Mirena Lawsuits Update 2013
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Transcript of Mirena Lawsuits Update 2013
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Mirena IUD UpdateMass Torts Made Perfect - April 12, 2013
Mass Torts Must Knows - Updates on Current Cases
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IUD - Evolution
Past Lessons Ignored
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Modern Revolution and Marketing Attack on Girls and WomenFriday, April 12, 13
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2006 - Genesis of Bayer HealthCare Pharmaceuticals7th Largest Specialty Pharma Company Worldwide
$11.7 Billion in Annual Revenue
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BAYER’S LEGACY - NOVEL CONTRACEPTIVES
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FDA LETTERS
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FDA LETTERS
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Cause For Alarm Since July 2010
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Remember her from YAZ ?
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Black Market IUDs in July 2010Friday, April 12, 13
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Claims of Safety & Efficacy
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ACOG Endorsement 2012
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April 8, 2013
Now think back to Papantonio’s opening remarks about the control over public opinion and related resources exerted by corporate interests.
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Case Selection & Screening• Placement or Insertion Confirmed as
Successful
• Post-Partum ? Number of Weeks or Months
• Evidence of Post-Insertion location or ultrasound confirmation
• History of Pelvic Inflammatory Disease or Infection - Medical Rule Out
• Need for Surgical Removal of Mirena
• Surgery means surgery
• Strictly define your injury criteria - Embedment, Peforation or Migration
• Out Patient or Hospitalization following surgical removal
• Hysterectomy vs. “Hysteroscopy”
• Surgical outcome or complications a factor
• Define your criteria and understanding of definitions for injury criteria
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MDL No. 2434In Re: Mirena IUD Products
Liability Litigation
• Transfer Order of April 8, 2013
• Southern District of New York
• The Honorable Cathy Seibel
• At time of filing over 40 related actions in 17 Federal Districts
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New Jersey
• BAYER sought consolidation in Summer 2012
• Denied
• Revisited in March 2013
• Ruling pending
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Mirena IUD • Intrauterine Device
• Intrauterine System
• A “Drug” despite “Device” being part of the IUD acronym
• Levonorgestrel T shaped releasing cylinder
• Placed in uterus with strings ideally hanging within reach for user to check on position monthly
• Left in place for up to 5 years
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• Self check will become a Defense Theme in vigilance of Learned Intermediary, Patient/User, questions regarding placement and choice of contraceptive
• Ask prospective clients if they were checking the strings
• Need to know regardless of their response
• Was promoted and touted as “set and forget” contraception
• It is not
• Look at info from February 2013 again
• Expect a Legal Battle Friday, April 12, 13
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Available to Co-Counsel or Lead Cases Nationwide
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