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Vaccine design claims-Bruesewitz v. Wyeth, SCT

From the Supreme Court’s webpage: Arguments Transcripts, for Bruesewitz v. Wyeth, Inc. 09-152 argued 10/12/10 (1), the case involves a vaccine designed in the 1940s that was administered to a child in 1992, some 30 years after scientist discovered a safer way to design the pertussis component of the DTP. Side effects of the administered vaccine allegedly caused injury to the child. The question presented in this SCT case (2)

is whether the Third Circuit erred in holding that, contrary to its plain text and the decisions of this Court and others, Section 22 (b) (1) [of National Childhood Vaccine Injury Act] preempts all vaccine design claims, whether the vaccine’s side effects were unavoidable or not? Whether Sec 22 (b) (1) of the Act encompasses both negligent and strict liability design defect claims is not at issue in this petition both the Ferrai and the court below found that it encompasses both these claims.
Justice Breyer refers to the Brief by the American Academy of Pediatrics and 21 other physician and public health orgs. who argue that
if [petitioner] wins, we’re turning this over to judges and juries instead of the FDA and the specialized agencies, that the result could well be driving certain vaccines from the market, and basically, a lot of children will die.(1)
Of related interest, read about the vaccine adverse reporting program (VAERS) created as an outgrowth of NCVIA. VAERS is administered by FDA and CDC and is a valuable tool for post-marketing safety surveillance.(6) FDA FAQs indicate that adverse event reporting is required of health care providers and licensed vaccine manufacturers. They also note that protecting a child through immunization is a parent's decision, taken in discussion with their doctor. The Federal Government may recommend that States develop laws or requirements for vaccines, but whether the State includes a given vaccine in its regulations and how informed consent is to be obtained are State decisions.
(1)http://www.supremecourt.gov/oral_arguments/argument_transcripts.aspx (72 pp)
(2) http://www.supremecourt.gov/Search.aspx?FileName=/docketfiles/09-152.htmhttp://www.supremecourt.gov/qp/09-00152qp.pdf
(3)http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/VaccineAdverseEvents/Overview/default.htmhttp://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm133806.htm


-Congress enacted NCVIA in 1986 and1987 against a long tradition of state –law design-defect claims against manufacturers for vaccines’ injurious side effects.
-The principle of the referenced as comment k the Restatement (Second) of Torts section 402A(1965) is that socially beneficial products that nonetheless have these adverse effects ought to be on the market and we ought not allow tort law to push them off the market.
-http://www.cdc.gov/mmwr/preview/mmwrhtml/00056803.htm FDA references this 1st article (1999) in a series on 10 great achievements in public health in the 20th century that highlighted the impact of vaccines universally recommended for children (Morbidity and Mortality Weekly Report; CDC 1999;48:243-48).

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This page contains a single entry from the blog posted on October 19, 2010 3:28 PM.

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