throbber
IN THE UNITED STATES DISTRICT COURT
`MIDDLE DISTRICT OF NORTH CAROLINA
`
`Civil Action No. ________
`
`
`JURY TRIAL DEMANDED
`
`
`
`
`
`
`KATHLEEN LENT,
`
` Plaintiff,
`
`v.
`
`ETHICON ENDO-SURGERY, INC.,
`ETHICON ENDO-SURGERY, LLC,
`JOHNSON & JOHNSON HEALTH
`CARE SYSTEMS, INC., and
`JOHNSON & JOHNSON
`CONSUMER, INC.,
`
` Defendants.
`
`
`
`
`
`
`COMPLAINT
`
`Kathleen Lent, Plaintiff (hereinafter referred to as “Plaintiff” or “Lent”)
`
`complaining of Defendants, Ethicon Endo-Surgery, Inc., Ethicon Endo-Surgery, LLC,
`
`Johnson & Johnson Health Care Systems, Inc. and Johnson & Johnson Consumer, Inc.
`
`(hereinafter referred to as “Defendants”), respectfully alleges as follows:
`
`I. INTRODUCTION
`
`1.
`
`Defendants, and each of them, designed, manufactured, and marketed
`
`without proper notice, defective Ethicon Endo-Surgery Staplers. The FDA recently
`
`reported that during the time period from January 1, 2011, through December 31, 2018, it
`
`received close to 110,000 reports related to issues with surgical staplers. Of these, 412
`
`
`
`1
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`were submitted as deaths, 11,181 were submitted as serious injuries, and 98,404 were
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`submitted as malfunctions.1
`
`2.
`
`Plaintiff Kathleen Lent was injured when a surgical stapler, designed,
`
`manufactured, and marketed by Defendants, malfunctioned/misfired during her July 30,
`
`2019 surgery, resulting in a staple line leak in her colon wall near the anastomosis which
`
`had to be repaired through a series of subsequent surgeries and hospitalizations.
`
`II. PARTIES
`
`3.
`
`At all times material, Plaintiff Kathleen Lent was an individual residing in
`
`Cabarrus County, in the State of North Carolina.
`
`4.
`
`At all times material, Defendant Ethicon Endo-Surgery, Inc., was and is an
`
`Ohio corporation with its principal place of business at 4545 Creek Road, Mail Location
`
`11, Cincinnati, Ohio 45242. At all times material, Defendant Ethicon Endo-Surgery,
`
`Inc., was conducting business throughout the State of North Carolina and it maintains
`
`significant, systematic and continuous contacts throughout the State of North Carolina,
`
`but does not appear to have a designated agent within the state upon whom service of
`
`process may be had for causes of action arising out of such business.
`
`5.
`
`Defendant Ethicon Endo-Surgery, LLC is incorporated in the State of
`
`Delaware and its principal place of business is located in Puerto Rico. Per its Certificate
`
`of Authorization to do Business of a Foreign Corporation filed with the Puerto Rico
`
`
`1 FDA Executive Summary, prepared for the May 30, 2019 Meeting of the General and
`Plastic Surgery Devices Panel, Reclassification of Surgical Staplers for Internal Use, p.
`13, available online at https://www.fda.gov/media/126211/download (accessed July 21,
`2021).
`
`
`
`2
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`Registry of Corporations and Entities, Defendant lists its designated office address in
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`Puerto Rico as 475 Street C Los Frailes Industrial Park, Suite 401, Guaynabo, PR 00969
`
`and its Corporate Domicile as 1209 Orange Street, Wilmington, DE 19801. According to
`
`Ethicon Endo-Surgery’s registration with the Registry of Corporations and Entities in
`
`Puerto Rico, the LLC has 20 Administrators, domiciled in Puerto Rico (8), New Jersey
`
`(6), and Ohio (6). No members are domiciled in the State of North Carolina. At all times
`
`material, Defendant Ethicon Endo-Surgery, LLC, has been conducting business
`
`throughout the State of North Carolina and maintains significant, systematic and
`
`continuous contacts throughout the State of North Carolina, but does not appear to have a
`
`designated agent within the state upon whom service of process may be had for causes of
`
`action arising out of such business.
`
`6.
`
`Defendant Johnson & Johnson Health Care Systems, Inc. (“Johnson &
`
`Johnson”) is a New Jersey corporation with its principal place of business at One Johnson
`
`& Johnson Plaza, New Brunswick, New Jersey 08933. Defendant Johnson & Johnson
`
`can be served with process through its Chief Executive Officer, Alex Gorsky, One
`
`Johnson & Johnson Plaza, New Brunswick, New Jersey 08933. At all times material,
`
`Johnson & Johnson has been conducting business throughout the State of North Carolina
`
`and maintains significant, systematic and continuous contacts throughout the State of
`
`North Carolina. Johnson & Johnson is registered to do business in North Carolina with
`
`its local registered agent listed as CT Corporation System, 160 Mine Lake Road, Suite
`
`200, Raleigh NC 27615-6417.
`
`
`
`3
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`7.
`
`At all times material Defendant Johnson & Johnson Consumer, Inc.
`
`(“Johnson & Johnson Consumer”) was and is a New Jersey corporation with its principal
`
`place of business at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933.
`
`Defendant Johnson & Johnson Consumer can be served with process through its Chief
`
`Executive Officer, Alex Gorsky, One Johnson & Johnson Plaza, New Brunswick, New
`
`Jersey 08933. At all times material, Defendant Johnson & Johnson Consumer has been
`
`conducting business throughout the State of North Carolina and maintains significant,
`
`systematic and continuous contacts throughout the State of North Carolina. Johnson &
`
`Johnson Consumer is registered to do business in North Carolina with its local registered
`
`agent listed as CT Corporation System, 160 Mine Lake Road, Suite 200, Raleigh NC
`
`27615-6417.
`
`8.
`
`Defendants Ethicon Endo-Surgery, Inc., Ethicon Endo-Surgery, LLC,
`
`Johnson & Johnson Health Care Systems, Inc., and Johnson & Johnson Consumer, Inc.,
`
`shall be referred to herein individually by name or jointly as the Defendants.
`
`III. JURISDICTION AND VENUE
`
`9.
`
`The Court has jurisdiction over this civil action pursuant to 28 U.S.C. §
`
`1332(a) inasmuch as the amount in controversy exceeds $75,000, exclusive of interests
`
`and costs, and Plaintiff is a citizen of a different state than Defendants.
`
`10. Venue in this district for pretrial proceedings in these civil actions is proper
`
`under 28 U.S.C. § 1391, inasmuch as a substantial part of the events or omissions giving
`
`rise to the claim occurred in this district.
`
`
`
`4
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`11. At all times material, Ethicon Endo-Surgery, Inc., has been in the business
`
`of the researching, developing, selling, and marketing of surgical staplers and staples. At
`
`all times material, Ethicon Endo-Surgery, Inc., has been in the business of and did design,
`
`research, manufacture, test, advertise, promote, market, sell, and distribute the surgical
`
`stapler and staples that make the basis of this suit in the State of North Carolina. This
`
`Court has personal jurisdiction over Ethicon Endo-Surgery, Inc., because Defendant has
`
`submitted itself to the jurisdiction of this Court by engaging in conduct set forth in this
`
`Complaint in the State of North Carolina.
`
`12. At all times material, Ethicon Endo-Surgery, LLC, has been in the business
`
`of the researching, developing, selling, and marketing of surgical staplers and staples. At
`
`all times material, Ethicon Endo-Surgery, LLC, has been in the business of and did
`
`design, research, manufacture, test, advertise, promote, market, sell, and distribute the
`
`surgical stapler and staples that make the basis of this suit in the State of North Carolina.
`
`This Court has personal jurisdiction over Ethicon Endo-Surgery, LLC, because
`
`Defendant has submitted itself to the jurisdiction of this Court by engaging in conduct set
`
`forth in this Complaint in the State of North Carolina.
`
`13. At all times material, Johnson & Johnson has been in the business of the
`
`researching, developing, selling, and marketing of surgical staplers and staples. At all
`
`times material, Johnson & Johnson has been in the business of and did design, research,
`
`manufacture, test, advertise, promote, market, sell, and distribute the surgical stapler and
`
`staples that make the basis of this suit in the State of North Carolina. This Court has
`
`personal jurisdiction over Johnson & Johnson because Defendant has submitted itself to
`
`
`
`5
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`the jurisdiction of this Court by engaging in conduct set forth in this Complaint in the
`
`State of North Carolina.
`
`14. At all times material, Johnson & Johnson Consumer has been in the
`
`business of the researching, developing, selling, and marketing of surgical staplers and
`
`staples. At all times material, Johnson & Johnson Consumer has been in the business of
`
`and did design, research, manufacture, test, advertise, promote, market, sell, and
`
`distribute the surgical stapler and staples that make the basis of this suit in the State of
`
`North Carolina. This Court has personal jurisdiction over Johnson & Johnson Consumer
`
`because Defendant has submitted itself to the jurisdiction of this Court by engaging in
`
`conduct set forth in this Complaint in the State of North Carolina.
`
`15.
`
`The Defendants are individually, jointly, and severally liable to Plaintiff for
`
`damages suffered by Plaintiff arising from their negligent design, manufacturing,
`
`marketing, labeling, distribution, sale, and placement of the defective product at issue in
`
`this suit. All acts were effectuated directly and indirectly through Defendants’ respective
`
`agents, servants, employees, and/or owners, acting within the course and scope of their
`
`representative agencies, services, employments, and/or ownership.
`
`16. Defendants are vicariously liable for the acts and/or omissions of their
`
`employees and/or agents, who were at all times relevant acting on Defendants’ behalf and
`
`within the scope of their employment or agency with Defendants.
`
`IV. FACTS
`
`17. On July 30, 2019, Plaintiff Kathleen Lent underwent a sigmoid colectomy
`
`surgery due to acute diverticulitis with suspected perforation by Dr. Mary Jordan at
`
`
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`Atrium Health Cabarrus Hospital located in Concord, North Carolina. Dr. Jordan had no
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`issues dissecting and removing the affected portion of Plaintiff’s colon, but when Dr.
`
`Jordan attempted to connect the two portions of the colon together using a 29 mm ILS
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`Circular Stapler, she encountered difficulties. Dr. Jordan stated in part in her operative
`
`report, “The stapler was closed and fired. It appeared to fire correctly, however, would
`
`not release to be removed in its usual fashion. Unfortunately, the efforts to release the
`
`stapler resulted in a hole forming in the colon just proximal to the stapler line.” As a
`
`result of the stapler malfunction, the low level of rectal division and the damage to the
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`Plaintiff’s colon, Dr. Jordan was unable to perform a repeat attempt to connect the two
`
`ends of Plaintiff’s bowel with a circular stapler and attempted to perform the anastomosis
`
`using hand sutures. Dr. Jordan was unsuccessful and abandoned her attempts to perform
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`hand sutures because of the low level of the anastomosis and the trauma suffered by the
`
`tissue because of the stapler malfunction. Dr. Jordan elected to perform diverting loop
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`ileostomy. Plaintiff’s postoperative course was unremarkable, and Plaintiff was
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`discharged on August 3, 2019.
`
`18.
`
`Following the surgery, Plaintiff experienced issues with her the catheter
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`located below her loop ileostomy which caused significant pain and excretion of her skin
`
`around the ostomy site. Additionally, Plaintiff complained of frequent abdominal pain
`
`and a pulling sensation at her ileostomy site. On August 9, 2019, she presented for post-
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`operative evaluation and the decision was made to remove her catheter and place a
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`Coloplast donut around the ileostomy to help alleviate her pain and address the excretion
`
`of her skin.
`
`
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`7
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`19.
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`Plaintiff’s abdominal pain worsened, and she developed a high fever along
`
`with vomiting, so she presented to the Atrium Health Emergency Room on August 27,
`
`2019. Plaintiff was admitted to the hospital and a CT scan was performed which was
`
`concerning for a partial small obstruction. Given Plaintiff’s frequent complains of
`
`abdominal pain it was determined she was most likely suffering from repeated issues of
`
`partial bowel obstructions, and it was recommended she undergo ileostomy reversal.
`
`20. On August 28, 2019, Plaintiff underwent an ileostomy reversal at Atrium
`
`Health. Plaintiff’s postoperative course was unremarkable, and Plaintiff was discharged
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`on August 30, 2019.
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`21. On September 3, 2019, Plaintiff once again presented to the Atrium Health
`
`Emergency Room complaining of abdominal pain and a fever for the past two days. A
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`CT scan was performed of her abdomen and pelvis which revealed a deep subcutaneous
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`fluid collection along her abdomen. Plaintiff was diagnosed with a postsurgical abscess
`
`and sepsis and was placed on intravenous antibiotics. On September 5, 2019, Plaintiff
`
`underwent irrigation and drainage of the abdominal wall abscess. It was determined
`
`during the procedure that the best way to allow the wound to heal was to leave the wound
`
`open and place a wound vac. Plaintiff was discharged on September 7, 2019, with orders
`
`for home health care to continue frequent wound vac changes. On September 16, 2019,
`
`Plaintiff had her wound vac removed.
`
`22.
`
`Since July 30, 2019, Plaintiff has continued issues with her wound site and
`
`has developed a hernia at the wound site which has required additional hospitalizations
`
`and treatment.
`
`
`
`8
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`23.
`
`The malfunction/misfire of the surgical stapler in Plaintiff’s July 30, 2019
`
`sigmoid colectomy surgery resulted in a number of complications, including:
`
`a.
`b.
`
`c.
`d.
`
`undergoing an emergency diverting loop ileostomy;
`repeated hospitalizations due to wound care complications and
`partial bowel obstructions;
`having to undergo an ileostomy reversal surgery;
`development of sepsis and need to undergo emergent irrigation and
`debridement of wound site;
`development of a hernia at the wound site which required additional
`hospitalizations and treatment; and
`ongoing care for the injuries she suffered in her July 30, 2019
`surgery.
`
`Plaintiff’s medical records and medical providers have identified the stapler
`
`e.
`
`f.
`
`24.
`
`that malfunctioned/misfired during Plaintiff’s July 30, 2019 surgery as an Ethicon
`
`circular stapler, product code: CVD ILS CDH29A.
`
`25.
`
`Plaintiff alleges on information and belief that the Ethicon circular stapler
`
`used in her July 30, 2019 surgery was a model known by Defendants to frequently
`
`malfunction. In April of 2019, the Ethicon Defendants issued a recall on Ethicon Endo-
`
`Surgery Intraluminal Staplers, because uncut washers in the stapler and malformed
`
`staples occur with their intraluminal circular staplers due to insufficient firing, which can
`
`compromise staple line integrity. The recall further states that the failure to cut the
`
`washer suggests complete 360-degree staple line failure, which could lead to potential
`
`risks to patients including death, sepsis, bleeding, the need for permanent ostomy "bag,"
`
`life-long nutritional and digestive issues, leak in the closure (anastomotic leak),
`
`additional surgeries, need for additional closures (anastomoses), need for antibiotics, and
`
`the need for additional imaging studies.
`
`
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`26.
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`Plaintiff has since learned that the stapler in question was likely recalled
`
`and that the FDA recently reported that surgical staplers, including those manufactured
`
`by Defendants, have been responsible for tens of thousands of adverse outcomes
`
`attributed to malfunctioning staplers.
`
`27. Based on the number of stapler-related injuries, in May 2019, the FDA
`
`proposed reclassifying surgical staplers for internal use from Class I to Class II (Special
`
`Controls).2
`
`28. Despite knowing that its Ethicon Endo-Surgery Staplers caused injuries due
`
`to malfunction, Defendants, and each of them, represented and marketed the staplers as
`
`safe and effective. Defendants, and each of them, failed to include warnings regarding
`
`potential malfunctions that were known to them, including the risks described in the FDA
`
`publication.3
`
`29. Defendants intentionally engaged in the following conduct: 1) failing to
`
`provide warnings regarding the potential for their staplers to malfunction in a manner
`
`exactly like what occurred during Plaintiff’s surgery; 2) failing to warn and inform
`
`surgeons of the potential for the staplers to malfunction in a manner exactly like what
`
`occurred during Plaintiff’s surgery; and 3) failing to recall their defective products until
`
`2019 when they knew earlier that the staplers were prone to malfunction. By engaging in
`
`the conduct described above, Defendants furthermore engaged in willful, wanton,
`
`
`2 FDA Executive Summary Prepared for the May 30, 2019 Meeting of the General and
`Plastic Surgery Devices Panel Reclassification of Surgical Staplers for Internal Use:
`https://www.fda.gov/media/126211/download
`3 Id. at Pg. 9.
`
`
`
`10
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`reckless, malicious behavior and/or exhibited a gross indifference to, and a callous
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`disregard for human life, the safety and the rights of others, and more particularly, the
`
`rights, life and safety of the Plaintiff; and Defendants were motivated by consideration of
`
`profit, financial advantage, monetary gain, economic aggrandizement and cost avoidance,
`
`to the virtual exclusion of all other considerations.
`
`PLAINTIFF’S CAUSES OF ACTION
`
`FIRST CAUSE OF ACTION
`NEGLIGENCE -- MANUFACTURING DEFECT
`
`The allegations of paragraphs 1 through 29 of the complaint are
`
`30.
`
`incorporated herein by reference.
`
`31.
`
`Plaintiff is a “Claimant” pursuant to the North Carolina Product Liability
`
`Act, N.C.G.S. § 99B-1(1).
`
`32.
`
`Each Defendant is either a "Manufacturer" pursuant to N.C.G.S. § 99B-1(2)
`
`or a "Seller" pursuant to N.C.G.S. § 99B-1(4).
`
`33.
`
`34.
`
`This matter is a “Product liability action" pursuant to N.C.G.S. § 99B-1(3).
`
`Plaintiff was harmed by Defendants’ defective Endo-Surgery stapler, which
`
`was distributed, manufactured, and sold by Defendants. Defendants’ stapler contained a
`
`manufacturing and design defect that made it unsafe to perform the function it was
`
`intended to perform. Specifically, there was a design or manufacturing defect that would
`
`result in staple line failure and anastomotic leak despite proper utilization by a surgeon.
`
`35.
`
`In April of 2019, the Defendants issued a recall for their Endo-Surgery
`
`Intraluminal Staplers, because uncut washers in the stapler and malformed staples occur
`
`
`
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`with their intraluminal circular staplers due to insufficient firing, which can compromise
`
`staple line integrity. The recall further states that the failure to cut the washer suggests
`
`complete 360-degree staple line failure, which could lead to potential risks to patients
`
`including death, sepsis, bleeding, the need for permanent ostomy "bag," life-long
`
`nutritional and digestive issues, leak in the closure (anastomotic leak), additional
`
`surgeries, need for additional closures (anastomoses), need for antibiotics, and the need
`
`for additional imaging studies. The recall also stated that an investigation conducted by
`
`Ethicon of the manufacturing process of the Ethicon Endo-Surgery Intraluminal Staplers
`
`detected a shift in a process, which occurred in March of 2018 through March 8, 2019, at
`
`which time the line was shut down.
`
`36. On May 15, 2019, the FDA issued a Class One Device Recall for
`
`Defendants’ Endo-Surgery Intraluminal Staplers which were designed and manufactured
`
`for use in gastrointestinal surgeries including in patients undergoing surgery for a
`
`sigmoid colectomy. The recall was issued because the stapler may have an insufficient
`
`firing stroke to break the washer and completely form staples. The recall also stated that
`
`an investigation conducted by Ethicon of the manufacturing process of the staplers
`
`detected a shift in a process, which occurred in March of 2018 through March 8, 2019, at
`
`which time the line was shut down. This recall notice is still active.
`
`37.
`
`Following her July 30, 2019 surgery, Plaintiff was advised by Dr. Jordan
`
`that the “stapler malfunctioned” in her July 30, 2019 surgery which necessitated Dr.
`
`Jordan performing the diverting ileostomy. The April 2019 recall issued by the
`
`Defendants and the May 2019 recall issued by the FDA both stated that as a “result of
`
`
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`manufacturing defects”4 in the recalled devices the stapler may have an insufficient firing
`
`stroke to break the washer and completely form staples which may result in compromised
`
`staple line integrity and anastomotic leak. This is exactly what the Plaintiff has alleged
`
`occurred and has been confirmed by her medical providers and medical records.
`
`38. On information and belief, Plaintiff alleges the device subject to the recalls
`
`is the same device used in her July 30, 2019 surgery and has also been identified as the
`
`device that was used in her surgery by her medical providers and medical records.
`
`39.
`
`The surgical stapler used in Plaintiff’s July 30, 2019 surgery was: (1).
`
`manufactured by the Defendants; (2) malfunctioned as a result of manufacturing defect
`
`which rendered the surgical stapler unreasonably dangerous; (3) the defect existed at the
`
`time the stapler was distributed by the Defendant as evidenced by the company’s own
`
`recall notice and the FDA recall notice; and (4) the defect was a substantial factor in
`
`causing Plaintiff’s injuries.
`
`40. As a direct and proximate result of Defendants’ negligence, manufacturing
`
`and design defects, Plaintiff has incurred losses and damages for personal injury, loss of
`
`use and enjoyment of life, the need for periodic medical examination and treatment, and
`
`economic losses, including additional medical expenses, and the expenditure of time and
`
`money, and will continue to incur losses and damages in the future.
`
`
`4 See generally Johnson & Johnson Subsidiary Ethicon Recalls Proximate® Reloadable
`Surgical Stapler, March 31, 2020, https://www.jdsupra.com/legalnews/johnson-johnson-
`subsidiary-ethicon-59595/ (accessed July 21, 2021); FDA labels Ethicon surgical staplers
`recall as Class I, May 20, 2019 https://www.medicaldevice-network.com/news/fda-
`ethicon-staplers-recall/ (accessed July 21, 2021).
`13
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`41. Due to Defendants’ negligence, failure to warn, manufacturing, and design
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`defects, Plaintiff is entitled to compensatory damages in a sum to be determined by a
`
`jury, plus punitive damages in a sum equal to a multiplier of damages determined to be
`
`adequate by a jury to the extent the evidence reflects the existence of an aggravating
`
`factor in accordance with N.C.G.S. § 1D-1, et seq.
`
`42. Wherefore, Plaintiff demands an award of damages in excess of $75,000.
`
`SECOND CAUSE OF ACTION
`NEGLIGENCE -- DESIGN DEFECT
`
`Plaintiff hereby incorporates the allegations contained in the preceding
`
`43.
`
`paragraphs 1 through 42, as though fully set forth herein.
`
`44.
`
`Plaintiff was harmed by Defendants’ Endo-Surgery Intraluminal Stapler,
`
`which was distributed, manufactured, and sold by Defendants. Defendants’ staplers
`
`contained a design defect that made it unsafe to perform the function it was intended to
`
`perform. Specifically, there was a design defect that would result in a compromised
`
`staple line integrity and anastomotic leak despite proper utilization by a surgeon.
`
`45. Defendants’ own recall notice and the FDA recall notice identified that the
`
`product used in Plaintiff’s July 30, 2019 surgery was defectively designed. Specifically,
`
`the October of 2019 recall instituted by the Defendants stated the recall was instituted
`
`because, “uncut washers in the stapler and malformed staples occur with their
`
`intraluminal circular staplers due to insufficient firing, which can compromise staple line
`
`integrity.” Plaintiff alleges on information and belief that the defective design of the
`
`
`
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`device used in Plaintiff’s surgery was a cause of the device to malfunction and lead to
`
`insufficient firing.
`
`46. Additionally, on May 15, 2019 the FDA issued a Class One Device Recall
`
`for Defendants’ Endo-Surgery Intraluminal Staplers because, “the staplers may have an
`
`insufficient firing stroke to break the washer and completely form staples.” Plaintiff
`
`alleges on information and belief that the defective design of the device used in Plaintiff’s
`
`surgery was a cause of the device to malfunction and fail to completely form staples.
`
`47.
`
`These recall notices continued for a significant period of time and/or are
`
`still active, and the Defendants have resumed manufacturing, marketing and selling the
`
`device that is the subject of Plaintiff’s claims. Presumably the design defect issues have
`
`been fixed, otherwise the Defendants would not have resumed the manufacturing,
`
`marketing and selling of the device. This clearly indicates that a safer alternative design
`
`of the surgical stapler in question existed at the time of Plaintiff’s surgery. The design
`
`defect of the surgical stapler in question was a producing cause of Plaintiff’s injuries as
`
`incorporated in the preceding allegations. Had Defendants implemented the safer
`
`alternative design prior to Plaintiff’s surgery it would have prevented or significantly
`
`reduced the risk of Plaintiff’s injuries and implementing the safer alternative design
`
`would not have substantially impaired Defendants’ product’s utility. Likewise, Plaintiff
`
`asserts it was economically and technologically feasible for the Defendants to implement
`
`the safer alternative design prior to the time the device left Defendants’ control.
`
`48. As a direct and proximate result of Defendants’ negligence, manufacturing
`
`and design defects, Plaintiff has incurred losses and damages for personal injury, loss of
`
`
`
`15
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`Case 1:21-cv-00596 Document 1 Filed 07/21/21 Page 15 of 24
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`use and enjoyment of life, the need for periodic medical examination and treatment, and
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`economic losses, including additional medical expenses, and the expenditure of time and
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`money, and will continue to incur losses and damages in the future.
`
`49.
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`Plaintiff alleges pursuant to N.C.G.S. § 99B-6(a) that at the time of its
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`manufacture, Defendants acted unreasonably in designing or formulating the product, this
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`conduct was a proximate cause of the harm for which damages are sought, and at the time
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`the product left the control of Defendants, they had unreasonably failed to adopt a safer,
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`practical, feasible, and otherwise reasonable alternative design or formulation that could
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`then have been reasonably adopted and that would have prevented or substantially
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`reduced the risk of harm without substantially impairing the usefulness, practicality, or
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`desirability of the product.
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`50.
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`Plaintiff furthermore alleges that at the time the product left the control of
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`the Defendants, the design or formulation of the product was so unreasonable that a
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`reasonable person, aware of the relevant facts, would not use or consume a product of
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`this design.
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`51.
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`Plaintiff furthermore alleges that Defendants’ conduct was unreasonable
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`when considering the nature and magnitude of the risks of harm associated with the
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`design in light of the intended and reasonably foreseeable uses, modifications, or
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`alterations of the product; the likely awareness of product users, whether based on
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`warnings, general knowledge, or otherwise, of those risks of harm; the extent to which
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`the design conformed to any applicable government standard that was in effect when the
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`product left the control of its manufacturer; the utility of the product, including the
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`
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`16
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`Case 1:21-cv-00596 Document 1 Filed 07/21/21 Page 16 of 24
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`performance, safety, and other advantages associated with that design; the technical,
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`economic, and practical feasibility of using an alternative design at the time of
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`manufacture; and the nature and magnitude of any foreseeable risks associated with the
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`alternative design.
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`52. Due to Defendants’ negligence, failure to warn, manufacturing, and design
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`defects, Plaintiff is entitled to compensatory damages in a sum to be determined by a
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`jury, plus punitive damages in a sum equal to a multiplier of damages determined to be
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`adequate by a jury.
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`53. Wherefore, Plaintiff demands an award of damages in excess of $75,000.
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`THIRD CAUSE OF ACTION
`FAILURE TO WARN
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`Plaintiff hereby incorporates the allegations contained in the preceding
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`54.
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`paragraphs 1 through 53 as though fully set forth herein.
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`55. Defendants, and each of them, failed to provide accurate information to the
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`public including surgeons, on the risks associated with using their Endo-Surgery
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`Intraluminal Staplers. Specifically, Defendants, and each of them, promoted the staplers
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`as being safe while they knew at least as early as March of 2018 about the risk of the
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`staplers to malfunction and fail to completely form which could compromise staple line
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`integrity. As a result, neither Plaintiff nor her surgeon knew of the risks of injury like the
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`one Plaintiff suffered, prior to her surgery.
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`56. Defendants, and each of them, knew that the Endo-Surgery Intraluminal
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`Stapler posed a risk to patients when used as intended because, as stated in the recalls
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`
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`17
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`Case 1:21-cv-00596 Document 1 Filed 07/21/21 Page 17 of 24
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`issued by the Defendants and the FDA both stated, “a breakdown in the manufacturing
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`process causing certain units to be manufactured with an insufficient firing stroke to
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`break the washer and completely form staples and the failure to form a staple line that
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`resulted in leakage.” Defendants have hidden the true risks of the using the devices from
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`surgeons and their patients.
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`57. Despite knowing about this defect, Defendants, and each of them, failed to
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`warn potential surgeons or patients until a recall in October of 2019.
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`58.
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`The Defendants continued to market, manufacturer and sell the devices
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`with the knowledge of the defects and potential risk of harm to patients and failed to
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`inform potential patients and their physicians of these known defects and risks at the time
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`of the sale of the devices. The failure to notify or warn the patients and their physicians
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`of the defects and risks renders the devices unreasonably dangerous to the patient and
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`their physicians. The failure to warn patients and their physicians of the defects and risks
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`of the devices in question was a producing cause of Plaintiff’s injuries.
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`59.
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`Plaintiff is unaware of any evidence that the Defendants warned Plaintiff’s
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`physicians of the defects and risks of the devices prior to Plaintiff’s surgery. Plaintiff
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`alleges on information and belief that had her physicians been warned or notified of the
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`defects and risk of the devices prior to Plaintiff’s surgery they would have not used the
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`devices or subjected Plaintiff to the risks associated with using these devices. Plaintiff
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`also alleges on information and belief that had her physicians been warned or notified of
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`the defects and risk of the devices prior to Plaintiff’s surgery they would have warned the
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`Plaintiff prior to her surgery of the defects and risks associated with using the devices and
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`
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`18
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`Case 1:21-cv-00596 Document 1 Filed 07/21/21 Page 18 of 24
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`Plaintiff would have been afforded the opportunity to make an informed decision on
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`whether to proceed with the surgery given the risks.
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`60. As a direct and proximate result of Defendants’ negligence, manufacturing
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`and design defects, Plaintiff has incurred losses and damages for personal injury, loss of
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`use and enjoyment of life, the need for periodic medical examination and treatment, and
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`e

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