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Questions raised over Michigan law that protects drug makers

LANSING, Mich. (AP) - January 2, 2005 - Their last evening together, a Friday, Susan Halvorsen and her husband Jim Gjebic stayed in. It was a simple start to what was supposed to be a restful 2001 Labor Day weekend -- dinner, followed by the horror flick, "Warlock."

At midnight, Gjebic felt pain in his upper right thigh. Like many times before, Halvorsen handed him the painkiller Vioxx, a drug used to treat his rheumatoid arthritis. She went to bed and her husband stayed up. The next morning, Halvorsen found Gjebic lifeless in their Grosse Pointe Farms home, sitting upright on the couch, dead of a heart attack. He was 34.

"When he passed away, I didn't think it was because of anything he was taking," Halvorsen said, holding back tears. Merck & Co. pulled Vioxx from the market on Sept. 30 after a study showed the drug doubled the risk of heart attacks and strokes. "I was floored when they took if off the market," said Halvorsen, a 37-year-old marketing consultant. "People don't die when they're 34 years old and have arthritis."

Now, Halvorsen and countless other Michigan residents want to sue the pharmaceutical giant. But a unique law makes that extremely difficult. Michigan is the only state in the country with a law that shields drug makers from liability if the drug was approved by the Food and Drug Administration, according to the Michigan Trial Lawyers Association. Plaintiffs can win damages only if they prove a company withheld or misrepresented information about a drug that would cause the FDA to not give or withdraw its approval.

Supporters say the 1995 law helps to cut down on junk or frivolous lawsuits that undermine public health and drive up insurance premiums and other business costs. It was part of tort reform legislation passed by the Legislature and former Gov. John Engler in the mid-1990s. The law presumes that companies do not manufacture defective or harmful drugs once they receive FDA approval, said Elizabeth Thomson, a Southfield attorney whose firm has been "bombarded" with calls from Vioxx users.

But in recent months, the FDA has come under intense scrutiny because of health risks linked to the use of Vioxx; painkiller Celebrex, Pfizer Inc.'s similar cox-2 inhibitor; and now Aleve, which is sold over the counter. A drug-safety director says the agency suppressed research showing the dangers of Vioxx. There also are concerns that FDA officials are too close with industry lobbyists. Critics say the Michigan law harms patients who have no recourse in state courts and cannot trust the FDA to adequately protect them.

"If the government isn't holding companies responsible, it is up to citizens to do so," said Megan Owens, the consumer advocate for the Public Interest Research Group in Michigan. "And if they're blocked from suing, who is keeping these things from happening?"

In the eight years since the law took effect, various FDA-approved drugs have gone to market and later been withdrawn: diet drug Fen-Phen, cholesterol-lowering Baycol, insulin substitute Rezulin and others. Lawyers say Michigan residents have some options to get around the state law, but they are unlikely. Suing out of state can be costly, and going to federal court usually means Michigan law will be applied if the case goes to trial. It also is difficult to prove that a company lied during the approval process. "It's a thin hope," said attorney J. Douglas Peters, who has filed a federal lawsuit against Merck on behalf of five state residents. He said it was mainly to keep their time limit from expiring in case the law is changed.

Peters said his Detroit firm, Charfoos & Christensen, has received more than 350 calls from Vioxx patients or their families. "I've been turning the cases down," he said. "The wrongdoer is getting off scot-free. To grant an entire industry immunity is unique in American jurisprudence."

A Merck spokeswoman said the drug maker, which faces at least 465 lawsuits nationwide, has a strong defense. The state law is favored by business groups and lawmakers who say companies need protection from greedy trial lawyers who file exorbitant lawsuits. They argue that limiting liability restrains the cost of doing business in an industry that spends millions of dollars on research and goes through rigorous screening.

Chuck Hadden, a lobbyist for the Michigan Manufacturers Association, said the law was intended to safeguard the Upjohn Co., a Kalamazoo-based pharmaceutical that later folded into Pfizer Inc. Pfizer employs thousands of workers in Michigan. "These companies go through a drug screening process that is the toughest in the world," he said. "They ought to have some sort of protection." At the heart of the debate is a fundamental difference over the effect of lawsuits.

Those who want the state law overturned say the lawsuits get drug makers' attention and help to compensate the injured or their families. Supporters of the law say lawsuits discourage companies from creating new drugs for society's benefit. There have been efforts to overturn the law, but courts upheld its constitutionality. In 1997, the then Democratic-controlled House passed a bill to reverse the law and it went nowhere in the Republican-led Senate. Republican Sen. Alan Cropsey of DeWitt was one of a few Republicans to oppose the shield law when he was in the House.

"It's devastating to consumers," he said. "It's so un-Republican for Republicans to be saying it's up to a government agency to determine what's right or wrong. We have to get some more people in the Legislature who understand how people have been hurt by this."

But backers say the real complaint may be with the FDA. "Changing tort reform will not improve the FDA's handling of drug approval," said Ari Adler, spokesman for Senate Majority Leader Ken Sikkema, R-Wyoming. "You don't get the FDA to do its job better by allowing trial lawyers to make more money."

Michigan Manufacturing Association: http://www.mma-net.org

Merck and Co.: http://www.merck.com

Pfizer Inc.: http://www.pfizer.com

Food and Drug Administration: http://www.fda.gov

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