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Smith v. Covidien, LLC

United States District Court, N.D. Indiana

May 30, 2017

AMANDA N. SMITH, Plaintiff,
COVIDIEN, LLC, Defendant.


          THERESA L. SPRINGMANN, Judge

         The Plaintiff, Amanda N. Smith, underwent a surgical procedure in which absorbable sutures were used. After an undissolved suture was removed during a second surgery performed three months later, she sued Covidien, LLC, the manufacturer of such sutures. The Amended Complaint alleges that the Plaintiff's injury, pain and suffering, and subsequent remedial surgery, “were the direct and proximate result of a faulty product designed and manufactured by Covidien.” (First Am. Compl. ¶ 9, ECF No. 21.)

         The Defendant has moved for summary judgment [ECF No. 37], arguing that the Plaintiff does not have evidence to establish an essential element of her claim - specifically, that there is insufficient evidence that the suture used during the Plaintiff's surgery was manufactured by the Defendant. The Defendant claims that even if such evidence existed, there is no expert who can identify a defect with a Covidien suture or who can opine that any such defect caused the Plaintiff's damages. The Plaintiff counters that genuine issues of material fact exist on the issue of product identification. She relies on the theory of res ipsa loquitur to argue that a jury should determine whether the Defendant manufactured a product containing a defect. Moreover, the Plaintiff argues that the testimony of her treating physician creates genuine issues of material fact whether this defect caused her injuries.

         For the reasons stated in this Opinion and Order, the Court GRANTS the Defendant's Motion for Summary Judgment.


         On December 28, 2013, David W. Stein, M.D., performed surgery on the Plaintiff to remove a mass located on the right side of her lower neck. One of the risks associated with the surgery was unintended injury to the spinal accessory nerve. During the procedure, Dr. Stein used a 3-0 Chromic Gut Surgical Suture to close deep, subcutaneous tissue. Following the procedure, the Plaintiff began to experience shoulder weakness and drooping.[1] On March 28, 2014, three months after her initial surgery, the Plaintiff underwent a second procedure to determine the cause of her shoulder symptoms. Dr. Susan Mackinnon performed the procedure. She removed a portion of a large absorbable suture that had “wrapped circumferentially about half to two-thirds around the nerve.” (MacKinnon Aff. ¶ 2, ECF No. 38-5.) When Dr. Mackinnon removed the suture remnant, she did not send it to pathology for analysis because it was not relevant to her treatment of the Plaintiff at that time. Dr. Mackinnon does not know who manufactured the suture.

         The Plaintiff has designated three non-retained experts for purposes of establishing liability and damages: Dr. David Stein, Dr. Susan Mackinnon, and Dr. Robert Thompson. Only Dr. Stein's testimony is pertinent to the issues before the Court on summary judgment. Dr. Stein is the only one of these three witnesses who provided deposition testimony. Additionally, the Plaintiff designated Dr. Stein's affidavit as an exhibit in opposition to summary judgment. The Plaintiff believes that Dr. Stein's testimony is relevant to the product identification and causation issues.

         The other two doctors have provided two affidavits each. After the Defendant obtained the first affidavits, the Defendant filed a motion [ECF No. 40], asking the Court to enter an Order striking the Plaintiff's Expert Witness Disclosures related to product identification, product defect, and causation because the disclosures were inconsistent with the witness's affidavit testimony. Specifically, the witnesses had not provided any testimony that the Plaintiff's injuries were caused by the failure of a Covidien suture to dissolve. The Plaintiff then obtained a second affidavit from both Dr. Mackinnon and Dr. Thompson, in which the doctors clarified that they had no opinion either way as to whether the particular suture at issue in this case was defective (as opposed to stating that they did not believe the suture was defective). The Plaintiff also clarified that she was withdrawing any reliance on these experts as to the issue of product defect, electing to prove the same through the doctrine of res ipsa loquitur and the relevant product liability laws.

         It is not necessary for the Court to strike the Plaintiff's expert witness disclosures. The Court will only rely on the actual, designated, testimony of the witnesses to resolve the summary judgment motion, see Fed. R. Civ. P. 56(c)(1), not on what the Plaintiff indicated in her Rule 26 disclosures that she expected the witnesses would establish through their testimony. Additionally, the Court will apply the appropriate standards regarding burdens of proof and the admissibility of testimony in the summary judgment context. In this case, that testimony largely comes from Dr. Stein's deposition and from his subsequent affidavit.

         According to Dr. Stein's affidavit, the surgery he performed on the Plaintiff was relatively common, and there was nothing unusual about her condition. (Stein Aff. ¶ 4, ECF No. 45-1.) The surgery proceeded without incident, and Dr. Stein was “particularly careful to avoid contact with the spinal accessary nerve with either the suture or surgical instrument or any other foreign objects.” (Id. ¶ 5.) Dr. Stein maintains that he has “a clear recollection of the fact” that “nothing came into contact with her spinal accessary nerve” either during the surgery or when he was closing the wound. (Id. ¶ 6.)[2] He would not have been trying to circumferentially wrap the suture around the spinal accessary nerve. (Id.) Also, “[t]he absorbable suture selected for this surgery was intentionally done so that the suture would be absorbed and thereby not contact nor harm the spinal accessary nerve.” (Id. ¶ 7.)[3] Dr. Stein notes that the instructions accompanying the package of Covidien 3-0 Chromic sutures “gave no reason to expect the lack of total absorption nor the risk of failure of total absorption causing damage to the spinal auxiliary nerve” and that he has not known “for a Chromic suture not to absorb within the 90-day period.” (Id. ¶ 9.)


         A. Summary Judgment Standard

         Summary judgment is warranted when “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). Summary judgment is the moment in litigation where the nonmoving party is required to marshal and present the court with evidence on which a reasonable jury could rely to find in that party's favor. Goodman v. Nat'l Sec. Agency, Inc., 621 F.3d 651, 654 (7th Cir. 2010). A court should only deny a motion for summary judgment when the nonmoving party presents admissible evidence that creates a genuine issue of material fact. Luster v. Ill. Dep't of Corrs., 652 F.3d 726, 731 (7th Cir. 2011) (first citing United States v. 5443 Suffield Terrace, 607 F.3d 504, 510 (7th Cir. 2010); then citing Swearnigen-El v. Cook Cnty. Sheriff's Dep't, 602 F.3d 852, 859 (7th Cir. 2010)). A court's role in deciding a motion for summary judgment “is not to sift through the evidence, pondering the nuances and inconsistencies, and decide whom to believe. [A] court has one task and one task only: to decide, based on the evidence of record, whether there is any material dispute of fact that requires a trial.” Waldridge v. Am. Heochst Corp., 24 F.3d 918, 920 (7th Cir. 1994).

         Material facts are those that are outcome determinative under the applicable law. Smith v. Severn, 129 F.3d 419, 427 (7th Cir. 1997). Although a bare contention that an issue of material fact exists is insufficient to create a factual dispute, a court must construe all facts in a light most favorable to the nonmoving party, view all reasonable inferences in that party's favor, see Bellaver v. Quanex Corp., 200 F.3d 485, 491-92 (7th Cir. 2000), and avoid “the temptation to decide which party's version of the facts is more likely true, ” Payne v. Pauley, 337 F.3d 767, 770 (7th Cir. 2003). Additionally, a court is not “obliged to research and construct legal arguments for parties, especially when they are represented by counsel.” Nelson v. Napolitano, 657 F.3d 586, 590 (7th Cir. 2011).

         B. Indiana Products Liability Act

         Both parties acknowledge that the Plaintiff's claims are governed by the Indiana Products Liability Act (IPLA). See Piltch v. Ford Motor Co., 778 F.3d 628, 632 (7th Cir. 2015) (“The IPLA governs all actions brought by a user or consumer against a manufacturer for physical harm caused by a product, regardless of the legal theory upon which the action is brought.”) (citing Ind. Code § 34-20-1-1). A plaintiff suing under the IPLA must establish that “(1) he or she was harmed by a product; (2) the product was sold ‘in a defective condition unreasonably dangerous to any user or consumer'; (3) the plaintiff was a foreseeable user or consumer; (4) the defendant was in the business of selling the product; and (5) the product reached the consumer or user in the condition it was sold.” Bourne v. Marty Gilman, Inc., 452 F.3d 632, 635 (7th Cir. 2006) (quoting Ind. Code § 34-20-2-1). In manufacturing defect cases, a plaintiff must also prove that her injuries were proximately caused by the defect. Piltch, 778 F.3d at 632 (citing Ford Motor Co. v. Rushford, 868 N.E.2d 806, 810 (Ind. 2007)). When an issue is not within the understanding of a lay person, expert testimony is required. Id.

         A. Product Identification

         The Defendant argues that it is entitled to judgment as a matter of law because no healthcare provider or medical record indicates that its sutures were used during the Plaintiff's December 28, 2013, surgery. The Plaintiff argues that the Defendant's contention is “contradicted by the factual record in this case.” (Pl.'s Mem. of Law 8, ECF No. 46.) Upon review of the factual record, the Court agrees with the Defendant.

         Dr. Stein testified that he did not know who manufactured the suture he used during the Plaintiff's surgery. (Stein Dep. 40 (“Q. How do you know who manufactured the suture used on Amanda Smith? A. I don't know. I don't know if they document or track the product supply and serial number or however they are coded.”); Id. at 42-43 (“Q. When you were working on Ms. Smith, did you understand what company manufactured that chromic suture? A. No.”).) In his subsequent affidavit, Dr. Stein indicated that he intentionally selected an absorbable suture, and noted that the instructions that accompany Covidien 3-0 Chromic sutures, a copy of which had been provided to the Plaintiff's lawyer, would give him no reason to expect the lack of total absorption. However, nowhere in his affidavit or during his deposition testimony, did Dr. Stein actually state that he was aware that Covidien manufactured the suture that he used during the Plaintiff's surgery. Nor does he ...

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