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December 1, 1988

INTERNATIONAL PLAYTEX, INC.; ABC COMPANY (a fictitious name); and XYZ COMPANY (a fictitious name), Defendants

The opinion of the court was delivered by: BISSELL

 This matter arises before the Court on the basis of a motion by defendant International Playtex, Inc. (Playtex) for partial summary judgment. Defendant moves to dismiss Counts 5 and 6 of the complaint by plaintiff Meyer on the grounds that these claims involve state common law tort claims that are preempted by the Federal Drug and Cosmetic Act, 21 U.S.C. § 360k(a) and 21 C.F.R. § 808.1(b).


 Plaintiffs Laura and Herbert Meyer's complaint, as amended, states that Laura Meyer began using Playtex tampons when she started her menses on or about March 3, 1984. Approximately one month later, while Meyer allegedly was using Playtex tampons, she became acutely ill and was diagnosed as suffering from Toxic Shock Syndrome. (Compl., Ct. 1, paras. 4, 5). As a result of her illness, Laura Meyer has allegedly suffered substantial pain and mental anguish, has required medical care, and has been prevented from engaging in her normal activities. She claims she will continue to suffer such personal and economic losses in the future. (Compl., Ct. 1, para. 7).

 Plaintiffs allege in Count 1 that International Playtex, Inc. and others were negligent in the manufacturing, marketing, distribution and sale of defective tampons. In Counts 2 and 3 plaintiffs allege that Playtex breached implied and express warranties that its tampons were safe and fit for their ordinary purposes. Count 4 alleges that Playtex made false representations as to the fitness of Playtex tampons for their ordinary and intended use. Counts 5 and 6 allege that Playtex is liable under theories of negligence and strict liability for failing to provide adequate warnings about risks associated with tampon use both before and after distribution of the tampons plaintiff used. Count 7 asserts that Playtex is strictly liable for selling allegedly defectively-designed tampons. Count 8 claims that Playtex negligently failed to manufacture, market, distribute and sell more safely-designed tampons and that Playtex is strictly liable for not doing so. Finally, Count 9 contains Herbert Meyer's per quod claim for medical expenses he has paid on Laura Meyer's behalf.


 Federal Preemption of Tampons Warnings

 (Based on Ignace v. International Playtex, Inc., No. 86-C-430-C (W.D. Wis. 1987))

 Defendant urges that plaintiffs' tort claims in strict liability and negligence, insofar as they allege a failure to warn, are preempted by the 1976 Medical Device Amendments, (21 U.S.C. §§ 360c to 360ee) to the Federal Food, Drug & Cosmetic Act of 1938 (the Amendments), and Food & Drug Administration (FDA) regulations promulgated thereunder. Defendant contends that the Amendments and the regulations, specifically 21 C.F.R. § 801.430, expressly confer upon the FDA the exclusive authority to establish labeling standards for tampons.

 Congressional power to preempt state law is rooted in the supremacy clause of article VI of the Constitution. Preemption can occur in a variety of ways. First, Congress has the power to preempt state law by so stating in express terms. Jones v. Rath Packing Co., 430 U.S. 519, 525, 51 L. Ed. 2d 604, 97 S. Ct. 1305 (1977). Absent explicit preemptive language, Congress' intent to supersede state law altogether may be inferred either because "the scheme of federal regulation may be so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it," or because "the Act of Congress may touch a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject" or because "the object sought to be obtained by the federal law and the character of obligations imposed by it may reveal the same purpose." Fidelity Fed. Sav. & Loan Ass'n v. De La Cuesta, 458 U.S. 141, 153, 73 L. Ed. 2d 664, 102 S. Ct. 3014 (1982) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947)).

 Even where Congress has not completely displaced state regulation in a specific area, state law is nullified to the extent that it actually conflicts with federal law. Such a conflict arises when "compliance with both federal and state regulations is a physical impossibility," Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43, 10 L. Ed. 2d 248, 83 S. Ct. 1210 (1963), or when state law "stands as an obstacle to the accomplishment and execution of the full purpose and objectives of Congress." Hines v. Davidowitz, 312 U.S. 52, 67, 85 L. Ed. 581, 61 S. Ct. 399 (1941). See also Fidelity Fed. Sav. & Loan Ass'n v. De La Cuesta, 458 U.S. at 154-59.

 The Supreme Court has repeatedly held, moreover, that state laws can be preempted by federal regulations as well as by federal statutes. See Hillsborough County v. Automated Medical Labs, 471 U.S. 707, 713, 85 L. Ed. 2d 714, 105 S. Ct. 2371 (1985) (citing cases). Thus,

Federal regulations have no less preemptive effect than federal statutes. Where Congress has directed an administrator to exercise his discretion, his judgments are subject to judicial review only to determine whether he has exceeded his statutory authority or acted arbitrarily. United States v. Shimer, 367 U.S. 374, 381-82, [6 L. Ed. 2d 908, 81 S. Ct. 1554] (1961). When the administrator promulgates regulations intended to preempt state law, the court's inquiry is similarly limited:
If his choice represents a reasonable accommodation of conflicting policies that were committed to the agency's care by the statute, we should not disturb it unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned. Id., at 383.

 Fidelity Federal, 458 U.S. at 153-54.

 In this case, defendant's preemption argument is bottomed first on the Medical Device Amendments, enacted by the United States Congress on May 28, 1976. It was observed by the Senate Committee reporting on the Amendments that they sought to balance two important goals. They were designed to encourage the research and development of increasingly sophisticated and critically important medical devices and at the same time to ensure "that the [Federal Drug Administration] has the proper authority to regulate that process so that Americans are not put at risk from the use of unsafe and ineffective medical devices." 1967 U.S. Code Cong. & Admin. News 1070, 1071.

 The Amendments established three categories of medical devices and authorized the FDA, after receiving a recommendation from a panel of experts, to classify all such devices. 21 U.S.C. § 360c(b)(1). After receiving the panel's recommendation regarding a particular device, the Secretary is required to publish the panel's recommendation, and a proposed regulation classifying the device, in the Federal Register. Upon reviewing comments from interested persons, the Secretary is further required, by regulation, to classify the device. 21 U.S.C. § 360c(d)(1). In February 1980, ...

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