Regulatory Climate at FDA May Slow Drug Advancement
In 2007, the Food and Drug Administration (FDA) approved 19 new drugs. This was the fewest number of new medicines approved in 24 years. At the same time, they announced nearly 75 new or revised black-box warnings about the risks of side-effects. Furthermore, approvable letters the FDA sends out when they believe more data is necessary, increased 40%. According to drug makers the FDA's focus on safety is delaying new drugs, and many of these drugs are potentially life-saving. So what's with the delay?
In 2004, the drug maker Merck, withdrew the painkiller called Vioxx after it was reportedly linked to heart attacks and strokes. As a result, Merck was flooded with criticism and 28,000 lawsuits. Accusations about the drug maker putting profits ahead of customers' safety and the FDA allowing the drug onto the market were made very public. While the FDA may hold some of the responsibility, the drug industry has allegedly manipulated data, concealed dangerous side-effects, and promoted products it knows are dangerous. Evidence points to this episode beginning a sea-change in policy at the FDA. According to Kenneth Kaitlin, director of the Tufts Center for the Study of Drug Development, the FDA is "viewed as an agency that is supposed to keep unsafe drugs off the market, not to speed access to life-saving drugs." Either situation is not likely to gain the government agency points with an already wary public.
While Vioxx is one of the most widely publicized drug recalls, others, such as GlaxoSmithKline's diabetes drug, Avandia, Pfizer Inc.'s smoking-cessation drug, Chantrix, and the recent contaminated heparin debacle have all become part of the public record. As a result, several senators have taken the FDA to task for not being vigilant enough.
Matter of Balance
Though the FDA has approved drugs whose side-effects have led to devastating injuries and death, one of the central parts of this story is that of balancing risks that may affect only a small percentage of users against the possibility of improving quality of life, or even saving lives of hundreds of people. However, the problem certainly goes beyond this. According to the FDA, they have 500 vacancies for its staff of reviewers, and claim that having to train new hires delays the reviewing drug applications. They also claim that the low number of approved drugs is simply because fewer new drugs were proposed. According to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, 33% fewer applications were submitted in 2006. Still, is this an industry response to fears of lawsuits when side-effects do harm users? Or is it that research showed the drugs had problems, and would never be green-lighted by the FDA? Dr. Woodcock denies that the FDA has become more conservative in its approvals, so it's unclear.
What is clear is that there are several drugs being held up that may, or may not, benefit users. Recently, Novartis quit trying to gain US approval for the diabetes drug Galvus and the painkiller Prexige even though Galvus is already on the market in Europe and Prexige has been approved in 50 countries. Glaxo's cancer vaccine Cervarix, Schering-Plough's sugammadex, a post-surgical drug designed to negate muscle relaxants, and Merck's pain medicine Arcoxia, were either delayed or rejected outright. These drugs are also on the market in Europe.
The outcome between balancing drugs to help people and drug safety is important, and this is part of the FDA's job. However, we, as current and potential future users need to know that we have access to them. And the drug makers and doctors need to rest assured that they will not encounter lawsuits for putting them on the market or prescribing the dosage.
Still, if you or a loved one has been harmed in anyway by a defective drug, please contact an experienced personal injury lawyer in your area.
Labels: defective pharmaceutical, drug injury, FDA

3 Comments:
YES - it is all about BALANCE!The drug companies will simply stomp al over safety issues, and are, via PRIVATE DEALS (settlements) are looking to move the rats out of the laboratory and into the PUBLIC DOMAIN.
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The FDA has been made a mere Paper Tiger, ever since the constant degradation when the drug companies began funding them? Huh? - yes, the drug companies fund them. Sound like the fox guarding the chicken coop.
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Now the drug companies are trying to hide behind the FDA. If the FDA approves it, then they claim they shoud not be liable! WOW! - I must be having a nightmare.
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A properly funded INDEPENDENT FDA iw what is needed to restore the proper check and balance here.
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I only hope that, as the legislature is now taking some action, that they just don't put bandaids on this failed relationship between the FDA and the drug companies.
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SO much could be done to correct the situation. Really, many people know what to do. It 'just" needs a supportive public and a legislature who responds to the public.
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Seems like things don't change until there is a disaster. We see this over, over and over in companies, government, and even our own selves.
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Lastly, let's hope that the legislature also realizes what is happening in another area; that is one of what is called MASS TORT REFORM, which is nothing less than the drug companies looking to cut their costs of litigation way down - why, well $ comes to mind. It will allow them to hardly even have to worry about the legal aspects. They will continue to develop products which just barely make it past the Statute of Limitations, then ignore the issues a couple of more years, the drag the lawsuits. Yes, it is in effect funding long term litigatin with products worried mostly about short term profits, and concerned only with short term side affects so they can be marketed....the long term problems....they will handle them as they come along, especially now that (if PRIVATE SETTLEMENT DEALS wors), are now very, very inexpensive (about 10% of what the cost should be)...
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THE FDA must be reformed and made independent.
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The MASS TORT DEFORM efforts MUST stop...in place must come a rational review of MASS TORT LITIGATION, like all things in life...
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There is a VIOXX EDUCATION PLAINTIFF EDUCATION GROUP (VPEG) for Vioxx Plaintiffs (now 355 and growing). Regardless of the “settlement” official position - "things are not as they always appear...", the group REMAINS very, very relative and is gaining increasing “name brand recognition”. VPEG concerns, etc., need to be dealt with, and VPEG is trying to become one of the lynchpins in converting a very unfair private settlement to what it should be.
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VPEG is alive and doing well - we are really learning and helping each other. VPEG, has picked itself up by its own two feet, and accepted the task of informing and education sharing.
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We are Plaintiffs - with much to care and share over. We work hard to provide much information and education via sharing. It also has several items, involving working "the issues" which suggest some active goals. The members are all respective of each other. You will find a great deal of empathy from vIOXX victims that are the same boat as the average vIOXX litigant.
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VPEG has built a reputable infrastructure to share information, help educate each other, member communications, polling, providing very useful links, and MORE! VPEG is the result of a very urgent need to get this infrastructure up and running in such a short time. So, so many vIOXX victims could benefit from much of which the average VPEG member has had the opportunity too; let alone finally have someone to “talk” to.
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Whether - whether an "opt-in" who was also "boxed-in" -or- and "opt-out" who was also to "boxed-out"; if you are a vIOXX Plaintiff and wish to become part of a dialogue of over 350 individuals and growing,. WE CERTAINLY HAVE NOT GIVEN UP and are a bunch of decent, compassionate, human beings - all damaged by (allegedly…) Merck, in the VIOXX debacle...if you are a Plaintiff feel free to submit a request to join the VIOXX PLAINTIFF EDUCATION GROUP (VPEG) - at:
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http://groups.yahoo.com/group/MerckSettlement/
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Feel free to check it out and join, nothing ventured, nothing gained. VPEG welcomes vIOXX victims that just wish information, wish to share, with to act, etc. - all are very welcome!
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The link is:
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http://groups.yahoo.com/group/MerckSettlement/
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Sincerely
Dennis Harrison – badbonehealing@hvc.rr.com
M.B.A. - BGS
Catskill, NY
Vioxx Plaintiff
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p.s. - I am a Plaintiff, with a lawsuit of (alleged) bone and spine healing problems of Vioxx. Though not MI/heart - I have learned very, very, much from VPEG. We share our thoughts, and we look for the synergies between our respective plights.
Unconscionability
From Wikipedia, the free encyclopedia
http://en.wikipedia.org/wiki/Unconscionability
The 3 items I refer to are:
Duress (contract law)
Undue influence
Non est factum
Some MASS TORT REFORM excerpts and observations
Content Copyright 2007, Portfolio Media, Inc.
“The uptake of the settlement seems to confirm, and if the program does succeed, people will look at this and learn from this as a positive example,” said Ted Mayer, an attorney with Hughes Hubbard & Reed who is a member of Merck's coordinating defense counsel.
OBSERVATION: A program which has placed so many attorney-client relationships in such disarray cannot be considered successful. While a purposeful laissez faire methodology is often useful in a business environment/negotiations – the Vioxx settlement is not purely a business negotiation – it is the convergence of business and legal. Both interests must be preserved and not get “lost”. This will require active court involvement to define and protect the legal rights that are certainly at risk; the playing field will not be level without active court involvement.
The Vioxx settlement should be viewed (which is useful input) as a learning experience. It showcases what happens when active court involvement in defining the parameters is not a requirement. The Vioxx settlement can be viewed as a real life example of what can happen within private negotiations unbounded by the sheer broad strength of a major corporation, which has purely and simply maximization of profits in its soul – certainly not ensuring that the rights coming into the court system are not lost going out of the court system.
Profit motivation is the engine of innovation and motivation. However, it will clear all in its path solely in the name of profit, and often needs “optimal” (but not excessive) supervision. This not only ensures the ultimate goal of overall public interest, but paradoxically ensures the long term survival of the corporation itself. Mr. Harrison is and has always been a proponent of free markets, but recognizes the danger of an unbridled corporation.
“I propose Vioxx is the model for future cases, especially cases where you have a known injury,” said Edward Blizzard, an attorney with Blizzard McCarthy & Nabers LLP who was part of the plaintiffs' Vioxx Negotiating Committee.
OBSERVATION: how could the Vioxx settlement be a “model” at this point? It’s benefits clearly do no outweigh its risks to civil rights nor contribute towards proper corporate behavior. It is merely the first large scale effort at privatization fraught with the issues so common at first. Rather than “model”, the term “proto-type” seems more befitting. However, real people, with real problems are being severely and unfairly impacted, and that must also be dealt with. A prototype evolving into a model must be done in a manner befitting of a first attempt at privatization. This includes safeguards as mentioned, and must be followed up to assess both defendant AND litigant fairness before it could even conceivably be considered a model. This (proposing it as a “model”) seems to be a very rash statement at this stage, and sends a dangerous message to the public, to Merck and other drug companies seeking draconian measure of risk relief, and to attorneys across the land who can begin to enjoy much of their business being essentially paperwork.
“The big improvement is that this is a settlement that might actually deliver settlement,” said Richard Nagareda, a mass tort professor at Vanderbilt University Law School who wrote the book "Mass Torts in a World of Settlement." “The big difficulty the law has been encountering is developing some sort of framework, such as class settlement or bankruptcy, that brings some binding peace for litigation.”
OBSERVATION: Is it is a major improvement to deliver a settlement that “actually” delivers a very poor settlement? One where the Plaintiffs are not properly represented? One where the “reward” valuation is so low that thousands of coerced opt-ins so reluctantly accepted? One which in no way discourages the alleged behavior, and in fact encourages such errant behavior? It begs the question if goals include – justice, fairness, and incentive for good corporate behavior, or a settlement unto itself?
With the prospect of tens of thousands of cases overloading court dockets, judges overseeing Vioxx cases, including Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana and Judge Carol Higbee of the New Jersey Superior Court, had appointed six trial attorneys to represent Vioxx plaintiffs in settlement negotiations with Merck. “One of the reasons the private settlement structure works so well is that it is not bogged down in appeals,” Blizzard said. “People can get their money relatively quickly.”
OBSERVATION: Statements imply that “the private settlement structure works so well”. are quite premature. The barrage of statements seems to be more of a sales pitch than a statement of facts. Of course the docket issue needs to be addressed; and perhaps privatization has a place. Yes, it would seem to need to minimize appeals – but not by what amounts to the equivalent of coercion to sign away rights. Work the appeal issues early, by gaining defendant AND litigant agreement up-front which would minimize the appeal issues – don’t spring such an unfair settlement on litigants who essentially have been forced into a situation to have no options except to agree to the terms and sign away their appeal grounds. “People can get their money relatively quickly” is not a good excuse for such very low valuations. The insurance industry is often known to leverage the desperate financial plight of an individual, and surely Merck has let time and financial desperation be a leveraging tool also.
“The fact it is a private settlement agreement is probably the most unique factor in my experience,” said Grant Kaiser, an attorney representing several Vioxx plaintiffs. “It removes obstacles presented by a class action settlement but give the benefits of a class action settlement.” For instance, he said a court under a class action could “put their finger on the scale for one side or another,” as part of the approval process for a class action deal.
OBSERVATION: “unique” means nothing unto itself. The reference to “finger on the scale…” is quite misleading. This would seem to suggest that it is better to entirely remove the court from the scale of justice. How can one come to terms with that concept? Vanishing the court from the scales of justice is unfair, unwise and dangerous. Most certainly would rather that the “finger” be the finger of justice rather than the finger of an interested, powerful corporation as Merck. The legal “obstacles” of a class action are there for reasons of justice and fairness – the speaker here doesn’t seem too interested in an environment which protects litigant’s rights.
Ronald Benjamin, an attorney representing more than 100 Vioxx plaintiffs, has filed an appeal to the U.S. Court of Appeals for the Fifth Circuit against the agreement, arguing that the settlement is illegal. “This is not a private settlement,” Benjamin said. “The people I represent never consented to attorneys in Louisiana consenting to an agreement on our behalf.”
OBSERVATION: Mr. Harrison has (above) presented the argument for proper litigant representation up-front in the negotiation parameter definition, safeguards throughout the negotiation, and follow-up and assessment as to the success of the agreement. Mr. Benjamin is right in vehemently protesting that his clients were not represented properly – i.e. they never consented, directly or properly indirectly, to have the NPC negotiate in their behalf. Proceeding without active involvement of Plaintiff’s directly approved counsel, who need to truly represent their clients is not consistent with the right for legal representation. The settlement was more oriented to just ending the litigation than to provide justice – the results are speaking for themselves.
He (Ronald Benjamin) said the plaintiffs' negotiating committee had no right to reach the settlement because the district court had rejected class certification in the case, which under Rule 23 of the Federal Rules of Civil Procedure would have allowed lead counsel to negotiate a settlement. “So they decided to simply ignore the rule and do it anyway, which as far as I'm concerned, is preposterous,” Benjamin said. “The issue the [appeals] court has to decide is whether they are going to let a group of private lawyers settle claims on behalf of clients they don't represent.
OBSERVATION: One can easily interpolate that the average litigant in whether opt-in or opt-out certainly does not feel that their legal rights were represented whether it be within the settlement definition/negotiation, or the decision to accept/reject the offer.
Benjamin said the deal was unfair because it excluded a large number of plaintiffs, such as those who suffered transient ischemic attacks, while also letting Merck off the hook when they could “easily” pay up to $70 billion. Anthony Sebok, a mass torts professor at the Benjamin N. Cardozo School of Law at Yeshiva University, said there would be questions about whether the recruitment of plaintiffs lawyers to reach a settlement will be permitted in the future.
OBSERVATION: part of the negotiations and seeking leverage by the litigant negotiating team should have been both what the fair reward should be and if Merck could afford the reward. This is one of the reasons why the business acumen and financial analysis capabilities, seeming to have been a missing resource within the PSC/NSC, should have been a requirement in the litigant negotiating team. The courts could assure this if private settlements do proceed are defined with active court supervision.
Mr. Harrison, with a major financial analysis background, has separately concluded that the estimates of Mr. Benjaim’s financial estimates are reasonable. Merck’s income statement continues to be very strong, and incredibly if the settlement is allowed to proceed, the cost will have been a minor blimp on Merck’s radar screen; merely a cost to be managed, not a penalty to be avoided in the future.Wall Street confirmed this. Proper financial insights within the NPC should have been concluded, and that should have been major leverage for the NPC.
…“I think the idea of plaintiffs lawyers making side deals with the defense is a very controversial idea,” Sebok said.
OBSERVATION: Agreed.
The Vioxx agreement also set up a system for pay claims based on several factors, including a plaintiff's health condition prior to the alleged injury, his age and how long he had been taking the drug. To be awarded damages, plaintiffs have to pass three gates: proof of injury, proof they took Vioxx within 14 days of their injury and proof they had been taking the medication for some time. “We wanted to design a program for the qualifying cases…
OBSERVATION: Merck does say “we” wanted to design a program for qualifying cases – that is a major part of the problem – there is too much “we” in “we”. While Merck is due input, they are not due such dominance in defining the artificial GATE process – they are too interested of a party. Proper legal safeguards could be put into place (and still can!) to ensure that the GATE process is represented upon more scientific background; post usage data could have been utilized by the NPC via statistical sampling, etc.. Merck’s biased opinion was not countered effectively by the PSC/NPC. If an active role had been defined for the court to supervise and ensure the litigants rights were not lost - then a more robust negotiating team (with the inclusion of finance, business, negotiating, statistical individuals) could have ensured that the ever so vital GATE process was at least fairly evaluated by an independent medical group, etc.
Mayer said. “We have no interest in a settlement that allows plaintiffs to cherry-pick plaintiffs, that encourages plaintiffs firms to sit on the sidelines even if the settlement is a good deal for their clients and hold up the company. “ Plaintiffs firms that initially had reservations about the settlement's details have since been converted.
OBSERVATION: “converted” in a sense that they (Plaintiffs firms) realized that it was primarily in their interests, not generally in their clients, and that they had tools available to “cover” their ethical duties…
Rein also believes the Vioxx system of evaluating injury and causation to arrive at a damage estimate would also likely be included in future settlements.
OBSERVATION: The concept of a GATE process seems to have validity. However, that said one would certainly hope that safeguards are put in place to ensure that this central go/no-go decision process was negotiated fairly as noted above, and then evaluated for fairness and supporting of a standard of medical science. There are no such real assurances in the Vioxx settlement. Also when new medical information becomes known, especially during the administration of a settlement, it is not fair to simply ignore it within a GATE process because of timing and technicality. New information must have a way to become part of the Gate definition.
Theodore Frank, the director of the American Enterprise Institute's Legal Center for the Public Interest, said Merck's strong position aided in reaching the deal. “Merck’s success in court and the lack of a smoking gun demonstrating wrongdoing meant they had a lot of leverage to negotiate favorable provisions,” Frank said. “To the extent future defendants can achieve such leverage in mass tort litigation, and to the extent the Vioxx settlement proves to be successful, we should see many elements be replicated.”
OBSERVATION: Yes Merck was very good at achieving “such leverage” – that is a point Mr. Harrison is trying to make – they saw the uneven playing field and went for the touchdown!
Until the court ensures fairness, one would hope that most of the elements are NOT repeated. Merck’s strong “leverage” existed because the PNC was not a competent negotiator in terms of having the proper team members and resources. The “lack of a smoking gun” is Mr. Frank’s opinion and seems to cloud the issue of weighing evidence. Must there be one single “smoking gun”?. One can certainly argue that there was some smoke here and there – that residual “smoke” came from somewhere.
Mr. Frank is a major proponent of TORT litigation reform and feels that the meager awards of the Vioxx victims are more than adequate. He has stated this in very unflattering terms. Mr. Frank seems to place much more value on the technical aspects of the legal field, and not goals of fairness and justice.
Trial experiences were not statistically valid, did not have the benefit of full discovery, were done at the peak level of Merck public sympathy, and were done before the issue of strategy consistency across (Vioxx, Fosamax, Vytorin…) and within drugs. Arguments that Mr. Frank has made in his blog that statistical reasonability is not necessary continue to perplex Mr. Harrison.
Posted by bones - a sickening possibility
Thursday, November 06, 2008 9:48 PM EST on a different web site…
This is NOT a vPEG sanctioned view, but frankly just sickened me today…
Please, put this in proper perspective – it is not a “sure thing”, but I am extremely concerned that it fits the puzzle that WE have been discovering over the last ten months in quite a sickening way. Frankly, all of the elements are right in front of us. I only wish I am able to take 6-8 weeks and document in this in a way one does not often see. It is not a view endorsed, obviously, by vPEG (yet?), but I have always done the best I can to immediately provide view/thoughts, and even recognizing that I sometimes do so to fast. Please just place it into the proper perspective and memory part of your brain and “think about it” for now..
While I remain stunned and depressed IF there is Merit here, I am also now, more determined than ever to dedicate my own personal lifetime, all of it - to this issue. In fact, I now view the litigation I am involved in as HAVING to STEP to the PLATE much harder and faster as such. The below is (to me) so, so piercing one’s heart and stomach… I am just, for the moment till I digest it further, so depressed… Think I am not serious, just do a google on my name and various things like vIOXX, vPEG, Merck, etc. and soak the last two+ years in…
Today, a theory was advanced that should it have merit, frankly makes my stomach sick and I am very serous when I tell you that I have spent the last 6 hours shocked and saddened, it really has taken the wind out of me. It is one that the MSA (the agreement) was actually written so that it could then be transferred into LAW by Congress… and the pharma, and other industry will use it (as planned) to shield themselves from MASS TORTS.
That does not mean that locally one cannot sue for being run over by a car, but it WOULD mean that damage perpetuated by a drug company will have one heck of a hard time gaining any shred of adequate compensation for the rest of our lives, and our children’s also. It will allow the adequate testing needed to come out of the laboratory and into the public and will discourage proper pharma post-marketing tracking/analysis. It will make litigation merely a fixed, product life cycle cost. By providing fixed costs and capping risk, it will then permit other reckless and too risky behavior by the pharma industry. The ramifications get worse….
Really, I have spent the last 6 hours sickened by what I now see as a real possibility, unless MAJOR NOISE IS MADE to the public, the Attorney Generals, the US Supreme Court, and the best we can do to warn Congress. It will complete the “loop” and it all fits very well. I am not a radical – in fact I have quite conservative values in re to family and right/wrong – but in re to CIVIL RIGHTS of MANY kinds, I would consider myself in the liberal camp, as I DO see movement towards as I say – “peeling away our CIVIL RIGHTS like onions”.
Shall it have merit, it is one of the worst things that we have seen in our lifetimes in re to real perversion of our Legal System; with Pharma/the courts and the large firms largely in control of protecting pharma, and now looking to suggest to Congress – “we have the perfect solution – look, it’s already done… all you need to do is sign on the dotted line, and you can go tell your constituents how well you FOUGHT for TORT REFORM (actually is DEFORM) - but the PUBLIC does not, cannot yet currently differentiate between frivolous litigation (and of course we understand that) and the massive fraud and collusion taking place under the guise of “TORT REFORM”.
Shall it have merit, it will mean that we really have to step up our efforts as described above, yet we are now “stuck” waiting for the inevitable of the “sign away” right clauses to clamp down too many. BUT on the other hand, as described, it DOES seem that we have at least a chance for opt-ins to find their way out of that (i.e. coercison, duress), we have opt-outs to carry it forward, we have “left-outs” to help us right this horrible momentum, we have the ol’ “kick-outs” that might be able to contribute and of course will have an increasing pool of pro se’s….
PLUS, one would feel I (I don’t know) that the “sign away rights might clamp down on future medical litigation – but CIVIL RIGHTS might be different, RICO might/is (I believe) different (but for the few), and of course “coercison and duress” should receive their proper documentation and pursuit.
This DOES NOT at all mean it is over, it may mean that we need to REALLY recognize that WE have just begun. IF you are a vIOXX Plaintiff and wish to get involved, in addition to learning/educating/sharing – please feel free to apply:
http://groups.yahoo.com/group/MerckSettlement/
Posted by Dennis Harrison (bones)
Sunday, November 09, 2008 1:42 AM EST
What I get out of CAFA is that jurisdiction for large class action is moved to Federal; that would then seem to be the first stage as it consolidates POWER centralized. Note that the STATES, by the way, ARE AGAINST PRE-EMPTION; kind of tells you that the STATES continue to be very way of Federal Power over-reaching. Some things certainly make sense from a Federal Point of view, certainly that is the case. However, in the case of TORT/PHARMA - it seems clear to me that the first step is to centralize power into the Federal Government, where it then becomes under their control how to move further.
http://en.wikipedia.org/wiki/Class_Action_Fairness_Act_of_2005
Then, along comes TORT REFORM - and since the PUBLIC DOES not understand what it really means, the PUBLIC thinks hot coffee/and near $50M (amt ?) award. SURE, the public opinion says, something must be done, let's support TORT REFORM.
http://en.wikipedia.org/wiki/Tort_reform
OK, now along comes PHARMA. Things are starting to look great for Pharma.
TORT REFORM? what a great way to PUSH a private "settlement" (DEAL), surely the public at large will support such a brave effort...
OK, now we get the "settlement" (DEAL)....
The Public has been quoted with MANY mean spirited quotations (we are blood sucking thieves, we steal $ from the research for children, we steal $ from greater research efforts, etc...).
Merck poor mouths itself and declares that $5B is SUCH A LARGE amount (don't we know where that amount gets now a days divided by so many people?).
The COURTS say - sure, we have been instructed by our Congress and House to seek TORT REFORM;
The COURTS collude (sorry, I know a lot don't like that word...) with PHARMA and design/collude the referred "private settlement" (DEAL) that has, without question, stolen CIVIL RIGHTS up the kazoo....
BUT, then go further.... while at it... why not actually draft the MSA ("settlement" (DEAL)) so that we can then bring it to the legislative body for their signature? Sounds quick and easy enough...
And that is where it seems to be:
1 - pharma knew for a long time where this was going...
2 - the courts are only too glad to have a nice, easy way to wipe away their dockets...
3 - the legislative branch wishes (this is NOT an issue of which party) to look good to their consitutents and claim - SURE, we have WORKED VERY HARD AT TORT REFORM (i.e. signing what Merck DIRECTED for the entire industry).... By the way, they do so via illegal "bill of attainer"
http://en.wikipedia.org/wiki/Bill_of_attainder
Besides seeking JUSTICE AND FAIR COMPENSATION, a goal of 2009 needs to beat back this new realization.
An opinion, certainly backed up by a lot of step by step actions... I DO think this is what we are seeing...
Remember more to come Giardasil, Fosamax, Vytorin and who knows what else.. Some call this “practice and patter’ which can lead to lawsuits of all kinds – Civil Lawsuits – Criminal Lawsuits –not a bad group of words to have for Google to pick up on in searches:
Giardasil – Fosamax – Vytorin – Merck – Murk – lawsuit – litigation – private settlement – collusion – corruption – MDL 1657 – justice – US Supreme Court – US Department of Justice – RICO – jail – unfairness – inadequate compensation – 10 cents on the dollar – Congress – Tort Reform – Tort Deform – Corporation Reform – Corporation Deform - Legislature – pharma – Merck settlement – PSC – The Honorable Judge Fallon – Dennis Harrison – bones – Vioxx Plaintiff Education Group – VPEG – AvPEG – RvPEG – preemption – CAFA – bill of attainer – Merck Star Chamber – Star Chamber – Merck – Merck – Merck – pharma – pharma – pharma – duress – coercision – duress – coercision – duress – public – public duped – publice coercision – public duress – vioxx victims – vioxx survivors – vioxx litigants – vioxx opt in – vioxx opt out – vioxx kick out – special master – vioxx appeal – vioxx settlement – vioxx merck settlement -
Class Action Fairness Act CAFA – Federal law – state law – pre emption – United States Supreme Court and pre emption – United States Supreme Court appeal RICO Merck Vioxx settlement – practice and patterns – proper legal representation – MDL 1657 – PSC – large law firms – collusion – nuisance law suits – Mass Tort Reform – Mass Tort litigation – fairness doctrine – RICO – RICO – Merck and RICO – Merck and patterns – mass murder – allged – statistically invalid – statisticall laughable – a crime – bias and prejudice – derelect of duty – Start Chamber – nuisance suits – Pulmonary Embolish – MI – Heart Attack – Bone Spine Healing – Inadequate Bone Repair – inflammation – Cox 2 – need for inflammation for bone spine repair – Merck hired consultant Boston - Giardasil Fosamax Vytorin – Giardasil – Fosamax – Vytorin – class actin – Rule 23 – Giardasil Fosamax Vytorin – bone spine healing – public needs to be warned – MI – heart attack – stroke – Pulmonary Embolism – stroke – MI – Pulmonary Embolism – stroke vioxx heart attack law suit litigatin Tort Reform – attorney client relationshiop – right to trial by jury – constitution – access to the courts denied merck psc MDL 1657
http://groups.yahoo.com/group/MerckSettlement/
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