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In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II)

United States Court of Appeals, Third Circuit

April 30, 2014

IN RE: FOSAMAX (ALENDRONATE SODIUM) PRODUCTS LIABILITY LITIGATION (NO. II) PATRICK WELCH, et. al, Appellants

Argued December 18, 2013

On Appeal from the United States District Court for the District of New Jersey (D.C. No. 3-11-cv-3045; MDL No. 2243 and 3-08-cv-00008) District Judge: Hon. Joel A. Pisano

Brandon L. Bogle, Esq. [ARGUED] Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor Scott D. Levensten, Esq. Counsel for Appellants

Karen A. Confoy, Esq. Fox Rothschild Counsel for Merck Sharp & Dohme Corp.

John K. Crisham, Esq. Kirkland & Ellis Glenn S. Kerner, Esq. Katherine D. Seib, Esq. Goodwin Procter Jay P. Lefkowitz, Esq. [ARGUED] Kirkland & Ellis George E. McDavid, Esq. Reed Smith Counsel for Barr Pharmaceuticals Inc., RP, Barr Laboratories, and Teva Pharmaceuticals USA, Inc.

Terry M. Henry, Esq. Blank Rome Counsel for Watson Laboratory and Watson Pharmaceuticals Inc.

Kelly E. Jones, Esq. Steven A. Stadtmauer, Esq. Harris Beach Harvey L. Kaplan, Esq. Shook, Bardy, Bacon Counsel for Mylan Inc. and Mylan Pharmaceuticals Inc.

Charles A. Fitzpatrick, III, Esq. Arthur B. Keppel, Esq. Rawle & Henderson Counsel for Apotex Corp.

Jeffrey A. Cohen, Esq. Flaster Greenberg Sandra J. Wunderlich, Esq. Stinson Leonard Street Counsel for Sun Pharma Global and Sun Pharmaceutical Industries Inc.

Terry M. Henry, Esq. Blank Rome Counsel for Watson Pharmaceuticals Inc., fka Cobalt Pharmaceuticals Co., aka Watson Pharmaceuticals Inc. and Cobalt Laboratories Inc.

Before: JORDAN, VANASKIE and GREENBERG, Circuit Judges

OPINION

JORDAN, Circuit Judge

This case involves product liability claims by individuals who allegedly suffered bone fractures because they took Fosamax® – a drug used to treat or prevent osteoporosis and Paget's Disease – or the generic equivalent of that drug, alendronate sodium. Those plaintiffs sued Merck Sharp & Dohme, Corp. ("Merck"), the manufacturer of Fosamax®, as well as several entities that manufacture the generic equivalent (the "Generic Defendants"). The United States District Court for the District of New Jersey granted judgment on the pleadings in favor of the Generic Defendants because it determined that the state-law claims against them were pre-empted by federal law. The District Court certified the finality of that order pursuant to Federal Rule of Civil Procedure 54(b), and a number of the plaintiffs have appealed. For the reasons that follow, we will affirm.

I. Background

A. Statutory and Regulatory Background[1]

The Food, Drug, and Cosmetic Act ("FDCA"), ch. 675, 52 Stat. 1040 (codified as amended at 21 U.S.C. § 301 et seq.), provides the framework for federal regulation of prescription drugs in the United States. Under the FDCA, a manufacturer must seek approval from the United States Food and Drug Administration ("FDA") to market a new drug and, in doing so, must first file a New Drug Application ("NDA") and then prove the drug's safety and efficacy and propose accurate and adequate labeling. 21 U.S.C. § 355(b)(1), (d). As the Supreme Court has recognized, "[m]eeting those requirements involves costly and lengthy clinical testing." PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2574 (2011).

Congress has amended the FDCA several times, including in 1984 by passage of the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act"), codified at 21 U.S.C. §§ 355, 360cc and 35 U.S.C. §§ 156, 271, 282. The Hatch-Waxman Act governs the production and sale of generic versions of previously approved brand-name drugs. In short, it allows the manufacturers of generic drugs to "gain FDA approval simply by showing equivalence to a … drug that has already been approved by the FDA." Mensing, 131 S.Ct. at 2574 (citing 21 U.S.C. § 355(j)(2)(A)). A manufacturer seeking approval of a generic drug will file an Abbreviated New Drug Application ("ANDA") demonstrating that the generic drug and the FDA-approved brand-name drug are bioequivalent;[2]in addition to having the same active ingredients, the brand-name drug and the generic version must share the same route of administration, dosage form, dosage strength, and labeling.[3] 21 U.S.C. § 355(j)(2)(A)(ii)-(v). The statutory aim is to "allow[] manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug." Mensing, 131 S.Ct. at 2574.

B. Factual and Procedural Background[4]

The FDA gave a green light to Merck's NDA for Fosamax® in September 1995. Teva Pharmaceuticals USA, Inc., one of the Generic Defendants, then developed alendronate sodium – a generic form of the branded drug – and obtained FDA approval on its ANDA in February 2008. The other Generic Defendants subsequently obtained approval for alendronate sodium formulations as well.[5]

Alendronate sodium is a bisphosphonate drug that, as already noted, is "used for treating bone conditions such as osteoporosis and Paget's disease." (J.A. Vol. 2 at 45.) The drug acts "by inhibiting bone resorption [or absorption] and suppressing bone turnover."[6] (Id.) Consequently, it also inhibits primary mineralization, [7] which is involved in the formation of new bone. Meanwhile, secondary mineralization of existing bone continues, which increases the bone's mineral content and results in higher bone mineral density. According to the plaintiffs, higher bone mineral density "does not necessarily correspond with reduction of fracture risk"; rather, it can make bone "highly mineralized, homogenous, brittle, and more susceptible to fracture." (Id. at 46.) According to some studies, the effects of alendronate sodium linger after treatment ends, with one study reporting that bone turnover may be inhibited by 50% even 5 years after discontinuing treatment.

On February 28, 2011, 91 plaintiffs, who are citizens of 28 different states, filed this products liability suit in Missouri state court against both Merck and the Generic Defendants (collectively, the "Defendants") for damages related to "long bone fractures" that they suffered after taking prescribed doses of Fosamax® or alendronate sodium.[8] (Id. at 21-41.) The grounds they asserted for liability focused on the Defendants' alleged "concealment of risks associated with [Fosamax® and/or alendronate sodium], " "gross exaggeration of the purported fracture reduction benefits conferred by the drugs, " and "overpromotion of the drugs for non-approved, or 'off-label, ' indications." (Id. at 17.) Specifically, they brought product liability claims under theories of design defect, failure-to-warn, negligence, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, and negligent misrepresentation.

With the consent of the Generic Defendants, Merck removed the action to the United States District Court for the Eastern District of Missouri. The United States Judicial Panel on Multidistrict Litigation later centralized the action with several other Fosamax®-related lawsuits in a multi-district litigation ("MDL"), MDL No. 2243, in the United States District Court for the District of New Jersey.

Once the MDL was established, the Generic Defendants moved under Rule 12(c) of the Federal Rules of Civil Procedure for judgment on the pleadings, arguing that the plaintiffs' claims are pre-empted by federal law under the Supremacy Clause of the United States Constitution. The District Court granted the motion, holding that claims against the Generic Defendants relate to duties under state tort law that directly conflict with duties under federal regulations. It read the strict-liability design-defect claims as alleging that "alendronate sodium should have been designed differently to comply with state tort law." (Id. at 188.) The District Court's pre-emption decision anticipated reasoning given by the Supreme Court in its opinion last term in Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013). While the District Court did not have the benefit of the Bartlett opinion, it was guided by another recent Supreme Court case, PLIVA, Inc. v. Mensing, which it understood to say "that a federal duty of sameness arising out of [the] FDA's regulatory requirements preempts any conflicting tort duty arising under state law." (J.A. Vol. 2 at 188.) The District Court thus concluded that the claims against the Generic Defendants are pre-empted because, just as those defendants cannot lawfully change drug labeling for alendronate sodium, they cannot lawfully change the active ingredient design of the drug either.

In a series of orders, the Court dismissed all of the Generic Defendants from the case, leaving only Merck as a defendant.[9] Several of the plaintiffs – 73 of the 91 (hereinafter the "Appellants") – then filed this appeal.

II. Jurisdiction

We first determine whether we have jurisdiction over this appeal before we proceed with the merits. The "parties have indicated their consent to our appellate jurisdiction, but 'it is well established that we have an independent duty to satisfy ourselves of our appellate jurisdiction regardless of the parties' positions.'" Papotto v. Hartford Life & Accident Ins. Co., 731 F.3d 265, 269 (3d Cir. 2013) (quoting Kreider Dairy Farms, Inc. v. Glickman, 190 F.3d 113, 118 (3d Cir. 1999)). The scope of our review concerning questions of our own jurisdiction is plenary. United States v. Pelullo, 178 F.3d 196, 200 (3d Cir. 1999). "[I]f we determine that we do not have jurisdiction over this appeal, our 'only function remaining [will be] that of announcing the fact and dismissing the case.'" Elliott v. Archdiocese of N.Y., 682 F.3d 213, 219 (3d Cir. 2012) (second alteration in original) (quoting Steel Co. v. Citizens for a Better Env't, 523 U.S. 83, 94 (1998)).

Pursuant to 28 U.S.C. § 1291, we have jurisdiction over appeals from "final decisions of the district courts of the United States." 28 U.S.C. § 1291. "Generally, an order which terminates fewer than all claims pending in an action or claims against fewer than all the parties to an action does not constitute a 'final' order for purposes of 28 U.S.C. § 1291." Elliot, 682 F.3d at 219. However, under Rule 54(b) of the Federal Rules of Civil Procedure, "a district court may convert an order adjudicating less than an entire action to the end that it becomes a 'final' decision over which a court of appeals may exercise jurisdiction under 28 U.S.C. § 1291." Id.

This appeal was originally taken from the District Court's order that, inter alia, dismissed all claims except those against Merck.[10] The District Court, at the time, did not enter judgment under Rule 54(b). We sua sponte raised the issue of jurisdiction, and the parties acknowledged in a Rule 28(j) letter that this appeal was taken from a non-final order for purposes of 28 U.S.C. § 1291. The parties have since jointly sought and obtained certification from the District Court under Rule 54(b) for "entry of a final judgment as to one or more, but fewer than all, claims or parties." Fed.R.Civ.P. 54(b).

Obtaining a final judgment cures the jurisdictional defect of an otherwise premature appeal. N.J. Tpk. Auth. v. PPG Indus., Inc., 197 F.3d 96, 102 n.5 (3d Cir. 1999) ("We conclude that any jurisdictional defects inherent in the District Court's [earlier, non-final] order were cured by the [Rule] 54(b) certification, and that we therefore have jurisdiction to consider th[e] appeal."); see also Cape May Greene, Inc. v. Warren, 698 F.2d 179, 185 (3d Cir. 1983) ("[A] premature appeal taken from an order which is not final but which is followed by an order that is final may be regarded as an appeal from the final order in the absence of the showing of prejudice to the other party." (internal quotation marks omitted)). Therefore, despite the premature filing of the initial notice of appeal, we now have jurisdiction to consider the District Court's rulings in favor of the Generic Defendants.

III. Discussion[11]

A. The Claims at Issue on Appeal

The Appellants challenge only the judgment entered against them on their design-defect claims, which were held to be pre-empted. Before turning to the merits, we need to determine the scope of the claims before us, as some shape-shifting has been attempted. The parties, and particularly the Appellants, have been trying to catch up with precedential developments, most importantly the Supreme Court's Bartlett decision. Consequently, as more fully described herein, the Appellants' arguments have changed from their opening to their reply briefs. In their reply brief, the Appellants contend that they preserved their appeal on "all aspects of their design defect claims, including … those based on negligent design theories." (Appellants' Reply Br. at 3.) They assert that their negligence-based design-defect claims are grounded on the theory that the Generic Defendants were negligent "because of their failure to properly analyze Alendronate Sodium to discover the product's defects and for negligently continuing to sell Alendronate Sodium after they were, or should have been aware, that it was defectively designed."[12] (Id. at 13.)

The Generic Defendants respond that the Appellants waived any arguments regarding negligence-based design-defect claims by raising them for the first time in their reply brief and that, instead, the only claims on appeal are the Appellants' strict-liability design-defect claims. We agree.

"We have consistently held that '[a]n issue is waived unless a party raises it in its opening brief, and for those purposes a passing reference to an issue … will not suffice to bring that issue before this court.'" Ethypharm S.A. France v. Abbott Labs., 707 F.3d 223, 231 n.13 (3d Cir. 2013) (alterations in original) (quoting Laborers' Int'l Union of N. Am. v. Foster Wheeler Energy Corp., 26 F.3d 375, 398 (3d Cir. 1994)). The Appellants contend that they did raise the issue of negligence in their opening brief, and they point to their Statement of the Issues, which says: "The only issues for this Court's determination are whether the district court erred when it granted the [G]eneric [Defendants'] motion to dismiss on the basis of federal preemption as to plaintiffs' design defect claims."[13] (Appellants' Opening Br. at 2.) The idea, it seems, is that the words "design defect claims" are broad enough to encompass negligence-based design-defect claims. However, the Appellants' Summary of the Argument in their opening brief states more specifically that "[t]he district court erred in dismissing appellants' risk-utility based design defect claims." (Id. at 9 (emphasis added).) Count IX, titled "STRICT LIABILITY – DEFECTIVE DESIGN, " is the only design-defect claim against the Generic Defendants brought under a risk-utility based theory, specifically that the "foreseeable risks exceeded the benefits associated with [alendronate sodium's] design or formulation" and that alendronate sodium "lacked efficacy and/or posed a greater likelihood of injury than other osteoporosis treatments."[14] (J.A. Vol. 2 at 69-70.) It is also the only count from the Appellants' complaint that they mention in their opening brief. Nowhere in the opening brief do they raise any arguments specific to a negligence-based design-defect claim or, for that matter, make any reference to such a claim at all.[15] Therefore, fairly read, that brief is limited to the risk-utility based strict-liability design-defect claim set forth in Count

IX.[16]

The Appellants' reply brief arguments, which go beyond the scope of Count IX and are outside of anything addressed in the opening brief, must be seen as waived. We thus decline to consider whether there is any basis for distinguishing between negligence-based design-defect claims and strict-liability design-defect claims for preemption purposes, and we withhold comment on whether negligence-based design-defect claims are or are not pre-empted.[17]

B. Pre-emption of the Appellants' Strict-Liability Design-Defect Claims

"[T]he States possess sovereignty concurrent with that of the Federal Government, subject only to limitations imposed by the Supremacy Clause." Tafflin v. Levitt, 493 U.S. 455, 458 (1990). That Clause of the Constitution provides that federal law "shall be the supreme Law of the Land[, ] … any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. The idea is simply stated, but it is seldom simple to determine whether the dissonance between a federal and state law is such that it requires the former to pre-empt the latter.

Circumstances giving rise to pre-emption are typically divided into three categories: "state law must yield" (1) when a federal statute includes "an express provision for preemption"; (2) "[w]hen Congress intends federal law to 'occupy the field'" in an area of law; and (3) when a state and federal statute are in conflict.[18] Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372 (2000) (citation omitted); see also Farina v. Nokia Inc., 625 F.3d 97, 115 (3d Cir. 2010) (recognizing three different types of pre-emption). The last variety is the one at issue here, and it comes in two sub-varieties: impossibility pre-emption, which is when "compliance with both federal and state regulations is a physical impossibility, " and obstacle pre-emption, which is when a state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Maryland v. Louisiana, 451 U.S. 725, 747 (1981) (internal quotation marks omitted); see also MD Mall Assocs., LLC v. CSX Transp., Inc., 715 F.3d 479, 495 (3d Cir. 2013). The Generic Defendants' arguments are confined to impossibility pre-emption.

In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court considered impossibility pre-emption in the context of pharmaceutical regulation and state tort law. The plaintiff in that case brought claims against the manufacturer of a brand-name drug, alleging that the manufacturer failed to adequately warn of the risks posed by a particular way of administering the drug. Id. at 559. The manufacturer argued that the claims were pre-empted because it was impossible for it to comply with its state-law duty to modify the drug's labeling without violating its duties under federal law. Id. at 568. The Levine Court "start[ed] with the assumption that the historic police powers of the States were not to be superseded … unless that was the clear and manifest purpose of Congress." Id. at 565 (internal quotation marks omitted) (citation omitted). The Court said that manufacturers of brand-name drugs remain responsible for updating drug labeling and, as the manufacturer had not submitted evidence that the FDA would not have approved a change to the brand-name drug's label, the manufacturer "failed to demonstrate that it was impossible for it to comply with both federal and state requirements."[19]Id. at 573. On the way to that conclusion, the Court "briefly review[ed] the history of federal regulation of drugs and drug labeling, " id. at 566, and stated that, "[i]n keeping with Congress' decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation, " id. at 578.[20]

The Appellants assert that, under Levine's presumption against pre-emption, we "should err on the side of not finding preemption … unless Congress has clearly spoken." (Appellants' Opening Br. at 13.) The Supreme Court's more recent opinions in Mensing, 131 S.Ct. 2567 (2011), and Bartlett, 133 S.Ct. 2466 (2013), however, hold that certain state-law claims against manufacturers of generic drugs conflict directly with federal law and are without effect because of impossibility pre-emption. "When such preemption is found, liability cannot attach if the manufacturer has complied with the applicable federal standard." Restatement (Third) of Torts: Products Liability § 6 cmt. b. The Appellants, recognizing the import of Mensing and Bartlett, argue that their strict-liability design-defect claims are materially distinguishable from the claims at issue in those cases.[21] To assess their arguments, then, we first consider Mensing and Bartlett in detail.

1. The Mensing Decision

In Mensing, the Supreme Court consolidated appeals arising from decisions made by the United States Courts of Appeals for the Fifth and Eighth Circuits. Both plaintiffs in the two underlying cases had sued the manufacturers of metoclopramide tablets, a generic drug, alleging that long-term use of the drug caused them to develop a severe neurological disorder. Mensing, 131 S.Ct. at 2572-73. They brought failure-to-warn claims, one under Louisiana law and the other under Minnesota state law. Their contention was essentially that, "'despite mounting evidence that long term metoclopramide use carries a risk of [the neurological disorder] far greater than that indicated on the label, ' none of the [generic drug] [m]anufacturers had changed their labels to adequately warn of that danger." Id. at 2573. The manufacturers countered with the argument that, as the Court put it, "federal statutes and FDA regulations required them to use the same safety and efficacy labeling as their brand-name counterparts, " such that they could not simultaneously fulfill their federal obligation while updating the labels for metoclopramide under their state tort law duty. Id. at 2573. The Fifth and Eighth Circuits each rejected that argument and held that the plaintiffs' failure-to-warn claims were not preempted by federal law. See id.

The Supreme Court granted certiorari on the question of "whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, … state-law [failure-to-warn] claims." Id. at 2572. The answer was "yes." As the Court explained, "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." Id. at 2581. The Court observed that the tort laws of Louisiana and Minnesota "require a drug manufacturer that is or should be aware of its product's danger to label that product in a way that renders it reasonably safe." Id. at 2573. At the same time, federal FDA regulations "require that the warning labels of a brand-name drug and its generic copy must always be the same – thus, generic drug manufacturers have an ongoing federal duty of 'sameness.'" Id. at 2574-75 (citing 57 Fed. Reg. 17961 (1992)). The particular issue was therefore whether "it is 'impossible for a private party to comply with both state and federal requirements.'" Id. at 2577 (quoting Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)).

The Court considered three arguments – two from the plaintiffs and one from the FDA[22] – for why generic drug manufacturers could comply with state-law warning requirements and avoid liability while also satisfying the FDA's requirement that generic drugs always have the same labeling as their brand name counterparts. First, the plaintiffs argued that the FDA's "changes-being-effected" ("CBE") process allows generic drug manufacturers to update warnings on labels, [23] but the Court concluded that the CBE process only allows those manufacturers to update their labeling to match the brand-name drug's labeling. Id. at 2575. Second, the plaintiffs submitted that the manufacturers can send out letters to inform physicians of new warnings. Id. at 2576. The Court held that the manufacturers cannot do that, though, because the FDA considers such letters to be "labeling" that must be consistent with the labeling provided with the drug. Id. (citing 21 C.F.R. § 201.100(d)(1)). Third, the FDA argued that generic drug manufacturers can satisfy both state- and federal-law duties by proposing stronger labeling to the FDA when they believe new warnings are needed. Id. The Court determined, however, that even if those manufacturers have a federal duty to ask for FDA assistance to change labeling, "federal law would permit [them] to comply with the state labeling requirements if, and only if, the FDA and the brand-name manufacturer changed the brand-name label to do so." Id. at 2578. The Court observed that one "can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it, " but "[i]f these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it [would be] unclear when, outside of express pre-emption, the Supremacy Clause would have any force." Id. at 2579.

Because it was impossible for the generic drug manufacturers to "independently do under federal law what state law requires of [them]" – to change the drug label – the Supreme Court held that the state law failure-to-warn claims against the manufacturers were pre-empted. Id. As other circuit courts have observed, and we concur, Mensing holds that manufacturers cannot unilaterally change a generic drug's labeling, and therefore a state-law claim premised on such a manufacturer being obligated to revise its label is preempted. See Drager v. PLIVA USA, Inc., 741 F.3d 470, 476 (4th Cir. 2014); Morris v. PLIVA, Inc., 713 F.3d 774, 776-77 (5th Cir. 2013) (per curiam); Bell v. Pfizer, Inc., 716 F.3d 1087, 1095-96 (8th Cir. 2013); Schrock v. Wyeth, Inc., 727 F.3d 1273, 1288 (10th Cir. 2013).

2. The Bartlett Decision

While the present case was pending, the Supreme Court decided Bartlett, which considered whether design-defect claims under New Hampshire law were pre-empted.[24]133 S.Ct. at 2473. The Court noted that the claims were strict-liability design-defect claims because New Hampshire law imposes a duty on manufacturers to ensure that their products are not "unreasonably dangerous, " a duty which can be achieved in the context of pharmaceuticals in two ways – "either by changing a drug's design or by changing its labeling."[25] Id. at 2474. Importantly, the Court held that manufacturers do not have the option of redesigning a generic drug because, under the FDCA's requirements, "were [a manufacturer] to change the composition of its [generic drug], the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce." Id. at 2475. The Bartlett Court thus observed that "New Hampshire law ultimately required [the defendant manufacturer] to change [the drug's] labeling." Id. at 2474. But under Mensing, "federal law prevents generic drug manufacturers from changing their labels." Id. at 2476. Accordingly, "federal law prohibited [the generic drug manufacturer] from taking the remedial action required to avoid liability under New Hampshire law, " and the rule of impossibility preemption applied. Id.

In the course of its analysis, the Supreme Court also rejected "as incompatible with … pre-emption jurisprudence" the so-called "stop-selling" argument. Id. at 2477. That argument, which had been endorsed by the United States Court of Appeals for the First Circuit, reasons that a manufacturer can avoid a conflict between its state- and federal-law duties by simply choosing to halt sales of the generic drug. Id. The Supreme Court said, however, that its "pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless." Id. (internal quotation marks omitted); see also Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 398 (6th Cir. 2013) (noting the Supreme Court's unqualified rejection of the stop-selling theory).

3. Analysis

The Appellants attempt to distinguish Mensing and Bartlett by arguing that those decisions were limited to the pre-emption of "warnings-based" claims. (Appellants' Reply Br. at 1, 6.) They say that the claims at issue here do not necessarily require the Generic Defendants to unilaterally change the labeling for alendronate sodium, so the Generic Defendants' state-law duties do not "conflict with … any specific provisions of the FDCA" and thus do not raise impossibility pre-emption. (Appellants' Opening Br. at 16.) In support of that argument, the Appellants draw our attention to the Supreme Court's choice of language in Bartlett: "[S]tate-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under [Mensing]." Bartlett, 133 S.Ct. at 2470 (emphasis added). Under the Appellants' reading of the case, Bartlett only stands for the pre-emption of strict-liability design-defect claims against generic manufacturers when a state imposes a duty to strengthen a drug's warning.[26]

That is too narrow a reading of the Supreme Court's instructions. As the United States Court of Appeals for the Fourth Circuit has held, "[t]ogether, [Mensing and Bartlett] establish that under the FDCA a generic [drug manufacturer] may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability." Drager, 741 F.3d at 476. Thus, to the extent it is impossible for a generic drug manufacturer to comply with its duty under a state tort law unless it takes one of those actions, that law is pre-empted by the FDCA. Id.

At oral argument, the Generic Defendants emphasized that, although the claims at issue were brought under the laws of 28 different states, they could only avoid liability by taking one of the options that Mensing and Bartlett say they cannot be forced to take: (1) changing alendronate sodium's labeling, (2) changing the drug's design, or (3) ceasing sales of the drug altogether. In the end, the Appellants were forced to concede that point, in effect if not in words. They tried to avoid the "scope of Mensing's reach" by saying that their design-defect claims are not intended to relate to any drug warnings accompanying alendronate sodium.[27] (Appellants' Opening Br. at 10.) They also state that they "do not seek a 'change' in [alendronate sodium's] design" (id. at 21), which is not yielding much, since the Bartlett decision clearly holds that such a redesign is impossible under federal law for a generic drug manufacturer. The Appellants are left with their position that their strict-liability design-defect claims impose liability "for the [Generic Defendants'] willful choice to sell a particular product" with an unreasonably dangerous design. (Id.) In other words, they are trying to resurrect the "stop-selling" theory, under which the Generic Defendants can only avoid state-law liability by halting their sales of alendronate sodium.[28] But Bartlett categorically rejected that theory, and that ends the argument.[29]

Admittedly, the Supreme Court was careful in both Mensing and Bartlett to consider pre-emption in the context of the specific state laws at issue in those cases. But we have not been directed to any specific state law regime by the Appellants and we need not ponder hypothetical state laws. When we pressed the Appellants at oral argument to give an example of a strict-liability design-defect claim under any relevant state regime that would not ultimately result in some combination of the same three options for the Generic Defendants – i.e., changing the labeling of alendronate sodium, changing the design of the drug, or pulling the drug from the market – they were unable to identify such a claim. Nothing in the briefing offered any state-specific pre-emption analysis either. Therefore, it is unnecessary for us to embark on a 28-state tour of strict-liability design-defect law.[30] Cf. Schrock, 727 F.3d at 1288 (finding that, as "[n]o effort [wa]s made to identify a mechanism through which [the generic drug manufacturer] could have modified or supplemented the warranties allegedly breached without running afoul of the duty of sameness identified in Mensing …, the [plaintiff's] claims are preempted to the extent they rest on inadequate labeling as broadly defined by the FDA.").

In sum, Mensing and Bartlett recognize that manufacturers have no control over the design or labeling of generic drugs. Short of exiting the market – which Bartlett rejects – the Appellants have failed to identify anything the Generic Defendants can do to reconcile their conflicting duties under state and federal law.[31] Therefore, the Appellants' strict-liability design-defect claims are preempted.

V. Conclusion

For the foregoing reasons, we will affirm the District Court's judgment for the Generic Defendants.


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