Ruscitto v. The Valley Hospital, Inc. et al

BRIEF in Opposition

D.N.J.February 21, 2017

ROBINS KAPLAN LLP RAYNA E. KESSLER, ESQ. (RK4122) 601 Lexington Avenue, Suite 3400 New York, NY 10022 Telephone: (212) 980-7431 Facsimile: (212) 980-7499 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY NEWARK DIVISION NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE, Plaintiff, v. THE VALLEY HOSPITAL, INC., HOWARD H. JONES, M.D., EUGENIA C. KUO, M.D., CELESTE A. TELFEYAN, D.O., KARL STORZ ENDOSCOPYAMERICA, INC., KARL STORZ GMBH & CO. KG; and JOHN DOES (1-10) AND XYZ CORP. (1-10) (such names and corporations being fictitious), Defendants. CIVIL CASE NO.: 2:15-CV-05704-JLL-JAD PLAINTIFF NICHOLAS ROCHE’S BRIEF IN OPPOSITION TO DEFENDANT KARL STORZ ENDOSCOPY-AMERICA, INC.’S PARTIAL MOTION TO DISMISS AND PLAINTIFF’S CROSS-MOTION FOR LEAVE TO AMEND PLAINTIFF’S COMPLAINT Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 1 of 16 PageID: 907 i TABLE OF CONTENTS Page PRELIMINARY STATEMENT .....................................................................................................1 STATEMENT OF FACTS ..............................................................................................................3 ARGUMENT ...................................................................................................................................5 I. PLAINTIFF NICHOLAS ROCHE SUFFICIENTLY PLEADS HARM AS DEFINED UNDER THE NEW JERSEY PRODUCTS LIABILITY ACT AND AS AGAINST DEFENDANT KARL STORZ. ....................................................5 II. IN THE ALTERNATIVE, PLAINTIFF’S CROSS-MOTION FOR LEAVE TO AMEND PLAINTIFF’S COMPLAINT SHOULD BE GRANTED AND DEFENDANT’S MOTION DENIED AS MOOT. ...........................9 III. DISMISSAL OF ANY COUNTS OF THE PLAINTIFF’S COMPLAINT (OR THE DENIAL IN WHOLE OR IN PART OF PLAINTIFF’S CROSS- MOTION TO AMEND) SHOULD BE WITHOUT PREJUDICE SUCH THAT PLAINTIFF CAN MOVE TO REINSTATE THE CLAIMS. ..........................10 CONCLUSION ..............................................................................................................................11 Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 2 of 16 PageID: 908 ii TABLE OF AUTHORITIES Page Cases Adams v. Gould, Inc., 739 F.2d 858 (3d Cir. 1984).......................................................................................................9 Ashcroft v. Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009) .........................................................5 Avatar Bus. Connection, Inc. v. Uni-Marts, Inc., 2006 U.S. Dist. LEXIS 44434 (D.N.J. June 30, 2006) ..............................................................9 Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007) .........................................................5 Borelli v. City of Reading, 532 F.2d 950 (3d Cir. 1976)...............................................................................................10, 11 Boryszewski v. Burke, 380 N.J. Super. 361, (App. Div. 2005) cert denied, 186 N.J. 242 (2006) ................................................................................................7 Forman v. Davis, 371 U.S. 178 (1962) ...................................................................................................................9 Hauck v. Danclar, 262 N.J. Super. 225 (1993) ....................................................................................................6, 9 Hedges v. United States, 404 F. 3d 744 (3d Cir. 2005)......................................................................................................5 Kehr Packages, Inc. v. Fidelcor, Inc., 926 F. 2d 1406 (3d Cir. 1991)....................................................................................................5 Litwin v. Whirlpool Corp., 436 N.J. Super. 80 (App. Div. 2014) .........................................................................................7 Mansour v. Leviton Mfg. Co., Inc., 382 N.J. Super. 594 (App. Div. 2006) .......................................................................................7 Patusco v. Prince Macaroni Inc., 50 N.J. 365 (1967) .................................................................................................................6, 9 Phillips v. County of Allegheny, 515 F.3d 224,234 (3d Cir. 2008)................................................................................................6 Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 3 of 16 PageID: 909 iii Pinker v. Roche Holdings Ltd., 292 F.3d 361 (3d Cir. 2002)...................................................................................................1, 6 Portee v. Jaffee, 84 N.J. 88 (1980) ...................................................................................................................7, 8 Voilas et al. v. General Motors Corp., et al., 173 F.R.D. 389 (D.N.J. 1997) ..................................................................................................10 Statutes N.J.S.A. 2A:58C-1 et seq. (1987) ...........................................................................................1, 2, 7 Rules Fed. R. Civ. P. 8(a)(2) ..................................................................................................................5, 6 Fed. R. Civ. P. 12(b)(6)................................................................................................................1, 5 Fed. R. Civ. P. 15 .............................................................................................................................1 Fed. R. Civ. P. 15(a)(2) ....................................................................................................................8 Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 4 of 16 PageID: 910 1 Plaintiff Nicholas Roche in the above-captioned action respectfully submits this memorandum of law in opposition to Defendant Karl Storz Endoscopy-America, Inc.’s partial motion to dismiss and in support of Plaintiff’s cross-motion for leave to amend his Complaint in accordance with Rule 15 of the Federal Rules of Civil Procedure. PRELIMINARY STATEMENT Defendant Karl Storz Endoscopy-America, Inc. (hereinafter “Karl Storz”) refiled its motion to partially dismiss Plaintiff’s action for failure to state a claim upon which relief can be granted pursuant to Fed. R. Civ. P. 12(b)(6), originally filed in the Roche matter, 2:16-cv-04474 (see ECF Dkt. No. 89). Specifically, Defendants argue that Count 1 for Negligent Infliction of Emotional Distress and Count 2 for Loss of Consortium of Plaintiff’s Complaint should be dismissed as to only Karl Storz Endoscopy-America, Inc., because these claims are subsumed by the New Jersey Products Liability Act, N.J.S.A. 2A:58C-1 et seq. (1987) (hereinafter referred to as the “PLA”). As the Court is aware, this matter is consolidated with Ruscitto v. The Valley Hospital, Inc., et al., 2:15-cv-05704-JLL-JAD, where the Executrix, Mirian Rivera, was substituted as the executrix of the estate of Viviana Ruscitto (see ECF Dkt. No. 70). Both complaints were brought as a result of Viviana Ruscitto’s untimely death caused by the defective and unreasonably dangerous surgical instrument, a laparoscopic power morcellator used during Viviana Ruscitto’s surgery performed by Dr. Howard Jones and Dr. Eugenia Kuo at The Valley Hospital (Pl. Compl. at ¶¶ 47, 50). The claims involve both medical malpractice and product liability claims, and thus claims both recoverable under common law and the PLA. Defendant Karl Storz’s partial motion is limited in scope, where it seeks to dismiss two claims only as to Karl Storz and only in the Complaint filed by Nicholas Roche, who is the late husband of Viviana Ruscitto and the guardian of Maximo Valentino Ruscitto-Roche, a minor (see Dft.’s Br. Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 5 of 16 PageID: 911 2 at 3). Since Nicholas Roche is being represented by independent counsel separate from the Executrix, Mr. Roche’s Complaint asserts claims that are both independent and derivative of those claims being asserted in the Executrix’s Complaint. The Complaint attempted to clarify the independent claims being brought solely on behalf of Nicholas Roche by listing them as separate counts: (1) Loss of Consortium and (2) Negligent Infliction of Emotional Distress. There is no dispute that these two independent claims are properly brought against the medical malpractice defendants, as they are clearly cognizable claims under New Jersey and New York common law. The fact that the Karl Storz Defendant is included in Count 1 and 2 was intended to place all Defendants on notice of the independent claims being asserted by Nicholas Roche which are distinct from those brought by Viviana Ruscitto’s estate. These two claims should not be dismissed as against Defendant Karl Storz because they sufficiently plead harm recoverable pursuant to the PLA, which specifically enumerates loss of consortium and emotional distress as recoverable harm in products liability claims. However, if the Court is inclined to grant Defendant Karl Storz’s partial motion to dismiss, Plaintiff respectfully requests that the Court instead grant Plaintiff’s cross-motion for leave to file an amended complaint and deny Defendant’s motion as moot. In the First Amended Complaint, Plaintiff Nicholas Roche further clarifies that the two counts of Loss of Consortium and Negligent Infliction of Emotional Distress are against only the medical malpractice defendants (The Valley Hospital, Inc., Howard Jones, M.D., and Eugenia Kuo. M.D.), and adds an additional count against the two product liability defendants alleging damages under the PLA for harm to Nicholas Roche pursuant to N.J.S.A. § 2A:58C-1 (defining harm to include “pain and suffering, mental anguish or emotional harm” and “any loss of consortium or services or other loss deriving from any type of harm described in subparagraphs (a) through (c) of this Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 6 of 16 PageID: 912 3 paragraph”). Because this litigation is in its initial stages and no formal discovery has occurred, Plaintiff’s cross-motion for leave to amend should be granted. STATEMENT OF FACTS Decedent, Viviana Ruscitto died on September 3, 2015, as a result of the defective and unreasonably dangerous surgical instrument used by Dr. Howard Jones and Dr. Eugenia Kuo during decedent’s surgery (Pl. Compl. at ¶¶ 47, 58, 61-62). On October 17, 2014, decedent underwent a robotic assisted laparoscopic surgery to treat uterine fibroids (id. at ¶ 46). Dr. Howard Jones and Dr. Eugenia Kuo performed the surgery, and used the defective and unreasonably dangerous laparoscopic power morcellator produced by Karl Storz on decedent (id. at ¶¶ 47, 50). Prior to the surgery, decedent was unaware that she had any gynecological cancer, but shortly after the surgery, decedent was diagnosed with leiomyosarcoma (id. at ¶¶ 48, 51). Defendants did not warn decedent of the risks of using the power morcellator, specifically that it could disseminate and upstage unsuspected cancer, even though decedent expressed her concerns about ovarian cancer to Dr. Howard Jones (id. at ¶ 49). Decedent underwent extensive and painful cancer treatments at Memorial Sloan Kettering including daily medications, injections, and chemotherapy (id. at ¶¶ 52-53, 55-56). Decedent suffered multiple metastases, including the right side of her abdomen, two pelvic lesions, and multiple lung lesions (id. at ¶ 54). Decedent only received nine of the twenty-one cycles of chemotherapy she was supposed to receive before her health deteriorated as the cancer and tumors spread throughout her abdomen (id. at ¶¶ 55-56, 58). Decedent was told that her illness was terminal and that surgery was impossible, decedent was anxious and feared her inevitable demise (id. at ¶ 58). Decedent died on September 3, 2015, leaving her infant son without a mother and Nicholas Roche without his spouse (id.) Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 7 of 16 PageID: 913 4 Decedent’s untimely death was a result of the defendants’ conduct. Using the power morcellator during decedent’s surgery disseminated cancerous tissue into decedent’s abdomen (id. at ¶¶ 61-62). This caused decedent’s cancerous condition and ultimately killed decedent (id.). The Karl Storz defendants knew that the power morcellator could spread unsuspected cancer, but they failed to disclose this information (id. at ¶¶ 71-76). Additionally, defendants failed to recommend, provide, or require the use of a closed system tissue bag to use with the laparoscopic power morcellator to capture any extraneous morcellated tissue that may contain cancerous cells (id. at ¶¶ 77-80). On July 22, 2015, decedent filed a complaint in the District of New Jersey, on only her behalf, claiming she suffered injuries as a result of the direct and proximate use of the laparoscopic power morcellator (see Pl. Compl., Dkt No. 1, Case No. 2:15-cv-05704-JLL-JAD). On November 16, 2015, counsel for decedent moved to amend the Complaint to correct and substitute her sister, Mirian Rivera, as the Executrix of decedent’s estate (see id. at Dkt Entry No. 46). In the Amended Complaint, Miriam Rivera asserted claims of wrongful death and survivorship (Pl. Amended Compl. at ¶ 5). On May 6, 2016, the Court denied Mirian Rivera’s Motion to Amend without prejudice to the refiling thereof pending the resolution of Nicholas Roche and Maximo Valentino Ruscitto-Roche’s involvement (see Case No. 2:15-cv-05704-JLL- JAD Dkt Entry No. 63). On June 28, 2016, the Court ordered Plaintiff Viviana Ruscitto and putative plaintiffs to file a motion to amend the complaint, or a new complaint, or both, on or before July 22, 2016 (see id. at Dkt. Entry No. 66). On July 22, 2016 Plaintiff Nicholas Roche filed his complaint as a new matter (see Case No. 2:16-cv-04474-JLL-JAD at Dkt. Entry No. 1). On October 31, 2016, Mirian Rivera filed her amended complaint after leave to file was granted by the Court (see Case No. 2:15-cv-05704-JLL-JAD at Dkt. Entry No. 70). On January 26, Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 8 of 16 PageID: 914 5 2017, the Court consolidated this matter for all purposes with the older matter, Civil Action No. 15-5704, serving as the lead case (ECF Dkt Entry No. 85). ARGUMENT I. PLAINTIFF NICHOLAS ROCHE SUFFICIENTLY PLEADS HARM AS DEFINED UNDER THE NEW JERSEY PRODUCTS LIABILITY ACT AND AS AGAINST DEFENDANT KARL STORZ. Under F.R.C.P. 8(a)(2), a pleading must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” To survive a motion to dismiss under F.R.C.P. 12(b)(6), a “complaint must contain sufficient factual matter, accepted as true, ‘to state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570, 127 S. Ct. 1955, 1974, 167 L. Ed. 2d 929, 949 (2007)). A claim is plausible on its face “when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. The defendant bears the burden of showing that no claim for relief has been presented. Hedges v. United States, 404 F. 3d 744, 750 (3d Cir. 2005) (citing Kehr Packages, Inc., 26 F. 2d 1406, 1409 (3d Cir. 1977). There is no dispute that the Plaintiff sufficiently pleaded Count 5 and Count 6 in his Complaint as to Defendant Karl Storz, as both of these counts specifically cite to the New Jersey Products Liability Act and only after detailing numerous factual allegations regarding the laparoscopic power morcellator both generally (including the FDA’s recommendation that based on data and literature reviewed, the laparoscopic power morcellators should not be used in patients with known or suspected malignancy and that many, if not all, of the literature cited was collected by and known to the Karl Storz who continued to distribute the product), as well as detailing the specific use of the product in Ms. Ruscitto, which ultimately led to her death (Pl. Compl. at ¶¶ 71-76). See Phillips v. County of Allegheny, 515 F.3d 224,234 (3d Cir. 2008); Fed. Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 9 of 16 PageID: 915 6 R. Civ. P. 8(a)(2); see also Pinker v. Roche Holdings Ltd., 292 F.3d 361, 374 n. 7 (3d Cir. 2002) (holding a complaint survives a 12(b)(6) motion to dismiss if “under any reasonable reading of the complaint, the plaintiff may be entitled to relief”). The Plaintiff alleges under the PLA that the Karl Storz Defendants’ (1) failed to adequately warn of the risks associated with morcellator use, by deliberately concealing and withholding after-acquired knowledge of the harmful effects of the power morcellator, and (2) failed to adequately recommend, require, or provide a safe, surgical tissue bag for use with the laparoscopic power morcellator to prevent dissemination of an unsuspected cancer (Pl. Compl. at ¶¶ 71-80). As such, Plaintiff has properly and sufficiently pleads relief under the PLA for failure to warn and design defect. Of course, the Executrix’s Complaint is asserting these claims as part of her wrongful death and survivorship claims1 (see Pl.’s Compl, Dkt Entry No. 70 at ¶¶ 2, 59, 60). Thus, in Nicholas Roche’s Complaint, Counts 5 and 6 are titled “derivative” to indicate they are the same in both Complaints (see e.g. Pl. Compl. at 40, 42). However, Count 1 and 2 are independent claims being asserted by Plaintiff Nicholas Roche, who suffered his own damages and economic loss as the widower of Ms. Ruscitto. Hauck v. Danclar, 262 N.J. Super. 225, 227-28 (1993) (citing Patusco v. Prince Macaroni Inc., 50 N.J. 365, 366 (1967) (stating “although a husband’s (or wife’s) consortium claim is derivative and dependent upon the other spouse prevailing in his/her suit for personal injuries, the claim remains independent, with separate and distinct damages available”). There is no dispute that the two claims are properly brought as against the medical malpractice defendants, where New Jersey or New York common law applies. 1 Notably, the Executrix’s Complaint also pleads the survivorship action and wrongful death claims as separate counts (see Dkt Entry No. 70 at ¶¶ 59-60). By Defendant’s reasoning, these claims would also be subsumed by the PLA and yet no similar motion to dismiss was filed in her matter. Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 10 of 16 PageID: 916 7 As to Defendant Karl Storz, the Plaintiff sufficiently pleads the PLA in Counts 5 and 6, alleging that Ms. Ruscitto was physically harmed by the morcellation product designed, manufactured and distributed by Karl Storz (see Pl. Compl. at ¶¶ 154 and 166). Counts 1 and 2 are derivative of these claims because the success of Mr. Roche’s claims depend on the Executrix’s claims prevailing; however, since they also represent distinct damages under the PLA separate and distinct from those brought by the Executrix, Plaintiff pleads them as separate counts to clarify this point. In other words, while these two counts are subsumed under the PLA as to Defendant Karl Storz (but not as to the medical malpractice defendants), they are not subsumed by the PLA claims pleaded in the Executrix’s Complaint. Therefore, Plaintiff argues that the two counts are sufficient as pleaded because they clarify Nicholas Roche’s independent and distinct claims as to the Executrix’s claims. The Plaintiff is clearly not seeking relief that is not provided for by the PLA; indeed, loss of consortium and emotional distress are specifically enumerated as cognizable harm under the PLA. N.J.S.A. 2A:58C-1 (defining harm to include “pain and suffering, mental anguish or emotional harm” and “any loss of consortium or services or other loss deriving from any type of harm described in subparagraphs (a) through (c) of this paragraph”).2 2 Certainly, a bystander negligent infliction of emotional distress claim is permitted by the PLA. Indeed, the seminal case by the New Jersey Supreme Court establishing this claim was a products liability case brought by a mother who sought to recover for mental and emotional distress caused by observing her son’s injuries and eventual death while trapped in an elevator shaft. Portee v. Jaffee, 84 N.J. 88 (1980). Since the Portee decision, and continuing after the enactment of the PLA in 1987, negligent infliction of emotional distress claims are commonly pursued against product liability defendants. See e.g., Mansour v. Leviton Mfg. Co., Inc., 382 N.J. Super. 594, 599 (App. Div. 2006) (permitting the plaintiff on remand to amend his complaint to more specifically allege negligent infliction of emotional distress in a products liability complaint); Litwin v. Whirlpool Corp.,436 N.J. Super. 80, (App. Div. 2014) (reversing the grant of summary judgment to product liability defendants in connection with the plaintiff’s bystander liability claim under Portee because it was not necessary for plaintiff to have been in the house witnessing his son being engulfed in the fire in order to maintain his Portee claim); Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 11 of 16 PageID: 917 8 Further, under the Portee standard, the Supreme Court of New Jersey held that the following four elements are required for a bystander to succeed on a claim for negligent infliction of emotional distress: “(1) the death or serious injury of another caused by defendant’s negligence; (2) a marital or intimate, familial relationship between plaintiff and the injured person; (3) observation of the death or injury at the scene of the accident; and (4) resulting severe emotional distress.” 84 N.J. at 101. Plaintiff Nicholas Roche’s Complaint sufficiently pleads each element of the Portee claim. First, Plaintiff’s Complaint details the Defendant’s negligence that ultimately led to the death of Viviana Ruscitto (see Pl. Compl. at ¶¶ 61-62; 71-76; 777-80), and in fact there is no dispute between the parties that these factual allegations are insufficient as pleaded. Second, the Complaint makes clear that Nicholas Roche was the husband of Viviana Ruscitto at the time of her death, and thus is a marital relationship satisfying the second Portee element (id. at ¶¶ 10, 106). Third, the Complaint states that Mr. Roche was present during the injuries that were caused or associated with the Morcellator and Viviana’s surgery in October 2014 (id. at ¶ 111), and therefore sufficiently pleaded the third Portee element. Fourth, Nicholas Roche alleges that he suffered shock and severe emotional distress as a result (id. at ¶ 112). Thus, all four of the Portee elements are properly pleaded in the Complaint. Since the Complaint details factual allegations supporting the Plaintiff’s loss of consortium and negligent infliction of emotional distress claims as well as sufficiently pleaded these claims under the PLA, Defendant’s motion should be denied in its entirety. Boryszewski v. Burke, 380 N.J. Super. 361, 366 (App. Div. 2005) (plaintiff surviving members brought bystander emotional distress claims against defendant minivan defendant in a products liability wrongful death action), cert denied, 186 N.J. 242 (2006). Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 12 of 16 PageID: 918 9 II. IN THE ALTERNATIVE, PLAINTIFF’S CROSS-MOTION FOR LEAVE TO AMEND PLAINTIFF’S COMPLAINT SHOULD BE GRANTED AND DEFENDANT’S MOTION DENIED AS MOOT. Although Plaintiff’s Complaint is sufficient in pleading relief as against the Karl Storz Defendant, if the Court is inclined to grant Defendant’s partial motion to dismiss, Plaintiff respectfully requests that the Court grant Plaintiff’s cross-motion for leave to amend Plaintiff’s Complaint. The Plaintiff’s Proposed First Amended Complaint is attached hereto as Exhibit A. The liberal approach to pleading under the Federal Rules of Civil Procedure provides that a court should freely give leave to amend when justice so requires. Fed. R. Civ. P. 15(a)(2); See Forman v. Davis, 371 U.S. 178 (1962). That principle “limits the district court’s discretion to deny leave to amend.” Avatar Bus. Connection, Inc. v. Uni-Marts, Inc., 2006 U.S. Dist. LEXIS 44434, at *6 (D.N.J. June 30, 2006). A court “may only deny leave to amend (A) ‘if a plaintiff’s delay in seeking amendment is undue, motivated by bad faith, or prejudicial’ to the defendant or (b) if the amendment would be futile (i.e., the amendment fails to state a cause of action).” Id., citing Adams v. Gould, Inc., 739 F.2d 858, 864 (3d Cir. 1984). To address the arguments raised in Defendant’s motion, the Proposed First Amended Complaint further separates Plaintiff’s allegations as to the medical malpractice defendants and the product liability defendants. In the First Amended Complaint, Plaintiff alleges Count 6 Loss of Consortium and Count 5 Negligent Infliction of Emotional Distress as against the medical malpractice defendants only, and adds Count 7 for Harm Alleged Pursuant to the New Jersey Product Liability Act as against only the product liability defendants, including loss of consortium and emotional distress (see Cert. at ¶¶ 3, 4; Ex. A at 45).3 Also, to avoid further 3 In addition to these amendments, Plaintiff also removed Defendant Celeste Telfeyan, M.D., who was named in the original Complaint and voluntarily dismissed prior to Plaintiff’s serving the Complaint on the Defendants (see Cert. at ¶ 6). Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 13 of 16 PageID: 919 10 confusion, Counts 1 through 4 are no longer listed as derivative in the claim headings (see Cert. at ¶ 5; Ex. A at 32, 38, 39, 41). Instead, a paragraph is added under “Parties” to clarify that the claims being brought by Plaintiff Nicholas Roche are derivative of claims being asserted by the Executrix’s Complaint (see Cert. at ¶ 5, 6; Ex. A at ¶ 18).4 These amendments effectively address the concerns expressed by Karl Storz in its partial motion to dismiss. Lastly, Plaintiff has not delayed seeking leave to amend his complaint. This litigation is still in its initial stages. The parties have not exchanged Initial Disclosures and no formal discovery has occurred. As such, no prejudice will exist to any party. Therefore, if the Court is inclined to grant Defendant Karl Storz’s partial to dismiss, Plaintiff respectfully requests the Court grants Plaintiff’s motion for leave to amend to the Plaintiff’s Complaint and deny Defendant’s motion as moot. III. DISMISSAL OF ANY COUNTS OF THE PLAINTIFF’S COMPLAINT (OR THE DENIAL IN WHOLE OR IN PART OF PLAINTIFF’S CROSS-MOTION TO AMEND) SHOULD BE WITHOUT PREJUDICE SUCH THAT PLAINTIFF CAN MOVE TO REINSTATE THE CLAIMS. If the Court were to grant Defendant’s partial motion to dismiss and deny Plaintiff’s motion for leave to file the First Amended Complaint attached as Exhibit A, Plaintiff respectfully requests leave to file a revised amended complaint within a specified period of time. This will not cause undue delay or prejudice to the Defendants, as this matter is still in its preliminary stages, including exchange of written discovery. 4 Although Plaintiff’s claims are derivative of the claims brought in the Executrix’s Complaint, the loss of consortium, severe emotional distress, and negligent infliction of emotional distress claims are distinct and independent from the Executrix’s claim for personal injuries. Hauck v. Danclar, 262 N.J. Super. 225, 227-28 (1993) (citing Patusco v. Prince Macaroni Inc., 50 N.J. 365, 366 (1967)(stating “although a husband’s (or wife’s) consortium claim is derivative and dependent upon the other spouse prevailing in his/her suit for personal injuries, the claim remains independent, with separate and distinct damages available”). Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 14 of 16 PageID: 920 11 While courts have broad discretion to decide motions to amend, they are to “heed Rule 15(a)'s mandate that amendments are to be granted freely in the interests of justice.” Voilas et al. v. General Motors Corp., et al., 173 F.R.D. 389, 396 (D.N.J. 1997). In the event this Court is inclined to deny Plaintiff’s motion in whole or in part, the Third Circuit has held that leave to further amend must be given in the situation in which a deficiency in a complaint could be cured by amendment but leave to amend is not sought. In Borelli v. City of Reading, 532 F.2d 950 (3d Cir. 1976), the court stated that a district court should use the following procedure in dismissing a complaint for failure to state a claim: [W]e suggest that district judges expressly state, where appropriate, that the plaintiff has leave to amend within a specified period of time, and that application for dismissal of the action may be made if a timely amendment is not forthcoming within that time. If the plaintiff does not desire to amend, he may file an appropriate notice with the district court asserting his intent to stand on the complaint, at which time an order to dismiss the action would be appropriate. Borelli, 532 F.2d at 951 n. 1. Although the Plaintiff addressed all of Defendant’s concerns in its Plaintiff’s Proposed First Amended Complaint, Plaintiff respectfully requests permission to file a revised amended complaint should the Court find that the claims need further clarification as to Defendant Karl Storz. CONCLUSION Based on the foregoing, the Plaintiff respectfully requests that the Court deny Defendant Karl Storz’s partial motion to dismiss or, in the alternative, grant Plaintiff’s cross-motion for leave to file his First Amended Complaint and deny Defendant’s motion as moot. Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 15 of 16 PageID: 921 12 DATED: February 21, 2017 s/ Rayna E. Kessler Rayna E. Kessler, Esq. (RK4122) ROBINS KAPLAN LLP 601 Lexington Avenue, Suite 3400 New York, New York 10022 Attorneys for NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE Case 2:15-cv-05704-JLL-JAD Document 91 Filed 02/21/17 Page 16 of 16 PageID: 922 ROBINS KAPLAN LLP RAYNA E. KESSLER, ESQ. (RK4122) 601 Lexington Avenue Suite 3400 New York, NY 10022-4611 Telephone: (212) 980-7431 Facsimile: (212) 980-7499 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY NEWARK DIVISION NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE, Plaintiff, v. THE VALLEY HOSPITAL, INC., HOWARD H. JONES, M.D., EUGENIA C. KUO, M.D., CELESTE A. TELFEYAN, D.O., KARL STORZ ENDOSCOPYAMERICA, INC., KARL STORZ GMBH & CO. KG; and JOHN DOES (1-10) AND XYZ CORP. (1-10) (such names and corporations being fictitious), Defendants. CIVIL CASE NO.: 2:15-CV-05704-JLL-JAD CERTIFICATION OF RAYNA E. KESSLER, ESQ. I, Rayna E. Kessler, Esq., hereby certifies as follows: 1. I am an attorney at law in the State of New Jersey and represent the Plaintiff, NICHOLAS ROCHE, individually and as guardian of Maximo Valentino Ruscitto- Roche, with reference to the above-captioned matter. As such, I am fully familiar with the facts herein. 2. In further opposition of Defendant Karl Storz Endoscopy-America, Inc.’s Partial Motion to Dismiss, Plaintiff cross-moved for leave to amend Plaintiff’s Complaint. Plaintiff has Case 2:15-cv-05704-JLL-JAD Document 91-1 Filed 02/21/17 Page 1 of 3 PageID: 923 2 prepared a form of the Plaintiff’s First Amended Complaint, which is attached hereto as Exhibit A. 3. In particular, if the Court is inclined to grant Defendant’s motion, Plaintiff seeks to address Defendant Karl Storz Endoscopy-America, Inc.’s concerns by clarifying that the Loss of Consortium and Negligent Infliction of Emotional Distress claims are only against The Valley Hospital, Inc., Howard Jones, M.D., and Eugenia Kuo, M.D. 4. Plaintiff further seeks to add an additional count as against Karl Storz Endoscopy America, Inc., and Karl Storz GMBH & Co, KG, to specifically plead harm pursuant to the N.J. Products Liability Act as to Nicholas Roche, individually and as guardian of Maximo Valentino Ruscitto-Roche, including loss of consortium and emotional distress. 5. In addition, Plaintiff removed the word “derivative” in the count headings for Counts 1 - 4 of the First Amended Complaint, and instead added Paragraph 18 stating that “Plaintiff’s claims are derivative of claims asserted in the Executrix’s Complaint, Case No. Case No. 2:15-cv-05704-JLL-JAD.” 6. In addition, Plaintiff removed all references to Defendant Celeste Telfeyan, D.O., who was voluntarily dismissed by the Plaintiff on November 21, 2016. 7. No formal written discovery has been exchanged in this matter and as such, this matter is in the initial stages of litigation. I hereby certify that the foregoing statements made by me are true. I am aware that if any of the foregoing statements made by me are willfully false, I am subject to punishment. Case 2:15-cv-05704-JLL-JAD Document 91-1 Filed 02/21/17 Page 2 of 3 PageID: 924 3 DATED: February 21, 2017 s/ Rayna E. Kessler Rayna E. Kessler, Esq. (RK4122) ROBINS KAPLAN LLP 601 Lexington Avenue, Suite 3400 New York, New York 10022 Attorney for NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE Case 2:15-cv-05704-JLL-JAD Document 91-1 Filed 02/21/17 Page 3 of 3 PageID: 925 EXHIBIT A Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 1 of 49 PageID: 926 75706020.1 ROBINS KAPLAN LLP RAYNA E. KESSLER, ESQ. (RK4122) 601 Lexington Avenue, Suite 3400 New York, NY 10022-4611 Telephone: (212) 980-7431 Facsimile: (212) 980-7499 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE, Plaintiff, CIVIL CASE NO.: 2:16-cv-00474-JLL v. Civil Action THE VALLEY HOSPITAL, INC., HOWARD H. JONES, M.D., EUGENIA C. KUO, M.D., D.O., KARL STORZ ENDOSCOPY-AMERICA, INC., KARL STORZ GMBH & CO. KG; and JOHN DOES (1-10) AND XYZ CORP. (1-10) (such names and corporations being fictitious), Defendants. [PROPOSED] FIRST AMENDED COMPLAINT AND JURY DEMAND Plaintiff, NICHOLAS ROCHE, by way of Complaint against the Defendants, alleges and states as follows: NATURE OF THE ACTION 1. This is an action brought by Plaintiff NICHOLAS ROCHE (hereinafter referred to as “Plaintiff”) individually and as a guardian of MAXIMO VALENTINO RUSCITTO- ROCHE, for damages suffered as a direct and proximate result of the defective and unreasonably dangerous surgical instrument, a laparoscopic power morcellator (hereinafter “the Morcellator”), Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 2 of 49 PageID: 927 2 used during her laparoscopic supracervical hysterectomy and bilateral salpingectomy procedures for the treatment of uterine fibroids and for such derivative claims as permitted by law. At all times relevant hereto, the Morcellator was manufactured, designed, tested, packaged, labeled, produced, created, made, constructed, assembled, marketed, advertised, distributed and sold by Defendants KARL STORZ ENDOSCOPY-AMERICA, INC. and KARL STORZ GMBH & Co. KG (hereinafter collectively “Karel Storz Defendants” or “Defendants Karl Storz”). 2. Plaintiff NICHOLAS ROCHE is suing in his individual capacity and as the legal guardian of MAXIMO VALENTINO RUSCITTO-ROCHE, a minor. 3. As a result of the use of the Morcellator on Decedent VIVIANA RUSCITTO, she suffered injuries to her person including metastasized Stage 4 cancer. She underwent extensive and difficult treatments for her advanced-stage cancer, including daily medications, regular injections and multiple rounds of radiation therapy. Decedent experienced the ill-effects of both her cancer and cancer treatments including, but not limited to, fatigue, body pain, joint pain, stiffness, inflammation, swelling, insomnia, gastrointestinal distress, and emotional distress. Decedent ultimately died on September 3, 2015. 4. On July 22, 2015, Decedent Viviana Ruscitto filed a complaint in the District of New Jersey on only her behalf, claiming she suffered injuries as result of the direct and proximate the use of Morcellator. See Case No. 2:15-cv-05704-JLL-JAD. 5. On November 16, 2015, counsel for Viviana Ruscitto moved to amend the Complaint to correct and substitute her sister, Mirian Rivera, as the Executrix of Viviana Ruscitto’s Estate [see id. at Dkt Entry No. 46]. In the Amended Complaint, Mirian Rivera asserted claims of wrongful death and survivorship. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 3 of 49 PageID: 928 3 6. On May 6, 2016, the Court denied Mirian Rivera’s Motion to Amend without prejudice to the refiling thereof pending the resolution of Nicholas Roche and Maximo Valentino Ruscitto-Roche’s involvement [see id. at Dkt Entry No. 63]. 7. On June 28, 2016, the Court ordered the Plaintiff Viviana Ruscitto and putative plaintiffs to file a motion to amend the Complain, or a new Complaint, or both, on or before July 22, 2016 [see id. at Dkt Entry No. 66]. In the case that a new Complaint is filed by Nicholas Roche, the Court will sua sponte consider consolidation [id.]. 8. Plaintiff Nicholas Roche expects Mirian Rivera to file an Amended Complaint pursuant to the Court’s Order of June 28, 2016, asserting survivorship and wrongful death claims 9. Plaintiff Nicholas Roche brings this Complaint pursuant to the Court’s June 28, 2016 Order [id.]. PARTIES 10. Plaintiff NICHOLAS ROCHE was the husband of the Decedent VIVIANA RUSCITTO at the time of her death. 11. MAXIMO VALENTINO RUSCITTO-ROCHE, age three, is the minor son of Decedent Viviana Ruscitto and Nicholas Roche. 12. Prior to Viviana Ruscitto’s death, Viviana Ruscitto, Nicholas Roche and Maximo Valentino Ruscitto-Roche resided at 100 Sierra Vista Lane, Valley Cottage, New York 10989. 13. After the death of Viviana Ruscitto, NICHOLAS ROCHE became the sole legal guardian of Maximo Valentino Ruscitto-Roche. 14. Nicholas Roche and Maximo Valentino Ruscitto-Roche are residents and citizens of East Hampton, Massachusetts. 15. NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE, is a party in interest, survivor and a beneficiary of the Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 4 of 49 PageID: 929 4 claims alleged by the Executrix of Viviana Ruscitto’s Estate, in addition to Plaintiff’s claims alleged herein. 16. Nicholas Roche and Maximo Valentino Ruscitto-Roche are survivors of the Decedent Viviana Ruscitto and therefore entitled to distribution pursuant to the Wrongful Death action brought on behalf of the personal representative. 17. Nicholas Roche and Maximo Valentino Ruscitto-Roche are beneficiaries or parties of interest to Viviana Ruscitto’s Estate and therefore are seeking an appropriate distribution of proceeds from the Survivorship Action brought on behalf of the Estate. 18. Plaintiff’s claims are derivative of claims asserted in the Executrix’s Complaint, Case No. Case No. 2:15-cv-05704-JLL-JAD. 19. Defendant KARL STORZ ENDOSCOPY-AMERICA, INC. (hereinafter “KS Endoscopy-America”), is a California corporation with its principal place of business at 2151 E. Grand Avenue, El Segundo, California 90245. Upon information and belief, Defendant KS Endoscopy-America is responsible for the sales, marketing and distribution of Storz instruments and products in the United States for the designer, developer, and manufacturer Defendant Karl Storz GMBH & Co.KG, including the morcellator. 20. At all relevant times, Defendant KS Endoscopy-America has transacted and conducted business in the State of New Jersey and derived substantial revenue from interstate commerce. 21. Defendant KARL STORZ GMBH & Co. KG, (hereinafter “Karl Storz”) is a foreign entity organized in Germany with its principal place of business at Dr. Karl-Storz-Strasse 34, 78532 Tuttlingen, Germany. Defendant Karl Storz is the parent company of Karl Storz Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 5 of 49 PageID: 930 5 Endoscopy-America, Inc. and together are responsible for the design, production, marketing, manufacturing, and sale of all information for Karl Storz products, including the morcellator. 22. At all relevant times, Defendant Karl Storz has transacted and conducted business in the State of New Jersey and derived substantial revenue from interstate commerce. 23. Defendant Karl Storz has purposefully availed itself of the benefits of doing business in New Jersey through manufacturing, designing, labeling, marketing, distributing, supplying and/or selling the morcellator, and by placing it into the stream of commerce for those purposes, and by promoting, selling, and intending its use for the surgery of Plaintiff in New Jersey. 24. Defendant KS Endoscopy-America is the alter ego of Defendant Karl Storz, and at all times relevant acted as the agent of Defendant Karl Storz. Therefore, all of the above activities of Defendant KS Endoscopy-America are imputed to Defendant Karl Storz. Hereinafter, these Defendants are referred to collectively as the “Karl Storz Defendants.” 25. At all times relevant, the Karl Storz Defendants were engaged in the business of developing, designing, licensing, manufacturing, distributing, selling, marketing, promoting and/or introducing into interstate commerce, either directly or indirectly through third parties, subsidiaries or related entities, the morcellator, which is the subject of this lawsuit. 26. At all times alleged herein, the Karl Storz Defendants include and included any and all parents, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind, their predecessors, successors and assigns and their officers, directors, employees, agents, representatives and any and all other persons acting on their behalf. 27. At all times herein mentioned, each of the Karl Storz Defendants was the agent, servant, partner, predecessors in interest, aider and abettor, co-conspirator and joint venturer of Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 6 of 49 PageID: 931 6 each other and was at all times operating and acting with the purpose and scope of said agency, service, employment, partnership, conspiracy and joint venture. 28. At all times hereinafter mentioned, Defendant HOWARD H. JONES, M.D. (“JONES”) was and is an obstetrician and gynecological doctor duly licensed to practice medicine in the State of New Jersey. 29. At all times hereinafter mentioned, Defendant JONES specialized and specializes in the field of gynecological surgery. 30. At all times hereinafter mentioned, Defendant JONES maintained and maintains an office for the practice of medicine at 1 Valley Health Plaza, Paramus, New Jersey 07652. 31. At all times hereinafter mentioned, Defendant THE VALLEY HOSPITAL, INC. (“The Valley Hospital”) is and was a domestic corporation, duly incorporated and existing by virtue of the Laws of the State of New Jersey with a principal place of business located at 223 N. Van Dien Avenue, Ridgewood, New Jersey 07450. 32. At all times hereinafter mentioned, Defendant The Valley Hospital, owns, operates, controls, and maintains surgical suites and/or operating rooms, which physicians, including Defendant JONES, used and use in connection with the surgery performed on Decedent VIVIANA RUSCITTO on October 17, 2014. 33. Upon information and belief, Defendants JOHN DOES (1-10) and XYZ CORP. (1-10) (the “Doe Defendants”) are corporations or other business entities, the names and addresses of which are unknown, who were involved in the business of developing, designing, licensing, manufacturing, distributing, selling, marketing, promotion and/or introducing into interstate commerce, either directly or indirectly through third parties, subsidiaries or related entities, the morcellator. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 7 of 49 PageID: 932 7 34. Defendants do business in New Jersey, where Viviana Ruscitto underwent her operation at The Valley Hospital in Paramus, New Jersey, during which the morcellator was used by Defendant JONES, as a result of and through the sales of the morcellator and other medical devices and instruments in the State by the Karl Storz Defendants. 35. At all times hereinafter mentioned, Defendant EUGENIA C. KUO (“KUO”) was and is a physician duly licensed to practice medicine in the State of New Jersey. 36. At all times hereinafter mentioned, Defendant KUO specialized and specializes in the field of gynecological surgery. 37. At all times hereinafter mentioned, Defendant KUO was a resident and an employee of The Valley Hospital, and maintained and maintains an office for the practice of medicine at 223 N. Van Dien Avenue, Ridgewood, New Jersey 07450. 38. In the interest of clarity, this Complaint refers to Defendant KS Endoscopy- America and Defendant Karl Storz as “Defendants Karl Storz” or the “Products Liability Defendants”). 39. Defendants do business in New Jersey, where Decedent underwent her operation during which the Morcellator was used, through the sales of the Morcellator and other medical devices and instruments in the state. JURISDICTION AND VENUE 40. This Court has jurisdiction over this action pursuant to 28 U.S.C.A. § 1332, as there is complete diversity of citizenship between Plaintiff and Defendants, and the amount in controversy exceeds $75,000, exclusive of interest and costs. 41. Venue is proper in the District of New Jersey pursuant to 28 U.S.C.A. § 1391, as a substantial part of the events giving rise to these claims occurred within this district, including Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 8 of 49 PageID: 933 8 the sale and use of the power morcellator on the Decedent, as well as Decedent’s resulting injuries. 42. The Court has personal jurisdiction over Defendants consistent with the New Jersey and United States Constitutions because Defendants transacted business in New Jersey and caused tortious injury in New Jersey by an act or omission outside New Jersey by virtue of Defendants’ regularly conducted business in New Jersey from which they respectively derive substantial revenue. Defendants do substantial business in the State of New Jersey, advertise in this district, and receive substantial compensation and profits from sales of the power morcellator within this District. 43. Defendants expected or should have expected that their business activities could or would have consequences within the State of New Jersey, as well as throughout the United States. FACTS COMMON TO ALL COUNTS 44. On October 17, 2014, Decedent VIVIANA RUSCITTO underwent a robotic assisted laparoscopic supracervical hysterectomy and bilateral salpingectomy, with the removal of the umbilical hernia sac procedure at Defendant The Valley Hospital in Ridgewood, New Jersey. 45. On October 17, 2014, Decedent’s surgery at The Valley Hospital (“HOSPITAL”) was performed by Howard H. Jones, M.D (“JONES”); and Eugenia C. Kuo, M.D. (“KUO”) who assisted. Defendants JOHN DOES (1-10) and XYZ CORP. (1-10) (such names and corporations being fictitious) were individuals or corporations otherwise involved in the surgery on the Decedent or the manufacture and distribution of the power morcellator described below. 46. Prior to Decedent’s surgery on October 17, 2014, Decedent was unaware she had any gynecological cancer. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 9 of 49 PageID: 934 9 47. On or before October 17, 2014, Decedent was never warned of the danger and likelihood that the use of a laparoscopic power morcellator device could disseminate and upstage unsuspected cancer. In fact, Decedent was specifically concerned about ovarian cancer, and verbally communicated her concerns to her surgeon, Defendant JONES, who duly documented Decedent’s concerns. 48. During the surgery, Defendant JONES used a power morcellator produced and sold by Karl Storz Endoscopy-America Inc. (“KARL STORZ ENDOSCOPY”), to assist in the removal of Decedent’s uterus. 49. On October 22, 2014, a Dr. Christiano of the Pathology Department of the HOSPITAL diagnosed Decedent with leiomyosarcoma. This diagnosis was confirmed by Dr. Young of Massachusetts General Hospital on October 29, 2014. 50. Decedent began cancer treatment at Memorial Sloan Kettering (“MSK”), and MSK discovered through a CT scan that the HOSPITAL failed to diagnose an ovarian vein clot in the Decedent and which required that the Decedent inject herself daily with Lovenox, a blood thinner, to prevent serious injury. 51. On November 28, 2014, Decedent underwent a total open hysterectomy, exploratory surgery, and a total abdominal pelvic wash by Carol M. Brown, M.D. at MSK, and the procedures required Decedent to remain in MKS as an inpatient for four full days. 52. Decedent suffered multiple metastases, including the right side of her abdomen, two pelvic lesions, and multiple lung lesions. 53. On or about December 22, 2014, Decedent began chemotherapy treatment at MSK under the supervision and care of Martee Hensley, M.D. The chemotherapy treatment was Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 10 of 49 PageID: 935 10 expected to continue until February 2016. Decedent had received 9 cycles of a total of 21 cycles of chemotherapy before her health deteriorated. 54. Decedent received chemotherapy for two weeks, then had one week off. She would arrive at MSK on Mondays at 7:45 a.m. to have lab work to clear her and her blood for chemotherapy, and then she would meet with the doctor. She received chemotherapy through an IV from about 10 a.m. to about 12 p.m. For the first week of the cycle, she received Gemicitabine and during the second, she received Gemicitabine and Doxitaxale. Due to an allergy to Gemicitabine, Decedent also received Benadryl via IV during her treatments. On Tuesdays, following her chemotherapy, Decedent received an injection of Meulasta, which is used to promote blood cell growth, as chemotherapy was killing her white blood cells. 55. The doctors at MSK surgically installed a Mediport so that Decedent could have IVs without inserting a needle into her arm for each treatment day. 56. Decedent’s health deteriorated as the cancer and tumors spread throughout her abdomen. No surgical intervention was possible and Decedent was told her illness was terminal. Decedent was anxious and feared her demise which was inevitable. Decedent was devastated her infant son would be deprived on his mother. Decedent died on September 3, 2015. 57. Each and every Defendant herein failed to warn Decedent or her physician about the possibility of dissemination of an occult uterine leiomyosarcoma throughout the abdomen. 58. Defendants were each aware of the risks, complications, and/or adverse events associated with the products used for uterine morcellation. 59. Had the laparoscopic power morcellator used on Decedent not released and disseminated cancerous tissue, she would not have been diagnosed with an advanced Stage IV metastatic cancer and/or would not have suffered and been diagnosed with leiomyosarcoma. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 11 of 49 PageID: 936 11 60. The laparoscopic power morcellator used on Decedent during her October 17, 2014 surgery caused Decedent’s cancerous condition, and it has profoundly and gravely injured Decedent and caused her death. 61. As a result of the conduct alleged herein by Defendants, Decedent suffered serious bodily injury and died from her condition. In addition to the medical bills that Decedent had, she suffered severe physical and mental pain as a result of her terminal condition. BACKGROUND ON LAPAROSCOPIC POWER MORCELLATORS Laparoscopic Uterine Power Morcellators 56. Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy).1 57. In the United States, it is estimated that 650,000 women a year will undergo a surgical myomectomy or hysterectomy for the management of symptomatic uterine fibroids. 58. In conventional non-power morcellator hysterectomies, the women’s entire uterus is removed essentially intact and in conventional myomectomies the uterine fibroids are removed essentially intact and the women’s uterus is left intact. 59. Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision 1 Food and Drug Administration, Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, April 17, 2014, available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 12 of 49 PageID: 937 12 sites.2 This technique is associated with dissemination of cellular material throughout the peritoneum.3 60. Once disseminated in the body, morcellated fragments can become implanted in surrounding tissue or organs, and begin to grow. 61. When tissue fragments escape into the abdomino-pelvic cavity and seed in other tissue or organs, complications can arise months or years after the surgery. 62. As a result, laparoscopic power morcellator can spread women’s parasitic uterine myomas and require additional surgical procedures, significantly worsening a women’s prognosis. The Karl Storz Power Morcellator Entered the Market Following Clearance by the FDA through the Expedited 510(k) Premarket Notification Process 63. In December 1994, Karl Storz Endoscopy-America Inc. asked the FDA to clear its new morcellator, the KSE Steiner Electromechanic Morcellator, citing a Cook Urological Inc. tool as one precedent, through the 510(k) process. 64. The Cook Urological Inc. device, the Cook Tissue Morcellator (510(k) Number K910939), was a product cleared through the 510(k) process for general surgery in 1991. In its documentation, Cook cited as precedents four devices, including manual morcellators called “tissue punches” and a motorized tool for clearing matter in joint surgery. 65. In 1995, the Food and Drug Administration (hereinafter “FDA”) approved the KSE Steiner Electromechanic Morcellator as the first laparoscopic power morcellator with a gynecology indication for use through its 510(k) process. Power morcellators are Class II 2 Id. 3 Michael A. Seidman, et al., Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms, PLOS One, vol 7, issue 11 (November 2012), available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3506532/pdf/pone.0050058.pdf. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 13 of 49 PageID: 938 13 medical devices. Since then, the agency has cleared about two dozen such devices for use in gynecology.4 66. The 510(k) Premarket Notification process is different, and substantially less rigorous, than the Premarket Approval (PMA) process. Medical devices cleared under the 510(k) process are typically classified as Class II devices, while medical devices approved under the PMA process are Class III devices. 67. Under the expedited 510(k) process, the FDA must find that a new device is “substantially equivalent” to another device exempt from premarket approval instead of making a determination regarding the safety and effectiveness of the device. 68. Most importantly, the device is not formally reviewed for safety or efficacy, and the FDA does not require that a device take any particular form for any particular reason unlike the PMA process, which requires the device to be made with almost no deviations from the specifications in its approval application. The focus is on equivalence, not safety-little or no clinical data is needed. See 21 C.F.R. § 807.87 Information Required in a Premarket Notification Submission. 69. The FDA completes its review under the 510(k) process in an average of only 20 hours, compared to the average 1,200 hours spent reviewing applications through the PMA process. 70. In its review of applications submitted through the 510(k) process, the FDA largely relies on what information the medical device manufacturer chooses to disclose. The FDA does not conduct its own independent research or conduct clinical studies into the safety and efficacy of the product. 4 Stephanie Cajigal, The Morcellation Controversy: A Timeline, April 24, 2014. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 14 of 49 PageID: 939 14 71. In its 510(k) application, Karl Storz deliberately concealed peer-reviewed medical literature, safety information, and adverse events of the risk of spreading unsuspected cancerous tissue beyond the uterus when laparoscopic power morcellators are used during gynecologic surgeries intended to treat benign fibroids. As early as the 1990s, numerous case reports and case series had been published that described the iatrogenic dissemination, implantation, and subsequent growth of unsuspected neoplastic tissue with the peritoneal cavity following laparoscopic morcellation of uterine tissue believed to contain fibroids based on preoperative diagnosis.5 These numerous case reports and case studies were known, or should have been known, to the Karl Storz Defendants. 72. Following the clearance of the Storz morcellators, in addition to other scientific literature, the following information became known to Defendants: a. In 2009, the American College of Obstetricians and Gynecologist (hereinafter “ACOG”) issued a statement recommending vaginal hysterectomy as the best procedure for removal in most cases of benign disease based on evidence that demonstrated vaginal hysterectomy associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy.6 b. In 2012, the researchers at the Brigham & Women’s Hospital/Harvard School of Medicine, published a study, which reviewed medical records of 1,091 women from 2005-2010 who underwent laparoscopic uterine morcellation at Brigham & Women’s Hospital and found the rate of unexpected sarcoma after the laparoscopic morcellation procedure was 0.09%, 9-fold higher than the rate quoted to patients during pre-procedure briefing, and this rate 5 See FDA, Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators (Nov. 25, 2014) (citing supportive scientific literature n. 2-4, 6-19), available at https://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm. 6 Cajigal, supra note 4. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 15 of 49 PageID: 940 15 may increase over time as diagnostically challenging or under-sampled tumors manifest their biological potential. This data strongly suggested uterine morcellation carried a risk of disseminating unexpected malignancy with apparent associated increase in mortality much higher than appreciated previously.7 c. In December of 2013, the Society of Gynecologic Oncology released a statement advising that power morcellation is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery.8 73. Not only was the scientific literature available to Defendants, but Karl Storz was explicitly told that there was concern the power morcellator could spread unsuspected cancer. The Wall Street Journal reported that the Karl Storz application documents show that in a January 1995 phone call, FDA Medical Officer Daniel Schultz expressed concern to Storz that the tool could spread dangerous cells.9 In December 1994, Schultz wrote in a summary for the record that the device “must be used with an appropriate tissue extraction bag for malignant and other tissues which are potentially harmful if disseminated within a body cavity.” 74. Yet, Karl Storz remained silent and deliberately concealed and withheld the information that its power morcellators were causing harmful effects to women across the country, including Viviana Ruscitto. Defendant was well aware of the risk of spreading unsuspected cancer prior to Ms. Ruscitto’s surgery in October 2014. 7 Seidman, supra note 3. 8 SGO Position Statement: Morcellation (Dec. 2013), available at https://www.sgo.org/newsroom/position-statements-2/morcellation/. 9 Jon Kamp & Thomas M. Burton, How FDA Approved Hysterectomy Tools It Now Disfavors (Dec. 16, 2014), available at http://www.wsj.com/articles/how-fda-approved-hysterectomy- tools-it-now-disfavors-1418700781. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 16 of 49 PageID: 941 16 75. Pursuant to the mandatory Medical Device Reporting (“MDR”) regulation, 21 C.F.R. 803.1, medical device manufacturers, such as Karl Storz, are required to report to the FDA when they learn that any of their devices may have caused or contributed to death or serious injury. 76. Karl Storz did not comply with this mandatory reporting outlined in the MDR regulation. 21 C.F.R. 803. As such, the Karl Storz Defendants knowingly withheld and misrepresented material, relevant information required to be submitted under the FDA’s regulations. Thus, Plaintiff is entitled to punitive damages under N.J.S.A. 2A:58C-5. Alternative Design - Surgical Tissue Bag 77. Defendants also failed to require the use of a closed system tissue bag in conjunction with morcellation of fibroid tissue, to capture any extraneous morcellated tissue that may contain cancerous cells. 78. Defendants’ instructions about use of the Morcellator accompanying the device stat that “use of a tissue extraction bag is advised for the morcellation of tumors or tissue suspected of being malignant and for tissue that the surgeon may consider to be harmful if disseminated in a body cavity.” That statement is insufficient in that it wrongly conveys that detection of cancerous tissue by conventional procedures and techniques prior to morcellation is feasibly and likely. It is not. Defendants knew or should have known that detection of such cancerous tissue is not feasible or likely. 79. The surgical tissue bag and method has been available since 1991, long before the Storz morcellator was marketed and used. Defendants knew (as evident by FDA Medical Officer Daniel Schultz’s warning) or should have known that use of the tissue bag could prevent the spread of malignant cells to healthy tissue in the body cavity, yet failed to require concomitant Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 17 of 49 PageID: 942 17 use of the bag, or warn that failure to use the tissue bag may result in the dissemination of cancerous cells throughout the body. 80. Because of Defendants’ failure to adequately warn surgeons of the risk of morcellator use and Defendants’ failure to adequately recommend, require or provide a safe, closed system tissue bag for use with the power morcellator to prevent dissemination of an unsuspected cancer, Decedent suffered physical injuries that may ultimately lead to her death. FDA Safety Alert 81. During the winter of 2013, the FDA began to investigate and review the data on the use of power morcellators in gynecology. 82. The FDA’s investigation, and thus awareness into these tragedies, was largely sparked due to a campaign against morcellation launched by a Boston-based anesthesiologist, Amy Reed, and her husband, a cardiothoracic surgeon, after Ms. Reed underwent a surgery with power morcellation at Brigham and Women’s Hospital and later found out the mass was cancerous. The manufacturers, including Karl Storz, failed to bring this to the attention of the FDA, failed to disclose the knowledge of the harmful effects, failed to comply with the MDR regulations, and instead continued to manufacturer and sell the morcellators. 83. On April 17, 2014, the FDA posted a safety alert discouraging the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids estimating that 1 in 350 women undergoing these procedures have an unsuspected uterine sarcoma. The agency noted that morcellation spreads the unsuspected cancerous tissue within the abdomen and pelvis and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discouraged the use of laparoscopic power morcellation. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 18 of 49 PageID: 943 18 84. Ethicon (holding the largest market share, approximately seventy-two percent, of laparoscopic morcellators at the time) suspended sales of its laparoscopic power morcellators, ultimately withdrawing the devices in July 2014, after an FDA Advisory Committee meeting. 85. In July 2014, the FDA convened an Advisory Committee (“AdCom”) meeting of the Obstetrics and Gynecological Medical Device Advisory Committee on Laparoscopic Power Morcellators to discuss, among other topics, “whether a ‘boxed warning’ related to the risk of cancer spread should be required for laparoscopic power morcellators.”10 86. In preparation for the AdCom meeting, the FDA prepared an Executive Summary, which detailed the results of the FDA’s safety review and stated: a. The risk of having an unsuspected sarcoma in the population of women undergoing hysterectomy or myomectomy for presumed fibroids may be as high as approximately 1 in 350 for all types of uterine sarcomas, and 1 in 500 for LMS [leiomyosarcoma] specifically; b. Peritoneal dissemination and/or cancer upstaging (to FIGO Stage III or IV) following morcellation of an unsuspected sarcoma may occur in approximately 25-65% of cases; c. Patients with unsuspected uterine sarcoma who undergo morcellation may be at significantly higher risk for local (pelvic/abdominal) and overall cancer recurrence compared to those who do not undergo morcellation; and 10 FDA, supra n. 1. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 19 of 49 PageID: 944 19 d. Patients with unsuspected sarcoma who undergo morcellation may have poorer disease-free survival and overall survival compared to patients who do not receive morcellation.11 87. On July 10 and 11, 2014, the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee convened the AdCom meeting on laparoscopic power morcellators. The two-day meeting consisted of presentations from FDA scientists, FDA invited speakers, laparoscopic power morcellator manufacturers, and members of the public. 88. Based on the data and literature reviewed, the panel made a number of recommendations on laparoscopic power morcellation labeling, including: a. Laparoscopic Power Morcellators should not be used in patients with known or suspected malignancy; b. A black boxed warning related to the risk of disseminating unsuspected malignancy during surgeries for presumed benign fibroids would be useful but not enough to address the issue alone; and c. The panel also expressed interest in exploring other ways to ensure that patients have the appropriate information related to the risks, including a mandatory patient consent form to be signed by the patient and physician.12 89. After reviewing published and unpublished scientific literature (which was available to Defendants prior to the date on which Decedent underwent her surgery), including patients operated on from 1980 to 2011, the FDA estimated the prevalence of unsuspected 11 See Food and Drug Administration Executive Summary, prepared for the July 10-11, 2014 meeting of the Obstetrics and Gynecology Devices Advisory Committee, Laparoscopic Power Morcellation during Uterine Surgery for Fibroids (“FDA Executive Summary”), pp. 23. 124. 12 See FDA Brief Summary of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting - July 10-11, 2014 (“FDA AdCom Summary Panel Findings”) p. 3. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 20 of 49 PageID: 945 20 uterine sarcoma in patients undergoing hysterectomy or myomectomy for presumed benign leiomyoma was 1 in 352 and the prevalence of unsuspected uterine leiomyosarcoma was 1 in 498. Both of the estimates were higher than the clinical community previously understood.13 90. On November 24, 2014, the FDA updated its safety communication warning against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women. In an Immediately in Effect Guidance, the FDA also recommended that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning stating: The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices. 91. In addition to the Black Box warning, the FDA recommended two contraindications that advise (1) laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision, and (2) laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous. 92. The FDA continues to review adverse event reports, peer-reviewed scientific literature and information from patients, health care professional, gynecologic and surgical 13 Food and Drug Administration, UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, Nov. 24, 2014, available at http://www.wsj.com/articles/fda-adds-new-warning-to-labels-for-laparoscopic-power- morcellator-1416842439?mod=djemalertNEWS. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 21 of 49 PageID: 946 21 professional societies and medical device manufacturers and may take further action in the future. Defendants Knew Laparoscopic Power Morcellators Were Defective and Failed to Warn 93. Defendants knew or should have known of the significant cancer risks associated with the morcellator at the time of Decedent’s procedure in November 2013. 94. Defendants failed to warn about the risks of seeding and disseminating an occult uterine leiomyosarcoma throughout the peritoneal cavity associated with the morcellator. 95. The Karl Storz Defendants have repeatedly and consistently failed to advise consumers and/or their healthcare providers of the causal relationship between their product and these cancer risks. 96. The Karl Storz Defendants affirmatively and actively concealed information that demonstrated the dangers of their product and misled the public, the FDA, and healthcare providers with regard to the material and clear risks associated with their power morcellators. 97. Many, if not all, of the literature cited below was collected by and known to the Medical Malpractice Defendants and the Karl Storz Defendants (or should have been known to the Defendants) at or before the time the literature was published. 98. First, Defendants knew or should have known that the morcellator could cause occult malignant tissue fragments to be disseminated and implanted in the body. a. Indeed, on August 6, 1991, a patent for a Surgical Tissue Bag and Method for Percutaneously Debulking Tissue was issued that describes the potential for laparoscopic power morcellators to disseminate and implant malignant tissue fragments in the body. b. The patent for the surgical tissue bag stated: Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 22 of 49 PageID: 947 22 Another problem associated with the debulking, removal or morcellation of large tissue volume is the concern for containing malignant or pathogenic tissue. The morbidity of patients significantly increases when malignant cells of such large volume tissue are permitted to come in contact with surrounding healthy tissue. A malignancy would typically indicate a more invasive procedure in which the cavity is opened and the affected tissue is removed. These invasive open cavity procedures increase the recovery period of the patient and subject the patient to additional discomfort and complications. As a result, the debulking of large malignant tissue volumes percutaneously through an access sheath presents significant morbidity risks to the patient. c. The patent Summary of the invention further stated that “containment of the tissue within the bag also prevents the spread of malignant cells to healthy tissue in the body cavity.” d. The Surgical Tissue Bag patent was publically available and was available to the Defendants, and/or known to Defendants, before they first sought approval of the morcellator and before Decedent’s surgery. e. Also, prominent medical journals reporting on laparoscopic power morcellators and the risk of spreading undetected cancer also began to accumulate in the 1990s, and continued thereafter. f. In 1997, Schneider published a case report in a medical journal, known to the Defendants as THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, titled “Recurrence of unclassifiable uterine cancer after modified laparoscopic hysterectomy with morcellation,” which reported a patient who underwent a laparoscopic supracervical hysterectomy by manual morcellation.14 14 Schneider, Recurrence of unclassifiable uterine cancer after modified laparoscopic hysterectomy with morcellation, J. AM. OBSTET. GYNECOL., 177(1):478-9 (1997). Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 23 of 49 PageID: 948 23 g. The following year the patient died due to the rapid progression of uterine adenocarcinoma that had been undetected prior to surgery.15 h. Schneider cautioned that evaluation for malignancy prior to surgery “grows even more important and should be mandatory when uteri are increasingly morcellated by introduction of laparoscopic techniques.”16 i. In 1998, Hutchins and Reinoehl published a case report in THE JOURNAL OF THE AMERICAN ASSOCIATION OF GYNECOLOGIC LAPAROSCOPISTS, which was known to the Defendants, in which the authors explained that “[b]ecause of the large quantity of tissue of such a uterus, it would be anticipated that numerous fragments would be generated during morcellation.”17 j. The authors cautioned that the morcellated fragments could become concealed in surrounding organs making it difficult for the surgeon to identify and remove all tissue fragments.18 k. INVASIVE GYNECOLOGY reported that “[t]he use of a power morcellator may produce smaller fragments than other techniques.”19 l. According to the authors, “implantation, rather than resorption of residual fragments of cervix and myometrium can occur,” a problem which they reported “ha[d] implications for possible benign and malignant sequelae.”20 15 Id. at 478. 16 Id. at 479. 17 Hutchins and Reinoehl, Retained Myoma after Laparoscopic Supracervical Hysterectomy with Morcellation, J. AM. ASSOC. GYNECOL. LAPAROSC., 5(3):293-295 (1998). 18 Id. at 294. 19 LaCoursiere et al., Retained fragments after total laparoscopic hysterectomy, J. MINIM. INVAS. GYNCOL., 12:67-69, 68 (2005). 20 Id. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 24 of 49 PageID: 949 24 m. In 2010, in THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY, Larraín et al. explained that, “[i]f retained fragments [from morcellation] can establish a blood supply and grow with benign disease, it is of concern that in situations in which an unsuspected malignant lesion is inadvertently morcellated, aberrant fragments will grow and metastasize.”21 n. Based on this evidence, Defendants were on notice that the morcellator exposed patients to a significant risk of disseminating and spreading parasitic uterine myomas. 99. Second, Defendants knew or should have known that, for women undergoing laparoscopic hysterectomies or myomectomies for presumed fibroids, the risk of having a hidden deadly sarcoma was much higher than 1 in 10,000. a. In 1990, Leibsohn et al. published a study titled “Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas” in the AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY in which the authors found that “...women with signs and symptoms of [benign] uterine leiomyomas [fibroids] that warrant hysterectomy have about a 1 in 140 chance of having a uterine leiomyosarcoma.”22 b. In 1999, Takamizawa et al. published another study titled “Risk of Complications and Uterine Malignancies in Women Undergoing Hysterectomy for Presumed Benign Leiomyomas” in GYNECOLOGIC AND OBSTETRIC INVESTIGATION, which found that 2/923 21 Larraín et al., “Iatrogenic” Parasitic Myomas: Unusual Late Complications of Laparoscopic Morcellation Procedures, MINIM. INVAS. GYNCOL., 17:719-724, 722 (2010) (“Larraín et al. paper”). 22 Leibsohn et al., Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas, AM. J. OBSTET. GYNECOL. 162:968-76, 972 (1990) (“Leibsohn et al. paper”). Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 25 of 49 PageID: 950 25 women who underwent hysterectomies for presumed benign fibroids had undiagnosable hidden sarcomas before their hysterectomies.23 c. Takamizawa et al. reported that their study results were consistent with the findings of other studies which suggested that 2-5 patients per 1,000 who undergo surgery for presumed fibroids have uterine sarcomas.24 d. This evidence was available to Defendants. e. However, upon information and belief, in seeking for approval for their laparoscopic power morcellators decades before Decedent underwent surgery, and, later, in promoting their devices to the medical community, Decedent and Decedent’s surgeon, the Karl Storz Defendants ignored this data and touted a much lower 1 in 10,000 risk. 100. Third, Defendants knew or should have known that women could not be adequately screened for malignancy prior to undergoing laparoscopic power morcellation surgery because certain types of cancers, including sarcomas, can mimic the radiographic appearance of benign uterine fibroids. a. In the 1990 Leibsohn et al. study, discussed supra, the authors described the difficulties in diagnosing leiomyosarcoma (a particularly aggressive form of cancer) preoperatively, noting that “abdominal ultrasonography of the pelvis and cervical cytology are not helpful preoperative tests for the diagnosis [of] leiomyosarcoma of the uterus.”25 b. Additional evidence became available to Defendants in 2001, when Stewart published an article in THE LANCET, which explained that malignant leiomyosarcoma 23 Takamizawa et al., Risk of Complications and Uterine Malignancies in Women Undergoing Hysterectomy for Presumed Benign Leiomyomas, GYNECOL. OBSTET. INVEST., 48:193-196, 196 (1999). 24 Id. 25 See Leibsohn et al. paper, at 192. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 26 of 49 PageID: 951 26 and benign fibroids may share histological features; thereby, making it more difficult for clinicians to identify the malignant potential of smooth muscle uterine tumors.26 c. The difficult in diagnosing uterine sarcoma preoperatively was not limited to leiomyosarcoma. d. Upon information and belief, in 2006, Robert Lamparter, M.D., a pathologist at Evangelical Community Hospital in Lewisburg, Georgia, wrote to the former medical director of Ethicon Women’s Health and Urology, a Johnson and Johnson subsidiary, imploring the company to reconsider the risk of power morcellators to the patient. Dr. Lamparter advised Ethicon that, virtually all uteruses have some sort of pre-op screening, whether it be an endometrial biopsy or an ultrasound, so whatever screening is being done misses a certain number of malignancies. However, when the operative procedure is a standard hysterectomy, no damage is done. If a morcellation is done, the patient’s survival is jeopardized. e. In 2008, Bansal et al. published a study in GYNECOLOGIC ONCOLOGY, in which the authors found that the predictive value of endometrial biopsy or curettage for diagnosing uterine sarcoma was very poor and, thus, “novel diagnostic techniques are needed to accurately identify uterine sarcomas preoperatively.”27 f. Similarly, in 2010, Della Badia and Karini published a case report in THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY, in which they warned that there was “no 26 Stewart, Uterine Fibroids, THE LANCET, 357:293-98 (2001). 27 Bansal et al., The utility of preoperative endometrial sampling for the detection of uterine sarcoma, GNECOL. ONCOL., 110:43-48, 47 (2008). Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 27 of 49 PageID: 952 27 reliable method for preoperative diagnosis of endometrial sarcoma” and “[s]ensitivity of preoperative endometrial sampling is only 64% for enabling a diagnosis of this tumor.”28 g. According to the authors, where malignancy is found before surgery, the standard treatment for uterine sarcoma is a total hysterectomy with staging of the cancer, not tissue morcellation.29 101. Fourth, Defendants knew or should have known that women undergoing surgery with laparoscopic power morcellators suffer worse long-term medical outcomes than women undergoing other available treatment options because of the cancer risks associated with the use of their devices. a. For example, in 2002, Goto et al. published a study in the INTERNATIONAL JOURNAL OF GYNECOLOGIC CANCER, which reported: Leiomyosarcoma of the uterus is one of the most difficult neoplasms to cure in gynecologic oncology. Its malignant behaviors such as rapid growth and high rate of metastasis are notorious. The 5-year survival in patients with advanced stages (stage III or higher) is less than 10%, although leiomyosarcoma resembles leiomyoma in clinical features. Until now LMS was diagnosed only in advanced stages or accidentally at total abdominal hysterectomy. [ ... ] Therefore it seems that the effective treatment of LMS is surgical removal of the tumor in the earlier stages. The problem regarding treatment of LMS is the difficult preoperative differential diagnosis of LMS in the early stages from leiomyoma, which is the most common tumor of the uterus.30 28 Della Badia and Karini, Endometrial Stromal Sarcoma Diagnosed after Uterine Morcellation in Laparoscopic Supracervical Hysterectomy, J. MINIM. INVAS. GYNCOL., 17:791-93, 791 (2010). 29 Id. 30 Goto, et al., Usefulness of Gd-DTPA contrast-enhanced dynamic MRI and serum Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 28 of 49 PageID: 953 28 b. Likewise, in 2003, Morice et al. published an article in the EUROPEAN JOURNAL OF GYNECOLOGIC ONCOLOGY, in which they found a substantial increase in pelvic recurrence of uterine sarcoma at three (3) months in 34 patients with uterine sarcoma who had morcellation during their initial surgery compared with 89 patients without morcellation.31 c. The authors concluded that, when the diagnosis of uterine sarcoma is known preoperatively, the optimal treatment for uterine sarcoma is a “monobloc” total abdominal hysterectomy and bilateral salpingo-oophorectomy without morcellation.32 d. In 2008, Einstein et al. presented a prospective study in the INTERNATIONAL JOURNAL OF GYNECOLOGIC CANCER involving all patients who had undergone any type of hysterectomy for presumed benign disease and were, subsequently, referred to Memorial Sloan-Kettering between January, 2000 and March, 2006 with diagnosed malignancy based on the final surgical pathology.33 e. According to their review, an astounding 40% percent of patients who underwent morcellation were found to have upstaged cancer compared with only 8% who had a supracervical hysterectomy.34 f. According to the authors, “[this] data support this trend toward worse outcomes in patients who had morcellation procedures.”35 determination of LDH and its isozymes in the differential diagnosis of leiomyosarcoma from degenerated leiomyoma of the uterus, INT. J. GYNECOL. CANCER, 12:354-361, 358 (2002). 31 Morice et al., Prognostic value of initial surgical procedure for patients with uterine sarcoma: analysis of 123 patients, EUR. J. GYNAECOL. ONCOL., 24(3-4);237-40, 238-39 (2003). 32 Id. at 239. 33 Einstein et al., Management of uterine malignancy found incidentally after supracervical hysterectomy or uterine morcellation for presumed benign disease, INT. J. GYNECOL. CANCER, 18: 1065-70, 1066 (2008). 34 Id. at 1069. 35 Id. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 29 of 49 PageID: 954 29 g. In 2009, Perri et al. published an article in the INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER, in which they explained: [u]nfortunately, however, it is not unusual to diagnose LMS [leiomyosarcoma] only postoperatively because its symptoms and signs resemble those of benign leiomyomas (LMs), and there are no imaging techniques for differentiation between the two. Consequently, on the assumption that they have LM, some patients with LMS are treated initially with hysteroscopic or abdominal myomectomy, subtotal hysterectomy, or laparoscopic hysterectomy or myomectomy with a morcellator knife. Those surgical techniques, unlike total abdominal hysterectomy (TAH), are likely to involve tumor injury or cut-through.36 h. According to the authors, “[their] data demonstrate[d] a significant disadvantage for patients in whom the primary surgery had involved tumor cut-through.”37 i. In the 2010 Larraín et al. study, discussed supra, they commented that “[i]f malignancy is suspected or known preoperatively, morcellation is formally proscribed. However, this situation [spread of malignant tissue] may occur, even if an appropriate preoperative workup including cervical cytologic analysis and endometrial sample are routinely performed.”38 j. Consistent with Perri et al.’s findings, in a paper published in 2011 in THE ANNALS OF SURGICAL ONCOLOGY, Park et al. found that women undergoing morcellation suffered worse outcome than women in the non-morcellated treatment group.39 36 Perri et al., Uterine Leiomyosarcoma: Does the Primary Surgical Procedure Matter?, INT. J. GYNECOL. CANCER, 19(2): 257-260, 257 (2009). 37 Id. at 260. 38 Larraín et al. paper at 722-23. 39 Park et al., The Impact of Tumor Morcellation During Surgery on the Outcomes of Patients with apparently Early Low-Grade Endometrial Stromal Sarcoma of the Uterus, ANN. SURG. ONCOL., 18:3452-61 (2011) (“Park et al. paper”). Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 30 of 49 PageID: 955 30 k. The authors compared outcomes between patients diagnosed post- operatively with low-grade endometrial stromal sarcoma who had undergone tumor morcellation and those who had not.40 l. They found a statistically significant difference in five-year disease-free survival rates between non-morcellated patients (85%) and morcellation patients (55%).41 m. In the 2011 Park et al. paper, the authors also found that five-year abdomino-pelvic disease-free survival was statistically significantly lower in morcellated patients, with 89% disease-free survival rate in the non-morcellated patients and only 58% in the morcellated group.42 n. The authors noted that “[a]s with other soft tissue sarcomas, iatrogenic rupture and intraperitoneal spillage of tumor may adversely affect the outcomes of patients with apparently early LGESS [low-grade endometrial stromal sarcoma], for whom complete surgical excision is the only established curative treatment modality.”43 102. Fifth, Defendants knew or should have known that when malignant tissue undergoes laparoscopic power morcellation, the resultant tissue specimens can delay diagnosis because their condition can prevent the pathologist from properly identifying and staging cancer, which can further worsen a patient’s prognosis and treatment outcomes. a. For example, in 2005, Rekha et al. discuss in their paper published in the AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, “[o]ne of the 40 Id. at 3454. 41 Id. at 3455. 42 Id. at 3456. 43 Id. at 3457. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 31 of 49 PageID: 956 31 disadvantages of tissue morcellation is loss of the gross appearance of the specimen and the possibility of missing the most suspicious area for the microscopic evaluation.”44 b. Rekha et al.’s case report involved a 40-year-old woman who underwent total laparoscopic hysterectomy for presumed benign uterine fibroids died several months after her initial surgery from dissemination of occult leiomyosarcoma.45 c. According to the authors, the patient’s “malignant component was missed at the time of initial histological evaluation due to evaluation of limited tissue.”46 d. Published in 2011, Hagemann et al. also discuss the difficulty of analyzing morcellated specimens in their case series “Risk of Occult Malignancy in Morcellated Hysterectomy: A Case Series” that appeared in the INTERNATIONAL JOURNAL OF GYNECOLOGICAL PATHOLOGY.47 e. In their article, Hagemann et al. explained that “[t]hese [morcellated] specimens are examined in the surgical pathology laboratory where, by their fragmented and unoriented nature, they present a special challenge to the pathologist. There is little evidence to guide the pathologic examination of these specimens.”48 103. As set forth herein, over the years numerous journal articles and published studies have examined laparoscopic power morcellators’ potential to spread parasitic uterine myomas and tissue. 44 Rekha et al., Unexpected complications of uterine myoma morcellation, AUST. N.Z. J. OBSTET. GYNECOL., 45: 248-49, 248 (2005). 45 Id. 46 Id. 47 Hagemann et al., Risk of Occult Malignancy in Morcellated Hysterectomy: A Case Series, INT. J. GY N ECOL. CANCER, 30:478-83 (2011). 48 Id. at 481-82. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 32 of 49 PageID: 957 32 104. This evidence should have placed Defendants on notice that the morcellator was associated with and/or could cause the dissemination and spreading of parasitic uterine myomas. 105. As a direct and proximate result of the use of the morcellator, Vivian Ruscitto suffered severe physical injury, emotional injury, and pain and suffering. 106. As a direct and proximate result of the use of the morcellator, Nicholas Roche incurred the loss of his wife. 107. As a direct and proximate result of the use of the morcellator, Maximo Valentino Ruscitto-Roche lost his mother. 108. Defendants’ acts, conduct and omission were willful, malicious, wanton, oppressive and fraudulent, and were done with a conscious disregard for the health, safety and rights of Plaintiff, and for the primary purpose of increasing Defendants’ profits. 109. Because of Defendants’ failure to adequately warn surgeons of the risk of morcellator use and Defendants’ failure to adequately recommend, require or provide a safe, closed system tissue bag for use with the power morcellator to prevent dissemination of an unsuspected cancer, Viviana Ruscitto suffered injury, including metastasized cancer. COUNT 1: MEDICAL MALPRACTICE AGAINST THE VALLEY HOSPITAL, INC., HOWARD JONES, M.D., and EUGENIA C. KUO, M.D. 110. Plaintiff incorporates by reference the averments of the preceding paragraphs of the Complaint as if fully set forth at length herein. 111. At all times hereinafter mentioned, Defendant THE VALLEY HOSPITAL supplied, permitted, allowed, used and/or provided Defendants Karl Storz GMBH & Co. and Karl Storz Endoscopy-America, Inc.’s power morcellator to Defendants JONES and KUO in connection with Decedent’s October 17, 2014 gynecological surgery. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 33 of 49 PageID: 958 33 112. Defendants JONES and KUO undertook to and did render certain medical care, diagnosis, and/or treatment to Decedent on or before October 17, 2014. 113. On or before October 17, 2014, Defendant JONES met with and performed a physical examination of Decedent VIVIANA RUSCITTO, including of her lower abdomen. 114. On or before October 17, 2014, Defendant JONES took a history from Decedent VIVIANA RUSCITTO of her physical condition. 115. On or before October 17, 2014, Defendant JONES reviewed the results of an abdominal MRI that showed “a large 8 cm posterior submucosal fibroid that is degenerating.” 116. On or before October 17, 2014, Defendant JONES also noted that Decedent had fibroids, menorrhagia, and that she was noted to have heavier bleeding that had been increasing over the last year. 117. On or before October 17, 2014, Defendant JONES neither requested nor sought a biopsy of Decedent’s large 8 cm posterior submucosal degenerating fibroid. 118. On or before October 17, 2014, Defendant JONES did not consider or schedule Decedent for a Dilation and Curettage (D&C). 119. On October 17, 2014, Defendants JONES and KUO, under general endotracheal anesthesia, performed on the Decedent a robotic assisted laparoscopic supracervical hysterectomy, bilateral salpingectomy, with the removal of the umbilical hernia sac at Defendant VALLEY (hereinafter described as “the surgery”). 120. On October 17, 2014, Defendants JONES and KUO discovered that the uterus had multiple large fibroids, several anterior and several large posterior lower uterine segment fibroids. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 34 of 49 PageID: 959 34 121. On October 17, 2014, Defendants JONES and KUO introduced the Defendants Karl Storz GMBH & Co. KG and Karl Storz Endoscopy-America, Inc.’s power morcellator through the left lower quadrant port, and then proceeded to serially morcellate the Decedent’s uterus intra-abdominally. 122. On October 17, 2014, the post-operative pathology report on portions of the uterus indicated leiomyosarcoma. 123. On or before October 17, 2014, Defendant JONES knew, and Decedent specifically told him, that she had tremendous anxiety of ovarian cancer. 124. Defendants VALLEY, JONES, and KUO, their agents, servants, and/or employees, held themselves out to the public, and specifically to Decedent VIVIANA RUSCITTO, as utilizing and employing medical personnel possessing the proper degree of learning and skill necessary to render proper medical care, perform a hysterectomy, and a salpingectomy in accordance with good and accepted medical practices, and that they undertook to use reasonable care and diligence in the treatment of patients, especially Decedent VIVIANA RUSCITTO, herein. 125. Defendants VALLEY and JONES performed a surgery, one year before Decedent’s surgery, on SUMAIRA KHAN, and during said surgery used a Karl Storz power morcellator which morcellated her LMS cancer tissue and caused in an upstaging of her cancer. That Defendants knew the significant risk of using the morcellator on Decedent and upstaging her cancer for at least one year before her procedure, and completely ignored and disregarded all the known risks to the Decedent, morcellated her cancerous uterus and fibroid and resulted in the upstaging of her cancer from stage 1 to stage 4 and resulting in her death on September 3, 2015. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 35 of 49 PageID: 960 35 126. Defendants VALLEY, JONES, and KUO, their agents, servants, and/or employees, were negligent and careless in failing to perform a pre-operative and/or inter- operative biopsy on Decedent’s large 8 cm posterior submusocal degenerating fibroid; in negligently using or employing a power morcellator in connection with Decedent’s hysterectomy and salpingectomy and intentionally shredding and spreading the leiomyosarcoma all over Decedent’s abdomen; in negligently failing to use a bag or sac internally to prevent the spread and contamination of the internal abdominal cavity with leiomyosarcoma; in failing to convert Decedent’s laparoscopic hysterectomy into an open procedure and simply removing the uterus in its entirety; in failing to perform a limited open procedure to remove Decedent’s uterus, or alternatively removing the uterus via her vagina, and thus avoiding morcellation completely; in failing to follow and adhere to previous well-publicized and commonly disseminated FDA warnings, which strongly advised against using power morcellators and required that patients be fully advised of the risks associated with using a power morcellator, including the spreading of leiomyosarcoma throughout the abdominal cavity, and potential upstaging a patient’s cancer; in failing to advise Decedent of any risks associated with the power morcellator, including but not limited to the risk that the large fibroid could contain leiomyosarcoma, and that the cancer could be spread throughout her abdominal cavity, thus increasing staging and decreasing Decedent’s best chance of survival; in failing to advise Decedent of alternative procedures available to the power morcellator, including an open hysterectomy, which were substantially safer to the patient; in the hospital failing to ensure the safety of the patient by prohibiting the use of the power morcellator during the laparoscopic hysterectomy, insisting that a bag be used to isolate any potentially cancerous tissue; failing to use or recommend the use of a containment bag (contained tissue extraction-CTE) while using the morcellator to prevent the unnecessary and Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 36 of 49 PageID: 961 36 easily preventable dissemination of the LMS cancer throughout the abdominal cavity of the Decedent, and/or securing the Decedent’s informed written consent regarding the increased risks of spreading her cancer and decreasing her chances of survival; in the hospital, through its CEO, in failing to develop policies and safeguards to ensure that all patients, including Decedent VIVIANA RUSCITTO, were adequately informed and protected from doctors using power morcellators; in failing to obtain valid informed consent from Decedent, including ensuring that the scope of surgery agreed to by the Decedent was what the Defendants intended to perform, thus deviating from the standard of care; in failing to implement a “time out procedure,” as indicated by community standards, ensuring that the surgical team members understand the scope and limitations of the procedure, and in failing to have the members of the surgical team sign off on the verification form; in failing to file a Sentinel Event Report, which is required by community standards when an unanticipated outcome of significant injury or death occurs; in failing to supervise, hire, train, retain, and employ competent staff at the hospital, to monitor FDA warnings, and disseminate that information to hospital staff to ensure compliance by its attending physicians who perform surgeries at its facilities; in failing to update hospital policy and protocols in response to the Society of Gynecological Oncology’s December 2013 Position Statement, outlining the risks, hazards and dangers of power morcellation, and indicating that all risks, benefits and alternatives to such a procedure should be discussed with a patient so that “an informed and voluntary decision” may be made; in failing to update hospital policy and protocols in response to the FDA’s April 17, 2014 Safety Communication, which discourages the use of “laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids” and which encouraged health care providers to “thoroughly discuss the benefits and risks of all treatments with patients,” as well as informing patients that unknown cancer may spread and Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 37 of 49 PageID: 962 37 worsen their prognosis; in failing to update hospital policy and protocols in response to the FDA’s April 17, 2014 Media Release, which discouraged the use of laparoscopic power morcellators for hysterectomies and myomectomies, as well as recommending that health care professionals “carefully consider all available treatment options” for women with uterine fibroids, and to discuss all benefits and risks associated with the use of power morcellation; in failing to update hospital policy and protocols in response to the American College of Obstetricians and Gynecologists’ May 2014 Special Report, which discouraged the use of power morcellation, and stated that “alternative treatment options as well as risks and benefits should be discussed” with patients and that patients must also be advised that “if occult cancer is present and morcellation is used…there is a risk that the cancer may spread and worsen the patient’s outcome;” in failing to update hospital policy and protocols in response to a manufacturer’s warning and notification of the aforementioned FDA pronouncements, and the dangers of the use of power morcellation in hysterectomies and myomectomies; in failing to make use of the best medical judgments available, in that the Defendants were guilty of negligence and malpractice, both active and passive, in the care and treatment of Decedent VIVIANA RUSCITTO, and also guilty of negligence and malpractice under the theory of res ipsa loquitur, and in otherwise being careless and negligent at or about the aforesaid time and place. 127. That as a result of the foregoing, the Defendants caused Decedent VIVIANA RUSCITTO’s leiomyocarcoma to be substantially upstaged, and she sustained an extension and spreading of her cancer, and was caused to suffer severe physical injuries, including a surgery in an attempt to remove all of her uterus that was morcellated by Defendants intra-abdominally, as well as a complete abdominal body wash, extensive chemotherapy treatments, pain and mental anguish, severe shock, and a decrease in her life expectancy; had been caused to incur certain Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 38 of 49 PageID: 963 38 expenses for medical attention and surgery; and had been caused to abstain from the duties of her vocation and lived in fear of her imminent death. Decedent also has a substantial future lost wage claim. Decedent died as a result of the actions of the Defendants stated above. 128. The amount of damages herein exceeds the jurisdictional limit of all lower courts, which would otherwise have jurisdiction in this matter. 129. As a result of the foregoing, Plaintiffs, collectively, demand damages against THE VALLEY HOSPITAL, INC., HOWARD H. JONES, M.D., and EUGENIA C. KUO, M.D., in an unspecified amount, together with costs and disbursements of this action to be determined by a jury at the time of trial. COUNT 2: LACK OF INFORMED CONSENT AGAINST THE VALLEY HOSPITAL, INC., HOWARD JONES, M.D., and EUGENIA C. KUO, M.D. 130. Plaintiff incorporates by reference the averments of the preceding paragraphs of the Complaint as if fully set forth at length herein. 131. That there were certain risks, hazards, and dangers with respect to the course of treatment and lack thereof undertaken by the Defendants. 132. That Defendant failed to warn and advise Decedent VIVIANA RUSCITTO of the risks, hazards, and dangers of aforesaid course of treatment. 133. That Decedent VIVIANA RUSCITTO had the right to know the risks, hazards, and dangers of the aforesaid course of treatment and the available alternatives to it. 134. That had the Decedent VIVIANA RUSCITTO known of the risks, hazards, and dangers of the aforesaid course of treatment, she would not have consented. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 39 of 49 PageID: 964 39 135. That had the Decedent VIVIANA RUSCITTO, or any reasonable person, been informed of the risks, hazards, and dangers with respect to the aforesaid course of treatment, they would not have consented to it. 136. That as a result of the foregoing, Decedent’s leiomyosarcoma of the fibroid uterus was substantially upstaged, and she sustained an extension and spreading of her cancer; she also lost her best chances for survival and has been caused to suffer severe physical injuries, including unnecessary surgical procedures, extensive chemotherapy, pain and mental anguish, severe shock, and a decrease in life expectancy; had been caused to incur certain expenses for medical attention and surgery; and had been caused to abstain from the duties of her vocation presently and in the future and subsequently died. 137. The amount of damages herein exceeds the jurisdictional limit of all lower courts, which would otherwise have jurisdiction in this matter. 138. As a result of the foregoing, Plaintiffs, collectively, demand damages against THE VALLEY HOSPITAL, INC., HOWARD H. JONES, M.D., and EUGENIA C. KUO, M.D., in an unspecified amount, together with costs and disbursements of this action to be determined by a jury at the time of trial. COUNT 3: PRODUCTS LIABILITY AND DEFECTIVE PRODUCT AGAINST THE KARL STORZ DEFENDANTS (N.J. Products Liability Act - N.J.S.A. 2A:58C-1 et seq.) 139. Plaintiff incorporates by reference the averments of the preceding paragraphs of the Complaint as if fully set forth at length herein. 140. The morcellator is a product designed, formulated, manufactured, marketed, distributed, promoted, advertised, packaged, sold and/or supplied by the Karl Storz Defendants Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 40 of 49 PageID: 965 40 that was placed into the stream of commerce by the Karl Storz Defendants in a condition that was defective and unreasonably dangerous as designed taking into consideration the utility of the products and the risks involved in their use. 141. The morcellator was unsafe for its intended and/or reasonably foreseeable purposes and uses at the time it was distributed, sold or supplied by the Karl Storz Defendants because the known side effects and adverse consequences outweighed the benefits of the product. The morcellator left the Karl Storz Defendants’ hands in this defective condition and caused dissemination and/or upstaging of unsuspected malignant tissue to spread throughout Plaintiff’s abdomen and the gravity of that damage outweighed the burden on Defendants to adopt an alternative design or method and the adverse effect of such alternative design or method on the utility of the device. 142. At the time the morcellator left the hands of the Karl Storz Defendants, there were safer alternative designs that were economically and technologically feasible by the application of reasonable scientific knowledge. 143. The Karl Storz Defendants failed to recommend the use of a containment bag (contained tissue extraction-CTE) while using the morcellator to prevent the unnecessary and easily preventable dissemination of the LMS cancer throughout the abdominal cavity of the Decedent. 144. The defectively designed condition of the morcellator rendered the product unreasonably dangerous and defective for its intended and reasonably foreseeable uses and was the producing and proximate cause of the injuries and damages sustained by Plaintiff, for which the Karl Storz Defendants are liable to Decedent. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 41 of 49 PageID: 966 41 145. As a result of the foregoing, Decedent’s leiomyosarcoma of the fibroid uterus was substantially upstaged, and she sustained an extension and spreading of her cancer; she also lost her best chances for survival and has been caused to suffer severe physical injuries, including unnecessary surgical procedures, extensive chemotherapy, pain and mental anguish, severe shock, and a decrease in life expectancy; had been caused to incur certain expenses for medical attention and surgery; and had been caused to abstain from many of the duties of motherhood of her beloved son presently and in the future; and was subsequently caused to die therefrom. 146. The amount of damages herein exceeds the jurisdictional limit of all lower courts, which would otherwise have jurisdiction in this matter. 147. By reason of the foregoing, Plaintiffs, collectively, demand judgment against the Karl Storz Defendants, for compensatory damages in a sum that exceeds the jurisdictional limits of all lower courts that otherwise might have jurisdiction, and punitive damages, together with interest, costs, and attorneys’ fees of this case, and all such other further and different relief as the Court deems proper. COUNT 4: PRODUCT LIABILITY ACT - FAILURE TO WARN AGAINST THE KARL STORZ DEFENDANTS (N.J. Products Liability Act - N.J.S.A. 2A: 58C-2 et seq.) 148. Plaintiff repeats, reiterates and re-alleges each and every allegation contained in the previous paragraphs as is set forth herein at length. 149. The Karl Storz Defendants were under an ongoing duty to keep abreast of medically known or knowable information related to their products and to advise clinicians of these risks in a timely manner to ensure the safe use of their product. 150. The Karl Storz Defendants failed to adequately warn health care professionals and the public, including Decedent and her surgeon, of the following risks associated with the use of Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 42 of 49 PageID: 967 42 the morcellator, all of which were known or scientifically knowable to the Karl Storz Defendants prior to the date on which the Decedent under surgery in 2014, including, but not limited to: a. The risk of aggressively disseminating unsuspected malignant tissue beyond the uterus; b. The device’s risk of spreading a patient’s parasitic uterine myomas; c. Failing to provide accurate warnings regarding the inadequacy of pre- operative screening for the presence of unsuspected malignant uterine tissue in women; d. Failing to provide accurate rates of the prevalence of unsuspected malignant tissue in women undergoing uterine morcellation; and e. Failing to advise doctors to carefully monitor patient following laparoscopic power morcellator surgery to evaluate for the presence of parasitic uterine myomas at an earlier date and to allow for appropriate treatment in the event of such a finding. 151. The Karl Storz Defendants’ failure to adequately warn Decedent and Decedent’s surgeon of the risks associated with laparoscopic power morcellators prevented Decedent and Decedent’s surgeon from correctly and fully evaluating the risks and benefits of undergoing surgery with the Karl Storz Defendants’ device. 152. The Karl Storz Defendants failed to timely include a Black Box Warning regarding the risks of dissemination of occult malignancy and the spreading of a patient’s parasitic uterine myomas. 153. The Karl Storz Defendants failed to timely include a Contraindication that power morcellators should not be used in women with tissue of unsuspected, occult, or unknown malignancy. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 43 of 49 PageID: 968 43 154. Had the Karl Storz Defendants timely and adequately warned of the risks of the laparoscopic power morcellator used during Decedent’s surgery, such warnings would have been heeded by Decedent’s surgeon, in that Decedent’s surgeon would have changed the manner in which he prescribed or selected the power morcellator for Decedent’s surgery, including but not limited to, communicating the risks to the Decedent prior to surgery, not using the power morcellator, and/or selecting an alternative and safer treatment option for the Decedent. 155. If Decedent had been adequately warned of the life-threatening risks of the use of the laparoscopic power morcellator, as stated herein, she would have chosen an alternative treatment, one that did not carry the avoidable risks of disseminating and/or spreading parasitic uterine myomas and, therefore, would have avoided the injuries described herein. 156. The Karl Storz Defendants’ failure to adequately warn about the risks of the morcellator was a substantial and contributing factor in causing Decedent’s injuries. 157. As a result of the foregoing, Decedent’s leiomyosarcoma of the fibroid uterus was substantially upstaged, and she sustained an extension and spreading of her cancer; she also lost her best chances for survival and has been caused to suffer severe physical injuries, including unnecessary surgical procedures, extensive chemotherapy, pain and mental anguish, severe shock, and a decrease in life expectancy; has been caused to incur certain expenses for medical attention and surgery; and has been caused to abstain from many of the duties of motherhood of her beloved daughters presently and in the future. 158. The amount of damages herein exceeds the jurisdictional limit of all lower courts, which would otherwise have jurisdiction in this matter. 159. By reason of the foregoing, Plaintiffs, collectively, demand judgment against the Karl Storz Defendants, for compensatory damages in a sum that exceeds the jurisdictional limits Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 44 of 49 PageID: 969 44 of all lower courts that otherwise might have jurisdiction, and punitive damages, together with interest, costs, and attorney’s fees of this case, and all such other further and different relief as the Court deems proper. COUNT 5: NEGLIGENT INFLICTION OF EMOTIONAL DISTRESS AGAINST THE VALLEY HOSPITAL, INC., HOWARD JONES, M.D., and EUGENIA C. KUO, M.D. 160. Plaintiff incorporates by reference the averments of the preceding paragraphs of the Complaint as if fully set forth at length herein. 161. Plaintiff was present during the injuries that were caused or associated with the Morcellator and Viviana Ruscitto’s surgery in October 2014. 162. As a result, Plaintiff suffered shock and severe emotional distress. 163. Plaintiff’s Loss of Consortium Claim is derivative of claims asserted in Viviana’s Ruscitto’s Complaint, Case No. Case No. 2:15-cv-05704-JLL-JAD. 164. By reason of the foregoing, Plaintiff collectively demands judgment in his favor and against the Defendants VALLEY HOSPITAL, JONES, and KUO, jointly and severally, for damages in an amount in excess of the jurisdictional limits of this Court, together with all lawful fees, costs and such other relief as this Court deems just and proper. COUNT 6: LOSS OF CONSORTIUM AGAINST THE VALLEY HOSPITAL, INC., HOWARD JONES, M.D., and EUGENIA C. KUO, M.D. 165. Plaintiff incorporates by reference the averments of the preceding paragraphs of the Complaint as if fully set forth at length herein. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 45 of 49 PageID: 970 45 166. Plaintiff NICHOLAS ROCHE has necessarily paid and has become liable to pay for medical aid, treatment, attendance and medications, and will necessarily incur further expenses of a similar nature in the future. 167. As a further result of the tortious conduct of the Defendants named herein, Plaintiff NICHOLAS ROCHE suffered, and will permanently suffer for an indefinite time in the future, loss of services, security, companionship, and consortium of his wife. 168. By reason of the foregoing, Plaintiff, collectively demands judgment against the above-named Defendants for damages, interest, costs of suit, and all other damages permissible under New Jersey law. COUNT 7: N.J. Products Liability Act - N.J.S.A. 2A: 58C-1 et seq. AGAINST THE KARL STORZ DEFENDANTS 169. Plaintiff incorporates by reference the averments of the preceding paragraphs of the Complaint as if fully set forth at length herein. 170. Pursuant to the New Jersey Products Liability Act and as a result of the Karl Storz Defendants’ tortious conduct, Plaintiff NICHOLAS ROCHE suffered and continues to suffer harm, including shock and severe emotional distress as well as loss of services, security, companionship, and consortium of his wife. 171. By reason of the foregoing, Plaintiff, collectively demands judgment against the above-named Defendants for damages, interest, costs of suit, and all other damages permissible under New Jersey law. Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 46 of 49 PageID: 971 46 PRAYER FOR RELIEF WHEREFORE, Plaintiff prays for judgment against the Defendants, jointly and severally, as follows: a. For an award of compensatory damages, including damages against Defendants and each of them for pain and suffering, medical and hospital expenses, loss of income, permanent disability, wrongful death damages, pecuniary damages, and other damages according to proof at trial in excess of $75,000; b. For an award of punitive damages against the Karl Storz Defendants; c. For reasonable attorneys’ fees and costs; d. For pre-judgment interest; and e. For such further and other relief the court deems just, equitable, and proper. f. Appropriate distribution of proceeds from the Complaint filed on behalf of Viviana Ruscitto’s Estate as the parties in interest, survivors and beneficiaries of Viviana Ruscitto. Dated: January 23, 2017 s/ Rayna E. Kessler Rayna E. Kessler, Esq. Robins Kaplan LLP 601 Lexington Avenue, Suite 3400 New York, New York 10022 Attorney for NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 47 of 49 PageID: 972 47 JURY DEMAND Plaintiff hereby demands a trial by jury on all issues so triable. Dated: January 23, 2017 s/ Rayna E. Kessler Rayna E. Kessler, Esq. Robins Kaplan LLP 601 Lexington Avenue, Suite 3400 New York, New York 10022 Attorney for NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 48 of 49 PageID: 973 48 CERTIFICATION OF OTHER ACTIONS The undersigned hereby certifies that the matter in controversy is not the subject of any other action pending in any court, arbitration, or administrative proceeding other than the matters of SUMAIRA KHAN v KARL STORZ ENDOSCOPY-AMERICA, INC.; KARL STORZ ENDOVISION, INC.; KARL STORZ GMBH & Co.KG; HOWARD H. JONES, M.D.; NOAH A. GOLDMAN, M.D.; THE VALLEY HOSPITAL, INC.; and JOHN DOES (1-10) and XYZ CORP (1-10) (such names and corporations being fictitious), Civil Case No.: 2:15-cv-07822- JLL-JAD and MIRIAN RIVERA, AS THE SOLE TRUSTEE OF THE VIVIANA RUSCITTO REVOCABLE LIVING TRUST, V. THE VALLEY HOSPITAL, INC., HOWARD H. JONES, M.D., EUGENIA C. KUO, M.D., KARL STORZ ENDOSCOPY-AMERICA, INC., KARL STORZ ENDOVISION, INC., KARL STORZ GMBH & Co.KG, and JOHN DOES (1-10) AND XYZ CORP (1-10) (such names and corporations being fictitious, Civil Case No.: 2:15-cv- 05704-JLL-JAD. s/ Rayna E. Kessler Rayna E. Kessler, Esq. Robins Kaplan LLP 601 Lexington Avenue, Suite 3400 New York, New York 10022 Attorney for NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE Case 2:15-cv-05704-JLL-JAD Document 91-2 Filed 02/21/17 Page 49 of 49 PageID: 974 ROBINS KAPLAN LLP RAYNA E. KESSLER, ESQ. (RK4122) 601 Lexington Avenue, Suite 3400 New York, NY 10022-4611 Telephone: (212) 980-7431 Facsimile: (212) 980-7499 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY NEWARK DIVISION NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE, Plaintiff, v. THE VALLEY HOSPITAL, INC., HOWARD H. JONES, M.D., EUGENIA C. KUO, M.D., CELESTE A. TELFEYAN, D.O., KARL STORZ ENDOSCOPYAMERICA, INC., KARL STORZ GMBH & CO. KG; and JOHN DOES (1-10) AND XYZ CORP. (1-10) (such names and corporations being fictitious), Defendants. CIVIL CASE NO.: 2:15-CV-05704-JLL-JAD [PROPOSED] ORDER GRANTING PLAINTIFF’S CROSS-MOTION FOR LEAVE TO AMEND PLAINTIFF’S COMPLAINT AND DENYING DEFENDANT KARL STORZ ENDOSCOPY-AMERICA, INC.’S MOTION TO DISMISS AS MOOT THIS MATTER having been opened to the Court upon application of Robins Kaplan LLP, attorneys for Plaintiff Nicholas Roche, for an Order allowing Plaintiff leave to amend his Complaint, upon notice to all counsel of record, and with full consideration of all matters brought before this Court regarding the motion, and for good cause shown: IT IS HEREBY on this _______ day of ____________, 2017; ORDERED that Plaintiff’s Cross-Motion for Leave to Amend Plaintiff’s Complaint is hereby granted, and it is further ORDERED that Defendant Karl Storz Endoscopy-America, Inc.’s Partial Motion to Case 2:15-cv-05704-JLL-JAD Document 91-3 Filed 02/21/17 Page 1 of 2 PageID: 975 2 Dismiss Plaintiff’s Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) (ECF Dkt. No. 89) is denied without prejudice as moot, Plaintiff having been granted leave to file a First Amended Complaint. IT IS SO ORDERED. _________________________________________ HONORABLE JOSE L. LINERAS, U.S.D.J. Case 2:15-cv-05704-JLL-JAD Document 91-3 Filed 02/21/17 Page 2 of 2 PageID: 976 ROBINS KAPLAN LLP RAYNA E. KESSLER, ESQ. (RK4122) 601 Lexington Avenue, Suite 3400 New York, NY 10022-4611 Telephone: (212) 980-7431 Facsimile: (212) 980-7499 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY NEWARK DIVISION NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE, Plaintiff, v. THE VALLEY HOSPITAL, INC., HOWARD H. JONES, M.D., EUGENIA C. KUO, M.D., CELESTE A. TELFEYAN, D.O., KARL STORZ ENDOSCOPYAMERICA, INC., KARL STORZ GMBH & CO. KG; and JOHN DOES (1-10) AND XYZ CORP. (1-10) (such names and corporations being fictitious), Defendants. CIVIL CASE NO.: 2:15-CV-05704-JLL-JAD CERTIFICATE OF SERVICE I hereby certify that on February 21, 2017, the attached Plaintiff’s Brief in Support of Opposition to Defendant Karl Storz Endoscopy-America, Inc.’s Partial Motion to Dismiss, as well as supporting documents, and Plaintiff’s Cross-Motion For Leave To File First Amended Complaint, as well as supporting documents, were filed with the Clerk of the U.S. District Court, Newark Division, Newark, New Jersey and all counsel of record were served via the ECF filing system. In addition, a courtesy copy will be sent via first class mail to the following: Case 2:15-cv-05704-JLL-JAD Document 91-4 Filed 02/21/17 Page 1 of 2 PageID: 977 Honorable Jose L. Linares, U.S.D.J. United States District Court 50 Walnut Street Newark, New Jersey 07102 Magistrate Judge Joseph A. Dickson, U.S.M.J. United States District Court 50 Walnut Street Newark, New Jersey 07102 DATED: February 21, 2017 s/ Rayna E. Kessler Rayna E. Kessler, Esq. (RK4122) ROBINS KAPLAN LLP 601 Lexington Avenue, Suite 3400 New York, New York 10022 Attorney for NICHOLAS ROCHE, INDIVIDUALLY AND AS GUARDIAN OF MAXIMO VALENTINO RUSCITTO-ROCHE Case 2:15-cv-05704-JLL-JAD Document 91-4 Filed 02/21/17 Page 2 of 2 PageID: 978