Vioxx and Merck Lose Again

Vioxx went to 3 for 6 in jury verdicts today as Merck lost a case in Texas (WSJ $).  Merck got hit with $7 million in damages plus $25 million in punitive damages, presumably since Merck was so clearly at fault as to be considered to have acted recklessly.  With that in mind, consider a couple of facts in the case:  First, the plaintiff..

died of a heart attack after taking Vioxx for less than a month.

I know what you are thinking.  How, after less than a month of use (and maybe as little as a week), could any plaintiff prove their heart attack was from Vioxx?   I mean, out of the thousands of people who took Vioxx, some statistically were due for a heart attack even had they not taken the drug.  Having one event (the heart attack) follow another (Vioxx use) does not prove causation, after all.  I guess the jury decided that this guy was not at risk for a heart attack otherwise.  Of course, they admitted that:

Mr. Garza, a Vietnam veteran who was 71 years old when he died in 2001,
had a history of smoking, had suffered a prior heart attack in 1981 and
had quadruple bypass surgery in 1985.

But I'm sure that had no bearing on his heart attack.  It must have been from the week of Vioxx.  His lawyers mitigated this by arguing:

he had a stress test shortly before his heart attack that showed he was in good health

Do you know how many men die of heart attacks within months of having a clean stress test?  A lot.

The plaintiffs initially asked for a billion dollars, so I guess if only by comparison the verdict was reasonable.  I wrote more about the danger of making uninformed juries the arbiter of what risk trade-offs we as individuals can take with our medications here and here and here.  I questioned multiple punitive damage awards for the same offense in the context of double jeopardy here.

  • abayrat

    Over at Pointoflaw.com Ted Frank pointed out the plaintiff did not have a prescription for Vioxx. His wife claimed he received the drug from his doctor as samples for 30 days in brown vials. His doctor testified he never gave Vioxx to the plaintiff and only gave out samples in 8 dose blister packs. This will most likely be reversed on appeal but is will still cost Merck money. I think we should change tthe current system to loser pays. This will cut down on borderline cases like this one.

  • B. England MD

    Another lame verdict. First of all, the cardiac risk demonstrated with Vioxx was only increased in those taking it for longer than 18 months, so there was no scientific basis for their claim.

    Secondly, there is a profound ignorance on the utility of treadmill stress testing. A regular stress test may pick of significant flow limiting stenosis (>70 percent occlusion), meaning if someone has a history of chest pain, a postive test means a coronary lesion is a likely source of the problem.

    Unfortunately, most acute coronary events occur from the rupture of smaller, less stable plaque (>50% occluding), which also happen to be far more numerous than larger plaque.

    Bottom line is that a regular treadmill is not very good at detecting underlying coronary disease, and virtually useless in predicting future coronary events.

  • http://amateureconblog.blogspot.com Christopher

    These awards are bad precents imho. What does it mean for future investment in pharmaceuticals that help so many of us?

    Chris
    http://amateureconblog.blogspot.com

  • http://badbonehealing.wordpress.com Dennis Harrison

    VIOXX - More than breaking hearts… make no bones about it!

    Merck may need to look behind its shoulder a bit more... a lawsuit originally filed in NY State Supreme Court may well help “peel the onion” of truth about the Merck/Vioxx debacle, as well as aid in establishing alleged patterns consistent with the heart related issues. Quite interesting, it is not about the current heart allegations. Also, there is still time to help others!

    Indeed, this may be the FIRST lawsuit that is NOT about the well-known heart issue(s) from VIOXX usage, which has swept center stage with near daily press releases. Rather it alleges that Vioxx inhibits, delays, and even PREVENTS bone/spine healing – and allegedly Merck both knew it, and should have known it. However, as alleged, Merck ignored it and did not properly address it at all!

    Think you "only" have to worry about heart problems if you took or are taking a Cox-2 inhibiting drug - think again! If you did or do, and are waiting for a bone or a spine to heal, allegedly you may have much longer to wait than you think. Allegedly, your healing may not be normal, and it may not even happen! Relative to warnings of any kind – it is alleged that there were none!

    This would be the second very significant, wide scale issue Merck must address. Mr. Dennis Harrison (Cementon, NY) alleges that once is an occurrence (heart issue), while twice (bone/spine) starts to provide evidence of a pattern. The lawsuit alleges that several of his major orthopedic operations did not heal because of Vioxx. These operations failed, required about an eight-month stay in hospitals and nursing homes (for what was to be a routine 3-4 day stay and 6-8 week recovery!), and contributed to two sepsis attacks as well as many other issues.

    Complicating his dilemma is a typical problem of acquiring legal help against Merck for anything but a related heart issue. Few lawyers can afford the expense/risk (ranging from an estimate of $125,000 to more!). Lawyers in general are (understandably) averse of the risk associated with going up against a company such as Merck, if the issue is not clearly heart related! Thus the Plaintiff (Mr. Dennis Harrison, Cementon, NY) is going it alone; filing "pro se" (i.e. by himself).

    This now has the makings of a real David and Goliath saga!

    Obviously the implications of not having a spine or major bone heal at all, or heal incorrectly can reverse the course of some-one's life quickly and drastically. It can stop a well-planned and (up to that point) well-executed plan of overall recovery. That was the case per Mr. Harrison’s allegations. Here are a few excerpts from independent research supporting the issue:

    February 02, 2005 - HSS Physicians Review Literature on the Safety of COX-2 Inhibitors…COX-2 inhibitors effect fracture healing and spine fusion…should be delayed for three-four weeks in fracture healing and should never be used in spinal fusion…physical therapy for patients with porous in growth should be delayed…

    December 23, 2002 - Bone Fractures…Cox-2 Inhibitors interfere with bone growth and, healing…Researchers at Stanford University Medical Center have found selective COX-2 inhibitors… interfere with the healing process after a bone fracture or cement less joint implant surgery… 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…COX-2 has an essential function during normal 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! As stated, Vioxx is a Cox-2 inhibitor.

    Journal of Bone Mineral Research 1999 Jun;14(6):969-79…initial immune response is crucial to fracture healing…suggests limited usage of COX-2 inhibitors in patients with healing fractures.

    A Merck hired consultant (to study the bone/spine issue), allegedly stated “it’s time to tell the public” and that the “evidence is compelling”. Mr. Harrison questions if that information is included in their recently announced, seemingly self serving study of their internal affairs during the Vioxx ordeal. Also, what all about the reaction to all of those independent studies?

    These independent R&D tests of Cox-2 inhibition medications, obviously indicated deleterious impact on bone/spine healing. Allegedly warnings were provided to Merck. Allegedly, Merck just denied/ignored the issue. Obviously, these allegations would have had a very negative impact on sales, especially in the short run, and if not handled properly at the time. Merck could have acted responsibly and provided proper physician and consumer education, as adequate warnings and education to physicians and consumers could have made it possible to make informed decisions. Between proper education/warnings and working the technical issues, perhaps Merck could have kept the drug on the market. However, allegedly Merck chose higher shorter-term profits versus working through the issues to properly address them (heart and bone/spine) and keeping Vioxx on the market for the longer-term benefit of consumers AND Merck! Such a pity – due to short-term thinking, the educated use of VIOXX might have “saved” it if used appropriately. However, it was basically forfeited for the quicker and higher impact of short term profit.. Unfortunately, this is often the sad state of American corporations in this day and age – short term profits and volatile stock price versus longer-term company viability and ultimately higher, more stable share prices. Volatiilty and short term impacts, unfortunately, can drive executive behavior to take advantage of the volatility in unethical ways.

    Mr. Harrison alleges that Merck skillfully, artfully, and successfully planned and created a "veil of safety" perception which was masking the issues behind this dangerous medication. This "veil of safety", contributed to the thought process that it was one of the safest drugs around. Thus it is alleged; physicians and consumers were skillfully lulled into a false sense of security. Allegedly and meanwhile, profits kept rolling in as cold calculations indicated that the profit was worth the cost of lawsuits and settlements.

    Allegedly, there were other factors (besides independent testing) that should have made Merck specifically test for this issue, and that at least a simple warning and honest education to physicians, surgeons, physical therapists and/or consumers should have been considered imperative. Mr. Harrison indicates that, without any doubt, he would have prevented Mr. Harrison from taking the drug.

    Not having any clue otherwise, Mr. Harrison continued to take VIOXX (he was a long term user – about 5 years, and took the maximum dosage of 50mg) VIOXX while receiving several very important operations, the Plaintiff's bone/spine operations (other ones without Vioxx succeeded) failed. Routine leg (femur) operations failed, infections and sepsis set in; broken, infected internal hardware had to be removed. Some broken hardware, a significant amount, remains in his body.

    In the NY lawsuit (broken leg (femur)) – he waited, waited, and waited for some bone healing so that he could be operated on and walk again – but it did not happen after almost the eight months (his surgeons and physicians also were not aware of the Vioxx bone/spine repair problem) Allegedly, surgeons and physicians were not made aware of the problem from Merck (no warnings, no education, etc.). They seemed puzzled as to why Mr. Harrison’s bones were not healing even the minimal amount needed to "maintain an anchor” for the correcting operation(s). Their notes speculate on improper bone healing. Unfortunately, and allegedly the link to Vioxx was purposely not conveyed to them (by Merck). Mr. Harrison alleges that reasons of PROFIT at all means, competition, etc. lead to the alleged neglect, deceit and fraud masking this very serious problem. Merck denies all charges. These allegations certainly sound similar to the current lawsuits that are unraveling what Mr. Harrison refers to as Merck’s weak and self-serving defenses.

    Thus he spent almost a year in hospitals and nursing homes for what was supposed to be a routine 3-4 day hospital stay and about 6 weeks recovery! Mr. Harrison was wheel chair bound, except for "hopping" around on one foot and undergoing painful rehabilitation in an attempt to keep him strong enough on a continuing basis while he waited, and waited. Meanwhile, his home life and finances embarked and continued on a steep, downward spiral.

    As Mr. Harrison waited, waited and. His confidence was reduced to despair and depression. But he kept doing what he was asked to by his physicians and physical therapists. He became desperate and called a well-known surgeon in NJ for help. A method was devised to get around the issue(s) from Vioxx. Far from the plan of record, the most optimal solution (which utilizes bone healing to “anchor” it, as well the ability for the bone to “grow” into the implant) it was basically his only chance to walk and save his leg. However, it is likely to require replacing much sooner than would have been the case. The preferred methodology uses interweaved bone growth into the implant for strength and durability instead of glue. Mr. Harrison, with his health declining, hopes at that time he will be strong enough. – and there is now sufficient reason to be wary of this issue.

    However, his trail to recovery was yet laden with more problems that he alleges simply would not have happened, if the “routine” operations in the beginning had just healed like they were supposed to. His last few months of hospitalization and nursing home experience (with a very brief time home) were plagued with excessive bleeding, infection, sepsis (twice) and obviously depression and ever diminishing hope. He alleges his whole life has been re-arranged, and NOT for the better!

    Before using Vioxx there were other operations, all healing very successfully without complications. His work ethnic is very high – it is very obvious as one looks at his past. Working his way part time (summer full time) during both undergraduate and graduate school, accepting positions almost immediately after graduating, often working without payed overtime, having an unblemished work record, and not taking time off during a few career changes, he has shown nothing but a consistently high work ethnic from the time he was seventeen. He also had returned to work promptly as soon as his physicians allowed him to in several operations in which he could go back to work. During his (successful, pre-Vioxx usage) hip replacements, he worked up to the last day possible, needing a cane for almost three months to move around at work – and he returned absolutely as soon as possible (in fact though his physician agreed it was o.k. – his physician was more than willing to support additional recuperation time), with two crutches (recommended for safety) used during the first several weeks. He left in agony and with a cane, and he came back to work absolutely as soon as possible with crutches! Certainly Mr. Harrison would prefer his extremely, and well payed enjoyable career versus disability payments and an extremely very reduced life style!

    He had felt, based upon what he became was surgically possible, he would again be able to work permanently. His hopes were very high, he had several major successes behind him, and even more importantly he was back on track to resume a more normal and happy family life. Just a bit more! Vioxx usage was, allegedly, about to change all that!

    Little did he know that the seeds to unravel and destruct his hopes for recovery were being planted with the introduction of Vioxx. He would never have projected such a negative turn about in his life. His hopes were to begin to slowly unravel, much to his chagrin, puzzlement, and increasing pain and major discomfort. His use of narcotic pain medication had to be increased significantly. All of this, slowly but surely, after he was induced, via advertisements and improper physician (non)-education allegedly as part of Merck’s product “strategy”, to utilize the new "wonder drug" with it’s alleged “safety profile”.

    The several FAILED operations from the broken leg, plus a planned major correction operation (which had to be cancelled because of the unhealed broken leg! – it was rescheduled when the leg was to be a routine operation, but could not be re-scheduled because of the unhealed bone, long miserable hospital/nursing home stay, and several other issues allegedly that just would not have happened had it not been for Vioxx) to correct a failed (also from inadequate bone repair – noted in medical notes) total Lumbar fusion, and the (up to then) highly successful path to recovery was stopped cold. So Mr. Harrison remains on disability, with failed hardware imbedded in his back, having had a miserable and lengthy hospital/nursing home stay, a permanently damaged family life, a depressing view of a bright future gone bad, and income not anywhere near where it was, and a most satisfying career gone sour.

    POSSIBLE OTHER PUBLIC CONERNS!

    While the following is based on facts, allegations, and “intelligent” speculation – Mr. Harrison raises several other potentially explosive issues that he feels, very strongly must be studied. He feels it is just not responsible, in any way, not to do so.

    VIOXX, and all COX-2 inhibitor drugs, work by inhibiting the body's natural response to inflammation and bone repair/regeneration. Mr. Harrison indicates that he would also have to wonder about other long-term effects on the bones (from Vioxx usage). Also, it begs other questions. 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”). This should cause one to 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? 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? And what other bone problems may develop with concurrent VIOXX and FOSAMAX USAGE?

    Mr. Harrison feels it is imperative that Merck, and the FDA finally need to act on more than just the heart issues - but also (1) on the bone/spine repair issues of Vioxx, (2) FOSAMAX taken alone (it's dreaded "dead jaw" issue), and (3) answer another very important question - what if one took Vioxx (or is currently taking another Cox-2) concurrently with FOSAMAX? Furthermore, (4) since FOSAMAX allegedly stays in the bones for up to 10 - 15 years, what might the impact be of having had VIOXX (or currently another Cox-2 inhibitor still on the market) and either taking FOSAMAX now, in the past, or in the future? Is it possible that even though the bones are supposed to become more “dense” from FOSAMAX (which creates the density by preventing natural bone regeneration), they are also more brittle (as is beginning to be alleged from various sources), and the bones will have healing issues until FOSAMAX finally leaves the bones? Is it possible that if one took FOSAMAX for 3-5 years, and it stays in the body for up to 10-15 years, that one is at risk when taking a Cox-2 drug (still on the market) within those next 10-15 years? Merck, the developer of both drugs, must be able to answer these questions! Incredibly, Vioxx and Fosamax are both produced by Merck! Merck, the FDA, and independent teams must finally review the above. It is unbelievable, with the “sophistication” one would expect from a major drug company, and the FDA that these are not already answered, and that ongoing studies, on a post-marketing basis are not being done NOW!

    These drugs had (have) been on the market a long time. There would seem to be no excuse for not testing the concurrent usage of these drugs, on both a pre and post-marketing basis. It certainly would seem, with Cox-2 inhibition at the core of both the heart and bone/spine issues, and the threat of both FOSAMAX taken alone, or possibly worse, with a Cox-2 inhibitor, that any remaining Cox-2 inhibitors on the market also may need to be brought into this analysis. The same potential relations and allegations, may be applicable. However it seems little, if anything (by either Merck or the FDA) is actively moving that caution forward!

    If you, a loved one, or just some-one you know, has/had similar issues as Mr. Harrison, have questions or thoughts, or are a knowledgeable individual with thoughts and/or information on the subject(s) please feel free to email:

    badbones@hvc.rr - for general bone concerns/history etc. potentially from medication(s)

    badbonehealing@hvc.rr.com - for specific experience with bone/spine healing problem(s) and the use of a Cox-2 inhibitor medication.

    There is now also a BLOG - badbonehealing.wordpress.com which would be a very good place to post comments and start discussions.

    There are no clumsy forms to fill out, no messages that vanish into thin air, and no character limits. Some reporting mechanisms messages are rigid and difficult – but with your email, just let it flow!

    We must work though the denials and bureaucy to ensure this issue is addressed. If it is not properly addressed now, what is to control it in the future – and in fact, by default, we have encouraged similar behavior in the future! Could tomorrow’s drugs be imbedded with the same short term thinking of shorter-term profits, highly volatile stock prices (also damaging consumers – but creating “opportunities” in some “inside” cases), and executive bonuses over reasonable public safety and reasonable corporation viability and stock valuation. America needs its Pharmaceutical companies. But we need them to be honest – and they all need to play on a level playing field. The issues alleged, must be seriously considered by Merck, the FDA, and the courts – the total impact to society, as poor as it is medically speaking in these cases, even goes beyond medical issues.

    Please include any concerns you may have noted above which apply to. Individual questions cannot be answered, as I am not in the Medical Field, though in some cases I might be able to relate your email to my experiences. Most importantly, selected representative statements, questions, and summary will be published at the end of October. It will NOT provide identifying information, unless you specifically request it. Perhaps making it an imperative goal - your emails will provide enough useful post-usage information that will fan the flames of fair warnings, “level the playing field”, proper analysis, and industry accountability. It is about time!