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Cerveny v. Aventis, Inc

United States Court of Appeals, Tenth Circuit

May 2, 2017

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.

         Appeal from the United States District Court for the District of Utah (D.C. No. 2:14-CV-00545-DB)

          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 women[3] 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, 133 S.Ct. 2466, 2470-71 (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 warning. Id. at 579; Appellants' App'x vol. 1, at 239.

         In 1986, the FDA ordered Aventis to add a "Pregnancy Category X" designation to Clomid's label. This designation would indicate that "the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit." 21 C.F.R. § 201.57(f)(6)(i)(e) (1986).[5] The FDA recommended this designation on the ground that Clomid does not benefit pregnant women and that any risk to pregnant women would be unjustified. Appellants' App'x vol. 3, at 586.

         Aventis resisted this change, and the FDA acknowledged a dilemma: Aventis needed to warn about taking Clomid during pregnancy, but no woman who was already pregnant would have any reason to take Clomid. In light of this dilemma, the FDA suggested in 1987 that Aventis change the label to add a clear warning about the risk of fetal harm when Clomid is taken during pregnancy:

PREGNANCY CATEGORY X. See Contraindications and Information for Patients.
CONTRAINDICATIONS: Clomid is contraindicated in pregnant women. Clomid may cause fetal harm when administered to pregnant women. Since there is a reasonable likelihood of the patient becoming pregnant while receiving Clomid, the patient should be apprised of the potential hazard to the fetus.

         Appellants' App'x vol. 3, at 596. Aventis eventually added a similar warning, but only after Alexander had been born.

         B. Conflict Preemption and the Clear-Evidence Standard

         There are three types of preemption: "(1) express preemption, which occurs when the language of the federal statute reveals an express congressional intent to preempt state law . . .; (2) field preemption, which occurs when the federal scheme of regulation is so pervasive that Congress must have intended to leave no room for a State to supplement it; and (3) conflict preemption, which occurs either when compliance with both the federal and state laws is a physical impossibility, or when the state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Mount Olivet Cemetery Ass'n v. Salt Lake City, 164 F.3d 480, 486 (10th Cir. 1998).

         Aventis asserts a form of conflict preemption known as impossibility preemption. Under impossibility preemption, state law is preempted "when compliance with both the federal and state laws is a physical impossibility." Id.

         For conflict preemption, the Supreme Court set forth the governing framework in Wyeth v. Levine, 555 U.S. 555 (2009). In Levine, the plaintiff was severely injured when she was administered an antinausea drug using the "IV-push" method of injection, which resulted in the drug accidentally entering her arteries. Levine, 555 U.S. at 559. The plaintiff sued Wyeth, the manufacturer of the drug, for failing to adequately warn of the risks of the IV-push method. Id. at 560. Wyeth responded that the failure-to-warn claim was preempted because the desired warning would have been disallowed by the FDA. Id. at 563.

         The Supreme Court rejected Wyeth's preemption argument, but the Court noted that the claim would have been preempted upon "clear evidence" that the FDA would have rejected the desired label change. Id. at 571 ("But absent clear evidence that the FDA would not have approved a change to Phenergan's label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements."). The Court reasoned that Wyeth had not (1) alleged an attempt to provide the kind of warning allegedly required under state law or (2) supplied the FDA with any analysis about the dangers from the IV-push method. Id. at 572-73.

         The Cervenys emphasize that in Levine, the Supreme Court held that the state tort claim was not preempted, downplaying the discussion of the "clear evidence" standard as dicta. But our court has relied on Levine in holding that a state tort claim is preempted if a pharmaceutical company presents clear evidence that the FDA would have rejected an effort to strengthen the label's warnings. Dobbs v. Wyeth Pharm., 606 F.3d 1269, 1269 (10th Cir. 2010). Thus, we must apply the "clear evidence" test set forth in Levine.[6]

         The resulting issue is whether this test involves a question of fact or law. On this issue, the Cervenys and Aventis debate the potential impact of a recent Third Circuit opinion: In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 852 F.3d 268, 2017 WL 1075047 (3d Cir. Mar. 22, 2017).[7]Fosamax interpreted the "clear evidence" language from Wyeth to refer to the "standard of proof" for the manufacturer to "convince the factfinder that the FDA would have rejected a proposed label change." In re Fosamax, 2017 WL 1075047, at *11. As a result, the court concluded that satisfaction of this standard involves a question of fact: "A state-law failure-to-warn claim will only be preempted if a jury concludes it is highly probable that the FDA would not have approved a label change." Id. at *18.

         The Cervenys did not argue in their briefing that the "clear evidence" standard involves a question of fact, and Aventis did not argue that the "clear evidence" standard raises a question of law. Nonetheless, the Cervenys insist that we should adopt the Third Circuit's approach and deny summary judgment if "no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected" the proposed label. Id. at *19. We are reticent to take this approach, for the parties' appeal briefs do not address this issue.

         Nonetheless, we may assume for the sake of argument that the Cervenys are correct, for their characterization of the issue is nondispositive because all of the material facts are undisputed. In applying these undisputed facts, we consider (1) whether Aventis presented clear evidence that the FDA would have disapproved of the warnings suggested by the Cervenys and (2) whether a reasonable juror could conclude that the FDA would have approved those warnings.

         C. Preemption of the Failure-to-Warm Claims: The Risks of Pre-Pregnancy Use of Clomid

         The parties agree that Mrs. Cerveny took Clomid before she became pregnant, but not afterward. The Cervenys contend that even pre-pregnancy use of Clomid may harm the fetus because (1) Clomid has a long half-life and can accumulate in the body with multiple courses of treatment, remaining active in the body after pregnancy, and (2) Clomid inhibits cholesterol, which may harm the fetus's development. For both reasons, the Cervenys allege in part that Aventis should have warned women about the risks when taking Clomid prior to pregnancy.

         Aventis argues that even if the Cervenys are correct, the FDA would not have allowed addition of a warning in 1992 about the risks when taking Clomid prior to pregnancy. Thus, Aventis contends that it would have been impossible to comply with both federal and Utah law. If Aventis is right, federal law would preempt the Utah tort claims. We agree with Aventis that the FDA would have prohibited Aventis from warning about the risk when taking Clomid prior to pregnancy.

         Aventis bears the burden to present clear evidence that the FDA would not have approved the desired warning. See Emerson v. Kan. City S. Ry. Co., 503 F.3d 1126, 1133-34 (10th Cir. 2007). To meet this burden, Aventis points to (1) the FDA's history of approving Clomid for use by women before becoming pregnant and (2) the FDA's rejection of a citizen petition by Mr. Terence Mix, [8] which had alleged a risk of fetal harm when Clomid is taken prior to pregnancy. In response, the Cervenys rely on the FDA's recommendation in 1987 for Aventis to warn of potential harm to the fetus. We conclude that clear evidence is not established by Clomid's regulatory history, but is ...


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