Can we or not, sue vaccine manufacturers?

A deep dive into the history of litigation for the last 70 years. Part 1.

The question of why in the United States citizens alleging injury from a vaccine cannot sue the manufacturer, has been a long standing and sometimes maligned question and answer session.

In a multi-part series, I will try to outline pre-NCVIA (National Childhood Vaccine Injury Act of 1986) litigation from 1950’s to 1986, The Act, pre-Bruesewitz and post-Bruesewitz, plus legal actions outside the jurisdiction of the National Vaccine Injury Compensation Program (NVICP).

Successful lawsuits were brought for vaccine injury against Cutter Labs, DTP and manufacturers of the Swine Flu vaccine.

First, let’s examine what happened 70 years ago.

Cutter Lab incident

In 1955, Cutter Laboratories released batches of the inactivated polio vaccine (Salk vaccine) that were not fully inactivated.

As a result, an estimated 40,000 people developed poliomyelitis, 200 were permanently paralyzed, and 10 died.

People did successfully win awards (some via jury verdicts, others via settlement). The amounts varied, many six-figure amounts; the largest cumulative settlement (approx. $3 million) was much less than the total claims but still substantial for the 1950s.

60 lawsuits were filed against Cutter Laboratories after the incident. Out of those, only a few went to trial; many were settled.

Published opinion summary of Gottsdanker v. Cutter Laboratories (California appellate decision) reporting jury verdicts of $139,000 for the two children and $8,300 for parents’ special damages.

A trial in 1961 involving four children paralyzed by the vaccine ended in a jury award of $120,000.

Another case Crane v. Cutter Laboratories settled for $189,000.

DTP lawsuits

The DTP (Diphtheria–Tetanus–Pertussis) vaccine was widely used in the U.S. beginning in the 1940s–1950s.

By the late 1970s and early 1980s, hundreds of lawsuits were filed claiming that the pertussis (whooping cough) component caused brain damage, seizures, or death in children.

These lawsuits were against vaccine manufacturers such as Wyeth, Lederle, Eli Lilly, Parke-Davis, and others.

1978–1985

Approximately 200 lawsuits filed by 1984; by 1986, over 300 pending cases nationwide. A number of jury verdicts for plaintiffs (some over $1 million); many confidential settlements. A number of jury verdicts for plaintiffs (some over $1 million); many confidential settlements.

1982–1985

Dozens of awards, including: Goss v. Lederle ($1.13M, 1984); Tinnerholm v. Parke-Davis (1976; $200k+ damages); Reyes v. Wyeth Labs (1974; affirmed liability)

Courts found manufacturers liable under strict liability or failure-to-warn theories.

By 1985

20+ successful verdicts or settlements totaling tens of millions. Wyeth, Lederle, and others raised prices or withdrew from DTP market.

Significant Suits won

Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974). Court found manufacturer liable for failure to provide adequate warnings — key precedent.

Tinnerholm v. Parke, Davis & Co., 285 F. Supp. 432 (S.D.N.Y. 1968). Judgment for plaintiffs (DPT injury).

Goss v. Lederle Laboratories, 1984 (Utah). Jury awarded $1.13 million for brain injury allegedly caused by DTP.

Toner v. Lederle Laboratories, 779 F.2d 1429 (9th Cir. 1986). Plaintiff’s verdict upheld — first major appellate affirmation of DTP liability after Reyes.

By 1985, only two DTP manufacturers (Wyeth and Lederle) remained in the U.S. market.

Vaccine prices increased from 11¢ per dose to over $11 due to liability costs. Vaccine prices rose 100×.

Insurers began refusing to underwrite vaccine liability, prompting Congress to intervene with the 1986 National Childhood Vaccine Injury Act, which moved future claims into a no-fault compensation system administered by our federal government.

All said and done with DTP lawsuits resulted in the following:

• Total lawsuits filed: 200+ by 1984, 300+ by 1986

• Plaintiff verdicts: ~20–25 documented successful verdicts nationwide

• Average award: $250,000–$1 million (many settlements undisclosed)

• Largest confirmed pre-1986 award: Goss v. Lederle — $1.13 million (1984)

• Total payouts (est.): Tens of millions across all DTP claims

The 1976 “Swine Flu” Vaccination Campaign

The Swine Flu Fiasco as outlined in my first book, The Vaccine Court - The Dark Truth of America’s Vaccine Injury Compensation Program (2014), was a complete disaster. Development of a vaccine that was untested, known to may cause harm prior to release to the public.

I interviewed 15 families who had mothers, fathers, aunts or uncles that were vaccinated. And some bizarre findings years later. Several of those who where vaccinated died several years later from very rare cancers. I did not have the resources at the time to research all the records.

Here are some of the facts about this fiasco.

In early 1976, a new influenza strain (H1N1 “swine flu”) was detected at Fort Dix, New Jersey, raising fears of a 1918-style pandemic.

President Gerald Ford announced a plan to vaccinate every American — about 200 million adults — under what became the National Influenza Immunization Program (NIIP).

Vaccine manufacturers (Merck, Wyeth, Parke-Davis, etc.) agreed to produce the vaccine — but refused to proceed unless they were indemnified against lawsuits.

• The companies told the federal government in March–April 1976 that they would not supply vaccines unless:

• They were protected from liability for adverse reactions (like Guillain-Barré Syndrome, GBS).

• The U.S. government assumed the legal risk and would defend and pay claims.

  Their reasoning:

• The vaccine had to be developed and distributed under extreme speed (months instead of years).

• It was to be given to tens of millions of healthy people, not patients already ill.

• Insurers refused to issue product-liability coverage, citing the massive exposure risk.

• So, without liability protection, all four manufacturers halted production in mid-1976.

To save the national immunization program, Congress passed the Swine Flu Act of 1976 (Public Law 94-380).

Key provisions:

• The U.S. government became the exclusive defendant for all vaccine-related injury and death claims.

• Claims had to be brought against the United States under the Federal Tort Claims Act (FTCA).

• Manufacturers, distributors, and medical personnel were indemnified (immune from direct suit).

• The government would defend and pay judgments or settlements as if it were the manufacturer.

• About 45 million Americans were vaccinated.

• The feared pandemic never occurred, but about 500 cases of Guillain-Barré syndrome (GBS) were reported after vaccination.

• Roughly 4,000 lawsuits were filed against the government.

• The U.S. government paid over $13 million by 1980, and later tens of millions more in settlements and judgments.

• The experience directly influenced the 1986 National Vaccine Injury Compensation Act, which created a permanent no-fault system for vaccine injuries.

Hundreds of adults developed Guillain-Barré Syndrome (GBS) within weeks of vaccination.

The U.S. government paid compensation to hundreds of claimants after scientific panels confirmed a causal connection between the vaccine and GBS.

Around 3,000 claims filed for GBS.

About 400–500 plaintiffs were compensated through settlements or judgments.

Total payouts: roughly $90 million. It is estimated that the initial filings sought over $800 million in damages.

In Gundy v. United States, 728 F.2d 484 (10th Cir. 1984)

Plaintiff developed GBS after swine flu vaccination. Court affirmed that the government was liable under the Swine Flu Act for injuries “proximately caused” by the vaccination. One of several appellate cases confirming the government’s legal responsibility.

In Bean v. United States, 533 F. Supp. 567 (D. Colo. 1980)

GBS following swine flu shot. The court found causation and awarded damages to the plaintiff. Helped set standards for proving vaccine-related GBS causation.

Total Compensation Late 1970s–1980s — approximately $90 million paid. Funded entirely by U.S. Treasury

The 1976 swine flu program became the first major test of federal assumption of vaccine liability, paving the way for the 1986 National Childhood Vaccine Injury Act. And a couple of federal attorneys assigned to prosecute the claims later would be appointed Special Masters in the NVICP.

It also established the precedent that when the government sponsors a public health vaccination campaign, it bears the legal risk if injuries occur.

Next, part 2 of this series: The Act, pre-Bruesewitz and post-Bruesewitz.

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Wayne Rohde, author of 2 books on the National Vaccine Injury Compensation Program and Legal Issues Research Fellow at IPAK-Edu.