Summary of Medtronic Inc v. Lohr, S. Ct 518 U S 470 
Defense: Pre-emption and Other Govt Actions
Relevant Facts: Lora Lohr is dependent upon pacemaker technology for her heart to function properly. I n 1987 she received a Medtronic Model 4011 pacemaker leads implanted into her heart. 3 yrs later the pacemaker failed, resulting in a complete heart block requiring surgery. The doctor stated the defect was in the lead causing the failure.
Legal Issue(s): Whether the Medical Device Amendment pre-empts a Florida State common law negligence action against the manufacturer, by the Pl who was injured by the devices failure?
Court’s Holding: Not in this case. The Lohr’s common law claims are not pre-empted by the federal labeling and manufacturing requirements.
Procedure: Trial ct granted Df Summary, dismissed all claims; Ct of App Affirmed in part( state claims were pre-empted), reversed in part(rejection of pre-emption defense); S. Ct. Reversed st claim, Affirmed rejection.
Law or Rule(s): The police powers of the States, (health and safety), are not to be superceded by Federal Act, unless there is a clear and manifest purpose of Congress to do so. There is a presumption against pre-empting state police power regulations. The purpose of Congress is the touch stone in every pre-emption case.
Court Rationale: If Cong intended the MDA to pre-empt state law, we must i/d the domain expressly pre-empted by that language. Congress’ intent is discern from the language of the statute and the “statutory framework," surrounding it. Also relevant is the ‘structure and purpose of the statute as a whole.’ The legislative hx confirms that the Act was not intended to pre-empt most, let alone all, general common law duties enforced by damage actions. This statutory and regulatory language doesn’t preclude “general’ federal reqs from ever pre-empting state reqs or ‘general’ state reqs from ever being pre-empted. State reqs must be ‘with respect to’ medical devices ‘different from, or in addition to,’ federal reqs. State reqs must also relate ‘to the safety or effectiveness of the device or to any other matter included in a req applicable to the device,’ and the regs provide that state reqs of “gen applicability," are not pre-empted EXCEPT where they have ‘the effect of establishing a substantive req for a specific device." Fed reqs must be “applicable to the device,’ in question, and according to the regs, pre-empt state law ONLY IF they are “specific counter-part regs’ or ‘specific’ to a ‘particular device."
Plaintiff’s Argument: The Act imposes no req on the design of the device; Congress did not intend to remove all means of recourse for those injured by illegal conduct. The state’s req are related to health and safety issues, and are different in scope and application than the Fed req.
Defendant’s Argument: Congress either intended to bar all common law tort claims based on medical devices or FDA’s rules reg manuf practices are reqs that pre-empt state reqs. B/c the State’s gen. rules imposing CL duties upon Df do not impose a req w/ respect to a device" they do not conflict w/ the FDA’s general rules relating to manufacturing and are therefor pre-empted.