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NORTHWEST TISSUE CENTER v. SHALALA

No. 93-1078.

1 F.3d 522 (1993)

NORTHWEST TISSUE CENTER, Department of the Puget Sound Blood Center, a Washington Corporation, and Oregon Tissue Bank, a Department of the Emmanual Hospital and Health Center, a Legacy Health System Affiliate, an Oregon Corporation, Plaintiffs-Appellants, v. Donna E. SHALALA, Secretary of the United States Department of Health and Human Services, and David Kessler, Commissioner of the United States Food and Drug Administration, Defendants-Appellees.

United States Court of Appeals, Seventh Circuit.

Decided July 27, 1993.

Rehearing and Suggestion for Rehearing Denied September 24, 1993.

Attorney(s) appearing for the Case

George M. Burditt (argued), Alan I. Becker, Deborah B. Norton, Jamie S. Freveletti, Burditt & Radzius, Chicago, IL, for plaintiffs-appellants.

Thomas P. Walsh, Asst. U.S. Atty., Crim. Div., Chicago, IL, William M. Zoffer (argued), Drake Cutini, Dept. of Justice, Consumer Litigation, Washington, DC, for defendants-appellees.

Before BAUER, Chief Judge, MANION and ROVNER, Circuit Judges.

Rehearing and Suggestion for Rehearing En Banc Denied September 24, 1993.

BAUER, Chief Judge.

In this appeal we revisit the United States Food and Drug Administration's ("FDA") treatment of human heart valve allografts2 as devices under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394 ("the FDC Act") and its implementing regulations. The district court dismissed the plaintiffs' complaint, ruling that it...

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