Dear Editor: Since 1996, Michigan has been the only state in the nation in which it is illegal to bring suit against pharmaceutical companies. If a drug has received FDA approval, Michigan citizens have no day in court. No judge or jury can assess whether damage has been done. Beyond FDA approval, nothing else matters — even when companies neglect danger signals, employ misleading marketing, spin medical journals, or intimidate medical researchers.
A law similar to Michigan’s is being proposed in Wisconsin (LRB 2890).
The doctrine that FDA approval should trump all other considerations is called “FDA pre-emption.” FDA pre-emption has been rejected by the FDA itself through 70 years of the agency’s history. In 2009 FDA pre-emption was rejected by the U.S. Supreme Court, including Justice Clarence Thomas. The same year, the New England Journal of Medicine, the most respected voice in American medicine, insisted that without product liability suits “FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct. Thus, rather than promote public health, the pre-emption of failure-to-warn claims would substantially threaten it.” (Emphasis in original)
For 16 years, Michigan has endured a law at odds with public health, consumer protection, the Supreme Court, and the FDA itself. My sister lives in Racine. I can only hope that Wisconsin will avoid our fate.
Ann Arbor, Mich.