In Re Fosamax (Alendronate Sodium) Products Liability Litigation
2017 U.S. App. LEXIS 5075
| 3rd Cir. | 2017Background
- Hundreds of plaintiffs alleged that Merck’s osteoporosis drug Fosamax caused atypical femoral fractures and that Merck failed to warn adequately in its FDA-approved label. Many plaintiffs also asserted related design-defect, negligence, and warranty claims.
- The cases were consolidated in an MDL in the District of New Jersey; plaintiffs at issue were injured before Sept. 14, 2010 (before the FDA task‑force report and before FDA-directed label language issued Oct. 2010/Jan. 2011).
- Merck submitted a PAS in 2008 proposing language for both the Warnings & Precautions and Adverse Reactions sections; FDA approved adding atypical fractures to Adverse Reactions (2009) but rejected Merck’s proposed Warnings & Precautions language in May 2009, criticizing Merck’s use of the term "stress fractures."
- FDA communications show evolving positions: in 2008 the FDA was "concerned" about a safety signal; in March 2010 the FDA said data did not show a "clear connection"; the Sept. 2010 task force reported evidence of an association; in Oct. 2010 the FDA required Warnings & Precautions language for all bisphosphonates and provided specific wording to Merck.
- The district court granted Merck summary judgment, holding plaintiffs’ pre‑Sept. 2010 claims preempted under Wyeth v. Levine because there was "clear evidence" the FDA would have rejected the label change; the Third Circuit vacated and remanded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Wyeth’s "clear evidence" standard denotes a standard of proof or a factual catalogue | "Clear evidence" is a standard of proof (intermediate — clear and convincing); manufacturer must show FDA rejection is highly probable | Same as plaintiff on standard but contends courts should decide the ultimate question as a matter of law | Court: "clear evidence" denotes a heightened standard of proof (highly probable / clear and convincing) |
| Who decides whether FDA would have rejected a proposed label change (judge or jury)? | It is a factual question for the jury because it requires weighing evidence, inferring agency motives, and predicting counterfactual agency action | Should be decided as a matter of law by the judge for consistency and institutional competence | Court: It is a question of fact for the jury; summary judgment appropriate only if no reasonable juror could conclude otherwise |
| Whether Merck met its burden on summary judgment to show preemption of Warnings & Precautions claims | Plaintiffs: evidence permits a reasonable jury to find FDA would have approved a properly worded warning (e.g., FDA approved Adverse Reactions language; FDA rejection may have rested on "stress fracture" wording) | Merck: FDA’s 2009 rejection and contemporaneous statements show FDA lacked scientific support pre‑2010 and would have rejected any CBE; thus Wyeth preempts claims | Court: Reversed — reasonable jurors could find it less than highly probable FDA would have rejected a corrected warning; summary judgment improper |
| Whether Merck was entitled to summary judgment on Adverse Reactions and non‑warning claims | Plaintiffs: Adverse Reactions claims were pleaded and supported by physician declarations; non‑warning claims are not merely failure‑to‑warn and should survive | Merck: Adverse Reactions claims either were not pled or would not have changed prescribing; non‑warning claims sound in failure‑to‑warn and are preempted | Court: Merck not entitled to summary judgment on Adverse Reactions or non‑warning claims; district court erred in resolving MDL-wide merits pretrial |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (state-law failure-to-warn preempted only when there is clear evidence FDA would have rejected the proposed label change)
- Boyle v. United Techs. Corp., 487 U.S. 500 (1988) (certain conflict‑preemption defenses require factfinding by the jury)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (impossibility preemption doctrine and manufacturer burden)
- Anderson v. Liberty Lobby, 477 U.S. 242 (1986) (summary judgment standard and reasonable-jury inquiry)
- Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91 (2011) (equating "clear evidence" with clear-and-convincing standard)
- In re Federal‑Mogul Global, Inc., 684 F.3d 355 (3d Cir. 2012) (discussion of preemption scope in the Third Circuit)