Product Liability and Vaccines Essay

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Product Liability and Vaccines

This study examines product liability as it relates to vaccine damages. This study investigates such cases and the decisions handed down by the judicial system on the liability of the drug manufacturers in cases where individuals have been harmed by the vaccinations. There are however, statutory protections afford to developers of vaccine immunizations which serve to protect the interest of these companies and as well as special victim compensation provision is made through the United States Secretary of Health and Human Services in the form of compensation for which individuals alleging harm by a vaccine can file to receive compensation for their injuries. Three cases are reviewed with the findings of the court and compensation awarded to the Petitioner in these cases.

Product Liability and Vaccines

Introduction

Biotechnology is reported as a new technology "capable of much good for humankind." (Traynor and Cunningham, 1989, p.1, para.1) However, vaccines are a source of litigation due to the individuals who claim that they have been harmed in some way by receiving the vaccination. Vaccinations are given regularly to infants and children to protect them against catching diseases such as polio, diphtheria, and whooping cough and other childhood diseases. Adults too are given vaccinations to protect them against swine flu and other illnesses. This study investigates such cases and the decisions handed down by the judicial system on the liability of the drug manufacturers in cases where individuals have been harmed by the vaccinations. There are however, statutory protections afford to developers of vaccine immunizations which serve to protect the interest of these companies and as well as special victim compensation provision is made through the United States Secretary of Health and Human Services in the form of compensation for which individuals alleging harm by a vaccine can file to receive compensation for their injuries.

I. Supreme Court of the United States, Russell Brusewitz, et al. v. Wyeth LLC, fka, Wyeth, Inc. fka Wyeth Laboratories, et al.:, No. 09-152: February 22, 2011.

In the first case examined in the study the parents of minor child allege that the child suffered a series of seizures that results in the developmental delay of the child following receipt of a dose of diphtheria-tetanus-pertussis (DTP) vaccine and brought a products liability action against the manufacturer of the vaccine following the United State Court of Federal Claims judgment having been rejected. The motion was granted by the United States District Court for the Eastern District of Pennsylvania. Parents appeal the motion and the United States Court of Appeals of the Third Circuit, Smith, Circuit Judge affirmed. Certiorari was granted. The Supreme Court, specifically, Justice Scalia, states findings that the National Childhood Vaccine Injury Act (NCVIA) "preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects." (Russell Brusewitz, et al. v. Wyeth LLC, fka, Wyeth, Inc. fka Wyeth Laboratories, et al.: Supreme Court of the United States, No. 09-152: February 22, 2011 ) The decision was affirmed with Justice Breyer concurring and Justice Sotomayor and Justice Ginsburg filing dissenting opinions and Justice Kagan taking no part in consideration of decision of the case. The findings in this case are stated to rely in part on the National Childhood Vaccine Injury Act of 1986 § 311(a), 42 U.S.C.A. § 300aa -- 22(b)(2), (c) which holds that vaccine manufacturers are generally immunized from liability from failure to warn if they have complied with all regulatory requirements including, but not limited to, warning requirements, and have given the warning either to the claimant or the claimant's physician. As well this decision is based on the National Childhood Vaccine Injury Act of 1986, § 311(a), 42 U.S.C.A. § 300aa -- 23(d)(2) which holds that under this act that vaccine manufacturers are "immunized for liability for punitive damages absent failure to comply with regulatory requirements, fraud, intentional and wrongful withholding of information, or other criminal and illegal activity." (Russell Brusewitz, et al. v. Wyeth LLC, fka, Wyeth, Inc. fka Wyeth Laboratories, et al.: Supreme Court of the United States, No. 09-152: February 22, 2011)

The National Childhood Vaccine Injury Act of 1986 created a "no-fault compensation program to stabilize and vaccine market adversely affected by an increase in vaccine-related tort litigation and to facilitate compensation to claimants who found pursuing legitimate vaccine-inflicted injuries too costly and difficult." (1070 Syllabus in: Russell Brusewitz, et al. v. Wyeth LLC, fka, Wyeth, Inc. fka Wyeth Laboratories, et al.: Supreme Court of the United States, No.

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09-152: February 22, 2011) The provision of the Act includes that the party that alleges a vaccine-related injury has the option to file a petition for compensation in the Court of Federal Claims in which they are to name the Health and Human Service Secretary as the respondent stating that the case must be resolved by the court within a specific deadline at which time the claimant can make the decision as to whether the judgment of the court is to be accepted or rejected and tort relief sought from the manufacturer of the vaccine. Awards, if any, are reported to be made available from a fund that is created through an excise tax on each does of a vaccine. The manufacturer liability is eliminated due to unavoidable and adverse effects of a vaccine and as well manufacturers are reported to "enjoy significant tort-liability protections" under this act. Section 300aa -- 22(b)(1) of the Act indicates that a vaccine's design "is not open to question in a tort action." ((Russell Brusewitz, et al. v. 09-152: February 22, 2011)

II. United States Court of Federal Claims, Corkern v. Secretary of Dept. Of Health and Human Services. September 9, 2011.

This case of Corkern v. Secretary of Dept. Of Health and Human Services, United States Court of Federal Claims, Office of the Special Masters, No. 08-651 V, involves a case where the petitioner filed a petition for vaccine compensation under the National Vaccine Injury Compensation Program 42 U.S.C. § 300aa -- 10 to 34 also known as the 'Vaccine Program'. The petitioner seeks compensation for injuries alleged in regards to the petitioner receipt of the Human Papillomavirus ("HPV") vaccines which is included in the Vaccine Injury Table located at 42 C.F.R. § 100.3(a). Facts of the case include that the petitioner was in receipt of the HPV immunizations twice in 2007, first on July 25, 2007 and then on September 24, 2007. Petitioner alleges that she developed transverse myelitis ("TM") due to her receipt of the HPV vaccinations and Petitioner claims having experienced residual effects of this injury for more than six months. There has been no prior award or settlement on any civil action in regards to damages sustained by the Petitioner from the receipt of the HPV vaccine due to her resulting condition. The Respondent in this case denied that transverse myelitis was developed by petitioner due to the receipt of the HPV vaccination and further denies that the petitioner has experienced residual effects of the injury alleged by the Petitioner for more than six months. With that stated that parties nevertheless came to an agreement that the issues would be settled between them and that a decision would be entered awarding the Petitioner compensation stated in paragraph 8 of the Stipulation. The Stipulation to the agreement in this case states as follows:

"8. As soon as practicable after an entry of judgment reflecting a decision consistent with the terms of this Stipulation, and after petitioner has filed an election to receive compensation pursuant to 42 U.S.C. § 300aa -- 21(a)(1), the Secretary of Health and Human Services will issue the following vaccine compensation payment: A lump sum of $150,000.00 in the form of a check payable to petitioner. This amount represents compensation for all damages that would be available under 42 U.S.C. § 300aa -- 15(a)" (Corkern v. Secretary of Dept. Of Health and Human Services. September 9, 2011; United States Court of Federal Claims)

Attorney fees were awarded in this case and the Petitioner was required to stipulate as follows:

"13. In return for the payments described in paragraphs 8 and 9, petitioner, in her individual capacity and on behalf of herself, and her heirs, executors, administrators, successors or assigns, does forever irrevocably and unconditionally release, acquit and discharge the United States and the Secretary of Health and Human Services from any and all actions or causes of action (including agreements, judgments, claims, damages, loss of services, expenses and all demands of whatever kind or nature) that have been brought, could have been brought, or could be timely brought in the Court of Federal Claims, under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa -- 10 et seq., on account of, or in any way growing out of, any and all known or unknown, suspected or unsuspected personal injuries to or death of petitioner resulting….....

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