Merck To Pay $8M In Damages In Fosamax Trial

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osteonecrosisIn replay of a courtroom battle that ended in a mistrial last fall, a federal jury today voted unanimously that Merck’s Fosamax osteoporosis drug was responsible for causing jawbone deterioration suffered by a Florida woman, who was awarded $8 million in compensatory damages (here is the lawsuit).

Merck, which argued 71-year-old Shirley Boles was at increased risk for dental and jaw problems if she was not taking Fosamax, quickly indicated it would appeal the decision. “We disagree with the jury’s verdict. We believe the jury verdict was a result of the plaintiff’s counsel’s gross mischaracteraization, and inflammatory and prejudicial remarks,” Paul Strain, an attorney representing Merck, tells us. “We believe the court, from his remarks, made it clear he shares those concerns about the improper closing argument by plaintiff’s counsel. That gives us a strong foundation moving forward.”

This was the second bellwether case over whether Merck failed to warn docs and patients that Fosamax may cause osteonecrosis, which is the painful death of jawbone tissue. Merck won the first trial last month (see here). As of March 31, the drugmaker faces 1,039 lawsuits in and federal and state courts that were feild by 1,417 plaintiffs.

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  1. Wel, that’s a “double Vioxx®, for Whitehouse Station — as there are 1,100 cases pending. Simple multiplication yields $8.8 billion. That’s twice what Vioxx was.

    Of course, some will settle, some will be dismissed, some will win lesser amounts. . .

    But even if only HALF of the 1,100 turn out this way — it will at least equal Vioxx.

    My bet is there will be a lot more claimants, now.

    Namaste, to all of good will.

  2. This all (IMHO) has to do with Merck having creatively (and perhaps, nefariously) “moved the goalposts” — by defining “osteoporosis” as including far more women — healthier women — than the F.D.A. or W.H.O. would properly define, as having the condition.

    I think that fact really hit home with the jury. It is (in part) an over-inclusion strategy at Merck — in order to medicate — and create new revenue, that lead to this moment.

    In fairness, Merck won the Louise Maley trial (earlier this Spring), by showing that Mrs. Maley had severe — and confounding conditions — and wouldn’t have been much better off without Fosamax (and maybe, though we’ll never know for certain), maybe a little worse off.

    So, there you have it.

    Namaste

  3. So sorry — broken link: “. . .This all (IMHO) has to do with Merck having creatively (and perhaps, nefariously) “moved the goalposts” — by defining “osteoporosis” as including far more women. . . .”

    Namaste

  4. Finally (I promise!) — I bet Juror No. 5 — the lone holdout — from Boles I, feels vindicated.

    She endured seven days of threats, badgering, verbal abuse and even — allegedly — a thrown chair. It was left behind, shattered, in the Jury Room, back in September 2009.

    Then came a mistrial, due to deadlock, in Boles I.

    See what she wrote in her note, to Judge Keenan, in Boles I.

    I’ll fall silent now.

  5. @ Condor- thank you

  6. Stay tuned–this will be an interesting story almost ready for prime time.

  7. It appears they are doing same with ivermectin and very young children with lice.

    http://www.clinicaltrials.gov/ct2/results?term=ivermectin+lice

  8. Best treatment I know for head lice is a buzz-cut. This is not usually acceptable for treating little girls. Fortunately, mechanical removal of lice and nits is effective. Apparently lice and nits can not survive heat - and one clever fellow has developed a modifified hair dryer and process for killing the bugs (and their eggs) without use of potentially harmful (or no longer effective) pesticides. There are a number of other apparently effective home remedies also.

    Head lice are not a serious public health threat, and desire for “treatment” is largely driven by school personnel and parents.
    More information on the hot air techniques is here: http://pediatrics.aappublications.org/cgi/content/full/118/5/1962

    Linking this back to the original article - significant contributors to osteoporosis include vitamin D deficiency, inadequate calcium intake/absorption, and insufficient weight bearing exercise. If our culture continues to rely primarily on medications to address health concerns, we will continue to be disappointed in the outcomes (intended or otherwise).

    Osteonecrosis (or esophageal erosion) is a pretty awful outcome, and my sympathies go to any who have suffered.

  9. Great discussion here, one and all!

    I was wrong (on the low side) as to the number of likely already pending Fosamax® suits: there are closer to 1,500 of them.

    Thus, one other way to think about the aggregate size of liability this verdict would imply — would be to call it (multiplied out) about “one-half” of the BP oil spill claims fund. Ouch.

    Now, some over-the-weekend perspective:

    There are more than a few reports circulating on the internet this weekend (largely from skittish investors — concerned about where Merck’s stock might open on Monday), that cite an Saturday Law360.com article — to suggest that Judge Keenan will (somehow) summarily set aside last Friday evening’s Boles II Fosamax jury verdict. These people point to remarks the able judge made from the bench, about the overly aggressive style of one plaintiff-lawyer’s summation.

    It is important to separate fact(s) — from wishful fictions, here.

    Judge Keenan is always in control of his courtroom. If he felt that the summation would unfairly enflame the jury, or unfairly prejudice Merck’s rights, he could have (and may well have) instructed the jury to disregard the offending remarks (made in summation), and not take them into account, when deliberating.

    Even if Judge Keenan decides to sanction the lawyer involved — it would be quite another matter to infer that Judge Keenan would rule that the jury’s verdict was “against the manifest weight of the evidence” — and effectively hold that no reasonable jury could have found in favor of Mrs. Boles. That’s a very tall order, for Merck.

    In fact, Merck made just such a motion (called a Rule 50(a) motion), at the end of the trial, and Judge Keenan effectively denied it — when he submitted the case to the jury, for deliberations. Just to keep it straight, here.

    In short — even if, months or years from now, Merck gets this verdict reduced on appeal — it is highly unlikely that Judge Keenan will set aside four weeks of trial work, and a jury’s verdict (after one mistrial had already been ordered — by him — in September 2009). Doubly so where — as here — the able judge had every opportunity to instruct the jury (and even allow Merck to respond in kind).

    Whatever he did, he did within the sound discretion of a very seasoned federal trial court judge.

    Merck faces many very significant hurdles to getting this verdict nullified — especially in the next year or two. Maybe two or three years from now, Merck will get it cut down — to $5 million or $4 million — but in the meantime, Merck will still have to post a bond to file its appeal.

    Namaste

  10. Some More Fosamax Trial “Shenanigans” Detailed:

    Do take a look, but here is a link that leads to the full 11 page PDF file — a letter from Merck’s lawyers.

    Since I wasn’t present, I’ll never be able to say for certain how much of this relief Judge Keenan granted Merck in the most recently-completed Fosamax® ONJ trial. What is known is that the jury awarded $8 million to Ms. Boles — even after these skirmishes, instructions and counter-instructions.

    I strongly suspect — based on the matters alleged in the letter — Judge Keenan gave Merck’s lawyers most of what they asked for, in the letter. This is exactly the sort of thing I said (over the weekend, before the letter was made a part of the public electronic court records) a seasoned, sound and able trial judge would do. And he did:

    . . . .15 minutes of additional closing argument/response to summation, in favor of Merck. . . . in addition, a set of curative instructions to the jury, and. . . revisions to the verdict form, and jury charge form. . . .

    The net effect of all of these remedial measures — if substantially granted by Judge Keenan — would be actually to decrease (as opposed to increase), in my opinion, the chances that Merck will get this verdict set aside quickly. Years from now, some sort of a reduction, maybe — but Judge Keenan is not likely to set it aside, in its entirety, any time soon. We’ll see.

    Namaste

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