Case 2:22-cv-00168-EEF-MBN Document 1 Filed 01/26/22 Page 1 of 24
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`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF LOUISIANA
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`CHRISTINE L. COLLIER and
`DENNIS COLLIER
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`VERSUS
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`ETHICON Inc. and JOHNSON AND
`JOHNSON
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` Defendants.
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`Plaintiff,
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`Civil Action No.:
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`Judge:
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`Magistrate Judge:
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`COMPLAINT FOR DAMAGES
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`TO THE HONORABLE UNITED STATES DISTRICT COURT FOR THE EASTERN
`DISTRICT OF LOUISIANA AND THE JUDGES THEREOF:
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`The complaint of Christine L. Collier and Dennis Collier, persons of the full age of
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`majority, through undersigned counsel, alleges the following upon personal knowledge and belief,
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`and investigation of counsel:
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`NATURE OF THE CASE
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`1.
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`This is a product liability action seeking recovery for substantial personal injuries and
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`damages suffered by Christine L. Collier (“Plaintiff”) and Dennis Collier (“Spouse Plaintiff”),
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`after Christine L. Collier was seriously injured when an Echelon 29mm Circular Powered Stapler
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`EEA misfired during colon surgery performed at Ochsner Northshore Medical Center, Slidell,
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`Louisiana.
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`2.
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`Ethicon, Inc., is a part of the Johnson and Johnson Medical Devices segment and a
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`subsidiary of Johnson & Johnson (referred herein collectively as “Defendants”), and designs,
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`manufactures, markets, imports, distributes and sells a wide range of surgical products, including
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`the Echelon 29mm Circular Powered Stapler EEA at issue in this case.
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`Case 2:22-cv-00168-EEF-MBN Document 1 Filed 01/26/22 Page 2 of 24
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`3.
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`On or about February 8, 2021, Plaintiff suffered serious and substantial injuries as the direct
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`and proximate result of the Echelon 29mm surgical stapler misfiring during a surgery that was
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`originally intended to remove a small portion of plaintiff’s sigmoid colon due to diverticulitis. The
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`misfire caused extensive tissue damage in the colon and rectum, requiring the surgeon to convert
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`from a minimally invasive scope surgery to a laparotomy with a midline incision. An extended left
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`colectomy was then required to be performed with colorectal anastomosis. A substantial portion
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`of the large colon was removed and resected due to tissue damage caused by the misfire. A hole
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`in the rectum also had to be repaired.
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`4.
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`The Plaintiff suffered post-surgical complications. Post-operatively, she required blood
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`transfusions. The Plaintiff suffered an abdominal wall abscess at the site of the incision. The mid-
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`line incision dehisced, requiring it to be opened and the Plaintiff placed on a wound vac for months.
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`The Plaintiff underwent two procedures caused by the stapler misfire: 1) debridement of the
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`infected abdominal incision, and 2) surgery to repair an incisional hernia and the weakened
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`abdominal wall.
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`5.
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`As a direct and proximate result of Defendant’s conduct, the Plaintiff in this case incurred
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`significant and painful bodily injuries, medical expenses, wage loss, physical pain, mental anguish,
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`and diminished enjoyment of life.
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`THE PARTIES
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`6.
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`Plaintiff and Spouse Plaintiff were at all relevant times, residents and citizens, and
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`domiciled in the city of Picayune, Mississippi. Plaintiff Christine L. Collier commuted to work at
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`Slidell Memorial Hospital in Slidell, Louisiana prior to the February 8, 2021 surgery. The February
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`8, 2021 surgery was performed at Ochsner Medical Center – North Shore, Slidell, Louisiana.
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`Plaintiffs are citizens of Mississippi for purposes of diversity jurisdiction under 28 U.S.C §1332.
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`Case 2:22-cv-00168-EEF-MBN Document 1 Filed 01/26/22 Page 3 of 24
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`7.
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`Defendants design, manufacture, market, import, distribute and sell a variety of surgical
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`products, including the subject Echelon 29mm Circular Powered Stapler EEA, upon information
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`and belief Product Code CDH29P.
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`8.
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`Defendant Johnson & Johnson (“J&J”) is a corporation organized and existing under the
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`laws of New Jersey, maintaining its principal place of business at 1 Johnson & Johnson Plaza,
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`New Brunswick, New Jersey 08933. J&J organizes its subsidiary businesses into individual
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`Business Units to coordinate the development, manufacture, testing, marketing promotion,
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`training, distribution and sale of its pelvic floor repair products. Within J&J there are three business
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`segments: medical devices, pharmaceutical, and consumer. Ethicon, operating in the medical
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`devices segment, is charged by J&J with the design, development, promotion, marketing, testing,
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`training, distribution and sale of the surgical stapler product at issue in this case. The Executive
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`Committee of J&J oversees and coordinates the activities of three business segments, including
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`the medical devised segment.1 J&J is a citizen of New Jersey.
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`9.
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`Defendant, Ethicon, Inc., is a wholly owned subsidiary of Defendant J&J located in
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`Somerville, New Jersey. Ethicon, Inc. is a corporation organized and existing under New Jersey
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`law, maintaining its principal place of business at 555 US Route 22, Somerville, New Jersey,
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`08876. Ethicon, Inc. is a citizen of New Jersey.
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`10.
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`J&J and Ethicon, Inc. are collectively referred to herein as “Ethicon” or “Defendants.”
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`11. All acts and omissions of the above-referenced Defendants as described herein were
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`done by its agents, servants, employees and/or owners, acting in the course and scope of their
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`respective agencies, services, employments, and/or ownership.
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`1 See J&J Annual Report 2020 pg. 1, https://www.jnj.com/annual report (accessed January 8, 2022).
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`Case 2:22-cv-00168-EEF-MBN Document 1 Filed 01/26/22 Page 4 of 24
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`JURISDICTION AND VENUE
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`12.
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`This Court has subject matter jurisdiction over this case pursuant to diversity jurisdiction
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`prescribed by 28 U.S.C. § 1332 because the matter in controversy exceeds the sum or value of
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`$75,000, exclusive of interest and costs, and there is complete diversity between the parties.
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`13.
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`Venue is proper in this Court pursuant to 28 U.S.C. § 1391 because all or a substantial part
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`of the events or omissions giving rise to this claim occurred in this district. Venue is also proper
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`in this Court pursuant to 28 U.S.C. § 1391 because Defendants have sufficient minimum contacts
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`with the State of Louisiana and intentionally availed themselves of the markets within Louisiana
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`through the promotion, sale, marketing, and distribution of their products.
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`CHOICE OF LAW
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`14.
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`In tort actions, under article 3542 of the Louisiana Civil Code, the court must apply “the
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`law of the state whose policies would be most seriously impaired if its law were not applied to that
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`issue.”
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`15.
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`In an exceptional case, Article 3547 provides:
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`“The law applicable under Articles 3443-3546 shall not apply if, from the totality of the
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`circumstances of an exceptional case, it is clearly evident under the principles of Article
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`3542 that the policies of another state would be more seriously impaired if its law were not
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`applied to the particular issue. In such event, the law of the other state shall apply.”
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`16.
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`Plaintiffs assert that Louisiana law should be applied to their causes of action detailed
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`herein.
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`17.
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`Plaintiffs reserve the right to move for leave to file an amended complaint to add punitive
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`damages should be determined that the law of another state should apply to this claim.
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`Case 2:22-cv-00168-EEF-MBN Document 1 Filed 01/26/22 Page 5 of 24
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` FACTUAL BACKGROUND
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`18.
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`On February 8, 2021, Plaintiff, Christine L. Collier, was scheduled to undergo a robotic
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`sigmoid colectomy surgery at Ochsner Northshore Medical Center, Slidell, Louisiana, due to acute
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`diverticulitis. Dr. Joshua Parks, according to his operative report, had no issues dissecting in the
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`retroperitoneal space and continuing the dissection on the right side to the rectum. He freed the
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`proximal sigmoid colon and descending colon robotically. He picked a point of proximal resection
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`in the mid descending colon. A purse string suture was then placed for the anvil of the Echelon
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`29mm stapler. The stapler was passed through the rectum and the anvil connect to the stapler. Dr.
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`Parks stated in part in his operative report that the stapler “is closed and attempted to fire. It does
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`not fire. The stapler misfired requiring mini laparotomy to release the stapler. In releasing the
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`stapler, a colectomy was made as well as proctotomy.” Dr. Parks made the decision to convert to
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`an open extended left colectomy with colorectal anastomosis and resect in the distal transverse
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`colon due to tissue injury. He then turned his attention to the rectal stump. “Patient has
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`approximately one inch hole on the anterior wall of the rectum” from the misfired stapler.
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`19.
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` On February 9, 2021, Christine Collier developed acute surgical blood loss anemia from
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`blood loss during surgery. She received a blood transfusion of two units.
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`20.
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`On February 13, 2021, Mrs. Collier developed a fever. Purulent drainage came from the
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`midline incision with cellulitis. The wound was opened and dressed.
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`21.
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`On February 15, Mrs. Collier’s wound dehisced and she developed abdominal wall
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`cellulitis and abscess. She was examined by the general surgeon. She was placed on intravenous
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`Vancomycin and Zosyn antibiotic therapy. A wound vac was placed over the open incision.
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`22. Ms. Collier’s wound infection continued for months. By May, 2021, Mrs. Collier was still
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`using the wound vac. She requested extended leave from her employment at Slidell Memorial
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`Case 2:22-cv-00168-EEF-MBN Document 1 Filed 01/26/22 Page 6 of 24
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`Hospital, where she worked as a nurse.
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`23. Mrs. Collier developed an incisional hernia and continued with significant abdominal pain.
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`On January 12, 2022, Mrs. Collier underwent a second surgery at the Ochsner Hospital, main
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`campus, to repair the incisional hernia and her weakened abdominal wall.
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`24.
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`The malfunction/misfire of the surgical stapler in Mrs. Collier’s February 8, 2021 sigmoid
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`colectomy surgery resulted in a number of complications, including:
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`a.
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`Converting robotic scope surgery to remove a small portion of the colon to
`an open surgery to remove significantly more colon due to tissue damage
`and increase infection risk with a mid-line incision;
`Blood loss and transfusion;
`Repeated treatment due to wound dehiscence;
`Having to undergo hernia and abdominal wall repair surgery;
`Development of infection and need to undergo extended wound care; and
`Ongoing care for the injuries she suffered in her February 8, 2021
`surgery.
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`25. Plaintiff's medical records identify the stapler that malfunctioned/misfired during Mrs.
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`b.
`c.
`d.
`e.
`f.
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`Colliers February 8, 2021 surgery as an Ethicon/Echelon 29mm Circular Powered Stapler EEA.
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`The product code is believed to be CDH29P, based upon products listed on the J&J Medical
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`Devices/Ethicon website.
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`26. In March, 2019 the Food and Drug Administration announced a sweeping plan to review
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`and address the safety of surgical staplers, including a new examination of seven years’ worth of
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`hidden reports highlighted several days earlier in a Kaiser Health News investigation.
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`27. In a letter 2 sent to health care providers on March 8, 2019, the FDA said it would convene
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`an advisory meeting on the safety of the devices and signaled that it might reclassify surgical
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`staplers to put them under tighter control. The agency also said it planned to issue proposed
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`recommendations to companies that make the devices, which are used in countless surgeries.
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`2 https://www.fda.gov./medical-devices/letters-health-care-providers/safe-use-surgical (accessed January 17, 2022)
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`28.
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`The FDA also acknowledged in its letter that “we are aware that many more device
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`malfunction reports during this time frame” were submitted as “summary reports,” which go to
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`the FDA but are not included in the public database known as Maude (the Manufacturer and User
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`Facility Device Experience). The agency said it “is conducting an analysis” of those summary
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`reports and the results will be made available to the public.
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`29.
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`The agency’s announcement said that public reports of harm by staples and staplers show
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`“that from January 1, 2011, to March 31, 2018, the FDA received more than 41,000 individual
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`medical device reports for surgical staplers and staples for internal use, including 366 deaths,
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`more than 9,000 serious injuries, and more than 32,000 malfunctions.”
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`30.
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`The FDA said some of the most commonly reported problems in the adverse event
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`reports were:
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`•
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`•
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`•
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`•
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`•
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`opening of the staple line or malformation of staples;
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`misfiring;
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`difficulty in firing;
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`failure of the stapler to fire the staple; and
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`misapplied staples.
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`31.
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`As required by section 513(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),
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`the Food and Drug Administration (FDA) convened the General and Plastic Surgery Devices
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`Advisory Panel (the Panel) on May 30, 2019 to discuss and make recommendations regarding
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`the regulatory classification of surgical staplers for internal use, currently under the classification
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`regulation 21 CFR 878.4800, which FDA has grouped under product code GAG. The scope of
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`this Panel meeting excluded surgical staplers for external use (i.e., skin staplers).
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`32.
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`The FDA said it was concerned by the recent number of adverse events associated with
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`surgical staplers. “Stapler/staple malfunctions may result in prolonged surgical procedures or
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`unplanned, additional surgical interventions, which may lead to other complications such as
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`bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer
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`recurrence, and death.” 3
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`33.
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`The FDA acknowledged that, prior to February 2019, surgical staplers for internal use
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`were also eligible for the ASR Program. This program enabled manufacturers of certain device
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`types to submit quarterly summary reports of specific well known and well characterized events
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`in lieu of individual reports of each such event. FDA said it carefully reviewed and considered
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`all such reports but reports prior to 2017 were not made publicly available because the format
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`was not compatible with the public database. In an effort to promote greater public transparency,
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`FDA announced it would be making ASR data that was reported to the FDA prior to 2017
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`available to the public on FDA.gov in the coming weeks. The analysis of MDRs associated with
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`surgical staplers for internal use provided herein includes all events received by FDA through the
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`standard individual MDR reporting mechanism as well as through the ASR Program.
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`34.
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`Because surgical staplers are used together with staples as a system, FDA conducted a
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`search of the Maude database was conducted for both surgical staplers for internal use under
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`product code GAG (Stapler, Surgical) and surgical staples for internal use under product code
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`GDW (Staple, Implantable) to obtain a comprehensive picture of the safety profile for surgical
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`staplers for internal use. The Maude database (which does not include reports received before
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`2017 through ASR) was searched for individual MDR reports received from January 1, 2011
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`through December 31, 2018 using the product codes GAG and GDW. The results yielded a total
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`of 53,720 reports. A total of 56,277 additional reports were submitted through ASR over this
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`same time period. All reports received through ASRs were malfunction reports. The combined
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`3 https://www.fda.gov./executive-summary/general-and-plastic-surgery (accessed January 19, 2022)
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`MAUDE/ASR total number of MDR reports received for product codes GDW and GAG was
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`109,997. Of the 109,997 reports received, 412 were submitted as deaths, 11,181 were submitted
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`as serious injuries, and 98,404 were submitted as malfunctions.
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`35.
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`The FDA executive summary said “the most reported device problems for these adverse
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`event reports were: failure to fire or misfire (38%), failure to form a staple (18%), difficulty
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`opening or closing (11%), breaking/detachment of device component (10%), and device
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`operating differently than expected (3%). The most reported patient problem codes were tissue
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`damage (4%), hemorrhage (2%), blood loss/ bleeding (2%), failure to anastomose (2%), and
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`delayed surgical procedure (1%).”
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`36.
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`The FDA database reports 254 recalls of Ethicon products between 2005 and 2021. The
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`products include staplers and “cutters” as well as sutures. On February 1, 2005, the FDA issued
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`the first recall of an Ethicon stapler, the Endopath EZ45 No Knife Linear Stapler.
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`37.
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`On May 15, 2019, the FDA issued twelve (12) Class 1 recalls of the Ethicon4 Intraluminal
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`Stapler due to “insufficient firing.” A Class I recall is the most serious type of recall. Recalls were
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`issued for each of the following models:
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`1.
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`2.
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`3.
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`4.
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`5.
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`6.
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`33mm Model SDH33A;
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`29mm Model SDH29A;
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`25mm Model SDH25A;
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`33mm Model ECS33A;
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`29mm Model ECS29A;
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`25mm Model ECS25A;
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`4 Ethicon Endo-Surgery is now merged with Ethicon Inc. under the J&J Medical Devices division. Initially, Ethicon
`Endo Surgery manufactured the surgical instruments, like staplers, and Ethicon Inc. manufactured staples and
`sutures.
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`7.
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`8.
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`9.
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`10.
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`11.
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`12.
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`21mm Model ECS21A;
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`33mm Model CDH33A;
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`29mm Model CDH29A;
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`25mm Model CDH25A;
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`21mm Model CDH21A;
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`21mm Model SDH21A.
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`According to the FDA recall, there were 434,614 instruments in commerce. Ethicon sent
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`an “urgent medical device recall” (removal) letter to U.S. customers.5
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`38.
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`Just five months later, on October 29, 2019, the FDA issued another Class 1 recall of an
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`Ethicon stapler, the Echelon Flex Powered 60mm Stapler, following seven serious injuries and
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`one reported death. Ethicon identified the reason for the recall as “an out of specification anvil
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`component within the jaw of the device.” The FDA determined the cause of the recall to be
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`“nonconforming material/component.” 255 of the units were in commerce. 6
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`39.
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`On August 19, 2021, the FDA issued a Class 2 recall of the Echelon Powered Plus Stapler
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`intended for transection, resection and anastomoses. The recall was issued for 763 products in
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`commerce because it was mislabeled. The package said it contained a 60mm size but contained
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`a 45mm instrument. Transection and resection staplers are sized according to tissue density and
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`use, according to the FDA. 7
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`40.
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`The FDA Maude database contain reports received by the FDA of adverse events
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`involving medical devices. The data consists of voluntary reports since June 1993, user facility
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`reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.
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`5 https://www.accessdata.fda.gove/scripts/cdrh/docs (accessed January 19, 2021)
`6 https://www.accessdata.fda.gove/scripts/cdrh/docs (accessed January 19, 2021)
`7 https://www.accessdata.fda.gove/scripts/cdrh/docs (accessed January 19, 2021)
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`41.
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`There are over 500 Maude adverse reports for the Echelon stapler between 2012 and 2021.
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`Most of the reported events were described as misfire, failure to fire, or incomplete firing, causing
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`a staple to remain lodged in the internal stapler. Many of the Maude reports identify tissue and
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`rectal damage, like that suffered by Christine Collier.
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`42.
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`On February 2, 2021, just 6 days before Mrs. Collier’s colon surgery, a Maude report was
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`filed for am Echelon 29mm Circular Powered Stapler EEA, Model CDH29P. The device failed
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`to fire. The patient was undergoing a laparoscopic sigmoid colectomy, the same surgery Mrs.
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`Collier would undergo. During the procedure the EEA stapler would not fire. The safety report
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`states that the surgeon had difficulty removing the stapler anvil and during the process of device
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`removal a perforation occurred. The surgeon was required to re-sect the stump where the rectum
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`was perforated. 8
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`43.
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`On September 7, 2021, another Maude report was filed for am Echelon 29mm Circular
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`Powered Stapler EEA, Model CDH29P. The device failed to fire. The Maude report quotes the
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`operative report: “the 29 EEA circular stapler was passed up the anus and brought out to the
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`staple line. The anvil and spike were joined at this point, the stapler did not fire despite changing
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`the battery and trying various other techniques.” 9 The language is very close to that in the
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`operative report prepared by Mrs. Collier’s surgeon, Dr. Parks.
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`44.
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`On October 8, 2021, the FDA issued a final order to reclassify surgical staplers from Class
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`1 to Class II medical devices due to safety concerns. The Class II designation subjects the devices
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`to the requirement of submitting a premarket notification (510k) and to mandatory special
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`controls.
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`45.
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`Plaintiffs allege on information and belief that the Ethicon circular stapler used in Mrs.
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`8 https://www.accessdata.fda.gove/scripts/cdrh/docs/cfMAUDE/detail (accessed January 19, 2021)
`9 https://www.federalregister.gov.documents/2021 (accessed January 20, 2022)
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`Collier’s surgery was a model manufactured and designed by Defendants and known by
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`Defendant to frequently malfunction.
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`46.
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`Plaintiffs assert that the stapler in question was likely the model CDH29P which has failed
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`to fire in surgeries like Mrs. Collier’s causing injury. The FDA reported that surgical staplers,
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`including those manufactured by Defendants, have been responsible for tens of thousands of
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`adverse outcomes attributed to malfunctioning staplers.
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`47.
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`Despite knowing that its Ethicon Staplers caused injuries due to malfunction, Defendants,
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`represented and marketed the staplers as safe and effective. In an August 2021 press release, J&J
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`touted the Echelon Circular Powered Stapler as being associated with a “major” reduction in
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`serious complications following colorectal surgery. Defendants, both failed to include warnings
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`regarding potential malfunctions that were known to them, including the risks described in the
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`FDA publication. 10
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`48.
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`Defendants intentionally engaged in the following conduct: 1) failing to provide
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`warnings regarding the potential for their staplers to malfunction in a manner exactly like
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`what occurred during Plaintiff s surgery; 2) failing to warn and inform surgeons of the
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`potential for the staplers to malfunction in a manner exactly like what occurred during Plaintiff
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`s surgery; and 3) failing to recall their defective products until 2019 when they knew earlier that
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`the staplers were prone to malfunction. By engaging in the conduct described above, Defendants
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`furthermore engaged in willful, wanton, reckless, malicious behavior and/or exhibited a gross
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`indifference to, and a callous disregard for human life, the safety and the rights of others, and
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`10 FDA Executive Summary Prepared for the May 30, 2019 Meeting of the General and Plastic Surgery Devices
`Panel Reclassification of Surgical Staplers for Internal https://www.fda.gov/media/126211/download (accessed
`January 17, 2021)
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`Case 2:22-cv-00168-EEF-MBN Document 1 Filed 01/26/22 Page 13 of 24
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`more particularly, the rights, life and safety of the Plaintiff; and Defendants were motivated by
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`consideration of profit, financial advantage, monetary gain, economic aggrandizement and cost
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`avoidance, to the virtual exclusion of all other considerations.
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`PLAINTIFF'S CAUSES OF ACTION
`PURSUANT TO THE LOUISIANA PRODUCTS LIABILITY ACT
`(LSA-R.S. 9:2800.52, ET SEQ.)
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`FIRST CAUSE OF ACTION
`MANUFACTURING DEFECT: R.S.2800.55
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`Plaintiff is a “Claimant” pursuant to the Louisiana Products Liability LSA-R.S. 9:2800.53.
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`Each Defendant is either a “Manufacturer” pursuant, LSA-R.S. 9:2800.53, to or a “Seller”
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`49.
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`50.
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`pursuant to LSA-R.S. 9:2800.53.
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`51.
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`52.
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`This matter is a “Product liability action” pursuant to LSA-R.S. 9:2800.52 et seq.
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`Plaintiff was harmed by Defendants’ defective Echelon Circular Powered Surgical Stapler
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`EEA, which was distributed, manufactured, designed and sold by Defendants. Defendants’ stapler
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`contained a manufacturing defect that made it unsafe to perform the function it was intended to
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`perform. Specifically, there was a defect of construction and composition that rendered the product
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`unreasonably dangerous.
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`53.
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`On May 15, 2019, the FDA issued a Class One Device Recall for 12 models of
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`Ethicon’s Curved Intraluminal Staplers, including three 29mm models, which were designed and
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`manufactured for use in gastrointestinal surgeries including in patients undergoing surgery for
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`a sigmoid colectomy, such as the Plaintiff. The recall was issued because the stapler had an
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`insufficient firing stroke to break the washer and completely form staples. The recall also stated
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`that an investigation conducted by Ethicon of the manufacturing process of the staplers
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`detected a “shift in a process”, which occurred in March of 2018 through March 8, 2019, at which
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`time the line was shut down. Subsequent to that recall, the FDA received Maude adverse reports
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`for the 29mm stapler used in Plaintiff’s surgery, reporting the same malfunction.
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`54.
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`Following her February 8, 2021 surgery, Plaintiff was advised by Dr. Parks that the
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`“stapler malfunctioned” in her surgery, which necessitated Dr. Parks to convert to an open surgery
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`with a midline incision and remove more of the colon due to tissue damage, and to repair a hole
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`in the rectum. Both the April 2019 recall of Ethicon surgical staplers issued by the Defendants
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`and the May 2019 recall of Ethicon surgical staplers issued by the FDA stated that as a “result of
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`manufacturing defects” in the recalled devices the stapler may have an insufficient firing stroke.
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`Plaintiff alleges the same or similar manufacturing defect occurred in production of the stapler
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`used in her February, 2021 surgery. Her medical provider and medical records confirm the stapler
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`failed to fire.
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`55.
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`Upon information and belief, Plaintiff alleges the device referenced in Maude adverse
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`event reports for failure to fire in February and August, 2021 is the device that was used in her
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`surgery by her medical providers and medical records, and it failed in the same way as previously
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`recalled Ethicon staplers.
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`56.
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`The surgical stapler used in Mrs. Collier’s February 8, 2021 surgery was: (1) manufactured
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`by the Defendants; (2) malfunctioned because of manufacturing defect which rendered the surgical
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`stapler unreasonably dangerous; (3) the defect existed at the time the stapler was distributed by the
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`Defendants as evidenced by the company's own recall notice and the FDA recall notice of a similar
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`product; and (4) the defect was a substantial factor in causing Plaintiff's injuries.
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`57.
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`As a direct and proximate result of Defendants' construction and composition
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`manufacturing defects, Plaintiff has incurred losses and damages for personal injury, loss of use
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`and enjoyment of life, the need for periodic medical examination and treatment, and economic
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`losses, including additional medical expenses, and the expenditure of time and money, and will
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`continue to incur losses and damages in the future.
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`58.
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`Plaintiff demands an award of damages in excess of $75,000.
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`SECOND CAUSE OF ACTION
`DESIGN DEFECT: R.S. 9:2800.56
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`Plaintiff hereby incorporates the allegations contained in the preceding paragraphs 1
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`59.
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`through 58, as though fully set forth herein. Ethicon’s 29mm Circular Powered Stapler EEA is
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`unreasonably dangerous in design.
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`60.
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`Plaintiff was harmed by the Ethicon 29mm Circular Powered Stapler EEA, which was
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`distributed, manufactured, and sold by Defendants. Defendants’ stapler contained a design defect
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`that made it unsafe to perform the function it was intended to perform. Specifically, there was a
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`design defect that would result in a failure to fire which compromised the surgery.
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`61.
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`Defendants' own recall notices and the FDA recall notices of staplers, similar to the one
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`used in Mrs. Collier’s February 8, 2021 surgery, identify the staplers as defectively designed.
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`Specifically, the October of 2019 recall of four models of the Echelon Powered Stapler, instituted
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`by the Defendants, stated the recall was instituted because, “uncut washers in the stapler and
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`malformed staples occur with their intraluminal circular staplers due to insufficient firing, which
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`can compromise staple line integrity.” Plaintiff alleges on information and belief that the same or
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`similar defective design of the device used in Plaintiff s surgery was a cause of the device to
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`malfunction and misfire.
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` 62. Additionally, on May 15, 2019 the FDA issued a Class One Device Recall of twelve (12)
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`models of Ethicon Curved Intraluminal Staplers because, “the staplers may have an insufficient
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`firing stroke to break the washer and completely form staples.” Plaintiff alleges on information
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`and belief that a similar defective design of the device used in her surgery was a cause of the device
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`to malfunction and misfire.
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`63.
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`These recall notices continued for a significant period of time and/or are still active, and
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`the Defendants have continued manufacturing, marketing and selling the device that is the subject
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`of Plaintiff’s claims. Clearly, the design defect issues have not been fixed. A safer alternative
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`design of the surgical stapler in question existed at the time of Plaintiff's surgery. The design defect
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`of the surgical stapler in question was a producing cause of Plaintiff s injuries, as incorporated in
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`the preceding allegations. Had Defendants implemented the safer alternative design prior to
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`Plaintiff's surgery it would have prevented or significantly reduced the risk of Plaintiff s injuries
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`and implementing a safer alternative design would not have substantially impaired Defendants'
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`product's utility. Likewise, Plaintiff asserts it was economically and technologically feasible for
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`Defendants to implement a safer alternative design prior to the time the device left Defendants'
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`control.
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`64.
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`As a direct and proximate result of Defendants’ negligence, manufacturing and design
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`defects, Plaintiff has incurred losses and damages for personal injury, loss of use and enjoyment
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`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
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`losses and damages in the future.
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`65.
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`Plaintiff alleges that at the time of its manufacture, Defendants acted unreasonably in
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`designing or formulating the product, this conduct was a proximate cause of the harm for which
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`damages are sought, and at the time the product left the control of Defendants, they had
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`unreasonably failed to adopt a safer, practical, feasible, and otherwise reasonable alternative design
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`or formulation that could then have been reasonably adopted and that would have prevented or
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`substantially reduced the risk of harm without substantially impairing the usefulness, practicality,
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`or desirability of the product.
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`66.
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`Plaintiff further alleges that at the time the product left the control of the Defendants, the
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`design or formulation of the product was so unreasonable that a reasonable person, aware of the
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`relevant facts, would not use or consume a product of this design.
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`67.
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`Plaintiff further alleges that Defendants’ conduct was unreasonable when considering the
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`nature and magnitude of the risks of harm associated with the design in light of the intended and
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`reasonably f