Vioxx settlement: February 8 update

by Ted Frank on February 8, 2008

(Updating and bumping Feb. 4 post about to roll off bottom of page because of new comment activity)

  • Judge Fallon denied the motion of Florida plaintiffs to expedite a hearing on their inclusion into a settlement when they did not even bring suit (Jan. 30). Merck and the PSC are required to respond Feb. 15, and the hearing will be Feb. 21, where one can expect the motion to be denied.
  • At Point of Law, I comment on the recent grand jury investigation into Merck marketing of Vioxx.
  • Update, Feb. 8: separately, Merck yesterday settles for $650 million different Medicaid fraud allegations over the marketing of Vioxx and other drugs. The qui tam relator will get a jackpot award of $68 million. [WaPo; DOJ; Merck] The pricing theories at the center of these lawsuits—which hold Merck liable for purportedly charging too little—definitely deserve longer discussion another time.

  • The Manhattan Institute’s Marie Gryphon has a well-written and interesting piece in City Journal on the Vioxx settlement. (Unnecessary disclosure: I am friends with Ms. Gryphon, and critiqued an early draft of her article. Also, she didn’t show up for my Super Bowl party, despite a positive response to the Evite.) Ms. Gryphon’s argument suffers, however, from a major error in the premise: she values the fourteen tried cases at $7 million each. This is a gross overestimate. First, the correct denominator is not fourteen cases, because many more cases than fourteen were scheduled for trial. Plaintiffs dismissed another fourteen cases that were scheduled rather than try them; the fourteen cases that reached verdict (of which Merck won ten) include the stronger cases plaintiffs brought (though they also include some weak cases that Merck nominated for scheduling first). So cut the $7 million figure in half. Second, Gryphon’s figures assume that all cases will be affirmed on appeal. That’s not so. The two Texas verdicts and the New Jersey punitive damages verdict in McDarby all contradict the Supreme Court’s decision in Buckman v. Plaintiffs’ Legal Committee and, unless there is a severe surprise in the Warner-Lambert v. Kent argument later this month (for which, see Beck/Herrmann), those cases will be reversed as a matter of law. (Merck has other excellent arguments for reversal that should knock out the Humeston verdict entirely and could well knock out all or most of the McDarby verdict.) Plus there is some chance that the Wyeth v. Levine appeal to be heard in the Supreme Court early next term would preempt all failure-to-warn litigation nationwide. So the $3.5 million/case figure needs to be discounted still further, perhaps as much as 95-99%. Add in present-value calculations, and the Vioxx settlement actually provides more for plaintiffs than they could expect to obtain in trial. (Notwithstanding the availability of judicial hellholes through forum shopping, plaintiffs have yet to win a case in Madison County, and such cases would still be subject to review in the Illinois Supreme Court down the road.) Gryphon’s argument that the attorneys are selling out their clients depends on the premise that the Plaintiffs’ Steering Committee actually believes their cases are worth millions each, yet is agreeing to settle for nuisance value rather than hold out for more money by continuing to litigate to put more pressure on Merck. What is the PSC’s economic incentive to leave billions of dollars on the table? It is not risk aversion: the PSC has a diversified inventory of cases and plenty of financing available to it, and the PSC as a group should be considerably more risk-neutral than their individual clients. It is no longer the case, if it ever was, that a mass-tort defendant can hope to win a litigation through attrition: lengthy litigation hurts a defendant’s access to capital markets far more than the organized mass-tort trial bar’s access to capital. If trial lawyers end up deciding to agree to settle their cases for nuisance value, it is because they recognize that the settlement fairly values the cases at nuisance value. One can certainly argue that the plaintiffs’ attorneys are acting unethically, but the ethical problem comes from the original decision to bring thousands of meritless cases in the first place. (That said, I certainly agree with Gryphon that a loser-pays rule would better structure incentives. In that alternative universe, however, there would not have been 60,000 cases brought, and Merck could have plausibly chosen to defend itself rather than settle.)

Previous update: Jan. 17.

{ 32 comments }

1 anonymous 02.05.08 at 12:38 pm

I wish to know how Judge Fallon can rule on Motions filed regarding the Settlement in the Vioxx litigation? Isn’t there a conflict of interest? He is wearing 2 hats and not doing well with either.

2 Ted 02.05.08 at 2:27 pm

I don’t see a 28 U.S.C. § 455 problem because Judge Fallon is not being paid to administer the settlement. (The fact that he is willing to administer the settlement means that plaintiffs will get money that otherwise would have gone to a third-party administrator.) Administering a settlement would seem to be within the power of the All Writs Act, 28 U.S.C. § 1651, though I haven’t looked at the Article III question of a federal judge ruling on a settlement of a case without diversity jurisdiction when there is no certified class. Can you be more specific about what you’re complaining about?

3 Dennis Harrison 02.07.08 at 10:34 pm

Overlaywered and Pointoflaw is just so full of themselves; your attempts at perverted, corrupted TORT reform are a sham.

Not many argue the need for reasonable TORT reform – but you do it with a butcher knife and take not prisoners, and let the blood flow. You do not do it in a rational, methodical, thoughtful way that protects the rights of all of us, including each of you! You want to make it easy for an administrator to serve the interests of attorneys, corporations, and federal agencies – making them all robot paper-pushers.

Your reasons and motivations are very well know. Why not at least, somewhat, think – there but for the Grace of GOD go I!

The best put I have seen in one paragraph:

xxxxxx wants to blame the whole deal on all the plaintiff’s lawyers not Merck or the PSC appointed by Judge Fallon. xxxxxx wants to do away with the whole system of tort compensation—xxxxxx thinks it is a bogus lottery. xxxxxx wants corporations to be immune and only accountable to fed agencies. xxxxxxs method is to make the system seem ridiculous. While the system is tough to bear at times—its the only one we have and xxxx like xxxxxxFrank are all about might makes right….

badbonehealing@hvc.rr.com

Dennis Harrison – M.B.A. Beta Gamma Sigma

Pro Se – Bone/Spine healing

Harrison v Merck & Co, Inc. case, Civil Action No. 07-905

4 Plaintiff 02.07.08 at 10:53 pm

Complaining about Judge Fallon being a judicial judge and also working for Merck, administrative law jusge. Seems like a conflict of interest to me. As has been said before The Settlement is for the lawyers and Merck and leaves the plaintiffs out in the cold. The real victims who have to take lots of costly meds just to stay alive. That is the victims that Merck didn;t kill with their poison.

5 Ted 02.08.08 at 7:28 am

10:53, your premise is incorrect; Fallon doesn’t work for Merck.

The settlement provides about $3 billion to plaintiffs who would get zero if they tried their cases in court.

I don’t know who “xxxxx” is, but there is no one on this blog who wants to “do away with the whole system of tort compensation.” We just distinguish between meritorious cases and cases where plaintiffs, egged on by trial lawyers, go after deep pockets who have no legitimate culpability.

It is the plaintiffs’ bar who believes “might makes right”: they extorted Merck into a $5 billion settlement despite the fact that Merck did not violate the law. Or see the case of Dickie Scruggs and Jim Hood, as explicit an example of the trial bar’s “might makes right” philosophy as any. Another example of the “might makes right” principle comes when you try to bury comments sections in insults rather than addressing the merits of the arguments of people you disagree with.

Mr. Harrison, thanks for providing your case number. I looked up your docket: you’re not even eligible for the Vioxx settlement because you did not suffer a stroke or MI. You’re pro se, so you don’t even have a lawyer who is threatening to cease to represent you. The settlement doesn’t affect your case one bit. (Indeed, your case will be dismissed when you fail to meet a May 1 deadline for submitting a Daubert-compliant expert report, since no legitimate scientist is going to blame Vioxx for the injuries caused by your preexisting genetic condition, which probably explains why you are proceeding pro se.) Why does a post about a completely different litigation bother you so?

6 Dennis Harrison 02.08.08 at 10:30 am

Ted – thank you very much for entering my POST. I will answer your questions:
1 – While you indicate that you may not want to completely gut the whole tort compensation system, there are many others – including Legal Scholars, many lawyers, and many other who feel a bit otherwise.
2 – PTO 28 appeal (to the 5th ckt court), among other things – these are my words, not quotes – I can do so later – also clearly points out that the healthy adversarial relationships, needed for justice, is threatened by this private “settlement” – to be replaced with amicable relationships between attorneys of both sides, and using the courts effectively as an “administrator”. This is where everything is headed, and why shouldn’t I care about VPEG and MI/stroke victims rights being taken away from them – my rights and my children will suffer in the same way. Why shouldn’t I be involved in understanding this and working to fend it off? More on why MI/stroke and VPEG later.
3 – In no way, could I, and so many others consider the VIOXX case “meritorious”. Merck has been having problems with many “products” – do I have to list them all? Merck’s apparent strategy (allegedly) is to use major short term profits to fund long term defense, and repeat the cycle. Along the way, Merck is looking for an even better way to provide a pittance to the victims left in its wake of an (alleged) neglectful development environment, (alleged) and fraudulent and deceitful marketing. That way, they would be able to reap in “ill gotten” gains of a much higher amount. There is much to come out into the light, if the TRIAL PACKAGE was not guarded so heavily.
4 – An MI/Stroke, caused by Merck, and there is so much evidence of the risk factor being unduly and greatly increased – causes major medical expenses, and besides all the problems at the time, impacts one for life (I know, Merck kind of just blows away the life problems and insists “just one heart attack allowed per victim (my words)”. So, let’s say one receives $300,000; ok – take away 1/3 off the top for legal expenses in this so called “settlement”, that leaves $200,000 (doesn’t sound like as much, does it?); ok, then again – Merck places the burden of subrogation on the litigant, and for the medical problems Merck caused – my gosh – here goes another $100,000. This leaves $100,000 – my gosh – for the sake of humanity – TED, do you really, really think that is adequate compensation for the Merck victims? Remember there are other victims in the wake of the either permanently damaged or deceased; the spouses and children in particular, among others. $100,000 – what was the PSC thinking? How can this truly be considered a fair “negotiation”, and how can this be considered legally representing Vioxx victims.
If you feel $5B is “extorted” – then ask yourself this. Why, and how could it possibly be, that the financial analysts and market, besides the media, have nothing but applauded Merck for the great “deal” that they did. This is distinguishable from what one would expect a positive reaction to ending a lawsuit would be. It It is a blatant statement that Merck got the upper hand, and by leaps and bounds, and is getting away with “murder”. And, by the way, financial analysis by several more than capable individuals indicate that Merck could have been much more fair in their awards, let alone fairness in the confusing, complexities, and unreasonable binding agreements that Merck seeks to place on confused litigants, and lawyers, on a very short time frame (seems like a good reason for, after all of this time, rushing this private “settlement” through). It has become ever clear that the litigants take real exception to all this hoopla, and it does nothing but add to what they are figuring out – this is a pittance – and a crying shame.
5 – You are aware of the VPEG group, I know that. You are aware of the lawyer group associated with that – you may wish to request the lawyer group. Perhaps you can join, as it is increasingly become more understandable that “light is the best disinfectant”. Perhaps, you and other lawyers can have conversations of the pros and cons of this. It is not my choice, but now I do support you being part of the “lawyer group”, however being a member of the Plaintiff Group (VPEG) just doesn’t make any sense.
6 – In the VPEG group, after reading so, so many blogs and having so many communications – it is just plainly apparent that this whole “settlement” is a rush “deal” so that before the litigants, and even their lawyers (those that want to do the right thing), are being rushed into making major decisions with confusing, complex, and decisions in the proposal extremely tilted towards Merck’s benefit. The “settlement” encourages the large firms to treat their cases as mere commodities – like a basket of wheat futures, etc. The pittances, multiplied many times over come to a great deal. Merck has slickly created this situation, as legal firms waited for the TRIAL PACKAGE and remands back to the states. The ridiculous form letter, that virtually all litigants have received is a pointless, vane, attempt at pretending to the litigants that their cases are being legally represented, and that their real, legal “interests” are being considered – which in most cases they are obvious not. Imagine, almost exclusively, attorney after attorney, being browbeaten into this “settlement” just merely passes along a mere form letter and effectively says take it or leave it – and I can see the cold, calculate timing of the settlement due dates, being a major contributor here. It has become increasingly, and very much so, obvious that the attorney-client relationship has just been corrupted by this “settlement” – a poll of how “satisfied” the average litigant was with their legal representation would certainly shed light on this – especially after they receive their net pittance.
7 – No, you are quite mistaken about why it has not been easy to gain representation. Fact is, several lawyers said that I have a very good case, but that they don’t have the resources (estimating $200,000 was average) to go against those “big, bad lawyer at Merck” – and they knew that Merck was only admitting to MI/stroke and furthermore that the MDL would do the “heavy lifting, financing, and risk taking’ associated with DISCOVERY of Merck’s (alleged) guilt. FACT is that my pre-existing condition has nothing to do with the bone and spine healing problems with VIOXX – of which so, so much Independent Research, and my own personal evidence supports – in ways that you don’t have a clue, and which are substantial. Merck, with the overwhelming and building evidence of bone and spine healing problems, just turned a deft ear, let the statute of limitations run out (which needs to be reversed by the courts as the evidence keeps mounting). In fact, a surgeon, well known for cox-2 inhibitor studies – and paid by Merck – indicated that “the evidence is compelling” and “it is time to tell the public”. Merck just ignored the surgeon and one can read between recent lines that the surgeon was also browbeaten by Merck. And, it goes on, and on….To make matters worse, FOSAMAX adds more problems with bones and is what I call (alleged) the VOODOO medicine of bone and spine medications by Merck. – and that is becoming increasingly known. Merck (allegedly) just didn’t care past the short term, they just wanted to get their cost/benefit in line which obviously indicated that a parameter, needed for a great “investment” was NOT to warn physicians, surgeons, nor consumers – and I have much on this also.
After much research, discussion, and plain analysis – it was so plain to see why bone and spine cases would not be taken by attorneys. I have personally presented the reasons why to the PSC, Merck (DSC) and Judge Fallon, and it is on the record. While set up with good intentions and spirit, the MDL process does have some major flaws – which could be rectified, instead of starting the dangerous road of private deals. One of the flaws is that the process, attempting to streamline for cost savings and more consistent rulings – does the whole DISCOVERY (except causation). Thus, lawyers can take the templated lawsuit, fill in the blanks, submit it, and let the MDL do the most expensive part – DISCOVERY.
The cases were SUPPOSED to be remanded back to the states of which they came from. The lawyers were supposed to have the TRIAL PACKAGE so that they could use that and supplement their cases with causation arguments. That is what the MDL was chartered to do – I don’t believe the MDL charter was to create a private “settlement” (though encouraging legal settlements, in which the litigants are really legally represented, is something that all courts encourage – but I can hardly find a way to rationalize this private “settlement” as falling in that category.
In fact, many lawyers, those that really want to provide real legal counsel, have been requesting remands for quite a while. They have been told it is in their best intersests to wait for the TRIAL PACKAGE. Unfortunately, the much guarded and vaulted TRIAL PACKAGE, which I believe likely did a great job on (that was the PSC charter!) is not seeing the day of light.
Oh, and I almost forgot: 15+ cases is statistically laughable. Nothing, but nothing, can be validly interpolated from those cases. Perhaps, much good work could have been done by the PSC if they had hired a professional negotiator(s) and even a statistician(s). The PSC was there for DISCOVERY, and should not have been in the business of negotiating a private “deal” with Merck legal, and business people – who quite frankly – just outwitted the PSC. Only freeing the TRIAL PACKAGE, and having the (about 300) cases in 2008 remanded back to the courts (and why not all cases?) could any reasonable statistical interpolation be the case. And that would be necessary for real, legal, negotiations on the part of VIOXX victims.
8 – In re to the Daubert “issue” – I wouldn’t make any determinations at this point if I were you on my success here. You seem to have some glee and hope that my case is dismissed, but not so fast….
9 – In re to “Why does a post about a completely different litigation bother you so?” First, one does not learn in a vacuum. I have known, for a while that there are synergies between MI/stroke and bone/spine of which I won’t discuss here, and to a greater degree than you would be able to know. I have been very upfront with VPEG in helping them understand how I may help them, how they may help bone/spine (and by the way, there are VPEG members with the same issue) and the synergies I refer to. I have worked diligently to help them understand why I thought this private “deal” is being attempted, and the timing of it (though we all recognize and would never attempt to provide legal advice…). Besides, history and cycles repeat itself. After Merck decimates the MI/stroke victims – they then look to decimate (I also call it “slaughtering the sheep (e.g. the “settlement” encourages mass slaughtering of individuals herded like sheep to be slaughtered). The PSC could very well have found these synergies, perhaps if they had not been so pre-occupied with the only problems of VIOXX which Merck mentioned when it withdrew VIOXX – and as Merck so (allegedly) skillfully avoided making the public aware of. I have credible estimates of up to 40,000+ individuals damaged by the (alleged) bone and spine healing problems of VIOXX.
Lastly, I can give VPEG nothing but credit. They have bootstrapped themselves up by their own two feet, and have tried to learn, inform, educate – never offering legal advice as many issues that they can, before making the decision of their lives. They have done so because, let’s estimate here. about 95% of their attorneys are passing on the form letter, not providing proper legal counsel. One would have to feel that many of these lawyers are as confused about this complex mess of a private deal and, by it being rushed through – even many of them don’t have a clue. VPEG is not the radicals – the private settlement – and the first step an dangerous “private deals” is.

Dennis Harrison

7 plaintiff 02.08.08 at 11:05 am

Did you read the papers this morning? It appears just about everyone works for big Pharma. Doctors, lawyers and such. Yes it is a one sided Settlement and the whole world is watching. George Cohen has it right it is not legal an unethical. Even though Judge Fallon changed the wording the amendement didn’t change anythings.

8 Ted 02.08.08 at 11:07 am

Point by point:

1) Again, I am not aware of anyone who wishes to entirely abolish the tort system. You’re raging against a straw man.

2) I’ve discussed why the PTO 28 appeal is not going anywhere in detail at Point of Law.

3) The plaintiffs’ lawyers in the Vioxx cases have effectively admitted that these cases are not meritorious.

4) Again, you are confusing compensation with liability. If Merck were liable, $100,000 would often not be adequate compensation for a heart attack of a healthy person. But this is a settlement, not a verdict. Merck isn’t liable, but is settling to avoid further legal expense, because of the imbalance in the legal system that permits attorneys to bring meritless cases without consequence. Financial analysts are applauding Merck for the deal because the deal resolves legal uncertainty, because Merck very easily could have panicked and settled much earlier in the litigation (which would have cost Merck much more money) and because previous settlements did not have the protections that this settlement has against multi-billion-dollar fraud. (Also, I regularly consult with stock market analysts. It is stunning how little most of them know about the legal system.) It doesn’t change the fact of extortion. Again, you haven’t answered the fundamental question: if the plaintiffs’ lawyers could win tens of billions of dollars in court, why would they leave that money on the table? These are the same people who negotiated other multi-billion dollar mass-tort settlements and made themselves rich in asbestos and tobacco litigation. Suddenly they’re helpless in the face of Merck?

5) I offered to join and have these conversations there, and my application was rejected. I understand that people only want to hear other people who agree with them, and that their arguments are so weak that they are afraid of seeing counterarguments. VPEG is heavily advertising on Google and spamming on blogs, yet it has only a handful of members reflecting less than a percent of plaintiffs, and, as best I can tell, not a single lawyer supporting them. And no telling how many of those VPEG members are plaintiffs like you who aren’t even eligible for the settlement.

6) The trial package can only organize evidence, not create new evidence. As I’ve previously discussed, there is no magic bullet in the trial package, which will be released eventually anyway. It has nothing to do with the settlement.

7) As I mentioned in the post above, there were 29 cases, not fifteen. Plaintiffs won five, and all of those are going to be reversed, and the trial bar knows it. The fact that the plaintiffs’ bar hasn’t been able to win a single case without committing reversible legal error is a fairly accurate signal. They’re settling now because they’ll be in a weaker position after Warner-Lambert v. Kent gets decided, and don’t want to waste another $60 million trying cases that aren’t going to change that fact.

7-9) There are many many wealthy trial lawyers out there. You really expect me to believe that no one is willing to invest $200,000 in a case worth (as you claim) $1.5 million? (And multiply by another 40,000 cases, as you claim, and you get $60 billion–but no lawyer wants to invest $200,000 in that windfall.) Lawyers can say lots of things, but what really speaks is when they put their money where their mouth is, and the fact that no one is even so much as willing to file a complaint on your behalf is quite telling.

I’m not the one you have to persuade that your case has merit. Who is your Rule 26(a)(2) expert? Without one by May 1, your case is getting dismissed. Your lobbying against a settlement that has nothing to do with you seems to be designed to drag other Vioxx plaintiffs (who can at least collect settlement money if they’re not foolish enough to reject the settlement) down with you.

9 Dennis Harriosn 02.09.08 at 3:14 am

1 – I’m not raging – I view it as the truth. I’m merely being firm about what I believe.

[2900 largely repetitive words deleted; the three-word executive summary is "No, it's not." I've offered Mr. Harrison the opportunity to resubmit his comment without dominating the comment section, but, given that I have already printed 2300 words from him to respond to a 740-word post and a 240-word comment, I'm not willing to give him yet another 2900 words to "respond" to my 650-word rebuttal when Mr. Harrison exhibits fundamental misunderstandings about the way the legal system works, largely ignores the arguments I make, and has not cited a single piece of legal precedent. Mr. Harrison is welcome to print his full speech on his own website, which has not let me post a single comment. But, unlike Mr. Harrison's website, the Overlawyered comment section is for dialogue, not monologue. – TF]

10 Melvin 02.09.08 at 4:43 am

Ted–Mr. Harrison makes me wonder what HE would say if, for example, a group of people whom Vioxx was definitely helping at the time it was withdrawn from the market (without the “supposed” problems that Mr. Harrison mentions with little or no proof) would/should sue HIM for HIS money [if any] from the Vioxx settlement, for ruining their quality of life.

Or, would Mr. Harrison return “his” money if it was proven that none of the “40,000+” bone/spine healing problems, were caused by Vioxx in the first place? Does he think how many people (admittedly, if any) might be put out of work by lawsuits like his which should be thrown out ASAP due to no standing?

NOT!

11 plaintiff 02.09.08 at 10:04 am

Vioxx is and was poison when Merck was selling it. They had studies and knew it and sold it. People were lied to in a way to make them think this was good medicine. Many higher ups knew about this deceit and did nothing. Now we are suffering. Many who took vioxx are in poverty from loss of jobs and can”t afford the costly meds it takes to stay alive. And these people are the lucky ones. Many are dead because of this drug and how it was sold.

12 Ted 02.09.08 at 10:15 am

Note that “plaintiff” left a different user name for his 10:04 comment to falsely imply that there were lots of different people leaving comments attacking Merck instead of just one or two. I’ve changed it back to “plaintiff.” Pick a username and stick to it instead of using sock puppets, please.

10:04′s account of the history of Vioxx sales suffers from not being true. Unless you think Merck had perfect foresight, they did not lie; they did not know about the increased risk (which appears to be the same mechanism as the increased risk from drugs still on the market like ibuprofen) until 2004, when they withdrew the drug from the market in the wake of the APPROVe study. And 80% of orthopedists think Vioxx should still be on the market.

10:04 needs to begin to acknowledge or address what other commenters say, or will be barred for abuse of the comment section.

13 Henry Smith 02.09.08 at 2:54 pm

Ted,

I guess t is your site and you are free to do what you want to administrate it, however, I think it is unnecessary and and somewhat unfair to unilaterally restrict/edit the bulk of any reply from a poster whom you have already chosen to engage in dialogue. I am specifically speaking of your failure to include the full text of Dennis Harrison’s last reply. Is there some software/hardware technical restriction on the length of Comments Section of your Webs Site? If not, it seems to me you have little good justification for such restriction/censorship.

[Yes: an off-topic 3000-word comment that is largely repetitive of what Dennis has already written on the same page will distract from the reading experience of site users and deter other readers from participating. It's an abusive attempt to drown out other participants and to change the subject. Dennis already has more than twice as many words as anyone else on the page, including me; I don't think I'm unreasonable in saying he doesn't get to have five times as many words, as it is not his website and he is not seeking to add any substantive comment relevant to the post. No one is stopping him from printing his Unabomber manifesto elsewhere, including his own website. It's no more censorship that I ask Dennis to adhere to some site standards than it is that I am not allowed to write or read a single word in Dennis's Yahoo group; as restrictions go, Dennis is far less restricted than I am. This is the last word on the topic: commenting here is a privilege, not a right.

Thanks for writing. -- TF]

14 Dennis Harriosn 02.09.08 at 5:00 pm

1 – I have done much more research than you know… a “straw man”? You are omnipresence and keep hammering your point to the masses – implying “they better try to put their lives back together, with such pittance to do so”.

2 – Your discussion of the PTO 28 appeal does not make your attitude about it correct. The 5th ckt makes that decision.

I hope that your brief discussion and mocking of PTO 28 does not negatively impact too many of the uninformed -. to just give in and say – YES, my gosh – I’ll just take anything… , it isn’t worth it, and I’ll just accept a much reduced standard and quality of living.

It is your dissertations and incremental peppering, not mine, that are designed to “drag down Vioxx plaintiffs with your constant war beat…

The right thing to do is get proper legal counsel, and their legal counsel should get enough time to figure the complexities, constraints, and bindings which the “settlement” strangles the average victim, and even the attorneys that want to do the right thing. Even well intentioned counsel is brow beaten, and not given enough time to do the proper legal representation that, so sadly, the Vioxx litigant then loses… look hard at the form letter – it is just chock full of fear mongering, which is almost always just passed on with a “take it or leave it attitude”.

It is a tragedy of the legal system that this is leading to thousands and thousands of Vioxx litigants not being properly legally represented…,

3 – “effectively admitted” – please provide more detail – the phrase “effectively admitted” first brings to mind things like “duped”, “tricked”, “gave up”, etc.

4 – I’m not confusing compensation with liability. I understand that Merck is doing everything it can to avoid admitting any liability so they can reduce the compensation .

5 – Your assumption that we only want the same opinion is so, so off base and plain wrong. Please now try to belong to join the LEGAL GROUP, they might be awaiting…

If VPEG numbers are not credible to you – why did you want to join when the numbers were about ½ of what they now are; and why do you want to join now? You seem to be effective using your time at cheerleading Merck – what are your motives?

6 – as a closely guarded asset (TRIAL PACKAGE), it is very likleyt there are many areas that Merck would rather not have exposed. You say it will be released anyway – well then why not now if it is so harmless? When will it be released – when the mass amount of agreements are made to the “settlement”, and it is too late for it to have an impact on the masses?

7-9: Quite frankly, whether the trial numbers are 15, 16, or 29 – all are laughable in terms of any kind of reasonable statistical relevance. 16 was quoted from the infamous, fear mongering FORM LETTER. YES – nearly 300 trials, with TRIAL PACKAGE in hand, was an MDL goal at one time.

I never said I needed, nor desired to persuade you that my case has merit. Where did you get that idea?

I have, always been right up front with VPEG. VPEG needs to be heard, they are real victims of VIOXX – shouldn’t they be heard? . The whole “settlement” is to encourage caving in from many angles… litigants and trial attorneys alike…

Dennis Harrison

15 Ted 02.09.08 at 5:54 pm

If Henry is wondering why I didn’t want to waste space on a 2900-word comment from Dennis, the similarly contentless 600-word comment (which loses nothing in the omitted 2300 words) shows why. Dennis fails to address any of the arguments in my 11:07 comment.

1) Dennis’s comment #1 purports to quote me, but I never said the words attributed to me. Perhaps Dennis is talking about something else, but his sentence is incomprehensible.

2) Yes, the Fifth Circuit will decide the PTO 28 appeal—but they will be bound by the law, and Dennis has not explained why 28 U.S.C. § 1291 will not inexorably lead to the dismissal of the appeal for lack of appellate jurisdiction, precisely as I analyzed. I posed this question weeks ago, and 6000 words later, Dennis still hasn’t answered it. Everything else is, as Shakespeare put it, sound and fury signifying nothing.

3-5) I’m interested in all information about the Vioxx litigation from all sides because it permits me to understand the most complete picture of the case. My membership application to legal group was denied again today, despite your invitation. Guess VPEG doesn’t have the courage to hear what I have to say, but if the discussion there is at the level of your blog comments, I’m not missing anything. I’ll have to make do with whatever VPEG files in court–and with less than three weeks before the critical Feb. 29 deadline VPEG has filed nothing. (VPEG didn’t even file anything in time to be put on the February 21 calendar.) My statement that VPEG has no impact is a factual observation reflecting the fact that VPEG has had no impact. (To the extent Dennis is giving its members bad advice, it may have impact for those poor souls who could be passing up free money for a mess of pottage and a frivolous lawsuit, but one hopes such people understand the principle of caveat lector.)

I call ‘em as I see ‘em, and I don’t cheerlead for Merck. I haven’t hesitated to criticize Merck when they’ve deserved it, as Dennis would know if he read my Point of Law posts on the Vioxx litigation over the last three years, or listened to the C-SPAN broadcast.

6) Dennis refuses to acknowledge we have already seen the trial package. It was created by the same attorneys who failed to develop a single winning case that can stand up on appeal, and lost 24 of the first 29 cases. Why does Dennis think that these attorneys weren’t already using the best strategy possible? I posed this question weeks ago, and 6000 words later, Dennis still hasn’t answered it.

7) Attorneys with experience do not need to see 300 trials to know how they are going to shake out. When you flip a coin 29 times, and it comes up heads 24 times, and the other five times are likely to be do-overs, you don’t need to flip that coin another 300 times to know that it’s not likely to come up tails. Both sides know the evidence that the other side is going to put on at trial, the legal arguments that are going to be made, and the likely consequences flowing from that evidence and legal arguments. Another 3 trials, or even another 300 trials, is not going to add to that information.

3, redux) Dennis still hasn’t answered the fundamental question that refutes his conspiracy theory: if the cases are worth more than $5 billion by taking them to trial, why would the PSC agree to settle for less? The question was posed weeks ago, and 6000 words later, Dennis still hasn’t answered it. The very fact of the settlement is effectively an admission that the cases are worthless if taken to trial. We wouldn’t see Florida attorneys filing emergency motions begging to be included in the settlement if settling for nuisance sums wasn’t a better deal for plaintiffs than going to trial.

In the absence of actual legal analysis, all Dennis has is fantasy.

16 Tracy 02.09.08 at 6:32 pm

Ted, love the site,and the Vioxx conversations are always “interesting” to say the least. I think Dennis makes one valid point (among many nonsensical ones). I do believe that a certain percentage of the attorneys would rather sign on to this agreement and take a guaranteed payday then the small percentage of a successful verdict. This does deprive some plaintiffs from the day in court they feel they deserve. (Im not saying that they deserve it,just that they feel like they do).

Keep up the great work.

17 Dennis Harrison 02.09.08 at 6:54 pm

Dear NOT! – sure it helped many with arthritis sufferers – yours truly also. The same reason that it was so effective is the same reason (cox-2 inhibition) that it stopped healing and repair – there is much information and Science on this, and it is accelerating – but Merck continues to turn a deft ear. However, their hand will be forced here as well.

However, as in my allegations, MERCK knew and hid this information; rather than provide proper warnings, educating physicians, surgeons, etc. – who are stunned when they somehow get a clue (but not by MERCK) that this situation existed.

I would have no problem with returning my “money” if it were proven that none of the 40,000+ bone and spine healing and repair problems were caused by VIOXX – no problem there – keep it, quote it!

Merck, so very skillfully duped physicians, surgeons, and consumers – behind their “veil of safety”, and prevented even an attempt at informed consent.

You falsely feel that my lawsuit has no standing. Let me assure you, after 1.5 years of dogged pursuit of evidence and an increasing number of very credible contacts, I know what I am saying, and it does have standing.

Dennis Harrison

18 Thorckmorton 02.10.08 at 11:37 am

Mr. Harrison, could you please post the sources you mentioned that relate to COX-2 inhibition of healing. My understanding is that that Vioxx was prescribed for the osteoarthritis which is infact the reason for the spinal problems. If indeed it is due to COX-2 inhibitions then we need to immedialy stop using all other agents that affect the same pathways.

19 Dennis Harrison 02.10.08 at 1:34 pm

Just a few, of SO many more… and I mean it when I say many more…

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…

DECEMBER 23, 2002 – BONE FRACTURES – Cox-2 Inhibitors interfere with bone growth and, healing… Researchers at Stanford Univ. University Medical Center…COX-2 inhibitors also impede the new bone growth that normally helps heal a fracture or stabilize a joint implant…

MAY 21, 2002 – JOURNAL OF BONE AND MINERAL RESEARCH – COX-2 DECREASES BONE HEALING? – mechanical testing revealed that COX-2 inhibitors…reduce bone strength…expression of COX-2 is critical for bone healing…essential for fracture healing…the inhibition of prostaglandin synthesis stops normal fracture healing.

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.

JOURNAL OF BONE MINERAL RESEARCH 1999 JUN;14(6):969-79 – initial immune response is crucial to fracture healing…

REPRINTED FROM: http://WWW.USATODAY.COM/NEWS – “It’s time to tell the public,” concludes Dr. Thomas Einhorn, Boston University’s orthopedic surgery chairman. 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.

KOMATSUBARA S ET AL. SPINE 2006; 31:E528-34. – “High-grade slippage of the lumbar spine in a rat model of spondylolisthesis: effects of cyclooxygenase-2 inhibitor on its deformity” (shows COX-2 inhibitor led to deterioration of bone healing which worsened vertebral slippage)

O’KEEFE R ET AL. ANN NY ACAD SCI 2006; 1068:532-42. – “COX-2 has a critical role during incorporation of structural bone allografts” (findings indicate that COX-2 dependent PGE2 production in the early stage of bone healing is needed for efficient skeletal repair and is essential for bone allograft incorporation; COX-2 inhibitor (Celecoxib or Ketorolac) reduced bone formation and bony ingrowths)

DALUISKI A ET AL. ORTHOPEDICS. 2006; 29:259-61. – “Cyclooxygenase-2 inhibitors in human skeletal fracture healing” (study indicates that COX-2 is naturally lower in nonunion fractures that don’t heal well, may reduce the bone-forming potential of precursor cells, and they note that limited use should be made of COX-2 inhibitors in patients with healing fractures since they need to mount an initial immune response in order to achieve fracture healing)

LI L, ET AL. CYTOKINE GROWTH FACTOR REV 2006; 17:203-16. – “Regulation of bone biology by prostaglandin endoperoxide H synthases (PGHS): a rose by any other name…” (this is a review article that includes some discussion of the importance of COX-2 (also known as PGHS-2) in bone fracture repair)

HILL K ET AL. FOOT ANKLE CLIN 2005; 10:729-42. “The role of cyclooxygenase-2 inhibition in foot and ankle arthrodesis” (this article notes that COX-2 inhibitors are valuable to help control postoperative pain but may have deleterious impacts on bone healing in patients undergoing hind foot arthrodesis)

Dennis Harrison

20 Ted 02.10.08 at 2:18 pm

Dennis is cherry-picking literature and quotes. You can do that in high-school debate, and trial lawyers are often allowed to do it at trial, but it’s not sound science.

Even as of today (much less as of when Merck sold Vioxx), the evidence is ambiguous. For example, his first link explicitly acknowledges that the alleged bone-healing problems have not been shown to be statistically significant, and doesn’t distinguish between Vioxx and NSAIDs. Other studies have said “We believe the administration of COX-2 inhibitors is a safer alternative to conventional NSAIDs, including ketorolac, in the management of pain after spinal fusion surgery”; another says in 2004 “the effects of COX-2 inhibitors on similar processes in humans remain largely unknown.” Most of the studies Harrison cites are not only post-2004 (which makes them legally irrelevant for purposes of failure-to-warn) but are not making independent findings, but merely noting the existence of the academic question.

Harrison’s hypothesis may be shown to be correct medically years down the road, but there’s no legitimate basis for legal liability for the pharmaceutical manufacturer when doctors reasonably prospectively disagree about the best pain-management approach. Again, there’s a reason why not even the worst trial-bar parasites want to take on this case: Merck can’t be held liable for what it didn’t know.

21 Dennis Harriosn 02.10.08 at 4:09 pm

Ted -

Thank you for your thoughts. However, it isn’t cherry picking – it is only the tip of an iceberg. You are throwing red herrings, now at bone and spine healing issues. These are certainly to become an issue that Merck will also have to deal with, in addition to all of the other (allegedly – but one doesn’t have to search far….) shoddy, dangerous products they have put out.

Merck is being hammered – and they darn well deserve it.

I am more than aware that Defense strategies are to throw red herrings, attack credibility, and confuse juries. I am prepared, at the proper time, to address that.

I do give you credit for having the guts to allow me to POST this. I won’t accuse you of not having guts and courage.

You are one heck of a defense lawyer. If you were also a Plaintiff lawyer, I would really like to spend time showing you what I have, and looking to work with you.

My most compelling evidence and it will be shown to be startling, well beyond the many, many Independent Research articles that one can find on the Internet, and converge on the same conclusion, is yet to be shared – it would be stupid of me to do so at the current time. At the proper time, Merck will say – “how the heck did he know and find out about that?” I cannot share that evidence until I prepare/get to jury (actually when I have my planning meeting with Judge Fallon and Merck and it leads to the real DISCOVERY phase I am entitled to). I do have faith, much so, in the judicial aspects of MDL 1657. There are some great people there.

I don’t quote legal reference, I can, but I don’t. I first look to find the truth and look at this from a medical and business perspective.

The legal specifics, which you so often mock me for, are very important procedural issues, which I obviously must adhere to, I understand that. I have learned much about them, and will continue to do so. I have to do both – and the legal quotations of rules, precedents, will be there when and as they are necessary. I have read and studied the relevant portions of the FEDERAL RULES OF CIVIL PROCEDURE, and more. I am not stupid.

Bone and Spine healing and repair problems are, indeed very significant – which (allegedly) Merck has so, so skillfully avoided. From a business perspective, who could blame them? They need all of the short/medium term profits to gain the resources (and yet still make a significant net profit) to fund the longer term litigation, and if they are successful in private “settlements” that brow beat and fear monger, litigants and attorneys alike the can get their costs down further. The patterns and cycles are repeating, and it certainly seems to be part of a well thought out business strategy they have made in the past, and are carrying out. Remember the FORD Pinto and the callous cost/benefit analysis of such?

As Merck’s “voodoo approach” to bone medications becomes increasingly obvious (the truth trumps), many people are not going to be happy campers! And, keep an eye on the accelerating issues and litigation on FOSAMAX also… it will (and is starting) to go well beyond the well known DEAD JAW problems.

Thanks

Dennis

22 Ted 02.10.08 at 5:08 pm

Mr. Harrison’s claimed expertise of the Federal Rules of Civil Procedure apparently doesn’t extend to a realization that, under FRCP 26(a)(1)(A), he doesn’t get to choose when he “shares” his evidence, much less wait until he is before a jury to surprise Merck with it. I doubt that Merck is especially concerned about Mr. Harrison’s case or evidence, and I’d wager good money that it never gets to a jury if Mr. Harrison weren’t so obviously judgment-proof. Again, actions speak louder than words, and Mr. Harrison cannot find a single plaintiffs’ lawyer who thinks it is in his economic self-interest to bring this lawsuit, even as tens of thousands of legally questionable lawsuits are being brought against Merck.

I haven’t thrown a single red herring. I’ve merely noted that Mr. Harrison hasn’t been able to address any of the legal arguments I’ve made, hasn’t been able to satisfactorily answer the legitimate questions other commenters have had here, and makes misleading cites to medical evidence he plainly doesn’t fully understand. Instead, confronted with uncomfortable questions, he changes the subject, which doesn’t fool anyone who notices that he has made three comments since my 5:54 pm comment and hasn’t addressed a single question in that post.

I do remember the Ford Pinto, another product unfairly maligned by trial lawyers more concerned about their wallets than consumer welfare or product safety.

23 Angie 02.10.08 at 9:35 pm

I realize that you think Merck did nothing wrong regarding Vioxx. I strongly disagree and believe it injured and killed many people. I also think the “settlement” is being forced on many who will never regain what they lost due to Merck caring more about their profits than human beings. Please explain the letter to Merck in this link. http://www.fda.gov/foi/warning_letters/archive/g1751d.pdf Also please note that the letter refers to an earlier “warning” to Merck regarding these same issues.

24 Ted 02.10.08 at 9:55 pm

The warning letter, when read in the proper context, proves my point that liability is inappropriate.

1. When faced with a violation, the FDA has discretion for engaging in an enforcement action or issuing a “warning letter” for a “minor violation.” See 21 U.S.C. § 336. This is an unreviewable decision of prosecutorial discretion. See Heckler v. Chaney, 470 U.S. 821, 837-38 (1985). If plaintiffs are allowed to seek civil damages on the basis of a warning letter, which was issued because Merck committed only a minor violation (the FDA is very strict about what pharmaceutical companies can say, sometimes even penalizing them for repeating scientifically-true facts that are published in medical journals), it completely disrupts the entire regulatory structure. “This flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (and often competing) objectives.” Buckman, 531 U.S. at 349.

2. The letter further demonstrates that there is no failure-to-warn problem: Merck was required to send a “Dear Healthcare Provider” letter (p. 7) and did so in April 2002. Doctors knew everything Merck did about the possibility of pro-thrombotic risk. The claim that Merck hid something is a claim that Merck had perfect foresight that it did not share.

3. The settlement isn’t being forced on anyone. If a plaintiff wants to bring a futile lawsuit against an innocent defendant instead of taking free money, Merck and the settling plaintiffs can do nothing to stop them other than defend itself in court at trial (or, more likely, in pre-trial motions). For the vast majority, and perhaps even all, of the plaintiffs, they are better off with the settlement than without it, however.

4. If anything, Merck is guilty of caring too much about safety, perhaps because of the perverse incentives of the legal system: 80% of orthopedists wish Vioxx was back on the market. COX-2 inhibitors have valuable gastrointestinal properties, and the decline in their use has dramatically and adversely affected GI problems. Meanwhile, it appears that the NSAIDs that are replacing Vioxx have the same CV issues that Vioxx does. Vioxx may well be safer overall than the drugs that replaced it.

25 grovek@aol.com 02.11.08 at 12:45 am

You must be on Merck’s payroll like the rest of the world

26 Ted 02.11.08 at 1:16 am

Merck doesn’t let people on their payroll talk of the litigation publicly, as I found out when I was organizing the panel on the Vioxx settlement broadcast by C-SPAN and couldn’t get a Merck attorney to appear on the panel.

So, no, not dollar one from Merck. I speak for myself, and haven’t hesitated to criticize Merck when they’ve merited it.

Tens of thousands of plaintiffs with meritless cases will be getting more money from Merck than me.

27 C.Mays 02.13.08 at 2:20 pm

With an impose 8% attorney fee, 50% in attorney’s Fees and expenses (average), plus since this is a punitive structure settlement state and federal taxes have to be paid from the full settlement amount, many could end up with nothing in their pockets.

If you have medicare or a subrogation clause those parties will need to be reimbursed.

In my case if I sign such an agreement I would end up owing around $36,000.00.

Rico Act:

Merck and these attornys are waiving the $5000.00 check around to lure people into the settlement with promise of more money to follow.

The attorneys that represent the clients have not inform their clients that they may end up with nothing. Lack of Full Disclosure.

What it comes down to is a large group of people (lawyers) trying to extort money w/o informing their clients to obtain large sums of money for lawyers and only the lawyers which may not be in the best interest of the client which is also misconduct and a failure to represent.

28 Ted 02.13.08 at 3:14 pm

The 8% comes out of your attorney’s end; if you agreed to a 50% contingent fee with your plaintiffs’ attorney, that’s certainly unfortunate, but hardly Merck’s fault, though perhaps a matter that should be taken up with the state bar. It’s certainly not a RICO issue.

Similarly, subrogation issues are a matter of state law, and would be equally at issue in a trial judgment. I’m not aware of any subrogation laws or tax laws that would leave a client with negative money for taking a settlement, so I fail to understand where the $36,000 loss would come from; if the insurer is coming after you for the payment, they’re coming after you whether or not you settle.

There are many many ethical problems with plaintiffs’ attorneys representing so many clients. But those problems were there from the day the trial lawyers signed you up and none of the ethicists complaining now were complaining then.

Good luck.

29 C.Mays 02.13.08 at 10:47 pm

An Antitrust has been sent out by Steven Cohen on the same lines.

On paper the 8% sounds nice that it is deducted from the attorney’s end. Here is the problem. You sign the 33% contract and the attorney donates the 8% back and makes that portion up in expenses. Of course we know all lawyers are honest and they would never drive up the expenses. Punitive Judgements are fully taxable under the IRC,104(a)2). Medicare holds a superlein.

In theory, people that are under SSDI Benifits would need to reimburse Social Security for medical expenses, but this also poses another question.

Since Punitive Damages are treated as income they may also need to pay any benifits back in the year they recived their settlement since there is not a Medical Clause for medical damages in the settlement agreement.

Another issue which relates back to income and taxes. If one falls under the AMT tax they will not be able to deduct andy expenses from Schd. A.

Two people with the same Gross Settlement amounts could end up with different Net Amounts.

Take the $100,000.00 settlement. 33% to the attorney plus 17% in expenses on average. Leaves you with $50,000.00. You fall under the AMT and 28% (-$28,000.00) is deducted for federal taxes of the gross amount. Leaves you with $22,000.00. Let’s do not forget about state taxes. 12% sounds like a good number. (-$12,000.00). Leaves you with a net amount of $10,000.00. Do the same numbers with a $200,000.00 settlement: Leaves you with a net amount of $20,000.00 are $10,000 more for each $100,000.00 above a $100,000.00 settlement. Say my hospital expenses where $50,000.00 in which there was a lien. There goes my net out the window.

If the government comes in and pushes for wages/benifits back since gross income was more than the allotted amount allowed to be earned during the year;

Hello Ted or Mr. Payday Loan.

I wonder if lawyers ever charge their clients for expenses and turn around and file for the same expenses when filing taxes?

A good reason why you do not find one lawyer bringing suit against another lawyer.

Back to Vioxx. Too many unanswered questioins as to the wording of the settlement agreement.

Sign the agreement and there is no backing out,Sorry.

30 Ted 02.13.08 at 10:57 pm

1) You mean George Cohen, and I was the one who publicized (and commented on) his one-paragraph complaint weeks ago.

2) Your calculations are completely wrong, not least because (A) the government doesn’t tax compensatory settlement damages; (B) the government doesn’t tax fees and costs you pay your attorney or subrogation amounts; (C) you’re ignoring Schedule A deductions and thus double-taxing yourself. And if your attorney had $17,000 in costs for a case that wasn’t litigated, you’re being ripped off. Talk to another lawyer before embarking on fruitless litigation on the false belief that agreeing to a settlement will cost you money.

31 Angie 02.14.08 at 10:23 pm

When I referred to the warning letter from the FDA to Merck I wasn’t citing law. I agree a warning letter from the FDA is not something to base a lawsuit on. I was thinking more of morals. You remember, don’t you? Morals. I agree that most drugs have risks. If we always read all the warnings and took them seriously we would never even take an aspirin. The people who took Vioxx should have had the choice and been aware of the risks. They, nor their doctors knew of the 4X increased risk of heart problems. Merck did, just didn’t think it was important enough compared to profits. I agree Vioxx was great for arthritis and the stomach, and I am sure it would still be helping a lot of people. You just don’t get it, do you? The point is these huge corporations should just be honest. When you hide, or delay adverse side effects from the public it is only for profit. We can’t quit caring about the people that are hurt. Families devastated by a 35 year old male or female that has very unexpectedly left his family. Just out of the blue, except that it happened to 4-5 more people taking Vioxx than not. My point in asking you explain the link to the FDA warning letter was only that the FDA had told Merck at least once before that they needed to quit being so deceptive in their marketing practices, to the public and the medical community. You did maybe notice that they said they needed to quit minimizing the risks to the heart?

32 Ted 02.15.08 at 7:32 am

This is a drug that Merck executives and their families were taking up until the day it was withdrawn.

Angie, your facts continue to be wrong. Merck didn’t know anything that it didn’t tell doctors. The VIGOR results were published and distributed by Merck, including on the label. And there isn’t a “4x” risk. The FDA’s complaint was not about what Merck wasn’t telling doctors, it was that Merck was telling doctors about still other studies that were equally true.

Again, you misunderstand the meaning of a warning letter. The FDA definition of “false and misleading” includes drug companies telling scientific truths that haven’t been officially signed off by the FDA, so a warning letter says nothing other than that the FDA bureaucracy is at work limiting the speech of a pharmaceutical company. If the FDA thought the violation was severe, it would have done more than send out a warning letter. FDA warning letters and overprotectiveness have killed more people than Vioxx ever did by forbidding drug companies to talk about the cardiovascular benefits of aspirin or of statins.

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