Preemption By Preamble â The Bush Administration's Backdoor Efforts to Kill Law Suits and Protect Manufacturers of Dangerous Products

By David Michaels

The federal regulatory system is in shambles. Regulated industries call the shots and career scientists are prohibited from pushing back. With the agencies in retreat, fear of litigation has become an increasingly important mechanism for discouraging bad corporate behavior. Now, âregulation by litigationâ is under attack.

Following a Bush Administration edict, a Texas judge is about to dismiss 1,000 Vioxx cases because the FDA asserts that any warning label the agency has approved -- no matter how faulty or inadequate -- must be considered adequate warning of danger.

Over the last few years, the Bush Administration has been quietly pushing a policy that would bar law suits from injured people if the manufacturer followed the letter of the federal agencyâs regulation. It doesnât matter if the agency succumbed (as has been the case many times recently, and certainly is true in the Vioxx case) to corporate political clout and scientific shenanigans â if the manufacturer didnât violate a regulation, no injured party can sue.

Catherine Sharkey, a law professor at Columbia University, has written a fascinating paper on this, called Preemption By Preamble: Federal Agencies and the Federalization of Tort Law. Nina Mendelson, a University of Michigan Professor with The Center for Progressive Reform, has also written on this issue.

Today's story is about Vioxx. As everyone now knows, there is lots of evidence that before Vioxx was approved for sale, Merck and the FDA saw plenty of data on increased heart disease risk. The drug should never have been approved, but once it was, the FDA had to negotiate with Merck on the contents of the drugâs warning label, since the FDA does not have the power to dictate the labelâs content. Risk of heart attack was downplayed. Tens of thousands of Vioxx-related heart attacks later, the drug was withdrawn from the market.

Heather Won Tesoriero, who has been following the Vioxx debacle for the Wall Street Journal (sub required) reports today that

A ruling from a Texas judge coming as soon as Monday is expected to undercut the legal foundation for all 1,000 Vioxx cases brought against Merck & Co. by Texas plaintiffs, providing a potentially significant boon to Merck's defense efforts.

The judge has informed both sides in a state-court Vioxx case that he will dismiss it based on a recently finalized Food and Drug Administration rule, according to a person familiar with the matter. He then told attorneys involved in some of the other 1,000 Vioxx cases in Texas state courts that his ruling could affect the whole group.

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Harris County District Court Judge Randy Wilson, who oversees all of the Texas Vioxx cases, told the attorneys he will suspend the lawsuits until the state's appeals court rules on his judgment. He said he would issue his written order as soon as next week, according to the person with knowledge of the matter.

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Judge Wilson is overseeing a case brought by Ruby Ledbetter, who blamed her heart attack on Vioxx, which she took for more than a year. Merck withdrew Vioxx from the market in September 2004 following a study that linked the painkiller to an increased risk of heart attacks and strokes.

Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks. It hasn't been clear how or if the rule would apply to Vioxx, which was approved long before 2006, and this case could prove to be an important test.

The vast majority of pharmaceutical product-liability cases hinge on whether or not a drug maker adequately warned of a drug's risks -- as have most of the Vioxx trials to date, of which Merck has won 10 and lost five.

Pre-emption is a tremendously strong defense for pharmaceutical manufacturers," said Mark Herrmann, a pharmaceutical defense attorney at Jones Day in Cleveland, who isn't involved with the Vioxx litigation. "For Merck, this is huge. If the decision stands, they won 1,000 lawsuits. That's a pretty good day for anybody."

The pre-emption argument isn't a silver bullet, however. Since the FDA rule was finalized, there have been about a dozen court rulings on pre-emption in pharmaceutical-liability cases around the country, according to a tally kept by Mr. Herrmann. Courts have ruled in favor of the defense in only four of those cases.

Judge Wilson's decision marks the largest and most significant application of the FDA rule because of the number of cases it stands to affect. Merck faces some 28,000 cases around the country, and Texas is one of three states that have consolidated the litigation in an effort to streamline the proceedings.

In January 2006, the FDA added a provision to its rule on prescription drug labels stating that FDA approval of a drug label âpre-empts conflicting or contrary State law.â But this drug label is not a document the FDA even controls. It is subject to extensive, closed-door negotiation with the manufacturer and primarily based on data that the manufacturer generates and supplies to the regulator. If the manufacturer does not provide complete information on a drugâs toxicity, or neglects to conduct the long-term follow-up necessary to determine that toxicity, the label will be hopelessly inadequate. Yet the FDA wants this label to protect the manufacturers from liability.

Since the beginning of the regulatory era in the 1970s, the corporations have argued that compliance with all pertinent regulations should inoculate them against litigation. To the naïve and the uninitiated, this seems fair enough; to those who know the influence the corporations exert over the writing of these same regulations and who therefore know how pathetically weak many of the regulations are, it is patent nonsense.

The problem is that law suits are an important part of our de facto system to protect public health. If the tide has turned against the entire tobacco industryâand I believe it hasâit is not due to actions by FDA or EPA, although the pioneering work of both these agencies raised public consciousness and helped reveal the workings of the tobacco industry. Rather, it is because the cigarette manufacturers have lost legal battles waged by the widows and widowers of deceased smokers, and by the states attempting to recoup the taxpayer money spent providing medical care for smoking-related diseases. As strong as it was and is, the strength of the science didnât convince Philip Morris to admit that tobacco causes lung cancer. Only after being pummeled by so much detrimental and expensive litigation has the cigarette-maker come up with a new strategy that involves telling at least partially the truth.

Likewise, the asbestos industry was tamed not by OSHA and EPA, not by a frank acknowledgment of the science, but by lawsuits brought by victims of mesothelioma, lung cancer, and asbestosis brought against Johns Manville and other producers.

Years after the first cases of flavoring-related lung disease appeared in food workers, OSHA still hasnât issued a standard protecting workers from diacetyl. But $100 million in court awards and settlements have convinced flavor manufacturers they have to address the problem.

Beyond the FDA rule that is being cited by the judge in Texas, the Bush Administration has issued other regulations that would preemptively override state laws governing lawsuits. Right now, Congress is considering legislation that would overturn the Homeland Security Department's efforts to preempt state law suits on chemical plant safety.

Here is another example. Vehicle rollover crashes kill more than 10,000 people each year in this country, about one-third of all vehicle occupant deaths, and injure another 16,000. In 2005, the National Highway Traffic and Safety Administration (NHTSA) issued a rule on vehicle roof strength that is so weak it could have been written by the auto industry lobbyists: almost 70% of existing vehicles already meet this proposed standard, and the agency itself estimates the new rule will prevent between 13 and 44 deaths each year, less than one-half of one percent of the annual total. And buried in this almost worthless rule was an even worse provision preempting all state laws, including those permitting product-defect lawsuits, if vehicle manufacturers meet these minimal new standards. Another case: The Consumer Products Safety Commission has included a similar preemption in a rule addressing mattress flammability.

As far as I know, today's Texas report is the first example of a state judges recognizing one of the Bush Administration preemptions as valid. Iâm hoping other judges reject them, since the preemptions have implications beyond compensation of actual victims. With anti-regulatory zealots running the health and safety agencies, issuing weak standards or simply ignoring hazards and refusing to issue any standards at all, lawsuit preemption is hazardous to the nation's health.

David Michaels heads the Project on Scientific Knowledge and Public Policy (SKAPP) and is Professor and Associate Chairman in the Department of Environmental and Occupational Health, the George Washington University School of Public Health and Health Services.