Stauber v. Shalala

• Decision Date: 04 August 1995
• Docket Number: No. 94-C-0090-C.,94-C-0090-C.
• Citation: 895 F. Supp. 1178
• Court: U.S. District Court — Western District of Wisconsin
• Parties: John STAUBER, Glenn Stoddard, on his own behalf and as next friend of Patrick Stoddard, Ronnie Cummins, and Marilyn Charbush, Plaintiffs, v. Donna SHALALA, in her official capacity as Secretary of Health and Human Services, and David Kessler, M.D., in his official capacity as Commissioner of the Food and Drug Administration, Defendants, and Monsanto Company, Intervenor-Defendant.

895 F. Supp. 1178

John STAUBER, Glenn Stoddard, on his own behalf and as next friend of Patrick Stoddard, Ronnie Cummins, and Marilyn Charbush, Plaintiffs, v. Donna SHALALA, in her official capacity as Secretary of Health and Human Services, and David Kessler, M.D., in his official capacity as Commissioner of the Food and Drug Administration, Defendants, and Monsanto Company, Intervenor-Defendant.

No. 94-C-0090-C.

United States District Court, W.D. Wisconsin.

August 4, 1995.

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Jacqueline H. Eagle, Office of Consumer Litigation, Washington, DC, for Donna Shalala.

Leslie Kux, Assoc. Chief Cnsl. for Veterinary Medicine, Office of the General Counsel, Rockville, MD, for David Kessler.

Michael L. Zaleski, Quarles & Brady, Madison, WI, for Monsanto Co. (Intervenor).

OPINION AND ORDER

CRABB, Chief Judge.

This is a civil action for declaratory and injunctive relief brought pursuant to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394, the National Environmental Policy Act, 42 U.S.C. §§ 4321-4370d, and the Administrative Procedure Act, 5 U.S.C. §§ 500-706. Plaintiffs are American consumers of commercially sold dairy products. Defendants are Donna Shalala, Secretary of the Department of Health and Human Services, and Dr. David Kessler, Commissioner of the Food and Drug Administration. Plaintiffs challenge defendants' approval of intervenor-defendant Monsanto Company's new drug application for Posilac®, a milk production-enhancing, synthetic bovine growth hormone drug. Specifically, plaintiffs contend that: 1) the approval was arbitrary and capricious because the FDA failed to consider health and safety issues related to the use of Posilac; 2) defendants failed to require mandatory labeling of products from cows treated with Posilac; and 3) defendants failed to conduct an adequate environmental assessment or issue an environmental impact statement assessing the environmental effects of Posilac's approval. Plaintiffs request both a declaration under 28 U.S.C. § 2201 and Fed.R.Civ.P. 57 that defendants failed to perform their statutory duties in approving Posilac and a permanent injunction suspending the approval of Posilac until defendants comply with their statutory obligations.

The case is before the court on the parties' cross-motions for summary judgment. After a close review of the parties' submissions, I find that plaintiffs have offered no admissible, relevant evidence putting any material facts into dispute. Plaintiffs have not shown that defendants acted arbitrarily and capriciously in approving Posilac or in declining to require product labeling and they have not shown that defendants' environmental assessment was inadequate. Therefore, plaintiffs' claims must be dismissed.

From the proposed findings of fact of the parties, I find that the following material facts are undisputed.

UNDISPUTED FACTS

Bovine somatotrophin (bST), a bovine growth hormone, is a naturally occurring protein hormone produced in the pituitary gland of all cattle. In the 1930s, scientists discovered that injecting dairy cows with bovine growth hormone from other cattle could increase the cows' milk production but the discovery was not pursued on a wide scale because extraction of the hormone from cattle was not cost effective. In the 1980s, however, scientists developed a synthetic recombinant bovine growth hormone. Scientists can now isolate the gene responsible for natural bovine growth hormone, transfer that genetic material into bacterial cells called a "recombinant fermentation organism" and "program" the bacterial cells to produce a synthetic version of the hormone.

In the early 1980s, the FDA approved intervenor-defendant Monsanto Company's investigative new animal drug application for Posilac, a synthetic recombinant bovine somatotrophin. In 1987, Monsanto submitted a new animal drug application for Posilac to the FDA. Over the next several years, Monsanto supported the application with studies and reports documenting the safety and effectiveness of the drug. After reviewing those materials, the FDA approved Monsanto's application for the subcutaneous (injectable) use of Posilac on November 5, 1993. Posilac is the first genetically engineered animal drug to be approved for use in dairy cows and the first milk production enhancement drug to be approved for sale by the FDA.

The FDA approved Posilac despite criticism that the drug would have a significant negative effect on the health of dairy cows and despite concern about potential negative health effects on human consumers of dairy products derived from cows treated with rbST. Scientists, economists, farmers, and environmental and animal welfare organizations have questioned the safety and quality of rbST-derived products. In addition, the FDA received thousands of letters from consumers asking it either to deny approval of rbST or to require labeling of rbST-derived products. The General Accounting Office advised the FDA to withhold approval of Posilac until further research of rbST's potential negative impact on human health could be conducted. After the FDA approved Posilac for marketing, Congress delayed sale of the drug for 90 days while an inter-agency task force supervised by the Office of the President reviewed the data upon which the FDA based its decision. In January 1994, the task force concluded that the FDA's position was adequately supported. The FDA made available to the public a summary of the safety and effectiveness data submitted by Monsanto on which the agency relied in approving Posilac for mass marketing.

A. Cow Safety

Use of Posilac may affect cows adversely in several ways. Posilac increases the risks of reduced pregnancy rates, ovarian cysts and uterine disorders, decreased lengths of gestation periods and lower birth weight of calves. Posilac increases the risk of retained placentas and twinning rates in cows. It may cause increased bovine body temperatures, indigestion, bloating, diarrhea, enlarged hocks, enlarged lesions and injection site swellings. Additionally, use of Posilac increases the risk of clinical and subclinical mastitis, a bacterial infection of the udder. In absolute terms, rbST increases the risk of mastitis by about 0.1 case per cow per year. This risk is less than the risk of mastitis posed by seasonal change.

Before approving Posilac, the FDA reviewed the data submitted by Monsanto as part of its new drug application and considered Posilac's effects on animal health, including: 1) the acute and chronic toxicity of the drug; 2) its effects on reproduction; 3) calf birth traits, growth and health; 4) increased incidence of mastitis; 5) musculoskeletal effects; 6) digestive disorders including indigestion, bloating and diarrhea; 7) injection site reactions; 8) nutrient intake, body weight and body condition; 9) general cow health; and 10) miscellaneous health variables, including circulating anti-somatotrophin binding, blood variables, body temperature and urinalysis results. The agency determined that the risks to cows associated with the use of Posilac could be managed properly under a "manageable risk" criteria and that the risks to animal health were not significant enough to warrant denial of the drug application. (The FDA has never applied a zero risk standard when assessing the safety of new animal drugs.) Monsanto conducted a 14-day drug tolerance study that involved injecting a herd with dosages of rbST up to thirty times the normal dosage. Analysis of both cow and fetal blood and tissue revealed only one health side effect: slight swelling at the injection site.

B. Human Consumer Safety

Before approving Posilac, the FDA considered Posilac's possible negative effects on human health, including the possible effects of 1) increased levels of rbST in milk; 2) increased levels of insulin growth factor in milk; and 3) increased amounts of antibiotic drug residues in milk.

1. RbST

BST and its synthetic counterpart rbST are protein hormones that are orally inactive in humans. Upon ingestion, protein hormones (unlike steroid hormones) are broken down by enzymes in the intestines and digested. BST and rbST are orally inactive in cows as well. Like insulin, which must be injected to take effect, bST and rbST must be injected to stimulate milk production in cows. Even if injected into humans, however, rbST would not stimulate growth because human somatotrophin has a significantly different amino acid sequence from that of rbST and human receptors will not bond with rbST. Furthermore, heat destroys rbST, so that pasteurizing milk and cooking meat would tend to destroy at least 90% of the rbST in milk or beef. The FDA found that even at exaggerated doses the ingestion of rbST poses no significant risk to human safety.

2. Mastitis and antibiotics

Antibiotics are used to treat bovine mastitis. Trace residues of the antibiotics can appear in the milk of dairy cows. The level of antibiotic residue in milk is regulated, however. Forty-nine states have adopted the Grade A Pasteurized Milk Ordinance, established by the FDA and the Public Health Service in cooperation with state and local regulatory agencies and members of the milk industry. The ordinance defines standards for milk purity, establishes standards for production of pasteurized milk and milk products, details the method of inspections of farms and processing plants and provides that only producers, haulers, processors and distributors who meet the requirements of the ordinance shall be given permits. Under the milk ordinance, milk that is inspected and found to contain drug residues in excess of the standard must be discarded and the responsible producer is subject to regulatory sanctions.

Although states test milk routinely for drug residues in accordance with the milk ordinance, they generally test only for the presence of four of the antibiotics most commonly used to treat...