The Wyeth v. Levine case presents a narrow set of facts in which the Food and Drug Administration had, for many years, known about the risks presented by intravenous push injection of Phenergan and worked with the manufacturer to carefully word the label description of this risk. There is no allegation of fraud in this case, nor has relevant information about this risk arisen since the label language was last amended. Nevertheless, disregarding the limiting facts in the Levine case, a flood of “friend of the Court” pleadings supporting Ms. Levine sought to broaden the preemption debate and persuade the Court of the critical need for additional tort-based supervision of the pharmaceutical industry. The FDA was portrayed as the vassal of the pharmaceutical industry, either unable or unwilling to protect the public against unsafe drugs. The industry was portrayed as a callous marketing machine committed to maximizing revenues – safety be-damned – and using promotion to skew medical decisions away from science-based, cost-effective medicine. Paying judgments was presented as a mere inconvenience given the enormous profit margins on pioneer branded drugs.
Ms. Levine’s supporters, who include the American Association for Justice (“AAJ”, formerly ATLA) are sophisticated enough to know that arguments relating to fact patterns not before the Supreme Court are unlikely, at best, to affect the Court’s judgment. Their briefs are more realistically targeted at a political audience which they wish to persuade to “right the wrong” should Wyeth prevail. Not surprisingly, AAJ has produced and is widely distributing a 22 minute video featuring Ms. Levine and promoting her cause. Thus, AAJ apparently believes that demonizing the pharmaceutical industry and denigrating the FDA is just one more means of obscuring the merits of federal preemption and positioning the issue as individual victim against industry Goliath – good versus evil.
On the actual policy merits, it is hard to conceive of any sound argument against the superiority of a uniform, scientifically based, expertly administered system for determining if and how prescription drugs should be approved for use, labeled and administered. Of course prescription drugs are powerful chemical and biological entities and their use will always entail a risk of injury. Some risks, as in the case of Phenergan, will be known, labeled and avoidable by proper medical procedures. Others, however, will be rare enough that only widespread use will suffice to detect and label them. In either case, given AAJ’s fundamental tenet that every injury warrants a legal proceeding and judicial remedy, injured patients like Ms. Levine will seek to have lay juries provide compensation by faulting the conduct of pharmaceutical companies. Sympathetic jurors, acting without scientific training, will set ex post facto standards of labeling conduct that override FDA’s determination that the drug allegedly causing injury was safe and effective for its labeled uses.
Absent preemption of these state-law conduct standards, pharmaceutical companies either will have to accommodate to jury determinations by restricting beneficial use of their products or face damages that have drained, and will continue to drain billions of dollars from the research-based industry, largely to the benefit of the pharmaceutical litigation industry. Moreover, practicing physicians will lack authoritative guidance for administering drug treatment and will be forced to consider whether they will be held accountable for failing to prevent injuries by considering any and all risks that might have been suggested in any publication an enterprising lawyer might later discover.
If faced with the question whether FDA experts or panels of lay people drawn randomly from the general population should make the hard call whether a drug’s effectiveness in treatment outweighs the risks it necessarily creates, few would opt for a lay decision. Yet a non-preemptive tort system makes exactly that choice and further distorts the decision process by focusing the inquiry on a single sympathetic drug-related injury and essentially ignoring the interests of all those who benefit from having the drug available.
AAJ and its allies no doubt hope to capitalize on the natural sympathy generated by innocent victims and the animosity whipped up by isolated instances of overzealous promotion or delayed recognition of emerging risk by pharmaceutical companies to overcome the sound policy support for uniform conduct standards enforced through federal preemption. Sadly, if they succeed in imposing dual level regulation by throwing brickbats at the pharmaceutical industry and the FDA, the harm to the public may spread even beyond a liability system run riot.
FDA professional staff, and FDA’s leadership are not insensitive to the criticisms levied at them in political debate and highlighted by jury verdicts proclaiming that drugs FDA has adjudged safe are, in fact, unreasonably unsafe. FDA’s likely reaction is to exercise greater caution in reviewing new drug applications, to demand more clinical testing in more sub-populations for longer periods before approval and to encourage defensive, use-restricting labeling and management systems. The inevitable consequence is to further limit the number of new drugs approved, to substantially increase the cost and risk of FDA’s new drug approval process and to deteriorate return on investment by deferring access to market.
The American pharmaceutical industry is one of the few successes left in an otherwise bleak industrial landscape. To survive, and hopefully thrive, American pharmaceutical manufactures need to have a regulatory apparatus reasonably tolerant of the risks arising from powerful new cures, the ability to disseminate meaningful information about new products, the pricing freedom to recoup the costs of research and development in a limited period of patent exclusivity and reliable upfront standards for the labeling and administration of their drugs. The looming fight over federal preemption will directly or indirectly affect each of these elements of pharmaceutical industry success. Indeed, winning the preemption battle may be essential to the survival of a privately financed, research-based, free enterprise pharmaceutical industry. Ironically, if the AAJ and its allies succeed in imposing dual regulation through attacking the industry on all fronts, they may wind up sorely missing their pharmaceutical industry whipping boy but they will not miss it nearly as much as the patient population of which we are all a part or the troubled American economy.
[Editor’s Note: Bert Rein, a founding partner in the Washington, DC law firm Wiley-Rein and a long-time friend of CEI, represents Wyeth in this case. This post appears by invitation.]