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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

ST. LOUIS UNIVERSITY, Plaintiff )

)

) ) ) v. ) ) ) THE UNITED STATES, ) ) Defendant ) __________________________________________)

Civil No.: JFM-95-CV-3639

AMERICAN CYANAMID CO., Plaintiff )

)

) ) ) v. ) ) ) ST. LOUIS UNIVERSITY, ) ) Defendant ) __________________________________________)

Civil No.: JFM-99-CV-1316

MEMORANDUM These two related cases may be the last involving the Sabin oral polio vaccine that was the subject of MDL proceedings before me. See In re Sabin Oral Polio Vaccine Prod. Liab. Litig., 743 F.Supp. 410 (D. Md. 1990) ("Sabin I"); 763 F.Supp. 811 (D. Md. 1991) ("Sabin II"); 774 F.Supp. 952 (D. Md. 1991) ("Sabin III"). They arise from a $16 million judgment obtained by Danny Callahan 1

in a medical malpractice action instituted against St. Louis University ("SLU") in Missouri. After the judgment was affirmed on appeal by the Missouri Supreme Court, SLU instituted an action against the United States in this court for contribution, contending that the paralysis from which Callahan suffers was caused by his having been administered a dose of vaccine derived from a seed I found in the MDL proceedings to have been wrongfully approved by the government. SLU instituted a similar action in Missouri against American Cyanamid ("Cyanamid"), the parent of Lederle Laboratories, the manufacturer of the vaccine. SLU eventually consented to the dismissal of that action after extensive discovery had been conducted. In April 1999, I granted a motion for summary judgment in favor of the United States against SLU. In the wake of that decision, Cyanamid filed a declaratory action against SLU, and I entered summary judgment in its favor as well. SLU appealed from both decisions. The Fourth Circuit reversed my rulings and remanded the cases for further proceedings. Although no further discovery has been conducted after remand, the parties have agreed that renewed summary judgment motions are appropriate. In its action against the United States, SLU has moved for partial summary judgment on the issues that the government was negligent and that its negligence was at least one of the proximate causes of Callahan's paralysis. The United States also has requested summary judgment. Similarly, Cyanamid has filed a summary judgment motion in its declaratory judgment action against SLU. I. The relevant background facts concerning the underlying Callahan action, the Sabin MDL proceedings, and the prior history of SLU's contribution action against the United States were succinctly stated by the Fourth Circuit in its opinion reversing my ruling in the case against the United 2

States. 5 Fed. Appx. 133, 136-37 (4th Cir. 2001). That opinion was not published in the Federal Reporter, and I will take the liberty of quoting from it verbatim:

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A. The State Court Action In 1978, three-month-old Danny Callahan received a dose of Orimune, an oral vaccine containing an attenuated strain of a live polio virus. Approximately one month later, Danny developed a perirectal abscess that was treated by employees of Cardinal Glennon Hospital and SLU. The abscess was not drained and no culture was taken to determine if the infection was caused by gram positive or gram negative bacteria. Danny was given an antibiotic that was effective only on gram positive bacteria. After several days, Danny's condition had not improved, and his mother noticed that his legs appeared to be "floppy." His parents took him back to the hospital, where the abscess was incised and drained. Cultures of the abscess revealed four types of gram negative bacteria, and Danny was given an antibiotic that was effective against those organisms. Although the abscess improved, Danny's legs and left arm remained paralyzed. Type III polio virus (the type in the vaccine dose he had received) was isolated in Danny's stool, and, although some experts disagree, it appears that Danny suffers from vaccineassociated polio. The Callahans filed a medical malpractice action against SLU, Cardinal Glennon, and American Cyanamid Company, parent company of the manufacturer of the vaccine. At the time of trial, only SLU and Cardinal Glennon remained as defendants. The Callahans' expert witnesses testified that Danny's paralysis was caused by the negligence of SLU and Cardinal Glennon in failing to treat the abscess properly when Danny was first brought to the hospital. According to the experts, the improper treatment allowed endotoxins to be released, which suppressed Danny's immune system. Because Danny's immune system was compromised, the attenuated polio virus contained in the vaccine was able to replicate fast enough to overcome his suppressed immune system, resulting in poliomyelitis. The Callahans' experts testified that if the abscess had been treated properly from the outset, the endotoxins would not have been released, his immune system would not have been suppressed, and he would not have contracted polio. SLU and Cardinal Glennon, however, presented evidence that Danny's paralysis was not connected to the abscess and that it was caused by the attenuated polio virus in the vaccine mutating to a virulent form after it had been ingested. They presented evidence showing that in the 1980s approximately one in four hundred thousand people receiving Orimune developed polio. Their experts also testified that the Callahans' theory that endotoxins suppress the immune system making a host more susceptible to vaccine-induced poliomyelitis was not supported by any known research. The jury returned a $16 million verdict against SLU and Cardinal Glennon. After the trial, Cardinal Glennon entered into a settlement agreement with the Callahans. SLU appealed, and the jury's verdict was affirmed by the Missouri Supreme Court sitting en banc. See Callahan v. Cardinal Glennon Hosp., 863 S.W.2d 852 (Mo. 1993) (en banc). B. In re Sabin 4

While the Callahan case was winding its way through the Missouri court system, multi-district Orimune cases filed against the United States government under the Federal Tort Claims Act were transferred to the District of Maryland for resolution of the common legal and factual questions. . . . The plaintiffs in the In re Sabin cases contracted polio after receiving a Type III Orimune vaccine or after coming into contact with a recipient of the Type III vaccine. They sued the government, alleging, inter alia, that the National Institute of Health's Division of Biologic Standards negligently issued a license to Lederle Laboratories (a subsidiary of American Cyanamid) to manufacture the vaccine and improperly approved vaccine that did not meet the "neurovirulence" standards set forth in the governing regulations. The district court ultimately concluded that the government violated the governing regulations and was negligent in approving certain vaccine "seeds" and the release of lots derived therefrom and that its negligence was a proximate cause of the injuries suffered by the plaintiffs, who received or were exposed to vaccines from lots derived from the improperly approved seeds. See 774 F.Supp. at 957-58, 763 F.Supp. at 821-25. The district court's Sabin opinions were affirmed by this Court on appeal. See In re Sabin Oral Polio Vaccine Prod. Liab. Litig. , 984 F.2d 124 (4th Cir.1993) (per curiam). The Orimune vaccine received by Danny Callahan was derived from one of the vaccine seeds that the In re Sabin cases concluded were improperly approved by the government. . . . 5 Fed. Appx. at 136-37. II. After stating these background facts, the Fourth Circuit went on to decide that I erred in holding that under Missouri law (which undisputably is applicable here) the findings adverse to SLU in the Callahan case would have a collateral estoppel effect in a subsequent contribution action. In effect, the Fourth Circuit held that SLU was free to present in a contribution action the defense it had lost in Callahan, i.e., that its alleged malpractice in improperly treating Callahan's abscess was immaterial because known research does not support the opinion expressed by Callahan's experts that endotoxins suppress the immune system, making a host more susceptible to vaccine-induced polio. SLU acknowledges that the invalidity of the immunosuppression theory has not yet been 5

established in this case, and it is not moving for complete summary judgment on the ground that its own negligence was de minimis or nil. It is seeking only a ruling that the United States was negligent and that the negligence was at least one of the proximate causes resulting in Callahan's paralysis. The United States has agreed to be bound in this litigation by the regulatory violations that were found to exist in Sabin II. (United States' Opp'n at 2.) It also has stipulated to owing a duty of care to Callahan. 1 (Id. at 15.) Although it stipulates to duty and to the regulatory violations, the United States does not admit to proximate cause. In my original opinion I found that "none of SLU's experts have expressed an opinion that, if Callahan had been given a vaccine that satisfied the neurovirulence requirements of the applicable regulations, he would not have contracted polio."2 SLU has not supplemented the record on this point In Sabin III, I applied the Good Samaritan doctrine of the Restatement (Second) of Torts

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