Cerveny v. Aventis, Inc.

• Decision Date: 02 May 2017
• Docket Number: No. 16-4050,16-4050
• Citation: Cerveny v. Aventis, Inc., 855 F.3d 1091 (10th Cir. 2017)
• Parties: Victoria CERVENY; Charles Cerveny; Alexander Cerveny, Plaintiffs–Appellants, v. AVENTIS, INC., Defendant–Appellee. Product Liability Advisory Council, Inc.; American Tort Reform Association; Pharmaceutical Research and Manufacturers of America; Biotechnology Innovation Organization ; Chamber of Commerce of the United States of America; National Association of Manufacturers, Amici Curiae.
• Court: U.S. Court of Appeals — Tenth Circuit

855 F.3d 1091

Victoria CERVENY; Charles Cerveny; Alexander Cerveny, Plaintiffs–Appellants,

v.AVENTIS, INC., Defendant–Appellee.

Product Liability Advisory Council, Inc.; American Tort Reform Association; Pharmaceutical Research and Manufacturers of America; Biotechnology Innovation Organization ; Chamber of Commerce of the United States of America; National Association of Manufacturers, Amici Curiae.

No. 16-4050

United States Court of Appeals, Tenth Circuit.

FILED May 2, 2017

Adam S. Davis (Christopher L. Schnieders, with him on the briefs), Wagstaff & Cartmell, LLP, Kansas City, Missouri, for Plaintiffs–Appellants.

Eric A. Swan, Shook, Hardy & Bacon L.L.P., Kansas City, Missouri (William F. Northrip, Shook, Hardy & Bacon, L.L.P., Chicago, Illinois; Shawn McGarry, and Gary T. Wight, Kipp and Christian, P.C., Salt Lake City, Utah, with him on the brief), for Defendant–Appellee.

Kate Comerford Todd, U.S. Chamber Litigation Center, Washington, D.C., Linda E. Kelly and Leland P. Frost, Manufacturers' Center for Legal Action, Washington, D.C., Jeffrey S. Bucholtz and Sheldon Bradshaw, King & Spalding LLP, Washington, D.C., and Andrew T. Bayman and Heather M. Howard, King & Spalding LLP, Atlanta, Georgia, filed an amicus curiae brief for Chamber of Commerce of the United States of America, American Tort Reform Association, and National Association of Manufacturers, on behalf of Defendant–Appellee.

Michael X. Imbroscio, Paul W. Schmidt, and Gregory L. Halperin, Covington & Burling, Washington, D.C., filed an amici curiae brief for Pharmaceutical Research and Manufacturers of America and Biotechnology Innovation Organization, on behalf of Defendant–Appellee.

Hugh F. Young, Jr., Product Liability Advisory Council, Inc., Reston, Virginia, Andrew E. Tauber, Mayer Brown LLP, Washington, D.C., and Charles M. Woodworth, Mayer Brown LLP, Chicago, Illinois, filed an amicus curiae brief for Product Liability Advisory Council, Inc., on behalf of Defendant–Appellee.

Before BACHARACH, PHILLIPS, and McHUGH, Circuit Judges.

BACHARACH, Circuit Judge.

Mr. Alexander Cerveny was born over twenty years ago with birth defects.¹ Alexander and his parents attribute these birth defects to Mrs. Cerveny's use of Clomid (a fertility drug) in 1992, before she became pregnant with Alexander. The Cervenys sued the manufacturer of Clomid (Aventis, Inc.), asserting various tort claims under Utah law: failure to warn under theories of strict liability and negligence, breach of implied warranty, negligent misrepresentation, and fraud.²

The district court granted summary judgment to Aventis based on federal preemption, reasoning that the U.S. Food and Drug Administration ("FDA") would not have approved the drug warnings that the Cervenys allege are required under Utah law. This reasoning led the district court to conclude that Aventis could not have complied with both federal law and Utah law. Based on this conclusion, the district court granted summary judgment to Aventis on all of the Cervenys' claims.

On appeal, the Cervenys note that they "did not advocate for a specific warning in laying out their failure-to-warn claims." Appellants' Opening Br. at 9. Instead, the Cervenys present two theories, pointing to two types of warning labels that Aventis had allegedly failed to provide: (1) a label that warned of risks to the fetus when a woman takes Clomid before becoming pregnant and (2) a label that unmistakably warned about harm to the fetus when Clomid is taken during pregnancy.

For both theories, the Cervenys point to a warning that the FDA proposed in 1987, which stated that "Clomid may cause fetal harm when administered to pregnant women." Appellants' App'x vol. 3, at 596. For their first theory, the Cervenys argue that this proposed warning demonstrates the FDA's willingness to approve warnings for women taking Clomid prior to pregnancy. For their second theory, the Cervenys argue that (1) the warning clearly informed women of risks to the fetus if taken during pregnancy and (2) Mrs. Cerveny would not have taken Clomid if Aventis had used the FDA's proposed wording.

The district court rejected the Cervenys' claims based on preemption. The ruling was correct on the Cervenys' first theory, for the undisputed evidence shows that the FDA would not have approved a warning about taking Clomid before pregnancy. But on the second theory, the district court did not explain why a state claim based on the FDA's own proposed language would be preempted by federal law.

The district court also erred in failing to distinguish the remaining claims (breach of implied warranty, negligent misrepresentation, and fraud) from the failure-to-warn claims. These claims are based at least partly on affirmative misrepresentations rather than on a failure to provide a warning. The district court failed to explain why claims involving affirmative misrepresentations would have been preempted.

I. Standard of Review

On the award of summary judgment, we engage in de novo review, drawing all reasonable inferences and resolving all factual disputes in favor of the Cervenys. Birch v. Polaris Indus., Inc. , 812 F.3d 1238, 1251 (10th Cir. 2015). Summary judgment was required if Aventis had shown that no genuine issue existed on a material fact and that Aventis was entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a).

In determining whether Aventis had satisfied this burden, we engage in de novo review of all the district court's legal conclusions.

Auraria Student Hous. at the Regency, LLC v. Campus Vill. Apartments, LLC , 843 F.3d 1225, 1244 (10th Cir. 2016) ("[W]e review the district court's conclusions of law de novo...."). Thus, we ordinarily consider preemption as a legal issue subject to de novo review. See Mount Olivet Cemetery Ass'n v. Salt Lake City , 164 F.3d 480, 486 (10th Cir. 1998) (stating that we review preemption rulings de novo); see also GTE Mobilnet of Ohio v. Johnson , 111 F.3d 469, 475 (6th Cir. 1997) ("Questions of federal preemption of state law generally are considered questions of law subject to de novo review.").

II. Preemption of the Failure-to-Warn Claims

Mrs. Cerveny had taken Clomid in September and October 1992, before she became pregnant with Alexander. When Mrs. Cerveny took Clomid, its label warned women³ against use during pregnancy, stating that Clomid had been shown to cause harm in fetuses for rats and rabbits.

The Cervenys contend that this warning was insufficient under Utah law. As mentioned above, the Cervenys support their failure-to-warn claims under two separate theories: (1) Aventis should have warned women of the risks of taking Clomid prior to pregnancy and (2) Aventis should have better warned women of the risks to the fetus when Clomid is taken during pregnancy. The district court correctly held that federal law preempted the first theory, which involved a failure to warn of risks prior to pregnancy. But the district court failed to explain the applicability of preemption to the second theory, which was based on the FDA's own proposed wording.

A. FDA Approval Process and Clomid's Regulatory History

The Federal Food, Drug, and Cosmetic Act has long required a manufacturer to obtain approval from the FDA before the manufacturer can introduce a new drug in the market. 21 U.S.C. § 355(a). For brand-name drugs, a manufacturer must submit an application. Mut. Pharm. Co. v. Bartlett , ––– U.S. ––––, 133 S.Ct. 2466, 2470–71, 186 L.Ed.2d 607 (2013). The application must include the proposed label, "full reports of investigations which have been made to show whether such drug is [safe and effective]," comprehensive information of the drug's composition and the "manufacture, processing, and packing of such drug," relevant nonclinical studies, and "any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source." 21 U.S.C. § 355(b)(1) ; 21 C.F.R. § 314.50(c)(2)(i), (d)(1), (2), (5)(iv).

If the FDA approves the application, the manufacturer generally is restricted from changing the label without advance permission from the FDA. 21 U.S.C. §§ 331(a), (c), 352 ; 21 C.F.R. § 314.70(a), (b). But an exception exists, allowing a manufacturer under certain circumstances to change the label before obtaining FDA approval. 21 C.F.R. § 314.70(c).⁴ But even when this exception applies, the FDA will ultimately approve the label change only if it is based on reasonable evidence of an association between the drug and a serious hazard. 21 C.F.R. §§ 201.80(e), 314.70(c)(6)(iii).

Against this regulatory backdrop, we consider the FDA's historical consideration of Clomid's labels. Clomid entered the market in 1967 upon approval by the FDA. Since 1967, Clomid's labels have consistently warned about the risk of fetal harm if the mother takes Clomid while she is pregnant. For example, the 1967 warning stated:

CONTRAINDICATIONS

Pregnancy

Although no causative evidence of a deleterious effect of Clomid... therapy on the human fetus has been seen, such evidence in regard to the rat and the rabbit has been presented.... Therefore, Clomid should not be administered during pregnancy. To avoid inadvertent Clomid administration during early pregnancy, the basal body temperature should be recorded throughout all treatment cycles, and the patient should be carefully observed to determine whether ovulation occurs . If the basal body temperature following Clomid is biphasic and is not followed by menses, the patient should be examined carefully for the presence of an ovarian cyst and should have a pregnancy test. The next course of therapy should be delayed until the correct diagnosis has been determined.

Appellants' App'x vol. 3, at 590. This warning addressed the risk of continuing to take Clomid after a woman has become pregnant, noting that the woman may be unaware of her pregnancy. The label was revised in both 1980 and 1991, but the revised labels contained the same pregnancy...