Riegel Preemption Does Not Include 510(k) Approved Medical Devices
Posted by
Armand RossettiSeptember 10, 2008 3:21 PMIn Riegel v. Medtronic, 552 US ___(2008), the Court stated that in 2005, the FDA authorized the marketing of 3,148 medical devices under §510(k), and granted premarket approval (PMA) to just 32 devices. While the §510(k) process is typically abbreviated and briefly reviewed, the PMA
process is substantially more stringent and requires manufacturers to submit multivolume applications. As a result, the FDA spends an average of 1,200 hours reviewing each PMA application.
During the PMA review process, a manufacturer must provide evidence that would reasonably assure the FDA that the device under review is safe and effective. The agency must conduct a risk benefit analysis to determine whether a device, on balance, will be marketable. On occasion, high risk devices that the FDA might not otherwise approve will pass muster, if the device offers relatively greater benefits than existing devices.
In contrast, the FDA does not impose “device specific” requirements for §510(k) approved devices. Instead, the FDA will accept a comparison of the device to be approved against one that has already received approval. With FDA approval, manufacturers may market §510(k) devices as long as they remain substantial equivalents of an existing marketed device. Substantial equivalence means that a new device is so similar to an older device on the market that the FDA can approve it by exemption rather than by imposing requirements that are specific to the device itself. As the Court stated, “While §510(k) is focused on equivalence, not safety, PMA is focused on safety and not equivalence.” An example might be appropriate here.
The Court in Medtronic v. Lohr, 518 US 470 (1996) analyzed 21 CFR §808.1(d), and were informed that state requirements are preempted “only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device…” Guided by that federal requirement the Court concluded that federal manufacturing and labeling requirements applicable across the board to almost all medical devices did not preempt the common law claims of negligence and strict liability at issue in Lohr. Of course, that did not mean that FDA regulations could never preempt state common law, just that, given the facts in Lohr no FDA preemption could occur.
Based on the complexity, the FDA divides medical devices into three classes. Regarding Preemption, however, courts will not treat all complex Class III medical devices the same way.
While the §510(k) review for Lohr’s Class III pacemaker device was device specific, the process did not impose device specific requirements under PMA, but instead relied upon a substantial equivalence comparison under §510(k). A Class III device can be substantially equivalent to a predicate device (predecessor device already on the market) even if it has different technological characteristics, as long as it has the same intended use and does not raise new questions of safety and effectiveness and is at least as safe and effective as the predicate device.
If a device (even if it is a Class III device) were to remain substantially equivalent to a pre-1976 device already being marketed, it is highly likely that the FDA would allow the manufacturer to bypass PMA requirements, and approve the device under the substantially less stringent §510(k) application process. Some examples of class designations are as follows: Class I includes elastic bandages and examination gloves; Class II includes powered wheel chairs and surgical drapes; and class III includes replacement heart valves and pacemaker pulse generators.
This means that some complex §510(k) approved Class III devices, such as the Medtronic pacemaker in Lohr, would not be preempted, while others that were approved under the PMA process would be preempted.
If a common law cause of action were to impose “requirements,” and those requirements were specific to the device, but different than FDA requirements, then FDA preemption would apply to that device. Therefore, if common law causes of action for negligence and strict liability do impose new and different “requirements,” it is highly likely that preemption might attach. Since liability determinations tend to be a potent way of motivating conduct and controlling policy, it is at the liability stage that the courts will decide preemption to the detriment of damages, no matter how horrible those damages might be.
There is one more thought worth pondering. Manufacturers have often attempted to rationalize that their new medical devices are substantial equivalents to existing predicate devices already on the market. There is a reason for this. The PMA process usually costs a manufacturer considerable time and money. In fact, the PMA application, itself, is substantially more expensive than the §510(k) application, which will cost substantially less. With the increased protection that preemption gives a manufacturer, perhaps more manufacturers will stop trying to fit their devices into a 510(k) procedure and opt instead for the more costly PMA procedure. Because in the long run, given the protection of FDA preemption, submitting a medical device to PMA scrutiny might be less costly for some manufacturers.
In conclusion, barring any more encompassing Supreme Court rulings regarding device exemption versus device requirements, FDA preemption will not attach to most medical devices that are on the market today, including some very complex Class III devices.