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Mirena IUD Update
                             Mass Torts Made Perfect - April 12, 2013
                       Mass Torts Must Knows - Updates on Current Cases




Friday, April 12, 13
Friday, April 12, 13
IUD - Evolution




                         Past Lessons Ignored
Friday, April 12, 13
Modern Revolution and Marketing Attack on Girls and Women
Friday, April 12, 13
Friday, April 12, 13
2006 - Genesis of Bayer HealthCare Pharmaceuticals
                        7th Largest Specialty Pharma Company Worldwide

                                 $11.7 Billion in Annual Revenue




Friday, April 12, 13
Friday, April 12, 13
BAYER’S LEGACY - NOVEL CONTRACEPTIVES

Friday, April 12, 13
Friday, April 12, 13
FDA LETTERS




Friday, April 12, 13
Friday, April 12, 13
FDA LETTERS




Friday, April 12, 13
Cause For Alarm Since July 2010




Friday, April 12, 13
Remember her from YAZ ?

Friday, April 12, 13
Friday, April 12, 13
Black Market IUDs in July 2010
Friday, April 12, 13
Friday, April 12, 13
Claims of Safety & Efficacy




Friday, April 12, 13
Friday, April 12, 13
Friday, April 12, 13
Friday, April 12, 13
Friday, April 12, 13
ACOG Endorsement 2012




Friday, April 12, 13
Friday, April 12, 13
Friday, April 12, 13
Friday, April 12, 13
Friday, April 12, 13
April 8, 2013




          Now think back to Papantonio’s opening remarks about the control over public
                 opinion and related resources exerted by corporate interests.

Friday, April 12, 13
Case Selection & Screening
                       •   Placement or Insertion Confirmed as       •   Strictly define your injury criteria -
                           Successful                                   Embedment, Peforation or Migration

                       •   Post-Partum ? Number of Weeks or         •   Out Patient or Hospitalization following
                           Months                                       surgical removal

                       •   Evidence of Post-Insertion location or   •   Hysterectomy vs. “Hysteroscopy”
                           ultrasound confirmation
                                                                    •   Surgical outcome or complications a
                       •   History of Pelvic Inflammatory Disease        factor
                           or Infection - Medical Rule Out
                                                                    •   Define your criteria and understanding
                       •   Need for Surgical Removal of Mirena          of definitions for injury criteria

                       •   Surgery means surgery

Friday, April 12, 13
Friday, April 12, 13
MDL No. 2434
                                   In 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

Friday, April 12, 13
New Jersey

                       •   BAYER sought consolidation in Summer 2012

                           •   Denied

                           •   Revisited in March 2013

                           •   Ruling pending



Friday, April 12, 13
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

Friday, April 12, 13
•   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
Friday, April 12, 13
Available to Co-Counsel or Lead Cases Nationwide

Friday, April 12, 13

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Mirena Lawsuits Update 2013

  • 1. Mirena IUD Update Mass Torts Made Perfect - April 12, 2013 Mass Torts Must Knows - Updates on Current Cases Friday, April 12, 13
  • 3. IUD - Evolution Past Lessons Ignored Friday, April 12, 13
  • 4. Modern Revolution and Marketing Attack on Girls and Women Friday, April 12, 13
  • 6. 2006 - Genesis of Bayer HealthCare Pharmaceuticals 7th Largest Specialty Pharma Company Worldwide $11.7 Billion in Annual Revenue Friday, April 12, 13
  • 8. BAYER’S LEGACY - NOVEL CONTRACEPTIVES Friday, April 12, 13
  • 13. Cause For Alarm Since July 2010 Friday, April 12, 13
  • 14. Remember her from YAZ ? Friday, April 12, 13
  • 16. Black Market IUDs in July 2010 Friday, April 12, 13
  • 18. Claims of Safety & Efficacy Friday, April 12, 13
  • 28. April 8, 2013 Now think back to Papantonio’s opening remarks about the control over public opinion and related resources exerted by corporate interests. Friday, April 12, 13
  • 29. Case Selection & Screening • Placement or Insertion Confirmed as • Strictly define your injury criteria - Successful Embedment, Peforation or Migration • Post-Partum ? Number of Weeks or • Out Patient or Hospitalization following Months surgical removal • Evidence of Post-Insertion location or • Hysterectomy vs. “Hysteroscopy” ultrasound confirmation • Surgical outcome or complications a • History of Pelvic Inflammatory Disease factor or Infection - Medical Rule Out • Define your criteria and understanding • Need for Surgical Removal of Mirena of definitions for injury criteria • Surgery means surgery Friday, April 12, 13
  • 31. MDL No. 2434 In 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 Friday, April 12, 13
  • 32. New Jersey • BAYER sought consolidation in Summer 2012 • Denied • Revisited in March 2013 • Ruling pending Friday, April 12, 13
  • 33. 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 Friday, April 12, 13
  • 34. 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
  • 36. Available to Co-Counsel or Lead Cases Nationwide Friday, April 12, 13