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Commentary |

Legal Concerns and the Influenza Vaccine Shortage

Michelle M. Mello, JD, PhD, MPhil; Troyen A. Brennan, MD, JD, MPH
JAMA. 2005;294(14):1817-1820. doi:10.1001/jama.294.14.1817.
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Concerns have arisen that the paucity of suppliers of influenza vaccine for the US market, which contributed to the shortage of vaccine in 2004, is largely attributable to the legal liability that vaccine manufacturers face. For instance, in October 2004, President Bush signed into law the American Jobs Creation Act of 2004,1 adding influenza vaccine to the federal Vaccine Injury Compensation Program (VICP), the administrative scheme that is the first-line legal remedy for certain vaccine-related injuries. Although the introduction of the bill predated the 2004 flu vaccine shortage,2,3 it presaged public concern about how the legal environment may be affecting vaccine supplies. In October, a nongovernmental organization called the Club for Growth ran a full-page newspaper advertisement4 that read, “Can’t get a flu shot? Thank the trial lawyers.” In the presidential debates, President Bush commented that manufacturers have stopped producing flu vaccine because they “are worried about getting sued.”5 A public opinion poll showed that 41% of Americans apportioned blame for the flu vaccine shortage to trial lawyers.6

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