Bruesewitz v. Wyeth Inc.

• Decision Date: 27 March 2009
• Docket Number: No. 07-3794.,07-3794.
• Citation: 561 F.3d 233
• Parties: Russell BRUESEWITZ; Robalee Bruesewitz, parents and natural guardians of Hannah Bruesewitz, a minor child and in their own right, Appellants v. WYETH INC. f/k/a Wyeth Laboratories, Wyeth-Ayerst Laboratories, Wyeth Lederle, Wyeth Lederle Vaccines, and Lederle Laboratories.
• Court: U.S. Court of Appeals — Third Circuit

561 F.3d 233

Russell BRUESEWITZ; Robalee Bruesewitz, parents and natural guardians of Hannah Bruesewitz, a minor child and in their own right, Appellants v. WYETH INC. f/k/a Wyeth Laboratories, Wyeth-Ayerst Laboratories, Wyeth Lederle, Wyeth Lederle Vaccines, and Lederle Laboratories.

No. 07-3794.

United States Court of Appeals, Third Circuit.

Argued September 11, 2008.

Filed March 27, 2009.

Collyn A. Peddie (Argued), Williams, Kherkher, Hart & Boundas, Houston, TX, for Appellant.

Reetu Dandora, Philadelphia, PA, Lauren Elliott, Richard W. Mark (Argued), Daniel J. Thomasch, Orrick, Herrington & Sutcliffe, New York, NY, Henry F. Reichner, Michael T. Scott, Reed Smith, Philadelphia, PA, for Appellee.

Before: McKEE, SMITH, and WEIS, Circuit Judges.

OPINION

SMITH, Circuit Judge.

This appeal presents three questions related to the National Childhood Vaccine Injury Act: (1) whether the Act preempts all design defect claims against the manufacturer of a vaccine; (2) whether the plaintiffs demonstrated that the manufacturer failed to adequately warn the plaintiffs of the risks associated with the vaccine; and (3) whether the plaintiffs provided sufficient evidence of a manufacturing defect to survive the defendant's motion for summary judgment. The District Court held that the Act preempted all design defect claims and concluded that the plaintiffs failed to provide sufficient evidence to support the other two claims. For the reasons that follow, we will affirm.

I.

A.

Historically, the states have possessed "great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet" of their citizens. Metro. Life Ins. Co. v. Massachusetts, 471 U.S. 724, 756, 105 S.Ct. 2380, 85 L.Ed.2d 728 (1985). This has been true with regard to drugs, as the Supreme Court has declared it "well settled that the State has broad police powers in regulating the administration of drugs by the health professions." Whalen v. Roe, 429 U.S. 589, 603, 97 S.Ct. 869, 51 L.Ed.2d 64 (1977). And the police powers extend to immunization, as state and local authorities have responded to illnesses like smallpox and sought to inoculate members of the populous. Center for Biologics Evaluation and Research, Food and Drug Administration, Science and the Regulation of Biological Products: From a Rich History to a Challenging Future 8 (2002). Despite calls in the late nineteenth-century for the federal regulation of vaccines to promote uniform safety regulations, Congress did not act until 1902, when thirteen children died after being vaccinated with contaminated diphtheria antitoxin. Id. at 12. Over the past century, however, the federal government has taken a predominate role in approving, regulating, and promoting vaccines—from the passage of the Biologics Control Act in 1902, Pub.L. No. 57-244, which authorized a federal agency to issue regulations related to vaccines, to the Public Health Service Act, Pub.L. No. 78-410, which required federal authorities to license vaccines and vaccine manufacturers, to the Emergency Supplemental Appropriations Act for Recovery from and Response to Terrorist Attacks on the United States, Pub.L. No. 107-9, which appropriated money for the acquisition of a sufficient quantity of the smallpox vaccine to inoculate the country.

The National Childhood Vaccine Injury Act ("Vaccine Act") is one such effort. P.L. 99-660, Title III, 100 Stat. 3743, 3756-3784 (codified at 42 U.S.C. § 300aa-1 et seq.). Enacted in 1986, the Vaccine Act established a national vaccine program to "achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines." 42 U.S.C. § 300aa-1. It sought to accomplish this primarily through the creation of the National Vaccine Injury Compensation Program ("NVICP") for claims against drug manufacturers for vaccine-related injuries and deaths. 42 U.S.C. § 300aa-10 et seq.

The NVICP has two parts. Part A creates a mandatory forum for the administration of claims—it requires a petitioner seeking compensation, including the injured party's legal representative, to file a petition in the "Vaccine Court," which is part of the United States Court of Federal Claims. Id. at § 300aa-11. The petitioner is entitled to receive compensation if: (1) the affected person received a vaccine covered by the Vaccine Act; (2) the affected person suffered a "Table injury";¹ and (3) it cannot be shown by a preponderance of the evidence that the injuries or death were not caused by the vaccine. Id. at §§ 300aa-11, 300aa-13. Alternatively, a petitioner who suffers a non-Table injury may still obtain compensation by proving affirmatively that the vaccine caused the injury. See Grant v. Sec'y of HHS, 956 F.2d 1144, 1148 (Fed.Cir.1992). Part B of the NVICP permits a petitioner, after the Vaccine Court has issued a final judgment, to either accept or reject that judgment. 42 U.S.C. § 300aa-21 et seq. If the petitioner rejects the judgment, she may pursue certain limited claims in state or federal court.² 42 U.S.C. § 300aa-21.

B.

Hannah Bruesewitz was born on October 20, 1991. At the time, the federal Advisory Committee on Immunization Practices recommended that children receive five doses of the diphtheria-pertussis-tetanus ("DPT") vaccine during the course of their childhood, one dose at each of the following ages: (1) 2 months; (2) 4 months; (3) 6 months; (4) 15-18 months; and (5) 4-6 years. Hannah received her first three shots of the DPT vaccine according to this schedule. After the third DPT shot, marketed under the trade name TRI-IMMUNOL and administered on April 1, 1992, she suffered a series of seizures. Doctors subsequently diagnosed Hannah as having residual seizure disorder and developmental delay. Hannah, who is now seventeen, will likely require some medical care related to that condition for the remainder of her life.

Defendant Wyeth, Inc. and its predecessors³ ("Wyeth") manufactured TRI-IMMUNOL until 1998. Approved in 1948, this vaccine contains the "whole-cell" pertussis vaccine—it is prepared using whole, inactivated pertussis bacterial cells. Although the whole-cell vaccine effectively reduced pertussis infections and deaths associated with these infections, it was also linked to a variety of adverse events. This led to interest in and efforts to develop a safer, acellular pertussis vaccine.

In December 1991, the Food and Drug Administration ("FDA") approved the defendant's application for an alternate DPT vaccine, which was known as ACEL-IMUNE. ACEL-IMUNE contains an acellular pertussis component. While the acellular vaccine contains parts of pertussis bacterial cells, because it does not contain a complete cell, it has less endotoxin and is less likely to cause adverse events.⁴ The FDA initially approved ACEL-IMUNE, however, for administration as the fourth and/or fifth DPT dose in the series of five. The FDA did not approve an acellular pertussis vaccine for the first three shots in the series until July 1996 when it approved the license of Connaught Laboratories, Inc. Defendant's ACEL-IMUNE did not receive approval for these same doses until December 1996.

Nonetheless, at the time of vaccination in April 1992, Hannah's doctor administered the TRI-IMMUNOL vaccine because there were no acellular pertussis vaccines commercially available for the third dose. Hannah's particular vaccine came from a lot that generated sixty-five reports of adverse reactions with the FDA and Centers for Disease Control and Prevention, including thirty-nine emergency room visits, six hospitalizations, and two deaths. Hannah's physician later indicated, as part of this litigation, that she would not have immunized Hannah had she known of the adverse event reports associated with this lot of the vaccine.

In 1998, Wyeth voluntarily discontinued manufacturing TRI-IMMUNOL.

C.

Hannah's parents ("plaintiffs") filed a petition in the Vaccine Court in April 1995, alleging that Hannah suffered an on-Table residual seizure disorder and encephalopathy.⁵ Bruesewitz v. Sec'y of Dep't of HHS, No. 95-0266V, 2002 WL 31965744, at *1 n. 1 (Fed.Cl. Dec. 20, 2002). The Court held a hearing in July 2002 and concluded in December of that year that Hannah's injuries were non-Table injuries and that the petitioners had not proven causation in fact. Id. at *13-17. Accordingly, it dismissed the claim with prejudice. Id. at *17. Hannah's parents rejected the Court's judgment on February 14, 2003.

Having exhausted their administrative remedies, the plaintiffs filed a Complaint in the Philadelphia Court of Common Pleas in October 2005. The complaint sought recovery on four claims: (I) negligent failure to produce a safer vaccine; (II) negligent failure to warn; (III) strict liability for design defect; and (IV) strict liability for manufacturing defect. Wyeth removed the action on the basis of diversity to the Eastern District of Pennsylvania and filed a motion for summary judgment. The District Court denied the motion without prejudice because the parties had not engaged in discovery. Following completion of discovery, Wyeth again moved for summary judgment on all four counts.

Although the District Court did not accept all of Wyeth's theories, it granted summary judgment in Wyeth's favor on all counts on August 24, 2007. The District Court concluded that Section 22(b)(1) of the Vaccine Act, 42 U.S.C. § 300aa-22(b)(1), preempts all design defect claims arising from a vaccine-related injury or death and dismissed Counts I and III on that basis. Regarding Count II, which alleged negligent failure to warn, the District Court concluded that the plaintiffs had not rebutted the statutory presumption created by Section 22(b)(2) of the Vaccine Act, 42 U.S.C. § 300aa-22(b)(2), that Wyeth's FDA-compliant warnings were proper. As to Count IV, which alleged that the particular lot from which Hannah's dose originated was especially...