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09-152 BRUESEWITZ V. WYETH DECISION BELOW: 561 F.3d 233 CHIEF JUSTICE ROBERTS TOOK NO PART; HEARD ARGUMENT<br /> JUSTICE KAGAN TOOK NO PART CERT. GRANTED 3/8/2010 QUESTION PRESENTED: Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 ["the Act"] expressly preempts certain design defect claims against vaccine manufacturers "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." 42 U.S.C. § 300aa-22(b)(1). A-104. The Question Presented 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) preempts all vaccine design defect claims, whether the vaccine's side effects were unavoidable or not?¹ ¹ Whether Section 22(b)(1) of the Act encompasses both negligent and strict liability design defect claims is not at issue in this petition. Both the Ferrari court and the court below found that it encompasses both claims. See A-35; Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236, 242 (Ga. 2008). ^ LOWER COURT CASE NUMBER: 07-3794
In the 2010 case of Russel Bruesewitz et al. v. Wyeth LLC, the U.S Supreme Court ruled in favor of Wyeth, a pharmaceutical company now owned by Pfizer Inc., stating that vaccine manufacturers cannot be sued under state law for damages caused by side effects from vaccines. The parents of Hannah Bruesewitz alleged that their daughter developed seizures and developmental problems after receiving a diphtheria-tetanus-pertussis (DTP) vaccine made by Lederle Laboratories (now part of Wyeth). They sought compensation through the National Vaccine Injury Compensation Program but were denied as it was determined her condition wasn't on the list of compensable injuries. They then filed a lawsuit against Wyeth under Pennsylvania law alleging design defect among other claims which led to this Supreme Court hearing. In its decision, Justice Antonin Scalia wrote for the majority opinion saying federal law preempted all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccines' unavoidable side effects.
In the dissenting opinion for Bruesewitz v. Wyeth, Justice Sonia Sotomayor, joined by Justice Ruth Bader Ginsburg, argued that the majority misinterpreted the National Childhood Vaccine Injury Act of 1986 (NCVIA). They contended that Congress intended to leave a role for traditional tort litigation in prompting vaccine safety improvements. The dissent disagreed with the majority's interpretation of "unavoidable" and believed it should be read as vaccines being unavoidably unsafe despite proper manufacturing and labeling. This would allow lawsuits claiming design defects against vaccine manufacturers if plaintiffs could show there was a safer alternative design available. Furthermore, they criticized the majority’s reliance on legislative history arguing it was inconsistent and unreliable while ignoring other parts of NCVIA which suggest an intent to preserve some manufacturer liability under state law.