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at the pleading stage does not nullify a plaintiff’s pleading obligations. Express and Implied Preemption Under the MDA
Prior to 1976, the regulation of medical devices was left largely for the states to supervise. Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). When Congress passed the Medical Device Amendments of 1976 (MDA), it “swept back some obligations and imposed a regime of detailed federal oversight” by the Food and Drug Administration (FDA). Id. at 316. Congress did so in response to a proliferation of complex devices and the perceived inability of the patchwork of state regulations and the common-law tort system to handle the associated risks. See id. at 315-16.
To that end, the MDA expressly pre-empts state requirements which are “different from, or in addition to, any requirement applicable . . . to the device” under federal law. 21 U.S.C. § 360k(a).1 In Riegel, the United States Supreme Court analyzed the pre-emption clause of the MDA and set forth a two-part analysis. In the first part, a court must decide whether the FDA has imposed “requirements” applicable to the medical device at issue. 552 U.S. at 321-25. Riegel held that common-law negligence and strict product liability claims pertaining to FDA-approved devices impose “requirements” subject to preemption. 552 U.S. at 323-25. The Supreme Court reasoned that a tort judgment establishes that a defendant has violated
a state-law duty, and absent a legislative intent to the contrary, reference to a state’s “requirements” includes its common law duties. Id. at 324. The court further reasoned, “State tort law that requires a manufacturer’s [devices] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect.” Id. at 325.
Under the second part of the Riegel analysis, the question becomes whether the state law claims at issue are “different from, or in addition to, any [FDA] requirement applicable . . . to the device.” See Riegel, 552 U.S. at 323 (quoting 21 U.S.C. § 360k(a)(1)). The MDA preemption clause does not preempt so called “parallel” claims. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (“Nothing in § 360k denies [states] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements . . . The presence of a damages remedy does not amount to the additional or different ‘requirement’ that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing ‘requirements’ under federal law.”). Parallel claims are those that provide a tort damages remedy for claims premised on a violation of FDA regulations, in other words, “the conduct that is alleged to give the plaintiff a right to recover under state law must be conduct
1 (a) General rule
Except as provided in subsection (b), no 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.
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