Preemption of State Law Claims in Pharmaceutical Liability: Gibbons v. Bristol-Myers Squibb & Pfizer

Introduction

In the landmark case of Catherine Gibbons, et al., Plaintiffs-Appellants, v. Bristol-Myers Squibb Company and Pfizer Inc., Defendants-Appellees, 919 F.3d 699 (2d Cir. 2019), the United States Court of Appeals for the Second Circuit addressed critical issues surrounding the preemption of state law claims under the Food, Drug, and Cosmetics Act (FDCA). This multi-district litigation (MDL) involved plaintiffs suing major pharmaceutical companies, Bristol-Myers Squibb (BMS) and Pfizer Inc., alleging that the blood-thinning medication Eliquis (apixaban) caused severe and fatal bleeding events due to its design and insufficient warning labels.

The key issues in the case revolved around the propriety of removing state court lawsuits to federal court under diversity jurisdiction, and whether the plaintiffs' state law claims were preempted by the FDCA. The plaintiffs argued that the district court erred in denying their motions to remand the cases to state courts and in determining that their claims were preempted. However, the appellate court upheld the district court's decisions, establishing significant precedents in federal preemption and removal statutes.

Summary of the Judgment

The United States District Court for the Southern District of New York, presided over by Judge Cote, initially dismissed sixty-four products liability claims against BMS and Pfizer for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). These claims alleged that Eliquis was defectively designed and inadequately warned users about the risks of severe bleeding. Plaintiffs appealed the dismissals, challenging both the denial of motions to remand the cases to state court and the preemption of their state law claims by the FDCA.

The Second Circuit appellate court affirmed the district court's decisions. It held that removal to federal court was proper under 28 U.S.C. § 1441(a) since the basis for federal jurisdiction was diversity of citizenship. Additionally, the court agreed that the plaintiffs' state law claims were preempted by the FDCA because they failed to adequately allege new information that would allow the defendants to modify the drug's labeling under the "changes being effected" (CBE) regulation.

Consequently, the appellate court denied the plaintiffs' motions to remand the cases to state court and upheld the dismissal of the claims, reinforcing the federal preemption doctrine in pharmaceutical litigation.

Analysis

Precedents Cited

The judgment extensively referenced several key precedents that influenced the court’s decision:

Wyeth v. Levine, 555 U.S. 555 (2009): Established that state law claims for failure to warn are preempted by the FDCA unless the manufacturer could have updated the label using the CBE regulation.
Pliva, Inc. v. Mensing, 564 U.S. 604 (2011): Affirmed that generic drug manufacturers are subject to the same preemption standards under the FDCA as brand-name manufacturers.
Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013): Clarified that plaintiffs must allege specific labeling deficiencies that could have been addressed via the CBE regulation to survive preemption.
Encompass Ins. Co. v. Stone Mansion Rest. Inc., 902 F.3d 147 (3d Cir. 2018): Discussed the applicability of the forum defendant rule under 28 U.S.C. § 1441(b)(2) in removal cases.
In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 852 F.3d 268 (3d Cir. 2017): Highlighted the burden on defendants to prove that the FDA would not have approved label changes.

Legal Reasoning

The court’s legal reasoning was twofold:

Removal to Federal Court: The court evaluated whether the removal of the cases to federal court under 28 U.S.C. § 1441(a) was proper. The plaintiffs contended that under the forum defendant rule (28 U.S.C. § 1441(b)(2)), removal should be barred because the defendants were being sued in their home state (Delaware). However, the court found that since the removal occurred before the defendants were properly joined and served, the forum defendant rule did not apply. The court emphasized a strict textual interpretation of the statute, asserting that the requirement for proper joinder and service must be met before the forum defendant rule can bar removal.
Preemption of State Law Claims: Regarding preemption, the court adhered to the precedent that state law failure-to-warn claims are preempted by the FDCA unless specific criteria under the Wyeth and Mutual Pharmaceutical standards are met. The plaintiffs failed to provide sufficient factual allegations demonstrating that Bristol-Myers Squibb and Pfizer had access to new information that could have been used to update Eliquis’s labeling under the CBE regulation. The court noted that the plaintiffs' claims were conclusory and did not meet the necessary pleading standards to overcome federal preemption.

Impact

This judgment has profound implications for future pharmaceutical litigation:

Reinforcement of Federal Preemption: The decision underscores the strong federal preemption of state law claims in the pharmaceutical context, especially concerning labeling and failure-to-warn allegations. Plaintiffs must now ensure that their claims meet the stringent requirements to survive under the Wyeth framework.
Clarification on Removal Procedures: The affirmation of the district court’s denial to remand cases to state court before proper service highlights the importance of timely and proper joinder and service in removal proceedings. It provides clarity on when the forum defendant rule can be invoked.
Guidance for Plaintiffs: Plaintiffs will need to provide more detailed and specific allegations regarding newly acquired information that can be acted upon by defendants to update labels, thereby ensuring their claims are not preempted.
Uniformity in Application of Removal Statute: By adhering to a strict textual interpretation, the court promotes uniform application of removal statutes, even in the face of differing state laws regarding service, thereby reducing the potential for non-uniform judicial outcomes.

Complex Concepts Simplified

Federal Preemption

Federal preemption occurs when federal law overrides or takes precedence over state laws. In the context of pharmaceutical litigation, if state law claims conflict with federal regulations like the FDCA, the federal law can preempt state law claims, rendering them invalid.

Removal Jurisdiction

Removal refers to the process by which a defendant can transfer a lawsuit filed in state court to federal court. This is typically permissible when the case involves federal questions or diversity of citizenship (parties from different states). The forum defendant rule limits removal if the case is solely based on diversity and involves a defendant being sued in their home state.

Changes Being Effected (CBE) Regulation

The CBE regulation allows pharmaceutical manufacturers to make certain label changes to their products without prior FDA approval, provided the changes are designed to increase the drug’s safe use or add new safety information. This regulation is crucial in determining whether a manufacturer could have acted to prevent alleged harm, thereby impacting preemption decisions.

Rule 8 Pleading Standard

Under Federal Rule of Civil Procedure 8(a)(2), a complaint must contain a short and plain statement of the claim showing that the pleader is entitled to relief. This standard requires more than mere conclusory statements; plaintiffs must plead enough factual matter to suggest that their claims are plausible.

Conclusion

The Second Circuit's decision in Gibbons v. Bristol-Myers Squibb & Pfizer reinforces the supremacy of federal law in regulating pharmaceutical liability, particularly through the lens of the FDCA. By upholding the district court's denial of motions to remand and affirming the dismissal of preempted state law claims, the court has clarified the boundaries within which plaintiffs must operate when challenging drug manufacturers. This case serves as a pivotal reference for future litigations, emphasizing the necessity for detailed and specific allegations in state law claims to withstand federal preemption and highlighting the procedural intricacies of removal jurisprudence.

Ultimately, this judgment underscores the delicate balance between state tort claims and federal regulatory frameworks, shaping the landscape of pharmaceutical litigation and influencing how both plaintiffs and defendants approach such cases in federal courts.