Report from the Department of Justice December 8, 2017

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Report from the Department of Justice December 8, 2017 Catharine E. Reeves Deputy Director, Torts Branch

Statistics Reporting Period: 8/16/17 11/15/17 I. Total Petitions Filed in the United States Court of Federal Claims this reporting period: 396 A. Minors: 33 B. Adults: 363 2

Statistics Reporting Period: 8/16/17 11/15/17 II. Total Petitions Adjudicated this reporting period: 196 A. Compensated: 141 i. Cases conceded by HHS: 56 1. Decision awarding damages: 2 2. Decision adopting Proffer: 54 3. Decision adopting Settlement: 0 ii. Cases not conceded by HHS: 85 1. Decision awarding damages: 0 2. Decision adopting Proffer: 0 3. Decision adopting Settlement: 85 B. Not Compensated/Dismissed: 55 i. Decision dismissing Non-OAP: 36 ii. Decision dismissing OAP: 19 3

Statistics Reporting Period: 8/16/17 11/15/17 III. Total Petitions Voluntarily Withdrawn this reporting period (no judgment will be issued): 5 4

Appeals: U.S. Court of Appeals for the Federal Circuit Recently Decided Cases Appeals by Petitioner: H.L. v. HHS (Entitlement): Affirmed Simmons v. HHS (Attys Fees and Costs): Affirmed All decisions are available on the CAFC s website: http://www.cafc.uscourts.gov 5

Appeals: U.S. Court of Appeals for the Federal Circuit Pending Cases Appeals by Petitioner: D Tiole v. HHS: (Entitlement) Anderson v. HHS: (Entitlement) Oliver v. HHS: (Entitlement) Depena v. HHS: (Entitlement) *Yellow cases are new this reporting period 6

Appeals: U.S. Court of Federal Claims Recently Decided Cases Appeals by Petitioner: Dean v. HHS (Entitlement): Affirmed Cottingham v. HHS (Attys Fees and Costs): Remanded Abbott v. HHS (Attys Fees and Costs): Affirmed Erxleben v. HHS (Entitlement): Affirmed All decisions are available on the CFC s website: http://www.uscfc.uscourts.gov 7

Appeals: U.S. Court of Federal Claims Pending Cases Appeals by Petitioner: Santacroce v. HHS (Attys Fees and Costs) Olson v. HHS (Entitlement) Fairchild v. HHS (Loss of Future Earnings) Clubb v. HHS (Entitlement) Hirmiz v. HHS (Attys Fees and Costs) Pless v. HHS (Attys Fees and Costs) Caron v. HHS (Entitlement) Krakow v. HHS (Attys Fees and Costs) Rogero v. HHS (Entitlement OAP) *Yellow cases are new this reporting period 8

Appeals: U.S. Court of Federal Claims Pending Cases (cont d) Appeals by Petitioner: Kukreja v. HHS (Attys Fees and Costs) McCollum v. HHS (Entitlement) Greene v. HHS (Entitlement) Diedrich v. HHS (Entitlement) Bender v. HHS (Entitlement) *Yellow cases are new this reporting period 9

Scheduled Oral Arguments U.S. Court of Appeals for the Federal Circuit: None scheduled at this time. U.S. Court of Federal Claims: Santacroce v. HHS (Attys Fees and Costs): 12/12/2017 10

Adjudicated Settlements* Reporting Period: 8/16/17 11/15/17 Vaccine(s) Alleged Injury(ies) Petition Filing to Settlement Filing 1. TDaP GBS 5 Years, 5 Months 2. Flu GBS 5 Years, 2 Months 3. DTaP; Flu; Hib; IPV; PCV; Hep B Evan's Syndrome; Thrombocytopenia; Coombs' Positive Hemolytic Anemia; Pancytopenia, Neutropenia; Diphtheria-Tetanus-Acellular Pertussis 4. Flu SIRVA 3 Years 5. TDaP ADEM; TM 3 Years 3 Years, 2 Months 6. Flu TM 2 Years, 5 Months 7. Hep A; Flu TM 2 Years, 3 Months 8. Meningococcal Persistent Headaches; Motor Tics 2 Years, 2 Months 9. MMR Eye Pain; Decreased Vision; Vision Loss; Optic Neuritis; Fatigue 2 Years, 2 Months 10. Flu Meniere's Disease 2 Years, 1 Month 11. Flu SIRVA 2 Years, 1 Month (continued... ) 11 *Terms of compensated settlements memorialized by Stipulation

Adjudicated Settlements* Reporting Period: 8/16/17 11/15/17 Vaccine(s) Alleged Injury(ies) Petition Filing to Settlement Filing 12. TDaP Arm Pain; Numbness; Tingling; Paresthesia; Neuropathic Pain Syndrome 2 Years, 1 Month 13. Flu Narcolepsy 2 Years, 1 Month 14. Flu Dyshidrosis 2 Years, 1 Month 15. Flu Parsonage-Turner Syndrome; SIRVA 2 Years 16. Flu GBS 2 Years 17. Flu Brachial Neuritis 2 Years 18. Flu Unspecified neurological injury 1 Year, 9 Months 19. TDaP SIRVA 1 Year, 8 Months 20. Flu SIRVA 1 Year, 8 Months 21. Hep A; Hep B; TDaP SIRVA 1 Year, 8 Months 22. Flu SIRVA 1 Year, 7 Months *Terms of compensated settlements memorialized by Stipulation (continued... ) 12

Adjudicated Settlements* Reporting Period: 8/16/17 11/15/17 Petition Filing to Vaccine(s) Alleged Injury(ies) Settlement Filing 23. DTaP; IPV; Hib; TM 1 Year, 6 Months PCV 24. Flu SIRVA 1 Year, 6 Months 25. Flu TM 1 Year, 6 Months 26. Flu GBS 1 Year, 6 Months 27. Flu GBS 1 Year, 6 Months 28. Flu SIRVA 1 Year, 6 Months 29. Flu TM 1 Year, 5 Months 30. Flu; MMR; TD Myelitis 1 Year, 5 Months 31. Flu SIRVA 1 Year, 5 Months 32. Flu GBS 1 Year, 5 Months 33. Flu SIRVA 1 Year, 5 Months (continued... ) 13 *Terms of compensated settlements memorialized by Stipulation

Adjudicated Settlements* Reporting Period: 8/16/17 11/15/17 Vaccine(s) Alleged Injury(ies) Petition Filing to Settlement Filing 34. Flu SIRVA 1 Year, 5 Months 35. Flu SIRVA; Adhesive Capsulitis; Rotator Cuff Tendinopathy 1 Year, 5 Months 36. Flu Neuropathy 1 Year, 4 Months 37. Flu TM 1 Year, 4 Months 38. TDaP GBS 1 Year, 3 Months 39. Flu SIRVA 1 Year, 3 Months 40. Flu GBS 1 Year, 3 Months 41. Flu SIRVA 1 Year, 3 Months 42. Flu GBS 1 Year, 3 Months 43. DTaP; IPV; Hep Synovitis 1 Year, 3 Months B; Hib; PCV; Rotavirus 44. Flu GBS 1 Year, 2 Months (continued... ) 14 *Terms of compensated settlements memorialized by Stipulation

Adjudicated Settlements* Reporting Period: 8/16/17 11/15/17 Vaccine(s) Alleged Injury(ies) Petition Filing to Settlement Filing 45. TDaP; Flu GBS 1 Year, 2 Months 46. Flu SIRVA 1 Year, 2 Months 47. Flu GBS 1 Year, 2 Months 48. Flu GBS 1 Year, 2 Months 49. Flu SIRVA 1 Year, 2 Months 50. PCV SIRVA; Arm Cellulitis; Index Finger Stenosing; Tenosynovitis 1 Year, 1 Months 51. Flu SIRVA 1 Year, 1 Month 52. Flu SIRVA 1 Year, 1 Month 53. Flu GBS 1 Year, 1 Month 54. Flu SIRVA 1 Year, 1 Month 55. Flu GBS; Miller Fisher Variant; Tibial Nerve Palsy 1 Year, 1 Month *Terms of compensated settlements memorialized by Stipulation (continued... ) 15

Adjudicated Settlements* Reporting Period: 8/16/17 11/15/17 Vaccine(s) Alleged Injury(ies) 56. Flu SIRVA 1 Year 57. Flu SIRVA 1 Year 58. Flu CIDP 1 Year Petition Filing to Settlement Filing 59. Flu SIRVA 1 Year 60. Flu GBS 1 Year 61. Flu Significant Aggravation Pericarditis 1 Year 62. Flu GBS 1 Year 63. Flu SIRVA 1 Year 64. Flu SIRVA 1 Year 65. Flu SIRVA 1 Year 66. PCV SIRVA 1 Year *Terms of compensated settlements memorialized by Stipulation (continued... ) 16

Adjudicated Settlements* Reporting Period: 8/16/17 11/15/17 Vaccine(s) Alleged Injury(ies) 67. Flu SIRVA 9 Months 68. Tdap Brachial Neuritis 9 Months 69. Flu SIRVA 9 Months Petition Filing to Settlement Filing 70. Flu Parsonage-Turner Syndrome; Brachial Plexopathy 9 Months 71. Flu SIRVA 9 Months 72. Flu SIRVA 9 Months 73. PCV SIRVA 9 Months 74. Flu SIRVA 9 Months 75. Flu Polyneuropathy 9 Months 76. Flu Mast Cell Activation Disorder 9 Months 77. Flu SIRVA 9 Months *Terms of compensated settlements memorialized by Stipulation (continued... ) 17

Adjudicated Settlements* Reporting Period: 8/16/17 11/15/17 Vaccine(s) Alleged Injury(ies) 78. Flu GBS 9 Months 79. Flu GBS 9 Months 80. Flu Parsonage-Turner Syndrome 8 Months Petition Filing to Settlement Filing 81. Flu SIRVA 8 Months 82. Flu SIRVA 7 Months 83. Flu SIRVA 7 Months 84. Flu SIRVA 6 Months 85. Flu GBS 7 Months *Terms of compensated settlements memorialized by Stipulation (continued... ) 18

Appendix 19

Glossary of Terms Petitions Adjudicated: Final judgment has entered on the petition in the United States Court of Federal Claims. Final Judgment: Clerk of Court, United States Court of Federal Claims, enters judgment awarding or denying compensation. Compensable: Petitioner received an award of compensation, which can be achieved through a concession by HHS, settlement, or decision on the merits by the special master, United States Court of Federal Claims. Conceded by HHS: HHS concluded that a petition should be compensated based on review and analysis of the medical records. 20

Glossary of Terms Settlement: Petition is resolved via a negotiated settlement between the parties, and results in the filing of a stipulation that memorializes the terms of the settlement. Decision: Special Master issues decision on the merits of the petition. Non-compensable/Dismissed: Petition dismissed. Proffer: After discussions between the parties regarding a reasonable amount of damages, respondent will file a suggested award of compensation, known within the Program as a Proffer, which is also agreed to by petitioners and their counsel. The Proffer is reviewed by the presiding special master to determine that it represents a reasonable measure of the amount of the award and describes compensation pursuant to 42 U.S.C. 300aa-15(a). The special master issues a final decision consistent with the terms of the Proffer. 21

Glossary of Terms Affirmed: Case has been reviewed on appeal, and the court on appeal agreed with the decision of the lower court. Reversed: Case has been reviewed on appeal, and the court on appeal disagreed with the decision of the lower court. The court on appeal typically provides reasons for reversing, and that decision becomes the law of the case, absent further appeal. Remanded: Case has been reviewed on appeal, and the reviewing court has a problem with the decision, and sends it back to the lower court. Typically, a case is remanded with a specific question or issue for the lower court to address. Vacated: Case has been reviewed on appeal, and the reviewing court has voided the lower court s decision. 22

Petition Processing in the Office of Special Masters Petition HHS Review Not Conceded Conceded Settlement Decision Damages Final Decision (award of compensation) Not compensable Compensable Hearing Settlement on damages Proffer Final Decision (no award of compensation) Final Decision (award of compensation) 23

Levels of Appeal in Vaccine Act Cases U.S. Supreme Court U.S. Court of Appeals for the Federal Circuit U.S. Court of Federal Claims Office of Special Masters

Office of Special Masters No Appeal Appeal Judgment CFC Affirm Reverse Reversal Remand Appeals Process Reverse CAFC Affirm Remand Reversal Supreme Court