Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 1 of 41 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF PENNSYLVANIA

Transcription

1 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 1 of 41 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF PENNSYLVANIA JASON SILVER 2720 Chambersburg Rd. Biglerville, PA v. Plaintiff, Case No. MEDTRONIC, INC. 710 Medtronic Parkway, Minneapolis, Minnesota 55432; MEDTRONIC NEUROMODULATION, a division of Medtronic, Inc Central Avenue NE, Fridley, Minnesota 55432; COMPLAINT JURY TRIAL DEMANDED MEDTRONIC PUERTO RICO OPERATIONS, INC.; Ceiba Norte Industrial Park Road 31, Km. 24, HM 4 Call Box 4070, Junco , Puerto Rico; and MEDTRONIC LOGISTICS, LLC, 710 Medtronic Parkway, Minneapolis, Minnesota Defendants. COMES NOW, Plaintiff Jason Silver, by and through his undersigned attorneys, and hereby files this Complaint against the above-named Defendants, Medtronic, Inc.; Medtronic Neuromodulation, a division of Medtronic, Inc.; Medtronic Puerto Rico Operations, Inc.; and

2 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 2 of 41 Medtronic Logistics, LLC (collectively Defendants or Medtronic ), and states and alleges as follows: I. INTRODUCTION 1. This is a products liability action seeking damages for personal injuries sustained by Jason Silver arising from his use of a defective product designed, manufactured, labeled, and distributed, or otherwise placed into the stream of commerce by Defendants and/or each of them. As set forth herein, Mr. Silver suffered severe and permanent injuries and hospitalization as a foreseeable, direct, and proximate result of defects in his Medtronic SynchroMed II Programmable Implantable Infusion Pump System for intrathecal drug delivery, which was implanted in his abdomen. Mr. Silver brings this action to recover damages caused by Defendants conduct. II. THE PARTIES, JURISDICTION, AND VENUE 2. Plaintiff Jason Silver is a citizen of Pennsylvania and resides in Biglerville, Pennsylvania. At all times relevant hereto, Plaintiff Jason Silver was a citizen of Pennsylvania and resided in York Springs, Pennsylvania. 3. At all times relevant hereto, Defendant Medtronic, Inc., was and is a corporation or other business entity with its principal place of business at 710 Medtronic Parkway, Minneapolis, Minnesota 55432, and was involved in the design and/or assembly and/or manufacture and/or testing and/or packaging and/or labeling and/or marketing and/or distribution and/or sale and/or promotion and/or was otherwise involved in the placing in the stream of commerce medical devices and a device specifically called the SynchroMed II Programmable Implantable Infusion Pump System (hereinafter referred to as SynchroMed II Device ). 1 1 The term SynchroMed II Device includes the intrathecal sutureless catheter. 2

3 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 3 of At all times relevant hereto, Defendant Medtronic Neuromodulation, a division of Medtronic, Inc., was and is a corporation or other business entity with its principal place of business at 7000 Central Avenue NE, Fridley, Minnesota 55432, and was involved in the design and/or assembly and/or manufacture and/or testing and/or packaging and/or labeling and/or marketing and/or distribution and/or sale and/or promotion and/or was otherwise involved in the placing in the stream of commerce medical devices and the SynchroMed II Device. 5. At all times relevant hereto, Defendant Medtronic Puerto Rico Operations Co., was and is a corporation or other business entity and a wholly owned subsidiary of Defendant Medtronic, Inc., with its principal place of business in Ceiba Norte Industrial Park Road 31, Km. 24, HM 4 Call Box 4070, Junco , Puerto Rico, and was involved in the design and/or assembly and/or manufacture and/or testing and/or packaging and/or labeling and/or marketing and/or distribution and/or sale and/or was otherwise involved in placing in the stream of commerce medical devices and the SynchroMed II Device. 6. At all times relevant hereto, Defendant Medtronic Logistics, LLC, was and is a limited liability corporation or other business entity and wholly owned subsidiary of Defendant Medtronic, Inc., with its principal place of business at 710 Medtronic Parkway, Minneapolis, Minnesota 55432, and was involved in the design and/or assembly and/or manufacture and/or testing and/or packaging and/or labeling and/or marketing and/or distribution and/or sale and/or was otherwise involved in placing in the stream of commerce medical devices and the SynchroMed II Device. 7. At all times relevant to this action, Defendants were authorized to do business within the Commonwealth of Pennsylvania, and manufactured, supplied, distributed, formulated, 3

4 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 4 of 41 prescribed, marketed, and sold or otherwise placed into the stream of commerce the SynchroMed II Device within the Commonwealth of Pennsylvania. 8. This Court has jurisdiction over this action pursuant to 28 U.S.C. 1332, as all parties are citizens of different states and the amount in controversy exceeds the sum or value of $75,000, exclusive of interests and costs. 9. Venue is proper pursuant to 28 U.S.C. 1391(b), as a substantial part of the events or omissions giving rise to this action occurred in this judicial district. III. FACTUAL ALLEGATIONS 10. Jason Silver is a fifty-two (52) year old man who suffered serious injuries from a malfunctioning and defective SynchroMed II Device. This Device was designed, tested, manufactured, produced, processed, assembled, inspected, distributed, marketed, labeled, promoted, packaged, advertised for sale, placed in the stream of commerce, and sold or otherwise provided to Mr. Silver by the Defendants. 11. Mr. Silver s injuries alleged herein proximately resulted from the negligent and/or reckless and/or other wrongful acts and omissions, and fraudulent representations of Defendants and/or each of them, all of which occurred within the jurisdiction of this Court. 12. In 2012, in order to treat chronic pain associated with his diagnosed cervical radiculopathy and cervicalgia, Mr. Silver was persuaded to have a SynchroMed II Device implanted in his abdomen to administer pain medication into the intrathecal space of his spine. 13. On December 7, 2012, Mr. Silver had a SynchroMed II Device, comprised of a Model # pump (Serial #NGV471492H) and an intrathecal catheter, implanted in his body. This procedure took place at WellSpan York Hospital in York, Pennsylvania. The 4

5 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 5 of 41 SynchroMed II Device implanted in his body was intended to deliver a programmed amount of pain medication into his spine, reducing or eliminating the need for oral medications. 14. For several months after Mr. Silver had his SynchroMed II Device implanted, his pain improved. However, in the summer of 2014, Mr. Silver suffered a severe overdelivery of pain medication from his Device. This resulted in severe pain, nausea, and lack of mobility. Mr. Silver was accordingly taken to the hospital. 15. On August 12, 2014, Jason Silver underwent a procedure to remove his malfunctioning SynchroMed II Device due to its malfunctions. 16. As a result of the aforementioned defects and malfunctions, Jason Silver s defective SynchroMed II Device failed to deliver the prescribed medication as programmed. These defects and malfunctions resulted a complete failure to deliver medication, causing severe damage and injury to Mr. Silver. 17. In addition, Mr. Silver s defective and malfunctioning SynchroMed II Device necessitated a removal surgery. The removal of the defective device and replacement of a new device is a serious, invasive, and dangerous procedure. 18. Throughout the history of the manufacture of the SynchroMed II Device, the U.S. Food & Drug Administration (FDA) has repeatedly notified Medtronic that their manufacture of the SynchroMed II Device failed to conform to manufacturing requirements enumerated in federal regulations and statutes. These federal violations caused the defects and malfunctions in Jason Silver s SynchroMed II Device, which caused his injuries and damages alleged herein 19. Throughout the history of the manufacture of the SynchroMed II Device, Medtronic has shown an indifference to federal manufacturing requirements. Further, 5

6 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 6 of 41 Medtronic, with full knowledge that they were manufacturing the SynchroMed II Device in violation of law, nonetheless demonstrated a pattern of delayed responses or complete failures to respond to reported and known safety issues with the SynchroMed II Device. 20. Because of Medtronic s years-long pattern of indifference to regulatory authority, noncompliance with federal manufacturing requirements, and violations of federal law, the U.S. Department of Justice and the U.S. Department of Health and Human Services on April 27, 2015 filed a Complaint against Medtronic requesting a Consent Decree for Permanent Injunction against the manufacture, distribution, and sale of the SynchroMed II Device. 21. As a foreseeable, direct and proximate result of Medtronic s conduct described herein, Jason Silver has suffered and will continue to suffer damages, including lost wages and benefits, diminished wages and future earnings, mental anxiety and anguish, loss of self-esteem, and medical bills in amounts to be proven at trial. A. The SynchroMed II Device 22. The SynchroMed II Device is a programmable drug infusion system implanted in the body for drug delivery. The SynchroMed II Device includes an infusion pump connected to a thin, flexible catheter attached to the intrathecal space (spinal canal) of the patient, into which the Device delivers medication. The relevant SynchroMed II Device was used to administer pain medication to Jason Silver. 23. The SynchroMed II Device is a Class III medical device, approved by the FDA through the Pre-Market Approval (PMA) process in Since the initial approval under PMA , Medtronic sought FDA approval of at least one hundred ninety-one (191) supplements or changes to the originally-approved Device. 6

7 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 7 of The pump of the SynchroMed II Device is supplied in twenty (20) and forty (40) ml reservoir sizes, Models # and respectively, and the Device is approved solely for the following uses: a. the chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) and Prialt (preservative-free ziconotide sterile solution) for the management of pain; b. the chronic intrathecal infusion of Baclofen (Lioresal) for the management of severe spasticity; and c. the chronic intravascular infusion of floxuridine (FDUR) and methotrexate for the treatment of primary or metastatic cancer. 25. The entire SynchroMed II Device is implanted and remains under the skin. A clinician measures a precise amount of medication and injects the medication into the pump s reservoir fill port. The medication passes through a reservoir valve and into the pump reservoir. At normal body temperatures, pressurized gas, used as a propellant, is stored below the reservoir and it expands and exerts constant pressure on the reservoir. This pressure pushes the medication into the pump tubing. The battery-powered electronics and motor gears deliver a programmed dose of medication through the tubing out through a catheter port and into a catheter. Medication delivery then continues through the catheter tubing and into the intrathecal space of a patient. 26. The intrathecal catheters and sutureless revision kits of the SynchroMed II Device are designed to connect the pump with the patient s intrathecal space. Each catheter has a pre-attached strain relief sleeve, a connector pin, and a sutureless pump connector that connects to the SynchroMed II pump. 7

8 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 8 of In their marketing, Medtronic represented the SynchroMed II Device as safe effective, reliable medical devices; implanted by safe and effective, minimally invasive surgical techniques for the treatment of medical conditions, including the controlled release of Morphine for the treatment of patients suffering from chronic and severe pain. 28. Medtronic marketed the SynchroMed II Device directly to patients through conversations with Medtronic employees, patient testimonials, and colorful brochures with images of individuals smiling and pain medication patients riding motorcycles. Medtronic s representations to patients include: a. a safer way to receive pain medication ; b. help you rejoin life so you can get back to the activities and people that make you happiest ; c. allows you to Tame your Pain ; d. reduce your need for oral pain medications ; e. provide peace of mind knowing that you ve selected a drug delivery system that was manufactured by Medtronic... f. give reassurance because only Medtronic offers a programmable drug delivery system that is FDA approved for MRI scans... ; g. increase your confidence when you consider that more than 150,000 people worldwide have used Medtronic drug delivery therapy to manage their chronic pain ; h. drug delivery therapy from Medtronic is a proven safe and effective therapy ; i. Medtronic drug delivery therapy has been tested, is shipped sterile, and is FDA approved ; and 8

9 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 9 of 41 j. more doctors trust Medtronic than any other company offering drug delivery therapy. B. FDA Pre-Market Approval (PMA) of the SynchroMed II Device 29. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III medical devices are those that 1) support or sustain human life, 2) are of substantial importance in preventing impairment of human health, or 3) which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, these devices require a premarket approval (PMA) application under Section 515 of the Federal Food Drug and Cosmetic Act (FD&C Act) before they can be sold in the United States. As mentioned, the SynchroMed II Device is a Class III medical device. 30. In a PMA application, the applicant is required to supply information to the FDA. The information required includes: a) device description, b) clinical safety trials, c) methods of its product testing, d) design of the device and specific manufacturing controls, e) outcome evaluation, and f) proposed labeling. The FDA does not conduct independent testing on a medical device in a PMA application. The FDA reviews the documentation provided to them by the PMA applicant and relies on the veracity of the company. The PMA applicant (in this circumstance, Medtronic) is solely responsible for submitting all truthful and necessary documentation to the FDA. 31. Once an application for PMA is approved, the holder (Medtronic) must comply with any and all post approval requirements established by the FDA and federal regulations. The legal requirements include but are not limited to: post marketing monitoring, evaluating and reporting adverse events, and compliance with Current Good Manufacturing Practices (CGMPs). 9

10 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 10 of 41 Regulations prohibit the PMA holder from selling an adulterated or misbranded product, and prohibit promoting a device for unapproved uses. 32. In particular, federal regulations require a PMA applicant such as Medtronic to comply with the following requirements: a. Review, evaluate, and report to the FDA, adverse events associated with the medical device. i. Report individual adverse events within thirty (30) days after becoming aware of an adverse event or aware of a reportable death, serious injury or malfunction (21 C.F.R (c)(1)), and ii. Report individual adverse events no later than five (5) work days after becoming aware of a reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health... (21 C.F.R (c)(2)(i)). b. Quality System. Establish and maintain a quality system that is appropriate for the specific medical devices designed or manufactured and that meets the requirement of this part. (21 C.F.R ). c. Management Responsibility. Management with executive responsibility shall establish its policy and objectives for, and commitment to quality. (21 C.F.R ). d. Qualified Personnel. Have sufficient personnel with the necessary educational background, training, and experience to assure that all activities required by this part are correctly performed. (21 C.F.R ). 10

11 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 11 of 41 e. Corrective and Preventative Action (CAPA). Establish and maintain procedures for implementing corrective and preventive action, and document all activities under this section. (21 C.F.R ). f. Complaint Files. Maintain complaint files, processed in a uniform and timely manner, oral complaints must be documents and must be evaluated to determine whether the complaint represents a reportable event under Medical Device Reporting. (21 C.F.R ). g. Statistical Techniques. Establish and maintain procedures for identifying valid statistical techniques required for establishing controlling and verifying the acceptability of process capability and product characteristics. (21 C.F.R ). h. Misbranded Drugs and Devices Prohibited. A device shall be deemed to be misbranded if its label is false or misleading in any particular. (21 C.F.R. 820, et al.). i. Adulterated Products Prohibited. If the manufacturer fails to ensure that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with applicable requirements, including but not limited to the Current Good Manufacturing Practice (CGMP) requirement of the Quality System regulations found at Title 21 Code of Federal Regulations Section 820, then such products are considered adulterated. (21 U.S.C. 351 (h) (emphasis added). j. Prohibition of Off-Label Promotion. A product may not be manufactured packaged, stored, labeled, distributed, advertised, or promoted in a manner that is 11

12 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 12 of 41 inconsistent with any conditions to approval specified in the PMA approval order for the device. (21 C.F.R ). C. Violations of federal law resulting in Jason Silver s defective and malfunctioning SynchroMed II Device 33. Medtronic, in their manufacture of the SynchroMed II Device, violated federal law governing manufacture and quality control of PMA medical devices, which was discovered during a series of inspections by the FDA at Medtronic s SynchroMed II Device manufacturing and quality control plants in Minneapolis, Minnesota and Puerto Rico. 34. The inspections were followed by a series of Warning Letters to Medtronic that identified federal manufacturing and quality control violations at the plants, ultimately leading to an April 27, 2015 Complaint Requesting a Permanent Injunction filed against Medtronic by the U.S. Department of Justice and U.S. Department of Health and Human Services, and a Court- Ordered Consent Decree imposing a moratorium on the manufacture, sale, and distribution of the SynchroMed II Device in violation of federal law The Warning Letters, agency action, and Court Order speak to the seriousness of Defendants violations of federal law and general negligence in the manufacture of the SynchroMed II Device. 36. In a 2006 Warning Letter, after an inspection of Medtronic s manufacturing plant located at rd Avenue NE, Minneapolis, Minnesota, the FDA identified Significant Deviations from CGMPs committed by Medtronic while manufacturing their SynchroMed II Devices, including that which was implanted in Jason Silver s body. Given these significant deviations, the SynchroMed II Devices were found to be adulterated. These significant deviations include, but are not limited to, the following: 2 Complaint for Permanent Injunction, attached as Exhibit 1. 12

13 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 13 of 41 a. Failure to control production processes to ensure that a device conforms to its specification. (21 C.F.R (a)); b. Failure to implement corrective and preventive action procedures addressing the investigation of the cause of nonconformities. (21 C.F.R (a)(2)); c. Failure to implement changes in methods and procedures needed to correct and prevent identified quality problems. (21 C.F.R (a)(5)); d. Failure to identify all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems. (21 C.F.R (a)(3)); and e. Failure to implement procedures to ensure that device history records for each batch, or unit are maintained to demonstrate that the device is manufactured in accordance with regulations. (21 C.F.R ). The FDA Warning Letter continued: The specific violations noted in this letter and the Form FDA may be symptomatic of serious underlying problems in your firm s manufacturing quality assurance systems The FDA inspected the same Minneapolis Medtronic facility less than a year later, and on July 3, 2007 issued another Warning Letter concerning the SynchroMed II Device. The FDA again warned Medtronic that their devices manufactured at the Minneapolis facility were adulterated and misbranded. A partial list of the violations the FDA found during the 2007 inspection includes: 3 August 29, 2006 FDA Warning Letter and Form FDA 483, dated January 24, 2007, attached collectively as Exhibit 2. 13

14 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 14 of 41 a. Medtronic failed to implement complaint handling procedures to ensure that all complaints are evaluated to determine whether the complaint represents an event that must be filed as a Medical Device Report (MDR). b. Medtronic failed to enter several medical and/or scientific literature articles discussing adverse events relating to devices the plant manufactured in the reporting system and failed to evaluate whether the adverse event related articles were required to be reported to the FDA under 21 C.F.R c. Medtronic failed to submit MDR reports within thirty (30) days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury (21 C.F.R (a)(1)). d. In that Letter, the FDA warned Medtronic: [y]our firm has several procedures for Medical Device Reporting and Adverse Drug Experience Reporting. These procedures, in turn reference several other procedures. You firm s current problems regarding MDR reporting, as discussed above in this Warning letter, may be exacerbated by the complexity of your procedures and might have contributed to your firm s deviations from the regulations regarding MDR reporting The FDA inspection also revealed several ongoing violations at Medtronic s Minneapolis Plant s Quality System that were noted in a Form 483, stating [t]he specific violations noted in this letter and Form FDA 483 may be symptomatic of serious underlying 4 July 3, 2007 FDA Warning Letter, attached as Exhibit 3. 14

15 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 15 of 41 problems in your firm s manufacturing and Quality Assurance systems. Specifically, the FDA warned that Medtronic: a. failed to achieve consistent compliance in areas such as design controls. (21 C.F.R ); and b. failed to achieve consistent compliance in Corrective and Preventative Action (CAPA). (21 C.F.R ) On June 1, 2009, the FDA issued a Warning Letter to Medtronic concerning their manufacturing facility in Juncos, Puerto Rico, detailing multiple violations of Current Good Manufacturing Practice (CGMP) requirement of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.) part 820 based on inspections conducted in late Based upon those violations, the FDA determined that Medtronic s SynchroMed II Devices were adulterated within the meaning of 831(h) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. et seq. in that the methods used in, or the facilities or controls used for, their manufacture, packing, sorting, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found at Title 21 Code of Federal Regulations (C.F.R.) Part The 2009 FDA Warning Letter concerning the Puerto Rico manufacturing plant specifically cited Medtronic for the following with regard to the SynchroMed II Device: a. Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, which shall 5 Id. 6 June 1, 2009 FDA Warning Letter, attached as Exhibit 4. 15

16 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 16 of 41 include monitoring and control of process parameters and component and device characteristics during production; b. Failure to establish and maintain procedures for implementing corrective and preventive actions that include identifying the actions needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 C.F.R (a); c. Failure to establish and maintain procedures that ensure the Device History Records (DHRs) for each batch, lot or unit are maintained to demonstrate that the device is manufactured in accordance with the DHR as required by 21 C.F.R ; d. Failure to review, evaluate and investigate complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications as required by 21 C.F.R (c); e. Failure to report to FDA no later than thirty (30) calendar days after the day that Medtronic received or otherwise became aware of information from any source, that reasonably suggests that a device Medtronic marketed: 1) may have caused or contributed to a death or serious injury; or 2) has malfunctioned and this device or a similar device that Medtronic marketed would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 C.F.R (a); f. Failure to have a person who is qualified to make a medical judgment reasonably conclude that a device did not cause or contribute to a death of serious injury, or 16

17 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 17 of 41 that a malfunction would not likely to cause or contribute to a death or serious injury if it were to recur, as required by 21 C.F.R. 803(c)(2); and g. Failure to ensure that persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomechanical engineers under 21 C.F.R (c)(2): [O]ur investigators determine that a product reporting specialist was making decisions about MDR reportability for the Medtronic SynchroMed II Implantable Pump Infusion System. The training record for this particular employee showed that this person only had a high school diploma with some additional in-house training At the time of inspection, the FDA informed Medtronic of the following manufacturing defects in the SynchroMed II Device: a. Pumps manufactured without propellant. The FDA noted that while Medtronic identified this problem in May of 2006, and initiated a corrective and preventative action (CAPA) investigation in January 2007, Medtronic did not voluntarily recall the thirteen thousand five hundred fifteen (13,515) devices affected by this defect until May 2008, a full two (2) years after the defect was identified. b. Pumps did not show evidence of perforated septum; c. Pumps were missing a safety mechanism that served to assure that pumps are never overfilled; and d. A critical step was left out of the manufacturing process, which is the calculation of drug reservoir levels and drug dispensing rates. Despite numerous complaints 7 Id. 17

18 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 18 of 41 that Medtronic received regarding accuracy rates, Medtronic failed to conduct any type of investigation into this problem. 42. The FDA determined that the SynchroMed II Device was misbranded by virtue of the cited violation involving the failure or refusal to furnish material or information required under the statute and regulations relating to information that the devices may have either caused or contributed to death or serious bodily injury, or malfunctions in such a way that if it were to recur would be likely to cause or contribute to a death or serious injury. 43. Additionally, while the FDA observed generally that the adequacy of Medtronic s responses could not be determined at the time, the FDA noted the adequacy of your corrective and preventative measures will be determined during the next inspection. It specifically noted that Medtronic s response to the violation related to the failure to establish and maintain procedures for implementing Corrective and Preventive Action (CAPA) procedures at [the Puerto Rico facility] will be conducted by July 31, In 2012, Medtronic s Minneapolis manufacturing plant was again inspected by the FDA. As a result of that inspection, the FDA issued a Warning Letter dated July 17, 2012 identifying Medtronic s specific violations of federal regulations in the manufacture of SynchroMed II Devices including violations of CGMPs and Quality Systems requirements. The FDA informed Medtronic that the SynchroMed II Devices were adulterated. 45. The FDA cited Medtronic for incomplete complaint data and incorrect coding decision. The FDA stated this violation may have compromised Medtronic s ability to detect and investigate [safety] signals. 9 8 Id. 9 July 17, 2012 FDA Warning Letter, attached as Exhibit 5. 18

19 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 19 of From February 14, 2013 through April 3, 2013, the FDA again inspected Medtronic s Neuromodulation manufacturing plant in Minneapolis. In April 2013, based on its inspection, the FDA informed Medtronic that the plant failed to manufacture devices that adequately conform to specifications and instead manufactured devices that were not adequately controlled. Specifically, Medtronic failed to establish procedures for corrective and preventative action for problems including: a. Feed through shorting resulting in motor stalls, whereby at least two hundred ninety-eight (298) serious adverse events have resulted from this defect; b. Based upon a reported problem with their device, Medtronic failed to implement a recommendation from its Risk Evaluation Board and delayed any action taken. Since the decision to delay the action, at least thirty-seven (37) serious adverse events have been possibly related to the problem; and c. Medtronic detected signals showing a problem with catheter occlusion, but failed to update a Health Hazard Assessment for this defect since 2008, with over three hundred (300) complaints occurring since that time Further, the FDA notified Medtronic of the following: Regulatory approval was received for Supplement 136 to PMA P on December 15, 2011 to change the design of SC Catheter models 8709 SC, 8731 SC, 8596 SC, and Revision Kit model 8578 to mitigate a known field issue associated with CAPA 1507-SC Catheter Occlusion. This design change was implemented via ECO , date March 6, 2012, and the new revisions of Catheter models were released to the field in September However, the previous SC catheter models which do not conform to the current design have continued to be distributed and have been attributed to 60 complaints of catheter occlusion since September FDA Form 483, Inspection Observations, Dated Feb. 14, 2013 April 3, 2013, attached as Exhibit Id. 19

20 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 20 of 41 D. SynchroMed II Device recalls initiated by the U.S. Food & Drug Administration 48. Since 2008, the FDA has issued nineteen (19) Class I Recall Actions for the SynchroMed II Device. A recall is an action taken to address a problem with a medical device that violates federal law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. 49. A Class I recall is the most serious recall category issued when there is a probability that the use of the product could cause serious health consequences or death. Any drug or medical device that has been the subject of a Class I recall can be deadly or cause serious life-long injury. 50. Up to December 13, 2012, The Class I and Class II recalls issued for the SynchroMed II Device include, but are not limited to: a. Formation of inflammatory masses near the tip of the intrathecal catheters (Class I, March 22, 2008); b. Pumps manufactured without propellant (Class II, September 3, 2008); c. Battery failure (Class II, September 29, 2009); d. Inadequate instruction for filling/refilling of pumps causing injection of all or some of the prescribed drug into the patient s subcutaneous tissue (Class I, August 29, 2011); e. Reduced battery performance leading to sudden loss of therapy (Class I, August 29, 2011); f. Software failure resulting in incorrectly displayed scheduled to replace the pump by date (Class II, March 30, 2012); and 20

21 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 21 of 41 g. Use of unapproved (off-label) drugs in the pumps leading to permanent motor stall and cessation of infusion (December 13, 2012). 51. On June 3, 2013, the FDA issued two (2) Class I recalls related to the Medtronic SynchroMed II Implantable Infusion Pump System. a. The first 2013 recall covers all of the SynchroMed II pumps implanted worldwide manufactured from May 1998 through June 2013 and distributed from April 1999 through June In the letter, the FDA warned that the following would happen with the defective pumps: i. Unintended delivery of drugs during the priming bolus procedure can result in drug underdelivery and overdelivery, leading to respiratory depression, coma or death, and ii. Potential for electrical shorting, internal to the SynchroMed II infusion pump, leading to a loss of or reduction in therapy, resulting in serious adverse health consequences including death. At the time of the 2013 recalls, there were two hundred sixty-one thousand, one hundred nine (261,109) SynchroMed II Implantable Infusion Pumps System implanted worldwide. b. The second 2013 recall affects all Sutureless Connector Intrathecal Catheters in the SynchroMed II Device, Models #8709SC, 8731SC, and Sutureless Revision Kits, Models #8596SC, and 8578 with a use by date of August 25, In the recall, the FDA noted the reasons for the recall: i. The sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion, which is the blockage 21

22 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 22 of 41 or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump. Medtronic is removing all unused products that were manufactured with the previous design. Medtronic recommends the previous design of Sutureless connector Intrathecal Catheter Products no longer be used due to greater potential for misalignment and subsequent occlusion. ii. This product may cause serious adverse health consequences, including drug under dose, loss of symptom relief, drug withdrawal symptoms caused by the lack of drug delivery to the intrathecal space, and/or death. E. The United States of America files a Complaint for Permanent Injunction against Medtronic, Inc. and individuals S. Omar Ishrak and Thomas M. Tefft 52. On April 27, 2015, the United States Department of Justice and United States Department of Health and Human Services filed a Complaint for Permanent Injunction against Medtronic, Inc. and S. Omar Ishrak and Thomas M. Tefft with respect to their manufacture of the SynchroMed II Device The Complaint alleges that Medtronic, S. Omar Ishrak, and Thomas M. Tefft are well aware that their practices violate the Act. FDA has repeatedly warned Defendants, both orally and in writing, about their violative conduct, and has emphasized the importance of Defendants compliance with the Act. 54. In addition to the cited Warning Letters, the Complaint alleges that representatives of Medtronic attended a meeting with FDA s Center for Devices and Radiological Health and Minneapolis District Office on January 31, At this meeting, 12 See Exhibit1. 22

23 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 23 of 41 Defendants stated that they were aware of the violations at their facilities and were taking steps to correct them. 55. The Complaint further alleges Medtronic made promises to correct their violations in written responses to each inspection; however, the Complaint alleged that none of the responses contained adequate evidence that Medtronic corrected their deviations. 56. The United States Attorney stated in the Complaint that, [b]ased upon Defendants conduct, Plaintiff believes that, unless restrained by order of this Court, Defendants will continue to violate 21 U.S.C. 331(a) and (k) [introducing into interstate commerce any article of device that is adulterated, or causing any article of device to become adulterated within the meaning of 21 U.S.C. 351 (h) while such devices are held for sale after shipment in interstate commerce]. 57. The United States of America s Complaint requested a permanent injunction to restrain Medtronic, in their manufacture of the SynchroMed II Device, from their continued violation of federal regulations, and, That the Court order Defendants and each of their directors, officers, agents, representatives, employees, attorneys, successors, and assigns, and any and all persons in active concert or participation with any of them, to cease directly and indirectly manufacturing, packing, labeling, and distributing (domestically and internationally) SynchroMed II implantable infusion pumps at or from its Medtronic s Neuromodulation faculties, unless and until Defendants methods, facilities, and controls used to manufacture, process, pack, label, hold and distribute the SynchroMed II implantable infusion pumps are established, operated, and administered in compliance with 21 USC 360j(f)(1) and the Quality System regulation prescribed in 21 C.F.R. Part 820, and in a manner that has been found acceptable to FDA Id. 23

24 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 24 of On April 27, 2015, United States District Court Judge Joan N. Erickson signed a Consent Decree of Permanent Injunction against Medtronic preventing the manufacture and distribution of the Medtronic SynchroMed Implantable Infusion Pump systems in violation of the terms of the Consent Decree Under the Consent Decree, Medtronic is permanently restrained and enjoined, pursuant to 21 U.S.C. 332(a), from directly or indirectly designing, manufacturing, processing, packing, labeling, holding, storing, and distributing, importing into or exporting from the United States of America, at or from any Medtronic Neuromodulation facilities, any model of, or components or accessories for, its SynchroMed devices. Under the Consent Decree, the permanent injunction would be lifted only in the event that Medtronic complies with a series of enumerated requirements to ensure that it would cease violating federal law in the production of its SynchroMed II Device. 60. Upon information and belief, Medtronic continues to produce, distribute, and sell their SynchroMed II Device in violation of the Decree. IV. CAUSES OF ACTION COUNT I MANUFACTURING DEFECT 61. Plaintiff incorporates by reference, as if fully set forth herein, each and every allegation contained in the preceding paragraphs of this Complaint. 62. Plaintiff herein asserts claims under Pennsylvania law that parallel Defendants duties under federal law governing the manufacture of Plaintiff s SynchroMed II Device. 14 Consent Decree of Permanent Injunction, attached as Exhibit 7. 24

25 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 25 of 41 Plaintiff s state law claims are based upon and arise from Defendants violations of and deviations from federal requirements in the manufacture of Plaintiff s Device. 63. Defendants, and each of them, are medical device companies engaged in the design and/or research and/or manufacture and/or production and/or testing and/or assembling and/or labeling and/or packaging and/or distribution and/or sale and/or otherwise placing into the stream of commerce various medical devices intended for human use, as set forth herein, including the SynchroMed II Device. 64. At all times relevant hereto, Defendants, and each of them, held themselves out as knowledgeable and possessing the requisite skill peculiar to the research and/or manufacture and/or production and/or testing and/or assembling and/or labeling and/or packaging and/or distribution and/or sale of such product(s). 65. Defendants manufactured, distributed, and sold Plaintiff s SynchroMed II Device. At all times relevant hereto, Plaintiff used his SynchroMed II Device for its intended purpose, which is intrathecal delivery of opioid medication for pain. 66. At all times relevant hereto, Medtronic had a duty under federal law to manufacture Plaintiff s Device in compliance with specifications imposed during the Pre-Market Approval for the device, and in compliance with Post Approval federal regulations, including but not limited to those set out in 21 C.F.R. 801, et seq., 21 C.F.R. 803, et seq., 21 C.F.R. 814, et seq., 21 C.F.R. 806, et seq., 21 C.F.R. 820, et seq., and 21 U.S.C Such regulations are promulgated to ensure that a manufactured device is free from defects. 67. At all times relevant hereto, Medtronic had a duty under Pennsylvania law to use reasonable care in the manufacture of their products, which includes a duty to manufacture Plaintiff s SynchroMed II Device in compliance with Medtronic s own specifications, a duty to 25

26 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 26 of 41 prevent non-conforming devices from entering into the stream of commerce, and a duty to comply with safety regulations applicable to the manufacture of the device. Such duties are parallel to those imposed under federal law and are expressly excepted from preemption under 21 C.F.R (d)(2), according to which state or local requirements that are equal to, or substantially identical to, requirements imposed by or under the [MDA] are not preempted. 68. Medtronic breached its duty under Pennsylvania law to use reasonable care in that it failed to ensure that Plaintiff s SynchroMed II Device complied with its own specifications and applicable safety regulations, including federal manufacturing requirements imposed by the Device s Pre-Market Approval (PMA) requirements and Post Approval Regulations, and failed to test and inspect plaintiff s SynchroMed II Device before placing it into the stream of commerce and making it available for sale to Plaintiff. 69. As a result of Medtronic s violations of federal statutory and regulatory standard of care and device specific regulations, the SynchroMed II Device implanted in Jason Silver s abdomen failed and required revision and removal surgeries. 70. At the time the SynchroMed II Device implanted into Jason Silver s abdomen left the control of Medtronic, it was unreasonably dangerous due to Medtronic s violations of the Federal Food, Drug, and Cosmetic Act, and the regulations promulgated pursuant to it in one or more of the following ways: a. The SynchroMed II Device was introduced or delivered for introduction into interstate commerce as adulterated in violation of 21 U.S.C. 331, 351(h) and 21 C.F.R. Part 820; b. The SynchroMed II Device was adulterated in interstate commerce in violation of 21 U.S.C. 331, 351 (h) and 21 C.F.R. Part 820; 26

27 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 27 of 41 c. The SynchroMed II Device was received in interstate commerce adulterated and was delivered for pay or otherwise, in violation of 21 U.S.C. 331, 351(h) and 21 C.F.R. Part 820; and d. The SynchroMed II Device implanted in Jason Silver was adulterated because it was manufactured in deviation from the manufacturing specifications approved by the FDA in Medtronic s PMA application in violation of the Federal Food, Drug, and Cosmetic Act. 71. At all times relevant hereto, federal law required Defendants to manufacture the SynchroMed II Device in compliance with federal specifications and requirements imposed through the PMA process for the device, and in compliance with post-approval federal regulations, including but not limited to those set out in 21 C.F.R. 801, et seq., 21 C.F.R. 803, et seq., 21 C.F.R. 814, et seq., 21 C.F.R. 806, et seq., 21 C.F.R. 820, et seq., and 21 U.S.C Such regulations are promulgated to ensure a manufactured device is free from a defective condition unreasonably dangerous to the consumer. 72. Jason Silver suffered injury due to his non-conforming, adulterated, and defective SynchroMed II Device. 73. As a result of Medtronic s failure to use reasonable care in complying with federal law in the manufacture of Jason Silver s SynchroMed II Device, Mr. Silver s Device was manufactured out of specification, was non-conforming, adulterated, and had the propensity for failure and malfunction and did fail and malfunction. 74. As a foreseeable, direct and proximate result of Defendants negligence in manufacturing Jason Silver s SynchroMed II Device, Mr. Silver experienced severe pain and suffering which continues through present day and will continue into the future, a surgery to 27

28 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 28 of 41 explant his defective SynchroMed II Device, extensive hospitalization and medical procedures, and other damages compensable by law. COUNT II FAILURE TO WARN 75. Plaintiff incorporates by reference, as if fully set forth herein, each and every allegation contained in the preceding paragraphs of this Complaint. 76. Plaintiff herein asserts claims under Pennsylvania law that parallel Defendants duties under federal law governing Plaintiff s Device. Plaintiff s state law claims are based upon and arise from Defendants violation of and deviation from federal regulations regarding Plaintiffs Device as set forth herein. 77. Defendants are medical device entities engaged in the design and/or research and/or manufacture and/or production and/or testing and/or assembling and/or labeling and/or packaging and/or distribution and/or sale and/or otherwise placing into the stream of commerce various medical devices intended for human use, including the SynchroMed II Device, which is a surgically implanted device that delivers medication into the intrathecal space of patients for the treatment of chronic pain, and as an alternative to oral pain medication. 78. At all times relevant hereto, Medtronic had a continuing duty under federal law and under Pennsylvania law to monitor the SynchroMed II Device placed into the stream of commerce, to discover and report to the FDA any complaints about the product s performance and any adverse health consequences of which Medtronic became aware, and that are or may be attributable to the product. (FD&C Act, Medical Device Reporting Title 21, Code of Federal Regulations (C.F.R.), Part 803)) [R]equires manufacturers, distributors, and initial distributors of medical devices to establish, maintain a record of and report the result to FDA certain adverse events that they receive from any source, and to establish and maintain reports. 28

29 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 29 of At all times relevant hereto, under Pennsylvania law, Defendants had a duty to disclose to users and purchasers, including the FDA, of potentially dangerous risks involved in their product s use. Such duty imposes an obligation on Medtronic to timely inform the FDA when Medtronic learned of the propensity for defects 80. Medtronic breached their duty under federal and Pennsylvania law, in that it: a. Failed to report known problems with Devices; 15 b. Failure to report consumer generated adverse events; c. Failed to report under 21 CFR 803, a malfunction event for an adverse event; 16 and d. Failed to submit FDA-mandated Medical Device Reports (MDRs) within 30 days of becoming aware that the SynchroMed II Device caused or contributed to a death or serious injury, under 21 C.F.R (a)(1), thereby resulting in the devices being misbranded Medtronic knew at all times before Jason Silver was implanted with his SynchroMed II Device that his Device was defective in that it would not deliver the programmed rate of medication, yet it failed to inform the FDA of the danger. 82. Because Medtronic failed to comply with their duty under federal law, they breached their duty to use reasonable care under Pennsylvania law to disclose material risks of the SynchroMed II Device to the FDA and the public, including Jason Silver. This duty 15 See Exhibit Id. 17 Id. 29

30 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 30 of 41 parallels Medtronic s requirements under federal law to timely and properly report adverse events and safety issues relating to the SynchroMed II Device. 83. Had the FDA been properly and timely warned of the known problems and defects associated with Jason Silver s Device, Jason Silver and his medical providers would have learned of the dangers and heeded that warning, thereby avoiding use of the Device. 84. As a foreseeable, direct and proximate result of Medtronic s failure to warn, as set forth above, about the defective condition of the SynchroMed II Device, Jason Silver experienced severe pain and suffering which continues through present day and will continue into the future, a surgical procedure to explant his defective SynchroMed II Device, extensive hospitalization and medical procedures, and other damages compensable by law. COUNT III NEGLIGENCE 85. Plaintiff incorporates by reference, as if fully set forth herein, each and every allegation contained in the preceding paragraphs of this Complaint. 86. Plaintiff herein asserts claims under Pennsylvania law that parallel Defendants duties under federal law governing Plaintiff s Device. Plaintiff s state law claims are based upon and arise from Defendants violation of and deviation from federal regulations regarding Plaintiffs Device as set forth herein. 87. Defendants, and each of them, are medical device entities engaged in the design and/or research and/or manufacture and/or production and/or testing and/or assembling and/or labeling and/or packaging and/or distribution and/or sale and/or otherwise placing into the stream of commerce various medical devices intended for human use, including the SynchroMed II Device, which is a surgically implanted device that delivers medication into the intrathecal space of patients for the treatment of chronic pain, and as an alternative to oral pain medication. 30

31 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 31 of At all times relevant hereto, Defendants manufactured, distributed and sold Jason Silver s SynchroMed II Device, comprising of a pump and catheter. Mr. Silver used his SynchroMed II Device as intended by the Medtronic. 89. Under Pennsylvania law, every manufacturer, including Medtronic has a duty to use reasonable care to avoid foreseeable dangers in their products. Specifically, Medtronic at all relevant times hereto had a duty to use reasonable care in the manufacturer, testing, monitoring, inspection, assembly, and sale of Jason Silver s SynchroMed II Device. Such duties are parallel to those imposed under federal law. 90. Federal law imposes post-market requirement on Medtronic, including those found under 21 C.F.R. 820, et seq., which promulgates Current Good Manufacturing Practices (CGMPs). The quality control requirements of the CGMPs are designed to ensure Medtronic s products conform to manufacturing specifications, that non-conforming products do not reach the market, and that problems with products in the field are properly monitored, tracked and reported. The CGMPs require Medtronic to evaluate signals of unexpected or serious events of injury in the field and report to the FDA when a device causes, or is suspected to cause, injury in the field. A device that has been manufactured, monitored, packed, stored, inspected, or installed in violation of this requirement is deemed to be adulterated. 21 C.F.R. 351 (h). A manufacturer is prohibited from introducing, delivering, or selling an adulterated device into interstate commerce. 21 C.F.R. 331(a),(k). 91. As a result of numerous FDA inspections from to Medtronic s manufacturing plants in Minneapolis, Minnesota and Juncos Puerto Rico, as alleged herein, the FDA determined the SynchroMed II Device was adulterated and misbranded and thereby violated specific CGMPs as outlined supra in paragraphs herein. 31

32 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 32 of Medtronic violated their duty to comply with their obligations to manufacture their SynchroMed II Device in conformity with CGMPs and therefore could not ensure the safety and effectiveness of the SynchroMed II Device received by Jason Silver. 93. As a foreseeable, direct and proximate result of the Medtronic s failure to use due care to avoid foreseeable dangers in their SynchroMed II Device, Jason Silver s SynchroMed II Device was manufactured out of specification and was misbranded and adulterated in violation of federal law. 94. As a further foreseeable, direct and proximate result of Medtronic s failure to use due care to avoid foreseeable dangers in their SynchroMed II Device, Jason Silver s nonconforming Device failed to deliver medication into his intrathecal space at the programmed rate, causing severe pain and suffering which continues through present day and will continue into the future, a surgical procedure to explant the defective SynchroMed II Device, extensive hospitalization and medical procedures, and other damages compensable by law. COUNT V BREACH OF EXPRESS WARRANTY 95. Plaintiff incorporates by reference as if fully set forth herein, each and every allegation contained in the preceding paragraphs of this Complaint. 96. At all times relevant hereto, Medtronic expressly warranted and promised by way of written literature, advertisements, and/or other documents and/or promotional materials directed to Jason Silver and his medical providers, that despite the significant cost difference in therapy, the use of an implanted SynchroMed II Device designed to deliver medication to the intrathecal space was a superior and safer method than oral medication and/or alternative means of therapy to treat his muscle spasticity. 32

33 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 33 of Jason Silver and his medical providers received, heard, and/or read Medtronic s express warranties that the SynchroMed II Device conformed to FDA regulations and specifications, and was safe, effective, and fit and proper for its intended uses and foreseeable uses. 98. Based upon Medtronic s representations of the significant benefits of the SynchroMed II Device as compared to other forms of pain medication delivery, Jason Silver purchased and underwent surgery for implantation of the SynchroMed II Device. 99. Jason Silver and his medical providers received, heard, and/or read Medtronic s express warranties that the SynchroMed II Device conformed to FDA regulations and specifications, and was safe, effective, and fit and proper for its intended uses and foreseeable uses Jason Silver and his medical providers relied upon Medtronic s express warranties that the SynchroMed II Device conformed to FDA regulations and specifications, and was safe, effective, and fit and proper for its intended uses and foreseeable uses, when in fact it was manufactured in violation of federal regulations and specifications and was unsafe and unfit for such uses Defendants breached their express warranties because the warranty and representations were untrue in that: a. The FDA had determined that the Medtronic SynchroMed II Device implanted in Jason Silver was manufactured in violation of federal regulations and specifications, including CGMPs; b. The FDA violations of CGMPs committed by Medtronic meant that Medtronic was unable to confirm that the SynchroMed II Device implanted in Jason Silver 33

34 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 34 of 41 was safe and effective, fully conformed to specifications, and was free of defects that could lead to malfunctions having the potential to cause or contribute to serious bodily injury; and c. The FDA had determined that the SynchroMed II Device implanted in Jason Silver was manufactured at a time when SynchroMed II Devices were labeled adulterated and misbranded The implanted SychroMed II Device s intrathecal infusion delivery of pain medication is not a superior method to oral pain medication or alternative therapy As a result of the aforementioned breach of their express warranties by Medtronic, Jason Silver experienced severe pain and suffering which continues through present day and will continue into the future, a surgical procedure to explant his defective SynchroMed II Device, extensive hospitalization and medical procedures, and other damages compensable by law. COUNT VI BREACH OF IMPLIED WARRANTIES 104. Plaintiff incorporates by reference as if fully set forth herein, each and every allegation contained in the preceding paragraphs of this Complaint Prior to purchasing the Medtronic s SynchroMed II Device, Defendants provided Jason Silver and his physicians written advertising materials (which were not part of the pre-approval process) describing the SynchroMed II Device as a better alternative to receiving oral medications in that it was: a. a safer way to receive pain medication ; b. Help you rejoin life so you can get back to the activities and people that make you happiest ; 34

35 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 35 of 41 c. allows you to Tame your Pain ; d. reduce your need for oral medications ; e. provide peace of mind knowing that you ve selected a drug delivery system that was manufactured by Medtronic... ; f. give reassurance because only Medtronic offers a programmable drug delivery system that is FDA approved for MRI scans... ; g. drug delivery therapy from Medtronic is proven safe and effective therapy ; h. Medtronic drug delivery therapy has been tested, is shipped sterile, and is FDA approved ; and i. More doctors trust Medtronic than any other company offering drug delivery therapy Jason Silver and his physicians relied on the written advertisements of Medtronic related to the SynchroMed II Device, leading to the implantation of the Device into Jason Silver s body The SynchroMed II Device implanted in Jason Silver failed to perform its essential purpose, which was to deliver programmed pain medication into his intrathecal space Jason Silver s SynchroMed II Device was not reasonably fit for ordinary use or use in the manner ordinarily contemplated in that it failed to deliver medication to Mr. Silver according to its programmed rate. Accordingly, Medtronic breached its implied warranty of merchantability with respect to Jason Silver s SynchroMed II Device At the time and place that Jason Silver purchased and used the SynchroMed II Device, Mr. Silver relied upon Medtronic s implied warranties, not knowing that Medtronic knew, that in fact the SynchroMed II Device was unfit and unsafe for its ordinary use, and had 35

36 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 36 of 41 been found by the FDA to be adulterated and misbranded in that it was not manufactured, and/or packaged, and/or labeled in accordance with FDA regulations, did not perform in accordance with approved specifications, and was therefore not safe nor effective for the intended, known, or foreseeable uses, nor of merchantable quality, as warranted by Medtronic As a result of Medtronic s aforementioned breach of their implied warranties, Jason Silver, after purchasing and being implanted with, and utilizing Medtronic s nonconforming, defective products, experienced severe pain and suffering which continues through present day and will continue into the future, underwent a surgical procedure to explant the defective SynchroMed II Device, and suffered extensive hospitalization and medical procedures. COUNT VII NEGLIGENT MISREPRESENTATION 111. Plaintiff incorporates by references, as if fully set forth herein, each and every allegation contained in the preceding paragraphs of this Complaint At all times relevant hereto, Medtronic had a duty under Pennsylvania law to advertise and represent correct information regarding the SynchroMed II Device, as such information involves public welfare and safety At all times relevant hereto, Defendants negligently misrepresented to Jason Silver and his medical providers that the SynchroMed II Device implanted in Mr. Silver was safe and effective, despite knowing that the SynchroMed II Device was defective and capable of causing the injuries described herein Defendants made the aforesaid representations with no reasonable ground for believing them to be true when Defendants possessed data showing the SynchroMed II Device to be defective and dangerous when used in the intended manner. 36

37 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 37 of The aforesaid representations were made to the medical providers prescribing the SynchroMed II Device prior to the dates prescribed to Jason Silver and used by Mr. Silver s medical providers with the intent that Jason Silver and his medical providers rely upon such misrepresentations about the safety and efficacy of the SynchroMed II Device Defendants failed to use reasonable care or competence in obtaining the information or communicating it to Jason Silver and his medical providers Jason Silver and his medical providers reasonably and justifiably relied upon such representations provided by Defendants that the SynchroMed II Device was safe for use for the prescribed and intended purposes Representations and communication by Defendants to Jason Silver and his medical providers were false, and thereby caused Jason Silver s injuries described herein, harming Mr. Silver as a result of the false representations of Defendants. COUNT VIII VIOLATION OF PENNSYLVANIA S UNFAIR TRADE PRACTICES AND CONSUMER PROTECTION LAW 119. Plaintiff incorporates by references, as if fully set forth herein, each and every allegation contained in the preceding paragraphs of this Complaint By reason of the conduct alleged herein, Defendants violated Pennsylvania s Unfair Trade Practices and Consumer Protection Law (UTPCPL), 73 P.S , et seq., by engaging in fraudulent and deceptive conduct which created a likelihood of confusion and/or misunderstanding At all times relevant hereto, Defendants knowingly and intentionally induced Jason Silver to use the SynchroMed II Device through the use of false and or/misleading representations and statements. 37

38 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 38 of The SynchroMed II Device failed to perform as represented and, in fact, was unsafe Defendants induced Jason Silver and his physicians, through the use of false and/or misleading advertising, representations, and statements, as described above, to use and/or implant the SynchroMed II Device, which Defendants manufactured and/or distributed and sold, all in violation of the UTPCPL, which proscribes, among other things: a. Engaging in unfair trade practices as defined in the statute by making false and misleading oral and written statements that have the capacity, tendency, or effect of deceiving or misleading consumers; b. Engaging in unfair trade practices as defined in the statute by making representations that its SynchroMed II Device had an approval, characteristic, use, or benefit which it did not have, including but not limited to statements concerning the consequences of the use of the SynchroMed II Device; c. Engaging in unfair trade practices as defined in the statute by failing to state material facts, the omission of which deceived or tended to deceive, including but not limited to facts relating to the health consequences of the use of the SynchroMed II Device; and d. Engaging in unfair trade practices as defined in the statute through deception, fraud, misrepresentation, and knowing concealment, suppression, and omission of material facts with the intent that consumers rely upon the same in connection with the use and continued use of the SynchroMed II Device As a foreseeable, direct and proximate result of Defendants statutory violations, Jason Silver had the SynchroMed II Device implanted, which he would not have had implanted 38

39 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 39 of 41 had Defendants not issued false and/or misleading advertisements, representations, and statements By reason of such violations and pursuant to the laws and regulations of this state, Plaintiff is entitled to recover all of the monies paid for the products; to be compensated for the cost of medical care arising out of the use of the SynchroMed II Device; together with any and all actual damages recoverable under the law including, but not limited to, past medical expenses, past pain and suffering, disability, and emotional distress In addition, Plaintiff is entitled to recover fees and disbursements, including costs of investigation, reasonable attorneys fees, and any other equitable relief as determined by this Court. V. PUNITIVE DAMAGES 127. Defendants, through their agents, committed the acts alleged herein outrageously, maliciously, willfully, because of Defendants evil motive or reckless indifference to the rights of others, including Jason Silver. Defendants received information that long term use of SynchroMed II Device increased the likelihood of drug under- and overdose, leading to respiratory depression, coma or death and potential for electrical shorting, leading to a loss of or reduction in therapy, resulting in serious adverse health consequences including death and other injuries, but despite this information continued to intentionally and falsely represent that using SynchroMed II Device was safe. Defendants failed to issue warnings until the incident rate of injury was so high. Even after that time, Defendants downplayed the adverse effects of the SynchroMed II Device, and misinformed and continued to promote the SynchroMed II Device to the public. Defendants did so in order to preserve the lucrative and growing market they had carefully built with deception. The failure to inform doctors and their patients of 39

40 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 40 of 41 material risks of the SynchroMed II Device was intentional. Defendants acted with greed and other improper and evil motives amounting to malice, and in conscious disregard of Jason Silver s rights. The acts taken toward Mr. Silver were carried out in a deliberate and intentional or grossly reckless manner with malice and without regard of the likelihood that Defendants products would injure and damage Jason Silver and others. Plaintiff is entitled to recover punitive damages from Defendants in an amount according to proof. VI. PRAYER FOR RELIEF Plaintiff hereby requests a trial by jury on all claims and issues so triable. WHEREFORE, Plaintiff demands judgment against Defendants in an amount of damages in excess of seventy-five thousand dollars ($75,000.00), individually, jointly, severally, and in the alternative, including: 1. Awarding actual damages to Plaintiff incidental to the purchase and use of the products at issue in an amount to be determined at trial; 2. Awarding the past and future costs of treatment for Plaintiff s injuries caused by the products at issue in an amount to be determined at trial; 3. Awarding damages for Plaintiff s physical pain and suffering in an amount to be determined at trial; 4. Awarding damages for Plaintiff s mental and emotional anguish in an amount to be determined at trial; 5. Awarding damages for Plaintiff s loss of earnings and future earning capacity; 6. Awarding pre-judgment and post-judgment interest to Plaintiff; 7. Awarding injunctive relief, including disgorgement of all profits made from and monies from and monies paid for the products at issue in an amount to be determined at trial; 40

41 Case 1:16-cv JEJ Document 1 Filed 08/12/16 Page 41 of Awarding punitive and/or exemplary damages; 9. Awarding the costs and expenses of this litigation incurred by Plaintiff; 10. Awarding reasonable attorneys fees and costs to Plaintiff as provided by law; 11. Awarding civil penalties for statutory violations as claimed above; and 12. Any other further relief in law or equity that this Court deems appropriate, necessary, just, and proper. Respectfully submitted by: /s/ Kevin Haverty Esther E. Berezofsky, Esq. (PA #50151) Kevin Haverty, Esq. (PA # 65789) WILLIAMS CUKER BEREZOFSKY, LLC 1515 Market Street, Suite 1300 Philadelphia, PA Telephone: (215) Facsimile: (215) eberezofsky@wcblegal.com khaverty@wcblegal.com Gale D. Pearson, Esq. PEARSON, RANDALL, & SCHUMACHER, P.A. 310 Fourth Avenue South, Suite 5010 Minneapolis, Minnesota Telephone: (612) Facsimile: (612) gpearson@prslegal.com Michelle A. Parfitt, Esq. Drew LaFramboise, Esq. ASHCRAFT & GEREL, LLP 4900 Seminary Road, Suite 650 Alexandria, Virginia Telephone: (703) Facsimile: (703) mparfitt@ashcraftlaw.com dlaframboise@ashcraftlaw.com ATTORNEYS FOR PLAINTIFFS 41

42 JS 44 (Rev. 0 /16) Case 1:16-cv JEJ Document 1-1 Filed 08/12/16 Page 1 of 2 CIVIL COVER SHEET The JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.) I. (a) PLAINTIFFS DEFENDANTS Medtronic, Inc., Medtronic Neuromodulation, a division of Medtronic, Jason Silver Inc., Medtronic Puerto Rico Operations, Inc., and Medtronic Logistics, LLC (b) County of Residence of First Listed Plaintiff Adams County of Residence of First Listed Defendant Hennepin, MN (EXCEPT IN U.S. PLAINTIFF CASES) NOTE: (c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known) Kevin Haverty, Esq., Williams Cuker Berezofsky, LLC 1515 Market Street, Suite 1300, Phila., PA (215) II. BASIS OF JURISDICTION (Place an X in One Box Only) (IN U.S. PLAINTIFF CASES ONLY) IN LAND CONDEMNATION CASES, USE THE LOCATION OF THE TRACT OF LAND INVOLVED. III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an X in One Box for Plaintiff (For Diversity Cases Only) and One Box for Defendant) 1 U.S. Government 3 Federal Question PTF DEF PTF DEF Plaintiff (U.S. Government Not a Party) Citizen of This State 1 1 Incorporated or Principal Place 4 4 of Business In This State 2 U.S. Government 4 Diversity Citizen of Another State 2 2 Incorporated and Principal Place 5 5 Defendant (Indicate Citizenship of Parties in Item III) of Business In Another State Citizen or Subject of a 3 3 Foreign Nation 6 6 Foreign Country IV. NATURE OF SUIT (Place an X in One Box Only) CONTRACT TORTS FORFEITURE/PENALTY BANKRUPTCY OTHER STATUTES 110 Insurance PERSONAL INJURY PERSONAL INJURY 625 Drug Related Seizure 422 Appeal 28 USC False Claims Act 120 Marine 310 Airplane 365 Personal Injury - of Property 21 USC Withdrawal 376 Qui Tam (31 USC 130 Miller Act 315 Airplane Product Product Liability 690 Other 28 USC (a)) 140 Negotiable Instrument Liability 367 Health Care/ 400 State Reapportionment 150 Recovery of Overpayment 320 Assault, Libel & Pharmaceutical PROPERTY RIGHTS 410 Antitrust & Enforcement of Judgment Slander Personal Injury 820 Copyrights 430 Banks and Banking 151 Medicare Act 330 Federal Employers Product Liability 830 Patent 450 Commerce 152 Recovery of Defaulted Liability 368 Asbestos Personal 840 Trademark 460 Deportation Student Loans 340 Marine Injury Product 470 Racketeer Influenced and (Excludes Veterans) 345 Marine Product Liability LABOR SOCIAL SECURITY Corrupt Organizations 153 Recovery of Overpayment Liability PERSONAL PROPERTY 710 Fair Labor Standards 861 HIA (1395ff) 480 Consumer Credit of Veteran s Benefits 350 Motor Vehicle 370 Other Fraud Act 862 Black Lung (923) 490 Cable/Sat TV 160 Stockholders Suits 355 Motor Vehicle 371 Truth in Lending 720 Labor/Management 863 DIWC/DIWW (405(g)) 850 Securities/Commodities/ 190 Other Contract Product Liability 380 Other Personal Relations 864 SSID Title XVI Exchange 195 Contract Product Liability 360 Other Personal Property Damage 740 Railway Labor Act 865 RSI (405(g)) 890 Other Statutory Actions 196 Franchise Injury 385 Property Damage 751 Family and Medical 891 Agricultural Acts 362 Personal Injury - Product Liability Leave Act 893 Environmental Matters Medical Malpractice 790 Other Labor Litigation 895 Freedom of Information REAL PROPERTY CIVIL RIGHTS PRISONER PETITIONS 791 Employee Retirement FEDERAL TAX SUITS Act 210 Land Condemnation 440 Other Civil Rights Habeas Corpus: Income Security Act 870 Taxes (U.S. Plaintiff 896 Arbitration 220 Foreclosure 441 Voting 463 Alien Detainee or Defendant) 899 Administrative Procedure 230 Rent Lease & Ejectment 442 Employment 510 Motions to Vacate 871 IRS Third Party Act/Review or Appeal of 240 Torts to Land 443 Housing/ Sentence 26 USC 7609 Agency Decision 245 Tort Product Liability Accommodations 530 General 950 Constitutionality of 290 All Other Real Property 445 Amer. w/disabilities Death Penalty IMMIGRATION State Statutes Employment Other: 462 Naturalization Application 446 Amer. w/disabilities Mandamus & Other 465 Other Immigration Other 550 Civil Rights Actions 448 Education 555 Prison Condition 560 Civil Detainee - Conditions of Confinement V. ORIGIN (Place an X in One Box Only) 1 Original 2 Removed from Proceeding State Court VI. CAUSE OF ACTION VII. REQUESTED IN COMPLAINT: VIII. RELATED CASE(S) IF ANY DATE FOR OFFICE USE ONLY 3 Remanded from 4 Reinstated or 5 Transferred from 6 Appellate Court Reopened Another District (specify) Cite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity): Multidistrict Litigation - Transfer 8 Multidistrict Litigation - Direct File 28 U.S.C Brief description of cause: Injuries resulting from a malfunctioning and defective Medtronic SynchroMed II Device CHECK IF THIS IS A CLASS ACTION DEMAND $ IN EXCESS OF CHECK YES only if demanded in complaint: UNDER RULE 23, F.R.Cv.P. 75, JURY DEMAND: Yes No (See instructions): JUDGE SIGNATURE OF ATTORNEY OF RECORD 08/12/2016 /s/kevin Haverty DOCKET NUMBER RECEIPT # AMOUNT APPLYING IFP JUDGE MAG. JUDGE

43 JS 44 Reverse (Rev. 0 /16) Case 1:16-cv JEJ Document 1-1 Filed 08/12/16 Page 2 of 2 INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44 Authority For Civil Cover Sheet The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers as required by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk of Court for each civil complaint filed. The attorney filing a case should complete the form as follows: I.(a) (b) (c) II. III. IV. Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, use only the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and then the official, giving both name and title. County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, noting in this section "(see attachment)". Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X" in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below. United States plaintiff. (1) Jurisdiction based on 28 U.S.C and Suits by agencies and officers of the United States are included here. United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box. Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendment to the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takes precedence, and box 1 or 2 should be marked. Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the citizenship of the different parties must be checked. (See Section III below; NOTE: federal question actions take precedence over diversity cases.) Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark this section for each principal party. Nature of Suit. Place an "X" in the appropriate box. If the nature of suit cannot be determined, be sure the cause of action, in Section VI below, is sufficient to enable the deputy clerk or the statistical clerk(s) in the Administrative Office to determine the nature of suit. If the cause fits more than one nature of suit, select the most definitive. V. Origin. Place an "X" in one of the seven boxes. Original Proceedings. (1) Cases which originate in the United States district courts. Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section When the petition for removal is granted, check this box. Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filing date. Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date. Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers or multidistrict litigation transfers. Multidistrict Litigation Transfer. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C. Section Multidistrict Litigation Direct File. (8) Check this box when a multidistrict case is filed in the same district as the Master MDL docket. PLEASE NOTE THAT THERE IS NOT AN ORIGIN CODE 7. Origin Code 7 was used for historical records and is no longer relevant due to changes in statue. VI. VII. VIII. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictional statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P. Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction. Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded. Related Cases. This section of the JS 44 is used to reference related pending cases, if any. If there are related pending cases, insert the docket numbers and the corresponding judge names for such cases. Date and Attorney Signature. Date and sign the civil cover sheet.

44 Case 1:16-cv JEJ Document 1-2 Filed 08/12/16 Page 1 of 11 EXHIBIT 1

45 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page 1 of 2 10 of 11 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA Civil No UNITED STATES OF AMERICA, ) ) Plaintiff ) ) v. ) ) COMPLAINT FOR MEDTRONIC INC., a corporation, and ) PERMANENT INJUNCTION S. OMAR ISHRAK and ) THOMAS M. TEFFT, individuals, ) ) ) Defendants. ) ) INTRODUCTION Plaintiff, the United States of America, by its undersigned attorneys, respectfully represents to this Court as follows: 1. This statutory injunction proceeding is brought under the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. 332(a), to enjoin Medtronic Inc. ( Medtronic ), a corporation, and S. Omar Ishrak, and Thomas M. Tefft, individuals (hereinafter, collectively, Defendants ) from violating: A. 21 U.S.C. 331(a), by introducing or delivering for introduction into interstate commerce, or causing the introduction or delivery for introduction into interstate commerce, articles of devices, as defined by 21 U.S.C. 321(h), that are adulterated within the meaning of the Act, 21 U.S.C. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, and

46 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page 2 of 3 10 of 11 installation are not in conformity with current good manufacturing practice requirements prescribed at 21 C.F.R. Part 820; B. 21 U.S.C. 331(k), by causing devices to become adulterated within the meaning of 21 U.S.C. 351(h), as described in paragraph A above, while such devices are held for sale after shipment in interstate commerce. JURISDICTION AND VENUE 2. This Court has jurisdiction under 21 U.S.C. 332(a) and 28 U.S.C and Venue in this District is proper pursuant to 28 U.S.C. 1391(b) and (c). DEFENDANTS 4. Medtronic is incorporated under the laws of Minnesota. Medtronic Neuromodulation ( Medtronic Neuro ), a business unit of Medtronic, manufactures medical devices, including but not limited to, SynchroMed II implantable infusion pumps. The headquarters of Medtronic Neuro is located at 7000 Central Ave. NE, Minneapolis, MN 55432, and its manufacturing facility is located at 53 rd Avenue, NE, Columbia Heights, MN S. Omar Ishrak is Medtronic s Chairman and CEO. He is the most responsible person at the firm, and oversees the firm's product development, product management, and international relations and sales. He performs his duties at 710 Medtronic Parkway, Minneapolis, MN Thomas M. Tefft is the Senior Vice President of Medtronic, and the President of Medtronic Neuro. He is the most responsible person at Medtronic Neuro, 2

47 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page 3 of 4 10 of 11 and oversees the business unit s product development, research, regulatory compliance and marketing. He performs his duties at 7000 Central Ave. NE, Minneapolis, MN Defendants have been, and are now, manufacturing and distributing in interstate commerce various articles of devices, as defined by 21 U.S.C. 321(h), including, but not limited to, SynchroMed II implantable infusion pumps, the subject of this injunction. 8. Defendants products are devices, within the meaning of 21 U.S.C. 321(h), in that they are intended to affect the structure or any function of the body of man. LEGAL STANDARDS 9. A device must be manufactured, packed, stored, and installed in conformity with good manufacturing practice to ensure its safety and effectiveness. 21 U.S.C. 360j(f). The statutory good manufacturing practice requirement is set out in the quality system ("QS") regulation for devices, 21 C.F.R. Part 820. A device that has been manufactured, packed, stored, or installed in violation of this requirement is deemed to be adulterated. 21 U.S.C. 351(h). 10. The introduction or delivery for introduction into interstate commerce of an adulterated article of device is a violation of the Act, 21 U.S.C. 331(a). 11. The adulteration of a device while it is held for sale after shipment in interstate commerce constitutes a violation of the Act, 21 U.S.C. 331(k). 3

48 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page 4 of 5 10 of 11 APRIL 2013 INSPECTION 12. FDA inspected Medtronic Neuro s manufacturing facility on February 14 April 3, 2013 ( April 2013 inspection ). During the April 2013 inspection, the FDA investigators documented numerous violations of the QS regulation at Medtronic Neuro. Many of these violations related directly to the manufacture of the SynchroMed II implantable infusion pump. FDA investigators observed the following violations of the QS regulation set forth in 21 C.F.R. Part 820: A. Defendants fail to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses, to complete proper risk analysis, and to document the results of the validation, in violation of 21 C.F.R (g); B. Defendants fail to establish and maintain adequate procedures to include requirements for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, in violation of 21 C.F.R (a)(3); C. Defendants fail to establish and maintain adequate procedures to include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, in violation of 21 C.F.R (a)(4); D. Defendants fail to establish and maintain procedures for implementing corrective and preventive action, in violation of 21 C.F.R (a); 4

49 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page 5 of 6 10 of 11 E. Defendants fail to establish and maintain procedures for verifying the device design, in violation of 21 C.F.R (f); F. Defendants fail to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, in violation of 21 C.F.R (i); and G. Defendants fail to establish and maintain procedures to control product that does not conform to specified requirements, in violation of 21 C.F.R (a). PRIOR INSPECTIONS 13. FDA inspected Medtronic Neuro s facilities previously in May 2012, January 2011, January 2007, and June At these inspections, FDA repeatedly observed and documented violations of the QS regulations similar to those cited above during the April 2013 inspection, including, but not limited to, violations involving: design controls (21 C.F.R ) and corrective and preventive action (21 C.F.R ). 14. At the conclusion of each of the prior inspections, the FDA investigators issued a Form FDA 483 detailing Defendants' numerous violations of the Act to Defendants, and discussed the documented observations with them. Defendants promised corrections at the conclusion of each inspection. 5

50 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page 6 of 7 10 of 11 PRIOR NOTICE OF VIOLATIONS 15. Defendants are well aware that their practices violate the Act. FDA has repeatedly warned Defendants, both orally and in writing, about their violative conduct, and has emphasized the importance of Defendants' compliance with the Act. 16. FDA issued a Warning Letter dated July 17, 2012 to Defendants, following the May 2012 inspection of the Medtronic Neuro facility. The letter discussed the QS violations involving corrective and preventive actions and complaint handling (21 C.F.R ) observed at the inspection. The letter also warned Defendants that further enforcement actions, including injunction, could occur if they did not correct the violations. 17. Defendants also received Warning Letters, dated July 3, 2007 and August 29, 2006, following the January 2007 and June 2006 inspections. These letters also addressed the numerous QS violations, including but not limited to design controls and corrective and preventive action, observed during the inspections and warned of further enforcement actions if corrections were not made. 18. Representatives of Medtronic also attended a meeting with FDA s Center for Devices and Radiological Health and Minneapolis District Office on January 31, At this meeting, Defendants stated that they were aware of the violations at their facilities and were taking steps to correct them. 19. At the conclusion of each of FDA's inspections of the firm, the FDA investigators issued a Form FDA 483 detailing Defendants' various violations of the Act 6

51 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page 7 of 8 10 of 11 to a responsible individual at the firm and discussed the documented observations with the recipient. 20. Defendants made promises to correct their violations in written responses to the April 2013 inspection, dated April 24, and several follow-up responses, detailing how and when the corrections promised in the April 24 letter had been made. None of these responses contained adequate evidence that Defendants have corrected their deviations. 21. Based on Defendants' conduct, Plaintiff believes that, unless restrained by order of this Court, Defendants will continue to violate 21 U.S.C. 331(a) and (k). WHEREFORE, Plaintiff prays: I. That Defendants and each of their directors, officers, agents, representatives, employees, attorneys, successors, and assigns, and any and all persons in active concert or participation with any of them, be permanently restrained and enjoined pursuant to 21 U.S.C. 332(a) from directly or indirectly: A. violating 21 U.S.C. 331(a), by introducing or delivering for introduction into interstate commerce, or causing the introduction or delivery for introduction into interstate commerce, any article of device that is adulterated within the meaning of 21 U.S.C. 351(h); or B. violating 21 U.S.C. 331(k), by causing any article of device to become adulterated within the meaning of 21 U.S.C. 351(h) while such devices are held for sale after shipment in interstate commerce. 7

52 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page 8 of 9 10 of 11 II. That the Court order Defendants and each of their directors, officers, agents, representatives, employees, attorneys, successors, and assigns, and any and all persons in active concert or participation with any of them, to cease directly and indirectly manufacturing, packing, labeling, and distributing (domestically and internationally) SynchroMed II implantable infusion pumps at or from its Medtronic Neuro facilities, unless and until Defendants' methods, facilities, and controls used to manufacture, process, pack, label, hold, and distribute the SynchroMed II implantable infusion pumps are established, operated, and administered in compliance with 21 U.S.C. 360j(f)(1) and the Quality System regulation prescribed in 21 C.F.R. Part 820, and in a manner that has been found acceptable to FDA; and III. That the Court authorize FDA, pursuant to this injunction, to inspect Defendants' Medtronic Neuro facility to ensure continuing compliance with the terms of this injunction, with the costs of such inspections to be borne by Defendants at the rates prevailing at the time the inspections are performed. 8

53 Case CASE 1:16-cv JEJ 0:15-cv Document 1-2 Filed Filed 04/27/15 08/12/16 Page Page 9 of of 11 IV. That Plaintiff be granted judgment for its costs herein, and that this Court grant such other and further relief as it deems just and proper. ANDREW M. LUGER United States Attorney s/ Chad A. Blumenfield CHAD BLUMENFIELD Assistant U.S. Attorney Attorney ID Courthouse 300 South Fourth St. Minneapolis, MN Ross S. Goldstein Trial Attorney Consumer Protection Branch U.S. Department of Justice Civil Division P.O. Box 386 Washington, DC OF COUNSEL: WILLIAM B. SCHULTZ Acting General Counsel ELIZABETH DICKINSON Associate General Counsel Food and Drug Division ANNAMARIE KEMPIC Deputy Chief Counsel, Litigation 9

54 Case CASE 1:16-cv JEJ 0:15-cv Document 11-2 Filed Filed 04/27/15 08/12/16 Page Page of 10 of 11 TARA BOLAND Associate Chief Counsel United States Department of Health and Human Services Office of the General Counsel New Hampshire Ave. Silver Spring, MD (301)

55 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 1 of 12 EXHIBIT 2

56 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 2 of 12 Archived Content The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived. Search Archive Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters 2006 Inspections, Compliance, Enforcement, and Criminal Investigations Medtronic, Inc. 29 Aug 06 Department of Health and Human Services Public Health Service Food and Drug Administration Minneapolis District Office Central Region 212 Third Avenue South Minneapolis, MN Telephone: (612) FAX: (612) August 29, 2006 CERTIFIED MAIL RETURN RECEIPT REQUESTED Arthur D. Collins, Jr. Chairman of the Board and Chief Executive Officer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN Dear Mr. Collins: WARNING LETTER Refer to MIN During a May 18 June 22, 2006, inspection of your establishment, Medtronic Neurological, located at rd Avenue NE, Minneapolis, MN 55421, our investigators determined that your firm manufactures implantable drug infusion and neurostimulation products to treat pain, movement disorders, and other medical conditions. These products are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(h)] because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. This inspection revealed that these devices are adulterated under Section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, found at Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following: 1. Failure to implement procedures to ensure that a device's design input requirements are appropriate and address its intended use, including user/patient needs, as required by 21 CFR (c). Design input work for the 8731 Intrathecal Catheter has not resulted in development of a complete design specification

57 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 3 of 12 for the Platinum/ Iridium (Pt/Ir) catheter tip bond. (For more detail on this deviation, see FDA 483 observation # 1 from the May 18 June 22, 2006, inspection. Copy of FDA 483 attached.) 2. Failure to conduct design validation using production units or their equivalents, as required by 21 CFR (g). Design validation testing of the Model 8731 Catheter was conducted with catheters manufactured with a Pt/Ir tip marker bonding process that was different than the process eventually used in production. (See FDA 483 observation #2.) 3. Failure to validate a process whose results cannot be fully verified by subsequent inspection and test as required by 21 CFR (a). For the 8731 Catheter, the Pt/Ir tip bonding process has not been validated (See FDA 483 observation #3.) 4. Failure to control production processes to ensure that a device conforms to its specifications, as required by 21 CFR (a). For the 8731 Catheter, the tip bonding manufacturing procedures contained an [redacted] of the tip, and instructions to [redacted] equipment that was no longer in service. (See FDA 483 observation #4.) 5. Failure to implement corrective and preventive action procedures addressing the investigation of the cause of nonconforrnities relating to product, processes, and the quality system as required by 21 CFR (a)(2). Examples include: a. Corrective / Preventive Action System (C/PAS) 747 (re: 8731 tip detachments) was closed with a root cause analysis that conflicts with information received in complaints. No additional C/PAS was opened to address the complaints and failures that do not fit the root cause analysis in C/PAS 747. (See FDA 483 observation #5a.) b. Product Comment Report (PCR) reported an 8731 catheter tip detachment and stated that "...post operative the patient showed pain in the left leg, which can be related with the remaining tip." In conflict with this reported event, a Health Hazard Analysis and "TECH NOTE" concluded that none of the tip detachments were associated with adverse clinical or neurological consequences. (See FDA 483 observation #5b.) c. System Correction Request (SCR) 877, which addresses pump motor stalls due [redacted] to failures in Synchromed EL implantable infusion pumps, was closed without evidence to support conclusions that were made. (See FDA 483 observation #5c.) 6. Failure to implement changes in methods and procedures needed to correct and prevent identified quality problems, as required by 21 CFR (a)(5). C/PAS 747 called for a redesign of the catheter tip and a new product specification defining a requirement for [redacted]. However, the product specification was not changed, and as a result, the revised manufacturing process was not validated, and no process monitoring was conducted. As of the inspection, [redacted] complaints had been received involving tip dislodgements in catheters produced after the redesign of the tip. (See FDA 483 observation #6.) 7. Failure to identify all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR (a)(3). In particular: a. C/PAS 747, which covered detachment of Pt/Ir tips in Model 8731 Catheters, did not include an action to address 8731 Catheters that were in finished goods or already distributed. (See FDA 483 observation #7a.) (NOTE: These Model 8731 Intrathecal Catheters were eventually recalled by your firm on July 21, 2006.) b. A field corrective action was not conducted until June 6, 2006, to address recurring Catheter Access Por (CAP) detachment failures in Synchromed EL implantable infusion pumps. (See FDA 483 observation #7b. 8. Failure to implement procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the Quality Systems regulation as required by 21 CFR Specifically: a. Traceability Cards for some Synchromed EL implantable infusion pumps did not include complete records of operations that were conducted under Manufacturing Process Variances or Product Review Requests (PRR's). (See FDA 483 observation #8a.) b. A copy of process variance 1955, which covered [redacted] of Synchromed EL pumps, was not maintained in the documentation control system. (See FDA 483 observation #8b.) This letter is not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility

58 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 4 of 12 to ensure compliance with the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action to bring your products into compliance. Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket approva applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected. You should take prompt action to correct the deviations described in this letter. Failure to promptly correc these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil mone penalties. On July 24, 2006, we received an undated letter from George Aram, Vice President of Quality, Neurological Sector, which describes corrective actions taken and planned by your firm to address the FDA 483 Inspectional Observations. Only two of the corrective actions (for FDA 483 observations # 8 and 9) have been completed. Mr. Aram provided target completion dates for corrective actions to address the remaining FDA 483 Inspectional Observations, and he stated that monthly progress reports would be provided to our office beginning on August 28, At this time, based on the limited information that has been provided, we are unable to determine whether your corrective actions are appropriate. In order to fully assess the implementation and effectiveness of the corrections, we will need to conduct a followup inspection. [Redacted] Please notify this office in writing within 15 working days to acknowledge receipt of this letter and to provide an update on the status of your corrective actions. Your response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead. Sincerely, /S/ W. Charles Becoat Director Minneapolis District Page Last Updated: 07/08/2009 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD Ph INFO FDA ( ) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive

59 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 5 of 12

60 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 6 of 12

61 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 7 of 12

62 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 8 of 12

63 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 9 of 12

64 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 10 of 12

65 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 11 of 12

66 Case 1:16-cv JEJ Document 1-3 Filed 08/12/16 Page 12 of 12