Michigan Legislature Could Reverse Protection for Drug Companies

Michigan is a real anomaly, legally speaking, in the way it protects drug companies from lawsuits. Michigan is the only state in the country that precludes an injured person from suing a drug manufacturer for injuries caused by that drug if it was approved for use by the FDA. On its face the statute, MCL § 600.2946, may make sense. Before the FDA approves any drug it has to go through a bunch of clinical tests and, if safe, it will be approved. Our system is much more cautious than those employed by European countries, and forget the Third World. Our drugs are the safest in the world right? Not really. The FDA makes mistakes all the time.

This past February the State House voted to change this rule and bring it more in line with the drug liability laws in other states. As yet, it has not passed the State Senate or gone to the Governor to be signed into law. The bill would make liability retroactive, which means if you were injured before the law went into effect you can still sue. The bill is now in the Republican-controlled State Senate. It is unlikely that the Senate will pass the measure, but hope springs eternal.

Because of Michigan's weird law, even if you are killed by a drug in Michigan you generally cannot sue the manufacturer. Perhaps the names Fen-Phen, Prempro, Vioxx, Ephedra, Zelnorm and Propulsid, to name just a few, may ring a bell. All were FDA approved. All caused serious health problems or death. The FDA got it wrong. But if you died here, you could not sue.
The only way you could sue is if you could prove that the drug company who sold the drug somehow "fooled" the FDA into approving it even though it was unsafe or if the company sold the drug after it was recalled by the FDA.

The primary purpose of tort liability for drug and other product manufacturers is to make sure that they do everything possible to turn out a safe product. That they do the proper testing in their labs (not that we do the testing for them in our living rooms). Potential liability verdicts are a great disincentive to kill and injure people. The company American Health Products (AHP) set aside more than $18.6 billion to compensate victims of its heavily marketed diet drug Fen-Phen. If that is not an incentive to proceed with caution when marketing powerful and potentially dangerous drugs I don't know what is.

Here is the text of the law in pertinent part:

(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration's approval at the time the drug left the control of the manufacturer or seller. However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval. This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:

(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act . . . and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.

(b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.

Just in case you were wondering how the law impacts real people, here's a story for you. In 2005, 187 Michigan residents injured by the diabetes drug Rezulin filed claims against the manufacturer, Warner-Lambert, in New York. Rezulin, as you may recall, was pulled off the market in 2000 after it was linked to nearly 400 deaths and thousands of other cases where the patients suffered liver failure. The claims by Michigan residents against Warner-Lambert were dismissed by a New York federal court judge because of the Michigan law. And there are thousands of similar stories.

The change in Michigan's goofy drug liability law would bring our jurisprudence in line with the rest of the country. If you are hurt, you can sue--FDA approvals be damned. Of course, as a practical matter, another feature of Michigan law may still prevent the vast majority of people injured by a dangerous drug to sue. The Michigan legislature also put into place caps on product liability awards. As the caps presently stand, it is very difficult for an injured person to find a lawyer to represent him or her on any products liability case in Michigan. Between the cost of litigation and experts, it is not economically feasible to pursue product liability cases in Michigan, at least on an individual basis. Class actions can provide a way. But repealing the drug liability law would be a great start.