Nationwide Flux: Mensing's Impact on State Tort Claim Pre-Emption and Generic Pharmaceuticals
Perry, Debra M., Merin, Sara F., Defense Counsel Journal
This article originally appeared in the August 2012 Drug, Device and Biotechnology Committee Newsletter.
Since the United States Supreme Court's holding in PLIVA v. Mensing (1) that federal regulations governing generic pharmaceuticals pre-empt state law failure-to-warn tort claims, the law governing pre-emption in regard to generic pharmaceuticals has been in flux within United States courts. This article addresses Mensing itself, lower court decisions interpreting Mensing, and recent legislation proposed as a response to Mensing, which would change the framework of the U.S. Food and Drug Administration's (FDA) regulation of generic pharmaceutical manufacturers.
Mensing was the consolidation of two cases in which plaintiffs alleged state law failure to warn claims against generic pharmaceutical manufacturers. (2) Each plaintiff claimed that her longterm use of metoclopramide "caused her tardive dyskinesia and that the [generic manufacturers of the metoclopramide] were liable under state law (specifically that of Minnesota and Louisiana) for failing to provide adequate warning labels." (3) They argued that the generic drug manufacturers should have and failed to change their labels in light of "mounting evidence" showing that tardive dyskinesia was a larger risk than was stated on the metoclopramide label. (4) The generic manufacturer defendants argued that plaintiffs' state law tort claims were pre-empted by federal statutes and FDA regulations that "required them to use the same safety and efficacy labeling as their brand-name counterparts and that it was impossible to simultaneously comply with both federal law and any state tortlaw duty that required them to use a different label." (5)
In an opinion delivered by Justice Thomas, the Supreme Court held that "federal drug regulations applicable to generic pharmaceutical manufacturers directly conflict with, and thus preempt," state law failure to warn claims. (6) Pre-emption occurs where "it is 'impossible for a private party to comply with both state and federal requirements.'" (7) As discussed below, there remains uncertainty as to the breadth of the holding in Mensing, namely whether it is limited to failure to warn claims or if it causes state law design defect product liability claims to be pre-empted as well.
The pre-emption question in Mensing was framed as applying to generic pharmaceutical manufacturers only, because regulations governing labeling for brand-name and generic manufacturers differ. (8) "A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label." (9) "A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name's." (10) Thus, federal regulations prevent generic pharmaceutical manufacturers "from independently changing their generic drugs' safety labels." (11)
The conflict in Mensing arose because, despite the federal regulations, the state tort law at issue (which has corollaries throughout the country) "place[d] a duty directly on all drug manufactures to adequately and safely label their products." (12) As a result, it was impossible for the generic pharmaceutical manufacturer defendant to comply with both federal and state law:
If the [generic pharmaceutical m]anufacturers had independently changed their labels to satisfy their state law duty, they would have violated federal law.... [S]tate law imposed on the [generic pharmaceutical m]anufacturers a duty to attach a safer label to their generic [pharmaceutical at issue]. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. See, e.g., 21 C.F.R. [section] 314.510(b)(10). Thus, it was impossible for the generic pharmaceutical manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same. (13)
In so finding, the Court explained that, "[w]hen the 'ordinary meaning' of federal law blocks a private party from independently accomplishing what state law requires, that party has established pre-emption[,]" rejecting an argument that the generic pharmaceutical manufacturers had the ability to work with the FDA to have the brand-name product's (and thus the generic product's) label changed. (14) Specific to the situation of generic pharmaceutical manufacturers, the Court stated that "[b]efore the [generic pharmaceutical m]anufacturers could satisfy the state law, the FDA--a federal agency--had to undertake a special effort permitting them to do so. To decide these cases, it is enough to hold that when 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, that party cannot independently satisfy those state duties for pre-emption purposes." (15)
The Court recognized the divergence between its decision in Mensing and its 2009 holding in Wyeth v. Levine that found no pre-emption for brand-name pharmaceuticals. In expressly pointing out the different treatment accorded to what are chemically the same products, the Court recognized that its holding in Mensing may "make little sense" to Plaintiffs. (16) The Court explained that the different outcomes were based on the different regulatory treatment of the two categories of pharmaceuticals, which resulted from the legislative choice to regulate generic drugs differently to "bring more drugs more quickly and cheaply to the public." (17) The Supreme Court has not addressed pre-emption and generic pharmaceuticals since.
The application of Mensing by lower courts has not been consistent. Most notably, lower courts are divided on whether Mensing strictly applies to failure to warn claims or if it extends to cause the pre-emption of design defect claims against manufacturers of generics, and that split continues to develop. For example, the First Circuit in Bartlett v. Mutual Pharmacy, found that design defect claims were not preempted, reasoning that the generic pharmaceutical manufacturer had a choice not to make the product at all: "a generic maker can avoid defective warning lawsuits as well as design defect lawsuits by not making the drug; and while PLIVA is itself a limited departure from a general rule of Wyeth, an extension of PLIVA to design defect claims would comprise a general rule for generics (although not one PLIVA expressly adopted)." (18) In so finding, the court stated that only the Supreme Court can decide whether the Mensing pre-emption exception for failure to warn claims extends to design defect claims and noted the split among courts. (19) Other courts have echoed that this is an "open question of law" and explained that design and warning defect cases raise different questions for pre-emption purposes. (20) However, Bartlett's reasoning was expressly rejected by the United States District Court for the Eastern District of Kentucky in In re Darvocet, Darvon & Propoxyphene Products' Liability Litigation, (21) when it dismissed all remaining claims against generic pharmaceutical defendants in that MDL. (22) Similarly, the United States District Court for the District of Vermont dismissed design defect claims as pre-empted after finding that "[t]he Generic Defendants' 'federal duty of sameness,'  therefore applies to the design or composition of the drug as well as to its labeling. Applying the Mensing holding requires dismissal of the Lymans' design claims as well." (23) The Lyman court is not alone in so holding; other courts have similarly found that "the 'federal duty of 'sameness,"  also applies in the context of generic drug design, and federal law preempts state laws imposing a duty to change a drug's design on generic drug manufacturers." (24)
Courts are also addressing other questions raised by Mensing, including what constitutes a generic manufacturer under Mensing. As an example, a federal district court in New Jersey found that Mensing extends to bar failure to warn claims against authorized distributors of a branded product due to the authorized distributor having no power to change the pharmaceutical's labeling. (25)
In a departure from what is developing into a rule of general divergence, courts appear to be consistently rejecting plaintiffs' attempts to use Mensing as a means of causing brand-name manufacturers to be liable for other companies' generic pharmaceutical products, which would result in a reversal of courts' general rejection of innovator liability. (26) As the Sixth Circuit plainly stated in Smith v. Wyeth, "[a]s have the majority of courts to address this question, we reject the argument that a name-brand drug manufacturer owes a duty of care to individuals who have never taken the drug actually manufactured by that company." (27)
While the courts continue to address the changed landscape caused by Mensing, a bill has been presented in both houses of Congress that would legislatively un-do the pre-emption found by the Supreme Court. (28) The Patient Safety and Generic Labeling Improvement Act was filed in the Senate by Patrick Leahy of Vermont and a corollary was introduced by Representative Christopher Van Hollen of Maryland in the House of Representatives. The bill proposes amending Section 505(j) of the federal Food, Drug, and Cosmetic Act (29) to add an additional section that expands the labeling abilities of generic pharmaceutical manufacturers to permit them to change the labeling of a pharmaceutical. The bill proposing adding the following language to the statute:
(11)(A) Notwithstanding any other provision of this Act, the holder of an approved application under this subsection may change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application under subsection (b). (B) In the event of a labeling change made under subparagraph (A), the Secretary may order conforming changes to the labeling of the equivalent listed drug and each drug approved under this subsection that corresponds to such listed drug. (30)
Thus, the bill authorizes generic pharmaceutical manufacturers to act on the information that they are presently required to gather regarding their products to change labels when necessary. (31) The generic manufacturer would be required to use the same methods as the original manufacturer to implement a labeling change, namely the "Changes Being Effected" process, which allows a change to be implemented while the proposal for that change is still undergoing FDA review. (32) Additionally, after the change is made, the bill authorizes the FDA to "order conforming changes across equivalent drugs to ensure consistent labeling among products." (33) As a result, for a period of time at a minimum, the generic label could be different from that of the brand-name product. (34)
The bill is framed as a consumer protection effort, with Senator Leahy explaining in his introduction of the bill on the Senate floor that it is a direct response to Mensing's creating "a troubling inconsistency in the law governing prescription drugs[.]" (35) Senator Leahy explained Mensing's effect as:
If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version ... she is unable to seek compensation for her injuries. The result is a two-track system that penalizes consumers of generic drugs even though many consumers have no control over which drug they take, because their health insurance plan or state laws require them to take generics if they are available. (36)
Both bills were introduced on April 18, 2012 and have been referred to committee. No action has been taken. The sponsor and all seven co-sponsors of the Senate bill are Democrats, as are the sponsor and the co-sponsor of the House bill. (37) While the partisan sponsorship of the bill gives pause as to its likelihood of passage, it has strong support outside of Congress. Notably, the Attorney Generals of 41 states have come out in support of the bill along with the powerful interest groups, including the AARP. (38)
In summary, the full impact of Mensing remains undetermined. Absent the unlikely enactment of the Patient Safety and Generic Labeling Improvement Act, the success of other not-yet-proposed Congressional action, or the Supreme Court's granting certiorari on a case that clarifies Mensing's scope, courts will likely to continue to divergently apply the doctrine of pre-emption to state law tort claims involving generic pharmaceuticals. The most likely outcome is that the still nascent development of case law within the Courts of Appeals will likely provide different guidelines based on the Circuit within which a case is pending.
(1) -- U.S. --, 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011).
(2) Id. at 2573.
(6) Id. at 2572.
(7) Mensing, 131 S. Ct. at 2577 (quoting Freightliner Corp. v. Myrick, 514 U.S. 230, 287, 115 S. Ct. 1483, 131 L. Ed. 2d 385 (1995)).
(8) Id. at 2574 (citations omitted); see also id. at 2581 (explaining how the state tort failure to warn claim in Wyeth v. Levine, 555 U.S. 555, 559-560, 129 S. Ct. 1187, 173 L. Ed. 2d 41 (2009), differed because a brand-name pharmaceutical manufacturer could comply with both federal and state law).
(9) Id at 2574 (citations omitted).
(10) Id. at 2574 (citations omitted).
(11) Id. at 2577.
(12) Id. at 2577.
(13) Id. at 2578.
(14) Id. at 2580.
(15) Mensing, 131 S. Ct. at 2580-2581.
(16) Id. at 2582.
(17) Id. at 2582.
(18) Bartlett v. Mutual Pharm. Co., Inc., 678 F.3d 30, 38 (1st Cir. 2012). On July 31, 2012, Mutual Pharmaceutical Company petitioned the Supreme Court for a writ of certiorari.
(19) Id. at 37-38.
(20) See, e.g., Halperin v. Merck Sharp & Dohme Corp., Docket No. No. 11 C 9076, 2012 U.S. Dist. LEXIS 50549, *11-*12 (N.D. Ill. Apr. 10, 2012) ("Illinois law does not base [the wholesale drug distributor's] potential liability on any failure to comply with a state law duty, like the affirmative duty to warn at issue in Mensing" and noting that the wholesale drug distributor is being sued for its place in the chain of commerce, not "for violating a state law duty to design safe pharmaceuticals and, thus, no conflict arises").
(21) MDL Docket No. 2226, 2012 U.S. Dist. LEXIS 89994 (E.D. Ky. June 22, 2012).
(22) Id. at *38-*39.
(23) Lyman v. Pfizer, Inc., No. 2:09-cv-262, 2012 U.S. Dist. LEXIS 13185, *12 (D. Vt. Feb. 3, 2012) (citations omitted).
(24) In re Pamidronate Prods. Liab. Litig., Docket No. 09-MD-2120, 2012 U.S. Dist. LEXIS 10901, *11 (E.D.N.Y. Jan. 30, 2012); see also, e.g., In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig., MDL No. 2226, 2012 U.S. Dist. LEXIS 30593, *106-*107 (D. Ky. Mar. 5, 2012) (dismissing "wrongful marketing" claims "based on strict liability design defect, negligent design, negligent marketing, and breach of implied warranty" after reasoning that they "are all based on the allegedly defective design of the drug" and preempted under the reasoning of Mensing).
(25) In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., MDL No. 2243, Docket No. 08-cv-0008, 2012 U.S. Dist. LEXIS 5817, *26-*27 (D.N.J. Jan. 17, 2012).
(26) E.g., Smith v. Wyeth, Inc., 657 F.3d 420, 423-424 (6th Cir. 2011); Phelps v. Wyeth, Inc., No. 09-CV-6168, 2011 U.S. Dist. LEXIS 154631, *4-*8 (D. Or. Nov. 11, 2011) (Mensing does not change Oregon law that a manufacturer cannot be held liable for injuries caused by its generic competitor's products); Metz v. Wyeth LLC, No. 8:10cv-2658, 2011 U.S. Dist. LEXIS 135667, *6-*7 (M.D. Fla. Nov. 18, 2011) (explaining that the Fourth Circuit's decision in Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), remains good law following Mensing, and that Florida law provides that, "irrespective of whether consumers could recover from generic drug manufacturers, a brand name manufacturer simply had no duty of care to individual consumers that did not use the named brand manufacturer's product"); Coundouris v. Wyeth, ATL-L-1940-10 6-7 (N.J. Super. Law Div. June 26, 2012) (slip op. 6-7) (applying New Jersey law wherein "an essential element of a plaintiff's prima facie products liability action case is proof that the manufacturer actually produced the product which gave rise to the plaintiff's injury[,]" to dismiss claims against brand-name manufacturers of the generic pharmaceuticals ingested by plaintiffs stating that, "Mensing did not address or impact ... whether a brand-name manufacturer owes a duty to a patient who ingested a drug that the brand-name manufacturer did not make or sell. Because Mensing did not alter New Jersey law, the [New Jersey Product Liability Act] and case law continue to govern").
(27) Smith, 657 F.3d at 423-424.
(28) See 158 CONG. REC. No. 56, S2498 (daily ed. Apr. 18, 2012).
(29) 21 U.S.C. 355(j).
(30) S. 2295; H.R. 4384.
(31) See S. 2295; 158 CONG. REC. No. 56, at S2498.
(32) See S. 2295; 158 CONG. REC. No. 56, at S2498.
(33) See S. 2295; 158 CONG. REC. No. 56, at S2498.
(34) See 158 CONG. REC. No. 56, at S2498.
(37) S. 2295; H.R. 4384.
(38) Letter from the National Association of Attorneys General to Senator Patrick J. Leahy and Senator Al Franken (May 11, 2012) (signed by 41 Attorneys General), available at http://www.naag.org/sign-on_archive.php; Letter from Joyce A. Rogers, Senior Vice President, Government Affairs of AARP to Senator Patrick J. Leahy (Mar. 30, 2012), in 158 CONG. REC. No. 56, at S2498-99; Letter from Alliance for Justice, Consumer Action, Consumer Federation of America, Consumers Union, Consumer Watchdog, National Association of Consumer Advocates, and US PIRG to Senator Patrick J. Leahy (April 17, 2012), in 158 CONG. REC. No. 56, at S2499; Allison M. Zieve, Director, Public Citizen Litigation Group and Sidney M. Wolfe, MD, Director, Public Citizen Health Research Group to Senator Patrick J. Leahy (April 18, 2012), in 158 CONG. REG. No. 56, at S2499.
Debra M. Perry is a Partner at McCarter & English, LLP in the firm's Newark, New Jersey office. Her practice focuses primarily on the area of products liability litigation with an emphasis on the national defense of pharmaceutical products and the coordination of mass tort products liability litigation involving occupational exposures. Sara F. Merin is an associate at McCarter & English, LLP in the firm's Newark, New Jersey office. She concentrates her practice in product liability litigation at the trial and appellate levels and also handles other complex civil litigation matters ranging from two-party disputes to complex class actions, including multidistrict litigation.…
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Publication information: Article title: Nationwide Flux: Mensing's Impact on State Tort Claim Pre-Emption and Generic Pharmaceuticals. Contributors: Perry, Debra M. - Author, Merin, Sara F. - Author. Journal title: Defense Counsel Journal. Volume: 79. Issue: 4 Publication date: October 2012. Page number: 498+. © 1999 International Association of Defense Counsels. COPYRIGHT 2012 Gale Group.
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