144 F. Supp. 3d 699
E.D. Pa.2015Background
- Decedent Denice Hayes used Extra Strength Tylenol (500 mg acetaminophen) after surgery and died in Aug. 2010; death certificate and treating physicians attributed death to acetaminophen-induced acute liver failure (ALF).
- Plaintiff (Rana Terry, on behalf of estate) alleges McNeil/Johnson & Johnson failed to warn that acetaminophen can cause ALF at or near recommended doses, especially in fasting/malnourished patients.
- Extra Strength Tylenol labeling history: was regulated under both NDA and OTC monograph processes; labels changed over time and the FDA issued a 2009 Final Rule requiring specific liver warnings effective April 29, 2010.
- Key factual disputes: which bottle/label Denice used (pre-2010 vs. post-2010 wording) and the cause of death (acetaminophen-induced ALF vs. sepsis/multi-organ failure).
- Defendants moved for summary judgment on failure-to-warn (insufficient evidence and implied federal preemption); the court denied summary judgment, finding sufficient evidence and that implied preemption was not established.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Adequacy of warning (failure-to-warn) | Label lacked adequate warnings about ALF at/near recommended doses and risk in fasting/malnourished patients; different dosing language could increase exposure | Label met regulatory expectations and warned of overdose; plaintiff cannot prove an adequate warning would have prevented death | Denied summary judgment — plaintiff presented sufficient evidence a jury could find the label inadequate and that an adequate warning could have prevented death (read-and-heed evidence exists) |
| Causation (read-and-heed / foreseeability) | Decedent would read and follow warnings; family and medical records support compliance; overdose was foreseeable given consumer misuse data | No direct evidence decedent read or heeded label; dosage taken is disputed; defendants point to other evidence suggesting overdose | Denied summary judgment — court found enough evidence (habit testimony, medical records, expert opinion) to let a jury decide causation/heeding and foreseeability |
| Implied federal preemption (FDA rule) | Even post-2009 Final Rule, state-law failure-to-warn claims are not preempted; manufacturer can change label (CBE principle from Wyeth) and TFM is non-final | FDA Final Rule’s omission of a fasting/malnourishment warning and monograph status prevent McNeil from unilaterally adding warnings — state claims conflict with federal scheme | Denied summary judgment — Wyeth controls; no "clear evidence" FDA would have rejected the change; monograph/TFM status and McNeil’s own label changes show it was not impossible to comply with both federal and state law |
| Genuine disputes of material fact | Plaintiff points to competing testimony and expert reports creating factual disputes | Defendants argue evidence favors them and supports summary judgment | Denied summary judgment — two genuine material disputes (which label was used; cause of death) require a jury determination |
Key Cases Cited
- Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment burden and evidentiary standards)
- Anderson v. Liberty Lobby, 477 U.S. 242 (standard for genuine dispute and drawing inferences at summary judgment)
- Wyeth v. Levine, 555 U.S. 555 (manufacturer responsibility for label content; CBE regulatory mechanism and impossibility preemption standard)
- Casrell v. Altec Indus., Inc., 335 So.2d 128 (Ala. 1976) (Alabama Extended Manufacturer’s Liability Doctrine governing product-liability/warnings)