Preemptive Defense May Soon Fade in Toxic Shock Syndrome Cases

Toxic Shock Syndrome, (hereinafter "TSS"), a serious and often fatal blood disease, has been linked to the use of menstrual tampons. Women who suffer from TSS as a result of using tampons, either die from complications of the disease or suffer from life-debilitating injuries including the loss of limbs. Not only do these women suffer physically, but also they have been generally unsuccessful in their state claims against tampon manufacturers because of the doctrine of federal preemption.

Menstrual tampons are classified as Class II medical devices regulated under the Medical Device Amendments of 1976 (hereinafter "MDA") to the Food, Drug and Cosmetic Act. See 21 U.S.C. § 301 et seq. (Supp. 1998), 21 C.F.R. §§ 884.5460, 884.5470 (1998). "The 1976 amendments were designed to 'protect the public health' by ensuring that medical devices are 'safe and effective.'" Stewart v. International Playtex, Inc., 672 F.Supp. 907, 909 (D. S.C. 1987). Specifically, 21 U.S.C. § 360 was enacted to provide uniform requirements for labeling and warning. As part of the regulatory scheme, Congress declared:

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 requirement 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. See 21 U.S.C. § 360k(a).

States are thus precluded from imposing any requirements whether it be by "statute, ordinance, regulation, or court decision" that are different from or in addition to any provisions of the MDA. See 21 C.F.R. § 808.1(b). To date, the FDA has specified labeling and warning requirements regarding the risks of acquiring TSS that must be included on the packaging and/or in inserts of tampon boxes.

Federal courts generally have held that FDA's labeling and warning regulations preempt plaintiffs' state claims regarding tampon manufacturers' failure to warn or failure to warn adequately about the risks associated with the use of tampons because 21C.F.R. § 801.430, entitled "User labeling for menstrual tampons" expressly grants the FDA authority to establish a labeling standard for tampons. For example, in Sloman v. Tambrands, Inc., 841 F. Supp. 699 (D. Md. 1993), the plaintiff contracted TSS resulting in the amputation of both of her legs.

In her complaint against Tambrands, the manufacturer of Tambrands tampons, the plaintiff alleged that she developed TSS as a "direct and proximate result of using Defendant's 'Tampax' tampons and that Tambrands 'failed to adequately, properly, and fully warn her of the dangers of TSS and thus caused her to contract TSS.' " Id. at 700. The court granted summary judgment for Tambrands with respect to the warnings issue, holding that the defendant successfully demonstrated that it had complied with each of FDA's requirements. Id. at 702. "As mandated by 21C.F.R. § 801.430 (c), the tampon package included an alert statement worded precisely as required by the regulation, and Tampax's insert provided all the information about TSS required by 21 C.F.R. § 801.430(d)." Id.

Although tampon consumers have often been unsuccessful in their claims based on failure to warn or inadequate warnings, plaintiffs have been more successful alleging design defect. "There are no federal regulations on tampon design or composition. Therefore, because there is no 'specific [federal] counterpart regulation' with which a jury decision on tampon design could conflict, the Court finds that the federal [MDA] does not preempt plaintiff's claim of design defect." Rinehart v. International Playtex, Inc., 688 F. Supp. 475, 478 (D. So. Ind. 1988). Plaintiffs alleging design defect rely on studies in which all-cotton tampons are found to be safer than the majority of the tampons on the market which are composed of rayon and cotton blends. Design defect cases also involve the claim that the tampon is designed to be more absorbent than it safely should be.

Plaintiffs pursuing claims against tampon manufacturers may also benefit from the Supreme Court's recent decision in Medtronics, Inc. v. Lohr, 518 U.S. 470 (1996), in which the Court held that the plaintiff's claims based on design defect, defective manufacture, and failure to warn were not preempted by the MDA. (See reference to Medtronics v. Lohr in related article on p.3.)

*article courtesy of S. Monica Mitzel.