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  1. Supreme Court Declines to Review Case About Generic Labeling

    Mar 11, 2015 | The Wall Street Journal

    By Ed Silverman

    ...As noted previously, the case involved a California woman who was prescribed a generic version of Fosamax, a medicine used to treat osteoporosis. The labeling of the brand-name drug, which is sold by Merck, was updated in 2010 and again in 2011 to warn about the risk of a femur fracture...
  2. Fosamax and Femur Fractures

    Mar 11, 2015 | Lawyers and Settlements

    By Jane Mundy

    In a recent Running & FitNews article, an athlete said she suffered several stress fractures in her tibia. She can’t understand how this could happen and neither can a number of specialists. She is also taking Fosamax to help prevent osteoporosis, a drug that may cause femur fractures, along with other bone injuries.

    3. Full Text of Stories Below

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    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

  1. Supreme Court Declines to Review Case About Generic Labeling

    Mar 11, 2015 | The Wall Street Journal

    By Ed Silverman

    The U.S. Supreme Court has declined to review a case that highlighted the contentious issue of product labeling and the extent to which generic drug makers are able to independently and quickly act to provide consumers with risk information.

    The debate in this case was whether a generic drug maker should be held responsible for failing to immediately update its product labeling to match the equivalent brand-name medicine. The issue is now likely to be decided, instead, by a rule that the FDA is considering.

    ...As noted previously, the case involved a California woman who was prescribed a generic version of Fosamax, a medicine used to treat osteoporosis. The labeling of the brand-name drug, which is sold by Merck, was updated in 2010 and again in 2011 to warn about the risk of a femur fracture. Comparable changes to the generic labels were made six weeks after each update, court documents show.

    The woman suffered a fracture, but her doctor was unaware of any side effect warnings that may have applied to the generics, according to court documents. As we noted previously, her lawyer maintained the generic drug makers could have quickly alerted physicians with Dear Doctor letters – a notice about important product updates – but this was not done...

    For full story:

    http://blogs.wsj.com/pharmalot/2015/01/21/supreme-court-declines-to-review-case-about-generic-labeling/?KEYWORDS=Fosamax

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  2. Fosamax and Femur Fractures

    Mar 11, 2015 | Lawyers and Settlements

    By Jane Mundy

    In a recent Running & FitNews article, an athlete said she suffered several stress fractures in her tibia. She can’t understand how this could happen and neither can a number of specialists. She is also taking Fosamax to help prevent osteoporosis, a drug that may cause femur fractures, along with other bone injuries.

    The 40-year-old woman says she is running out of ideas. She has seen an orthopedic surgeon, a podiatrist, a physical therapist, a sports medicine doctor and two chiropractors. She has been running competitively for six years and has a heavy training schedule. She has done everything possible to address these femur problems:

    “I run on a rubberized track once a week; I run on a treadmill once a week; I run on trails once a week; I take Fosamax, isoflavones and hydro-calcium supplements; I have had orthotics; I wear arch supports; after no impact exercise for six weeks, I had pain immediately while trying to run on grass.”

    She also had two bone scans that revealed “some bone thinning” in her back. Given the number of specialists this woman has seen, it is surprising that she doesn’t know about Fosamax side effects and subsequent Fosamax lawsuits.

    As of December 2013, more than 4,000 Fosamax femur fracture lawsuits had been filed in both state and federal courts. Although settlement talks claiming Fosamax caused femur fractures were stalled after Merck won five out of seven bellwether osteonecrosis trials, Fosamax femur lawsuits are going forward.

    The law firm Parker Waichman LLP reported last month that three core discovery deadlines in the Fosamax litigation have been extended based on a Case Management Order (CMO). The CMOs extended the following deadlines:

    • Tier II Femur Fracture Discovery Pool: Extended to December 30, 2014
    • Tier III Femur Fracture Discovery Pool: Extended to December 30, 2014
    • Tier IV Femur Fracture Discovery Pool: Extended to February 27, 2015...

    For full story:

    http://www.lawyersandsettlements.com/articles/fosamax/fosamax-side-effects-lawsuit-femur-16-20260.html#.VQA1jeG-XaU

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