KATHLEEN A. WAGNER, Plаintiff-Appellant, v. TEVA PHARMACEUTICALS USA, INC., et al., Defendants-Appellees.
No. 15-2294
United States Court of Appeals For the Seventh Circuit
Argued February 12, 2016 — Decided October 18, 2016
Before WOOD, Chief Judge, ROVNER, Circuit Judge, and BLAKEY, District Judge.
Appeal from the United States District Court for the Western District of Wisconsin. No. 13-CV-497-JDP — James D. Peterson, Judge.
I. Background & Procedural History
Appellant Kathleen Wagnеr, who is a licensed attorney proceeding pro se, took both brand-name and generic hormone therapy drugs as prescribed by her gynecologist to treat her post-menоpausal endometrial hyperplasia. After taking the drugs, Wagner developed breast cancer. Wagner sued multiple pharmaceutical companies that dеsigned, manufactured, promoted and distributed the drugs she took. Appellees Teva Pharmaceuticals USA, Barr Pharmaceuticals and Barr Laboratories are the only рharmaceutical companies that manufactured the generic form of the hormone therapy drugs.
In her 12-count First Amended Complaint, Wagner asserted numerous Wisconsin stаte 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 thе Food, Drug, and Cosmetics Act (FDCA),
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 complaint 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 рlausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct allegеd.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In assessing a motion for judgment on the pleadings, we draw all reasonable inferences and facts in favor of the nonmovant, but need not accept as true any legаl assertions. Vesely v. Armslist LLC, 762 F.3d 661, 664–65 (7th Cir. 2014).
On appeal, Wagner raises two challenges. First, she argues that, given the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA), her claims are not preеmpted. Wagner also argues that her claims are not preempted to the extent they are based upon Appellees’ failure to update their generic drug lаbels to match the updated 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 Wagner‘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 correctly explained, impose a “duty of sameness” on generic drug manufacturers that requires “generic drug labels be the
By way of background, in Mensing, the Supreme Court held that the FDCA preempts any state law that requires companies to improve genеric 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 Bartlett, 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. Altеrnatively, 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 lаst option (withdrawal of the product from the market) was unreasonable. Id. at 2470.
Although Mensing and Bartlett dealt with failure to warn and design defect claims, respectively, federal courts have extеnded 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).
Wagner claims that Mensing and Bartlett are outdated in light of the FDAAA, which the Supreme Court did not consider. 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 Fosamax). 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 manufacturеrs 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 оf sameness without FDA permission.” Id. at 514.
B. Wagner‘s Failure to Update Theory
Wagner, in the alternative, argues that she can still proceed 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-
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 futile. 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 district court found persuasive the Fifth Circuit‘s decision in Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) (finding federal law preempts failure-to-update claims) (per curiam).1 Factually, the district court found Wagner‘s theory of
causation insufficient because she asserted that both the generic drug manufacturers’ labels and the updated brand label were deficient.
In light of the undeveloped record here, we need not answer the open question of preemption of state failure-to-update claims; the factual deficiencies in Wagner‘s complaint alone precludе reversal of the district court. At various times in the proceedings, Wagner has made conflicting assertions undermining any causation of her failure-to-update claim. Even in her rеply brief to this Court, Wagner characterizes both the brand-name and generic labels as deficient. Yet, at oral argument, Wagner maintained that the brand name label was аdequate, 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 alleged such a claim in her complaint. As a result, she waived the right tо 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).
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 Wisconsin state-law claims, and that the operative complaint lacks the factuаl allegations necessary to support any failure to update theory.
For these reasons, the judgment of the district court is AFFIRMED.