Ginochio v. Surgikos, Inc.

• Decision Date: 22 August 1994
• Docket Number: No. C-93-2587-CAL.,C-93-2587-CAL.
• Citation: 864 F. Supp. 948
• Court: U.S. District Court — Northern District of California
• Parties: Louis J. GINOCHIO, Plaintiff, v. SURGIKOS, INC, et al., Defendants.

864 F. Supp. 948

Louis J. GINOCHIO, Plaintiff, v. SURGIKOS, INC, et al., Defendants.

No. C-93-2587-CAL.

United States District Court, N.D. California.

August 22, 1994.

Joseph Anthony Ferrante, A.J. Fusco, Jr., Passaic, NJ, for plaintiff.

Susan Market Sharko, Shanley & Fisher, Morristown, NJ, Thomas W. Pulliam, Jr., Preuss Walker & Shanagher, San Francisco, CA, for defendants.

OPINION AND ORDER ON MOTION FOR SUMMARY JUDGMENT

LEGGE, District Judge.

In 1987 plaintiff was fitted with two artificial knee implants called Microloc Total Knee Systems, manufactured by defendant Johnson & Johnson Orthopedics, Inc¹. The implants subsequently failed.

I.

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.

II.

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 Cosmetic 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.

III.

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.

IV.

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, 103 S.Ct. 2890, 2899, 77 L.Ed.2d 490 (1983).

The Supreme Court has instructed that federal preemption should be narrowly construed. Cipollone v. Liggett Group, Inc., ___ U.S. ___, ___, 112 S.Ct. 2608, 2618, 120 L.Ed.2d 407 (1992). A federal statute will supersede state tort remedies only if that is the clear and manifest purpose of Congress. Id. at ___, 112 S.Ct. at 2617. The Supreme Court instructs that "we must fairly but — in light of the strong presumption against preemption —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 ___, 112 S.Ct. at 2621.

The specific statute at issue here is 21 U.S.C. § 360k(a), which provides:

... 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).

See also, Stamps v. Collagen Corp., 984 F.2d 1416, 1420-21 (5th Cir.1993), cert. denied, ___ U.S. ___, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993).

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 both federal and state law, there is neither a conflict nor a frustrated purpose.

Bravman v. Baxter Healthcare Corp., 842 F.Supp. 747, 753 (S.D.N.Y.1994).

V.

Plaintiff argues that there are no specific regulations, as required by 21 C.F.R. § 808.1(d), affecting these devices and therefore none of his claims are preempted. Defendants argue that regulation 808.1(d) is invalid if it compels specific requirements that the statute, § 360k(a), does not. Defendants further argue that even if regulation 808.1(d) applies, plaintiff's claims are preempted because 21 C.F.R. § 888.3560 specifically regulates these devices and several other regulations also apply to them.

VI.

This court first addresses defendants' contention that regulation 808.1(d) is invalid because it is contrary to § 360k(a) of the MDA. As the agency charged with administering this federal act, FDA's regulations are dispositive unless its interpretation is inconsistent with clearly expressed congressional intent. See Hillsborough County v. Automated Medical Labs Inc., 471 U.S. 707, 714-15, 105 S.Ct. 2371, 2375-76, 85 L.Ed.2d 714 (1985). "If the intent of Congress is clear, that is the end of the matter," because FDA must give effect to the unambiguously expressed intent of Congress. Chevron U.S.A, Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842, 104 S.Ct. 2778, 2781, 81 L.Ed.2d 694 (1984). If the statute is ambiguous, the question is whether FDA's interpretation is based on a permissible construction of the statute. Id. at 843, 104 S.Ct. at 2782.

Section 360k(a) provides that state "requirements" are preempted if they are different from or in addition to any federal "requirement applicable ... to the device." The term "requirement" is undefined. If § 360k(a) had not included the phrase "applicable ... to the device," it would be clear that no common law claims could be brought if they were different from or in addition to any of the general requirements of the statute. However, § 360k(a) only preempts state requirements which are different from or in addition to federal requirements applicable to the device. That phrase can be read as including all regulations to which the device may be subject, or only the regulations which are specifically applicable to that particular device. The FDA has chosen the latter interpretation. Because the language of § 360k(a) is reasonably subject to this construction, it is invalid only if it is contrary to the intent of Congress.

The legislative history of the MDA is not very helpful. Congress promulgated the MDA in order to increase the protection afforded to medical device consumers under then existing law. Congress enacted the statute "to assure that medical devices ... meet the requirements of safety and effectiveness before they are put in widespread use throughout the United States." S.Rep. No. 33, 94th Cong., 2d Sess. at 3 (1976), reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1071. Congress enacted the House version of what became § 360k(a). The House report indicates that the purpose behind § 360k(a) was to limit states from establishing administrative agencies and rules without federal approval. House Rep. No. 853, 94th Cong., 2d Sess. at 45-46 (1976). See Bravman, 842 F.Supp. at 755. The Senate had considered a broader provision, which would have preempted states from regulating the "performance, composition, contents, design, finish, construction, packaging, or labeling of a device" if the device had undergone a performance standard or scientific review. S.B. 510 § 903, reported in 121 Cong.Rec. 10709 (April 17, 1975). But this broader form was not the one enacted by Congress.

The courts that have...