827 F. Supp. 2d 443
E.D. Pa.2011Background
- Plaintiff Bentzley, a Type 1 diabetic, sued Medtronic for injuries allegedly from the MMT-522 Paradigm Real-Time Insulin & Glucose Monitoring System.
- The MMT-522 System is a Class III device approved by the FDA via a PMA supplement in 2006, forming a three-component system (sensor, transmitter, insulin pump).
- FDA regulation and PMA process impose federal requirements on the device; the 2007 Class 2 recall related to MRI/EMF warnings addressed but did not substitute FDA warnings per se.
- Plaintiff alleges the system malfunctioned due to EMF exposure and that the recall did not adequately warn users, including Plaintiff, about EMF-related risks.
- Defendants moved for summary judgment arguing MDA preempts Pennsylvania state-law claims; Plaintiff contends some claims parallel federal requirements and are not preempted.
- The Court granted summary judgment on most claims, preserving only the express-warranty claim, and held manufacturing defect and failure-to-warn claims are preempted or parallel as appropriate.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does MDA preempt Pennsylvania claims? | Plaintiff contends some claims parallel federal requirements and are not preempted. | MDA preempts state-law requirements that differ from or add to federal ones. | Yes, preemption applies to several claims; express warranty survives. |
| Are the claims based on parallel federal requirements? | Claims mirror FDA requirements and/or FDA warnings. | Most claims conflict with FDA labeling and manufacturing standards. | Manufacturing-defect and failure-to-warn claims treated as preempted or parallel; some survive as express warranty. |
| Does the express-warranty claim survive preemption? | Express warranties arise from negotiated terms and are not preempted. | Express warranties may be preempted if they rely on federal requirements. | Express warranty claim survives preemption. |
| Do manufacturing defect and failure-to-warn claims survive summary judgment? | There are triable issues about FDA compliance. | Evidence shows compliance with FDA standards and warnings; no genuine issues of material fact. | Claims either preempted or unsupported; summary judgment in Defendants' favor. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (premarket approval imposes federal requirements preempting certain state claims)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (parallelism of state duties and federal requirements; FDA regulations may provide parallel remedy)
- Lohr, 518 U.S. 470 (U.S. 1996) (parallel federal requirements may permit state-law damages)
- Williams v. Cyberonics, Inc., 388 F. App’x 169 (3d Cir. 2010) (illustrates parallel vs. preempted claims under MDA)
- Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir. 1995) (preemption of certain design/manufacturing defect claims)