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November 09, 2007
Vioxx Settlement
The Vioxx case has finally been settled. Merck has agreed to pay $4.85 billion to settle all of the claims from its drug, Vioxx, that was withdrawn from sale three years ago.
Three years after withdrawing its pain medication Vioxx from the market, Merck announced today that it will pay $4.85 billion to settle 27,000 lawsuits by people who contend they or their family members suffered injury or died after taking the drug.
The settlement, one of the largest ever in civil litigation, comes after nearly 20 Vioxx civil trials over the last two years from New Jersey to California. After losing a $253 million verdict in the first case, Merck has won most of the rest of the cases that reached juries, giving plaintiffs little choice but to settle.
The settlement will help put Vioxx behind Merck, as well as sharply reduce its Vioxx-related legal defense fees, which are now running at more than $600 million annually.
Judges in Louisiana, New Jersey and California, who oversee nearly all the lawsuits, had pressed for a deal before a new wave of trials was scheduled to begin in January.
That $600 million annual legal bill....well, even though they were winning almost all the cases that came to court, that doesn't help all that much in hteUS system. Even if you win you've still got to pay your own legal costs. So $4.85 billion to get Vioxx behind them is probably a good deal:
Merck & Co has agreed to pay $4.85 billion to settle claims that its painkiller Vioxx caused heart attacks and strokes in thousands of users, the drugmaker said on Friday.
Of course, we shouldn't leave out the law firm that achieved this agreement:
And here's an agency report on Vioxx to give you the whole picture.
November 9, 2007 in Business | Permalink
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VIOXX – Should there be a ROUND 2?
What about alleged bone/spine healing problems?
For those of you who seem to criticize most, or all of the claimants and feel that Merck just did no wrong, and is as pure as the driven snow - and are whining that the “settlement dollars could have been used for R&D), some interesting research you may wish to start Googling on are terms such as:
vioxx bone spine healing
cox-2 bone spine healing
fracture bone spine healing Vioxx
and remember this:
1 – there are hundreds of thousands of broken bones, spine injuries, ortho. operations, etc.
2 – with the sales of Vioxx having been so high, it is not hard to interpolate tens of thousands of individuals have been very negatively impacted by Vioxx – and they don’t even know how it might (allegedly) have happened! Furthermore, considering there is still a cox-2 inhibitor on the market (Celebrex); AND others drugs in the same class have attempted to get to the market (ARCOXCIA/Merck; PREXIGE/Novartis) which one would assume will attempt again as the Vioxx settlement works its way through.
For the record – I definitely support the “agreement”. It is up to the people to now vote, and let the chips fall where they may! Interesting food for thought on the timing of the agreement: the results of several years of work by the PSC within the MDL process was apparently a month away from making their “PSC MDL Trial Package” available generally available for the attorneys to use as their cases would be remanded back to the states from which they came. Thus, hundreds, perhaps thousands of Vioxx lawsuits were about to be launched.
I also support what I would like to call – VIOCC Round 2.
Just one Independent Research (IR) snippet - more follow; there are hundreds representing many studies PLUS a quite logical analysis of the bone/spine healing process by so, so many very well respected surgeons, physicians, researchers, etc.
In fact, the 2003 Merck Manual very well describes the healing process – certainly a good enough description to logically assume that they (Merck) allegedly would (and should) have been at least wary of the cox-2 inhibitors! I may be wrong; but it seems that the Merck description of the bone/healing process seems to have worked its way out of the manual – if I am right, seems like interesting timing…
Just one of the hundreds of Google “hits” that may be of interest…
MAY 21, 2002 - JOURNAL OF BONE AND MINERAL RESEARCH - COX-2 DECREASES BONE HEALING? - mechanical testing revealed that COX-2 inhibitors…reduce bone strength ((in healing) – note by this BLOG’s author))…expression of COX-2 is critical for bone healing…essential for fracture healing…the inhibition of prostaglandin synthesis stops normal fracture healing;
You will continue to find Research, and scientific description that (allegedly) another, very significant problem of Vioxx existed and was (allegedly) known (and certainly should have been known) by Merck. Unfortunately for the public – Merck has (allegedly) successfully swept the issue(s) under the rug and radar; with severe consequences for many people, but with many benefits (allegedly) for Merck.
I allege that the responsible action would have been to announce this issue when Vioxx was taken off the market – (allegedly) Merck knew, or should have known, enough to have at least more than a passing interest in the problem. Instead, “this muddy picture," (as termed by Dr. Scott Reuben of Baystate Medical Center in Springfield, Mass.; and of which one of my own surgeons referred to similarly) was allegedly maintained by Merck rather than provide any kind of caution, warning(s), consumer or physician education, etc. Nope – this was one issue that apparently and allegedly was better just to keep “muddy” as long as possible….delay creates confusion and allows red herrings to become a strategic tool for profits… One red herring example – many studies were done on animals - sure that does not (by itself) correlate directly into human problems – however there is enough other evidence, research and very well understood scientific explanations of the bone/spine healing process (including the 2003 Merck Manual) that there is enough “evidence” converging to at least raise a healthy convergence that just should not have been ignored. Furthermore, and get this, it (allegedly) seems that Merck also used animal studies to justify many of the benefits (and potential ones) of Vioxx. So, which is it? – do animal studies have justification or don’t they? You may hear another red herring that it would not be ethical to conduct human experiments. There are, of course, other ways to predict the impact on humans (controlled studies of people who have already broken a bone, for example). Now that I have been off of Vioxx since the day of withdrawal, perhaps I can offer to have a broken bone or two (but not a major bone this time! and in a controlled manner) in the name of science and Public Awareness.
I still have hope that the Public will demand that Merck acknowledge the (alleged) bone/spine healing issues, NOW, and that the STATUTE OF LIMITATIONS clock be reset for potential bone/spine litigants. Because this (acknowledgement) was not done, Merck (allegedly) most likely avoided many (thousands) more lawsuits. This also would have made their general publicity much worse, and perhaps juries would have seen (allegedly) not one, but a pattern of alleged deceit by active concealment, as well as the other charges. If this had happened, the value of the heart/cv/stroke “settlement” quite likely would have been higher. But let’s get back to the bone/spine (alleged) problems – ROUND 2.
I believe that I have become very well versed and researched on many of the issues as I continue to pursue my own, “pro se” litigation (attorney’s ONLY wanted to take cases which were heart/CV/stroke oriented – I better not get started on that subject also but I have come to understand why – and it’s not what you will be told…). I tried to have the public, and attorneys across the land, become aware of the bone/spine healing problems, but with limited success. After all - it has been much easier and offers much less risk submitting a lawsuit and letting the MDL do the “heavy lifting Discovery” of “common issues”, than actually conduct a jury trial, along with its own Discovery process. As of yet, I have not reached the critical mass (of Public awareness) needed for logical and responsible actions to be put into motion (i.e. Merck – Round 2). I still hope to do so, and consider this another attempt at Public Awareness….
How about this idea – if indeed the “settlement” is approved with its 85% threshold, the legal community (esp. the Plaintiff’s BAR) should now tackle the bone/spine alleged problems. The issues are very are real, there is plenty of evidence, and perhaps the causation issues are more direct to deal with. At least, for gosh sake, a real investigation by the Plaintiff’s BAR as to whether or not it should pursue bone/spine litigation, and push to have the STATUTE OF LIMITATIONS extended should be a very high priority. And while they are at it, perhaps it is appropriate for another review of Celebrex (another Cox-2 inhibitor) along the same lines.
As mentioned above, perhaps tens of thousands) people, in the past (Vioxx) and CURRENTLY (Celebrex), were (are) being adversely impacted. It is about time that both Merck (and Pfizer/Celebrex) finally takes a comprehensive, cohesive, position on Cox-2 inhibitors as well as the potential negative synergies with emerging (alleged) issues and litigation with bio-phosphates, such as FOSAMAX. I, personally, would shutter at taking a Cox-2 inhibitor and something like FOSAMAX concurrently – especially since FOSAMAX can stay in the bones for about 10 years. This is quite possibly an explosive issue that should be addressed now, not later after the (potential) massive damage. A little bit of “preventive medicine” is certainly due here – and wouldn’t you think that Merck and Pfizer (and by the way – Novartis), being the “bone experts” should have already have had position(s) on this?. Also, though any degree of reasonableness and safety concerns would have called for post-marketing monitoring. Why should these companies have to be ordered for monitoring. My gosh, it is only common sense and what you would expect of “world class” organizations!
Back to Vioxx, just a small sample of the Independent Research (IR) that Merck (allegedly) just simply ignored and (allegedly) apparently hoped would just fade away. By the way, (allegedly) there were NO warnings, nor public or physician education on the bone/spine healing issue(s)…
…And there were, and are, other factors that should have caused responsible actions but allegedly failed to so the issue(s) would remain in never never land! It certainly would seem that even just the general industry “wariness” (of Cox-1 inhibitor concerns) SHOULD have motivated Merck to address the matter with Vioxx (as well as its new proposed Cox-2 inhibitor entry – Arcoxia). Wouldn’t you think that they would be the SUBJECT MATTER EXPERTS! There seems to be no reasonable explanation as to why Merck did not tackle the mounting Independent Research (IR), the very scientific explanations, and general industry wariness of early generation of Cox-1 inhibitors (which also, by the way, were(allegedly) not treated in an open or fair manner
REPRINTED FROM: WWW.USATODAY.COM/NEWS - "It's time to tell the public," concludes Dr. Thomas Einhorn, Boston University's orthopedic surgery chairman (Einhorn, A PAID CONSULTANT for Vioxx maker Merck & Co. and Celebrex maker Pharmacia Corp)….New research suggests some of the most widely used painkillers may delay healing of a broken bone… "If it were my fracture ... to me every day counts," he says. Vioxx and Celebrex are among the culprits…. the makers of Vioxx and Celebrex deny any link. Comment by author – a paid consultant’s for Merck and Pharmacia (at the time) is apparently not even followed up….apparently his results were not what they wanted to see…
Copyright 2002 The Associated Press. All rights reserved. …O'Connor says his findings prompted some colleagues to withhold cox-2 inhibitors from broken-bone patients … Arthritis Foundation… urges more research... surgeons made the surprise discovery a few years ago that high doses of the intravenous NSAID Toradol delays spinal surgery healing… a recent British study concluded using NSAIDS was the biggest factor in delayed healing of a broken leg. …"It is confusing. ... You see this muddy picture," says Dr. Scott Reuben of Baystate Medical Center in Springfield, Mass., who conducted that study -- and calls for targeted research on broken-bone sufferers… It's an important question, as more Americans regularly use Vioxx, Celebrex and other anti-inflammatory painkillers called NSAIDS… Doctors increasingly offer bone surgery or fracture patients higher and higher doses of such painkillers in place of narcotics… At issue is the discovery that an enzyme called cox-2, which causes pain and inflammation, also appears to play a crucial role in bone healing. …Einhorn, a paid consultant for Vioxx maker Merck & Co. and Celebrex maker Pharmacia Corp (at the time)….despite the companies displeasure…concludes "a prudent approach" is to temporarily quit using either NSAIDS, Vioxx or Celebrex if you break a bone.
"If you don't know, you should err on the side of caution." - my comment – apparently and allegedly, Merck decided not to err on the side of caution!
COX-2: WHERE ARE WE IN 2003? - THE ROLE OF CYCLOOXYGENASE-2 IN BONE REPAIR - EINHORN TA. PROFESSOR AND CHAIRMAN, DEPARTMENT OF ORTHOPEDIC SURGERY, BOSTON UNIVERSITY MEDICAL CENTER, BOSTON, MASSACHUSETTS - both non-specific and specific inhibitors of cyclooxygenases impair fracture healing - but that this is due to the inhibition of Cox-2 and not COX-1! Vioxx is a Cox-2 inhibitor. "It's time to tell the public," concludes Dr. Thomas Einhorn;
“Somehow, this study flew under the radar,” SAYS JASON THEODOSAKIS, MD, MS, MPH., AUTHOR OF THE ARTHRITIS CURE (ST. MARTIN’S PRESS 2004). This information is unlikely to be broadcast by pharmaceutical companies, he explains: “It could affect the billions of dollars in sales of the COX-2 inhibitors if people knew they might be destroying cartilage while they’re trying to relieve their pain.”;
FEBRUARY 02, 2005 - HSS PHYSICIANS REVIEW LITERATURE ON THE SAFETY OF COX-2 INHIBITORS - COX-2 inhibitors effect fracture healing and spine fusion… should never be used in spinal fusion;
The unnecessary victimized (including myself!) who's bones and/or spines didn't heal correctly, or even at all, never even knew what hit them! We didn’t even have a warning – not even a chance to make an informed decision. Certainly I would have not taken Vioxx if I were to at least have been warned! Especially sad is that the period in question generally revolves around the first three or four weeks of healing – not really a very long time.
POSSIBLE OTHER PUBLIC CONERNS! – taken from a Vioxx Blog….
VIOXX, and all COX-2 inhibitor drugs, work by inhibiting the body's natural response to inflammation and bone repair/regeneration. It begs other questions. (1) What might be the impact of FOSAMAX (also produced by Merck!) on bone healing? It has already been alleged, and there are lawsuits pending, that it can prevent the jaw from healing after a tooth extraction (bone dies - the issue is called “Dead Jaw”). (2) This should cause one to question - what about FOSAMAX's relation to other bones? (3) Furthermore, what if some one took VIOXX, or another Cox-2 inhibitor, and FOSAMAX at the same time? Since both work basically by interfering with the body’s natural reaction of bone repair and healthy regeneration - could the problem be even worse with concurrent use – which did and does exist?
Also, what other bone problems may develop with the past- concurrent (Cox-2 inhibitor VIOXX and FOSAMAX USAGE?) Incredibly, both drugs are/were produced by Merck! Shouldn’t Merck (allegedly) have a formal opinion on this by now, as well as some kind of testing and Post Marketing follow-up? Also, since Celebrex exists today and it is also a Cox-2 inhibitor, what about current concurrent use (Celebrex and Fosamax)? Shouldn’t the maker of Celebrex (allegedly) also have a formal opinion about this, as well as some kind of testing and Post Marketing follow-up?
If you would like to review more of Mr. Harrison’s history and gain more thoughts on your situation if similar, please visit the blog - http://badbonehealing.wordpress.com/.
Yes - do some research as suggested above; and those of you who blame the claimants; perhaps realize that (allegedly and potentially) a pattern of deceit by omission is emerging; and perhaps many, many of the claimants have good cause. And remember when you see a person, (allegedly) deformed from using Vioxx during bone/spine healing...."there but for the Grace of God, go I".....
Dennis Harrison
Catskill, NY
Posted by: Dennis Harrison, Catskill, New York | Nov 14, 2007 6:52:28 PM
Everyone seems to agree the Vioxx Settlement is a win for Merck - including a lot of the poor individual plaintiffs who are very concerned about this settlement and already have begun to discuss their feelings and what can be done at a Yahoo group -
http://groups.yahoo.com/group/MerckSettlement/
Posted by: Butch | Dec 2, 2007 4:11:18 AM
I am a plaintiff in the vioxx settlement, and would like to hear from others about what they are thinking about doing regarding this case, also I would like a copy of your Nov;9,2007 trackback letter about round 2, bone and spine problems, as my printer will not work.
Thank You Very Much,
Tim Newcomb
e-mail t.newcomb@hotmail.com
Posted by: Tim Newcomb | Dec 2, 2007 4:56:00 PM
i would much rather have my dad mmy family has fallen apart since his death i hope the settlement will help familys patch back up the damage
Posted by: sarah ping | Jan 14, 2008 10:43:17 PM
i would much rather have my dad mmy family has fallen apart since his death i hope the settlement will help familys patch back up the damage
Posted by: sarah ping | Jan 14, 2008 10:44:25 PM
SETTLED? WHAT PLANET ARE YOU ON?
Posted by: VIDEOMASTER | Feb 25, 2008 4:58:36 AM
