Former FDA commissioners Donald Kennedy and David Kessler have told the Supreme Court that drug company and FDA arguments promoting FDA pre-emption of state failure-to-warn claims in drug safety cases “threaten to undermine, not advance, the underlying goal of our nation's drug safety laws, which is ‘to protect consumers from dangerous products.'”
The two express their opinions in a friend-of-the-court brief supporting a patient who is seeking to sue Wyeth in state court over injuries caused by Phenergan. The Supreme Court is to hear the case this fall.
Kennedy and Kessler say the nation's drug safety laws have never placed responsibility for drug safety solely on the FDA. Rather, they say, primary responsibility is given to drug manufacturers. Kennedy and Kessler insist there is no conflict between federal and state law over labeling contents or over a manufacturer's duty to warn physicians, patients and the FDA about emerging safety hazards.
“To be sure,” they write, the “FDA also plays an important role; it oversees, and when necessary compels, compliance with safety standards. But the ultimate responsibility remains with the manufacturer.” FDA pre-emption would turn that understanding upside-down, they say, relieving manufacturers of front-line responsibility for the safety of their drugs and giving that role to the FDA.
Failure-to-warn litigation doesn't challenge the FDA's decisions about labels, but rather challenges a company's failure to alert physicians and patients to risks that were unknown or poorly understood when FDA approved the label, but were evident to the company at the time a patient sustained injury.