Toner for Toner v. Lederle Laboratories, a Div. of American Cyanamid Co., 84-3906

• Decision Date: 26 October 1987
• Docket Number: No. 84-3906,84-3906
• Parties: David TONER, Guardian ad litem for Kevin TONER, an infant child, and David Toner and Susan Toner, husband and wife, individually, Plaintiffs-Appellees, v. LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID CO., a corporation, Defendant-Appellant.
• Court: U.S. Court of Appeals — Ninth Circuit

Page 180

831 F.2d 180

David TONER, Guardian ad litem for Kevin TONER, an infant child, and David Toner and Susan Toner, husband and wife, individually, Plaintiffs-Appellees, v. LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID CO., a

corporation, Defendant-Appellant.

No. 84-3906.

United States Court of Appeals, Ninth Circuit.

Oct. 26, 1987.

Elam, Burke, Evans, Boyd & Koontz, and Robert J. Koontz, Boise, Idaho, for defendant-appellant.

Kenneth L. Pedersen and Curtis R. Webb, Webb, Burton, Carlson, Pedersen & Webb, Twin Falls, Idaho, and Richard D. Poling, Charlotte, N.C., for plaintiffs-appellees.

Before WRIGHT, KENNEDY and ANDERSON, Circuit Judges.

Appeal from the United States District Court for the District of Idaho.

ORDER

Upon consideration of the parties submissions, it appears there are certain erroneous or ambiguous statements in the first opinion of the court in this matter, Toner v. Lederle Laboratories, 779 F.2d 1429 (9th Cir.1986).

The opinion is amended by striking the last two sentences in the fifth paragraph, which state:

"Because of this difficulty, at the time of Kevin Toner's vaccination, the whole cell pertussis vaccine was the only pertussis vaccine licensed by the Food and Drug Administration (FDA) for use in the United States. It remains the only licensed vaccine today."

In lieu of those sentences, the following language is inserted:

"At the time of Keven Toner's vaccination, the whole cell pertussis vaccine was the only pertussis vaccine licensed by the Food and Drug Administration (FDA) and distributed in the United States."

The opinion is further amended by striking the last two sentences in the ninth paragraph, which state:

"However, in 1972, a review panel within the Bureau of Biologics of the FDA refused to certify Tri-Solgen as "safe and effective" although it did so certify the whole cell vaccines. Because the FDA has refused to relicense Tri-Solgen or any other fractionated cell product, the manufacture and sale of such a vaccine by Lederle, or any other pharmaceutical company, would constitute a criminal offense under the Food, Drug and Cosmetic Act. See 21 U.S.C. Secs. 331(d), 333(a), 355(a) (1982)."

In lieu of those sentences, the following language is inserted:

"However, in 1972, a review panel within the Bureau of Biologics of the FDA refused to certify Tri-Solgen as "safe and effective" although it did so certify the whole cell vaccines. Thus, whole cell vaccine was the only pertussis vaccine marketed...