Bert Rein

Wyeth v. Levine: Policy Arguments Regarding Preemption

by Bert Rein on February 13, 2009 · 9 comments

in Healthcare, Legal, Precaution & Risk, Regulation

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.]

Preemption in Wyeth v. Levine: Broader Implications

by Bert Rein on February 13, 2009 · 2 comments

in Healthcare, Legal, Precaution & Risk, Regulation

The Supreme Court’s pending, and perhaps imminent, decision on the preemptive effective of FDA drug labeling approvals in Wyeth v. Levine has stimulated a flood of legal and public policy debate on the roles that federal regulation and state-law based tort litigation should play in regulating pharmaceutical manufacturers. That debate, which is almost certain to continue in a legislative forum should Wyeth prevail before the Court, may determine the future of the now-lucrative litigation industry. More importantly, arguments made in the debate by those seeking to protect or expand litigation opportunities may exacerbate an onslaught of public policy initiatives that threaten the future viability of a private enterprise, research-based pharmaceutical industry.

The Wyeth v. Levine case itself presents a relatively narrow preemption issue. Ms. Levine lost her right forearm to gangrene when Wyeth’s drug Phenergan was improperly administered by intravenous push injection to deal with her severe migraine-related nausea. The drug entered an artery and caused gangrene. The administering clinic failed to observe a number of cautions prominently displayed on Phenergan’s label relating to the maximum total dosage, rate of administration, cessation of treatment on complaint of pain and extreme caution in avoiding exposure of Phenergan to arterial blood. Nevertheless, after settling her claim against the administering clinic, Ms. Levine successfully sued Wyeth under Vermont law for failing to totally foreclose push injection of Phenergan in its labeling and thus allegedly making the product unreasonably unsafe.

Wyeth’s constitutional preemption defense was two pronged. Wyeth first argued that, under federal law, it could not have complied with Vermont’s labeling standard. The FDA, in first approving Phenergan in 1955 and then repeatedly approving Wyeth’s evolving label, had determined that push injection – the fastest and most efficacious method of administration – was safe given the cautions included in the label. Wyeth’s post-approval experience had provided no additional information that would authorize a deviation from FDA’s position and any unauthorized deviation would put Wyeth in violation of federal law. Wyeth also argued that Congress had given FDA national authority to optimize prescription drug use by balancing benefit and risk and that state law – particularly case-by-case setting of labeling standards in jury trials – should not override FDA’s scientific risk assessments. Wyeth presented both arguments to the Supreme Court in seeking certiorari and in arguing the merits of its case.

Ms. Levine’s response to Wyeth was that FDA’s balancing determinations should be viewed as minimum standards subject to imposition of added safety requirements under state law. Congress had not included an express preemption clause in FDA’s prescription drug authority as it had, for example, in FDA’s medical device authority and thus a presumption against preemption should prevail. In any case, Ms. Levine argued, Vermont’s labeling standard only required Wyeth to compensate Ms. Levine and did not force Wyeth to change its federally-approved label.

The legal arguments of the parties, and the incremental approach typical of the Supreme Court, strongly suggest that the Court will issue a narrow legal ruling addressing FDA preemption only in the context of fully-informed FDA labeling decisions directly challenged in state tort actions. The Court is unlikely to rule on the consequences of allegedly fraudulent representations to the FDA or of pharmaceutical company failures to disclose or act upon new safety information available to the manufacturer after FDA approval. If other cases present those issues the Court will be able to deal with them on a full factual record.

Still, a number of organizations have filed amicus curiae (“friend of the Court”) briefs making “policy” rather than legal arguments regarding the importance of this case. Many, including the American Association for Justice (“AAJ”, formerly known as the Association of Trial Lawyers of America) have disregarded the narrow facts presented in Wyeth v. Levine to argue that preemption ought to be denied because of a need for additional tort-based supervision of the pharmaceutical industry. I will discuss the merits of these policy arguments in my next post.

[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.]