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Litigation Could Make Vaccines Extinct

it has the legislative model in hand

By | January 19, 2004

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Brad Fitzpatrick

Vaccines have eradicated some killer diseases and protected against others. But they face eradication themselves – by litigation. As the United States rushes to defend itself against bioterrorism by developing vaccines against biological agents, Congress must pass legislation to ensure that vaccines themselves do not become extinct.

All vaccines carry risks, including side effects such as encephalitis. For example, severe allergic reactions, such as breathing problems and shock, can occur in less than one in a million doses of diphtheria, tetanus pertussis vaccine.1 Almost all US children enjoy the health benefit from immunization, but a tiny proportion, despite efforts to make the vaccine safe, have severe side effects. Before Congress acted in 1986, these children often had no financial recourse2 for their medical and rehabilitative needs other the tort system.

The result was a dwindling supply of vaccines and an increased cost of inoculations. Case in point: The 1994 Nevada case of Allison v. Merck, in which 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 reasonably expected manner. In holding Merck responsible for the disclosed adverse reaction of encephalitis, the Court reasoned that the DPT vaccine's intended function was to immunize a child without causing this side effect. Because the vaccine may have resulted in this side effect and its sequellae, the Court concluded that it was defective.

Even before Allison, similar litigation had resulted in reducing the DPT vaccine supply; by 1986, only two companies produced it. Overall, the number of vaccine producers has dropped, from 25 in the 1970s to five today.3 Litigation continues against manufacturers of polio vaccine (in asbestos litigation) and of DPT (claiming that the vaccine's preservative, thimerosal, causes autism). Unless checked, the threat of litigation against unavoidable, yet rare, reactions to vaccines designed to protect against and to treat viruses and bacteria used by terrorists might have the same effect.

Congress adopted liability protection as part of the 2002 Safety Act to protect those who develop counter-bioterrorism measures. But, it didn't go far enough to ensure that companies don't abandon the opportunity to manufacture vaccines because of the real ongoing threat of litigation.

There is a model. In 1986, Congress passed the National Childhood Vaccine Injury Act, recognizing the importance of inoculations and the deleterious health 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 top public 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 achieving either of the above goals;

• Economic conditions have resulted in an unstable and unpredictable childhood vaccine market, making the threat of vaccine shortages a real possibility.

Substitute "children" for today's "national population" and these policies are as relevant today as they were in the 1980s.

The following features of the Vaccine Act could be a model for an amended Safety Act:

• Claims are filed with the US Court of Federal Claims;

• The injury must be one that is recognized as an adverse reaction to the specific vaccine within identified time frames as established by a Vaccine Injury 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 the injury; if not, the individual must prove that the vaccine caused the specific harm;

• A special master determines the compensation that would include, at a cap 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, and punitive damages cannot be recovered. Taxes collected from vaccine sales would pay for the plan.

A possible additional source of funding: taxing the 25% to 40% contingency fees recovered by plaintiffs' attorneys who continue to sue the vaccine industry.

James M. Wood, a partner in the law firm of Reed Smith Crosby Heafey, is based in Oakland, Calif. He focuses on product liability cases, with a special emphasis on representing manufacturers of pharmaceuticals, vaccines, and medical devices.

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