Bartlett v. Mutual Pharmaceutical Co., Inc.
678 F.3d 30
| 1st Cir. | 2012Background
- Bartlett suffered severe SJS/TEN after taking generic sulindac, leading to extensive burns, long hospitalization, and permanent injuries including near-blindness.
- Bartlett asserted NH design defect, failure-to-warn, and related claims against Mutual; the case was removed to federal court on diversity grounds.
- The district court permitted a design-defect theory under New Hampshire law, focusing on risk-benefit unreasonableness rather than a safer alternative design as an element.
- At trial, Bartlett presented pharmacologist/toxicologist and burn-surgeon experts; Mutual did not present an affirmative case but cross-examined extensively.
- A $21.06 million compensatory verdict was returned for Bartlett; Mutual moved for judgment as a matter of law and for a new trial, which the district court denied.
- Mutual appeals contending NH design-defect law, preemption under FDCA/Hatch-Waxman, expert admissibility, labeling instructions, counsel conduct, and excessiveness of damages are reviewed on appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether NH design defect requires a safer alternative design. | Bartlett argues unreasonableness outweighs utility; alternative design not essential. | Mutual contends no defect without safer alternative design. | NH design defect review allowed; safer-alternative design not required. |
| Whether FDCA preempts Bartlett's design-defect claim for a generic. | Wyeth-like framework should allow state design claims. | PLIVA preemption may bar design defects for generics. | Preemption not conclusively decided; Wyeth guidance applied; PLIVA exception not extended to design defect. |
| Whether Bartlett's experts were properly admissible under Daubert. | Experts qualified and based on relevant literature. | Opinions unreliable or undisclosed in reports. | Expert testimony admitted; district court did not abuse gatekeeping. |
| Whether the jury instruction on labeling was plain error given generics cannot change labels. | Labeling context relevant to risk-benefit analysis; evidence admissible. | Jury told to consider FDA labeling; generic cannot alter label. | Instructions not plain error; labeling considerations properly tied to design defect analysis. |
| Whether the damages award was excessive and warranted a new trial. | Award reflects real harms and suffering from extensive injuries. | Award is disproportionate and unprecedented in NH. | Verdict not clearly excessive; affirmed. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (state-law claims complement FDA regulation; not preempted generally)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (S. Ct. 2011) (federal labeling preempts certain state failure-to-warn claims for generics)
- Buckingham v. R.J. Reynolds Tobacco Co., 713 A.2d 384 (N.H. 1998) (design defect requires weighing danger against product utility; no strict alternative design rule)
- Vautour v. Body Masters Sports Indus., Inc., 784 A.2d 1178 (N.H. 2001) (proof of safer alternative design should not be essential in every design-defect case)
- Brochu v. Ortho Pharm. Corp., 642 F.2d 652 (1st Cir. 1981) (New Hampshire adopts Restatement approach to defective product design)
- Loughren v. Unum Grp., 613 F.3d 300 (1st Cir. 2010) (reaffirms de novo review for pure questions of law in preemption context)