Fosamax Mistrial Declared

PJ Hamel Health Guide
  • If you’re a fan of the television show "Law and Order," or grew up with Perry Mason, the following story is right up your alley. Filled with violence, intrigue, and conflicting versions of the truth – and with billions of dollars at stake – it ranks right up there with Judge Judy for entertainment value.

    What, O.J. Simpson’s in the news again? A federal lawmaker has been accused of accepting luxury Tahiti vacations? Maybe one of those Wall Street financiers has confessed implication in a money-laundering scheme?

    Nope, I’m talking a trial pitting over 700 osteoporosis patients against Big Pharma’s Merck & Co., manufacturer of the osteoporosis drug Fosamax – a multi-billion dollar cash cow for Merck. The trial, the first of three “bellwether” lawsuits involving Fosamax, got underway in New York August 12. Presided over by U.S. District Judge John Keenan, it’s a consolidation of some 700 separate lawsuits against Merck & Co.

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    The suits allege that Merck failed to adequately warn consumers about a possible Fosamax side effect, osteonecrosis of the jaw (ONJ), a.k.a. dead jaw; and that Merck made “false and misleading statements” about the drug’s safety.

    The suit’s main plantiff is Shirley Boles, 71, of Fort Walton Beach, Fla. Boles contends that her severe ONJ, developed after a tooth extraction in 2002, was caused by Fosamax. She suffers from ongoing infections in her lower jaw, draining from open wounds in her chin.

    Merck counters with the claim that it didn’t know about any potential problems in 2002, and it was only after reports connecting ONJ with bisphosphonate use were published in medical journals in late 2003 that they became aware of the issue. Merck also contends that there is still no “definitive medical evidence” that Fosamax (and other bisphosphonates) cause ONJ; and that Boles’ ONJ wasn’t cause by Fosamax, but by underlying medical issues.

    After weeks of testimony by both sides, and 9 days of deliberation by the jury, Judge Keenan declared a mistrial on Sept. 11. The jury of five women and three men was unable to come to a unanimous decision concerning Merck’s culpability in the case.

    A mistrial isn’t that unusual. But this one is a definite departure from the normal.

    All but one of the jurors had decided that Fosamax might indeed be dangerous, but that it hadn’t caused Boles’ ONJ; they were ready to award the verdict to Merck. But one juror – Juror No. 5, Theresa Ciccone – refused to go along with her peers on the panel. The result?

    According to Bloomberg News, Ciccone reported, “I am being intimidated, threatened, screamed at as well as verbally insulted that I am stupid because I do not agree… I have had two physical threats against me – a chair thrown – and a verbal threat to beat me up.”

    Judge Keenan, after hearing from Ciccone, ordered a one-day “cooling-off period,” after which the jury still failed to reach a unanimous verdict. At that point, Keenan declared the mistrial.


  • Interestingly, The National Osteoporosis Foundation says ONJ occurs “rarely” in patients being treated with bisphosphonates. But a study in the Journal of the American Dental Association, published last January, reports that 4 percent of Fosamax patients at the USC School of Dentistry have “active ONJ.”

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    Who’s right? Who’s wrong? Who’ll win the subsequent trials involving Merck and ONJ, the next of which is scheduled for Dec. 1?

    I don’t know the answer to those questions. But I do know this – there’s already one loser here: the American system of jurisprudence.

    No American drafted into service to their country, via the judicial system, should be subjected to what Juror No. 5, Theresa Ciccone, endured at the hands of her jury mates.

    Here’s hoping for less vitriol and more “civil” in the next civil suits that come to trial.




Published On: October 08, 2009