UNITED STATES DISTRICT COURT, SOUTHERN DISTRICT OF NEW YORK
July 6, 1982
Georgia YOUNG, Plaintiff,
UNITED STATES of America, Defendant
The opinion of the court was delivered by: EDELSTEIN
OPINION, FINDINGS OF FACT AND CONCLUSIONS OF LAW
This is an action under the Federal Torts Claims Act ("FTCA"), 28 U.S.C. § 2671 et seq., in conjunction with the National Swine Flu Immunization Program Act ("Swine Flu Act"), 42 U.S.C. § 247b. Plaintiff alleges that on or about November 17, 1976, she received a swine flu vaccination at United Hospital in Port Chester, New York, as a result of which she sustained injury. The action was transferred to the District of Columbia for coordinated and consolidated pre-trial proceedings pursuant to 28 U.S.C. § 1407. Upon completion of these proceedings, the case was remanded to this district for trial. See Final Pretrial Order, In Re Swine Flu Immunization Products Liability Litigation, MDL No. 330, Misc. No. 78-0040 (D.D.C. Nov. 15, 1979).
After a full trial on the merits, and after consideration of all the evidence, the court finds that plaintiff was adequately warned of the potential risks of the swine flu vaccination and finds no liability on the part of defendant. The court makes the following Findings of Fact and Conclusions of Law.
The Swine Flu Act was an attempt by the Federal Government to inoculate the entire adult population of the United States against the threat of a swine flu epidemic. It was the largest immunization program in this country's history, and over 45 million Americans-or one-third of the adult population-were vaccinated. The initial vaccination was on October 1, 1976, and the program was suspended on December 16, 1976. The program, for which $ 135 million was initially appropriated by Congress, called for using both private and public health care systems to achieve its goal of inoculating the entire adult population by the end of November 1976. The November deadline was critical since the season of intense flu transmission in the United States is generally considered to be September through March.
The Swine Flu Act became law on August 12, 1976 and was applicable to all swine flu inoculations administered after September 30, 1976. Important provisions of the Act include the following:
1. The Act creates a cause of action against the United States for any personal injury or wrongful death sustained as a result of the swine flu inoculation resulting from the act or omission of a program participant upon any theory of liability that would govern in an action against such program participant including negligence, strict liability in tort, and breach of warranty; 42 U.S.C. § 247b(k)(2)(A);
2. It makes that cause of action the exclusive remedy (42 U.S.C. § 247b(k)(3)) and abolishes the cause of action against the vaccine manufacturer; and
3. It makes the procedures of the FTCA applicable to suits brought pursuant to the Swine Flu Act (42 U.S.C. § 247b(k)).
The program was prompted in part by the medical discovery in early February, 1976 at Fort Dix, New Jersey, of military servicemen having a new strain of influenza virus antigenically related to the virus prevalent during the 1918-19 swine flu pandemic. That pandemic was responsible for 20 million deaths worldwide, including 500,000 in the United States alone. Prior to 1930, this strain was the predominant cause of influenza in the United States. Since 1930, the virus had been limited to transmission among swine only with occasional transmission from swine to human, with no secondary person-to-person transmission.
History has demonstrated that no swine flu epidemic occurred during the winter of 1976-77. As one might expect, many people who were inoculated incurred discomforts, illnesses, or injuries in a period relative to the vaccination. Lawsuits such as the instant one were filed throughout the country for illnesses allegedly resulting from the swine flu immunization program. In addition, numerous administrative claims have been filed.
Findings of Fact
1. Plaintiff Georgia Young
was born on December 11, 1932.
2. In her childhood years, plaintiff reacted allergically to several types of food, for which she was vaccinated by a physician. In her early twenties, plaintiff had an allergic reaction after receiving an oral polio vaccination. However, plaintiff had no history of allergic reaction to egg.
3. On November 17, 1976, plaintiff was a resident of the State of New York.
4. On November 17, 1976, plaintiff received a swine flu inoculation at United Hospital, Port Chester, New York pursuant to the Swine Flu Act. Port Chester, New York is in the Southern District of New York.
5. Plaintiff went to United Hospital with a friend, Blanche Fowler. When they arrived at the hospital, plaintiff and Ms. Fowler joined a group of people waiting to register for the inoculation.
6. While registering for her inoculation, plaintiff was handed two printed pages. The first page was an introduction to and a summary of the swine flu vaccination program.
The second page was a consent form entitled "IMPORTANT INFORMATION ABOUT SWINE INFLUENZA (FLU) VACCINE (MONOVALENT)." The full text of the consent form is as follows:
Influenza (flu) is caused by viruses. When people get flu they may have fever, chills, headache, dry cough or muscle aches. Illness may last several days or a week or more, and complete recovery is usual. However, complications may lead to pneumonia or death in some people. For the elderly and people with diabetes or heart, lung, or kidney diseases, flu may be especially serious.
It is unlikely that you have adequate natural protection against swine flu, since it has not caused widespread human outbreaks in 45 years.
The vaccine will not give you flu because it is made from killed viruses. Today's flu vaccines cause fewer side effects than those used in the past. In contrast with some other vaccines, flu vaccine can be taken safely during pregnancy.
One shot will protect most people from swine flu during the next flu season; however, either a second shot or a different dosage may be required for persons under age 25. If you are under 25 and a notice regarding such information is not attached, this information will be provided to you wherever you receive the vaccine.
Possible Vaccine Side Effects
Most people will have no side effects from the vaccine. However, tenderness at the site of the shot may occur and last for several days. Some people will also have fever, chills, headache, or muscle aches within the first 48 hours.
As with any vaccine or drug, the possibility of severe or potentially fatal reactions exists. However, flu vaccine has rarely been associated with severe or fatal reactions. In some instances people receiving vaccine have had allergic reactions. You should note very carefully the following precautions:
Children under a certain age should not routinely receive flu vaccine. Please ask about age limitations if this information is not attached.
People with known allergy to eggs should receive the vaccine only under special medical supervision.
People with fever should delay getting vaccinated until the fever is gone.
People who have received another type of vaccine in the past 14 days should consult a physician before taking the flu vaccine.
If you have any questions about flu or flu vaccine, please ask.
7. At the bottom of the consent form, there was a space for persons receiving the inoculation to fill in information and sign their names.
8. Plaintiff read the consent form that was given to her at United Hospital and signed it.
9. Above the signature and below the heading "REGISTRATION FORM," the following statement appears:
I have read the above statement about swine flu, the vaccine, and the special precautions. I have had an opportunity to ask questions, including questions regarding vaccination recommendations for persons under age 25, and understand the benefits and risks of flu vaccination. I request that it be given to me or to the person named below of whom I am the parent or guardian.
10. Plaintiff's signature on the consent form acknowledged and confirmed that she read the consent form including the paragraphs describing the swine flu, the swine flu vaccine, and the special precautions relating to the swine flu vaccine. Plaintiff's signature also acknowledged and confirmed that she had an opportunity to ask questions about the swine flu vaccine program, that she understood the risks and benefits of the swine flu vaccine, and that she had requested that the vaccine be given to her.
11. A sign prominently displayed in the registration area gave the same warnings as were contained in the "Special Precautions" section of the consent form.
12. On November 17, 1976, there was a doctor on duty at United Hospital, available to answer the questions of potential vaccinees regarding the swine flu vaccine. There were also nurses on duty at all times.
13. On or about November 19, 1976, plaintiff developed hives.
14. Prior to the initiation of the Swine Flu Program in 1976, the only reasonably foreseeable risk of allergic reaction to influenza vaccine was for persons with a known egg allergy.
15. Plaintiff's history of allergic reactions did not contraindicate the swine flu vaccine in 1976. Doctor Michael H. Grieco, the Director of the R. A. Cooke Institute of Allergy at St. Luke's-Roosevelt Hospital Center and chief of that hospital's Division of Infectious Diseases in Epidemiology and Division of Allergy and Clinical Immunology, testified convincingly that there was nothing in plaintiff's medical history which would have precluded a reasonable person from having the vaccination administered.
16. A reasonably prudent person in plaintiff's position fully informed of the risks and benefits known at that time would have elected to receive the vaccine.
CONCLUSIONS OF LAW
Under the FTCA, state law determines the standard of conduct against which the allegedly tortious government acts are to be measured. Laird v. Nelms, 406 U.S. 797, 92 S. Ct. 1899, 32 L. Ed. 2d 499 (1972). In addition, it has recently been held that state law determines the proper standard of conduct of tortious acts under the Swine Flu Act. Petty v. United States, 679 F.2d 719 (8th Cir. 1982).
The legal standard in New York governing plaintiff's claim of lack of informed consent is found in N. Y. Public Health Law § 2805-d (McKinney). The elements required to be proven are as follows:
(1) what risks and benefits involved in the shot were "reasonably foreseeable" (s 2805-d(1));
(2) what risks and benefits a reasonable medical practitioner under similar circumstances would have disclosed (s 2805-d(1));
(3) whether a reasonably prudent person in plaintiff's position would not have received the shot if she had been fully informed (s 2805-d(3));
(4) whether defendant, after considering all of the attendant facts and circumstances, used reasonable discretion as to the manner and extent to which such alternatives or risks were disclosed to the plaintiff (s 2805-d(4)(d)).
In Kaempfe v. Lehn and Fink Products Corp., 21 App.Div.2d 197, 249 N.Y.S.2d 840 (App.Div.1964), aff'd mem. 20 N.Y.2d 818, 284 N.Y.S.2d 708, 231 N.E.2d 294 (1969), the New York standard on the adequacy of a warning was discussed. In that case, the Appellate Division of the New York Supreme Court rejected a challenge to the adequacy of a warning published by a drug manufacturer. Plaintiff alleged that she had sustained a severe case of dermatitis resulting from an allergic reaction to a deodorant manufactured by the defendant. Conceding that an allergic reaction to this deodorant is rare, the plaintiff alleged that the defendant manufacturer had been negligent in failing to warn the few people who might suffer such a reaction. She also claimed that the label's statement "safe for normal skin" was inadequate.
The Appellate Division held the following issue determinative in this case: Whether the product contained an ingredient "to which a substantial number of the population are allergic" and if so, whether there was adequate warning against the possibility of such an allergic reaction. The court explained: "(If) the allergy is one common to any substantial number of possible users, the seller may be required at least to give warning of the danger." 249 N.Y.S.2d at 845.
Applying this test, the court held that plaintiff had failed to satisfy her burden and did not show that defendant was remiss in not warning the defendant since she had not proven
(1) that she was one of a substantial number or of an identifiable class of persons who were allergic to defendant's product, and (2) that defendant knew or with reasonable diligence should have known of the existence of such number or class of persons.
249 N.Y.S.2d at 848.
In the present case, defendant has shown that the only substantial identifiable class of persons predictably allergic to the swine flu vaccine were those allergic to egg. Defendant specifically and adequately warned against the risk of such an allergic reaction in its informed consent form and in the notice in the registration area.
In addition, there was also a general warning of the possibility of an allergic reaction in the consent form. Plaintiff is not among the group of egg-sensitive individuals and thus, it was not reasonably foreseeable that she would react in the manner that she did to the inoculation. Therefore, defendant is not liable for the failure to warn plaintiff more particularly against her specific reaction. The general warning of the possibility of an allergic reaction was sufficient and adequate.*
Plaintiff has failed to establish by a preponderance of all credible evidence any negligence on the part of the United States in failing to adequately warn of the risks of the swine flu vaccine. Plaintiff was warned of all reasonably foreseeable risks. Plaintiff's consent to the vaccination was informed. A reasonably prudent person, having been informed of these risks, would not have foregone the shot based on these warnings.
Plaintiff, therefore, has failed to satisfy her burden of proof in this action. Accordingly, defendant is entitled to judgment on the merits.
The foregoing shall constitute the court's Findings of Fact and Conclusions of Law pursuant to Rule 52(a) of the Federal Rules of Civil Procedure.