Vaccine safety in the news yet again

According to the New England Journal of Medicine on April 21, 2011, vaccine issues and safety is a hot topic once again.

There has always been a concern about the effectiveness of a vaccine versus the risks involved with it. In the early 1980s, lawsuits from adverse reactions to vaccines were on the rise, and manufacturers were getting scared. It actually got to the point that the supply of some essential childhood vaccines was threatened by manufacturers who argued that the cost of persistent lawsuits exceeded the income they could earn from these products. In particular, companies were held responsible for alleged vaccine-related injuries even when scientific evidence did not establish causation. Manufacturers claimed that the threat of such liability made it impossible to obtain liability insurance coverage and therefore to maintain operations.

In response, to the concerns from mounting lawsuits and fears from the manufacturers, Congress enacted the National Childhood Vaccine Injury Act (NCVIA), establishing a no-fault compensation system (“vaccine court”) for children who were harmed by adverse events following vaccine administration, as long as there was evidence that the vaccine actually caused the problem. The system is expert-driven, and there are no jury trials. Compensation covers the costs of medical expenses, projected lost earnings, and up to $250,000 for pain and suffering but does not include punitive damages. It is paid out of taxes levied on each dose of vaccine. Although the NCVIA permits plaintiffs to reject an outcome and file a claim in court, its key preemption provision says that “no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death . . . if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

The article states that controversy over the interpretation of this legislation led to Bruesewitz v. Wyeth. Bruesewitz v. Wyeth is a case stemming from 1992, when 6-month-old Hannah Bruesewitz received a third dose of her diphtheria–tetanus–pertussis (DTP) vaccine with whole-cell pertussis (Tri-Immunol) and had seizures shortly afterward, followed by a residual seizure disorder and developmental delay. In the vaccine court, the case was denied because the Department of Health and Human Services, concluding that there was no medical evidence of a connection, had recently removed residual seizure disorder from the list of adverse events eligible for administrative compensation.

Because it was denied by the “vaccine court” and the Bruesewitz family rejected the judgment, they sued the manufacturer for failing to develop a safer vaccine, in keeping with the original legislature that if they did not agree with the ruling that they would be entitled to seek further court proceedings.

The case made its way all the way to the Supreme Court. And on February 22, 2011, the U.S. Supreme Court ruled in Bruesewitz v. Wyeth that vaccine makers are immune from lawsuits charging that the design of a vaccine is defective. Many physicians and public health organizations applauded this outcome, believing that it will help to ensure the availability and promote the appropriate use of childhood vaccines. Others worry about what it may mean for patients’ rights.


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