Manko v. United States

Decision Date05 June 1986
Docket NumberNo. 79-1011-CV-W-9.,79-1011-CV-W-9.
Citation636 F. Supp. 1419
PartiesLouis H. MANKO, Plaintiff, v. UNITED STATES of America, Defendant.
CourtU.S. District Court — Western District of Missouri

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Charles M. Thomas, Jeffrey D. Zimmerman, Grier, Swartzman & Weiner, Kansas City, Mo., for plaintiff.

W. Russell Welsh, U.S. Dept. of Justice, Civ. Div., Washington, D.C., Judith Strong, Asst. U.S. Atty., Mary McElroy Leach, Trial Atty., Torts Branch Civ. Div. — U.S. Dept. of Justice, Washington, D.C., for defendant.

MEMORANDUM ORDER AND JUDGMENT

BARTLETT, District Judge.

Anticipating an outbreak of swine flu in 1976, the federal government undertook a massive immunization effort through the National Swine Flu Immunization Program Act of 1976, Pub.L. No. 94-380, § 2, 90 Stat. 1113 (August 12, 1976) (codified at 42 U.S.C. § 247b(j)) (repealed by Pub.L. No. 95-626, § 202, 92 Stat. 3574 (1978), 42 U.S.C. § 247b (1978)) (hereafter called the Swine Flu Act). The program was directed at the prevention of an anticipated epidemic of swine flu in the United States adult population through the vaccination of large numbers of people in nationwide immunization centers. To encourage pharmaceutical companies to supply the vaccine, Congress relieved the companies of liability for injuries resulting from its use and provided remedies against the United States under the Federal Tort Claims Act, 28 U.S.C. § 1346(b).

On October 1, 1976, the swine flu immunization program began. On December 18, 1976, the Center for Disease Control declared a moratorium on swine flue vaccinations to investigate an increased incidence of Guillain-Barre Syndrome (GBS) in the adult population and an apparent association between GBS and the swine flu vaccination.

Plaintiff Louis Manko received a swine flu vaccination on October 20, 1976. On January 15, 1977, plaintiff was admitted to Menorah Medical Center with paralysis in his legs and arms that was diagnosed as GBS.

On November 14, 1979, plaintiff Louis Manko initiated this lawsuit by filing his complaint against defendant the United States seeking damages under the Federal Tort Claims Act and the Swine Flu Act. On January 31, 1980, this case was transferred by the Judicial Panel on Multidistrict Litigation to the United States District Court for the District of Columbia, In re: Swine Flu Immunization Products Liability Litigation, MDL 330, Misc. No. 78-0040, Civil Action No. D.C. 80-0255, for coordinated and consolidated pretrial proceedings pursuant to 28 U.S.C. § 1407. On June 9, 1980, the Judicial Panel on Multidistrict Litigation remanded this case to the United States District Court for the Western District of Missouri for further pretrial proceedings and trial.

The Final Pretrial Order, paragraph IX, p. 9 issued by the United States District Court for the District of Columbia in the Multidistrict Litigation (D.D.C. November 15, 1979) stated in relevant part that:

The United States and the plaintiffs disagree as to whether the injuries alleged can be caused by administration of the vaccine, except that the United States has stipulated that the Guillain-Barre Syndrome can be caused by the vaccine in certain instances.
If the United States has stipulated that the plaintiff in fact developed the Guillain-Barre Syndrome at any time, it will remain to be determined whether such injuries were in fact caused by administration of the vaccine, but it will not be necessary for plaintiff to establish any theory of liability, i.e. negligence or any available theory founded on the law of the applicable jurisdiction. Thus, the only liability issue in such cases will be causation, unless the United States has also stipulated as to causation....

In defendant's response to plaintiff's request for admission filed January 20, 1981, defendant admitted that subsequent to receipt of the swine flu vaccine, plaintiff contracted GBS and that plaintiff need not prove negligence or any other legal theory in order to establish liability against the United States. Therefore, pursuant to the Final Pretrial Order and defendant's January 20, 1981, admission, the sole liability issue is whether plaintiff's swine flue vaccination caused his GBS.

I.

MOTIONS

Motion to Strike Mayo Clinic Records

On December 5, 1983, pursuant to defendant's motion and plaintiff's consent, this Court ordered plaintiff to submit to a medical examination at the Mayo Clinic to evaluate plaintiff's alleged impotence. Plaintiff was examined and tested over a five day period in December, 1983.

On November 27, 1984, during the hearing on damages, the Mayo Clinic records (Plaintiff's Exhibit 409) were admitted in evidence without objection by defendant. Tr. 25-96. Dr. Lichtenfield, plaintiff's neurological expert, testified on direct examination about the Mayo Clinic records and specifically about the diagnoses of the Mayo Clinic physicians. Tr. 25-39. On cross-examination, defendant examined Dr. Lichtenfield about the tests conducted at Mayo Clinic (Tr. 25-107) and the diagnosis from Mayo Clinic. Tr. 25-121. Then the Court examined Dr. Lichtenfield about the Mayo Clinic records. Tr. 25-137 to 25-140. The Mayo Clinic records were mentioned by other witnesses, including Dr. Rhamy, Dr. Leifer and Dr. Victor.

At oral argument on the issue of damages on December 14, 1984, the United States made an oral motion to limit the admissibility of the Mayo Clinic records based on Skogen v. Dow Chemical Co., 375 F.2d 692 (8th Cir.1967). Tr. 31-10. At that time the Court reserved ruling on defendant's motion to give plaintiff an opportunity to read the case cited by defendant and brief the issue. On December 20, 1984, plaintiff filed a brief on this issue.

In Skogen, the Eighth Circuit held that a doctor's opinion of how his patient's accident occurred is inadmissible hearsay under the business records statute, 28 U.S.C. § 1732(a). Thereafter, Congress enacted Rule 803(6), Federal Rules of Evidence, and repealed § 1732(a). The diagnoses contained in the Mayo Clinic records are admissible under the more liberal standards contained in Rule 803(6). The Advisory Committee notes to Rule 803(6) expressly state that Skogen and its interpretation of § 1732 are no longer good law. Rule 803, Federal Rules of Evidence, Notes of the Advisory Committee on Proposed Rules, note to Exception 6.

Further, the defendant waived its objection by its failure to timely object. Defendant's objection at oral argument after the evidentiary record had been closed only served to needlessly complicate the issues before the Court.

Therefore, defendant's oral motion to strike the Mayo Clinic records (Plaintiff's Exhibit 409), is denied.

Defendant's Motion to Keep Open the Record

Presentation of evidence on the issue of causation concluded on February 17, 1984. During oral argument on February 21, 1984, the United States made an oral motion to keep the record open so that Dr. Nathanson could submit a revision of Defendant's Exhibit 273 (Dr. Nathanson's analysis of whether there was a drop in reporting the occurrence of GBS in the immunized population after December 18, 1976). Plaintiff objected to the admission of additional evidence after the record closed and the Court suggested defendant file a written motion. On February 22, 1984, defendant filed a written motion to keep the record open. On April 16, 1984, defendant filed a renewed motion to keep the record open and attached a copy of Dr. Nathanson's revision of Defendant's Exhibit 273.

During presentation of defendant's case, Dr. Nathanson testified extensively on behalf of defendant. Later, Dr. Nathanson was recalled at the Court's request and testified concurrently with Dr. Goldfield in rebuttal. Dr. Nathanson has been given an adequate opportunity to present his expert opinion and its basis.

If the tendered revision of defendant's Exhibit 273 was admitted into evidence, it is fair to assume that plaintiff would request an evidentiary hearing to cross-examine Dr. Nathanson. Further delay in concluding this case is not justified. Defendant's request to introduce a revised defendant's Exhibit 273 is denied.

Motion to Strike Dr. Goldfield's Testimony

During the trial, the United States objected to Dr. Goldfield's expert testimony on the cohort analysis. Tr. 7-53. After the trial, both parties briefed the issues raised by this objection.

Defendant first argues that Dr. Goldfield's testimony about his cohort analysis should be stricken because it does not satisfy the standard for scientific techniques set forth in Frye v. United States, 293 F. 1013 (D.C.Cir.1923). In Frye, the Court held that testimony based on the results of a polygraph test was inadmissible because scientific recognition of the accuracy of the technique was inadequate.

Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while the courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.

Id. at 1014.

Apparently, the United States believes that because its experts did not use the Mantel/Haenszel cohort analysis to make their epidemiological evaluations, then the cohort analysis is not generally accepted in the epidemiological community. Although plaintiff's experts and defendant's experts dispute whether the underlying data is stratified, i.e., whether there was a drop in reporting after December 18, 1976, all the experts agreed that the Mantel/Haeznel approach is a recognized and generally accepted method of analyzing stratified epidemiological data. Based on the Court's conclusion that the data was stratified,...

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