The Scientist Magazine: Litigation Could Make Vaccines Extinct

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- Deborah A Delp

The Scientist Magazine: Litigation Could Make Vaccines Extinct

Litigation Could Make Vaccines Extinct Congress must act--it has the legislative model in hand | By James M. Wood Brad Fitzpatrick Vaccines have eradicated some killer diseases and protected against others.But they face eradication themselves--by litigation. As the United Statesrushes to defend itself against bioterrorism by developing vaccines againstbiological agents, Congress must pass legislation to ensure that vaccinesthemselves do not become extinct. All vaccines carry risks, including side effects such as encephalitis. Forexample, severe allergic reactions, such as breathing problems and shock,can occur in less than one in a million doses of diphtheria, tetanus andpertussis vaccine.1 Almost all US children enjoy the health benefit fromimmunization, but a tiny proportion, despite efforts to make the vaccinesafe, have severe side effects. Before Congress acted in 1986, thesechildren often had no financial recourse2 for their medical andrehabilitative needs other than the tort system. The result was a dwindling supply of vaccines and an increased cost ofinoculations. Case in point: The 1994 Nevada case of Allison v. Merck, inwhich the DPT vaccine became the object of personal injury litigation. In this case, the Nevada State Supreme Court held that any product,including a vaccine, is defective when it fails to perform in a reasonablyexpected manner. In holding Merck responsible for the disclosed adversereaction of encephalitis, the Court reasoned that the DPT vaccine's intendedfunction was to immunize a child without causing this side effect. Becausethe vaccine may have resulted in this side effect and its sequellae, theCourt concluded that it was defective. Even before Allison, similar litigation had resulted in reducing the DPTvaccine supply; by 1986, only two companies produced it. Overall, the numberof vaccine producers has dropped, from 25 in the 1970s to five today.3Litigation continues against manufacturers of polio vaccine (in asbestoslitigation) and of DPT (claiming that the vaccine's preservative, thimerosalcauses autism). Unless checked, the threat of litigation againstunavoidable, yet rare, reactions to vaccines designed to protect against andto treat viruses and bacteria used by terrorists might have the same effect.Congress adopted liability protection as part of the 2002 Safety Act toprotect those who develop counter-bioterrorism measures. But, it didn't gofar enough to ensure that companies don't abandon the opportunity tomanufacture vaccines because of the real ongoing threat of litigation. There is a model. In 1986, Congress passed the National Childhood VaccineInjury Act, recognizing the importance of inoculations and the deleterioushealth consequences of litigation. The act mandates, among other things,that health providers report adverse reactions to the federal government,and that injured children are entitled to "no-fault compensation." The legislators determined that: The availability and use of vaccines to prevent childhood diseases is a toppublic health priority; The Federal government should make immunization available to all children;injured youngsters should have access to sufficient compensation; Private or nongovernmental activities have proven inadequate in achievingeither of the above goals; Economic conditions have resulted in an unstable and unpredictable childhoodvaccine market, making the threat of vaccine shortages a real possibility. Substitute "children" for today's "national population" and these policiesare as relevant today as they were in the 1980s. The following features of the Vaccine Act could be a model for an amendedSafety Act: Claims are filed with the US Court of Federal Claims; The injury must be one that is recognized as an adverse reaction to thespecific vaccine within identified time frames as established by a VaccineInjury Table; Proof of the vaccination must be offered within the time periods specified; If these are satisfied, then it's presumed that the vaccine caused theinjury; if not, the individual must prove that the vaccine caused thespecific harm; A special master determines the compensation amount that would include, at acap of $250,000, prior reimbursements as well as future medical expenses,lost earnings, damages for pain and suffering, and reasonable attorneys'fees and costs. If the patient has died, the cap is set at $250,000, andpunitive damages cannot be recovered. Taxes collected from vaccine saleswould pay for the plan. A possible additional source of funding: taxing the 25% to 40% contingencyfees recovered by plaintiffs' attorneys who continue to sue the vaccineindustry. -- To : To : All Website and e-mail design, text, graphics, the selection and arrangement thereof, is 2003. AutismLink.com. ALL RIGHTS RESERVED. Permission must be granted in writing to electronically copy and/or print in hard copy portions of this Website. Any other use of materials on this Web site -- including reproduction for purposes without consent, modification, distribution, or republication--without the prior written permission of AutismLink.com is strictly prohibited.