Reason Foundation said on March 5 that litigation was responsible for the removal of the only approved Lyme disease vaccine from the U.S. market and warned that proposed legislation to eliminate vaccine manufacturer liability protections could lead to similar outcomes for other vaccines.
The organization said this issue is significant because changes to liability protections could affect vaccine availability and public health. According to Reason Foundation, "litigation drove the only approved Lyme disease vaccine off the U.S. market and said proposed legislation to remove vaccine manufacturer liability protections could repeat that outcome for other vaccines."
Bailey reported that LYMErix, approved by the Food and Drug Administration in 1998 and found to be 76% effective, was pulled from the market in 2002 after a class-action lawsuit filed on behalf of 121 individuals claiming adverse reactions. An FDA review found no proof that the vaccine was dangerous. The lawsuit settlement paid over $1 million in legal fees but provided no compensation to plaintiffs, according to Bailey as reported by Reason.
Since LYMErix was removed from the market, reported Lyme disease cases in the United States have risen to nearly 500,000 new cases per year, according to the Centers for Disease Control and Prevention (CDC). The disease has spread to new regions, with cases reported in all 50 states. No replacement vaccine has reached the U.S. market in the two decades since LYMErix was withdrawn according to AAMC.
Senator Rand Paul and Senator Mike Lee introduced the End the Vaccine Carveout Act in February, which would remove liability protections that have shielded vaccine manufacturers since 1986. Before those protections existed, lawsuits drove all but one pertussis vaccine manufacturer out of the U.S. market by 1985, and vaccine prices rose sharply according to History of Vaccines Project.
Reason Foundation is a nonprofit organization founded in 1978 and based in Los Angeles that advances public policy research rooted in individual liberty, free markets, and the rule of law. It publishes Reason magazine, which covers policy issues including healthcare regulation, innovation, and government accountability according to Reason Foundation.
