CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 1 of 27 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA OF Plaintiff. Case No. MEDTRONIC. INC. a corporation, and CONSENT DEC RE OF S. OMAR ISI-IRAK and M. PERMANENT INIUNCTION individuals. Defendants. Plaintiff. the United States ofAmeriea, by its undersigned attorneys. haying ?led a complaint for permanent injunction against Medtronie. lnc. t"l\ledtronic"l. a corporation. and 3. Omar lshrak and 'l?homas M. 'lbff?t. individuals (collectively. ??Defendants?). and Defendants, haying appeared and having consented to entry of this Decree without contest. without admitting or denying the allegations in the Complaint. and disclaiming any liahility in connection therewith and before any testimony has been taken. and the United States haying consented to this Decree. IT IS HEREBY ORDERED. AND DECREED I. This Court has jurisdiction over the subject matter of this action and has personal jurisdiction over all parties to this action. EXHIBIT A CASE 0:15-cv-O2168 Document 3 Filed 04/27/15 Page 2 of 27 2. The Complaint for Permanent Injunction states a cause of action against Defendants under the Federal Food. Drug. and Cosmetic Act (the 21 30] at. seq. 3. The Complaint alleges that Defendants violate the Act. 2.1 ILSC. ?331(a). by introducing or delivering for introduction into interstate commerce. or causing the introduction or delivery for introduction into interstate commerce. articles of device. as de?ned by 21 32101}. namely Implantable Infusion Pump Systems. that are adulterated within the meaning onI 351m). in that the methods used in. or the facilities or controls used for. their manufacture. packing. and storage are not in conformity with current good manufacturing practice requirements prescribed at 21 GER. Part 820. 4. The Complaint also alleges that Defendants violate the Act. 21 331(k). by causing the Synehrohled Implantable Infusion Pump systems to become adulterated within the meaning onI ti 351(h] while such devices are held for sale after shipment in interstate commerce. a. For the purposes oftbis Decree. the following de?nitions apply: A. device" shall mean all implantable infusion pumps and their accessories that are designed. manufactured. processed. packed. labeled. held. stored. installed. and distributed at or from any Medtronic Neuromodulation facility. B. ?Medtronic Neuromodulation" shall mean the Medtronic Neuron?iodulation Business Unit Inc.. which is responsible for designing, CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 3 of 27 manufacturing, processing. packing. labeling. holding. storing. and distributing. among other devices. the devices. (I. ?Medtronic Neuromodulation facilities" shall mean Medtronic Ncuromodulation?s headquarters. locatetl at 7000 Central Ave. NE. Minneapolis. MN. and the manufacturing facility located at 53"? Nli. Columbia Heights. MN. D. A SvnehroMed device is ?medically necessary" ifti) it is used to treat one or more of the following conditions for which the bene?ts of using the device outweigh the risks: severe spastieitv; chronic intractalile pain; severe chronic pain: and/or primary or metastatic cancer; and (ii) the physician. after reviewing the noti?cation letter attached hereto as Exhibit A. signs a form approved by FDA. attached hereto as Exhibit B. certifying that sfhe is aware of FDA's ?ndings and deems the device necessarv to treat his/her patient under the conditions referred to in this paragraph thereafter. ?Certi?cate of Medical Necessity"). E. Days shall refer to calendar days unless otherwise stated. PROVISIONS (3. Upon entry of this Decree. except as described in paragraph 9. Defendants. and each and all oftheir directors. of?cers. agents. representatives. employees. attornevs. successors. and assigns. and anv and all persons in active concert or participation with any of them (including franchisees. af?liates. and ?doing business as" entities} who have received actual notice of the contents of this Decree by personal service or otherwise are permanently restrained and enjoined. pursuant to 2] USE. 332{al. from directly or indirectly designing. manufacturing. processing. packing. labeling. holding. storing. and distributing. importing into or exporting from the United States ofAmerica. at or from any CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 4 of 27 Medtronic Neuromodulation facilities, any model of. or components or accessories for, its deyiees, unless and until: A. Defendants' methods, facilities, and controls used to design, manufacture. process, pack, label, hold, store, and distribute devices are established. operated, and administered in compliance with 31 ll.S.(I. and the Quality System regulation set forth in 21 (LER. Part 820. B. Defendants select and retain at Medtronic's expense, within thirty (30} days of the entry ofthis Decree, an independent person or persons {the ?Expert"), to conduct inspections of Dcfendants' operations and to review Defendants? procedures and methods for designing, manufacturing, processing, packing, labeling, holding, storing, anti distributing devices. to determine whether their methods, facilities, and controls are operated and administered in conformity with the Act, its implementing regulations, and this Decree. The Expert shall be quali?ed by education. training. anti experience to conduct such inspections. and shall be without personal or ?nancial ties (other than a consulting agreement between the Expert and Medtronic or Medtronic Neuromodulation} to Defendants? of?cers or employees or their immediate families. Defendants shall notify FDA in writing ofthe identity ofthc Expert within ten [10) days of retaining such Expert. C. The Expert shall perform comprehensive inspections of Medtronic Neuromodulation facilities that design, manufacture. process, pack, label, bold, store, or distribute the devices or any component thereof and certify in writing simultaneously to Defendants and FDA: that he or she has inspected Defendants? facilities, processes, and controls; whether Defendants have corrected all ?ndings and CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 5 of 27 violations set forth in Inspectitmal Observations (?Forms FDA 483?} and \Kv?arning Letters issued to Medtronic Neuromodulatitm facilities From all FDA inspections since january 2011; and based upon these comprehensive inspections. whether Defendants' operations are operated in conformity with the Act. its implementing regulations. and this Decree. The Expert's certi?cation report shall but not be limited to. an evaluation of the following as they relate to devices: Defendants" compliance with 2] 351th} and 21 CPR. Part 820: (ii) Defendants? procedures for their Corrective and Preventive Action system. including. but not limited to. analyzing quality data to identify. correct. and prevent existing and potential causes of nonconforming product and other quality problems: Defendants? procedures for their design control system. including. but not limited to. establishing and implementing adequate design and development plans. inputs. outputs. design reviews. veri?cation, validation. risk analyses. design change controls. and a design history ?le for each type of device.- (iv) Defendants' procedures For their nonconforming product. including. but not limited to. the identi?cation. documentation. evaluation. segregation. and disposition. including rework. ofnonconforming product; and Defendants" design veri?cation and design validation documents for the device to ensure that the approved product speci?cations are being met. In circumstances where the Defendants have identi?er! a design defect that causes the device to not perform according to the approved product CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 6 of 27 speci?cations. the Expert shall review the design defect analvsis documentation. The design defect analysis documentation should include a description ofthe design defect. the potential risk to patients associated with the defect. a timeline of actions taken during the defect investigation. proposed corrective actions. design changes being considered. developed. and [or tested. and actions that have been taken or will be taken to potentially correct the design defect. The Expert shall also review design changes made to the Ss??nchrobled device in the previous ?ve (5) vears to verifv that the changes previouslv implemented are effective and do not adverselv affect the device. D. Within forty-?ve days of receiving the Expert?s inspection report under paragraph (LC. Defendants shall submit a written report plan")I to FDA detailing the speci?c actions Defendants have taken andl'or will take to address the Experts observations and to bring the methods. facilities. processes. and controls used to design. manufacture. process. pack. label. hold. store. and distribute the device into compliance with the requirements of this Decree. the Act. and the QB regulation. The speci?c actions in the work plan shall be set forth in numbered steps and. where appropriate. the numbered steps mav include subordinate lettered steps. The tit-'ork plan shall include a timetable with a speci?c date for completing each numbered step and may include. where appropriate. interim dates for completing subordinate lettered steps. The work plan. including its proposed speci?c actions and timetable. shall be subject to FDA approval. and Defendants shall ensure the implementation ofthe numbered steps in the work plan in accordance with the timetable approved by FDA. FDA shall approve or disapprove in writing the proposed work plan within sixty days. (i CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 7 of 27 F.. Defendants may begin implementing the work plan as soon as they receive written FDA apprm-al. Under no circumstances may silence be construed as approval. As the actions detailed in the work plan are completed. Defendants shall notify the Expert in writing. who shall inspect and verify whether those actions have been completetl in a manner that complies with the requirements of this Decree. the Act. and the Q5 regulation to the Expert?s satisfaction and in accordance with the work plan timetable. F. If the Expert determines that an action has not been completed to his or her satisfaction. the Expert shall notify Defendants in writing. Beginning thirty (30) days after implementation of the work plan. and quarterly thereafter. the Expert shall submit to FDA a table that summarizes the Expert's ?ndings regarding whether the actions have been completed to the Expert's satisfaction and in accordance with the numbered steps in the work plan timetable. FDA may, at its discretion and without prior notice. periodically inspect hledtronic Neuromodulation facilities and undertake such additional examinations, reviews. and analyses as FDA deems appropriate to verify whether the actions reported to the Expert as completed have in fact been adequately completetl on time. In the event that FDA determines that an action that has been reported to be completed is inadequate. FDA shall notify Defendants in writing. and Defendants shall take appropriate action in accordance with a timetable approx-ed by FDA. G. When the Expert determines that all of the actions identi?ed in the work plan have been completed to his or her satisfaction. the Expert shall provide Defendants and FDA with a written certi?cation that all of the actions have bicen completed and that. based on the inspections conducted under paragraph (LC and on the CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 8 of 27 satisfactory completion of the actions in the work plan identi?ed under paragraph 6.1). Defendants? methods. facilities. processes. and controls used to design. manufacture. process. pack. label. hold. store. and distribute the SynehroMed devices. are and. if properly maintained and implemented by l_)efendants. will continuously remain in conformity with the requirements ofthis Decree. the Act. and the GS regulation. The Expert?s certi?cation shall include a full and complete detailed report of the results of his or her inspection. II. Within thirty (30) business days of FDr?fs receiving the Experts certi?cation under paragraph 6.6. duly authorized DA representatives may inspect. as DA deems necessary and without prior notice. the Neuromodulation facilities. including buildings. equipment. personnel. ?nished and un?nished materials. containers. and labeling. and all records relating to the methods used in. and the facilities and controls used for. the manufacture. design. processing. packing. labeling. holding. storage. and distribution of devices. to determine whether the requirements of paragraphs (MK-G of this Decree have been met. and whether Defendants are otherwise operating in conformity with this Decree. the Act. and the QS regulation. I. If FDA determines that Defendants are not operating in conformity with the requirements of this Decree. the Act. and the QS regulation with regard to the devices. FDA will notify Defendants of the de?ciencies it observed and will take any other action FDA deems appropriate tag. issuing an order pursuant to paragraph ll). Within thirty {30} days of receiving this noti?cation from FDA. Defendants shall submit to FDA a plan describing the actions Defendants propose to take and a timetable for correcting the de?ciencies. The timetable and plan shall be subject to FDA approval. Defendants shall correct all de?ciencies noted by FDA in accordance with the CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 9 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 10 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 11 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 12 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 13 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 14 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 15 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 16 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 17 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 18 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 19 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 20 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 21 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 22 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 23 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 24 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 25 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 26 of 27 CASE 0:15-cv-02168 Document 3 Filed 04/27/15 Page 27 of 27