Oral Argument: Oct. 12, 2010

Appealed From: United States Court of Appeals for the Third Circuit (Mar. 8, 2010)

NATIONAL CHILDHOOD VACCINE INJURY ACT, PREEMPTION, TORT LAW, PERTUSSIS, DTP, DTaP

After their daughter suffered severe health problems following a routine vaccination for diphtheria-tetanus-pertussis ("DTP"), Russell and Robalee Bruesewitz sued Wyeth, Inc., the manufacturer of the vaccine, alleging that Wyeth's DTP vaccine was outmoded and inadequately designed. In response, Wyeth argued that Section 22(b)(1) of the National Childhood Vaccine Injury Act ("NCVIA") exempted vaccine manufacturers from all design-defect claims, including the one asserted by the Bruesewitz family. The Third Circuit Court of Appeals agreed with Wyeth and dismissed the claim. The Supreme Court must now determine whether to sustain the categorical preclusion of all design-defect claims advanced against vaccine manufacturers, or whether to expose vaccine manufacturers to potential design-based litigation. This decision will affect the right of vaccine victims to seek compensation for their injuries and the ability of vaccine manufacturers to avoid costly litigation that may drive them out of the vaccine market.

Question presented

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?

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Issue

Whether 42 U.S.C. § 300aa-22(b)(1) of the National Childhood Vaccine Injury Act provides a blanket immunity to vaccine manufacturers from tort actions filed in state or federal court by injured victims seeking compensation for injuries allegedly arising from defectively designed vaccines.

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Facts

This case turns on the Supreme Court's interpretation of the word "unavoidable" as it is used in 42 U.S.C. § 300aa-22(b)(1) of the National Childhood Vaccine Injury Act ("NCVIA"). See Bruesewitz v. Wyeth Inc., 561 F.3d 233, 245 (3d Cir. 2009). The plaintiffs, Russell and Robalee Bruesewitz ("the Bruesewitzes") claim that, among other factors, poor design of the vaccine TRI-IMMUNOL ("DTP") by vaccine manufacturer Wyeth, Inc. ("Wyeth") caused an injury to their daughter, Hannah Bruesewitz ("Hannah"). See id. at 237.

Hannah was six months old when she received her third scheduled injection of DTP on April 1, 1992. See Bruesewitz, 561 F.3d at 236. Shortly after the injection, Hannah began experiencing seizures. See id. The seizures persisted and the Bruesewitzes counted 126 seizures over a sixteen-day period. See Brief for Petitioners, Russell Bruesewitz and Robalee Bruesewitz at 19–20. Eventually, these seizures left Hannah lethargic, developmentally stunted, and displaying autistic-like symptoms. See id. at 20. In 2003, doctors diagnosed Hannah with a residual seizure disorder and encephalopathy. See id. Because of these conditions, Hannah will likely require lifelong medical care. See Bruesewitz, 561 F.3d at 236.

Despite the success of DTP in reducing pertussis (or "whooping cough") infections, the Bruesewitzes contend that Wyeth and other medical professionals and organizations were aware of several adverse effects associated with the vaccine. See Bruesewitz, 561 F.3d at 236. In fact, Hannah's injection was drawn from a vaccine lot that had over sixty-five complaints of adverse reactions filed with the Food and Drug Administration ("FDA") and the Center for Disease Control and Prevention ("CDC"). See id. Of these, thirty-nine resulted in emergency room visits, six in hospitalizations, and two in death. See id. In retrospect, Hannah's physician insists that had she been aware of the incidents associated with this lot, she would not have administered the vaccine. See id.

The Bruesewitzes contend that Hannah's injuries could have been avoided had Wyeth used an alternate design called ACEL-IMUNE ("DTaP"). See Bruesewitz, 561 F.3d at 236. However, though the FDA approved DTaP in 1991, the approval extended to only the fourth and fifth injections following three scheduled injections of the DTP formula. See id. It was not until 1996 that the FDA licensed DTaP for all five injections. See id. at 237. Wyeth ceased distribution of DTP in 1998. See id.

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