Burnham v. Wyeth Labs. Inc.
348 F. Supp. 3d 109
D.D.C.2018Background
- Plaintiff Arthur Burnham, proceeding pro se, was prescribed Effexor (venlafaxine) by Dr. Shukair on June 16, 2015 while hospitalized for suicidality; he alleges acute adverse reactions that same day.
- After discharge, Plaintiff set a police car on fire, was arrested, and later brought multiple claims including a product liability claim against Wyeth Pharmaceuticals LLC (manufacturer of Effexor).
- Plaintiff alleges Wyeth’s product caused his injuries and that warnings were inadequate; he also alleges the medication came with a "BLACK BOX WARNING."
- Wyeth moved to dismiss under Fed. R. Civ. P. 12(b)(6) for failure to state a claim.
- The court accepted the complaint’s factual allegations as true for the motion-to-dismiss stage and noted Plaintiff’s pro se status but applied ordinary pleading standards.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Plaintiff pleaded a manufacturing defect | Burnham alleges Effexor caused adverse reactions but does not allege the pill deviated from intended design | Wyeth contends no facts show a manufacturing deviation | Dismissed — no allegations of manufacturing defect |
| Whether a design-defect theory is available for prescription drugs | Burnham claims product was defective (generally) | Wyeth argues prescription drugs are treated under comment k and not subject to design-defect claims when properly prepared and warned | Dismissed — design-defect claim not cognizable for prescription drugs under comment k |
| Whether Wyeth can be liable for failure to warn to the patient | Burnham alleges he was not warned or explained medication risks; notes physician ignored risks | Wyeth invokes the learned-intermediary doctrine: duty to warn runs to prescribing physician, not directly to patient; Plaintiff admits a black-box warning existed | Dismissed — no plausible failure-to-warn claim against Wyeth under learned-intermediary doctrine |
| Causation/pleading sufficiency to survive Rule 12(b)(6) | Burnham links medication to his acute symptoms and later conduct | Wyeth argues allegations are legal conclusions lacking facts tying a manufacturing or warning defect to injury | Dismissed — complaint fails to plausibly allege a defect or actionable failure to warn against Wyeth |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility standard for Rule 12(b)(6))
- Ashcroft v. Iqbal, 556 U.S. 662 (court must draw on judicial experience and common sense in plausibility inquiry)
- Ocasio-Hernandez v. Fortuno-Burset, 640 F.3d 1 (First Circuit discussion of inference reasonableness at pleading stage)
- Langadinos v. American Airlines, 199 F.3d 68 (pleading standards and inferences)
- Erickson v. Pardus, 551 U.S. 89 (pro se pleadings construed liberally)
- Cottam v. CVS Pharmacy, 436 Mass. 316 (learned-intermediary doctrine for prescription drugs)
- Vassallo v. Baxter Healthcare Corp., 428 Mass. 1 (Massachusetts adoption of Restatement §402A principles for drug cases)
- Payton v. Abbott Labs, 386 Mass. 540 (recognition of comment k in drug liability context)
- Evans v. Lorillard Tobacco Co., 465 Mass. 411 (elements of product liability and warning defect)
- Back v. Wickes Corp., 375 Mass. 633 (manufacturing defect requires deviation from design)