RALEIGH (AP) — North Carolina consumers could find it more difficult to sue drug companies if legislation passed by the state Senate becomes law.
The Senate approved a measure Wednesday that gives drug companies a presumption in court that they are without fault as long as they have previously warned of specific side effects cited in any lawsuit and as long as they have followed all Food and Drug Administration rules.
Supporters said the change, included as an amendment to a larger commerce bill, levels the playing field for drug companies and consumers, but critics said it could affect people harmed by products if adverse side effects are discovered after drugs are approved.
A Senate committee struck down a provision earlier this week that would have shielded manufacturers from product liability if they followed federal rules.
Sen. Tamara Barringer, R-Wake, introduced the amendment. She said it was very limited in scope and would not prevent anyone from having their day in court.
Pharmaceutical companies endure a rigorous regulatory process before their products are approved and the amendment would help the state maintain a friendly atmosphere for company investment and research, Barringer said.
Some senators expressed reservations about the impact the rules would have on efforts to make companies take responsibility in cases where people are harmed by defective or dangerous drugs.
“What I worry about is recalls when a company reasonably should know they ought to do something, to take a dangerous product off the market, but it’s before the FDA or whatever the intervening agency might be, orders a recall order,” said Sen. Dan Blue, D-Wake.
The amendment applies only to pharmaceutical drugs, and does not include design defects for a product or a medical device.
“It’s certainly not a bar to recovery,” Barringer responded. “The plaintiff would have to come forward and show that, but it’s no bar whatsoever.”
The Senate bill also lays out rules to help companies fight false claims of patent infringement in court, and mandates transparency in contracts between the Attorney General’s office and private attorneys. It also establishes a three-judge panel of the Wake County Superior Court to hear cases on the constitutionality of General Assembly laws. The judges on the panel would be appointed by the Chief Justice of the state Supreme Court.
The bill now heads to the House for consideration.