Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Bruesewitz v. Wyeth Inc.

March 27, 2009


On Appeal from the United States District Court for the Eastern District of Pennsylvania District Court No. 05-cv-05994 District Judge: The Honorable Michael M. Baylson.

The opinion of the court was delivered by: Smith, Circuit Judge.


Argued September 11, 2008

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


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.



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 (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 (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 diptheria 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";*fn1 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.*fn2 42 U.S.C. § 300aa-21.


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 predecessors*fn3 ("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. ACELIMUNE 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.*fn4 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.


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.*fn5 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 prone to adverse reactions due to a manufacturing defect, the District Court concluded that the plaintiffs had failed to present sufficient evidence that the lot was defective or that it caused Hannah's injuries.

The District Court's ruling on the first and third claims warrants further examination. Both counts alleged a design defect-Count I alleged that Hannah's vaccine was negligently designed because the defendant knew of a safer alternative and failed to produce it, while Count III alleged strict liability design defect. The District Court ruled that both claims were preempted by the Vaccine Act. It rested this decision on four points. First, it stated that a case-by-case consideration of whether a vaccine was unavoidably safe would not protect vaccine manufacturers from suit. Second, it reasoned that Congress passed the Vaccine Act to "provide an umbrella under which manufacturers would improve the safety of their products while remaining immune from design defect claims." Third, the Court found that Congress achieved an appropriate balance by offsetting the effect of the preemption of design defect claims with creation of a compensation program for individuals injured by vaccines. Finally, it concluded that the Vaccine Act preempts both strict liability and negligent design defect claims against FDA-approved vaccines. Accordingly, it dismissed plaintiffs' first and third claims.

The plaintiffs appealed. Their appeal presents this Court with three questions: (1) does § 300aa-22(b)(1) act as a complete bar to design defect claims; (2) have the plaintiffs in this case met their burden under § 22(b)(2) of the Vaccine Act to show that defendants failed to provide an adequate warning of the alleged dangers of the vaccine; and (3) have the plaintiffs provided sufficient evidence of a manufacturing defect to survive the defendant's motion for summary judgment.


The District Court had jurisdiction under 28 U.S.C. §§ 1332 and 1441, and we have appellate jurisdiction under 28 U.S.C. § 1291. Our review of a District Court's grant of summary judgment is plenary, and we apply the same standard as the District Court to determine whether summary judgment was appropriate. Norfolk S. Ry. Co. v. Basell USA Inc., 512 F.3d 86, 91 (3d Cir. 2008). A grant of summary judgment is appropriate "if the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). In making this determination, we must view the facts in the light most favorable to the nonmoving party and draw all inferences in that party's favor. Norfolk, 512 F.3d at 91.


Preemption doctrine is rooted in the Supremacy Clause of the United States Constitution. Article VI declares that the laws of the United States "shall be the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. "Under the Supremacy Clause, federal law may supersede state law in several different ways." Hillsborough County, Fla., v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985). Over the years, the Supreme Court has recognized three types of preemption: express preemption, implied conflict preemption, and field preemption. Id.

A federal enactment expressly preempts state law if it contains language so requiring. Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 541 (2001). Thus, when construing an express preemption clause, a reviewing court must necessarily begin by examining the "plain wording of the clause," as this "necessarily contains the best evidence of Congress' pre-emptive intent." Sprietsma v. Mercury Marine, 537 U.S. 51, 62--63 (2002) (quoting CSX Transp. v. Easterwood, 507 U.S. 658, 664 (1993)). Though the language of the provision offers a starting point, courts are often called upon to "identify the domain expressly pre-empted by that language." Medtronic, Inc. v. Lohr, 518 U.S. 470, 484 (1996) (internal quotation marks and citations omitted). This, in turn, is guided by two principles. Id. at 485. First, "Congressional purpose is the 'ultimate touchstone' of our inquiry." Lorillard Tobacco Co., 533 U.S. at 541 (quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992)); see also Altria Group, Inc. v. Good, 129 S.Ct. 538, 543 (2008) ("If a federal law contains an express pre-emption clause, it does not immediately end the inquiry because the question of the substance and scope of Congress' displacement of state law still remains."). Second, courts must operate under the "assumption that the historic police powers of the States [a]re not to be superseded by the Federal Act unless that [is] the clear and manifest purpose of Congress." Cal. Div. of Labor Standards Enforcement v. Dillingham Constr., N.A., Inc., 519 U.S. 316, 325 (1997).

Implied conflict preemption arises when state law conflicts with a federal statute in one of two situations. First, it arises when it is "impossible for a private party to comply with both state and federal requirements." English v. General Elec. Co., 496 U.S. 72, 78--79 (1990). It is also present when state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Hines v. Davidowitz, 312 U.S. 52, 67 (1941). Furthermore, implied preemption may exist even in the face of an express preemption clause. As the Supreme Court observed in Freightliner Corp. v. Myrick, 514 U.S. 280, 288 (1995), "Congress' enactment of a provision defining the preemptive reach of a statute implies that matters beyond that reach are not pre-empted," but that "does not mean that the express clause entirely forecloses any possibility of implied pre-emption."

When confronting arguments that a law stands as an obstacle to Congressional objectives, a court must use its judgment: "What is a sufficient obstacle is a matter of judgment, to be informed by examining the federal statute as a whole and identifying its purpose and intended effects." Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 373 (2000). In fact, we must look to "'the entire scheme of the statute'" and determine "'[i]f the purpose of the [federal] act cannot otherwise be accomplished-if its operation with its chosen field [would] be frustrated and its provisions be refused their natural effect.'" Id. (quoting Savage v. Jones, 225 U.S. 501, 533 (1912)). Once again, this requires an examination of the "'whole law, and to its object and policy.'" Gade v. Nat'l Solid Wastes Mgmt. Assn. , 505 U.S. 88, 98 (1992) (quoting Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41, 51 (1987)).

Field preemption arises by implication when state law occupies a "field reserved for federal regulation." United States v. Locke, 529 U.S. 89, 111 (2000). This occurs when "Congress [] left no room for state regulation of these matters." Id.; see also Lorillard Tobacco Co., 533 U.S. at 541. It may also be inferred when "an Act of Congress 'touch[es] a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.'" English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)). Nonetheless, because field preemption typically arises in areas traditionally regulated by states under their police powers, "congressional intent to supersede state laws must be 'clear and manifest.'" Id. (citation omitted).

Yet despite the development of the foregoing preemption jurisprudence, courts must begin their analysis of these questions by applying a presumption against preemption. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992). "In areas of traditional state regulation, we assume that a federal statute has not supplanted state law unless Congress has made such an intention 'clear and manifest.'" Bates v. Dow AgroSciences, 544 U.S. 431, 449 (2005). When faced with two equally plausible readings of statutory text, we "have a duty to accept the reading that disfavors preemption." Id; see also Altria Group, Inc., 129 S.Ct. at 543; Cipollone, 505 U.S. at 518. This is true even in the event of an express preemption clause. Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1014 (2008) (quoting Bates, 544 U.S. at 449). That issues of health and safety have traditionally fallen within the province of state regulation is beyond refute. That safety of vaccines is an issue of health and safety is equally clear. See, e.g., Medtronic, Inc., 518 U.S. at 485. Nonetheless, in the face of clear evidence, the presumption against preemption can be overcome. See ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.