Moody v. Allergan USA, Inc.

MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM

W.D.N.Y.November 16, 2016

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF NEW YORK FRANCES MOODY, Plaintiff, - vs - ALLERGAN USA, INC., Defendant. NOTICE OF MOTION TO DISMISS PURSUANT TO FRCP 12(b)(6) Civil Action No. 1:16-cv-901 Hon. Lawrence J. Vilardo, U.S.D.J. Oral Argument is Requested PLEASE TAKE NOTICE that Defendant, Allergan USA, Inc. (“Defendant”), by counsel, will move this Court, at a date and time to be set by the Court, for an Order dismissing Plaintiff’s Complaint pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure; alternatively, granting Defendant thirty (30) days after a decision is rendered on this motion to file an answer; and granting such other and further relief as the Court deems proper. The primary grounds for dismissal, as further described in the accompanying Memorandum of Law in support of this Motion, which is incorporated by reference and filed contemporaneously herewith, are federal preemption under 21 U.S.C. §360k(a) of the Medical Device Amendments (“MDA”) to the Food Drug and Cosmetic Act (“FDCA”), and the United States Supreme Court’s decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), which control whether a complaint states a claim upon which relief can be granted under the MDA and FDCA. As further basis for dismissal, Plaintiff’s claims otherwise fail to state a claim and/or are untimely. In support of this motion, Defendant will rely upon this Notice, the Memorandum of Law submitted herewith, the concurrently filed Request for Judicial Notice with Exhibits, and the pleadings on file in this action. Case 1:16-cv-00901-LJV Document 3 Filed 11/16/16 Page 1 of 3 PLEASE TAKE FURTHER NOTICE that Defendant Allergan USA, Inc. intends to file and serve reply papers. Therefore, pursuant to Local Rule 7(b), any papers in opposition to this motion must be filed and served at least eight (8) business days prior to the return date of this motion, or as otherwise ordered by the Court. Respectfully submitted, NIXON PEABODY LLP By: /s/ Vivian M. Quinn Vivian M. Quinn, Esq. 40 Fountain Plaza, Suite 500 Buffalo, New York 14202 Telephone: (716) 853-8100 Email: vquinn@nixonpeabody.com Attorneys for Defendant Allergan USA, Inc. Case 1:16-cv-00901-LJV Document 3 Filed 11/16/16 Page 2 of 3 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF NEW YORK FRANCES MOODY, Plaintiff, - vs - ALLERGAN USA, INC., Defendant. CERTIFICATE OF SERVICE Civil Action No. 1:16-cv-901 I, Vivian M. Quinn, an attorney admitted to practice before this Court, and a member of the law firm of Nixon Peabody LLP, attorneys for Defendant, do hereby certify that on November 16, 2016 I caused the foregoing Notice of Motion and Motion to Dismiss, Memorandum of Law in Support and Request for Judicial Notice with Exhibits to be served via regular mail, by depositing same in the custody and control of the United States Postal Service, addressed to the following: Ashley Andrews-Santillo, Esq. Joseph Parise, Esq. Munawar & Andrews-Santillo, LLP 420 Lexington Avenue, Suite 2601 New York, NY 10170 Attorneys for Plaintiff Dated: November 16, 2016 Buffalo, New York NIXON PEABODY LLP By: /s/ Vivian M. Quinn Vivian M. Quinn, Esq. 40 Fountain Plaza, Suite 500 Buffalo, New York 14202 Telephone: (716) 853-8100 E-mail: vquinn@nixonpeabody.com Attorneys for Defendant Allergan USA, Inc. Case 1:16-cv-00901-LJV Document 3 Filed 11/16/16 Page 3 of 3 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF NEW YORK FRANCES MOODY, Plaintiff, - vs - ALLERGAN USA, INC., Defendant. DEFENDANT’S REQUEST FOR JUDICIAL NOTICE AND MEMORANDUM IN SUPPORT Civil Action No. 1:16-cv-901 TO: THE JUDGES OF THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF NEW YORK PLEASE TAKE NOTICE that, pursuant to Federal Rule of Evidence 201, Defendant Allergan USA, Inc. (“Allergan”), appearing through undersigned counsel, respectfully requests that the Court take judicial notice of the Food and Drug Administration (“the FDA”)’s pre- market approval (“PMA”) of the medical device at issue in this products liability case, as reflected in the following publicly-available documents: Exhibit 1: The FDA’s “Approval Order Letter” dated June 5, 2001 regarding PMA number “P000008” relating to the LAP-BAND® System; and Exhibit 2: The FDA’s “Summary of Safety and Effectiveness Data” published simultaneously regarding PMA number “P000008” relating to the LAP-BAND® System. This documentation concerning the FDA’s pre-market approval of the LAP-BAND® System (Exhibits 1 and 2) is freely available to the public on the FDA’s website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p000008 (last visited Oct. 4, 2016). This Honorable Court may take judicial notice of these government documents from this reliable public resource. Fed. R. Evid. 201(b). Case 1:16-cv-00901-LJV Document 3-1 Filed 11/16/16 Page 1 of 3 MEMORANDUM IN SUPPORT Under the Federal Rules of Evidence, a Court may “judicially notice a fact that is not in dispute” when such facts are “(1) generally known within the trial court’s territorial jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b). The FDA’s website is a source whose accuracy cannot reasonably be questioned. Pursuant to Rule 201, Courts routinely take judicial notice of FDA materials in cases involving PMA medical devices, like the one at bar. See Ali v. Allergan USA, Inc., No. 1:12-cv-115, 2012 WL 3692396, at *3 (E.D. Va. 2012) (taking judicial notice of FDA documents related to the PMA for the LAP-BAND® System); Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197, 201 n.3 (W.D.N.Y. 2011) (taking judicial notice of the PMA of the device in question based on information which was publicly accessible on FDA’s website); In re Zyprexa Prods. Liab. Litig., 549 F. Supp.2d 496, 501 (E.D.N.Y. 2008) (taking judicial notice of FDA documents); Gale v. Smith & Nephew, Inc., 989 F. Supp.2d 243, 246 n.2 (S.D.N.Y. 2013) (taking judicial notice of fact that product received pre-market approval); Simon v. Smith & Nephew, Inc., 990 F. Supp.2d 395, 401 n.2 (S.D.N.Y. 2013) (“For the purpose of resolving the present motion [to dismiss under 12(b)(6)], the Court takes judicial notice of public records contained on the FDA website.”). More specifically, this Court may take judicial notice of the pre-market approval (PMA) granted to the LAP-BAND® System at issue in this lawsuit, as reflected in records publicly available on the FDA’s website. The FDA’s 2001 approval of PMA number “P000008” relating to the LAP-BAND® System is reflected in the FDA’s “Approval Order Letter” and “Summary of Safety and Effectiveness Data,” two public documents which have been attached as Exhibits 1 and 2, respectively. Those documents confirm that LAP-BAND® received FDA approval under Case 1:16-cv-00901-LJV Document 3-1 Filed 11/16/16 Page 2 of 3 the rigorous PMA process for Class III medical devices, which provides the basis for federal preemption under the express preemption provision of the Medical Device Amendments of 1976. In support of Allergan’s contemporaneously-filed Motion to Dismiss, Allergan respectfully requests that this Honorable Court take judicial notice of the fact that LAP-BAND® has been pre-market approved. In adjudicating a motion to dismiss under Rule 12(b)(6) a court may properly take judicial notice of facts pursuant to Fed. R. Evid. 201(b). David Lerner Assocs., Inc. v. Philadelphia Indem. Ins. Co., 934 F. Supp.2d 533, 539 (E.D.N.Y. 2013), aff’d, 542 Fed. Appx. 89 (2d Cir. 2013); SC Note Acquisitions, LLC v. Wells Fargo Bank, N.A., 934 F. Supp.2d 516, 524 (E.D.N.Y. 2013), aff’d, 548 Fed. Appx. 741 (2d Cir. 2014). WHEREFORE, Defendant Allergan USA, Inc. respectfully requests that the Court take judicial notice as set forth above. DATED: Buffalo, New York November 16, 2016 NIXON PEABODY LLP By: /s/ Vivian M. Quinn Vivian M. Quinn, Esq. 40 Fountain Plaza, Suite 500 Buffalo, New York 14202 Telephone: (716) 853-8100 Email: vquinn@nixonpeabody.com Attorneys for Defendant Allergan USA, Inc. Case 1:16-cv-00901-LJV Document 3-1 Filed 11/16/16 Page 3 of 3 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ; t Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 5 2001 Ms. Ellen Duke President and Chief Executive Officer BioEnterics Corporation 1035 Cindy Lane Carpinteria, California 93013 Re: P000008 LAP-BAND® Adjustable Gastric Banding (LAGS®) System Filed: March 24, 2000 Amended: April 20, May 3 and 23, and December 26, 2000; and May 18 and June 1, 2001 Dear Ms. Duke: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) for the LAP-BAND® Adjustable Gastric Banding (LAGB®) System. This device is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lbs. or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame). It is indicated for use only in severely obese adult patients who have failed more conservative weight- reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives. We are pleased to inform you that the PMA is approved subject to the conditions described below and in the "Conditions of Approval" (enclosed). You may begin commercial distribution of the device upon receipt of this letter. The sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR 801.109 within the meaning of section 520(e) of the Federal Food, Drug, and Cosmetic Act (the act) under the authority of section 515(d)(1)(B)(ii) of the act. FDA has also determined that, to ensure the safe and effective use of the device, the device is further restricted within the meaning of section 520(e) under the authority of section 515(d)(1)(B)(ii), (1) insofar as the labeling specify the requirements that apply to the training of practitioners who may use the device as approved in this order and (2) insofar as the sale, distribution, and use must not violate sections 502(q) and (r) of the act. In addition to the postapproval requirements in the enclosure, the postapproval reports must include annual progress reports on the postapproval study that you agreed to conduct to gather long-term safety and effectiveness data on the subject device. You agreed to continue follow-up on subjects enrolled under prOtocol A and protocol B of your investigational study. These post-approval subjects must be followed for a total of 5 years from the time of implantation. The protocol must include the items identified in your outline entitled "Outline for Lap-Band System Post-Market U.S. Study" submitted on May 25 and 31, 2001. The results of the post-approval study should be reflected in the labeling via a PMA supplement when the study is complete. Case 1:16-cv-00901-LJV Document 3-2 Filed 11/16/16 Page 1 of 6 Sincerely y. „-- Page 2 - Ms. Ellen Duke CDRH will notify the public of its decision to approve your PMA by making available a summary of the safety and effectiveness data upon which the approval is based. The information can be found on the FDA CDRH Internet HomePage located at http://www.fda.gov/cdrhipmapage.html. Written requests for this information can also be made to the Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The written request should include the PMA number or docket number. Within 30 days from the date that this information is placed on the Internet, any interested person may seek review of this decision by requesting an opportunity for administrative review, either through a hearing or review by an independent advisory committee, under section 515(g) of the Federal Food, Drug, and Cosmetic Act (the act). Failure to comply with the conditions of approval invalidates this approval order. Commercial distribution of a device that is not in compliance with these conditions is a violation of the act. You are reminded that, as soon as possible and before commercial distribution of your device, you must submit an amendment to this PMA submission with copies of all approved labeling in final printed form. As part of our reengineering effort, the Office, of Device Evaluation is piloting a new process for review of final printed labeling. The labeling will not routinely be reviewed by FDA staff when PMA applicants include with their submission of the final printed labeling a cover letter stating that the final printed labeling is identical to the labeling approved in draft form. If the final printed labeling is not identical, any changes from the final draft labeling should be highlighted and explained in the amendment. Please see the CDRH Pilot for Review of Final Printed Labeling document at http://www.fda.gov/cdrhipmat/pilotpmat.html for further details. All required documents should be submitted in triplicate, unless otherwise specified, to the address below and should reference the above PMA number to facilitate processing. PMA Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 If you have any questions concerning this approval order, please contact Kathleen M. Olvey at (301) 594-1220. Daniel G. Schultz, M.D. Deputy Director for Clinical and Review Policy Office of Device Evaluation Center for Devices and Radiological Health Enclosure Case 1:16-cv-00901-LJV Document 3-2 Filed 11/16/16 Page 2 of 6 Issued: 3-4-98 CONDITIONS OF APPROVAL APPROVED LABELING. As soon as possible, and before commercial distribution of your device, submit three copies of an amendment to this PMA submission with copies of all approved labeling in final printed form to the PMA Document Mail Center (HFZ-401), Center for Devices and Radiological Health, Food and Drug Administration (FDA), 9200 Corporate Blvd., Rockville, Maryland 20850. ADVERTISEMENT. No advertisement or other descriptive printed material issued by the applicant or private label distributor with respect to this device shall recommend or imply that the device may be used for any use that is not included in the FDA approved labeling for the device. If the FDA approval order has restricted the sale, distribution and use of the device to prescription use in accordance with 21 CFR 801.109 and specified that this restriction is being imposed in accordance with the provisions of section 520(e) of the act under the authority of section 515(d)(1)(B)(ii) of the act, all advertisements and other descriptive printed material issued by the applicant or distributor with respect to the device shall include a brief statement of the intended uses of the device and relevant warnings, precautions, side effects and contraindications. PREMARKET APPROVAL APPLICATION (PMA) SUPPLEMENT. Before making any change affecting the safety or effectiveness of the device, submit a PMA supplement for review and approval by FDA unless the change is of a type for which a "Special PMA Supplement-Changes Being Effected" is permitted under 21 CFR 814.39(d) or an alternate submission is permitted in accordance with 21 CFR 814.39(e). A PMA supplement or alternate submission shall comply with applicable requirements under 21 CFR 814.39 of the final rule for Premarket Approval of Medical Devices. All situations which require a PMA supplement cannot be briefly summarized, please consult the PMA regulation for further guidance. The guidance provided below is only for several key instances. A PMA supplement must be submitted when unanticipated adverse effects, increases in the incidence of anticipated adverse effects, or device failures necessitate a labeling, manufacturing, or device modification. A PMA supplement must be submitted if the device is to be modified and Ee modified deviCe should be subjected to animal or laboratory or clinical testing designed to determine if the modified device remains safe and effective. A "Special PMA Supplement - Changes Being Effected" is limited to the labeling, quality control and manufacturing process changes specified under 21 CFR 814.39(d)(2). It I Case 1:16-cv-00901-LJV Document 3-2 Filed 11/16/16 Page 3 of 6 allows for the addition of, but not the replacement of previously approved, quality control specifications and test methods. These changes may be implemented before FDA approval upon acknowledgment by FDA that the submission is being processed as a "Special PMA Supplement - Changes Being Effected." This acknowledgment is in addition to that issued by the PMA Document Mail Center for all PMA supplements submitted. This procedure is not applicable to changes in device design, composition, specifications, circuitry, software or energy source. Alternate submissions permitted under 21 CFR 814.39(e) apply to changes that otherwise require approval of a PMA supplement before implementation of the change and include the use of a 30-day PMA supplement or annual postapproval report. FDA must have previously indicated in an advisory opinion to the affected industry or in correspondence with the applicant that the alternate submission is permitted for the change. Before such can occur, FDA and the PMA applicant(s) involved must agree upon any needed testing protocol, test results, reporting format, information to be reported, and the alternate submission to be used. POSTAPPROVAL REPORTS. Continued approval of this PMA is contingent upon the submission of postapproval reports required under 21 CFR 814.84 at intervals of 1 year from the date of approval of the original PMA. Postapprovai reports for supplements approved under the original PMA, if applicable, are to be included in the next and subsequent annual reports for the original PMA unless specified otherwise in the approval order for the PMA supplement. Two copies identified as "Annual Report" and bearing the applicable PMA reference number are to be submitted to the PMA Document Mail Center (HFZ-401), Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, Maryland 20850. The postapproval report shall indicate the beginning and ending date of the period covered by the report and shall include the following information required by 21 CFR 814.84: (I)Identification of changes described in 21 CFR 814.39(a) and changes required to be reported to FDA under 21 CFR 814.39(b). (2) Bibliography and summary of the following information not previously submitted as part of the PMA and that is known to or reasonably should be known to the applicant: (a)unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices ("related" devices include devices which are the same or substantially similar to the applicant's device); and (b)reports in the scientific literature concerning the device. If, after reviewing the bibliography and summary, FDA concludes that agency review of one or more of the above reports is required, the applicant shall submit two copies of each 2 Case 1:16-cv-00901-LJV Document 3-2 Filed 11/16/16 Page 4 of 6 identified report when so notified by FDA. ADVERSE REACTION AND DEVICE DEFECT REPORTING. As provided by 21 CFR 814.82(a)(9), FDA has determined that in order to provide continued reasonable assurance of the safety and effectiveness of the device, the applicant shall submit 3 copies of a written report identified, as applicable, as an "Adverse Reaction Report" or "Device Defect Report" to the PMA Document Mail Center (HFZ-40I), Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, Maryland 20850 within 10 days after the applicant receives or has knowledge of information concerning: (1)A mix-up of the device or its labeling with another article. (2)Any adverse reaction, side effect, injury, toxicity, or sensitivity reaction that is attributable to the device and (a)has not been addressed by the device's labeling or (b)has been addressed by the device's labeling, but is occurring with unexpected severity or frequency. (3)Any significant chemical, physical or other change or deterioration in the device or any failure of the device to meet the specifications established in the approved PMA that could not cause or contribute to death or serious injury but are not correctable by adjustments or other maintenance procedures described in the approved labeling. The report shall include a discussion of the applicants assessment of the change, deterioration or failure and any proposed or implemented corrective action by the applicant. When such events are correctable by adjustments or other maintenance procedures described in the approved labeling, all such events known to the applicant shall be included in the Annual Report described under "Postapproval Reports" above unless specified otherwise in the conditions of approval to this PMA. This postapproval report shall appropriately categorize these events and include the number of reported and otherwise known instances of each category during the reporting period. Additional information regarding the events discussed above shall be submitted by the applicant when determined by FDA to be necessary to provide continued reasonable assurance of the safety and effectiveness of the device for its intended use. REPORTING UNDER THE MEDICAL DEVICE REPORTING (MDR) - REGULATION. The Medical Device Reporting (MDR) Regulation became effective on December 13, 1984. This regulation was replaced by the reporting requirements of the - Safe Medical Devices Act of 1990 which became effective- July 31, 1996 and requires - that all manufacturers and importers of medical devices, including in vitro diagnostic devices, report to the FDA whenever they receive or otherwise become aware of 3 Case 1:16-cv-00901-LJV Document 3-2 Filed 11/16/16 Page 5 of 6 information, from any source, that reasonably suggests that a device marketed by the manufacturer or importer: (1)May have caused or contributed to a death or serious injury; or (2)Has malfunctioned and such device or similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were tarecur. The same events subject to reporting under the MDR Regulation may also be subject to the above "Adverse Reaction and Device Defect Reporting" requirements in the "Conditions of Approval" for this PMA. FDA has determined that such duplicative reporting is unnecessary. Whenever an event involving a device is subject to reporting under both the MDR Regulation and the "Conditions of Approval" for a PMA, the manufacturer shall submit the appropriate reports required by the MDR Regulation within the time frames as identified in 21 CFR 803.10(c) using FDA Form 3500A, i.e., 30 days after becoming aware of a reportable death, serious injury, or malfunction as described in 21 CFR 803.50 and 21 CFR 803.52 and 5 days after becoming aware that a reportable MDR event requires remedial action to prevent an unreasonable risk of substantial harm to the public health. The manufacturer is responsible for submitting a baseline report on FDA Form 3417 fora device when the device model is first reported under 21 CFR 803.50. This baseline report is to include the PMA reference number. Any written report and its envelope is to be specifically identified, e.g., "Manufacturer Report," "5-Day Report," "Baseline Report," etc. Any written report is to be submitted to: Food and Drug Administration Center for Devices and Radiological Health Medical Device Reporting PO Box 3002 Rockville, Maryland 20847-3002 Copies of the MDR Regulation (FOD # 336&1336)and FDA publications entitled "An Overview of the Medical Device Reporting Regulation" (FOD # 509) and "Medical Device Reporting for Manufacturers" (FOD #987) are available on the CDRH WWW Home Page. They are also available through CDRH's Fact-On-Demand (F-O-D) at 800- 899-0381. Written requests for information can be made by sending a facsimile to CDRH's Division of Small Manufacturers Assistance (DSMA) at 301-443-8818. 4 1 Case 1:16-cv-00901-LJV Document 3-2 Filed 11/16/16 Page 6 of 6 THE LAP-BAND® ADJUSTABLE GASTRIC BANDING SYSTEM SUMMARY OF SAFETY AND EFFECTIVENESS DATA I GENERAL INFORMATION Device Generic Name: Device Trade Name: Applicant's Name and Address: Adjustable Silicone Gastric Band, Implanted LAP-BAND® Adjustable Gastric Banding (LAGB ) System BioEnterics Corporation 1035 Cindy Lane Carpinteria, California 93013 PMA Number: P000008 Date of Panel Recommendation: June 19, 2000 Date of Notice of Approval to the Applicant: June 5, 2001 II INDICATIONS FOR USE The LAP-BAND System is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lbs. or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame). It is indicated for use only in severely obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives. III CONTRAINDICATIONS The LAP-BAND System is contraindicated in: 1. Patients with inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease. 2. Patients with severe cardiopulmonary diseases or other serious organic disease which may make them poor surgical candidates. 3. Patients with potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices or congenital or acquired intestinal telangiectases. Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 1 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) 4. Patients with portal hypertension. 5. Patients with congenital or acquired anomalies of the GI tract such as atresias or stenoses. 6. Patients who have/experience an intra-operative gastric injury during the implantation procedure, such as a gastric perforation at or near the location of the intended band placement. 7. Patients with cirrhosis. 8. Patients with chronic pancreatitis. 9. Patients who are addicted to alcohol and/or drugs. 10. Non-adult patients (patients under 18 years of age). 11. Patients who have an infection anywhere in their body or where the possibility of contamination prior to or during the surgery exists. 12. Patients on chronic, long-term steroid treatment. 13. Patients who are unable or unwilling to comply with dietary restrictions, which are required by this procedure. 14. Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system or who have exhibited a pain intolerance to implanted devices. 15. Patients or family members with a known diagnosis or pre-existing symptoms of autoimmune connective tissue disease such as systemic lupus erythematosus or scleroderma. 16. Pregnancy: Placement of the LAP-BAND System is contraindicated for patients who currently are or may be pregnant. Patients who become pregnant after band placement may require deflation of their bands. IV WARNINGS, AND PRECAUTIONS Warnings WARNING: Laparoscopic or laparotomic placement of the LAP-BAND System is major surgery and death can occur WARNING: Failure to secure the band properly may result in its subsequent displacement and necessitate reoperation. WARNING: A large hiatal hernia may prevent accurate positioning of the device. Placement of the band should be considered on a case-by-case basis depending on the severity of the hernia. 2 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 2 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) WARNING: The band should not be sutured to the stomach. Suturing the band directly to the stomach may result in erosion. WARNING: Patients' emotional and psychological stability should be evaluated prior to surgery. Gastric banding may be determined to be inappropriate, in the opinion of the surgeon, for select patients. WARNING: Patients should be advised that the LAP-BAND System is a long-term implant. Explant and replacement surgery may be indicated at any time. Medical management of adverse reactions may include explantation. Revision surgery for explantation and replacement may also be indicated to achieve patient satisfaction. WARNING: Esophageal distension or dilatation has been reported to result from stoma obstruction due to over-restriction, due to excessive band inflation. Patients should not expect to lose weight as fast as gastric bypass patients, and band inflation should proceed in small increments. Deflation of the band is recommended if esophageal dilatation develops. WARNING: Some types of esophageal dysmotility may result in inadequate weight loss or may result in esophageal dilatation when the band is inflated and require removal of the band. On the basis of each patient's medical history and symptoms, surgeons should determine whether esophageal motility function studies are necessary. If these studies indicate that the patient has esophageal dysmotility, the increased risks associated with band placement must be considered. WARNING: Patients with Barrett's esophagus may have problems associated with their esophageal pathology that could compromise their post-surgical course. Use of the band in these patients should be considered on the basis of each patient's medical history and severity of symptoms. WARNING: Patient self-adjustment of superficially placed access ports has been reported. This can result in inappropriate band tightness, infection and other complications. Precautions CAUTION: Laparoscopic band placement is an advanced laparoscopic procedure. Surgeons planning laparoscopic placement must: 1. Have extensive advanced laparoscopic experience, i.e., fundoplications. 2. Have previous experience in treating obese patients and have the staff and commitment to comply with the long-term follow-up requirements of obesity procedures. 3. Participate in a training program for the LAP-BAND System authorized by BioEnterics Corporation or an authorized BioEnterics distributor (this is a requirement for use). 3 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 3 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) 4. Be observed by qualified personnel during their first band placements. 5. Have the equipment and experience necessary to complete the procedure via laparotomy, if required. 6. Be willing to report the results of their experience to further improve the surgical treatment of severe obesity. CAUTION: It is the responsibility of the surgeon to advise the patient of the known risks and complications associated with the surgical procedure and implant. CAUTION: As with other gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the gastrointestinal tract. Any damage to the stomach during the procedure may result in erosion of the device into the GI tract. CAUTION: During insertion of the calibration tube, care must be taken to prevent perforation of the esophagus or stomach. CAUTION: In revision procedures the existing staple line may need to be partially disrupted to avoid having a second point of obstruction below the band. As with any revision procedure, the possibility of complications such as erosion and infection is increased. Any damage to the stomach during the procedure may result in peritonitis and death, or in late erosion of the device into the GI tract. CAUTION: Care must be taken to place the access port in a stable position away from areas that may be affected by significant weight loss, physical activity, or subsequent surgery. Failure to do so may result in the inability to perform percutaneous band adjustments. CAUTION: Care must be taken during band adjustment to avoid puncturing the tubing which connects the access port and band, as this will cause leakage and deflation of the inflatable section. CAUTION: The LAP-BAND System is for single use only. Do not use a band, access port, needle or calibration tube which appears damaged (cut, torn, etc.) in any way. Do not use one of them if the package has been opened or damaged, or if there is any evidence of tampering. If packaging has been damaged, the product may not be sterile and may cause an infection. Do not attempt to clean, re-sterilize or re-use any part of the LAP-BAND Adjustable Gastric Banding System. The product may be damaged or distorted if re-sterilized. CAUTION: It is important that special care be used when handling the device because contaminants such as lint, fingerprints and talc may lead to a foreign body reaction. 4 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 4 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) CAUTION: Care must be taken to avoid damaging the band, its inflatable section or tubing, the access port or the calibration tube. Use only rubber-shod clamps to clamp tubing. CAUTION: The band, access port and calibration tube may be damaged by sharp objects and manipulation with instruments. A damaged device must not be implanted. For this reason, a stand-by device should be available at the time of surgery. CAUTION: Failure to use the tubing end plug during placement of the band may result in damage to the band tubing during band placement. CAUTION: Do not push the tip of any instrument against the stomach wall or use excessive electrocautery. Stomach perforation or damage may result. Stomach perforation may result in peritonitis and death. CAUTION: Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation. CAUTION: Failure to use an appropriate atraumatic instrument such as the LAP-BAND Closure Tool to lock the band may result in damage to the band or injury to surrounding tissues. CAUTION: The band is not intended to be opened laparoscopically with surgical instruments. Unrecognized damage to the band may result in subsequent breakage or failure of the device. CAUTION: When adjusting band volume take care to ensure that the radiographic screen is perpendicular to the needle shaft (the needle will appear as a dot on the screen). This will facilitate adjustment of needle position as needed while moving through the tissue to the port. CAUTION: When adjusting band volume use of an inappropriate needle may cause access port leakage and require re-operation to replace the port. Use only LAP-BAND System Access Port Needles. Do not use standard hypodermic needles, as these may cause leaks. CAUTION: When adjusting band volume never enter the access port with a "syringeless " needle. The fluid in the device is under pressure and will be released through the needle. CAUTION: When adjusting band volume once the septum is punctured, do not tilt or rock the needle, as this may cause fluid leakage or damage to the septum. CAUTION: When adjusting band volume if fluid has been added to decrease the stoma size, it is important to establish, before discharge, that the stoma is not too small. Care must be taken during band adjustments not to add too much saline, thereby closing the gastric stoma. Check the adjustment by having the patient drink water. If the patient is unable to swallow, remove some fluid from the port, then recheck. A physician familiar with the adjustment procedure must be available for several days post-adjustment to deflate the band in case of an obstruction. 5 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 5 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) CAUTION: It is the responsibility of the surgeon to advise the patient of the dietary restrictions which follow this procedure and to provide diet and behavior modification support. Failure to adhere to the dietary restrictions may result in obstruction and/or failure to lose weight. CAUTION: Patients must be carefully counseled on the need for proper dietary habits. They should be evaluated for nutritional (including caloric) needs and advised on the proper diet selection. If necessary to avoid any nutritional deficiencies, the physician may choose to prescribe appropriate dietary supplements. The appropriate physical monitoring and dietary counseling should take place regularly. CAUTION: Patients must be cautioned to chew their food thoroughly. Patients with dentures must be cautioned to be particularly careful to at their food into small pieces. Failure to follow these precautions may result in vomiting, stoma! irritation and edema, possibly even obstruction. CAUTION: Patients must be seen regularly during periods of rapid weight loss for signs of malnutrition, anemia or other related complications. CAUTION: Anti- inflammatory agents, which may irritate the stomach, such as aspirin and non-steroidal anti- inflammatory drugs, should be used with caution. The use of such medications may be associated with an increased risk of erosion. CAUTION: Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands. CAUTION: All patients should have their reproductive areas shielded during radiography. CAUTION: Insufficient weight loss may be caused by pouch enlargement or more infrequently band erosion, in which case further inflation of the band would not be appropriate. CAUTION: Elevated homocysteine levels have been found in patients actively losing weight after obesity surgery. Supplemental folate and vitamin B12 may be necessary to maintain normal homocysteine levels. Elevated homocysteine levels may increase cardiovascular risk and the risk of neural tube abnormalities. CAUTION: Although there have been no reports of autoimmune disease with the use of the LAP-BAND System autoimmune diseases, connective tissue disorders (i.e., systemic lupus erythematosus, scleroderma) have been reported following long-term implantation of other silicone devices. These conditions have primarily been hypothesized to be associated with silicone breast implants. There is currently no conclusive clinical evidence to substantiate a relationship between connective-tissue disorders and silicone implants. Definitive long-term epidemiological studies to further evaluate this possible association are currently underway. However, the surgeon should be aware that if autoimmune symptoms develop following 6 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 6 of 25 CoalleCti011 Whiny Summary of Safety and Effectiveness Data LAP-RAND® System (P000008) implantation, definitive treatment and/or band removal may be indicated. Likewise, patients who exhibit preexisting autoimmunc symptoms should be carefully evaluated prior to implantation of the LAP-BAND System and may not be appropriate candidates (see Contraindications). V DEVICE DESCRIPTION The LAP-BAND System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption (restrictive rather than malabsorption). The device is surgically implanted. using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components (Figure 1) of the device are the silicone elastomer band. the access port and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site). The access port is placed in or on the rectus muscle to permit non-surgical, percutaneous adjustme nts to the band and thus, the stoma diameter, using sterile saline. Figure 1: LAP-BAND SYSTEM Access port (reservoir) Gastric band The LAP-BAND Atijastable Gastric Banding System The implantable components of the LAP-BAND System: Adjustable Gastric Band — a 13mm-wide, sterile, band which, when fastened, forms a circular ring. Two sizes are available: 9.75cm and 10.00cm inner circumference. Each size transitions to a length of kink-resistant tubing which is 50cm in length. The band's slip- through buckle facilitates laparoscopic placement around the stomach resulting in the formation of a small gastric pouch and stoma. Access Port — a stainless steel component with a self-sealing injection site. This sterile port is designed to allow for post-operative percutaneous adjustment in the stoma diameter. The port is attached to the inner surface of the gastric band by the kink-resistant tubing. Saline can be injected into the access port causing the inner surface of the band to inflate and thus decreasing the size of the stoma. Saline can also be removed from the LAP-BAND causing the band to deflate and increasing the size of the stoma. The access port is available in two 7 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 7 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) sizes (1.2" and 0.98" diameter). The larger diameter port is a component of the LAP-BAND System while the smaller port is available as a replacement component. Kink-Resistant Tubing— a 50cm silicone tube (I.D. 0.5", O.D. 0.13") which connects the inner surface of the gastric band to the access port. Other components used during the implantation procedure of the LAP-BAND System include: Calibration Tube Assembly — a 157cm dual lumen, translucent, silicone tube with a 13mm- diameter sensor tip and an inflatable balloon attached to its distal end. The device is inserted into the patient's esophagus intraoperatively and used to position and size the stoma of the gastric pouch. The calibration tube is supplied with the system and is provided clean, non- sterile, and for single use. The balloon is inflated via an inflation port, which is connected to the calibration tube's smaller lumen and remains external during the procedure. Silicone End Plug with Stainless Steel Connector— used to temporarily seal the System while the band is being positioned around the stomach. The end plugs are then removed and the other components of the system connected. LAP-BAND Closure Tool (non-sterile, multiple use) — reusable laparoscopic surgical instrument measuring 50cm in length and with a diameter of lOmm. It is designed specifically for use when placing the LAP-BAND. The closure tool is used for "locking" the LAP-BAND in place around the patient's stomach. It is designed for autoclave re- sterilization. Blunt tip flushing needles — provided to facilitate preparation of the System by operating room personnel prior to surgery. The 16 gauge band priming needle is used to flush and prime the band tubing and inflatable shell with sterile saline. The 22 gauge access port flushing needle is used to flush and prime the access port with sterile saline. Access Port Needle — a 20-gauge, 89mm long, non-coring, deflected-tip needle designed to penetrate the access port during postoperative adjustment of the band. Access port needles are provided sterile and are also available separately. VI ALTERNATIVE PRACTICES AND PROCEDURES Alternative practices and procedures available for the treatment of severe obesity (body mass index of greater than 35 kg/m) can be divided into two categories, non-surgical treatments and obesity surgery. Non-Surgical Treatments (Medical Therapy) Non-surgical treatments of obesity include • diet, exercise, and behavior modification programs; • prescription weight loss medications; and 8 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 8 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) • other procedures and practices, such as jaw-wiring, hypnosis, counseling, psychotherapy, nutritional supplements, etc. Several reports have suggested a rather high incidence of failure for severely obese patients to sustain long-term weight loss with any form of non-surgical treatment'. 2 Obesity Surgery Numerous surgical techniques have been developed for the treatment of severe obesity. The most common obesity surgery procedures performed in the United States are the Roux-en-Y Gastric Bypass and the Vertical Banded Gastroplasty. Roux-en-Y Gastric Bypass (GBP) GBP is the most common of the restrictive-malabsorptive procedures. These procedures are considered to be restrictive (a small gastric pouch restricting the amount of food consumed) as well as having a malabsorptive component (bypassing some part of the intestines). In the GBP, the surgeon constructs a proximal gastric pouch, and then creates an outlet from the pouch to a limb of the small bowel. This results in a bypass of most of the stomach and duodenum. Vertical Banded Gastroplasty (VBG) VBG is one of a group of restrictive obesity procedures which decrease the amount of solid food a patient is able to ingest. Rows of staples are used to create a small stomach pouch along the lesser curvature of the stomach. The pouch outlet (stoma) is reinforced with a copolymer band or silicone ring placed through a hole in the stomach. VII MARKETING HISTORY The LAP-BAND® System has been in use in Europe since 1993. In 1997, the BioEnterics Corporation LAP-BAND® System was CE-marked. Regulatory approval has also been obtained in Australia (1994), Canada (1998), Israel (1997), Mexico (1996) and other countries. No regulatory approvals have been withdrawn. Over 50,000 LAP-BAND® Systems have been distributed internationally and it has been widely reported on in the medical literature. VIII POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH Adverse events that may result from use of the LAP-BAND System are both those commonly associated with obesity surgical procedures and others associated with the device specifically. Potential adverse events include perforation of the stomach and complications associated with laparoscopic surgery (e.g., spleen or liver damage, thrombosis and rupture of the wound, infection, and death). Other risks reported after gastric restriction procedures include ulceration, gastritis, gastroesophageal reflux, gas bloat, dysphagia, dehydration, constipation, nausea and vomiting, and weight regain. Elevated homocysteine levels have been found in patients actively losing weight after obesity surgery and may increase cardiovascular risk. In addition, the developing fetus of pregnant women with elevated homocysteine may be at risk for neural tube defects. During periods of rapid weight loss 9 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 9 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) patients may experience malnutrition, anemia or other related complications, such as the development of cholelithiasis. Risks associated specifically with the LAP-BAND System are the possibility of intolerance to the components (foreign body reaction), mechanical malfunction (leakage and deflation of the inflatable section), access port site pain and access port displacement, band slippage/pouch dilatation, band erosion, gastric or esophageal perforation, stoma obstruction, and esophageal dilatation/dysmotility. Peritonitis and death can occur either as a consequence of a gastrointestinal perforation during implantation of the device or as a result of erosion of the gastric band. The LAP-BAND System is a long-term implant and the System or a component may need to be either explanted or replaced. In addition, medical management of adverse events may necessitate reoperation to revise or explant the device. As with any revision procedure, the possibility of complications such as erosion and infection are increased. In the LAP-BAND System U.S. clinical trial, 266 of 299 (89%) subjects reported at least one adverse event. Peri-operative adverse events were reported in 44% of the study subjects. The most commonly reported peri-operative adverse events were abdominal pain and nausea and/or vomiting. Eighty-two percent (82%) of subjects reported having one or more adverse events during the post-operative period. The most commonly reported adverse events in the post-operative period were nausea and/or vomiting, gastroesophageal reflux, and band slippage/pouch dilatation. The most frequently reported adverse events (occurring with a frequency of .5%) are shown in Table 6. Many adverse events were mild and required no intervention. Serious and severe adverse events were most commonly addressed either by band adjustment or by reoperation to revise, replace or remove either a component or the entire LAP-BAND System. IX SUMMARY OF PRE•CLINICAL STUDIES Testing of product samples was performed on the various components of the LAP-BAND® System to ensure the product performed according to product specifications. Testing was performed to evaluate all levels of the manufacturing process (i.e., raw materials used to fabricate the device, components from which the device is assembled, the finished device, the device's packaging, sterilization process of the device, and product shelf life performance). Laparoscopic placement of the LAP-BAND® System was evaluated and demonstrated as feasible in a series of procedures in pigs in 1993. Physical Testing LAP-BAND® System component mechanical testing was performed for all components. This data demonstrated that the components met design specifications and intended use. These components were subjected to dimensional and visual inspection as well as to break force and tensile strength testing. The finished assemblies were packaged and subjected to thy heat sterilization prior to testing. Testing included the following: • Fill Tube Patency and Shell Inflation • Laparoscopic Device Insertion 10 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 10 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) • Belt Head Insertion Force • Shell Crease Fill Volume • Shell Burst Volume • Locked Buckle and Belt Head Tensile Strength • Tear Strength of Punched Buckle Tab Hole • Tensile Strength of Adhesive Bond of the Buckle • Tensile Strength of Adhesive Bond of the Belt • Tubing/Belt Bond Pull Test • Tubing Kink Resistance • End-Plug Pullout force • Access Port Multiple Puncture and Over-Pressurization • Access Port Assembly Fatigue Testing Data from these tests demonstrated that finished devices meet the requirements and specifications for functionality as established in the LAP-BAND® System product specification. Biocompatibility Testing The materials and components of the LAP-BAND® System (including the Access Port, Tubing Connector, the Calibration Tube, Access Port Needle, and End Plug) that contact the patient are fabricated primarily from silicone elastomers and polymers. All patient- contacting materials have been evaluated and tested for biocompatibility and toxicity. The materials used to fabricate the components in contact with the body were tested and evaluated for biocompatibility per ISO 10993-1, "Biological Evaluation of Medical Devices, Part 1: Guidance on Selection of Tests." The tests were carried out in compliance with 21 CFR Part 58 Good Laboratory Practice Regulations. Materials used in the LAP-BAND° System included silicone elastomers, polysulfone, titanium and stainless steel. These materials have also been tsed in other medical device applications. Biocompatibility test results demonstrated that sterilized finished devices met the acceptance criteria for each of the tests. Packaging and Sterilization Dry heat sterilization was validated to provide a sterility assurance level (SAL) of Ie. Studies demonstrated that the packaging system maintains the sterile barrier and the devices remain sterile after being stored on the shelf for up to two years. Real-time shelf life testing has been conducted; the LAP-BAND System has a two-year shelf life. Package qualification testing consists of three phases of evaluation: physical testing of the heat seals, functionality testing of the LAP-BAND assembly and calibration tube, and sterility testing of the device. The LAP-BAND°Closure Tool, a reusable surgical instrument, is provided non-sterile and designed to be used in the surgical procedure for band closure. The procedures for cleaning and sterilizing this instrument have been validated and met acceptance criteria. 11 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 11 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) X SUMMARY OF CLINICAL STUDIES Objectives: A clinical study was conducted within the United States under a significant risk Investigational Device Exemption (IDE) to assess the safety and effectiveness of the LAP- BAND System in the treatment of severe obesity. Study design: The clinical study was a prospective, multi-center, single-arm trial in which each subject served as his or her own control. Subjects were implanted with the LAP-BAND System at 8 clinical sites within the United States beginning in April 1995. The last subject was implanted in June 1998. A total of 299 subjects were enrolled in the study and 292 were implanted with the device. Seven subjects had previously been implanted with an earlier version of the device, the Adjustable Silicone Gastric Band (ASGB), and were not included in the study except for safety analyses of adverse events. Follow-up evaluations were conducted at 3 weeks, and 3, 6, 9, 12, 18, 24, 30 and 36 months post- implantation. Evaluation of the safety and effectiveness of the LAP-BAND System was based on 36-month evaluation of the following clinical endpoints: Effectiveness: 1. percent excess weight loss (%EWL) defined as weight loss divided by baseline excess weight. Excess weight was determined from ideal body weights based on sex and height- adjusted weight for a medium frame according to 1983 Metropolitan Life tables. 2. absolute weight loss 3. change in excess weight 4. change in BMI 5. change in quality of life (based on Beck Depression Index, the Multi-Dimensional Body- Self Relations Questionnaire (MBSR) questionnaire, and the RAND SF-36 questionnaire) Safety: Incidence and severity of complications (device and non-device related) Patient Selection: The inclusion criteria for study enrollment included: 1. age 18-55 2. male or female 3. BMI > 40 or at least 100 pounds above ideal weight according to the 1983 Metropolitan Life Insurance Tables (medium frame) 4. willingness to comply with the substantial lifelong dietary restrictions required by the procedure 5. history of obesity for at least 5 years 6. history of failure with non-surgical weight loss methods 7. willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing quality of life questionnaires, completing 12 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 12 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) laboratory tests, completing diet and behavior modification counseling 8. residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow-up visits The exclusion criteria were: 1. surgery or treatment represents an unreasonable risk to the subject 2. family or patient history of inflammatory disease of the gastrointestinal tract (including ulceration, duodenal ulceration, Grade 2-4 esophagitis, or specific inflammation such as Crohn's disease or ulcerative colitis) 3. severe cardiopulmonary disease or other serious organic disease 4. severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia 5. congenital or acquired anomalies of the GI tract such as atresias or stenoses 6. severe hiatal hernia 7. pregnant or has the intention of becoming pregnant in the next 12 months 8. alcohol or drug addiction 9. mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for gastric band surgery 10. previous bariatric surgery (except Adjustable Silicone Gastric Band), intestinal obstruction or adhesive peritonitis 11. infection anywhere in the body at the time ofsurgery 12. family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder 13 participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the LAGB clinical trial Only those patients satisfying the inclusion and exclusion criteria were allowed to participate. All patients signed an informed consent prior to being enrolled in the clinical trial. Demographic Data: A total of 247 women (85%) and 45 men (15%) met the inclusion criteria and were implanted with the LAP-BAND device. The majority of patients enrolled were Caucasian (81%), while African-Americans comprised 15% of the study population and Hispanics 4%. Almost half the patients enrolled had hypertension as a comorbidity (43%). Other comorbidities included gallbladder disease (26%), gastrointestinal diseases (24%), asthma (16%), and diabetes mellitus (16%). The average age at time of surgery was 38.8 years (range of 18-56). The average weight at baseline was 293 pounds (range of 193-475) and the average BMI at baseline was 47.4 (range of 36.6-74.3). Thirty subjects had a BMI over 50 at entry. Patients had gained an average of 54 pounds in the 5 years prior to enrollment. 13 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 13 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) Device Implantation: Patients enrolled in the study underwent implantation of the LAP-BAND System. The band was left empty or minimally inflated at the completion of the surgery. The first post- operative band adjustment occurred no sooner than 4-6 weeks, allowing a fibrous capsule to form around the band (helping to avoid slippage). At the initial adjustment, 1-2cc of normal saline was added. The majority of subjects had the device placed laparoscopically (259 patients or 89%). Thirty-three subjects had the device implanted using an open procedure. Twenty of these 33 subjects were scheduled for the open procedure while the remaining 13 patients (5%) were converted from a laparoscopic attempt to open surgery during implantation. The reason for conversions included difficult anatomy, concomitant surgery, bleeding, and technical problems. The average hospital length-of-stay for patients was 1.6 days if performed laparoscopically and 4.4 days if done by open surgery. Mean surgery time was 178 minutes for laparoscopically placed devices and 166 minutes for open procedures. Study Results: Patient Accountability Two hundred and ninety-nine subjects were enrolled into the study. The last subject was enrolled in June 1998. Thirty-six month follow-up data were available for 178 subjects. The remaining 121 subjects were subdivided into 4 groups as shown in Figure 2 below. Seven (7) subjects had been previously implanted with the Adjustable Silicone Gastric Band (ASGB) and were included only in the safety analysis, 46 subjects had the device explanted, 12 subjects were lost to follow-up and 56 subjects either missed or had not yet reached the 36 month follow-up visit. Figure 2: Patient Accountability — 36 months Patients Enrolled N=299 36 Month Visit Not Completed N= 121 36 Month Visit Complete N=178 ASGB Patients N=7 Lost to follow- up N=12 Explanted N=46 Data not available N=56 14 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 14 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) Primary Effectiveness Endpoint: The primary endpoint for the U.S. clinical trial was percent excess weight loss (defined as [baseline wt - measured wt at the given timepoint]/[baseline wt - ideal body wt]). Data representing %EWL is presented in Table 1 below: Table 1: %EWL by Visit Visit N Mean SD Median Range 95% Confidence Interval 3 Weeks 184 _ 9.9 5.0 9.8 -8.1 - 30.3 9.2 - 10.6 3 Months 245 18.4 10.0 17.6 -13.5 - 49.0 17.2 - 19.7 6 Months 233 26.5 13.8 25.9 -10.3 - 70.0 24.7 - 28.2 9 Months 185 _ 30.8 17.1 29.1 -14.9 - 72.5 28.4 - 33.3 12 Months 233 34.5 19.0 32.0 -9.0 - 89.3 32.1 - 37.0 18 Months 190 36.4 20.4 33.7 -14.4 - 93.1 33.5 - 39.3 24 Months 189 37.8 22.5 34.7 -16.8 - 102.7 34.6 - 41.0 30 Months 148 37.9 22.9 34.8 -15.5 - 99.3 34.2 - 41.6 36 Months 178 36.2 24.6 34.0 -9.8 - 113.0 32.6 - 39.8 The %EWL increased between 3 weeks and 18 months and then remained relatively stable between 18 and 36 months. Patients who reached 36 months of follow-up were able to lose, on average, 36% of their excess body weight. It should be noted that by 3 weeks after implantation, before the first post-operative band adjustment, patients had lost an average of 10% of their excess body weight. The reason for this is not known. Although not shown in Table 1, there were no significant differences in %EWL noted based on age, gender, or race. Table 2 depicts the number and percentage of patients who were able to achieve certain benchmark changes in %EWL: Table 2: Percentage of Subjects with Subsets of %EWL Excess weight loss at 3 years % # patients Gained more than 5% EWL 2% 4 No change 5% EWL 5% 9 Lost at least 25% EWL 62% 110 Lost at least 33% EWL 52% 93 Lost at least 50% EWL 22% 39 Lost at least 75% EWL 10% 18 Table 2 shows that for those patients successfully completing 36 months of follow-up (178 patients), 22% were able to lose ?_50% of their excess body weight and an additional 40% lost at least 25% of their excess body weight. Five percent of patients had minimal or no (±5%EWL) change in excess body weight and 2% gained more than 5% of their original excess body weight. Ten percent of patients lost at least 75% of their excess body weight. 15 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 15 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) Secondary Effectiveness Endpoints: Other study endpoints included absolute weight loss and change in BMI. These results are depicted respectively in Tables 3 and 4 below: Table 3: Mean Weight by Visit (in sounds Visit N Mean SD - Median - Range 95% Confidence Intervals Baseline 288 293.5 53.8 282.8 193.0 - 475.0 287.3 - 299.7 3 Weeks 184 278.8 52.2 267.2 185.4 - 446.0 271.3 - 286.3 _ 3 Months 245 266.2 49.6 257.5 169.3 - 437.0 260.0 - 272.4 6 Months 233 254.5 _ 51.5 244.5 161.8 - 435.0 247.9 - 261.1 9 Months 185 250.6 54.5 240.3 152.0 - 411.5 242.8 - 258.4 12 Months 233 241.8 53.1 240.0 138.0 - 412.0 235.0 - 248.6 18 Months 190 240.5 51.4 236.0 139.0 - 396.5 233.2 - 247.9 24 Months 189 234.5 52.2 230.0 125.0 - 400.0 227.1 - 241.9 _ 30 Months 148 235.4 52.5 233.9 120.0 - 395.1 226.9 - 243.8 36 Months 178 240.6 55.1 239.5 113.0 - 405.6 232.5 - 248.7 Table 3 shows that for those patients completing 36 months of follow-up, the mean body weight decreased by 53 pounds, or 18% (293.5 to 240.6 pounds). Maximum mean weight loss (59 pounds), however, occurred at the 24 month point with a subsequent slight gain in weight between 24 and 36 months. Table 4: Mean BMI by Visit Visit N Mean SD Median Range 95% Confidence Intervals Baseline 288 47.5 7.0 45.8 36.6 - 74.3 46.7 - 48.3 3 Weeks 184 45.1 6.9 43.8 33.5 - 70.6 44.1 - 46.1 3 Months 245 43.2 7.1 41.6 30.9 - 68.1 42.3 - 44.1 6 Months 233 41.2 7.3 40.0 26.5 - 67.8 40.3 -42.1 _ 9 Months 185 40.4 7.6 39.7 27.6 - 68.8 39.3 - 41.5 12 Months 233 39.0 7.3 38.3 24.6 - 67.9 38.1 - 40.0 _ 18 Months 190 38.7 7.1 38.7 23.3 - 65.4 37.7 - 39.7 24 Months 189 38.1 7.5 37.9 21.4 - 67.3 37.0 - 39.2 30 Months 148 38.1 7.1 38.7 23.3 - 60.7 37.0 - 39.3 36 Months 178 38.7 7.9 39.0 19.3 - 63.6 37.5 - 39.8 Patients enrolled in the study were required to have a BMI of .40 for implantation. The mean BMI at baseline was 47.5. As Table 4 above shows, the mean BMI decreased to 38.1 at 24 months and 38.7 at 36 months for those completing follow-up. This represents a 19% reduction in BMI for those patients by study's end. Changes in quality of life as measured by the Beck Depression Index, Multi- Dimensional Body-Self Relations Questionnaire (MBSR) and the RAND SF-36 scales are depicted in Table 5 below: 16 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 16 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) Table 5: Quality of Life by Visit Scale Basel'ne (n=282) 36 months (n=145) Mean SD Mean SD _ Beck Depression Index 13.5 8.5 7.0 8.3 MBSR Appearance Evaluation 1.9 0.6 2.7 0.9 RAND SF-36 Physical function 49.1 24.5 76.1 25.9 Role Limit: Physical 39.1 40.6 78.8 35.9 Role Limit: Emotional Energy/Fatigue Emotional Well-Being Social Function 60.6 37.1 65.2 57.4 40.3 21.0 18.6 27.3 78.2 58.1 71.9 81.2 34.6 21.6 20.2 24.3 Pain 58.2 25.4 78.6 24.7 General Health Mental Health Composite Physical Health Composite 52.4 44.5 23.6 23.0 11.0 8.5 71.6 48.6 31.4 19.7 10.1 7.6 Table 5 shows that for patients completing Quality of Life questionnaires at 36 months, there was an improvement in mean scores for all categories measured. Safety and Adverse Events: During the course of the US clinical study, 266 (89%) of the subjects enrolled reported at least one adverse event with 34% reported as being severe. Although signs and symptoms were recorded separately as individual adverse events, many of the events were associated with a "syndrome." For example, patients with band slippage/pouch dilatation may also have reported nausea, vomiting, and stoma obstruction. Adverse events were reported for the peri-operative period, 21 days post LAP-BAND implantation, or the post-operative period. The severity of each event was rated as mild, moderate or severe and then further rated as serious or not serious (Figure 3). These were defined as: Mild - symptom barely noticeable to the patient; does not affect performance or functioning. Prescription drugs not ordinarily needed for relief of symptom. Moderate - symptom of sufficient severity to make patient uncomfortable; performance of daily activities affected; patient is able to continue in study; treatment of symptoms is needed. Severe - symptom causes severe discomfort and may be of such severity that patient cannot perform daily activities. Severity may result in cessation of treatment or require removal of the device, or treatment of symptom may be given and/or patient hospitalized. Adverse events were reported as serious if considered to be life threatening, permanently disabling, unexpected, fatal, requiring hospitalization, or prolonged hospitalization. All 17 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 17 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) events categorized as serious in the US clinical study were associated with intervention that required hospitalization or prolonged hospitalization. Figure 3: Classification of Adverse Events Peri-Operative _I Study Period Post-Operative All Adverse Events Mild Serious Severity Moderate Not Serious Severe Adverse events occurring during the study with a frequency of greater than or equal to 5% are shown in the following table: 18 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 18 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) Table 6: All Adverse Events in the US Clinical Trial Occurring with Frequency.5% All Adverse Events (Mild, Moderate, Severe) (N=299) (1>_5%) Digestive N % Nausea and/or Vomiting 152 51 Gastroesophageal Reflux 103 34 Stoma Obstruction 41 14 Constipation 27 9 Dysphagia 26 9 Diarrhea 26 9 Abnormal Stools 18 6 Body as a Whole Abdominal Pain 80 27 Asthenia 25 8 Incisional Infection 21 7 Infection 20 7 Fever 18 6 Hernia 16 5 Pain 16 5 Chest Pain 15 5 Pain Incision 14 5 Band-Specific Band Slippage/Pouch Dilation 72 24 Esophageal di latation/dysmotility 29 10 _ Metabolic and Nutritional Healing Abnormal 23 8 Port-Specific Port Site Pain 26 9 Port Displacement 18 6 Skin and Appendages Alopecia 23 8 Peri-operative adverse events were reported in 44% of the study subjects. The most commonly reported peri-operative adverse events were abdominal pain (10%), nausea and/or vomiting (9%), asthenia (5%), and incisional infection (5%). Other peri-operative adverse events occurred in <5% of the subjects. Eighty-two percent of subjects reported having one or more adverse events during the post- operative period. The most commonly reported adverse events in the post-operative period were: nausea and/or vomiting (42%), gastroesophageal reflux (32%), band slippage/pouch dilatation (24%), abdominal pain (18%), stoma obstruction (14%), dysphagia (8%), alopecia (7%), esophageal dilatation (7%), diarrhea (6%), port site pain (6%), constipation (5%), port displacement (5%), infection (5%), hernia (5%), and constipation (5%). Other post-operative adverse events occurred in less than 5% of the subjects. 19 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 19 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) The severity of common adverse events (>5%) was also reported, (see Table 7 below). The last two columns in the table represent the total number and percentage of subjects who experienced at least one of the specified events. The severity scale represents the total number of events reported; one subject may have experienced a specific event more than once, and the percentage of all events were rated as mild, moderate, or severe. Table 7: Common Adverse Events (>5%) in the US Clinical Trial by Severi Severity Scale Adverse Event Mild (n*=299) Moderate (n=299) Severe (n=299) with at one Total subjects (n=299) n least event N ** % N % N % Nausea/Vomiting 128 77.6 32 19.4 5 3.0 152 51 GE Reflux 72 60.5 39 32.8 8 6.7 103 34 Abdominal pain 55 64.7 23 27.1 7 8.2 80' 27 Slippage/pouch dilatation 19 24.4 34 43.6 25 32.1 72 24 Stoma obstruction 6 14.6 18 43.9 17 41.5 41' 14 Dysphagia 14 50.0 11 39.3 3 10.7 27 9 Diarrhea _ 23 85.2 3 11.1 1 3.7 26 9 Constipation 20 76.9 6 23.1 0 0 27' 9 Alopecia 20 95.2 1 4.8 0 0 234 8 Abnormal stool 18 100 0 0 0 0 18 6 Esophageal dilatatioritlysmotility 7 30.4 8 34.8 8 34.8 29' 9.7 Port displacement 5 31.25 9 56.25 2 12.5 18° 6 Port site pain 19 73.1 6 23.1 1 3.8 26 - 9 Incision infection 11 50.0 7 31.8 4 18.2 21 7 Infection 9 40.9 10 45.5 3 13.6 20 7 * n=number of subjects 1 severity not reported for 17 events 3 1 Subject with no severity 5 Severity not reported for 9 events **N=number of events 2 Severity not reported for 11 events 2 subjects with no severity 6 2 Subjects with no severity Some of the commonly reported events associated with the device necessitated revision in some subjects. Surgery may have been required to revise, replace or remove any or all components of the device. The most commonly reported events included: Band slippage and/or pouch dilatation (BS/PD) - 72 subjects (24%) reported 78 events of band slippage/pouch dilatation Band slippage refers to slippage of the stomach up through the band rather than slippage of the band down lower on the stomach. This results in an increase in the proximal pouch and a difference in the relative position of the band from where it was implanted. Slippage most commonly involves the posterior gastric wall, but can include any portion of the stomach. 20 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 20 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) Slippage and pouch dilatation are reported together due to the fact that pouch dilatation can result from band slippage or it may develop independently, and there is no standard for distinguishing between the two events. The consequences of band slippage varied from subject to subject. In some cases, slippage was documented after radiological inspection of the band position. If subjects showed no symptoms of slippage, often no intervention was deemed necessary or the adjustment of the stoma was sufficient to resolve these asymptomatic findings. Signs and symptoms reported in association with band slippage included abdominal pain, nausea and/or vomiting, gastroesophageal reflux, dysphagia, and gastric obstruction. For the 56 events reported as "resolved," 52% of the subjects recovered after stoma adjustment or no intervention, while 48% underwent reoperation, either revision, replacement, or explantation of the device. Stoma obstruction— Forty-one subjects (14%) in the US clinical trial experienced 52 events of stoma obstruction. Ten patients reported multiple episodes. Signs and symptoms associated with stoma obstruction included band slippage, asthenia, epigastric pain, nausea and vomiting, gastroesophageal reflux, dehydration and hypokalemia (secondary to vomiting). Fifty-six percent (23/41) of the subjects recovered after stoma adjustment or no intervention; 39% (16/41) of the events required surgery (7% revision or replacement and 32% band removal), and in 5% (2/41), the method of resolution was not reported. Stoma obstruction and the band slippage/pouch dilatation that may be associated with it were the most common causes of LAP-BAND System reoperations. Abdominal pain — Eighty subjects (27%) reported 102 events of abdominal pain. Abdominal pain often accompanied other events such as dysphagia, gastroesophageal reflux, or nausea and vomiting. Dywhagia — was reported in 26 (9%) of subjects. It was most commonly associated with, or related to, stomach/band slippage, stoma obstruction, or nausea and/or vomiting. Esophageal dilatation/dvsmotilitv — Twenty nine subjects (10%) reported 32 events of either esophageal dilation (21), dysmotility (8) or both (3). Esophageal dilatation may be a consequence of incorrect band placement, over-restriction, stoma obstruction, or excess vomiting. Twenty of the events occurred at one site and were believed to be related to band over-inflation. Although most events appeared to resolve with deflation of the band, the long term consequences of this event are not known. Port site pain— Twenty-six subjects (9%) reported port site pain. Seven were reported in the peri-operative period, 18 in the post: operative period, and one in both 21 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 21 of 25 Summary of Safety and Effectiveness Data LAP-BAND System (P000008) the peri- and post-operative periods. Port displacement — was reported in 18 subjects (6%). In several of the events the port was suspected on x-ray of being displaced but was found not to have been displaced on further examination. Serious adverse events reported with a frequency of less the 5% are presented below. Except for the 2 reported deaths, these events always required surgery to remove, replace or revise the device. Deaths — Two deaths occurred during the course of the study. One subject died from "mixed drug intoxication" one week after explantation. A second patient died one day after explantation of the LAP-BAND and conversion to a Roux-en-Y. Death was due to multiple pulmonary emboli. Neither death is believed to have been device- related. Erosions — Four subjects (1%) experienced an erosion of the band into the gastric lumen. Two of the erosions were considered to have been secondary to intra- operative gastric perforations. All erosions resolved with explantation of the device. Mechanical malfunctions — Eight subjects (3%) reported port leakage. The leakage was associated with either cracking of the kink-resistant tubing or disruption of the tubing connection from the port to the band. All of the events resolved after replacement of the port and/or port tubing. In addition, two subjects (0.7%) reported band leakage. One was reported to be due to a leak from a puncture through the thickness of the shell and the other was noted to have resulted from two small holes through the shell. In addition, there were two reports of malfunction (irregular inflation) of the calibration tube and one report of breakage of the luer- lock connector end of the calibration tube. Reoperations — Revisions, Replacements, and Explants Twenty-six subjects (9%) underwent 27 surgical revisions involving the gastric band; one subject had two separate procedures. In 9 of the 27 procedures the band was removed and replaced during a single surgical procedure. Two subjects were reimplanted with a new band during a separate surgical procedure. In 16 of the 27 revision procedures the gastric band was not removed. Most revisions were to correct band slippage/pouch dilatation. Thirteen of the procedures (48%) were completed laparoscopically. There were twenty-six revisions involving the access port. Thirteen access ports were removed and replaced due to tubing leaks at or near the tubing connections to the port (8/13), port displacement (1/13), or infection (4/13). Nine of these were replaced during the same surgical procedure. The four access ports explanted due to infection were reimplanted at a later time. An additional 13 access ports required revision but did not require removal of the port. The port was repositioned and/or re-sutured in place to correct either misalignment or 22 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 22 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) movement which resulted in an inability to access the port (9/13), pain associated with movement (3/13), or associated infection (1/13). A total of 46 subjects (15%) underwent 48 device explantations within 3 years of implantation An additional twenty-seven subjects (9%) had the band explanted after the 3 year study period. Fifty-one of the 75 explants (68%) were due to complications, primarily band slippage/pouch dilatation and/or obstruction 32% (24/75). Other adverse events cited for explantation of the band included erosion 5% (4/75), infection 4% (3/75), gastroesophageal reflux and/or dysphagia 11% (8/75), system leaks 4% (3/75), and esophageal dilatation or dysmotility 7% (5/75). In the other 24 subjects (32%), insufficient weight loss was cited as the reason for explantation. In 45 subjects (60%) the explant procedure was performed laparoscopically. Approximately one-half of the explained patients (37) were converted to a gastric bypass, 3 subjects were converted to a vertical banded gastrosplasty, and 35 subjects had the system removed with no other obesity surgery. Nineteen of the subjects had their obesity surgical procedure (e.g., gastric bypass) performed at the same time that the study device was removed. Adhesions — Forty-two percent (42%) of those patients undergoing a revision procedure were reported to have developed adhesions involving the stomach. The exact incidence of adhesions is not known, as many of the implanted patients did not undergo re-operation. XI CONCLUSIONS DRAWN FROM THE STUDIES The pre-clinical and clinical data provide reasonable assurance of the safety and effectiveness of the LAP-BANDS System for use in weight reduction for severely obese patients, when the system is used in accordance with its labeling. Results from the pivotal U.S. clinical trial indicate that, for those subjects who were able to complete 36 months of follow-up, a mean excess weight loss (EWL) of 36% and mean overall weight loss of 18% were achieved. Over half of these subjects (62%) lost more than 25% of their excess weight and 22% were able to lose more than 50% of their excess weight. Mean BMI decreased by 19% over the same period of time for these subjects. In addition, quality of life measures showed general improvement for subjects at 3 years. A majority of the subjects implanted (89%) experienced at least one device-related adverse event. The most common events were nausea/vomiting (51%), gastroesophageal reflux symptoms (34%), abdominal pain (27%), and band slippage/pouch dilatation (24%). Twenty-six (26) of the 292 subjects originally implanted (9%) required surgical device revision and 46 (16%) required device explantation within 3 years of implantation The indications for these re-operations included band slippage/pouch dilatation, GERD/dysphagia, esophageal dilatation, band erosion and component leakage. Site-to-Site Variation Some site-to-site variations in effectiveness and especially in safety were observed in the U.S. Clinical Study. Experience with advanced laparoscopic procedures, attitudes regarding restrictive bariatric procedures, and patient management and support practices were factors. For example, one site reported the majority of esophageal dilatations, which upon review 23 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 23 of 25 Summary of Safety and Effectiveness Data LAP-BAND System (P000008) ... appeared to be related to a difference in postoperative management. No centers performed more than an average of two to three procedures a month. This limited and infrequent experience would be expected to cause and did cause a protracted learning curve in both laparoscopic placement and patient management, resulting in a higher incidence of adverse events and reoperations than reported in the published literature by surgeons with more experience. XII PANEL RECOMMENDATION The Gastroenterology and Urology Devices Panel met on June 19, 2000, to consider the safety and effectiveness of the BioEnterics Corporation LAP-BAND Adjustable Gastric Banding (LAGB) System. The Panel voted six to four to recommend that the Center for Devices and Radiological Health (CDRH) not approve the PMA for the LAP-BAND System. They believed that 2 years of follow-up data was not adequate and they recommended at least 3 years of follow-up prior to approval. The study protocol for the U.S. clinical study called for 3 years of patient follow-up. XIII CDRH DECISION CDRH agreed with the advisory panel recommendation and sent a major deficiency letter on August 7, 2000, detailing the data and information that was still needed. In addition to the 3 years of patient follow-up, recommendations concerned the labeling and a post-approval study. The applicant continued its clinical study and on December 26, 2000, amended the PMA. After review of the additional information, CDRH determined that there is sufficient safety and effectiveness data to approve the LAP-BAND Adjustable Gastric Banding System. The sponsor submitted revised labeling and an outline for the post-approval study via email and fax. In the post approval study the subjects enrolled in the U.S. clinical trial will continue to be followed for a total of five years post implantation. The purpose of the post-approval study is to obtain additional information on excess weight loss, and adverse events, primarily esophageal dilatation and band erosion. Subjects will have continued follow-up for 5 years post-implantation. XIV APPROVAL SPECIFICATIONS Directions for Use: See attached Physician Labeling Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings, Precautions, and Adverse Events from labeling. Patient Information: A Surgical Aid in the Treatment of Morbid Obesity — LAP-BAND Adjustable Gastric Banding System Information for Patients Post-approval Requirements and Restrictions: See approval order. 24 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 24 of 25 Summary of Safety and Effectiveness Data LAP-BAND® System (P000008) Training Program Surgeon participation in a training program authorized by BioEnterics or by an authorized BioEnterics distributor is required prior to use of the LAP-BAND System. XV REFERENCES 1. National Institutes of Health Technology Assessment Conference Panel. Methods for Voluntary Weight Loss and Control. Ann Intern Med. 1993; 119(7):764-770. 2. National Task Force on the Prevention and Treatment of Obesity. Long-term Pharmacotherapy in the Management of Obesity. JAMA 1996; 276(23):1907-1915. 25 Case 1:16-cv-00901-LJV Document 3-3 Filed 11/16/16 Page 25 of 25 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF NEW YORK FRANCES MOODY, Plaintiff, - vs - ALLERGAN USA, INC., Defendant. Civil Action No. 16-cv-901 Hon. Lawrence J. Vilardo, U.S.D.J. ______________________________________________________________________________ MEMORANDUM OF LAW IN SUPPORT OF DEFENDANT ALLERGAN USA, INC.’S MOTION TO DISMISS ______________________________________________________________________________ Vivian M. Quinn, Esq. NIXON PEABODY LLP 40 Fountain Plaza, Suite 500 Buffalo, New York 14202 Telephone: (716) 853-8100 Email: vquinn@nixonpeabody.com Attorneys for Defendant Allergan USA, Inc. ON THE BRIEF: Robert J. McGuirl, Esq. (admission pending) James C. Suozzo, Esq. (“) Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 1 of 32 TABLE OF CONTENTS TABLE OF AUTHORITIES ………………………………………….…………………...……..ii PROCEDURAL HISTORY AND PRELIMINARY STATEMENT ………………………...…..1 STATEMENT OF FACTS .……………………………………………………………..………..1 ARGUMENT AND CITATION TO AUTHORITY …….…………………….…………..……..5 INTRODUCTION AND JUDICIAL NOTICE…………………………………….…..…5 POINT I: COMMON LAW CLAIMS ARE BARRED BY THE PREEMPTION PROVISION OF THE MEDICAL DEVICE AMENDMENTS OF 1976 ………………………………………………………………………………..…6 POINT II: APPLYING THE TWO-STEP ANALYSIS TO THIS CASE INVOLVING AN APPROVED LAP-BAND® DEVICE, PLAINTIFF’S COMMON LAW CLAIMS ARE PREEMPTED ………………………………..…..…10 1. The FDA Has Established Regulations and Requirements Applicable to the LAP-BAND® …………………………………………………………...….... 10 2. The State Claims Here Are Different From and In Addition to the FDA Requirements ………………………………….……………..11 a. State tort claims are requirements ……………………………………...…….11 b. The requirements imposed by Plaintiff’s state court claims are different from or in addition to the requirements imposed by the federal government via the PMA for the LAP-BAND® System………….….11 POINT III: STATUTORY INTERPRETATION IS A JUDICIAL FUNCTION AND A RULING ON PREEMPTION CAN BE MADE AS A MATTER OF LAW WITHOUT DISCOVERY ………………………………………………………………25 CONCLUSION ...……………………………………………...…………………………….…..25 Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 2 of 32 TABLE OF AUTHORITIES CASES Ambrosio v. Barnes-Hind, Inc. 211 A.D.2d 70 (3d Dept. 1995)………………………..………………………………..11 Anderson v. Hedstrom Corp. 76 F. Supp.2d 422 (S.D.N.Y. 1999) …..……………………………………..…………15 Ashcroft v. Iqbal 556 U.S. 662 (2009) ……………………………………………..6, 12, 13, 15, 17, 19, 24 ATSI Communications, Inc. v. Shaar Fund, Ltd. 493 F.3d 87 (2d Cir. 2007) ……………………………………………………………..…5 Bass v. Stryker Corp. 669 F.3d 501 (5th Cir. 2012) .…………………………………………………….…10, 25 Bates v. Dow Agrosciences LLC 544 U.S. 431 (2005) ……………………………………………..………………………23 Bell Atlantic Corp. v. Twombly 550 U.S. 544 (2007) ……………….………………………………5, 6, 12, 13, 15, 19, 23 Bryant v. Medtronic, Inc. 623 F.3d 1200 (8th Cir. 2010) ...……………………………………………….………..22 Buckman Co. v. Plaintiffs’ Legal Comm. 531 U.S. 341 (2001) ………………………………………………………………5, 21, 22 Cipollone v. Liggett Group, Inc. 505 U.S. 504 (1992) .…………………………………………………..……………….7, 9 Colon v. BIC USA, Inc. 199 F. Supp.2d 53 (S.D.N.Y. 2001) ..…………………………………………….…12, 19 Desabio v. Howmedica Osteonics Corp. 817 F. Supp.2d 197 (W.D.N.Y. 2011) ……………………………………………..20, 21 Gale v. Smith & Nephew, Inc. 989 F. Supp. 2d 243 (S.D.N.Y. 2013) …….……………………………………….……18 Geier v. American Honda Motor Co. 529 U.S. 861 (2000) …………………………………………………………………..…21 ii Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 3 of 32 Gelber v. Stryker Corp. 788 F. Supp.2d 145 (S.D.N.Y. 2011) ………………………………………….……17, 22 Goodlin v. Medtronic, Inc. 167 F.3d 1367 (11th Cir. 1999) ……………………………………………………..……8 Hillsborough County, Fla. v. Automated Med. Labs., Inc. 471 U.S. 707 (1985) ………………………………………………………………………7 Horn v. Thoratec 376 F.3d 163 (3d Cir. 2004) …………………………………………………….………...8 Horowitz v. Stryker Corp. 613 F. Supp.2d 271 (E.D.N.Y. 2009) …...…………………...…..….12, 13, 16, 18, 19, 25 Ilarraza v. Medtronic, Inc. 677 F. Supp.2d 582 (E.D.N.Y. 2009) ...…………………………………………………21 Kemp v. Medtronic, Inc. 31 F.3d 216 (6th Cir. 2000) ……………………………………………………………....8 Levine v. Landy 832 F. Supp.2d 176 (N.D.N.Y. 2011) ……….…………………………………………..23 Martin v. Hacker 83 N.Y.2d 1 (1993) ……………………………………….…………………....………..15 Medisim Ltd. v. BestMed LLC 2012 U.S. Dist. LEXIS 169042 (S.D.N.Y. Nov. 28, 2012) …….…………………….…23 Medtronic, Inc. v. Lohr 518 U.S. 470 (1996) …………………………………………………………....7, 9, 11, 23 Parker v. Stryker Corp. 584 F. Supp.2d 1298 (D. Colo. 2008) ………………….………………………………21 Reed v. Pfizer, Inc. 839 F. Supp.2d 571 (E.D.N.Y. 2012) ….……………………………………..…………14 Riegel v. Medtronic, Inc. 552 U.S. 312 (2008) ……………………………………………………...…………passim Riegel v. Medtronic, Inc. 451 F.3d 104 (2d Cir. 2006) …………………………………………………………16, 18 iii Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 4 of 32 Riley v. Cordis Corp. 625 F. Supp.2d 769 (D. Minn. 2009) …………………………………………………...23 Sita v. Danek Med., Inc. 43 F. Supp.2d 245 (E.D.N.Y. 1999) …………………………………………...………..15 Scott v. Ciba Vision Corp. 38 Cal.App.4th 307, 44 Cal.Rptr.2d 902 (Ct. App.1995) .…...………………….…11, 25 Simon v. Smith & Nephew, Inc. 990 F. Supp.2d 395 (S.D.N.Y. 2013) …….…...…………………………...13, 14, 17, 20 Simon v. Smith & Nephew, Inc. 18 F. Supp.3d 423 (S.D.N.Y. 2014) ...……………………………………………..…....25 Stadt v. Fox News Network LLC 719 F. Supp.2d 312 (S.D.N.Y. 2010) …….…………………………………..…………24 Wolicki-Gables v. Arrow Intern., Inc. 634 F.3d 1296 (11th Cir. 2011) …..……………………………………………...…20, 21 STATUTES AND REGULATIONS Food, Drug and Cosmetic Act (FDCA) …………….………………………….....…... 2, 6, 21, 22 Medical Device Amendments of 1976 (MDA) ………………………..………….………..passim 21 U.S.C. § 332 …………………………………………………………………………………22 21 U.S.C. § 333 …………………………………………………………………………………22 21 U.S.C. § 334 …………………………………………………………………………………22 21 U.S.C. § 360e(d)(1)(A) ………………………………………………………….….………..14 21 U.S.C. § 360e(d)(6)(A)(i) ……………………………………………………..……………..10 21 U.S.C. § 360k(a) ……………………………………………………………………....8, 22, 25 21 C.F.R. § 801.109 ……………………………………………………………….…….......……2 21 C.F.R. § 808.1(d) …………………………………………………………………………...…8 iv Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 5 of 32 21 C.F.R. § 814.20(b) ………………………………………………………….......…….…….…7 21 C.F.R. § 812.1-150 ………………………………………………………………...…..………7 New York General Business Law § 349 ……………………………………………….……23, 24 New York General Business Law § 349 (a) …………………………………………….………23 New York General Business Law § 350 …………………………………………….………23, 24 N.Y. U.C.C. § 2-725(1) ……………………………………………………………..……….17, 19 U.S. CONST. Art. VI, cl. 2. ………………………………………………………………………7 RULES Federal Rule of Civil Procedure Rule 12(b)(6) …………………………………….……1, 5, 6, 19 Federal Rule of Evidence 201 ………………………………..……………………….………..…6 Federal Rule of Evidence 201(b) ….………………………………………………..……….……2 v Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 6 of 32 4833-1581-4717 1 PROCEDURAL HISTORY AND PRELIMINARY STATEMENT This case involves a surgically implanted medical device, the LAP-BAND® obesity system, which was deemed safe by the FDA when it granted pre-market approval. Plaintiff Frances Moody alleges that the LAP-BAND® was “unsafe.” On October 13, 2016, she filed a Verified Complaint in New York State Supreme Court, County of Niagara, against Allergan USA, Inc. (“Allergan”), the sole defendant which manufactured the device. See Verified Complaint (“Complaint”) (Dkt. No. 1). Allergan removed the state court action to federal court based upon complete diversity. Plaintiff seeks to recover under negligence, strict products liability, and breach of warranty theories and has also alleged a Violation of New York’s Deceptive Trade Practices Act. These claims are barred as a matter of federal preemption law. The pleading also lacks factual detail supporting those allegations, rendering it ripe for dismissal under Fed. R. Civ. P. 12(b)(6). The breach of warranty claims fail for the additional reason that they are untimely. For the foregoing reasons, and as more fully detailed below, Plaintiff’s eight causes of action against the device manufacturer Allergan should be dismissed at this time. STATEMENT OF FACTS THE MEDICAL DEVICE AND PRE-MARKET APPROVAL IN 2001 LAP-BAND® is a surgically implanted gastric banding system designed to induce weight loss in obese patients. Summary of Safety and Effectiveness Data (“Summary)”, attached as Ex. 2 to Allergan’s Request for Judicial Notice (“RJN”) at p. 7. It received pre-market approval (PMA) from the United States Food and Drug Administration (“the FDA”) in 2001. See FDA Approval Order Letter dated June 5, 2001 (“FDA Approval Letter”), attached to RJN as Ex. 1. The manufacturer (then BioEnterics Corporation and later its successor in interest, Allergan) is Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 7 of 32 4833-1581-4717 2 required to market the device with the design reviewed and approved by the FDA, according to the manufacturing specifications reviewed and approved by the FDA, and with labeling/warnings reviewed and approved by the FDA. Id. After the FDA’s approval, the sale, distribution and use of the LAP-BAND® was restricted to prescription use in accordance with 21 C.F.R. § 801.109 within the meaning of section 520(e) of the Federal Food, Drug and Cosmetic Act (“FDCA”). Id. at p. 1. Documentation concerning the FDA’s pre-market approval of the LAP-BAND® System is freely available to the public on the FDA’s website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p000008 (last visited Oct. 14, 2016). This Honorable Court may take judicial notice of these government documents from this reliable public resource. Fed. R. Evid. 201(b). Allergan has simultaneously filed a request for judicial notice with regard to these documents. PLAINTIFF’S ALLEGATIONS IN THE COMPLAINT Plaintiff Frances Moody alleges that sole defendant Allergan designed, manufactured, marketed, promoted and sold the subject LAP-BAND® medical device. Compl. ¶1 (Dkt. No. 1). Plaintiff alleges that after implantation of the device on or about February 7, 2011 she “subsequently suffered complications that required surgery to remove the LAP-BAND® and repair damage caused to the gastrointestinal system ....” Id. ¶¶13 and 20. Plaintiff alleges that she had the device removed on or about April 17, 2014 due to “slippage and gastric erosion.” Id. ¶19. Plaintiff further alleges that as a result of a defective LAP-BAND® she sustained “gastric perforation” and “pelvic abscess.” Id. ¶21. Plaintiff’s Verified Complaint references in the first four counts (for Negligence and Strict Products Liability) the traditional three bases of product liability: design defect (id. ¶¶11, Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 8 of 32 4833-1581-4717 3 22a, 22f, 26o), manufacturing defect (id. ¶¶11, 22f, 26k, 26o) and failure to warn (id. ¶¶12, 22m, 22n, 26p). Breach of implied and express warranties are alleged in the next three causes of action. No detail on the warranties is provided in the pleading save for the generic allegation that Allergan warranted that the LAP-BAND® “was a safe and effective weight loss system.” Id. ¶68. That representation of safety and effectiveness is also at the heart of the eighth and final cause of action, Violation of the New York Deceptive Trade Practices Act. Id. ¶90. The pleading claims that federal law is cited for the purposes of pleading “parallel” state law claims, and various regulations are alleged to have been violated including failure to investigate adverse events and failure to report product failures to the FDA, among other unsupported claims. Id. ¶¶4 and 22, generally. The Verified Complaint frequently alleges that the LAP-BAND® was “unsafe.” Id. ¶¶26j, 43, 44, 46, 50. Although the pleading avers that the LAP-BAND® was defective because Allergan knew or should have known that the device “could fail in patients … but failed to give consumers adequate warnings of such risks” (id. ¶60), documents maintained by the FDA demonstrate that Allergan knew the device could fail, and revealed that risk to the FDA and to patients via their physicians. SUMMARY OF SAFETY AND EFFECTIVENESS DATA Band slippage, erosion and perforation were complications known to the FDA at the time it approved LAP-BAND® as safe and effective. See Summary, RJN Ex. 2. Any of these potential risks could result in the medical device being surgically removed and/or replaced. The Summary, publicly available from the FDA’s website, states in relevant part (with emphasis supplied): CAUTION: As with other gastroplasty surgeries, particular care must be taken during dissection and during implantation of the device to avoid damage to the Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 9 of 32 4833-1581-4717 4 gastrointestinal tract. Any damage to the stomach during the procedure may result in erosion of the device into the GI tract. Id. at p. 4. CAUTION: Over-dissection of the stomach during placement may result in slippage or erosion of the band and require reoperation. Id. at p. 5. CAUTION: Insufficient weight loss may be caused by pouch enlargement or more infrequently band erosion, in which case further inflation of the band would not be appropriate. Id. at p. 6. Risks associated specifically with the LAP-BAND® System are the possibility of intolerance to the components (foreign body reaction), mechanical malfunction (leakage and deflation of the inflatable section), access port site pain and access port displacement, band slippage/pouch dilatation, band erosion, gastric or esophageal perforation, stoma obstruction, and esophageal dilatation/dysmotility. Peritonitis and death can occur either as a consequence of a gastrointestinal perforation during implantation of the device or as a result of erosion of the gastric band. The LAP-BAND® System is a long-term implant and the System or a component may need to be either explanted or replaced. In addition, medical management of adverse events may necessitate reoperation to revise or explant the device. As with any revision procedure, the possibility of complications such as erosion and infection are increased. Id. at p. 10. Complications from LAP-BAND® surgery were known to lead to additional surgery. The potential need for further surgery is noted throughout the Summary, as noted above and including under Warnings and Precautions (with emphasis supplied): “Failure to secure the band properly may … necessitate reoperation.” (id. at p. 2); “Explant and replacement surgery may be indicated at any time.” (id. at p. 3); and under Potential Adverse Effects of the Device on Health: “… medical management of adverse events may necessitate reoperation to revise or explant the device.” Id. at p. 10. The clinical studies presented to the FDA showed that one out of every four patients would need either a revision procedure or surgery to remove the LAP- BAND®: “Twenty-six (26) of the 292 subjects originally implanted (9%) required surgical device revision and 46 (16%) required device explantation within 3 years of implantation. The indications for these re-operations included band slippage/pouch dilatation, GERD/dysphagia, esophageal dilatation, band erosion and component leakage.” Id. at p. 23. Nevertheless, the Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 10 of 32 4833-1581-4717 5 FDA determined that the clinical data provided “reasonable assurance of the safety and effectiveness of the LAP-BAND System” when used in accordance with its labeling. Id. ARGUMENT AND CITATION TO AUTHORITY INTRODUCTION AND JUDICIAL NOTICE The FDA determined in 2001 that the medical device in question was safe after its exhaustive review during the pre-market approval (PMA) process. Plaintiff Frances Moody’s case is premised on the allegation that the device was unsafe. This conflict gives rise to federal preemption. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). The law of federal preemption in the area of FDA-approved Class III medical devices was clarified by the United States Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The Medical Device Amendments of 1976 (“MDA”) contain an express preemption provision. Plaintiff’s state-law claims that the LAP-BAND® System was defective are expressly preempted by the MDA because those claims would impose requirements “different from, or in addition to” the specific federal requirements imposed on that medical device via the PMA. Allergan can only manufacture the device in conformance with the federal requirements, and not according to alternative designs, labeling, or manufacturing processes this Plaintiff, or any plaintiffs in other civil actions, might suggest. Thus, Allergan moves to dismiss on the grounds that Plaintiff’s claims are preempted and, in any event, fail to state a claim for relief. Fed. R. Civ. P. 12(b)(6). To survive a motion to dismiss under Rule 12(b)(6), a plaintiff must provide the grounds upon which the claims rest, through factual allegations sufficient to raise a right to relief above the speculative level. Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007); ATSI Communications, Inc. v. Shaar Fund, Ltd., 493 F.3d 87, 98 (2d Cir. 2007). A complaint must plead “enough facts to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 11 of 32 4833-1581-4717 6 570. “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009). A complaint is properly dismissed where, as a matter of law, “the allegations in a complaint, however true, could not raise a claim of entitlement to relief.” Twombly, 550 U.S. at 558. The tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Iqbal, 556 U.S. at 678. “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id. In adjudicating a motion to dismiss under Rule 12(b)(6) a court may properly take judicial notice of facts pursuant to Rule 201 of the Federal Rules of Evidence that are “not subject to reasonable dispute” and “capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Specifically, this Court may take judicial notice of the pre-market approval (PMA) granted to the LAP-BAND® System at issue in this lawsuit. See RJN Exhibits 1 and 2. POINT I COMMON LAW CLAIMS ARE BARRED BY THE PREEMPTION PROVISION OF THE MEDICAL DEVICE AMENDMENTS OF 1976 In 1976, Congress enacted the Medical Device Amendments (MDA), which modified the federal Food, Drug and Cosmetics Act (FDCA) to allow the FDA to regulate medical devices. The MDA “imposed a regime of detailed federal oversight.” Riegel, 552 U.S. at 316. The MDA assigns each medical device into one of three “classes.” The class of the device determines the process by which the device is regulated. Class III devices, like the LAP-BAND®, are subjected to the most rigorous safety evaluation via the pre-market approval (PMA) process. Id. at 317. Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 12 of 32 4833-1581-4717 7 Manufacturers must provide the FDA with samples of the device, an outline of the device's components, a description of the manufacturing process, copies of proposed labels, and certain other items. 21 C.F.R. § 814.20(b). After receiving these submissions from the product manufacturer, the FDA reviews the materials for an average of 1,200 hours before either approving or disapproving the device. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996); 21 C.F.R. § 812.1-150. Few medical devices survive the rigorous premarket approval process. “In 2005, for example, the FDA … granted premarket approval to just 32 devices.” Riegel, 552 U.S. at 317. In 2001 the FDA determined after exhaustive review that the LAP-BAND® device was safe and effective, and granted pre-market approval to BioEnterics Corporation, a predecessor to Allergan. See FDA Approval Letter, RJN Ex. 1. It is this rigorous review and approval by a federal governmental agency of the Class III medical device at issue, combined with a Congressional act, which bars the conflicting state common law claims of Plaintiff. SUPREMACY CLAUSE AND EXPRESS PREEMPTION CLAUSE The Supremacy Clause of the United States Constitution provides that the “Laws of the United States . . . Shall be the supreme Law of the Land.” U.S. CONST. Art. VI, cl. 2. When state law conflicts with federal law, the state law is without effect under the Supremacy Clause. Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992). However, because of the important principles of federalism in areas of public health and safety, the states’ police power will not be preempted by federal law unless congressional intent to the contrary is clearly expressed. Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985). In the MDA, Congress clearly indicated its intention to preempt at least some state laws by including an express preemption clause, which provides: Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 13 of 32 4833-1581-4717 8 [N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement -- (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. § 360k(a). Courts have ruled that the above-quoted clause is the MDA’s express preemption provision. Horn v. Thoratec, 376 F.3d 163 (3d Cir. 2004); Riegel, 552 U.S. at 316. An FDA regulation construing § 360k specifically addresses when preemption applies: State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements. 21 C.F.R. § 808.1(d) (emphasis supplied) TWO-STEP ANALYSIS Courts of Appeal throughout the nation adopted generally accepted guidelines on when the MDA preempts state claims. A state claim that focuses on the safety of a device is preempted if (1) the FDA has established specific counterpart regulations or other specific federal requirements that are applicable to the particular device; and (2) the state claim is different from, or in addition to, the specific FDA requirements. Kemp v. Medtronic, Inc., 231 F.3d 216, 224-225 (6th Cir. 2000); Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1371 (11th Cir. 1999). The required analysis focuses first on the specificity and applicability of the federal requirement and second, if necessary, on whether the state claim is different from or in addition to the federal requirement. This is the analysis the United States Supreme Court affirmed and implemented in Riegel, the leading case in preemption of pre-market approved (PMA) medical devices. The Court held that the first step was satisfied, that the FDA had established requirements applicable to the Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 14 of 32 4833-1581-4717 9 catheter, the Class III device at issue in Riegel, via the PMA process. “Unlike general labeling duties, premarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review – it is federal safety review.” Riegel, 552 U.S. at 322-23 (italics in original). The “FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.” Id. at 323. The PMA process thus represents a federal “requirement” that is specific to the device under review. With the first question satisfied, the Supreme Court Justices turned to the second question and noted, “Safety and effectiveness are the very subjects of the Riegels’ common-law claims, so the critical issue is whether New York’s tort duties constitute ‘requirements’ under the MDA.” Id. In Riegel, the United States Supreme Court adhered to the view of five Justices in Lohr, supra, who concluded that common-law causes of action for negligence and strict liability do impose “requirement[s]” and would be preempted by federal requirements specific to a medical device. Riegel, 552 U.S. at 324. Citing another of its plurality opinions, the majority in Riegel noted that common-law liability is premised on the existence of a legal duty, and a tort judgment therefore establishes that the defendant has violated a state-law obligation. Id., citing Cipollone, 505 U.S. at 521-22. State tort suits are preempted just like state statutes and regulations. The view adopted for PMA devices by the United States Supreme Court in Riegel is the law of the land. / / / / / / / / / Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 15 of 32 4833-1581-4717 10 POINT II APPLYING THE TWO-STEP ANALYSIS TO THIS CASE INVOLVING AN APPROVED LAP-BAND® DEVICE, PLAINTIFF’S COMMON LAW CLAIMS ARE PREEMPTED 1. The FDA has established regulations and requirements applicable to the LAP- BAND® The PMA process is a specific federal requirement applicable to the medical device at issue. The rigorous PMA process to which the FDA subjected the LAP-BAND® culminated with a determination by the FDA that the device was safe and effective. See FDA Approval Letter, RJN Ex. 1. Allergan’s predecessor had previously submitted a voluminous amount of material related to the design, manufacturing, and labeling of the specific product. The FDA had previously required extended clinical studies and changes to the device’s labeling. See Summary, RJN Ex. 2 at p. 24. Allergan’s predecessor had made those changes and ultimately the FDA gave its approval to the marketing of the LAP-BAND®. Id. The FDA cautioned that the manufacturer was prohibited from altering any of the product’s specific design or safety features without FDA permission. “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness. §360e(d)(6)(A)(i).” Riegel, 552 U.S. at 319. In this manner, the PMA review process of LAP-BAND®, including the review and approval of the specific labeling, including warning information, satisfies the first prong of the Court’s analysis. The PMA process represents a federal “requirement” that is specific to Allergan’s device, the LAP-BAND®. The Justices succinctly noted, “premarket approval is specific to individual devices.” Id. at 323; see also Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir. 2012) (“Devices that are approved through PMA procedures automatically satisfy the Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 16 of 32 4833-1581-4717 11 ‘federal requirements’ prong.”). The first prong for preemption is satisfied. 2. The State Claims Here Are Different From and In Addition To the FDA Requirements a. State tort claims are requirements. Since there are specific federal requirements applicable to the medical device in question, this Court ultimately must analyze whether the state claims are different from, or in addition to, the specific federal requirements. Courts have held both before and after Lohr, that civil tort suits qualify as such state requirements. “Since State regulations can be as effectively exerted through an award of damages as through some form of preventive relief, State common-law tort claims may be preempted along with State statutes and regulations.” Ambrosio v. Barnes-Hind, Inc., 211 A.D.2d 70, 72-73 (3d Dept. 1995); accord, Scott v. Ciba Vision Corp., 38 Cal.App.4th 307, 316, 44 Cal.Rptr.2d 902 (Ct. App. 1995). As noted above, the United States Supreme Court reached the same conclusion. Riegel, 552 U.S. at 324-325. State tort law claims can be preempted because the verdicts that result from such cases can have an effect on manufacturers just like statutes and regulations. b. The requirements imposed by Plaintiff’s state court claims are different from or in addition to the requirements imposed by the federal government via the PMA for the LAP-BAND® System. In Riegel, the “District Court held that the MDA pre-empted the plaintiffs’ claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection distribution, labeling, marketing, and sale of the catheter.” Id. at 320. “It also held that the MDA pre-empted a negligent manufacturing claim insofar as it was not premised on the theory that Medtronic violated federal law.” Id. at 321. The Court of Appeals for the Second Circuit affirmed those dismissals, noting that the Riegels’ claims would, if successful, impose state requirements that differed from, or added to, the device-specific federal requirements. Id. Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 17 of 32 4833-1581-4717 12 The common-law claims filed by Plaintiff Frances Moody, if successful, would impose requirements that are different from or in addition to the federal requirements imposed via the PMA process. Her negligence and strict product liability claims allege that the LAP-BAND® contained a manufacturing defect, design defect, and warning defect. She also alleges that Allergan breached warranties by representing that the device was “safe and effective” and that such a representation was false, violating the deceptive practices act. Each of those claims does not survive a preemption analysis and must be dismissed. Additionally, each cause of action is not factually supported, mandating dismissal under Twombly and Iqbal. (i) Design Defect To state a claim for strict products liability under a design defect theory, a plaintiff must allege that “(1) the product as designed posed a substantial likelihood of harm; (2) it was feasible to design the product in a safer manner; and (3) the defective design was a substantial factor in causing Plaintiff’s injury.” Colon v. BIC USA, Inc., 199 F. Supp.2d 53, 83 (S.D.N.Y. 2001). And “for the purposes of analyzing a design defect claim, the theories of strict liability and negligence are virtually identical.” Id. Plaintiff references negligence and design defect in the First Cause of Action and strict liability and design defect in the Third Cause of Action. See Compl. ¶¶11, 22a, 22f, 26a, 26o, 52 (Dkt. No. 1). She alleges that the medical device’s “unsafe, defective and inherently dangerous condition was a cause of injury to Plaintiff.” Id. ¶46. But those claims are necessarily barred by federal preemption. “Plaintiff’s defective design claim, which challenges the FDA’s findings concerning the safety of the [medical device’s] design, necessarily imposes requirements that are different from, or in addition to, federal regulations.” Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 282 (E.D.N.Y. 2009). Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 18 of 32 4833-1581-4717 13 Plaintiff’s design defect claim cannot survive preemption, as the design of the LAP- BAND® was exhaustively reviewed by the FDA and deemed to be safe and effective. See RJN Exs. 1 and 2. By alleging that the design was improper, Plaintiff is putting the manufacturer in an impossible position, as it can only market the device with the design reviewed and approved by the FDA. Allergan cannot alter the design of the product every time a plaintiff alleges a defect, yet a necessary part of Plaintiff’s product liability design claim is proof that a different, feasible alternative design to the one mandated by the FDA be used. This would necessarily require a jury to compare Plaintiff’s alternative design with the product design that caused the injury, namely the product design approved by the FDA and mandated by the PMA. A jury cannot usurp the role of the FDA, to which Congress has assigned the role of determining whether or not a device is safe and effective. Riegel, 552 U.S. at 325. Because a particular jury’s determination could conflict with the federal determination of safety and the requirements imposed by the PMA, design defect claims of approved medical devices are preempted by the express provision in the MDA. See Simon v. Smith & Nephew, Inc., 990 F. Supp.2d 395, 405 (S.D.N.Y. 2013) (“[D]esign defect claims regarding a PMA-approved device are squarely preempted by the MDA.”); see also Horowitz, 613 F. Supp.2d at 282. Consequently, Plaintiff’s defective design claim in the First and Third Causes of Action must be dismissed as a matter of law. Additionally, Plaintiff’s design defect allegations are so vague and conclusory as to render them implausible under Twombly and Iqbal. No facts related to design are alleged which would allow this Court “to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 663. Ms. Moody never indicates what the alleged problem with the device was, or how it could have been designed better. “Plaintiffs do not plead facts alleging the existence of a feasible alternative design that would make the product safer, as Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 19 of 32 4833-1581-4717 14 is required to establish a design defect, under … New York … law.” Reed v. Pfizer, Inc., 839 F. Supp.2d 571, 578 (E.D.N.Y. 2012). Ms. Moody’s pleading does not mention any other design. (If it did, it would run squarely into preemption anyway). See Simon, 990 F. Supp.2d at 406. Because the Verified Complaint fails to include facts alleging the existence of a feasible alternative design that would make the product safer, as is required to establish a design defect under New York law, the design defect claim fails as a matter of law and must be dismissed. (ii) Warnings Defect Allergan is also obligated to utilize the warnings reviewed and approved by the FDA, and any claim by a litigant that those warnings should be different would conflict with the federal requirement established by the FDA via the PMA. Ms. Moody’s failure to adequately warn claim against Allergan must be preempted. See Compl. ¶¶12, 22m, 22n, 26p, 60 (Dkt. No. 1). Before approving a device, the FDA “must determine that the proposed labeling is neither false nor misleading, § 360e(d)(1)(A).” Riegel, 552 U.S. at 318. As noted above, an FDA panel recommended changes to the labeling, and the manufacturer made those changes, before the FDA approved the LAP-BAND® for sale. See Summary, RJN Ex. 1 at p. 24. In this manner, after a “rigorous” and highly detailed review during the PMA process, the FDA approved the warning language that BioEnterics and later Allergan was required to use and did use on the subject product. Allergan cannot draft the warning materials as requested by this Plaintiff or any other claimants seeking money, but rather must market the medical device in compliance, and only in compliance, with the requirements and specifications approved by the FDA. Warnings that are “different from, or in addition to” the requirements mandated by the federal government are preempted by the MDA. For this reason, Plaintiff’s defective warning claim must be dismissed. Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 20 of 32 4833-1581-4717 15 The Complaint asserts both negligence and strict liability claims based upon the alleged failure to warn. See Compl., First and Fourth Causes of Action (Dkt. No. 1). “Where liability is predicated on a failure to warn, New York views negligence and strict liability claims as equivalent.” Anderson v. Hedstrom Corp., 76 F. Supp.2d 422, 439 (S.D.N.Y. 1999) (quoting Martin v. Hacker, 83 N.Y.2d 1, 8 n.1 (1993)). Accordingly, this Court can consider Plaintiff’s failure to warn claims together. Even if Ms. Moody’s failure to warn claim was somehow able to survive preemption, New York's learned intermediary doctrine provides that “the manufacturer of a medical device does not have a duty to directly warn a patient of risks associated with the device, but instead discharges its duty by providing the physician with sufficient information concerning the risks of the device.” Sita v. Danek Med., Inc., 43 F. Supp.2d 245, 259 (E.D.N.Y. 1999). By providing warnings to physicians and on the label of the LAP-BAND®, which the FDA necessarily found adequate, Allergan fulfilled its duty to warn. Additionally, Plaintiff’s failure to warn allegations are too vague and conclusory to be plausible under Twombly and Iqbal. Ms. Moody alleges that Allergan “failed to provide adequate warning regarding the propensity of the LAP-BAND to cause injury” and failed to warn that the device “was likely to fail and require removal, revision, and/or gastrointestinal repair surgery.” See Compl. ¶¶22m, 22n (Dkt. No. 1). Those are just conclusions, and a court need not accept a complaint’s legal conclusions as true, only its well-pled facts. Iqbal, 556 U.S. at 678. Ms. Moody’s conclusions are also belied by reliable materials located on the FDA’s website. The risks of bodily injury including perforation as well as the potential need for removal surgery are noted throughout the Summary (RJN Ex. 1): “Failure to secure the band properly may … necessitate reoperation.” (Id. at p. 2); “Explant and replacement surgery may be Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 21 of 32 4833-1581-4717 16 indicated at any time.” (Id. at p. 3); and “… medical management of adverse events may necessitate reoperation to revise or explant the device.” (Id. at p. 10). The clinical studies presented to the FDA showed that one out of every four patients would need either a revision procedure or surgery to remove the LAP-BAND® within three years, which is what allegedly happened to Ms. Moody, whether for slippage, erosion or other anticipated complications. Id. at p. 23. There is absolutely no support offered for Plaintiff’s allegation that the LAP-BAND® “was defective due to inadequate warnings because Defendant knew or should have known that the LAP-BAND could fail in patients and, therefore give rise to physical injury, … and the need for removal, revision, and/or gastrointestinal repair surgery … but failed to give consumers adequate warnings of such risks.” Compl. ¶60 (Dkt. No. 1). (iii) Breach of Implied Warranty The Second Circuit has held implied warranty claims are preempted. See Riegel v. Medtronic, Inc., 451 F.3d 104, 121 (2d Cir. 2006). Ms. Moody alleges breaches of the implied warranties of both merchantability and fitness. Compl. ¶¶11, 13, 16 & 19 (Dkt. No. 1). Both are preempted. In New York, to recover under a breach of implied warranty of merchantability claim a plaintiff must establish that the subject medical device was not reasonably fit for the ordinary purpose for which it was intended. Horowitz, 613 F. Supp.2d at 284. “For plaintiff to succeed on her claim, a jury would have to find that defendants breached the implied warranty of merchantability by manufacturing a medical device that was unsafe in its federally approved design or manufacture. Such a claim falls squarely within the MDA's preemption provision.” Id. (internal citation omitted). A PMA device has been deemed safe by the FDA, and a plaintiff cannot have a jury rule that it is unsafe. “Plaintiff's breach of the implied warranty of fitness claim fails for the same reason.” Id. at 284-285. Ms. Moody’s claims of breach of implied warranty are nothing more than a formulaic Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 22 of 32 4833-1581-4717 17 recitation of the elements of those causes of action. Compl. ¶¶75-78, 83-86 (Dkt. No. 1). “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice” to state plausible claims. Iqbal, 556 U.S. at 678. New York courts will dismiss such generic implied warranty claims for failure to state a claim. In Simon, supra, 990 F. Supp.2d at 407, the plaintiff generically alleged that the device manufacturer impliedly represented and warranted that the device was safe and of merchantable quality, and that these representations and warranties were false, misleading, and inaccurate in that the device was unsafe, unreasonably dangerous, and improper, not of merchantable quality and otherwise defective. The district judge dismissed these implied warranty claims, noting: “This barebones allegation, however, is conclusory. There are no concrete factual allegations to support the claim …” Id. at 407-408. Ms. Moody’s breach of implied warranty claim must suffer the same fate for the same reasons. The breach of warranty claims in the Fifth, Sixth and Seventh Causes of Action also must be dismissed as a matter of law because they were made out of time. In New York, the statute of limitations for warranty claims is four (4) years from the date of placement of the product into the stream of commerce. N.Y. U.C.C. § 2-725(1); see also Gelber v. Stryker Corp., 788 F. Supp.2d 145, 166 (S.D.N.Y. 2011) (“Under New York law, the usual limitations period for breach-of-warranty claims is four years from the date when tender of delivery is made.”). The subject LAP-BAND® was delivered/placed into the stream of commerce more than four years before suit was filed on October 13, 2016, given that Plaintiff alleges that the device was implanted on or about February 7, 2011. Compl. at ¶13 (Dkt. No. 1). (iv) Breach of Express Warranty “The Second Circuit has held implied warranty claims are pre-empted, see Riegel v. Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 23 of 32 4833-1581-4717 18 Medtronic, Inc., 451 F.3d at 121, and seemed to indicate express warranty claims are also pre- empted, …” Gale v. Smith & Nephew, Inc., 989 F. Supp.2d 243, 249 (S.D.N.Y. 2013) (strip citations omitted). If a plaintiff criticizes a manufacturer’s written materials or consistent verbal statements that were approved by the FDA during the PMA, that claim is clearly preempted. “Plaintiff's breach of express warranty claim is preempted to the extent that it is premised on FDA approved representations made by the manufacturer.” Horowitz, 613 F. Supp.2d at 285. Ms. Moody alleges that Allergan “breached its express warranty made through their marketing campaigns, promotional activities, product labeling, package inserts, and/or written and verbal assurances that the LAP-BAND was safe and effective for use.” Compl. ¶22h (Dkt. No. 1). As statements on a PMA product’s label and in package inserts are pre-approved by the FDA as neither false nor misleading, and mandated by the PMA, such statements are necessarily preempted. Horowitz, 613 F. Supp.2d at 285. The only potentially verbal express statement that Ms. Moody alleges Allergan made is that LAP-BAND® was “safe and effective.” Compl. ¶¶22h, 68 (Dkt. No. 1). That statement is one with which the FDA would agree given that pre- market approval is only given after it has received reasonable assurances that a device is both safe and effective. Thus, Ms. Moody’s breach of express warranty claim is preempted in its entirety. Further, Plaintiff’s express warranty claim offers only a conclusion, not a fact. “Even assuming plaintiff’s breach of express warranty claim is not pre-empted, her conclusory allegations fail to identify any actionable conduct or include sufficient factual detail to state a claim.” Gale, supra, 989 F. Supp.2d at 249. Ms. Moody’s conclusory allegations as to express warranty similarly require dismissal. Finally, as noted above, Plaintiff’s breach of express warranty claim is barred as matter of Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 24 of 32 4833-1581-4717 19 law by New York’s four year statute of limitations for warranty claims. N.Y. U.C.C. § 2-725(1). (v) Manufacturing Defect Plaintiff vaguely asserts in the First Cause of Action that Allergan failed to use reasonable care by “negligently manufacturing the LAP-BAND in a manner which was dangerous to those individuals who had it implanted.” Compl. ¶26k (Dkt. No. 1). Plaintiff vaguely asserts in the Second Cause of Action that the that LAP-BAND® was “defective in its manufacture when it left the hands of Defendant in that it deviated from product specifications, ...” Id. at ¶36. That is just a description or definition of a manufacturing defect, not a factual allegation worthy of the presumption of truth. See Iqbal, 556 U.S. at 678. Under New York law, to state a manufacturing defect claim under either negligence or strict liability, the plaintiff must show that the specific product unit was defective as a result of some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction, and that the defect was the cause of plaintiff's injury. Horowitz, 613 F. Supp.2d at 283 (citing Colon, 199 F. Supp.2d at 85). Ms. Moody has not made such a showing. Her vague, conclusory allegations lack a factual basis that would suggest her claims of manufacturing defect are more than mere conjecture. “The plausibility standard … asks for more than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 556). By failing to allege any facts surrounding the defectiveness of the device implanted in her or a plausible theory for how the device was manufactured improperly, Plaintiff does not give Allergan any notice of the basis for the manufacturing defect claim. “[O]nly a complaint that states a plausible claim for relief survives a motion to dismiss.” Iqbal, 556 U.S. at 679. Consequently, the manufacturing defect claims asserted in the First and Second Causes of Action must be dismissed for failure to state a claim Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 25 of 32 4833-1581-4717 20 under Fed. R. Civ. P. 12(b)(6). The FDA during the PMA process necessarily reviewed and approved the manufacturing specifications and processes for the LAP-BAND®. That approval conflicts with Ms. Moody’s generic allegation that her device “deviated from product specifications” in some unstated manner. Compl. ¶36 (Dkt. No. 1). Those specifications and the accompanying processes were necessarily approved by the FDA during the rigorous PMA process. The Supreme Court noted, “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319. Consequently, Plaintiff’s vague manufacturing defect claim is preempted and must be dismissed as matter of law. See Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197, 202 (W.D.N.Y. 2011) (“Common law negligence claims are precisely the type of claims Riegel held are preempted by the MDA.”); Simon, 990 F. Supp.2d at 406 (“[C]laims of negligent manufacture with respect to PMA-approved devices are preempted.”). To the extent that Plaintiff has attempted to plead a parallel claim, she has not succeeded. While it is true that a rare, well-pled manufacturing defect claim can survive a preemption analysis, that happens only when a pleading includes claims premised on a violation of specific FDA regulations, and state duties “parallel,” rather than add to, federal requirements. Riegel, 552 U.S. at 330. “Parallel claims must be specifically stated in the initial pleadings.” Wolicki- Gables v. Arrow Intern., Inc., 634 F.3d 1296, 1301 (11th Cir. 2011). Ms. Moody does not set forth parallel claims in her Complaint. She merely mentions the phrase “‘parallel’ state law claims” (Compl. ¶4) but then fails to set forth any such parallel claims. “A plaintiff must allege that ‘[the] defendant violated a particular federal specification referring to the device at issue.’” Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 26 of 32 4833-1581-4717 21 Wolicki-Gables, 634 F.3d at 1301, citing Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582, 589 (E.D.N.Y. 2009). “‘To properly allege parallel claims, the complaint must set forth facts’ pointing to specific PMA requirements that have been violated.” Wolicki-Gables, 634 F.3d at 1301 (quoting Parker v. Stryker Corp., 584 F. Supp.2d 1298, 1301 (D. Colo. 2008)). Ms. Moody’s Complaint fails to do so, referencing general current good manufacturing practices (CGMPs) applicable to all devices, not requirements specific to LAP-BAND®. Compl. ¶¶22i-w (Dkt. No. 1) and Ilarraza, 677 F. Supp.2d at 588-89 (rejecting non-specific allegation that defendant violated broad federal CGMPs applicable to all devices). “Plaintiff’s vague, proposed amendments are readily distinguished from pleadings that have been found to state parallel claims.” Desabio, 817 F. Supp.2d at 204. Consequently, Ms. Moody’s manufacturing defect claim must be dismissed for failing to set forth a viable parallel claim. Her claims also fail because of implied preemption.1 The FDCA contains a no-private- right-of-action clause, 21 U.S.C. § 337(a), which impliedly preempts state law actions that attempt to enforce provisions of the FDCA. See Buckman, supra. Section 337(a) specifies that all proceedings to enforce the FDCA, of which the MDA are a part, “shall be by and in the name of the United States.” The Supreme Court has held that § 337(a) “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for non- compliance with the medical device provisions” of federal law. Buckman, 531 U.S. at 349 n.4. Buckman and § 337(a) impliedly preempt the other miscellaneous claims that Ms. Moody attempts to make in her pleading, including those based on Allergan’s alleged failure: to properly maintain records on serious injury and death; to comply with federal requirements and 1 The Supreme Court has held that an express preemption provision does not “bar the ordinary working of conflict preemption principles.” Geier v. Am. Honda Motor Co., 529 U.S. 861, 869 (2000). Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 27 of 32 4833-1581-4717 22 regulations; to timely report adverse events; to timely investigate LAP-BAND® failures and malfunctions; to timely report events to the FDA; to comply with FDA quality system requirements and regulations; to fully inform the FDA of unanticipated adverse effects; etc. Compl. ¶¶22i-w (Dkt. No. 1). Such alleged failures by Allergan must be enforced exclusively by the federal government, which is amply qualified to do so given the “variety of enforcement options that allow it to make a measured response” to any wrongdoing that it uncovers. Buckman, 531 U.S. at 349. Those options include seizing the device, injunctive relief, civil penalties and criminal prosecutions. See 21 U.S.C. §§ 332, 333, 334. State law claims that seek to enforce the FDCA and its implementing regulations, like those by Ms. Moody here, are impliedly preempted because they would usurp the FDA’s exclusive enforcement authority under § 337(a) and thereby conflict with the federal regulatory scheme. See Gelber, 788 F. Supp.2d at 161-166 (preempting failure to report claims and failure to identify causes of device failure, under Buckman, and dismissing those claims and several others for failure to state a claim, noting there are “no facts supporting plaintiffs’ allegation”). Plaintiff’s manufacturing defect claim is preempted. “Riegel and Buckman create a narrow gap through which a plaintiff’s state law claim must fit if it is to escape express or implied preemption.” Bryant v. Medtronic, Inc., 623 F.3d 1200, 1204 (8th Cir. 2010). In order to avoid dismissal, a “plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA ([because] such a claim would be impliedly preempted under Buckman).” Bryant, 623 F.3d at 1204 (internal quotation marks omitted). Stated differently, “[f]or a state-law claim to survive the claims must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 28 of 32 4833-1581-4717 23 FDCA.” Riley v. Cordis Corp., 625 F. Supp.2d 769, 777 (D. Minn. 2009). Ms. Moody has not pleaded claims that fit into this “narrow gap.” She cites numerous federal regulations (see Compl. ¶¶22p-y) but not the state laws that are allegedly equivalent. To be considered parallel, a state law requirement must be “identical” (Lohr, 518 U.S. at 495), or at least “genuinely equivalent” (Bates v. Dow Agrosciences LLC, 544 U.S. 431, 454 (2005)), to a pre-existing federal requirement. This analysis necessarily requires a comparison between the state law requirement and the federal law requirement. If both laws are not stated, it is virtually impossible to compare them and no viable parallel claim will have been stated. Consequently, no parallel claim is effectively made by Ms. Moody and her manufacturing defect claim is preempted. (vi) Violation of the New York Deceptive Trade Practices Act New York General Business Law §§ 349 and 350 make unlawful deceptive acts, practices, and false advertising “in the conduct of any business, trade or commerce or in the furnishing of any service[.]” N.Y. Gen. Bus. Law §§ 349(a), 350. To state a claim under §§ 349 and 350, the plaintiff must show that the act, practice, or advertisement was (1) consumer- oriented; (2) misleading in a material respect; and (3) caused his injury. See Levine v. Landy, 832 F. Supp.2d 176, 192 (N.D.N.Y. 2011) (quotations omitted). In addition, for § 350, ‘“the plaintiff must “point to [a] specific advertisement or public pronouncement” upon which [the consumer] relied.’” Medisim Ltd. v. BestMed LLC, 2012 U.S. Dist. LEXIS 169042, *22 (S.D.N.Y. Nov. 28, 2012) (footnote omitted). In her Eighth Cause of Action, Plaintiff has failed to plead the necessary elements of §§ 349 and 350 violations, let alone allege sufficient facts “to raise a right of relief about the speculative level.” Twombly, 550 U.S. at 555 (citation and footnote omitted.) She merely Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 29 of 32 4833-1581-4717 24 alleges that (1) Defendant deceptively advertised and represented the LAP-BAND® as a safe and effective weight loss system, see Compl. ¶90; (2) Allergan knew or should have known that medical device imposed “unreasonable dangers and serious health risks,” see id. ¶91; and (3) she would not have purchased the LAP-BAND® had Allergan not engaged in such deceptive conduct, see id. ¶93. Beyond these flat assertions and conclusory statements, Plaintiff advances no sufficient allegations regarding how Allergan’s alleged deceptive or misleading business practices harmed consumers. See Stadt v. Fox News Network LLC, 719 F. Supp.2d 312, 324 (S.D.N.Y. 2010) (finding no GBL §349 violation where the complaint lacked allegations that the defendant “harmed consumers or the public interest in any material respect” (footnote omitted)). Significantly, Ms. Moody also fails to identify any specific advertisement or public pronouncement on which she relied. See N.Y. Gen. Bus. Law § 350. She only generically alleges, “These representations were made in uniform promotional materials.” Compl. ¶104 (Dkt. No. 1). No such materials were attached to her pleading. The Eighth Cause of Action – at best – contains only a formulaic recitation of the elements discussed in the Deceptive Trade Practice Act. “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice” to state plausible claims. Iqbal, 556 U.S. at 678. In any event, the allegedly false statement that the device is safe and effective is actually true according to the FDA after its rigorous review of the LAP-BAND®, and this claim should be preempted on the same grounds discussed in the prior sections. Accordingly, Plaintiff has failed to state a cause of action for violations of GBL §§ 349 and 350 and this cause of action must be dismissed. / / / / / / Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 30 of 32 4833-1581-4717 25 POINT III STATUTORY INTERPRETATION IS A JUDICIAL FUNCTION AND A RULING ON PREEMPTION CAN BE MADE AS A MATTER OF LAW WITHOUT DISCOVERY Plaintiff’s claims are preempted by the MDA by virtue of the PMA granted to the type of medical device at issue in this litigation. The question of whether Plaintiff’s claims are preempted turns on the interpretation and application of the preemption clause of the MDA. “Statutory interpretation is a judicial function involving only questions of law.” Scott, 38 Cal. App.4th at 313. The preemption provision applies to Plaintiff’s strict liability, negligence, and warranty claims, as the Supreme Court determined in Riegel, so dismissal for Allergan is warranted. No discovery is required before this Court can make that determination. Numerous federal courts throughout the country have granted dismissal based on preemption without the departing defendant having provided discovery. See, e.g., Simon v. Smith & Nephew, Inc., 18 F. Supp.3d 423, 430 (S.D.N.Y. 2014) (additional discovery would not be fruitful as it would not alter the Court’s preemption analysis); Bass, 669 F.3d at 508; Horowitz, 613 F. Supp.2d at 288. Given the state of the law of preemption, engaging in discovery to determine whether, how or why the LAP-BAND® device allegedly caused Plaintiff’s damages would be moot, and a waste of judicial resources and the litigants’ time and money. Such discovery will not change the fact that the FDA has ruled that the product in question is safe, nor will it change the fact that the MDA provides for preemption expressly in 21 U.S.C. § 360k(a). Engaging in discovery will not change the fact that Plaintiff’s common law tort claims are preempted as a matter of law. CONCLUSION For the foregoing reasons, Allergan’s motion to dismiss should be granted in its entirety, with prejudice. Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 31 of 32 4833-1581-4717 26 Dated: November 16, 2016 Buffalo, New York NIXON PEABODY LLP By: /s/ Vivian M. Quinn Vivian M. Quinn, Esq. 40 Fountain Plaza, Suite 500 Buffalo, New York 14202 Telephone: (716) 853-8100 E-mail: vquinn@nixonpeabody.com Attorneys for Defendant Allergan USA, Inc. Case 1:16-cv-00901-LJV Document 3-4 Filed 11/16/16 Page 32 of 32