Poloney v. Tambrands, Inc., s. S90A1298

• Decision Date: 10 January 1991
• Docket Number: S90X1299,Nos. S90A1298,s. S90A1298
• Citation: 412 S.E.2d 526,260 Ga. 850
• Parties: , Prod.Liab.Rep. (CCH) P 12,695, Prod.Liab.Rep. (CCH) P 13,113 POLONEY, et al. v. TAMBRANDS, INC. TAMBRANDS, INC. v. POLONEY.
• Court: Georgia Supreme Court

Page 526

412 S.E.2d 526

260 Ga. 850, Prod.Liab.Rep. (CCH) P 12,695,

Prod.Liab.Rep. (CCH) P 13,113

POLONEY, et al. v. TAMBRANDS, INC.

TAMBRANDS, INC. v. POLONEY.

Nos. S90A1298, S90X1299.

Supreme Court of Georgia.

Jan. 10, 1991.

H. Darrell Greene, Jack M. Smith, Paul Shimek, III, Greene & Davis, Marietta, Arthur H. Bryant, Trial Lawyers for Public Justice, Washington, D.C., for Poloney.

John A. Gilleland, Atlanta, for Tambrands, Inc.

Roger E. Podesta, Debevoise & Plimpton, Roberta G. Gordon, Debevoise & Plimpton, New York City.

Michael Maher, President, Ass'n of Trial Lawyers of America, Washington, D.C., Marc Wetherhorn, Georgia Citizen Action, Atlanta, Ruth Jones, NOW Legal Defense & Education Fund, New York City, Foy R. Devine, Atlanta, Eugene Brooks, Richard H. Middleton, Jr., Middleton & Anderson, Savannah, amicus appellant.

Marlys A. Marshall, Wichita, Kan., Roger E. Podesta, Debevoise & Plimpton, New York City.

Frank J. Beltran, Chairman, Georgia Trial Lawyers Assoc., Atlanta.

CLARKE, Chief Justice.

Janis Poloney died after using tampons made by Tambrands, Inc. Her parents alleged that she died from toxic shock syndrome and brought an action against Tambrands for products liability and wrongful death. The trial court granted Tambrands' motion for partial summary judgment on the grounds that the Poloneys' state law claims alleging failure to warn, inadequate warning and misrepresentation are preempted by federal law. We granted the Poloneys' interlocutory application to address the preemption issue.

1. The issue to be decided in the main appeal is whether applicable federal statutes and regulations preempt claims based on state law standards for evaluating the adequacy of the toxic shock syndrome warning. Tambrands' only contention is that the legal sufficiency of its warning must be judged solely on the basis of the federally prescribed standards.

The Supremacy Clause of the United States Constitution dictates that federal law preempts inconsistent state law. U.S. Const., Art. VI, cl. 2. "Pre-emption may be either express or implied, and is 'compelled whether Congress' command is explicitly stated in the statute's language or implicitly contained in its structure and purpose.' Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604 (1977)." Fidelity Federal Savings & Loan Association v. de la Cuesta, 458 U.S. 141, 152, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982). Although it is often necessary to examine legislative history to determine whether Congress intended to preempt state law, "[w]hen a federal statute unambiguously precludes certain types of state [law], we need go no further than the statutory language to determine whether the state [law] is preempted." Exxon Corp. v. Hunt, 475 U.S. 355, 362, 106 S.Ct. 1103, 1109, 89 L.Ed.2d 364 (1986).

This is an express preemption case. The 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, specifically, 21 U.S.C. § 360(k) and the regulations promulgated thereunder, govern the labeling of tampons. 21 U.S.C. § 360(k) provides that no state or political subdivision may establish or continue any requirement with respect to a medical device which is (1) "different from, or in addition to," the federal requirement for that device; and (2) related to safety or effectiveness or any other matter included in the federal requirements for the device. Under 21 C.F.R. § 808.1(b) the prohibition is extended to any requirement whether created by statute, ordinance, regulation or court decision.

The preemptive intent of the above provisions is clear. However, we agree with the Fifth Circuit Court of Appeals that "[t]he FDA did not intend to preempt all state laws and regulations pertaining to tampons." Moore v. Kimberly-Clark Corp., 867 F.2d 243, 244 (5th Cir.1989). Pursuant to 21 C.F.R. § 801.1(d), state 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...." Moore, supra at 245.

The FDA has addressed the precise health risk at issue in this case, toxic shock syndrome, and has established very specific tampon warning label requirements. These may be found in 21 C.F.R. §§ 801.430(c); 801.430(d); 884.5640 and 884.5470. We hold, as have the overwhelming majority of courts that have considered the issue, that these provisions expressly preempt state tampon warning label requirements for toxic shock syndrome, including those that emanate from state tort law. See, e.g. Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th Cir.1989); Krause v. Kimberly-Clark Corp., 749 F.Supp. 164 (W.D.Mich.1990); Lindquist v. Tambrands, Inc., 721 F.Supp. 1058 (D.Minn.1989); Edmondson v. International Playtex, Inc., 678 F.Supp. 1571 (N.D.Ga.1987).

In other words, the legal sufficiency of a tampon label warning about toxic shock syndrome must be judged solely on the basis of the federally prescribed standards. Because there is no dispute in this case that Tambrands' warning complied with the federal standards, the trial court was correct in granting summary judgment to Tambrands on the Poloneys' claims based on inadequate warning.

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