In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the plaintiffs alleged that the defendant's catheter, a class III device, was "designed, labeled, and manufactured in a manner that violated" state common law, and that these defects caused severe injuries. (Riegel, at p. 320 128 S.Ct. at p. 1005.) The plaintiffs' complaint stated claims for "strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter." (Riegel, at p. 320 128 S.Ct. at p. 1006.) At issue was whether the preemption provision in the MDA barred common law claims that challenged the safety and effectiveness of class III devices which had received premarket approval by the FDA. (Riegel, at p. 315 128 S.Ct. at p. 1002.) In resolving this issue, the court articulated a two-part test: (1) "whether the Federal Government has established requirements applicable to" the defendant's catheter, and (2) if so, whether the "common-law claims are based upon state requirements with respect to the device that are ?different from, or in addition to' the federal ones, and that relate to safety and effectiveness." (Riegel, at pp. 321-322.) The United States Supreme Court considered "whether the pre-emption clause enacted in the Medical Device Amendments of 1976, 21 United States Code section 360k, bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration (FDA)." Riegel, the plaintiff, sued Medtronic, Inc., after Medtronic's catheter device ruptured during Riegel's coronary angioplasty procedure. Riegel alleged that the catheter was "designed, labeled, and manufactured in a manner that violated New York common law ... ." (Ibid.) The MDA (Medical Device Amendments of 1976) includes an express preemption provision that provides: " ' "Except as provided in subsection (b) of this section, 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." The Riegel court determined that the preemptive effect of the MDA applies to any state requirement of general applicability that relates to the "safety or effectiveness" of medical devices "that is different from, or in addition to, federal requirements," and not only to state requirements that pertain only to medical devices. The court first found that premarket approval imposes federal requirements because it is granted "only after the FDA determines that a device offers a reasonable assurance of safety and effectiveness" and because "the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application." (Riegel, supra, 552 U.S. at p. 323.) Turning to the second question, the court concluded that tort duties under common law impose " 'requirements' and would be pre-empted by federal requirements specific to a medical device." (Riegel, at pp. 323-324 128 S.Ct. at p. 1007.) As the court explained, "excluding common-law duties from the scope of pre-emption would make little sense. State tort law that requires a manufacturer's catheters 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. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation. A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court." (Riegel, at p. 325 128 S.Ct. at p. 1008.) Accordingly, the court held that the plaintiffs' common law claims were preempted by federal law. (Riegel, at pp. 323-324) In Riegel, the court noted that the MDA preemption provision did "not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." (Riegel, supra, 552 U.S. at p. 330 128 S.Ct. at p. 1011.) In Riegel, the court declined to consider whether the plaintiffs had stated parallel claims because the issue was not raised before the Second Circuit or in their petition for review. (Riegel, supra, 552 U.S. at p. 330.) In Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, the United States Supreme Court considered whether the MDA's preemption provision barred common law claims that challenged the safety and effectiveness of class III medical devices which received approval through the PMA process. At issue there was a catheter marketed by Medtronic--a class III device that had received premarket approval from the FDA and supplemental approvals for label changes thereafter. (Riegel, supra, at p. 320.) The plaintiffs alleged the catheter was "designed, labeled, and manufactured in a manner that violated" state common law, and that these defects caused severe injuries. (Ibid.) They brought claims for "strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter." (Ibid.) The Riegel court concluded that resolving the preemption issue involved a two-part inquiry. First, the court "must determine whether the Federal Government has established requirements applicable to" the medical device at issue. (Riegel, supra, 552 U.S. at p. 321.) If there are applicable federal requirements, the court must then determine whether the "common-law claims are based upon state requirements with respect to the device that are 'different from, or in addition to' the federal ones, and that relate to safety and effectiveness. " (Id. at p. 322) Riegel held that "premarket approval imposes federal requirements because it is granted 'only after the FDA determines that a device offers a reasonable assurance of safety and effectiveness' and because 'the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application.' (Riegel, supra, 552 U.S. at p. 323.