Sparks v. Wyeth Laboratories, Inc.

• Decision Date: 13 May 1977
• Docket Number: No. CIV 77-0173-B.,CIV 77-0173-B.
• Court: U.S. District Court — Western District of Oklahoma
• Parties: Donna J. SPARKS, Plaintiff, v. WYETH LABORATORIES, INC., a Foreign Corporation, Parke, Davis & Company, a Foreign Corporation, Merck, Sharpe & Dohme Orthopedics, Inc., a Foreign Corporation, and Merrill National, a Foreign Corporation, Defendants.

431 F. Supp. 411

Donna J. SPARKS, Plaintiff, v. WYETH LABORATORIES, INC., a Foreign Corporation, Parke, Davis & Company, a Foreign Corporation, Merck, Sharpe & Dohme Orthopedics, Inc., a Foreign Corporation, and Merrill National, a Foreign Corporation, Defendants.

No. CIV 77-0173-B.

United States District Court, W. D. Oklahoma.

May 13, 1977.

COPYRIGHT MATERIAL OMITTED

Gene Stipe, John B. Estes and Robert K. McCune of Stipe, Gossett, Stipe & Harper, Oklahoma City, Okl., for plaintiff.

Neil R. Peterson, Asst. Chief, and W. Russell Welsh, Atty., Torts Section, Civ. Div., U. S. Dept. of Justice, Washington, D. C., for defendants.

MEMORANDUM OPINION

BOHANON, District Judge.

This is a civil action wherein the plaintiff, Donna J. Sparks, prays judgment against the defendant manufacturers jointly and severally for $6,675,210.00; and the intervenor defendant, United States of America, has filed certain motions which come on for hearing.

This case comes on before the court on two motions:

1. The United States has moved to substitute itself as sole party defendant in the place of the four defendants named by plaintiff (Wyeth Laboratories, Inc.; Merrill-National; Parke, Davis and Company; and Merck, Sharpe and Dohme Orthopedics, Inc. hereinafter called "vaccine manufacturers"). These four defendants are the sole manufacturers of so-called swine flu vaccine (Dr. David W. Berry Affidavit) under the National Swine Flu Immunization Program of 1976 (Public Law 94-380; 42 U.S.C. § 247b(j)-(l) hereinafter referred to as "Swine Flu Act"). The motion to substitute is made pursuant to 42 U.S.C. 247b(k)(5)(A).

2. Assuming that the substitution is accomplished, the United States has moved to dismiss the action against it because of the failure of the plaintiffs to file an administrative claim as required by 28 U.S.C. § 2675(a), a part of the Federal Tort Claims Act hereinafter referred to as "Tort Act".

Plaintiff opposes these dual motions on three grounds: 1) that the Swine Flu Act is unconstitutional because it violates the due process and equal protection clauses and the Seventh and Tenth Amendments; 2) that an injured party may still sue a vaccine manufacturer directly for negligence notwithstanding the provisions of the Swine Flu Act; and 3) that the claim procedures of the Tort Act may not be invoked in a suit against a manufacturer who is not an employee of the United States. Because this will be the seminal decision dealing with the Swine Flu Act, the Court deems it appropriate to express its reasoning on each of these issues in some detail.

It is noted that plaintiff had moved for an injunction and the empaneling of a three judge court to determine the constitutionality of the Swine Flu Act. That motion was withdrawn by counsel for plaintiff at oral argument, since, as the United States had pointed out in its opposition, the statute on which it was based (28 U.S.C. § 2282) had been repealed by Public Law 94-381.

Plaintiff allegedly received a swine flu immunization on November 24, 1976 at the office of a private physician and within six hours experienced a condition which has left her with "some paralysis in her body and loss of vision and ability to speak" (Complaint, paragraphs 7, 8, 9). The Court accepts this statement as true, without, of course, deciding whether there is any medical or legal causation between the inoculation and the purported condition, and, if so, whether the condition is compensable.

The Swine Flu Act became law on August 12, 1976 and was to apply in the instance of all swine flu inoculations given after September 30, 1976 (42 U.S.C. § 247b(k)(2)(A)). Its provisions are simple. It applies to three categories of "program participants" as defined in 42 U.S.C. § 247b(k)(2)(B):

1. Manufacturers or distributors of vaccine who make no profit on the vaccine;

2. Public or private agencies or organizations that provide an inoculation with informed consent and without charge to the recipient for the vaccine or its administration; and,

3. Medical or other health personnel who provided or assisted in providing an inoculation with informed consent and without charge to the recipient for the vaccine or its administration.

We are here concerned with only the first or manufacturers category, although what is said as to it would apply with equal validity to the other categories.

The Swine Flu Act does three basic and relevant things:

1. It creates a cause of action against the United States for any personal injury or wrongful death sustained as a result of a swine flu inoculation (42 U.S.C. § 247b(k)(2)(A)).

2. Making that cause the exclusive remedy (42 U.S.C. § 247b(k)(3)), it abolishes the cause of action against the manufacturer-program participant.

3. It makes the procedures of the Tort Act applicable to the suits against the United States (42 U.S.C. § 247b(k)(2)(A)). However, the Swine Flu Act does not limit a plaintiff's theory of recovery to negligence alone as under the Tort Act (28 U.S.C. 1346(b), 2674), but rather specifies that the United States shall be liable upon any theory available against a program participant under the law of the place where the act or omission occurred, "including negligence, strict liability in tort, and breach of warranty" (42 U.S.C. 247b(k)(2)(A)(i)).

The Swine Flu Act does contain other provisions which are set forth only insofar as necessary to the discussion which follows.

The Swine Flu Act was generated and enacted by Congress in good faith haste. This is apparent both from the fact that the bill was not even referred formally to the House Judiciary Committee and the fact that no formal report of either chamber of Congress exists. In fact, such a report is contained only in the remarks of Representative Paul Rogers (Fla.) in the Congressional Record of August 26, 1976 which supplement his remarks during the August 10, 1976 debate on the bill. Congressman Rogers is Chairman of the House Subcommittee on Interstate and Foreign Commerce, the committee which drafted the bill and held applicable hearings. His remarks contain an exposition of the legislative history of the Swine Flu Act, its rationale, the alternatives considered and rejected by Congress, and a section-by-section analysis of the bill. They are set forth at pp. E 4695-4707 of the Congressional Record of August 12, 1976. Debate occurred in both chambers on August 10, 1976, that of the House appearing at Cong.Rec., H 8643-8655 and that of the Senate appearing at Cong.Rec., S 14108-14122.

It is sufficient to say that the bill was occasioned by the collapse of the commercial liability insurance market, both for the manufacturers and other program participants (Cong.Rec., Liability, E 4698-4699). Since the bill was generated by the House Interstate and Foreign Commerce Committee with some amendments by the Senate, it is natural that the legislative history would evidence such connection with the commerce clause as was apparent. This was found in two areas. First, the economic cost of the last flu epidemic in the United States, the Hong Kong flu of 1968-69, was $3,900,000,000 with 33,000 excess deaths (Cong.Rec., E 4696), much of the economic loss being due to lost wages. As a corollary, flu was noted to be the one disease with the capacity to close plants (Ibid.). Second, the vaccine would not be available for distribution in interstate commerce unless the insurance-liability problem was solved.

The need for haste arose from the need to inoculate the population before the flu season began (Cong.Rec., E 4701, S 14110).

The collapse of the insurance market was occasioned by two factors:

1. The miniscule claims experience of insurers with prior flu vaccines was not a problem (Cong.Rec., E 4699). However, the significant problem was the potential for a large number of claims with the attendant costs of investigation and defense. Insurance company witnesses estimated that this cost alone could run into the billions of dollars (Cong.Rec., H 8648-9). Such claims were called frivolous or non-meritorious.

2. The recent cases of Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir., 1968) and Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir., 1974) had held a manufacturer of polio vaccine liable on a non-negligence, strict liability in tort theory for failure to warn a vaccinee of the risks attendant upon the vaccine. Thus, while the manufacturers could insure themselves against negligence, they could not afford insurance premiums for the cost of defense of frivolous, non-meritorious claims or for attenuated theories of non-negligent liability (Cong.Rec., E 4698-9, 4700). Since the manufacturers could insure themselves for negligence liability, the manufacturers would thus be liable in a suit over by the United States on a negligence theory (42 U.S.C. § 247b(k)(7)) if it has settled any claim or has been found liable on any theory and can make out a case of negligence against a manufacturer (Cong.Rec., E 4705).

It is apparent that both the text of the Swine Flu Act and the legislative history show that the statute passes any test of its constitutionality. But, the Court will deal with each of the plaintiff's contentions in order.

1. There is no question but that the Swine Flu Act comports with the due process clause of the Fifth Amendment. It is manifest that the statute, insofar as it abolishes a cause of action against a program participant, does so only prospectively. It does not suffer the infirmity of the cases cited by plaintiff in which abolitions of vested rights were found to be a due process violation. This is the teaching of Keller v. Dravo Corporation, 441 F.2d 1239 (5th Cir., 1971). As has been stated by the Supreme Court:

A person has no property, no vested interest, in any rule of the common law. Mondou v. New York, New Haven & Hartford Railroad Co., 223 U.S. 1, 50, 32 S.Ct. 169, 175, 56 L.Ed. 327 (1912).

And again:

No person has a vested interest in any rule of law

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