Posted On: November 21, 2007 by

Columnist Who Criticizes Personal Injury Attorneys and the Justice System Fails To See the Big Picture

In his Nov. 17 “Talking Business” Column, New York Times columnist Joe Nocera meted out a scathing criticism of personal injury attorneys who represent about 27,000 victims of the defective drug, Vioxx, manufactured and aggressively marketed by pharmaceutical giant, Merck, a few years ago. I am one of those attorneys he criticized.

Nocera’s problem is not only with plaintiffs' attorneys but with the justice system. His column is titled “Forget Fair; It’s Litigation as Usual.” Nocera asks this question: “Is a mass tort really the right mechanism to settle disputes about product safety, or to punish corporate wrongdoing?”

His answer, if you can guess from that sarcastic headline, is a resounding “no.” Nocera argues that product liability lawsuits make personal injury lawyers rich and leaves the people who were really affected with very little. He calls it an “unfair” system and a “rogue form of regulation.”

Well, Mr. Nocera, when the Food and Drug Administration doesn’t do its job and greedy corporate giants in the pharmaceutical and auto industry flood the market with defective products, who else is there to “regulate”?

The plaintiff's attorneys of America make it their business to go after wrongdoers and hold them accountable. Mr. Nocera, how would you suggest holding Merck and other corporate giants liable when they have injured the public? Your article didn't have an answer, it only complained about the only effective process we currently have in this country -- a process that works.

There is no doubt that when studying the minute details of each individual case, there are plaintiffs who should be compensated and are not, and there are plaintiffs who are awarded more than maybe they individually should get (even though they rarely ever get what a jury awarded due to the “appeals” process). If Mr. Nocera would put his microscope on litigation in general, business litigation, family law cases, criminal prosecutions and so on, he will find the same thing, each individual case does not necessarily dole out perfect “justice” to the litigants. There are winners and losers.

That said, did Mr. Nocera give us the big picture? Did he mention that Merck's stock went up in value multiple times the amount of the settlement after the settlement was announced? What a windfall for Merck and its stock holders. They made billions by settling the case of their own wrongdoing, did Mr. Nocera mention that?

Did he mention how much money Merck’s attorneys have made on this litigation? It’s a lot more than the plaintiff’s attorneys have made. Merck’s attorneys got their money at the end of each month, had all their expenses paid as incurred and had nothing at risk, ever. The plaintiffs’ attorneys will be lucky to see a cent a year from now for a battle we have been waging for over two years. The plaintiffs’ attorneys have risked millions. Our firm alone has hundreds of thousands into our cases.

However, what our system does do is provide every individual, business entity and corporation in America a relatively even playing field (although some participants can afford more and better lawyers, experts and support troops) to have their disputes resolved. This playing field is what we call our “justice system.” It does not produce pure or perfect “justice” (whatever that might be) in each individual case. It is a system to produce justice in general, and it works better than any other system employed in our world today. What comes out of this “system” is that we define as “justice.”

Merck played the litigation game very well. Its army of attorneys won 10 out of the first 15 cases. Its army of attorneys were initially better equipped and financed to take on the attorneys representing the people harmed by Vioxx who were out gunned and out financed by one of the world's richest corporations.

But the little guys didn't give up. They banned together. They combined resources to gain the strength to take on one of the world’s most powerful multi-national corporations.

So, armed with their 10 wins in 15 cases, Merck worked out a settlement with the little guys that would compensate the victims and dramatically raise the price of Merck’s stock. So our “justice system” worked. It compelled the litigation participants to settle the matter themselves, rather than leave it to our “system” to do it for them, which is the design of our system and it work. It works every day.

The vast majority of the legal disputes in this country are settled without a trial because we have a system, that isn’t perfect, that will resolve the dispute for the litigants if they cannot do it themselves. And that system doesn't necessarily get it right in each individual case.

Comments

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

Sources for the following quotes are towards the end of this writing:

... Cox-2 inhibitors effect fracture healing and spine fusion… should never be used in spinal fusion…
... impair fracture healing… 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…
... It could affect the billions of dollars in sales of the COX-2 inhibitors if people knew they…
…cox-2, which causes pain and inflammation, also appears to play a crucial role in bone healing…
..."a prudent approach" is to temporarily quit using either NSAIDS, Vioxx or Celebrex if you break a bone…
... calls for targeted research on broken-bone sufferers…

While the emphasis has been on heart and stoke (alleged) issues; one may be quite surprised that there is, as researched and (allegedly) experienced by this writer, bone and spine healing issues that have not (allegedly) been addressed by Merck. It is NOT a small issue, and potentially impacts tens of thousands of people who, even today, don’t know why their spine operation did not heal correctly, or why after many months a leg would not heal. This writer feels very strongly that Merck (allegedly) knew, or should have known, that there were bone and spine healing issues which should have been addressed. If you are interested in some related, and in general consistent enough to be compelling enough to scream a warning, do some Google searches on the following:

vioxx bone spine healing
cox-2 bone spine healing
fracture bone spine healing Vioxx

and remember this:

1 – there are over 1 million fractures per year requiring hospitalization (United States Bone and Joint Decade, NFP
6300 N. River Road, Rosemont, IL 60018).

2 – with the sales of Vioxx having been so high (approximately 20 million users), it is not hard to interpolate tens of thousands of individuals have been severely impacted by Vioxx – and they don’t even know how it might (allegedly) have happened! Furthermore, consider that 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). These “newer” Cox-2 inhibitors are likely to attempt approval again as the Vioxx settlement works its way through..

Bone and Spine healing (alleged) problems with Vioxx – time for Round 2?

Just one Independent Research (IR) snippet - more follow: there are hundreds representing many studies PLUS a quite logical analysis (also called the Science of Vioxx) of the bone/spine healing process by so many well respected surgeons (who also do research) and professional researchers, etc. This writer just cannot understand how Merck could (allegedly) just blithely ignore the (alleged) issues without even formally establishing a position on them or doing their own research. After all, Merck, with all of its development on arthtiris and bone medications (Vioxx, Arcoxcia, Fosamax) should be considered – one would think – subject matter experts on the bone and spine healing and regeneration process. 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.

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;

I maintain that the responsible action would have been to announce the (alleged) bone/spine concerns when Vioxx was taken off of 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.

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 neglect and 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) been successful in the past of (allegedly) concealing the issue.

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 do original DISCOVERY and conduct a jury trial. 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, at least a solid, and sxxxxxx preliminary investigation to understand the issue(s) and the potential number of impacted individuals. In this case (vs the heart) the causation issues would seem a bit more direct to understand and prove on a case by case basis. And while they are at it, perhaps it is appropriate for a 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 and their (alleged) bone/spine healing problems.

…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 with….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 on the pros and cons ourselves. Pathetic, on our backs (and the heart victims) we carried the weight of Merck’s (alleged) ill-gotten gains. 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…
You may or not know it, but there are also emerging (alleged) issues and litigation with bio-phosphates, such as FOSAMAX and how it impacts the natural, healthy process of bone regeneration. The process of bone/spine healing, as well as natural, healthy bone regeneration is not hard to understand. It has already been alleged, and there are active lawsuits, that FOSAMAX can prevent the jaw from healing after a tooth extraction (bone dies - the issue is called “Dead Jaw”). This should cause one to ask this question - what about FOSAMAX's relation to other bones? 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?

Take the time to understand the process and I believe that you would shutter at taking a Cox-2 inhibitor (not only Vioxx – but how about Celebrex and the other “proposed” Cox-2 inhibitors) and something like FOSAMAX concurrently – especially since FOSAMAX can stay in the bones for about 10 years!

This is (potentially) 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, any degree of reasonableness and safety concerns would cry out for post-marketing monitoring. My gosh, it is only common sense and what you would expect of “world class” organizations!

VIOXX, and all COX-2 inhibitor drugs, work by inhibiting the body's natural response to inflammation and bone repair. FOSAMAX works by interfering with the natural, healthy process of bone regeneration. Doesn’t that sound like a potentially dangerous combination? It begs other questions. (1) What might be the impact of FOSAMAX (also produced by Merck!) on bone healing and what about the concurrent use of VIOXX 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?

And remember when you see a person, deformed and suffering (allegedly) 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
Pro Se – Bone/Spine healing
Harrison v Merck & Co, Inc. case, Civil Action No. 07-905

I'd like to add this to the last post:

Some mention, vehemently, that R&D investments could have been made instead of compensating the claimants. Obviously, 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?

Dennis Harrison
Pro Se – Bone/Spine healing
Harrison v Merck & Co, Inc. Civil Action 07-905
Cementon, NY 12414


No one talks enough about what our system does to ensure patient safety. Drug companies are running amok with the threat of litigation handing over their heads. What would they be doing if the FDA was dispensed justice?

It is also worth noting that the weakness of the Vioxx cases from the plaintiffs' perspective was not the question of whether Merck was negligent. Instead, it was one of causation. Winning 10 our of 15 proved nothing in terms of whether Merck was negligent.

Ron Miller
www.marylandinjurylawyerblog.com

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