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November 14, 1994


Appeal from the Circuit Court of St. Clair County. No. 89-L-357. Honorable Robert L. Craig, Judge, presiding.

Petition for Appeal as a Matter of Right or Leave to Appeal Allowed February 1, 1995.

Chapman, Maag, Goldenhersh

The opinion of the court was delivered by: Chapman

JUSTICE CHAPMAN delivered the opinion of the court:

In November 1985 Dr. Simmons inserted a Howmedica knee implant into Donald Haudrich and told him it should be good for approximately 10 years. Three years later the implant failed, and Dr. Simmons successfully inserted another, different type of Howmedica knee, but Donald could not return to work. Donald sued Howmedica, the manufacturer, on a product liability theory, and after a bench trial, Donald was awarded $1,686,988.70. (Donald died during this appeal, and Marilyn Haudrich has been substituted as plaintiff. Both will be referred to as plaintiff.)

The only issue we will address in this opinion is whether this product liability claim is preempted by the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. We conclude that there is no preemption of this claim. Neither the statute involved nor its legislative history nor the regulations promulgated under the authority of the statute supports a claim of preemption under the United States Supreme Court's consensus of rules for analyzing such claims. ( Cipollone v. Liggett Group, Inc. (1992), 505 U.S. , 120 L. Ed. 2d 407, 112 S.Ct. 2608.) The preemption doctrine in tort cases has been raised only relatively recently. (Foote, Administrative Preemption: An Experiment in Regulatory Federalism, 70 Va.L.Rev. 1429, 1430 (1984) (Administrative Preemption).) Commentators have offered different reasons for its late arrival on the legal scene. Some have suggested that respect for federalism has protected the States' court systems from intrusion in an area that has been recognized as a matter for local rather than Federal law since the inception of the nation. (Winokur & Robbins, Consumer Product Safety: Preemption, The Commerce Clause & State Regulatory Authority, 25 Vill.L.Rev. 232.) Others have suggested that parties' concerns about federalism are pendulum-like and swing from a desire for no intrusion to a prayer for full preemption depending upon which side feels preemption will be beneficial to its position. (Administrative Preemption, 70 Va.L.Rev. at 1466.) Regardless of the reasons for the doctrine's prepubescent involvement in the tort field, it has existed long enough for litigation with claims of preemption to reach the United States Supreme Court.

In Cipollone v. Liggett Group, Inc. (1992), 505 U.S. , 120 L. Ed. 2d 407, 112 S.Ct. 2608, the Supreme Court addressed the defendant's claim of preemption, which was based on the Federal Cigarette Labeling and Advertising Act of 1965 (Act) and its 1969 amendments. Although Justice Stevens wrote for the plurality, a rearrangement of the three opinions serves to highlight the agreement on certain rules that are shared by all the Justices.

Justices Kennedy, Souter, and Blackmun concurred in part because they agreed that the 1965 Act did not preempt tort claims against cigarette manufacturers, and they Dissented in part because they concluded that its 1969 amendments also did not preempt.

Justices Scalia and Thomas also concurred in part and Dissented in part. They Dissented because they thought that both the 1965 Act and its 1969 amendments preempted all such tort claims, but they agreed with Justice Stevens' relation of most of the rules for the determination of preemption claims. The Scalia-Thomas Dissent disagreed with the other seven Justices on only one of its stated rules:

"The pre-emptive scope of the 1965 Act and the 1969 Act is governed entirely by the express language in § 5 of each Act." (Emphasis added.) (Cipollone, 505 U.S. at , 120 L. Ed. 2d at , 112 S.Ct. at 2618.)

Therefore, on the express-language point, seven of the nine members of the Supreme Court are in agreement, and on the other rules for determining preemption, all nine are in agreement.

What then are the rules governing the resolution of preemption claims that are agreed upon by all nine members of the Court?

(1) "Consideration of issues arising under the Supremacy Clause 'starts with the assumption that the historic police powers of the States [are] not to be superseded * * * unless that [is] the clear and manifest purpose of Congress.'" (Emphasis added.

(2) Perhaps a corollary to number 1, but separately stated, "'"The purpose of Congress is the ultimate touchstone"' of pre-emption analysis. [Citations.]" (Emphasis added.)

(3) There is a "presumption against the pre-emption of state police power regulations."

(4) Perhaps as a corollary to number three's presumption, but separately stated, "This presumption reinforces the appropriateness of a narrow reading * * *."

(5) The fact "that Congress requires a particular warning label does not automatically pre-empt a regulatory field.

(6) "There is no general, inherent conflict between federal pre-emption of state warning requirements and the continued vitality of state common law damage actions."

(7) Common law damage actions can impose requirements. Cipollone, 505 U.S. at , 120 L. Ed. 2d at , 112 S.Ct. at 2617-20.

The Blackmun-Kennedy-Souter concurrence supplies an addendum to number seven, and as this addendum is neither rejected nor criticized by any of the other opinions, it is also presumably agreed upon by all nine members of the court.

"The principles of federalism and respect for state sovereignty that underlie the Court's reluctance to find preemption where Congress has not spoken directly to the issue apply with equal force where Congress has spoken, though ambiguously. In such cases, the question is not whether Congress intended to pre-empt state regulation, but to what extent. We do not, absent unambiguous evidence, infer a scope of pre-emption beyond that which clearly is mandated by Congress' language. I therefore agree with the Court's unwillingness to conclude that the state common-law damages claims at issue in this case are pre-empted unless such result is '"the clear and manifest purpose of Congress."'" (Emphasis in original.) Cipollone, 505 U.S. at , 120 L. Ed. 2d at , 112 S.Ct. at 2626 (Blackmun, J., Concurring in part and Dissenting in part, joined by Kennedy and Souter, JJ.).

This compilation of the rules relied upon by the Supreme Court in one of its more recent rulings on the preemption issue makes two things clear. One, case law can constitute a requirement which can be barred by the preemption doctrine. Two, in order for case law to constitute such a requirement and to invoke preemption, it must be abundantly clear that Congress intended that result.

In addition to the general principles laid down in Cipollone, we think it is significant that the Justice Stevens opinion largely based its Conclusions of no preemption for the 1965 Act and preemption for the 1969 amendment on the differences in wording. The 1965 Act provided in part:

"(a) No statement relating to smoking and health, other than the statement required by section 4 of this Act, shall be required on any cigarette package.

(b) No statement relating to smoking and health shall be required in the advertising * * *." (Emphasis added.) (Federal Cigarette Labeling and Advertising Act, Pub.L. 89-92, 79 Stat. 282, as amended, 15 U.S.C.A. secs. 1331-40 (West 1982).)

Justice Stevens concluded that "[section] 5 of the 1965 Act only pre-empted state and federal rulemaking bodies from mandating particular cautionary statements and did not pre-empt state law damages actions." (Cipollone, 505 U.S. at , 120 L. Ed. 2d at 112 S.Ct. at 2619.) Justice Stevens then compared the 1965 Act with the 1969 amendment, which provided:

"No requirement or prohibition based on smoking and health shall be imposed under State law with regard to the advertising * * *." (Emphasis added.) (Public Health Cigarette Smoking Act of 1969, Pub. L. 91-222, 84 Stat. 87, as amended, 15 U.S.C.A. §§ 1331-40 (West 1982).)

Justice Stevens concluded that the emphasized language, among other things, warranted extending preemption to State damage actions. This comparison and Conclusion is significant because, even though the Medical Device Amendments preemption provision does not mirror either the 1965 Act or the 1969 amendment, it is certainly closer in tenor to the 1965 Act.

With these principles in mind, we turn first to an examination of the statute involved in this case.


Section 360k of the Medical Device Amendments to the Federal Food, Drug, and ...

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