In his latest Forbes.com column, Richard Epstein explains why the outcome of Wyeth v. Levine, which the Supreme Court heard this week, matters a very great deal:
Wyeth v. Levine…posed one simple question. Once the Food and Drug Administration has approved the warnings about drugs licensed for sale, may a plaintiff bring state law action for damages on the ground that those warnings are inadequate?
The principled answer to that question is a resounding "no." Concede—no insist—that the FDA is far from flawless. All too often, however, its extreme risk aversion keeps newer and safer drugs off the market—or requires strong, "black box" warnings that over-deter valuable use.
Against this backdrop, it is folly to act as if the private lawsuits attacking FDA warnings just backstop a porous and lax FDA. Often those lawsuits add an unwanted deterrent against the sale of desperately needed drugs. That risk is multiplied by hyperventilated state tort law that, in many instances, is lopsidedly pro-plaintiff.
The specter of heavy litigation expense and crushing liabilities by runaway juries could easily block the pharmaceutical industry from initiating life-saving changes.