While the Bruesewitz's vaccine claim is not autism related, its outcome will have legal implications for the efforts to link vaccinations to autism. Attempts to seek compensation for the diagnosis have persisted despite overwhelming scientific evidence that has found no connection. In February, the British medical journal The Lancet retracted a study that linked the measles-mumps-rubella vaccine to autism and contributed to a rash of parents fleeing the inoculation. In March, special masters in the Vaccine Court likewise ruled against parents claiming the vaccine was responsible for their children's autism.
While the 1986 Vaccine Injury Act bars state tort lawsuits alleging defective design, two other kinds of lawsuits go forward all the time in pharmaceutical industry product liability cases. In the first version, plaintiffs may allege that the manufacturer failed to give adequate warnings about the dangers of the product. In the second, plaintiffs may claim that the vaccine itself was not manufactured properly.
The Bruesewitz case is of particular interest because it falls into the bucket of so-called express pre-emption cases, in which a law explicitly bars state tort claims. In 2008's Riegel v. Medtronic, the Supreme Court ruled that federal law explicitly pre-empted state product liability for medical device claims. There, as here, the alternative remedy was favored by a horde of trial lawyers hoping for a new state tort jackpot.
At oral argument on Tuesday, the Justices seemed to be dubious of plaintiff claims that the 1986 vaccine law left room for debate. Responding to the suggestion that Congress's intent was not to pre-empt all suits, Chief Justice John Roberts responded that "I would have thought the argument would go the other way: That because they set up a compensation scheme, that was a good sign that they didn't want to allow state law claims." Anthony Kennedy, often a swing vote, was skeptical that manufacturers could survive the assault from new tort claims.
I have written a book on the politics of autism policy. Building on this research, this blog offers insights, analysis, and facts about recent events. If you have advice, tips, or comments, please get in touch with me at jpitney@cmc.edu
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Saturday, October 16, 2010
Wall Street Journal on Bruesewitz
Wednesday, October 13, 2010
The Bruesewitz Case
The Supreme Court on Tuesday struggled to divine the balance Congress had meant to strike in a 1986 law that established a system to compensate people injured by vaccines while barring some, but not all, lawsuits against vaccine manufacturers.
David C. Frederick, a lawyer for a couple who said their daughter had been badly hurt by a vaccine, said their lawsuit should be allowed to go forward. “We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury from vaccines that we compel children to take,” he said.The 1986 law, Mr. Frederick said, was meant to allow claims both in a special tribunal known as the vaccine court and in ordinary lawsuits.
Kathleen M. Sullivan, a lawyer for the defendant, said that approach would expose the industry to crushing liability that could drive companies from the marketplace and imperil the nation’s vaccine supply.
Ms. Sullivan, who represents Wyeth, now a part of Pfizer, added that the ruling in the case, Bruesewitz v. Wyeth, No. 09-152, could affect thousands of unrelated cases concerning autism in the vaccine court.
The Washington Post reports that the Court "seemed divided" on the case:
Justice Elena Kagan was recused from the case because of her past work on it when she was solicitor general. Roberts sold his holdings in Pfizer in August so that the case would not be heard by only seven justices.
The lack of a full court makes it harder for the Bruesewitzes. The justice Kagan replaced, John Paul Stevens, was one of the court's strongest believers in consumers' ability to sue in state courts. And Frederick must persuade five of the eight to overturn the U.S. Court of Appeals for the 3rd Circuit to allow the suit to proceed.
If the justices are evenly split, the judgment of the lower court is upheld, but it does not set a national precedent.
From the transcript of oral argument:
MS. SULLIVAN: But there are 5,000 claimants in vaccine court now who claim there is a relationship between the mumps, measles, and rubella vaccine and autism. They have lost all six test cases and when the individual cases are resolved, that is 5,000 potential claimants in State court.
Congress was worried about episodic waves of fear about vaccines leading to future litigation. They took care of existing Claimants with vaccine injuries back in 1986 with the compensation system. The reason they put in 22(b)(1) was to prevent future litigation in State court where manufacturers could be driven from the market by the fear of liability that had in 1986 involved the withdrawal of insurance, the escalation of insurance costs, the withdrawal of one manufacturer from the vaccine market.
And today there are very few vaccine manufacturers and the risk of the vaccine supply on which the nation's protection from contagious disease depends, it depends upon the existence of that stable supply of vaccines