638 F. App'x 508
7th Cir.2016Background
- Plaintiff Michael Houston developed Stevens-Johnson Syndrome (SJS) after taking generic allopurinol prescribed by a physician’s assistant (Pecard) at the federally funded Komed Holman Health Center; he alleges permanent disfigurement.
- Houston sued in state court: medical-malpractice claims against Komed, Pecard, supervising physician Shariff (healthcare defendants), and product-liability claims against generic manufacturer Qualitest for defective design/failure to warn.
- The United States removed the case, certified the healthcare defendants as federal employees under the Public Health Service Act, and substituted itself under the FTCA; Houston contested scope-of-employment and amended his complaint after limited discovery.
- The United States moved to dismiss for failure to exhaust administrative remedies under the FTCA (28 U.S.C. § 2675(a)); Qualitest moved to dismiss on federal preemption grounds, invoking Mensing and Bartlett.
- The district court dismissed with prejudice: FTCA claims were dismissed as against the United States for lack of exhaustion (because employees were within scope), and product-liability claims against Qualitest were preempted by federal law governing generic-drug sameness.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Pecard and Shariff acted within scope of employment, making the United States the proper defendant under FTCA | Houston: factual allegations (lack of supervising physician signature, failure to warn) show they acted outside scope | U.S.: allegations show they were performing duties of their Komed positions; certification stands | Held: acted within scope; FTCA substitution proper; dismissal for failure to exhaust affirmed |
| Whether failure to exhaust administrative remedies warranted dismissal of claims against the United States | Houston: scope-of-employment dispute removes FTCA bar | U.S.: scope established, so FTCA applies and administrative exhaustion required and not satisfied | Held: exhaustion required; dismissal proper |
| Whether Houston’s state-law claims against Qualitest are preempted by federal law requiring generic manufacturers to match brand-name drug labeling/design (duty of sameness) | Houston: state claims do not necessarily require changing label/design; post-2007 FDA amendments allow negotiated labeling changes | Qualitest: Mensing/Bartlett preempt state duties that would force label/design change or market exit | Held: claims preempted; Mensing/Bartlett control; amendments do not eliminate the impossibility conflict |
| Whether remaining claims should be remanded or amended to add brand-name manufacturer | Houston: claims against Qualitest should be remanded if U.S. dismissed; seeks to add Zyloprim maker | Qualitest: supplemental jurisdiction applies; adding brand-name barred by statute of limitations and lack of timely notice | Held: supplemental jurisdiction exists; amendment to add brand-name barred by Illinois statute of limitations/time for service |
Key Cases Cited
- Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) (state-law design/labeling duties preempted when they conflict with federal duty of sameness for generics)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (generic manufacturers’ state-law failure-to-warn claims preempted by federal law imposing duty of sameness)
- Osborn v. Haley, 549 U.S. 225 (2007) (FTCA substitution applies when federal certification that employee acted within scope stands)
- McNeil v. United States, 508 U.S. 106 (1993) (FTCA requires administrative exhaustion before suit)
- Taboas v. Mlynczak, 149 F.3d 576 (7th Cir. 1998) (plaintiff must allege facts showing government certification of scope-of-employment is wrong)
- Brinkley v. Pfizer, Inc., 772 F.3d 1133 (8th Cir. 2014) (applying Mensing/Bartlett to preempt design-defect and related state claims against generic manufacturers)