Saturday, November 10, 2007
The Vioxx Settlement
What does the Vioxx settlement tell us about mass tort strategy, procedure, and ethics? Merck's mass aggregate settlement, which weighs in at $4.85 billion and up to 47,000 plaintiffs, matters not only to its many participants, but also to anyone interested in understanding how mass tort litigation works.
THE PARTICIPANTS. Before turning to the deal's broader implications, let's talk about its significance to the five major sets of participants -- Merck, plaintiffs, plaintiffs' counsel, judges, and defense counsel. Assuming the settlement goes through (the deal is subject to several conditions, including an 85% walkaway clause), it's happy news for most of them.
- For Merck, the settlement allows the company to take its hit, slash its litigation expenses, limit its remaining exposure, and get back to business. That's why Merck's stock was up sharply yesterday despite a down day in the market. The first time I saw a stock price go up after a company announced a massive settlement, I found it odd (this is, after all, a multi-billion dollar expense); now I expect it.
- For most plaintiffs, the settlement provides compensation rather than the delay and uncertainty of litigation. Many participating plaintiffs will be disappointed with the amount of compensation they receive, but that's the nature of settlement. It's a compromise.
- For participating plaintiffs' counsel, the settlement offers a signficant payday after several years of unpaid Vioxx work and significant expenditure of resources. It also offers lawyers the chance to get out of Vioxx and to move on to the next mass tort or other litigation opportunity. And for the lawyers involved in negotiating the deal, such as Russ Herman, Chris Seeger, Andy Birchfield, and Arnold Levin, yesterday's announcement represents a satisfying accomplishment and the sort of attention-generating event that cannot be bad for business.
- For the judges -- particularly Judges Eldon Fallon (overseeing the MDL in E.D. La.), Carol Higbee (NJ), Victoria Chaney (CA), and Randy Wilson (TX) -- the settlement clears away a huge number of docket-clogging cases. For some of the judges, the settlement also reflect a personal victory, a professional accomplishment, and, one hopes, a sense of getting justice done. Judge Fallon, in particular, had announced early on in the litigation his desire to drive the parties toward a large-scale settlement. To whatever extent he may have experienced Merck's ongoing refusal to settle as a source of frustration and embarrassment, yesterday's announcement surely brought relief, satisfaction, and some vindication of his handling of the litigation.
- Of the major participants, the only apparent losers are Merck's outside counsel, who lose an important revenue stream. But that's taking an unnecessarily grudging view of defense counsel's position. For lead counsel Theodore Mayer of Hughes Hubbard & Reed, a settlement like this caps an overall successful defense strategy, and for other lawyers involved in negotiating the deal, including Doug Marvin of Williams & Connolly, John Beisner of O'Melveny & Myers, and Adam Hoeflich of Bartlitt Beck, the deal represents a professional accomplishment and a business-generating news event. A satisfied client is always good news. Except perhaps for local defense counsel, who experience a loss in revenue from upcoming trials that won't happen, but who may get little attention or client gratitude.
STRATEGY. Nearly all the commentary on the settlement emphasizes the success of Merck's defense strategy in the VIoxx litigation, with lots of comments suggesting that future mass tort defendants should take a page from Merck's playbook. I agree that the settlement reflects the culmination of a successful strategy for Merck, but before assuming the same thing will work for other defendants, you have to look at the confluence of factors that made the strategy work in Vioxx.
Merck took an aggressive approach, fighting each case individually. This strategy had three main components: refusing to settle either wholesale or retail, opposing trial aggregation, and pouring resources into litigating each individual case on the merits. Although early on Merck suggested that it would settle cases involving over 18 months exposure, it quickly backed off and pursued a strong no-settlement strategy. On aggregation, Merck accepted and even embraced aggregated pretrial handling (MDL and statewide consolidations), but staunchly resisted class certification and any form of joint trial. And in each plaintiff's case, Merck fought hard on specific causation and every other contestable issue. Merck could have settled many of those cases more cheaply than going to trial, but by refusing to settle Merck sent a powerful message to plaintiffs' counsel: there's no easy money to be had here.
The no-settlement, individual-trial strategy worked in the Vioxx litigation because several critical factors came together:
- First, Vioxx was off the market. This is often the case, as product recalls are a common triggering event for mass tort litigation, but not always. Plenty of mass tort litigation involves products that remain available. Think Zyprexa, Oxycontin, tobacco, guns. And lots of other mass tort litigation involves products that, while no longer on the market, present an ongoing risk of exposure -- lead paint, asbestos, certain medical devices. Because Vioxx was no longer available, Merck did not have to worry about a never-ending stream of potential plaintiffs, and could get some finality with a mass aggregate settlement. Also, with the product off the market, Merck could focus on litigation strategy without worrying about protecting the Vioxx brand and its ongoing prescribability by physicians, in contrast with, for example, Eli Lilly's position on Zyprexa.
- Second, Vioxx did not raise significant problems of latent disease. In some mass torts, such as asbestos and tobacco, latency creates enormous settlement difficulties. How can a defendant get peace without binding future claimants? This was the driving factor behind the Amchem and Ortiz asbestos settlement class actions, and an important cause of their failure. It was the primary reason for the multiple back-end opt-outs in the fen-phen nationwide settlement class action, which later proved so problematic. When I worked on the American College of Trial Lawyers Mass Tort Litigation Manual, asbestos and fen-phen were front and center, and we took time-dispersed disease manifestation as a defining characteristic of mass torts. So did Richard Nagareda in Mass Torts in a World of Settlement. Vioxx, by contrast, did not involve such significant latency problems. Latency was a disputed issue in the litigation, but the settlement reflects a willingness on the part of plaintiffs' counsel to let go of claims by persons who experience heart attacks or strokes long after their exposure to Vioxx. This, combined with the fact that Vioxx was off the market, and the statute of limitations, allowed Merck to seek peace in the litigation without worrying much about future claimants.
- Third, Merck had stronger individual defenses than general defenses. Like tobacco defendants, who always try to focus attention on the individual smoker, Merck focused on each individual plaintiff. In the case of tobacco, it's more about personal responsibility; with Vioxx, it's all about individual causation. Compare this with Bendectin, silicone gel breast implants, or Agent Orange, where the defendants had strong scientific defenses on general causation. In Bendectin, Merrell favored (and won) a mass aggregated trial in which it could present its scientific argument on general causation without the jury hearing from individual plaintiffs. Merck did not think it had a strong enough chance to defeat liability on a wholesale basis to be worth the risk, so it preferred to take a series of wins and losses in individual trials.
- Fourth, the issues were sufficiently individualized that Merck was able to defeat efforts at class certification and mass trials. On class certification, Vioxx is no different from most other mass tort personal injury cases (and post-CAFA, defendants have even greater confidence that mass tort class cert will usually be denied), but it differs markedly from other types of mass litigation. Aside from class cert, Merck was able to avoid large-scale joint trials. Even Judge Higbee's relatively modest effort at a ten-plaintiff consolidated trial in New Jersey fizzled. In other mass torts, even if defendants defeat class cert, they won't always have Merck's success at avoiding large multi-plaintiff trials.
- Fifth, and most important, Merck mostly won. That's because individual causation was hard for Vioxx plaintiffs to prove. Heart attacks and strokes are common. They are especially common among older people, who were Vioxx's primary consumers. So it's hard to show by a preponderance of the evidence that a particular person's heart attack or stroke was caused by Vioxx. Compare this with mesothelioma and asbestos, or PPH and fen-phen, or lung cancer and tobacco, or rhabdo and Baycol. Because of the difficulty establishing specific causation, Merck was able to win most of the individual cases that went to trial. Defense wins drive down settlement values, pure and simple. Had Merck lost several more of the individual trials, it would have cost a lot more than $4.85 billion to settle this.
Without this confluence of factors, Merck's no-settlement, no-aggregation, try-every-case strategy could easily have backfired. That's why in the future some mass tort defendants will continue to settle cases individually, others will seek early wholesale settlements whether by settlement class action or by non-class aggregate settlement, and others may even seek mass adjudication.
PROCEDURE. The Vioxx litigation shows the successful use of informal bellwether trials to drive a mass aggregate settlement. As a matter of procedural policy, the Vioxx litigation and settlement show mass tort litigation functioning reasonably well, as Byron Stier points out. There have, of course, been enormous litigation costs, unpredictable and inconsistent results along the way, and a fair amount of unseemly forum-shopping and forum-fighting, but that's par for the course in mass tort litigation. More significantly, look at what worked. The vast majority of cases were consolidated, at least for pretrial handling, in a small number of courts. Most of the cases were before Judge Higbee in New Jersey (cases were filed disproportionately in Merck's home state to make them non-removable under 28 U.S.C. 1441(b)); many others were before Judge Fallon in the multidistrict litigation, as well as in large statewide consolidations in California and Texas. Class certification was appropriately rejected; these cases are too individualized to be suitable for representative litigation that binds non-parties. Nor did courts employ formal bellwethers, in the sense of trials from which binding results could be extrapolated for other parties. Rather, Judges Fallon, Higbee and others used informal bellwether trials. That is, they scheduled cases for trial on steady basis, trying to get a range of representative cases, with the goal not only of resolving those particular actions but of providing enough data points to allow the parties to reach a widespread settlement. It worked.
ETHICS. Despite viewing the settlement mostly as good news for the participants and the litigation system, I have some concerns. Mass aggregate settlements always raise troubling ethical issues, and this one is no exception.
Here's the good news, ethically speaking. The parties seem to understand clearly that acceptance of the settlement is up to the clients, not the lawyers, and that any participating plaintiff must give informed consent after adequate disclosure. Also, the parties were wise to include a walkaway provision. The deal is conditioned upon acceptance by 85% of the plaintiffs (actually, 85% of each of a number of plaintiff groups). This provides Merck with adequate assurance of peace, while providing a safety valve so that not every plaintiff need accept the deal. As I've commented before, all-or-nothing settlements are much more troubling than those with walkaway provisions.
Now the bad news. The deal contains a term that requires each participating lawyer to recommend the settlement to 100% of the lawyer's eligible clients (paragraph 22.214.171.124 of the Settlement Agreement). That's troubling. A lawyer's duty of loyalty to each client cannot be bargained away to an adverse party. Some Vioxx plaintiffs' lawyers represent hundreds or thousands of clients, and even if the lawyer thinks the settlement's terms are generally fair, that does not necessarily mean that acceptance is the right decision for each individual client.
Worse, the deal requires that any participating lawyer withdraw from representing any client who declines the settlement (paragraph 126.96.36.199) . That's really troubling. It makes it nearly impossible for a client to say no. The paragraph tries to avoid ethical impropriety by adding "to the extent permitted by the equivalents to Rules 1.16 and 5.6 of the ABA Model Rules of Professional Conduct." Withdrawing from the representation of clients under these circumstances may well violate both RPC 1.16 and RPC 5.6, but with this term in the Settlement Agreement, it is unrealistic to expect any of the plaintiffs' lawyers to continue representing Vioxx claimants.
In a mass settlement, lawyers ideally should be able to say to their clients: "Here's the settlement we negotiated with the defendant. Here are all the terms and conditions of the deal, and here's where you fit in. I think it's a good deal, and I recommend that you accept it. But you're the client, and it's your call. And if you decide not to accept the settlement, I'll be right by your side and continue to represent you."
Compromise is one thing. The lawyer-client relationship is another. The problem, of course, is that in mass aggregate settlements, the interests of the defendant, plaintiffs' counsel, and judges align, and don't necessarily correspond with the interests of individual plaintiffs. Merck, with its $4.85 billion, expects to buy not only peace from tens of thousands of plaintiffs, but also peace from the law firms that have been the biggest thorns in its side. The challenge, which the Vioxx settlement only partly surmounts, is to craft a settlement that accommodates the interests of the parties without unduly interfering with the lawyer's core duty of loyalty.
It will be interesting to see if 85% of the vioxx plaintiffs go for the offer. It will also be interesting to see a breakdown of injury groups according to severity. Merck had the luxury of picking and choosing the cases they wanted to go up against in court. They still lost 33% of those cases. The drug company knows that thousands of cases exist that they do not want to go up against in court. I certanily hope the lawyers for these people do not expect their clients to be happy and content with a low settlement offer. A $120,000.00 settlement offer for an injury caused by Vioxx is not a good plaintiff settlement. Double or triple that offer and it still only good (for the drug company). The bottom line is that a 4.85 Billion dollar settlement is way too small. Vioxx plaintiffs have some serious thinking to do before Jan, 15th.
Posted by: ransbiker | Dec 11, 2007 11:07:06 PM
do not settle . lets take merck to court .lets push for criminal charges against merck and raymond gilmartin. they have sent ceo's to jail for taking money from investors surely taking a life is worse. call henry waxmans office he likes a good fight and he already know how merck works. since were not going to have anyting after the lawyer,doctor,insurance co,medicare etc. i say screw merck will see who caves first.i,ve looked everywhere to see if ceo gilmartin had to testify or answer questions ,about what he did or did not do. how can that be it all started with him.
Posted by: j haydue | Dec 13, 2007 8:36:54 PM
If I took a $100,000.00 settlement it would break down as follows since there was not a provision for medical damages:
8%...imposed attorney fee
50%..attorney fee and expenses (average)
50%..federal and state taxes to prevent under payment
Loss of SSDI Benifits.
Reimbursement of medical and hospital care
Reimbursement for insurance and loss of.
If I sign the agreement, I would start out in the hole, the only winners in this case, are the lawyers.
Posted by: Mays | Jan 19, 2008 12:31:07 AM
In Shanks vs. Wal-Mart, Mrs shanks had an accident in which her settlement was around $700,000.00 and after her attorney fee and expenses around 417,000.00 was deposited into a trust for furture expenses. You may find this on the web.
Wal-Mart had a Subrogation Clause in her insurance policy and Wal-Mart was able to claim Ms. Shanks $417,000.00.
In the Vioxx (Merck) needs to file a motion with the settlement team placing a Medical Damage Clause in the settlement agreement along with a motion that no one insurance company, state or federal govt. or any agency can not recover settlement fees since they are not a party of such suit and the Statute of Limitations have expire.
It is my understanding that some attornys are saying with a Sch. A, 1040 that you can itemize, but where the problem lies in having to claim the whole settlement as gross income is with the ATM Tax in which you can not deduct expenses.
Forcing these companies and govt. agencies into a suit is more settlement income for the lawyers in which I have nothing against as long as the parties come out fair in the settlement.
In my case if I sign the agreement I would lose around $36,000.00, my insurance, my home and benifits in which I could do w/o the help of an attorney and handing over a $50,000 fee if I wanted to go down that road and live on the streets.
Merck and the lawyers for both parties have a chance to save face and do what is right.
Trail Lawyers need to seek a change in Tort Law.
You lawyers, I am sick, I have a low I.Q. (stroke) but I know when something smells like a skunk, looks like a skunk and acts like a skunk, 99% of the time it is a skunk.
I also know we need a reform.
Posted by: Mays | Jan 27, 2008 11:57:35 AM
Vioxx did raise significant problems of latent disease. People that had a heart attack or stroke are continuing to have heart attacks and strokes. The settlement pays for 1 and only 1 event. DON'T SIGN away your rights to justice.
Posted by: Jockey Lady | Feb 7, 2008 6:00:23 PM
It is sad that it took so many years to learn the risks associated with Mesothelioma and its even more alarming how long a patient can go undetected.
Posted by: David Kitwell | Dec 19, 2008 12:13:11 PM
My husband took vioxx for over two years. The va quite sending rx in March, but doctor gave samples until sept then wrote an rx. The heart attack was in July and my husband will get nothing because the doctor signed an affidavit she likely gave sample, but did not document. It would be stupid for someone to think he took for years had a heart attack waited two months and then took again. Where is the justice.
Posted by: Bill | Jan 19, 2009 5:46:37 PM
1. Did the Vioxx trials include periodical urine analyses for toxin build up? It would seem logical to check for this bio marker but I haven't found any evidence that this was done after about 1993. Why wasn't Merck's hand held to the fire on this research design issue?
2. The Settlement has several flaws. One that is incomprehensible is in 10th grade probability mathematics. It results in a serious miscalculation of offsetting plaintiff risk factors and in computing second phase compensation that could be as high as $600,000, but that few will qualify for due to strangulating stipulations: E.g., it requires a min. loss of $250, 000 over about 48 months but with the following offsets: SS income; LTD insurance income; any other part-time hold-yourself-together-income; no consideration for loss of pension and pension income that is ongoing; and, a further offset for risk factors based upon the prior miscalculations. (These may be unintended consequence, but they come down very hard on responsible people.)
3. As a person who accepted this settlement I had little thought that there should be a consideration for surrendering damages for very likely latent effects such as further increased risk of a second and future Heart/Stroke attacks, and no idea about Bone issues that could have residual effects for up to 10 years.
4. Why was there no additional compensation consideration to persons who were a given VIoxx post heart attack and surgery? I was a zombie for over 2 ½ years. Current Celebrex ads inform that there is much greater risk post CV events, where was this information before?
5. Why are the plaintiffs paying compensation to the Health Insurance carriers? I owe Blue Cross over $41,000.
6. And, yes, I was one of those people who signed for the settlement because if I had not I would have had to engage new lawyers, new costs, and potentially deadly stress...I had no idea how extensively one is disabled when heart muscle is damaged
Posted by: Anthony Manzo, Ph.D. | Mar 13, 2009 4:51:57 PM
I know a person whom claimed to have had a heart attack from the use of vioxx. Never happened..Is recieving compesation checks from settlement..How does this happen
Posted by: Sildenafil 100mg | Jun 5, 2012 6:20:46 AM
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".....
Posted by: Dennis Harrison | Nov 14, 2007 8:50:38 AM