Murphy v. Playtex Family Products Corp.

• Decision Date: 19 December 2001
• Docket Number: No. AMD 00-3664.,AMD 00-3664.
• Parties: Allison A. MURPHY, a Minor, By Rita and John MURPHY, As Parents and Next Friends, and Rita and John Murphy, Individually, Plaintiffs, v. PLAYTEX FAMILY PRODUCTS CORPORATION, Defendant.
• Court: U.S. District Court — District of Maryland

Page 473

176 F.Supp.2d 473

Allison A. MURPHY, a Minor, By Rita and John MURPHY, As Parents and Next Friends and Rita and John Murphy, Individually, Plaintiffs, v. PLAYTEX FAMILY PRODUCTS CORPORATION, Defendant.

No. AMD 00-3664.

United States District Court, D. Maryland.

December 19, 2001.

COPYRIGHT MATERIAL OMITTED

Gregory R. Smouse, Law Office, Towson, MD, for plaintiffs.

Terrence Mark Ranko Zic, Law Office, William H. Robinson, Jr., Wright Robinson Osthimer and Tatum, Washington, DC, for defendant.

MEMORANDUM

DAVIS, District Judge.

This is a products liability case arising under Maryland law, here on diversity, in which Allison A. Murphy ("Murphy") and her parents, Rita and John Murphy (collectively "plaintiffs")¹ allege that Murphy suffered toxic shock syndrome ("TSS") in January 1998 from her use of Playtex tampons. Defendant is Playtex Products, Inc.² ("defendant"), the manufacturer of Playtex tampons. Plaintiffs allege claims for negligence, strict liability, violation of the Maryland Consumer Protection Act, breach of express warranty, breach of implied warranty and restitution. Murphy also seeks punitive damages. Now pending is defendant's motion for summary judgment on all claims. I have given careful attention to the parties' memoranda and exhibits and a hearing is not needed. Local R. 105.6. For the reasons explained below, I shall grant defendant's motion for summary judgment on all claims.

(i)

Pursuant to Fed.R.Civ.P. 56(c), summary judgment is appropriate "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Anderson v. Liberty Lobby Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A fact is material for purposes of summary judgment, if when applied to the substantive law, it affects the outcome of the litigation. Id. at 248, 106 S.Ct. 2505. Summary judgment is also appropriate when a party "fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

A party opposing a properly supported motion for summary judgment bears the burden of establishing the existence of a genuine issue of material fact. Anderson, 477 U.S. at 248-49, 106 S.Ct. 2505. "When a motion for summary judgment is made and supported as provided in [Rule 56], an adverse party may not rest upon the mere allegations or denials of the adverse party's pleading, but the adverse party's response, by affidavit or as otherwise provided in [Rule 56] must set forth specific facts showing that there is a genuine issue for trial." Fed.R.Civ.P. 56(e); see Celotex Corp., 477 U.S. at 324, 106 S.Ct. 2548; Anderson, 477 U.S. at 252, 106 S.Ct. 2505; Shealy v. Winston, 929 F.2d 1009, 1012 (4th Cir.1991). Of course, the facts, as well as justifiable inferences to be drawn therefrom, must be viewed in the light most favorable to the nonmoving party. Matsushita Elec. Indust. Co. v. Zenith Radio Corp., 475 U.S. 574, 587-88, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The court, however, has an affirmative obligation to prevent factually unsupported claims and defenses from proceeding to trial. Felty v. Graves-Humphreys Co., 818 F.2d 1126, 1128 (4th Cir.1987).

(ii)

I shall turn now to the merits of the motions for summary judgment. I view the facts in the light most favorable to plaintiffs, the non-movants.

Murphy contracted TSS in January 1998 as a result of using Playtex Super Absorbency tampons. Complaint ¶¶ 3-7. TSS is a rare, but potentially serious disease. Aff. of Dr. Irwin Butensky ¶ 3 (hereinafter Butensky Aff.). This condition is believed to be caused by a toxin or toxins produced by certain strains of Staphylococcus aureus ("staph.aureus") bacteria. Id. The toxin most commonly associated with menstrual TSS is known as toxic shock syndrome toxin-1 ("TSST-1"). Id.

Plaintiffs have designated Philip M. Tierno, Ph.D., and Bruce A. Hanna, Ph.D., as expert witnesses with respect to plaintiffs' design defect claim. Pls.' Expert Witness Disclosure Statement. Drs. Tierno and Hanna are microbiologists who have collaborated in research. Id. These witnesses are expected to testify (based, in part, upon their unblinded tube experiments) that the Playtex tampons used by Murphy were defectively designed because they were manufactured with rayon fiber instead of cotton fiber. Id. In their opinion, tampons made with cotton fiber present less of a risk of tampon-associated TSS than tampons made with rayon fiber. Id. More specifically, the witnesses claim:

Our data shows that all-cotton tampons, whether washed or unwashed, caused no detectable TSST-1 toxin to be produced as compared to the synthetic non-all-cotton tampons. This difference in toxin production was likely due to the fact that cotton provides fewer phsyicochemical factors that favor TSST-1 production .... Cotton is less absorbent, has less surface area, does not effectively concentrate protein in aqueous solutions, and provides less viscous environment compared with all of the synthetics that were used in tampon manufacture ... or that still are used in tampon manufacture (viscose rayon). That tampon that Ms. Murphy was using when she became ill was a Playtex tampon made of viscose rayon.

Id. (citations omitted).

Plaintiffs' witnesses, however, have conceded that tampon-associated TSS will occur regardless of what fiber is used, even if all cotton tampons are used. Dep. Test. of Philip M. Tierno, Kaminski v. Kimberly-Clark Corp., No. 93NP, p.250 (Mich. Cir. Ct.-Kent County, August 18, 1995). They have also conceded that they do not know of any other scientist that shares their opinion regarding the purported advantages of cotton fiber over rayon fiber in the manufacture of tampons.³ Dep. Test of Philip M. Tierno, Johnson v. Tambrands, Inc., No. 4-92-80034, p. 261 (S.D.Iowa, March 19, 1994). Plaintiffs' witnesses have also stated that their work remains to be verified by in vivo and epidemiological work. Dep. Test. of Philip M. Tierno, Haddix v. Playtex, No. 9302004, pp. 198-99 (C.D.Ill., January 28, 1995); Tierno & Hanna, Propensity of Tampons and Barrier Contraceptives to Amplify Staphylococcus Aureus Toxic Shock Syndrome Toxin 1, 2 INFECTIOUS DISEASES IN OBSTETRICS & GYNECOLOGY 140, 144 (1994).

Published peer-reviewed scientific studies conducted by independent scientists, other than plaintiffs' witnesses, indicate that no greater quantity of TSST-1 is produced in the presence of rayon fiber tampons than cotton fiber tampons in laboratory and animal tests. Butensky Aff. ¶ 12. The first published work to address the relationship of tampon fiber to the production of TSST-1 concluded in 1984 that tampon fibers, including rayon fiber, did not provide nutrients for growth of TSS staph. aureus or factors that induce production of TSST-1. Id. ¶ 13 (referring to Schilievert, et. al., Toxic Shock Syndrome Staphylococcus Aureus: Effect of Tampon on Toxic Shock Syndrome Toxin 1 Production, 64 OBSTETRICS & GYNECOLOGY 666, 670 (1984)). This finding regarding rayon fiber has been echoed in other published, peer-reviewed scientific studies since then, including 1989 articles reporting on separate studies authored by Playtex's experts, Dr. Fischetti (in vitro testing) and Dr. Melish (in vivo (animal) testing). Id. ¶ 14 (citations omitted). These findings have been further corroborated by subsequent studies. Id. ¶ 15.

The United States Food and Drug Administration ("FDA") has promulgated mandatory device specific regulations that address the distribution of tampons in light of the reported risk of TSS. These regulations are applicable to all tampon manufacturers, including manufacturers of all-cotton tampons. 21 C.F.R. § 801.430 (2000) (Def.'s Ex. 7). Only months after the publication of the first data suggesting a possible statistical link between tampon use and menstrual TSS, the FDA, in October 1980, issued proposed regulations requiring tampon manufacturers to provide warnings about the risk of TSS.⁴ 45 Fed. Reg. 69840 (1980) (Def.'s Ex. 8). Playtex began placing voluntary TSS warnings on and in its tampon packages in the fall of 1980. Butensky Aff. ¶ 4.

During the comment periods on the proposed regulations, the FDA "particularly invit[ed] comments" relating to its proposed warnings, but specifically stated that the "FDA invites comments on all aspects of TSS and its relationship with tampons ...." 46 Fed.Reg. 23766, 23768 (1981) (Def.'s Ex. 9). The FDA received more than 300 comments from consumers, manufacturers, government health departments, consumer organizations, and industry organizations. 47 Fed.Reg. 26982 (Def.'s Ex. 10). In June 1982, the FDA issued its final regulations that required that all tampon manufacturers provide specific warnings about TSS. Id. at 26982, 26990. These regulations became effective December 20, 1982. Id. at 26982. It was at this time, 1982, that Playtex stopped providing its voluntary TSS warnings and began complying with federally mandated warning requirements regarding tampon use and TSS. Butensky Aff. ¶ 4.

The FDA specifically considered and rejected a comment urging reclassification of tampons as Class III devices rather than Class II devices.⁵ 47 Fed.Reg. at 26988-89. In rejecting this comment, the FDA noted that "TSS is a rare disease" and determined that "it cannot be said that tampons, in and of themselves, present a potentially unreasonable risk to health." Id. The FDA further stated that none of the data available to it demonstrated "an association between the occurrence of TSS and (1) a particular tampon fiber, ingredient, or combination of ingredients ... or (2) any other product characteristic, including tampon materials, construction...