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MiBiz
Michigan’s Pharmaceutical Product Liability Laws Protect Consumers, Businesses and Employees

9/19/2005

For the first time in months Michigan has given up the title of “highest unemployment rate in the nation.” However, only one-tenth of a percentage point marked our dethronement and we still lag behind the rest of the nation by 1.8 percent. Despite our precarious economic situation, Michigan lawmakers are currently moving legislation that would eliminate one of the main benefits for certain manufacturers to operate in our state; a move that could potentially increase Michigan’s unemployment.

In 1995 the Michigan Manufacturers Association (MMA) led the fight to get control of our state’s product liability laws to reduce frivolous lawsuits and encourage companies — including pharmaceutical companies — to stay in Michigan. One provision of the tort reform law, approved by a bi-partisan Legislature, provided that companies who went through the extensive review required by the U.S. Food and Drug Administration (FDA) and received approval could not be sued for putting on the market a product that government testers agreed was useful and safe.

Today lawmakers are challenging these measures, trying to open Michigan to lawsuits brought by consumers in other states, such as the $230 million Vioxx judgment in Texas last month.

The point that our legislators seem to have lost track of is why these laws were established in the first place. The reason was, and still is, to eliminate costly, frivolous product liability claims because consumers’ rights are already protected by the FDA. The benefit of the laws was to encourage economic growth in our state by giving manufacturers some assurance that if they manufactured a product that was deemed safe by the FDA, they would be protected from product liability lawsuits — unless, of course, they withheld information from the government or misrepresented the information provided.

We must remember that pharmaceutical companies work with the FDA for at least seven years in trials and tests proving that their product is safe for consumers, a thorough (and expensive) endeavor that no other industry must complete. Our national government approves of these products before they are ever placed on the market. That approval must count for something or it makes no sense. How can we expect companies to stay in business if we require them to undergo such a stringent process and then say, “Sorry, you’re on your own” if they are later sued?

The FDA’s approval process protects consumers. It should also stand to protect pharmaceutical companies. If a drug manufacturer cannot have at least a minimum level of assurance that they are protected from frivolous lawsuits by the FDA’s approval, what will entice them to research and develop the next miracle drug? Yes, there is a desire to help mankind but even philanthropic organizations have a bottom line and need to make sound business decisions.

Michigan’s pharmaceutical product liability laws protect the consumer from unscrupulous companies. Any pharmaceutical company that is shown to have deliberately misled the FDA anywhere in the product approval process loses its immunity and can then be sued by consumers. Through the approval process scientists may have differing opinions and this information is noted in the drug trial records. Consumers with a concern can access this information to make a case for whether or not the drug company withheld information from the FDA.

With all prescription drugs, warnings are issued to physicians and handed out on literature declaring that patients with certain conditions should not take the product or certain serious side effects may occur. How can a court determine whether or not a patient had one of these underlying conditions or even if the patient followed the correct dosage. As with anything in life, we must weigh the risks and benefits of any decision we make. Consumers and doctors must assume this responsibility with medication.

There is no doubt that Michigan needs an economic revival. The Granholm Administration has made it a priority to increase Michigan’s biotechnology sector by offering tax incentives to pharmaceutical companies to perform product development here. The biotech industry is one of the fastest growing industries in the nation. Encouraging these companies to locate and stay in our state could vastly improve our economic climate and reduce our unemployment rate. It’s good business for Michigan.

The question remains then, why would Michigan’s legislators take a huge step backward and rescind laws that are working, protecting both consumers and businesses? Michigan needs to protect its best interests for both consumers and businesses and that means protecting the current pharmaceutical product liability laws.

Chuck Hadden is vice president of government affairs for the Michigan Manufacturers Association, an advocacy organization representing manufacturers statewide.

This article appeared in the September 2005 issue of MiBiz, read by upper management executives in West and Southwest Michigan. Print subscriptions are free to qualified individuals who are employed in West and Southwest Michigan. For further information about MiBiz Network, see the MiBiz Web site.

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