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December 07, 2020 Articles

The Swine Flu Litigation

The United States is currently on the verge of a national vaccination program for COVID-19. But the last time the country ran a program to immunize every American, in 1976, a very serious side effect began to appear.

By Paul D. Rheingold and Clifford J. Shoemaker

Given the current mass COVID-19 vaccination program under way, it is interesting to see how liability and compensation issues were handled the last time the United States undertook to vaccinate every citizen—the swine flu program of 1976. The situation then was different from the present—virtually no one had it, but the scientific community was convinced that administering a newly developed vaccine was necessary to prevent the disease.

Also completely different was the way compensations for vaccine-related injuries were handled then as compared to what is planned now should there be serious side effects from the COVID-19 vaccines. In 1976, the manufacturers of the swine flu vaccine refused to sell it unless they had immunity, so the government stepped into their shoes and agreed to be sued under the Federal Tort Claims Act. 

Unfortunately, a very serious side effect began to appear in the 1976 vaccinees—Guillain-Barre Syndrome. Ultimately there were thousands of suits, and the cases were congregated into an early multidistrict litigation in 1978. We were members of the Plaintiffs' Steering Committee and wrote about the litigation in Litigation Magazine's Fall 1981 issue. That article follows below.

With vaccination for COVID-19 beginning, litigators should look to the swine flu vaccination program to prepare for what could come next.

With vaccination for COVID-19 beginning, litigators should look to the swine flu vaccination program to prepare for what could come next.

Credit: 10'000 Hours/DigitalVision via Getty Images

Litigating with the government has taken on new dimensions in the swine flu vaccine cases. Not only can the government be liable under the Federal Tort Claims Act (FTCA), but it also can be sued in the shoes of manufacturers, distributors, and administrators of the 1976 swine flu vaccine.

In 1976, the usual suppliers of flu vaccine refused to produce and sell swine flu vaccine because they feared that they would be subjected to ruinous liability. The government, however, was committed to an unprecedented program to vaccinate every "man, woman and child" in the United States against what its scientists believed was the risk of a killer epidemic like that of 1918-19. See Neustadt & Fineberg, The Swine Flu AF­Fair, (H.E.W. 1978).

When manufacturers and their insurers balked at sup­plying vaccine for the swine flu inoculation program, Congress hurriedly passed a law providing that the United States would take over, in its own name, the defense of all suits that might be brought against manufacturers, distributors,    and administrators by persons claiming injury because of the vaccine. National Swine Flu Immunization Program of 1976, Pub. L. No. 94-380, 90 Stat. 1113 (1976) (the Swine Flu Act).

Under the Swine Flu Act, the United States agreed to stand in the shoes of these various "program participants." Liability would be determined under the law of the state where the allegedly tortious acts or omissions of the program participants had occurred. Thus, more than 50 sets of product liability and malpractice laws were at once applicable in the litigation. In addition, plaintiffs could succeed under the existing FTCA if they could show that the government itself had been negligent.

For the most part, Congress employed FTCA mechanisms for dealing with the suits. Administrative claims had to be filed and denied (or not accepted within six months) before suit could be commenced. U.S. District Court judges tried the cases without juries. FTCA defenses were available except that the United States could not assert the defense that it was performing a ''discretionary function'' if the government was sued in the place of a vaccine manufacturer or other program participant.

Not even the most strenuous critics of the program could have guessed at the outpouring of litigation that has resulted under the Swine Flu Act. As of summer 1981, approximately 4,000 administrative claims had been filed, resulting in more than 1,500 suits in federal district courts across the United States.

Serious Injuries

The most serious and common basis for suit is a potentially paralyzing neurological disorder known as "Guillain-Barre syndrome." Indeed, it was the appearance of this condition that led to termination of the vaccination program in December 1976, after three months of operation and the vaccination of approximately 40 million Americans. Other suits have claimed a wide variety of injuries, including neurological diseases and allergic reactions.

By early 1977, it became apparent that the Department of Justice, federal district courts, and the plaintiffs' bar would be involved in protracted litigation. Since the suits were to be filed in federal courts, the Judicial Panel on Multi-District Litigation ordered the consolidation of all the swine flu cases for pretrial discovery according to the multidistrict litigation (MDL) rules under 28 U.S.C. § 1407. These cases were assigned to U.S. District Judge Gerhard Gesell of the District of Columbia. Cases were filed under his jurisdiction from February 28, 1978, to November 15, 1979, and even after he remanded the cases to the transferor courts for trial, the panel has continued to send subsequently filed cases to Washington to have the MDL plan applied to them.

Under the MDL plan, litigators produced a great volume of material for use in the swine flu litigation. Seventy depositions were taken of government employees who had been involved with the program, health officials who criticized or defended the program, and paid experts for each side. The government produced an estimated 50,000 documents from the many agencies that had taken part in the vaccination program. The plaintiffs served many interrogatories and requests for admissions on the government, and the government submitted to every plaintiff a uniform set of interrogatories on injuries and damages.

The plaintiffs elected members to the Plaintiffs' Swine Flu Litigation Steering Committee, which worked at an hourly rate and had the power to bind all plaintiffs. The 14 firms on the committee divided the work, which included conducting formal discovery, hiring experts on liability causation, and organizing the cases during this pretrial stage. The plaintiffs also opened a liaison office, staffed by lawyers from a Washington area firm, to handle communications among the plaintiffs, the court, and attorneys for the government. The Department of Justice, which represented the government during the MDL work, established a swine flu litigation team of lawyers and paralegals, headed by the chief of the Civil Division's Torts Section.

National Resolution

During the MDL stage, Judge Gesell held approximately 17 formal meetings with counsel and numerous informal ones. His goal was to see the cases prepared as fast as possible, and also, as in any MDL proceeding, to see if the whole dispute could be resolved nationally or at least if the issues could be narrowed. He was not markedly successful. At the end of the MDL phase, the United States did concede liability in some cases of Guillain-Barre syndrome, but only where the syndrome occurred a short time after the shot. At the end of the MDL stage, Judge Gesell entered a final pretrial order setting out guidelines for the judges to whom the cases were remanded.

The first wave of cases returned to the local district courts in November 1979, some 21 months after they were first transferred to Washington. More waves followed. Approximately 1,200 cases had been remanded by summer 1981.

Most district courts which are handling the cases for trial have adopted one of two procedures. In some districts, such as New Jersey, Massachusetts, and the Eastern District of New York, the swine flu cases have been assigned to one judge. One judge sitting in Denver has been assigned every case filed in the Tenth Circuit. In other districts, the cases have stayed with whomever judge was assigned when the case was filed. This requires each judge to become a specialist in the field. Jurisdictions with many cases have adopted this approach, including the Southern District of New York, Virginia, and some California districts.

When the cases returned to the trial courts, they again came under the control of the individual plaintiffs' counsel. For the most part, these lawyers have managed their cases individually. In some instances, however, they have brought in counsel with special knowledge from work on the Plaintiffs' Steering Committee. After the termination of the MDL phase, the Plaintiffs' Steering Committee and liaison counsel have conducted schools for legal counsel and reported swine flu trials and settlements. The United States schooled the local U.S. attorneys who have been assisted by experienced Department of Justice lawyers.

Plaintiffs' pretrial preparation varied greatly from virtually nothing to thorough depositions.

The amount of discovery after the cases were remanded has varied greatly among the various districts because of the autonomy of the local U.S. attorneys. In some districts, the government has deposed aggressively every treating doctor and trial expert, and has served a multitude of interrogatories upon the plaintiff. In other districts, the government has sought virtually no local discovery. As might be expected, plaintiffs have varied greatly in their pretrial preparation, which has ranged from virtually nothing to thorough depositions of defense witnesses and the inspection of many documents relating to the local vaccination program.

As of summer 1981, many cases have been disposed of through trial or settlement. Virtually all settlements have been in cases involving the Guillain-Barre syndrome. Many judges have approached the cases on a "trifurcated" or even "quadrified" basis. The first issue tried is diagnosis, because if the court finds that the injury is Guillain-Barre syndrome, then liability is conceded, and only causation and damages remain to be tried. If there is a different injury, many judges proceed to find if it is a condition that was caused by the vaccination. If so, the court tries liability, and then damages. If the condition is Guillain-Barre syndrome, but it put in a delayed appearance, the government often contests liability and the court will have to try all four issues—diagnosis, causation, liability, and damages.

The unique feature of the swine flu litigation—the potential liability of the United States in the place of drug companies and doctors—has not changed the trials very much. Tort law varies in each forum, of course; the requirements of manufacturers' warnings or informed consent differ somewhat from state to state. But, as in most drug cases, liability depends in part on what the person getting the vaccination knew and what a prudent drug company should have known and warned of in its labeling. Causation and damages are presented as in any bench trial, where there is decidedly less opportunity for plaintiffs' emotional play than in a jury trial.

The parties have made extensive use of the MDL discovery. In liability trials, both sides have presented portions of MDL depositions often by videotape. On causation issues, the depositions of MDL experts have been used, often supplemented with live testimony by local doctors who treated the plaintiffs. There have been very few disputes over identifying and using depositions and govern­ment documents obtained in the MDL stage.

Of the 53 cases tried through the end of March 1981, the parties stipulated to liability and causation in 21. These damage trials resulted in verdicts totaling approximately $9.1 million. Of the 31 fully contested cases, the government won 26, and the plaintiffs prevailed in only 5, obtaining damages of approximately $1 million. Many of the government's victories were in cases where the injuries were very unusual and difficult to relate, other than by timing, to the swine flu shot. For example, Guillain-Barre syndrome cases that occurred some time after vaccination have been difficult to link to the shot. In cases where liability was conceded, several individual judgments have exceeded $1 million. One recent verdict amounted to $2.9 million. These results have had a strong impact, of course, upon subsequent settlement offers in other cases.

Districts vary dramatically in the percentage of cases that have been disposed of. Many cases have been tried in Colorado and the Eastern District of Virginia. On the other hand, as of summer 1981, none had been tried in the Southern District of New York. Routine calendar delays and the appointment of a single judge are a major factor in determining how quickly the cases are resolved.

The American legal system has proven in recent years that it can handle in an orderly fashion mass litigation concerning catastrophes. The swine flu litigation is another example of this orderly process. The swine flu litigation can be criticized, however, for the delays in some jurisdictions and the expense—both for the government and individual plaintiffs. Moreover, the government has become an adversary of the citizens it originally acted to protect. No matter who wins the remaining cases, the wisdom of Congress's decision to permit the government to step into the private world of the manufacturers and defend the swine flu suits is certain to be a hotly debated issue the next time scientists warn of an impending, nationwide health hazard.

Originally published in Litigation 8:1.

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Paul D. Rheingold and Clifford J. Shoemaker

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Paul D. Rheingold is senior counsel at Rheingold, Giuffra, Ruffo & Plotkin LLP in New York City, New York. Clifford J. Shoemaker was associated with Mr. Rheingold in Washington, D.C. Both Mr. Rheingold and Mr. Shoemaker were members of the Plaintiffs' Swine Flu Litigation Steering Committee, and Mr. Shoemaker served as a liaison counsel for the plaintiffs.


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