Terry v. McNeil-PPC, Inc.
198 F. Supp. 3d 446
E.D. Pa.2016Background
- MDL involving alleged acetaminophen (Tylenol)–induced acute liver failure (ALF); this is a bellwether case where plaintiff claims Denice Hayes died from recommended-dose acetaminophen.
- Plaintiff offers Dr. Timothy Davern, a board‑certified hepatologist and long‑time ALF/DILI investigator, as general and specific causation expert.
- Davern opines that acetaminophen at or near 4 grams/day can cause ALF in susceptible patients and applied a DILI causality assessment methodology (CAM) to Hayes’s records, citing clinical experience, case series/reports, trial data (e.g., Watkins), ALFSG registry data, FDA working‑group materials, animal studies, and literature.
- Defendants moved to exclude Davern under Daubert, challenging (1) lack of epidemiologic/statistically significant studies, (2) reliance on studies showing enzyme elevations (not ALF), (3) use of case reports/registries, (4) application of CAM and alleged failures to rule out alternatives (e.g., sepsis), and (5) alleged cherry‑picking.
- Court found Davern well qualified, his methodology (weighing totality of evidence and using CAM) reliable for both general and specific causation given rarity/ethical limits on trials, and that challenges go to weight not admissibility. Motion to exclude denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of expert (qualification) | Davern is a leading DILI/ALF expert with extensive clinical/research experience | Qualifications insufficient or outside expertise for claimed opinions | Qualified — Davern’s training and experience exceed lay knowledge; qualification not disputed materially |
| Reliability of general causation methodology | Reasonable to rely on totality: case series, trials, animal studies, ALF registries, FDA workgroup, and clinical experience given rarity of ALF | Must have epidemiologic/case‑control studies/statistically significant associations; Watkins and other data insufficient | Reliable — epidemiologic proof not required; methodology and sources acceptable given rarity and infeasibility of trials |
| Use of case reports/registries (ALFSG) and Watkins trial | Case reports, ALFSG, and Watkins are appropriate, especially when combined with other evidence; Watkins showed ALT elevations and study halted for safety | Case reports/registries are anecdotal and uncontrolled; Watkins measures enzyme changes, not ALF; reliance is improper | Admissible — case reports and registry data may support expert opinions when used with other evidence; Watkins relevant as surrogate/injury indicator |
| Specific causation and CAM application; alternative causes | Applied CAM/differential assessment to Hayes’s records, ruled out alternatives (including discussion of gastric bypass, malnutrition, sepsis) | Misapplied CAM; failed to rule out sepsis and relied on a non‑generally accepted CAM instrument | Reliable — Davern applied accepted CAM methods; defendants’ criticisms go to weight and cross‑examination, not exclusion |
Key Cases Cited
- Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) (establishes admissibility gatekeeper and reliability inquiry under Rule 702)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (extends Daubert gatekeeping to non‑scientific expert testimony and gives trial judge discretionary authority on reliability)
- In re Paoli R.R. Yard PCB Litig. (Paoli II), 35 F.3d 717 (3d Cir. 1994) (Third Circuit’s articulation of Daubert standards, including liberal admissibility and Rule 403 caution)
- Pineda v. Ford Motor Co., 520 F.3d 237 (3d Cir. 2008) (discusses expert qualification and liberal admissibility under Rule 702)
- Benedi v. McNeil‑P.P.C., Inc., 66 F.3d 1378 (4th Cir. 1995) (epidemiologic studies not always required; experts may rely on other evidence to opine on causation)
- In re TMI Litig., 193 F.3d 613 (3d Cir. 1999) (proponent bears burden to demonstrate reliability by preponderance; admissibility does not require correctness)
- Holbrook v. Lykes Bros. S.S. Co., Inc., 80 F.3d 777 (3d Cir. 1996) (an expert need not be the best possible; qualification threshold is comparative to a layperson)