At the behest of Wisconsin Governor Scott Walker, a state Senate committee has proposed a bill that would protect drug and device makers from liability in state lawsuits, so long as their products were approved by the FDA. The only exception that would be granted under the legislation is if a manufacturer committed fraud against the FDA.
The move comes four months after a similar effort in North Carolina was shelved, but not before generating some controversy over the extent to which consumers would be able to recover any damages from products that may have harmed them. Like the North Carolina proposal, the provisions in the Wisconsin bill would be among the most restrictive in the nation (here is the bill).
At issue is preemption, which is the notion that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued two years ago before the US Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness (back story).
However, the US Supreme Court ruled three years ago in a case brought against the Medtronic device maker that patients injured by defective devices cannot sue for damages in state courts if the FDA approved the device under the pre-market approval process (read here). Recently, though, the PMA process has come under fire. Of 113 products recalled between 2005 and 2009 for posing potentially life-threatening risks, 71 percent were never tested on humans, suggesting reforms are needed (back story).
Opponents of the Wisconsin legislation - which mirrors a law in Michigan, the only state in the country to have preemption on its books - argue that citizens will lose the right to recover damages from harm that citizens in other states are allowed to pursue. Earlier this year, by the way, a Michigan appeals court ruled the state cannot sue Merck in an effort to recover millions of dollars spent on the Vioxx painkiller (read this).
"The bill eliminates the check on manufacturers the civil justice system provides," Ed Vopal, president-elect of the Wisconsin Association for Justice, tells The Center for Media and Democracy's PR Watch. "Manufacturers will have less of an incentive to make their products safe...All this bill will do is prohibit Wisconsin citizens from pursuing justice in the civil court system. It would be devastating for Wisconsin consumers."
The bill, by the way, was one of several submitted to Walker as part of a 'Special Jobs Session' and, essentially, mimics a version of the ALEC 'Drug Liability Act,' according to PR Watch. What is ALEC? As PR Watch notes, this is a corporate-funded national organization that works to craft 'model' bills that legislators can then take on a ready-made basis to propose in their states.