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NC Lawmakers Punt on Drugmaker Liability Bill

Subcommittee sends bill back to larger Judiciary Committee, “questions” still linger

By Rose Hoban

Bill Prewitt gave emotional testimony about the loss of his granddaughter, Brittany, who died while she was taking a drug to control her acne.

At the March subcommittee hearing, Bill Prewitt gave emotional testimony about the loss of his granddaughter, Brittany, who died while she was taking a drug to control her acne.

A bill that would significantly raise the bar for people suing pharmaceutical companies when they’re injured by a drug was sent back to the senate judiciary committee yesterday after several months of meetings and, at times, emotional testimony from opponents.

Senators on the judiciary Subcommittee on Pharmaceutical Liability did not make any changes to the proposed legislation and said there were still ‘questions’ about the bill.

Subcommittee head Sen. Tom Goolsby (R-Wilmington) was unwilling to comment whether he would introduce the bill to the larger General Assembly during the legislative session next month. He said he would leave that decision up to the head of the Senate J1 Justice committee.

Official photo: Tom Goolsby

Tom Goolsby, Official photo from NC General Assembly

Usually, subcommittee members create reports, mark up bills or make recommendations to committee chairs on proposed legislation, but Goolsby said his subcommittee would not be making any changes or recommendations.

The bill, labeled a ‘product liability defense based on FDA regulatory compliance’, was resurrected after being cut out from a larger piece of tort reform legislation considered last year. Senate Bill 33 eventually went on to become law after product liability language was taken out of the bill.

The bill would create a defense for drug companies sued after patients are harmed from taking medications that had been approved by the Food and Drug Administration. A patient could proceed with suing a drugmaker only if their lawyers could prove drug companies engaged in fraudulent behavior during the drug approval process, or bribed an FDA official.

Only one other state, Michigan, has such legislation. Several other states have bills that are weaker than what is proposed in North Carolina.

The state attorney general’s office has expressed opposition to the bill. Eddie Kirby from the AG’s office testified the bill would place an “enormous evidentiary burden the state” making it difficult for North Carolina to recoup expenses created when drugs harm patients.

Michigan was unable to participate in a lawsuit against drugmaker Merck to recoup money for harm done to that state’s Medicaid patients by the painkiller Vioxx as a result of their law. Kirby estimated the loss to Michigan to be about $20 million.

Drugmakers from inside and outside of North Carolina support the measure and representatives from GlaxoSmithKline and the Pharmaceutical Research and Manufacturers of America (PhRMA) spoke at Wednesday’s subcommittee meeting as well as at the other two hearings in February and March.

“Pharmaceutical companies are competing in a global economy. North Carolina is not only competing with other states, but with other countries like Spain, the United Kingdom and Singapore,” Roland Larino, finance director at GSK’s Zebulon facility told the committee. “Passage of this bill would illustrate North Carolina’s commitment to the industry and to innovation.”

Eric Mansfield, headshot

Eric Mansfield, Official photo from NC General Assembly

Families of patients killed by problematic drugs also delivered, at times, emotional testimony at earlier meetings.

This year’s version of the bill had slight changes from last year’s language, but Mansfield said he still had large questions about the wisdom of the bill.

“My biggest concern is… is the guy who just goes to his doc and his doc says, take this medicine and he goes OK, because you told me to. He takes it and he has some bad problem,” said Sen. Eric Mansfield (D-Fayetteville), an ear, nose and throat doctor. “He has to have some recourse other than the bar that we’re setting that is pretty high.”

“Obviously when the Department of Justice and the Attorney General’s office has some serious concerns, and I have some serious concerns… hopefully we need to chew on it more,” Mansfield said.

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