Our Opinion: Drugmaker immunity is a poison pill

Here are four compelling reasons why Gov. Sonny Perdue’s proposal to create a liability-free haven for drugmakers threatens the welfare of Georgians — Vioxx, Rezulin, fen-phen and Bextra.

Perdue proposes to grant drug companies immunity from legal action if the drug in question was approved by the federal Food and Drug Administration. Vioxx and the other three drugs all had FDA approval. All were later pulled from the market after being linked to sometimes fatal problems, including hypertension, stroke, liver failure, severe allergic skin reactions and cardiac failure.

FDA approval doesn’t guarantee that a drug will be 100 percent safe. The agency acknowledges that approved drugs arrive on the market with the possibility of unforeseen risks. The question is who should bear those risks — patients or pharmaceutical companies?

Under Perdue’s plan, consumers bear all the risks. The governor is willing to barter away the common-law right of product liability actions to entice biotech companies to the state.

“This legislation will say that companies with a significant presence in Georgia will not be subject to product liability claims within this state if the FDA approved the medical device, drug or the labeling along with it,” said Perdue on Tuesday. “The legislation will make Georgia an even more attractive environment for biotechnology companies.”

In 1995, Michigan passed the broadest drug manufacturer shield law in the country. Have biotech companies flocked to the state?

“We have had some pharmaceutical companies pack up and leave since then,” says John LaMacchia, legislative aide to Michigan Democratic state Sen. John Gleason, who is fighting to repeal the immunity law. “If we are supposed to be able to harbor these types of companies and provide them great opportunities, then why are they leaving?”

Because it’s not civil liability rules that matter most to biotech companies. It’s a skilled work force, which is why the industry favors New York, Massachusetts and California.

Perhaps conceding that Georgia can’t compete on education, the Legislature seems to be packaging the state as “the place where you can’t get sued.” Lawmakers overlook the critical role of civil liability in policing corporate behaviors and protecting consumers.

Rather than casting the FDA and the tort system as opponents, they should be seen as dual regulators of a billion-dollar industry that impacts the lives and health of millions of Americans. Liability laws exert pressure on Big Pharma to maintain the highest safety standards and to act fast to yank products when problems arise. And when the FDA gets it wrong, the tort system offers insurance to harmed consumers that they can seek corrective justice.

That justice has been denied Leslie Richter of Lansing, Mich. Her husband, Richard, died of a heart attack in 2003 after taking Vioxx for arthritis for two years. Retired from General Motors after 31 years, Richard Richter was a fit and avid hunter when he suffered a stroke in 2002.

“He worked really hard to walk again and get use of his left arm,” said his wife Tuesday in a telephone interview. “Everything was going fine and then in January of 2003, he suffered a brain stem stroke.” He died 44 days later, leaving his family puzzled over how a robust 62-year-old died of a stroke. And then the news broke about Vioxx doubling the risk of stroke in longtime users. “This whole time he was on Vioxx, even when he was in the hospital,” said Leslie Richter.

“In Michigan, people who are harmed have no recourse because of our law,” she said. “We have become second-class citizens. People in Georgia need to be aware of what this could do to them.”

— Maureen Downey, for the editorial board (mdowney@ajc.com).