North Carolina lawmakers have approved legislation that would shield drug companies from state liability suits. The state's House voted 86-32 to grant FDA-approved drugs immunity from lawsuits, putting the new law in the hands of the state Senate.
If the legislation passes, it would be among the most sweeping protection for drugmakers in the U.S., second only to a Michigan law that allows FDA approval to preempt state-court liability claims.
The North Carolina version originally protected drugmakers from suits over FDA-approved meds, so long as fraud wasn't involved. But as Pharmalot reports, the new version allows suits if plaintiffs have "clear and convincing evidence" that a drug was unsafe or ineffective. That's a pretty high bar to clear up-front, "a higher standard than in most civil cases," one legal expert tells Pharmalot.
North Carolina's attorney general is among critics of the bill; he's worried that the state wouldn't be able to go after drugmakers for fraud if the bill passes. In Michigan, for instance, an appeals court recently ruled that the state can't sue Merck over the millions of dollars it spent on the now-withdrawn painkiller Vioxx.