Zyprexa Reps Told Not To Raise Diabetes Concern
43 CommentsBy Ed Silverman // July 31st, 2008 // 1:12 pm
Just when you think the Zyprexa litigation is unlikely to yield anything terribly new and revealing, along come some documents that shed still more light on how the drugmaker handled the marketing of its antipsychotic. Lilly, you will recall, has been accused of failing to properly warn states and healthcare providers that Zyprexa could result in weight gain, high blood sugar and diabetes, and has paid about $1.2 billion to resolve claims brought by more than 31,000 patients.
Documents from the lawsuit in Alaska, where Lilly agreed to pay $15 million to settle, contain some interesting remarks and disclosure. For instance, Lilly’s research showed some patients on Zyprexa gained as much as 80 pounds and that the incidence of high blood sugar at diabetes levels was 3.5 times higher than for placebos, Bloomberg News writes.
Before those findings were known, docs already saw a “logical link between weight gain and diabetes,” an instruction sheet advised the sales force in 2002. “We believe it is essential to weaken this link to neutralize the diabetes/hyperglycemia issue,” Lilly wrote in the sales document. “Neutralizing any concern from our customers will be essential to the future growth of Zyprexa in the marketplace.”
The unsealed documents show 550 sales reps were greeted at an October 2000 meeting with a “Viva Zyprexa” version of the Elvis Presley song, “Viva Las Vegas,” touting the “many wonderful indications” for the drug. Zyprexa’s “attributes line up so beautifully in the elderly,” Alan Breier, then-team manager for the drug, told the group, according to a recording provided for the Alaska lawsuit. “The need for better treatment in Alzheimer’s and other elderly conditions is so paramount and so key.”
However, Zyprexa wasn’t approved for use with Alzheimer’s or for elderly conditions, Sidney Taurel, Lilly’s chairman, said under questioning by Alaska’s lawyers in September, when he was also ceo.
Then, there’s this: Before the October 2007 label change, Lilly didn’t instruct its sales force to say Zyprexa’s diabetes rates were higher, former marketing director David Noesges said in a January deposition. “We will NOT proactively address the diabetes concern,” the Zyprexa sales force was advised in 2002. “The competition wins if we are distracted into talking about diabetes.”
Lilly doesn’t engage in improper marketing and hasn’t downplayed the risks, a Lilly spokeswoman e-mailed Bloomberg. The documents “are a tiny fraction of the more than 20 million pages” provided by Lilly, Ryker said. “They do not accurately portray our company strategy or our overall conduct.”
Justice in MI
Obviously, this is a version of a story we’ve heard many times before. And, for the public at large (who attend to such things), it reinforces the already eroded trust in the industry.
So I’d like to step back from that for a minute and ask, as I’ve done before, what impact stories like this have on people who work for the industry? That remains a perspective which we don’t hear anywhere near often enough except in “official statements” and “releases.” I think it has led to uniquely productive exchanges that are not “the usual.”
Doc
The Lilly official repsonses are BS. The vast majority of pharma companies (if not all) marketing and sales departments routinely put profit before patient well being. The problem, many of the execs either really believe that these risks are minor vs the benefits or they know outright that certain issues equal less sales.
Regardless of the reason, the public should know and should be outraged by these schemes. How many emails and intra-company directives must we see instructing reps to minimize and spin the risks to patients and the potential negative effects on sales?
It has happened, it continues to happen, and it will continue to happen because the FDA is a paper tiger. Who knows the reasons the FDA will not hold pharma companies to a high standard in promotional trickery - but most of the time, they do not.
Next time it could be your family member, friend or YOU that is put on a drug that the MD has been ’sold’ on in a twisted and unbalanced manner.
Big Pharma Guy
Employees of BP feel shame, particularly those on the clinical research side of things. Once the product is approved and turned over to the “dark side” of the industry, all that matters to the business people is money, money, money! The scientific and medical people who try to work in commercial are powerless to change the greedy behaivior. If you have a conscience and are ethical, they don’t want you. They only tolerate you if you blindly sign off on everything and approve all of their schemes. Big Pharma is in a sorry state.
The bottom line is - no accountability by the key execs for their actions. If they get caught, the lawyers negotiate a financial settlement that comes out of the shareholders pockets, the company and its’ execs admit no wrongdoing, employees get laid off, and it’s more business as usual - over and over again. Throw a couple of these jerks into jail and that should at least put a dent in these disgusting activities. Don’t let them get away with it and laugh all the way to the bank
Laurie
And pharma continues to fight for preemption! It’s examples, like mentioned above, that make the argument against preemption. Lilly knew, the FDA “supposedly” didn’t know and the consumers can’t do a darn thing about it when injured.
Ethicist
Lilly’s behavior regarding this issue is so predictable. So many of these once-proud companies have long ago thrown away their ethics and integrity for the piles of money. It’s capitalism at its’ worst and its’ the public that suffers.
BP Watch
Disgusting and deplorable! Pharma is an industry that is steep moral and ethical decline. The problem is that until the execs are held responsible for things that take place on their watch, nothing will ever change. Put a few of them away for time and take some of their winnings and they may think twice before allowing the next off-label scheme. They think they’re above the law. just ask them!
Justice in MI
It is so tempting to condemn Lilly and leave it at that. And, for reasons I’ll explain here some day, it is particularly tempting for me.
But I think it is critical that we don’t think in terms of “the industry” or “pharma” or “company X” in some monolithic way, just as we don’t think about FDA, politicians, and even trial lawyers (I hear Nathan groaning) in that way. Some of my best students now work for Lilly, and these are people whose integrity and dedication to the public good meet anyone’s I know.
There are scuzzy practices indulged in by some number of people. The task, I think, is to zero in on where the problems are and find the hammer that hits the right nails.
Re: preemption (you knew I’d get there), yes, promotional practices of the sort described here essentially never come to FDA’s attention while they are happening. If they eventually do, it is usually too late to make any difference. And FDA’s response is almost always too meek to make any difference. So, while I also see problems with the tort system, “law enforcement” of another kind - as we usually understand the term - essentially does not exist in this realm.
Laurie
I think most realize that not all in any company can be painted with the same brush. It’s the company deception that creates that animosity towards the industry. That animosity is not directed at those who do their jobs honestly and with integrity.
“yes, promotional practices of the sort described here essentially never come to FDA’s attention while they are happening. If they eventually do, it is usually too late to make any difference.”
This is the crux of the argument over preemption. The premise of preemption is that the FDA has the final say over a drugs safety based on all of the available research, we are finding time and time again that they are woefully misinformed in the drug approval process.
Justice in MI
I agree with the core of what you say, Laurie. What is “interesting” about cases like Zyprexa, based on what is reported, is that they have less to do with defrauding the FDA over risks than defrauding docs, pts, and agencies (like state Medicaid systems).
The FDA is defrauded to the extent that knowingly false or distorted promotion is pursued with the anticipation - sometimes explicitly stated - that FDA will not respond in a meaningful and timely way.
Every study of FDA confirms that that anticipation is almost always fulfilled. There is, de facto, a kind of “honor system” that, in practice, functions more as a cheating system.
truthman30
Any corporation which brings in profits of Billions of dollars a year is above and beyond the law. This doesn’t just apply to the pharmaceutical industry. The corporations are the defining institutions of our times , they have more protection than the average citizen, they get away with it because they are allowed to. It is simply just the ugliest side of capitalism. The corporations have become such monolithic monstrosities now and their sphere of influence is so powerful in governments that it could be argued that they are the government.
Doc
The FDA does little unless pushed. Please go to the following link and read the new GAO report on off-label promotion and the FDA. They are a paper tiger. The report is very eye opening!
http://www.gao.gov/new.items/d08835.pdf
Justice in MI
Thanks for the link, Doc. I agree - it is hard to imagine how one could defend preemption in light of (yet another) such report. This excerpt from the executive summary:
“In addition to its reviews, FDA conducts monitoring and surveillance to identify violations that would not be identified through its review of submitted material—for instance, discussions between doctors and sales representatives.
These efforts are also limited because FDA cannot observe all off-label promotion activities as they can take many forms and occur in a myriad of places.
FDA and DOJ have taken regulatory and enforcement actions against drug companies in response to off-label promotions. During calendar years 2003 through 2007, FDA issued 42 regulatory letters in response to off-label promotions requesting drug companies to stop dissemination of violative promotions. FDA took an average of 7 months to issue these letters from the time it first drafted them. In addition, drug companies that were cited for more serious violations took an average of 4 months to take the corrective actions requested. While FDA did not refer any of these violations to DOJ for enforcement action, during calendar years 2003 through 2007, DOJ settled both civil and criminal cases that involved, at least partially, off-label promotion. These actions were initiated as a result of violations identified by sources other than FDA and resulted in 11 settlements.”
A brief summary of the summary:
1. FDA took an seven months to get each of 43 friggin letters out.
2. The companies that violated FDA most egregiously, took four months to act on remediation plans. Given past history, this usually means they stopped using fraudulent promo materials that they had already planned to stop using once/if they got busted.
3. FDA initiated no criminal or civil action whatsoever for violation of its regulations whatsoever. Warning letters and “remediation plans” (delayed and ignored) were it.
4. The actions DOJ took were initiatied “as a result of violations identified by sources _other_ than FDA” - that means mostly whistleblowers and lawsuits. Even there, settlements - no prosecution, no conviction, no serious accountability.
This has been the pattern for at least twenty-five years.
Serious quetion: Is there anyone out there who can explain to me why it is not grotesque. We know folks like Peter Pitts and others on the preemption side read this blog. Please explain how this can be OK?
NO-POOP!
It stands for National Organization of People Outraged Over Preemption. And we are organizing.
Stay tuned.
In the meantime, scoop it, bag it, and throw it away.
Laurie
“Is there anyone out there who can explain to me why it is not grotesque”
I would love to hear their rationale. Patients rights are being denied based on the FDA being the ultimate authority..yet the FDA has shown that they are completely incapable of even maintaining or monitoring a minimum standard of practice.
With preemption that patient is being told that they can’t take action against a pharmaceutical manufacturer because the FDA did “catch” them…not that the FDA made a complete evaluation of the drug involved and approved it based on complete and accurate information.
Justice in Michigan
Laurie - The last part of your comment is exactly Catherine Sharkey’s point in her excellent article I’ve mentioned. She finds a middle ground which seems reasonable to me. If FDA can show that they have done a thorough and up-to-date review of the issue involved (which is premised on their having whatever company has that is relevant), then preemption holds. That seems to me to me rational policy, if not so easy to work out in practice (given realities of the relationship between FDA and industry as things stand).
But I haven’t heard a preemptor yet who supports moving in that direction.
Melody
Truthman, you state: “The corporations are the defining institutions of our times , they have more protection than the average citizen, they get away with it because they are allowed to.”
I believe THIS is the ultimate problem for all (or at least most) corporations–not just pharma. Corporations fought for and gained the ‘rights of personhood.’ I feel, therefore, they should be held to the same bar in re: responsibilities. When an individual KNOWINGLY kills others, he received a life-altering punishment. To merely require of corporations the payment of a fine or submission to a monitored ‘compliance’ agreement/settlement leaves a foul taste in the mouths of those who believe in the rule of law.
If severe penalties (yes, even the death penalty) were meted out to criminally-behaving corporations (or the executives who guide them), I expect we would see a change in behavior. For too long corporations have had the best of both worlds (personhood/non-personhood). Perhaps before we attack the consumer-goods, we should define/attack the decision-makers who authorize their production.
Laurie
“If FDA can show that they have done a thorough and up-to-date review of the issue involved (which is premised on their having whatever company has that is relevant), then preemption holds. ”
I totally agree. But with the history of the drug companies I’m not sure the public would ever have the confidence to believe that ALL of the information was presented to the FDA. And with the history of months and years passing before the FDA acts on any problems, that scenario is going to take alot of changes before the public is truly going to accept the FDA’s authority as reliable.
Dianne
NO-POOP! – Thank you the discussion on FDA preemption.
Preemption is an assault on the health, safety and civil rights of all Americans. If Levine loses this Fall, all Americans will likely lose their right to legal redress in claims against drug manufacturers.
The following is quoted from a response I received from Rep. Henry Waxman:
June 2, 2008
“As you know, a February 2008 Supreme Court decision
has, for the first time, immunized medical device companies from
state lawsuits brought by patients who are injured by certain
medical devices. This decision has left consumers without any
ability to seek compensation for their injuries, medical expenses
and lost wages resulting from injuries caused by defective
premarket approval devices or inadequate safety warnings. It also
removes one of the industry’s most important incentives to
maintain product safety after approval and disclosure newly-
discovered risks to patients and physicians…”
“Should the Supreme Court make a similar decision in the
upcoming case regarding FDA-approved pharmaceuticals, you can
be sure I am prepared to take corrective action.”
Bush will veto the Waxman/Pallone Medical Device Safety Act of 2008, H.R. 6381. And the same will be true of the Kennedy/Leahy companion bill designed to protect consumers of pharmaceutical drugs.
A 2/3 vote of both the House and Senate is needed to override a president’s veto. That probably will not happen–unless the American public let their representatives and senators know they are opposed to FDA preemption.
The problem is, the media has not reported on FDA preemption, and, therefore, the American public has no idea what this policy is or how it will affect their lives.
Please, contact your U.S representatives and senators and tell them you are opposed to FDA preemption. And, also, please, spread the word to every voter you know. Thank you.
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
Daniel Haszard
Zyprexa has generated a lot of bad press for Eli Lilly and they still have unresolved Zyprexa settlement claims.
Eli Lilly is ‘reaping the whirlwind’ for aggressive marketing of Zyprexa that has caused suffering and deaths.
Zyprexa is being avoided by doctors they aren’t prescribing it for new patients at all anymore.
–
Daniel Haszard 4 year Zyprexa patient who got diabetes from it. http://www.zyprexa-victims.com
Meg
Even preemption will not solve the problem so graphically laid out with Lilly/Zyprexa/FDA. Winning a financial award is nothing; nothing; compared to the killing of my son by this drug. Almost every day I plead with the DOJ to bring a criminal trial against the Lilly execs who hid the drug’s lethal effects. Lawyers tell me it could be a second degree murder or manslaughter trial. Come on, DOJ. As far as what Pharmas tell the FDA about a drug, not only did Lilly hide the lethal side effects but the FDA knew in the Spring of 2002 that Japan and the UK (on the ball, unlike the U.S.) required Lilly to place a black box warning on the drug for diabetes, hyperglycemia, and death - having witnessed these results. What did the FDA do with this information and three front-page stories on the topic? You guessed it.
Laurie
” Winning a financial award is nothing; nothing; ”
You’re right. Money doesn’t fix the damage and physical torment that those who are affected by these drugs had to endure.
Justice in Michigan
Meg - As you’ll see further up the thread, DOJ essentially _never_ bings civil or criminal actions against drug companies. The exceptions, also as documented in the recent GAO report, are when they are essentially forced to it by non-FDA sources info sources . Thus usually means because of criminal activity brought to light to civil suits, other suits, or whisleblowers
Thus, you are right that preemption (or no preemption) does not solve the problem. But preemption would remove one of the few sources of into that _ever_ leads DOJ to act. It also removes that info from the press and public, sometimes important health data which has not otherwise been released or clarification of fraudulent promotion. One can see related efforts like “simplifying the label,” raising the standards by which companies are expected to report new safety findings on their own, etc., as related efforts.
I believe this constitutes an undeclared domestic war, and we are all “the enemy” and, too often, the casualties as well.
Jaynesday
First let me say I am totally against preemption but….
Seeking to hold billion dollar corps accountable through legal means has failed and therefore defeating preemption will not completely solve the problem either. It’s a step in the right direction but we will still have product and producer issues on the table at the unacceptable level we have today.
Corporations will still be taking the calculated risk – what can we get away with and still make a profit?
Quoting Truthman “The corporations are the defining institutions of our times, they have more protection than the average citizen, they get away with it because they are allowed to.”
I would add to and change this statement slightly -
“they have more protection than the average citizen, they get away with it because *we allow them to* - and because they can afford to.”
We have to get this train on a different track.
The only force strong enough to prevail against billion dollar public corporations including their leaders and their protectors is the entity that fills their pockets - The American Consumer.
An aware consumer can make or break absolutely *any* public or political concern it has a mind to.
How do we turn the public light on bad actors in the pharma industry?
First we can start by divorcing from the process those parties that we have given the job of protecting us but who have (knowingly or unknowingly) become pawns of the bad actors. Parties such as the FDA, politicians, The Supreme Court, Trial Lawyers and State Courts aren’t doing the job because over time large pharma has been able to integrate these forces for their own use. Preemption is another deviously brilliant step in that direction.
Second we must establish a means to force the pharma industry to deal directly with the consumer. No more mediation or side stepping or slick tricks. If the product performs as the consumer requires, at a fair price, you will be praised and given a raise. If you’re product fails you as a producer or corporation will be ostracized and suffer the consequences.
By knowing this up front (before drugs/devices are designed and marketed) pharma’s will establish an internal management composed of checks and balances within the corporation (top to bottom) where it belongs. The risk/benefit equation will be tightened. No more “turning a blind eye” in the design or testing phase, no more ignoring of detrimental trials or “steering” results and consequently less and less need for legal correction.
Dianne
Jaynesday, to me, the only hope is “An aware consumer [who] can make or break absolutely *any* public or political concern it has a mind to.”
I’m not against medicine. But I am for justice and the protection of our civil rights.
Where is the media on this? All I can say is write your representative, senators, newspapers, and tell everyone you know about FDA preemption.
Jaynesday
Dianne, agreed - I hope you don’t think I am against medicine. I am highly disappointed in pharma leadership and management. With the right incentive I know our pharma could be so much more than it has become. Because of the unequalled talent and intelligence of the good people in the industry, I don’t think they really need the crutches they’ve claimed. It’s just easier and more profitable with a crutch.
As you might know from a previous post/thread - because I live in Illinois, I did write Barak Obama, among others. The good thing is he/his people did answer. The bad thing was he completely sidestepped my question about his stance on preemption. He is not being a leader. He, like some politicians wait for the public outcry to reach a point that 51% of the voting public have made their concerns evident. I guess that’s what a democracy is all about but if there is an injustice a real leader is out front of the issue, as some politicians are.
I’ve also written to my local paper and had our views published in the Letters to the Editor. This along with a blog that I have, don’t get any enduring traction.
Here’s the honest truth as I know it. The general public that hasn’t been touched by a bad drug or device really doesn’t care to be concerned about these issues. I know I would not be here if they had not touched my family. The really strange thing is when you are in our position you find it unbelievable that other’s don’t seem to care.
We (the public) are like the sleeping giant. I don’t know how to turn up the noise of this issue to wake up the giant but I do think it hinges on the media.
laura
Ed,
I don’t mean to put you on the spot but, you’re in the media…do you have any suggestions for creating media awareness of preemption? How can we expect a public outcry unless the public truly knows what is going on, and how can the public know what is going on without the media somehow showcasing the inequities that preemption creates?
Dianne
Hi- Jaynesday – I didn’t take your comment as being against medicine. My post could have been better stated by saying that, although I’m against preemption, I believe in the good of medicine. However, when things go wrong, we need our Justice system. To me, this is a civil rights issue.
Thank you for all your good efforts in bringing preemption to light.
Meg and Laurie – I agree. Financial reward does not, and will never, replace one’s health or life. However, the right to fight a drug company whose product caused harm, or death, is, under tort law, a civil right. As we know, Court is where the public learns about dangerous drugs. The hope is that justice will prevail and that financial damage awards will be effective as a punishment and deterrent to corporate crime.
If FDA preemption becomes law, there will be no Court; the drug industry will be given a “free pass,” and the health and safety of Americans will certainly be in greater jeopardy.
Drug companies have fought long and hard for preemption, but they are just one of many industries courting the federal government. I fear preemption is the wave of the future for the handling of corporate product liability:
The total spent per month by special interests wining, dining, and seducing federal officials is now nearly $200 million. Per month. – Bill Moyers (Feb. 24, 2006), TomPaine.com - Restoring The Public Trust
We are at war, right in our own backyard. The only rescuer is the American public.
Laurie
Dianne, I agree with you. An attorney once told me, in relation to an ssri case..”The only thing that Pharma can do is a financial settlement, they can’t make the effects of their drug better”.
Sad, but true. I don’t know how to get people motivated. I’ve been working on the ssri issue for years and it has taken a LONG time to get anyone to listen. But slowly they are. Politicians…hmmm, some are awesome, others are so indebted to pharma for campaign contributions that they will jeopardize the health of children to save that campaign donation and pharma connection. Those are the one we have to expose.
Lisa Van S
Laurie,
Senator Joe Vitale comes to mind, not awesome!, but a politician who can be bought,.. Vitale has no problem with sacraficing the life of a child for political; financial gain!!!!
Justice in Michigan
Hi Folks - Of course, I agree with most of the comments in recent posts. I think Jaynesday is right on target. Neither major party candidate wants to deal with preemption unless we (as citizens) make it an issue. At core, that means showing up. And showing up. And showing up.
I believe Ed has done a superlative job. There is no other source (besides DDL) that so consistently reports on preemption-related issues. Those of us who want this to be a free and open policy debate owe him a great deal of gratitude.
No one from the other side responded to my invitation to work together to make it a free and open debate. Which tells you, I believe, how threatened they are by anything even resembling democratic process. For those of us who believe in “We, the people,” that should be inspiring enough.
I believe that, as the election and Levine approach, there will be more on the issue. Almost certainly the current Court will avoid a ruling on Levine before the election. Given that arguments will probably not be until October, that makes sense. (No, I do not think it is an accident.)
So it is up to us, in every village and farm, to spread the word. I agree with Jaynesday that defeating preemption (which we have already half failed to do - Riegel) will not solve our problems. But it is a symbol of much else that we have endured as American citizens for the past eight years.
Someone talking about “change we can believe in”? I will not believe in it until this becomes part of the discussion.
Otherwise, I do not hesitate to say that Mr. O. is feeding us the same business as usual horse hockey to which we have become accustomed.
Lisa Van S
Justice,
Decades Ago,.. My grandfather referred to it as Donkey Dust..
Justice in Michigan
My goodness. How far we have progressed….But let’s not forget Elephant droppings.
Lisa Van S
Ahhhhh,.. But Justice,
A girl can always trust her grandfather!!!
Lisa Van S
With the exception that Dan Troy is Grandfather!!
Ed Silverman
Hi Laura,
Sorry for not responding sooner, but I took the afternoon off. It’s Saturday, after all.
To answer your question, I don’t know exactly. Preemption is a complicated topic and the average person is consumed with their own problems. And for some number of people, this may mean gas prices, housing or credit issues, a job, or other economic turmoil. Even health care costs, in general, have slipped down the list of priority items this summer.
I do know that a compelling story that focuses on an individual may generate some interest. This was one key reason that I interviewed Diana Levine earlier this year - she’s the one whose suit against Wyeth will be heard by the Supreme Court - and the NYT did a piece about her and preemption shortly afterward. Perhaps another individual’s experience would help to illuminate the legal issues and the ensuing debate.
Hope this helps,
ed
Justice in Michigan
Agree with Ed, but even the “personal angle” has limits. In the 12-year fight against preemption in Michigan, “victims” who have no recourse have often figured centrally as spokespeople, testifiers, etc.. This can be compelling, but the pols and sometimes media also treat them as patronizing (especially if they are women, btw).
It can be a kind of “poor baby” approach, and one that reinforces the fantasy that this “could never happen to me.” Thus the core point is lost in denial and sentimentality.
On the other hand, when a young healthy 40-something MD with no CV hx stroked on Vioxx, that was a more “effective story.” For a few minutes.
Justice in Michigan
Addendum: So don’t give up on politics either. Again in Michigan, our law became a big issue in the 2006 state races - big enough that that anti-preemption forces won the State House. Their first action was to vote 60-something to 39 to repeal our law. A number of pr0-preemption incumbents were defeated, Dems and Reps, and that was why. Our House speaker, who was the pro-est of them all, was also history.
Unfortunately, from my perspective, the Senate was tougher. A couple of squeaker races gave the preemptors a very narrow (a vote or two) eduge. They have thus been able to bottle up the House vote in committee.
Polls show people in Michigan are against preemption by about 2=to=1. That is probably why the preemptors are so anxious that there is no open and public debate on the topic. Michigan is a purple state. If it’s 2-to-1 there, it would be even more overwhelmingly rejected most other places.
If they had ever heard of it.
laura
Ed,
Thanks for the response. As Justice said, we all owe you a great deal of gratitude. You have provided us a forum in which preemption, as well as other pharma issues, can be discussed, debated, brought to light.
Your point about the public’s lack of concern with regard to preemption due to their focus on other issues in their lives is spot on. I think Jaynesday said in an earlier post that, unless your own life has been touched in some way by preemption, you’re not concerned. The frustrating thing is that we know what is coming with Levine and we just don’t know how to stop it. It’s like a bad dream where you see the train coming and you can’t move fast enough to get out of the way…
So, anyway, thank you Ed for doing what you do. All of us, on both sides of the issues, appreciate your reporting, insights and dedication to providing a place where we can go to air our views and see what’s going on on the other side of the fence.
Ed Silverman
Hi Laura,
Thanks much for the kind words, and you’re very welcome. I enjoy what I do here and I’m glad to know the information and forum provided are helpful.
Have a nice day,
ed
Jaynesday
No-Poop
National Organization for People Outraged Over Preemption.
Are you serious?
Justice in Michigan
Jaynesday and Laura - I don’t know about NoPoop, but please don’t hesitate to contact me. We already have a pretty interesting group. In Michigan, we have twelve years of practice: justiceinmich@gmail.com
Re: Laura, as an example of how easy it is to ignore this issue, we ourselves almost always ignore the fact that preemption has _already_ been upheld in the medical devices arena. We are so focused on drugs, that we forget that half the war is already lost (Riegel).
It may be that some version of the Waxman/Pallone bill will ultimately change the devices situastion, but that remains to be seen. It may remain to be seen for a long time.
We are looking for a few (more) dedicated people.
Lilly Man
I think our once proud company has sunken to the depths of the gutter. It seems that ethics no longer is part of our vocabulary, but money certainly is.
Rachel
I think this article made some interesting points, I read a textbook directly related to this topic, its called Perspectives on Tort Law, Fourth Edition by Robert L. Rabin , I found my used copy for less than the bookstores at http://www.belabooks.com/books/9780735518551.htm