LANSING – In an effort to repeal a state law that gives drug companies complete immunity when their products harm or kill, State Representative Gary McDowell (D-Rudyard) on Thursday took a stand for Michigan residents who have been affected by dangerous prescription drugs.
"There aren't very many businesses that can get away scot-free when their products cause harm," McDowell said. "The protection for drug companies in Michigan has to end. This plan will ensure our residents, who have been hurt or even killed because of harmful side effects, get their say – not suffer without any chance of repercussions. It is time to end this law."
The House has been fighting to repeal drug industry immunity since 2005. The House took action to end drug industry immunity in 2007, but the plan met with opposition in the Republican-controlled Senate. The plan that passed the Michigan House on Thursday will:
- Repeal a 1996 law granting immunity to drug companies. Passed by then-Governor John Engler and the Republican-controlled Legislature, the law gives companies complete immunity in Michigan when their products harm or kill if the drug has been approved by the U.S. Food and Drug Administration (FDA).
- Make the repeal retroactive so Michigan residents who have been harmed by dangerous drugs since 1996 can hold drug companies accountable.
- Include drug companies in the Consumer Protection Act, from which they are exempt.
Recent action in the U.S. Supreme Court and in Georgia has called attention to the flaws in Michigan's drug industry immunity law.
The U.S. Supreme Court ruled on March 4 that a drug manufacturer is responsible for the content of its label if the product causes harm or death, despite FDA approval of the label.[1] The ruling came in the case of a woman who took action to hold drug maker Wyeth accountable when she lost her arm to gangrene after being injected with an anti-nausea medication.
In 2005 claims by 187 Michigan residents against Warner-Lambert, maker of the diabetes drug Rezulin, were dismissed by a New York federal court judge because of the Michigan law. Rezulin was pulled off the market in 2000 after it was linked to nearly 400 deaths and thousands of cases of liver failure.[3] Vioxx, an anti-inflammatory drug that its maker, Merck, pulled off the market in 2004, may have caused heart attacks or cardiac deaths in up to 139,000 Americans, based on Merck's own studies.[4] Bextra was taken off the market in 2005 due to an increased risk of heart attack and serious skin reactions among the painkiller's users.
In the wake of scandals surrounding drugs such as Vioxx, Rezulin and Bextra, there have been revelations that members of FDA drug-approval boards have ties to the pharmaceutical industry. The public testimony of FDA scientists such as Dr. David Graham has indicated that the FDA's system for drug evaluation is "broken."[5]
"Our residents must be our first priority," McDowell said. "Michigan is the only state in the nation that lets big drug companies off the hook when their products harm or kill. I call on my colleagues in the Senate to pass this plan and put our residents' best interests before profits."
[2] The Atlanta Journal-Constitution, "Drugmaker immunity is a poison pill," Jan. 14, 2009
[3] Anstett, Patricia and Norris, Kim. "Michigan Rezulin lawsuits tossed," Detroit Free Press, Feb. 25, 2005
[4] Testimony of David Graham, associate director for science and medicine in the FDA Office of Drug Safety, before the Senate Finance Committee, Nov. 18, 2004
[5] Graham testimony before the Senate Finance Committee, Nov. 18, 2004