942 N.E.2d 831
Ind. Ct. App.2011Background
- Newborn Samantha McGookin diagnosed with complete heart block; Guidant Insignia 1290 pacemaker implanted 4/30/2004; plaintiff family alleged labeling omissions for pediatric use; FDA approved Insignia 1290 labeling in Nov 2003; suit filed 8/25/2006 alleging multiple claims including failure to warn and product liability; trial court granted summary judgment on implied warranty and held many claims preempted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are preempted by federal law | McGookin argues noncompliant warnings were allowed, not required, so state law not preempted | Guidant argues MDA preempts any claim seeking to impose a standard beyond FDA requirements | Preemption upheld; claims premised on adding warnings are preempted. |
| Whether Wyeth and Cook apply to MDA preemption context here | Wyeth/Cook support allowing state claims when federal scheme provides floor, not ceiling | Wyeth and Cook do not apply to MDA preemption for class III devices | Wyeth/Cook do not control MDA preemption in this context; MDA preemption applies. |
| Whether Riegel controls the preemption analysis | Riegel supports broad preemption of state-law claims challenging FDA requirements | Riegel supports preemption where claims seek different or additional requirements | Riegel supports preemption of these state-law claims. |
| Whether Appellants’ claims based on FDA-regulation violations survive | Claims based on FDA-regulated conduct could be preempted if not aligned with federal requirements | Such claims would still be preempted if adding requirements beyond FDA rules | Claims premised on adding requirements beyond FDA rules are preempted. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMA preemption: federal requirements preempt state-law claims seeking different/additional requirements)
- Wyeth v. Levine, 129 S. Ct. 1187 (U.S. 2009) (FDCA failure-to-warn claims not preempted; labeling not exclusive to federal regulation)
- Cook v. Ford Motor Co., 913 N.E.2d 311 (Ind. Ct. App. 2009) (Safety Act preemption floors vs. ceilings; savings clause allows greater safety via state law)
- Geier v. American Honda Motor Co., 529 U.S. 861 (U.S. 2000) (context for floor/ceiling distinction in federal regulation preemption)
- McMullen v. Medtronic, Inc., 421 F.3d 482 (5th Cir. 2005) (illustrates state law adding to federal medical-device requirements is preempted)