RALEIGH -- Legislation that would protect pharmaceutical companies from lawsuits over drugs that have been approved by federal regulators has been resurrected in time for the short session this spring.
Last year, the protection was stripped from a broader bill that put new restrictions on medical malpractice lawsuits after the bill stalled in the state Senate. Now two draft versions of potential bills focused on that single issue have surfaced in a Senate subcommittee, where they were discussed Tuesday. At least two more public discussions are planned, said the judiciary subcommittee's chairman, Sen. Thom Goolsby, a Republican from Wilmington.
"I don't think there's anybody on the committee who has made their mind up one way or the other," Goolsby said Wednesday. "There's recognition that this was a much bigger issue that warranted study."
Lawyers who represent people who claim they were injured by medicine call the proposal an extreme measure that only two other states - Michigan and Texas - have embraced. They contend the Federal Drug Administration is not able to adequately determine whether a drug is safe.
"We are entrusting the health and safety of our children, our parents and our spouses to a billion-dollar profitable private industry and an underfunded, understaffed bureaucratic agency," Kimberly Wilson, a plaintiff's attorney in Raleigh, told the subcommittee.
Sam Taylor, president of the N.C. Biosciences Organization trade group, says the FDA can be trusted to abide by standards that should also be good enough in court. Drugmakers do their best, he said, to test their products to an extent that is economically feasible, while recognizing that there will always be some people who have different reactions to drugs.
"The challenge we have these days is to try to make a drug that helps the most people possible without harming people whose DNA is different and who react to the drug differently," Taylor said Wednesday. "We don't want to do so little that you run into unintended consequences, but not do so much testing the drug will never make it to market."
Details and the 'off-label' exception
As proposed in the draft bills, the law would give drug companies near immunity from lawsuits over any product that has been approved by the FDA. The person attempting to sue would have to prove a drug was unsafe or ineffective by "clear and convincing evidence," which is a higher standard than that in most civil cases.
Drug manufacturers or sellers would not be able to use the regulatory compliance defense if the product was sold after the FDA withdrew its approval or recalled the drug, if a company intentionally withheld or misrepresented information, or if a bribe was paid to obtain approval.
One version of the draft bill said companies could be held liable if a drug that was marketed for "off-label use" - taken for a reason other than what it was approved for - harmed the person seeking to sue.
Representatives from the state's consumer protection and Medicaid fraud divisions in the state Attorney General's Office also spoke at the meeting to express concerns raised last year that North Carolina could lose out on millions of dollars in settlements. Eddie Kirby, civil chief in the Medicaid Investigations Unit, told the committee the state recovered $39.5 million in civil damages last year. Almost all of the 18 cases the unit settled last year involved allegations of fraud by pharmaceutical manufacturers, he said.
An attorney with the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America told the subcommittee that there was a patchwork of laws from state to state that increases health care costs, discourages innovation and prompts drugmakers to pull products from the market unnecessarily.
