Preemption: Now Available On DVD
51 CommentsBy Ed Silverman // November 14th, 2008 // 10:13 am
Now that the US Supreme Court has heard the controversial case that pitted Wyeth against Diana Levine, who claims an insufficient warning on a Wyeth med contributed to the loss of part of her right arm, a non-profit group, Alliance For Justice, is trying to keep the issue in the public eye with a new documentary that argues against preemption.
Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, will be closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. Here is the trailer…
You can watch the entire film here and you can order a DVD, should you wish, at the AFJ web site for that house party you’re planning.
Hat tip to the PAL blog, which wants to know who will play Henry Waxman in the feature film version
Prescription Access Litigation
Anything that helps the public understand preemption and how it’s going to affect their rights is most welcome. With the Supreme Court likely to find for pharmaceutical companies and against consumers in Wyeth v. Levine, this is more important than ever.
Kudos to Alliance for Justice.
Over at the PAL blog, we’ve speculated about who would play Rep. Henry Waxman in the preemption feature film. Take a look, and nominate your choice for his celebrity lookalike, at http://blog.prescriptionaccess.org/?p=397
Jaynesday
In trying to find any reason for preemption it appears there is basically one main argument.
We (pharmaceutical companies) need freedom from product liability so that we can devote more of our profits to the development of wonderful new drugs and devices for the betterment of society.
This argument is based on a number of assumptions that are:
1. The financial weight of “frivolous law suits” has prevented the development and marketing of *some number* of products that otherwise would have improved or saved *some number* of lives.
2. The increased but unknown number of new products that would/could be marketed if the industry had the protection of product liability immunity (preemption) would certainly in no way ever harm a consumer to the extent that the industry should be held accountable for this harm.
3. Without the protection of liability immunity suddenly, maybe over night, the unknown financial weight of product liability law suits will increase to an unbearable and as of yet un-established burden through the proliferation of an untold amount of “frivolous law suits”. We haven’t yet defined the totality of the “frivolous law suit” but take our word for it, it’s bad and it’s huge.
4. State tort is incapable of preventing frivolous law suits.
5. State torte is incapable of judging right from wrong when it comes to pharmaceutical products. Or pharmaceutical liability resolution defies logic and is always based on emotion and results in unwarranted restitution. Or a jury of citizens does not have the mental capacity to understand the testimony of industry experts.
6. The only reason for state tort is to make the consumer and his/her lawyers rich.
7. The FDA is the “gold standard”. Once it has decided that a drug is safe for consumption any other opinion should be considered frivolous and/or will cause pharmaceutical companies to become confused by more than one opinion about the safety of their product.
8. The FDA is properly managed, with up to date technology and has the capacity to approve and monitor all current and new products and manufacturing facilities - even after the gold rush of the impending liability free, blockbuster heaven.
9. The FDA is free of political and industry influence. It does its job with one goal in mind and that is the protection of the American consumer.
10. Pharmaceutical companies will never try to falsely influence the approval of their products and will react quickly when they find a problem.
11. There is always a risk when taking any drug or device, therefore the industry does not deserve to live under the burden of accountability no matter how many people its product kills or injures.
Of course I’m being a bit facetious or maybe along the lines of Daniel Troy’s tactics, I’ve made it sound more like a Hollywood movie. As a matter of fact I wonder how close to Mr. Troy’s script I came?
Condor
O/T — breaking, though — Schering’s Vytorin/Zetia scrips FLAT for Oct. 2008.
More later.
Salmon
Jaynesday,
If you want a hypothetical scenario for the basis of these huge numbers of “frivolous lawsuits see my comments under:
Pharma Plans Ads To Attack Obama Drug Plan
http://www.pharmalot.com/2008/11/pharma-plans-ads-to-attack-obama-drug-plan/
Salmon
Jaynesday
Thanks Salmon, could you break it down for me?
Is it your opinion that one reason for the push for preemption is in anticipation of a catastrophic increase in law suits caused by adverse events for certain drugs and that the industry is aware of this?
Salmon
Yes.
Salmon
Jaynesday,
Note that the liability for Judgements for Phen-Fen totaled $13.1 Billion and that occurred over 10 years ago and sales were not nearly in the same league as some drugs. For example in the class I’m think of there are multiple drugs with multibillions in annual sales (e.g. $5B /yr), and sales have been ongoing since the time of Phen-Fen. Now if that population has had a progreesive decrease in life expectancy due to CV illness, etc. etc., and the CEO of one of the company with the $5B in ann sales said back in 2004 at a public meeting that the lawsuits have gotten their attention. Now if you look at a variety of structurally similar compounds and how FDA has been addressing their cardiovascular toxicities since Phen-Fen. It might even lead you to believe that companies and FDA senior management might have been aware of this since the early 1990’s and have been slowly working towards protection of the companies, for example by banning ephedra in dietary supplements, coming down hard on ‘herbal viagra’ which is only different by a single additional hydroxy-group.
One way to say new drugs are OK and invoke preemption would be to have all drugs with cardiac problems screened by thorough QT studies under a group headed by a ex-Pharma VP and say they’re only screening for the risk of Torsades d’ Pointe, when that’s simply an extremely rare complication and other effects like inflammantion and growth of heart valves and the pulmonary artery are extremely common, and can be detected if you look for it. Remember effect may not be limited to a specific receptor but for similar receptors too resulting in other toxicities with various drugs and drug classes.
Now all this is hypothetical. I just read a lot and connect the dots, kind of like Robert Redford in 3 days of the Condor.
Ben
Drugs have side effects. They always have and always will. It is the health care industries responsibility to minimize the harm and prevalence of those side effects.
Its amazing to think that a 0.000whatever % occurrence is grounds for a lawsuit if the drug companies, physicians, pharmacists and nurses have all done what is asked and required to ensure safe drug therapy.
Now if it can be found that anyone in that process acted in gross negligence then the lawsuits are justified, but please don’t start looking for blame when you start putting controlled amounts of poison in your body.
atlex
Janesday,
You may not care to listen, but your strawman that pharma’s argument boils down to future innovation is incorrect. That may be the ultimate consequence, but the argument is much more complex than that. Among other things, it avers that it must follow federal government regulation and that regulation pre-empts state laws. It is a rational argument that has its merits. No doubt, those against pre-emption have strong arguments as well. If this was a slam dunk case either way it would neither have made it this far nor have generated the strong passions on both sides. Trying to blame this on pharma greed, which is the essence of what you said, is no more fair than to suggest that the only reason Wyeth has been found liable is because it has deep pockets.
Atlex
Salmon
Ben,
Who says they have done even the minimum to try to minimize harm? Let the pharmaceutical companies release publicly all information in the FDA including submissions and reviews I would bet you will find not only gross negligence but intentional fraud.
Atlex,
The basis for the argument for preemption is predicated on various assumptions that Congress and others have already shown simply don’t hold. It’s a completely bankrupt argument that those of us closest to the facts know is simply absurd.
Companies are simply scared that past actions may come back to haunt them in the near future, and that this will minimize sales growth of the inapproprirate use of certain medications. Of course this if it’s big enough it might effect innovation but considering a midsize company like BMS has close to $7B in cash on hand and the entire industry has ~$600 billion in annual sales, there would have to be some really massive lawsuits to effect innovation long term.
An FDA Reviewer
Steve
Salmon,
Your last sentence says a lot about your lack of business sense.
What you are effectively saying is, keep it up, we can afford the larger awards. I don’t think that this kind of thinking/attitude is conducive to companies exploring the future. I believe all of us agree that this direction is wrong and a very poor use of company profits.
Jaynesday
Ben, I really I do care to listen. As a matter of fact I am gropping for an explanation for preemption. Please let me know the real reason that we need preemption.
I have obviously made a number of assumptions in my post mainly out of frustration. I am frustrated that after so many months of discussion on the subject I have found very little defense for preemption. I have searched the web for comments both pro and con and have to tell you there is little written in its defense.
Therefore I made up my defense for preemption and added a little Daniel Troy melodrama to fill the voids.
When you have lack of reason assumption tends to fill the void.
Btw - the reference to D. Troy meledrama has to do with his comment “We can’t afford to get involved in every case,” he said, according to an affidavit written by someone who was there. “We have to pick our shots…so make it sound like a Hollywood pitch.”
This was at a time when he worked for the FDA and was helping to support the defense of drug company litigation.
George
Steve,
I don’t think Salmon is saying what you’re trying to claim he is.
Let’s say there’s a $25 billion judgement against Lilly for Zyprexa. So far Zyprexa has probably had $50 billion in sales. It’s not going to effect innovation across the entire industry. Unless of course all the new innovation has similar toxicities that the companies are afraid of being liable for if they don’t warn about it. Merck and Wyeth after all went on after $13 and $5 billion dollar judgements respectively and continued with other innovations.
There have been some companies like Schering that have had multiple $0.5 billion dollar awards, yet it hasn’t seemed to effect the way they do business. For some business is to make as much money as possible by any means necessary. For those punitive damages as a means of reigning in their natural tendencies may be the only way possible to prevent future intentional damages.
If a company hasn’t done anything wrong then they won’t have anything to worry about. $6 million judgements like in the Wyeth case are rare, and they can be overturned or limited. It’s just that a broad agreement with preemption would open a Pandora’s box and would only encourage more problems.
Justice in MI
I will put myself in the very unaccustomed role of defending preemption…or at least a version of it. (Hold on to your torts….).
I am aware of instances in which people inside companies knew of serious safety data which was being spun or suppressed - both from FDA and from the public. At the same time, they felt that lawyers on the other side were themselves so overreaching that, rather than voice their concerns in a way that could be used to cause _inappropriate_ harm to their companies, they remained silent.
This is one reason why I have tried (obviously, in vain) to get us to stop talking about “frivolous lawsuits” - which is an entirely politicized and, in its way, viciously dismissive term - and speak instead of “exploitative lawsuits.” To speak of exploitation puts what is worst about the trial bar on the same footing as what is worst in industry - neither one typical of either profession, in my view, but both certainly real.
So it is time for those of us who try to speak for justice to do so with all rightful claims in mind. I _do_ think that exploitative lawsuits sometimes work to the detriment of public health via, for example, the scenario I described above. It pushes some number of people of conscience into the shadows. That said, I have _not_ seen any credible data which suggests lawsuits of any kind - exploitative or appropriate - can be linked to suppression of new drug development. And the business about “defensive over-warning” and a “chaos of conflicting standards” appears to be entirely mythological - as the “leaks” from FDA officials (not connected with the Office of Chief Counsel) recently seem to have confirmed.
Beyond that, I would be glad to play Waxman were I not already committed to play Dingell. Oh well. That’s showbiz.
Justice in MI
Additional note, and here again I part company with some in the trial bar (which I am not).
I believe that if there is no evidence that a company has acted to supress relevant data, and FDA can show that they have conducted a reasonably thorough review of relevant risk/benefit, than there is no grounds for liability. We do not need preemption for this. In virtually every case (some will argue re: Levine in this context) when those two situations apply, no liability is assessed.
We have also recently heard from FDA Reviewer - and his/her examples could be multiplied many times - about how easy it is for companies to be technically ‘in compliance’ but still be able to manipulate FDA, or coordinate with their pals there, in ways that lead to safety data being suppressed. For that reason especially, I continue to believe that all of us are best served - industry, shareholders, patients, HCPs, and more - without even a narrow concept of preemption. The tort system properly run, including the “rebuttable presumption” that FDA approval supercedes tort claims which is the law in 31 states, serves us better than compromising it with preemption - a doctrine that remains, at its core, ethically, empirically, and practically bankrupt.
Susan
Steve,
Instead of monetary damages that might effect innovation, if there’s a pattern or intentional harm resulting in death of children then perhaps CEOs from the company(s) involved could be held accountable for murder
18 USC 1111
Murder is the unlawful killing of a human being with malice aforethought. Every murder perpetrated by poison, lying in wait, or any other kind of willful, deliberate, malicious, and premeditated killing; or committed in the perpetration of, or attempt to perpetrate, any arson, escape, murder, kidnapping, treason, espionage, sabotage, aggravated sexual abuse or sexual abuse, child abuse, burglary, or robbery; or perpetrated as part of a pattern or practice of assault or torture against a child or children; or perpetrated from a premeditated design unlawfully and maliciously to effect the death of any human being other than him who is killed, is murder in the first degree.
This might help prevent future problems and wouldn’t excessively penalize companies financially.
In fact those doing research or regulatory filings in companies who might have information might be more willing to come forward and provide evidence of what was known and not told FDA if they weren’t so afraid it might effect their job security due to huge financial penalities.
Steve
Susan, et al
Corporations are not set up as a DBA, they are insulated from many criminal acts which include murder. Money crimes can be prosecuted by government agencies but does not include the SEC (they have no police or arrest authority). Money crimes (fidelity) are usually handled by police agencies who do have arrest authority. Attorneys General can also prosecute corporate crimes, including corporate employees but only as part of corporation activities.
Yes,if an “individual” employee working for the corporation commits murder, he or she is held accountable. If the corporation also knew that murder would take place as a result of their product, it can also be prosecuted but this is really a rare moment. You have to have a heck of a lot of evidence, and to prove this, is most difficult.
The only viable way of making a claim or lawsuit is through the tort system, aka, civil system. That is why the FDA can be involved.
Preemption by a federal institution such as the FDA makes more sense than to have a lot of states with all sorts of conflicting statutes.
Maybe a modified preemption such as medical malpractice claims have, would suffice. Many states have mandatory “general damage” limits. I agree with it, as this is a way of limiting outrageous awards by a jury of peers who may very well be made by their emotions and not the law.
If preemption becomes law re the FDA, I would not be opposed to a general damage maximum. To me, this is fair.
CRH
Salmon–
Not to quibble with your opinions or arguments, but your stating “coming down hard on ‘herbal viagra’ which is only different by a single additional hydroxy-group”, doesn’t make much sense. Obviously, you’re not a chemist, nor have you done much research; but a “single hydroxy-group” can make all the difference in the world between a drug being safe and effective or not. I’m not saying it is in this particular case; however, you must be careful when making statements such as a “single additional hydroxy-group”. Anyone remember thalidomide? The (R) enantiomer is effective, the (S) is teratogenic. This is a simple (not so simple chemically, but for this argument), interconversion of one carbon atom.
Anon
I recall reading about the mandatory general damage limits in businessweek. My understanding is that it tends to be limited to $250,000 for medical malpractice. Since lawyers may make 30% on contingency and the average cost to bring a case are slightly over $100,000 lawyers actually lose money bringing cases in those states and so don’t bring them. Also effectively limits damages regarding lost income (Elderly may have no or very little income to lose, and children since they’re too young to work everything is hypothetical and thus there’s no real loss). Therefore the $250,000 would never be reached for cases of death in these populations. Yes I’m sure anyone who is afraid of losing the preemption case would like to have limits on damages that in essence prevent the bringing of lawsuits.
In this respect I agree that the differences between states as to preemption and maximum damages really is problematic. However, I don’t see what the FDA has to do with it.
Would you change your mind if Congress were to release documents that prove that a drug company hid deaths from the FDA, and that includes documents with signatures of VPs from major pharmaceutical companies that indicate that the VPs were intentionally trying to hide the deaths, since they knew there was a problem in the patient and instead of stopping the drug (per protocol after being notified by the physician) simply decided to wait and see and thus allowed the patient to die? What if this was accompanied by documentation that FDA knows about this and instead of pursuing it retaliated against the person who found the evidence.
Steve
Medical malpractice claims consist of the following: All medical expenses, all lost wages, continuing medical treatment if necessary and, general damages which is for “pain and suffering”. This is the portion that has the limitation. Nothing else.
As far as the FDA is concerned, this is the subject we are discuussing as it pertains to preemption.
I was simply saying that if there was an attachment (addendum) to the preemption for a maximum pain and suffering allocation,it would be a good idea and more fair.
Anon
What if the pain and suffering was more horrible than anything you can imagine but only lasts a few weeks before death. In contrast you have severe suffering but it goes on for decades. In which case would you limit it and to how much?
Alternatively if a child dies within 2 weeks due to drug induced suicide when there’s no suicide at all on placebo I don’t see any medical expenses, or lost wages. As for limitations for pain and suffering how is anyone going to prove it was the drug if the data is hidden at FDA. Anyway no matter what it won’t bring back the child nor will it prevent the company from just continuing to sell the drug and claiming that the suicides are due to the underlying illness.
Jaynesday
Concerning fair restitution for product liability - Susan eluded to it but much of the discussion has missed what to me is at least as important as how much the harmed party should receive; that being how much punishment does it take to stop the manufacturer from continuing bad business practices. This is what is really offensive about preemption to me.
Also -
If future innovation is harmed by large settlements who’s fault is that? Part of innovation, maybe the most important part, is quality and safety. What good is a drug that cures some number of people of cancer but also kills the same amount by heart attack? Some people might call that innovation but I don’t.
Steve
Anon and Jayne,
I do not disagree with your thoughts but this is the law of many states.
My thinking is, at least there is some mitigation, rather than no avenue at all, through preemption. This is at least a compromise to the door being slammed on the sufferer.
Nathan
Jaynesday asks: “I am frustrated that after so many months of discussion on the subject I have found very little defense for preemption.”
Try this (below) from PhRMA if you want really want an answer. I don’t think it’s quite as clear-cut as the “anti-preemption” people like to make it out to be. I agree with the person above (Atlex?) who commented that if it were so clear cut, it wouldn’t have reached the supreme court.
————–
Washington, D.C. (November 3, 2008) – Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding federal preemption:
“Federal preemption, at its heart, is about protecting patients through nationally uniform and scientifically based warnings on prescription drug labels. Contrary to critics’ assertions, federal preemption is not about providing blanket immunity for America’s pharmaceutical research and biotechnology companies.
“Upholding federal preemption will not deny patients their day in court. State judges and juries may still levy damages against manufacturers that fail to comply with Food and Drug Administration (FDA) standards. But those state judges and juries should not be permitted to interfere with an important public health goal: Uniform, science-based risk communication.
“The FDA should be allowed to do its job to protect patients by overseeing drug warnings. Federal preemption can play a constructive role in achieving these national goals.
“One important point often remains silent in this debate: All medicines have some risks. FDA’s expert scientists must sometimes make tough choices when they approve a medicine that can help treat or save millions of patients, even as they recognize that some patients will experience serious side effects.
“For 70 years, Congress has charged the FDA with ensuring that medicines are adequately labeled to warn about potential side effects. Patients and healthcare providers should be concerned that, without adequate preemption, personal injury lawyers and individual states could require information that conflicts with FDA’s expert judgment. These inconsistencies may be, at best, confusing or, at worst, life-threatening, because patients and providers could be scared away from needed medicines.
“Inadequate preemption can also harm patients by slowing or denying their access to potentially life-saving therapies. Look no further than the experience of domestic vaccine manufacturers driven from the market, in part, due to excessive liability exposure.
“Indeed, patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines. That is why Congress empowered the FDA to approve how that information is conveyed on the medicine’s label.
“PhRMA’s support of the Agency’s label oversight is consistent with five former FDA chief counsels, who maintained in a bipartisan letter: ‘If every state judge and jury could fashion their own labeling requirements for drugs and medical devices, there would be regulatory chaos for these two industries that are so vital to public health, and FDA’s ability to advance the public health by allocating scarce space in product labeling to the most important information would be seriously eroded.’
“FDA has acted aggressively, setting high and consistent standards for warning labels. While transparency is not an issue in the case that is before the Supreme Court, America’s pharmaceutical research and biotechnology companies should be accountable to a strong, well-resourced FDA. Any company that attempts to hide critical safety information from the FDA should be punished to the full extent of the law.
“The FDA has the power to punish companies with civil and criminal penalties if they fail to report required information to the Agency. The FDA takes this authority seriously and PhRMA fully supports accurate and timely reporting of side effects.
“But it is difficult to explain why the law should penalize companies that fully disclose all known risks to FDA, update those safety disclosures appropriately when new risks come to light, and work with the Agency to change the labels on medicines to accurately reflect new risks (or benefits).
“America’s patients benefit from a regulatory system that is one of the world’s best at balancing safety and access. Permitting state law actions to undermine this inherently federal function could serve to impede patient access to needed medicines, while adding no real benefit.”
Nathan
Since it is a long statement, I’ll highlight a couple parts that are especially interesting to me:
1) “Upholding federal preemption will not deny patients their day in court. State judges and juries may still levy damages against manufacturers that fail to comply with Food and Drug Administration (FDA) standards.”
2) “One important point often remains silent in this debate: All medicines have some risks. FDA’s expert scientists must sometimes make tough choices when they approve a medicine that can help treat or save millions of patients, even as they recognize that some patients will experience serious side effects.”
3) “PhRMA’s support of the Agency’s label oversight is consistent with five former FDA chief counsels, who maintained in a bipartisan letter: ‘If every state judge and jury could fashion their own labeling requirements for drugs and medical devices, there would be regulatory chaos for these two industries that are so vital to public health”
4) “Any company that attempts to hide critical safety information from the FDA should be punished to the full extent of the law. The FDA has the power to punish companies with civil and criminal penalties if they fail to report required information to the Agency. The FDA takes this authority seriously and PhRMA fully supports accurate and timely reporting of side effects.
5) “But it is difficult to explain why the law should penalize companies that fully disclose all known risks to FDA, update those safety disclosures appropriately when new risks come to light, and work with the Agency to change the labels on medicines to accurately reflect new risks (or benefits).”
Justice in MI
Wow. I have responded point-by-point to the PhRMA statement in an earlier post. It is, in the main, misleading. But I won’t repeat myself here.
I was interested in Steve’s statement:
“The only viable way of making a claim or lawsuit is through the tort system, aka, civil system. That is why the FDA can be involved.
Preemption by a federal institution such as the FDA makes more sense than to have a lot of states with all sorts of conflicting statutes.”
I am not clear how paragraph 2 follows from paragraph 1 - I would have expected the reverse conclusion. Second, if the “chaos of conflicting standards” argument were genuine, why has it been FDA’s own position, through most of its history, that civil liability usually complemented rather than conflicted with the agency?
Everything that would be served by “narrow” preemption can also be attained through rationalizing punitive damage and a series of other reforms to the tort system as it exists. Indeed, in most states (those with ‘rebuttable presumption’ as noted up thread) the equivalent of narrow preemption already exists.
Nathan
Justice writes: “I believe that if there is no evidence that a company has acted to supress relevant data, and FDA can show that they have conducted a reasonably thorough review of relevant risk/benefit, than there is no grounds for liability.”
I’m glad you believe that, Justice. Unfortunately, the court system doesn’t seem to believe it. There are 5000 liability cases against Wyeth right now for Premarin causing breast cancer. Wyeth has lost many of them. What’s interesting is that Wyeth has warned of increased risk of breast cancer EVER SINCE THE DRUG WAS INTRODUCED. See this link:
http://www.totalinjury.com/article_wyeth_product_liablity.asp
Nathan
Justice, I know you’ve responded to the PhRMA position before. (although this is a new statement - released only days ago) I posted it because Jaynesday wanted some sort of defence. While it isn’t perfect, it’s a better defence than I can provide. What do you think of the below statement? It seems to disagree with what you have previously posted:
“3) “PhRMA’s support of the Agency’s label oversight is consistent with five former FDA chief counsels, who maintained in a bipartisan letter: ‘If every state judge and jury could fashion their own labeling requirements for drugs and medical devices, there would be regulatory chaos for these two industries that are so vital to public health”
Justice in MI
OK, dammit, I can’t resist. I’ll go with Nathan’s summary:
Since it is a long statement, I’ll highlight a couple parts that are especially interesting to me:
1) “Upholding federal preemption will not deny patients their day in court. State judges and juries may still levy damages against manufacturers that fail to comply with Food and Drug Administration (FDA) standards.”
-This is a blatant lie. Read the DOJ/FDA amicus in the Kent case. Following the Buckman precedent, only the FDA can find fraud against itself. And even if it does (which is almost never) that would _not_ open the door to any patient’s day in court. That’s what the amicus says. Read it.
2) “One important point often remains silent in this debate: All medicines have some risks. FDA’s expert scientists must sometimes make tough choices when they approve a medicine that can help treat or save millions of patients, even as they recognize that some patients will experience serious side effects.”
-This, as always, is true but entirely irrelevant. What is relevant is what did a company know, when did they know it, what did they do. “All drugs have dangers” has not only not been “silent” - it is a truism that has been shouted at us endlessly. But that has not provided it any relevance whatsoever.
3) “PhRMA’s support of the Agency’s label oversight is consistent with five former FDA chief counsels, who maintained in a bipartisan letter: ‘If every state judge and jury could fashion their own labeling requirements for drugs and medical devices, there would be regulatory chaos for these two industries that are so vital to public health”
- The fact remains that FDA as a whole has supported civil liability as generally complementary, not conflicting, with its regulatory role. It’s not hard to find ‘five former chief counsels” for most any position. Levine had two former Commissioners, quite a bit up the chain of command, arguing the contrary.
4) “Any company that attempts to hide critical safety information from the FDA should be punished to the full extent of the law. The FDA has the power to punish companies with civil and criminal penalties if they fail to report required information to the Agency. The FDA takes this authority seriously and PhRMA fully supports accurate and timely reporting of side effects.
- More blantant misinformation. Name ONE case in the past twenty years not involving off-label promotion - and in the drug, not device, arena -= when FDA levied significant civil or criminal penalties. I can tell you through a FOIA of my own there have been three, all were small, and none involved safety issues. FDA may “have the power.” But FDA never uses it.
5) “But it is difficult to explain why the law should penalize companies that fully disclose all known risks to FDA, update those safety disclosures appropriately when new risks come to light, and work with the Agency to change the labels on medicines to accurately reflect new risks (or benefits).”
- The law (assuming that means torts) should _not_ penalize such companies. In the majority of states with “rebuttable presumption,” it simply doesn’t. Show me one case in which a company did all the above, honestly and in good faith (with none of the kind of gaming that FDA Reviewer recently summarized) in which a company was, in fact, penalized. (If all you can come up with is Bendectin, I win.)
Nathan
Justice writes: “Show me one case in which a company did all the above, honestly and in good faith (with none of the kind of gaming that FDA Reviewer recently summarized) in which a company was, in fact, penalized.”
See my previous post: Premarin.
Justice in MI
Just now seeing Nathan’s post above mine. I partly answer it above, but here is more:
Show my one judge or jury that has _ever_ fashioned “their own labeling requirements.” It doesn’t happen. What juries sometimes do is say that a label is inadequate because a company did not act, when it might have, on known risk information and/or FDA did not adequately review the relevant risk. (Whether either applies in Levine is a worthy debate, but not the debate we’re having.)
As for “regulatory chaos,” name one instance in the entire history of the FDA - during with civil liability and FDA co-existed - when anything resembling it occurred. Who was confused? What chaos ensued? What problems resulted?
Answer: Nobody and none.
Justice in MI
I don’t know the Premarin case, so I will leave it to others to decide whether there were, indeed, exploitative and successful lawsuits in that instance. Certainly the story you site takes the plaintiff’s perspective: e.g., “According to a Reuters story, the jury found Wyeth’s conduct to be “malicious, wanton, willful or oppressive” and to show “reckless indifference to the interests of others.”
I don’t know what is or is not true.
But let’s grant you are right. Does not one case justify preemption as a complete policy change?
Justice in MI
Meanwhile, there is the rest of my rebuttal of the PhRMA statement to rebut…
Justice in MI
Last for the moment. The debate format has its pros and cons. At core, I don’t think Nathan and I disagree on truly fundamental points. There are, indeed, exploitative lawsuits, just as there are exploitative industry actions. Both need to be reigned in.
The question is whether preemption is the instrument to do this. And in the meantime, preemption’s real advocates, as represented, for example, on Drug and Device Law, do not have some nuanced and narrow notion of the goal. I quote again the conclusion to their blog on Levine:
“So we don’t think we’ll be seeing prescription drug litigation vanishing from the face of the earth any time soon.
But we’ll keep trying.”
Compare that with PhRMA’s reassurances about the “day in court” we can rely on. Their own lawyers, when they imagine the face of the earth, appear to have a very different vision.
Jaynesday
Nathan, thanks for the PhRMA explanation on the benefits of preemption. Some good points are made but I think that most of them are based on conjecture. The arguments require that we forget about the past 70 year of experience we’ve had with the corrective force of product litigation and suddenly come to a new realization that the future is exceedingly bleak for drug manufacturers and consumers unless the industry can be exempted from liability.
One way to evaluate the benefits or harm of this assumption is to consider what a world with preemption might be like. Imagine if we had been living with it for the last 70 years. How different, better or worse, would it have been for everyone involved?
With preemption would we have had more or less people killed or harmed by prescription drugs and devises?
With preemption how many more and better drugs would we now enjoy?
How many companies would have been “punished” by the FDA for noncompliance?
How many criminal penalties would have been handed out for failure to report, how many companies would have been “prosecuted to the full extent of the law”? Would we have been satisfied with this single means of control afforded by the FDA?
How many less people would have suffered from life threatening avoidance of drugs due to excessive warnings?
In the opening statement PhRMA pleads for preemption - “Federal preemption, at its heart, is about protecting patients through nationally uniform and scientifically based warnings on prescription drug labels.”
How many non-uniform and unscientifically based warnings on labels have we seen in the past 70 years?
I’m not asking for numbers here (though they would be nice), just look at the logic of it. Look at the current reality and past experience and tell me that my future is going to be better with preemption.
It seems to me that PhRMA and others are inventing a brand new future that is not based on reality. There are too many “could be’s” and “may be’s” in their statements.
For an industry that is profoundly adept at statistical analysis there seems to be a stark lack of hard data to support these theories.
Nathan
Moving slightly back from the preemption issue, there seem to be a quartet of forces creating a “perfect storm” against pharma right now:
1) Courts ruling against our patent protection rights on certain drugs (think Protonix) and allowing generic competition prior to patent expiry.
2) FDA and other regulatory bodies showing increasing scrutiny of applications – there are higher and higher percentages of our drugs being delayed and rejected. I don’t think the quality of our packages are down. Rather, scrutiny is going up – resulting in much fewer drugs approved.
3) The true “payers” (insurance & government) refusing to pay for new drugs on the grounds that they are not cost effective or are not a significant advancement over existing (cheaper) treatment.
4) Huge increases in the # of lawsuits.
That said, it’s interesting to watch my own pharma management. They vigorously and passionately deal with issues 1, 2, and 3. Yet, they remain (almost) completely silent on issue #4. The same is true of financial analysts. When they assess the future prospects our industry and companies, they deal extensively with issues 1, 2, and 3. However, they don’t deal with lawsuits. They don’t mention preemption.
This silence from management and analysts leads me to believe that either:
a) At heart, they really don’t support preemption. (in spite of the official press releases)
or
b) Lawsuits aren’t as big of a financial burden as is perceived.
I don’t know which is true, but it seems that one or the other must be true.
Jaynesday
Nathan,
I would be interested in the numbers for #4. I’ve heard differently but I haven’t been able to put my hands on the data yet.
I also wonder what the real cause of this increase is. Is it the exploitive lawsuit? A study - Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005 - states that “From 1998 through 2005, reported serious adverse drug events increased 2.6 fold from 34,966 to 89,842, and fatal adverse drug events increased 2.7 fold from 5,519 to 15,107. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period.”
If there really is a “huge increase” in lawsuits, this might be the real reason why.
Also here is something I found that might be a viable option to medical tort reform. Its a series of discussions at Northwestern U about a concept that has been studied called “Health Courts”. It proposes a specialized system that would take medical related suits only. (very simply stated)
http://www.youtube.com/watch?v=1fduA3eW4ec&feature=related
I would be interested in what pharma generally thinks about this option as opposed to preemption. After all preemption is not really tort reform.
Condor
Or, Nathan — Alternative (c): The number of lawsuits ISN’T ACTUALLY “EXPLODING” — it is a myth — being used to help “sell” preemption.
The reality is that pharma has suffered several high-profile losses (which, in all likelihood were actually supported by the evidence) — but pharma suffered these losses in a couple of counties/parishes in Texas, Southern Illinois and Louisiana — each of which seems to seat juries willing to award very-high boxcar-type damages. [To be clear, the evidence supported a verdict -- but perhaps not a verdict of the SIZE the jury awarded -- in any event, our appellate courts are well-equipped to handle this sort of anomaly. But pharma wants to lay waste to all that.]
So — in a nutshell — pharma NOW wants to make MANDATORY the “removal” of ALL local lawsuits — to the (generally more conservative) federal courts, exclusively — when and where lawsuits would still exist, at all.
I think you’ve had too much Kool-Aid, Nathan.
Time to step away from the punch-bowl. Just a thought.
Namaste
Condor
Good points, Jaynesday. Especially that part about adverse events actually driving whatever increase there might be in lawsuits being filed.
Cheers!
Justice in MI
I’d pick up on Nathan’s point #2. If FDA is, indeed, showing increased scrutiny that, in itself, may be the result of anticipated preemption. FDA will be holding the ball, excusively, and they already know how much bad press they’ve received (not all fair) in the competence department.
This is only a speculation, but it would also explain why companies don’t focus on #4 as much. Another reason is that they have PhRMA, corp. lawyer groups, and a variety of “blog tanks” (DrugWonks, Manhattan Inst., Fed. Soc., etc.) to do it for them. For companies themselves to do it becomes almost a DTC that says, “We can’t be trusted to do the right thing.” As I’ve said many times, that would be not be true, but it could well be so perceived.
Finally, I am aware of a fair number of people wihin industry, just as at FDA, who _oppose_ preemption. I can’t call it a statistical or representative sample - I have no idea. But it is not a tiny number.
Atlex
Jaynesday,
While we rarely would agree, I would be open to “health courts” or some similar concept. Most courts and juries have a very difficult time understanding the complex science behind many medical suits. I suspect, however, that the trial lawyers would fight against this concept. They know that that can use bad science to convince a jury of almost anything.
Atlex
Jaynesday
Alex, agreed that bad science is used in a lot of ways to get what one wants - in juries and otherwise.
Nathan
Condor writes: “The number of lawsuits ISN’T ACTUALLY “EXPLODING” — it is a myth — being used to help “sell” preemption.”
Read this article from USA Today, then we’ll talk. There *IS* an explosion of lawsuits. We can debate the reasons — but there is no denying an increase in numbers.
http://www.usatoday.com/money/industries/health/drugs/2006-08-23-drug-lawsuits-usat_x.htm
Justice in MI
Nathan - Good article; thanks for citing it. There is no question about the numbers. The question will be whether how many of these are exploitative given particular cases.
Interesting also to hear from Lars Noah, who is a committed critic of the tort system. His comment that pharma is “in tobacco-land in terms of how much people hate it” should certainly give pause, as well as his view that none of this impacts development of new drugs (which the Chamber of Commerce person contests).
Salmon
CRH,
I may not have been clear, but you made my point for me. A single hydroxy group can totally change the effect of a drug. For those of you who don’t know sufentenil is Viagra. It was originally developed to treat pulmonary arterial hypertension (I don’t know the proposed mechanism offhand) however it was found to induce erections as a side effect. The PAH indication was put on the back burner until recently (Good move if you think this orphan indication may soon explode as a generic would not be able to be reimbursed for this indication under Medicaid if there’s another version of the drug from Pfizer approved for it with exclusivity.) However since PAH can be caused by stimulation of 5HT2B (the mechanism of Phen-Fen’s toxicity) it’s possible that viagra actually downregulates this while the hydroxy might actually stimulate it. Thus ‘herbal viagra’ might be exceptionally dangerous. This is speculation on my part but my point as CRH also points out is that a minor change in a molecule can have huge consequences.
Now I want to discuss something that I’ve been alluding to but I am not going to talk about my concerns explicitly and how I came to them.
About a year ago for my own sake I decided that I needed to get up to date on the new antipsychotic medications. I used to know antipsychotics in depth nearly 25 years ago so I started to build all sort of comparison tables, indications, receptor binding, study designs, toxicities, kinetics, etc.. Then last April I was talking to a colleague from one of the big Pharma companies about the atypical antipsychotics and how I needed to bone up on all the different serotinin receptors. He encouraged me and I said maybe some day I’ll get around to it. Well instead that night at home I did take a look at them and what the different receptors did and it refreshed me on 5HT2B Phen-Fen aortic valve stenosis, PAH and all the symptoms and complications. As well as all the effects for the other serotonin receptors. A few days later I decided to start working again on my knowledge of the different atypical antipsychotics and since I had gotten as much as I could from the labeling. I decided to look at the summary basis of approvals and decided to start with olanzapine (Zyprexa) (you can look it up yourself on http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/). As I was going through it I noticed the warning letter on PAH and then as I tried to make sense of the SBA. I found a number of things.
Paul Leber who was the Director of the Division of Neuropharmacologic drug products at the time wrote a very strange memo to the file talking about how toxicities in the 3 different cohorts may be different and that this might become apparent post marketing. I then tried to figure out what these different cohorts (groups) were but they were often redacted. Also there was an indication that was not approved but was also redacted. From the list of phase III studies it became apparent that the 3 cohorts were adults, children, and the elderly with psychosis related to dementia and this last cohort was probably the indication that was not approved. There were also an exceptional number of cardiovasculat deaths and toxicities in this group, but it was explained away as being simply that they were old. (However I was looking at this after the off-label push of this indication by Lilly and the black-box warning not to give it due to the risk of CV death and stroke (stroke with antipsychotics is thought to be related to serotonergic effects on platelets among other mechanisms.)
As I went through the SBA I found a number of symptoms that could potentially due to 5HT2B stimulation including a neonatal death, (just like the warning letter.)
Then if you look at the metabolism of Zyprexa 80% of the circulating radioactivity from a mass balance study isn’t identified. Which leads to the question of what other metabolites are there that Lilly doesn’t want anyone to know about. Then there’s a figure of the metabolic scheme, but it doesn’t include a 7-OH metabolite that’s mentioned in the text that’s formed by CYP3A4. Yet hydroxylaton at this position would be expected to be the most facile metabolic route and it and secondary metabolites such as sulfate, glucoronide, or even methylated metabolites via COMT would be expected. Then Lilly clearly used the lowest possible dose of carbamazepine and incredibly potent inducer of CYP3A and claimed that the entire decrease in olanzapine was due to effects on CYP1A. Then in clinical studies for adjunctive treatment of bipolar disorder they studied other drugs in combination but not carbamazepine but still got an indication for combination with all other drugs used for bipolar. (this is a way to avoid finding side effects due to a drug interaction if you really expect one.)
If you look at the receptor binding they talk about inhibition or binding of various 5HT2 receptors that are very close to 5HT2B but don’t mention 5HT2B or whether agonism was looked at yet the experiments will always tell you if there is upregulation or down regulation, but they don’t mention it, and they don’t mention many different 5HT receptors. Plus they clearly don’t mention effects of various metabolites. (If you look at other atypicals it’s the same with varying reporting).
There’s simply too much information missing and according to the FD&CA it’s clear that Zyprexa should have been turned down for lack of information. Companies are supposed to provide all safety information to FDA, however in a case like this it they suspected something what they could have done is examined other backup compounds in development or clozapine itself and looked at activity of metabolites on 5HT2B, yet they would never have to report any of this to the FDA.
For many similar drugs from the past there’s a history of severe reactions when given with a MAOI, which would result in a buildup of a 7-OH metabolite
According to the SBA Safra Ibrahim was the reviewer of this metabolism data. I know Safra and she wouldn’t have the right experience to have picked up a problem but even she was concerned about the lack of information on the metabolism.
Also Lilly only studied Symbyax (Prozac and Zyprexa) for bipolar depression for only 8 weeks whereas standard study periods for depression are always 12 weeks. However with phen-fen 30% of people had symptoms on 2D echo after 3 months (and symptoms began to become apparent). I also knew that Indocin is used to treate Patent Ductus Arteriosus and they Vioxx tends to cause the symptoms with the opposite effect and they become apparent largely after a year.
Looking at a similar compound clozapine I found lots of black box warnings on the same side effects as Zyprexa including heart attacks and RBBB which all can be secondary symptoms of PAH and 5HT2B stimulations.
I then did a search on PAH and found the symptoms of carbegoline and pergolide associated with 5HT2B stimulation was the same as the constellation of symptoms with clozapine and olanzapine.
I now strongly suspected that Zyprexa is another Phen-Fen and it was being intentionally promoted off-label for children, but that the phen-fen like toxicities may take a long time to show up.
It’s recently been reported by Pharmalot that Sen Grassley’s office released info that 1% of all children on Medicaid are on antipsychotics.
Even if this was only children from 6 - 18 yo this would be 1% of ~60,000,000 (5,000,000/yr). Yet since mania and schizophrenia are each 1% of the adult population and don’t tend to be diagnosed until 18, 19, or more so the early 20’s and the younger you go the more rare the diagnosis is (it’s even rare at 16 yo) to have 1% of all kids on these drugs points to incredible amounts of misuse even if you believe that it’s appropriate and can diagnose these disorders in children as the usage is likely concentrated in the older kids and so over time may easilgy grow into several % of the pop. These drugs are also now being prescribed off label for bipolar II (hypomania and even being promoted by NIMH for kids with ADHD who have temper tantrums (it might eventually be bipolar and maybe we can prevent it) What if it’s like antidepressants where it only works in the more severe cases) then you could get an indication in mania but including a lot of hypermanics in the study even if it doesn’t work in mania. Plus they’re being studied for bipolar depression (2.5% of the pop) quicker onset of antidepressant activity (5%) of the pop, and even GAD another 3 -4% of the pop. For adults the median duration on an antipsychotic is 3.7 months but a child has forced compliance. So several years down the line from now we might be looking at several % of the pediatric population being treating with drugs that if given long enough might cause permanent cardiac problems in nearly everyone who takes them. It this is the case then if I was Lilly’s CEO I would be concerned about lawsuits just like he said he was back in 2004.
When you look there’s also evidence that cardiac toxicity with Zyprexa may be a class effect, with different degrees of severity for different drugs. Right now this is a hypothesis but it can be easily examined. However how are we going to get the information?
There’s other things also. We know that Lilly hid the diabetes yet when you look at the PDR for the very first year they put advertisements for diabetes education of their drugs right after Zyprexa. (Believe me the placements are carefully thought out). Plus there was a lot of hepatotoxicity especially if people also had a history of viral hepatitis, which is now a standard exclusion criteria in studies. Then after approval Lilly published and article about an N-formyl metabolite that they don’t mention in the SBA. They would not have gone back and done another mass balance radiolabeled drug study to do this so they had to have had this information prior to submission of the NDA and didn’t report it. (A friend told me that Pfizer did the same thing with ziprasidone and there’s some very interesting side effects and possible structure activity relationships regarding toxicities with ziprasidone and some other drugs. Getting back to this N-formyl metabolite it reminds me very much of both Vertex’s and Schering’s drugs for treating viral hepatitis.
To all the preemption folks when drug companies don’t look into things there’s usually a reason. It looks to me like Lilly was definitely trying to hide something. Plus you have to realize that maybe 5 people at FDA are reviewing a drug and each person has to cover a half dozen specialized fields and it’s likely that they may not know very much about a couple of them. So it’s relatively easy to pull a fast one past the reviewers, even without all the tricks that have been described. It’s only the super-overeducated and experienced reviewers who even have a chance to pick up on things.
As an example look at troglitazone (Rezulin) it was pulled from the market for being hepatotoxic but only after 3 different medical reviewers were harassed and 2 of them lost their jobs and went public. Yet if you look at the original labeling it says right in there that it’s metabolized to a quinone, and quinones are incredibly reactive. In fact the hepatotoxicity of tylenol is due to a semi-quinone. So it’s very likely that Warner Lambert knew that this drug was very likely hepatotoxic even before they saw their first case. Yet no one at FDA picked up on this due to a lack of expertise of the pharmacologist and pharmacokineticist who worked on the drug and they even put the mechanism right in the labeling without even knowing it. Yet to the company with multiple experts looking at it for years and having the clinical data they probably knew but just kept their mouths shut and hoped FDA would overlook it like they did (except for the medical reviewers who were then forced out.)
Salmon
Regarding the article.
The vast vast majority of these cases are against premarin, prempro. This drug has been on the market since the 1940’s and breast cancer is extremely common (1 in 7 women) no wonder there is a lot of potential cases here.
As for the other drugs actually I’m amazed at how few there are.
I’m not sure that a single drug that’s an exception proves a rule.
Salmon
Nathan
Salmon writes: “The vast vast majority of these cases are against premarin”
That’s not the case at all. Read it carefully and here’s the numbers I gleaned:
-There were 17,027 lawsuits filed against pharma in 2005. (more than 5x the number for any other industry)
-There were 6000 lawsuits filed against Wyeth for Premarin “in recent years” (not 2005)
-Between 2000-2006 there were ~65,000 lawsuits filed against pharma
-There are still 14,000 outstanding lawsuits for Vioxx alone. (as of when this article was written)
I’ve been looking for more recent numbers, but haven’t been able to find them. In all fairness, I agree that these numbers may reflect a couple of major drugs (Vioxx, Premarin among them) rather than a true trend. Also, it would be interesting to plot # of lawsuits alongside the total drug usage. As drug usage skyrockets (as it has), it would make some sense that lawsuits would also skyrocket. Unfortunately, these numbers seem very hard to come by. (probably because they are handled state-by-state rather than nationally)
Jaynesday
Nathan, don’t forget to plot the number of serious AE’s for the same time period also. Although FDA records for these are not very accurate here either. One reports says that only btw 1% and 10% are reported. Quite a range, sounds like a guess.
It would be a very interesting graph and one that I would think should be known, published and examined often.
It is also inexcusable in this day and age that one would have go hunting for such information.
When people’s life, health and wellbeing are at issue we shouldn’t be debating which numbers are correct or even where and how to find them.
Happy hunting, if I find any data that I think might be valid, I’ll let you know.
Salmon
Nathan,
Must have spaced out. I was looking at the last table. I have to agree with your statement that the numbers may reflect a couple of major drugs. It could also be a true trend due to increased awareness. We don’t know without a lot more details.
I can’t remember how many drugs (different chemicals) there are on the market however it’s well over 1000. However there are only about 200 or 300 widely prescribed drugs.
Considering that there were 17,000 in 2005 right after Vioxx became public and about 50 K for the remaining years from 2000 - 2006 and also a big hump from Zyprexa we might ordinarily be talking about 5 - 7 K lawsuits filed per year. Of course it can’t be distributed evenly across drugs. From what I’ve read the ones with massive numbers of suits are largely ones where the toxicities were especially egregious and companies and even FDA hid them.
When you consider drugs like Seroquel having a fes hundred lawsuits and similar drugs like risperidone having resulted in the reported deaths of well over 1000 people (likely 10x more in actuality), the number of lawsuits is likely an underreflection of the true harm being done.
I personally wouldn’t be surprised if there has been a true increase. My impression is that Pharma is putting out more and more dangerous drugs simply because they need to in order to maintain sales figures. Plus FDA has been talking the past several years about making people aware that drugs are dangerous and they should get used to it.”We can’t call a drug that kills 1 in 10,000 people toxic” Even though that might mean that 1 in 1000 are seriously maimed and 1 in 100 are have a related injury. It is also my impression talking to lawyers that they are more aware of bringing lawsuits against pharma.
I’m not one to bring lawsuits. I’ve been seriously injured myself through the negligence of others and even though I could have brought a nonfrivolous lawsuit I didn’t. I still have problems with preemption. If you read a previous post of mine you’ll see I believe the evidence suggests that Lilly marketed Zyprexa intentionally to the elderly off-label even when they knew the FDA turned it down for this indication because FDA felt it was too dangerous. Plus they also hid the diabetes. Now it looks to me like they’re going after off-label sales to kids when it may kill and maim in this group also and they likely know it. We need some way to reign repetitive behavior like this. Unfortunately lawsuits may be the only way. Show me that the FDA can really do what the people who want preemption says it does, and show me a way that you can reign in actions like I describe.
I’m not so sure that Health Courts are the way to go. Professionals are more likely to dismiss injuries as they become immune to them, you can see this by simply showing specialists AEs in their own field and in other fields. Plus the experts under the Daubert rules are typically made experts by manipulations by the pharmaceutical companies. Believe me I’ve seen it.
There is no perfect system, but I think that preemption will only make the current system worse.
Justice in MI
Without making more or less of it, interesting to me that Ortho Evra one of the drugs for which many suits filed. We learned only this year - on Pharmalot and from reporting elsewhere - about some of the trial documents that showed J&J knew about the increased risks of thrombotic events even before OE went on the market. (The lawsuits were initiated before this became public - indeed, it was the lawsuits that made it public - another reason why such suits contribute to public health, accountability, as well as justice.)
According to what has come out, it appears to be a classic case of “camoflage” compliance. A special way of counting was devised apparently to minimize the signficance of these events in the data submitted to FDA. The way of counting is indirectly referred to in one obscure bit of a 400 page document.
You be the judge.
Salmon
Interesting article on page B5 of today’s Washington Post. Eliot Spitzer talks about his experiences as Attorney General of NYS and going after AIG etc. and being told don’t meddle, trust us, we know what we’re doing.
This is what he has to says about preemption:
“And when the attorneys generals of all 50 states sought to investigate subprime lending, believing that some lending practices might be toxic, we were blocked by a coalition of the major banks and the Bush adminisitration, which invoked a rarely used statute to preempt states’ ability to probe. The administration claimed that they had the situation under control and that our inquiry was unnecessary.”
Salmon