Justices wrestle with issue of protecting vaccine makers

The Supreme Court is grappling with the question of how much protection the 1986 National Childhood Vaccine Injury Act was meant to provide vaccine manufacturers against lawsuits. The case involves Hannah Bruesewitz, whose parents claim that a Wyeth-manufactured D.T.P. vaccine she received as an infant in 1992 led to developmental problems. At issue is whether Bruesewitz's parents should be allowed to sue Wyeth on the premise that the drug maker could have offered a safer vaccine but opted not to do so. The case has moved from the "vaccine court" to the Pennsylvania state court to federal court; Wyeth has thus far prevailed.

The 1986 law in question "established a system to compensate people injured by vaccines while barring some, but not all, lawsuits against vaccine manufacturers," and "bars ordinary lawsuits '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,'" The New York Times reports. The meaning of the word "unavoidable" was the subject of debate within the Supreme Court on Tuesday. A lawyer for Wyeth said allowing the case to move forward "would expose the industry to crushing liability that could drive companies from the marketplace and imperil the nation's vaccine supply." (Liptak, 10/12).

The Wall Street Journal: Supreme Court justices were divided on the case. Justice Anthony Kennedy argued that "defending against product-liability lawsuits is a 'tremendous expense,' adding that drug makers may face pressure to settle cases even if they were likely to win them on the merits." Justice Sonia Sotomayor countered that "if federal law pre-empted lawsuits, vaccine makers wouldn't have much incentive to keep testing their products or look for safer alternatives" (Kendall, 10/13).

The Associated Press: "Wyeth, backed by the Obama administration and many public health groups, argued that Congress shielded drug companies from most vaccine lawsuits when it created a special vaccine court 24 years ago to handle the claims." Justice Ruth Bader Ginsburg argued that if lawmakers had intended to prevent lawsuits like this one, "'they could have said simply that no vaccine manufacturer may be held civilly liable if the vaccine is properly prepared and accompanied by proper directions and adequate warnings.'" Justice Stephen G. Breyer argued that a ruling against drug companies, as physicians and public health organizations have asserted, "'could well be driving certain vaccines from the market, and basically, a lot of children will die'" (Sherman, 10/13).

The Washington Post: The Supreme Court's ruling will bear significant implications for other pending cases in the "Vaccine Court," a special tribunal set up by the 1986 law to deal with claims against drug makers. Wyeth's lawyer, Kathleen Sullivan, "said the ruling will be important for the future as well. 'There are 5,000 claimants in vaccine court now who claim there is a relationship between the mumps, measles and rubella vaccine and autism,' she said. 'They have lost all six test cases, and when the individual cases are resolved, that is 5,000 potential claimants in state court'" (Barnes, 10/12).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.