In the
United States Court of Appeals
For the Seventh Circuit
____________________
No. 15‐2294
KATHLEEN A. WAGNER,
Plaintiff‐Appellant,
v.
TEVA PHARMACEUTICALS USA, INC., et al.,
Defendants‐Appellees.
____________________
Appeal from the United States District Court for the
Western District of Wisconsin.
No. 13‐CV‐497‐JDP — James D. Peterson, Judge.
____________________
ARGUED FEBRUARY 12, 2016 — DECIDED OCTOBER 18, 2016
____________________
Before WOOD, Chief Judge, ROVNER, Circuit Judge, and
BLAKEY, District Judge.
BLAKEY, District Judge. Appellant Kathleen Wagner ap‐
peals the decision of the district court granting judgment on
the pleadings in favor of Appellees Teva Pharmaceuticals
Of the Northern District of Illinois, sitting by designation.
2 No. 15‐2294
USA, Barr Pharmaceuticals and Barr Laboratories. For the
reasons explained below, the decision of the district court is
affirmed.
I. Background & Procedural History
Appellant Kathleen Wagner, who is a licensed attorney
proceeding pro se, took both brand‐name and generic hor‐
mone therapy drugs as prescribed by her gynecologist to
treat her post‐menopausal endometrial hyperplasia. After
taking the drugs, Wagner developed breast cancer. Wagner
sued multiple pharmaceutical companies that designed,
manufactured, promoted and distributed the drugs she took.
Appellees Teva Pharmaceuticals USA, Barr Pharmaceuticals
and Barr Laboratories are the only pharmaceutical compa‐
nies that manufactured the generic form of the hormone
therapy drugs.
In her 12‐count First Amended Complaint, Wagner as‐
serted numerous Wisconsin state law tort claims, all based
upon allegations that Appellees sold dangerous products
and failed to adequately warn of their risks.
After answering the Amended Complaint, Appellees
moved for Rule 12(c) judgment on the pleadings, arguing
that federal law preempted Wagner’s claims. In response,
Wagner asserted, for the first time, that Appellees delayed
updating their generic brand labels to match the updated,
stricter labels on the brand‐name drug.
The District Judge granted the motion for judgment on
the pleadings, finding that the Food, Drug, and Cosmetics
Act (FDCA), 21 U.S.C. § 301 et seq., preempted Appellant’s
state law claims. Wagner appealed.
No. 15‐2294 3
II. Discussion
We review de novo a district court’s Rule 12(c) decision.
Adams v. City of Indianapolis, 742 F.3d 720, 727 (7th Cir. 2014).
To survive a motion for judgment on the pleadings, a com‐
plaint must “state a claim to relief that is plausible on its
face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). A
claim has “facial plausibility when the plaintiff pleads factu‐
al content that allows the court to draw the reasonable infer‐
ence that the defendant is liable for the misconduct alleged.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In assessing a mo‐
tion for judgment on the pleadings, we draw all reasonable
inferences and facts in favor of the nonmovant, but need not
accept as true any legal assertions. Vesely v. Armslist LLC, 762
F.3d 661, 664–65 (7th Cir. 2014).
On appeal, Wagner raises two challenges. First, she ar‐
gues that, given the passage of the Food and Drug Admin‐
istration Amendments Act of 2007 (FDAAA), her claims are
not preempted. Wagner also argues that her claims are not
preempted to the extent they are based upon Appellees’
failure to update their generic drug labels to match the up‐
dated label on the brand name drug. We address both issues
in turn.
A. Preemption and the FDAAA
The district court found that the FDCA preempted Wag‐
ner’s state law claims. In support, the district court relied
upon two Supreme Court cases: PLIVA, Inc. v. Mensing, 564
U.S. 604 (2011), and Mutual Pharmaceutical Co. Inc. v. Bartlett,
133 S. Ct. 2466 (2013). These cases, as the district court cor‐
rectly explained, impose a “duty of sameness” on generic
drug manufacturers that requires “generic drug labels be the
4 No. 15‐2294
same at all times as the corresponding brand‐name labels.”
Mensing, 564 U.S. at 618. Flowing from that duty, federal law
preempts state tort laws when the generic drug manufactur‐
er could not have abided by this duty without: (1) changing
the drug’s formula; (2) changing the drug’s label; or (3)
withdrawing the generic drug from the market altogether.
By way of background, in Mensing, the Supreme Court
held that the FDCA preempts any state law that requires
companies to improve generic drug labels. Id. at 616−20. The
Court reasoned that it would be impossible for companies to
change both the generic drug label and maintain sameness
with the corresponding brand‐name drug label. Id. In Bart‐
lett, the Court extended the principles in Mensing to cover
state defective‐design laws. 133 S. Ct. at 2470. To comply
with the defective‐design tort law, the Court determined
that generic drug companies would have to either change
the drug’s formula or change its label. Id. at 2474. Alterna‐
tively, generic drug companies could choose to stop selling
the generic drug altogether. Id. at 2477. The first two options
were impossible because of the FDCA and the last option
(withdrawal of the product from the market) was unreason‐
able. Id. at 2470.
Although Mensing and Bartlett dealt with failure to warn
and design defect claims, respectively, federal courts have
extended their rationale to similar state law claims. E.g.,
Brinkley v. Pfizer, Inc., 772 F.3d 1133, 1139−40 (8th Cir. 2014)
(preempting breach of implied warranty cases); Johnson v.
Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 613−14 (5th Cir.
2014) (preempting express warranty claim); Lashley v. Pfizer,
Inc., 750 F.3d 470, 475−76 (5th Cir. 2014) (per curiam)
(preempting strict liability and breach of warranty claims).
No. 15‐2294 5
Such cases do not stand alone, and for good reason. As the
Fifth Circuit explained in Lashley, these types of claims still
rely upon the same essential grounds: “the generic manufac‐
turer’s failure to provide adequate information.” By exten‐
sion, federal law preempts Wagner’s claims, regardless of
how they are styled in her complaint.
Wagner claims that Mensing and Bartlett are outdated in
light of the FDAAA, which the Supreme Court did not con‐
sider. Other courts have rejected this argument. E.g., In re
Fosamax (Alendronate Sodium) Prod. Liab. Litig. (No. II), No.
CIV. 08‐008 GEB‐LHG, 2011 WL 5903623, at *7 (D.N.J. Nov.
21, 2011); Whitener v. PLIVA, Inc., No. CIV.A. 10‐1552, 2011
WL 6056546, at *3 (E.D. La. Dec. 6, 2011) (citing In re Fosa‐
max). We reject it as well, as we did in Houston v. United
States, 638 Fed. App’x 508, 513−514 (7th Cir. 2016). The
FDAAA imposed certain obligations on generic drug manu‐
facturers when they propose labeling changes. But the
FDAAA did not remove the prohibition against doing so
unilaterally. As we noted in Houston, “the amendments still
forbid a generic‐drug maker from violating the duty of
sameness without FDA permission.” Id. at 514.
B. Wagner’s Failure to Update Theory
Wagner, in the alternative, argues that she can still pro‐
ceed on her claims against Appellees to the extent they are
based upon Appellees’ failure to update the generic drug
label to match the updated label on the brand name drug.
The district court denied this claim for two reasons.
First, Wagner failed to raise this theory in her complaint.
Having reviewed the First Amended Complaint, we agree
with the district court’s assessment. Wagner fails to effec‐
6 No. 15‐2294
tively respond to this fact on appeal, and instead makes an
untimely request of this Court for leave to file a Second
Amended Complaint. Wagner never sought leave to amend
her complaint in the proceedings below, and the factual as‐
sertions regarding her failure to update theory appeared for
the first time in her opposition to the Rule 12(c) motion. This
attempt comes far too late. Clearly, the district court did not
abuse its discretion by failing to order, sua sponte, an
amendment to the First Amended Complaint that Wagner
never requested.
Second, as an alternate basis for its ruling, the district
court found that, even if Wagner were given leave to amend,
any amendment would have been legally and factually fu‐
tile. While acknowledging a split in authority as to whether
federal law preempts state law failure‐to‐update claims, and
noting that the question remains open in this circuit, the dis‐
trict court found persuasive the Fifth Circuit’s decision in
Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) (find‐
ing federal law preempts failure‐to‐update claims) (per curi‐
am).1 Factually, the district court found Wagner’s theory of
1
The Sixth Circuit, by contrast, disagrees, finding that such claims
may be viable. Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 583−85 (6th Cir.
2013). In Brinkley v. Pfizer, Inc., 772 F.3d 1133, 1137−39 (8th Cir. 2014), the
Eighth Circuit noted the circuit split and proceeded to address a failure
to update theory on its merits. This ruling suggests, though not conclu‐
sively, that the Eighth Circuit would follow the Sixth Circuit. See also
Teva Pharmaceuticals USA, Inc. v. Superior Court, 217 Cal. App. 4th 96,
108−09, 110 n.3, 115 (2013) (after collecting and summarizing federal dis‐
trict court and state court cases reaching the same decision as the Sixth
Circuit, California Court of Appeals expressly stated its disagreement
No. 15‐2294 7
causation insufficient because she asserted that both the ge‐
neric drug manufacturers’ labels and the updated brand la‐
bel were deficient.
In light of the undeveloped record here, we need not an‐
swer the open question of preemption of state failure‐to‐
update claims; the factual deficiencies in Wagner’s com‐
plaint alone preclude reversal of the district court. At vari‐
ous times in the proceedings, Wagner has made conflicting
assertions undermining any causation of her failure‐to‐
update claim. Even in her reply brief to this Court, Wagner
characterizes both the brand‐name and generic labels as de‐
ficient. Yet, at oral argument, Wagner maintained that the
brand name label was adequate, and that her claim really
arose because Appellees failed to bring their labels in line
with the brand‐name drug in 2007. Putting aside whether
Wagner—who began taking the brand‐name drug in 1993
and the generic drug in 2000—could establish causation
based upon a failure to update in 2007, Wagner never al‐
leged such a claim in her complaint. As a result, she waived
the right to press the claim here. See, e.g., Darif v. Holder, 739
F.3d 329, 336−37 (7th Cir. 2014) (arguments raised for the
first time in a reply brief are waived); Central States, Southeast
and Southwest Areas Pension Fund, 181 F.3d 799, 808 (7th Cir.
1999) (arguments not developed in any meaningful way are
waived).
with the Fifth Circuit). On January 20, 2015, the Supreme Court denied a
petition of certiorari in Teva Pharmaceuticals. 135 S. Ct. 1152, 1153 (2015).
8 No. 15‐2294
III. Conclusion
Because Wagner’s complaint in the proceedings below
lacked the requisite factual allegations to support a failure to
update theory, any further consideration of the legal merits
of that issue is unnecessary. For the purposes of this appeal,
it is enough to note that federal law preempts Wagner’s Wis‐
consin state‐law claims, and that the operative complaint
lacks the factual allegations necessary to support any failure
to update theory.
For these reasons, the judgment of the district court is
AFFIRMED.