Comments Regarding Preemption at the FDLI Annual Meeting

Edward J. Parr, Jr., Esq.
April 16 2004, Washington DC
All rights reserved

When FDA promulgated the current prescription drug labeling regulations 25 years ago, the agency expressly denied any intent to interfere in state tort law and endorsed the concept that drug companies can do more than FDA requires to put risk information into the hands of health care professionals. When the Kefauver-Harris amendments were debated and enacted 42 years ago, Congressman Harris argued on the House floor that the Food, Drug, and Cosmetic Act was not intended to preempt state law and would not prevent States from imposing additional requirements on drug companies. The bill enacted in 1962, which first required premarketing approval, specifically rejects federal preemption unless there is a direct and material conflict between state law and FDA regulations. And President Reagan signed an executive order that requires federal agencies to justify any intrusion on state sovereignty. But times, it seems, have changed.

Now, FDA lawyers argue that the agency's standards are both the least and the most that can be expected of drug companies. FDA lawyers file amicus briefs in favor of preemption without advising or getting advice from senior CDER officials. FDA argues - without supporting data -- that health care providers should not be given too much information about risks because it might cause "under-utilization" of prescription drugs. While FDA vigorously fights for the disgorgement of ill-gotten profits from companies that violate federal safety regulations, patients who are injured by corporate misconduct are to be left without a remedy and without compensation. These compassionate conservatives argue that the human and economic costs of severe and fatal injuries caused by drug company negligence and misconduct should be bourne by patients, their families, public and private health insurers, and state and federal governments. And drug companies that reap billion dollar profits from gross negligence and criminal misconduct argue that such wrongdoing is necessary to optimize stock value and fund further research and development.

Although States across the nation have recognized that FDA regulations reflect the minimum which can be expected from drug companies, in the practice of state product liability law, an implicit (sometimes explicit) presumption already exists that a drug approved by FDA is adequately labeled and is not defective. In every drug product liability lawsuit, the plaintiff bears the burden of rebutting that presumption, even though, under the Supreme Court's decision in Buckman, plaintiffs may eventually be barred from even introducing evidence that a drug company committed serious violations of federal law. Preemption - any law that immunizes a manufacturer from liability for injuries caused by an FDA approved product - does far more than create a rebuttable presumption. Preemption reflects a determination that, because of the FDA's actions, the conduct of the manufacturer is unassailable. Preemption prevents inquiry into the merits of a claim that a manufacturer was negligent or reckless. It prevents the collection of evidence that a manufacturer was negligent or reckless. It protects the manufacturer who in fact was negligent or reckless.

What violations, what negligence, what misconduct, you ask? Let me give you some real examples. In one case, the company marketed a drug that had a minute superiority over placebo and no superiority at all over OTC remedies, yet they touted this nearly useless product as a life-saving cure-all to millions of patients around the world with no apparent concern about its potentially fatal side effect. In other cases, companies have belittled long term outcome data even when many safer, cheaper, and more effective drug alternatives were readily available. They ignore non-clinical studies which clearly indicate that a drug has serious health risks. They use animal models to tout efficacy and then argue animal safety data cannot be extrapolated to humans. Their pharmacologists openly admit that the pharmacodynamics of the drug make certain safety risks predictable, and they were predicted, but they were not discussed with FDA. In fact, they raise safety issues with FDA that they know are illusory in order to distract the attention of the medical officers. They do no dose-ranging studies to determine the optimal safe dose. They ignore potential drug interactions which are likely to occur in actual clinical practice. They promote doses which far exceed the approved product labeling even when the drug has a narrow therapeutic index. When Medical Affairs submits a Supplemental NDA for an even higher dose, they can no longer say anything to FDA that might jeopardize the sNDA's approval.

They pay their clinical investigators thousands of dollars to act as consultants but never once ask for advice. They rewrite clinical study protocols so that the study is only capable of collecting positive data, then pressure investigators to downplay adverse events, and data dredge, so they can draft positive study reports. They falsify data. They pay medical journals to publish glowing articles in supplements that appear to be but are not actually peer-reviewed and then have these supplements sent to thousands of doctors. They hire ambitious investigators to present sanitized data to thousands of physicians in purportedly independent educational forums and pay these educators through sham companies intentionally set up to avoid FDA restrictions. When the results of a study are negative, they suppress the data. They delay completion of negative study reports for years simply to avoid the obligation to provide that data to the FDA or lie to the agency about the results.

They hire sales representatives who dance at topless bars - no kidding - and train them to tout the efficacy of their drug products with lobster and fine wines. Sales reps are trained to solicit requests for information beyond the approved product labeling and refer those requests to the company's professional communications department, which in turn systematically provides false information to thousands of physicians and patients, something which is virtually unregulated by the FDA. They provide kickbacks to managed care organizations to force patients off effective generics and on to their questionable brand name drugs without the physician's knowledge or consent.

They illegally change reported adverse event terms and bury significant information in report narratives. When their own epidemiologists argue that their drug product poses a danger to the public, others suppress the analysis. They openly debate whether FDA will notice anything wrong, even when the company is coming clean with European, Australian, and UK regulators. When FDA does find out about a problem, these companies point the finger at other products and background risks for weeks or months before they finally agree to a labeling change. In one infamous case, the man put in charge of both safety and marketing assured the company's president that he would never allow anything in the label that would impede sales, and he succeeded for years. Sales reps are trained to contradict the new warnings. The marketing department conducts surveys which indicate that virtually no doctors are aware of the new warnings, and they take no steps to correct that situation. When there are more label changes, no one even bothers to print the new package insert or inform the sales reps. Although they agree with FDA on a Dear Doctor letter, the letter is never actually mailed.

These companies should and many have paid for the injuries and deaths they have caused. Some criticism has been raised, in support of a vaccine-style fund, that the mass tort system compensates victims inequitably. It's surprising that people in favor of preemption would favor a government-run anything or favor the government collecting and distributing compensatory damages. But perhaps there is some inequity - clearly some lawyers and some jurisdictions are better for plaintiffs than others. Others would indict the jury system on which our justice system was founded, yet even Novartis agreed, in a recent press release, that juries are fully capable "to understand extensive scientific, medical and regulatory evidence." In any event, headline grabbing multi-million dollar verdicts are not representative of how this nation's mass tort system works. The results in most pharmaceutical and medical device product liability litigations are, in my experience, very uniform and equitable to victims. For example, in Diet Drugs, the class settlement matrix-based system was upheld after numerous fairness reviews; in the Baycol litigation, Bayer has done an admirable job of compensating individuals with serious injuries uniformly; and in the Propulsid litigation, Janssen has agreed to a mediation program that will also ensure the uniform settlement of bona fide injury cases.

My colleagues and I support the position that more balanced, truthful, and non-misleading information needs to be put in the hands of health care professionals, that the fidelity and support of both opinion leaders and small-office physicians should not be bought, that the art of medical science must be saved from bias and corruption, and that risk management is a means to reduce adverse experiences - not a means to reduce liability. Preemption will fund research and stock dividends with profits from the injured and dead, fuel the corruption of medical science, and stifle the flow of information to physicians. Preemption, in the end, will undermine the agency's public health mission, allow gross misconduct to go undeterred, and leave the victims of corporate misconduct without a remedy.