RESPONDENT: Wyeth, Inc., fka Wyeth Laboratories, et al.
LOCATION: United States District Court for the Eastern District of Pennsylvania
DOCKET NO.: 09-152
DECIDED BY: Roberts Court (2010-2016)
LOWER COURT: United States Court of Appeals for the Third Circuit
CITATION: 562 US 223 (2011)
GRANTED: Mar 08, 2010
ARGUED: Oct 12, 2010
DECIDED: Feb 22, 2011
Benjamin J. Horwich - Assistant to the Solicitor General, Department of Justice, for the United States, as amicus curiae, supporting the respondents
David C. Frederick - for the petitioners
Kathleen M. Sullivan - for the respondents
Facts of the case
Two hours after Hannah Bruesewitz received her six-month diphtheria, tetanus and pertussis vaccine in 1992, she started developing seizures and was hospitalized for weeks. Hannah has continued to suffer from residual seizure disorder that requires her to receive constant care, according to her parents. When their daughter was three-years-old, Russell and Robalee Bruesewitz filed a petition seeking compensation for her injuries. One month prior to the petition, new regulations eliminated Hannah's seizure disorder from the list of compensable injuries. The family's petition was denied. Three years later, in 1998, the drug company Wyeth withdrew the type of vaccine used in Hannah's inoculation from the market.
The Bruesewitzes filed a lawsuit against Wyeth in state court in Pennsylvania. They claimed the drug company failed to develop a safer vaccine and should be held accountable for preventable injuries caused by the vaccine's defective design. A federal judge dismissed the lawsuit, ruling that the National Childhood Vaccine Injury Act protected Wyeth from lawsuits over vaccine injury claims. The U.S. Court of Appeals for the 3rd Circuit affirmed.
Can a federal law shield vaccine manufacturers from certain product liability lawsuits in state court that seek damages for serious health problems suffered by children?
Media for Bruesewitz v. Wyeth Inc.Audio Transcription for Oral Argument - October 12, 2010 in Bruesewitz v. Wyeth Inc.
Audio Transcription for Opinion Announcement - February 22, 2011 in Bruesewitz v. Wyeth Inc.
This case is here on writ of certiorari to the United States Court of Appeals for the Third Circuit.
Hannah Bruesewitz was born on October 20th, 1991.
About six months later, the pediatrician administered doses of the diphtheria-tetanus and pertussis vaccines so-called the DTP vaccine.
Within 24 hours, Hannah started to experience seizures.
Her doctors eventually diagnosed her with -- with something called residual seizure disorder and developed mental delay.
Hannah now, a teenager, is still diagnosed with both conditions.
Her parents filed a vaccine injury claim with the National Vaccine Injury Program in 1995.
That no-fault program created by the National Childhood Vaccine Injury Act of 1986, which is a legislation of that issue here, was part of a congressional effort to stabilize a vaccine industry that had almost been destroyed by an increase in vaccine related tort litigation.
At one point, only a single domestic manufacturer continued to produce the DTP vaccine, and to facilitate compensation to claimants who found pursuing legitimate vaccines inflicted injuries too costly and too difficult.
Under the Act, the claimants are not required to show that the administered vaccine was defectively manufactured, labeled or designed.
And for the most common and first side effects, no showing of causation is even necessary if the injury first manifested itself at the express -- at the expected time after vaccination.
Compensation awards are paid out of a fund created by an excise tax levied against vaccine manufacturers.
The quid pro quo for the compensation program was the enactment of significant tort liability protections for manufacturers.
Most relevant to the present case, 42 U.S.C. Section -- never mind, eliminates -- it goes on and on -- eliminates manufacturer liability "In a civil action for damages arising from a vaccine related injury or death 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."
A Special Master denied the Bruesewitz's claim under the no-fault program, so they then filed this federal lawsuit -- or this lawsuit.
As relevant here, they alleged that defective vaccine design caused Hannah's injuries in violation of Pennsylvania common law.
After Wyeth removed this suit from Pennsylvania State Court to Federal Court, the District Court held that the section in question preempted the Pennsylvania common law and the Court of Appeals for the Third Circuit affirmed.
We agree with the Court of Appeals at the National Childhood Vaccine Injury Act preempts all design defect claims against vaccine manufacturers.
To repeat state law, liability is expressly preempted "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."
If a manufacture could be held for a failure to use a different design, the word "unavoidable" in this passage would do no work.
A side effect could always be avoided by designing the vaccine to omit the harmful element.
It might be must -- much less effective but it would not cause harm.
The language of the provision does suggests that the design of the vaccine is a given, not subject to question in a tort action.
The expressio unius common leads to the same conclusion.
Products liability law establishes a well-known triumvirate of grounds for liability, defective manufacturer, inadequate directions or warning and defective design.
The text of the statute explicitly lists the first two grounds for liability as types of avoidable injury.
If all three were intended to be preserved, it would be strange to live the third defective design to implication.
Petitions contrary textual argument presumes that the word "unavoidable" in the statutory section is a term of art that incorporates comment K to the Restatement Second of Torts, Section 402 (a) which they contend was commonly understood to require a case specific showing that a design was as safe as possible.
There is no textual reason to believe that the statute was invoking comment K.
The statute uses the word unavoidable hardly a rare word, while comment K and the relevant judicial decisions use the precise raise unavoidably, unsafe product.