Immunity for makers of FDA-approved drugs upheld in Michigan.

In a setback for consumers allegedly harmed by prescription drugs, the Michigan Supreme Court upheld the immunity from liability suits that the state bestows on manufacturers and sellers of FDA approved pharmaceuticals. It rejected the plaintiffs' argument that a 1995 amendment to the statute conferring immunity was an unconstitutional delegation of the legislature's powers to the FDA. (Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003).)

The decision arose from two consolidated cases filed against the manufacturers and distributors of prescription diet drugs, notably dexfenfluramine (Redux), and fenfluramine and phentermine (known as fen-phen when taken together).

The plaintiffs allege that the drugs caused side effects such as primary pulmonary hypertension and psychological and neurological ailments. These claims were not resolved in a 2000 class action settlement between users of diet drugs and American Home Products (AHP), which had the exclusive right to market fenfluramine until 1997. AHP is one of the defendants in Taylor.

In each of the two cases, filed in different trial courts, the defendants cited Michigan's immunity statute and asked the judge to dismiss the claims. The plaintiffs opposed the summary judgment motions by challenging the constitutionality of the statute.

The two courts arrived at different conclusions on the issue. The court of appeals consolidated the lawsuits and found the statute unconstitutional, saying that it makes the FDA the final arbiter of whether a particular drug may be the subject of a products liability suit in Michigan. (Taylor v. Gate Pharms., 639 N.W.2d 45 (Mich. Ct. App. 2001).)

The supreme court disagreed, holding that "a delegation of legislative power does not occur" just because a state chooses to use the findings of a federal agency as a legal standard in litigation. If the findings are the result of agency work that is wholly separate from the statute that has adopted those findings, rather than undertaken with the intent of making state law, then the restriction on delegation of powers has not been violated.

"The FDA does not decide who may bring a products liability action in Michigan," Judge Clifford Taylor wrote for the majority. "Rather, for its own reasons that are independent of Michigan tort law, it simply makes a factual finding regarding the safety and efficacy of drugs." The legislature chose to adopt the FDA's findings only as a standard by which to determine whether reasonable care has been taken by drug manufacturers or sellers, the court said, in the same way that states adopt the findings of the National Bureau of Standards when referring to weights.

The plaintiffs will refile, this time claiming that the manufacturers defrauded the FDA when they withheld information that suggested the drugs could cause heart-valve damage from their application for approval. Michigan's immunity does not apply if a manufacturer withholds or misrepresents information that would have prevented the FDA from approving the product.

David Parker of Detroit, who represented the plaintiffs on appeal, said this loophole offers faint hope. "We can show the misrepresentations," he said, but proving the FDA's reliance on them might be more difficult: "The FDA is notoriously tight-lipped about saying what they would have done if the entire submission had been available to them at the time they made their decision."

However, Parker said he will be able to show the court that the level of misrepresentation was so great that the FDA must have relied on the distorted information, and he expects that the case ultimately will qualify for the exception. He said Michigan is the only state to confer such immunity on drug makers and to require plaintiffs to demonstrate what the FDA relied on in its decision-making process.

Plaintiff lawyers in Michigan said refiling the case provides an opportunity to bring the statute's effects to the legislature's attention. "Unfortunately ... you have to have innocent victims who are harmed in the worst way with unjust results until we ultimately open people's eyes," said Bryan Waldman of Lansing, president of the Michigan Trial Lawyers Association.

Many legislators who enacted the statute have since left office, and Waldman said it important that their successors "see that these 'reforms' are causing harm. They're not helping anyone. They're harmful to constituents, and they're harmful to society."