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.]
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{ 9 comments }
For years, the CEI fought against there being an FDA at all. Rather, "market forces" ought to determine whether drugs succeed or fail.
Among those market forces continually cited by those who made that argument was, you guessed it, the tort system. Read Milton Friedman on the topic. More recently, read Dennis Klein. In his September, 2000, article, "Economists Against the FDA," Klein wrote: "Drug safety would be–and is–certifed and assured by a panoply of private-sector, voluntary institutions, and by the tort system. Whe a company harms consumers with ann unsafe drug, it suffers devastating losses. Its reputation suffers, and it pays hefty damages to victims."
So it is ironic that those who claim still to support "competitive enterprise" would champion a policy that is precisely the opposite of competitive enterprise.
In the meatime, Rein (and, yes, Justice Breyer) notwithstanding, no jury has ever changed a drug's label, withdrawn a drug, or done any of the other things that remain solely within the FDA's jurisdiction. On the other hand, there are plenty of instances in which FDA has changed labels or withdrawn drugs _as a result_ of litigation brought by whistleblowers or private plaintiffs.
Preemption, as a policy, would guarantee less safe drugs and, in the not very long run, end up being a disaster for the industry itself. And that means a disaster for all of us. That is why, when the CEI was calling for the dissolution of FDA, the industry knew better.
One can only hope they will also know better than their "friends" this time as well.
I see a problem with the assumption that the tort process should be shut down in favor of the FDA/pharmaceutical Company’s expertise about acceptable sacrifice of the public's health.
First – Unwilling sacrifice, by an unaware citizen for the betterment of others should be seriously questioned regardless of the level of benefit realized by the rest of the population. At its core this is not a humane way to conduct business. At most this should not be considered acceptable and at least some means of recompense is demanded for the un-recruited citizen.
Let's take it apart, piece by piece:
Rein says: "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."
This is a description of pharma (one I don't agree with) that is confirmed by many within industry itself–especially on the science side. Virtually all agree that the ethical standards that held fifteen years ago have precipitously declined–in essential part, precisely because of marketing. In any event, the industry's continuing resistance to comparative efficacy studies clearly suggests that it is _not_ primarily interested in "science-based, cost effective medicine."
Rein describes opponents to preemption as "positioning the issue as individual victim against industry Goliath – good versus evil."
Read the piece. The demonizing is Rein's–focused on those greedy trial lawyers, ruthless and merciless, bloodsucking, destructive, vampiric–we know the drill.
Rein writes: "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."
Ah, the fair maiden corrupted by those bloodsuckers. Anyway, all of this is beside the point. In many states, FDA compliance is a rebuttable presumption–a standard with which I'd agree. In the meantime, only FDA determines labels. Until 2002, it was FDA's expert determination that the dual system of civil liability and its own regulation was, in fact, optimal. It is preemptors like Rein who wish to overturn half a century of FDA's expert opinion. They are the ones who are "second-guessing" the FDA.
Rein writes: "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."
More blood-sucking imagery–but it is always the other side, he says, who demonize.
Rein writes: "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. "
Well, we all know docs don't read labels anyway. In the meantime, Rein will have to explain why the past six editors of the New England Journal of Medicine, the Journal itself, and the Journal of the American Medical Association all condemn FDA preemption–without qualification. It does, indeed, take a helluva lot of mischief for docs to defend trial lawyers so vehemently. Preemption is a helluva lot of mischief.
Rein writes: "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."
This is, well, horse hockey. Juries don't withdraw drugs, companies and FDA does. Do I hear Benedectin? Benedectin, at the time it was withdrawn, was composed of two active ingredients, both then available over the counter. In the meantime, listen to the defense lawyers in the Baycol trials. They have themselves said that, most of the time, *juries get it right.* How surprising that those sentimental yahoos would earn such a comment.
Rein writes: "isolated instances of overzealous promotion or delayed recognition of emerging risk by pharmaceutical companies."
Good grief. In a recent PwC survey almost 50% of pharma execs agreed that off-label promotion was out of control. 20% agreed that companies _knowingly_ and _routinely_ suppress or distort risk data. Is that a lot? If 20% of physicians agreed that a not-trivial number of other docs deliberately misdiagnose on a routine basis, I'd be a little concerned. And I'd be right.
OK, enough. This piece has more disinformation than Swiss cheese has holes.
DRAFT
A brief response to Mr. Greenspan, Axiomatic and NotLawyerNotPlaintiff might enlighten the debate. Mr. Greenspan first appears to endorse calls to eliminate all FDA drug regulation but then applauds the industry because it "knew better" than to support the idea. Whether or not it is good public policy, FDA's comprehensive regulatory authority is a reality and one unlikely to change. And whether or not non-scientific, ex post regulation by lay juries, would provide a viable alternative to federal regulation, the need for second guess litigation is very different in the real world where substantial public and private resources already are committed to FDA's regulatory process in order to strike a scientifically-based balance on the availability of and proper uses of prescription drugs. Mr. Greenspan further argues that juries cannot wield FDA's regulatory power over labels and drug approvals implicitly claiming that tort verdicts have no direct effect on manufacturer conduct. Technically correct, but what then supports Mr. Greenspan's further contention that litigation has forced FDA to require label changes and drug withdrawals. Mr. Greenspan provides no evidence that these FDA actions would not otherwise occurred as FDA reacted to emerging adverse event reports and independent scientific evidence. More importantly, Mr. Greenspan has no evidence that the myriad allegations of drug imperfection alleged in tort litigation have predictable merit other than as foundations to compensate sympathetic injuries.
Axiomatic raises a separate concern that those who encounter the adverse consequences of drugs that, despite their risks, provide important benefits to the overall patient population are making an "unwilling sacrifice" that should be recompensed. Compensation is a social welfare issue that can be debated and addressed separately from the merits of a fault-based tort system in which administrative costs exceed actual compensation and compensation itself is a hit or miss outcome. Endorsing a tort system that second guesses FDA's scientific judgments because it provides one means — but certainly not the only means — of compensating those injured by drugs lets the tail wag the dog.
NotLawyerNotPlaintiff joins the chorus of those who claim that industry "ethical standards that held fifteen years ago have precipitously declined – in essential part, precisely because of marketing." Pointing out that free enterprise drug companies act like profit maximizing entities hardly justifies any form of legal imposition including tort judgments that contravene FDA's considered scientific decisions. NotLawyerNot-Plaintiff is willing to concede only a "rebuttable presumption" to FDA compliance – in other words to have FDA scientific decisions put on trial before lay juries. NotLawyer-NotPlaintiff also argues that those supporting preemption are "second guessing" FDA's expert opinion "that the dual system of civil liability and its own regulation was, in fact, optimal". NotLawyerNotPlaintiff apparently has not read FDA's brief supporting Wyeth in the Levine case or FDA's prior pro-preemption brief in Pfizer v. Kent. Finally, NotLawyerNotPlaintiff finally contends that the medical profession condemns preemption — without qualification — thus ignoring the brief in support of Wyeth filed in Levine by the American College of Emergency Physicians. More important, the medical community has been bombarded with arguments that limiting unwarranted lawsuits against pharmaceutical companies could unleash the litigation machine against physicians. A recent published analysis of the probable impact of preemption liability claims against physicians by David Studdert and Aaron Kesselheim (hardly captives of the pharmaceutical industry) has laid that canard to rest.
I appreciate Bert Rein's taking the time to respond to my comments among others. It is a genuine service, I think, to have this discussion.
Re: my own comments, he responds: "but what then supports Mr. Greenspan’s further contention that litigation has forced FDA to require label changes and drug withdrawals. Mr. Greenspan provides no evidence that these FDA actions would not otherwise occurred as FDA reacted to emerging adverse event reports and independent scientific evidence. More importantly, Mr. Greenspan has no evidence that the myriad allegations of drug imperfection alleged in tort litigation have predictable merit other than as foundations to compensate sympathetic injuries."
There are two points here. First, I did not say that litigation "forced" FDA to do anything. I did say that FDA has often acted "as a result" of whistleblower action or civil litigation.
There are many, many cases to use as examples, but the best are probably from the FDA itself. When fen-phen, for example, was eventually withdrawn from the market, Steve Galson, then head of FDA's drug division, said that they simply missed the signal. And were it not for the initiatives of dedicated people in Fargo, ND, and eventually the Mayo Clinic–which called a news conference after numerous attempts to provoke the FDA to action failed–FDA finally did act, many months and many deaths too late.
I purposely choose a case which did not involve civil litigation or whistleblowing, because it is much closer to "everyday life" as far as the FDA and its actions are concerned. The reality is that, even in these circumstances, FDA acknowledged that it simply missed the boat. And it would have continued to miss the boat had the folks in Fargo and at Mayo not acted as they did.
Of course, fen-phen was another Wyeth product, and I must say that was not in my thinking when I chose the example. When Dan Troy was asked, at a meeting of the Federalist Society I attended, to name an instance of a significant FDA/DOJ action involving a drug or device company, the only isstance named was the Guidant case, also whistleblower based. If anyone would know what the FDA/DOJ is or is not likely to do on its own, and why, it is Dan Troy.
Finally, we know from court documents that companies, in egregious instannces, _count on_ the fact that FDA does not have the resources to "react" based on Medwatch or other emerging data. Every independent study of FDA including those commissioned by FDA itself–by the Institute of Medicine, GAO, Science Board–give those who would play the FDA this way ample reason to know they will likely be successful. And, indeed, so they have been. The internal documents as well as the outward history tell the tale.
As far as the merit of tort actions, all of that is mostly besides the point. It is likely that Mr. Rein would find ways to tell the tales of litigation over fen-phen, Baycol, Rezulin, thalidomide, et. al., in some narrative other than the obvious. All "alleged"? All without "predictable merit"? I would cite Milton Friedman again, who ackowledged, whatever else, that the manufacturers and distributors acted in ways that went beyond "alleged"–they were knowing and contemptible.
But the real issue of merit here is not about this or that litigation, but about preserving the system we have had for the whole of the FDA's history and supported by FDA itself. It is, precisely, the point that judges (in their initial review) and juries decide whether cases "have merit." Not me. And not Mr. Rein.
I would challenge Mr. Rein to provide "evidence" that cases involving fraud, negligence, and the like in the drug arena are inherently more "above the heads" of jurors than other challenging cases with which they are presented every day. Or, at core, would he like to see the end of product liability suits altogether?
I hope not. I certainly do not want to see the devastation of the pharmaceutical industry (in which I am also an investor, financially and as a patient). But, like others, I fear that FDA preemption will lead us precisely there.
p.s. I don't know about others, but I _have_ read the FDA briefs in Wyeth and Kent. I take them as representing the views of FDA (Office of Chief Counsel) at a particular moment. Relative to the FDA's long history, they are an aberration. (But, yes, today's aberration _may_ become tomorrow's policy).
As Mr. Rein knows, some judges have dismissed the preemption argument in general–including the form it has taken in these briefs and in the preemption preamble–as not worthy of more deference than other "political documents." Other judges have viewed them differently.
I am, needless to say, with the first group of judges.
Errata-There was a paragraph missing in my initial response above. The reference to the Guidant case was not about FDA or DOJ actions re: label changes or product withdrawal, but about significant sanctions for serious malfeasance, and the contribution of civil liability or whistleblowers in that context.
Of course, re: warnings, etc., FDA has acted without the aid of whistleblowers or civil litigation. What Mr. Rein demanded was evidence that whistl3dblowers or litigation contributed to such regulatory actions that would not have "otherwise occurred."
By definition, no one provide evidence proving or disproving what might "otherwise occur." One can only assess evidence concerning what actually does and does not occur often enough to be noteworthy.
Likewise, the Friedman reference was to his commentary on thalidomide specifically. Beyond that, it appears that Mr. Rein wishes to suggest that there has_never_ been any meritorious litigation against a pharmaceutical company. It's all "alleged" malfeasance for the sake of compensating "sympathetic injuries."
As noted by one of the other comments above, 20% of drug company senior execs themselves would dispute that description of reality.
Thanks for the reply Mr. Rein,
I'll keep it brief because this is a common point that is well known.
The basis of your argument can be boil down to one term – "second guess" litigation. I suppose all litigation can be condensed to this way of thinking, especially if you are on the defense side. The other side is always thought of as unknowing, unwise and just plain greedy. It's the nature of getting to the truth. Our court system pits one claim against the other. If you suggest we eliminate "second guess" litigation I suppose you would have to mean all litigation. But that would be foolish.
Every day juries are asked to decide on issues that are "above their heads". When we begin to decide that our particular specialty is unapproachable by a jury we enter into the new world of things that are "above the law". Commercial endeavors should never be above the law.
Preserving the right to second guess the FDA is in all of our best interests. As you know the FDA is not the organization that it should be for a number of reasons which I can provide if you like. If we can't question a failing regulatory agency we have come to a new low in consumer safety.
Mr Rein,
I read your article and response to the comments with great interest. You have some excellent points in defense of preemption. My only concern is that your entire argument is based upon one fallacy, the FDA's "expertise". If the FDA were highly funded, did all of its own research, and didn't depend upon the pharmaceutical industry for financial support, I might agree with you.
In reality, however, the FDA's "expert opinion" is based upon the good will of the drug and medical device companies whose products they are approving and overseeing.
The FDA does not conduct clinical trials, the drug and medical device companies conduct them and report their results to the FDA.
The FDA does not generally receive adverse event reports directly. Instead, they are reported to the companies and passed on to the FDA.
It is naive to think that there are never situations where companies fudge the trial results or under report adverse events in order to get and keep their product on the market.
It is in those situations that the FDA's "expert opinion" fails.
Like the emperor's clothes, the beauty of the FDA's expertise lies in the fact that it exists.
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