Lindquist v. Tambrands, Inc.

• Decision Date: 21 September 1989
• Docket Number: Civ. No. 4-88-443.
• Parties: Cynthia Jo LINDQUIST and Stanley Lindquist, Plaintiffs, v. TAMBRANDS, INC., d/b/a Tampax Brand and Wal-Mart Stores, Inc., Defendants.
• Court: U.S. District Court — District of Minnesota

721 F. Supp. 1058

Cynthia Jo LINDQUIST and Stanley Lindquist, Plaintiffs, v. TAMBRANDS, INC., d/b/a Tampax Brand and Wal-Mart Stores, Inc., Defendants.

Civ. No. 4-88-443.

United States District Court, D. Minnesota, Fourth Division.

September 21, 1989.

Stephen J. Smith, Smith & Tollefson, Owatonna, Minn., for plaintiffs.

Michael S. Ryan, Shelley A. Simmering and Susan D. Hall, Murnane, Conlin, White, Brandt & Hoffman, St. Paul, Minn. (Roger E. Podesta, Joseph P. Moodhe and Daniel J. Goldstein, Debevoise & Plimpton, New York City, of counsel), for defendants.

MEMORANDUM AND ORDER

MacLAUGHLIN, District Judge.

This matter is before the Court on the motion of defendant Tambrands, Inc. for partial summary judgment. The motion will be granted.

I. INTRODUCTION

Plaintiff Cynthia Jo Lindquist developed toxic shock syndrome (TSS) following her use of Tampax-brand tampons purchased from Wal-Mart Stores, Inc.¹ Tampaxbrand tampons are manufactured by Tambrands, Inc. (Tampax). Plaintiff and her husband have sued Tampax and Wal-Mart under Minnesota law on theories of strict liability, negligence, breach of express and implied warranties, misrepresentation and consumer fraud and, under federal law, for violation of the Magnuson-Moss Warranty Act, 15 U.S.C. § 2310.

Tampax now moves for partial summary judgment on the ground that federal law has preempted state law warning claims. The first issue is whether state law warning claims are preempted by the federal statutes and regulations concerning medical devices. The second issue, reached only because the Court decides that the warning claims are preempted, is whether plaintiffs have established a genuine issue concerning Tampax's compliance with the federal regulations.

II. FEDERAL REGULATION OF TAMPON LABELING

Tampons are classified as Class II medical devices and regulated under the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. 21 U.S.C. §§ 360c; 21 C.F.R. §§ 884.5460, 884.5470. In enacting the MDA in 1976, Congress intended to assure "that Americans are not put at risk from the use of unsafe and ineffective medical devices." S.Rep. No. 33, 94th Cong., 2d Sess. 2 (1976), reprinted in 1976 U.S.Code Cong. & Admin.News 1070, 1071. The drafters of the MDA were concerned that "interstate commerce would be unduly burdened" if states imposed "a substantial number of differing requirements" for medical devices. H.R.Rep. No. 853, 94th Cong. 2d Sess. 45 (1976).

Section 521(a) of the MDA, 21 U.S.C. § 360k, expressly prohibits a state from adopting any requirement applicable to medical devices "different from, or in addition to," any requirement applicable under the MDA. The statute provides:

(a) General rule

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 requirements 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.

21 U.S.C. § 360k(a). Subsection (b) provides authority for the FDA, upon application by a state, to exempt state law requirements from preemption.

The regulations implementing section 521(a) are published at 21 C.F.R. § 808. These regulations interpret section 521(A) to preempt state law requirements established by "court decisions."

Section 521(a) prescribes a general rule that after May 28, 1976, 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 which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under the act.

21 C.F.R. § 808.1(b) (emphasis added). The regulations also state that federal law only preempts those state or local regulations "applicable to a device" and for which there is a specific federal counterpart.

State and 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. There are other State and local requirements that affect devices that are not preempted by section 521(a) of the act because they are not "requirements applicable to a device" within the meaning of section 521(a) of the act.

21 C.F.R. § 808.1(d). A list of examples of State or local requirements that are not regarded as preempted by section 521(a) is provided. None of these examples discusses the relationship between the regulations and state tort law.

Manufacturers of medical devices are required to secure premarket approval for their products. 21 C.F.R. § 814.20. The premarket approval process includes an evaluation of the labeling of the device. 21 C.F.R. § 814.20(b)(10). The manufacturer is under a continuing duty to determine whether the device, including its labeling, is safe and effective. 21 C.F.R. § 814.39(a). Before making a change affecting the safety or effectiveness of the device, a manufacturer must file a supplement to its premarket approval application and secure the approval for the change. 21 C.F.R. § 814.39(a). An exception is made for changes which enhance the safety of the device. Such changes may be put into effect prior to the receipt of FDA approval. 21 C.F.R. § 814.39(d). The regulation specifically identifies three types of labeling changes as examples of the changes that can be put into effect without prior approval.

(i) Labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction.

(ii) Labeling changes that add or strengthen an instruction that is intended to enhance the safe use of the device.

(iii) Labeling changes that delete misleading, false, or unsupported indications.

21 C.F.R. § 814.39(d)(2). Although it is not clear when these changes are required to be made, in other contexts the FDA has required the changes to be made at the "earliest possible time." See 21 C.F.R. § 514.8(d) (concerning drugs for use in animals).

In 1982, in response to the discovered association between TSS and tampon use, the FDA adopted labeling requirements for tampons. The regulations required the following consumer information to appear "prominently and legibly in a package insert or on the package in terms understandable by the layperson:"

(1) the warning signs of TSS and what to do if the warning signs appear;

(2) the statistical risk of TSS to women using tampons;

(3) the advisability of using tampons with the minimum absorbency needed to control menstrual flow;

(4) the potential for avoiding the risk of getting tampon-associated TSS by not using tampons and the potential for "possibly reducing" the risk of getting TSS by alternating tampon use with sanitary napkin use during menstrual periods;

(5) the need to seek medical attention "before again using tampons if TSS warning signs have occurred in the past, or if women have any questions about TSS or tampon use."

21 C.F.R. § 801.430(d). If, as is true in most cases, the above information is provided in a package insert, then the following "alert statement" must appear "prominently and legibly" on the package label:

ATTENTION: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information.

21 C.F.R. § 801.430(c).

III. WHETHER STATE LAW WARNING CLAIMS ARE PREEMPTED BY THE FEDERAL REGULATIONS GOVERNING TAMPONS

The doctrine of preemption is based upon Article VI, Clause 2 of the Constitution which establishes the supremacy of federal law. Federal law will preempt state law in either of two ways.

If Congress evidences an intent to occupy a given field, any state law falling within that field is pre-empted. If Congress has not entirely displaced state regulation over the matter in question, state law is still pre-empted to the extent it actually conflicts with federal law, that is, when it is impossible to comply with both state and federal law, or where the state law stands as an obstacle to the accomplishment of the full purposes and objectives of Congress.

Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 621, 78 L.Ed.2d 443 (1984) (citations omitted). State law may be preempted by federal regulations as well as federal statutes. Hillsborough County v. Automated Medical Laboratories, 471 U.S. 707, 105 S.Ct. 2371, 2375, 85 L.Ed.2d 714 (1985). State common law is as subject to preemption as state statutes. Sperry v. Florida, 373 U.S. 379, 403, 83 S.Ct. 1322, 1335, 10 L.Ed.2d 428 (1963); San Diego Building Trade Council v. Garmon, 359 U.S. 236, 247, 79 S.Ct. 773, 780, 3 L.Ed.2d 775 (1959) ("even the States' salutary effort to redress private wrongs or grant compensation for past harm cannot be exerted to regulate activities that are potentially subject to the exclusive federal regulatory scheme").

Under our federal system of government, any analysis of preemption "starts with the basic assumption that Congress did not intend to displace state law." Maryland v. Louisiana, 451 U.S. 725, 101 S.Ct. 2114, 68 L.Ed.2d 576 (1981). This is especially true where health and safety matters are concerned. The regulation of health and safety has traditionally been the central concern of state government. Therefore, in this area, the courts will hold...