Case 3:21-cv-03877-SK Document 1-1 Filed 05/24/21 Page 1 of 79
`Case 3:21-cv-03877-SK Document 1-1 Filed 05/24/21 Page 1 of 79
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`EXHIBIT 1
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`EXHIBIT 1
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`a
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`Jessica A. Schaps (CA Bar No. 266333)
`THE LAW OFFICES OF JESSICA A. SCHAPS
`816 H. St, Ste 200
`Sacramento, CA 95814
`(540) 819-6071
`Schapslaw@gmail.com
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`Attorney for Plaintiff
`
`ENDORSEU
`FILED
`ALAMEDA CAUN'11Y
`APR 012021
`CLERK OF THE SUPE
`By CHRISTNA R~~
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`UR1
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`IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA
`COUNTY OF ALAMEDA
`UNLIMITED JURISDICTION
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`LHC GROUP, INC., Administrator of tlie
`LHC Group Benefit Plan, on behalf of the Plan
`and as subrogee,
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`Case No.: R G 210 94 6 5 6
`COMPLAINT FOR DAMAGES AND
`DEMAND FO.R JURY TRIAL.
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`Plaintiff,
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`vs.
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`'BAYER CORP.;
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`BAYER HEALTHCARE LLC;
`BAYER ESSURE INC. (F/KfA CONCEPTUS, )
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`INC.);
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`BAYER HEALTHCARE
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`PHARMACEUTICALS, INC.; and
`)
`DOES lthrough 10, inclusiv.e,
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`Defendant.
`
`(1)
`(2)
`(3)
`(4)
`(5)
`(6)
`(7)
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`Negligence
`Strict Products Liability
`Concealment
`Interitional Misrepresentatiom
`Negligent Misrepreseritation
`Breach of Express Warranty
`Quasi-Contract and Unjust
`Enrichment
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`PLAINTIFF' S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`COMES NOW Plaintiff LHC Group, Inc., Administrator of the LHC Group Benefit
`Plan (the "Plan"), on behalf of the Plan, and as subrogee of the Covered Persons and former
`Covered Persons ("Members") identified in Exhibit A(the "Injured Members"), and files
`judgment against Defendants BAYER CORP.; BAYER
`this Complaint seeking
`HEALTHCARE LLC; BAYER ESSURE INC. (F/K/A CONCEPTUS, INC.); BAYER
`HEALTHCARE PHARMACEUTICALS, INC.; and DOES 1 through 10, inclusive,
`(hereinafter collectively referred to as "Defendants" or "Bayer") for personal injuries
`suffered as a result of Injured Members being implanted with the defective and unreasonably
`dangerous product, Essure®; for the cost of Plaintiff's purchase of such defective and
`unreasonably dangerous product on behalf of its Members; and for the cost incurred by
`Plaintiff to pay its Injured Members' healthcare costs when such costs should have been
`borne by Defendants. At all times relevant hereto, Essure® was manufactured, designed,
`formulated, tested, packaged, labeled, produced, created, made, constructed, assembled,
`marketed, advertised, promoted, distributed, and sold by Defendants.
` INTRODUCTION
`I.
`The primary responsibility for timely communicating complete, accurate and current
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`safety and efficacy information related to a medical device rests with the manufacturer. The
`manufacturer has superior, and in many cases exclusive, access to the relevant safety and
`efficacy information, including post-market complaints and data.
`To fulfill this essential responsibility, a manufacturer must vigilantly monitor all
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`reasonably available information. The manufacturer must closely evaluate the post-market
`clinical experience with the device and its components and timely provide updated safety
`and efficacy information to the U.S. Food and Drug Administration ("FDA"), and thereby to
`the healthcare community and to consumers. The manufacturer also must carefully monitor
`its own quality controls post-market to ensure that the device uniformly conforms with its
`representations and warranties and with specifications of approval.
`When monitoring and reporting the post-market experience with its product,
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`including any adverse events as required by both federal regulations and state law, including
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`PLAINTIFF'S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`California law, time is of the essence. The purpose of monitoring a product's post-market
`experience is to detect potential safety signals that could indicate to the manufacturer and the
`medical community that a public safety problem exists. If a manufacturer waits to report
`post-market information, even for a few weeks or months, that bottleneck could mean that
`researchers, regulatory bodies, and the medical community are years behind in identifying a
`public safety issue associated with the device. In the meantime, more patients are harmed by
`using the product without understanding its true risks. This is why a manufacturer must not
`only completely and accurately monitor, investigate and report post-market experience, but
`it must also report the data to the FDA as soon as it is received, take appropriate actions to
`identify the root cause of product failures, and take corrective and preventative actions as
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`appropriate.
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`failure
`from Defendants'
`This action arises
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`responsibilities to warn about serious health risks that became apparent to the manufacturer
`after their permanent birth control device, Essure®, was marketed in the United States. In
`2002, the FDA approved the device for sale in the United States based on clinical studies of
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`their post-market
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`to uphold
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`only 745 women presented by the device manufacturer.
`After the FDA approved the Essure device for sale and it began to be implanted in
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`patients in a real-world setting, Defendants became aware of serious issues and adverse
`events that should have led Defendants to, among other things, report the adverse events to
`the FDA pursuant to 21 C.F.R. § 803, et seq. For example, Defendants failed to disclose to
`health care providers and consumers that they had received thousands of complaints of
`serious injuries associated with Essure® after the device was approved for sale. The FDA
`was not made aware that the device could cause serious health risks, such as perforation of
`the uterus or fallopian tubes, device migration or fracture, chronic pain, prolonged bleeding,
`and unintended pregnancies. The FDA was also not made aware that the frequency and
`severity of complications was greater than expected, and ultimately the device must be
`removed requiring major surgery.
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`PLAINTIFF'S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`Defendants failed to timely report this new information to the FDA. When the FDA
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`later became aware of this information, it made Essure a restricted device and required
`additional warnings, including a black box warning and Patient Decision Checklist, to
`reflect serious health risks that were ultimately suffered by Injured Members. If the
`Defendants had timely and adequately disclosed this information and had reported serious
`adverse events to the FDA, Injured Members' injuries would have been avoided.
`Despite their actual knowledge about the frequency, severity, and permanence of the
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`clinical complications associated with Essure®, Defendants persisted in conducting a
`nationwide false and misleading marketing campaign. In Defendants' own words, their
`marketing strategy aimed to capitalize on a physician's position of trust with patients.
`The conduct of Defendants violated their obligations under relevant federal and state
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`law, including California law, governing the post-market conduct of Class III medical device
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`manufacturers.
`Plaintiff seeks relief only (1) as subrogee of its Injured Members for medical
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`expenses actually paid, but not associated co-pays, co-insurance amounts or similar amounts
`expended by its Injured Members; (2) for damages it suffered directly, not as subrogee of its
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`17 Members, and for which its Members have no claim; and (3) for punitive damages
`associated with these two types of claims only. Notwithstanding the foregoing allegations
`of this paragraph, or any other allegations of this Complaint, Plaintiff does not seek relief for
`damages that it cannot assert directly on its own behalf and to which it is not subrogated, or
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`for which any of its Members are an indispensable party.
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` PARTIES, JURISDICTION AND VENUE
`II.
`Plaintiff LHC Group, Inc. ("LHC Group") is a Delaware corporation with its
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`principal corporate offices at 901 Hugh Wallis Road, South Lafayette, Louisiana 70508.
`LHC Group is the Administrator of the LHC Group Benefit Plan (the "Plan"), a copy of
`which is attached hereto as Exhibit B. LHC Group brings this action as Administrator of the
`Plan, both directly and as subrogee of Injured Member's claims against Defendants pursuant
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`to Section 11.03 of the Plan.
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`PLAINTIFF' S COMPLAINT FOR DAMAGES AND DEMAND FOR NRY TRIAL
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`The claims to which Plaintiff is subrogated and which Plaintiff asserts in this action
`are identified on Eachibit A. Plaintiff does not seek relief on behalf of any Members who
`previously have filed suit against any Defendant for damages arising from their use of the
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`Essure® product.
`The Court has personal jurisdiction over Defendants. Defendant Bayer Essure® Inc.
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`(f/k/a Conceptus, Inc.) and Bayer HealthCare LLC have at all relevant times maintained
`their corporate headquarters in, and purposefully availed themselves of the benefits, profits
`and privileges deriving from their business activities in this state. At the time of each Injured
`Member's implant, all Defendants centralized Essure®'s research and development,
`labeling, regulatory, manufacturing, and marketing strategy in California, and each
`Defendant participated in that joint effort. The Essure® devices sold to California and non-
`California residents were part of a common course of distribution from California; the
`Essure device was conceived of, tested, manufactured, packaged, approved, marketed,
`distributed, and sold directly from California to the 50 states and overseas. Clinical trials
`which formed the basis of the approval of this device were conducted from California,
`including facilities in Santa Clara County. Neither the product design nor the deceptive
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`representations and omissions made about the devices differed from state to state.
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`Defendant BAYER CORP. is a for-profit corporation incorporated in the state of
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`Indiana with its principal place of business in Pennsylvania. Bayer Corp. indirectly owns
`both Bayer Essure, Inc., which is one of the members of Bayer HealthCare, LLC, and Bayer
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`HealthCare Pharmaceuticals, Inc. Bayer Corp. presently and in the past has simultaneously
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`shared officers, agents, and/or employees with Bayer HealthCare, LLC, Bayer HealthCare
`Pharmaceuticals, Inc., and Bayer Essure, Inc. (f/k/a Conceptus). Bayer Corp. also provided
`support for Bayer's acquisition of Bayer Essure, Inc. (f/k/a Conceptus) and it is the
`custodian of documents related to the acquisition. Bayer Corp. maintains offices in
`Commerce, San Ramon, Fresno, Chula Vista, Mission Viejo, and Long Beach, California.
`Bayer Corp.'s U.S. Innovation Center, a 48-acre Multipurpose Biotechnology Plant, is
`located in Berkeley, California. At all relevant times, Bayer Corp. engaged in conduct in
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`PLAINTIFF' S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`California, together with Bayer HealthCare Pharmaceuticals, Bayer HealthCare, LLC, and
`Bayer Essure, Inc., concerning the design, research, development, manufacturing, testing,
`packaging, promotion, marketing, distribution, labeling, dissemination and/or sales of
`Essure® throughout the United States, including the Essure® devices implanted in Injured
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`5 Members.
`Defendant BAYER HEALTHCARE LLC is a for-profit limited liability company
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`organized under the laws of the state of Delaware with its principal place of business in
`Pennsylvania. It is a wholly-owned subsidiary of Bayer A.G. Bayer HealthCare, LLC's sole
`member is Defendant Bayer Corp. Bayer HealthCare, LLC is authorized to and does
`business throughout the state of California and during the time period relevant to this
`litigation had manufacturing operations located in Berkeley, Alameda County, California
`and research and development operations in San Francisco, San Francisco County,
`California. At all relevant times, Bayer HealthCare, LLC's principle place of business for its
`Essure® operations, including, but not limited to, Quality Assurance through which
`technical and medical complaints were processed, was in a plant in Milpitas, California,
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`which is the same plant from which Conceptus performed Essure® functions. At present,
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`Bayer HealthCare, LLC maintains facilities in Berkeley, California and corresponds with the
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`FDA regarding Essure® from this location. At all relevant times, Bayer HealthCare, LLC
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`engaged in conduct in California, in concert with Bayer HealthCare Pharmaceuticals, Bayer
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`Corp., and Bayer Essure, Inc., concerning the design, research, development, manufacturing,
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`testing, packaging, promotion, marketing, distribution, labeling, dissemination and/or sales
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`of Essure® throughout the United States, including the Essure® devices implanted in
`Injured Members. At all times relevant to this action, Bayer Essure, Inc. and Bayer
`HealthCare LLC, both Califon7ia entities, acted as agents for Bayer Corp. in the design,
`testing, packaging, promotion, marketing,
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`research, development, manufacturing,
`distribution, labeling, dissemination and/or sales of Essure® throughout the United States.
`Defendant BAYER ESSURE® INC. (F/K/A CONCEPTUS, INC.) is a for-profit
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`corporation incorporated in the state of Delaware and is a wholly-owned subsidiary of Bayer
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`PLAINTIFF'S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`A.G. and/or Bayer HealthCare, LLC. Conceptus, Inc. ("Conceptus") was a Silicon Valley
`"start-up", founded in 1992 by Julian Nikolchev, a self-described "medical technology
`developer and serial entrepreneur." On or about Apri128, 2013, Conceptus, Inc. entered into
`an Agreement and Plan of Merger (the "Merger Agreement") with Bayer HealthCare, LLC.
`On or about June 5, 2013, pursuant to the Merger Agreement, Conceptus, Inc. became a
`wholly-owned subsidiary of Bayer HealthCare LLC and, thereafter was renamed "Bayer
`Essure Inc." For purposes of this Complaint, Conceptus, Inc. and Bayer Essure Inc. are one
`and the same. Bayer Essure Inc.'s headquarters were located at 1021 Howard Avenue, San
`Carlos, California 94070, until 2005 when they relocated to 331 East Evelyn Avenue,
`Mountain View, California 94041. In July of 2013, Bayer Essure Inc. moved its
`headquarters to 1011 McCarthy Boulevard, Milpitas, Santa Clara County, California 95035.
`On or about July 1, 2013, Bayer HealthCare LLC and Conceptus entered into an Asset Sale
`Agreement, whereby Conceptus agreed to transfer substantially all of its operating tangible
`assets and certain liabilities to Bayer HealthCare LLC. That same day, Conceptus assigned
`its lease of the Milpitas facility, from which it was conducting substantially all of its
`Essure® functions, to Bayer HealthCare LLC. Thereafter, Bayer HealthCare LLC was the
`lessee and occupant of the premises and performed its Essure® functions from the premises
`at least until March 2016 or later. In July 2015, Bayer Essure, Inc. transferred its remaining
`assets and liabilities (except certain tax assets and liabilities) to Bayer HealthCare LLC in
`exchange for common membership units in Bayer HealthCare LLC. Upon information and
`belief, as of May 20, 2016, Bayer Essure Inc. surrendered its right to conduct intra-state
`business in the state of California. In its 2017 Annual Report, Bayer AG listed Bayer Essure,
`Inc. as a fully consolidated subsidiary with a place of business in Milpitas, California. Bayer
`Essure, Inc. played a primary role in Essure®-related operations, such as manufacturing,
`marketing, promotion, product labeling, and regulatory affairs. At all times relevant hereto,
`Bayer Essure, Inc. engaged in conduct in California, in concert with Bayer HealthCare
`Pharmaceuticals, Bayer HealthCare, LLC, and Bayer Corp., concerning the design, research,
`testing, packaging, promotion, marketing, distribution,
`development, manufacturing,
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`PLAINTIFF'S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`labeling, dissemination and/or sales of Essure® throughout the United States, including the
`Essure® devices implanted in Injured Members. At all times relevant to this action, Bayer
`Essure, Inc. and Bayer HealthCare LLC, both California entities, acted as agents for Bayer
`Corp. in the design, research, development, manufacturing, testing, packaging, promotion,
`marketing, distribution, labeling, dissemination and/or sales of Essure® throughout the
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`United States.
`Defendant BAYER HEALTHCARE PHARMACEUTICALS, INC. is a for-profit
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`corporation incorporated in the state of Delaware and is a wholly-owned subsidiary of Bayer
`A.G. Bayer HealthCare Pharmaceuticals is authorized to and does business throughout the
`state of California. Bayer HealthCare Pharmaceuticals played a role in the marketing,
`promotion, product labeling, and post-market surveillance for Essure®. Bayer HealthCare
`Pharmaceuticals, Inc. maintains offices in San Pablo, Emeryville, and San Diego and
`employs roughly 500 employees in California. At all relevant times, Bayer HealthCare
`Pharmaceuticals, Inc. engaged in conduct in California, together with Bayer Corp., Bayer
`HealthCare, LLC, and Bayer Essure, Inc., concerning the design, research, development,
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`testing, packaging, promotion, marketing, distribution,
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`dissemination and/or sales of Essure® throughout the United States, including the Essure®
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`devices implanted in Injured Members.
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`In as early as 2004, the Defendants began sub-contracting the manufacture and
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`sterilization of the device to several other companies, including Accellent Corp., f/k/a
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`21 II Venusa, Ltd., Accellent Inc. d/b/a Lake Region Medical Inc., F1ex.Medical, formerly named
`22 ' Avail Medical, and Sterigenics International. Defendants are liable for the actions and
`inactions of these sub-contractors.
`At all times herein mentioned, there existed a unity of interest, and activity in
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`furtherance of that interest, among Defendants such that any individuality and separateness
`among them has ceased, and these Defendants are the alter egos of each other with respect to
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`Essure® operations.
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`PLAINTIFF' S COMPLAINT FOR DAMAGES AND DEMAND FOR NRY TRIAL
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`Defendants acted jointly and in combination with one another to take advantage of
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`each Defendants' resources, personnel, services, and sales, marketing and promotional
`networks. This includes the Defendants transacting, soliciting, and conducting business in
`California through their offices, employees, agents andlor sales representatives, from which
`they derived substantial revenue in California.
`At all times herein mentioned, Defendants, jointly and individually, were engaged in
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`the business of, or were successors in interest to, entities engaged in the business of
`researching, designing, formulating, compounding, testing, manufacturing, producing,
`assembling, inspecting, distributing, marketing, labeling, promoting, packaging, prescribing,
`and/or advertising for sale, and selling the Essure® device. These products were for use by
`Injured Members and Injured Members' physicians and were implanted into Injured
`Members in the same condition as when the Essure® devices left Defendants' control. As
`such, each of the Defendants is individually, as well as jointly and severally, liable to the
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`Injured Members for their damages.
`The true names and capacities of those defendants designated as DOES 1-10,
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`16 , whether individual, corporate, association or otherwise, are unknown to Plaintiff at the time
`I
`of filing this Complaint and Plaintiff, therefore, sues said defendants by such fictitious
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`names and will ask leave of Court to amend this Complaint to show their true names or
`capacities when the same have been ascertained. Plaintiff is informed and believes, and
`thereon alleges, that each of the DOE defendants is, in some manner, responsible for the
`events and happenings herein set forth and proximately and/or directly caused injury and
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`damages to Injured Members as herein alleged.
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` DESCRIPTION OF ESSURE®
`III.
`Essure® is a medical device manufactured, formulated, tested, packaged, labeled,
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`produced, created, made, constructed, assembled, marketed, advertised, promoted,
`distributed, and sold by Defendants.
`Essure® was first manufactured, formulated, tested, packaged, labeled, produced,
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`created, made, constructed, assembled, marketed, advertised, promoted, distributed, and sold
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`PLAINTIFF' S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`by Conceptus, Inc. and initially developed under the name Selective Tubal Occlusion
`Procedure or "STOPTM" Permanent Contraception device.
`Essure® is touted as a form of permanent female birth control (female sterilization)
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`with a 99.3% effectiveness rate of preventing pregnancy. Defendants intended the device to
`be implanted "permanently," i.e., to remain securely in place for each patient's lifetime.
`Essure® consists of three components: (1) two micro-inserts; (2) a disposable
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`delivery system; and (3) a disposable split introducer. All components are intended for a
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`single use.
`The micro-inserts are composed of two metal coils: one coil made of nitinol (nickel
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`and titanium) and the other made of steel with polyethylene terephthalate ("PET") fibers
`wound in and around the coil. The micro-inserts are inserted through the vagina, cervix, and
`uterus and then implanted into a woman's fallopian tubes via Defendants' disposable
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`delivery system.
`27. Defendants' disposable delivery system consists of a single handle that contains a
`nitinol core delivery wire, release catheter, and delivery catheter. The micro-inserts are
`attached to the delivery wire. The delivery handle controls the device, delivery, and release.
`Physicians monitor this process through hysteroscopic equipment, including a hysteroscope,
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`a lightbox, and a monitor, collectively known as a"tower."
`The hysteroscopic equipment is not part of the Essure® device or its pre-market
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`approval process, but the equipment is necessary for proper implantation of the Essure®
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`device.
`After implantation of the coils in the fallopian tubes, the micro-inserts are intended to
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`expand and cause a chronic inflammatory and fibrotic response to the PET fibers which
`elicits tissue growth that blocks the fallopian tubes and prevents pregnancy.
`The Instructions for Use ("IFU") accompanying the Essure® device provide that
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`patients should be counseled to receive a confirmation test three months post-implant to
`determine that there is complete occlusion in each fallopian tube. The Confirmation Test is
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`PLAINTIFF' S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`performed using a hysterosalpingogram ("HSG Test") and, as of July 2015, a transvaginal
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`ultrasound ("TVU").
`Since Essure®'s market entry in 2002, the device has undergone several design
`31.
`changes. The Selective Tubal Occlusion Product ("STOP") device was the original model
`used in the two clinical trials (STOP 10 and STOP2000) submitted in an effort to obtain
`FDA approval of the device. The first U.S.-launched device was the ESS205 model, which
`was comprised of the same coil insert as the STOP device but incorporated a different
`delivery system (i.e., support catheter). The original support catheter was discontinued in
`2003 to address continued reports of difficulty/failure to disengage or detach the delivery
`wire from the Essure micro-insert during implantation. Additional changes were later made
`to the delivery system. In 2007, Defendants changed the shape of the inserts by removing
`the tapered "pigtail" at the proximal end of the outer coil and renamed the device the
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`ESS305 model.
` PREMARKET APPROVAL AND POST-MARKET OBLIGATIONS
`In April 2002, Conceptus submitted its Premarket Approval Application to the FDA
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`IV.
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`for the Essure® device.
`Premarket Approval ("PMA") is the FDA process of scientific and regulatory review
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`to evaluate the safety and effectiveness of Class III medical devices based on the
`information available at the time. See 21 U.S.C. § 360(e); 21 C.F.R. § 814.3(e).
`On November 4, 2002, the FDA conditionally approved the Essure® PMA
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`34.
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`application to market the device in the United States.
`FDA approval in 2002 was based on studies of only 745 clinical trial patients for a
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`short period of time; the majority of the clinical trial data regarding the coils and PET in the
`fallopian tube was based on only 12-24 months of implantation. Beyond 24 months,
`therefore, the nature of the body's cellular and fibrotic response to the inserts and the ability
`of the devices to maintain occlusion were unknown. The FDA advised Conceptus of these
`facts and emphasized their special significance with respect to the risk of ectopic
`pregnancies, putting Conceptus on clear notice that the company's duty to vigilantly monitor
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`PLAINTIFF' S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`and report the real-world clinical experience with the device was paramount. Thus, the
`importance of maintaining the integrity of post-marketing data collection and reporting was
`known to Defendants from the outset.
`Approval of a device through the PMA process signals the beginning, not the end, of
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`a device manufacturer's duties to patients under both federal regulations and established
`state law, including California law. The FDA's initial approval of a device label amounts to
`a finding by the FDA that the label is adequate for purposes of gaining initial approval to
`market the device. It does not represent a finding by the FDA that the label can never be
`deemed inadequate after approval as new safety information from the real-world experience
`with the device becomes available to the manufacturer. Sound reasons support these
`principles: there are products, such as Essure®, for which evidence of the device's defects
`come to light only after the device is used in a real-world setting.
`The FDA's Conditional Premarket Approval ("CPMA") Order for Essure® outlined
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`several requirements for the manufacturer, and the CPMA expressly made non-compliance
`with any of these requirements a violation of federal law. For example, the Order required
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`that the manufacturer:
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`a.
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`conduct a post-approval study in order
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`to gather long-term safety and
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`effectiveness data on Essure®;
`conduct a post-approval study in the U.S. to "document the bilateral placement
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`b.
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`rate [of Essure®] for newly trained physicians";
`annually report on the patients who participated in the post-approval studies;
`ensure that any warranty statements are truthful, accurate, not misleading, and are
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`d.
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`C.
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`consistent with applicable federal and state laws;
`submit a PMA supplement when unanticipated adverse effects, increases in the
`e.
`incidence of anticipated adverse effects, or device failures necessitate a labeling,
`manufacturing, or device modification;
`submit pursuant to 21 C.F.R. § 814.84 a post-approval Annual Report that
`f.
`includes 1) a bibliography and summary of information from unpublished reports of data
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`-12-
`PLAINTIFF' S COMPLAINT FOR DAMAGES AND DEMAND FOR NRY TRIAL
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`from any clinical investigations or non-clinical laboratory studies involving Essure® as well
`as reports in the scientific literature concerning Essure®, 2) identification of changes made
`pursuant to §814.39(a) or (b) that effect the safety or effectiveness of the device, and 3) any
`failures of the device to meet the specifications established in the approved PMA that were
`correctable by procedures described in the approved labeling;
`submit pursuant to 21 C.F.R. § 814.82(a)(9) a"Device Defect Report" or
`g.
`"Adverse Reaction Report" to the FDA within 10 days after Defendants receive or have
`knowledge or information of any adverse reaction, side effect, injury, toxicity, or sensitivity
`reaction that has either not been addressed by the device's labeling, or has been addressed by
`the device's labeling but is occurring with unexpected severity or frequency. The express
`purpose of this requirement is to provide continued reasonable assurance of the safety and
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`effectiveness of the device; and
`submit pursuant to 21 C.F.R. § 814.82(a)(9) a"Device Defect Report" or
`h.
`"Adverse Reaction Report" to the FDA within 10 days after Defendants receive or have
`knowledge or information of any significant change or deterioration of the device, or any
`failure of the device to meet specifications established in the approved PMA, that could not
`cause or contribute to death or serious injury, but is not correctable by adjustments or other
`procedures described in the approved labeling. The express purpose of this requirement is to
`provide continued reasonable assurance of the safety and effectiveness of the device.
`The CPMA Order for Essure® further outlined reporting requirements that
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`Defendants were required to follow under the Medical Device Reporting regulations
`("MDR"). Under these requirements, pursuant to 21 C.F.R. § 803.50, et seq. Defendants
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`a.
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`were required to:
`report to the FDA within thirty (30) days whenever they receive or otherwise
`become aware of information, from any source, that reasonably suggests a device
`may have caused or contributed to serious injury. See 21 C.F.R. § 803.50(a)(1);
`report to the FDA within thirty (30) days whenever they receive or otherwise
`b.
`become aware of information, from any source, that reasonably suggests a device has
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`- 13-
`PLAINTIFF'S COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL
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`malfunctioned and would be likely to cause or contribute to serious injury if the malfunction
`were to recur. See 21 C.F.R. § 803.50(a)(2);
`report to the FDA within 5 days after Defendants received or became aware that a
`C.
`reportable MDR event requires remedial action to prevent an unreasonable risk of
`substantial harm to the public health. See 21 C.F.R. § 803.52; and
`report to the FDA within 30 days after Defendants received any supplemental
`d.
`information that was not provided in the initial report. See 21 C.F.R. § 803.56.
`The CPMA Order acknowledged the Defendants' obligation and ability to update
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`safety warnings for Essure® without prior FDA approval by utilizing the "Changes Being
`Effected" provision in 21 C.F.R. § 814.39(d)(2).
`The FDA made clear in the CPMA order that "[f]ailure to comply with the
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`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."
`In order to comply with its reporting obligations under the Essure® CPMA and
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`federal law, Defendants were required to conduct an investigation of each adverse event and
`evaluate the cause of the event. See 21 C.F.R. §§ 803.S0(a); 803.50(b)(3).
`To competently investigate whether a complaint represents an adverse event required
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`to be reported under § 803.50, et seq., Defendants were required to estab