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Why We Must Rescind Michigan's Drug Shield Law

By Anonymous - Posted on 21 April 2009

Guest columnist Henry Greenspan, Ph.D.

At a meeting last June of the prestigious national Institute of Medicine, Alan Goldhammer winged it. Goldhammer, an associate vice-president of PhRMA (the Pharmaceutical Research and Manufacturers Association) was asked by a committee member what incentives drug companies have to do their own monitoring of drug safety. After referring to "regulatory obligations" associated with the FDA, Mr. Goldhammer improvised: "I did note there were a fair number of lawyers on the committee," he reflected, and "there is also a liability concern from the perspectives of the company that also means that they need to address all safety considerations promptly."

Obviously unrehearsed, and all the more credible for that, Alan Goldhammer’s comments are worth listening to closely. Because of liability concerns, drug companies feel "the need to address all safety concerns promptly." Legal liability is a major incentive to do so.

To the average citizen, the connection between liability and "safety considerations" would be self-evident. And yet, for the past several years, the pharmaceutical industry and its "tort reform" allies have been working hard to eliminate the very liability to which Mr. Goldhammer refers. The goal of this movement, coordinated nationally, is not simply to limit punitive damages or exaggerated claims. Explicitly stated in position papers and in proposed legislation, the goal is blanket immunity. If a drug has received initial FDA approval, its manufacturer is to be shielded, fully and forever.

If anyone wants to know what complete legal immunity looks like, it is here in Michigan. Since the passage of a 1995 law under then Governor John Engler, Michigan is the only state in the nation in which citizens are fully prohibited from filing liability claims against drug companies. The prohibition includes state courts and federal courts, individual actions and class actions. And so Michigan citizens (or their survivors) who have been seriously injured or killed by drugs like Redux ("fenphen"), Rezulin, Baycol, or Vioxx—a few of the sixteen drugs that have been withdrawn because of safety problems since 1997—have been shut out of court. If the champions of "tort reform" succeed, all other Americans will be shut out as well. Former Governor Engler has asserted that the "Michigan model" is intended to be the law of the land. If it becomes so, the result will go beyond the savaging of legal rights. What is also at stake, as Alan Goldhammer told us, is the integrity of drug safety itself.

Those are the issues. But there have been enough attempts to confuse us about them that at least some of these should be addressed directly.

We hear, for example: "All drugs have dangers, many of which cannot be anticipated until after a drug has been FDA-approved and used widely." That is as true as it is irrelevant. Lawsuits are not about whether a drug "has dangers" or, indeed, may cause serious injury or death. Lawsuits are about whether a company took reasonable and timely action to make a drug’s risks known — above all, to the FDA and to physicians—when that company became aware of those risks. Were red flags appropriately reported? Were studies initiated or even considered to assess the risk? Were existing studies reviewed and made public? Or, conversely, was safety information obscured, ignored, denied, delayed, disguised or—in the most egregious cases—knowingly suppressed or falsified? Lawsuits are about the failure to appropriately warn, through any of these means. A company that responds to danger signals in a reasonable and timely way—and many companies do--has nothing to fear from the legal system. A company that does not so respond ought to fear it.

We also hear that FDA surveillance provides safety enough, and tort liability is unnecessary. Once again, Alan Goldhammer had it right: Federal regulation and legal liability mutually reinforce drug safety. Goldhammer’s view is shared by most courts, and most experts, on the matter. Summarizing several earlier decisions, a U.S. District Court recently wrote that "FDA regulations are generally minimum standards of conduct," and an FDA determination about warning "may be sufficient for federal regulatory purposes but still not be sufficient for state tort law purposes." Margaret Porter, when she was FDA Chief Counsel, asserted that "FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection." Another U.S. District Court recently reiterated that FDA regulations are "minimum standards" and that "FDA approval does not shield a manufacturer from liability."

It is important to note that even an ideal FDA—one provided enormously more resources and enforcement powers than the real FDA today—would still be dependent on drug companies to flag dangers and disclose risk data in an appropriate and timely fashion. Thus, even in such utopian circumstances, tort liability would continue to provide an important "layer of consumer protection." In the context of the actual FDA’s resources and powers—the limits of which we have become all too aware--that protection is nothing short of essential. In late 2002, the Department of Health and Human Services’ Office of Inspector General conducted a survey of the FDA’s own medical reviewers—the scientists on whom we all rely. Fully two-thirds (66%) of those reviewers lacked confidence that the agency "adequately monitors the safety of prescription drugs once they are on the market." The scientists’ lack of confidence is well founded. In many instances, a drug is approved on the condition that its manufacturer will pursue additional ("post-marketing") studies to help resolve remaining safety concerns. Several recent reviews have determined that less than 40% of these studies are even initiated (let alone completed) by companies within the time frame FDA provides. This is the industry that says, "trust us to do the job." And yet, far too often, they do not do the job.

That is the primary reason why the majority of Americans do not much like the pharmaceutical industry right now. In most polls, their integrity is rated at the same level as big oil and big tobacco in their worst days. What a terrible irony that those companies whose products do, indeed, save lives, and make other lives worth living, are viewed by so many citizens as spiraling to the ethical bottom. So far, the public still generally trusts the products, the drugs themselves, if not their manufacturers. But make no mistake. In the post-Vioxx era, the "big one" has made landfall, and the levees are broken. When the next storm hits, as it inevitably will within the present system, recovery is more difficult to imagine . Everything that remains good and hopeful about this industry depends on public trust. The increasingly aggressive efforts to absolve drug companies’ legal liability is a virtual admission, a direct-to-consumer advertisement, that that trust is misplaced.

What happens now in Michigan, therefore, has genuinely national implications. On one side, there is now strong and bi-partisan effort to rescind the 1995 shield law. Legislation to restore the rights we lost--House Bills 4773, 4811, and 5527—has been introduced in the State House, and most observers believe that there is a good chance of passage as more and more citizens learn the facts.

Meanwhile, lobbyists from national "tort reform" associations flood the state--they come from Washington, from Texas, from Mississippi—trying to prop up a shield law that was bankrupt, ethically and economically, from the start.

Michigan representatives from across the political spectrum are ready to fight this onslaught and do the right thing. They deserve, and they need, our support.

Henry Greenspan, Ph.D., teaches social psychology and social ethics at the University of Michigan, Ann Arbor.

Copyright © 2006 Henry Greenspan. Reprinted with permission.