Stauber v. Shalala and Kessler

895 F. Supp. 1178 (1995)

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Stauber v. Shalala and Kessler

United States District Court for the Western District of Wisconsin
895 F. Supp. 1178 (1995)

  • Written by Brett Stavin, JD

Facts

The United States Food and Drug Administration (FDA) and the United States Department of Health and Human Services (HHS) approved a new drug application from Monsanto Company for Posilac, a synthetic bovine growth hormone (rbST) designed to increase milk production. Prior to approval, the FDA determined that although Posilac had the potential to cause adverse health effects in dairy cows, those effects could be mitigated by labeling the drug to inform dairy farmers of such risks. The required warning label stated that before using Posilac, dairy farmers should implement a herd reproductive-health program and evaluate mastitis management practices. Additionally, the FDA determined that no label would be required for dairy products derived from cows treated with rbST, because rbST had no significant effect on the organoleptic properties of milk products, meaning that it had no effect on the sensory aspects of the products. In coming to this conclusion, the FDA considered testimony from the medical, agriculture, and scientific communities, as well as data from Monsanto. The FDA, therefore, did not require disclosure of the use of rbST but allowed the voluntary labeling of products from cows not treated with rbST. John Stauber and a group of American dairy-product consumers (collectively, Stauber) (plaintiffs) filed a lawsuit in federal district court against Secretary Donna Shalala of the HHS and Commissioner David Kessler of the FDA (defendants) for a declaratory judgment that the approval of Posilac was unlawful under the Food, Drug, and Cosmetic Act and the Administrative Procedure Act. Stauber argued that the FDA failed to consider health and safety issues relating to the use of Posilac and that the FDA and HHS should have required mandatory labeling of products derived from Posilac-treated cows. Stauber also asserted that consumer demand for knowledge of the use of rbST was a sufficient basis to require such disclosure in labeling. The parties cross-moved for summary judgment.

Rule of Law

Issue

Holding and Reasoning (Crabb, C.J.)

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