Edmondson v. International Playtex, Inc.
Decision Date | 30 September 1987 |
Docket Number | Civ. A. No. C85-306R. |
Citation | 678 F. Supp. 1571 |
Parties | Rebecca EDMONDSON, Plaintiff, v. INTERNATIONAL PLAYTEX, INC., Defendant. |
Court | U.S. District Court — Northern District of Georgia |
Timothy Arnold McCreary, Howe Sutton McCreary & Dettmering, Tallapoosa, Ga., Mark B. Hutton, Michard Cordry Michaut Hutton & Hutton, Wichita, Kan., for Rebecca Edmondson.
Jack Harrell Senterfitt, Alston & Bird, Atlanta, Ga., Franklin M. Tatum, William H. Robinson, Jr., Wright Robinson McCammon & Tatum, Richmond, Va., for Intern. Playtex, Inc.
Presently before the Court is plaintiff's objection to the Magistrate's Order filed June 16, 1987. That Order dealt with the issue whether plaintiff could introduce evidence or argument regarding the adequacy of the language contained in defendant's labeling. The Magistrate granted defendant's motion in limine, concluding that federal law preempts any state law claim based upon alleged inadequacy of warning.
In objecting to the Magistrate's ruling plaintiff argues
Given that the parties agreed that this motion, which was styled as a motion in limine, would be referred to and ruled upon by the Magistrate, the Court finds plaintiff's objection to be without merit. The Court also agrees with the Magistrate's ruling. Nevertheless, even if the Magistrate did not have the power to rule on this issue, after reviewing the relevant materials in the record and considering the Magistrate's Order to constitute findings of fact and recommendations for disposition, pursuant to 28 U.S.C. § 636(b)(1)(B), the Court finds as follows:
That Congress, through 21 U.S.C. § 360k, and the Food and Drug Administration, through 21 C.F.R. §§ 801.430 and 808.1, expressly excluded the states from establishing labeling standards (whether by statute, ordinance, regulation, or court decision) for tampons. These federal provisions bar plaintiff's state tort claims that the warnings in issue can be inadequate even if such warnings are in compliance with 21 C.F. R. §§ 801.430 and 808.1. See Ignace v. Playtex Family Products, Inc., No. 86-C-480-C, Report and Recommendation of Magistrate (W.D. Wis. July 27, 1987, ADOPTED as the court's own August 14, 1987).
CLINTON J. MORGAN, United States Magistrate.
On September 30, 1985, the Complaint in the captioned matter was filed, seeking the recovery of damages for personal injuries that allegedly resulted from the use of a tampon device manufactured by the Defendant (Playtex). The Plaintiff bases her claim on the ground, inter alia, that the labeling and instructions were inadequate to give proper warning necessary for the safe use of the product.
The Defendant filed a Motion in Limine on December 31, 1986, to exclude any evidence or argument regarding the adequacy of the labeling warning, on the ground that said issue has been pre-empted by the federal government.
By Order dated May 19, 1987, said issue was referred to the undersigned Magistrate. The Order is interpreted by the Magistrate as a referral "to hear and determine" under the provisions of 28 U.S.C. 636(b)(1)(A).
The Supremacy Clause in Article VI of the Constitution of the United States is the basis for the doctrine of pre-emption.
In Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984), the Court stated that pre-emption can occur in either of two general ways, namely: (1) if Congress evidences an intent to occupy a given field, or (2) even if the entire field is not pre-empted, certain portions of state law that actually conflict with federal law are pre-empted, that is, when it is impossible to comply with both state and federal law or where state law is an obstacle to the accomplishment of the full purposes and objectives of Congress. The Court further stated that pre-emption should be judged on whether there is an irreconcilable conflict between the federal and state standards or whether the imposition of a state standard in a damages action would frustrate the objectives of the federal law.
The tampon involved in the captioned case is within the scope of 21 U.S.C. 360k, it being a "device intended for human use". That statute reads in part as follows:
(Subsection (b) provides for the grant of exemptions from subsection (a) by the Secretary.)
(Code Sections 360d through 360k are known as the Medical Device Amendments of 1976.)
Section 360j(h) directs the Secretary to promulgate regulations for the dissemination to the public of information respecting the safety and effectiveness of a device.
The regulation relating to the labeling of tampons is found at 21 C.F.R. Section 801.430, which is dated June 22, 1982, and which contains specified information that must appear either in a package insert or on the package.
In the case of Commonwealth of Mass. v. Hayes, 691 F.2d 57 (1st Cir.1982), the Court affirmed the denial by the Secretary of an exemption to the Commonwealth, which had been sought under 21 U.S.C. 360k(b) relative to hearing aids. The Court treated Section 360k as a pre-emption statute, and it stated that the regulations promulgated by the Secretary were in accord with the overriding purpose of the Medical Device Amendments, "which was to protect the public health by assuring the safety and effectiveness of medical devices ... while accommodating the purpose of the preemption section, which was to prevent an undue burden on interstate commerce through the proliferation of varying state requirements ...". (pp. 60-61)
In Howard v. Uniroyal, Inc., 719 F.2d 1552 (11th Cir.1983), the Court held that a common law state court action for a handicapped-based discrimination was pre-empted by the federal Rehabilitation Act. The Court noted that prior cases on pre-emption are not precise guidelines because every case turns on the special features of the federal regulatory scheme in question. The Court also stated that The Court found no express pre-emption, but it found an implied intent in the comprehensiveness and pervasiveness of the federal enforcement scheme, in the dominant federal interest in the subject matter, and in the desire to preclude the enforcement of state laws on the same subject.
In Northern States Power Co. v. State of Minnesota, 447 F.2d 1143 (8th Cir.1971) (affirmed 405 U.S. 1035, 92 S.Ct. 1307, 31 L.Ed.2d 576 (1972)), the Court stated the principle that "Where Congress has unequivocally and expressly declared that the authority conferred by it shall be exclusive, then there is no doubt but that states cannot exert concomitant or supplementary regulatory authority over the identical activity".
In the recent case of Exxon Corp. v. Hunt, 475 U.S. 355, 106 S.Ct. 1103, 89 L.Ed.2d 364 (1986), the Court stated, at 362, 106 S.Ct. at 1109, 89 L.Ed.2d at 374:
"When a federal statute unambiguously precludes certain types of state legislation, we need go no further than the statutory language to determine whether the state statute is pre-empted."
In San Diego Building Trades Council (etc.) v. Garmon, 359 U.S. 236, 247, 79 S.Ct. 773, 780, 3 L.Ed.2d 775, 784 (1959), the Court held as follows:
In Tectonics, Inc. of Florida v. Castle Construction Co., 753 F.2d 957, 961 (11th Cir.1985), the Court stated that "Nevertheless, there are instances where federal legislation can preempt any state cause of action".
The issue in the case at bar, and...
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