Bruesewitz V. Wyeth

1. What Happened: The parents of Hannah Bruesewitz filed a claim with the Vaccine Court, which is part of the U.S. Federal Claims Court. They had given their daughter the DTP vaccine, which they claim in turned cause their daughter to have health problems including but not limited to seizures. After their case was denied they took the case to the state court of Pennsylvania where the case was then moved to Federal Court. This case fell under the National Childhood Vaccine Injury act of 1986. After presenting the case, the jury found that because the manufacturer provided warning labels for this vaccine, Hannah’s family could not hold them liable for this defect due to the language used by the manufacturer.

2. o Procedural History • Issue: The legal question before the court in this case was whether or not manufacturers of healthcare vaccines are responsible for the side effects of the vaccine when they provide proper warning labels and directions on how to use the medication. This court decisions holds if its ok for the federal court to make decisions about children who suffer from defects due to vaccines. • Rule of Law: The court reviewed the National Childhood Vaccine Injury Act of 1986, which was signed into law by President Reagan to provide financial stability to vaccine makers that were being sued for claims regarding injuries post usage. Prior to this act when vaccine companies were being sued over claims they quit producing as much, thus increasing the price and limiting the supply which caused havoc amongst people in need. There was never previous evidence that the vaccine is what caused these health deficiencies. Thus the National Childhood Vaccine Injury Act of 1986 was put into place. Vaccine providers are required in this act to report claims stating their product caused health issues.

3. • Analysis/Application: Plaintiff: Hannah’s family claimed she got her DTP shot and was then disabled afterwards, blaming Wyeth. Their daughter starting having seizures two hours post vaccine that caused her to have life long defects. Prior to going to court for their daughter, the act of 1986 made it to where her family could no longer be compensated due to the defective vaccine. When their claim was denied they brought it to Pennsylvania State where they presented the argument that Wyeth was careless with their vaccine design thus causing their daughters developmental and physical disabilities and seizures. Defendant: Wyeth claimed that there was no proof their vaccine caused the disability, and used the law in their favor. Their claim was that because they had provided the properly prepared vaccine with labeling and warning instructions, they could not be held liable for damages caused that could not be avoided. They were protected by the Childhood Vaccine Act of 1986 with this terminology. Since there was nothing listed in the act in regards to design, Wyeth could not be held legally responsible for Hannah’s health issues.

4. Court: Congress interpreted and expanded the law in this case, where they determined that Wyeth could not be held responsible, as they knew that if they were going to penalize every vaccine company due to negligence then the vaccines would be limited in availability to U.S. citizens. The court held that if patients can prove that these injuries occurred or were accrued immediately after the vaccine was given, then injured parties or their families were able to be provided up to a certain amount of compensation and the vaccine and/or pharmaceutical companies would not be further penalized. The list of injuries that the patient receives from the vaccine has to match up with the vaccine table for that particular disease, which hurts any families including Hannah’s as they are not entitled for further compensation. In this highly publicized case the jurors felt that if they were to side with Hannah’s family then the rest of the American people would be in danger of not being able to have affordable access to vaccines when in need. It was more important for them to provide vaccine safety for the American people as a whole, particularly as they were unable to prove beyond a reasonable doubt that Hannah’s illness was actually caused by the DTP vaccine and not some type of other congenital birth defect.

5. • Conclusion: Impact, Importance, and Influence One case that considers the impact of this holding is Wyeth V. Levine, where Levine was a patient who lost her hand to gangrene after receiving an injection of Phenergan for nausea. Wyeth argued that they could not comply with both state and federal laws, but the court denied this and ruled that Levine could take this to jury where she was able to protect her case before a state jury. A second case that cites this. holding is Militrano vs. Lederle Labs presented in 2003. The plaintiff in this case, Mr. Militrano was injured by a vaccine and during his case he presented he stated that Lederle Labs was negligent in the manufacturing of their vaccine, and a safer one could have been approved by the FDA. His family denied the award given by the court from the National Childhood Vaccine Injury Act of 1986, and persued a civil case . Congress dismissed the case, as Lederle provided warning labels that were presented in regulation with the FDA laws. This decision is important for business professionals as it provides manufacterers with protection over vaccines, but it also raises concern and the importance of making sure that there are no defects in the product design in order to protect people. There are several cases regarding Autism in relation to vaccines that have occurred after this case. While no vaccine is perfect, a lot can be learned from this case by business professionals in regards to how the law works for manufacturers as well as how product design can make or break a patients life. Vaccines are now being tested pre and post licensing for safety with the passing of this act. The labs are testing these vaccines in the lab as well as on humans, with the federal government now monitoring all reactions that are occurring with a certain vaccine as influenced by this holding. Another business practice that this holding has changed for the better in order to reduce vaccine side effects is the implementation of DTaP vaccine opposed to STP vaccine, as well as needless injections and edible vaccines for safer administration to prevent health defects.