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Merck Found Liable in Vioxx User's Death

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  • Merck Found Liable in Vioxx User's Death

    Widow Awarded $253 Million in Painkiller Case; Company to Appeal
    By KRISTEN HAYS and THERESA AGOVINO, AP

    ANGLETON, Texas (Aug. 20) - Pharmaceutical giant Merck & Co. said it will appeal a $253.4 million damage award given to the widow of a man who took its once-popular painkiller drug Vioxx in the first of thousands of lawsuits to go to trial.

    The award, handed down by a jury Friday, is likely to be drastically reduced to no more than $26.1 million because Texas law caps punitive damages - which made up $229 million of the total.

    But attorneys for plaintiff Carol Ernst were no less ecstatic when the verdict was read, gleefully shouting "Amen, amen," while Ernst began to cry. Her lawyer, Mark Lanier, hugged her.

    "This is right. Justice is done, amen," said Lanier, who trained as a preacher before he turned to law.

    Jurors in the semi-rural county about 60 miles south of Houston rejected Merck's argument that Robert Ernst, 59, died of clogged arteries rather than a Vioxx-induced heart attack that led to his fatal arrhythmia. Ernst, a produce manager at a Wal-Mart store, ran marathons and taught aerobics classes on the side.

    The case drew national attention from pharmaceutical companies, lawyers, consumers, stock analysts and arbitrageurs as a signal of what lies ahead for Merck, which has vowed to fight the more than 4,200 state and federal Vioxx-related lawsuits pending across the country.

    Ernst called the verdict a "wake-up call" for pharmaceutical companies.

    "This has been a long road for me," she told reporters later. "But I felt strongly that this was the road I needed to take so other families wouldn't suffer the same pain I felt at the time."

    After news of the late-afternoon decision, Merck shares fell 7.7 percent to close at $28.06, wiping away almost $5.2 billion in market capitalization.

    Merck lawyer Jonathan Skidmore said the appeal would center on what he termed "unreliable scientific evidence."

    "It'll be based on the fact that we believe unqualified expert testimony was allowed in the case; there were expert opinions that weren't grounded in science, the type that are required in the state of Texas," he said. "We don't believe they (plaintiffs) met their burden of proof."

    The jury, which voted 10-2 in favor of Ernst, awarded $450,000 in economic damages for Robert Ernst's lost pay, $24 million for mental anguish and loss of companionship and $229 million in punitive damages.

    But state law caps punitive damages at twice the amount of economic damages and up to $750,000 on top of noneconomic damages, which are comprised of mental anguish and loss of companionship.

    "This case did not call for punitive damages," Skidmore said in a prepared statement. "Merck acted responsibly - from researching Vioxx prior to approval in clinical trials involving almost 10,000 patients - to monitoring the medicine while it was on the market - to voluntarily withdrawing the medicine when it did."

    Juror Derrick Chizer, who voted for Ernst, said the majority of jurors believed a heart attack triggered the Texas man's fatal arrhythmia, or irregular heartbeat.

    "It could have been prevented," he said. "That is the message (to pharmaceutical companies). Respect us."

    But James Friudenberg, one of the two jurors who voted for Merck, said he "couldn't go with the probabilities" of what caused Robert Ernst's death.

    "I think there are a lot of good people there who care," he said of Merck.

    Merck pulled Vioxx, a $2.5 billion seller, from the market in September 2004 when a long-term study showed it could double risk of heart attack or stroke if taken for 18 months or longer. By then, more than 20 million Americans had taken the medicine.

    Another Vioxx trial is set to begin in New Jersey, where Merck is based, next month, and the first federal trial is slated for late November in New Orleans.

    If Merck loses in those cases, experts predict it will open the floodgates for more lawsuits and could force the drug company to settle cases. Analysts have speculated that Merck's liability could reach $18 billion. But if Merck prevails in future cases, lawsuits could fade away, easing some of the pressure on its stock.

    Unlike many other pending lawsuits involving obvious heart attacks, the Ernst case centered on an autopsy that attributed his death to an arrhythmia secondary to clogged arteries. That autopsy - and the coroner who performed it - proved critical to the trial's outcome.

    Merck pointed to the autopsy as proof that Vioxx could not have caused the death of Ernst.

    However, Dr. Maria Araneta, the pathologist who performed Ernst's autopsy, testified for the plaintiff that a blood clot she couldn't find probably caused a heart attack that triggered Ernst's arrhythmia. She also said the heart attack killed Ernst too quickly for his heart to show damage.

    While Araneta couldn't say definitively that he had a blood clot and heart attack, she insisted they were the likely culprits in triggering an arrhythmia, which she said wouldn't happen on its own.

    Araneta didn't blame Vioxx, however, noting she knew little about the drug when she performed Ernst's autopsy. But three plaintiff's experts in arrhythmia, cardiology and public health did.

    Merck's experts agreed with Araneta's conclusions in the autopsy, but not her undocumented theory of what triggered the arrhythmia.

    Vioxx inhibits an enzyme known as COX-2, which thins the blood. That feature allows it and other drugs in its class - Pfizer's Bextra and Celebrex - to relieve acute pain and arthritis without causing stomach bleeds or ulcers, as painkillers such as aspirin can.

    A U.S. Food and Drug Administration panel concluded in February that Vioxx, Celebrex and Bextra all pose heart risks but should be available to consumers.

    In April, however, Pfizer withdrew Bextra from the market at the FDA's request when the agency said it carries risk of serious and sometimes fatal skin reactions in addition to heart attacks and strokes. Celebrex remains available to consumers.


    08-20-05 03:32 EDT

  • #2
    My two cents on the matter- Pharmaceutical Reps did try to downplay the allegations with Vioxx at first- then you would not hear a peep from them. Vioxx, and several other drugs are under a great deal of scrutiny. However, remember that all drugs have side effects and don't be surprised if this ruling gets overturned- unless the company showed willful intent to injure others.

    As a Doctor of Oriental Medicine working with an MD--Many patients that I have seen over the past three years were on it and thru acupuncture and herbal remedies -most patients with pain have been either cured or managing it on a daily basis.
    The main secret to ridding yourself of pain can be confusing since the diagnosis of the condition is paramount to the relief. Drugs do not cure you. Drugs treat you for the time and the hope is the body can get back into normalcy soon enough. But in over 25 years of doing bodywork and then acupuncture- I can say without some physical work being done- the meds increase and the pain is coming back-only now your pain tolerance level has become lower- meaning you need a larger dose- which Docs give ya or change to something stronger. I see patients on meds for years or going to a chiropractor for years because of pain--- go into fibromyalgia- which is a the fascia becoming an added pain and 25% cure rate. I could go on but hopefully a few of you can see the folly in this.
    Concerning diagnosis- A little info

    If you have a sharp pain- your tongue will appear generally be red -maybe with a yellow coating (indicating excessive heat in the body) or purple or even grey in the middle- which means you have an excess of blood in the area or a stagnation of excessive blood. It might be some other soft tissue pressing on nerves in the area (such as swelling, subluxation of bone, muscle spasm, adhesions, etc. This pain is generally worst in the morning upon waking. I have my patients- get up and move around or exercise and this pain will lessen.

    If you know of someone with Fibromyalgia - same thing - movement is the key and if you stay in the same position for over 20 minutes- thats all it takes for the fascia to crystalize and give you pain. Thats why you hate long trips or even vegging in front of a TV. Since most of you are guys- this effects women generally and is somewhat common.

    If you have a dull pain- it indicates a deficiency of blood is in the region. When this is seen - your tongue will appear pale. This is known as eschemia- when a lack of blood can not nourish the area adequately. This is the type that you feel fatigue and can not perform as long in normal duties without some rest. This indicates the spleen is involved and warm foods and drink is helpful since the spleen hates cold.

    The difference between just two types of pain is that excess hates touch and of course heat. The deficent pain loves massge and heat.

    Other types of pain can be caused by barometric differences, rain, cold, heat, repetitive action, lack of magnesium and potassium, subluxations, spinal involvement, growths and tumors, displacements, breakage of bone, etc.
    Hope that helps just one of you or a love one at least. Take care all.--Spearit
    Last edited by Spearit; 08-20-2005, 11:00 AM.
    "The range of what we think and do is limited by what we fail to notice.

    Comment


    • #3
      Wow, that company is gonna drown after all these lawsuits!

      Comment


      • #4
        yes RJ.....but we are all going to be losers if it goes through......#1 med cost will be passed on of course....#2 R & D will slow down

        fact of the matter is that vioxx was a good drug, but was used too broad based and with people with cardiovascular disease and the REPS were told when a physician discussed cardiovascular implications and AE's to re-direct the conversation.......this to me shows malice......but not to that amount.......BIG PHARMA has already put many new plans in place to change.....the ads for celebrex have been pulled, bextra was voluntarily removed although no data shows mcardio events.....

        americans want a quick fix cheap, yet bitch and moan when things go wrong.....fact is many people do not comply with the dosing instructions and are also not aware of the AE's which are all in the package insert.....

        i think we should stop being a reactive society of lazy fat fucks and be in better shape and concentrate on preventative health care

        i just think the award is overboard....she should get something...but he died of an arrythmia not a heart attack and had occlusions in his arteries of over 50%

        when i was fighting and was always in chronic pain i used vioxx and of the 3 (celebrex,vioxx and bextra) it was by far the best.....just have to know the risks and that is where merck was wrong.....need to be honest with the public and show transparency

        Comment


        • #5
          #1 will go up anyway as the more price increase of drugs the higher profits for the pharm companies. History shows that the prices of drugs continue to rise.

          #2 research and developement is already slow. Especially with the FDA taking forever to allow a drug onto the market. There are drugs being used for years in Europe that aren't over here and it will be more years before they are.

          Comment


          • #6
            Originally posted by BettorsChat
            #1 will go up anyway as the more price increase of drugs the higher profits for the pharm companies. History shows that the prices of drugs continue to rise.

            #2 research and developement is already slow. Especially with the FDA taking forever to allow a drug onto the market. There are drugs being used for years in Europe that aren't over here and it will be more years before they are.

            this is true....over 80% of drugs in R&D are me-too drugs ...meaning they are almost identical to what is out there, except there may be a slight molecular difference in terms of delivery for efficacy or tolerablilty........why should the drug companies hang their nuts on the line when there is so much litigous exposure???? it is limited in other parts of the world.....when there is a rush to market...there are risks and even when a drug is on the market and appears safe...long term effects are not known....so what do we do??? wait 10 years and see???? or do we roll it out and continually have clinical trials as we do know.....i say the latter, but people can not have it both ways.......when they want a drug to come out fast....there may not be enough phase III clinical trials...but i trust the FDA......but i would caution all patients to read the package insert....and do not trust your primary care physician to know all facets of the drug......they have over 600 meds and they can not keep up with the changes........BIG PHARMA is greedy....i know...i work in big pharma......much fat should be cut....a shame what they pay and there are people who can not afford our drugs....JMHO

            Comment


            • #7
              Thanks for the info Two Ton Tony- Your input is helpful.My brother who is an MD has echoed some of your sentiments. He believes the precedent will allow numerous attacks on other medications that people may have sensitivities, allergies, etc to sue the pharma companies. As we sit and eat the lunches brought in- the rep will either turn on his computer for a info session or verbally educate us on the benefits of the drug line. Biased tests show this- graphs show this- But the big picture is our phsicians are being educated by these reps in some degree. It seems a shame that with little time to ****** the material usually- the ************ of new drugs are a type of crap shoot. Yes they all have their favorites and some educate others at dinners that the reps put on for Doctors and staff (at fancy restaurants with guest speakers) in favor of their drugs or drug line.
              "The range of what we think and do is limited by what we fail to notice.

              Comment


              • #8
                Originally posted by Spearit
                Thanks for the info Two Ton Tony- Your input is helpful.My brother who is an MD has echoed some of your sentiments. He believes the precedent will allow numerous attacks on other medications that people may have sensitivities, allergies, etc to sue the pharma companies. As we sit and eat the lunches brought in- the rep will either turn on his computer for a info session or verbally educate us on the benefits of the drug line. Biased tests show this- graphs show this- But the big picture is our phsicians are being educated by these reps in some degree. It seems a shame that with little time to ****** the material usually- the ************ of new drugs are a type of crap shoot. Yes they all have their favorites and some educate others at dinners that the reps put on for Doctors and staff (at fancy restaurants with guest speakers) in favor of their drugs or drug line.

                the good thing about the "the pharma guidelines" is that a speaker can not endorse a drug per se at an event....he can present clinical data on the drug, but can not say he prefers it....can just let the clinical trials tell the story....may also add that he uses this class of drug.......most docs rely on the clinical data that is supplied by drug reps...(many do not trust the drug reps)....but also are kept abreast by local thought leaders (respected physicians) and roundtable discussions.....


                however, specialsts on the other hand have a better understanding of the drugs they prescribe, since it is a much narrower scope.....but PCP's are inundated with too much data....many are practicing outdated medicine....JMHO

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