Cardillo v. United States

• Decision Date: 09 November 1984
• Docket Number: Civ. No. N-80-40(TFGD).
• Citation: 622 F. Supp. 1331
• Parties: Charles D. CARDILLO, Administrator C.T.A. for the Estate of Sandra L. Cardillo, and Charles D. Cardillo, individually, Plaintiffs, v. UNITED STATES of America, Defendant.
• Court: U.S. District Court — District of Connecticut

622 F. Supp. 1331

Charles D. CARDILLO, Administrator C.T.A. for the Estate of Sandra L. Cardillo, and Charles D. Cardillo, individually, Plaintiffs, v. UNITED STATES of America, Defendant.

Civ. No. N-80-40(TFGD).

United States District Court, D. Connecticut.

November 9, 1984.

Clifford J. Shoemaker, Vienna, Va., James M.S. Ullman, Meriden, Conn., for plaintiffs.

John Hughes, Leslie Ohta, Asst. U.S. Attys., Alan H. Nevas, U.S. Atty., New Haven, Conn., Roger D. Einerson, Dept. of Justice, Civil Division, Torts Branch, Washington, D.C., for defendant.

MEMORANDUM OF DECISION

DALY, Chief Judge.

In April of 1980, Charles Cardillo brought this action against the United States pursuant to the National Swine Flu Immunization Program Act, 42 U.S.C. § 247b, and the Federal Tort Claims Act, 28 U.S.C. § 1346(b), § 2671, et seq. At that time, Charles Cardillo presented the claims as Conservator for the Estate of Sandra L. Cardillo as well as in his individual capacity for loss of consortium. Shortly before trial, the government moved to have the complaint dismissed as to Charles Cardillo in his individual capacity based on a failure to meet the jurisdictional prerequisites of filing an administrative claim with respect to the claim for loss of consortium. The Court noted that if liability was established, the motion would then be decided in connection with its ruling on damages. On December 12, 1983, during a recess in the course of the trial of this case, Sandra Cardillo died. Thereafter, subsequent to the filing and government rejection of an administrative claim, the complaint was amended to include a claim for wrongful death.

After transfer of this case to the United States District Court for the District of Columbia by the Judicial Panel on Multi-District Litigation, the matter was remanded to this Court for further proceedings and trial. The plaintiffs allege that Sandra Cardillo suffered from Guillain-Barre Syndrome (GBS) as a result of her receiving the Swine Flu vaccine on December 6, 1976. The government agrees that Sandra Cardillo suffered from GBS, but disputes that her case of GBS was caused by the Swine Flu vaccine. The plaintiffs and the government are in agreement that, under the terms of the order entered in the Multi-District Litigation proceedings, the first issue for this Court is to determine whether the plaintiffs have proven that Sandra Cardillo's case of GBS was caused by the Swine Flu vaccination. In Re Swine Flu Immunization Products Liability Litigation, M.D.L. No. 330, Misc. No. 78-0040, at ¶ IX (D.D.C.1979). If the result of this inquiry is that causation is established, the government's liability is thereby established, and damages are to be calculated and awarded. Id.

The plaintiffs present to the Court two alternative theories of causation. The first is that the onset of the GBS was shortly after Mrs. Cardillo received the vaccine, well within the appropriate period of time under the government's interpretation of epidemiological data concerning the likelihood of GBS being causally related to the vaccine. This theory posits that Mrs. Cardillo's case of GBS was of a "smouldering" type, which did not peak until almost 17 weeks after the vaccine was administered. The plaintiff's second theory of causation is that, even if the date of onset was 16 to 17 weeks after the vaccine was administered, the government's interpretation of the epidemiological data is significantly flawed in several respects, and accounts for an inaccurate and artificially low relative risk figure that is not actually warranted for that date of onset. Plaintiffs argue that a proper interpretation of the epidemiological data demonstrates a relative risk for onset during the 16th and 17th week after vaccination sufficiently high to indicate that Mrs. Cardillo's case of GBS was more likely than not causally related to the Swine Flu vaccine.

In response, the government has two lines of defense. First, the government argues that onset of Mrs. Cardillo's case of GBS was in late March of 1977, or approximately 17 weeks after she had received the vaccine. The government asserts that the proper interpretation of the epidemiological data reveals that Mrs. Cardillo's case of GBS was not causally related to the vaccine, as the likelihood of GBS being causally related to the Swine Flu vaccine is less than 50% if onset is beyond the 8th week after vaccination. Instead, the government claims that Mrs. Cardillo had an antecedent virus in late March of 1977, to which her case of GBS is likely causally related. Second, despite the stipulation noted above, the government argues that if onset was within a few weeks of the administration of the vaccine, while the flare-up of the disease was not for another 13 to 15 weeks, then Mrs. Cardillo's disease was not GBS. Instead, the government claims that this malady was chronic idiopathic polyradiculoneuropathy (CIP), which the government describes as a malady clinically separate from GBS.

DISCUSSION

A. Background

Sandra Cardillo was born on December 25, 1940. After a two-year courtship, she married Charles Cardillo in 1960. Mrs. Cardillo became the mother of two boys; Charles, Jr., who was born in 1962, and Todd, who was born in 1968. Just short of her 36th birthday, on December 6, 1976, Sandra Cardillo received the Swine Flu vaccine pursuant to the nationwide government program to immunize the population against a possible epidemic of the Swine Flu. Prior to this, Mrs. Cardillo appears to have been a basically healthy and very active person.

The only noteworthy aspect of her medical history prior to this date is that in 1968 a chest x-ray revealed small calcifications in the right upper lobe and right hilum of her lung. At that time no treatment was necessary. Later, in August of 1974, Mrs. Cardillo had a physical examination related to her employment with the City of Meriden. Due to the condition that had existed in 1968, a chest x-ray was taken in 1974. This x-ray showed a primary tuberculosis complex in the right lung which was healed with evidence of calcification. Because of this condition, medication was prescribed for Mrs. Cardillo, which she took from October, 1974 through December, 1974. This medication was stopped, apparently because Mrs. Cardillo felt it had caused her to become constipated. Her constipation appears to have continued into much of 1975. Mrs. Cardillo never told Charles Cardillo of this condition in her right lung or of her taking medicine for the condition for that three-month period in 1974.

The testimony before this Court demonstrates that, prior to the Swine Flu shot, Mrs. Cardillo was a very active and energetic person who was full of vitality. Charles Cardillo testified that she was an active person who enjoyed skiing, swimming, hiking and tennis. In addition, Mrs. Cardillo played softball, made clothes, did the housework, took care of her sons and knitted and crocheted when she could. She also did some gardening, rode a motorcycle with her husband, and attended a ceramics class. Mrs. Cardillo prepared the family meals. The testimony also reflects that she baked quite a bit, particularly around family holidays. In addition, Charles and Mrs. Cardillo socialized with family, friends and neighbors.

Moreover, Mrs. Cardillo had been a working wife and mother. Mrs. Cardillo was employed at Pratt & Whitney Aircraft after her marriage in 1960 until the birth of her youngest son Todd in 1968, with the exception of the time she took off when Charles, Jr. was born in 1962. Thereafter, Mrs. Cardillo went to work in a book factory rather than returning to Pratt & Whitney. From this factory position, Mrs. Cardillo took a job as a school bus driver for the City of Meriden. At some point in 1974 or 1975, Mrs. Cardillo took a position with the dispatcher's office overseeing the bus drivers for the City of Meriden. While employed with the City, Mrs. Cardillo worked approximately 180 to 200 days per year. Even though she was in the dispatcher's office, Mrs. Cardillo kept her school bus driver's license so that she could substitute as a driver when needed.

Consistent with the above, all of the witnesses who described Mrs. Cardillo noted her abundance of energy and her zest for life. Nancy Minor, one of Mrs. Cardillo's friends and a co-worker of Mrs. Cardillo over the years, stated that she was "a very bubbly, energetic person, always on the go." (T. 112). And although he had difficulty remembering exactly when Mrs. Cardillo began not feeling well, Mrs. Cardillo's father-in-law, Dominic Cardillo, testified that, while he could not recall her complaining to him about specific ailments, Sandra Cardillo "was always active ..., she used to run around like a spring chicken, she had plenty of pep, and all of a sudden she ran out of gas, that's all." (T. 182). Mrs. Cardillo's mother-in-law, Claire Cardillo, also described Sandra Cardillo as a person "always on the go." (T. 187).

Shortly after receiving the Swine Flu vaccine, Mrs. Cardillo's condition changed. Her activities slowed down a great deal and in some instances stopped. Although she continued to go to work, she felt weak and tired and wanted to rest. She even canceled a weekend skiing trip to Vermont. Within two or three weeks after the vaccination, Mrs. Cardillo mentioned to her husband that she had a numbness in her back. After a quick look at her back, Mr. and Mrs. Cardillo dropped the subject. Before the arrival of Christmas, Mrs. Cardillo mentioned to Charles Cardillo that she had a "scratchy burning sensation in the back of her throat." (T. 9).

Christmas of 1976 was very different from prior Christmases for Mrs. Cardillo. She did not feel like decorating the house as she had done with the family in earlier years. She decided to cancel the family's Christmas trip to Maine to see her parents, and then, at the last minute, decided to go. While in Maine, however, she did not ski with the family, which for her...