Tuesday, January 13, 2009

An interesting article from DDL

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.


  1. So basically, consumers should no longer consume unless they are willing to put all of their faith in an agency which has failed time and again to make informed approvals without full and transparent cooperation from drug and device makers.
    That should kill the industry and possibly we can disband the regulatory system at the same time.

  2. So much illogic, so many non sequiturs, so many false empirical claims.... in just a few paragraphs. If nothing else, Bert Rein's piece is - in those ways - efficient. Better to read a short statement than in a long brief.

    Want to really discuss this. Bert Rein, we invite you to Pharmalittle! You will be genuinely welcome, and we'll discuss these issues point by point.

    What do you say?

  3. A few notes on Mr. Rein's call to arms for preemption.
    Overall I am struck by the feeling that the desire is to keep the consumer/patient out of the picture; certainly not to consider that the consumer has any right to complain about the product. I think that it is unfortunate that this industry doesn’t trust the producer - consumer relationship. This kind of attitude will only lead to a lack of trust and will ultimately cause the industry much difficulty.

    Concerning Mr. Rein’s desire for "a unitary FDCA regulatory regime" - Generally a single point of control is not the best approach, especially in the realm of big money and politics as we have with the pharmaceutical industry and the FDA. With the industry's commandeering of the FDA our tort system, while not perfect does afford some incentive toward safety.

    By "scientifically based regulatory standards" one can assume that he means we need to forget about the real life post trial experiences of harmed patients in lieu of pre market trials. I find his comment that we need to not be overwhelmed by "sympathy for the injured" when discussing how to regulate devices and drugs supportive of a view that considers the consumer a non entity in this process. Assuming that state tort is always guided by emotion and not by the desire to correct poor management practices is a closed minded approach.

    Mr. Rein’s second point – “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.” I find it telling that safety is put in quotes here, almost like it is an annoyance that such matters need to be considered in product development and production - and this is the crux of the problem. Somewhere along the line the pharmaceutical industry has decided that a “safe” product is unattainable, therefore the consumer should not press the matter when they are harmed by the product.

    As for the third point about the reason for tort claims, sorry, that makes no sense to me.

    Mr. Rein says “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.” Here again we see the belittlement of the harmed consumer and the elevation of the pharmaceutical industry to almost god like importance. I hope that someday the industry realizes that the only real importance that they are imparted is allowed by their consumer. Until they do they stand a good chance of losing the consumers favor. It will be regrettable for all if that day comes and it appears with each day’s news the day is getting closer.

  4. First, I find Mr. Rein's following statement laughable:
    "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."
    Industry hacks and insiders as well as the politicians who receive large donations from corporate America have been conducting a marvelous campaign of convincing the American Public that almost all actions brought against corporate America are Frivolous.

    Mr. Rein also writes that States should not be allowed to impose standards over and above what the FDA requires and while the Wyeth case does seem to indicate that the State action was predicated on the existing FDA approved label, I don't believe that this is the case in the majority of State Tort Claims. The Fen-Phen case is a perfect example of a State Tort action bringing to light shortcomings and unethical behavior on the part of the pharmaceutical industry and the FDA. If preemption becomes the law of the land we may as well eliminate the FDA and just have the Pharmaceutical Industry look for the "Good Housekeeping" seal of approval.

  5. Lots of good points made above.

    Related to the "frivolous" argument, the reality is that a number of defense lawyers (including those who defend drug and device companies) have acknowledged that, in the majority of cases, the juries get it right.

    Re: "conflicting standards," a number of states - initially Washington and Oregon - did, indeed, create a Medicaid formulary based on safety and appropriateness, not cost (which would have been illegal). On that basis, Vioxx was taken off the formulary for most pts by 2002. No one in Idaho became confused or deterred.

    Indeed, we have learned - from FDA itself - that the "overdeterrence" argument is, well, a crock.

    For that matter, during the thirty years or so the modern FDA and civil liability have co-existed, there has been no "chaos of conflicting standards." Another crock. (Have there been particular instances of conflict - of course. They do not justify an all-encompassing doctrine like preemption.

    The mantra that lawsuits stifle innovation, drive up costs, and retard access to "life-saving medication" is precisely the same argument that the now-preemptors used against the FDA when, not long ago, they were deregulators - the same agency (once they gained control over it) they would now canonize. There was no empirical evidence for those claims then. There is no empirical evidence for them now.

    Related to JimK's point, absolutely. The majority of "failure to warn cases" already consider whether the company was in compliace with FDA. But they also look further - what did they know, when did they know it, what did they do. FDA has no subpeona power. It must rely on companies not only to abide _by_ regulations, but also not to play with them - which is extraordinarily easy to do, and still be technically in compliance.

    Rein and Company will say that, if there's negligence or fraud, the FDA will handle it. But they know, and won't say, that in actuality the FDA virtually never does - and certainly not in a way that entails meaningful sanctions. Here in Michigan, where we have had a preemption law with a so-called "fraud exception" since 1995, there has not been a single case in the past twenty-five years (well before the Michigan law) that would meet the criteria of Michigan's "exception." Even the industry does not claim that is because companies records during that quarter-century have been spotless.

    In 2006, the Washigton Legal Foundation, one of the "think tanks" that has spearheaded preemption, wrote to pharma defense lawyers that the goal of preemption is "to see that law students in 2016, when they hear about past pharmaceutical product liability cases, chuckle to themselves over this curious historical anomaly."

    Here is my prediction. In 2016, law students - and many other students too - will look back on preemption as one of the several most dangerous policy initiatives of recent times.

  6. Justice, I would further predict that the industry will at some point curse the day if preemption spreads to drugs. Little by little the public will see it as an indicator of the industry's "tactics" and realize that they are not an entity to be trusted. We already see the industry worried about their reputation. Add preemption to the mix and I think you have a lethal combination.

  7. More evidence of what I like to call the "Daddy-state" which is characterized by a father-knows-best attitude, a reverence for authority figures, and belittling honest concerns of citizens.

    As to the rest - SS has a scathing review of the decision at Health Care Renewal.

    Thanks for this. I was missing all of the discussions. And you.

  8. Harpy!!! Great to see you here! I hope you'll stick around - Always one of my favorite folks with whom to bounce ideas (and one-liners).

    Yes, I've been arguing for a while that preemption will do in pharma if they get it broadly. It is a short-term "fix" to save some bucks - like laying off more and more people, closing sites, bringing out combo drugs rather than anything new, etc. - in order to avoid having to deal with the real problem: The bankrupty of the blockbuster model and all that goes with it.

    In the end, it just brings the industry - and the rest of us - closer to the cliff.

    There are enough people in industry who know this, and would be willing to act, if other companies also did a "draw down." We've seen that with reducing sales forces, which almost every company seems to want to do - just not be the first. If PhRMA (the organization) is capable of leadership, coordinating such a draw down may be the last chance.

  9. A link to the Kyle decision is below. I tried to post it on Health Care Renewal without success. Perhaps someone else can.



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