Immunizing the Manufacturer

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Q: When my son was six months old, his pediatrician administered doses of the diphtheria-tetanus-pertussis (DTP) vaccine, according to normal recommended childhood immunization schedule.  Within 24 hours, my son started to experience seizures.  He suffered over 100 seizures during the next month.  To this day, he suffers from what the doctors call residual seizure disorder and developmental delay.

A: At first blush, one might think (1) that any drug manufacturer is subject to a legal duty to improve the designs of its drugs in light of advances in science and technology and (2) that that duty would be enforceable through a traditional state-law tort action for defective design.  But the federal Vaccine Act is considered to pre-empt all such claims for injuries stemming from vaccines covered under the Act.

The law is essentially that Congress intended to remove issues concerning the design of FDA-licensed vaccines from the tort system – leaving complex judgments about vaccine design to the FDA and to the National Vaccine Program.

The Act establishes a no-fault compensation program.  A person injured by a vaccine, or his legal guardian, may file a petition for compensation in the United States Court of Federal Claims.  Then you can either accept the court’s judgment and forgo a traditional tort suit for damages, or reject the judgment and seek narrowly circumscribed tort relief from the vaccine manufacturer.

In this circumscribed tort relief, a manufacturer is generally immunized from liability for failure to warn if it has complied with all regulatory requirements (including but not limited to warning requirements) and has given the various warnings to the claimant’s physician.  The manufacturer is generally immunized from liability for punitive damages.

Importantly, the Act expressly eliminates liability for a vaccine’s ‘unavoidable’ adverse side effects.  Under current interpretation – provided that there was proper manufacture and warning – any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable.

By: Scott Baron,
Attorney at Law Advertorial

The law responds to changed conditions; exceptions and variations abound. Here, the information is general; always seek out competent counsel. This article shall not be construed as legal advice.

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