Drug manufacturers are a step closer to winning liability protections they say they need before they will invest in medicines to combat a bird flu epidemic.
Opponents described the protections, approved Monday by the U.S. House of Representatives, as a “massive Christmas bonus to the drug companies.”
Consumers seeking damages on claims of harm by a vaccine would have to prove willful misconduct on the part of the drug manufacturers. That is a higher standard than negligence, which is used in many product liability cases.
“Negligence is much easier to prove; it’s the failure to exercise reasonable care,” said Carl Tobias, a professor at the University of Richmond School of Law. “Willful misconduct is a much higher standard. You must intentionally misbehave. … The high standard would clearly discourage many suits.”
Senate Majority Leader Bill Frist, a medical doctor, led the fight for the additional protections. Amy Call, a Frist spokeswoman, said drug companies don’t view flu vaccine as profitable and won’t get in the business if the potential liabilities outweigh the potential benefits.
“When you’re asking a company to come in and develop something new that they won’t make money off, … there’s no reason for them to get into the market,” Call said.
Frist attached the legislation to the Defense Appropriations Bill, passage of which is viewed by lawmakers as mandatory because it will pay for military operations in Afghanistan and Iraq. The Senate will take up the bill Wednesday or Thursday.
Democrats opposed attaching the liability protections to the defense bill, as well as the substance of the legislation.
“This liability shield can be granted to any product used to prevent or treat an epidemic or a pandemic, and the secretary gets to decide what that means. No court can review that decision,” said Democratic Rep. Henry Waxman.
Trial lawyers also attacked the legislation.
“In the dead of night, when no one was watching, U.S. Senator Bill Frist provided his corporate friends in the drug industry with an unprecedented giveaway that puts the health and safety of Americans at risk,” said Ken Suggs, President of the Association of Trial Lawyers of America.
Frist’s family earned a fortune in the hospital industry.
“The trial lawyers apparently would prefer to keep filing frivolous lawsuits and collecting excessive attorney fees rather than making sure public health is protected and injured parties are compensated,” Frist spokeswoman Call said.
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