Judge Reverses Preemption Ruling In Paxil Case
51 CommentsBy Ed Silverman // July 19th, 2008 // 1:02 am
US District Court Judge David Hamilton has reversed his prior opinion in which he had dismissed a Paxil suicide case based on preemption, which says that FDA approval supercedes state law claims challenging safety, efficacy, or labeling. The FDA and drugmakers argue preemption exists by maintaining agency actions are the final word on safety and effectiveness. The case is now re-opened.
The lawsuit was brought by Debra Tucker whose brother, Father Rick Tucker, was a Catholic priest for more than 26 years in Indiana. He was prescribed the antidepressant in August 2002 by his family doctor, and took the pill for 22 days until his death the following month at age 55, when he shot himself in the head with a .25 caliber pistol.
In his 28-page opinion, Hamilton wrote that, in his prior ruling, he “failed to appreciate the significance of the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer.” Here are some additional excerpts…
Glaxo “has acknowledged that the regulations give it the responsibility for proper labeling of Paxil, and that it had the ability to make changes to Paxil’s label when there was “reasonable association” between a serious hazard and a patient’s ingestion of the drug.
“…The FDA’s current position on preemption is not ‘long standing’ but is in fact a ‘180-degree reversal’ from its earlier stance…the court, on reconsideration, gives relatively little weight to the FDA’s opinion on the preemptive effects of its regulations…Drug manufacturers have the authority to strengthen warnings without the advance permission of the FDA.
“[F]ailure to warn litigation can serve to reinforce the FDA’s regulations, which already place the obligation to strengthen the warnings on a drug’s label squarely on the shoulders of the drug’s manufacturer…
“The FDA’s statement, made several years after the fact, that it would not have approved a warning change that was never actually proposed, is speculative and will not serve as the basis for a finding of a preemptive conflict.”
This fall, the US Supreme Court will hear a preemption case involving Wyeth and a Vermont woman. Diana Levine successfully argued before the Vermont Supreme Court that, even though labeling for Wyeth’s Phenergan complied with FDA requirements, the adequacy of the warning still wasn’t established. She lost an arm and was awarded $6 million.
Levine’s attorneys contend Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. The Supreme Court ruling could, therefore, determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
UPDATE: A Glaxo spokeswoman send us this comment on Monday, July 21: “The decision in this case would allow a jury to determine whether an FDA-approved label adequately informs physicians about a medication’s risks and benefits, as the label generally has to be found to be inadequate before the manufacturer can be held liable.
“This could result in a patchwork of labels that vary from state to state for no good scientific reason, placing doctors and patients in an untenable position. Glaxo strongly believes that FDA, rather than a jury, has the responsibility to determine whether the labels on medicines offered in the U.S. are appropriate. The agency has the scientific expertise and the ability to evaluate the potential risks and balance them against the benefits of the medication, so that doctors have good information upon which to make prescribing decisions.
“The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm or suicidal thinking. On the basis of research in tens of thousands of patients taking antidepressants, including Paxil, there is no increased risk of suicidal thinking or behavior in people age 24 and older and, in patients older than 65, there was a reduction in risk in suicidal thoughts and behavior. The decedent in this case was 55.”
Dianne
Thank you Judge Hamilton!
Sadly, the right to hold a drug manufacturer accountable for harm or death due to a FDA approved drug may soon be gone.
If FDA preemption becomes the law of the land, the lives of all of us will be endangered. The New England Journal of Medicine (NEJM) called FDA preemption, “A disaster for patients’ rights, public safety, and industry accountability.”
FDA preemption is not being reported in the media. Most Americans have no idea what FDA preemption is, or that we are a hair away from losing the precious right of legal redress.
The clock is ticking. Levine will be heard this Fall. Americans deserve to know what is underway. If anyone reading this has the voice and power to inform the public, please use it now! Thank you.
Justice in MI
Just a few clarifying bits for those who may be interested.
As some will recall, this past year FDA issued new guidelines on when and what companies were obliged to make known (via label change, Dear HCP letter, etc.) without having to wait for formal FDA approval. In FDA law, these are mainly under the heading of “CBE regulations” - “Changes being effected.”
I’m not recalling the exact language (someone will, Ed posted on this), but the new guidelines move from something like “reasonable probablility of association” (not law’s language) to a standard approaching evidence of causality. Thus the new guidelines raised the bar for reporting risk data considerably. (Preemptors argue that they merely “clarified” what was always FDA’s intent.)
Not surprisingly, the issue is at the center of a great many of the preemption cases. If it is true that companies can - and, indeed, should - independently warn based on relevant safety info they have - then a company cannot claim, in essence, its “hands were tied” until FDA changed label. Thus, “failure-to-warn” stays alive.
Of course, any such change is reviewed by FDA and must finally be approved. The preemption lawyers like to argue that this still means companies can do little or nothing on their own, and risk being “in violation” of FDA if label change is denied.
In actuality, however, I don’t believe there is a single instance of a strengthened label actually being denied by FDA. And, even if FDA disagreed, there is no legal violation or risk by company for having made the change. The label would simply revert - end of story.
So, from my perspective, nothing substantive in that argument.
The preemptors also like to argue that, in response to potential liability, companies will defensively “overwarn” (with horrific consequences, so they suggest).
Once again, the last hundred years during which we’ve had both FDA and civil liability do not show that. Indeed, the pattern is warnings that meet, but do not exceed, FDA overall guidelines, and the push is almost always against adding more.
So one more argument that will “sound good” to some, but is not supported by reality.
truthman30
The whole concept of “preemption” in regards to drug liability seems to me to be a feeble and pathetic attempt at protecting corporate interests and screwing the consumer under the guise of “law”..
If this happens, then the concept of law itself should be removed from having any associations with the concept of “justice”..
Justice in MI
Truthman - Trust me, it’s happening. It has already happened in the U.S. in the arena of medical devices (Riegel case). There is an effort in Congress to pass a law that would effectively reverse Riegel, but it is not at all clear the votes are there, particularly to overturn a veto.
As Ed reports, drugs will come with the Levine case, almost certain to go the same way in the Supreme Court.
So, at this point, rhetoric is not enough. The following are needed:
1. A free, open, and very public debate on the policy. As Dianne suggests, it deserves to be central in this election season. There may well be much more at stake with this issue than the price of gasoline; a great deal more.
So far, very few candidates have taken it up. No need to speculate on why. But given the now very public positions of NEJM and more and more groups who are not “trial lawyers,” and have no connection whatsoever with “trial lawyers,” the usual rhetorical tarring should be less inhibiting.
2. People within industry know the realities of what the impact of potential liability really is on decision-making. For most, it is not a consideration - it doesn’t need to be. But for those decision-makers inclined to push the envelope, it can certainly be a meaningful constraint, sometimes the last one.
People within industry also know what “FDA compliance” does and does not mean, under various circumstances. They know the difference between playing by the rules and play _with_ them.
So their perspectives are also critical in the discussion.
3. FDA line staff also know the extent to which what is “on the books” translates into meaningful, evidence-based regulation. How much science prevails; how much other considerations do.
So their experience-based perspectives are also critical.
Justice in MI
I wrote, “In actuality, however, I don’t believe there is a single instance of a strengthened label actually being denied by FDA.”
Correction: I should have noted that the complex phenergan/Wyeth regulatory history might qualify as such a case, which is why it is a good one for the company.
It also opens the possibility of a narrow ruling in Levine, in which, effectively, only in such instances (certainly rare) that preemption prevails.
Jaynesday
I sent the following to Mr. Obama, I hope that other constituents that know about preemption do the same.
Dear Mr. Obama,
I am a Republican from the heart of the nation. I have a question and a suggestion.
What is your stance on the issue of Drug and Medical Device Company’s Preemption from Product Liability law suits? Are you for or against suspending our due process of law?
I understand that generally Democrats are against preemption. I applaud you for this. It is one Democratic political stance I can get behind.
You see, my mother lost her life due to a severe reaction to a medical device she was given in the course of elective surgery. Now with preemption approved by the Supreme Court and backed by Republicans, we have no recourse to force the manufacturer to be held accountable for their product. Our intention is not to get money, but to cause this manufacturer to be kept from harming others. They seem much too comfortable claiming they have no responsibility because the FDA approved their fast tracked product.
Here is my suggestion. Make this an out front political issue ASAP. I say ASAP because the Supreme Court/Republicans are about to expand preemption to drugs. Also other Democrats in Congress are seeking to overturn the preemption ruling for medical devices.
The average American knows nothing of these preemption shenanigans. You can put an end to that and make some points with the American public. You don’t need Pharma money but you do need American voter support.
Your constituent
Justice in MI
Good letter, Jaynesday. I would say there is no reason not to write to McCain and all other candidates (House, Senate) as well, of both parties.
I believe the issue can honestly be approached in a non-partisan way. It is probably accurate to say that those who identify as “neo-cons” lean strongly toward preemption. But that is not necessarily true of conservatives more generally, and certainly of Republicans more generally.
Principles concerning states rights, federalism, and the “presumption against preemption” (any power not formally ceded to the center, etc…) have led a number of conservatives to be against preemption.
truthman30
Hi Justice..
Oh I am well aware that it is in the process of happening..
If i was an american citizen I would be extremely concerned..
Nathan
Since preemption is an “American” issue, it begs the question: Where to other countries stand on this issue? Are there other countries that have an equivalent of a “preemption” doctrine? It certainly seems that the US is the major place where lawsuits are happening. Why is that? Only about 50% of revenue comes from the US. It seems that only 50% of the lawsuits would come from the US. Yet it seems like closer to 90% of the lawsuits are in the US. Why? Is it because there is already some sort of “preemption” in place abroad or is it that US citizens are just “lawsuit happy”?
Justice - I would STRONGLY disagree with this statement: “People within industry know the realities of what the impact of potential liability really is on decision-making. For most, it is not a consideration - it doesn’t need to be.”
The consideration is this: Due to these lawsuits and public outcry, the FDA no longer acts as a rational medical-epidemiological decision body. Instead, it serves as a body that simply follows the public’s wishes. The public doesn’t have any clear sense of risk-benefit analysis and absolute vrs. relative risk. The FDA is essentially being “usurped” by the public’s whim. Thus, we in the drug industry don’t have any idea what safety and efficacy “standard” to apply to drugs currently in development. We don’t know what tests we need to do now in order to obtain approval for a drug 5-10 years from now. We barely can predict FDA decisions 1-2 years from now. This is having an ENORMOUS impact on our R&D at even the earliest stages. We are becoming far more risk-averse. This is a shame because the most innovative treatments are likely to come from taking risks and trying things that are fundamentally new. Unfortunately, in the current FDA environment (due to lawsuits) these innovative treatments aren’t going to get a fair review. Rather than developing new standards that adjust based on technology and medical need, the FDA continues to apply the same old policies - just getting ever tighter in reguards to safety. It’s a sad state we’re in.
Laurie
“The public doesn’t have any clear sense of risk-benefit analysis and absolute vrs. relative risk. The FDA is essentially being “usurped” by the public’s whim. Thus, we in the drug industry don’t have any idea what safety and efficacy “standard” to apply to drugs currently in development”
Nathan..the drug industry has created this environment with their hiding data, misinterpreting data,altering data etc… If there were no problems discovered then the attitude toward pharma would be very different. Absolute risk vs relative risk numbers don’t mean much when it’s your family member’s life that is in the statistic.
The “public” is much smarter than you think. They are no longer willing to be the guinea pigs for pharma’s next big blockbuster drug.
“This is a shame because the most innovative treatments are likely to come from taking risks and trying things that are fundamentally new.”
This is what clinical trials are all about. Those who participate know the risks and are willing to accept those risks. Testing a drug on that population has been widely accepted as the norm. Releasing a drug to the general population with minimal safety information, in the hopes of gathering more information down the line is unethical..unless it is clear to those taking the drug that they are part of a large clinical trial.
Until pharma cleans up their act and is forthcoming about risks they will continue to be scrutinized, as they should be.
The internet age has educated the public, who are no longer willing to “just take this pill”. They want more information than ever before and pharma is going to have to step up to the plate and provide that information.
“it’s a sad state we live in”…no, it’s a state that has been long overdue.
Justice in MI
Hi Nathan - I am not aware of other countries that have a preemption regime, but perhaps others do. Not long ago, I referenced here an article that discusses some of the different models of civil liability in general in other countries. I’ll see if I can dig that up. Either way, that’s different kinds of tort systems, not preemption which means the end of torts in the drug/device arenas.
Re: tort litigation in pharma, I would be interested to know how the number of suits does or does not correlate with the amount of meds used within relevant countries. I have no idea beyond the fact that we are certainly well in the lead there as well.
Beyond that, to the extent there are far more lawsuits in the U.S., one could ask the same question about them as about DTCA: Why is 90% of DTCA in the U.S.? (I don’t know how much is in New Zealand.) Are U.S. citizens
“DTCA happy”?
My guess is that both phenomena reflect the ways we frame rights and liberties within the kind of capitalism that is our system. As citizens, and as business people, we have certain expectations about what we ought to have the right to do - a day in court, an ad on television. (I am not equating the two, just suggesting the ways each may reflect a our particular economic and political culture.)
I am not sure you understood my meaning in the statement with which you strongly disagreed. What I was saying was that most people in industry don’t need the threat of liability to do the right thing. I would think you’d agree with that.
As far as FDA “following the public’s wishes” - Wow, I suspect a lot of FDA folks would be surprised to hear that, not to mention others here. And later you seem to equate “public whims” with “lawsuits.” What I take from this is the sense of an industry besieged. Why that is so, we can leave for another moment. Whether it’s because of an ignorant public, greedy lawyers, or other reasons. But if I follow the core, what I think you are saying is that if industry was just left alone - no lawsuits, no media spotlight, no public outcries - all would be well. As you well know, the question that arises which is the cart and which is the horse (or in what proportions).
Whatever else, I think we would agree that an ideal FDA would, indeed, be evidence and science based. What would be interesting would be to hear from people who have long experience with the agency to get their sense of the degree, and direction, that may have changed over, say, the past thirty years.
Certainly, we have had recent posts about suits
laura
Nathan wrote: “The public doesn’t have any clear sense of risk-benefit analysis and absolute vrs. relative risk.”
The term “risk-benefit analysis” is a term to which pro-preemptionists often refer…there are risks involved in using drugs and medical devices, but the benefits outweigh the risks so, if a death or injury occurs…deal with it. The problem with this thesis, however, is that it is entirely based upon the presumption that drug and medical device companies are always honest in the development, testing and marketing of their products. It doesn’t consider the fact that injuries and deaths sometimes occur not from a fluke reaction but, instead, from a calculated, premeditated decision to do whatever needs to be done to sell the product. Preemption takes away the accountability that drug and medical device companies bare and leaves their victims with absolutely no recourse.
Nathan
Laura writes: “risk benefit analysis… doesn’t consider the fact that injuries and deaths sometimes occur not from a fluke reaction but, instead, from a calculated, premeditated decision to do whatever needs to be done to sell the product.”
That’s very true. I agree there has to be some sort of recourse when pharma companies lie and cover the truth. But it also sickens me to see lawsuits for side effects that were clearly already documented or for which the company was truely completely unaware of the liability. There has to be a balance. Preemption would swing the pendulum completely in favor of pharma. However, I feel that the in the current environment, the pendulum is swung completely in favor of the plaintiff. Something has to shift. If not preemption, then what? The current situation isn’t tenable in my opinion.
Justice in MI
Nathan - As you know, I am against suits for clearly documented AEs or when the company was unaware of those risks.
In the cases that I know of, these considerations pretty much always play a role. Which cases are you thinking of when they don’t? (Real question - I know there are some who feel a company should be held accountable regardless. I am not one of those people.)
I also agree with a number of reforms that have been suggested, including limits on class actions, a more limited and rational system of punitive damages, a hard look at legal fees, and alternative compensation schemes in some contexts (as we have for mandated vaccines, although pts can still sue if they opt that way).
Ideally, I would like to see a package of reforms that included regulatory and tort issues together, exactly in the interest of balancing the flaws in all the relevant institutions.
Getting back to other countries, the countries that have minimal civil liability also have robuts national healthcare and national compensation systems into which industries contribute in some instances. Going that way would be a profoundly different model, needless to say.
So I return to the notion that the U.S. situation reflects our particular pol/ec culture. Assuming we don’t opt for a radically different system, than torts (in some form) are as much a reflection of it as apple pie, chevrolet, and dtc. But that does not mean we can’t make the system more fair and rational for all concerned (which means all of us).
laura
But, Nathan, the nature of lawsuits is that the legitimate and the illegitimate become clear as the lawsuits progress (and please don’t say that juries are incapable of determining this because our entire judicial system is based upon the fact that they are). Why should my family be denied our day in court simply because the product that killed my mother is a medical device? If she were killed be any other product, the manufacturer would be held accountable, and those products are also regulated by federal agencies. What makes the FDA so all knowing and drug and medical device companies so altruistic that anything that they touch is perfect?
Nathan
JIM - I know that the court system weeds out SOME of the lawsuits for side effects that were already disclosed and for truely unforseen problems. But we are still stuck paying huge amounts of money to defend ourselves against such claims — and we still frequently loose. The one that comes to mind from recent events is Premarin/PrePro. To my knowledge, the labeling has always included information about increased risk of breast cancer. How can people sue AND WIN when they get breast cancer??? (and they HAVE won) The risks were disclosed. We followed FDA policy. To my knowledge, nothing was hidden. Yet we still face thousands of lawsuits and billions of $$ in potential liability over the coming years. The system is completely screwed up. Preemption may screw it up even more — but I’m willing to try SOMETHING to get away from the current system that so favors plaitiffs.
Nathan
“the nature of lawsuits is that the legitimate and the illegitimate become clear as the lawsuits progress”
That would be fine if we were talking about defending ourselves against a few dozen lawsuits. The pharma industry IS NOT just like any other industry out there. Hence the HUGE number of liability lawsuits. As we’ve discussed previously on this site, the pharma industry faces about 5x more lawsuits than ANY other industry. And we are NOT the biggest industry out there in terms of revenue (contrary to what many on this site believe). And please don’t argue that we are more unethical that other industries - we aren’t. We have our share of bad apples - as do all industries. But we don’t deserve what we’re getting from the judicial system today. Each year we have to defend ourselves against about 15,000 lawsuits. Who pays the legal costs? WE DO. Does the plaintiff pay anything? NO. The deck is stacked against us.
Justice in MI
Nathan - All I know about Prempro is what I read on Pharmalot. From that, I gather that many of the cases are based on the claim that the relevant companies knowingly “downplayed” the risks. Keep in mind that the label includes all communications a company makes about a drug - not just the PI. Whatever is going on with Prem, we have certainly seen other instances in which companies add something to the label and then go out of their way in other contexts to send a contrary message; above all, to docs, of course. (Lots of that in the Baycol saga, for example.)
I assume, but don’t know, that’s some version of what is being claimed here. Some judges (like the one we just read about in New Jersey) have dismissed Prem cases for lack of evidence of such downplaying. Others have not. So it does not sound like the King of Torts can do whatever he wishes. (Even Canada - not known to be a “judicial hellhole” - recently certified a Prem class action.)
As you know, I have consistently argued against the idea that pharma is less ethical than other industries. I’ve assumed the large number of suits has to do with kind and degree of damage (which does not negate all the good) drugs _can_ do when the bad apples have their day. And the number of people (millions with Vioxx) that might be taking a single product.
The contingency option is not specific to pharma, of course. So I guess I would want to see evidence that the industry is being specifically targeted by the greedy trial lawyers in ways that are different from the ways other industries are targeted. If it’s there, I will be the first to condemn it.
Laurie
I agree that the number of lawsuits is due to the number of people affected by the drug. When millions are taking a drug that turns out to be one of those who’s risks were not revealed, you’re going to get alot more lawsuits.
This is the downside to having a “blockbuster” drug, like Vioxx, that has a dark side. Millions used it, thousands were claiming harm. It doesn’t take much to get to that 15,000 lawsuits. So, while one can claim an unusual number of lawsuits for a specific industry, the ratio of lawsuits to product number is within reason.
Merck was selling alot more Vioxx than GM sold defective cars resulting in death.
Nathan
“So, while one can claim an unusual number of lawsuits for a specific industry, the ratio of lawsuits to product number is within reason.”
That’s interesting: How many lawsuits have there been against toy manufacturers? (even with all the lead paint scares) What about auto manufacturers? Ok, we’ll limit it health issues. How many lawsuits against cosmetic/skincare manufacturer? What about herbal/homeopathic therapies?
I would bet in terms of number of units sold, that any of those categories would be comparable to pharmaceuticals. Yet we have 5x more lawsuits against us than all of those COMBINED.
Nathan
JIM writes: “I gather that many of the cases are based on the claim that the relevant companies knowingly “downplayed” the risks.”
That’s exactly the point of preemption. The FDA approves the product labeling. The FDA also enforces DTC ads. If both labeling and DTC ads are deemed appropriate by the FDA, why should a jury second-guess them? How else would a company “downplay” a risk? We say what the FDA lets us say. Why should be be sued when our hands are already tied by the FDA?
Laurie
When was the last time you heard of anyone dying from a cosmetic?People are not going to sue over a rash or irritation from a cosmetic. Herbal/homeopathic items are not FDA approved and it’s well known that they are a “use at your own risk” item.
I doubt that those two industries are anywhere comparable to the pharmaceutical industry.
Justice in MI
Nathan writes: “How else would a company “downplay” a risk?”
Yikes. Let me count some ways.
How about misleading promo materials to docs.
In Baycol-related materials, there is a direct quote from one of the marketing execs that by the time some misleading promo stuff (for docs) was picked up by FDA, it would no longer be in use. Worth the risk. Here is the quote:
“Senior Management discussed the risks associated with using material that likely violated FDA regulations and concluded that it would be acceptable to use because by the time the FDA reviewed the questionable material, another Baycol sales aid would be out, and therefore the impact of any FDA warning letter would be negligible.”
Remember Vioxx’s “cardio card” right after the VIGOR results? FDA eventually sent one of the strongest warning/condemnation letters I’ve ever seen. Once again, the damage was done.
Here is some of what the FDA letter said:
“Your minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns. Your misrepresentation of the safety profile for Vioxx is particularly troublesome because we have previously, in an untitled letter, objected to promotional materials for Vioxx that also misrepresented Vioxx’s safety profile.”
Remember the CLASS study published in JAMA in which half the data was left out? (And written mostly by Pharmacia-tied people). Bob Temple himself, probably most seasoned guy at FDA, said about the torqued study that “the hype [resulting from the cherry-pickced study] probably has more impact than our labeling does.”
FDA does not control JAMA’s editorial policy.
So there’s some downplay, upplay, and sideplay.
And none of these materials were approved prior to their use. Nor were they required to be.
Pure cat-and-mouse. The cos (those responsible) won. Public health lost.
Put a bunch of these together. How many would be required, in your view, to reach the level of potential liability? Let’s assume docs rx’d in response to some of the misleading materials and some number of pts were killed or injured? How many then?
Under preemption, you could have as many such instances as you choose to imagine, and there would be no liability whatsoever.
Justice in MI
Re: above, I should have added that a lot of this kind of stuff (there’re a lot more examples) would never come to light at all were it not for the discovery process in civil cases.
Do we want it to come to light even later, that much _after_ mega disaster that might be associated?
What would _that_ cost the industry in public trust? What would the Harris poll look like then? How would that impact financial viability? Morale? Job security?
Voila preemption.
Nathan
Good points, as always, Justice. Thanks for enlightening me.
Laurie
“How else would a company “downplay” a risk? ”
Paxil study 329….yet we see this comment from GSK in the newspaper today in response to a book about Paxil side effects:
“We believe in transparency of data, irrespective of outcome, to safeguard those patients who use our medicines and vaccines.
John E. Kraus, MD, PhD
Senior Director, Neurosciences Medicines Development Center,
GlaxoSmithKline”
Nathan
Laurie, is it that you don’t like what he’s saying or don’t believe what he’s saying? I would HOPE that GSK and all other pharma companies believe in transparency of data, don’t you? What else do you expect this guy to say?
Laurie
“I would HOPE that GSK and all other pharma companies believe in transparency of data, don’t you?”
Nathan, if I had seen this transparency practiced in the past by GSK, I would believe it. I think my skepticism of their “official statement” is valid.
Nathan
Laurie - I understand your skepticism. But I don’t really know what else you expect him to say. I thought you were criticizing what he was saying. I guess you were just cynical at what he was saying…
jane
At some point Nathan GSK needs to take responsiblity and admit they were wrong. Especially now that the doc’s are in public domain.
Just A Thought
Good Man, Judge Hamilton,
This family’s case deserves to be evaluated and considered.
Laurie
“At some point Nathan GSK needs to take responsiblity and admit they were wrong. Especially now that the doc’s are in public domain.”
Nathan the above statement is what I want to hear from GSK. Plain and simple….”we didn’t reveal what we knew and the public needs to have this information so no one else is harmed.” If they had done this in the first place my opinion of pharma would be much different than it is right now.
The statement “The scientific evidence does not establish that paroxetine causes suicide, suicide attempts, self-harm or suicidal thinking. On the basis of research in tens of thousands of patients taking antidepressants, including Paxil, there is no increased risk of suicidal thinking or behavior in people age 24 and older and, in patients older than 65, there was a reduction in risk in suicidal thoughts and behavior. “, is insulting to those who have had horrible reactions to paxil.
What is the difference between a 24 year old and a 25 year old? Are their brains so massively different in one year that a suicidal reaction is impossible?
These are the type of canned responses from GSK that destroys their credibility. They deny withdrawal/suicide in the public eye and then pay millions in lawsuits and gag those that were part of that lawsuit from speaking about their experience.
Am I cynical about GSK…absolutely.All I want is honesty from them, and we have yet to see that.
Lisa Van S
Geeee,.. GSK behaving badly again.. No Surprise here!
Nathan
Laurie,
I can understand what you are saying. But as you are probably aware, it’s highly unlikely that you’ll ever hear a statement like that. It would open the door up further liabilities than they currently face. It may also open them up to CRIMINAL (rather than just civil) prosecution. The board would probably fire the CEO if he made such a statement.
Do you know of any major corporation (not just pharma) that has addmitted real wrongdoing following civil prosecution? What about Firestone with the rollovers a few years back? The toy manufacturers with lead paint? FEMA for the faulty trailers after Katrina? The Federal Government for going into Iraq on false premices? People don’t like to admit fault until they are completely backed into a corner. GSK isn’t there yet.
Laurie
“People don’t like to admit fault until they are completely backed into a corner. GSK isn’t there yet.”
Sad, but true. What especially bothers me is the trickle down attitude of “our drug is fine” ,to doctors who are still prescribing it today telling patients “It has minimal side effects, just don’t read the internet”..yup, this is directly from a patient.
Jack2
I agree with your Laurie, and I work for the pharma industry.
For me, the worst evidence (if true - and I suspect it is) was when the run-in phase suicides were moved to the placebo group during the pivotal clinical trials. I feel a lot of the stuff on these boards becomes unfairly negative of the pharmaceutical industry, but I cannot defend deliberate data falsification.
If you’re really looking for an apology I doubt you will get it, but at least consider this…the standard pro-pharma crusaders on this site (and I consider myself a part-time crusader) don’t poke their nose in threads to defend that behavior.
I’d like to say that I think this is a unique situation, and I think it’s exceedingly rare, but I guess I don’t really know. All I can offer is that I wouldn’t do what they (the Paxil-people) did.
deb
Thank you, Laurie, for your eloquence. As multiple Pharma companies have hidden the evidence in one way or another, it now seems that what Lilly did with Zyprexa’s lethal side effects is almost ho-hum ordinary. Yet I continue to write and push for a criminal trial for the death of my son and other sons whose parents I know who died unexpectedly with no warning. (The revealing Zyprexa papers are on the site furious seasons). Why isn’t second degree murder or manslaughter part of the picture for these basically premeditated deaths?
Jaynesday
quote from deb,
“Why isn’t second degree murder or manslaughter part of the picture for these basically premeditated deaths?”
Unfortunately it isn’t but even worse
preemption may be.
I like the comment one poster had… what color is the sky in your universe? It is hard to believe that this is reality in ours.
daniel
This preemption turn-about in medical devices and soon-to-be drug cases is just another example of the Bush administration screwing the American people. Funny thing that Daniel Troy worked for the drug industry before being appointed FDA counsel by Bush before representing the drug industry again. Troy masterminded the deceit that brought all this about; moreover, Ted Olsen was Soliciter General to the Supreme Court before he was hired by the medical device industry to plea its case to the Supreme Court. Who wants to bet as to how the Court will rule on Levine in October? Then, there’s this thing about the justices owning stock in various drug companies. Something stinks.
The sad thing, however, is the people whose lives have been ruined by all of this, people who have endured hell because a drug company withheld information, or worse, lied about it. We are waging two wars supposedly to protect the American public; yet, there is no greater threat to our people than what is happening with this preemption tool the Bush aministration is using. What has happened to this country that is suppose to be “of the people and for the people”? It is a sad, sad day,
Lisa Van S
U.S. Supreme Court rules 8-1 w/ Wyeth on PreEmption in Wyeth vs Levine!!!!!!
Laurie
Sad day for the American public. It’s truly a buyer beware.
Nathan
Nice try Lisa. The court is out of session till mid-september. You had me fooled for a few minutes…
Justice in MI
Folks - The below is probably what Lisa saw. it is false, of course - the Court is not only out of session, the amici in the case aren’t even all due until early/mid-Aug.
Looks like someone who doesn’t know anything confused Riegel, of a few months ago, with pre-emption in general, in some sort of poorly prepared brain sandwich.
Don’t believe all you read on the internet. But here is what I received from “Wired.” I guess they’re not …………….
*************
Supreme Court rules States cannot add to FDA regulatons
July 27, 2008
Dallas, Texas (WiredPRNews.com) America is facing a tough call deciding who should hold the final say when it comes to the accountability of pharmaceutical and drug companies. Thus far, the Supreme Court has ruled in favor of pre-emption (i.e. that federal regulations automatically overrule state laws). The Supreme Court case of Wyeth vs. Levine may potentially create a precedent for all future related drug-company liability cases (by placing the FDA above state courts).
The case involves a musician from Vermont, Diana Levine, who lost her arm to gangrene caused by an anti-nausea drug. The drug was injected by means of a method that was not specified in the label (called the IV-push method). After settling with her health care provider, she sued Wyeth (the drug company) and was awarded $6.7 million by a Vermont jury. On appeal, The Vermont Supreme court upheld the ruling and found that the drug company could have been held accountable according to state standards and additional labels validating the risks involved with the IV-push method could have been added (without interfering with the FDA).
Wyeth’s lawyers argued that different states could not hold drug companies to different standards. In addition, the drug company argued that the FDA’s required label was not to be considered a minimum requirement/standard but the best, most effective and most informative. The final and most effective argument was that the State of Vermont could not rule to prohibit the administration of the drug via the IV-push method, as that would interfere with the FDA.
The Supreme Court ruled 8-1 in favor of Wyeth based on preemption and thus further increasing the power of the federal government (as has been the trend since the beginning of the 20th century). The ruling in this case could set a precedence that may shield tobacco and drug companies from liability lawsuits and any state regulation (as such responsibility is explicitly within domain of the federal government not the state).
Legal News Desk
Laurie
Thanks Nathan
Justice in MI
I guess there are several cautionary tales here. Besides the fact that it didn’t happen, whoever wrote the Wired summary has the basic facts mixed up. So maybe they really _are_ “wired”……….
It is probably a sign of things to come. When the SC does uphold preemption, as they almost certainly will, we will probably read a bunch of stories that are similarly bungled.
For people interested, google up a recent Colloquy by Catherine Sharkey which is called, “What Riegel Portends for FDA Preemption of State Law Products Liability Claims.”
Sharkey essentially tries to stake out a middle ground between full preemption and the current system by placing the onus on the FDA. If the FDA can show that it adequately reviewed data relevant to the issue raised in the suit, than preemption would prevail. That means FDA would have to keep a thorough record of its reviews (which Sharkey suggests it doesn’t always do). And it obviously means they would have to have the whatever data company had to make such a review.
I mentioned this in another thread. Worth reading, I think.
Dianne
Thanks Justice.
FDA preemption is about to happen. This policy needs to be made known to the American public, right now.
I’ve written Senators Obama and McCain and our representatives and senators. I’ve also asked friends, family and neighbors to do the same. Also, letters have been sent to local newspapers and to TV/radio pundits.
Not a word back, so far. It’s a little scary. Who put the clamps on the media? Why all the hush-hush?
Following are questions I asked Obama, McCain, and our representatives and senators. Please feel free to use them.
● What is your stance on FDA preemption?
● What efforts have you made to protect the health, safety and civil Rights of Americans, who are being assaulted by favors to big business?
● How will you vote on the Waxman/Pallone Medical Device Safety Act of 2008, H.R. 6381?
● How will you vote on the Kennedy/Leahy companion bill, designed to protect consumers of FDA approved drugs and state tort law?
Anyone with an idea of how to inform the public of FDA preemption, please post it here. Thanks.
U.S. House of Representatives - https://forms.house.gov/wyr/welcome.shtml
Ph. (202) 225-3121
U.S. Senate: - U.S. Senate: Senators Home
Ph. (202) 224-3121
Justice in MI
Hey Dianne! At this point, I think hang-gliding into the opening ceremony of the Olympics may be the only way.
But (a) no one would see it through the smog and (b) you would inevitably be shot down (and rightfully so). So that is not a recommendation.
Those of us who care about the issue just have to keep on truckin. It is pretty clear that the last thing the “offical” spokespeople for preemption want is a free, open, and public discussion of the issue.
If I am wrong, and any of them read this, please correct me and let’s work together to find a find the right way to foster that discussion on such a critical policy question.
Contact me at: justiceinmich@gmail.com
Would love to hear from you.
Jaynesday
If preemption becomes law - Woe to all those who were a part of its creation and either pushed for or allowed preemption to become law.
They will forevermore have a black mark by their names and suffer for the foolishness of their actions, when they realize the ill-effect it has loosed upon this nation.
Of course we will list their names and alert the world to their devious acts.
Jaynesday
Dianne
Quite a coincidence, I just got an email from Barak Obama. I won’t share the whole letter but he acknowledges receiving my email about my concern for preemption and the information about my family’s personal experience related to an adverse event that caused the death of my mother.
Sadly this is as far as it went. He did not share his stance on the subject or let us know how he might support us. His lack of commitment on the subject concerns me.
There must be some reason that politicians are afraid to make this a policy issue. I can only assume the worst; that there are some negative political repercussions for taking a stance. It must be that the torte reform lobby is much stronger than the right to due process (constitution). In that case it becomes obvious that politicians will not take the lead on this issue, they will only follow the vote, the money, or the public outcry. They will only make a decision after someone else (the American public) has decided for them. In other words unfortunately some politicians are not leaders they are followers.
Dianne
Justice - Do you know where I can sign up for a cheap, hang-gliding 101 class?
Justice in MI
Jaynesday - Sadly, I think there is probably a lot of truth in what you say, and I think it applies not only to both Presidential candidates, but to many others, of both parties, through Congressional races as well. Of course, there are exceptions. But not many.
But I would be equally interested (even if I disagreed) to hear from candiates who support preemption. In other words, to have the free, open, public discussion I refer to above.
Nathan asked a few days ago why we don’t hear more about it in the media and elswhere. I think it’s a great question. And I think the answer has something to do cowardice on several sides and parties.
In the end, this is an issue (again, on whatever side) that voters are going to have to _bring_ to the campaigns. Through persistent letters, questions, etc., at every opportunity, of the sort that Dianne listed.
The people whose voices may count the most, as I’ve said before, are those inside of industry who _know_ what FDA compliance does and does not mean depending on who is calling the shots and in what context. Likewise, those in FDA who know the same thing from their side.
Again, though, I am pushing above all for the discussion. How it shakes down is not the point.
But if I was a preemtor, I would also want to keep the issue out of public debate as long as possible. It doesn’t wear well in sunlight.