The Medical Device Amend-ments of 1976 to the Food, Drug, and Cosmetics Act (MDA) authorized
the federal Food and Drug Administration to regulate medical devices while preempting state efforts to enforce any legal requirement
that (1) relates to the device’s safety, effectiveness, or other matters committed to the FDA and (2) “is different
from, or in addition to,” any requirement imposed under the MDA. 21 U.S.C. § 360k(a).
In a series of decisions culminating in Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1008 (2008), federal courts came
to recognize that the MDA preempted not only traditional products liability claims such as those based on an alleged defect
or implied warranty but also causes of action premised on theories such as consumer fraud. Since any legal “requirement”
for a device that is “different from, or in addition to” that imposed by the MDA (or FDA in its regulatory capacity)
is preempted, the only way to avoid preemption is to allege a failure to meet FDA requirements.
The broad scope of MDA preemption has become apparent as District courts around the country have applied § 360k(a),
as interpreted in Riegel, to dispose of one products liability case after another, all of which allege injuries from
Class III medical devices and seek recovery under various theories, including strict products liability, breach of warranty,
and negligence. In general, claims that have alleged something other than a failure by the device manufacturer to adhere to
FDA requirements with respect to the device at issue (either with respect to its manufacture or the directions for its use)
have been dismissed on preemption grounds.
Congress may amend § 360k to overrule Riegel. The Medical Device Safety Act of 2008, H.R. 1346, currently before
the House Subcommittee on Health, would add a new subsection (c) to § 360k (entitled “No Effect on Liability under
State Law”) to make clear that “[n]othing in this section [360k] shall be construed to modify or otherwise affect
any action for damages or the liability of any person under the law of any State.” (An identical bill, S. 540, is pending
before the Senate Committee on Health, Education, Labor and Pensions.) The enactment of the bill has been identified as a
top legislative priority by the American Association for Justice.
Nonetheless, pending congressional action, Riegel applies to bar even claims by plaintiffs who have suffered injuries
caused by devices that malfunctioned or were arguably defective in their manufacture. In one of the many post-Riegel
cases that illustrate this phenomenon, a New Jersey District Court recently granted summary judgment for the defendant manufacturer
of a Class III device that was alleged to have injured the plaintiff, where the plaintiff failed to present admissible evidence
that the manufacturer had deviated from FDA requirements when it manufactured the device. Banner v. Cyberonics, Inc.,
2010 WL 455286 (D.N.J. Feb. 4, 2010). In unusually blunt language, the court emphatically rejected plaintiff’s
argument that the device, an implantable VNS therapy unit, could be manufactured according to FDA requirements yet still contain
an “anomaly” leading to plaintiff’s injury that would support liability on a non-preempted theory.
Applying Riegel to grant the manufacturer’s summary judgment motion, the court observed that “[t]he
FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured
in that process will work. Thus, if the FDA approves a manufacturing process and the defendant-manufacturer conforms with
it, a device thereby produced that nevertheless does not function as intended does not give rise to liability.” Banner,
2010 WL 455286 at *4. The fact that a device may in fact be “defective” (differing from its design in a way
that may cause it to malfunction) does not take it outside the scope of MDA preemption. As the court recognized, “[i]t
is distinctly possible that the FDA-approved process introduces a margin of error wherein a properly manufactured device may
nevertheless depart from its intended design. Under Riegel, state law cannot capture this departure and create liability
for it because that would, in effect, require the manufacturer to use greater care than required by the FDA.” Banner
at *4. The scope of MDA preemption thus parallels the risk calculus employed by FDA in determining whether to grant premarket
approval for a Class III medical device.•
John P. Twohy is a partner in the Hammond office of Eichhorn & Eichhorn and is a director of the
DTCI. The opinions expressed in this article are those of the author.