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Militrano v. Lederle Laboratories

11/3/2003

This opinion is uncorrected and subject to revision before publication in the printed Official Reports.


The following papers numbered 1 to 4 read on this motion: Papers Numbered


Notice of Motion/Order to Show Cause, Affidavits (Affirmations)& Exhibits Annexed 1


Answering Affidavit (Affirmation) 3


Reply Affidavit (Affirmation) 4 Affidavit (Affirmations) 2


In this action, it is alleged that plaintiff, Bruce Militrano, was injured when a vaccine, manufactured by defendant Lederle Laboratories ("Lederle"), was administered to him by his doctor in 1994. At its core, it is plaintiff's principle contention that, although all vaccines may contain certain health risks, Lederle could have developed a safer vaccine - a vaccine that allegedly could have been approved by the Food and Drug Administration ("FDA") and that could have avoided the injury suffered by plaintiff. Lederle, on the other hand, asserts, inter alia, that this action is barred by the National Childhood Vaccine Injury Act of 1986 ("the Act"), which, as will be discussed, is a no-fault system established to provide recompense for children injured by vaccines. Moreover, it asserts that plaintiff's injuries were the result of unavoidable side effects of a product necessary to prevent pertussis, commonly referred to as whooping cough, and that it provided adequate warnings for the relevant risks. For the reasons that follow, I conclude that this action, to the extent it asserts a claim premised upon an alleged design defect, is barred by the Act and must be dismissed. As to those claims not barred by the Act, dismissal is also warranted.


Plaintiff received his first diphtheria, tetanus, pertussis (DTP) and Haemophilus b conjugate (Hib) vaccinations on January 11, 1994, when he was five weeks old, and his second vaccination, in the form of the combined DTP-Hib vaccination, on March 7, 1994. At that time, plaintiff did not demonstrate any adverse reactions following the first two administrations of the DTP vaccinations. However, following the third vaccination, on August 18, 1994, it is alleged that he suffered injuries causally related to the vaccine.


On April 23, 1996, plaintiff's mother filed a petition on his behalf in the United States Court of Federal Claims seeking compensation under the National Childhood Vaccine Injury Act of 1986 (see 42 USC §§ 300aa-1 through 300aa-34) for the injuries he allegedly suffered as a result of the August 18, 1994 administration of the DTP-Hib vaccination, one of the vaccines covered by the Act (42 USC § 300aa-14; 42 CFR § 100.3). As he was entitled to do under the Act (see 42 USC § 300aa-21 ), plaintiff elected to reject the award given by the special master in the Court of Federal Claims and pursue civil litigation. Plaintiff commenced this action in May 2001 and has pled causes of action with respect to Lederle premised on: (1) strict products liability; (2) negligence in the research, development, manufacturing, and imparting of warnings; and (3) breach of implied and express warranties.


Determination of Lederle's motion requires some historical background. Pertussis, commonly referred to as whooping cough, is a serious childhood disease and was, at one time, one of the leading causes of death in children in this country. In 1934, this country suffered its worst pertussis epidemic. That year there were 265,000 reported cases and 7,500 pertussis related deaths. By the early 1940's, pertussis was responsible for 2 ½ times the number of deaths of all the following diseases combined: measles, mumps, rubella, diphtheria, polio, meningitis, chicken pox, and scarlet fever (see Graham v Wyeth Laboratories, 906 F2d 1399

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