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Can Vaccine Makers Be Sued?

By       Message Sudeep Bhatia       (Page 1 of 1 pages)     Permalink    (# of views)   No comments

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Bruesewitz v. Wyeth

On October 12th, the U.S. Supreme Court heard oral arguments in the case of Bruesewitz v. Wyeth. The National Childhood Vaccine Injury Act protects vaccine manufacturers from liability for certain injuries caused by their vaccines (giving injured patients compensation from the government instead). The court examined whether that immunity applies when the victim claims that the design of the drug created an avoidable and unnecessary risk to patients.

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On April 1, 1992, Hannah Bruesewitz, then a healthy six-month-old baby girl, received her third dose of Wyeth's Tri-Immunol vaccine. Within hours, Hannah experienced her first seizure. Her medical problems continue to this day. She will require a lifetime of supervision and care.

Her family filed a claim with the Vaccine Court, which was set up by the U.S. Government in 1986 by the National Childhood Vaccine Injury Act to handle injury claims from vaccines. Since they could not prove a causal connection between the injuries and the vaccine, her claim was denied.

The Bruseweitzes then filed a claim in state court under the theory that the vaccine had a design defect and therefore Wyeth was liable for Hannah's injuries. The court did not agree and denied their claim. Successive appeals failed, and now the Petitioners are asking the Supreme Court to let their claim go forward. This case is about the claim procedure set up by the vaccine court. Vaccine makers are not liable when the injury is unavoidable. The only time an injury is avoidable is if the vaccine maker did not manufacture the product properly or if the required warnings were not provided. To prove a design defect claim, the petitioner has to prove that an imagined, hypothetical vaccine that was never researched, tested or produced would be safer and thus the injuries are avoidable. The justices were skeptical of this nebulous claim.

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Wyeth made it clear that this was a public safety matter, and that the vaccine compensation system has been effective in ensuring a safe supply of vaccines and providing a financial cushion for the vaccine makers. The justices did question, however, whether the compensation system would result in vaccine makers becoming lax in safety matters, as there is no incentive under the National Childhood Vaccine Injury Act to improve their products - they are shielded from liability in this respect.

If the petitioners win, it means they would be able to file a lawsuit for damages in state court. They would still have to establish a factual record and demonstrate that the vaccine caused the petitioner's injuries. They face years of litigation. It also means that the MMR-autism claims, 6 of which have been denied in the vaccine court, would be able to proceed in state court. Over 5,000 autism cases would be filed, even though the findings of Dr. Andrew Wakefield, which initially established the vaccine-autism connection, have been discredited.


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I like to read and write about the Supreme Court. I read my articles on the radio in Washington, DC.

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Can Vaccine Makers Be Sued?