Pillboxed in

Today, however, Cropsey considers the tort reform movement “misguided.” What helped convert him was a decision made last March by the Michigan Supreme Court to throw out lawsuits from female victims of the drug fen-phen, a once-popular weight-loss aid blamed for hundreds of deaths in the mid-1990s. Many of the women have pulmonary hypertension, the usually-fatal lung disease linked to Pondimin, the “fen” in fen-phen. Yet despite indications that Wyeth, the manufacturer of Pondimin, had sat on knowledge of the drug’s dangers while the U.S. Food and Drug Administration was reviewing it, the court ruled that the company could not be sued. Why? Under a 1995 law pushed by then-Gov. John Engler and backed by a well-funded array of business groups and conservative activists, if a drug had been approved by the FDA, its manufacturer cannot be sued in Michigan for any harm it may cause–even if the manufacturer knew in advance of potential hazards. Cropsey calls the law “horrible,” saying his opposition is “a matter of moral principle.” The women, he argues, “are being denied justice.”

In fact, similar “shield laws” exist in Utah, New Jersey, Oregon, Colorado, and Arizona, while several other states, including Ohio, are considering their own version–thanks to a sophisticated squeeze play by pharmaceutical lobbyists and tort-reform activists. On one side, they’ve been pushed to defang the FDA: In 1994, after complaining about the spiraling costs involved in getting a drug approved by the agency, pharmaceutical companies convinced Congress to pass legislation forcing the FDA to approve drugs more quickly. The legislation has enabled some groundbreaking new drugs, including some lifesaving new AIDS medications, to get on the market faster. But the changes have also resulted in the FDA overruling doctors who have legitimate concerns about safety. According to a 1998 survey by Public Citizen, for example, at least 27 drugs were approved during the late 1990s over the objections of the FDA’s safety reviewers. Ten of them have been withdrawn from the market since Michigan’s FDA shield law went into effect, including the diabetes drug Rezulin; the heartburn drug Propulsid; the painkiller Duract; and the anti-cholesterol drug Baycol. Yet even as drug industry lobbyists continue to push for further weakening of the FDA approval process, industry funded tort-reform activists have worked to convince state legislatures that drug companies shouldn’t be held accountable when those changes result in drugs that kill people. In Cropsey’s view, Michigan’s shield law is the functional equivalent of welfare without work requirements. “It’s a way of protecting companies from their own behavior,” Cropsey says. “If welfare mothers have to pay for their behavior and their mistakes, why shouldn’t large corporations that knowingly sell deadly drugs?”

The fight over Redux, a diet drug almost identical to Pondimin, is a case in point. Internal Wyeth documents show that while Redux was undergoing FDA review during the mid-1990s, cases of pulmonary hypertension linked to the drug were skyrocketing in Europe. Intent on moving Redux into the lucrative U.S. market, Wyeth downplayed evidence that might have given FDA examiners second thoughts. (By early 1996, for instance, Wyeth was already maintaining an internal pulmonary hypertension “death listing report,” suggesting it was aware of problems with the drug.) It took an unprecedented two meetings of the FDA’s advisory committee for the drug to finally be approved, and even then, in April 1996, the senior doctor in charge of reviewing Redux refused to sign the approval letter.

A year and a half later, after the Mayo Clinic publicly reported that some of its patients taking the drug had required heart surgery, Wyeth “voluntarily” withdrew Redux–which did not deter its lawyers from arguing in the Michigan lawsuit that, since the drug was still technically approved by the FDA, the victims should not be able to sue. The court agreed. And users of Rezulin, Baycol, Propulsid, Duract, and several drugs linked to hundreds of deaths before the drugs were “voluntarily” withdrawn by their manufacturers will likely encounter the same obstacle in states with shield laws. Moreover, thanks to a U.S. Supreme Court ruling in 2001, no one can sue a drug maker for fraud against the FDA unless the FDA itself does (which the agency appears disinclined to do, especially under a pro-business Republican administration). Michigan’s law does make an exception in cases where plaintiffs can prove that the FDA would not have approved the drug had it known the scope of the danger beforehand. But that’s proven a very tough standard to meet since, as Jane Bailey, head of the Michigan Trial Lawyers Association, puts it, the FDA “will never let one of its doctors testify about whether or not it would have approved a drug.”

Cropsey, who calls Michigan’s shield law a “get-out-of-jail-free card,” would like to junk it entirely. But given the forces aligned against him, for now he’s pushing for smaller changes. One possible amendment would revive a loophole deleted from the original bill in 1995, allowing lawsuits in cases where a drug company knowingly hid information from the FDA about a product’s possible effects. Another amendment would allow lawsuits in cases where a drug was approved by FDA administrators over the objections of FDA safety reviewers, as was the case with Redux. “People are starting to realize that this law protects corporations–but it hurts consumers,” says Michigan state Rep. Alexander Lipsey, who sits on the House Judiciary Committee.

But while Cropsey and his allies try to fix Michigan’s law, business groups are working to get versions of it passed in other states. The American Tort Reform Association (ATRA), a key force behind the new state laws, cites 20 states as considering either shield laws or caps on verdicts against drug manufacturers. And just in case gaming the FDA and blocking state-level lawsuits don’t do the trick, the pharmaceutical industry is going after Congress. Last year’s Republican-inspired legislation to limit damages in medical malpractice lawsuits also included, not coincidentally, provisions designed to shield drug companies from such actions. That legislation failed, but the GOP is widely expected to revive it during next year’s election campaign. Says Cropsey, “They are using the doctors’ crises with malpractice insurance to hide a blanket protection of the drug industry.”

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Alicia Mundy

Alicia Mundy is a former Wall Street Journal reporter and author of Dispensing with the Truth, about a drug industry scandal. She is writing a new book on the pharmaceutical business and consults for health care analysts.