TorteDeForm

Justinian Lane

Critiquing the economic argument for preemption

Regular Tortdeform commenter and Overlawyered star Ted Frank recently submitted an Amicus brief in the Wyeth case on behalf of several economists. I’ve reproduced the brief almost in its entirety, omitting only procedural information, headings, footnotes and citations to improve ease of reading. The whole brief is available here.  The text of the brief is normal, my comments are in bold.

In approving the safety and efficacy, of prescription drugs, FDA faces the possibility of two types of error. First, it can approve a drug that should not have been approved because of safety problems. These errors are called Type I errors. Second, it can fail to approve a drug that should have been approved.

These errors are called Type II errors. Under well-established economic principles, the question whether FDA is more likely to commit Type I errors or Type II errors can be answered by focusing on the societal or institutional incentives that push FDA to err on one side or the other.

Repeated economic investigation of this question indicates that FDA incentives are skewed toward excessive caution in the regulation of drug development and the approval of new drugs, i.e., Type II errors.

This skewing can be best understood by considering the likely consequences to FDA’s image of a Type I versus a Type II error. When deciding whether the benefits of a proposed new drug exceed its risks, FDA staff know that if they commit a Type I error—the approval of a drug that turns out to be insufficiently safe once marketing begins—their error will become known. Because the harmful side-effects of the drug may be highly visible, a Type I error can and often does lead to impassioned criticism of the agency.

A Type I error also can and often does lead to injuries or death of large numbers of people. The brief suggests that FDA staff members are more concerned with public criticism than public health, a proposition I certainly hope is incorrect.

On the other hand, a Type II error—the failure to permit marketing of a drug that would in fact provide benefits in excess of harms—is typically known only by the relatively few persons who are intimately involved in developing the drug and are largely hidden from patients and the larger medical community who suffer the consequences of the error.

Yet the adverse public health impact of a failure to approve a beneficial drug may be even more severe than the approval of an insufficiently safe drug. Moreover, Type I errors in approving unreasonably unsafe drugs are often quickly corrected precisely because the public learns of the error. But the failure to approve a beneficial drug may go uncorrected for years, if at all. As a result, the net effect of the asymmetry in public knowledge and publicity is to bias even the best-intentioned FDA regulators towards excessive caution and delay in approving new drugs.

Let’s assume arguendo that the economists are right, and FDA regulators are biased towards excessive caution out of fear of public criticism. It’s a non sequitur that FDA preemption will alleviate this fear. Preemption won’t prevent the media, consumer groups, or legislators from criticizing the FDA for committing a Type I error. Instead, preemption will prevent the victims of that Type I error from receiving compensation for their injuries.

If anything, preemption may exacerbate Type I errors. Product liability lawsuits often force the FDA to correct a Type I error when it otherwise wouldn’t, or sooner than it otherwise would. For example, because of litigation over Paxil, GlaxoSmithKline agreed to publicize the results of all of its drug trials. Dr. Steven Nissen analyzed these documents and published a study linking Avandia to increased heart risks. As a direct result of the documents released because of litigation, the FDA put a black box warning on Avandia. If not for the litigation the economists hope to eliminate, the FDA would not have corrected its Type I error when it did, if ever.

When FDA approves a new drug, it also approves a detailed label to accompany the drug. The label contains indications (conditions to be treated), dosage, administration, and other details including warnings and contraindications, along with summaries of clinical trials and other data. These labels are designed for use by learned intermediary physicians (without whom prescription drugs may not be obtained), although others, including patients, may also make use of labels. As new information arrives about the risks and benefits of approved drugs, FDA continues to review the drug labels and effects labeling changes as appropriate. FDA employs specialized experts in the field to conduct this ongoing review and gathers voluminous post-marketing information from pharmaceutical firms, medical care providers, and other sources. (Citation omitted)

The “other sources” include documents revealed through litigation. The FDA doesn’t have subpoena power on its own, so it generally has to rely upon pharmaceuticals to voluntarily turn over all relevant drug information. In more than a few product liability lawsuits, plaintiffs’ lawyers have discovered important documents that pharmaceuticals didn’t turn over to the FDA.

FDA has long recognized that labels must give varying degrees of emphasis to specific items of information, and that labels should not contain all information of possible interest. FDA has for many years sought to modify and improve drug labels while avoiding the constant danger of overwarning.

If all potentially negative information were to be included, such as every known possible side-effect, two adverse consequences would follow. One is overwarning: the presence on labels of unfounded or disproportionately prominent warning information, which could deter or discourage drug use that would be beneficial after taking reasonable account of risks and benefits. The second is “clutter”: the presence of so much information that physicians would find it hard to distinguish important information from relatively unimportant information and might not even bother to peruse all the information.

FDA’s decisions about drug labels are strongly affected by the incentives faced by FDA staff. We have described how those incentives cause FDA to exercise excessive caution when approving new drugs. Similar reasoning applies to FDA decision making about what risk and benefit information to require in drug labels.

When deciding about the contents of new drug labels and changes in labels for approved drugs, FDA is once again faced with the possibility of both Type I and Type II errors, i.e., providing inadequate warnings or requiring warning language and contraindications that overstate risk and discourage beneficial use. And once again, the incentives facing FDA in making that decision cause FDA to err on the side of being overly cautious.

Note that the economists claim that it is the FDA, and not pharmaceuticals that decide what information to put on drug warning labels. This is Wyeth’s position. The economists later change their position and claim that pharmaceuticals may alter the warning labels on their own.

In deciding not to require a specific warning, for example, the FDA staff faces the prospect of vigorous, public criticism if patients are harmed by the drug, even if the more aggressive warning was not scientifically warranted or would have lead to disincentives in drug usage that outweighed any potential reduction in risks.

Far less criticism is likely to occur if the label warns too strongly about harms that in fact almost never occur, or if the label contraindicates certain uses that are likely to be more beneficial than harmful for patients. Patients would probably not know that they had foregone treatments that in fact would have been worth the true risks, and the victims of this FDA error accordingly will never call FDA to task. On the whole, the agency is likely to be far more risk averse than is justified by the actual balance of risks and benefits as known at the time.

Victims of any FDA error cannot call the agency to task; the FDA is immune from suit for any errors it makes. Again, assuming arguendo that the FDA is overly cautious in its labeling, the economists attribute that caution to the threat of “vigorous, public criticism.” The economists have just made a case that the First Amendment is to blame for Type II errors – not the tort system. 

It’s strange that a brief authored by economists declines to mention the strong financial incentive the FDA has to commit Type II errors. In 1992, the Prescription Drug User Fee Act (PDUFA) was enacted to help speed the drug approval process. The PDUFA authorizes the FDA to charge pharmaceuticals various fees for reviewing drug submissions. The fee varies depending upon several factors, but is generally close to $1 million dollars. However, the FDA only collects the fee if it approves or denies the drug by a specific deadline. If the FDA hasn’t made a decision by the deadline, it loses the $1 million dollars. Remember, the FDA is so cash-strapped as to have made an unheard-of request to Congress for an additional $275 million in emergency funds. The FDA has also made a commitment to meet the deadline in 90% of applications.

When approaching the PDUFA deadline for a drug, the FDA has three choices if it isn’t confident that a drug is ready to be marketed. First, the FDA can choose to allow the product to be released anyway, and risk committing a Type I error. The consequences of this action of course include “vigorous, public criticism” but also may result in the injury or death of patients. The second option is to risk committing a Type II error by rejecting the drug and asking the manufacturer to submit supplemental information or conduct further studies. The consequences of this action to the FDA are small: The FDA gets to collect its fee, and as the economists note, there is little risk of public criticism.

The final option is to miss the deadline entirely and approve or deny the drug in its own time. The consequences for this action are actually the worst for the FDA. First, it will forfeit the million dollar fee. Next, it will risk criticism and investigation by Congress for failing to meet its 90% commitment. And of course, there’s no guarantee that even if the agency won’t make a Type I or II error after missing the deadline. Clearly, choosing to miss the deadline is the worst possible decision for FDA regulators.

It is again surprising that the economists failed to discuss the financial incentives that pressure the FDA to commit a Type II error. What’s even more surprising is that the economists offer no evidence that preemption will reduce the likelihood that the FDA will commit Type I or Type II errors. Even if failure to warn lawsuits were completely preempted, the FDA will still face “vigorous, public criticism” if it makes a Type I error, and the FDA will still face little criticism if it commits a Type II error. And of course, preemption will do nothing to address the large financial incentive the FDA has to commit a Type II error rather than miss the PDUFA deadline.

While advocates of state tort law prescription drug litigation often argue that litigation requirements complement FDA requirements by countering the risk of FDA underwarning or underregulation, the economic analysis of FDA incentives in the drug and drug labeling approval process demonstrates that FDA is far more likely to err in the other direction. Accordingly, rather than creating requirements that cure FDA Type I errors, state tort law creates requirements that exacerbate FDA Type II errors by causing pharmaceutical manufacturers to hold back on seeking approval of new drugs or to add defensive labeling, including further undue contraindications or overwarnings that further squeeze out physician understanding of more significant labeled information.

Recall that earlier the economists argued that it was the FDA employs “specialized experts” to determine what information to include on a product warning label. That’s the position of Wyeth, the litigant that this brief is supposed to support. In its brief, Wyeth argues that it is not permitted to engage in defensive labeling:

Had Wyeth unilaterally altered the labeling to change the warnings with respect to arterial blood exposure or to eliminate IV push as an approved method of administration, it would have been in violation of federal law and subject to enforcement action by FDA for unauthorized distribution or misbranding.” - Wyeth brief

The Pharmaceutical Research and Manufacturers of America also filed an Amicus brief, and it too supports the proposition that manufacturers may not engage in defensive labeling:

“[T]he actual freedom of manufacturers to unilaterally change the packet insert is minimal.” - Pharma brief

The U.S. Chamber of Commerce also agrees:

"...Wyeth was not at liberty to change the Phenergan label after its approval by the FDA. As the dissenting opinion explains, the applicable "regulation does not allow manufacturers to simply reassess and draw different conclusions regarding the same risks and benefits already balanced by the FDA." - Chamber of Commerce Brief

In their fervor to blame the tort system for Type II errors, the economists have actually advanced the antithesis of the legal argument for preemption in this case. If pharmaceuticals are in fact free to include “undue contraindications or overwarnings” that the FDA doesn’t approve, then Levine’s failure to warn claim is not preempted and Wyeth must lose. 

In state tort lawsuits, juries necessarily focus on a highly specific personal tragedy rather than on societal trade-offs, giving more weight to the harm allegedly suffered by the plaintiff than to the benefits realized by past and future non-injured users of the drug, because benefited patients will play no role in the trial. Given the one-sided nature of their inquiry, there is little reason to expect the lay jurors’ labeling decisions to be superior to those of FDA in terms of balancing the risks and benefits of additional contraindications and warnings on the drug label. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1008 (2008). Rather, the jury balance will be skewed in favor of more warnings. Of course, juries will not always decide for the plaintiff. But when they do, there is an excellent chance that the verdict will fault the manufacturer for failing to provide an overwarning or unwarranted contraindication or warning language that would have unduly cluttered the drug label, given that the label already reflects FDA’s excess caution.

The reason that jury decisions may be superior to FDA decisions is that jurors often have superior information upon which to base their decision. Thanks to the discovery process, jurors often see reports, memos, and emails that pharmaceuticals specifically chose not to send to the FDA, such as internal concerns over drug safety and efficacy. Perhaps this wouldn't be so if Congress chose to grant the FDA subpoena power.

The impact of this added layer of tort liability overdeterrence leads to numerous adverse consequences that are contrary to public wellbeing, such as:

1. Limiting drug availability: Because prescription drug product liability lawsuits often involve allegations of substantial harm, plaintiff verdicts not uncommonly involve sizable awards for pain and suffering damages, punitive damages, or both. Experience has shown that pharmaceutical firms often treat a large damages verdict as a predictor of more such verdicts to come. Cite omitted

While estimates of the cost of liability for pharmaceuticals are few, liability costs are not trivial. For example, a report prepared by the Council of Economic Advisors found that in 2000, liability costs across all U.S. industries were $180 billion, or roughly 1.8 percent of GDP.5 In the area of drugs and medical devices, Richard Manning identified liability costs for the diphtheria-pertussis-tetanus vaccine by comparing changes in the price of the diphtheriatetanus vaccine, estimating that at their peak, expected liability costs accounted for roughly 90 percent of the vaccine’s price. In related work, Manning found that differences in product liability regimes can explain much of the difference in Canadian and U.S. prices on drugs.

The total liability costs of all U.S. industry is of no value in determining whether pharmaceuticals bear an undue burden. But let’s put that $180 billion in perspective. Wal-Mart’s total sales last year were nearly twice that amount at $348 billion. When a single U.S. company’s sales are almost twice the entire liability costs of “all U.S. industries,” does that really suggest that the tort system is out of control?

The expected costs of product liability litigation are added to a firm’s cost-benefit analysis in the marketing of drug products and can lead to the unavailability of drug products, both because some patients may no longer be able to afford treatment and because the expected litigation costs may drive products off the market entirely. For example, childhood vaccine manufacturers quickly raised prices and in many cases exited the market in the wake of a few adverse verdicts in the 1980s. The anti-nausea drug Bendectin was withdrawn from the market in 1983 after a small number of adverse verdicts (which were subsequently reversed), despite FDA insistence that the drug did not cause the birth defects that gave rise to litigation. See Paul H. Rubin, John E. Calfee, and Mark F. Grady, BMW vs Gore: Mitigating the Punitive Economics of Punitive Damages, Sup. Ct. Econ. Rev. vol. 5, pp. 179, 194 (1997); see also American Medical Association, Report of the Board of Trustees, Impact Of Product Liability On The Development Of New Medical Technologies 1, 79 (1988) (“AMA Board Report”) (“Certain older technologies have been removed from the market, not because of sound scientific evidence indicating lack of safety or efficacy 6 Richard M. Manning, but because product liability suits have exposed manufacturers to unacceptable financial risks.”).

The "reform" movement always alleges that but for the tort system, a slew of new miracle drugs would save us all from the ravages of disease.  Yet the best example they can come up with is Benedictin, an anti-nausea drug taken off the market after a few bogus lawsuits.  So why isn't Benedictin back on the market in the U.S.?  Probably because Benedictin is made of two ingredients: Vitamin B-6 and doxylamine succlinate.  You know where to find Vitamin B-6.  But where to find doxylamine succlinate?  Buy some Unisom or Nyquil - it's the active ingredient in both.  25mg in the former and 6.25 mg in the latter, plus varying amounts in about a dozen knock-offs.  Now, why on Earth would a pharmaceutical spend the millions of dollars to bring Benedictin back to market when it (a) wouldn't receive patent protection and (b) can be exactly duplicated by taking a cheap vitamin pill and a Unisom?  

If fear of lawsuits were what was keeping Benedictin off the market, its active ingredient wouldn't be found in over a dozen cold & flu remedies.  Benedictin is hardly evidence that lawsuits are keeping medication off the market.

2. Disincentives for Research & Development:

The costs imposed by product liability litigation have an impact not only on the availability of drugs already on the market but on the pipeline for new drugs, because pharmaceutical companies necessarily factor these costs into decisions whether to incur the significant expense required to research and develop drug products and bring them to the market. Where the level of risk is high, the risk of state tort law liability is inversely related to investment in research and development activity. Firms invest less in drugs that promise to provide substantial clinical benefits but also have significant side-effects (such as many drugs for cancer and multiple sclerosis). Thus, particularly to the extent companies are faced with state tort liability risks that are largely divorced from the FDA balancing of risks and benefits in drug and drug labeling approval, the financial payoff from researching these drugs and bringing them to market is reduced, causing fewer such drugs to be made available to patients.

The economists also fail to point out one of the fundamental economic decisions that go into new drug research: Expected sales. The market for cancer and multiple sclerosis drugs is much smaller than the market for erectile dysfunction drugs, or arthritis drugs, or weight loss drugs, or a variety of other drugs that treat more common illnesses. The harsh economic reality is that firms invest less in drugs that promise to provide substantial benefits to a small number of people than drugs that promise to provide marginal benefits to a large number of people. A pill that cures baldness will be far more profitable than one that cures multiple sclerosis.

3. Loss of FDA control over drug labeling:

Even a single costly loss in a state tort lawsuit alleging failure to warn imposes a legal standard that effectively requires a manufacturer to make changes in its labeling to avoid anticipated costs of future litigation. Although it theoretically might be possible to change labels only for drugs sold in the state in which the lawsuit was brought (assuming such a state-by-state approach was legal [Wyeth and the FDA contend that it isn’t.]), this seems unlikely. For drugs used in doctors’ offices, a state-by-state labeling arrangement would require considerable control over the actions of wholesalers, who are normally free to resell their supply more or less where they please. [Such an arrangement would probably violate the Commerce clause of the Constitution, too.]It would also be hard to prevent patients from using the drug in another state after purchase. Finally, advertising and marketing, which involve risk communication, would become far more complex. Thus it seems likely that the label would be changed nationwide, not just in the state in which the adverse verdict occurred. As a result, a single state tort judgment could effectively wrest control of nationwide drug labeling requirements from FDA, thus depriving the medical community in all states of the benefits of FDA expert determinations on proper and balanced drug warnings.

The economists misunderstand the extent of FDA regulation – the FDA also regulates the content of advertisement and marketing materials. If, as the FDA and Wyeth contend, a pharmaceutical may not add warnings to a drug label without FDA approval, neither can the pharmaceutical add warnings to a drug advertisement. 

4. Defensive labeling:

Firms that suffer adverse verdicts would reasonably attempt to predict other warnings which, if added to the label, might prevent costly litigation in the future. Their competitors, who can be expected to pay close attention to litigation and its outcomes, would perform similar analyses on their own drugs. With no way to know exactly what would be required through future litigation, firms are likely to add new warning language and contraindications and create overly crowded labels that seek to anticipate a wide variety of potential plaintiff allegations. Much of this new warning information would have greater prominence than would be justified by the balance of risks and benefits (precisely because FDA declined to require such information notwithstanding its tendency toward excessive caution). The effect would be to discourage beneficial use of drugs whose labels contain these litigation-induced contraindications and warnings.

As the FDA and others have long recognized, faced with state tort liability regardless of FDA approval of specific warning language, manufacturers may seek to supply warnings about virtually all possible harms that might form the basis for a lawsuit. For example, a series of Wall Street Journal articles published in 2005 noted that the three erectile dysfunction drugs on the market each carried labels more than 20 pages long. This litigation-defensive manufacturer tendency to clutter labels with risk information exacerbates FDA’s tendency toward excess caution in drug labeling.

Perhaps the economists meant to file this brief on behalf of Levine, because they repeatedly contradict Wyeth's position that it legally cannot "clutter labels."  The United States filed a brief in this case as well, and here’s what it had to say about manufacturers cluttering drug labels to avoid litigation:

“Thus, any changes to a drug’s labeling without prior FDA approval still must be the subject of a supplemental application, which FDA can approve or reject, and must be based on material new information—not information that was previously available to FDA, nor even cumulative new information that does not add materially to the information that was previously available to the agency. As the dissent explained, Section 314.70(c) does not “allow manufacturers to simply reassess and draw different conclusions regarding the same risks and benefits already balanced by the FDA.” - United States brief

Thus, under Wyeth and the FDA’s interpretation of the law, there is only one circumstance in which a pharmaceutical may change its label if it loses a product liability lawsuit: If the pharmaceutical is forced to produce documents in the litigation that it previously withheld from the FDA and the FDA then approves changes based upon those documents. In such an instance, litigation would actually have corrected a Type I error. (Although it’s terribly unfair to attribute an error to the FDA under those circumstances.)

5. Problems exacerbated further in state tort cases alleging missing contraindications:

The concerns discussed above based upon state tort law requirements for added warnings take on particular prominence where, as in this case, a plaintiff is arguing that a drug should have contained a contraindication not required by FDA. Normally, the risk-benefit balancing process for prescription drugs operates at two points: first, when FDA decides what warnings to include on the label and how those warnings are organized, and second, when physicians take account of label warnings as they decide what drugs to prescribe. If failure-to-warn lawsuits cause unfounded or excessive warnings to be placed on the label, physicians can still exercise their usual role in balancing risks and benefits, albeit with less accurate information than would otherwise be available.

Now the economists state that the FDA “decides what warnings to include on the label” but just one sentence later revert to the assumption that litigation will dictate the content of warning labels. The FDA is never a party to product liability lawsuits. A jury verdict is not binding upon the FDA in any way. Nor does a jury verdict force a pharmaceutical to change its label after a verdict. It is the position of the FDA that only it can determine when to modify a warning label, and it will not revisit that decision because of an adverse jury verdict. The FDA and Wyeth argue that if a manufacturer wants to add a warning label after a jury verdict, it would have to submit new information to the FDA in support of that warning label.

Contraindications work differently. Physicians are likely to view contraindications as outright bans, because to prescribe in the face of a labeled contraindication is to court a malpractice lawsuit and punitive damages if anything goes wrong. Contraindications therefore largely replace, rather than supplement, the usual balancing of risks and benefits.

Even if we assume that contraindications do “largely replace, rather than supplement” the risk benefit balance, preemption won’t change how physicians treat contraindications.

Again, there is no reason to expect juries in tort liability trials to perform a better balancing act than FDA. Juries will tend to impose new contraindications, which would prevent physicians from taking due account of comparative risks and benefits in the highly fact-specific situations in which physicians often making prescribing decisions. As the dynamics of litigation play out, the problem will probably become worse. A contraindication imposed by a jury in one state will likely be translated by pharmaceutical firms into a nationwide contraindication because of the practical inability to limit litigation exposure by single-state label changes. If juries in certain states or regions are especially inclined to find fault with drug labels and impose contraindications, physicians in other states will likely face the same contraindications as label changes are implemented nationwide. Then patients who would have benefited from the contraindicated use will be denied those benefits even if the expected benefit greatly exceeds the likelihood of harm. In extreme cases, manufacturers may choose to remove useful drugs from the market, as happened with many childhood vaccines in the 1980s.

Once more, the economists contradict the FDA and Wyeth, both of whom argue very strenuously that neither jurors nor manufacturers can unilaterally add new contraindications to a warning label.  Perhaps Levine will cede time at oral argument to let the economists argue that Wyeth and the FDA are wrong.

CONCLUSION

The question whether state tort litigation can complement public safety by imposing requirements in excess of those imposed by FDA necessarily depends in part on whether FDA regulation itself is insufficiently or overly cautious. Because FDA is faced with incentives that lead it to stake out overly cautious positions on drug approval and drug labeling, state tort litigation imposing additional requirements leads to a further departure away from the most socially beneficial outcome.

Given this background, it is clear that the public health would only be improved if state tort lawsuits like the one below were held preempted. For the reasons set forth above, the economist Amici, Messrs. Calfee, Berndt, Hahn, Philipson, Rubin, and Viscusi, respectfully submit that the decision of the Supreme Court of Vermont should be reversed.

If anything is clear, it's that preemption won't solve and may in fact exacerbate many of the problems the economists complain of.  Even if the FDA is predisposed to commit Type II errors, preemption won't eliminate the incentives for it to do so.  It especially won't eliminate the large financial incentive for the agency to commit a Type II error, and in fact the economists don't even mention the financial incentive. 

Justinian Lane: Author Bio | Other Posts
Posted at 4:03 PM, Jun 05, 2008 in Federal Preemption
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Comments

Justinian: What are the Type I and Type II error rates of torts litigation? Why are the error rates preempted from accountability, not by the Supremacy Clause, but by self-dealt, criminal cult enterprise privileges?

Why will you not answer, one way or another, why you do or do not support bringing the great benefits of torts to the lawyer, judge and legislature businesses? What about compensating the massive numbers of victims of bogus litigation in a mass action against the plaintiff bar and their running dogs on the bench?

One of the underestimated benefits of torts is that it substitutes for self-help.

Posted by: Supremacy Claus | June 5, 2008 4:22 PM

"Let’s assume arguendo that the economists are right, and FDA regulators are biased towards excessive caution out of fear of public criticism. It’s a non sequitur that FDA preemption will alleviate this fear."

Indeed it is. Of course, we never make that argument. A shame you couldn't be bothered to address the argument we actually did make, but I see you're more interested in playing with strawmen.

"In their fervor to blame the tort system for Type II errors, the economists have actually advanced the antithesis of the legal argument for preemption in this case. If pharmaceuticals are in fact free to include “undue contraindications or overwarnings” that the FDA doesn’t approve, then Levine’s failure to warn claim is not preempted and Wyeth must lose."

Justinian appears never to have heard of a counterfactual argument. If the Supreme Court rejects Wyeth's argument on the law, bad public policy consequences follow. And that's all we say. The economists never say that Wyeth is incorrect about the law.

"Even if the FDA is predisposed to commit Type II errors, preemption won’t eliminate the incentives for it to do so."

Again, it would be nice if you address the argument we do make rather than trumpeting an argument that is not made.

Posted by: Ted | June 5, 2008 6:19 PM

"Let’s assume arguendo that the economists are right, and FDA regulators are biased towards excessive caution out of fear of public criticism. It’s a non sequitur that FDA preemption will alleviate this fear."

Indeed it is. Of course, we never make that argument. A shame you couldn't be bothered to address the argument we actually did make, but I see you're more interested in playing with strawmen.

"In their fervor to blame the tort system for Type II errors, the economists have actually advanced the antithesis of the legal argument for preemption in this case. If pharmaceuticals are in fact free to include “undue contraindications or overwarnings” that the FDA doesn’t approve, then Levine’s failure to warn claim is not preempted and Wyeth must lose."

Justinian appears never to have heard of a counterfactual argument. If the Supreme Court rejects Wyeth's argument on the law, bad public policy consequences follow. And that's all we say. The economists never say that Wyeth is incorrect about the law.

"Even if the FDA is predisposed to commit Type II errors, preemption won’t eliminate the incentives for it to do so."

Again, it would be nice if you address the argument we do make rather than trumpeting an argument that is not made.

I haven't read all of Justinian's post: I looked at three sections, and each of the three sections contained a severe misrepresentation of the brief's arguments. No doubt the rest of the post contains other misrepresentations that I'm not discussing in this comment. I don't know whether the misrepresentations stem from dishonesty or ignorance, but either way, it's not worth further time reading.

Posted by: Ted | June 5, 2008 6:23 PM

"A Type I error also can and often does lead to injuries or death of large numbers of people."

Seeing as how Ted's main thesis is that FDA regulators are more inclined to prevent Type I errors than Type II, it would seem that this point only makes his claim stronger, to the extent the regulators want to prevent injuries.

"The reason that jury decisions may be superior to FDA decisions is that jurors often have superior information..."

I think this misses the point. The brief is not arguing who can make better decisions; it's arguing that jury trials decide *different issues* than FDA approvals. Trials are about money and one party's fault. FDA decisions are based on the general welfare of the United States. This is why the brief clearly states that juries "giv[e] more weight to the harm allegedly suffered by the plaintiff than to the benefits realized by past and future non-injured users of the drug, because benefited patients will play no role in the trial." The question is which party better maximizes the total benefit to society.

"Preemption won’t prevent the media, consumer groups, or legislators from criticizing the FDA for committing a Type I error."

Of course not. Nobody is saying that preemption from litigation prevents unsafe drugs from entering the marketplace. This is a strawman.

"It is again surprising that the economists failed to discuss the financial incentives that pressure the FDA to commit a Type II error."

Is it really that surprising? Surely it's an incentive to meet the deadline. But remember, the regulators of the FDA aren't shareholders -- they're just employees. Because they don't personally see a dime of any this money, it's hard to imagine how large an incentive it can be, other than to those whose jobs are on the chopping block for budget cuts (who tend not to be the high decision makers anyway).

Posted by: Lawyer | June 5, 2008 6:31 PM

Ted: I'm sorry you don't want to discuss the brief further. I'll just respond to your standard accusations briefly. It's hardly "playing with strawmen" to point out that the problems of an overly-cautious FDA that you discuss in your brief won't be corrected in any way by preemption. You even acknowledged that in your reply to me. We're both in agreement that there are many incentives for the FDA to be overly cautious, and we apparently agree that the tort system isn't one of those incentives. So it seemed odd that you'd spill so much ink over Type II errors when you acknowledge that preemption won't affect their frequency.

I'd also be very interested to know the tactical reasons you decided not to mention the PDUFA fees in your brief as they certainly bolster your claims that the FDA is biased to commit Type II errors.

Lawyer: Just as FDA employees don't personally see a dime of the PDUFA fee, they also don't personally receive critcism over Type I errors. The FDA was pilloried in the media over Vioxx, but the dozens of individuals who worked to approve Vioxx weren't. If anything, I therefore believe that the economists overestimate the influence that public criticism has on FDA decisions.

"Preemption won’t prevent the media, consumer groups, or legislators from criticizing the FDA for committing a Type I error.

Nobody is saying that preemption from litigation prevents unsafe drugs from entering the marketplace. This is a strawman."

But the economists claim that public criticism is the incentive that biases the FDA into being overly cautious. That's a major point of their brief. Yet the relief requested - preempting failure to warn lawsuits - won't change how cautious the FDA is. The whole brief is a non sequitur.

Posted by: Justinian Lane | June 6, 2008 10:27 AM

Why has there been no comment on the proper analyses of the Avandia data. The original FDA report noted that Avandia produced a 2.5% cardiac risk compared with 1.5% for the control froup. The relative increase has been reported (about 60% in this example) when the absolute increased risk from the drug is 1%.

Posted by: George Mandler | June 6, 2008 12:00 PM

As a patient, I feel totally threatened by the long series of black box warnings based on clinically meaningless differences between drug and placebo. These are not even statistically significant once the difference is correct for the large sample sizes.

I find the FDA seeking to cover its rear end by these disruptive black box warnings. In the case of Vioxx, the care of millions was disrupted. In the case of anti-depressants, family docs were deterred, and hundreds of untreated people died by suicide. The hard outcome to be prevented was aggravated by FDA error. This supports the thesis of Ted and of many others that the FDA is better off politically with excess caution to fend off the land pirate attacks. But the patients suffer.

These government workers are heinous working for lawyer run government oppression machines. Upon leaving, they revert back to superb scientist and academic.

Patient direct action groups should kick the asses of the land pirates attacking clinical care at the FDA. Once the land pirate feels some pain, and Vioxx is refused, it will get the message.

Posted by: Supremacy Claus | June 6, 2008 12:16 PM

SC is correct as he mentions that actual data. We can argue all we want about Type I and Type II errors but it all really comes down to how the drugs are actually tested. That is the toxicology and clinical Phase 1 through 3 studies. This is what Ted is talking about. The drug has already shown its toxicology, it has shown is clinical effects and it has been compared to other treatments. The last question is to approve or disapprove the drug for a specific indication. Now the hard part. You have a drug that will benefit a certain number and then like all drugs there will be some that will be harmed. Where is the right level? At what point is the patient liable for knowing the possible side effects? Is the FDA liable because the drug had side effects?

Lets look at a simple drug that is very dangerous like aspirin. It can cause hepatorenal failure and death in infants and children, gastric perforation and ulcers, hearing loss and leads to hemmorhagic stokes. Is it a bad drug? It saves millions of lives each year. Because it is associate with other problems that affect thousands should it be pulled?

The answer to this problem is already being given to patients. Go overseas to be treated where the new drugs are available and stock up.

Posted by: THROCKMORTON | June 6, 2008 1:23 PM

Throckmorton, just to be clear: The FDA is never liable if a person gets injured by a prescription drug. They have complete legal immunity for their decisions on which drugs to approve or deny. So product liability lawsuits have little if any impact on the FDA's approval decisions.

Posted by: Justinian Lane | June 6, 2008 1:37 PM

Justinian misleads a bit. The cult criminal will haul FDA officials, down to low pay grades before Congressional hearings. Land pirate bullies will call up, and threaten staff. These staff will get fired immediately if the slightest resistance and advocacy for clinical care interferes with the sicko agendas of the cult criminals. I do not distinguish between political parties. So the biggest blowhard and enemy of clinical care is Grassley, a Republican who is not even a lawyer.

The President does not care enough about the agency to make the dirtbags back off. He only gets involved if someone proposes an experiment on an isolated stem cell.

That leaves it to patients. They should bust up the offices of these enemies of clinical care, get on Iowa TV and show the result of Grassley's bullying by parading dead family.

Posted by: Supremacy Claus | June 6, 2008 4:09 PM

"Just as FDA employees don't personally see a dime of the PDUFA fee, they also don't personally receive critcism over Type I errors. The FDA was pilloried in the media over Vioxx, but the dozens of individuals who worked to approve Vioxx weren't."

This is just wrong. People get blamed all the time; people got blamed for Vioxx. Just look at this Mother Jones article, and how many FDA employees are mentioned:

"In August 2004, [David] Graham told his supervisors that...Vioxx...should be banned. They told him to be quiet. Their reasoning was circular: That's not the FDA's position; you work here; it can't be yours. *Dr. John Jenkins*, the FDA director of new drugs, argued that because Graham's findings didn't replicate the drug's warning label, Graham shouldn't be raising the warning. Another supervisor, *Anne Trontrell*, called Graham's position "particularly problematic since FDA funded this study."...*Dr. Steven K. Galson,* the acting director of the drug-evaluation division at the FDA, told reporters that Graham's work "constitutes junk science." Then he ... question[ed] the "integrity" of Graham's data...The FDA's acting commissioner, *Dr. Lester Crawford,* criticized Graham for evading the agency's "long-established peer review and clearance process."

And this is just one article. Graham named these four people, by name, on 60 Minutes and during Congressional testimony, just to name a few venues.

The point here is not to take sides in this dispute between Graham and his higher-ups. The point is that FDA regulators know that if a Type I error happens, the likelihood of one of their colleagues going on 60 Minutes blaming them drastically increases. And if you're the head, your chance of being fired rises exponentially. I don't think it's too far fetched to say that being blamed for a Vioxx-type problem seriously jeopardizes not only your job at the FDA, but your entire career, which you've spent literally decades creating.

By contrast, there is no risk of any of this happening in the event a Type II error occurs.

This of it this way: tortdeform, et. al., often argues that arbitration contracts are involuntary because people are willing to sign just about anything to keep their job. Well, can't that same reasoning apply here, where a person can lose not only their current job, but all future jobs?

Posted by: Lawyer | June 6, 2008 5:19 PM

Lawyer, let's just assume that you're right and there are huge incentives for the FDA to be overly cautious. Let's even say that the FDA routinelycommits Type II errors. Clearly, we all suffer when that happens. But just as clearly, preempting suits against pharmaceuticals won't diminish the FDA's tendency to commit Type II errors.

Posted by: Justinian Lane | June 6, 2008 5:35 PM

"So it seemed odd that you'd spill so much ink over Type II errors when you acknowledge that preemption won't affect their frequency."

That you repeat this non sequitur that is irrelevant to the argument of the brief shows either that you do not understand the argument or that you are trying to divert the debate away from the actual argument in the argument. The brief never claims that preemption will reduce Type II errors by the FDA. The brief argues that FDA is biased towards Type II errors, that overwarning and the loss of useful drugs is a consequence of that bias, that those problems will be exacerbated by the lack of preemption, and that therefore preemption produces superior health results to tort litigation. If the FDA weren't biased towards Type II errors, then there might be an argument for tort litigation as a supplement to FDA regulation. But repeating this is pointless, since that's what the brief says, and you refuse to address the actual argument. So there's nothing to discuss because you're not discussing the brief, you're discussing something irrelevant.

"We're both in agreement that there are many incentives for the FDA to be overly cautious, and we apparently agree that the tort system isn't one of those incentives."

The tort system most definitely is one of the reasons the FDA is overcautious.

1) The litigation lobby has a strong incentive to pillory FDA officials for committing Type I errors, because then they create a political environment against preemption. Rep. Waxman and Sen. Kennedy and the like then public lambaste FDA officials. One need only look at Justinian's own posts complaining the FDA doesn't do enough. I'm pleased to see Justinian admit that the FDA is overcautious: we shall remind him of this the next time he is inclined to criticize the FDA for committing an inevitable Type I error.

2) Lobbying by trial lawyers hoping to benefit their cases is one reason that the FDA is overly cautious: such lobbying was behind the black-box warnings for SSRIs, and these overwarnings have had detrimental effects on public health. Unfortunately, and the trial bar's lobbying is based on its self-interest rather than on the public health, just another example of how the litigation lobby puts profits ahead of people.

Posted by: Ted | June 6, 2008 5:43 PM

"The brief argues that FDA is biased towards Type II errors, that overwarning and the loss of useful drugs is a consequence of that bias, that those problems will be exacerbated by the lack of preemption..."

That's exactly what I claim you argued, Ted. But you offer no evidence that preemption will eliminate that bias. The only source of the bias you offer in your brief is the fear of public criticism, and I also pointed out the large financial incentives. Neither of those two incentives will be diminished by preemption. So if anyone is guilty of advancing a non sequitur, it's you.

"I'm pleased to see Justinian admit that the FDA is overcautious..."

Nice try at twisting my words, but I actually said: "We're both in agreement that there are many incentives for the FDA to be overly cautious..." Personally, I think you overemphasize the fear of public criticism, but I do agree that there are incentives for the agency to be too cautious. I would point to your favorite drug Vioxx as proof that they aren't overly cautious, as well as the drop in enforcement actions and warning letters in the last few years.

Ever think about the incentives to commit Type I errors, such as doing a pharmaceutical a favor and then taking a cush job with the pharma for double your agency salary?

If the FDA is likely to give in to trial lawyer lobbying to be overly cautious, they're just as likely to give in to pharmaceutical lobbying to not be cautious enough. Perhaps even more so since the FDA gets so much funding from PDUFA fees.

Posted by: Justinian Lane | June 6, 2008 6:23 PM

"But just as clearly, preempting suits against pharmaceuticals won't diminish the FDA's tendency to commit Type II errors."

This is true. But remember, the reason a "Type II error" bears that name is because it describes the activity of preventing an otherwise helpful and profitable drug from entering the market due to excessive fear.

Thus, what preemption does is help *alleviate* that fear with regard to drug companies. When companies fear huge lawsuits from varying states, each with their own different laws/standards from which any plaintiffs lawyer can forum shop, they are more inclined to over-test a drug, reduce its medicinal properties, or not even bring it to market at all. So, in effect, the drug companies are committing their own Type II error, from an societal viewpoint.

I think this was a cental theme in the brief that was missed in your post. It was not argued that preemption, strictly as a legal doctrine, will magically *do* anything. This is especially true regarding the FDA, since they're never a party to a lawsuit. Rather, it prevents over-cautiousness by pharm. companies and reduces risks and costs, thereby giving Americans more/cheaper prescription drugs.

The central thesis of the brief is thus that without preemption, between the drug companies and the FDA being essentially hedging their bets against anyone getting injured, the amount/cost of prescription drugs in the U.S. would go from an already worrisome to an outright atrocious.

Posted by: Lawyer | June 6, 2008 6:25 PM

Ted, I think we're being punk'd by Justin, since we're the only ones biting on this routine.


Brief:

"Product liability
litigation...leads to
further distortions of the drug approval and labeling
process and exacerbates FDA’s inherent overly cautious
approach. Preemption of state tort law where it conflicts with FDA requirements will minimize these
distortions."


Justin: It’s a non sequitur that FDA preemption will alleviate [the FDA's] fear [of public criticism]."

Ted's reponse: "Indeed it is. Of course, we never make that argument."


Justin: "Even if the FDA is predisposed to commit Type II errors, preemption won’t eliminate the incentives for it to do so."

Ted's response: "Again, it would be nice if you address the argument..."


Justin: "Preemption won’t prevent the media, consumer groups, or legislators from criticizing the FDA."

Lawyer's response: "Nobody is saying that..."


Justin: "the problems of an overly-cautious FDA...won't be corrected in any way by preemption...[I]t seem[s] odd that you'd spill so much ink over Type II errors when you acknowledge that preemption won't affect their frequency...[P]reempting failure to warn lawsuits won't change how cautious the FDA is...[P]reempting suits against pharmaceuticals won't diminish the FDA's tendency to commit Type II errors."

Ted's Response: "That you repeat this non sequitur...shows either that you do not understand the argument or that you are trying to divert the debate...The brief never claims that preemption will reduce Type II errors by the FDA."


Justin: "But you offer no evidence that preemption will eliminate that [Type II] bias. The only source of the bias you offer...is the fear of public criticism, and I also pointed out the large financial incentives. Neither of those two incentives will be diminished by preemption."

Lawyer's response: "It was not argued that preemption... will magically *do* anything. This is especially true regarding the FDA, since they're never a party to a lawsuit. Rather, it prevents over-cautiousness by pharm."

Posted by: Lawyer | June 6, 2008 7:17 PM

Lawyer, if you don't mind I'd prefer to be addressed as either Justinian or Lane... just a little nitpicky thing. I also wouldn't mind knowing your name, but that's totally up to you.

OK, if preemption won't "magically *do* anything" regarding the FDA's purported overcaution, then Ted's brief is an entire waste of the court's time. He makes a case that a major threat to public health is FDA overcaution, and because of this threat, asks the court to support Wyeth. Yet we apparently all agree that if the court does support Wyeth, the public health threat of FDA overcaution won't diminish one whit.

Only here, without the need to cite reliable authority, does Ted begin to blame rapacious trial lawyers for Type II errors. (Ok, he does mention Benedictin, but I thoroughly debunked that hoary old claim.)

Besides, accoring to Wyeth, product liability litigation does not "lead tofurther distortions of the drug approval and labeling process" because Wyeth claims that ONLY the FDA determines what goes on the label. Even if a manufacturer WANTS to add a warning it is forbidden to do so without FDA approval. (That's Wyeth's claim, anyway.) Yet Ted comes along and claims that because of litigation, pharmaceuticals do in fact change labels and add useless crap... clutter, I think he called it. Ted therefore contradicts Wyeth. And once again, if Wyeth can unilaterally add a warning, then their claim about preemption fails and they lose.

Posted by: Justinian Lane | June 6, 2008 8:36 PM

I thank the heavens that each of the nine justices reading the amicus brief will have better reading comprehension that Justinian, who still doesn't understand the brief after having it spelled out for him. Or perhaps Lawyer is right, and we're being punk'd; it's hard to believe that Justinian really doesn't understand how a counterfactual argument works, or that the argument "If the Court takes Incorrect Position X, then Bad Result Y will follow, therefore the argument that Incorrect Position X will lead to Good Result Not-Y is incorrect" is not the same as "Incorrect Position X is Correct." An elementary logic course would solve that problem: the truth-value of "If A then B" does not depend on the truth-value of A.

Justinian, your statements about Bendectin are as ignorant as all of your other statements. Do some basic research: for example, maybe you can read contemporaneous reports where the manufacturer said it was withdrawing the drug from the market because it was costing more to litigate meritless cases than they were making from selling the drug.

Posted by: Ted | June 7, 2008 1:48 AM

Justinian: You refuse to support ending all self-dealt immunities of the criminal cult enterprise, so they may enjoy the great benefits of torts. OK. That refusal makes you a hypocrite. Hypocrisy justifies dismissing your utterances on torts.

All lawmaking, including appellate and regulatory decisions, is human experimentation. Where are the data that FDA oversight has ever helped anyone? If you have data, next, show that the overall cost-benefit ratio was favorable.

Shouldn't all FDA rulings get pilot testing in a small jurisdiction, then a count of adverse events gets compared to the count in a control jurisdiction? Should all court decisions that will apply to the nation get the same testing?

This ghoulish human experimentation violates Nuremberg Principles. One underlying doctrine is that the experimenter should be willing to undergo the experiment himself.

http://en.wikipedia.org/wiki/Nuremberg_Code

For example, test the black box warning that anti-depressants induce suicidal ideas. Learn the unintended consequence that family docs of a county will be deterred from treating depression. The resulting increase in the rate of undertreated depression will result in an increase in the suicide rate of young people. Cancel the black box warning. It is lethal.

If you oppose requiring pilot testing of all lawmaking, and proof of safety and efficacy in the clearly stated and measurable goal, that refusal goes beyond hypocrisy. It reaches approval of a crime against humanity, ghoulish, unauthorized human experimentation.

Posted by: Supremacy Claus | June 7, 2008 6:46 AM

Ted: "If the Court takes Incorrect Position X, then Bad Result Y will follow..."

Incorrect position X is that Levine's claims are not preempted? Correct?

Bad result Y is "overwarning and the loss of useful drugs" because of FDA overcaution? Correct?

Non sequitur. Your brief suggests that the FDA is overly cautious and that incentives bias the FDA towards Type II errors. Since the FDA isn't a party to these lawsuits and preemption won't remove the incentives, your argument fails. If you wanted to make the argument that pharmaceuticals are overly cautious and preemption will encourage them to submit more drugs, well, that argument at least makes sense.

Why don't you try addressing my arguments instead of making strawmen, Ted? I stated that the reason they haven't brought it BACK on the market is that the lack of patent protection coupled with the cheap and ubiquitous availability of Benedictin's active ingredient means that the drug won't make money. And since Unisom/Nyquil/etc. are still on the market, legal costs can't be a reason not to bring it BACK on the market.

Posted by: Justinian Lane | June 7, 2008 9:42 AM

"Bad result Y is "overwarning and the loss of useful drugs" because of FDA overcaution? Correct?"

Your demonstration of your reading comprehension continues to be unmarred by accuracy, even after Lawyer spelled it out for you.

"If you wanted to make the argument that pharmaceuticals are overly cautious and preemption will encourage them to submit more drugs, well, that argument at least makes sense."

And, indeed, that is exactly what the brief says. Perhaps you could do more than cut and paste, and instead try to understand what you're cutting and pasting.

Lack of patent protection doesn't prevent a manufacturer from bringing Bendectin back on the market--the only thing stopping generic Bendectin from being sold is the same fear of legal expense that prevents brand-name Bendectin from being sold. Again, your fallacious arguments stem from ignorance of what "patent protection" means. And have you not noticed that Nyquil has a warning against being used during pregnancy?

Posted by: Ted | June 7, 2008 4:00 PM

"And, indeed, that is exactly what the brief says." Except for the lion's share of the brief, which is devoted to listing the incentives for the *FDA* to be overly cautious... Well, some of the incentives. Again, you strangely didn't mention the financial incentives. I personally think you needed to offer more evidence that the FDA's overcaution is exacerbated by lawsuits. But as long as you think it's a good brief, Ted, that's all that matters.

With respect to Benedictin:

I've already explained to you that the product is routinely duplicated by home users. There's no compelling market reason to bring it back on the market since people make generic versions of it very cheaply. Bringing it back to market would be costly in two ways. First, they would have to do a big PR campaign to persuade people that the product is safe. Second, there might be another expensive & lengthy FDA approval process... I don't know if it could come right back onto the market after a 25ish year hiatus. And then after they do the heavy lifting with the PR campaign, a generic could come right along and undercut them on price because there is no patent protection.

The cost to bring it back onto market, the current availability of homemade generics, and the likelihood of competition from pharma generics means that there's not much profit to be made in bringing it back onto the market. You're an econ guy, you should understand that.

Further proof that any fear of lawsuits is unwarranted is the fact that neither Nyquil nor Unisom have been barraged by lawsuits. Perhaps lawsuits are what took Benedictin off the market, but they aren't the reason Benedictin stays off the market.

Posted by: Justinian Lane | June 7, 2008 4:52 PM

"There's no compelling market reason to bring [Bendectin] back on the market"

Except for the fact that hospitalizations of pregnant women for morning-sickness-induced dehydration have doubled since trial lawyers drove it from the market. But who cares about public health and safety when trial lawyer profits are at issue, right?

Posted by: Ted | June 7, 2008 6:45 PM

And except for the fact that those same women are often told by their doctors to just take half a Unisom and a Vitamin B-6 pill and get the *exact* same thing as Benedictin. And of course, Unisom hasn't been driven off the market.

Posted by: Justinian Lane | June 8, 2008 1:22 AM

The FDA is doing a great job despite a few errors. We have seen different health products of questionable quality especially in erectile dysfunction and penis enlargement categories.

Posted by: Procalisx Herbal Remedy For Erectile Dysfunction | June 8, 2008 5:56 AM

1. The lawsuits against Bendectin were bogus.
2. The lawsuits against Bendectin drove Bendectin from the market.
3. Bendectin's withdrawal from the market had an adverse effect on public health.
4. Preemption would have prevented this.

All four of these statements are true. Justinian hasn't responded to any of them.

Instead Lane notes that some doctors have figured out how to get around the Bendectin withdrawal. Which doesn't change that others haven't or that others refuse to risk being sued or that morning sickness dehydration remains a bigger problem now than it was 25 years ago.

Posted by: Ted | June 8, 2008 7:18 AM

You two should answer these non-trivial questions.

1) Should all judge and lawyer immunities end to improve their atrocious performance? Should patients like me be able to get damages for the consequences of idiotic judge and regulatory decisions? On policy grounds, liability shrinks the entire enterprise and not just misconduct. Wouldn't everyone enjoy seeing government shrunk and bankrupted, as it bankrupts and shrinks entire economic sectors by its unlawful industrial policy disguised as torts? I would. Government does nothing well, with one exception, rent seeking.

2) Should the FDA be closed, since it has no necessity and does nothing right?

3) Should patents, another highly damaging lawyer scam, have a term shortened to 5 years?

Otherwise, no one cares about your narrow anecdotal debate.

Justinian, I know that the criminal cult indoctrination of 1L has erased what you learned down to fifth grade. The Civil War? That lawyer caused catastrophe? It settled the question of pre-emption. You are beating a dead horse.

Posted by: Supremacy Claus | June 8, 2008 8:30 AM

Ted, let's not even get into a debate about the public health. You've got Benedictin on your side, and I've got:

Dalkon Shield, Vioxx, Avandia, Seroquel, Zyprexa, SSRI's in general but especially Paxil, Fen-phen, Bextra, Baycol, Rezulin... the list goes on. Any public harm caused by the withdrawal of Benedictin is more than offset by the thousand of deaths caused by these and other drugs. Drugs approved by your "over-cautious" FDA, btw. It's like comparing a paper cut to a sucking chest wound. Oh, I almost forgot Phenergan. Trial lawyers don't cause gangrene.

Honestly, the "reform" movement's attempt to claim that preemption is for our safety is pathetic, desperate, and disingenuous. Especially since the best example of a drug you've got on your side is Benedictin. By the way, where was your criticism of Bilbray for claiming that lack of Benedictin killed his son? Or is junk science OK when it's used against trial lawyers?

Posted by: Justinian Lane | June 8, 2008 12:30 PM

Justinian: Each of those drugs you listed represent hideous, unwarranted interference by the FDA with the use of great drugs. The adverse reactions were trivial, outright false, and pretexts for false class actions. Meanwhile, the actions on these drugs caused the disruption of the care of millions. In the case of SSRI's, the black box warning increased the suicide rate. The entire Psychopharmacology Committee and the Commissioner need to resign. I would, if a decision I made at work foreseeably killed hundreds of young people.

That list is one of evidence for the end of the FDA. They are a total threat to clinical care.

As Dr. T said, those decisions are between patient and doctor. Lawyers should stay out or face patient direct action group self-help. Patients have to wake up, and start to act on the land pirate. Once patients get rid of the land pirate oppressor, they can count on a 10 fold increase in new medications and treatments.

Today, patients have all the information that doctors do. Patients have a duty to Google. Otherwise, get this ridiculous, dangerous government lawyer threat to clinical care out. The lawyer has killed millions of people by delaying progress and intentionally obstructing public health.

Posted by: Supremacy Claus | June 8, 2008 1:18 PM

Justinian, having been refuted, changes the subject. But once again he opens his mouth without bothering to learn the facts.

I've got more than Bendectin on my side. I've got the hundreds of thousands of deaths from FDA Type II errors. And SSRIs are on my side, not yours, in case you haven't seen what's happened to teen suicide rates since the black box was added at the insistence of trial lawyers who cared more about profits for lawyers than the health of people. Again, as the brief shows, and you have failed to rebut, the Type II errors committed by the FDA far overwhelm the health effects of the Type I errors -- which are no more common (or rare) in the US than in countries with sensible product liability and drug approval systems.

And those are just the Type II errors we know about. We don't know how many drugs aren't being developed because trial lawyers have increased the costs of drug development to the point that cures for Alzheimer's, cancer, diabetes, and other diseases aren't happening. Maybe there would be a drug that would have cured Ted Kennedy's glioma if the trial lawyers hadn't stopped it. Maybe there wouldn't. But those are very real costs, even if we can't measure them. A 1% increase in costs decreases drug development 4%, so we've lost dozens of life-saving drugs because of trial lawyers -- we just don't know which ones, because they weren't developed. But of course, to Justinian, trial lawyer profits are more important than people's health.

As for Avandia, the health effects of trial lawyer advertising causing schizophrenics to stop using the drug outweigh the side effects of Avandia itself--all of which were disclosed.

Your ignorance about Phenergan and its warning label is appalling, but consistent with your ignorance about everything else you write about. For all your complaining about medical malpractice, you finally have a case of medical error right in front of your nose, and you're blaming the drug company because a doctor made precisely the mistake that the warning label warned not to make?

Posted by: Ted | June 8, 2008 4:44 PM

We know that every excess lawyer destroys over a $million in value a year. We know that less lawyered nations have growths of 9% instead of anemic 3% of the United States. We know that within Europe, overlawyered economies stagnate compared to right lawyered ones next door, with the same language and culture.

We know that every social problem has a lawyer depending on it for a job. We know that the politics of the lawyer does not matter when it comes to criminal cult enterprise rent seeking. When crime drops by a half after the enactment of sentencing guidelines, Scalia leads the charge to loose millions of vicious predators. We are now experience the Scalia Bounce in murder rates all over the country.

The profession is in utter failure in every goal of every law subject except for rent seeking. Its criminal cult hierarchy must be stopped by a courageous Executive.

The indoctrination is so good, even Ted does not know he underwent it. Indeed by his excellent performance in school, he is a bigger victim than Justinian, who is average in performance.

Posted by: Supremacy Claus | June 8, 2008 9:46 PM

"It could be zero."

No, it couldn't, unless the laws of economics magically disappear for drug companies. But we know they don't, because, again, we have evidence that drug development is a function of expected drug revenues, as I note in my 2005 paper on the subject. Every dollar going to a lawyer is reducing money that could be going to promote public health.

And you still haven't addressed the substantial evidence that Type II errors have killed tens of thousands more than Type I errors -- and now you're denying that one cannot decrease Type I errors without increasing Type II errors further, showing that you have no intention of discussing this honestly.

"Oh, now the trial lawyers control FDA labeling?"

But, of course, I forget that you're incapable of discussing issues honestly and that it's a waste of my time to engage you since you persist in making up arguments instead of addressing the ones I actually make. Have fun talking to yourself.

Posted by: Ted | June 8, 2008 10:37 PM

I've asked you to name another drug besides Benedictin that isn't on the market here because of litigation. You instead engage in rank speculation that "maybe" there might be some good drugs on the market if it weren't for litigation... "maybe" even one that would have cured Ted Kennedy. I can only imagine the dressing-down you'd give me if I resorted to such a flimsy claim.

You completely disregard the thousands of proven, actual deaths caused by Type I errors and instead claim that Type II errors have caused more deaths. A claim that cannot possibly be proven and is based entirely upon theory. Well, in theory Type II errors have killed thousands of hypothetical citizens. But in reality, Type I errors have killed thousands of real citizens with real names and real families. And in reality, you're working to ensure that those real victims never get any compensation. Instead, you'd rather have innocent individuals, insurance companies, and even taxpayers pick up the bill for the damage caused by your corporate masters. Why on Earth should Medicaid or Blue Cross have to pay for the treatment of a woman who suffered a stroke after using the Ortho Evra patch?

You utterly failed - both here and in your brief - to present evidence that trial lawyers force the FDA to commit Type II errors. The best you can do is assert that trial lawyers exert political pressure on the FDA, but you refuse to admit that pharma not only exerts political pressure but also financial pressure. And of course, you refuse to acknowledge that many FDA staffers leave the FDA for a high-paying job in pharma - evidence that there is a large incentive for individual staffers to commit Type I errors.

You refused to rebut my true assertion that litigation has corrected Type I errors by eliminating the information asymmetry between the FDA and pharma. Litigation saves lives by revealing information that pharma concealed from the FDA. Would you support granting subpoena power to the FDA? If it had subpoena power, and the resources to use it, litigation might not be so important to public health. But it is.

You complain about the overly cautious FDA but don't point out how the FDA has saved lives by being "too cautious." Recall that we didn't have the thalidomide disaster that something like 40 other countries had.

You also fail to take into account the cost of Type I errors, both in loss of life and in loss of dollars. You certainly have no evidence that the cost of Type II errors exceeds Type I errors because, again, there is absolutely no way to accurately measure the cost of Type II errors, which you yourself admit.

You have routinely ducked questions, twisted words, made baseless personal attacks, and engaged in other sophistry rather than have to admit that the corporate interests who pay your salary sometimes have done very bad things. In your world, Merck didn't kill people by concealing the risks of Vioxx - trial lawyers killed people when they revealed those risks. And you accuse me of intellectual dishonesty.

Posted by: Justinian Lane | June 8, 2008 11:48 PM

Rent seeking cult criminals at HHS have final say over all FDA decisions. That is why the FDA should be closed. Any scientist enemy of clinical care serving it is a Trojan Horse for the rent seeking cult criminal. Vioxx, and countless never brought to market drugs that had the slightest chance of generating a lawsuit. As a patient, I feel totally threatened by the lawyer caused antics of the FDA, a front organization for cult criminals.

Posted by: Supremacy Claus | June 9, 2008 1:10 AM

And around we go: Justinian, having been refuted, changes the subject once again.

"instead claim that Type II errors have caused more deaths. A claim that cannot possibly be proven and is based entirely upon theory. "

You're lying again. There are hundreds of thousands of documented deaths from Type II errors caused by FDA non-approval or delay, and I provided a cite, and that outweighs the Type I errors. On top of that, there are the theoretical deaths caused because we're losing drug development to attorneys' fees.

"You also fail to take into account the cost of Type I errors, both in loss of life and in loss of dollars."

Yet more dishonesty from Lane, since I explicitly take that into account in the comment you replied to.

"You utterly failed - both here and in your brief - to present evidence that trial lawyers force the FDA to commit Type II errors."

Now you're just trolling, since it's been pointed out to you multiple times that this isn't the crux of the argument. See Lawyer | June 6, 2008 07:17 PM.

Once I saw that sentence, I realize I should've kept my promise to stop wasting time here. Lane has the disturbing pattern of making false argument A, having A refuted, ignoring the refutation and making false argument B, iterating the process with false arguments B, C, D, E, and F, and is now making false argument A again, without ever acknowledging that there was already a discussion on this that you never addressed.

I don't know whether it's your reading comprehension or your honesty at issue, but either way makes discussion fruitless. You're talking fantasies to yourself, and I don't have time for your monologues.

Posted by: Ted | June 9, 2008 9:02 AM

And again Ted bristles when someone challenges his "Corporations: good, lawyers: bad" world view. The last word is yours if you want as this is my final post in this thread. I'm just compelled to point out that the cite you posted has nothing to do with litigation, and also doesn't document actual deaths. It's merely another argument for laissez-faire FDA regulation. There is one quote in there worth noting, though:

"The historical record—decades of a relatively free market up to 1962—shows that voluntary institutions, the tort system, and the pre-1962 FDA succeeded in keeping unsafe drugs to a low level."

Thanks for providing more evidence that the tort system saves lives.

Posted by: Justinian Lane | June 9, 2008 10:14 AM

Justinian: You will soon turn 30. At that point, every 5 years, for the rest of your life, an organ will fail. Your pain and fear of death will settle this debate. The lawyer has obstructed the pace of progress in clinical care to about a tenth what it needs to be, all for lawyer job creation. Restrain this criminal cult enterprise hierarchy running government, and progress will explode. We have a Sierra Leone class of bureaucracy and obstructionism.

Pain will teach you best.

Posted by: Supremacy Claus | June 9, 2008 12:18 PM

"The historical record—decades of a relatively free market up to 1962—shows that voluntary institutions, the tort system, and the pre-1962 FDA succeeded in keeping unsafe drugs to a low level."

Justinian, the point of this paragraph is not to prove that the tort system "saves lives", but to enumerate the cogs in the pre-1962 regulatory framework, showing that the post-1962 powers granted to the FDA have done more harm than good.

In any event, it seems a somewhat glib retort to claim simply that the tort system "saves lives." Of course the tort system saves lives. We could ban every drug on the market and someone's life would be saved. The same applies to just about anything consumers use (e.g., cars, planes, swimming pools, etc.) While this may seem a Nader-esque dream-world, few would argue that many of the everyday products we use today should be banned simply because such would save lives.

Thus, the question here is not whether the tort system saves lives, but whether, at the margin, allowing federal regulation to preempt state failure-to-warn lawsuits makes society better off, considering the societal benefits of drug development and the economic role of incentives within the drug industry.

Ultimately, until anti-tort reformers such as yourself are willing to engage in this honest debate, blogs such as this one can never achieve its supposed goal of working to increase the welfare of society.

Posted by: Lawyer | June 9, 2008 12:58 PM

Wow, this is a war. You both would disagree with this but both of you - Justinian and Ted - know what you are talking about. You just disagree. I'm on Justinian side on the whole thing but I also realize that on this economic question, people smarter than me disagree with me. (I suggest agreeing to disagree with a little bit more of a respect for the others position. Perhaps you should hug it out.)

Supremacy Claus, while I'm sure Ted appreciates your support, I really don't think he would agree with you on much. You position that we should abolish the FDA and that there have never been bad drugs on the market are just plain silly.

Ron Miller
www.marylandinjurylawyerblog.com

Posted by: Ron Miller | June 10, 2008 4:40 PM

Ron: Ted and I are adversaries. He has zero tolerance for any statement I make. He gets easily upset by anyone who disagrees with him. The feeling is not mutual. I still like Ted a lot, and always learn from him. He is like a kid. Nevertheless, I commend the courage and sincerity of Justinian in not dealing with me by total shunning and censorship. Justinian and I have a cordial, private relationship. He has an open invitation to lunch whenever in town.

I do not support tort reform. I do not even support the limits on punitive damages from the Supreme Court. I do support the procedural due process rights of civil defendants. I support ending all lawyer and judge immunities from adverse third parties for legal malpractice, thus exploding your business. ALI tort expert types have retorted, litigation explosion, which I found funny. Their ALI President, Geoffrey Hazard, proposed the same in 1995. There is nothing original nor out of the mainstream in that viewpoint. It is quite consistent with the view of the lawyer establishment and most prof. resp experts.

Liability is stealth industrial policy that deters and shrinks the entire targeted enterprise, not just misconduct. Open the liability of government and the judiciary, and it will shrink, instead of its current explosive growth. The latter is driven mostly by its absolute immunity.

I find Ted a corporatist hypocrite. He is also getting really close to entering the lawyer hierarchy. They all hang when a courageous Executive arrest the hierarchy for insurrection against the Constitution. You are still quite safe from that enforcement.

*****************

In 1906, there was need for an FDA. In 2006, there is a need for independent judgment of clinicians and patients based on clinical data posted to the web. The FDA should not prevent people from making their informed choices.

Let's say, a drug helps 1% of people and gives 99% of people horrible side effects with zero benefit. Let's say, it kills many in the premarket testing. That drug will not get approval today. What if I am in the 1% of people who respond and there are a million people with the targeted condition. The 10,000 responders would not get their treatment today.

The FDA is a lawyer Trojan Horse and a totally bogus scam. All its substantive decisions are made by rent seeking cult criminal, politically appointed, amoral hacks at HHS. It is part of government, a wholly owned subsidiary of the criminal cult enterprise that is the lawyer profession.

Posted by: Supremacy Claus | June 10, 2008 7:00 PM

FDA pointlessly destroys an industrial sector, out of fear of potential litigation.

http://www.reuters.com/article/topNews/idUSN6A33595920080610?feedType=RSS&feedName=topNews&rpc=22&sp=true

The FDA should pay all damages. The national plaintiff bar should also be sued for past intimidation and threats of litigation. Make these cult criminals pay for every lost opportunity cost.

Posted by: Supremacy Claus | June 10, 2008 10:25 PM