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Bill: FDA approval would bar drug liability claims

Sylvia Adcock//March 25, 2011//

Bill: FDA approval would bar drug liability claims

Sylvia Adcock//March 25, 2011//

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By SYLVIA ADCOCK, Staff Writer

[email protected]

In what plaintiffs’ lawyers are calling a “radical” move, House Republicans are pushing for a measure that would give immunity in products-liability cases to pharmaceutical manufacturers so long as a drug was approved by the Federal Drug Administration.

The provision says that no manufacturer or seller shall be held liable in a products-liability action so long as the product was designed, manufactured, packaged and sold in accordance with the terms of an approval of a government agency.

The immunity would be lifted only if the claimant could prove that the seller sold the product after the date of a move by the government to withdraw it from the market or if the manufacturer obtained approval by the government by bribery or by misrepresentation.

Several other jurisdictions have similar restrictions on liability of pharmaceutical manufacturers, but only one state, Michigan, would prevent claims against FDA-approved drugs in almost any circumstance.

A draft of the bill was unveiled March 23 at a meeting of the House Select Committee on Tort Reform. The draft has also incorporated elements of an earlier bill introduced in the Senate that would give virtual immunity to health-care providers in emergency settings, since the claimant in those cases would have to prove “gross negligence, wanton conduct or intentional wrongdoing.” The draft House bill limits non-economic damages to $250,000; the Senate bill would establish a cap of $500,000. Currently there is no cap on non-economic damages.

Rep. Danny McComas, R-New Hanover, and Sen. Johnathan Rhyne, R-Lincoln, are the bill’s sponsors.

“These proposals would benefit CEOs of corporations, drug companies and groups like the North Carolina Medical Society at the expense of the average North Carolinian,” said Dick Taylor of the N.C. Advocates for Justice in a statement released after the meeting. “These priorities are upside down.”

The draft bill also says that when punitive damages of over $100,000 are awarded, 75 percent of the amount over $100,000 shall go to a government forfeiture fund and 25 percent will remain with the plaintiff.

The committee is expected to hold a public hearing on the issue this week. Last week, the only member of the public who spoke was a representative from pharmaceutical giant GlaxoSmithKline.

John F. Del Giorno, vice president for government relations at GlaxoSmithKline, noted that regulatory compliance makes sure medicines are available to people who need it. He said it takes 10 to 15 years and hundreds of millions of dollars to bring a new drug to market, and that lay judges and juries consider only a “fraction” of what went on to get the approval needed.

Del Giorno said he works closely with the N.C. Chamber of Commerce on legal reform issues.   A state’s legal climate can be a major factor in where a company locates, he said, adding that

“companies look for fairness and predictability, so they can structure their business dealings to conform to the law.  They also look for a cost-effective and efficient civil justice system.”

Del Giorno said the U.S. civil liability system is the most expensive in the world, “increasingly putting companies in North Carolina and other states at a disadvantage compared with their international competitors.”

GSK employs 6,000 people in North Carolina.

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