Legislative Modifications to Tort Liability: the Unintended Consequence of Public Health and Bioterrorism Threats

• Publication year: 2022

45 Creighton L. Rev. 337. LEGISLATIVE MODIFICATIONS TO TORT LIABILITY: THE UNINTENDED CONSEQUENCE OF PUBLIC HEALTH AND BIOTERRORISM THREATS

LEGISLATIVE MODIFICATIONS TO TORT LIABILITY: THE UNINTENDED CONSEQUENCE OF PUBLIC HEALTH AND BIOTERRORISM THREATS

Hon. Karen Shichman Crawford(fn*) Jeffrey Axelrad(fn**)

I. INTRODUCTION

Public health concerns, bioterrorism, and limited vaccine availability have prompted the enactment of laws that modify causes of action ordinarily available to litigants. Vaccine manufacturers, producers of qualified anti-terrorist technologies, and manufacturers of other products deemed necessary to address public health threats, including entities in the line of distribution, have benefitted from these revised tort remedies. The U.S. Congress continues to use legislation as a tool to assist the federal government in protecting the public health and well-being of U.S. citizens.

The rationale for such legislative modifications to traditional tort law remedies is simple: to encourage manufacturers to produce products deemed essential by the federal government to protect citizens against public-health and other threats without undue risk of liability. This Article discusses the diverse legislative enactments, whether and how they have achieved their stated goals, the impact of such legislation on principles of traditional tort law in the United States, and the methods available for achieving legislative protection.

II. ORIGINS OF TORT LAW MODIFICATION: THE 1976 SWINE FLU PROGRAM

Legislative tort modification is a concept that was initially considered in response to what was believed to be an exigent health crisis. When faced with the possibility of a flu pandemic, the federal government, acting through both the executive and legislative branches, believed creative solutions were necessary to provide the government with tools to protect U.S. citizens. In particular, tort liability regimes in both state and federal judicial systems were modified.

A. History and Background

The genesis of the Swine Flu Program was the apparent isolation of the swine flu virus from a small number of soldiers at the Fort Dix U.S. Army Base in New Jersey in January 1976.(fn1) Throat cultures taken from sick soldiers grew what scientists at the Centers for Disease Control and Prevention ("CDC identified as a "swine-like flu virus which was believed to have been inactive in the human population since 1930 with the exception of a handful of cases of swine-to-person transmission."(fn2) Fearful that the isolation of this virus meant that the country was on the verge of a large-scale influenza pandemic, government scientists promptly responded.(fn3)

In the days and weeks that followed, a flurry of meetings were held involving representatives of various federal agencies, including the CDC, the United States Food and Drug Administration ("FDA, Bureau of Biologics ("BoB, the National Institute of Allergies and Infectious Diseases ("NIAID, and the World Health Organization ("WHO. The representatives from these agencies extensively debated numerous alternatives on how to respond to the outbreak, including stock-piling vaccine, delaying administration pending a second outbreak, or doing nothing.

On March 18, 1976, Dr. Theodore Cooper, the Assistant Secretary for the United States Department of Health, Education, and Welfare ("HEW, issued a memorandum-which was drafted by CDC Director Dr. David Sencer-addressed to David Mathews, Secretary of HEW, bearing the heading "Swine Influenza: ACTION," which contained seven facts. The second fact stated: "The virus [isolated at Fort Dix] is antigenically related to the influenza virus . . . implicated as the cause of the 1918-1919 pandemic which killed 450,000 people-more than 400 out of every 100,000 Americans."(fn4) With this, Dr. Cooper stated that the following factors were "the ingredients for a pandemic": "person-to-person spread had been proven[,] . . . additional outbreaks [could] not be ruled out[, then-p]resent evidence and past experience indicate[d] a strong possibility that this country [would] experience widespread Influenza A/swine influenza in 1976-77[,] . . . and the population under 50 was almost universally susceptible."(fn5)

Following further discussions, and in accordance with the unanimous views of his professional and scientific advisors (including Drs. Jonas Salk and Albert Sabin), President Gerald Ford announced on March 24, 1976, that he would seek supplemental funds from Congress for the purpose of organizing and conducting an influenza mass immunization program.(fn6) That same date, President Ford announced on national television his recommendation for a nationwide influenza vaccination program to include "every man, woman and child in the United States."(fn7) Indeed, he committed to giving the swine flu program his direct and continuous attention "[b]ecause the health of our nation is at stake . . . ."(fn8)

Congressional hearings promptly followed President Ford's public pronouncement.(fn9) On April 12, 1976, Congress passed the supplemental appropriation legislation President Ford had requested. President Ford signed the bill into law on April 15, 1976.(fn10)

B. THE ROLE OF VACCINE MANUFACTURERS AND THEIR INSURERS IN THE SWINE FLU PROGRAM

Legislation alone, however, was not enough to implement a mass immunization program. To actually proceed with such a program, a suitable vaccine needed to be developed and tested, which required difficult decisions on the scope and extent of the program. Even assuming a suitable vaccine could be developed, a major stumbling block remained: liability protection for the vaccine manufacturers from the very viable threat of litigation following the contemplated mass immunization program, even if such anticipated claims lacked merit.(fn11)

Manufacturers raised their concern early on regarding liability exposure. The issue became more pronounced after insurers for the four major vaccine manufacturers, one by one, advised that they would exclude manufacturers from products liability coverage for all indemnity and defense costs associated with claims arising out of the swine flu program.(fn12) The Pharmaceutical Research and Manufacturers of America also cautioned that the government should indemnify the manufacturers for claims regarding the "quality of the vaccine, since it was being produced according to strict government specifications."(fn13)

Insurers drew a bold line in the sand, clarifying that coverage for all indemnity and defense costs associated with claims arising out of the swine flu program would be excluded.(fn14) Just months before the program was to begin, the manufacturers and their insurers firmly stated their refusal to participate in the program, unless they were assured of complete governmental indemnification.(fn15) On June 25, 1976, the chief of the Washington branch of the American Insurance Association, Leslie Cheek, advised government representatives that the insurance industry would not provide insurance to vaccine manufacturers because the liability potential was "enormous and worse, un-certain."(fn16) Perhaps smarting from earlier vaccine-related injury claims stemming from polio immunizations, the insurers asserted that there was no experience from which they could draw to assess the costs associated with such a massive vaccination program, and they bristled about the overhead and management costs associated with defending litigation that might arise from the administration of 200 million doses of vaccine.(fn17)

Even before the swine flu event at Fort Dix, a lawyer on the HEW staff questioned whether federal indemnification, wherever there was federal sponsorship of immunization, had potential ramifications far beyond the indemnification of vaccine manufacturers for vaccine-associated disability, which would create an undesirable precedent almost across the board.(fn18)

In response to industry concerns, the government initially proposed that it would assume the duty to warn all vaccine recipients.(fn19) The manufacturers would accept responsibility for simple negligence, and no more.(fn20) The response to this proposal was lukewarm, and as the president of one vaccine manufacturer stated in hindsight, "If the public was really endangered, the government should take the risk; it certainly could, we couldn't."(fn21) With the benefit of hindsight, the large number of lawsuits filed after the cessation of the Swine Flu Program proved that insurers' and manufacturers' concerns were ultimately justified.

On Capitol Hill, hearings on vaccine manufacturer indemnification drew a harsh response. Some members of the House Health Subcommittee could "not understand why insurers were reluctant to insure a vaccine whose medical risks appeared minimal."(fn22) Despite this objection on the Hill, and the accompanying risk of derailing the Swine Flu Program, President Ford remained resolute. When advised about the continuing risk of a pandemic, he stated, "[W]e are going to find a way, either with or without the help of Congress, to carry out this program that is absolutely essential . . . ."(fn23)

C. CONGRESSIONAL ACTION

On August 12, 1976, after much discussion and debate, Congress enacted the National Swine Flu Immunization Program Act of 1976(fn24) ("Swine Flu Act "to amend the Public Health Service Act to authorize the establishment and implementation...