LANSING – Macomb County lawmaker in the Michigan House of Representatives today took a stand for Michigan residents who have been hurt by dangerous prescription drugs by voting to repeal a state law that gives drug companies complete immunity when their products harm or kill.
"It's not right that our state is the only one in the whole country that protects big drug companies when their products harm or kill," said State Representative Jennifer Haase (D-Richmond). "Michigan residents deserve the same consumer protections that every other American has. We must act to ensure they are not treated as second-class citizens simply because they live in Michigan."
The plan that passed the Michigan House today will:
- Repeal a 1996 law granting immunity to drug companies. 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.
"Our state is the only state in the nation that gives pharmaceutical companies a free ride when their products harm or kill," said State Representative Sarah Roberts (D-St. Clair Shores). "Michigan consumers deserve a voice when a dangerous drug makes it through the FDA's screening process and is later proven to be unsafe. We must give the people of Michigan the power to hold drug companies accountable."
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.
Georgia's Governor proposed a drug industry immunity law for that state that would be similar to Michigan. The measure met with opposition from the Republican-controlled Senate. An editorial in the Atlanta Journal-Constitution called the plan a "poison pill" that would "create a liability-free haven for drugmakers." (2)
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)
"For more than 10 years, our residents have been put at risk by FDA-approved drugs such as Vioxx and Rezulin, only to discover that they're on their own when these drugs turn out to be harmful," said State Representative Jon Switalski (D-Warren). "We must put our residents' needs ahead of wealthy special interests. I urge my colleagues in the Senate to stand up for our residents and hold drug companies to the same consumer-protection standards that other businesses are."
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(1) U.S. Supreme Court, Wyeth v. Levine, March 4, 2009
(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