North Carolina Preemption Effort Is Shelved

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North Carolina Preemption Effort Is Shelved

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By Ed Silverman // June 14th, 2011 // 7:34 am

A contentious provision in a North Carolina bill that would protect drugmakers and those selling medications from liability in lawsuits was removed late yesterday by a legislative committee, effectively tabling the proposal. The move ends a heated debate over legislation that would have made it harder for North Carolina consumers to recover damages from harm allegedly suffered by a prescription drug than citizens in any other state in the US, except Michigan. At issue has been preemption, which is the notion that FDA approval of a drug 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. Michigan is the only state that has a preemption law.

However, North Carolina legislators earlier this year began considering a similar proposal, prompting furious lobbying between the pharmaceutical industry and plaintiffs’ lawyers. State legislators recently softened their proposal, but not enough to avoid repeated criticism from North Carolina Attorney General Ray , who worried the state would be precluded from recovering damages from drugmakers that commit fraud, but are shielded due to FDA approval (back story).

At a committee meeting late yesterday, state Senator Pete Brunstetter announced the section containing language offering protection for drugmakers was being pulled from the bill and sent to a study committee. Brunstetter noted several senators had expressed reservations, according to reports. For now, the bill is dead, although it could be revived in the 2012 legislative session next spring.

In arguing against the bill, Burton Craige, legal affairs counsel for North Carolina Advocates For Justice, a non-profit group that represents attorneys, cited several policy reasons: drugmakers failed to explain why North Carolina consumers deserve less protection than citizens in 47 other states; backers never identified any verdict under current North Carolina law that justifies new legislative protection for the pharmaceutical industry.

The group also maintained the bill does not provide incentive for any out-of-state drugmaker to locate or stay in North Carolina, and would not create new jobs in North Carolina. GlaxoKline, for instance, has a large presence in the state. At the same time, the group maintained the bill would have caused millions of dollars in losses to state Health Plan and Medicaid funds.

Hank Greenspan, a social ethics lecturer and faculty scholar in integrated medicine at the University of Michigan Medical Center, who was active behind-the-scenes in the debate in North Carolina, sent us this note: “North Carolina now joins a group of states that have rejected statutes even vaguely resembling Michigan’s absolute drug industry immunity law. In these states, sanity and justice have prevailed. The positions of the US Supreme Court, NEJM and JAMA, and 70 years of FDA history have been affirmed.