COMMONWEALTH OF MASSACHUSETTS SUFFOLK, SS. ' SUPERIOR COURT DEPARTMENT OF THE TRIAL COURT : = ) ^

Transcription

1 COMMONWEALTH OF MASSACHUSETTS SUFFOLK, SS. ' SUPERIOR COURT DEPARTMENT OF THE TRIAL COURT : = ) ^ COMMONWEALTH OF MASSACHUSETTS, ) ) Plaintiff, ) CIVIL ACTION NO. _ ) v. ) ) MYLAN SPECIALTY L.P. and PFIZER INC., ) ) Defendants. ). ) FINAL JUDGMENT BY CONSENT AS TO MYLAN SPECIALTY, L.P. The Court has reviewed the Complaint filed in this case by the Commonwealth of Massachusetts (the "Commonwealth"), the assented-to Motion for Entry of Final Judgment by Consent and the attached Consent. The Court finds that it properly has subject matter jurisdiction of this Complaint and personal jurisdiction over the defendant, Mylan Specialty L.P. ("Mylan Specialty"), and finds that the entry of this Final Judgment by Consent as to Mylan Specialty, L.P. ("Consent Judgment") is in the interest of justice. WHEREAS, without admission of liability, in order to amicably resolve their differences. concerning the Complaint and in order to avoid the cost and uncertainty of litigation, the parties have agreed to the entry of this Consent Judgment; WHEREAS, during the time period at issue in this action, Pfizer Inc. ("Pfizer") held NDA # for the EpiPen and EpiPen Jr (epinephrine) Auto-Injectors (collectively, "EpiPen"), which the Food and Drug Administration ("FDA") has approved for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions; 1

2 WHEREAS, during the time period at issue in this action, Mylan Specialty held the exclusive license from Meridian Medical Technologies, Inc., a subsidiary of Pfizer, to market, sell, and distribute EpiPen in the United States; ' WHEREAS, Mylan Specialty recently acquired the NDA for EpiPen from Pfizer; and WHEREAS, Mylan Specialty ran a direct-to-consumer advertising campaign for the EpiPen, including print and television advertising, with the television advertisement running from April 16, 2012 until April 19, 2012, and, for a limited number of cable TV channels, until April 22, 2012 (the "Advertising Campaign"); WHEREAS, this Consent Judgment resolves the Commonwealth's allegations, set forth in the Complaint, that Mylan Specialty engaged in an act or practice declared to be unlawful by the Massachusetts Consumer Protection Act, G.L. c. 93 A, 1 et seq., in connection with the Advertising Campaign; and WHEREAS, the Commonwealth has filed an assented-to motion seeking entry of this Consent Judgment; Accordingly, good cause being shown, IT IS ORDERED THAT: 1. Mylan Specialty and any of its parent corporations, subsidiaries, affiliates, predecessors or successors-in-interest, or any of its directors, officers, or employees are permanently enjoined from disseminating in any media the Advertising Campaign. 2. Effective immediately upon entry of this Consent Judgment by the Superior Court, Mylan Specialty or any of its parent corporations, subsidiaries, affiliates, predecessors or successors-in-interest, or any of its directors, officers, or employees shall not run any new direct to consumer ("DTC") television advertising campaigns for EpiPen in Massachusetts until (1) such new DTC television advertising campaigns have been submitted to the FDA for pre-review, 2

3 (2) Mylan Specialty has waited a reasonable time (not less than 45 days) for the FDA to respond to the submission, and (3) in the event the FDA provides written comments identifying material issues with the subject advertisement, Mylan Specialty addresses such comments. In the event the FDA does not provide a pre-review response addressing the substance of the new DTC television advertising campaign within the 45-day waiting period, then simultaneous with running the subject advertisement, Mylan Specialty will provide the Commonwealth written notice that it is running the advertisement and of the submission and non-response by the FDA, together with a copy of all material submitted to the FDA for the review of the subject advertisement. For the purposes of this paragraph, a "new DTC television advertising campaign" is one where there has been a substantial change in an advertisement's script or theme and/or changes in the advertisement such that the benefit and/or risk information is presented in a materially different manner. The requirements of this Consent Judgment as stated in this paragraph shall expire oh April 22, Within ten (10) days after the entry of this Consent Judgment by the Superior Court, Mylan Specialty shall make payment of $250,000 by electronic fund transfer to the Office of the Massachusetts Attorney General to an account or accounts identified by the Commonwealth, comprised of (1) $25,000 for civil penalties; (2) $175,000 for the purpose of assisting the Office of the Attorney General to discharge its duties, in accordance with G.L. c. 12, 4A, and to be used in the sole discretion of the Attorney General to promote initiatives designed to assist Massachusetts health care consumers or to support efforts to enforce compliance with state and federal laws and regulations that protect such individuals, including, but not limited to, through grants or other distributions to one or more political subdivisions of 3

4 the Commonwealth, non-profit organizations, or to the Local Consumer Aid Fund, as established by G.L. c. 12, 11G; and (3) $50,000 for the costs of investigation and attorneys' fees. 4. Neither this Consent Judgment, nor any part thereof, including, without limitation, any statements or notices required by this Consent Judgment, shall be treated or construed as an admission of liability or wrongdoing, admitted into evidence against Mylan Specialty or any of its parent corporations, subsidiaries, affiliates, predecessors or successors-in-interest, or any of its directors, officers, or employees (all collectively referred to as the "Mylan Entities") or used for any other purpose in any proceeding, except in a proceeding to enforce the terms of this Consent Judgment. Mylan Specialty does not admit or concede any actual or potential fault, wrongdoing, liability or violation of law in connection with any facts or claims that have been or could have been alleged against it. 5. This Consent Judgment shall not be construed or used as a waiver or limitation of any defense otherwise available to the Mylan Entities in any action, or of the Mylan Entities' right to defend themselves from, or make any arguments in, any private individual or class claims or suits relating to the subject matter or terms of this Consent Judgment. This Consent Judgment is made without trial or adjudication of any issue of fact or law or finding of liability of any kind. 6. a. By entry of this Consent Judgment, the Commonwealth releases and forever discharges the Mylan Entities from the following: all civil claims, causes of action, parens patriae claims, damages, restitution, fines, costs, attorneys' fees, remedies and/or penalties that were or could have been asserted against the Mylan Entities by the Attorney General under G.L. C.93A or any amendments thereto, or for common law claims concerning 4

5 unfair, deceptive, or fraudulent trade practices, other than claims that could be asserted under Paragraph 6.b below, resulting from the Advertising Campaign, up to and including the present date (collectively, the "Released Claims"). b. Notwithstanding any term of this Consent Judgment, specifically reserved and excluded from the Released Claims as to any entity or person, including the Mylan Entities, are any and all of the following: i. Any criminal liability that any person or entity, including the Mylan Entities, has or may have to the Commonwealth; ii. Any civil or administrative liability that any person or entity, including the Mylan Entities, has or may have to the Commonwealth, under any statute, regulation, or rule not expressly covered by the release in Paragraph 6.a. 7. No part of this Consent Judgment shall create a private right of action or confer any right to any third party for violation of any federal or state law, rule, or regulation. 8. In accordance with the attached Consent, Mylan Specialty has waived all rights of appeal. Mylan Specialty has also waived the requirements of Rule 52 of the Massachusetts Rules of Civil Procedure with respect to the entry of this Consent Judgment. 9. This Consent Judgment represents the entire agreement between the Commonwealth and Mylan concerning the matters addressed herein. It supersedes any prior agreement, understandings or stipulations between the parties regarding the subject matter hereof and may not be modified except by further order of the Court obtained after reasonable notice to all parties has been provided. 10. If the Attorney General believes that Mylan is in violation of any provision of this Consent Judgment, the Attorney General shall, prior to any application to this Court for relief, ' 5

6 provide Mylan with written notice of any suspected violation of this Consent Judgment. Upon receipt of that written notice, Mylan will have twenty-one (21) days to address any such violation, within which period the Attorney General and Mylan shall make good faith efforts to ; meet and confer, and to resolve, the alleged violation; provided however that if the Attorney General believes that Mylan is engaged in a violation of this Consent Judgment that is placing any member of the public at immediate risk of irreparable harm, the Attorney General, in order to protect the public interest, may seek immediate relief in this Court from that violation. Nothing in this section shall affect or apply to any action that might be brought by the Attorney General except actions to enforce this Consent Judgment. 11. Any notices or communications required to be transmitted between Mylan and the Commonwealth pursuant to this Consent Judgment shall be provided in writing by first- class mail, postage prepaid, and by electronic mail to the parties or successors as follows, unless otherwise agreed in writing. For Mylan Specialty L.P.: Michael K. Loucks Skadden, Arps, Slate, Meagher & Flom LLP One Beacon Street Boston, MA michael.loucks@skadden.com For the Commonwealth of Massachusetts: Eric M. Gold Assistant Attorney General Office of the Attorney General One Ashburton Place Boston, MA eric.gold@state.ma.us

7 CONSENT OF MYLAN SPECIALTY L.P. Mylan Specialty L.P. ("Mylan Specialty"), through its officer and attorney signing below, admits to the continuing jurisdiction of the Superior Court over the persons and subject matter of this action, and consents to the entry of the Final Judgment by Consent regarding the claims between the Commonwealth and Mylan Specialty without trial or adjudication of any issue of fact or law. In so consenting, the officer and attorney of Mylan Specialty signing below certify that they have personally read and understand the Judgment, and represent that they are authorized to enter into this settlement on behalf of Mylan Specialty. Mylan Specialty waives the entry of findings of fact and conclusions of law pursuant to Rule 52 of the Massachusetts Rules of Civil Procedure with respect to the claims between the Commonwealth and Mylan Specialty. The officer and attorney signing below on behalf of Mylan Specialty understand that any violation of this judgment may result in civil or criminal contempt proceedings, penalties pursuant to G.L. c. 93 A and any additional penalties and sanctions as are provided by law. Neither this consent nor any part thereof shall be treated or construed as an admission of liability or wrongdoing, or admitted into evidence or used for any other purpose except in a proceeding to enforce the terms of this Consent Judgment. Assented to, waiving all rights of appeal: By: [Officer] [Title] Mylan Specialty L.P. [Address] Dated: November,2013 7

8 And its attorney Michael K. Loucks Skadden, Arps, Slate, Meagher & Flom LLP One Beacon Street Boston, MA Dated: November,2013

9 CONSENT OF MYLAN SPECIALTY L.P. Mylan Specialty L.P. ("Mylan Specialty"), through its officer and attorney signing below, admits to the continuing jurisdiction of the Superior Court over the persons and subject matter of this action, and consents to the entry of the Final Judgment by Consent regarding the claims between the Commonwealth and Mylan Specialty without trial or adjudication of any issue of fact or law. In so consenting, the officer and attorney of Mylan Specialty signing below certify that they have personally read and understand the Judgment, and represent that they are authorized to enter into this settlement on behalf of Mylan Specialty. Mylan Specialty waives the entry of findings of fact and conclusions of law pursuant to Rule 52 of the Massachusetts Rules of Civil Procedure with respect to the claims between the Commonwealth and Mylan Specialty. The officer and attorney signing below on behalf of Mylan Specialty understand that any violation of this judgment may result in civil or criminal contempt proceedings, penalties pursuant to G.L. c. 93 A and any additional penalties and sanctions as are provided by law. Neither this consent nor any part thereof shall be treated or construed as an admission of liability or wrongdoing, or admitted into evidence or used for any other purpose except in a proceeding to enforce the terms of this Consent Judgment. President Mylan Specialty L.P Corporate Drive Canonsburg, PA Dated: /Qfl V,2013 8

10 lichael K. Loucks Skadden, Arps, Slate, Meagher & Flom LLP One Beacon Street Boston, MA Dated ILh