Kmak v. Sorin Group Deutschland GMBH

CourtDistrict Court, N.D. Illinois
DecidedDecember 12, 2017
Docket1:17-cv-04759
StatusUnknown

This text of Kmak v. Sorin Group Deutschland GMBH (Kmak v. Sorin Group Deutschland GMBH) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Kmak v. Sorin Group Deutschland GMBH, (N.D. Ill. 2017).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION

SUSAUN KMAK, as independent administrator ) of the estate of MICHAEL KMAK, deceased, ) ) Plaintiff, ) ) No. 17 CV 4759 v. ) ) Hon. Amy J. St. Eve SORIN GROUP DEUTSCHLAND GMBH ) and ) SORIN GROUP USA, INC., ) ) Defendants. 1 )

MEMORANDUM OPINION AND ORDER

AMY J. ST. EVE, District Court Judge: Plaintiff Susaun Kmak (“Plaintiff”) brings this action against Defendants Sorin Group Deutschland GmbH, now known as LivaNova Deutschland GmbH (“LivaNova Deutschland”), and Sorin Group USA, Inc., now known as LivaNova Holding USA, Inc. (“LivaNova USA,” and collectively with LivaNova Deutschland, “Defendants” or “LivaNova”), as the independent administrator of her deceased husband Michael Kmak’s (“Kmak”) estate. (R. 1.) Plaintiff alleges multiple counts against Defendants for damages resulting from Defendants’ Sorin 3T Heater-Cooler System (“3T System”) used in Kmak’s 2015 open heart surgery. (Id.)

1 Plaintiff moved to dismiss Defendant LivaNova, PLC on August 23, 2017. (R. 9.) Judge Bucklo granted the unopposed motion on September 6, 2017 and terminated LivaNova PLC as a defendant. (R. 17.) Defendants are both now a part of LivaNova: Sorin Group Deutschland GMBH is LivaNova Deutschland GmbH and Sorin Group USA, Inc. is LivaNova Holding USA, Inc. (R. 11 at 1.) Before the Court is Defendants’ motion to dismiss Counts I through VII of Plaintiff’s nine-count Complaint.2 (R. 12.) For the following reasons, the Court grants in part with prejudice and grants in part without prejudice Defendants’ motion to dismiss. BACKGROUND According to Plaintiff,3 Decedent Kmak underwent open heart surgery, specifically

“coronary artery bypass graft surgery with aortic valve replacement,” at the University of Chicago Medical Center in Chicago, Illinois, on June 25, 2015. (R. 1 at ¶ 1, 36.) Defendants’ 3T System was purportedly used to assist in the heating and cooling of Kmak’s blood during the procedure. (Id.) Plaintiff alleges that the medical device exposed Kmak to non-tuberculosis Mycobacteria and thus contributed to or caused his deteriorating condition after the surgery. (Id. at ¶ 1, 14, 20, 34, 37.) Kmak passed away at Franciscan St. Anthony Hospital in Michigan City, Indiana, on July 18, 2016. (Id. at ¶ 41.) LivaNova marketed and sold the 3T System for use during certain surgeries in operating rooms in the United States. (R. 11 at ¶ 9, 10.) Further, a Food and Drug Administration

(“FDA”) “510(k) Premarket Notification was submitted for the 3T System, the 3T System is a Class II device, and its Intended Use is ‘to provide temperature controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.’ ” (Id. at ¶ 11.)

2 On November 28, 2017, the Executive Committee reassigned this case to this Court. (R. 29.)

3 The following facts are taken from the Complaint and are accepted as true, and all reasonable inferences are drawn in Plaintiff’s favor. Roberts v. City of Chicago, 817 F.3d 561, 564 (7th Cir. 2016); Mann v. Vogel, 707 F.3d 872, 877 (7th Cir. 2013). The FDA posted a Class II Device Recall of the 3T System on or about July 15, 2015 that lists the “Manufacturer[‘s] Reason for Recall” as “[p]otential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.” (R. 11 at ¶ 20; R. 1-1 at 8-10.) Further, the FDA issued a Warning Letter to Defendants on or about December 29, 2015 regarding inspections

conducted at LivaNova’s facilities in the United States and Germany. (R. 11 at ¶ 24; R. 1-1 at 24-30.) “These inspections revealed that your firm’s devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.” (R. 1-1 at 24.) The FDA noted several other violations in the warning letter. (Id. at 24-30.) The University of Chicago Medical Center sent a letter to Plaintiff and/or Kmak on October 19, 2016 regarding the potential infection risk associated with the use of the 3T System

in Kmak’s cardiac surgery. (R. 1 at ¶ 14; R. 1-1 at 1.) Plaintiff does not otherwise describe or make factual allegations concerning LivaNova’s promotional materials, statements or activities. Plaintiff filed this lawsuit on June 26, 2017, as the administrator of decedent Kmak’s estate. (R. 1.) Plaintiff alleges nine Counts against Defendants in her Complaint: Count I, negligence; Count II, strict product liability; Count III, breach of express warranty; Count IV, breach of implied warranty; Count V, negligent misrepresentation; Count VI, misrepresentation by omission; Count VII, violation of the Illinois Consumer Fraud and Deceptive Business Practice Act (the “ICFA”); Count VIII, under the Illinois Wrongful Death Act (“Wrongful Death Act”); and Count IX, under the Illinois Survival Act (“Survival Act”). (R. 1 at 10-19.) Plaintiff seeks actual damages, but no punitive damages. (Id. at 19.) Before the Court is the Defendants’ motion to dismiss Counts I through VII of Plaintiff’s Complaint. (R. 12.) LEGAL STANDARD “A motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) challenges the viability of a complaint by arguing that it fails to state a claim upon which relief may be

granted.” Camasta v. Jos. A. Bank Clothiers, Inc., 761 F.3d 732, 736 (7th Cir. 2014) (referencing Fed. R. Civ. P. 12(b)(6)); see also Hill v. Serv. Emp. Int’l Union, 850 F.3d 861, 863 (7th Cir. 2017). Under Rule 8(a)(2), a complaint must include “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). The short and plain statement under Rule 8(a)(2) must “give the defendant fair notice of what the claim is and the grounds upon which it rests.” Bell Atlantic v. Twombly, 550 U.S. 544, 555 (2007) (citation omitted). A plaintiff’s “factual allegations must be enough to raise a right to relief above the speculative level.” Id. Put differently, 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 (2009) (quoting Twombly, 550 U.S. at 570). When determining the sufficiency of a complaint under the plausibility standard, courts must “accept all well-pleaded facts as true and draw reasonable inferences in the plaintiffs’ favor.” Roberts v. City of Chicago, 817 F.3d 561, 564 (7th Cir. 2016); Mann v. Vogel, 707 F.3d 872, 877 (7th Cir. 2013). However, “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Iqbal, 556 U.S. at 678; see also Thulin v. Shopko Stores Operating Co., LLC, 771 F.3d 994, 997 (7th Cir. 2014).

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