Tuesday, January 13, 2009

Guest Post - In Defense Of Preemption & FDA Regulatory Authority

This is the first of what we hope will be many guest posts by Bert Rein, a founding partner of Wiley Rein, LLP. Among many other accomplishments, Bert represents Wyeth in the pending Wyeth v. Levine appeal in the Supreme Court.

What follows are Bert's own thoughts, for which he gets all the credit and/or blame:

Judge Kyle’s comprehensive rejection on preemption grounds of all plaintiffs’ claims in the Medtronic Sprint Fidelis litigation is providing a rallying point for legislative efforts to repeal or override the express preemption clause of FDCA’s Medical Device Amendments. Judge Kyle not so subtly pointed in this direction by proclaiming that “the absence of particular remedy . . . does not imply . . . the lack of a legal wrong” (quoting Pacelli v. de Vito, 972 F. 2d 871, 879 (7th Cir. 1992)) and noting that Congress’s retroactive repeal of preemption language in the Federal Railroad Safety Act had permitted claims relating to a noxious gas discharge following a derailment to proceed after initial dismissal. Lundeen v. Canadian Pac. Ry. Co., 532 F.3d 682, 687 (8th Cir. 2008). Given the attractive facts of the Sprint Fidelis case from a plaintiff’s perspective – product recall, serious injury and an alleged manufacturing defect not reflecting a clear or particularized benefit/cost judgment by FDA – Sprint Fidelis is an almost ideal poster child for urging legislative action on medical device preemption with a potential spillover to prescription drugs, perhaps even before Levine is decided by the Supreme Court. It is, therefore, none too soon for those of us who care about safeguarding a unitary FDCA regulatory regime and scientifically based regulatory standards to start making our case to the public as well as the courts.

First, to the extent possible, we need to ensure that rational debate over how best to regulate devices and drugs is not overwhelmed by the plaintiff bar's focus on isolated instances of alleged negligence or by sympathy for the injured. An argument for having states regulate the design, testing and labeling of medical devices and prescription drugs through their own legislative/administrative regimes is, at best, a hard sell. No state has resources or expertise coming close to FDA nor has there been any political push for comprehensive state device and drug regulation. Even if there were reasons to believe that specific local factors required localized regulatory approaches – and no one has identified any – proponents of state based device and drug regulation would still have to justify the enormous costs and confusion inevitably arising from multiple state regulatory regimes. On this battle front, proponents of a unitary, federal regulatory regime clearly have the upper hand.

Second, we need to counteract plaintiffs' fallback position that state regulatory standards that merely “supplement” federal standards to make devices and drugs “safer” are an unalloyed public good. This argument conveniently ignores the “no free lunch” principle. In almost all cases, the proposed “safety” improvements would increase manufacturing costs, drag out access to market for beneficial new products or deter beneficial use. The critical question whether design modifications, additional pre-approval testing or added warnings would or would not, on balance, serve the overall public health interest is one that can be answered best by a scientifically staffed agency considering the interests of the entire potential patient population. Any attempt to resolve that core regulatory issue in the context of a specific alleged injury in a trial before a lay jury is a proposition whose lack of merit may seem obvious to those deeply involved but now needs to be laid bare for the general public.

Third, we need to deal with the contention that tort actions are not really conduct regulation but simply a means of forcing manufacturers whose products caused an injury, whether or not avoidable, to bear a cost that would otherwise fall on an innocent victim. Plaintiffs' arguments on this score speak with the proverbial forked tongue – they claim both that tort suits are necessary to discipline manufacturer conduct and protect against future harm and simultaneously that tort suits do not require conduct changes, only money payments.

We need to force the opponents of preemption to come clean on whether they are advocating state-based device and drug regulation as an exclusive tool, two-tier federal/state regulation or exclusively federal regulation with a compensation/insurance overlay for injury. If they seek to duck the issue of how best to regulate, and focus exclusively on compensation, we need to question whether the tort system with its heavy administrative costs, long delays and essentially random distribution of relief is a beneficial means of providing compensation to anyone except lawyers and their coterie of selected “experts”. Even more fundamentally, as we move toward universal health care and a more pervasive welfare state, we need to question why those even unavoidably injured by medical devices or drugs need greater relief than those harmed by industry-wide lay-offs, natural disasters or any of the other exigencies of a modern society.

Sprint Fidelis is a commendable high-water mark in giving due deference to FDA – even when FDA leaves regulatory choices to manufacturer’s discretion – and full weight to express preemption language. It is potentially troublesome from a legislative perspective, however, because it is not clear that the FDA/tort law conflict involved would require dismissal under conflict preemption theory, thus placing the onus of denying relief on Congress’s decision to block state action by express language rather than, as in the case of conflict preemption, Congress’s decision to enact a comprehensive and protective federal regulatory regime. The legislative risk is clear and, hopefully, the stimulus to reinforce the public policy factors supporting unitary federal regulation is equally clear. Putting these factors into simple words and supporting them with practical examples and understandable studies should be an urgent priority.

4 comments:

Anonymous said...

Question for Bert: What is the likely legislative response to Riegel and Levine (assuming Levine comes out favorably to us)? I seem to remember a draft bill being passed around Congress last year to overturn Riegel, but never heard of it coming to anything. And is the industry doing anything yet about the potential legislative response?

Anonymous said...

I'm guessing Bert didn't really write that but some associate did...

Bert Rein said...

Reversing Riegel is already a top priority of the AAJ and the ABA (somewhat inexplicably) has supported the AAJ position. Last year's efforts to amend the device law might have been slowed by Administration opposition but times are about to change. Congressman Waxman has said that he would seek to reverse Levine if Wyeth prevailed.

Anonymous said...

2:50 has obviously never met Bert Rein...