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PUBLIC CITIZEN HEALTH RESEARCH GROUP v. COMMISSION

August 28, 1989

PUBLIC CITIZEN HEALTH RESEARCH GROUP, et al., Plaintiffs,
v.
COMMISSIONER, FOOD AND DRUG ADMINISTRATION, et al., Defendants



The opinion of the court was delivered by: PARKER

 BARRINGTON D. PARKER, SENIOR UNITED STATES DISTRICT JUDGE

 In this litigation, plaintiffs Public Citizen Health Research Group ("HRG") *fn1" charge several responsible federal government officials with unreasonable delay in failing to promulgate long-needed regulations which would require tampon manufacturers to display meaningful, standardized absorbency information in packaging their product for sale. They seek declaratory and injunctive relief against the Commissioner, Food and Drug Administration ("FDA"); Secretary, Department of Health and Human Services ("HHS"); and Director, Office of Management and Budget ("OMB"). *fn2" Plaintiffs charge that in the absence of such action by the defendants, women who frequently use tampons are exposed to the risks and possible contraction of the Toxic Shock Syndrome ("TSS") disease.

 The parties have filed cross motions for summary judgment. Plaintiffs seek the immediate promulgation of a regulation which would require tampon manufacturers to sell their product in packages -- displaying standardized absorbency information and containing unambiguous notices of the risks and dangers associated with continuous tampon usage. The defendants, FDA and HHS, argue that they have exercised reasonable and informed judgment in the matter, that federal courts have traditionally granted considerable discretion and deference to administrative agencies in discharging their responsibilities in the rulemaking process, and that the circumstances presented here do not warrant a departure from such principles. All defendants seek dismissal of plaintiffs' charges or hold that a grant of summary judgment is warranted on the facts.

 The record in this proceeding shows clearly that the FDA has unreasonably delayed promulgating necessary regulations. It has been lethargic in responding to and carrying out its legal obligation, and thus has failed to adequately inform and protect the public on this important health issue. The Court therefore determines, and reluctantly so, that plaintiffs are entitled to immediate injunctive and declaratory relief.

 I. BACKGROUND

 There is little, if any, dispute about the sequence of events and underlying facts surrounding this litigation. Indeed, the parties' proffers of material facts submitted *fn3" and other pleadings reflect a near complete agreement on the chain of events and facts.

 A.

 Toxic Shock Syndrome is believed to be caused by a toxin-producing strain of bacteria. It is thought that the use of tampons enhances the growth of the bacterium. The term surfaced in the late 1970's when it was introduced to describe a rare, serious and potentially fatal disease. *fn4" Although the symptoms of the disease occur most often in menstruating women 30 years of age or younger, who use high-absorbency tampons, its incidence has been note among other ages. The disease is characterized by a marked drop in blood pressure and shock. Warning signs include a sudden fever (usually 102 degrees or more), vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or a rash resembling a sunburn.

 B.

 Unusual attention was focused on the disease in 1980 when a tampon brand manufactured by Proctor and Gamble was linked to TSS. Later, the manufacturer voluntarily withdrew its product, labeled the "Rely" brand, from the market. However, women who used other brands, continued to experience similar types of familiar and serious symptoms. Epidemiological studies and scientific evidence developed immediately before and after that time, showed that women who used high-absorbency tampons had a greater relative risk of developing TSS than those who used low-absorbency products.

 In 1981, the FDA was aware of an epidemiological research study -- Tri-State Toxic Shock Syndrome Study, Epidemiologic Findings ("Tri-State Study" or "Study"), 145 Infectious Diseases 431 (U.Chi., 1982). (Px. 3.) *fn5" The authors and investigative team responsible for the Study, included reputable and highly recognized public health officials and epidemiologists from the States of Minnesota, Wisconsin and Iowa. They reported that high-absorbency tampons carried an increased risk for TSS. The Tri-State Study concluded: "Another major finding . . . is that women who use high-absorbency tampons had a greater relative risk of developing TSS than women who used low-absorbency tampons." Id. at 438. Upon reviewing those findings, the FDA tentatively agreed that the data supported the conclusion that "users of high-absorbency tampons have a greater risk of contracting TSS than users of low-absorbency tampons." *fn6" 46 Fed.Reg. 23,767 (1981). (emphasis added.)

 The Tri-State Study was followed immediately by a report prepared by the Institute of Medicine entitled: Toxic Shock Syndrome: Assessment of Current Information and Future Research Needs ("Institute Report" or "Report"); (National Academy Press, 1982). (Px. 1.) The Report recognized that "The Tri-State case-control study, the most detailed of the six . . . studies conducted to seek TSS risk factors for the menstrual cases, found that the use of high absorbency tampons increased the risk of developing TSS more than . . . lower absorbency tampons." Id. at 4-5. Based on the then available information, the Institute Report advanced several important recommendations: that women who have had TSS should be advised not to use tampons and postpartum women should be informed that tampon usage is likely to increase TSS risk; and that adolescent women, especially, should be advised to minimize the use of high absorbency tampons. Id. at 85-86.

 C.

 Due to the findings of these reports, the FDA promulgated regulations shortly thereafter, mandating tampon manufacturers to warn tampon users of the risks associated with tampon usage and toxic shock syndrome. 21 C.F.R. § 801.430 (1982). The preface to the rule noted that as tampon absorbency decreased, so too did the risk of TSS. A provision of the regulation required tampon manufacturers to include within the labeling a statement advising women "to [use] tampons with the minimum absorbency needed to control menstrual flow." Id.

 Moreover, the regulation was flawed and doomed from the start. While it did require that manufacturers provide a tampon absorbency warning, it failed to require them to use standardized terminology. No disclosure of the relative absorbency of a specific tampon brand as related to other brands on the market was required. Indeed, the FDA recognized that there was no voluntary standard, industry agreement, or other common understanding of the meaning of "super", "regular", or any word used by manufacturers to characterize absorbency. 47 Fed.Reg. 26,982, 26,987 (1982). Since women cannot reasonably identify lower tampon absorbency from product labeling, they cannot intelligently choose among tampons for the ones that would minimize their risk of contracting TSS. Id.

 D.

 Recognizing that women were still unable to make an intelligent and informed decision as to tampon absorbency amongst brands and thus avoid the risk of disease, on July 29, 1982, plaintiff HRG filed a Citizen Petition. (Px. 5.) The Petition called for the FDA to issue standards under § 514a of the Medical Device Amendments of 1976, 21 U.S.C. § 360d(a) which would prescribe standards and justifiable test methods for determining tampon absorbency; require tampon manufacturers, using the above mentioned standards and test methods, to determine the absorbency capacity of each style of tampon manufactured; establish uniform nomenclature for tampon absorbency, so that terms such as "regular", "super", and "super plus" would define absorbency within a specified range; and require tampon manufacturers to disclose tampon absorbency, as determined by FDA standards, on the outside of tampon packages.

 Several months later, on September 22, 1982, the FDA issued a tentative response agreeing "in substance" with the Citizen Petition. (Px. 6.) It noted, however, a preference to actively work with a task force including manufacturers, consumers and FDA representatives to establish voluntary standards addressing the problems of tampon absorbency, testing and labeling. *fn7" The FDA also promised to closely monitor the progress of the task force, and to reconsider its position on voluntary standards if it became evident that efforts were frustrated, unduly delayed or were not adequately addressing the immediate issues of absorbency and disclosure.

 On November 2, 1982, HRG supplemented and clarified its July 29 Citizen Petition, stating that it considered tampons to be misbranded within the meaning of the Act. *fn8" It reiterated its request that performance standards for tampons be established.

 On April 22, 1983, nine months after HRG filed its petition, the FDA issued a final response denying it. (Px. 7.) Even though the FDA agreed with the objectives of HRG's application and continued to note that absorbency terms were not standardized, consumers nonetheless were left unable to make interbrand comparisons based on the labeling statements. The FDA, however, did state that it would reevaluate the need to take regulatory action in the event that the task force did not propose a satisfactory standard in a timely fashion.

 E.

 On May 7, 1984, in light of the failure to reach a consensus, HRG directed still another letter to the FDA (Px. 8), renewing its petition for a tampon absorbency standard or suggesting, in the alternative, that the agency:

 
Consider proceeding under its general authority to mandate particular labelling requirements for medical devices. Acting under this authority FDA has already required tampon manufacturers to include warning statements about TSS with every tampon package. This authority could be used to require a particular format for disclosing absorbency as well as a method for determining absorbency.

 In concluding, HRG noted:

 
It is unfortunate that for the last two years tampon manufacturers have been able to continue using arbitrary descriptions of absorbency. We hope that FSA will recognize the importance of alleviating this confusion and proceed in the most expeditious manner possible.

 Id. at 2 (emphasis added).

 On June 29, 1984, to the surprise of many, the FDA publicly released a "Talk Paper." *fn9" (Px. 10.) It announced long-awaited proposals for consistent tampon labeling so that consumers could compare absorbency between brands. Three reasons were offered for the decision: (1) disclosure of such information would promote public health; (2) a standard proposal from the voluntary task force appeared impossible; and (3) the task force, "develop[ed] and prove[d] the feasibility of a test method for measuring tampon absorbency. Thus a consistent means [existed] for manufacturers to establish the absorbency of their products." Id. at 2.

 Several days later on July 9, 1984, the FDA also responded to HRG's letter of May 7, 1984, through John C. Villforth. *fn10" (Px. 9.) In his response, Director Villforth readily agreed that:

 
[A] labeling regulation is necessary to assure that consumers can make meaningful interbrand comparisons with respect to absorbency . . . . We intend to specify in the regulation the absorbency test to be used, with the result to be expressed as a numerical . . . factor, somewhat analogous to the sun protection factor used in sunscreens.

 Id. (emphasis added). In concluding, he noted: "We will develop a proposed absorbency test and labeling requirement as soon as possible." Id.

 Despite what then appeared to be a significant change of course by the FDA, nothing of consequence occurred over the next 12 months although there was an indication that the agency would not give serious consideration to a proposal requiring manufacturers to list tampon ingredients on the package. This position seemed to be based on FDA reasoning that developing requirements for ingredient labeling might cause a delay in developing regulations for absorbency labeling. *fn11"

 Several years later, in August 1987, the Centers for Disease Control ("CDC") published an epidemiological study -- Relationship of Tampon Characteristics to Menstrual Toxic Shock Syndrome. JAMA, Aug. 21, 1987, Vol. 258 at 917. (Px. 12.) The CDC Study confirmed, as did the earlier 1982 Tri-State Study, *fn12" the association between increased absorbency and enhanced risk of TSS. At the same time, on August 20, 1987, HRG filed a second Citizen Petition (Px. 4), requesting the FDA to require standardized numerical absorbency ratings on tampon packages, to thereby eliminate the use of confusing descriptive terms.

 Again, the FDA responded at its customary lethargic pace and took no immediate action. Not until April 25, 1988, eight months later, did the agency respond in a positive manner and issue a notice of proposed rulemaking.

 It was not until September 23, 1988, however, that the notice was actually published. 53 Fed.Reg. 37,250 (1988). The Summary provision of the notice provided:

 
The FDA is proposing to amend its regulations to require that manufacturers of menstrual tampons add to each tampon package label a letter designation of the range of absorbency of the products. The purpose of the proposed rule is to enable consumers to compare the absorbency of one brand and style of tampons with the absorbency of other brands and styles.
 
* * * *
 
FDA is also announcing the availability of, and requesting comments on, a citizen petition submitted by the Public Citizen Health Research Group (HRG) concerning absorbency labeling for tampons.

 Interested persons were invited and requested to submit written comments on the proposal by December 22, 1988.

 F.

 On January 17, 1989, a telephone status conference was held in this matter amongst all counsel. Defendants' counsel was instructed to file an in camera, ex parte letter explaining what was anticipated with respect to publishing a final rule on tampon absorbency labelling. On January 24, 1989, defendants filed a letter indicating that as of that date, the FDA had reviewed, summarized and organized practically all of the comments it received; draft responses were being prepared for the significant comments and a final rule and preamble were ...


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