Preemption of Failure to Warn Claims under Tex. Civ. Prac. & Rem. Code §82.007(a): McKay v. Novartis Affirmed

Introduction

The case of Thomas W. McKay; Leticia McKay v. Novartis Pharmaceutical Corporation (751 F.3d 694, 5th Cir. 2014) presents significant insights into the interplay between state-specific failure to warn statutes and federal preemption in the context of multidistrict litigation (MDL). Thomas and Leticia McKay initiated a lawsuit against Novartis alleging that the drugs Aredia and Zometa caused severe jaw bone conditions due to inadequate warnings. After a protracted legal battle spanning eight years and multiple forums, the Fifth Circuit Court of Appeals affirmed the district court’s summary judgment in favor of Novartis. This commentary delves into the critical aspects of the judgment, exploring the application of Texas law, the impact of federal preemption, and the broader implications for future litigation involving pharmaceutical liability.

Summary of the Judgment

The McKays sued Novartis in the Western District of Texas, alleging that Aredia and Zometa caused osteonecrosis of the jaw due to insufficient warnings. The case was transferred to the Middle District of Tennessee for MDL proceedings, where the court granted partial summary judgment for Novartis. The court applied Texas law, specifically Tex. Civ. Prac. & Rem. Code §82.007(a), which imposes a rebuttable presumption against liability for failure to warn when FDA-approved warnings are present. The MDL court concluded that the McKays could not rebut this presumption without meeting stringent criteria under §82.007(b)(1), which involves proving that Novartis withheld material information from the FDA. On remand, the Western District of Texas adhered to the MDL court’s findings, further dismissing the McKays' remaining claims based on breach of warranty and loss of consortium. The Fifth Circuit affirmed these decisions, upholding the application of §82.007(a) and the dismissal of the McKays' claims.

Analysis

Precedents Cited

The judgment extensively references Lofton v. McNeil Consumer & Specialty Pharmaceuticals, where the Fifth Circuit held that §82.007(b)(1) is preempted unless the FDA has found fraud. This precedent underscores the high threshold plaintiffs must meet to rebut the presumption against liability. Additionally, referencing XEROX CORP. v. GENMOORA CORP. and IN RE FORD MOTOR CO., the court emphasized the "law of the case" doctrine in MDL settings, reinforcing the principle that transferee courts’ decisions should prevail unless there is a clear error or new, substantial evidence is introduced.

Legal Reasoning

The court’s legal reasoning hinged on the application of Tex. Civ. Prac. & Rem. Code §82.007(a), which provides a rebuttable presumption against liability for failure to warn claims when FDA-approved warnings are present. The MDL court identified that the McKays failed to meet the stringent criteria required to rebut this presumption under §82.007(b)(1). Furthermore, the court applied the "law of the case" doctrine, maintaining consistency across multiple court decisions within the MDL framework. The McKays' attempts to introduce new arguments on remand, such as evidence of off-label promotion and the invalidation of §82.007, were dismissed as procedurally deficient and not raised in initial motions, rendering them ineligible for consideration.

Impact

This judgment has profound implications for future pharmaceutical litigation, particularly in cases involving failure to warn claims. It reinforces the robustness of state-specific statutes like §82.007(a) in precluding liability when FDA-approved warnings are present, unless plaintiffs can incontrovertibly demonstrate that manufacturers withheld material information from the FDA. Additionally, the affirmation of the "law of the case" doctrine in MDL contexts underscores the importance of presenting all viable arguments early in litigation to avoid being precluded from raising them on appeal or remand.

Complex Concepts Simplified

Tex. Civ. Prac. & Rem. Code §82.007(a)

This Texas statute establishes that pharmaceutical manufacturers are presumed not liable for failing to warn about drug risks if the warnings they provided are approved by the FDA. To hold the manufacturer liable, plaintiffs must prove that the manufacturer withheld crucial information from the FDA that was directly related to the plaintiff’s injury.

Rebuttable Presumption

A rebuttable presumption is a legal assumption that holds true unless disproven. In this case, it's assumed that Novartis was not negligent in warning about drug risks because the FDA approved their warnings, unless the McKays can provide evidence to the contrary.

Law of the Case Doctrine

This legal principle ensures consistency in court decisions throughout the duration of a case, especially in MDLs. Once a court has made a ruling on a specific issue, that ruling generally stands in subsequent proceedings unless there is a substantial change in facts or law.

Rule 56(d) Motion

Under Federal Rule of Civil Procedure 56(d), a party can request additional time to gather evidence before opposing a summary judgment motion. However, such motions are granted only if the requesting party can show that essential facts are unavailable despite diligent efforts.

Conclusion

The Fifth Circuit’s affirmation in McKay v. Novartis underscores the stringent barriers plaintiffs face when challenging FDA-approved warnings under state-specific failure to warn statutes. By upholding the application of Tex. Civ. Prac. & Rem. Code §82.007(a) and reinforcing the "law of the case" doctrine in MDL settings, the court has set a clear precedent that favors pharmaceutical manufacturers unless exceptional evidence is presented. This decision not only fortifies the protective measures for drug manufacturers but also emphasizes the necessity for plaintiffs to meticulously adhere to procedural requirements and present compelling evidence from the outset of litigation.