Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 1 of 41
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`5:22−cv−00208 (BKS/TWD)
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`EXHIBIT A
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 2 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`Index No.:
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`SUPREME COURT OF THE STATE OF NEW YORK
`COUNTY OF CAYUGA
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`KRYSTAL DAINS,
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` Plaintiff, SUMMONS
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`JURY TRIAL DEMANDED
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`BAYER, INC., BAYER HEALTHCARE LLC.,
`Plaintiff designates
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`BAYER ESSURE INC., (F/K/A CONCEPTUS, INC.)
`CAYUGA COUNTY
`BAYER HEALTHCARE PHARMACEUTICALS, INC.,
`as the place of trial
`And BAYER A.G.,
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`The Basis of the Venue is
` Defendants,
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`Plaintiff’s Residence
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`TO THE ABOVE-NAMED DEFENDANTS:
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`YOU ARE HEREBY SUMMONED and required to serve upon Plaintiff’s attorneys an
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`Answer to the Complaint in this action within twenty (20) days after the service of this Summons,
`exclusive of the day of service, or within (30) days after service is complete if this Summons is not
`personally delivered to you within the State of New York. In case of your failure to answer,
`judgment will be taken against you by default for the relief demanded in the Complaint.
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` The basis of venue designated is the residence of Plaintiff and the location of the incident
`that is the subject of this action.
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`DATED: January 31, 2022
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`BELLUCK & FOX, LLP
`Attorneys for Plaintiff
`546 Fifth Avenue ∙ 5th Floor
`New York, NY 10036
`(212) 681-1575
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`By:
` Kristina M. Georgiou, Esq.
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`TO: BAYER INC.,
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`100 BAYER BLVD
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`WHIPPANY, NJ 07981
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`1 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 3 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`BAYER CORP.
`100 Bayer Road, Building 4
`Pittsburgh, PA 15205
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`BAYER HEALTH CARE, LLC
`100 Bayer Road
`Building 4
`Pittsburgh, PA 15202
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`Bayer Essure, Inc.,
`331 East Evelyn Avenue
`Mountain View, CA 94041
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`Bayer HealthCare Pharmaceuticals, Inc.
`100 Bayer Blvd.
`Whippany, NJ 07981
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`2
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`2 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 4 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`Plaintiffs,
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`COMPLAINT
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`Index No.:
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`SUPREME COURT OF THE STATE OF NEW YORK
`COUNTY OF CAYUGA
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`KRYSTAL DAINS,
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` -against-
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` BAYER, INC., BAYER HEALTHCARE LLC.,
` BAYER ESSURE INC., (F/K/A CONCEPTUS, INC.),
` BAYER HEALTHCARE PHARMACEUTICALS, INC.,
` And BAYER, A.G.,
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` Defendants.
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`Hereinafter mentioned, resides at 106 E. Genesee Street, Auburn, New York 13021.
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`Organized and existing by virtue of the laws of the State of New Jersey with its corporate
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`headquarters and principal place of business at 100 Bayer Blvd., Whippany New Jersey 07981 and
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`conducted business and sales of pharmaceutical products within the State of New York, and the
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`entire United States.
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`Plaintiff, as and for her complaint against the Defendants, state and allege as follows:
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`1.
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`Plaintiff KRYSTAL DAINS, is a resident of the County of Cayuga, and at all times
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`2.
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`Upon Information and belief, the Defendant, BAYER Inc., is a corporation duly
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`3.
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`Upon information and belief, Bayer Corp., is a for -profit corporation incorporated in
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`The state of Indiana with its principal place of business at 100 Bayer Rd., Building 4, Pittsburgh,
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`Pennsylvania 15205 and is a wholly owned subsidiary of Bayer A.G. Bayer Corp. is a citizen of
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`Pennsylvania and conducted business and sales of pharmaceutical products within the State of New
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`York and all of the United States.
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`3 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 5 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`4.
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`Upon information and belief, Bayer HealthCare, LLC is a for-profit corporation
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`formed under the laws of the State of Delaware and is a wholly owned subsidiary of Bayer A.G.
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`Bayer HealthCare, LLC and is a citizen of Delaware and conducted business and sales of
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`pharmaceutical products within the State of New York and all of the United States.
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`5.
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`Upon Information and belief, Bayer Essure, Inc., (f/k/a Conceptus, Inc) is a for-
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`profit corporation incorporated in the State of Delaware and is a wholly-owned subsidiary of Bayer
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`A.G. and/or Bayer HealthCare LLC and conducted business and sales of pharmaceutical products
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`within the State of New York and all the United States.
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`6.
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`On or about April 28, 2013, Conceptus, Inc entered into an Agreement and Plan of
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`Merger with Bayer HealthCare LLC. On or About June 5, 2013, pursuant to the Merger Agreement,
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`Conceptus, Inc., a wholly owned subsidiary of Bayer HealthCare LLC and/or Bayer A.G., and
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`thereafter renamed BAYER ESSURE INC. For purposes of this complaint, Bayer Essure Inc. and
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`Conceptus, inc. are one and the same. Bayer Essure Inc’s headquarters are located at 331 East
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`Evelyn Avenue, Mountain View, California 94041 and conducts business and sales of
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`pharmaceutical products within the State of New York and all the United States.
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`7.
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`Upon information and belief, Bayer HealthCare Pharmaceuticals, Inc. is a for-profit
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`corporation incorporated in the State of Delaware and is wholly owned subsidiary of Bayer A.G.
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`and has its principal place of business in New Jersey conducts business and sales of pharmaceutical
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`products within the State of New York and all the United States.
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`8.
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`Upon information and belief, the Court has personal authority over the defendants
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`herein, because at all relevant times they have engaged in substantial business activities in the State
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`of New York. At all relevant times, the Defendants transacted, solicited, and conducted business in
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`New York through their employees, agents and/or sales representatives, and derived substantial
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`revenue from such business in New York.
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`4 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 6 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`9.
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`Upon information and belief, each, any, and/or all the named defendants herein are
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`subject to the jurisdiction of the State of New York pursuant to Section 302(a) of the New York
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`Civil Practice Law & Rules particularly as follows:
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`302(a)(1) Each, any, and/or all of the named defendants herein transacts business within the
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`State of New York and/or contracts anywhere to supply goods or services in the state; or
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`302(a)(2) Each and/or all of the named defendants herein continued a tortious act within the
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`state. Each and/or all of said defendants committed a tortious act outside the State of New York that
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`caused injury to person and property inside the State of New York, and.
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`302(a)(3)(i) Each, any and/or all of the named defendants herein regularly does or solicits
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`business, or engages in any other persistent course of conduct, or derives substantial revenue from
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`goods used or consumed or services rendered in the State or.
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`302(a)(3)(ii) Each, any and/or all of the named defendants herein expects or should
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`reasonably expect the act to have consequences in the state and derives substantial revenue from
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`interstate or international commerce.
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`10.
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`At all times hereinafter mentioned, Bayer authorized and directed and or participated
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`in the promotion of Essure, a permanent Birth Control system consisting of two metal coils that are
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`implanted into the fallopian tubes that expand and are intended to elicit tissue growth which causes
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`blockage of the tubes thus prevents conception.
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`11.
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`Upon information and belief at all times herein mentioned, Bayer authorized and
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`directed and/or participated in the promotion and sale of Essure when they knew, or should have
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`known, of the increased risks, hazards and unreasonably dangerous propensities and thereby
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`actively participated in the tortious conduct which resulted in the serious injuries to the plaintiff
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`herein.
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`5 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 7 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`12.
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`Upon information and belief, the defendant engaged in the business of researching,
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`designing, formulating, compounding, testing, manufacturing, producing, assembling, inspecting,
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`distributing, marketing, labeling, promoting, packaging, prescribing and/or advertising for sale, and
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`the selling of the Essure device. This product was for use by the Plaintiff and Plaintiff’s physicians.
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`As such, Bayer is individually, jointly, and severally liable to the Plaintiffs for their damages.
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`13. Upon information and belief, the Essure system is considered a permanent form of
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`female birth control and is not intended to be removed.
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`14.
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`The Essure system consists of three components: (1) two micro-inserts; (2) a
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`disposable delivery system, and (3) a disposable split introduced. All the components are intended
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`for single use.
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`15.
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`The Essure micro-inserts are constructed of a stainless-steel inner coil, a dynamic
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`outer coil made from a nickel and titanium alloy, called Nitinol, and a layer of polyethylene
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`terephthalate, or polyester fibers wound between the inner and outer coils.
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`16.
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`Essure’s disposable delivery system consists of a single handle containing a delivery
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`wire, release catheter and delivery catheter. These micro-inserts are attached to the delivery wire.
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`The delivery handle controls the device, delivery, and release. Physicians are allowed to visualize
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`this complicated process through the hysteroscopic (camera) equipment provided by Bayer. Once
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`the physician has properly positioned the delivery system in the fallopian tube, the physician
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`releases the micro-insert. When released, the micro-insert automatically expands the contours of the
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`fallopian tube to anchor into the fallopian tube permanently.
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`17. After the device is inserted and over a 3 month period, the PET fibers on the micro-
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`inserts are supposed to elicit tissue growth around the coils, which causes bilateral occlusion
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`(blockage) of the fallopian tubes. Buildup of tissue creates a barrier that keeps sperm from reaching
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`the eggs, thus preventing conception.
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`6 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 8 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`18.
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`After the three- month period following the procedure, the patient is to receive a
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`“confirmation test” to determine whether the Essure micro-inserts have created a complete
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`occlusion in each fallopian tube.
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`19.
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`Upon information and belief, to conduct the Essure Device procedure you must be
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`trained in Essure and must be a skilled operative hysteroscopist.
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`20.
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`From the beginning of the sale of the Essure device, Conceptus (k/n/a Bayer) was
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`repeatedly cited by regulatory authorities for continuous violations that impacted patient safety.
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`21.
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`In July of 2002, the FDA conducted an inspection/audit of Conceptus. After the
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`inspection, the FDA inspector cited Conceptus for failing to report adverse events identified by
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`patients.
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`22.
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`Upon information and belief, Conceptus (kin/a BAYER) became aware that the
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`following failures could occur with the devices and could lead to adverse consequences for the
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`patient.
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`a)
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`The stainless steel used in the device became m1-passivated, and can cause the
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`device to rust;
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`b)
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`c)
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`d)
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`The nitinol could have a nickel rich oxide which the body attacks.
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`The no lead solder could have traces of lead in it.
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`The Galvanic action between the metals used to manufacture Essure which cause the
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`encapsulation of the product of the fallopian tubes, could be an irritant to some patients.
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`e)
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`The nitinol in the device can degrade due to high nickel ion release, which can
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`increase the toxicity of the product to the patient.
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`f)
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`Latent manufacturing defects such as scratches, cracks and other disruption of the
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`surface of the metal coil, may have existed in the finished product causing excess nickel to leach in
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`the surrounding tissues after implantation.
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`7 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 9 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`g)
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`PET fibers used in the device degrade at 65 degrees, therefore considerable
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`degradation is expected at 90 degrees in the body and degradation products of the PET used in the
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`implant can be toxic to patients, causing both chronic inflammation and possible autoimmune
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`issues.
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`h)
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`The mucosal immune response to nickel is different that the immune response in on
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`mucosal areas of the body.
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`i)
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`There was an inadequate solder joint between the inner and outer coils of the micro-
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`insert which can cause the micro-insert to fracture and/or break apart., and which the defendant
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`admits is or could be a reason for device breakage, and.
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` j)
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`The central axis was not fully adhered to the spring which can cause the micro-insert
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`to break and/or fracture, and for which Bayer admits is or could be a reason for device breakage.
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`23.
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`Conceptus (kin/a BAYER) concealed thousands of migrations and perforation
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`reports including instances wherein the Essure device has migrated in a woman or perforated a
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`woman’s organs.
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`24.
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`Prior to 2011, defendant had accumulated thousands of reports that the device had
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`migrated throughout their bodies or punctured one of their organs.
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`25.
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`To protect the marketability of the device, the defendant chose not to report the vast
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`majority of complaints.
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`26. Upon information and belief, in or around September 2015, plaintiff presented to
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`Guthrie Cortland Medical Center, 134 Homer Avenue, Cortland, New York 13045 and underwent
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`an implantation of Essure devices.
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`27.
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`Upon information and belief, the plaintiff at a later date, Krystal Dains returned to
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`Guthrie Cortland Medical Center to have the “confirmation test” to determine whether the device
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`has created a complete occlusion in each fallopian tube.
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`8 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 10 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`28.
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`At the time of the follow up it was discovered that one of the Essure inserts was
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`missing.
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`29.
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`Thereafter, the plaintiff underwent additional surgery and a tubal litigation as the
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`result of the migration of the Essure device.
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`30.
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`In addition, the plaintiff thereafter underwent a series of additional surgeries due to
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`continued pain to her lower left pelvic area, all caused by the defective Essure devices.
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`31. Upon information and belief, the plaintiff has continued to treat with Guthrie
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`Cortland Medical Center from September 2015 up to an including the present with continuous pain,
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`heavy bleeding, and in February 18, 2021, plaintiff underwent yet another surgery where it was
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`found that the fallopian tube had connected to the uterus all as a result of the defective nature of the
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`Essure devices. Further surgery will be required.
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`32.
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`Plaintiff has been significantly injured because of the implantation of the Essure
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`device causing the Plaintiff and her family to adjust their lives to accommodate her ongoing
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`injuries.
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`33.
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`In reliance on Bayer’s marketing of the Essure device, Plaintiff and her physician
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`expected that this Essure device would provide her with permanent birth control.
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`34.
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`Upon information and belief Plaintiff and her physician believed that the device
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`should have been a safe and permanent solution to her birth control, which did not occur and she
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`continues to suffer pain that continues to impact her emotionally and physically.
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`35. Had Plaintiff known that the Essure device would cause the injuries she has suffered,
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`she would not have elected the Essure device for permanent birth control.
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`36. As a direct and proximate result of the failure of her Essure device and the
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`complications that arose because of that failure, Plaintiff sustained and continues to suffer severe
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`and permanent disabling injuries, including but not limited to, past, present and future pain and
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`9
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`9 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 11 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`suffering; loss of enjoyment of life; anguish, and severe possibly permanent injuries; emotional
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`distress; disability; and the possibility of future surgeries. As a result, Plaintiff has sustained and
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`will continue to sustain losses and damages in an amount to be proven at trial.
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`37.
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`All the injuries and complications suffered by the Plaintiff were caused by the
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`defective design, warnings, construction, and unreasonably dangerous character of the Essure
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`device implanted in the Plaintiff and had Defendants not concealed the known defects, the failure
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`rate, the known complications, and the unreasonable risks associated with the use of the Essure
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`device, Plaintiff would not have consented to the use of Essure.
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`38. As a direct and proximate result of the negligence, carelessness, and recklessness of
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`the Defendants herein, and the defective nature of the Essure device, Plaintiffs hereby seek
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`judgment in such fair and reasonable amount as may be awarded by a jury of their peers, together
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`with such other further relief as to the Court may seem just and proper.
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`39.
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`Upon information and belief, the amount in controversy exceeds the jurisdictional
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`limitation of all lower courts.
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` AND AS AND FOR A FIRST, SEPARATE, AND
` DISTINCT CAUSE OF ACTION,
` PLAINTIFFS ALLEGE AS FOLLOWS
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`40.
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`Plaintiffs hereby incorporate by reference all preceding paragraphs as if fully set
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`forth herein.
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`41. Upon information and belief, and at all times hereinafter mentioned, defendants,
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`BAYER INC., BAYER HEALTHCARE, LLC., BAYER ESSURE INC., (F/K/A CONCEPTUS,
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`INC.), BAYER HEALTHCARE PHARMACEUTICALS, INC., and BAYER A.G. and each of
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`them knew or in the exercise of ordinary and reasonable care should have known, that the Essure
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`device was a product of such a nature that if it was not properly manufactured, designed,
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`assembled, compounded, tested, inspected, packaged, labeled, fabricated, constructed, analyzed,
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`10
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`10 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 12 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`distributed, services, merchandized, recommended, advertised, promoted, marketed and sold, for
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`the use and purpose for which it was intended, it was likely to injure the person or persons by whom
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`it was used.
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`42.
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`Upon information and belief, and at all times hereinafter mentioned, the Defendants,
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`and each of them, so negligently and carelessly manufactured, designed, assembled, compounded,
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`tested or failed to test, inspected or failed to inspect, packaged, labeled, fabricated, marketed and
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`sold the Essure Device, and its components parts and constituents, so that it was in a dangerous and
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`defective condition, and unsafe for the purpose for which it was intended when used as
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`recommended by the Defendants.
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`43.
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`Upon information and belief, despite Bayer’s knowledge of the defects and serious
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`injuries associated with the use of the Essure Device, Defendants engaged in a marketing and
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`advertising program which by affirmative and material representations and omissions, falsely and
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`deceptively sough to create the image and impression that the use of the Essure Device was safe and
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`effective.
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`44.
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`Upon information and belief, the defective and dangerous character and condition of
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`the Essure Device that it was unsafe for the purpose for which it was intended when used as
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`recommended by the Defendants was known to the Defendants, and each of them, or in the exercise
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`of ordinary and reasonable care should have been known and discovered by Defendants, and each
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`of them.
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`45.
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`Upon information and belief and at all times hereinafter mentioned, as a result of the
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`negligence, careless and recklessness of the Defendants herein, and without any culpable or
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`comparative negligence of the Plaintiff contributing thereto, Plaintiff, Krystal Dains was caused to
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`suffer severe, permanent, and disabling injuries.
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`11
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`11 of 36
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`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 13 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
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`46. Upon Information and belief, as a direct and proximate result of the negligence,
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`carelessness and recklessness of each of the aforesaid Defendants and without any negligence of the
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`Plaintiff contributing thereto, Plaintiff was caused to sustain a significant amount of pain, suffering,
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`mental anguish, emotional distress, loss of enjoyment of life, and has otherwise incurred medical
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`bills, additional care and treatment, including undergoing unnecessary additional surgical
`
`procedures, directly and proximately related to the negligence and medical malpractice as outlined
`
`above, and will in the future need additional medical care and treatment, and will have continuing
`
`pain, suffering, mental anguish and distress, loss of enjoyment of life, and emotional distress, all to
`
`her detriment.
`
`
`
`47. As a direct and proximate result of the negligence, carelessness, and recklessness of
`
`the Defendants herein, Plaintiff hereby seeks judgment in such fair and reasonable amount as may
`
`be awarded by a jury of their peers, together with such other further relief as to the Court may seem
`
`just and proper.
`
`
`
`48. Upon information and belief, the amount in controversy exceeds the jurisdictional
`
`limitations of all lower courts.
`
`
`
`49. Defendants actions, and each, any and/or all, were done in reckless disregard of the
`
`rights of the consuming public, and otherwise were done purposely, willfully and in reckless
`
`disregard of the rights of the plaintiff individually so as to have defendants liable for punitive
`
`damages.
`
`
`
`
`
`
`AND AS AND FOR A SECOND, SEPARATE, AND DISTINCT CAUSE OF
`ACTION, PLAINTIFF ALLEGES AS FOLLOWS:
`
`50.
`
`Plaintiff hereby incorporates by reference all preceding paragraphs as if fully set
`
`forth herein.
`
`
`
`12
`
`12 of 36
`
`

`

`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 14 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
`
`
`
`51.
`
`Upon information and belief, Defendant, BAYER, was negligent, careless and
`
`reckless with regard to the care and treatment of Plaintiff, Krystal Dains herein in that said
`
`Defendant’s agents, servants, and/or employees failed to exercise the degree of skill and care in
`
`treatment of Plaintiff as would be in accordance with the standards of practice among members of
`
`the medical profession in general; failed to exercise reasonable care and diligence in the application
`
`of their knowledge, skill and ability in the care and treatment of Plaintiff; failed to exercise best
`
`judgment in the care and treatment of Plaintiff; failed to advise its agents, officers, employees
`
`and/or physicians using the Essure device of the possibility of perforations, heavy bleeding,
`
`debilitating pain, and other life altering complications; failed to seek and obtain expert advice on
`
`the proper manner and method to insert a Essure device; failed to properly assess Plaintiff’s
`
`condition post placement of the Essure device to determine whether any complications were caused
`
`by the placement of the Essure device. Failed to take the appropriate steps to prevent Plaintiff’s
`
`injury in the first instance; failed to properly manage the treatment of Plaintiff; failed to properly
`
`train agents, staff and/or employees; failed to implement the proper policies and procedures
`
`regarding the care and treatment of patients; and said Defendant was otherwise negligent, careless
`
`and reckless with regard to the care and treatment of Plaintiff.
`
`
`
`52.
`
`Upon information and belief, as a direct and proximate result of the negligence
`
`carelessness and recklessness of each of the aforesaid Defendants and without any negligence of the
`
`Plaintiff contributing thereto, Plaintiff was caused to sustain severe, permanent, and disabling
`
`injuries, and has otherwise been rendered sick, sore, lame and disabled and has suffered
`
`excruciating pain, suffering, mental anguish and distress, emotional distress, and has otherwise been
`
`caused to incur loss of enjoyment of life, caused to undergo additional surgical procedures, incur
`
`medical bills, and other expenses, and has otherwise been damaged in such a fair and reasonable
`
`amount as may be awarded by a jury of her peers.
`
`
`
`13
`
`13 of 36
`
`

`

`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 15 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
`
`
`
`53.
`
`As a direct and proximate result of the aforesaid, Plaintiff Krystal Dains hereby
`
`seeks judgment as against Defendants, and each of them, joint, severally, and individually, in such
`
`fair and reasonable amount as may be awarded by a jury of her peers, together with interest, costs of
`
`suit, attorney’s fees, and such further relief as the Court deems just and equitable.
`
`
`
`54.
`
`Defendants’ actions, and each, any and/or all, were done in reckless disregard of the
`
`rights of the consuming public, and otherwise were done purposely, willfully and in reckless
`
`disregard of the rights of the plaintiff individually so as to have defendants liable for punitive
`
`damages.
`
` AND AS FOR A THIRD, SEPARATE, AND DISTINCT CAUSE OF ACTION,
` PLAINTIFF ALLEGES AS FOLLOWS:
`
`Plaintiff hereby incorporates by reference all preceding paragraphs as if fully set forth
`
`55.
`
`
`
`herein.
`
`
`
`56.
`
`Upon and belief, Defendants, BAYER, INC., BAYER HEALTHCARE LLC.,
`
`BAYER ESSURE
`
`INC.,
`
`(F/K/A CONCEPTUS,
`
`INC.), BAYER HEALTHCARE
`
`PHARMACEUTICALS, INC., And BAYER A.G. and each of them, were negligent, careless and
`
`reckless in that said Defendants failed to use reasonable care as described herein in designing,
`
`manufacturing, marketing, labeling, packaging, and selling the Essure device; failed to design the
`
`Essure device so as to avoid an unreasonable risk of harm to women in whom said products were
`
`implanted, including Plaintiff herein; failed to use reasonable care in testing of the Essure device so
`
`as to avoid an unreasonable risk of harm to women in whom said products were implanted, including
`
`the Plaintiff herein; failed to use reasonable care inspecting the Essure device so as to avoid an
`
`unreasonable risk of harm to the women in whom the products were implanted; and was otherwise
`
`negligent, careless and reckless in designing, manufacturing, marketing, labeling, packaging and/or
`
`selling the Essure device; failed to warn or instruct the Plaintiff herein and/or her health care providers
`
`
`
`14
`
`14 of 36
`
`

`

`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 16 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
`
`of the extreme complications that could occur from the Essure Device, and said Defendants were
`
`otherwise negligent, careless and reckless with regard to the Plaintiff herein.
`
`
`
`57.
`
`Upon information and belief, their existed at the time of the design, manufacture, sale
`
`and use safer design alternatives that could and should have been used by the defendants.
`
`
`
`58.
`
`Upon information and belief, as a direct and proximate result of the negligence,
`
`carelessness and reckless of each of the aforesaid Defendants and without any negligence of the
`
`Plaintiff contributing thereto, Plaintiff was caused to sustain server, permanent, and disabling injuries,
`
`and has otherwise been rendered sick, sore, lame and disabled and has suffered excruciating pain,
`
`suffering, mental anguish and distress, emotional distress, and has otherwise been caused to incur
`
`loss of enjoyment of life, caused to undergo unnecessary additional surgical procedures, incur
`
`medical bills, and other expenses, and has otherwise been damaged in such a fair and reasonable
`
`amount as may be awarded by a jury of her peers.
`
`
`
`59.
`
`Defendants, BAYER, INC., BAYER HEALTHCARE LLC, BAYER ESSURE INC.,
`
`(F/K/A CONCEPTUS, INC.), BAYER HEALTHCARE PHARMACEUTICALS, INC., and
`
`BAYER A.G. and each of them, are strictly liable in tort to Plaintiff for designing, manufacturing,
`
`marketing, labeling, packaging, and selling a defective product(s).
`
`
`
`60.
`
`As a direct and proximate result of the aforesaid, Plaintiff, Krystal Dains hereby seeks
`
`judgment as against Defendants, and each of them, jointly, severally, and individually, in such fair
`
`and reasonable amount as may be awarded by a jury of her peers, and requests compensatory
`
`damages, punitive damages, together with interest, costs of suit, attorney’s fees, and such further
`
`relief as the Court deems just and equitable.
`
`
`
`61.
`
`Defendants’ actions, and each, any and/or all, were done in reckless disregard of the
`
`rights of the consuming public, and otherwise were done purposely, willfully and in reckless disregard
`
`of the rights of the plaintiff individually so as to have defendants liable for punitive damages.
`
`
`
`15
`
`15 of 36
`
`

`

`INDEX NO. E2022-0068
`FILED: CAYUGA COUNTY CLERK 01/31/2022 02:30 PM
`Case 5:22-cv-00208-BKS-TWD Document 2 Filed 03/04/22 Page 17 of 41
`NYSCEF DOC. NO. 1
`RECEIVED NYSCEF: 01/31/2022
`
`AND AS AND FOR A FOURTH, SEPARATE,
` AND DISTINCT CAUSE OF ACTION
` PLAINTIFFS ALLEGE AS FOLLOWS
`
`
`
`62.
`
`Plaintiff hereby incorporates by references all preceding paragraphs as it fully set
`
`
`
`
`
`forth herein.
`
`
`
`63. Upon information and belief, the knowing and active concealment and denial of the
`
`facts have tolled any applicable statutes of limitations as alleged herein by Defendants. Plaintiff has
`
`been kept in ignorance of vital information essential to the pursuit of these claims, without any fault
`
`or lack of diligence on her part. Plaintiff could not reasonably have discovered the unreasonable
`
`adverse side effects associated with, and dangerous nature of Essure device prior to July 2014.
`
`
`
`64.
`
`The Defendants are and were under a continuing duty to disclose the true character,
`
`quality, and nature of the Essure device to Plaintiff. Because of Defendant’s concealment of the true
`
`character, quality, and nature of the Essure device, the Defendants are estopped from relying on any
`
`statute of limitations defense.
`
`
`
`65.
`
`As a result of the fraud, fraudulent concealment of all facts set forth above, the
`
`plaintiff has been seriously and permanently injured.
`
`
`
`
`
`
`
`
`
`AND AS AND FOR A FIFTH, SEPARATE, AND DISTINCT
`CAUSE OF ACTION, PLA