1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 MICHELLE KINNEE, Case No.: 22-CV-604 JLS (DDL)

12 Plaintiff,

ORDER DENYING DEFENDANTS’

13 v. MOTION TO DISMISS

14 TEI BIOSCIENCES INC.; INTEGRA (ECF No. 58)

LIFESCIENCES CORPORATION;

15 LIFESCIENCE SALES LLC; and DOES 16 1 through 50, inclusive, 17 Defendants. 18 19 Presently before the Court is Defendants Integra Life Sciences Corporation 20 (“Integra”) and Integra Lifesciences Sales LLC’s (“Integra Sales”) (collectively, 21 “Defendants”) Motion to Dismiss Plaintiff’s Third Amended Complaint (“Mot.,” ECF No. 22 58) and accompanying Memorandum of Points and Authorities (“Mem.,” ECF No. 58-1).1 23 Plaintiff Michelle Kinnee filed an Opposition to the Motion (“Opp’n.,” ECF No. 59), and 24 Defendants submitted a Reply (“Reply,” ECF No. 60). The Court took the Motion under 25 26 1 In addition, Defendants accompanied their Motion with a Request for Judicial Notice (“Request,” ECF No. 58-2), wherein Defendants ask the Court to take judicial notice of the same documents the Court 27 declined to consider when ruling on Defendants’ previous motion to dismiss. Request at 1; ECF No. 50-2 28 at 1. Once again, the arguments in Defendants’ Motion do not rely on these documents. See generally 1 submission without oral argument on June 7, 2024. ECF No. 61. Having carefully 2 reviewed Plaintiff’s Third Amended Complaint (“TAC,” ECF No. 57), the Parties’ 3 arguments, and the law, the Court DENIES Defendants’ Motion to Dismiss. 4 BACKGROUND 5 The Court here incorporates by reference the recitation of this action’s factual and 6 procedural history contained in its April 18, 2024, Order (“Order,” ECF No. 56). The Court 7 thus sets forth only those facts relevant to the instant Motion. 8 This action stems from alleged injuries caused by the SurgiMend Collagen Matrix 9 (“SurgiMend”). TAC ¶¶ 9, 41. On April 26, 2017, Plaintiff underwent a procedure to 10 repair a ventral hernia using the SurgiMend device. Id. Three years later, on April 28, 11 2020, Plaintiff underwent a subsequent procedure to address complications stemming from 12 the original procedure, including “bowel injury, bowel blockage, bowel perforation, severe 13 inflammatory response, and pain.” Id. ¶ 42. During this second procedure, the surgeon 14 determined Plaintiff’s SurgiMend device had shrunk from a pre-implant size of 25 cm x 35 15 cm to a post-removal size of 23 cm x 10.2 cm. Id. The device had also intertwined with 16 and “eroded into Plaintiff’s bowel.” Id. As a result, “Plaintiff continues to experience pain 17 and suffering . . . [,] including distress and anxiety, disfigurement, difficulties with bowel 18 movements, and economic loss.” Id. ¶ 43. 19 The present Motion constitutes Defendants’ fourth attempt to dismiss all or part of 20 Plaintiff’s suit. Regarding Defendants’ initial Motion, the Court found that it lacked 21 personal jurisdiction over Defendants and allowed jurisdictional discovery. See ECF No. 22 23 at 14, 17. The Parties resolved these jurisdictional issues through a stipulation that 23 dismissed then-Defendant TEI Biosciences Inc. (“TEI”) from the action. ECF No. 32 at 2. 24 Plaintiff then filed a First Amended Complaint (“FAC,” ECF No. 41) asserting causes of 25 action for failure-to-warn strict products liability, negligence, fraudulent concealment, and 26 breach of express warranty against Defendants Integra and Integra Sales. Defendants again 27 moved to dismiss (ECF No. 42), and, reaching the merits, the Court dismissed Plaintiff’s 28 negligent manufacturing defect and fraudulent concealment claims with leave to amend. 1 See ECF No. 48 at 28. 2 After Plaintiff filed a Second Amended Complaint (ECF No. 49), Defendants filed 3 a third motion to dismiss. See ECF No. 50. The Court then granted the motion only as to 4 Plaintiff’s claim for negligent manufacturing defect. See Order at 19. Though Plaintiff 5 had sufficiently described the nature and cause of her SurgiMend device’s alleged defect, 6 she failed to plausibly allege that this defect caused her injury. Id. at 7–10. Specifically, 7 the Court found it implausible, based on the facts alleged, that bacterial contamination at 8 the time of initial implantation would first cause symptoms three years down the line. Id. 9 at 9–10. 10 In the TAC, Plaintiff now alleges: 11 High levels of bacterial endotoxins can cause a patient to suffer from fever, infection, and inflammation. Over time, this 12 increased inflammation and infection can cause severe adhesions 13 to form between the mesh and the patient’s internal organs and viscera. The patient may develop a chronic infection, which will 14 cause them pain and discomfort. The adhesions and chronic 15 infection can eventually erode into the bowel over time. This leads to the development of fistula(s) or other bowel injuries as 16 the mesh becomes more and more adhered to the patient’s bowel. 17 18 TAC ¶ 30. Plaintiff adds, “excessive levels of endotoxins cause dense adhesions to form. 19 Over time, as the mesh becomes more and more adhered to the patient’s bowel, bowel 20 injuries are likely to occur.” Id. ¶ 69. Finally, Plaintiff asserts, “Plaintiff’s Surgi[M]end 21 mesh had excessive levels of endotoxins when it was implanted. These endotoxins were a 22 substantial contributing cause in Plaintiff developing a severe inflammatory response in 23 her abdomen, dense adhesions to the mesh, and injury to her bowel.” Id. ¶ 70. 24 The present Motion followed. In it, Defendants again seek to dismiss Plaintiff’s 25 negligent manufacturing defect claim. Mem. at 6. 26 / / / 27 / / / 28 / / / 1 LEGAL STANDARD 2 I. Rule 12(b)(6) 3 Federal Rule of Civil Procedure 12(b)(6) permits a party to raise by motion the 4 defense that the complaint “fail[s] to state a claim upon which relief can be granted.” A 5 court evaluates whether a complaint states a cognizable legal theory and sufficient facts in 6 light of Federal Rule of Civil Procedure 8(a), which requires a “short and plain statement 7 of the claim showing that the pleader is entitled to relief.” Although Rule 8 “does not 8 require ‘detailed factual allegations,’ . . . it [does] demand more than an unadorned, the- 9 defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) 10 (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). In other words, “a 11 plaintiff’s obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’ requires more 12 than labels and conclusions, and a formulaic recitation of the elements of a cause of action 13 will not do.” Twombly, 550 U.S. at 555 (alteration in original) (quoting Fed. R. Civ. P. 14 8(a)). 15 To survive a motion to dismiss, “a complaint must contain sufficient factual matter, 16 accepted as true, to ‘state a claim to relief that is plausible on its face.’” Iqbal, 556 U.S. at 17 678 (quoting Twombly, 550 U.S. at 570). A claim is facially plausible when the facts 18 pleaded “allow[] the court to draw the reasonable inference that the defendant is liable for 19 the misconduct alleged.” Id. That is not to say that the claim must be probable, but there 20 must be “more than a sheer possibility that a defendant has acted unlawfully.” Id. Facts 21 “‘merely consistent with’ a defendant’s liability” do not demonstrate a plausible 22 entitlement to relief. Id. (quoting Twombly, 550 U.S. at 557). 23 Review under Rule 8(a) requires a context-specific analysis involving a court’s 24 “judicial experience and common sense.” Id. at 679. A court must “accept[] all factual 25 allegations in the complaint as true and constru[e] them in the light most favorable to the 26 nonmoving party.” Skilstaf, Inc. v. CVS Caremark Corp., 669 F.3d 1005, 1014 (9th Cir. 27 2012). That said, the Court need not accept as true “legal conclusions” contained in the 28 complaint. Iqbal, 556 U.S. at 678. 1 If a complaint does not state a plausible claim for relief, a court should grant leave 2 to amend unless it determines that no modified contention “consistent with the challenged 3 pleading could . . . cure the deficiency.” DeSoto v. Yellow Freight Sys., Inc., 957 F.2d 655, 4 658 (9th Cir. 1992) (quoting Schreiber Distrib. Co. v. Serv-Well Furniture Co., 806 F.2d 5 1393, 1401 (9th Cir. 1986)). “The Ninth Circuit has instructed that the policy favoring 6 amendments ‘is to be applied with extreme liberality.’” Abels v. JBC Legal Grp., P.C., 7 229 F.R.D. 152, 155 (N.D. Cal. 2005) (quoting Morongo Band of Mission Indians v. Rose, 8 893 F.2d 1074, 1079 (9th Cir. 1990)). 9 ANALYSIS 10 To state a negligence claim in California, a plaintiff must establish “a legal duty to 11 use due care, a breach of such legal duty, and that the breach is the proximate or legal cause 12 of the resulting injury.” Kesner v. Super. Ct., 384 P.3d 283, 289 (Cal. 2016) (alterations 13 adopted but internal quotation marks omitted) (quoting Beacon Residential Cmty. Ass’n v. 14 Skidmore, Owings & Merrill LLP, 327 P.3d 850, 853 (Cal. 2014)). In products liability 15 cases, a plaintiff must show “both that a defect caused the injury and ‘that the defect in the 16 product was due to negligence of the defendant.’” Hannan v. Bos. Sci. Corp., No. 19-CV- 17 08453-PJH, 2020 WL 2128841, at *8 (N.D. Cal. May 5, 2020) (quoting Merrill v. Navegar, 18 Inc., 28 P.3d 116, 124 (Cal. 2001)). Put differently, a plaintiff must (ultimately) prove that 19 the alleged defect was “a substantial factor in producing [her] injury.” Soule v. Gen. Motors 20 Corp., 882 P.2d 298, 312 (Cal. 1994). 21 The Court previously determined Plaintiff had sufficiently pleaded the nature and 22 cause of her SurgiMend device’s manufacturing defect. Order at 7–9. The Court thus turns 23 to whether Plaintiff has plausibly alleged that this manufacturing defect—the alleged 24 presence of bacterial endotoxins on her SurgiMend device—caused her injury. See id. at 25 9–10. The Court finds that Plaintiff has met her burden at this stage. 26 To survive a motion to dismiss, Plaintiff need only allege facts “demonstrat[ing] a 27 plausible connection between the [defect] . . . and the worsening of h[er] specific medical 28 condition.” Davallou v. Glenmark Pharms. US Head Quarters, No. 20-CV-00619-DMS- 1 MDD, 2020 WL 4284965, at *2 (S.D. Cal. July 27, 2020). Here, per Plaintiff, “high levels 2 of bacterial endotoxins” can cause inflammation. TAC ¶ 30. Prolonged inflammation in 3 turn can lead to the formation of “severe adhesions,” which then create “fistula(s) or other 4 bowel injuries” over time. Id. These new, nonconclusory, factual allegations, coupled with 5 those stating Plaintiff experienced the very symptoms allegedly associated with long-term, 6 endotoxin-related inflammation, see id. ¶¶ 42, 70, are sufficient to plausibly allege injury 7 causation, see Hannan, 2020 WL 2128841, at *9. 8 Defendants argue that the “only new allegation [Plaintiff] provides is: ‘Plaintiff’s 9 Surgi[M]end device had excessive levels of endotoxins when it was implanted. These 10 endotoxins were a substantial contributing cause in Plaintiff developing a severe 11 inflammatory response in her abdomen, dense adhesions to the mesh, and injury to her 12 bowel.’” Mem. at 6 (quoting TAC ¶ 70). To be sure, these conclusory statements would 13 not suffice on their own. Defendants, however, largely ignore the additional factual 14 allegations set out in Paragraphs 30 and 69 of the TAC. Once these paragraphs are factored 15 in, Defendants’ contention that there are no facts “linking the endotoxin levels to Plaintiff’s 16 own alleged injury” is unpersuasive. Id. at 7. 17 Judge Koh’s opinion in Ferrari v. Natural Partners, Inc. is instructive. No. 15-CV- 18 04787-LHK, 2016 WL 4440242, at *5 (Aug. 23, 2016). There, the court credited the 19 plaintiff’s allegations stating they had suffered specifically identified symptoms consistent 20 with chloramphenicol exposure (the product’s alleged contaminant). Id. at *5–6. In so 21 doing, the court rejected the defendants’ argument that the plaintiff’s theory was 22 inconsistent with common sense, noting that it must accept the plaintiff’s factual 23 allegations as true. Id. Though Defendants argue that Ferrari is inapposite, they fail to 24 persuasively distinguish it from the case at bar. 25 “[A] well-pleaded complaint may proceed even if it strikes a savvy judge that actual 26 proof of those facts is improbable, and ‘that a recovery is very remote and unlikely.’” 27 Twombly, 550 U.S. at 556 (quoting Scheuer v. Rhodes, 416 U.S. 232, 236 (1974)). Thus, 28 “any weighing of the evidence is inappropriate on a 12(b)(6) motion.” Jones v. Johnson, 1 || 781 F.2d 769, 772 n.1 (9th Cir. 1986) overruled on other grounds by Peralta v. Dillard, 2 || 744 F.3d 1076 (9th Cir. 2014). Plaintiff has provided nonconclusory factual allegations 3 ||suggesting a mechanism by which elevated endotoxin levels can, over time, cause 4 || adhesion-related injuries. Whether or not Plaintiff is ultimately able to offer proof of such 5 ||mechanism is beside the point at this stage; a motion to dismiss is not the appropriate 6 || vehicle to make that determination. 7 CONCLUSION 8 In light of the foregoing, the Court DENIES Defendants’ Motion to Dismiss 9 || Plaintiff's TAC (ECF No. 58). Defendants shall file an answer to the TAC within twenty- 10 |] one (21) days of the date of this Order. 11 IT IS SO ORDERED. 12 ||Dated: June 28, 2024 paca nm maillind- 13 on, Janis L. Sammartino 14 United States District Judge 15 16 17 18 19 20 21 22 23 24 25 26 27 28