Case: 12-30319 Document: 00512143917 Page: 1 Date Filed: 02/14/2013
IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT United States Court of Appeals
Fifth Circuit
FILED
February 14, 2013
No. 12-30319
Lyle W. Cayce
Clerk
PENNY MORRIS; JOHN MORRIS,
Plaintiffs - Appellants
v.
PLIVA, INCORPORATED, formerly known as
Pliva USA, Incorporated; TEVA PHARMACEUTICALS
USA, INCORPORATED; ACTAVIS ELIZABETH, L.L.C.,
as successor in interest, on behalf of Purepac
Pharmaceutical Company,
Defendants - Appellees
Appeal from the United States District Court
for the Western District of Louisiana
USDC No. 3:09-CV-854
Before DAVIS, JONES, and SMITH, Circuit Judges.
PER CURIAM:*
Appellants Penny and John Morris sued Appellees PLIVA, TEVA, and
Actavis—generic drug manufacturers—for injuries related to use of the drug
metoclopramide (brand-name Reglan). This case is yet another in the expanding
cohort controlled by PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which held
state law claims against generic manufacturers of Reglan preempted by FDA
*
Pursuant to 5TH CIR. R. 47.5, the court has determined that this opinion should not
be published and is not precedent except under the limited circumstances set forth in 5TH CIR.
R. 47.5.4.
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No. 12-30319
regulations. See also Demahy v. Actavis, Inc., 650 F.3d 1045 (5th Cir. 2011) (per
curiam). Accordingly, we AFFIRM the dismissal of this suit.
BACKGROUND
Penny Morris took metoclopramide from early 2006 to July 2008.
Ingesting the drug for more than twelve weeks, however, has been contra-
indicated on FDA-approved labels since 2004 and by “black box” labeling since
2009. She developed the movement disorders tardive dyskinesia and akathisia
as a result of taking the drug and brought this suit in May 2009. Appellants
sued under theories of defective construction and composition of the drug;
defective design; breach of express warranty; and inadequate warning. The suit
was subsequently stayed to await the Supreme Court’s decision in Mensing—a
case dealing with almost identical claims against the same generic
manufacturers. While state law “failure to warn” claims are allowed against
brand-name manufacturers, Wyeth v. Levine, 555 U.S. 555, 129 S. Ct. 1187
(2009), Mensing held such claims against generic manufacturers conflict-
preempted by federal law as interpreted by the FDA. Mensing, 131 S. Ct. at
2580–81.
Finding the Morrises’ only factually supported claim—inadequate
warning—to be preempted, the district court dismissed the complaint “pursuant
to Rule 12(b)(6) and/or 12(c) of the Federal Rules of Civil Procedure.” Appellants
subsequently moved the district court under Rule 59(e) to amend its earlier
ruling based on four theories: (1) Appellant PLIVA failed to comply with the
2004 FDA-approved label change; (2) the generic defendants failed to properly
test their products and report that information; (3) breach of express warranty;
and (4) Appellant TEVA may be held liable for a “failure to warn” because of its
status as a reference listed drug (“RLD”) holder.1 The first three of these had
1
All of these theories except breach of warranty are predicated on the Louisiana
Products Liability Act, La. R.S. 9:2800.51, et seq. We need not explore pleading deficiencies
under state law, as the claims are preempted.
2
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No. 12-30319
previously been asserted, but the last theory was raised as “newly discovered
information.” The district court denied the motion and the Morrises timely
appealed its adverse rulings.2
DISCUSSION
Judgments on the pleadings are reviewed de novo; Rule 12(c) motions are
governed by the same standard as Rule 12(b)(6) motions. Jebaco, Inc. v.
Harrah’s Operating Co., 587 F.3d 314, 318 (5th Cir. 2008). The fundamental
question is whether the plaintiff states a claim on which relief may be granted.
“To survive a Rule 12(b)(6) motion to dismiss, a complaint ‘does not need detailed
factual allegations,’ but must provide the plaintiff’s grounds for entitlement to
relief . . . .” Cuvillier v. Taylor, 503 F.3d 397, 401 (5th Cir. 2007) (quoting Bell
Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S. Ct. 1955, 1964 (2007)).
Alternatively, Rule 59 orders are reviewed for abuse of discretion and “cannot
be used to raise arguments which could, and should, have been made before the
judgment issued.” Schiller v. Physicians Res. Grp. Inc., 342 F.3d 563, 567 (5th
Cir. 2003) (quoting Rosenzweig v. Azurix Corp., 332 F.3d 854, 863 (5th Cir.
2003)).
I. Failure-to-Warn Claims
Mensing held that federal law demands “generic drug labels be the same
at all times as the corresponding brand-name labels.” Mensing, 131 S. Ct. at
2578. This is known as the “duty of sameness.” Whether a warning is placed on
the label on the bottle or in letters to distributors, any state law duty requiring
generic manufacturers to act unilaterally in this area is preempted by federal
law. Id. at 2580–81.
2
Brand-name manufacturers Wyeth, Inc. and Schwarz Pharma, Inc. were included as
defendants in the original suit but dismissed with prejudice in November of 2009. The district
court denied Appellants’ Rule 60(b)(5) motion for relief from judgment. Appellants noticed
appeal of the 60(b) denial but it was not briefed or argued to this court.
3
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Appellants first contend that Mensing did not dispense with claims
concerning a failure to communicate approved warnings. They allege the generic
defendants are liable for failing to convey FDA-approved information;
information communicated by generic manufacturers that is consistent with the
brand-name labeling does not violate the duty of sameness.3
On the contrary, Mensing forecloses such claims because failure to
“communicate” extends beyond just a label change. To avoid liability, the
manufacturer must take affirmative steps to alert consumers, doctors, or
pharmacists of changes in the drug label. Because the duty of sameness
prohibits the generic manufacturers from taking such action unilaterally, they
are dependent on brand-names taking the lead. Id. at 2576 (“[I]f generic drug
manufacturers, but not the brand-name manufacturer, sent [additional warnings
such as a ‘Dear Doctor’ letters], that would inaccurately imply a therapeutic
difference between the brand and generic drugs and thus could be impermissibly
‘misleading.’”). Under federal law, the inquiry is whether the brand-name
manufacturers sent out a warning, not whether the proposed warning to be
disseminated contains substantially similar information as the label. Because
no brand-name manufacturer sent a warning based on the 2004 label change,
the generic manufacturers were not at liberty to do so. As Mensing concluded,
preemption is thus triggered since it would be impossible for PLIVA to comply
with both the state law duty to warn and the federal law duty of sameness.
Appellants also fault PLIVA specifically for not adopting the 2004 FDA-
approved warning label.4 To reach the merits of this argument, we would have
to overlook that no such claim appears in Appellants’ live pleading, their Fourth
3
This argument has been rejected by other circuits. See Smith v. Wyeth, Inc., 657 F.3d
420, 423 (6th Cir. 2011), cert. denied, 132 S. Ct. 2103 (2012); Mensing v. Wyeth, Inc., 658 F.3d
867 (8th Cir. 2011), vac’g 588 F.3d 603 (8th Cir. 2009).
4
The argument that generic manufacturers may be subject to inadequate warning
claims was only pressed against PLIVA. Actavis and TEVA conformed to the 2004 update.
4
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Amended Complaint. The trial court was disinclined to allow yet another
amendment and did not thereby abuse its discretion. But any amendment would
be futile. First, it is logically incoherent to contend that PLIVA had a duty to
apply the 2004 warning label when Appellants also assert repeatedly that no
labels predating 2009 were adequate. Tort liability does not arise for failure to
attach an inadequate label. Second, a claim that PLIVA breached a federal
labeling obligation sounds exclusively in federal (not state) law, and is
preempted. 21 U.S.C. § 337(a); see Buckman Co. v. Plaintiffs’ Legal Comm.,
531 U.S. 341, 349 n.4, 121 S. Ct. 1012, 1018 n.4 (2001).
Appellants also argue that TEVA may be held responsible for a failure-to-
warn claim notwithstanding that it is a generic manufacturer. TEVA’s product
was designated an RLD by the FDA, making it the equivalent of a brand-name
manufacturer’s metoclopramide. As the district court noted, the Fourth
Amended Complaint did not raise this claim, which Appellants mislabeled in
2010 as “newly discovered.” The information was available in the 2003 “FDA
Orange Book.” Yet even if an amendment were allowed, we agree with the
district court’s analysis, in rejecting this claim, that it “assumes, without
authority, that the FDA considered TEVA to be a brand name manufacturer
with the requisite duty to unilaterally change its product’s labeling simply
because the FDA designated TEVA’s metoclopramide as the RLD.”5
II. Non-Failure-to-Warn Claims
Appellants next argue that the generic defendants failed to test and
inspect the product according to federal law. This claim fails for several reasons.
First, the Federal Food, Drug, and Cosmetic Act (“FDCA”) provides no private
right of action for these violations. “[A]ll such proceedings for the enforcement,
or to restrain violations of [the FDCA] shall be by and in the name of the United
States.” 21 U.S.C. § 337. Nor can a violation be used as evidence of a breach of
5
In fact, the metoclopramide ingested by Morris (tablets) may be distinguishable from
that for which TEVA was the RLD (oral solution).
5
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duty. While any testing and reports could have been used to alert the FDA of
the need to strengthen labels and warnings, the Supreme Court specifically
addressed this argument in Mensing. A federal duty to ask for such help might
have existed but state tort law “did not instruct the Manufacturers to
communicate with the FDA about the possibility of a safer label.” Mensing,
131 S. Ct. at 2578. Finally, any “useful” reporting—at least from the standpoint
of those injured—would ostensibly consist of some sort of warning. This
argument, then, is yet another attempt to circumvent disfavored failure-to-warn
claims.
Appellants’ final claim is for breach of express warranty based on the
generic defendants’ introducing a defective product into the stream of
commerce.6 It is urged that the drug is unreasonably dangerous as designed and
so, in fact, no warnings would have been sufficient: metoclopramide should not
have been sold at all. While this type of claim has been recognized by the First
Circuit,7 it has been rejected by this one. See Demahy v. Schwarz Pharma, Inc.,
702 F.3d 177, 186–87 (5th Cir. 2012) (per curiam). Demahy is more convincing.
A breach of warranty claim that goes directly to the sufficiency of the generic
manufacturers’ labeling is clearly unacceptable. Metoclopramide has legitimate
therapeutic purposes, as evidenced by the FDA’s approval of Reglan in the first
place. Any state law-based holding that the generic manufacturers should have
acted differently with respect to warnings or should have ceased manufacturing
these products because of insufficient warnings not only violates the duty of
6
While Appellants brief this point as three distinct issues (Breach of Express
Warranty, Design Defect, and Construction or Composition Defect), each argument goes to the
same point—Appellees marketed an inherently dangerous product—and so we examine them
together. Appellants recognized this commonality at oral argument by noting that the design
defect argument was essentially the same as the breach of warranty claim in the Bartlett case.
7
Bartlett v. Mutual Pharm. Co., 678 F.3d 30 (1st Cir. 2012), cert. granted, 133 S. Ct.
694 (2012).
6
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sameness but conflicts with FDA’s exclusive authority to approve drugs and drug
labels. This claim is preempted.
CONCLUSION
For the foregoing reasons, we affirm both the district court’s denial of
Appellants’ motion to alter or amend the judgment and the grant of Appellees’
motion to dismiss.
AFFIRMED
7