CLOSED
U.S. District Court United States District Court for the Western District of Washington (Seattle)
CIVIL DOCKET FOR CASE #: 2:16-cv-00227-JCC

B.E. et al v. Teeter Assigned to: U.S. District Judge John C Coughenour Cause: 42:1983 Civil Rights Act

Date Filed: 02/16/2016 Date Terminated: 04/10/2017 Jury Demand: None Nature of Suit: 440 Civil Rights: Other Jurisdiction: Federal Question

Plaintiff B. E.

represented by Amy Louise Crewdson COLUMBIA LEGAL SERVICES (OLY) 711 CAPITOL WAY S STE 706 OLYMPIA, WA 98501 360-943-6260 Fax: 360-754-4578 Email: amy.crewdson@columbialegal.org LEAD ATTORNEY ATTORNEY TO BE NOTICED

Kevin Costello CENTER FOR HEALTH LAW & POLICY INNOVATION OF HARVARD LAW SCHOOL 122 BOYLSTON STREET JAMAICA PLAIN, MA 02130 617-390-2578 Email: kcostello@law.harvard.edu LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED

Richard E Spoonemore SIRIANNI YOUTZ SPOONEMORE HAMBURGER 3101 WESTERN AVENUE STE 350

Plaintiff
A. R. on their own behalf and on behalf of all similarly situated individuals

SEATTLE, WA 98121 206-223-0303 Fax: 206-223-0246 Email: rspoonemore@sylaw.com LEAD ATTORNEY ATTORNEY TO BE NOTICED
Eleanor Hamburger SIRIANNI YOUTZ SPOONEMORE HAMBURGER 3101 WESTERN AVENUE STE 350 SEATTLE, WA 98121 206-223-0303 Fax: 206-223-0246 Email: ehamburger@sylaw.com ATTORNEY TO BE NOTICED
represented by Amy Louise Crewdson (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Kevin Costello (See above for address) LEAD ATTORNEY PRO HAC VICE ATTORNEY TO BE NOTICED
Richard E Spoonemore (See above for address) LEAD ATTORNEY ATTORNEY TO BE NOTICED
Eleanor Hamburger (See above for address) ATTORNEY TO BE NOTICED

V.
Defendant
Dorothy F Teeter in her official capacity as Director

represented by Angela D. Coats McCarthy ATTORNEY GENERAL'S OFFICE (40124-OLY)

of the Washington State Health Care Authority

7141 CLEANWATER DR SW PO BOX 40124 OLYMPIA, WA 98504-0124 360-586-6484 Email: AngelaC3@atg.wa.gov ATTORNEY TO BE NOTICED
Jennifer Smith Meyer ATTORNEY GENERAL'S OFFICE (TORTS-OLY) TORTS DIVISION 7141 CLEANWATER DR SW PO BOX 40126 OLYMPIA, WA 98504-0126 360-586-6503 Fax: 360-586-6662 Email: jennifer.meyer@atg.wa.gov ATTORNEY TO BE NOTICED
Nissa Ann Iversen WASHINGTON STATE ATTORNEY GENERAL (CLEANWATER) 7141 CLEANWATER DRIVE SW OLYMPIA, WA 98504 360-753-2769 Fax: 360-586-6657 Email: NissaI@atg.wa.gov ATTORNEY TO BE NOTICED

Date Filed 02/16/2016
02/16/2016 02/17/2016

# Docket Text
1 COMPLAINT (CLASS ACTION) against defendant(s) Dorothy F Teeter (Receipt # 0981-4341269) Attorney Eleanor Hamburger added to party B. E.(pty:pla), Attorney Eleanor Hamburger added to party A. R.(pty:pla), filed by A. R., B. E.. (Attachments: # 1 Exhibit A)(Hamburger, Eleanor) (Entered: 02/16/2016)
2 CIVIL COVER SHEET re 1 Complaint, ; filed by Plaintiffs B. E., A. R.. (Attachments: # 1 Summons)(Hamburger, Eleanor) (Entered: 02/16/2016)
NOTICE to Filer: ATTACHMENTS FILED SEPARATELY:Please remember the Civil Cover Sheet and the Summons(es) should be attachments to your Complaint. The Summons(es) should never be

02/17/2016 02/17/2016 02/18/2016 02/18/2016
02/22/2016

attached to the Civil Cover Sheet, but instead, if you have forgotten to attach it to the Complaint, use the event "Praecipe For a Summons" found under "Other Documents." Thank you. (DJ) (Entered: 02/17/2016)
U.S. District Judge John C. Coughenour added. (DJ) (Entered: 02/17/2016)
3 Summons electronically issued as to defendant(s) Dorothy F. Teeter. (DJ) (Entered: 02/17/2016)
4 ORDER REGARDING DISCOVERY AND DEPOSITIONS by U.S. District Judge John C. Coughenour. (PP) (Entered: 02/18/2016)
5 MINUTE ENTRY re: STATUS CONFERENCE.
The attorney who will be responsible for trying the case should attend the conference and be prepared to discuss the following matters at the conference: 1. The nature of the case; 2. The status of matters which are presently set before the Court, e.g., hearings, motions, etc.; 3. The status of discovery and a time schedule for its completion; 4. A statement of any legal issues about which motions are contemplated and a possible briefing schedule; 5. An estimate of the number of days needed for trial; 6. Whether the case is jury or non-jury; 7. The date by which the case will be ready for trial; 8. Settlement probabilities; and 9. Whether the parties consent to proceed to trial before an assigned magistrate judge pursuant to 28 U.S.C. 636(c). If counsel's office is outside of the Greater Metropolitan Seattle area, arrangements may be made to participate telephonically in the conference by contacting the Courtroom Deputy Clerk at (206) 370-8805 at least TEN (10) days prior to the proceeding. Counsel do NOT need to file a Joint Status Report or Rule 26(f) Report in advance of the Status Conference. Counsel should plan on arriving 1015 minutes early to check in with the Courtroom Deputy Clerk, as the Court's calendar begins promptly at 9:00 a.m. COUNSEL OR THE PRO SE PARTY WHO FILED THIS MATTER SHALL IMMEDIATELY NOTIFY ALL PARTIES OF THE DATE AND TIME OF THE SCHEDULED STATUS CONFERENCE.
A Status Conference is set for 5/24/2016 at 9:00 AM in Courtroom 16206 before U.S. District Judge John C. Coughenour. (PP) (Entered: 02/18/2016)
6 MOTION To Redact Plaintiffs' Names re 1 Complaint, by Plaintiffs B. E., A. R.. (Attachments: # 1 Proposed Order Granting Motion to Redact Plaintiffs' Names) Noting Date 3/11/2016, (Hamburger, Eleanor) (Entered: 02/22/2016)

02/22/2016

7 DECLARATION of B.E. filed by Plaintiffs B. E., A. R. re 6 MOTION To Redact Plaintiffs' Names re 1 Complaint, (Hamburger, Eleanor) (Entered: 02/22/2016)

02/22/2016

8 DECLARATION of A.R. filed by Plaintiffs B. E., A. R. re 6 MOTION To Redact Plaintiffs' Names re 1 Complaint, (Hamburger, Eleanor) (Entered: 02/22/2016)

02/23/2016

9 AFFIDAVIT of Service of Summons and Complaint on WSHCA c/o (1) Dorothy F. Teeter, Director, and (2) Office of the Attorney General on 2/18/2016, filed by Plaintiffs B. E., A. R.. (Hamburger, Eleanor) (Entered: 02/23/2016)

02/24/2016

10 APPLICATION OF ATTORNEY Kevin Costello FOR LEAVE TO APPEAR PRO HAC VICE for Plaintiffs B. E., A. R. (Fee Paid) Receipt No. 0981-4351577 (Hamburger, Eleanor) (Entered: 02/24/2016)

02/24/2016

11 ORDER re 10 Application for Leave to Appear Pro Hac Vice. The Court ADMITS Attorney Kevin Costello for B. E., and A. R., by Clerk William M McCool. No document associated with this docket entry, text only.

NOTE TO COUNSEL: Local counsel agrees to sign all filings and to be prepared to handle the matter, including the trial thereof, in the event the applicant is unable to be present on any date scheduled by the court, pursuant to LCR 83.1(d).(DS) (Entered: 02/24/2016)

02/24/2016

12 NOTICE of Appearance by attorney Angela D. Coats McCarthy on behalf of Defendant Dorothy F Teeter. (Coats McCarthy, Angela) (Entered: 02/24/2016)

02/24/2016

13 DECLARATION of Service filed by Plaintiffs B. E., A. R. re 6 MOTION To Redact Plaintiffs' Names re 1 Complaint, (Hamburger, Eleanor) (Entered: 02/24/2016)

02/25/2016

Attorney Nissa Ann Iversen for defendant Dorothy F Teeter added; per 12 Notice of Appearance. (CDA) (Entered: 02/25/2016)

03/07/2016

14 RESPONSE, by Defendant Dorothy F Teeter, to 6 MOTION To Redact Plaintiffs' Names re 1 Complaint, . (Iversen, Nissa) (Entered: 03/07/2016)

03/10/2016

15 REPLY, filed by Plaintiffs B. E., A. R., TO RESPONSE to 6 MOTION To Redact Plaintiffs' Names re 1 Complaint, (Hamburger, Eleanor) (Entered: 03/10/2016)

03/10/2016 16 ANSWER to 1 Complaint, by Dorothy F Teeter.(Iversen, Nissa) (Entered: 03/10/2016)

03/18/2016 17 MOTION to Certify Class by Plaintiffs B. E., A. R.. Noting Date 4/15/2016, (Hamburger, Eleanor) (Entered: 03/18/2016)

03/18/2016 18 MOTION for Preliminary Injunction by Plaintiffs B. E., A. R.. Noting Date 4/15/2016, (Hamburger, Eleanor) (Entered: 03/18/2016)

03/18/2016 19 DECLARATION of Robert G. Gish, M.D. filed by Plaintiffs B. E., A. R.

re 17 MOTION to Certify Class , 18 MOTION for Preliminary Injunction (Attachments: # 1 Exhibit A-K)(Hamburger, Eleanor) (Entered: 03/18/2016)

03/18/2016

20 DECLARATION of Richard E. Spoonemore filed by Plaintiffs B. E., A. R. re 17 MOTION to Certify Class (Hamburger, Eleanor) (Entered: 03/18/2016)

03/18/2016

21 DECLARATION of Amy L. Crewdson filed by Plaintiffs B. E., A. R. re 17 MOTION to Certify Class (Hamburger, Eleanor) (Entered: 03/18/2016)

03/18/2016

22 DECLARATION of Kevin Costello filed by Plaintiffs B. E., A. R. re 17 MOTION to Certify Class (Hamburger, Eleanor) (Entered: 03/18/2016)

03/18/2016 23 DECLARATION of Elizabeth Landry filed by Plaintiffs B. E., A. R.

re 18 MOTION for Preliminary Injunction (Attachments: # 1 Exhibit A-D)(Hamburger, Eleanor) (Entered: 03/18/2016)

03/18/2016 24 DECLARATION of Eleanor Hamburger filed by Plaintiffs B. E., A. R.

re 17 MOTION to Certify Class , 18 MOTION for Preliminary Injunction (Attachments: # 1 Exhibit A-H)(Hamburger, Eleanor) (Entered: 03/18/2016)

03/23/2016 25 ERRATA re 18 MOTION for Preliminary Injunction by Plaintiffs B. E., A. R. (Spoonemore, Richard) (Entered: 03/23/2016)

03/31/2016 26 NOTICE of Appearance by attorney Jennifer Smith Meyer on behalf of Defendant Dorothy F Teeter. (Meyer, Jennifer) (Entered: 03/31/2016)

04/07/2016

27 MINUTE ORDER by U.S. District Judge John C Coughenour granting plaintiffs' 6 unopposed motion to have their names redacted. (AD) (Entered: 04/07/2016)

04/11/2016 28 RESPONSE, by Defendant Dorothy F Teeter, to 17 MOTION to Certify Class . (Coats McCarthy, Angela) (Entered: 04/11/2016)

04/11/2016

29 RESPONSE, by Defendant Dorothy F Teeter, to 18 MOTION for Preliminary Injunction . (Coats McCarthy, Angela) (Entered: 04/11/2016)

04/11/2016 30 DISREGARD, DOCUMENT TO BE REFILED/DECLARATION of Evelyn Cantrell filed by Defendant Dorothy F Teeter re 17 MOTION to

Certify Class , 18 MOTION for Preliminary Injunction (Attachments: # 1 SEALED Attachment A, # 2 SEALED Attachment B, # 3 SEALED Attachment C)(Coats McCarthy, Angela) Modified on 4/12/2016 (RS). (Entered: 04/11/2016)

04/11/2016 31 DECLARATION of Dr. Daniel Lessler filed by Defendant Dorothy F

Teeter re 17 MOTION to Certify Class , 18 MOTION for Preliminary Injunction (Coats McCarthy, Angela) (Entered: 04/11/2016)

04/11/2016 32 DECLARATION of Nissa A. Iversen filed by Defendant Dorothy F

Teeter re 17 MOTION to Certify Class , 18 MOTION for Preliminary Injunction (Attachments: # 1 Attachment A, # 2 Attachment B)(Coats McCarthy, Angela) (Entered: 04/11/2016)

04/11/2016 33 DECLARATION of MaryAnne Lindeblad filed by Defendant Dorothy F

Teeter re 18 MOTION for Preliminary Injunction (Coats McCarthy, Angela) (Entered: 04/11/2016)

04/12/2016

NOTICE of Docket Text Modification re 30 Declaration, : Document to be refiled, attachments have been sealed and redacted versions to be filed (RS) (Entered: 04/12/2016)

04/12/2016 34 DECLARATION of Evelyn Cantrell filed by Defendant Dorothy F

Teeter re 17 MOTION to Certify Class , 18 MOTION for Preliminary Injunction (Attachments: # 1 Attachment A, # 2 Attachment B, # 3 Attachment C)(Coats McCarthy, Angela) (Entered: 04/12/2016)

04/15/2016 35 REPLY, filed by Plaintiffs B. E., A. R., TO RESPONSE to 18

MOTION for Preliminary Injunction (Spoonemore, Richard) (Entered: 04/15/2016)

04/15/2016 36 REPLY, filed by Plaintiffs B. E., A. R., TO RESPONSE to 17 MOTION to Certify Class (Spoonemore, Richard) (Entered: 04/15/2016)

04/15/2016 37 Supplemental DECLARATION of Eleanor Hamburger filed by Plaintiffs

B. E., A. R. re 17 MOTION to Certify Class , 18 MOTION for Preliminary Injunction (Attachments: # 1 Exhibit I-K)(Spoonemore, Richard) (Entered: 04/15/2016)

04/15/2016

38 PROPOSED ORDER (Unsigned) re 35 Reply to Response to Motion, 36 Reply to Response to Motion re (1) Class Certification, and (2) Preliminary Injunction (Spoonemore, Richard) (Entered: 04/15/2016)

05/16/2016

39 NOTICE OF RESCHEDULED STATUS CONFERENCE. The Court, on its own motion and in the interest of judicial economy, specifically, two pending motions by Plaintiff, hereby orders the Status Conference RESET from 5/24/17 to 7/26/2016 at 9:00 AM in Courtroom 16206 before U.S. District Judge John C. Coughenour.(PP) (Entered: 05/16/2016)

05/27/2016

40 ORDER granting plaintiffs' 18 Motion for Preliminary Injunction; joint status report due in 60 days by U.S. District Judge John C Coughenour.(RS) (Entered: 05/27/2016)

06/01/2016

41 MINUTE ORDER REQUESTING ADDITIONAL BRIEFING by U.S. District Judge John C Coughenour re Plaintiffs' 17 MOTION for class certification. Plaintiffs' brief due 6/8/2016; Defendant's response brief due 6/15/2016; Plaintiffs' optional reply brief due 6/17/2016. Motion is RENOTED for 6/17/2016. (PM) (Entered: 06/01/2016)

06/08/2016

42 SUPPLEMENT re 41 Order to Re-Note Motion, [Plaintiffs' Supplemental Briefing in Support of Class Certification] by Plaintiffs B. E., A. R. (Hamburger, Eleanor) (Entered: 06/08/2016)

06/08/2016

43 DECLARATION (w-Ex. A) of Jeffrey Keddie re 42 Supplement, 41 Order to Re-Note Motion, by Plaintiffs B. E., A. R. (Hamburger, Eleanor) (Entered: 06/08/2016)

06/08/2016

44 DECLARATION (w-Exs. A-E) of Eleanor Hamburger re 43 Declaration (non motion), 42 Supplement, 41 Order to Re-Note Motion, by Plaintiffs B. E., A. R. (Hamburger, Eleanor) (Entered: 06/08/2016)

06/15/2016

45 RESPONSE by Defendant Dorothy F Teeter to Pltfs' Supplemental Briefing in Support of Class Certification (Iversen, Nissa) (Entered: 06/15/2016)

06/15/2016

46 DECLARATION of Angela Coats McCarthy re 45 Response (non motion) by Defendant Dorothy F Teeter (Attachments: # 1 Attach. A, # 2 Attach. B, # 3 Attach. C, # 4 Attach. D)(Iversen, Nissa) (Entered: 06/15/2016)

06/15/2016

47 DECLARATION of Trudi Glant re 45 Response (non motion) by Defendant Dorothy F Teeter (Attachments: # 1 Attach. A, # 2 Attach. B)(Iversen, Nissa) (Entered: 06/15/2016)

06/17/2016 48 SUPPLEMENT re 41 Order to Re-Note Motion, Plaintiffs' Reply Brief by Plaintiffs B. E., A. R. (Crewdson, Amy) (Entered: 06/17/2016)

06/17/2016

49 DECLARATION of Amy L. Crewdson re 48 Supplement, 41 Order to Re-Note Motion, by Plaintiffs B. E., A. R. (Attachments: # 1 Exhibit Exhibit A to Declaration of Amy L. Crewdson)(Crewdson, Amy) (Entered: 06/17/2016)

06/20/2016

50 SUPPLEMENT re 41 Order to Re-Note Motion, Defendants' Response Briefing by Defendant Dorothy F Teeter (Meyer, Jennifer) (Entered: 06/20/2016)

06/20/2016

51 DECLARATION of Jennifer Kennedy re 50 Supplement by Defendant Dorothy F Teeter (Attachments: # 1 Attachment A)(Meyer, Jennifer) (Entered: 06/20/2016)

06/20/2016

52 DECLARATION of Donna Sullivan re 50 Supplement by Defendant Dorothy F Teeter (Attachments: # 1 Attachment A)(Meyer, Jennifer) (Entered: 06/20/2016)

06/29/2016

53 NOTICE OF RESCHEDULED STATUS CONFERENCE. The Court, on its own motion, hereby orders the Status Conference continued from 7/26/16 to 9/13/2016 at 9:00 AM in Courtroom 16206 before U.S. District Judge John C. Coughenour.(PP) (Entered: 06/29/2016)

07/21/2016

54 ORDER CERTIFYING CLASS by U.S. District Judge John C Coughenour granting Plaintiffs' 17 Motion for Class Certification. The Court further appoints B.E. and A.R. as class representatives and appoints Richard E. Spoonemore and Eleanor Hamburger of Sirianni Youtz Spoonemore Hamburger, Amy L. Crewdson of Columbia Legal Services, and Kevin Costello of Harvard Law School Center for Health Law and Policy Innovation as class counsel. (PM) (Entered: 07/21/2016)

07/26/2016 55 JOINT STATUS REPORT signed by all parties (Coats McCarthy, Angela) (Entered: 07/26/2016)

09/13/2016 56 MINUTE ENTRY for proceedings held before U.S. District Judge John C. Coughenour; CRD: Paul Pierson; Plaintiffs' Counsel: Richard

Spoonemore; Defense Counsel: Angela McCarthy & Jennifer Meyer; CR: Nicki Drury; Time of Hearing: 9:00 am; Courtroom: 16206;Status Conference was held on 9/13/2016. Counsel respond to the Court's inquiry concerning the proposed class notice and related further proceedings. The Court orders counsel to return for a further Status Hearing set on 10/11/2016 at 9:00 AM in Courtroom 16206 before U.S. District Judge John C. Coughenour. (PP) (Entered: 09/13/2016)

10/11/2016

57 MINUTE ENTRY for proceedings held before U.S. District Judge John C. Coughenour; CRD: Paul Pierson; Plaintiffs' Counsel: Richard Spoonemore; Defense Counsel: Angela McCarthy & Jennifer Meyer; CR: Nicki Drury; Time of Hearing: 9:00 am; Courtroom: 16206;Status Hearing was held on 10/11/2016. Counsel advised the Court that a settlement is pending and the Court ordered counsel to return for a Further Status Hearing set for 10/25/2016 at 9:00 AM in Courtroom 16206 before U.S. District Judge John C. Coughenour. (PP) (Entered: 10/11/2016)

10/20/2016

58 MINUTE ORDER by U.S. District Judge John C Coughenour per parties' telephonic notice of settlement, the status conference scheduled for October 25, 2016, is VACATED. Parties to file a motion for preliminary approval by 11/21/2016. (PM) (Entered: 10/20/2016)

11/21/2016

59 Unopposed MOTION (1) Preliminary Approval of Settlement Agreement; (2) Approval of Class Notice Package; (3) Establish Final Settlement Approval Hearing and Process re 58 Minute Order, Terminate Deadlines and Hearings by Plaintiffs B. E., A. R.. (Attachments: # 1 Exhibit Appendices A-D) Noting Date 12/9/2016, (Spoonemore, Richard) (Entered: 11/21/2016)

11/21/2016

60 DECLARATION of Richard E. Spoonemore filed by Plaintiffs B. E., A. R. re 59 Unopposed MOTION (1) Preliminary Approval of Settlement Agreement; (2) Approval of Class Notice Package; (3) Establish Final Settlement Approval Hearing and Process re 58 Minute Order, Terminate Deadlines and Hearings (Spoonemore, Richard) (Entered: 11/21/2016)

11/21/2016

61 PROPOSED ORDER (Unsigned) re 59 Unopposed MOTION (1) Preliminary Approval of Settlement Agreement; (2) Approval of Class Notice Package; (3) Establish Final Settlement Approval Hearing and Process re 58 Minute Order, Terminate Deadlines and Hearings (Spoonemore, Richard) (Entered: 11/21/2016)

01/03/2017

62 NOTICE of Change of Address/Change of Name of Attorney Eleanor Hamburger. Filed by Plaintiffs B. E., A. R.. (Hamburger, Eleanor) (Entered: 01/03/2017)

01/05/2017

63 ORDER granting plaintiff's 59 Motion for an order preliminarily approving the settlement; Fairness Hearing set for 4/4/2017 at 09:00 AM before U.S. District Judge John C Coughenour. by U.S. District Judge John C Coughenour.(RS) (Entered: 01/05/2017)

01/11/2017

64 Stipulated MOTION RE: CLASS NOTICE, filed by Plaintiffs B. E., A. R.. (Attachments: # 1 Proposed Order) Noting Date 1/11/2017, (Crewdson, Amy) (Entered: 01/11/2017)

01/12/2017

65 MINUTE ORDER granting parties' 64 stipulated motion to translate the class notice into Spanish. Authorized by U.S. District Judge John C Coughenour. (PM) (Entered: 01/12/2017)

02/02/2017

67 SEALED LETTER filed by non party potential class member (RS) Modified on 3/14/2017: letter emailed to counsel (PM). (Entered: 02/09/2017)

02/06/2017

66 DECLARATION of Nissa A. Iversen re 63 Order on Motion for Miscellaneous Relief, Set/Reset Hearings by Defendant Dorothy F Teeter (Iversen, Nissa) (Entered: 02/06/2017)

02/17/2017

68 Unopposed MOTION for Attorney Fees , Costs and Incentive Awards, filed by Plaintiffs B. E., A. R.. Noting Date 4/4/2017, (Spoonemore, Richard) (Entered: 02/17/2017)

02/17/2017

69 DECLARATION of Kevin Costello filed by Plaintiffs B. E., A. R. re 68 Unopposed MOTION for Attorney Fees , Costs and Incentive Awards (Spoonemore, Richard) (Entered: 02/17/2017)

02/17/2017

70 DECLARATION of Amy L. Crewdson filed by Plaintiffs B. E., A. R. re 68 Unopposed MOTION for Attorney Fees , Costs and Incentive Awards (Spoonemore, Richard) (Entered: 02/17/2017)

02/17/2017

71 DECLARATION of Eleanor Hamburger filed by Plaintiffs B. E., A. R. re 68 Unopposed MOTION for Attorney Fees , Costs and Incentive Awards (Spoonemore, Richard) (Entered: 02/17/2017)

02/17/2017

72 DECLARATION of Richard E. Spoonemore filed by Plaintiffs B. E., A. R. re 68 Unopposed MOTION for Attorney Fees , Costs and Incentive Awards (Spoonemore, Richard) (Entered: 02/17/2017)

03/09/2017

73 SEALED LETTER filed by non party potential class member, S.R. (PM) Modified on 3/14/2017: letter emailed to counsel on 3/14/2017 (PM). (Entered: 03/10/2017)

03/10/2017

74 SEALED LETTER filed by non party potential class member K.R.S. (PM) Modified on 3/14/2017: letter emailed to counsel on 3/14/2017 (PM). (Entered: 03/13/2017)

03/14/2017

NOTICE of Docket Text Modification re 74 Sealed Letter, 73 Sealed Letter: letters emailed to counsel per direction of chambers. Dkt. 67 Sealed Letter was previously emailed to counsel on 3/9/2017. (PM) (Entered: 03/14/2017)

03/16/2017

75 SEALED LETTER filed by non-party potential class member, D.G. (swt) (cc: all counsel via email) Modified text on 3/16/2017 (swt). (Entered: 03/16/2017)

03/16/2017

76 SEALED LETTER filed by non-party potential class member, T.C. (swt) (cc: all counsel via email) Modified text on 3/16/2017 (swt). (Entered: 03/16/2017)

03/16/2017 77 SEALED LETTER filed by non-party potential class member, E.A. (swt) (cc: all counsel via email) (Entered: 03/16/2017)

03/20/2017 78 SEALED LETTER filed by non-party potential class member, M.D. (swt) (cc: all counsel via email) (Entered: 03/20/2017)

03/21/2017 79 SEALED LETTER filed by non-party potential class member, C.R. (swt) (cc: all counsel via email) (Entered: 03/21/2017)

03/21/2017 80 SEALED LETTER filed by non-party potential class member, N.B. (swt) (cc: all counsel via email) (Entered: 03/23/2017)

03/24/2017 81 SEALED LETTER filed by non-party potential class member, J.H. (cc: all counsel via email) (RS) (Entered: 03/28/2017)

03/24/2017 82 SEALED LETTER filed by non-party potential class member, A.K. (cc: all counsel via email) (RS) (Entered: 03/28/2017)

03/28/2017

83 MOTION for Final Approval of Settlement Agreement, Award of Attorneys' Fees, Litigation Costs and Case Contribution Awards to Plaintiffs re 63 Order on Motion for Miscellaneous Relief, Set/Reset Hearings , filed by Plaintiffs B. E., A. R.. (Attachments: # 1 Proposed Order (1) Granting Final Approval of Settlement Agmt; (2) Approving Attorneys' Fees and Costs; and (3) Approving Incentive Award) Noting Date 4/4/2017, (Spoonemore, Richard) (Entered: 03/28/2017)

03/28/2017

84 DECLARATION of Eleanor Hamburger filed by Plaintiffs B. E., A. R. re 83 MOTION for Final Approval of Settlement Agreement, Award of Attorneys' Fees, Litigation Costs and Case Contribution Awards to Plaintiffs re 63 Order on Motion for Miscellaneous Relief, Set/Reset

Hearings (Attachments: # 1 Exhibit A-H (index sheets only) - Exhibits Filed Under Seal)(Spoonemore, Richard) (Entered: 03/28/2017)

03/28/2017

85 SEALED DOCUMENT Exhibits A-H to Declaration of Eleanor Hamburger by Plaintiffs B. E., A. R. re 27 Order on Motion for Miscellaneous Relief, 84 Declaration, (Spoonemore, Richard) (Entered: 03/28/2017)

03/30/2017 86 SEALED DOCUMENT filed by non-party potential class member, H.K. (cc: all counsel via email) (PM) (Entered: 03/31/2017)

04/10/2017

87 ORDER FINALLY APPROVING CLASS SETTLEMENT granting Plaintiff's 83 Motion. The Settlement Agreement is approved as fair, reasonable, and adequate under Federal Rule of Civil Procedure 23. WHCA is required to provide coverage for direct-acting antivirals (DAAs) for the treatment of HCV as set forth in paragraph 11 of order. Class counsel is awarded fees and litigation costs in the amounts of $335,377 and $8,016.86, respectively. Case contribution awards of $7,500 per named Plaintiff as set forth in the Agreement are approved. Signed by U.S. District Judge John C Coughenour. (PM) (Entered: 04/10/2017)

04/10/2017 88 JUDGMENT BY COURT. The Court finally approved the class settlement agreement. (PM) (Entered: 04/10/2017)

05/23/2019 89 LETTER from Joseph L. Walker requesting a copy of the docket. Copy sent via USPS. (MW) (Entered: 05/28/2019)

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 Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 1 of 16

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UNITED STATES DISTRICT COURT

WESTERN DISTRICT OF WASHINGTON
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AT SEATTLE

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B. E. and A. R., on their own behalf and on 11 behalf of all similarly situated individuals,

NO. 2:16-cv-227

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Plaintiffs,

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v.

14 DOROTHY F. TEETER, in her official 15 capacity as Director of the Washington State
Health Care Authority,
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Defendant.
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COMPLAINT (CLASS ACTION)

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I. INTRODUCTION

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Plaintiffs are Medicaid enrollees who have contracted Hepatitis C, a

20 communicable disease that afflicts millions of Americans. There is a cure for Plaintiffs

and thousands of others, but the Washington State Health Care Authority does not cover
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22 curative, breakthrough drugs for all Medicaid beneficiaries for one impermissible

23 reason: they are expensive. It is unlawful to withhold prescription drugs that cure a

disease from Medicaid beneficiaries based on the cost of those drugs. Plaintiffs ask this
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25 Court to order the Health Care Authority to cover these drugs so they and others

26 similarly situated may be cured.

COMPLAINT (CLASS ACTION) – 1

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 2 of 16

II. PARTIES
1
1. B.E. Plaintiff B.E. is a resident of Seattle, Washington. Ms. E. is eligible for
2
and enrolled in Medicaid, which is administered by the Washington state Health Care
3
Authority (“WHCA”). Ms. E. is diagnosed with Hepatitis C virus (“HCV”). Her treating
4
provider prescribed Harvoni®, ledipasvir-sofosbuvir (“Harvoni”), a prescription drug
5
that effectively cures the disease in more than 90% of the individuals who are treated
6
with it. When she attempted to fill her prescription through her Medicaid coverage,
7
WHCA denied Ms. E.’s request because Harvoni is expensive. WHCA did not offer
8
Ms. E. any other medication as an alternative to treat her HCV.
9
2. A.R. Plaintiff A.R. is a resident of Lakewood, Washington. Mr. R. is also
10
eligible for and enrolled in Medicaid. He is also diagnosed with HCV for which his
11
treating medical provider has prescribed Harvoni. WHCA also denied Mr. R.’s request
12
for Harvoni for the same reason it denied B.E.’s request. WHCA did not offer Mr. R. any
13
other medication as an alternative to treat his HCV.
14
3. Dorothy F. Teeter. Defendant Dorothy F. Teeter is the Director of the
15
Washington State Health Care Authority. WHCA is the designated single state agency
16
for Washington’s Medicaid programs. Ms. Teeter is responsible for ensuring that the
17
Medicaid program is administered in a manner consistent with all state and federal laws,
18
including the Medicaid Act. Ms. Teeter is sued in her official capacity only. All alleged
19
acts by Ms. Teeter and WHCA were made under color of state law.
20
III. JURISDICTION AND VENUE
21
4. Jurisdiction. Jurisdiction of this Court arises under 28 U.S.C. § 1331
22
because this action arises under the laws of the United States, and 28 U.S.C. § 1343(3)
23
and (4), which confer on the federal district courts original jurisdiction over all claims
24
asserted pursuant to 42 U.S.C. § 1983 to redress deprivations of rights, privileges or
25
immunities guaranteed by Acts of Congress and the United States Constitution.
26

COMPLAINT (CLASS ACTION) – 2

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 3 of 16

1

5. Venue. Venue is proper pursuant to 28 U.S.C. § 1391(b). A substantial part

2 of the events or omissions giving rise to plaintiffs’ claims occurred in the Western District

3 of Washington, and defendants may be found here.

4

IV. NATURE OF THE CASE

5

6. Plaintiffs’ Need for Treatment with Harvoni. Both Ms. E. and Mr. R. have

6 been diagnosed with Hepatitis C (“HCV”). Both seek treatment with Harvoni, one of

7 several direct-acting antiviral medications (“DAAs”) recommended for nearly all

8 patients diagnosed with chronic HCV infection by the American Association for the

9 Study of Liver Diseases and the Infectious Diseases Society of America. Treatment

10 results in a more than 90% cure rate. There is no alternative medication or medical

11 intervention that would provide Ms. E. or Mr. R. with equally beneficial results.

12

7. WHCA Limits Coverage for Harvoni and other DAAs for Fiscal Reasons

13 Only. WHCA, pursuant to a uniform coverage policy, will not approve plaintiffs’

14 treatment with Harvoni. WHCA has put in place internal coverage restrictions that

15 impermissibly restrict DAA coverage. Specifically, WHCA rations HCV treatment,

16 excluding all coverage except to its insureds who are most severely ill. The restrictions

17 on coverage do not have a clinical purpose, but are imposed solely due to WHCA’s fiscal

18 concerns.

19

8. WHCA’s Uniform Policy Risks the Lives and Health of Medicaid

20 Enrollees. WHCA’s restrictive internal coverage criteria require that infected

21 individuals wait for treatment – potentially for years – until they demonstrate serious

22 scarring or cirrhosis of the liver from HCV infection. In the meantime, Ms. E., Mr. R. and

23 others are forced to live with a chronic inflammatory disease, including the pain, fatigue,

24 depression, deteriorating health and increased risk of cancer and death that accompany

25 it.

26

COMPLAINT (CLASS ACTION) – 3

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 4 of 16

1

9. WHCA’s Restrictive Coverage Criteria Violate the Medicaid Act. This

2 lawsuit seeks to end WHCA’s improper exclusion of Harvoni and other DAAs for the

3 treatment of HCV for certain enrollees. It seeks legal and equitable remedies against

4 WHCA on behalf of plaintiffs and the class they seek to represent. It also seeks a court

5 order declaring WHCA’s internal categorical exclusionary criteria illegal, void, and

6 inconsistent with its obligations to provide reasonably prompt coverage of medically

7 necessary prescription drugs to all Medicaid enrollees to whom they are prescribed. The

8 lawsuit further seeks an injunction to prevent any future or ongoing efforts by WHCA

9 to use and enforce any policies or practices that impermissibly deny, exclude or limit its

10 insureds’ access to medically necessary prescription drugs to treat HCV, in addition to

11 ensuring that both coverage and corrective notice be provided to its insureds.

12

V. FACTUAL AND LEGAL FRAMEWORK

13

HCV TREATMENT

14

10. HCV Is Widespread. HCV is a chronic, life-threatening, communicable,

15 blood-borne viral disease. It is estimated that approximately five million individuals in

16 the United States are living with HCV, accounting for over 1% of the population. The

17 Washington Department of Health estimates over 100,000 Washington residents are

18 infected with HCV.

19

11. HCV Is a Serious Disease. In addition to the baseline manifestation of

20 chronic inflammation throughout the body, HCV can lead to severe liver damage,

21 infections, liver cancer, and death. Nearly 20,000 people in the United States die each

22 year due to liver disease caused by HCV. See http://www.cdc.gov/hepatitis/

23 Statistics/index.htm (last visited 1/25/16). Even before the advanced stages of the

24 disease, individuals with HCV can suffer from heart attacks, fatigue, joint pain,

25 depression, sore muscles, arthritis and jaundice. Statistics from the Centers for Disease

26 Control and Prevention indicate that up to 70% of those with HCV will develop chronic

COMPLAINT (CLASS ACTION) – 4

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 5 of 16

1 liver disease, 20% will develop cirrhosis, and 5% will develop liver cancer. HCV is the

2 leading indication for liver transplants in the United States. See

3 http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm (last visited 2/3/16).

4

12. Severity of HCV Is Measured by a Fibrosis Score. Liver health for those

5 who are infected with HCV is graded according to the level of liver scarring under a

6 fibrosis score. The scoring ranges from a score of F0 (mild scarring or scarring absent)

7 to F4 (significant liver damage; cirrhosis).

8

13. Prior Treatments Were Expensive, Often Ineffective and Accompanied by

9 Significant Side Effects. Until DAAs were approved, the standard of care for the

10 treatment of HCV was a three-drug treatment containing boceprevir, interferon and

11 ribavirin. The treatment only provided at most a 70% cure rate, and was accompanied

12 by significant adverse side effects such as anemia, insomnia, anxiety, depression, nausea,

13 bone pain, muscle, liver failure, joint pain, memory loss and death. On information and

14 belief, WHCA covered the three-drug treatment for any Medicaid beneficiary who was

15 HCV irrespective of the person’s Metavir Fibrosis score.

16

14. FDA Approves Harvoni and other DAAs as a “Breakthrough Therapy.”

17 Fortunately for Ms. E., Mr. R. and others like them, the federal Food and Drug

18 Administration (“FDA”) has approved DAAs, a class of curative pharmaceutical drug

19 treatments for HCV. One such DAA, Harvoni, was approved on October 10, 2014. It

20 has a success rate over 90% and is accompanied by few, if any, side effects. Harvoni was

21 designated a “breakthrough therapy” by the FDA, a classification reserved for drugs that

22 have proven to provide substantial improvement over available therapies for patients

23 with serious or life-threatening diseases.

24

15. Harvoni and Other DAAs Are Recommended for Nearly All Patients with

25 HCV, Without Regard for Fibrosis Score. Harvoni and other DAAs are the standard of

26 medical care for the treatment of all HCV. This includes treatment of all individuals

COMPLAINT (CLASS ACTION) – 5

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 6 of 16

1 irrespective of fibrosis score. Treatment guidelines approved by the American

2 Association for the Study of Liver Diseases and the Infectious Diseases Society of

3 America (“AASLD/IDSA”) confirm that Harvoni and other DAAs should not be

4 reserved for only individuals with fibrosis scores of F3 and F4. See

5 http://hcvguidelines.org/ (last visited 1/25/16). Rather, the standard of care is treating

6 “all patients with chronic HCV infection, except those with short life expectancies that

7 cannot be remediated by treated HCV, by transplantation, or by other directed therapy.”

8 See http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy (last

9 visited 1/25/16). Treating nearly all HCV patients is the standard of care in the

10 community.

11

16. There Is No Equally Effective Alternative Medication or Medical

12 Intervention. DAAs are the only medication or medical intervention for HCV that

13 produce a sustained virologic response (“SVR”) in more than 90% of patients. SVR

14 status means that the virus is virtually undetectable in a patient; this is considered to be

15 a cure of the infection. The prior intervention offered to HCV patients, treatment with

16 boceprevir, interferon and ribavirin, only produced SVR in approximately 70% of

17 patients, resulted in a host of adverse side effects. Without treatment, Medicaid enrollees

18 infected with chronic HCV will never rid themselves of the inflammatory disease,

19 placing these Medicaid enrollees at significantly higher risk for extrahepatic symptoms,

20 liver disease, liver cancer, and even death.

21

17. People with HCV Can Transmit It. HCV is a communicable disease. The

22 CDC lists people known to be at increased risk for HCV infection. See

23 http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm (last visited 2/3/16). Among those at

24 risk are health care workers after needle-sticks involving HCV-positive blood, and

25 infants born to HCV-positive mothers. WHCA’s policy of restricting DAAs ignores the

26 public health risks associated with not curing HCV.

COMPLAINT (CLASS ACTION) – 6

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 7 of 16

THE MEDICAID ACT REQUIRES COVERAGE OF DAAs TO TREAT HCV.
1
18. The Medicaid Act Includes Prescription Drug Coverage. The Medicaid Act
2
requires participating state programs (known as “State Medicaid Plans”) to make
3
medical assistance available to qualified individuals for certain services. 42 U.S.C.
4
§ 1396a(a)(10)(A). The State Medicaid Plan has the option to make medical assistance
5
available for other specified services, including prescription drugs. 42 U.S.C.
6
§ 1396d(a)(12). Once the state chooses to provide medical assistance prescription drugs,
7
it must comply with the requirements of § 1396r–8(k) for payments of covered outpatient
8
drugs. 42 U.S.C. § 1396a(a)(54). Washington state has chosen to provide prescription
9
drug coverage as part of its State Medicaid Plan.
10
19. All of the Requirements for Coverage Of DAAs Under Washington’s State
11
Medicaid Plan Are Met. State Medicaid plans, including Washington’s, are generally
12
required to provide coverage for any covered outpatient drug that is medically necessary
13
once the drug manufacturer enters into a rebate agreement and the medicine is approved
14
by the FDA and prescribed by a provider. Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S.
15
644, 652, 123 S. Ct. 1855 (2003) (“PHARMA”); 42 U.S.C. §§ 1396r-8(a)(1), 1396r-8(d)(B),
16
1396r-8(k)(2)(A); (6). WHCA covers DAAs, including Harvoni, under the Washington
17
State Medicaid Plan, but only for the most severely ill individuals with HCV. WHCA
18
refuses to cover the medication for Medicaid enrollees with less severe liver damage or
19
other symptoms of HCV, even though the medications will likely cure them.
20
20. Covered Prescription Drugs, Including DAAs, Must Be Provided When
21
Medically Necessary, with “Reasonable Promptness,” for All Comparable Medicaid
22
Enrollees. Since Harvoni and other DAAs meet the standard for coverage under
23
Washington’s Medicaid program, the Medicaid Act requires coverage of the medicine
24
when it is medically indicated. 42 U.S.C. §§ 1396a(a)(10)(A); 1396r-8. See also WAC
25
182-500-0070 (defining “medical necessity” in Washington’s Medicaid program). Under
26

COMPLAINT (CLASS ACTION) – 7

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 8 of 16

1 Washington’s Medicaid program, if the treatment is covered and medically necessary, it

2 must also be provided with “reasonable promptness,” typically within 90 days.

3 42 U.S.C. § 1396a(a)(8); Doe v. Chiles, 136 F.3d 709, 714 (11th Cir. 1988). In addition,

4 medically necessary prescription drug coverage, including access to Harvoni and other

5 DAAs, cannot be made available in a lesser amount, duration or scope than the coverage

6 made available to any other individual eligible under the State Medicaid Plan. 42 U.S.C.

7 § 1396a(a)(10)(B); 42 C.F.R. § 440.240. This is known as Medicaid’s “comparability”

8 requirement. See Jenkins v. Washington Department of Social and Health Services, 162 Wn.

9 2d 287, 296-97 (2007). WHCA’s coverage criteria for HCV treatment must comply with

10 all three of these Medicaid Act requirements.

11

WHCA’S UNIFORM EXCLUSIONARY COVERAGE CRITERIA

12

21. WHCA Has Adopted Coverage Criteria for Harvoni and Other DAAs.

13 WHCA has adopted a uniform coverage approach with respect to when and under what

14 conditions it will approve Harvoni and other similar DAAs for coverage under

15 Washington’s Medicaid program. A copy of WHCA’s Coverage Criteria is attached as

16 Appendix 1.

17

22. WHCA Does Not Provide Coverage for All Its HCV-infected Insureds.

18 WHCA’s coverage criteria generally exclude coverage for Harvoni and other DAAs for

19 Medicaid enrollees with fibrosis scores of F0, F1 and F2 where no other conditions are

20 present.

21

23. WHCA’s Coverage Criteria Are Inconsistent With Accepted Medical

22 Practice. WHCA has no clinical or medical basis to deny treatment to Medicaid

23 enrollees who have a fibrosis score of F0, F1 or F2. On the contrary, the HCV Guidelines

24 provide that “[b]ecause of the myriad benefits associated with successful HCV

25 treatment, clinicians should treat HCV-infected patients with antiviral therapy with the

26 goal of achieving an SVR, preferably early in the course of their chronic HCV infection

COMPLAINT (CLASS ACTION) – 8

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 9 of 16

1 before the development of severe liver disease and other complications.” See

2 http://hcvguidelines.org/full-report/when-and-whom-initiate-hcv-therapy

(last

3 visited 1/25/16) (emphasis added). Treatment of HCV even in patients with mild or no

4 liver disease decreases complications and death rate due to liver disease and prevents

5 transmission of HCV to others.

6

24. WHCA’s Coverage Criteria Put Medicaid Enrollees at Risk of Multiple

7 HCV Complications, Including Death. WHCA’s Medicaid enrollees who meet the

8 standards set forth by the American Association for the Study of Liver Diseases and the

9 Infectious Diseases Society of America, but who are excluded under WHCA’s coverage

10 criteria, are put at risk. They are needlessly exposed to health conditions caused by

11 HCV, including cirrhosis, cancer, fatigue, joint pain, depression, sore muscles, arthritis,

12 avoidable liver transplants, jaundice and even death. In addition, the lack of treatment

13 of infected individuals increases the chance that members of the insured’s household

14 and the public will be exposed to and contract HCV.

15

25. WHCA Has Publicly Stated Its Coverage Position. WHCA’s coverage

16 position is publicly posted on WHCA’s website. See http://www.hca.wa.gov/

17 medicaid/pharmacy/Documents/hepatitis_c_treatment_policy.pdf (last visited

18 02/02/16). It is known by many doctors treating Medicaid enrollees.

19

26. WHCA’s Coverage Criteria Impermissibly Ration Care. WHCA’s

20 coverage criteria are not tied to the requirements of the Medicaid Act, or to WHCA’s

21 regulations governing coverage of medically necessary prescription medications.

22 Rather, WHCA’s denial of coverage is an effort to ration care because of its concern over

23 the perceived expense of Harvoni and other DAAs. As stated by Donna L. Sullivan,

24 M.S., Pharm. D., HCA’s Chief Pharmacy Officer, the real reason that HCA continues to

25 employ the excessively restrictive coverage criteria is a political one:

26

COMPLAINT (CLASS ACTION) – 9

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 10 of 16

I’ve had discussions with Dr. Lessler, with Charissa and with

1

the specialists in the community with the Department of

2

Corrections as well as Labor and Industries, and I can

guarantee you that all of us agree that everyone should be

3

treated whether they are at stage 2, stage 3, stage 4.

However, we have received funding only based on the
4
criteria that we gave for F3. So we are having discussions

5

with the Office of Financial Management with legislative

staff. We have requested a supplemental budget to expand

6

our coverage criteria to F3, but we can’t just open up our

7

doors right now and do that. … It’s out of our hands. None

of us would argue that we should not expand it, that it’s not

8

the right thing to do, but we live in a political environment

as a state that I have to operate within the resources and rules
9
around those resources that have been given to us.

10
See http://www.hca.wa.gov/pdp/ptmeetingdocuments/Transcript_102115.pdf, p. 64

11
(emphasis added). These concerns cannot usurp WHCA’s obligations under the

12
Medicaid Act.

13
PLAINTIFFS E. AND R. REQUIRE HARVONI TO TREAT HCV.

14
27. Plaintiffs Are Enrolled in Medicaid. During certain time periods on and

15
after October 10, 2014, Plaintiffs E. and R. have been, are or will be enrolled in

16
Washington state’s Medicaid program, which is administered by WHCA. Both are

17
“qualified individuals” as defined in 42 U.S.C. § 1396a(a)(10)(A).

18
28. Treatment With Harvoni Is Recommended and Prescribed for Both

19
Plaintiffs. Plaintiffs E. and R. both are diagnosed with HCV. Plaintiffs both have a

20
Metavir Fibrosis Score of F0. Both plaintiffs had Harvoni prescribed by their treating

21
medical providers.

22
29. Treatment With Harvoni Is “Medically Necessary” for Plaintiffs B.E.,

23
R.A. and Similarly Situated Others Under the WHCA Definition of Medical

24
Necessity. Treatment with Harvoni is “medically necessary” for plaintiffs and similarly

25
situated others under the established definition of “medically necessary” located in

26
WAC 182-500-0070, and established by the consent order in Mead v. Burdman, No. 818663

COMPLAINT (CLASS ACTION) – 10

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 11 of 16

1 (King Cty. Sup. Ct., J. Hunter, March 20, 1978). Harvoni and other similar DAAs are

2 likely to cure plaintiffs E., R. and other similarly situated individuals. There is no equally

3 effective, less costly alternative prescription drug or medical intervention, and WHCA

4 has offered none. WHCA apparently takes the position that treatment may be delayed

5 because the adverse health effects of chronic HCV can be reversed until a Metavir

6 Fibrosis Score of F3 or F4 is reached. This position is inconsistent with clinical studies of

7 HCV treatments, the AASLD/ISDA Treatment Recommendations and the standard of

8 care for treatment of HCV in Washington state.

9

30. Plaintiffs’ Request for Coverage of Harvoni Was Denied Under WHCA’s

10 Uniform Coverage Criteria. WHCA denied Ms. E.’s preauthorization request for

11 treatment with Harvoni on January 12, 2016 because her Metavir Fibrosis Score was

12 under F3 and she had no qualifying co-morbid condition. WHCA did not offer Ms. E.

13 any other medication as an alternative to treat her HCV. WHCA denied Mr. R.’s

14 pre-authorization request for treatment with Harvoni on June 15, 2015 because his

15 Metavir Fibrosis Score was under F3 without a qualifying co-morbid condition. WHCA

16 did not offer Mr. R. any other medication as an alternative to treat his HCV. Neither

17 plaintiff was provided with notice of the denial that met constitutional due process

18 requirements. Nonetheless, Mr. R. appealed. An administrative hearing was held on

19 September 30, 2015. Mr. R. appeared pro se, and the Administrative Law Judge issued

20 an initial decision, upholding WHCA’s denial. Mr. R. appealed the decision to the

21 WHCA Board of Appeals, which, sua sponte, remanded the case to the Administrative

22 Law Judge for an additional hearing.

23

24

25

26

COMPLAINT (CLASS ACTION) – 11

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 12 of 16

VI. CLASS ALLEGATIONS
1

31. Size and Definition of Class. The class consists of:
2

(a) all individuals who:
3
(i) were, are, or will be enrolled in Washington state

4

Health Care Authority’s Medicaid Program on or

after October 10, 2014;
5

(ii) require, or are expected to require treatment for

6

Hepatitis C with Harvoni/ledipasvir-sofosbuvir

7

or other similar direct acting antivirals under

the current guidelines adopted by the American

8

Association for the Study of Liver Diseases and the

Infectious Diseases Society of America (see
9
http://www.hcvguidelines.org/full-report/when-

10

and-whom-initiate-hcv-therapy) (last visited

1/25/16); and

11
(iii) do not meet the coverage criteria for HCV

12

medication adopted by WHCA, as set forth in

Appendix 1.
13

32. Class Representatives B.E. and A.R. As noted above, named plaintiffs B. E.
14

and A. R. are enrolled in WHCA’s Medicaid Program. Both have HCV and require
15

treatment with Harvoni. Both have been denied coverage of Harvoni because their
16

Metavir Fibrosis Score is under F3 and they have no qualifying co-morbid condition.
17

Both plaintiffs meet the criteria for treatment under the guidelines approved by the
18

American Association for the Study of Liver Diseases and the Infectious Diseases Society
19

of America. Their claims are typical of the claims of the other members of the class, and
20

they will fairly and adequately represent the interests of the class. Neither have any
21

conflicts of interest with the class.
22

33. Size of Class. The class is sufficiently numerous. WHCA has denied
23

coverage of Harvoni and other DAAs to at least 900 Medicaid consumers since January 1,
24

25

26

COMPLAINT (CLASS ACTION) – 12

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 13 of 16

1 2015, likely because the enrollees had a Fibrosis Score of F0, F1 or F2.1 WHCA estimates

2 that if it expanded its coverage to include all enrollees with Fibrosis Score of F2, an

3 additional 4700 Medicaid enrollees would be affected.2 As a result, the class numbers in

4 the thousands and is so large that joinder of all members is impracticable.

5

34. Common Questions of Law and Fact. This action requires a determination

6 of whether WHCA’s coverage criteria that denies, excludes and/or limits coverage of

7 Harvoni and other similar DAAs violates the Medicaid Act. A determination of this

8 issue will in turn determine whether plaintiffs and the class are entitled to declaratory

9 and injunctive relief.

10

35. WHCA Has Acted on Grounds Generally Applicable to the Class. WHCA,

11 by applying a uniform policy that results in the exclusion of Harvoni and other similar

12 DAAs to plaintiffs and others similarly situated, has acted on grounds generally

13 applicable to the class. Certification is therefore proper under Fed. R. Civ. P. 23(b)(2).

14

36. Class Counsel. Plaintiff has retained experienced and competent class

15 counsel capable of representing the class expertly and without conflict of interest.

16

VII. CLAIMS FOR RELIEF

17

FIRST CLAIM: EXCLUSION OF QUALIFIED INDIVIDUALS FROM

COVERED MEDICAL ASSISTANCE UNDER THE MEDICAID ACT
18

37. Plaintiff re-alleges all of the above paragraphs.
19

38. Plaintiffs and the class are entitled to declaratory and injunctive relief
20

pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 that defendant has violated
21

Title XIX of the Social Security Act (also known as the Medicaid Act) by excluding
22

qualified Medicaid recipients from medically necessary treatment as required by
23

24

1 See http://www.hca.wa.gov/pdp/ptmeetingdocuments/Hep_C_DUR_1015.pdf, p. 3 (WHCA 25 received 1695 requests for HCV treatment from January-June 2015, and only approved 45% of the requests,

denying more than 900 Medicaid enrollees curative treatment). 26
2 http://www.hca.wa.gov/Documents/budget/2016_PL-2_Hepatitis_C_Treatment_Expansion.pdf.

COMPLAINT (CLASS ACTION) – 13

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 14 of 16

1 42 U.S.C. §1396a(a)(10)(A).

2

SECOND CLAIM: VIOLATIONS OF MEDICAID COMPARABILITY

3

39. Plaintiff re-alleges all of the above paragraphs.

4

40. Plaintiffs and the class are entitled to declaratory and injunctive relief

5 pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 because defendant, by

6 discriminating among similarly situated Medicaid recipients on the basis of categorical

7 restrictions that are not based upon prevailing clinical standards, has violated Medicaid

8 Act comparability requirements, 42 U.S.C. § 1396a(a)(10)(B)(i) and (ii); 42 C.F.R.

9 § 440.240.

10

THIRD CLAIM: VIOLATIONS OF REASONABLE PROMPTNESS

11

41. Plaintiff re-alleges all of the above paragraphs.

12

42. Plaintiffs and the class are entitled to declaratory and injunctive relief

13 pursuant to 42 U.S.C. § 1983 and 28 U.S.C. §§ 2201 and 2202 that defendant has violated

14 the “reasonable promptness” requirement of Title XIX of the Social Security Act, 42

15 U.S.C. § 1396a(a)(8), by implementing a policy that de facto rations coverage for Medicaid

16 enrollees seeking HCV treatment, thereby requiring plaintiffs and the class to wait until

17 they have developed severe liver damage before receiving medically necessary

18 treatment.

19

VIII. DEMAND FOR RELIEF

20

WHEREFORE, plaintiffs request that this Court:

21

(a) Certify this case as a class action, designate the named plaintiffs as class

22 representatives, and designate SIRIANNI YOUTZ SPOONEMORE HAMBURGER, Richard E.

23 Spoonemore and Eleanor Hamburger, COLUMBIA LEGAL SERVICES, Amy L. Crewdson,

24 and CENTER FOR HEALTH LAW AND POLICY INNOVATION, Kevin Costello, as class counsel;

25

(b) Declare that WHCA may not apply policies or practices that exclude or

26 impermissibly limit treatment of HCV with Harvoni or other similar DAAs pursuant to

COMPLAINT (CLASS ACTION) – 14

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 15 of 16

1 coverage criteria that are inconsistent with the current AASLD/IDSA Treatment

2 Guidelines;

3

(c) Enjoin WHCA from continuing to implement and apply its current HCV

4 Treatment Policy, attached as Appendix 1;

5

(d) Require WHCA to provide corrective and constitutionally adequate notice

6 to class members, and to reprocess and approve coverage for all class members who

7 were previously denied coverage under WHCA’s current HCV Treatment Policy;

8

(e) Award plaintiffs and the class their attorney fees and costs pursuant to 42

9 U.S.C. § 1988; and

10

(f) Award such other relief as is just and proper.

11

DATED: February 16, 2016.

12

SIRIANNI YOUTZ

13

SPOONEMORE HAMBURGER

14

By: s/ Richard E. Spoonemore

By: s/ Eleanor Hamburger

15

Richard E. Spoonemore (WSBA #21833)

16

Eleanor Hamburger (WSBA #26478)

999 Third Avenue, Suite 3650

17

Seattle, WA 98104

Tel. (206) 223-0303

18

Email: rspoonemore@sylaw.com

ehamburger@sylaw.com
19

20

COLUMBIA LEGAL SERVICES

21

By: s/ Amy L. Crewdson

Amy L. Crewdson (WSBA #9468)

22

711 Capitol Way South, #304

23

Olympia, WA 98501

Tel. (360) 943-6585, Ext. 214

24

Email: amy.crewdson@columbialegal.org

25

26

COMPLAINT (CLASS ACTION) – 15

SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

Case 2:16-cv-00227-JCC Document 1 Filed 02/16/16 Page 16 of 16

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
COMPLAINT (CLASS ACTION) – 16

HARVARD LAW SCHOOL CENTER FOR HEALTH LAW & POLICY INNOVATION By: s/ Kevin Costello Kevin Costello (pro hac vice admission to be sought)
122 Boylston Street Jamaica Plain, MA 02130 Tel. (617) 390-2578 Email: kcostello@law.harvard.edu Attorneys for Plaintiffs
SIRIANNI YOUTZ SPOONEMORE HAMBURGER
999 THIRD AVENUE, SUITE 3650 SEATTLE, WASHINGTON 98104 TEL. (206) 223-0303 FAX (206) 223-0246

 
 THE HONORABLE JOHN C. COUGHENOUR 1

2

3

4

5

6

7

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON

8

AT SEATTLE

9 B.E. and A.R., on their own behalf and on behalf of all similarly situated individuals,
10

11

Plaintiffs,

12

v.

DOROTHY F. TEETER, in her official 13 capacity as Director of the Washington

14

State Health Care Authority,

15

Defendant.

CASE NO. C16-227-JCC
ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION

16

This matter comes before the Court on Plaintiffs’ motion for a preliminary injunction

17 (Dkt. No. 18), Defendant’s opposition to both motions (Dkt. No. 29), and Plaintiffs’ reply (Dkt.

18 Nos. 35). Having thoroughly considered the parties’ briefing and the relevant record, the Court

19 finds oral argument unnecessary and hereby GRANTS the motion for the reasons explained

20 herein.

21 I. BACKGROUND

22

Plaintiffs in this action are Washington Medicaid enrollees who have contracted Hepatitis

23 C (“HCV”), a chronic, contagious liver disease, but have not received the life-altering

24 medication they have been prescribed, known as Direct-Acting Antivirals (“DAAs”). (Dkt. No. 1

25 at 3.) Plaintiffs bring this case on behalf of others similarly situated.

26

As it progresses, HCV causes severe liver damage, among the many other effects

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 1

1 including heart attacks, diabetes, fatigue, joint and muscle pain, depression, nerve damage, and

2 jaundice. (Dkt. No. 19 at 2.) The virus’s progressive damage, known as “fibrosis,” is scored on

3 an ascending fibrosis score of F0 (no liver damage) through F4 (cirrhosis of the liver). (Id. at 3.)

4 HCV is both widespread and deadly: over 20,000 people in the United States die every year due

5 to liver disease caused by HCV. (Id. at 2.)

6

Before DAAs were available, the main treatment for HCV was a three-drug course of

7 treatment that resulted in, at most, a 70% cure rate, and was accompanied by significant adverse

8 side effects. (Dkt. No. 19 at 3–4.) The FDA began approving DAAs in 2011 and designated them

9 as “breakthrough therapies,” a classification given to “drugs that have proved to provide

10 substantial improvement over available therapies for patients with serious or life-threatening

11 diseases.” (Id. at 4.) Harvoni, a DAA treatment, was FDA-approved on October 10, 2014 and has

12 a success rate of achieving “sustained virological response [] of nearly 100%, with little to no

13 side effects. (Id.)

14

Plaintiffs bring a claim under 42 U.S.C. § 1983, alleging violation of Title XIX of the

15 Social Security Act (also known as the “Medicaid Act”) against the Washington State Health

16 Care Authority (“WHCA”) and seek declaratory and injunctive relief pursuant to 28 U.S.C.

17 §§ 2201 and 2202. (Dkt. No. 1 at 13–15.) On March 18, 2016, Plaintiffs moved to certify their

18 class and also moved for a preliminary injunction. (Dkt. Nos. 17 and 18.) Plaintiffs, on behalf of

19 the proposed class, request that the Court “enjoin [the] WHCA from continuing to apply its

20 February 25, 2015 HCV treatment policy, including its exclusion of all treatment based on

21 fibrosis score, and to require WHCA to return to providing coverage for prescription medications

22 to treat Hepatitis C virus (“HCV”) without regard to fibrosis score, consistent with existing state

23 and federal Medicaid requirements.” (Dkt. No. 18 at 10.) In this Order, the Court addresses

24 Plaintiffs’ request for injunctive relief but does not yet reach the class certification question.

25

At the center of this dispute is the WHCA’s HCV treatment policy, which excludes

26 Plaintiffs from receiving these breakthrough therapies, DAAs. On February 25, 2015, the WHCA

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 2

1 implemented a Hepatitis C Treatment Policy (“Policy”) restricting DAA coverage based on

2 enrollees fibrosis score and other health conditions. (Dkt. No. 1-1.) Plaintiffs contend that the

3 Policy categorically excludes “all monoinfected patients—patients without another diagnosis,

4 such as HIV—who have a fibrosis score of F0 through F2.” (Dkt. No. 18 at 13.) Many insurers in

5 Washington State have voluntarily removed similar restrictions on the availability of HCV

6 treatment, including Premera BlueCross, Aetna, United Healthcare, Medicare, and the VA. (See

7 Dkt. No. 18 at 8) (linking to policies). Other insurers, Bridgespan, Regency BlueShield, and

8 Group Health Cooperative, changed their policies within weeks after lawsuits were filed against

9 them on similar grounds to those brought in the above-captioned matter. (Dkt. No. 24 at 4.)

10 II. PRELIMINARY INJUNCTION

11

A. Legal Standard

12

Under Fed. R. Civ. P. 65(a), the Court may issue a preliminary injunction if a plaintiff

13 establishes that she “[1] is likely to succeed on the merits, [2] that [s]he is likely to suffer

14 irreparable harm in the absence of preliminary relief, [3] that the balance of equities tips in [her]

15 favor, and [4] that an injunction is in the public interest.” Winter v. Nat. Res. Def. Council, Inc.,

16 555 U.S. 7, 20 (2008). Mandatory preliminary injunctions, the kind requested here, are generally

17 disfavored in the law as they seek relief beyond maintaining the status quo, and will only be

18 ordered when the law and facts clearly favor the moving party. Stanley v. Univ. of S. Cal., 13

19 F.3d 1313, 1319–20 (9th Cir. 1994).

20

B. Success on the Merits

21

Plaintiffs assert claims under 42 U.S.C. § 1983, alleging that the WHCA failed to provide

22 medically necessary treatment as required by the Medicaid Act. Plaintiffs claim that the

23 WHCA’s HCV policy violates three distinct provisions of federal Medicaid law: (1) excluding

24 qualified Medicaid recipients from “medically necessary” treatment as required by 42 U.S.C.

25 § 1396a(a)(10(A); (2) discriminating among similarly situated Medicaid recipients in violation of

26 42 U.S.C. § 1396a(a)(10)(B)(i); and (3) failing to provide medically necessary treatment with

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 3

1 “reasonable promptness” as required by 42 U.S.C. § 1396a(a)(8). The Court first considers the

2 likelihood of Plaintiffs’ success on the merits of these claims.

3

a. Medically Necessary Treatment

4

The Court first considers the likelihood that Plaintiffs will prevail on their claim that the

5 WHCA failed to provide “medically necessary” DAAs for enrollees in violation of 42 U.S.C.

6 § 1396a(a)(10(A). WHCA participates in Medicaid, receiving federal matching funds, and

7 therefore is required to provide payment for FDA-approved, covered prescription drugs to all

8 Medicaid enrollees when the treatment is “medically necessary.” Alvarez v. Betlach, 572 F.

9 App’x 519, 520–21 (9th Cir. 2014); see also Armstrong v. Exceptional Child Ctr., Inc., 135 S.

10 Ct. 1378, 1382 (2015) (“Medicaid offers the States a bargain: Congress provides federal funds in

11 exchange for the State’s agreement to spend them in accordance with congressionally imposed

12 conditions.”).

13

i. State and Federal Legal Structure

14

The federal Medicaid Act and Washington Administrative Code set forth the legal

15 structure that guides the Court’s analysis. The crux of this claim is whether the WHCA’s Policy

16 excludes DAAs that are “medically necessary.” Plaintiffs have provided strong evidence that

17 DAAs are, in fact, “medically necessary,” as defined by law, for all enrollees with HCV,

18 regardless of fibrosis score. They submitted a plethora of exhibits showing that providing DAAs

19 to all HCV-infected enrollees is the standard espoused by national liver disease organizations

20 and experts, leading medical officers of major Washington providers and the federal agency

21 responsible for administering Medicaid. These facts “clearly favor” Plaintiffs’ claim that the

22 WHCA’s Policy excluding monoinfected enrollees with a Fibrosis score of F0-F2 violates

23 Federal law. Stanley at 1319–20.

24

The WHCA is the sole state agency responsible for implementing the Medicaid program.

25 (Dkt. No. 18 at 13.) As the agency has opted to provide prescription drug coverage, the Medicaid

26 program must adhere to the Medicaid Act’s specific limits regarding prescription drugs. (Id.)

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 4

1 (Citing RCW §§ 74.04.055; 74.08.090); see also 42 U.S.C. § 1396a(a)(54). Under

2 § 1396a(a)(10)(A), the Medicaid Act “prohibits states from denying coverage of ‘medically

3 necessary’ services that fall under a category covered in their Medicaid plans.” Alvarez v.

4 Betlach, 572 F. App’x 519, 521 (9th Cir. 2014) (quoting Beal v. Doe, 432 U.S. 438, 444 (1977)).

5 The Washington Administrative Code provides the definition of “[m]edically necessary”:

6

[A] term for describing requested service which is reasonably calculated to

7

prevent, diagnose, correct, cure, alleviate or prevent worsening of conditions in the client that endanger life, or cause suffering or pain, or

8

result in an illness or infirmity, or threaten to cause or aggravate a

handicap, or cause physical deformity or malfunction. There is no other

9

equally effective, more conservative or substantially less costly course of

treatment available or suitable for the client requesting the service. For the

10

purposes of this section, “course of treatment” may include mere

11

observation or, where appropriate, no medical treatment at all.

12 Wash. Admin. Code 182-500-0070.

13

The WHCA’s procedure for determining whether a requested service is “medically

14 necessary” is established in Wash. Admin. Code 182-501-0165(6). First, the agency rates the

15 evidence of the service’s effectiveness and safety on a scale from A to D, with A being the

16 highest level. Wash. Admin. Code 182-501-0165(6). If the requested service has an evidence

17 level of A or B, then it must be approved so long as it does not expose the enrollee “to a greater

18 risk of mortality or morbidity” and “is not more costly” when compared to an equally effective

19 treatment. Wash. Admin. Code 182-501-0165(6)(c)(i).

20

ii. Plaintiffs’ Evidence

21

It is undisputed that DAAs such as Harvoni have been rated at an “A” evidence level.

22 (Dkt. No. 19 at 10.) Defendants concede that there is no equally effective alternative medication.

23 (Dkt. No. 16 at 4.) Despite this rating, the current WHCA Policy mandates rejecting DAA

24 requests from enrollees who have an F0-F2 fibrosis score, absent other concerning health factors,

25 and instead offering “monitoring” as the “equally effective treatment” in lieu of DAAs. (See

26 Dkt. No. 1-1.) Plaintiffs argue that mere “monitoring” is not an equally effective treatment

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 5

1 because “waiting until a Medicaid enrollee’s liver is damaged before providing treatment is

2 harmful to his/her health and significantly increases the risk of both morbidity and mortality.”

3 (Dkt. No. 18 at 19–20.) Plaintiffs provide a plethora of evidence to support this assertion.

4

Plaintiffs provide a letter from liver specialists, physicians, and the medical officers of

5 nearly every major health care provider in the State of Washington, urging the Washington

6 Insurance Commissioner to remove restrictions on the availability of life-saving HCV treatment.

7 (Dkt. No. 19-1 at 32–35.) The letter states in part, “The cost of these drugs cannot compare to the

8 human toll on our patients and their families and the eventual cost and expense we would pay as

9 a society by postponing treatment.” (Dkt. No. 19-1 at 33.)

10

Plaintiffs attach an internal meeting transcript in which Donna L. Sullivan, M.S.,

11 Pharm.D., the WHCA’s Chief Pharmacy Officer, stated with respect to patients with HCV: “I

12 can guarantee you that all of us agree that everyone should be treated whether they are at stage 2,

13 stage 3, stage 4.” (Dkt. No. 24-1 at 10.) Ms. Sullivan identified fiscal concerns as the sole basis

14 for the WHCA’s exclusionary policy, adding, “we have received funding only based on the

15 criteria that we gave for F3 . . . It’s out of our hands. None of us would argue that we should not

16 expand it, that it’s not the right thing to do, but we live in a political environment as a state that I

17 have to operate within the resources and the rules around those resources that have been given to

18 us.” (Id.)

19

Furthermore, the Centers for Medicare and Medicaid Services (“CMS”), the federal

20 agency responsible for the administration of Medicaid, has specifically rejected the WHCA’s

21 current policy. On November 5, 2015, CMS issued a Notice entitled, “Assuring Medicaid

22 Beneficiaries Access to Hepatitis C Drugs.” (Dkt. No. 24-1 at 27–30.) In the Notice, CMS

23 explicitly states: “CMS is concerned that some states are restricting access to DAA HCV drugs

24 contrary to the statutory requirements . . . by imposing conditions for coverage that may

25 unreasonably restrict access to these drugs. For example, several state Medicaid programs are

26 limiting treatment to those beneficiaries whose extend of liver damages has progressed to [a]

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 6

1 fibrosis score [of] F3 . . .” (Id. at 28.) This interpretation of the Medicaid Act is entitled to

2 deference. Katie A. v. L.A. Cnty., 481 F.3d 1150, 1155, n. 11 (9th Cir. 2007).

3

Finally, the use of DAAs such as Harvoni is considered the “standard of care” by the

4 American Association for the Study of Liver Disease (“AASLD”) and the Infectious Diseases

5 Society of America (“IDSA”). (Dkt. No. 19 at 4.)

6

Despite these facts, the WHCA argues that the Policy is in line with the “medically

7 necessary” definition because monitoring is suitable for people who have HCV but show either

8 mild or no symptoms. (Dkt. No. 29 at 16.) The WHCA does not address the liver damage that

9 enrollees could suffer during this “monitoring” period and, instead, argues that by refusing to

10 provide the DAA drugs, the Policy “ensures these people are not unnecessarily exposed to the

11 currently ill-defined risks of these new medications.” (Id.) This assertion of “ill-defined risks” is

12 not supported by any clinical evidence and is contradicted by the WHCA’s own documents.

13

In fact, when the WHCA was making a budget request to cover DAAs like Harvoni, it

14 presented a completely opposite argument. The WHCA’s 2016 Supplemental Budget Request

15 Adjustment states that DAAs like Harvoni are “highly effective,” “safe,” and even “cost-

16 effective.” (Dkt. No. 24-1 at 2–3.) The Budget Request refutes the argument now presented by

17 the WHCA that there are “ill-defined risks” associated with DAAs, stating instead that “because

18 the new therapies are so effective, there is the potential to completely eradicate [HCV].” (Dkt.

19 No. 24-1 at 15.) The extensive evidence provided by the Plaintiffs and the lack of substantial

20 counter-evidence from the WHCA establishes that there is a consensus among medical experts

21 and providers that the life-saving DAAs are “medically necessary” for all HCV-infected persons,

22 regardless of Fibrosis score. Plaintiffs have adequately demonstrated that they are likely to

23 prevail on their claim.

24

The WHCA argues that its interpretation of what is “medically necessary” is entitled to

25 deference. (Dkt. No. 19 at 10–11.) This Court has previously considered a similar argument in

26 A.H.R. v. Washington State Health Care Authority, 2016 WL 98513, at *14 (W.D. Wash. Jan. 7,

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 7

1 2016) (Robart, J.). In A.H.R., the Court declined to defer to the WHCA because there was no

2 indication that CMS was aware of the WHCA’s practices. Id. In this case, unlike in A.H.R., CMS

3 has explicitly stated that policies like the WHCA’s contravene the Medicaid Act. (See Dkt. No.

4 24-1 at 27–30.) In other words, the agency to defer to under Chevron, CMS, has clearly stated

5 that the WHCA’s HCV policy defies the relevant statutory requirements.

6

The WHCA does not address whether its Policy is in line with the procedure enumerated

7 in Wash. Admin. Code 182-501-0165(6). Instead, the WHCA asserts that the “Policy is the

8 agency’s best attempt at making reasonable medical necessity determinations.” (Dkt. No. 29 at

9 15.) However, whether the WHCA made its “best” attempt is not the pertinent standard. The

10 appropriate legal test is whether Plaintiffs will likely establish that the current WHCA Hepatitis

11 C Treatment Policy deprives Medicaid enrollees from access to a life-saving drug in situations

12 where it is “medically necessary.” And this turns on whether there is an equally effective

13 alternative treatment that does not expose the enrollee to “a greater risk of mortality or

14 morbidity.” WAC 182-501-0165(6)(c)(i)(A). The Court is satisfied that Plaintiffs’ evidence will

15 likely establish that the WHCA is failing to follow its own definition of medical necessity by

16 refusing to provide DAAs to monoinfected enrollees with a F0-F2 score and offering only

17 “monitoring” in lieu of this breakthrough treatment.

18

b. Medicaid Comparability & Reasonable Promptness

19

The Court finds that Plaintiffs are likely to succeed on the merits of their first claim.

20 Plaintiffs’ latter two claims similarly turn on whether DAAs are “medically necessary” because

21 if they are given that designation, then the Medicaid Act requires the WHCA to provide that

22 treatment with “reasonable promptness” in a non-discriminatory manner. For the same reasons

23 discussed above, the Court concludes that Plaintiffs are likely to succeed on the merits with

24 respect to their second and third claims.

25

C. Likelihood of Irreparable Harm

26

Next, the Court considers whether Plaintiffs are likely to suffer irreparable harm in the

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 8

1 absence of this preliminary injunction. Winter, 555 U.S. at 20.

2

It is well-established that denying necessary Medicaid services causes irreparable harm.

3 Rodde v. Bonta, 357 F.3d 988, 999 (9th Cir. 2004) (finding that while the injunction would cause

4 the county financial hardship, the plaintiffs met their burden by showing delayed or lack of

5 necessary treatment, increased pain, and medical complications); Beltran v. Myers, 677 F.2d

6 1317, 1322 (holding that plaintiffs’ showing of risk of irreparable injury as a result of denying

7 needed medical care was sufficient to meet this factor for a preliminary injunction).

8

Plaintiffs argue, persuasively, that without an injunction “they are at imminent risk of

9 deteriorating health, liver damage and even death.” (Dkt. No. 18 at 25.) Plaintiffs maintain that

10 denying “necessary medical benefits directly impacts an individual’s health, creating ‘(1)

11 substantial risk to plaintiffs’ health; (2) severe financial hardship; (3) the inability to purchase

12 life’s necessities; and (4) anxiety associated with uncertainty.’” (Id.) (quoting LaForest v.

13 Former Clean Air Holding Co., Inc., 376 F.3d 48, 55 (2nd Cir. 2004)).) The WHCA argues that

14 this claim of imminent risk is “completely speculative.” (Dkt. No. 29 at 20.)

15

An experience endured by a Medicaid enrollee provides a clear example of the

16 substantial risk of deteriorating health and death presented by the Policy. L.B., a Washington

17 Medicaid enrollee, was prescribed Solvaldi, a DAA, in July 2014. (Dkt. No. 23 at 1–2.) His

18 request was denied. (Id. at 2.) The WHCA’s letter on August 21, 2014 states that because L.B.

19 did not have a fibrosis score of “F3 or greater,” the treatment was not “medically necessary.”

20 (Dkt. No. 23-1 at 5.) Soon after, in October 2014, Harvoni was approved by the FDA and L.B.’s

21 provider submitted his prescription to WHCA. (Dkt. No. 23 at 2.) His provider noted that his

22 “cirrhosis and renal function [were] worsening. [He n]eeds HCV treatment ASAP” and that 23 [w]ithout it, [he will] likely die.” (Id.) Again, his request was denied.1 (Id). While he awaited a

24
25 1 The WHCA notes that L.B.’s request for Harvoni was denied because “his provider did not provide requested documentation” and asserts that if documentation of Hepatitis C induced renal disease would
26 have been sent the Harvoni request would have been approved. (Dkt. No. 29 at 21, n. 9.) However, under the proposed injunction, L.B.’s provider would not need to submit additional documentation because the

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 9

1 hearing on his Medicaid administrative appeal, “his kidneys deteriorated so significantly that his

2 provider could no longer recommend Harvoni.” (Id. at 2–3.) In other words, the window of

3 L.B.’s ability to seek a cure for his HCV has likely closed. This is not speculative harm. It is

4 concrete evidence that under the Policy, an enrollee suffered such severe liver damage that DAA

5 treatment may no longer be an available option.

6

In arguing that Plaintiffs will not suffer irreparable harm, the WHCA again contradicts its

7 own pronouncements. The WHCA argues in its response brief that a HCV diagnosis alone,

8 “without further complicating factors, does not warrant authorization” of DAAs like Harvoni.

9 (Dkt. No. 29 at 20.) And in a budget request, the WHCA noted that only treating “people with

10 more severe disease[,] those patients who by definition have cirrhosis, liver cancer or are in need

11 of a liver transplant[,] . . . would be objectionable from a medical ethical standpoint.” (Dkt. No.

12 24-1 at 16.)

13

Plaintiffs have introduced compelling evidence that they will suffer irreparable harm if

14 the preliminary injunction is denied. This factor weighs strongly in favor of a preliminary

15 injunction.

16

D. Balance of Equities and Public Interest

17

Next, the Court assesses whether the balance of equities tips in Plaintiffs’ favor and the

18 injunction is in the public interest. Winter, 555 U.S. at 20. These factors may be considered

19 together. A.H.R. v. Wash. State Health Care Auth., 2016 WL 98513, at *17 (W.D. Wash. Jan. 7,

20 2016). As discussed above, Plaintiffs’ evidence establishes they will suffer severe hardship if the

21 WHCA continues to follow the Policy. The Ninth Circuit holds that “the balance of hardship

22 favors beneficiaries of public assistance who may be forced to do without needed medical

23

24 request would have been approved on the basis of his HCV diagnosis alone. He suffered irreparable
25 damage to his liver because the WHCA’s policy required proof of other concerning health factors with an F2 fibrosis score. Moreover, his initial request for DAA treatment in July 2014 was denied because
26 WHCA determined it was not “medically necessary.” (Dkt. No. 23 at 2.) The WHCA does not address this determination.

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 10

1 services over a state concerned with conserving scarce resources.” M.R. v. Dreyfus, 697 F.3d

2 706, 737–38 (9th Cir. 2012). The Ninth Circuit also noted the strong public interest in protecting

3 access to health care for Medicaid enrollees, those deemed by Congress as “the most needy in

4 the country.” Id. (quoting Schweiker v. Hogan, 457 U.S. 569, 590 (1982)).

5

Plaintiffs argue that the injunction is in the public interest because it seeks to bar a public

6 agency from violating “existing law.” (Dkt. No. 18 at 27.) The Court agrees. “[H]aving

7 government officials act in accordance with law . . . invokes a public interest of the highest

8 order.” Seattle Audubon Soc. v. Evans, 771 F. Supp. 1081, 1096 (W.D. Wash. 1991).

9 Furthermore, as Plaintiffs emphasize, an injunction is an important matter for the public because

10 it deals with the treatment and management of a communicable disease. (Dkt. No. 18 at 27.)

11

The WHCA argues that the injunction would double the State’s Medicaid outpatient

12 Pharmacy budget and cause them to reduce Medicaid enrollments, benefits, or provider rates to

13 compensate for the increased expenditure in HCV treatment. (Dkt. No. 29 at 22.) The Ninth

14 Circuit has also addressed the question of balancing the risk of irreparable harm with the risk of

15 financial hardship for the enjoined institution. Posed with this question, the Ninth Circuit held

16 that when “[f]aced with such a conflict between financial concerns and human suffering, we

17 have little difficulty concluding that the balance of hardships tips decidedly in plaintiffs’ favor.”

18 Lopez v. Heckler, 713 F.2d 1432, 1437 (9th Cir. 1983).

19

In conclusion, the Court finds that the Plaintiffs have satisfied all factors necessary to

20 warrant granting a preliminary injunction.

21

E. Scope of Injunction

22

The WHCA is hereby ENJOINED from continuing to apply its February 25, 2015 HCV

23 treatment policy, including its exclusion of all treatment based on fibrosis score, and is required

24 to return to providing coverage for prescription medications to treat Hepatitis C virus (“HCV”)

25 without regard to fibrosis score, consistent with existing state and federal Medicaid requirements.

26 The parties are hereby ORDERED to submit a joint status report to the Court sixty (60) days

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 11

1 after the date of this order with an update as to the implementation of these changes.

2

F. Pending Class Certification Motion

3

The Court’s review of Plaintiffs’ motion for class certification (Dkt. No. 17) remains

4 pending.

5 III. CONCLUSION

6

For the foregoing reasons, Plaintiffs’ motion for a preliminary injunction (Dkt. No. 18) is

7 GRANTED.

8

DATED this 27th day of May 2016.

9

10

11

12 13

A

14 John C. Coughenour

15

UNITED STATES DISTRICT JUDGE

16

17

18

19

20

21

22

23

24

25

26

ORDER GRANTING PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION PAGE - 12

 
 THE HONORABLE JOHN C. COUGHENOUR 1

2

3

4

5

6

7

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON

8

AT SEATTLE

9 B.E. and A.R., on their own behalf and on behalf of all similarly situated individuals,
10

11

Plaintiffs,

CASE NO. C16-0227-JCC ORDER CERTIFYING CLASS

12

v.

DOROTHY F. TEETER, in her official 13 capacity as Director of the Washington

14

State Health Care Authority,

15

Defendant.

16

This matter comes before the Court on Plaintiffs’ Motion for Class Certification (Dkt.

17 No. 17), which Defendant opposes (Dkt. No. 28). On May 27, 2016 the Court granted Plaintiffs’

18 motion for a preliminary injunction and ordered the Washington Health Care Authority

19 (“WHCA”) enjoined from applying its 2015 policy regarding the treatment of the Hepatitis C

20 virus (“HCV”). (Dkt. No. 40.) After granting Plaintiffs’ request for a preliminary injunction, the

21 Court ordered additional briefing discussing “what effect—if any—the issuance of the

22 preliminary injunction has on Plaintiffs’ motion for class certification.” (Dkt. No. 41 at 2.) The

23 Court has received this additional briefing. (Dkt. Nos. 42, 45, and 48.) Having thoroughly

24 considered the parties’ briefing and the relevant record, the Court finds oral argument

25 unnecessary and hereby GRANTS the motion for the reasons explained herein.

26 I. BACKGROUND

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1

Without reciting the factual background provided in the Court’s order granting Plaintiff’s

2 motion for a preliminary injunction (Dkt. No. 40 at 1–3), the above-captioned matter is brought

3 by Washington Medicaid enrollees who have contracted HCV and not received medication

4 known as Direct-Acting Antivirals (“DAAs”) despite the well-documented success rate of DAA

5 treatment. (Dkt. No. 1.) Plaintiffs bring this suit under 42 U.S.C. § 1983, alleging violation of

6 Title XIX of the Social Security Act (also known as the “Medicaid Act”). (Id. at 13–15.)

7

In tandem with their motion for a preliminary injunction, Plaintiffs move the Court to

8 certify their class under Fed. R. Civ. P. 23. (Dkt. No. 17.) The class is defined as:

9

“All individuals who:

10 (1) Were, are, or will be enrolled in WHCA’s Medicaid Program on or after

11

October 10, 2014;

12

(2) Require, or are expected to require treatment for HCV with

13

Harvoni/ledipasvir-sofosbuvir or other similar DAAs under the current guidelines adopted by the American Association for the Study of Liver

14

Diseases and the Infectious Diseases Society of America; and

15

(3) Do not meet the coverage criteria for HCV medication adopted by WHCA, as

reflected in Appendix 1 to Plaintiffs’ Complaint.1”

16

(Id. at 5.)

17

II. DISCUSSION

18

A. Standard of Review

19

Fed. R. Civ. P. 23 provides the standard for class certification. As the party seeking class

20

certification, Plaintiffs “bear[] the burden of demonstrating that the requirements of Rules 23(a)

21

and (b) are met.” United Steel, Paper & Forestry, Rubber, Mfg. Energy, Allied Indus. & Serv.

22

Workers Int'l Union v. ConocoPhillips Co., 593 F.3d 802, 807 (9th Cir. 2010). A court facing a

23

class certification motion is required to conduct “a rigorous analysis” to ensure that the Rule 23

24

25
26 1 This coverage policy was recently enjoined by the Court’s Order Granting Plaintiffs’ Motion for a Preliminary Injunction. (Dkt. No. 40 at 11.)

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1 requirements are satisfied. Gen. Tel. Co. of Sw. v. Falcon, 457 U.S. 147, 161 (1982). Pursuant to

2 Rule 23(a), a court may certify a class only if the following four elements are met:

3

(1) the class is so numerous that joinder of all members is impracticable; (2) there

4

are questions of law or fact common to the class; (3) the claims or defenses of the

representative parties are typical of the claims or defenses of the class; and (4) the

5

representative parties will fairly and adequately protect the interests of the class.

6

Fed. R. Civ. Proc. 23(a). After satisfying the Rule 23(a) prerequisites, a plaintiff must

7 also demonstrate that the case is maintainable as a class action under one of the three Rule 23(b)

8 prongs. Here, Plaintiffs argue that the class is certifiable under the second prong of Rule 23(b).

9 This prong—Rule 23(b)(2)—provides that class certification is appropriate where the defendant

10 has “acted or refused to act on grounds that apply generally to the class, so that final injunctive

11 relief or corresponding declaratory relief is appropriate respecting the class as a whole.” Fed. R.

12 Civ. P. 23(b)(2).

13

In determining whether the Rule 23 requirements have been met, “the question is not

14 whether the plaintiff [has] stated a cause of action or will prevail on the merits.” Eisen v. Carlisle

15 & Jacquelin, 417 U.S. 156, 177–78 (1974) (quoting Miller v. Mackey Int’l, 452 F.2d 424, 427

16 (5th Cir. 1971)) (internal quotation marks omitted). A court is required to examine the merits of

17 the underlying claim, “only inasmuch as it must determine whether common questions exist; not

18 to determine whether class members could actually prevail on the merits of their claims.” Ellis v.

19 Costco Wholesale Corp., 657 F.3d 970, 983 n.8 (9th Cir. 2011) (citing Wal-Mart Stores, Inc. v.

20 Dukes, 131 S. Ct. 2541, 2552 n.6 (2011)); see also United Steel, 593 F.3d at 809 (“But a court

21 can never be assured that a plaintiff will prevail on a given legal theory prior to a dispositive

22 ruling on the merits, and a full inquiry into the merits of a putative class’s legal claims is

23 precisely what both the Supreme Court and we have cautioned is not appropriate for a Rule 23

24 certification inquiry.”).

25

The WHCA argues that class certification is “unnecessary” because the preliminary

26 injunction benefits all class members regardless of whether they are formally certified. (Dkt. No.

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1 28 at 4; Dkt. No. 45 at 3–4.) As Plaintiffs argue in response, however, necessity is not a required

2 showing for certification under Fed. R. Civ. P. 23(b)(2). (See Dkt. No. 36 at 3.) “Rule 23 clearly

3 sets forth the required findings a court must make prior to certifying a class action and

4 ‘necessity’ is not a listed requirement.” Fernandez v. Dep’t of Soc. & Health Servs., 232 F.R.D.

5 642, 646 (E.D. Wash. 2005). In fact, class certification may be appropriate even if the requested

6 relief could be obtained through individual lawsuits. Id. (citing Zepeda v. I.N.S., 753 F.2d 719,

7 729 n. 1 (9th Cir. 1983). Other courts have declined to impose a necessity requirement and this

8 Court follows suit. Californians for Disability Rights, Inc. v. California Dep’t of Transp., 249

9 F.R.D. 334, 349 (N.D. Cal. 2008) (“there is no requirement that class certification must be

10 ‘necessary.’”); Smith v. Univ. of Wash. Law School, 2 F. Supp. 2d 1324, 1344 (W.D. Wash.

11 1998) (Zilly, J.); Nehmer v. U.S. Veterans’ Admin., 118 F.R.D. 113, 119 (N.D. Cal. 1987).

12

Additionally, the WHCA argues that the availability of further administrative appeals

13 means that there is an adequate alternative remedy to filing this class action lawsuit. (Dkt. No. 28

14 at 7.) However, Plaintiffs were not required to exhaust their administrative remedies prior to

15 filing their case. “In the absence of a statutory provision to the contrary, it is not necessary to

16 exhaust administrative remedies before commencing a § 1983 action.” Arc of Washington State

17 Inc. v. Braddock, 129 F. App’x 348, 351 (9th Cir. 2005).

18

Accordingly, the Court focuses its review of the class certification from the well-

19 established Rule 23 framework.

20

B. Rule 23(a) Application

21

1. Numerosity

22

The first requirement under Rule 23(a) is that “the class is so numerous that joinder of all

23 members is impracticable.” Fed. R. Civ. P. 23(a)(1). “‘[I]mpracticability’ does not mean

24 ‘impossibility’” rather, impracticability means only “the difficulty or inconvenience of joining all

25 members of the class.” Harris v. Palm Springs Alpine Estates, Inc., 329 F.2d 909, 913–14 (9th

26 Cir.1964) (internal citations omitted). While there is no bright-line rule regarding the number of

ORDER CERTIFYING CLASS PAGE - 4

1 class members that would typically satisfy this criteria, “[i]n general, courts find the numerosity

2 requirement satisfied when a class includes at least 40 members.” Rannis v. Recchia, 380 F.

3 Appx. 646, 651 (9th Cir. 2010); see also Dunakin v. Quigley, 99 F. Supp. 3d. 1297, 1326–27

4 (W.D. Wash. 2015) (Robart, J.).

5

Here, there is no real dispute as to whether the numerosity requirement is satisfied: it is.

6 75,000–100,000 people are estimated to be infected with HCV in Washington State. (Dkt. No.

7 24-1 at 2.) By the WHCA’s own estimates, over 900 Medicaid recipients with HCV were denied

8 coverage for DAAs in 2015. (Dkt. No. 24-1 at 19) (Demonstrating that, of the 1,695 members

9 requesting treatment, 45 percent were approved.) Joinder of this very large class would be

10 impracticable, and the Court concludes that the numerosity requirement is satisfied.

11

2. Commonality

12

The commonality prong of the certification test requires there to be “questions of fact and

13 law which are common to the class.” Fed. R. Civ. P. 23(a)(2). This requirement has been

14 “construed permissively,” such that not all legal and factual questions must be the same. Hanlon

15 v. Chrysler Corp., 150 F.3d 1011, 1019 (9th Cir. 1998). “The existence of shared legal issues

16 with divergent factual predicates is sufficient.” Id. Rule 23(a)(2) may be satisfied by “a single

17 significant question of law or fact.” Mazza v. American Honda Motor Co., Inc., 666 F.3d 581,

18 589 (9th Cir. 2012).

19

The WHCA argues that commonality is not met in this case due to the variation in

20 medical symptoms present in the proposed class. (Dkt. No. 28 at 8.) “[E]very person’s situation

21 and circumstance might be different as to why they should or should not receive the drug . . .”

22 (Id. at 9.) By the WHCA’s logic, because individuals living with HCV will manifest symptoms

23 and react to drugs differently, “the correct forum for contesting denials of these drugs is the

24 administrative forum” and “there is no commonality of facts to justify certification of a class.”

25 (Id.) This argument, however, misses the mark. Plaintiffs have brought forth a single, central

26 common question of law in this case: whether the WHCA’s February 25, 2015 HCV treatment

ORDER CERTIFYING CLASS PAGE - 5

1 policy violates the Medicaid Act. In this case, the Court has already issued a preliminary

2 injunction due to the compelling nature of this central legal question. (Dkt. No. 41.) The Court

3 finds that the commonality prong is satisfied with respect to this class.

4

3. Typicality

5

Under Rule 23(a)(3), named plaintiffs must demonstrate that (1) other members of the

6 class have the same or a similar injury, (2) the action is based on conduct which is not unique to

7 the named plaintiffs, and (3) other class members have been injured by the same course of

8 conduct. Hanon v. Dataproducts Corp., 976 F.2d 497, 508 (9th Cir. 1992). This presents a

9 “permissive standard,” in that the circumstances of the named plaintiffs need only be “reasonably

10 co-extensive with those of absent class members; they need not be substantially identical.”

11 Hanlon, 150 F.3d at 1020. “It does not matter that the named plaintiffs may have in the past

12 suffered varying injuries or that they may currently have different health care needs,” so long as

13 the named plaintiffs’ claims are typical of the class. Parsons v. Ryan, 754 F.3d 657, 686 (9th Cir.

14 2014).

15

B.E. and A.R. are both Washington residents and Medicaid enrollees. (Dkt. No. 1 at 2.)

16 They were both prescribed Harvoni and denied coverage for the drug by the WHCA. (Id.) Both

17 B.E. and A.R. have contracted HCV and have fibrosis scores lower than F3, such that they have

18 been excluded from DAA treatment coverage under the WHCA’s February 2015 policy. (Id. at

19 10.) Nothing on the record before the Court indicates that there is any conflict such that B.E. and

20 A.R. should not be named class representatives, or that the WHCA’s actions were unique to B.E.

21 or A.R. Noticeably, the WHCA does not argue that the named plaintiffs are atypical. (Dkt. No.

22 28.) The Court concludes that the typicality requirement is met.

23

4. Adequacy of Representation

24

The final question under Rule 23(a) is whether Plaintiffs and their counsel will perform

25 as adequate representatives for the class. Fed. R. Civ. P. 23(a)(4). In performing this inquiry, the

26 Court looks to whether (1) named plaintiffs or counsel have any conflicts of interest with other

ORDER CERTIFYING CLASS PAGE - 6

1 class members, and (2) named plaintiffs and counsel will “prosecute the action vigorously on

2 behalf of the class[.]” Hanlon, 150 F.3d at 1020.

3

Once again, the record before the Court demonstrates no conflicts of interest, but rather

4 that the named Plaintiffs’ interests are aligned with those of the class. (Dkt. No. 7 at 2; Dkt. No.

5 8 at 2–3.) The same is true of class counsel: three legal organizations with significant experience

6 litigating on behalf of low-income medical consumers. (Dkt. Nos. 20, 21, 22, and 24.) Once

7 again, the WHCA does not attempt to refute the adequacy of representation. (Dkt. No. 28.) The

8 Court finds this prong of the class certification test satisfied.

9

C. Rule 23(b)(2) Application

10

“The key to the (b)(2) class is ‘the indivisible nature of the injunctive or declaratory

11 remedy warranted—the notion that the conduct is such that it can be enjoined or declared

12 unlawful only as to all of the class members or as to none of them.’” Wal-Mart Stores, Inc. v.

13 Dukes, 564 U.S. 338, 360 (2011). “In other words, Rule 23(b)(2) applies only when a single

14 injunction or declaratory judgment would provide relief to each member of the class.” Id. Here,

15 the Court has already ruled on the appropriateness of injunctive relief which applies to each

16 member of the class proposed by Plaintiffs. (Dkt. No. 40 at 11.)

17

Certification under Rule 23(b)(2) is appropriate here. The Plaintiffs are “not asking the

18 court to make separate determinations concerning the individual services that are appropriate for

19 each class member. Rather, class members seek relief from systemic barriers to proper treatment

20 and services.” Dunakin v. Quigley, 99 F. Supp. 3d 1297, 1333 (W.D. Wash. 2015),

21 reconsideration denied, No. C14-0567JLR, 2015 WL 4076789 (W.D. Wash. July 1, 2015). The

22 relief sought—and, indeed, already preliminarily awarded—in this case is applicable to the class

23 as a whole.

24

D. Practical Considerations

25

As discussed above, after granting Plaintiffs’ motion for a preliminary injunction, the

26 Court requested additional briefing to determine whether the issuance of the injunction had a

ORDER CERTIFYING CLASS PAGE - 7

1 practical impact on Plaintiffs’ request for class certification. (Dkt. No. 41.) Plaintiffs assert that

2 certification will protect the due process rights of absent class members via notice and

3 enforcement, enable class counsel to more meaningfully ensure that the court-ordered

4 preliminary injunction is followed, promote efficient litigation, and prevent the mootness of the

5 named Plaintiffs’ claims. (Dkt. No. 42.)

6

In its supplemental response, the WHCA once again emphasizes that a class action is

7 “unnecessary” despite the lack of a necessity requirement in Rule 23. (Dkt. No. 45 at 3–4.) The

8 WHCA refutes the notion that class certification would assist in enforcing the preliminary

9 injunction, pointing out that it has already updated its HCV policy and begun complying with the

10 Court’s Order. (Id. at 2–3.) The WHCA further argues that notice is being provided by their

11 website and that it “intends to notify all Medicaid recipients who were previously denied about

12 the updated Treatment Policy.” (Id. at 6.)

13

These prudential concerns contribute to the appropriateness of class certification. In

14 addition to the Rule 23 factors being met, the Court emphasizes the need to provide notice to

15 class members and ensure enforcement of the preliminary injunction. While publication of the

16 changes to the HCV treatment policy on the WHCA is an important start, there are hundreds, if

17 not thousands, of Medicaid enrollees affected by the newly increased availability of DAAs. (Dkt.

18 No. 24-1 at 2) (estimating 4,700 individuals would be covered if WHCA expanded its policy to

19 cover HCV patients with a fibrosis score of F2). Individualized notice will be helpful and

20 appropriate to ensure access to medically-necessary treatment. While the WHCA cites to a

21 website and a portion of the Coats McCarthy Declaration for the premise that it will provide

22 notice, on review the Court finds no such assurances in the materials cited, let alone a specific

23 course of action about how and when notice will occur. (See Dkt. No. 45 at 6.) Class certification

24 will ensure that this notice and enforcement of the Court’s Order is vetted by both parties and the

25 Court rather than unilaterally determined by the WHCA.

26

Finally, as a practical matter, if a broadly-applicable preliminary injunction nullified

ORDER CERTIFYING CLASS PAGE - 8

1 requests for class certification, Fed. R. Civ. P. 23(b)(2) would be rendered meaningless. Rather

2 than militating against class certification, the existence of the preliminary injunction actually

3 weighs in favor of certification especially considering the need to explain the Court’s ruling to

4 all class members. This is consistent with other rulings from this Court. See K.M. v. Regence

5 BlueShield, 2014 WL 801204, at *15–16 (W.D. Wash. Feb. 27, 2014) (certifying class and

6 granting preliminary injunction); Gonzales v. U.S. Dep’t of Homeland Sec., 239 F.R.D. 620,

7 623–29 (W.D. Wash. 2006), vacated and remanded on other grounds, 508 F.3d 1227 (9th Cir.

8 2007) (certifying 23(b)(2) class and ordering preliminary injunction); Gorbach v. Reno, 181

9 F.R.D. 642, 644 (W.D. Wash. 1998) (ordering a preliminary injunction and certifying class in

10 order to effectuate nationwide relief).

11 III. CONCLUSION

12

For the foregoing reasons, Plaintiffs’ motion for class certification (Dkt. No. 17) is

13 GRANTED.

14

The Court certifies the following class:

15

All individuals who:

(1) Are or will be enrolled in Washington State Health Care Authority’s Medicaid

16

Program on or after October 10, 2014;

17 (2) Require, or are expected to require treatment for Hepatitis C with

18

Harvoni/ledipasvir-sofosbuvir or other similar direct acting antivirals under

the current guidelines adopted by the American Association for the Study of

19

Liver Diseases and the Infectious Diseases Society of America; and

20

(3) Do not meet the coverage criteria for HCV medication adopted by WHCA in

21

February 2015, as reflected in Appendix 1 to Plaintiffs’ Complaint (Dkt. No.

1-1.)

22

The Court further appoints B.E. and A.R. as class representatives and appoints Richard E.

23 Spoonemore and Eleanor Hamburger of Sirianni Youtz Spoonemore Hamburger, Amy L.

24 Crewdson of Columbia Legal Services, and Kevin Costello of Harvard Law School Center for

25 Health Law and Policy Innovation as class counsel.

26

//

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1

DATED this 21st day of July 2016.

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ORDER CERTIFYING CLASS PAGE - 10

A
John C. Coughenour UNITED STATES DISTRICT JUDGE

 
 Case 2:16-cv-00227-JCC Document 63 Filed 01/05/17 Page 1 of 4

THE HONORABLE JOHN C. COUGHENOUR 1

2

3

4

5

6

7

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON

8

AT SEATTLE

9 B. E. and A.R., on their own behalf and on behalf of all similarly situated individuals,
10

11

Plaintiffs,

12

v.

CASE NO. C16-227-JCC
ORDER GRANTING PLAINTIFF’S MOTION FOR AN ORDER PRELIMINARILY APPROVING THE SETTLEMENT

13 DOROTHY F. TEETER, in her official

14

capacity as Director of the Washington State Health Care Authority

15

Defendant.

16 Upon consideration of Plaintiffs’ unopposed motion pursuant to Federal Rule of Civil
17 Procedure 23(e) for an order preliminarily approving the settlement of this action (Motion for
18 Preliminary Approval, Dkt. No. 59) and in accordance with the parties’ settlement agreement
19 (Agreement, Dkt. No. 59-1 at 2) the Court ORDERS as follows:
20 1. Based on the record before it, the Court tentatively finds, pursuant to Federal Rule
21 of Civil Procedure 23(e), that the Agreement attached as Appendix A to the Motion for
22 Preliminary Approval (Dkt. No. 59-1 at 2) is fair, reasonable, and adequate. The Court finds
23 that:
24 (a) the Agreement resulted from extensive arm’s-length negotiations;
25 (b) there is no evidence at this stage of the proceedings of fraud, collusion, or
26

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Case 2:16-cv-00227-JCC Document 63 Filed 01/05/17 Page 2 of 4

1

overreaching, or that the rights of absent Class Members were disregarded; and

2

(c) counsel has sufficient experience in similar litigation to propose the Agreement.

3 The Agreement codifies this Court’s May 27, 2016, preliminary injunction order (Dkt. No. 40)

4 for a period of three years and restricts Washington State Health Care Authority’s (WHCA)

5 ability to enforce its February 25, 2015, treatment policy that restricted access to treatment based

6 on fibrosis score. The Agreement appears to provide substantial prospective relief to the class

7 members; i.e., class members will be entitled to seek coverage for direct-acting antivirals to treat

8 Hepatitis C without regard to their fibrosis score, subject only to narrow and reasonable

9 exceptions. The Court’s preliminary approval is subject to change pending the outcome of the

10 final settlement approval hearing (Fairness Hearing) established herein.

11

2. The Court finds that the proposed class notices, attached as Appendices B, C, and

12 D to the Motion for Preliminary Approval (Dkt. No. 59 at 16, 21, 26) meet the requirements of

13 Federal Rule of Civil Procedure 23, due process, and the applicable law. The proposed notices

14 fairly and adequately describe the terms of the Agreement, including the attorney fees and costs

15 and incentive awards; give notice of the time and place of the Fairness Hearing; and describe

16 how a class member may comment on, object to, or support the Agreement. The Court ORDERS

17 that the blanks in the proposed notices shall be filled in prior to mailing to reflect the dates and

18 deadlines set forth in this Order.

19

3. The Court DIRECTS the WHCA to mail, by direct first-class United States mail,

20 forwarding requested, the following notices:

21

(1) to all class members who are currently on Medicaid and previously requested

22

treatment with a DAA, the form of notice attached as Appendix C to the Motion for

23

Preliminary Approval (Dkt. No. 59-1 at 21);

24

(2) to all class members who are not currently on Medicaid and previously requested

25

treatment with a DAA, the form of notice attached as Appendix D to the Motion for

26

Preliminary Approval (Dkt. No. 59-1 at 26);

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1

(3) to all other class members, the form of notice attached as Appendix B to the Motion

2

for Preliminary Approval (Dkt. No. 59-1 at 16).

3 WHCA shall complete its mailing within 21 days after the date of this Order. WHCA shall

4 submit a declaration to the Court confirming its compliance with the class notice procedures

5 contained in this Order and in the Agreement within 30 days of the date of this Order.

6

4. Within 14 days of the date of this Order, WHCA shall prominently post on its

7 web page a link to the Agreement and the class notice in the form attached as Appendix B to the

8 Motion for Preliminary Approval (Dkt. No. 59-1 at 16).

9

5. Within 14 days of the date of this Order, class counsel shall establish the

10 settlement web page identified in the class notices. The web page shall contain the information

11 referenced in the Agreement section 2.2.3.2.

12

6. The Court concludes that direct mail notice to the class, in addition to web-based

13 notice, is the best notice practicable under the circumstances and complies with the requirements

14 of Federal Rule of Civil Procedure 23, due process, and any other applicable law.

15

7. A Fairness Hearing to consider whether the proposed Agreement is fair,

16 reasonable, and adequate and should be finally approved is scheduled for April 4, 2017, at 9 a.m.

17 at the United States Courthouse, 700 Stewart Street, Seattle, WA 98101.

18

8. A class member who wishes to comment on or object to the Agreement must

19 submit written comments and/or objections to the Court no later than March 21, 2017.

20

9. A class member who wishes to appear at the Fairness Hearing may do so if he or

21 she submits written notice to the Court, with copies to counsel, that he or she intends to appear in

22 person or through counsel. In that written notice to appear, the Class Member must describe the

23 nature of his or her comment or objection. Written notice of intent to appear must be filed with

24 the Court and mailed to counsel by March 21, 2017.

25

10. A Motion for Final Approval of the Agreement, together with any supporting

26 declarations or other documentation, must be filed no later than March 28, 2017. Class counsel

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Case 2:16-cv-00227-JCC Document 63 Filed 01/05/17 Page 4 of 4

1 shall also mail the Motion for Final Approval to all class members who object to the Agreement

2 or file written notice with the Court that they intend to appear at the Fairness Hearing.

3

11. Class counsel shall file any motion for an award of attorney fees or

4 reimbursement of expenses or costs and any motion for an incentive awards no later than

5 February 17, 2017. Class counsel shall post this motion on the settlement web page within three

6 days of its filing with the Court.

7

12. The Court reserves the right to adjourn the date of the Fairness Hearing without

8 further notice to class members, and it retains jurisdiction to consider all further applications

9 arising out of or connected with the Agreement. The Court may approve the Agreement, with

10 such modifications as may be agreed to by the Parties, if appropriate, without further notice to

11 class members.

12

DATED this 5th day of January 2017.

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16 17

A

18 John C. Coughenour

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UNITED STATES DISTRICT JUDGE

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Appendix A

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MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 28 [Case No. 2:16-cv-00227-JCC]

Appendix B

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 16 of 29

UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF WASHINGTON

ARE YOU OR A FAMILY MEMBER ON MEDICAID? HAVE YOU BEEN DIAGNOSED WITH HEPATITIS C? YOU COULD BE ENTITLED TO NEW
DRUG TREATMENTS.

A federal court authorized this notice. This is not a solicitation from a lawyer.
 If you have Hepatitis C and are on Medicaid, guidelines for treatment have changed. You could get treatment with new highly effective drugs such as Harvoni™ and others. Harvoni™ may or may not be right for you. There are other drugs which may be better for you.
 A liver fibrosis score tells how badly a person’s liver has been scarred by Hepatitis C. Under the old guidelines, people with fibrosis scores of F0, F1, and most with F2, could not get treatment with the new drugs. Only people with fibrosis scores of F3 and F4 were approved. As the result of a lawsuit, that has now changed. Fibrosis score does not matter anymore. You cannot be denied treatment because your fibrosis score is too low.
 If you have Hepatitis C and are on Medicaid go see your doctor. Take this notice, show it to your doctor, and ask if the new drugs are right for you. If they are, ask your doctor to apply to Medicaid.
 The state told some people with lower fibrosis scores they could not get the new drugs. Two people denied because of their fibrosis scores sued the state in a class action lawsuit. A federal court made a preliminary court order that stopped the state from taking into account fibrosis scores. The same court also said the case was a class action that covers everyone on Medicaid with Hepatitis C. The case is called B.E. and A.R. v. Teeter, United States District Court for the Western District of Washington, Case No. C16-0227-JCC.
 Both sides decided to settle the case. The state agreed it will not deny the new drugs based on fibrosis score. It makes the preliminary court order permanent. If you are a member of the class, then you have certain rights. These are explained below.

YOU MAY COMMENT ON THE PROPOSED SETTLEMENT AGREEMENT.

YOUR LEGAL RIGHTS IN THIS LAWSUIT
You have the right to comment on, object to, or support the proposed Settlement Agreement. The Court will decide whether to approve or reject the proposed Settlement Agreement after a Final Hearing on _______________, 2017 at _______, at ________________________.

YOU MAY APPLY FOR TREATMENT WITH HARVONI™ OR A SIMILAR DRUG.

Your doctor may apply for coverage with one of the new Hepatitis C drugs. You cannot be turned down because of your fibrosis score. If you have Hepatitis C, go see your doctor to see if treatment with one of the new drugs is right for you.

YOU MAY DO NOTHING.

If you do nothing, then you will remain in the class. If you decide to get treatment, you cannot be turned down because of your fibrosis score. Hepatitis C is harmful to your health. For example, it can cause cancer and other serious health problems. Go see a doctor about treatment options.

MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 29 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 17 of 29
FREQUENTLY ASKED QUESTIONS
1. Why did I get this notice? You got this Notice because you or your family member may be someone who:
(1) Was, are, or will be enrolled in the Medicaid Program on or after October 10, 2014; (2) Need, or are expected to need treatment for Hepatitis C with Harvoni™ or other new
Hepatitis C drugs; and (3) Did not meet the coverage criteria for the drugs adopted by WHCA because, for
example, the state determined that you were not sick enough to get treatment with the new drugs.
2. What is this lawsuit about? Two people on Medicaid brought this lawsuit. They said the state was keeping some people on Medicaid from getting the Hepatitis C treatment they needed. They said the state was using a person’s fibrosis score to decide who got treatment. Only people with fibrosis scores of F3 and F4, and some with an F2 score were getting treatment. A person’s fibrosis score tells how much Hepatitis C has scarred the person’s liver. A higher score means more scarring. They asked the judge to say that using fibrosis scores this way was not allowed under the law. They wanted people with lower fibrosis scores to get treated with the new Hepatitis C drugs. These new drugs usually cure Hepatitis C.
3. What is a class action, and who is involved? In a class action lawsuit, one or more people (“Class Representatives”) sue on behalf of other people who have similar claims. The people together are a “Class” or “Class Members.” All of the Class Members are called the Plaintiffs. One court resolves the issues for everyone in the Class. In this case, B.E. and A.R., are people on Medicaid with Hepatitis C. They are the Class Representatives. The defendant is the Director of the Washington State Health Care Authority. The Health Care Authority operates the Medicaid program.
4. What has happened in this case? Three months after the case was filed the judge ordered the state to stop using fibrosis scores to decide who could get the new Hepatitis C drugs. This order was a preliminary order. Later, the judge said the case could be a class action. You can see these two court orders at: [link]
The state and the plaintiffs then talked with each other to see if the case could be settled. Those talks resulted in an agreement to settle the case.
5. What does the proposed Settlement Agreement say? The bullet points below tell you the main points of the proposed Settlement Agreement. You can see the whole Agreement online at: www.symslaw.com/medicaidhepc
The judge will hold a hearing on the Agreement. The judge has to approve the Agreement before it takes effect. If you need treatment, do not wait for the judge’s approval. You may be eligible to get Harvoni or one of the other new drugs right now.
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 30 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 18 of 29
• Coverage of Harvoni and other similar drugs for the treatment of Hepatitis C
The Agreement says the state will follow the court’s preliminary order for at least three years into the future. Fibrosis scores cannot be used to deny coverage for Harvoni or one of the other new drugs.
• Attorney’s Fees, Litigation Costs, and Costs of Claims Administration
Under the proposed Settlement Agreement, the state will pay the attorneys’ fees of the attorneys representing the class. This amount will be based upon the attorneys’ normal hourly rates and the time they spent on the case. The court will determine the exact amount. In addition, the state will pay the attorneys the money they paid out of pocket on behalf of the class. The judge must approve these out-of-pocket costs as well.
• Case Contribution Awards
The judge will be asked to award $7,500 each to B.E. and A.R. B.E. and A.R. are the class representatives. The state is responsible for paying this sum. The judge must approve the case contribution awards.
6. How do I respond to the proposed Settlement Agreement?
• You May Comment on, Object to, or Support the Proposed Settlement Agreement.
The judge will hold a final hearing on the proposed Settlement Agreement on _______________, 2017 at _________, at _____________________.
You do not have to attend the hearing. You can if you want to.
You can send comments to the judge instead of coming to the hearing. Comments must be in writing. You must send them to the judge before the hearing.
You may attend the hearing, and you may bring a legal representative if you wish at your own expense. You must send the judge a letter before the hearing if you want the judge to allow you to speak at the hearing. Send your letter to:
Clerk of Court, B.E. v. Teeter, No. 2:16-00227 U.S. Courthouse 700 Stewart Street Seattle, WA 98101-9906
If you choose to send written comments or come to the hearing, the judge must get your letter no later than ___________. You also have to send a copy of your letter to all the attorneys. Mail your letter to:
Eleanor Hamburger Sirianni Youtz Spoonemore Hamburger 999 Third Avenue, Suite 3650 Seattle, WA 98104 and
Angela Coats McCarthy, Jennifer Meyer and Nissa Iversen OFFICE OF THE ATTORNEY GENERAL P.O. Box 40124 Olympia, WA 98504-0124
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 31 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 19 of 29 7. Where can I get more information?
 For more information, go to: www.symslaw.com/medicaidhepc  You can email Class Counsel at medicaidhepc@columbialegal.org  You can call Class Counsel at 1-800-260-6260 ext. ???.
INSERT LANGUAGE ABOUT ACCESS TO TRANSLATED COPIES HERE
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 32 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 20 of 29

MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 33 [Case No. 2:16-cv-00227-JCC]

Appendix C

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 21 of 29

UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF WASHINGTON

ARE YOU OR A FAMILY MEMBER ON MEDICAID? HAVE YOU BEEN DIAGNOSED WITH HEPATITIS C? YOU COULD BE ENTITLED TO NEW
DRUG TREATMENTS.
A federal court authorized this notice. This is not a solicitation from a lawyer.
 Guidelines for Hepatitis C treatment have changed. You could get treatment with new highly effective drugs such as Harvoni™ and others. Harvoni™ may or may not be right for you. There are other drugs which may be better for you.
 A liver fibrosis score tells how badly a person’s liver has been scarred by Hepatitis C. Under the old guidelines, people with fibrosis scores of F0, F1, and most with F2, could not get treatment with the new drugs. Only people with fibrosis scores of F3 and F4 were approved. As the result of a lawsuit, that has now changed. Fibrosis score does not matter anymore. You cannot be denied treatment because your fibrosis score is too low.
 You are getting this notice because you are on Medicaid and the state denied you the new drugs to treat your Hepatitis C. You may now be eligible to get them. Go see your doctor. Take this notice, show it to your doctor, and ask if the new drugs are right for you. If so, ask your doctor to reapply.
 The state told some people with lower fibrosis scores they could not get the new drugs. Two people denied because of their fibrosis scores sued the state in a class action lawsuit. A federal court made a preliminary court order that stopped the state from taking into account fibrosis scores. The same court also said the case was a class action that covers everyone on Medicaid with Hepatitis C. The case is called B.E. and A.R. v. Teeter, United States District Court for the Western District of Washington, Case No. C16-0227-JCC.
 Both sides decided to settle the case. The state agreed it will not deny the new drugs based on fibrosis score. It makes the preliminary court order permanent. If you are a member of the class, then you have certain rights. These are explained below.

YOU MAY COMMENT ON THE PROPOSED SETTLEMENT AGREEMENT.

YOUR LEGAL RIGHTS IN THIS LAWSUIT
You have the right to comment on, object to, or support the proposed Settlement Agreement. The Court will decide whether to approve or reject the proposed Settlement Agreement after a Final Hearing on _______________, 2017 at _______, at ________________________.

YOU MAY APPLY FOR TREATMENT WITH HARVONI™ OR A SIMILAR DRUG.

Your doctor may apply for coverage with one of the new Hepatitis C drugs. You cannot be turned down because of your fibrosis score. If you have Hepatitis C, go see your doctor to see if treatment with one of the new drugs is right for you.

YOU MAY DO NOTHING.

If you do nothing, then you will remain in the class. If you decide to get treatment, you cannot be turned down because of your fibrosis score. Hepatitis C is harmful to your health. For example, it can cause cancer and other serious health problems. Go see a doctor about treatment options.

MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 34 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 22 of 29
FREQUENTLY ASKED QUESTIONS
1. Why did I get this notice? You got this Notice because you or your family member may be someone who:
(1) Was, are, or will be enrolled in the Medicaid Program on or after October 10, 2014; (2) Need, or are expected to need treatment for Hepatitis C with Harvoni™ or other new
Hepatitis C drugs; and (3) Did not meet the coverage criteria for the drugs adopted by WHCA because, for
example, the state determined that you were not sick enough to get treatment with the new drugs.
2. What is this lawsuit about? Two people on Medicaid brought this lawsuit. They said the state was keeping some people on Medicaid from getting the Hepatitis C treatment they needed. They said the state was using a person’s fibrosis score to decide who got treatment. Only people with fibrosis scores of F3 and F4, and some with an F2 score were getting treatment. A person’s fibrosis score tells how much Hepatitis C has scarred the person’s liver. A higher score means more scarring. They asked the judge to say that using fibrosis scores this way was not allowed under the law. They wanted people with lower fibrosis scores to get treated with the new Hepatitis C drugs. These new drugs usually cure Hepatitis C.
3. What is a class action, and who is involved? In a class action lawsuit, one or more people (“Class Representatives”) sue on behalf of other people who have similar claims. The people together are a “Class” or “Class Members.” All of the Class Members are called the Plaintiffs. One court resolves the issues for everyone in the Class. In this case, B.E. and A.R., are people on Medicaid with Hepatitis C. They are the Class Representatives. The defendant is the Director of the Washington State Health Care Authority. The Health Care Authority operates the Medicaid program.
4. What has happened in this case? Three months after the case was filed the judge ordered the state to stop using fibrosis scores to decide who could get the new Hepatitis C drugs. This order was a preliminary order. Later, the judge said the case could be a class action. You can see these two court orders at: [link]
The state and the plaintiffs then talked with each other to see if the case could be settled. Those talks resulted in an agreement to settle the case.
5. What does the proposed Settlement Agreement say? The bullet points below tell you the main points of the proposed Settlement Agreement. You can see the whole Agreement online at: www.symslaw.com/medicaidhepc
The judge will hold a hearing on the Agreement. The judge has to approve the Agreement before it takes effect. If you need treatment, do not wait for the judge’s approval. You may be eligible to get Harvoni or one of the other new drugs right now.
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 35 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 23 of 29
• Coverage of Harvoni and other similar drugs for the treatment of Hepatitis C
The Agreement says the state will follow the court’s preliminary order for at least three years into the future. Fibrosis scores cannot be used to deny coverage for Harvoni or one of the other new drugs.
• Attorney’s Fees, Litigation Costs, and Costs of Claims Administration
Under the proposed Settlement Agreement, the state will pay the attorneys’ fees of the attorneys representing the class. This amount will be based upon the attorneys’ normal hourly rates and the time they spent on the case. The court will determine the exact amount. In addition, the state will pay the attorneys the money they paid out of pocket on behalf of the class. The judge must approve these out-of-pocket costs as well.
• Case Contribution Awards
The judge will be asked to award $7,500 each to B.E. and A.R. B.E. and A.R. are the class representatives. The state is responsible for paying this sum. The judge must approve the case contribution awards.
6. How do I respond to the proposed Settlement Agreement?
• You May Comment on, Object to, or Support the Proposed Settlement Agreement.
The judge will hold a final hearing on the proposed Settlement Agreement on _______________, 2017 at _________, at _____________________.
You do not have to attend the hearing. You can if you want to.
You can send comments to the judge instead of coming to the hearing. Comments must be in writing. You must send them to the judge before the hearing.
You may attend the hearing, and you may bring a legal representative if you wish at your own expense. You must send the judge a letter before the hearing if you want the judge to allow you to speak at the hearing. Send your letter to:
Clerk of Court, B.E. v. Teeter, No. 2:16-00227 U.S. Courthouse 700 Stewart Street Seattle, WA 98101-9906
If you choose to send written comments or come to the hearing, the judge must get your letter no later than ___________. You also have to send a copy of your letter to all the attorneys. Mail your letter to:
Eleanor Hamburger Sirianni Youtz Spoonemore Hamburger 999 Third Avenue, Suite 3650 Seattle, WA 98104 and
Angela Coats McCarthy, Jennifer Meyer and Nissa Iversen OFFICE OF THE ATTORNEY GENERAL P.O. Box 40124 Olympia, WA 98504-0124
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 36 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 24 of 29 7. Where can I get more information?
 For more information, go to: www.symslaw.com/medicaidhepc  You can email Class Counsel at medicaidhepc@columbialegal.org  You can call Class Counsel at 1-800-260-6260 ext. ???.
INSERT LANGUAGE ABOUT ACCESS TO TRANSLATED COPIES HERE
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 37 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 25 of 29

MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 38 [Case No. 2:16-cv-00227-JCC]

Appendix D

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 26 of 29

UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF WASHINGTON

WERE YOU OR A FAMILY MEMBER DIAGNOSED WITH HEPATITIS C? WERE YOU DENIED TREATMENT WHILE YOU WERE ON MEDICAID?
A federal court authorized this notice. This is not a solicitation from a lawyer.
 You are getting this notice because:
o You were on Medicaid in the past. You are not on Medicaid now.
o While you were on Medicaid, you asked for treatment for Hepatitis C.
o You were denied treatment.
 Guidelines for treatment have changed. Check to see if you can go back on Medicaid. If you can, you could get treatment with new highly effective drugs such as Harvoni™ and others.
 A liver fibrosis score tells how badly a person’s liver has been scarred by Hepatitis C. Under the old guidelines, people with fibrosis scores of F0, F1, and most with F2, could not get treatment with the new drugs. Only people with fibrosis scores of F3 and F4 were approved. As the result of a lawsuit, that has now changed. Fibrosis score does not matter anymore. If you go back on Medicaid, you cannot be denied treatment because your fibrosis score is too low.
 If you get back on Medicaid, go see your doctor. Take this notice with you, show it to your doctor, and ask if the drugs are right for you. If so, ask your doctor to apply for the new drugs.
 If you cannot get back on Medicaid, you can talk to a lawyer. You may have a claim under state law.
 The state told some people with lower fibrosis scores they could not get the new drugs. This may be the reason you were denied treatment. Two people denied because of their fibrosis scores sued the state in a class action lawsuit. A federal court made a preliminary court order that stopped the state from taking into account fibrosis scores. The same court also said the case was a class action that covers everyone on Medicaid with Hepatitis C. The case is called B.E. and A.R. v. Teeter, United States District Court for the Western District of Washington, Case No. C16-0227-JCC.
 Both sides decided to settle the case. The state agreed it will not deny the new drugs to people on Medicaid based on fibrosis score. It makes the preliminary court order effective for three years. If you are a member of the class, then you have certain rights. These are explained below.

YOUR LEGAL RIGHTS IN THIS LAWSUIT

YOU MAY COMMENT ON THE PROPOSED SETTLEMENT AGREEMENT.

You have the right to comment on, object to, or support the proposed Settlement Agreement. The Court will decide whether to approve or reject the proposed Settlement Agreement after a Final Hearing on _______________, 2017 at _______, at ________________________.

IF YOU GO BACK ON
MEDICAID, YOU MAY APPLY
FOR TREATMENT WITH
HARVONI™ OR A SIMILAR DRUG. IF YOU CANNOT GET BACK ON MEDICAID, YOU CAN TALK TO A LAWYER.

If you go back on Medicaid, your doctor may apply for coverage with one of the new Hepatitis C drugs. You cannot be turned down because of your fibrosis score.
You may have state law claims to seek coverage. Those claims have not been settled or released.

YOU MAY DO NOTHING.

If you do nothing, then you will remain in the class. If you go back on Medicaid, you cannot be turned down because of your fibrosis score. Hepatitis C is harmful to your health. For example, it can cause cancer and other serious health problems.

MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 39 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 27 of 29
FREQUENTLY ASKED QUESTIONS
1. Why did I get this notice? You got this Notice because you or your family member may be someone who:
(1) Was enrolled in the Medicaid Program on or after October 10, 2014; (2) Was denied treatment for Hepatitis C with Harvoni™ or other new Hepatitis C drugs;
and (3) Did not meet the coverage criteria for the drugs adopted by the state because, for
example, the state determined that you were not sick enough to get treatment with the new drugs.
2. What is this lawsuit about? Two people on Medicaid brought this lawsuit. They said the state was keeping some people on Medicaid from getting the Hepatitis C treatment they needed. They said the state was using a person’s fibrosis score to decide who got treatment. Only people with fibrosis scores of F3 and F4, and some with an F2 score were getting treatment. A person’s fibrosis score tells how much Hepatitis C has scarred the person’s liver. A higher score means more scarring. They asked the judge to say that using fibrosis scores this way was not allowed under the law. They wanted people with lower fibrosis scores to get treated with the new Hepatitis C drugs. These new drugs usually cure Hepatitis C.
3. What is a class action, and who is involved? In a class action lawsuit, one or more people (“Class Representatives”) sue on behalf of other people who have similar claims. The people together are a “Class” or “Class Members.” All of the Class Members are called the Plaintiffs. One court resolves the issues for everyone in the Class. In this case, B.E. and A.R., are people on Medicaid with Hepatitis C. They are the Class Representatives. The defendant is the Director of the Washington State Health Care Authority. The Health Care Authority operates the Medicaid program.
4. What has happened in this case? Three months after the case was filed the judge ordered the state to stop using fibrosis scores to decide who could get the new Hepatitis C drugs. This order was a preliminary order. Later, the judge said the case could be a class action. You can see these two court orders at: [link]
The state and the plaintiffs then talked with each other to see if the case could be settled. Those talks resulted in an agreement to settle the case.
5. What does the proposed Settlement Agreement say? The bullet points below tell you the main points of the proposed Settlement Agreement. You can see the whole Agreement online at: www.symslaw.com/medicaidhepc The judge will hold a hearing on the Agreement. The judge has to approve the Agreement before it takes effect. If you get back on Medicaid, you may be eligible to get Harvoni™ or one of the other new drugs.
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 40 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 28 of 29
• Coverage of Harvoni and other similar drugs for the treatment of Hepatitis C
The Agreement says the state will follow the court’s preliminary order for at least three years into the future. Fibrosis scores cannot be used to deny coverage for Harvoni or one of the other new drugs.
• Attorney’s Fees, Litigation Costs, and Costs of Claims Administration
Under the proposed Settlement Agreement, the state will pay the attorneys’ fees of the attorneys representing the class. This amount will be based upon the attorneys’ normal hourly rates and the time they spent on the case. The court will determine the exact amount. In addition, the state will pay the attorneys the money they paid out of pocket on behalf of the class. The judge must approve these out-of-pocket costs as well.
• Case Contribution Awards
The judge will be asked to award $7,500 each to B.E. and A.R. B.E. and A.R. are the class representatives. The state is responsible for paying this sum. The judge must approve the case contribution awards.
6. How do I respond to the proposed Settlement Agreement?
You May Comment on, Object to, or Support the Proposed Settlement Agreement.
The judge will hold a final hearing on the proposed Settlement Agreement on _______________, 2017 at _________, at _____________________.
You do not have to attend the hearing. You can if you want to.
You can send comments to the judge instead of coming to the hearing. Comments must be in writing. You must send them to the judge before the hearing.
You may attend the hearing, and you may bring a legal representative if you wish at your own expense. You must send the judge a letter before the hearing if you want the judge to allow you to speak at the hearing. Send your letter to:
Clerk of Court, B.E. v. Teeter, No. 2:16-00227 U.S. Courthouse 700 Stewart Street Seattle, WA 98101-9906
If you choose to send written comments or come to the hearing, the judge must get your letter no later than ___________. You also have to send a copy of your letter to all the attorneys. Mail your letter to:
Eleanor Hamburger Sirianni Youtz Spoonemore Hamburger 999 Third Avenue, Suite 3650 Seattle, WA 98104 and
Angela Coats McCarthy, Jennifer Meyer and Nissa Iversen OFFICE OF THE ATTORNEY GENERAL P.O. Box 40124 Olympia, WA 98504-0124
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 41 [Case No. 2:16-cv-00227-JCC]

Case 2:16-cv-00227-JCC Document 59-1 Filed 11/21/16 Page 29 of 29 7. Where can I get more information?
 For more information, go to: www.symslaw.com/medicaidhepc  You can email Class Counsel at medicaidhepc@columbialegal.org  You can call Class Counsel at 1-800-260-6260 ext. ???.
INSERT LANGUAGE ABOUT ACCESS TO TRANSLATED COPIES HERE
MOTION FOR PRELIMINARY APPROVAL OF SETTLEMENT AGREEMENT, ETC. - 42 [Case No. 2:16-cv-00227-JCC]

 
 Case 2:16-cv-00227-JCC Document 87 Filed 04/10/17 Page 1 of 5

THE HONORABLE JOHN C. COUGHENOUR 1

2

3

4

5

6

7

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON

8

AT SEATTLE

9

B. E. and A.R., on their own behalf and on

10

behalf of all similarly situated individuals,

11

Plaintiffs,

v.

12

DOROTHY F. TEETER, in her official

13

capacity as Director of the Washington

State Health Care Authority, 14

15

Defendant.

CASE NO. C16-0227-JCC
ORDER FINALLY APPROVING CLASS SETTLEMENT

16 I. BACKGROUND
17 On January 5, 2017, the Court preliminarily approved a proposed Settlement Agreement,
18 attached at Dkt. No. 59-1 (Agreement), between the class and Defendant Dorothy F. Teeter, in
19 her official capacity as the Director of the Washington State Health Care Authority (WHCA).
20 (Dkt. No. 63.) In conjunction with that order, the Court directed notice to be provided by direct
21 mail to all class members by January 26, 2017. The Court approved a form of notice.
22 The order further provided that class members who wished to comment on or object to
23 the proposed Agreement were required to do so by March 21, 2017. Class members were
24 informed of their rights, and of this deadline, in the notices that were mailed to them.
25

26

ORDER FINALLY APPROVING CLASS SETTLEMENT PAGE - 1

Case 2:16-cv-00227-JCC Document 87 Filed 04/10/17 Page 2 of 5

1

The order further scheduled a final settlement hearing, which was held on April 4, 2017,

2 to consider objections and comments by class members and to determine whether the proposed

3 Agreement is fair, reasonable, adequate, and should be approved by the Court.

4

II. FINDINGS

5

1. The parties have reached a Settlement Agreement providing coverage for direct

6 acting antiviral medications for the treatment of class members diagnosed with Hepatitis C, the

7 exact terms of which are set out in the Agreement.

8

2. The Agreement codifies this Court’s May 27, 2016, preliminary injunction order,

9 (Dkt. No. 40), for a period of three years and restricts WHCA’s ability to enforce its February

10 25, 2015 treatment policy that restricted access to treatment based on fibrosis score. The

11 Agreement provides substantial prospective relief to the class members; i.e., class members will

12 be entitled to seek coverage for direct-acting antivirals to treat Hepatitis C without regard to their

13 fibrosis score, subject only to narrow and reasonable exceptions.

14

3. The Court’s order required WHCA to mail court-approved notices to class

15 members by direct mail. The notices informed class members that they had an opportunity to

16 object or submit comments to the Court regarding the proposed Agreement and that they must do

17 so in writing by March 21, 2017. Counsel for WHCA confirmed, by declaration, that the notices

18 were timely mailed. (Dkt. No. 66.)

19

4. The Court and the Parties received 21 letters concerning the Settlement

20 Agreement. The majority of the letters were supportive of the Agreement, while others were

21 written by class members seeking information on how to obtain treatment. Significantly, no class

22 members objected to the Settlement Agreement or any of its terms or conditions.

23

III. CONCLUSIONS

24

5. Federal Rule of Civil Procedure 23(e) provides that “[t]he claims, issues, or

25 defenses of a certified class may be settled, voluntarily dismissed, or compromised only with the

26

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1 court’s approval.” Compromise and arbitration of complex litigation is encouraged and favored

2 by public policy. See Simula, Inc. v. Autoliv, Inc., 175 F.3d 716, 719 (9th Cir. 1999).

3

6. A presumption of fairness and adequacy attaches to a class action settlement

4 reached in arm’s-length negotiations by experienced class counsel after meaningful discovery. 5 See, e.g., Officers for Justice v. Civil Service Com., 688 F.2d 615, 625 (9th Cir. 1982); Pickett v.

6 Holland Am. Line-Westours, Inc., 145 Wn. 2d 178, 209, 35 P.3d 351 (2001).

7

7. The following factors are generally considered when determining whether a

8 settlement is fair, adequate, and reasonable: the likelihood of success by plaintiffs; the amount

9 of discovery or evidence; the settlement terms and conditions; recommendation and experience

10 of counsel; future expense and likely duration of litigation; recommendation of neutral parties, if

11 any; number of objectors and nature of objections; and the presence of good faith and absence of

12 collusion. Officers for Justice, 688 F.2d at 625.

13

8. Based upon these factors, the Court finds that the Agreement is fair, reasonable,

14 and in the best interests of the class. The requirement of Federal Rule of Civil Procedure 23 and

15 due process have been satisfied.

16

9. Specifically, the Court concludes that the Agreement was the result of arm’s-

17 length bargaining. It was reached after discovery and motions practice, including a preliminary

18 injunction order from this Court. Although the class had a strong likelihood of success, a

19 settlement in which class members will be able to obtain coverage of direct acting antivirals for

20 the treatment of their Hepatitis C without regard to fibrosis score achieves the goals of the

21 litigation. There is no evidence of collusion between the parties, and the agreement was reached

22 in good faith.

23

10. The class was provided with adequate notice, and due process has been satisfied

24 in connection with the distribution of the notice. There were no objections to the proposed

25 Agreement.

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1

IV. EXTENSION OF INJUNCTION ORDER

2

11. Pursuant to Sections 2.3 and 5.1.1 of the Settlement Agreement, the class

3 requests, and WHCA does not oppose, that the Court order that the requirements contained in the

4 May 27, 2016 Preliminary Injection Order, (Dkt. No. 40), remain in effect for a period of three

5 years from the effective date of the settlement. The Court so orders. WHCA shall not apply its

6 February 25, 2015 Hepatitis C virus (HCV) treatment policy, including its exclusion of all

7 treatment based on fibrosis score, and is required to provide coverage for prescription

8 medications to treat HCV without regard to fibrosis score, consistent with existing state and

9 federal Medicaid requirements for a period of three years from the effective date of settlement.

10 The Court retains jurisdiction for purposes of enforcement of this Order.

11

V. ATTORNEY FEES AND LITIGATION COSTS

12

12. Pursuant to the Settlement Agreement, WHCA is obligated to pay the reasonable

13 fees of class counsel. Class counsel seeks $335,377 in fees, which WHCA has elected not to

14 oppose. The Court finds this sum reasonable, and it is approved.

15

13. No objections were received to class counsel’s fee request.

16

14. Class counsel is also entitled to reimbursement of its actual litigation costs and

17 expenses. Class counsel seeks reimbursement in the sum of $8,016.86, reflecting its

18 unreimbursed actual out-of-pocket litigation costs and expenses. This request is supported, is

19 reasonable, and is approved.

20

15. No objections were received to class counsel’s request for an award of costs and

21 expenses.

22

VI. CASE CONTRIBUTION AWARDS

23

16. Pursuant to the Settlement Agreement, WHCA has agreed to pay each class

24 representative the sum of $7,500 as a case contribution award. This amount is reasonable, and is

25 approved.

26

17. No objections were received to the request for case contribution awards.

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1

VII. ORDER

2

It is hereby ORDERED that:

3

1. The Settlement Agreement is approved as fair, reasonable, and adequate under

4 Federal Rule of Civil Procedure 23.

5

2. WHCA is required to provide coverage for direct-acting antivirals (DAAs) for the

6 treatment of HCV as set forth in paragraph 11, above.

7

3. Class counsel is awarded fees and litigation costs in the amounts of $335,377 and

8 $8,016.86, respectively.

9

4. Case contribution awards of $7,500 per named Plaintiff as set forth in the

10 Agreement are approved.

11

DATED this 10th day of April 2017.

12 13

A

14

John C. Coughenour

15

UNITED STATES DISTRICT JUDGE

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