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Medical Devices/Federal Preemption of State Law

Federal courts split over whether PMA approval triggers federal preemption under the MDA - Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000)

See: 5th Circuit Reaffirms MDA Preemption - Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001)

Plaintiff in this case suffered significant injures when her cardiac pacemaker's lead failed.  She sued the device manufacturer, which moved to dismiss her claims as preempted by federal law.  The trial court did dismiss some of her claims and she appealed, leading to this ruling on the extent of federal preemption of state law for FDA regulated medical devices.

In the aftermath of Congressional hearing on dangerous medical devices, Congress granted the FDA the authority to regulate medical devices in the Medical Device Amendments of 1976 (MDA).  The MDA represents a political compromise between the public demand to regulate medical devices and the difficulty of imposing regulations on an established industry.  The core compromise was that devices already on the market could continue to be sold until the FDA developed performance standards for classes of devices and found that specific devices did not meet those standards.  New devices that were substantially the same as those already on the market could be marketed with only cursory review though a process know as 510(k) for the applicable statutory section.  New devices that were not substantially the same as a pre-1976 device had to undergo a significant pre-market approval (PMA) review, which is like a very abbreviated version of the review for marketing a new drug.  Part of the legislation established three risk classes - I, II, III - with III being the class for high risk devices such as pacemakers.  The FDA was expected to use the risk classes to decide where to put its resources in reviewing pre-1976 devices and in developing standards for PMA.  Congress did not increase the FDA's budget with the MDA and thus the FDA has not reviewed most pre-1976 devices.  Even class III devices, which include pacemakers, were allowed to be sold with only a 510(k) review for many years.  Class III devices have generated a lot of products liability litigation, with the instant case being a typical example.  These cases all raise the issue of whether state tort law has been preempted by sec. 360 of the MDA, which provides:

At the center of the instant dispute lies section 360k of the MDA, which expressly preempts certain state law requirements governing medical devices:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement-

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. 360k(a).

 The United States Supreme Court, in Cipollone v Liggett Group, Inc. 505 U.S. 504 (US 1992), found that similar language in the Cigarette Labeling Act preempted state tort law claims.  Defendants in medical devices cases argued that the MDA should thus preempt tort claims against devices regulated by the FDA.  Some lower circuit courts agreed and dismissed claims that would have had the effect of requiring device manufactures to change the way FDA approved devices were manufactured or the warnings provided with those devices.  The United States Supreme Court granted cert. in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) and used the case to address the extent of preemption under the MDA.  Unfortunately, Lohr is an example of bad facts complicating legal analysis.  Lohr involved a pacemaker, but one that had been approved through the 510(k) process and that thus never received a detailed review by the FDA.  The Lohr court found that the FDA had not imposed any significant requirements on the device and thus there were no requirements for the state law to conflict with.  While Lohr clearly finds that 510(k) devices do not trigger preemption under the MDA, it left open on the possibility that devices going through PMA would be trigger preemption.  Since Lohr, most courts have found that the MDA does not preempt state tort claims, thus the importance of this case.

After a detailed review of Lohr, the court distinguished the legal status of the pacemaker in this case, which had undergone PMA review, from the product in Lohr, which had only had a 510(k) review.  The court found that through PMA the FDA had made specific requirements related to the design and manufacture of this pacemaker.  The plaintiff claims that the FDA approved design was dangerous.  If the plaintiff is successful, the manufacturer will have to modify the design to avoid future liability.  Medtronic argued on appeal:

". . . that the FDA's "PMA approval" and the "Conditions of Approval," taken together, comprise the FDA's administrative response to Medtronics' PMA Supplement, establishing the specific federal requirements for the Model 4004M. As part of the PMA process, Medtronic submitted a detailed request for approval of a specific device of a particular design, using particular manufacturing processes and labels. Once approved, Medtronic concedes that the design, manufacturing processes, and labels may not be modified without further FDA approval, unless the modifications do not affect the device's safety or effectiveness. See 21 C.F.R. 814.39. Thus, Medtronic argues it is the totality of the design, manufacturing processes, and labeling - when coupled with the prohibition against modifying them - that represents the specific federal requirement 'applicable under [the MDA] to the device.' 21 U.S.C. 360k(a)(1)."

The heart of plaintiff's claims is that defendant failed to put a sufficiently thick anticorrosion coating on the wires in the pacemaker's leads.  Plaintiff claims that the FDA approval was based on a specific thickness of coating and the defendant's failure to use that thickness was negligence per se and a fraud on the FDA.  While the court intimated that the MDA may not be sort of law that supports negligence per se claims, it did not need to reach the issue because it could not find any specific requirement by the FDA that the coating be a set thickness.  The court found that requiring a thicker coating on the lead wire would constitute requirements different from those imposed by the FDA and thus found all of plaintiff's claims preempted.  Given the significant split in the circuits, one of these cases should go to the United States Supreme Court to resolve the issues left by the peculiar facts of Lohr.

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