909 F. Supp. 2d 901
S.D. Ohio2012Background
- Hawkins alleges injury from a Medtronic IPG Model 7425 implanted Oct 15, 2009, designed to deliver spinal cord electrical stimulation to relieve pain.
- IPG initially functioned, but by late 2009/early 2010 Hawkins experienced painful shocks at the implant site despite attempts to turn the device off.
- Doctors, with a Medtronic agent, repeatedly tried to fix the IPG; in March 2010 it was replaced with a new model.
- Hawkins asserts multiple Ohio-law product-liability theories and alleges violations of the Federal Food, Drug, and Cosmetic Act as amended by the MDA.
- Medtronic moved to dismiss under Rule 12(b)(6); the court granted in part and denied in part the motion.
- Court reviews preemption framework under the MDA, focusing on PMA-approved devices and whether state claims parallel federal requirements.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether PMA preemption bars the state claims at issue | Hawkins claims parallel state duties to FDA requirements. | Medtronic argues many claims are preempted as different/additional to federal requirements. | Claims may proceed if they parallel federal requirements. |
| Count One – Design/manufacturing defects | Alleges design/manufacturing defect under Ohio law. | Claims are preempted if they impose state requirements beyond FDA PMA standards. | Court denies preemption; design defect claim allowed. |
| Count Two – Failure to warn | Defendant failed to warn or instruct adequately under state law. | Warnings beyond FDA-approved labels preempted. | Court denies preemption; failure-to-warn claim allowed. |
| Count Three – Negligent handling | Alleges negligent handling/controls per MDA and 21 C.F.R. provisions. | No Ohio-law basis; MDA provides none. | Count Three dismissed. |
| Counts Five and Six – Misrepresentation and failure to report | Claims premised on post-approval misrepresentations and reporting failures. | Misrepresentation and reporting claims preempted under MDA. | Counts Five and Six dismissed. |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (MDA preemption framework and parallel claims concept)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA-specific requirements; parallel state claims may proceed if not different/additional)
- Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir., Ohio 2000) (design-defect preemption analysis under PMA; distinguishes investigational vs PMA devices)
- Gomez v. St. Jude Med. Daig Div., Inc., 442 F.3d 919 (5th Cir. 2006) (express warranty preemption analysis in PMA context; look-through approach rejected here)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (fraud-on-the-FDA claims impliedly preempted)