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Militrano v. Lederle Laboratories11/3/2003
6 - Geier, Affidavit, exhibit 8). A May 1996 article, which notes that the whole cell vaccine is generally safe and effective, states that " ecommendations for the use of the DTaP for primary immunizations in children younger than 15 months await results from ongoing efficacy trials in Europe and elsewhere" (see Rosenthal, The Safety of Acellular Pertussis Vaccine vs Whole-Cell Pertussis Vaccine, 150 Arch Pediatr. Adolesc. Med. 457 - Geier, Affidavit, exhibit 42). Indeed, a 2001 article submitted by plaintiff notes that the merits of the new acellular vaccine with respect to potency is still a subject of debate (see Donnelly, Whole-Cell but Not Acellular Pertussis Vaccines Induce Convulsive Activity in Mice: Evidence of a Role for Toxin-Induced Interleukin-1รก in a New Murine Model for Analysis of Neuronal Side Effects of Vaccination, 69 Infec Immun 4217 - Geier, Affidavit, exhibit 36). Thus, many of the reports and article's relied upon by Dr. Geier cut against his unsubstantiated assertion that Lederle could have obtained FDA approval for an acellular vaccine with data available in 1990.
In sum, Dr. Geier's conclusory and scattershot affidavit, which is undermined by many of the materials submitted in support of it, fails to demonstrate that a viable alternative to the whole cell pertussis component of the DTP-Hib vaccine could have been marketed at the time the vaccine was administered to the plaintiff here. While the FDA is a passive agency that decides whether or not to approve vaccine designs when a manufacturer submits a proposal (see Hurley v Lederle Laboraties, 863 F2d 1173, 1177), the record demonstrates that the FDA and the scientific community in this country had concerns regarding the efficacy of the acellular vaccine that precluded its earlier approval. While each case must rest upon the facts before the court, this conclusion is also supported by a majority of the decisions that have considered the availability of the acellular vaccine when faced with a similar evidentiary record (see Ackley, 919 F2d 397; Miller, 1995 WL 579969; Pease, 795 FSupp 755; Jones v Lederle Labs., 785 FSupp 1123, 1127 [EDNY][in granting defendants judgment as a matter of law, the court stated that "even today (1992), years of further development and testing will be required for a more advanced vaccine for two-month-old infants will be available in this country"], affd 982 F2d 63, 63-64; Koehler v Wyeth Labs., 1987 WL 47831 [US Dist Ct, SDInd]; White, 40 OhioSt3d at 396, 533 NE2d at 753; but see Graham,666 FSupp at 1497, affd in part and reversed on other grounds 906 F2d 1399; Foyle v Lederle Labs., 674 FSupp 530 [EDNC]). In the absence of a viable alternative to the whole cell vaccine, plaintiff's strict liability design defect claim must fail because the whole cell pertussis vaccine is not an unreasonably dangerous product (see Felix v Akzo Nobel Coatings, 262 AD2d 447, 448; Jones, 785 FSupp at 1127) and if it must be so deemed, it is an unavoidably unsafe product for purposes of 42 USC 300aa-22 (b) (1) and Comment k under New York law.
One final observation is warranted concerning plaintiff's argument that a safer drug could have been designed and approved by the FDA. According to section 6(c) of the Restatement (Third) of Torts, a plaintiff may not prove defectiveness by showing that the defendant manufacturer could have designed and marketed a safer prescription product that has not received FDA approval and is therefore not on the market. As explained by the former reporters of the American Law Institute's Restatement Third:
Such refusal rests not on deference to the FDA but on an understandable reluctance to allow courts to determine whether a proposed alternative drug would have receive
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