In Re Fosamax (Alendronate Sodium) Products Liability Litigation

PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
_____________
No. 12-2250
_____________
IN RE: FOSAMAX (ALENDRONATE SODIUM)
PRODUCTS LIABILITY LITIGATION (NO. II)
PATRICK WELCH, et. al,
Appellants
_______________
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
_______________
Argued
December 18, 2013
Before: JORDAN, VANASKIE and GREENBERG,
Circuit Judges
(Filed: April 30, 2014)
_______________
Brandon L. Bogle, Esq. [ARGUED]
Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor
316 S. Baylen Street, Suite 600
Pensacola, FL 32502
Scott D. Levensten, Esq.
1420 Walnut Street, Suite 801
Philadelphia, PA 19102
Counsel for Appellants
Karen A. Confoy, Esq.
Fox Rothschild
997 Lenox Dr.
Princeton Pike Corporate Center, Bldg. 3
Lawrenceville, NJ 08648
Counsel for Merck Sharp & Dohme Corp.
John K. Crisham, Esq.
Kirkland & Ellis
655 15th St., N.W., Suite 1200
Washington, DC 20005
Glenn S. Kerner, Esq.
Katherine D. Seib, Esq.
Goodwin Procter
620 Eighth Avenue
The New York Times Bldg.
New York, NY 10018
Jay P. Lefkowitz, Esq. [ARGUED]
Kirkland & Ellis
601 Lexington Ave.
New York, NY 10022
2
George E. McDavid, Esq.
Reed Smith
136 Main Street, Suite 250
Princeton, NJ 08540
Counsel for Barr Pharmaceuticals Inc., RP,
Barr Laboratories, and Teva Pharmaceuticals USA,
Inc.
Terry M. Henry, Esq.
Blank Rome
130 N. 18th Street
One Logan Square
Philadelphia, PA 19103
Counsel for Watson Laboratory and
Watson Pharmaceuticals Inc.
Kelly E. Jones, Esq.
Steven A. Stadtmauer, Esq.
Harris Beach
One Gateway Center , Suite 2500
Newark, NJ 07102
Harvey L. Kaplan, Esq.
Shook, Bardy, Bacon
2555 Grant Bldg.
Kansas City, MO 64108
Counsel for Mylan Inc. and
Mylan Pharmaceuticals Inc.
Charles A. Fitzpatrick, III, Esq.
Arthur B. Keppel, Esq.
Rawle & Henderson
3
1339 Chestnut Street, The Widener Bldg.
One South Penn Square, 16th Floor
Philadelphia, PA 19107
Counsel for Apotex Corp.
Jeffrey A. Cohen, Esq.
Flaster Greenberg
1810 Chapel Ave. West
Cherry Hill, NJ 08002
Sandra J. Wunderlich, Esq.
Stinson Leonard Street
7700 Forsyth Blvd., Suite 1100
St. Louis, MO 63105
Counsel for Sun Pharma Global and
Sun Pharmaceutical Industries Inc.
Terry M. Henry, Esq.
Blank Rome
130 N. 18th St.
One Logan Square
Philadelphia, PA 19103
Counsel for Watson Pharmaceuticals Inc.,
fka Cobalt Pharmaceuticals Co., aka Watson
Pharmaceuticals Inc. and Cobalt Laboratories Inc.
_______________
OPINION OF THE COURT
_______________
4
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,
1
Be prepared for an avalanche of acronyms; for
practical purposes, it is unavoidable.
5
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
2
The FDA defines “bioequivalence” as “the absence
of a significant difference in the rate and extent to which the
active ingredient or active moiety in pharmaceutical
equivalents or pharmaceutical alternatives becomes available
at the site of drug action when administered at the same molar
dose under similar circumstances in an appropriately designed
study.” 21 C.F.R. § 320.1(e).
6
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
3
This is, necessarily, a general and incomplete
summary of a complicated regulatory scheme.
4
These facts are taken from the complaint and treated
as true because, “[i]n reviewing the grant of a Rule 12(c)
motion, we must view the facts presented in the pleadings and
the inferences to be drawn therefrom in the light most
favorable to the nonmoving party.” Rosenau v. Unifund
Corp., 539 F.3d 218, 221 (3d Cir. 2008) (quoting Jablonski v.
Pan Am. World Airways, Inc., 863 F.2d 289, 290-91 (3d Cir.
1988)) (internal quotation marks omitted).
5
The parties treat all of the Generic Defendants as
manufacturers of alendronate sodium, and so shall we.
7
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
6
Bone turnover, or bone remodeling, is the
“absorption of bone tissue and simultaneous deposition of
new bone; in normal bone the two processes are in dynamic
equilibrium.” Dorland’s Illustrated Medical Dictionary
1623, 1991 (32d ed. 2012). “Up to the age of 30 to 40, the
two activities ([absorption] and formation) are balanced.
Later in life, [absorption] exceeds new bone formation.” J.E.
Schmidt, Attorney’ Dictionary of Medicine, at B-166 (Pub.
No. 609 Rel. No. 46 Oct. 2012).
7
“Mineralization” refers to “[t]he introduction of
minerals into a structure, as in the normal mineralization of
bones.” Stedman’s Medical Dictionary 1214 (28th ed. 2006).
8
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
8
The following entities were named as the Generic
Defendants in the complaint filed in state court: Apotex
Corp.; Barr Laboratories, Inc.; Barr Pharmaceuticals, Inc.;
Mylan Inc. f/k/a Mylan Laboratories, Inc.; Mylan
Pharmaceuticals Inc.; Sun Pharma Global, Inc. o/b/o and f/k/a
Caraco Pharmaceutical Laboratories, Ltd.; Sun
Pharmaceutical Industries, Inc.; Teva Pharmaceuticals USA,
Inc.; Watson Laboratories, Inc.; Watson Pharmaceuticals,
Inc.; and Watson Pharmaceuticals, Inc. o/b/o and f/k/a Cobalt
Pharmaceuticals Co. On the District Court’s docket, Cobalt
Laboratories, Inc. was also listed as one of the Generic
Defendants.
The corporate disclosure statements before us attempt
to clarify the identities of several of the Generic Defendants,
but those details are not relevant here.
9
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
10
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
9
The District Court initially denied the Generic
Defendants’ motion for judgment on the pleadings as to
Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc.
(collectively, the “Watson Defendants”) because, under Rule
12(c), the Court took as true the Plaintiffs’ allegation that the
Watson Defendants were not generic manufacturers.
However, the Court subsequently granted the Watson
Defendants’ motion for reconsideration, thereby granting
judgment on the pleadings to them as well. In addition, the
District Court initially denied the Generic Defendants’ motion
for judgment on the pleadings as to plaintiffs who had filed a
motion for remand and/or notice of voluntary dismissal. The
Court later resolved the motion for remand and “dismisse[d]
… Plaintiffs’ claims against Generic Defendants as
preempted.” (J.A. Vol. 1 at 11.)
11
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
10
The District Court exercised diversity jurisdiction
under 28 U.S.C. § 1332 after it “disregard[ed], for purposes
of jurisdiction, the citizenship of fraudulently joined” parties.
(J.A. Vol. 1 at 10.) That ruling is not challenged on appeal,
and we see no reason to disturb it.
12
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.
13
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
11
The Appellants technically appealed the District
Court’s order, signed on April 2, 2012, that granted in part
and denied in part the plaintiffs’ motion for remand. In that
order, the Court dismissed the claims against the Generic
Defendants as pre-empted, “[t]o the extent” its previous
judgment on the pleadings did not already reach all of the
Generic Defendants. (J.A. Vol. 1 at 11.) The Appellants’
arguments focus on, and demonstrate an intention to appeal,
only the portion of the order relating to the judgment on the
pleadings. We review de novo an order granting judgment on
the pleadings pursuant to Rule 12(c) of the Federal Rules of
Civil Procedure. Rosenau v. Unifund Corp., 539 F.3d 218,
221 (3d Cir. 2008); Werwinski v. Ford Motor Co., 286 F.3d
661, 665 (3d Cir. 2002).
14
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’
12
The Appellants do not identify which count in their
complaint allegedly constitutes their negligence-based design-
defect claim, but Count XI, titled “NEGLIGENCE,” is the
only one pled against the Generic Defendants that seems to fit
that description. (J.A. Vol. 2 at 74.)
15
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
13
The Appellants misidentify the motion for judgment
on the pleadings as a motion to dismiss in that statement.
14
Count IX alleges, in part:
232. When placed into the stream of commerce,
ALENDRONATE SODIUM was defective in
its design or formulation and was unreasonably
dangerous in that its foreseeable risks exceeded
the benefits associated with its design or
formulation. When placed into the stream of
commerce, ALENDRONATE SODIUM was
defective in design or formulation in that it
lacked efficacy and/or posed a greater
likelihood of injury than other osteoporosis
treatments on the market and was more
dangerous than ordinary consumers or their
physicians could reasonably foresee or
anticipate.
16
(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
233. Alternatively, when placed into the stream
of commerce, ALENDRONATE SODIUM was
defective in design and was unreasonably
dangerous in that its label failed to warn
physicians and patients of the dangers
associated with long-term use of
bisphosphonates, including, but not limited to
the risk of severely suppressed bone turnover,
brittle bones and a greater susceptibility to
stress fractures or long bone fractures; and the
label failed to instruct physicians and patients
about the limited length of time
ALENDRONATE SODIUM was actually
effective in preventing fractures.
(J.A. Vol. 2 at 69-71.)
15
The shift to negligence-based arguments in the
Appellants’ reply brief is not surprising given that the
Supreme Court’s Bartlett decision – which, as discussed
below, addressed strict-liability design-defect claims – issued
during the pendency of this appeal. According to the Generic
Defendants, “[t]he bottom line … is that [the Appellants]
placed their bets on the First Circuit’s Bartlett decision [that
credited the theory embraced by the Appellants in their
opening brief] … and they lost.” (Appellees’ Br. at 3.) After
the Supreme Court overturned the First Circuit’s Bartlett
17
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 pre-
emption purposes, and we withhold comment on whether
opinion, the Appellants did not seek to file a revised opening
brief. They proposed for the original briefing to be continued
with the Generic Defendants’ answering brief and their reply
brief.
16
The Appellants note that their design-defect claims
under a risk-utility theory are rooted in the Restatement
(Third) of Torts: Product Liability, which provides:
A prescription drug … is not reasonably safe
due to defective design if the foreseeable risks
of harm posed by the drug … are sufficiently
great in relation to its foreseeable therapeutic
benefits that reasonable health-care providers,
knowing of such foreseeable risks and
therapeutic benefits, would not prescribe the
drug or medical device for any class of patients.
Restatement (Third) of Torts: Products Liability § 6(c)
(1998).
18
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
17
Our lack of comment is not a tacit endorsement of
the Appellants’ negligence theory. We have yet to hear how
the Generic Defendants’ duties under negligence-based
design-defect claims would be any different from their duties,
discussed below, under strict-liability design-defect claims,
i.e., changing the labeling, changing the composition, or
removing the product from the market.
18
Field pre-emption and conflict pre-emption may be
viewed as “implied” pre-emption, as opposed to “express”
19
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
pre-emption. Roth v. Norfalco LLC, 651 F.3d 367, 374 (3d
Cir. 2011). As the Supreme Court has recognized, though,
“the categories of preemption are not ‘rigidly distinct.’”
Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372
n.6 (2000) (quoting English v. Gen. Elec. Co., 496 U.S. 72,
79 n.5 (1990)).
20
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
19
The Levine Court also rejected the brand-name drug
manufacturer’s obstacle pre-emption argument. Levine, 555
U.S. at 573-81.
20
The Court concluded that impossibility pre-emption
was not applicable to design-defect claims against brand-
name manufacturers because federal law reflects “the [brand-
name] manufacturer’s ultimate responsibility for its label and
provides a mechanism for adding safety information to the
label prior to FDA approval.” Id. at 571.
21
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.
21
The Appellants cite several decisions for the
proposition that “[e]very circuit court of appeals … has found
no FDCA pre-emption of design-defect claims.” (Appellants’
Opening Br. at 18 (citing Wimbush v. Wyeth, 619 F.3d 632,
646 (6th Cir. 2010); Desiano v. Warner-Lambert & Co., 467
F.3d 85, 87-88 (2d Cir. 2006); Tobin v. Astra Pharm. Prods.,
Inc., 993 F.2d 528, 537 (6th Cir. 1993); Graham v. Wyeth
Labs., 906 F.2d 1399, 1405 n.9 (10th Cir. 1990); Abbot v. Am.
Cyanamid Co., 844 F.2d 1108, 1114-15 (4th Cir. 1988); and
Hurley v. Lederle Labs. Div. of Am. Cyanamid Co., 863 F.2d
1173, 1177-78 (5th Cir. 1988)).) All of those cases pre-date
the Supreme Court’s Mensing and Bartlett decisions,
however, and are distinguishable because they address pre-
emption in the context of claims against manufacturers of
branded, not generic, drugs. The Appellants also try to
analogize this case to Medtronic, Inc. v. Lohr, 518 U.S. 470
(1996), in which the Supreme Court held that the FDA’s
“substantial equivalency” requirement for streamlined
medical device approval did not pre-empt state-law design
defect claims. (Appellants’ Opening Br. at 26.) But the
process for obtaining FDA approval of generic drugs under
22
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 pre-
empted by federal law. See id.
the Hatch-Waxman Act is materially different from the
streamlined medical device approval process. As the
Mensing Court noted, “different federal statutes and
regulations may … lead to different pre-emption results.”
Mensing, 131 S. Ct. at 2582.
23
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
22
The United States filed an amicus brief setting forth
the FDA’s views. See Brief for the United States as Amicus
Curiae Supporting Respondents, PLIVA, Inc. v. Mensing, 131
S. Ct. 2567 (2011) (Nos. 09-993, 09-1039, 09-1501), 2011
WL 741927; Mensing, 131 S. Ct. at 2575 n.3.
24
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
23
As the Supreme Court summarized, the CBE process
“permits drug manufacturers to ‘add or strengthen a
contraindication, warning, [or] precaution,’ or to ‘add or
strengthen an instruction about dosage and administration that
is intended to increase the safe use of the drug product’” by
filing a supplemental application with the FDA. Mensing,
131 S. Ct. at 2575 (alteration in original) (quoting 21 C.F.R.
§ 314.70(c)(6)(iii)(A), (C)). In the CBE process, “drug
manufacturers need not wait for preapproval by the FDA,
which is ordinarily necessary to change a label.” Id.
25
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 pre-
empted. 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
24
We granted the Generic Defendants’ motion to stay
this appeal pending the Supreme Court’s decision in Bartlett.
26
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 pre-
emption 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
25
The Supreme Court contrasted “strict liability” and
“absolute liability” by noting that a “‘strict-liability’ regime”
is one “in which liability does not depend on negligence, but
still signals the breach of a duty,” while an “‘absolute-
liability’ regime” is one “in which liability does not reflect
the breach of any duties at all, but merely serves to spread
risk.” Bartlett, 133 S. Ct. at 2473.
27
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
28
claims against generic manufacturers when a state imposes a
duty to strengthen a drug’s warning. 26
26
The Appellants lay particular emphasis on comment
k to § 402A of the Restatement (Second) of Torts as an
example of what Bartlett held to be pre-empted. That
comment requires manufacturers of “[u]navoidably unsafe
products” to provide adequate warnings in order to avoid
strict liability for design defects. 2 Restatement (Second)
Torts § 402A cmt. k (1965). It states:
There are some products which, in the present
state of human knowledge, are quite incapable
of being made safe for their intended and
ordinary use. These are especially common in
the field of drugs. … Such a product, properly
prepared, and accompanied by proper directions
and warning, is not defective, nor is it
unreasonably dangerous. … The seller of such
products, … with the qualification that they are
properly prepared and marketed, and proper
warning is given, where the situation calls for it,
is not to be held to strict liability for unfortunate
consequences attending their use, merely
because he has undertaken to supply the public
with an apparently useful and desirable product,
attended with a known but apparently
reasonable risk.
Id. In other words, comment k is a defense to a strict-liability
design-defect claim when a product that is unavoidably
unsafe is accompanied by proper warnings. See Restatement
(Third) Torts: Products Liability § 6 Reporter’s Note cmt. f
29
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
(citing cases recognizing comment k to § 402A of the
Restatement (Second) Torts as a defense).
However, the Supreme Court’s Bartlett decision did
not hinge on the availability of the comment k defense. The
Court determined that it is not possible, under federal law, for
a manufacturer to redesign a generic drug. Bartlett, 133 S.
Ct. at 2475. Thus, a generic drug manufacturer facing
liability under a risk-utility legal framework – regardless of
whether a comment k defense is available – is in an
impossible position: keep the drug the same and violate state
law, or change the drug and violate federal law. Id. (“In the
drug context, either increasing the ‘usefulness’ of a product or
reducing its ‘risk of danger’ would require redesigning the
drug … .”).
30
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
27
They note that plaintiffs in other cases have been
“guilty of sloppy draftsmanship” for asserting design-defect
claims that “allege[] that part of what makes a product
defective by design is that the ‘design’ of the product did not
include appropriate warnings.” (Appellants’ Opening Br. at
12.) But, they say, they have “carefully pleaded their
complaint” to avoid such a reliance on the adequacy of
alendronate sodium’s warnings. (Id.)
28
The Appellants also argue that, when the comment k
defense is not available or applicable, “states applying
[§] 402A generally impose no duty on a manufacturer to
either re-design their product or strengthen their warnings”
because it promotes a “risk-spreading goal.” (Appellants’
Reply Br. at 10 (emphasis added).) To the extent the
Appellants ask us to consider an absolute-liability regime,
31
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
that argument was waived because it was not raised in their
opening brief. See Ethypharm S.A. France v. Abbott Labs.,
707 F.3d 223, 231 n.13 (3d Cir. 2013) (finding an issue
waived “unless a party raises it in its opening brief”). Like
the Bartlett Court, we need not address absolute liability
claims, and we “save for another day the question whether a
true absolute-liability state-law system could give rise to
impossibility preemption.” Bartlett, 133 S. Ct. at 2474 n.1.
29
The Generic Defendants argue that the Appellants
waived their stop-selling theory with respect to their design-
defect claims for not raising it in the District Court. We do
not reach that waiver issue because, even if the argument
were not waived, the stop-selling rationale was expressly
rejected by the Bartlett Court as inconsistent with
impossibility pre-emption jurisprudence.
32
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
30
The Appellants argue in their reply brief that their
design-defect claims “differ greatly from state to state and
must be analyzed individually, rather than through a summary
dismissal on the pleadings.” (Appellants’ Reply Br. at 14.)
However, this contradicts the position in their opening brief
that, although the “Appellants hail from 28 different states, …
each [with] their own laws governing design defect claims[,]
… this Court should simply consider Appellants’ design
defect claims as pled and in light of the prevailing view of
preemption as to state tort law claims generally and design
defect claims specifically.” (Appellants’ Opening Br. at 6 n.3
(emphasis added).) Moreover, the Appellants never raised
any state-specific pre-emption arguments in the District
Court. Rather, they only argued, in generalities, that their
design-defect claims survive Mensing, and they rebutted the
notion that some states do not “recognize defective design as
a vital theory of liability.” (J.A. Vol. 2 at 165.) They did not
argue that a state-by-state analysis is necessary for
determining whether such claims – if they are indeed
recognized by all 28 states relevant to this case – are pre-
empted.
33
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 pre-
empted.
V. CONCLUSION
For the foregoing reasons, we will affirm the District
Court’s judgment for the Generic Defendants.
31
The Appellants argue that the Hatch-Waxman Act
“did not give generic drugmakers a free pass in remaining
ignorant of drugs’ risks (or concealing those risks).”
(Appellants’ Opening Br. at 15.) Regardless of the appeal
such policy arguments may have, they are unavailing
because, as the Supreme Court stated in Bartlett, “sympathy
for [a plaintiff] does not relieve us of the responsibility of
following the law.” 133 S. Ct. at 2478.
34