By: Henry Greenspan, Milwaukee Journal Sentinel
Wednesday, October 26, 2011
Since 1995, Michigan has been the only state in the country in which citizens cannot bring suit against drug companies. If a drug has received Food and Drug Administration approval, that manufacturer cannot be held liable for deaths or injuries caused by its product. Whatever the merits of any individual case, the point is that Michigan citizens have been denied a day in court where that merit could be tested.
An identical law is being proposed for Wisconsin.
Proponents of our Michigan statute call it an "FDA-defense law." They suggest that FDA approval trumps all other considerations - a doctrine called "FDA pre-emption." The irony is that the FDA itself has consistently rejected the doctrine.
In 1997, FDA Chief Counsel Margaret Porter wrote: "FDA's view is that product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection." Simply put, FDA pre-emption takes one layer of consumer protection and throws it away.
Those who propose FDA-only legislation try to mask the attack on consumer protection by including a clause suggesting that immunity from liability does not hold if the FDA finds that the manufacturer committed fraud in the approval process. What we are not told is that FDA never makes such findings. That is because conviction of fraud against the FDA - a serious felony - would bar a company from participation in federal programs such as Medicare, Medicaid or Veterans Administration programs. A lot of innocent people would be hurt as a result.
For that reason, when FDA has "the goods" on a company, the consequences are a plea bargain yielding monetary fines, admission of misdemeanors and a "corporate integrity agreement" in which a company promises to behave (many companies carry several such agreements). None of this qualifies as a fraud conviction. The so-called "fraud exception" is thus itself, de facto, fraudulent.
Also fraudulent is the suggestion that eliminating accountability has economic benefits. The opposite is true. Almost all of our once-thriving drug and device industry has left Michigan while our law has been in effect. The same companies moved to states such as Connecticut and Massachusetts, known for robust liability systems. Indeed, many who work in the drug and device industries - especially research scientists - argue that accountability encourages the creation of the best products, the best jobs and the growth of the best companies.
Physicians agree. Eleven current and former editors of the New England Journal of Medicine, the most respected voice in American medicine, noted: "Without the tort system, the 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, civil justice, economic growth, consumer protection and the FDA itself. We can only hope that Wisconsin will avoid the same fate.
Henry Greenspan teaches about ethics, policy, and the pharmaceutical industry at the University of Michigan, Ann Arbor. He writes as a private citizen.