Mcdonald v. United States

555 F.Supp. 935 (1983)

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Nature of the Case

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Facts

The National Swine Flu Immunization Program of 1976 was instituted by the federal government to inoculate the entire adult population of the United States against the perceived threat of a swine flu epidemic. The Act created 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 the 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). The Swine Flu Act made the above cause of action the exclusive remedy and abolished any causes of action against the vaccine manufacturer by individual claimants. 42 U.S.C. § 247b(k)(3). It made the procedures of the Federal Tort Claims Act applicable to suits brought pursuant to the Swine Flu Act. 42 U.S.C. § 247b(k)(4). A plaintiff must establish by the fair weight or preponderance of the evidence: (1) the nature of his or her illness; (2) a causal nexus with the swine flu vaccine; (3) a theory of liability against the government or program participant, i.e., strict liability, negligence, or breach of warranty; and (4) damages. Plaintiffs who can establish that they contracted Guillain-Barre Syndrome after receipt of the swine flu vaccine need not establish a theory of liability; only causation and damages must then be proven. P sued contending that she is suffering from GBS caused by the swine flu vaccine. P's medical history was unremarkable. She has hypertension and is insulin dependent since her diagnosis as a diabetic in 1975. Neither of these conditions interfered with her normal life or employment, nor contributed to her present condition. Because of her diabetic condition, she was administered the bivalent, rather than the monovalent, vaccine. Prior to receiving this injection, Lucy was interviewed briefly by non-medical personnel and given a document entitled 'Influenza Immunization Consent/Data Form' to peruse and sign. 'A small percentage of persons receiving this vaccine may experience one or more of the following symptoms: Redness, warmth, and tenderness of the injection site, fever (usually 101 degrees or less), chills, nausea, loss of appetite, muscle aches, joint pains, headache or fatigue. These reactions are usually short-lived, lasting less than 48 hours, but local reactions at the injection site may persist for more than several days. As with any vaccine or medication, the possibility of severe or potentially fatal reactions to flu vaccine must be considered. However, flu vaccine has rarely been associated with severe or fatal reactions.' P signed it and was then instructed to report to the appropriate line to receive the bivalent vaccine. P was handed another document entitled 'Fight Flu -- Immunize.' 'These vaccines have been field tested and shown to produce very few side effects. Some people who receive the vaccine had fever and soreness during the first day or two after vaccination. These tests and past experience with other flu vaccines indicate that anything more severe than this would be highly unlikely..... As indicated, some individuals will develop fever and soreness after vaccination. If you have more severe symptoms or if you have fever which lasts longer than a couple of days after vaccination, please consult your doctor or a health worker wherever you receive medical care.' P experienced the predicted fever along with nausea, headache, diarrhea and a general achy feeling throughout her body. These went away, but a few days later she felt some numbness in her right hand, and things progressed from there getting worse and affecting her entire body. She was finally admitted to Wilkes-Barre General Hospital. She remained at the hospital for almost 3 months. Her major physical deficits were paralysis from the waist down and dysfunction of the bowel and bladder.