Bartlett v. Mutual Pharmaceutical Company, Inc.
2011 U.S. Dist. LEXIS 1376
| D.N.H. | 2011Background
- Bartlett suffered SJS/TEN and permanent injuries (blindness) after taking sulindac, a generic drug sold by Mutual.
- Bartlett asserted NH strict-liability defective design, failure-to-warn, fraud, and negligence, later narrowed to defective design.
- Court granted summary judgment on failure-to-warn, fraud, and parts of negligence; trial on defective design proceeded; jury awarded $21.06 million in compensatory damages.
- Post-trial motions (Rule 50 and Rule 59) denied; court held risk-benefit outweighed by harms but not pre-empted; rejected other theories and upheld verdict.
- Mutual had withdrawn its comment-k and related defenses pre-trial, and the court allowed warning-related evidence for limited purposes; trial spanned nearly three weeks with Bartlett presenting extensive expert and medical testimony.
- Judgment entered in Bartlett’s favor; Mutual’s post-trial motions denied; execution stayed pending appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Bartlett proved sulindac’s risks outweighed its benefits for defective design | Bartlett’s experts showed SJS/TEN risk and high severity; FDA data and adverse reports support risk/benefit imbalance | SJS/TEN risk remote and outweighed by sulindac’s benefits; no alternative design proven | Yes; risk/benefit supported defect; not pre-empted by federal law |
| Whether a safer alternative design was required under NH law | No safer alternative design needed; risk-utility balancing suffices | Plaintiff must show a safer alternative design or Buckingham defense applies | No requirement for safer alternative design; plaintiff met risk-utility burden |
| Whether NH law’s pre-emption doctrines bar Bartlett’s design-defect claim | Federal law allows state-law design liability for unreasonably dangerous drugs; FDA approval not a shield | FDCA pre-empts state-law risk/benefit judgments and design claims | No pre-emption; design-defect claim survives; claims not pre-empted" |
| Whether Bartlett presented sufficient causation evidence tying sulindac to injuries | Inherent propensity of sulindac to cause SJS/TEN caused Bartlett’s injuries | Causation could require safer design or warning; reliance on warning limited | Sufficient causation evidence; Sullivan’s risk/defect caused injury |
Key Cases Cited
- Malone v. Lockheed Martin Corp., 610 F.3d 16 (1st Cir. 2010) (stringent standard for Rule 50 motions; deference to jury verdict)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (FDA labeling standards; state-law claims complement FDA regulation)
- Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) (pre-emption questions in generic-drug labeling; under appeal)
- Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) (post-Mensing pre-emption discussion; supports state-law liability scenarios)
- Geier v. American Honda Motor Co., 529 U.S. 861 (U.S. 2000) (obstacle pre-emption analysis; federalism interaction with regulatory scheme)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (Buckman pre-emption; limits on state-law claims that would undermine FDA’s processes)