Wednesday, April 13, 2005

Bextra recall prompts Michigan law change

Michigan is the only state in the United States that has robbed its residents of the right to ask for compensation if a drug company makes defective drugs. The idea initially was to make the state "business friendly" but the net result is that thousands of victims of Vioxx and Bextra (and many other drugs) have no legal rights to sue drugmakers. Texas also has some laws that make it extremely difficult for residents in the state to sue drugmakers. (Previous article: Michigan and Texas residents not allowed to sue Merck)

The democrats in Michigan now want to change the law so that Michigan residents will have the same rights as residents of 49 other states. Most other countries in the world allow similar rights to their citizens. The Michigan House Democrats recently announced a package of bills to end the drug industry’s legal immunity from responsibility for dangerous drugs, saying the industry must be held responsible when its products harm Michigan residents. It is unlikely that the legislation will pass since it is bound to encounter stiff opposition from drugmakers, pharmaceutical industry lobbyists, and Republicans.

“There is only one state in the country that gives the powerful drug industry absolute immunity for the harm their products cause, and that state is Michigan,” said Rep. Dianne Byrum (D-Onondaga), House Minority Leader and a lead sponsor of the bills. “We should be leading the country in consumer protection. But when it comes to protecting consumers from the drug industry, we’re dead last. It is shameful that Michigan residents who have been harmed by prescription drugs have no recourse simply because they live in our state.”

The proposed bills would repeal a 1996 law granting legal immunity to drug companies. Passed by Gov. John Engler and the Republican-controlled legislature, that law gives companies complete immunity from legal action so long as the drug in question has been approved for safety and efficacy by the U.S. Food and Drug Administration (FDA). However, now it is widely believed that the FDA has been hijacked by the drug industry and no one can trust the judgment of FDA any more when it comes to drug safety. (Related article: Doctors lose trust in FDA)

But in the wake of recent scandals surrounding drugs like Vioxx, Rezulin, Fen-Phen and Bextra; the revelation that many members of FDA drug-approval boards have ties to the pharmaceutical industry; and the public testimony of FDA scientists like Dr. David Graham that the FDA’s system for drug evaluation is “broken,” House Democrats said Michigan residents cannot blindly trust the FDA and must have legal recourse when harmful drugs make it to the market. (Related article: Merck successfully manipulated FDA in Vioxx recall case)

The Democrats’ bills are retroactive so that Michigan residents harmed by prescription drugs since 1996 can seek legal remedy, and include drug companies in the Consumer Protection Act, from which they are currently exempted. “For too long, our residents have been put at risk by FDA-approved medications like Vioxx and Rezulin, only to be told by the courts they’re on their own,” said Rep. Gary McDowell (D-Rudyard). “It’s past time to end special protection for big drug companies that profit from drugs that harm and even kill people.”

In February, 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.

Vioxx was banned in 2004, and may have caused heart attacks or cardiac deaths in up to 139,000 Americans, based on Merck’s own studies. And the weight-loss medication Fen-Phen was banned in 1997 after causing hypertension and heart-valve abnormalities in tens of thousands of people nationwide. Bextra was taken off the market last week due to an increased risk of heart attack and serious skin reactions among the painkiller’s users.

“The drug industry has the highest profit margin of any industry in the country,” said Rep. Marie Donigan (D-Royal Oak). “Those profits were built on drugs like Vioxx, which raked in $2.5 billion in worldwide sales in 2003 alone. It is ludicrous that such a profitable industry should be allowed to dispense any medication it can strongarm the FDA into approving and then escape responsibility when those drugs harm our residents.

“Michigan residents shouldn’t be treated like second-class citizens,” Donigan added. “It’s time for Michigan to join the other 49 states and hold the drug industry accountable for its actions.”

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