The opinion of the court was delivered by: CHARLES A. LEGGE
In 1987 plaintiff was fitted with two artificial knee implants called Microloc Total Knee Systems, manufactured by defendant Johnson & Johnson Orthopedics, Inc.
The implants subsequently failed.
In this action, plaintiff alleges the following claims: 1) defendants were negligent in the manufacture, testing, labeling, inspection, processing and sale of the products; 2) defendants failed to provide adequate warnings; 3) defendants failed to properly design and manufacture the products; 4) defendants were generally negligent; and 5) the products did not meet express warranties or the implied warranty of fitness and merchantability. Plaintiff brings these claims under general principles of state tort law. However, in the pending motion plaintiff also argues that defendants failed to comply with federal statutes and regulations.
Defendants move for summary judgment on the ground that plaintiff's state law claims are preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetics Act. Defendants also argue that plaintiff has no standing to bring claims for enforcement of the federal statutes or regulations. Plaintiff opposes the motion.
The court has reviewed the moving and opposing papers, the record of the case, the arguments of counsel, and the appropriate authorities -- primarily the language and the history of the MDA and the regulations under it. The court concludes that defendants' summary judgment motion based on preemption must be denied, but that plaintiff does not have standing to assert the alleged violations of federal law.
Under the MDA, the Food and Drug Administration (FDA) is required to classify all medical devices into one of three categories. 21 U.S.C. § 360c. Class I devices are generally simple devices, such as tongue depressors and crutches; they pose little or no threat to public health and safety, and general controls are deemed sufficient to provide reasonable assurance of their safety and effectiveness. 21 U.S.C. § 360c(a)(1)(A)(i). Class II devices are more complex. Those devices may be subject to regulatory recommendations, post-marketing surveillance, patient registries and specific performance standards, if the FDA determines they are sufficiently dangerous products to require specifications and warnings. 21 U.S.C. § 360(a)(1)(B). Class III devices require premarket approval because they present a potential unreasonable risk of illness or injury. 21 U.S.C. § 360c(a)(1)(C)(ii)(II).
The parties agree that these knee joints should be treated as Class II devices. The FDA approved their marketing as being substantially similar to those already in the market, but the FDA did not classify them at the time because the regulations classifying this type of knee device were not yet final.
Neither the United States Supreme Court nor the Ninth Circuit has yet considered the preemptive effect of the MDA on tort actions in general, or on Class II devices in particular. Therefore, this court must "ascertain Congress' intent in enacting the federal statute at issue." Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 95, 77 L. Ed. 2d 490, 103 S. Ct. 2890 (1983).
The Supreme Court has instructed that federal preemption should be narrowly construed. Cipollone v. Liggett Group, Inc., 120 L. Ed. 2d 407, 112 S. Ct. 2608, 2618 (1992). A federal statute will supersede state tort remedies only if that is the clear and manifest purpose of Congress. Id. at 2617. The Supreme Court instructs that "we must fairly but -- in light of the strong presumption against pre-emption -- narrowly construe the precise language of [the statute] and we must look to each of petitioner's common law claims to determine whether it is preempted." Id. at 2621.
. . . 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. (emphasis added).
The FDA interprets this preemption as applying to state common law tort claims. Title 21 C.F.R. § 808.1(b) provides:
. . . no State or political subdivision of a State may establish or continue in effect any requirement with respect to a medical device intended for human use having the force and effect of law (whether established by statute, ordinance, regulation, or court decision) which is different from, or in addition to, any requirement applicable to such device under any provision of the act. . . . (emphasis added).
However, FDA regulation § 808.1(d) provides that:
State or local 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 under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements. . . . (emphasis added).
As stated by one district court applying the MDA, defendants claiming preemption:
must establish that Congress has spoken clearly and made its intention to preempt unmistakable. Alternately, [defendants] must demonstrate that federal law preempts state law to the extent that the state law actually conflicts with or frustrates the purpose of federal law. Thus, if it is possible to comply with ...