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Supreme Court Spotlight: No “Cure” For Injuries Caused by Vaccines?

Theodore Y. Choi, Esq. on 3/9/2011

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The balancing of the need for vaccination to promote public health versus the right of an individual to recover for injuries or death sustained through the use of those vaccines, was the focus in Bruesewitz, et. al. v. Wyeth, Inc., et. al., a recent case heard by the Supreme Court of the United States.  The development of vaccinations through the use of modern technology has changed societal viewpoints regarding the perilous nature of communicable diseases.

The effectiveness of vaccines has in essence become a double edged sword for vaccine manufacturers and the general public.  Through the use of vaccines, the number of reported people with communicable diseases dramatically decreased.  However, as Isaac Newtown’s Third Law of Motion states, “for every action there is an equal and opposite reaction.”  As vaccines became more effective at preventing communicable diseases, the public became much less fearful of those diseases and less concerned with trying to find the most effective cure for an illness.  Rather, the public shifted their attention and concerns to the risk of injury that could come about through the use of the vaccines that were designed to prevent their diseases.  Thus, the amount of tort product liability suits filed against vaccine manufacturers increased over the years.  In turn, the increase in lawsuits incited many manufacturers to close their businesses as the cost to defend against potential tort liability suits exceeded their annual sales.  The remaining vaccine manufacturers were then free to increase the cost of vaccines, thus deterring individuals from opting to pay for a vaccination which again raised public health concerns.

In an effort to alleviate these problems, Congress enacted the National Childhood Vaccine Injury Act of 1986 (“NCVIA”).  The NCVIA established an expedited no-fault compensation system whereby a person claiming that a vaccine has caused injury could file a petition in the United States Court of Federal Claims, naming the Secretary of Health and Human Services as the respondent.  A special master was assigned to review the petition and enter an informal adjudication.  Any objections to the decision rendered by the special master was reviewed by the Court of Federal Claims who then entered a final judgment.  A claimant then had the option to accept the final judgment or seek tort relief from the vaccine manufacturer.

Incorporated within the NCVIA was a Vaccine Injury Table listing compensable injuries sustained through the use of a vaccine.  Injuries that were shown to have met the criteria of a listed vaccine were prima facie entitled to compensation without the need to show causation.  Those side effects which were unlisted could still be entitled to compensation but causation was needed to be proven.  Although the burden of causation rested upon the claimant, the NCVIA did not require proof of a defectively manufactured, labeled or designed vaccine as a pre-requisite to recovery.  Successful claimants received compensation that was paid out of a fund created by an excise tax on each administered vaccine dose.  On the other hand, the NCVIA provided manufacturers immunity from liability arising from suits for failure to warn where all regulatory requirements have been met.  Manufacturers were also not subject to punitive damages and it eliminates liability for damages resulting from a vaccine’s unavoidable, adverse side effect.  Specifically, the NCVIA, codified under 42 U.S.C. § 300aa-22(b)(1), states: “No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, 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.”

Whether an unavoidable, adverse side effect provided tort liability immunity to vaccine manufacturers for claims based upon a defective design claim, was the issue confronted by the Supreme Court in Bruesewitz, et. al. v. Wyeth, Inc., et. al.  The minor complainant in the aforesaid matter received a diphtheria, tetanus, and pertussis (DTP) vaccine and soon after experienced seizures.  The complainant suffered from more than 100 seizures over the next few months.  The complainant was later diagnosed with “residual seizure disorder” and “developmental delay,” both disorders which she will suffer from for the rest of her life.  The parents of the complainant filed a petition alleging that the vaccine manufacturer’s defective design was the cause of their daughter’s disability and that compensation should be awarded based upon the theories of strict liability and negligent design under Pennsylvania common law.  In a 6-2 decision (Justice Kagan did not participate), the Court held that the NCVIA precluded compensation against manufacturers for tort liability resting upon a design defect claim for three (3) reasons and thus state-law design defect claims were preempted.

The Supreme Court first took a textual analysis into the language of the statute and found that the “even though” clause of the statute precluded design defect claims.  So long as there was proper manufacturing and warnings, any side effects were deemed to be unavoidable and thus, manufacturers could not be held liable.  Products liability law allows for claims to be brought upon three (3) grounds: defective manufacture, inadequate directions or warnings, or defective design.  The Supreme Court found that the failure to specifically mention defective design liability within the statute was a deliberate choice by Congress to preclude such claims.

The Supreme Court next delved into the reasons for which Comment “k” of the Restatement (Second) of Torts § 402A does not apply.  The Restatement (Second) of Torts § 402A exempts from strict liability rules “unavoidably unsafe products.”  Cases interpreting Comment “k” to determine situations in which the exemption from strict liability would apply, analyze the term “unavoidably unsafe products” rather than the word “unavoidable” standing alone.  If the NCVIA were meant to incorporate such an exemption, Congress would have utilized conjunctive language rather than use the phrase “even though.”  If Comment “k” were to apply, the entire “even though” clause would be rendered superfluous and meaningless.

Lastly, the Supreme Court found that the failure to mention design defect claims within the text of the NCVIA of the Food and Drug Administration’s regulations denotes the proposition that such claims were not meant to be a basis for liability.  The Court held that the NCVIA’s compensation scheme provides for a mechanism which promotes the very purpose of design defect claims.  In addition, the Court held that the purpose in which the NCVIA was created was to coax manufacturers back into the market in order to produce vaccines at a competitive price.  To hold manufacturers liable for funding the compensation program while leaving no means of protection against design defect claims, would in essence deter manufacturers from re-entering the market and defeat the very purpose for which the NCVIA was created.

In the final analysis, it appears that the Supreme Court attempts to strike a balance in an era where public concern for the health and welfare has come to the forefront in the face of an increasing number of newfound diseases.  Although the Supreme Court held that all defect claims brought under the NCVIA are preempted, a claimant seeking damages for injuries stemming from the use of the vaccines is not without recourse.  A party still has means of recovery through a defective manufacture or inadequate directions or warnings claim.  Even still, any claim must first proceed under the compensation system before any tort relief against a manufacturer may be sought.

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