The Scientist Magazine: Litigation Could Make Vaccines Extinct

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Subject: The Scientist Magazine: Litigation Could Make Vaccines Extinct

Litigation Could Make Vaccines Extinct

Congress must act--it has the legislative model in hand | By M. Wood

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 and

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 than 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 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 , 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 amount 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.