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BAILEY v. ELI LILLY CO.

April 29, 1985

SARA JANE BAILEY, Administratrix of the Estate of Hazel Stehman, Plaintiff
v.
ELI LILLY CO., INC., and THE UNITED STATES OF AMERICA FOOD & DRUG ADMINISTRATION, Defendants



The opinion of the court was delivered by: CALDWELL

 I. Introduction

 Pursuant to Fed. R. Civ. P. 12(b), defendant, United States of America, has moved to dismiss plaintiff's complaint based upon the discretionary function exception to the Federal Tort Claims Act. *fn1" 28 U.S.C. § 2671 et seq. Plaintiff's complaint alleges that the Food and Drug Administration (FDA) negligently failed to follow its own regulations in permitting Eli Lilly Co., Inc. to market the drug Oraflex and in also failing to take appropriate action to restrict the use of the drug or take it off the market after deaths and other injuries from its use became apparent. Plaintiff's decedent, taking Oraflex as a treatment for arthritis, allegedly died from bladder cancer caused by the drug. For the reasons set forth below, we grant the motion.

 II. Discussion

 The United States has waived its sovereign immunity from suit under certain circumstances.

 
The district court shall have exclusive jurisdiction of civil actions on claims against the United States . . . for injury or loss of property, or personal injury or death caused by the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred.

 28 U.S.C. § 1346(b). *fn2"

 The waiver, however, does not apply to any claim "based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused." 28 U.S.C. § 2680(a).

 The FDA is statutorily charged with determining whether a new drug is, among other things, "safe for use" before approving the drug's marketing or in deciding to remove an already approved drug from use by the public. See 21 U.S.C. § 355. Defendant contends that this is a discretionary function protected by section 2680(a). Plaintiff argues, on the other hand, that the FDA's regulations have refined its statutory duty and that the FDA can be found liable for failing to follow its own regulations, program decisions, standards and data. Her claim does not involve second guessing the FDA in the general area of drug approval. Rather, it involves holding the agency responsible for failing to comply with its own specific, objective procedures which, if followed correctly, would have inevitably led to Oraflex's never being approved, and once approved, its removal from the market. Hence, in plaintiff's view, this case does not call into question the exercise of the agency's discretion.

 Plaintiff cites in her support Griffin v. United States, 500 F.2d 1059 (3d Cir. 1974), and Gross v. United States, 676 F.2d 295 (8th Cir. 1982), but we find these cases distinguishable. Gross is cited for the proposition that intentionally refusing to carry out a regulatory duty and consistently disregarding program standards and decisions does not fall within the discretionary function exception. In Gross, plaintiff sued state and county officials for excluding him from a United States Department of Agriculture feed grain program. The court rejected the discretionary function exception defense because the local officials had been ordered by national ones to permit plaintiff into the program. Unlike the FDA here, the local officials had no discretion to exercise.

 In Griffin, the Third Circuit Court of Appeals held that the discretionary function exception did not apply to the government's negligence in releasing for public use, in violation of a regulation, a quantity of polio vaccine which exceeded a reference strain in neurovirulence. The court stated:

 
The implementation called for a judgmental determination as to the degree to which each of the enumerated criteria indicated neurovirulence in monkeys. The judgment, however, was that of a professional measuring neurovirulence. . . . At issue was a scientific, but not policy-making, determination as to whether each of the criteria listed in the regulation was met and the extent to which each such factor accurately indicated neurovirulence.

 Id. at 1066 (footnote omitted) (brackets added).

 In the instant case, a scientific evaluation was not the crux of the FDA's allegedly wrongful conduct. Hence, Griffin is inapplicable although there is some similarity between it and the instant case in that in both of them there is no challenge to the propriety of ...


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