 05, 2016 Articles

Mullin' Over Preemption: Lohr, FDA Regulations, and Mullins

By Anonymous

Federal preemption of state law is one of the most significant defenses employed by drug and medical device manufacturers defending product liability lawsuits. The defense has risen in significance over the past decade on the heels of several Supreme Court decisions expanding the reach of the preemption doctrine. Today, a dispositive motion predicated on preemption is likely to be the first made, or faced, by a mass tort attorney in any nascent drug or medical device case. Therefore, it is important for attorneys, especially young attorneys, to understand the preemption doctrine, the federal drug and device regulatory regimes, and the relevant Supreme Court cases. Further, attorneys must stay abreast of additional developments in preemption law, whether precedent-setting appellate and Supreme Court decisions or trial court opinions construing the precedent.

Demonstrative of the doctrine’s popularity, Southern District of West Virginia Judge Joseph R. Goodwin has entertained preemption motions in the Ethicon multidistrict litigation on four separate occasions. At issue in Ethicon is the design of tension-free vaginal tape (TVT), a mesh medical device approved by the U.S. Food and Drug Administration (FDA) via the section 510(k) process. See Mullins v. Ethicon, Inc., 2015 U.S. Dist. LEXIS 161336, at *1 (S.D. W. Va. Dec. 2, 2015). In 2014, Judge Goodwin denied three express preemption motions relying on the Supreme Court’s decision in Medtronic, Inc. v. Lohr, 518 U.S. 470, 478 (1996). More recently, on December 2, 2015, Judge Goodwin denied the defendant’s fourth implied preemption motion, concluding that it is possible for a section 510(k) device manufacturer to simultaneously comply with state tort law and federal regulations. Mullins, 2015 U.S. Dist. LEXIS 161336, at *2. The Mullins decision was only the second to consider whether impossibility preemption bars state tort claims against section 510(k) device manufacturers—the other being In re Depuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 2014 U.S. Dist. LEXIS 97743 (N.D. Tex. July 18, 2014)—and the first to give the matter extended analysis. Thus, the decision presents a good opportunity to review the federal drug and device regulatory schemes, examine the Supreme Court’s preemption decisions, and analyze the Mullins opinion.

Preliminarily, two principles guide courts considering whether preemption renders a state law without effect. First, “the purpose of Congress is the ultimate touchstone in every pre-emption case”; second, “the historic police powers of the States [are] not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Wyeth v. Levine, 555 U.S. 555, 565 (2009) (citing Lohr, 518 U.S. at 485). With these twin principles in mind, the Supreme Court has considered whether a variety of federal regulatory schemes preempt state products liability laws.

Brand-name drugs. Under the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq., drug manufacturers must obtain approval from the FDA before marketing their drugs in interstate commerce. To obtain approval, a manufacturer must submit a New Drug Application (NDA) to the FDA, initiating a protracted review process during which the FDA scrutinizes the drug for safety and effectiveness. 21 U.S.C. § 355(b)(1)(A); 21 C.F.R. § 314.50(d)(2), (5) (2012). If the NDA is approved, the manufacturer may place the drug on the market. Thereafter, any changes the manufacturer seeks to make to the drug’s design or label must first receive additional FDA approval. 21 U.S.C. § 355; 21 C.F.R. § 314.105(b). The FDA’s “changes being effected” regulation is an exception to this last rule. 21 C.F.R. § 314.70(c)(6)(iii)(A), (C). The rule permits a manufacturer unilaterally to strengthen the language of its drug label to reflect “newly acquired information,” provided it simultaneously files a supplemental application. Id. However, in theory, if not in practice, such changes may be short-lived, as they remain subject to the FDA’s subsequent approval. 21 C.F.R. § 314.70(c)(5).

In Wyeth, the Supreme Court considered whether the FDA’s restriction on changes to brand-name drug labels preempts state failure-to-warn actions. 555 U.S. at 564. The majority concluded that because a manufacturer can unilaterally strengthen its drug label pursuant to the “changes being effected” process, it is possible to improve an inadequate drug label (as required by state tort law) and remain in compliance with FDA restrictions on drug alterations. Id. at572–73. Therefore, and in light of the presumption against preemption, state failure-to-warn actions do not trigger preemption “absent clear evidence that the FDA would not have approved a change” thereafter. See id. at 571. Levine was solely a warning case. The Court has yet to consider whether state design defect actions against brand-name drug manufacturers are preempted. For a recent appellate decision on that issue, see Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015).

Generic drugs. To provide consumers with a broader range of drug choices, Congress passed the Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585, in 1984. The act provides for the expedited approval of generic drugs without submission of an NDA if the drug is equivalent in ingredient, labeling, safety, and efficacy to a previously approved brand-name drug. 21 U.S.C. § 355(j)(2)(A). Generic drugs must maintain equivalency, in both composition and labeling, as long as they remain on the market. See 21 U.S.C. §§ 355(j)(2)(A)(v), 355(j)(4)(G). This “duty of sameness” precludes generic manufacturers from taking advantage of the “changes being effected” process, which would be disruptive of label equivalence. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2575 (2011). If a generic manufacturer wants to strengthen its drug label, it must propose the change to the FDA and then work with the agency to create a new label for both the brand-name and generic drug. See id. There is no formal process for making a label or design change to a generic drug.

In Mensing, the Supreme Court held that preemption bars state failure-to-warn actions because a generic manufacturer cannot independently satisfy its state duty to strengthen an inadequate drug label without first obtaining the federal government’s “special permission and assistance.” Id. at 2580–81. The Court distinguished Wyeth because the generic manufacturer cannot avail itself of the “changes being effected” process without violating the “duty of sameness.” See id. at 2578. It additionally held that the preliminary act of proposing a change to the drug label to the FDA would not have satisfied the manufacturer’s state duty. See id. Thus, the Court limited Wyeth to situations in which the manufacturer can independently and immediately “strengthen its label in compliance with its state tort duty.” Id. at 2581.

In Mutual Pharmaceutical Co. v. Bartlett, the Supreme Court applied its Mensing rationale to generic drug designs, holding that preemption bars state design defect laws because it is impossible for a generic manufacturer independently to improve the design of its drug and remain in compliance with the federal “duty of sameness.” 133 S. Ct. 2466, 2476–77 (2013). Notably, in Bartlett the Court rejected the plaintiffs’ additional argument that it was possible for the generic manufacturer to follow both state and federal law by simply exiting the market, finding the “stop-selling” rationale “incompatible with our pre-emption jurisprudence.” Id. at 2477. The Court observed that a defendant’s ability to stop the conflicting conduct altogether had never previously avoided preemption, and embracing the rationale would render “the vast majority—if not all—of the cases in which the Court has found impossibility pre-emption, [] wrongly decided.” Id. at 2478.

Medical devices. Congress enacted the Medical Device Amendments of 1976 (MDA), 90 Stat. 539, to the FDCA “to provide for the safety and effectiveness of medical devices intended for human use.” To achieve that goal, the MDA established three regulatory classes based on the degree of federal oversight necessary to ensure a device’s safety and effectiveness. 21 U.S.C. § 360c. Class III devices (e.g., pacemakers, hip implants, bone growth hormone) are subject to the most extensive oversight, followed by Class II devices (e.g., surgical mesh, knee implants, spinal fixation devices) and Class I devices (e.g., bandages, examination gloves). 21 U.S.C. § 360c(a)(1)(A).

For devices that fall into Class III, section 515 of the MDA requires a rigorous Premarket Approval Application (PMA) not unlike the NDA process. The FDA grants approval of a PMA only if the device design, labeling, and manufacturing provide a “reasonable assurance” of the device’s safety and effectiveness. 21 U.S.C. § 360e(d). After approval, a manufacturer may sell the device but must obtain FDA permission if it wishes to make any additional changes that affect the device’s safety, effectiveness, or labeling. 21 U.S.C. § 360e(d)(6)(A)(i). To obtain FDA permission, a manufacturer must submit an application for supplemental premarket approval, evaluated under criteria similar to that used in the PMA process. 21 U.S.C. § 360e(d)(6).

An exception to the MDA’s review process exists for Class II and III devices that were on the market at the time the MDA became effective in 1976. Pursuant to the MDA’s grandfather clause, previously sold devices may remain on the market without undergoing FDA review until the FDA promulgates a regulation specifically requiring that device’s premarket approval. 21 U.S.C. §§ 360c(f)(1), 360e(b)(1). To avoid the monopoly power that the grandfather clause would grant pre-1976 devices, Congress also provided that manufacturers of devices similar to grandfathered devices may circumvent the review process. 21 U.S.C. § 360c(f)(1)(A). In what is known as the section 510(k) process, if the FDA determines by limited review that the device is “substantially equivalent” to a grandfathered device, the device may immediately enter the market. 21 C.F.R. § 807.92(a)(3). Note, however, that section 510(k)’s “limited review” is “by no means comparable to the PMA.” Lohr, 518 U.S. at 478–89 (“In contrast to the 1,200 hours necessary to complete a PMA review, the § 510(k) review is completed in an average of only 20 hours.”). After approval, if a section 510(k) device manufacturer wishes to “significantly change[] or modif[y the device] in design, components, methods of manufacture, or intended use,” it must first submit a section 510(k) notification. 21 C.F.R. § 807.81(a)(3) (significant changes include anything that “significantly affect[s] the safety or effectiveness of the device”). A section 510(k) notification will be approved if the FDA determines that the device will remain substantially equivalent to the grandfathered device. 21 C.F.R. § 807.81(a)(3).

Congress included an express preemption clause in the MDA barring the states from establishing any “requirement . . . which is different from, or in addition to, any requirement applicable under [the MDA], and [] which relates to the safety or effectiveness of the device. . . .” 21 U.S.C. § 360k(a).

In Lohr, the Supreme Court held that the MDA’s preemption clause does not bar state tort actions against section 510(k) device manufacturers. Justice Stevens, writing for a plurality, began by opining that a categorical bar on state actions against device manufacturers based on the language of the MDA’s preemption clause “is implausible.” Lohr, 518 U.S. at 487. The Court explained that it could not have been the intent of Congress for the MDA to bar consumers from pursuing remedies for injuries due to defective devices while in the same breath improving consumer protections. See id. Thus, the Court interpreted the MDA’s proscription of state-established “requirements” not to cover state tort claims. See id. The Court further observed that even if the clause did apply to state actions, section 510(k) does not establish “specific safety requirements,” only equivalency requirements. See id. at 494. Therefore, even if state product liability actions are “safety requirements,” they do not conflict with section 510(k)’s equivalency requirements. See id. Finally, the Court noted that “[n]othing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.” Id. at 495.

In Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Court unanimously held that fraud-on-the-FDA claims against a section 510k device manufacturer are impliedly—not expressly—preempted because allowing state courts to adjudicate manufacturers’ compliance with the FDCA regulatory scheme would “skew” the “delicate balance of statutory objectives.” Id. at 348. Lohr, an express preemption case, did not apply because “neither an express pre-emption provision nor a saving clause ‘bar[s] the ordinary working of conflict pre-emption principles.’” See id. at 352 (quoting Geier v. American Honda Motor Co., 529 U. S. 861, 869 (2000)). One conflict the Court recognized was that fraud-on-the-FDA claims might result in a prophylactic “deluge” of information to the FDA, impeding the agency’s review process. See id. at 351. Further, plaintiffs’ claims would be duplicative because the FDA “has at its disposal a variety of enforcement options.” Id. at 350–51. Finally, the Court noted that the presumption against preemption did not apply because fraud-on-the-FDA claims are predicated on a duty that arises solely from “the relationship between a federal agency and the entity it regulates.” Id. at 352–53; 21 U.S.C. § 337(a).

In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court considered whether the MDA’s preemption clause bars state actions against PMA-reviewed device manufacturers. The Court began by finding state product liability laws to be safety requirements. Id. at 324. Because the PMA process (unlike the section 510(k) process) “is a safety review” and imposes significant, individualized device-safety requirements, the Court concluded that the MDA’s preemption clause bars state tort claims against PMA-reviewed device manufacturers. See id. at 330. The Court also held that whether Congress intended to preempt state claims is irrelevant to the analysis because the preemption clause is clear. See id. at 325. In dicta, however, the Court noted that nothing bars “a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Id. at 330 Together with Buckman, Riegel’s parallel-claim dicta “create[d] a narrow gap through which a plaintiff’s state law [PMA-approved device] claim must fit if it is to escape express or implied preemption.” Bryant v. Medtronic, Inc., 623 F.3d 1200, 1204 (8th Cir. 2010).

Having reviewed the FDA’s regulatory schemes and the Supreme Court’s relevant preemption decisions, we turn to the decision in Mullins.

Judge Goodwin structured his opinion around the twin principles of preemption analysis, beginning with the presumption against preemption applying because (unlike in Buckman) the section 510(k) review process is a “quintessential example of Congress legislating in a field [(public safety)] historically occupied by state police powers. . . .” Mullins, 2015 U.S. Dist. LEXIS 161336, at *17. Turning to the intention of Congress, Judge Goodwin looked to the MDA’s preemption clause and the decision in Lohr, concluding that Congress did not intend to impliedly preempt state claims. See id. at *17–18. In reasoning contrary to Buckman, 531 U.S. at 352, that express and implied preemption operate independently, Mullins held that because Congress explicitly defined the scope of preemption in the MDA, Congress implied that it did not intend to preempt state law outside the clause’s scope. See id. at *18. Therefore, because Lohr established that state actions against section 510(k) device manufacturers are not within the clause’s scope, Congress did not intend to preempt the plaintiffs’ claims. See id. (citing Lohr, 518 U.S. at 494). To further support this conclusion, Judge Goodwin again cited Lohr for its discussion of the disparity in safety requirements between the PMA and section 510(k) processes. See id. at *19–20 (citing Lohr, 518 U.S. at 477–78). That disparity, Judge Goodwin reasoned, evinced a congressional intent that section 510(k) only prevent grandfathered devices from gaining monopoly power, and not to otherwise affect state or federal safety legislation. See id. at *20–21. Therefore, Congress did not intend to preempt state tort law.

Having found that the two guiding principles of preemption disfavored preempting the plaintiffs’ claims, Judge Goodwin concluded that preemption did not bar the plaintiffs’ claims. He began by noting that “the core of any preemption analysis is whether state law undermines the effectiveness of federal legislation.” Id. at *14. In Mullins, West Virginia state law requires a product to be reasonably safe, while the federal section 510(k) process requires a product to be substantially equivalent to a grandfathered device. See id. at *7. Thus, “the state safety requirement does nothing to undermine or interfere with the federal law because the federal law does not make specific demands on safety.” Id. Further, Judge Goodwin reasoned that the FDA’s discretion to refuse changes to approved section 510(k) devices does not give rise to preemption. In support, he cited Wyeth, in which the Supreme Court concluded that FDA discretion did not trigger preemption “absent clear evidence that the FDA would not have approved a change. . . .” See id. at *21 (quoting Wyeth, 555 U.S. at 571). Thus, the Supreme Court established that the relevant question is whether there is a direct conflict between state and federal law, not simply “contact” between the two. See id. at *21–22. Judge Goodwin also relied on a distinction between Bartlett / Mensing and Mullins. He observed that, unlike a section 510(k) device manufacturer’s duties under the MDA, a generic drug manufacturer’s “duty of sameness” directly conflicts with the state duty to improve unsafe drug designs or labels. See id. at *23. In contrast, there is no federal law prohibiting design changes to section 510(k) medical devices, only a notification and approval process. See id. at *23–24. Further, that process is concerned with equivalence, not safety. See id.

In analysis, Judge Goodwin’s decision begins on solid ground with the presumption against preemption. In Lohr, Wyeth, and Mensing, the Supreme Court applied a presumption against preemption triggered by the conflict between federal law and “state regulation of matters of health and safety.” See, e.g., Lohr, 518 U.S. at 485. Further, while Riegel and Bartlett did not consider whether the presumption applied, Riegel concerned only express preemption and Bartlett was a sequel to Mensing, in which the Supreme Court discussed the presumption at length. Thus, neither exception counsels against the application of the presumption in Mullins. Finally, unlike in Buckman, the Ethicon plaintiffs’ actions are predicated on a state duty to provide the consumer with safe products, not a duty arising out of the FDA’s relationship to Ethicon. See Buckman, 531 U.S. at 347. Therefore, the presumption against preemption was properly applied in Mullins. However, whether Congress intended to preempt the plaintiffs’ claims is more debatable.

In concluding that Congress did not intend to preempt state actions against section 510(k) device manufacturers, Judge Goodwin relied on the analysis in Lohr. But Lohr was solely concerned with whether the plaintiffs’ claims fell within the MDA’s preemption clause. In Lohr, the plaintiffs’ claims survived because the Supreme Court concluded that Congress did not intend for “safety requirements” to include section 510(k)’s equivalency requirements. Lohr, 518 U.S. at 487. The Supreme Court made no pronouncement as to whether there was a conflict between state and federal requirements. In contrast, the question before Judge Goodwinwas whether there are any federalrequirements that conflict with state tort actions. See Mensing, 131 S. Ct. at 2580–81.Thus, the court’s reliance on Lohr’s analysis of the federal section 510(k) requirements and congressional intent is questionable.

Judge Goodwin’s conclusion that impossibility preemption does not bar the plaintiffs’ claims is vulnerable to criticism. According to the decision, there is no preemption inquiry unless state law “poses some impediment to federal law. . . .” Mere “[c]ontact is not conflict.” Mullins, 2015 U.S. Dist. LEXIS 161336, at *14–15. Yet, Judge Goodwin’s construction of impossibility preemption left out the Supreme Court’s statement in Mensing that impossibility arises when a manufacturer cannot unilaterally act without the federal government’s “special permission and assistance.” The court addressed this omission, explaining that the language of Mensing was not a new standard for preemption, only a rhetorical flourish. See id. at *22. In support of this reasoning, Judge Goodwin observed that in two subsequent Supreme Court opinions citing Mensing, Wos v. E.M.A., 133 S. Ct. 1391 (2013), and Bartlett, 133 S. Ct. at 2473, the Supreme Court did not reiterate “special permission and assistance,” but it returned to the language of “direct conflict” and “federal prohibition.” See Mullins, 2015 U.S. Dist. LEXIS 161336, at *22. But the absence of “special permission and assistance” in subsequent decisions does not mean the Supreme Court abrogated that standard.

Further, Judge Goodwin’s interpretation runs counter to Wyeth, which, ironically, he cited for the proposition that preemption is not triggered in the absence of a direct conflict or clear evidence that the FDA would not approve the alteration of a drug label. See id. at *21. In doing so, Judge Goodwin left out a crucial distinction between the brand-name drug scheme in Wyeth and the section 510(k) device process in Mullins: Brand-name drug manufacturers can change their labels unilaterally and then seek FDA ratification, whereas section 510(k) device manufacturers are prohibited from materially changing device designs or labels without prior—not subsequent—FDA approval. Thus, because state law requires a device manufacturer to improve its unsafe product design, it is impossible for the manufacturer immediately to comply with state law before receiving the FDA’s “special permission.” In contrast, a brand-name manufacturer can unilaterally execute a change in its product label that will remain unless the FDA does not grant “special permission.” That distinction undermines Judge Goodwin’s assertion. Further, even ignoring Mensing’s “special permission and assistance” language, Mensing established elsewhere that there is an “irremediable conflict” where state law “demand[s] a safer label” and the only unilateral step a manufacturer can take is to “communicate with the FDA about the possibility of a safer label.” Mensing, 131 S. Ct. at 2577. That same irremediable conflict exists where state law demands a safer design and the only unilateral step a section 510(k) device manufacturer can take is to submit a notification to the FDA requesting approval for a design change. See id. Thus, Judge Goodwin’s interpretation of Mensing may have been mistaken.

Federal preemption of state product liability claims is an increasingly complex aspect of mass tort litigation. Despite its complexity, however, practitioners frequently encounter the doctrine due to the absolute nature of a successful defense. Further, Supreme Court cases over the past two decades have cumulatively invigorated the doctrine and rendered it a viable argument for early dismissal of plaintiffs’ claims. Eventually, the Supreme Court may resolve the questions presented by impossibility preemption and section 510(k) and brand-name claims, or Congress will amend its legislation to avoid preemption altogether. Until then, however, the doctrine will remain a constant feature of mass tort lore that young attorneys seeking to enter this field should take care to master. In accomplishing that task, young attorneys should keep current with legal and administrative developments in mass torts—for example, by subscribing to the FDA’s Press Announcements page and to mass-tort-oriented legal blogs.

Keywords: mass torts litigation, impossibility preemption, Ethicon, section 510


Copyright © 2018, American Bar Association. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or downloaded or stored in an electronic database or retrieval system without the express written consent of the American Bar Association. The views expressed in this article are those of the author(s) and do not necessarily reflect the positions or policies of the American Bar Association, the Section of Litigation, this committee, or the employer(s) of the author(s).