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Wednesday, November 21, 2007

Sebok & Zipursky on Vioxx Settlement

In this week's Findlaw Writ column, Tony Sebok joined by Benjamin Zipursky address the recent Vioxx settlement.  Sebok and Zipursky do not comment on the end result (a $4.85 billion settlement), but rather analyze various structural issues such as "the process by which the agreement was reached, the process by which the payment-and-release program will come into effect (if it does), and the process by which the settlement agreement and the program will be "enforced.""   


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VIOXX – Should there be a ROUND 2?
What about alleged bone/spine healing problems?

Many people criticize most, or all of the Merck/Vioxx claimants, feel that Merck just did no wrong, and is as “pure as the driven snow”. There is also a good deal of whining that the “settlement dollars could have been used for R&D”. Some interesting research that one may wish to do, whether you are positive or negative about the “agreement” is 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 (per year!) 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 would seem likely to attempt again as the Vioxx settlement works its way through..

For the record – I do support the “agreement”. On the whole and at first view it looks reasonable. I understand it must strike a balance between the very strong cases and the very weak ones – certainly many cases have a low value, and Merck does have to protect itself from providing unjust reward amounts. However, I do hope that this does not come at the expense of the strong cases. It is a difficult walk to balance. I understand also that there are some potential ethical issues in with respect to a Plaintiff accepting (or not) the agreement and how that might impact the attorney-client relationship. On the other hand, experiences such as fen-phen also show that there is a fine walk to balance there also. Hopefully there are mechanisms to facilitate fairness in attorney disposal/representation and award distribution – it is too early to understand. It is up to the people to now vote and provide input to their respective lawyers…

However, 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 about one month away from making the “PSC MDL Trial Package” generally available for the trial attorneys to use as their cases were to be remanded back to the states from which they came. Thus, hundreds, perhaps thousands of Vioxx lawsuits were about to be launched – along with the publicity, etc.

I also support what I will calll – VIOXX 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 many 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 (bone/spine healing) 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 the bone/spine concerns 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 and should have taken a position. 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 in a similar way), 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 likely will other 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 and have records showing that they took Vioxx first comes to mind….). 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.

The Public needs to 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 was not done when Vioxx was taken off of the market, 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 have made some initial, and conservative, estimates of how much Merck’s liability could be on the bone/spine problem(s), and it is not a pretty sight for Merck – perhaps that is why Merck has (allegedly) has been successful in the past of (allegedly) concealing the issue. I have seen a slow, but steady, increase of PUBLIC AWARNESS – but still on the tip of the iceberg as the issue generally continues to be very well (allegedly) concealed.

I have become 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 would be told…). I continue to work to have the public, and attorneys across the land, become aware (and motivated) of the bone/spine healing problems, but it is a slow process. After all - it has been much easier (for an attorney) and offers much less risk submitting a lawsuit and letting the PSC within 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 look to make significant progress in 2008.

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, it is (allegedly) likely that (tens of thousands of) 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!

…there were, and are, other factors that should have caused responsible actions but allegedly failed to - thus 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.

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)…

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 usage of Cox-2 inhibitor and FOSAMAX). Incredibly, both drugs have been produced by Merck! Shouldn’t Merck (allegedly) have a formal opinion on concurrent usage, especially during the bone/spine healing process by now?Also, how about 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 - The blog is almost one year old, but it provides insight to what may represent many other severe cases (obviously there is a range).

Yes - do some research as suggested above; and those of you who are critical of the claimants; perhaps you might realize that things are not so simple. Perhaps you might feel as I, that (allegedly and potentially) a pattern of deceit by omission is emerging and had the Vioxx lawsuit been worked that way, things might have been worse for Merck. Perhaps you will realize that it is quite likely that many, many of the claimants have good cause; let alone the potentially tens of thousands of bone/spine victims that never knew what hit them.

Some mention, vehemently, that R&D investments could have been made instead of compensating the claimants. Obvioysly, R&D is essential to maintain profits AND serve the public interest by contributing to the public’s health. At the same time, punishing a company that has (allegedly) received ill-gotten gains is also essential and ALSO serves the public interest and the public’s health. Should a minority of victims be sacrificed, without even compensation for the (unknowing and uninformed sacrifice), in the name of maximizing Merck’s R&D? Furthermore, in the long run the restitution by Merck actually does contribute to profit, as any company harming the public time and time again will not survive in that long run. Consider it like a boat – unless the minor corrections are made and the ship’s crew learns how to steer correctly (i.e. learns that you cannot run roughshod over unsuspecting victims), as early as possible, the ship will drift even further off course until it is hopelessly drifting and forever lost (i.e. gone out of business). If Merck were not “set straight” by the legal and market forces, it would not survive the free market of which it must abide by those same legal and market forces. What’s the alternative – anarchy and a land strewn with victims without recourse, so that R&D can be maximized for the sake of maximizing it?

And remember when you see a person, (allegedly) deformed because he/she was not warned (and nor were the physicians) of using Vioxx during bone/spine healing....

"there but for the Grace of God, go I".....

Dennis Harrison
Catskill, NY

Posted by: Dennis Harrison | Nov 22, 2007 11:28:21 AM

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