Author Affiliations: Department of Health Policy
and Management, Harvard School of Public Health (Drs Mello and Brennan) and
Department of Medicine, Harvard Medical School (Dr Brennan), Boston, Mass.
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
Mello MM, Brennan TA. Legal Concerns and the Influenza Vaccine Shortage. JAMA. 2005;294(14):1817-1820. doi:10.1001/jama.294.14.1817