North Carolina Law Makers Float Drug Company Immunity Bill

Lawmakers in North Carolina have proposed a bill that would shield drug manufacturers from lawsuits by consumers who have been injured by their products. 

The draft bill (pdf), floated last week by North Carolina Republicans, would prevent anyone from suing a drug company for injuries caused by a medication they were taking as long as the drug was approved by government regulators.

If passed, it would make North Carolina the second state to pass such a restrictive measure. Michigan has a similar law that restricts their residents from holding pharmaceutical companies responsible for selling dangerous or defective medications, and there are currently ongoing efforts to have that law repealed.

The North Carolina legislation is part of a larger tort reform package that seeks to cap noneconomic damages, such as pain and suffering, at $250,000 from each defendant in a tort lawsuit. North Carolina House Republicans are also proposing in the bill that the state be able to step in when a jury awards punitive damages and take from the plaintiff any money in excess of $100,000. That money would be added to a state fund to support public schools. The bill has been proposed by State Rep. Johnathan Rhyne Jr., chairman of the House Select Committee on Tort Reform, and Rep. Daniel F. McComas.

A similar bill has already been passed by the North Carolina Senate, but that bill has a $500,000 cap and no provisions to protect drug companies from residents seeking compensation for injuries they cause. It also contains no provision allowing the state to take a portion of a plaintiff’s punitive awards.

The proposed shield law for drug companies is commonly referred to as preemption. Supporters of such laws argue that drug companies should not be held liable for medications when they received approval from the FDA. However, critics say that the agency is woefully underfunded and does not have the power, reach or infrastructure to completely carry the burden of U.S. drug safety. Opponents also argue that drug manufacturers, not federal regulators, are ultimately responsible for ensuring that they adequately research their medication and take steps to warn consumers about potential injury that may be caused by their product.

In 2009, the U.S. Supreme Court ruled that failure to warn cases against drug makers are not preempted by federal law because a medication is approved by the FDA. In Wyeth v. Levine, the court determined that drug companies could be held responsible for failing to warn the public about potential drug side effects that go beyond what is required by the FDA.