Hickey v. Hospira, Inc.

102 F.4th 748

Tina HICKEY; Hilda Adams; Gloria J. Cooper;Carol R. Woodson, Plaintiffs—Appellees, v. HOSPIRA, INCORPORATED; Hospira Worldwide, L.L.C.,formerly known as Hospira Worldwide, Incorporated;Accord Healthcare, Incorporated, Defendants—Appellants.

No. 23-30323

United States Court of Appeals, Fifth Circuit

FILED May 24, 2024

Appeal from the United States District Court for the Eastern District of Louisiana, USDC Nos. 2:16-CV-17583, 2:16-MD-2740, 2:17-CV-12674, 2:18-CV-194, 2:18-CV-4731, Jane T. Milazzo, U.S. District Judge

Matthew Palmer Lambert, Esq., Pendley, Baudin & Coffin, L.L.P., New Orleans, LA, Andre M. Mura (argued), Gibbs Law

Group, L.L.P., Oakland, CA, for Plaintiffs-Appellees.

Richmond Turner Moore (argued), Heidi Kaye Hubbard, Williams & Connolly, L.L.P., Washington, D.C., John F. Olinde, Chaffe McCall, L.L.P., New Orleans, LA, for Defendants-Appellants Hospira, Incorporated, Hospira Worldwide, L.L.C., formerly known as Hospira Worldwide, Incorporated.

Michael J. Ruttinger, Esq., Attorney (argued), Julia A. Callsen, Esq., Tucker Ellis, L.L.P., Cleveland, OH, for Defendant-Appellant Accord Healthcare, Incorporated.

David Geiger, Foley Hoag, L.L.P., Boston, MA, for Amicus Curiae Product Liability Advisory Council, Incorporated.

Ilana H. Eisenstein, Attorney, Marie Bussey-Garza, Rachel Horton, DLA Piper, L.L.P., Philadelphia, PA, for Amici Curiae Sanofi-Aventis, U.S., L.L.C., Sanofi U.S. Services, Incorporated.

Jesse Wadell Wainwright, Justin Lewis Bernstein, Greenberg Traurig, L.L.P., Austin, TX, Lori Gail Cohen, Greenberg Traurig, L.L.P., Atlanta, GA, Gregory E. Ostfeld, Esq., Greenberg Traurig, L.L.P., Chicago, IL, for Amicus Curiae Sandoz, Incorporated.

Before Wiener, Haynes, and Higginson, Circuit Judges.

Per Curiam:

The question before us is whether federal law preempts Plaintiffs' state law failure-to-warn claims against Defendant drug manufacturers. The district court held that it did not and denied Defendants' motion for summary judgment. For the reasons that follow, we VACATE the district court order denying summary judgment and REMAND for further consideration of one outstanding issue discussed below.

I. Background

We start this section with some background on the relevant statutory framework. Then we describe the facts particular to this appeal. Finally, we explain the procedural posture.

A. Statutory Background

Under the Food, Drug, and Cosmetics Act ("FDCA"), 21 U.S.C. §§ 301-99i, a drug manufacturer must obtain approval from the Food and Drug Administration ("FDA") before selling its drug in the United States. 21 U.S.C. § 355(a). "[A] manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate." PLIVA, Inc. v. Mensing, 564 U.S. 604, 612, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) (citations omitted). "Meeting those requirements involves costly and lengthy clinical testing." Id. (citations omitted). "Originally, the same rules applied to all drugs." Id. But the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (the "Hatch-Waxman Amendments") changed that. See id. The public policy behind the Hatch-Waxman Amendments was to "allow[ ] manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug." Id. This was done to assist patients in being able to afford the drugs. Now, under the law, there are three primary routes through which a manufacturer can obtain approval of drugs.

The method for approval of a brand new drug is laid out in § 505(b)(1)¹ of the FDCA. See 21 U.S.C. § 355(b)(1). It requires manufacturers to file a New Drug Application ("NDA"), which includes, inter alia, "full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use." 21 U.S.C. § 355(b)(1)(A)(i). The first drug of a specific kind to be approved under § 505(b)(1) is called the Reference Listed Drug ("RLD"). Thereafter, other manufacturers who want to prepare the same drug or a drug that is similar enough may use two abbreviated pathways to obtain FDA approval with less burden and expense.

One such pathway is § 505(j), which permits the manufacturer of a generic drug to submit an Abbreviated New Drug Application ("ANDA"). See 21 U.S.C. § 355(j). With limited exceptions, the generic drug must have the same active ingredients, route of administration, dosage form, strength, and proposed labeling as the RLD. 21 U.S.C. § 355(j)(2)(A). Because a § 505(j) drug is the same as the RLD in these respects, the manufacturer may rely on the safety and efficacy data submitted in the RLD's NDA. Id.

The final path—the one at issue here—is § 505(b)(2), which is available for drugs that differ from the RLD in ways that are slight enough for the manufacturer to still rely on the RLD's safety and efficacy data. See 21 U.S.C. § 355(b)(2). "Th[e] § 505(b)(2) application need contain only that information needed to support the modification(s) of the listed drug." 21 C.F.R. § 314.54(a). Unlike § 505(j) drugs, § 505(b)(2) drugs are not required to use the exact same labeling as the RLD. See 21 C.F.R. § 314.54(a)(2).

When the FDA approves a new drug, it also approves the exact text that will be included in the drug's labeling. Wyeth v. Levine, 555 U.S. 555, 568, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) (citing 21 U.S.C. § 355). "Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemental application." Id. But in some circumstances, the changes-being-effected ("CBE") regulation allows manufacturers to file a supplemental application with the FDA and simultaneously implement a labeling change before obtaining FDA approval. 21 C.F.R. § 314.70(c)(6).

The CBE regulation is available " 'to add or strengthen a . . . warning' where there is 'newly acquired information' about the 'evidence of a causal association' between the drug and a risk of harm." Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299, 304-05, 139 S.Ct. 1668, 203 L.Ed.2d 822 (2019) (ellipses in original) (quoting 21 C.F.R. § 314.70(c)(6)(iii)(A)). The regulation defines "[n]ewly acquired information" as "data, analyses, or other information not previously submitted to the Agency," including but not limited to, "data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA." 21 C.F.R. § 314.3(b).

We now turn to the facts specific to this case.

B. Factual Background

In 1996, the FDA approved Taxotere, the branded version of docetaxel, for the treatment of metastatic breast cancer. Taxotere is manufactured by Sanofi US Services Inc. and Sanofi-Aventis U.S. LLC (collectively, "Sanofi"). In 2004, the FDA also approved Taxotere as an adjuvant chemotherapy treatment for early-stage breast cancer. See Earnest v. Sanofi U.S. Servs., Inc. (In re Taxotere (Docetaxel) Prods. Liab. Litig.), 26 F.4th 256, 260 (5th Cir. 2022). Once Sanofi's patent expired, Defendants Hospira, Inc. and Hospira Worldwide, LLC (together, "Hospira") and Accord Healthcare, Inc. ("Accord") sought FDA approval under § 505(b)(2) to sell docetaxel. Defendants' applications relied on the FDA's findings of safety and effectiveness from Taxotere's NDA. Accord's docetaxel differs from Taxotere only in the inclusion of two inactive ingredients: citric acid and polyethylene glycol. Hospira's docetaxel differs from Taxotere only in that it involves a less concentrated formulation and a one-step, rather than two-step, dilution process. The FDA approved Hospira's application on March 9, 2011, and Accord's on June 8, 2011.

Accord's approved docetaxel label matched Taxotere's. Hospira's did too, except for the preparation-and-administration sections, due to the differences discussed above. Relevant to this case, as of 2011, the labels all included identical warnings about alopecia (a medical term for hair loss) as an adverse reaction and instructed doctors to explain that hair loss was one of the drug's most common side effects. The label did not state whether the hair loss could be permanent.

In March 2015, after oncology-patient advocates contacted the FDA to express concern that docetaxel was causing permanent, not just temporary, alopecia, the FDA sent Sanofi a request for its internal data regarding permanent alopecia. Sanofi produced 2,172 reports of alopecia generally, which included 117 reports of permanent alopecia, irreversible alopecia, or alopecia lasting longer than two years. Roughly 70% of the people who reported alopecia to Sanofi were taking docetaxel in combination with other chemotherapy agents with links to alopecia, and many reports concerned patients who also received hormonal therapies associated with alopecia. In October 2015, after reviewing Sanofi's submission, the FDA requested additional information and instructed Sanofi to update its label. In re Taxotere (Docetaxel) Prods. Liab. Litig., 508 F. Supp. 3d 71, 78 (E.D. La. 2020).

In response to the FDA's request, Sanofi updated its label via the CBE regulation to add that "[c]ases of permanent alopecia have been reported." The FDA approved the update in December 2015. In approving the changes, the FDA stated that "the sponsor's simple statement that permanent cases have been reported is all that can reliably be said given the tremendous limitations of the data." In other words, the FDA did not conclude that the cases of permanent alopecia were necessarily caused by the docetaxel.

Three weeks later, Accord updated its label with the same changes via the CBE regulation, which the FDA approved in July 2016. In March 2017, Hospira also made similar changes via the CBE regulation, which the FDA approved in September...