Bruesewitz v. Wyeth LLC (Case 09-152)
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1. 1) Facts
1.1. a) Parties
1.1.1. Russell and Robalee Bruesewitz, parents of Hannah Bruesewitz.
1.1.2. Wyeth LLC, FKA Wyeth, Inc. et al.
1.2. b) What Happened
1.2.1. Hanah Bruesewitz, at 6 mos old, contracted residual seizure disorder after receiving DTP vaccine manufactured by Lederle Labs (owned by Wyeth).
1.2.2. Parents of Hannah Bruesewitz, filed law suit against Wyeth, Inc and Lederle Labs when Hannah was 3, for manufacturing a defectively designed DTP vaccine which was administered to Hannah when she was 6 mos old due to contracting residual seizure disorder with mental delay 2 hrs after the vaccine, which left her permanently disabled.
1.3. c) Procedural History
1.3.1. Vaccine-injury petition was initially filed with Court of Federal Claims. Claim was denied.
1.3.1.1. Later filed suit in Pennsylvania State Court alleging defective design stating that Laderle Labs were subject to strict liability and liability or negligent design under PA common law.
2. 4) Application
2.1. Plaintiff presented vaccine was defective and there was a superior product previously marketed by manufacturer (Lederle knew about) which was taken off the market.
2.1.1. Wyeth presented they were protected by NCVIA.
2.2. Courts applied language set forth by Congress and intent of the NCVIA as protection for manufacturers for the purpose of keeping vaccine products on the market and manufacturers still producing them.
2.2.1. Public Policy referenced here was that millions of children would die if there was no vaccine for DTP or they set a precedence for the elimination of other vaccines.
3. 3) Rule of Law
3.1. 6 requirements of Strict Liability
3.1.1. 1) Product must be defective when defendant sold it.
3.1.1.1. Not proven
3.1.2. 2) Defendant normally engaged in business of selling/distributing product
3.1.2.1. Yes
3.1.3. 3) Product must be unreasonably dangerous to consumer due to defective condition.
3.1.3.1. Not proven.
3.1.4. 4) Plaintiff must incur physical harm through use or consumption of product.
3.1.4.1. Yes, injury was imminent/timely to dose.
3.1.5. 5) Injury condition must be within proximate cause of use or consumption of product.
3.1.5.1. Yes, within 2 hrs as in #4.
3.1.6. 6) Product must not have been substantially changed from time it was sold to time of injury.
3.1.6.1. Was not provem
3.2. NCVIA - National Childhood Vaccine Injury Act of 1986
3.2.1. (1) direct vaccine research and development within the Federal Government
3.2.2. (2) ensure the production and procurement of safe and effective vaccines
3.2.3. (3) direct the distribution and use of vaccines
3.2.4. (4) coordinate governmental and nongovernmental activities. Requires the Director of the Program to report to specified congressional committees.
4. 2) Issue before the Court
4.1. 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?
5. 5) Conclusion
5.1. National Childhood Vaccine Injury Act protected Wyeth from lawsuits over vaccine injury claims. The U.S. Court of Appeals for the 3rd Circuit affirmed.
5.1.1. Oversees regulations regarding manufacturing guidelines and cautions risks associated with developing vaccines.
5.1.2. Regulates labeling and warnings.
5.1.3. Limits Manufacurers strict liability for product defects, in
5.1.4. Mandates strict documentation on risks and benefits.
5.1.5. Requires Registration with Vaccine Injury Table
5.1.6. Establishes NIH, Nat'l Institute of Health as task force Chairman.
5.1.7. Compensate injured families who had been administered childhood vaccines.