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Vaccine Lawsuits: Balancing Consumer Protection with Public Health

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Vaccine Lawsuits: Balancing Consumer Protection with Public Health

Controversy surrounding vaccines pre-dates Jenny McCarthy and even the 1998 study by Andrew Wakefield. Injuries arose since the beginning of their use. Before the passage of the U.S. Biologics Control Act of 1902, those injured had little recourse to collect damages.

Vaccine injuries are unique in that they are very rare but can also be quite serious. Life-threatening allergic reactions, seizures, brain disorders, and death can lead to large awards for suffering plaintiffs and their family members. These awards chill vaccine manufacturing and delay development of safer and more effective vaccines.

However, the recent rise of epidemics once thought eliminated proves vaccines are vital to protecting public health. Not only do vaccines need to be available and in adequate supply but vaccine research must continue without the threat of one large lawsuit derailing the effort. Through its National Vaccine Injury Compensation Program (VICP), the U.S. Department of Health Resources and Services Administration manages claims, tracks data, and compensates victims without risking financial ruin to manufacturers of vaccines. This encourages development but also benefits consumers.

The Development of a “Vaccine Court”

The Cutter Incident established standing for future vaccine lawsuits. In 1955, 200 people contracted polio and suffered paralysis or death from the Salk polio vaccine. The deaths and injuries were due to a manufacturing error resulting in vaccines containing active polio viruses, which violated federal standards. Families filed lawsuits and most were settled out-of-court, resulting in no immediate legal precedent.

One case heard by the District Court of Appeal of California did establish a precedent for future vaccine lawsuits. In Gottsdanger v. Cutter Laboratories, the appellate court upheld a trial court verdict in favor of plaintiffs. Using a breach of implied warranty theory, the jury awarded verdicts of $139,000.00 to two children and $8,300.00 to their parents. This established using breach of implied warranty for damages sought from vaccine safety issues.

Lawsuits filed in the 1970’s and 1980’s concerned the combined diphtheria-pertussis-tetanus (DPT) vaccines. In Toner v. Lederle, a jury verdict awarded $1,131,200.00 to Plaintiffs against manufacturer Lederle, based on the theory that Lederle could have manufactured a safer vaccine but chose to distribute the dangerous version. That same year, 1984, a jury awarded $2 million in compensatory damages and $8 million in punitive damages after parents were not informed that the Salk polio vaccine was safer than the administered vaccine, the Sabin vaccine. This large verdict was overturned but manufacturers were now gun-shy with vaccines due to potential liability. DPT vaccines decreased in supply and increased in price from $0.11 to $11.40 by 1986. (See excerpt from Lawyers, Lawsuits and Legal Rights: The Battle over Litigation in American Society here.) In 1957, there were 26 vaccine manufacturers but after the mid-1980’s lawsuits, that number decreased to four.

The vaccine market was becoming precarious and to counter the impacts to public health, Congress passed the National Childhood Vaccine Act in 1986. Containing laws related to informed consent and adverse reaction reporting, the Act also established new programs. The Vaccine Adverse Event Reporting System (VAERS) tracked vaccine reactions and the VICP soon followed. Using a tax of $0.75 per vaccine dose, the VICP set up a fund to compensate injury victims and set up a specialized court in the U.S. Court of Federal Claims to process vaccination injury cases.

This system intends to serve both manufacturers and injury victims. Plaintiffs with a meritorious claim for vaccine injury can receive compensation and manufacturers do not have to expend resources for this compensation. This allows the manufacturers to continue researching, developing, and distributing vaccines without fear of financial impacts which stabilizes supply and encourages better vaccines.

Vaccine Injuries Compensated

Side effects from vaccines are usually very mild and include swelling at the injection site or muscle soreness. Serious side effects can include anaphylaxis, encephalitis, chronic arthritis, and even development of the disease the vaccine was meant to prevent. Depending on the vaccine, these side effects are actionable in Vaccine Court if they arise within four hours to 30 days after administration of the vaccine.

Autism is the center of the current vaccine controversy. The case of Ryan Mojabi became a flagship case for anti-vaccination movements and the alleged link between vaccines and autism. Ryan Mojabi developed encephalitis within fifteen days after receiving the MMR (measles-mumps-rubella) vaccination. His earliest records indicated that the high fever, skin rash, tremors and lethargy were likely due to an adverse reaction to the vaccine. He was later diagnosed with autism. The court considered the encephalitis a “compensable injury” but did not advance a direct link to the vaccine and autism. (The written opinion is no longer available online and this case is vulnerable to unbalanced reporting. However, government statements regarding the lack of an established link in the final verdict were represented here and also here.) He was reportedly awarded a verdict in the millions.

However, autism is not included in the injury table for vaccine injuries. The court ran test cases, and even awarded damages when it was determined the plaintiffs suffered an encephalopathy (brain damage) that may have lead to the development of autism. While the anti-vaccination movement considers these cases substantive in establishing a link, the reality is the court never ruled such a conclusion. Current studiescontinue to dispute the link and Vaccine Court is a no-fault claim processing court and not a scientific body.

Other brain injury cases were filed and compensated. In one unpublished but reported verdict, an anonymous New Jersey patient whose development stopped at two months old received a $4.7 million settlement from the VICP. The child developed symptoms within 11 hours after a DTP vaccine. She became lethargic, silent, and experienced difficulty breathing. Due to the time passed from vaccine and symptoms, the court determined the patient’s condition was possibly linked to the vaccine.

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