Thacker v. Ethicon, Inc.

• Decision Date: 17 November 2021
• Docket Number: Case No.: 5:20-cv-0050-JMH-MAS
• Citation: 571 F.Supp.3d 691
• Parties: Connie J. THACKER, Plaintiff, v. ETHICON, INC., et al., Defendants.
• Court: U.S. District Court — Eastern District of Kentucky

571 F.Supp.3d 691

Connie J. THACKER, Plaintiff,

v.ETHICON, INC., et al., Defendants.

Case No.: 5:20-cv-0050-JMH-MAS

United States District Court, E.D. Kentucky, Central Division. at Lexington.

Signed November 17, 2021

G. Sean Jez, Pro Hac Vice, Gregory D. Brown, Pro Hac Vice, Keith E. Smith, Pro Hac Vice, Kelsey L. Stokes, Pro Hac Vice, Fleming, Nolen & Jez, LLP, Houston, TX, Karl N. Truman, Jeffersonville, IN, for Plaintiff.

Jordan N. Walker, Pro Hac Vice, Paul S. Rosenblatt, Pro Hac Vice, Butler Snow LLP, Ridgeland, MS, Lori E. Hammond, Frost Brown Todd LLC, Louisville, KY, Matthew P. Smith, Pro Hac Vice, Butler Snow LLP, Nashville, TN, Philip J. Combs, Pro Hac Vice, Thomas Combs & Spann, PLLC, Charleston, WV, Susan J. Pope, Frost Brown Todd LLC, Lexington, KY, for Defendants Ethicon, Inc., Johnson & Johnson.

Joseph M. Hood, Senior United States District Judge

This matter is before the Court on Defendants' Motion for Summary Judgment [DE 159]. Plaintiff Connie J. Thacker filed suit against Defendants, Ethicon, Inc. and Johnson & Johnson (collectively "Ethicon"), for claims arising out of the surgical implantation of Pelvic Mesh Products manufactured by Ethicon. For the reasons set forth below, Defendants' motion will be granted in full.

I. BACKGROUND

On May 8, 2009, Dr. Michael Guiler surgically implanted the TVT-Secur (TVT-S) mesh sling and Prolift posterior mesh for Ms. Thacker to treat her stress urinary incontinence

and rectocele. [Second A. Short Form Complaint, DE 19 at ¶ 10-12]. After experiencing continued problems, Ms. Thacker attempted to have the devices removed. [Defendants' Separate Statement of Undisputed Facts in Support of Motion for Summary Judgment, DE 159-10 at ¶¶ 3 & 8-9, undisputed by Plaintiffs, DE 225 at 2].

Ms. Thacker alleges the TVT-Secur and Prolift devices caused pain, voiding dysfunction and urge incontinence, fecal incontinence

(only a "couple" of times), and painful intercourse. [Connie J. Thacker Dep., DE 159-8 at 111:25–112:13; 115:2-18; 116:24–117:16]. Ms. Thacker brought suit in 2012 against Ethicon, the maker and seller of the device in question, alleging several counts related to the surgical implantation of the devices: Negligence (Count I), Strict Liability - Manufacturing Defect (Count II), Strict Liability - Failure to Warn (Count III), Strict Liability - Defective Product (Count IV), Strict Liability – Design Defect (Count V), Fraud (Count VI), Fraudulent Concealment (Count VII), Constructive Fraud (Count VIII), Negligent Misrepresentation (Count IX), Negligent Infliction of Emotional Distress (Count X), Breach of Express Warranty (County XI), Breach of Implied Warranty (Count XII), Violation of the Kentucky Consumer Protection Act (Count XIII), Gross Negligence (Count XIV), Unjust Enrichment (Count XV), Punitive Damages (Count XVII), Discovery Rule/ Tolling (Count XVIII).

II. DISCUSSION

A. SUMMARY JUDGMENT

"The court shall grant summary judgment if 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). A "genuine dispute" exists when "a reasonable jury could return a verdict for the non-moving party." Olinger v. Corporation of the President of the Church , 521 F. Supp. 2d 577, 582 (E.D. Ky. 2007) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ); Smith v. Perkins Bd. Of Educ. , 708 F. 3d 821, 825 (6th Cir. 2013). In the Court's analysis, "the evidence should be viewed in the light most favorable to the non-moving party." Ahlers v. Schebil , 188 F. 3d 365, 369 (6th Cir. 1999) (citing Anderson , 477 U.S. at 255, 106 S.Ct. 2505 ).

The initial burden falls on the moving party, who must identify portions of the record establishing the absence of a genuine issue of material fact. Chao v. Hall Holding Co. , 285 F. 3d 415, 424 (6th Cir. 2002) (citing Celotex Corp. v. Catrett , 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) ). If established, the non-moving party "must go beyond the pleadings and come forward with specific facts to demonstrate that there is a genuine issue for trial." Id. The nonmoving party will not overcome a motion for summary judgment by simply showing "some metaphysical doubt as to the material facts." Id. (citing Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp. , 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) ). In other words, "the respondent must adduce more than a scintilla of evidence to overcome the motion." Street v. J.C. Bradford & Co. , 886 F. 2d 1472, 1479 (6th Cir. 1989). As a "mere scintilla of evidence" is insufficient, the non-movant must show the existence of "evidence on which the jury could reasonably find for the non-moving party." Sutherland v. Mich. Dept. of Treasury , 344 F. 3d 603, 613 (6th Cir. 2003) (citing Anderson , 477 U.S. at 251, 106 S.Ct. 2505 ). Instead, the non-moving party is required to "present significant probative evidence in support of its opposition." Chao , 285 F. 3d at 424.

"As a federal court exercising diversity jurisdiction, the choice-of-law rules of the forum state, Kentucky, determine what substantive law to apply." State Farm Mut. Auto. Ins. Co. v. Norcold, Inc. , 849 F.3d 328, 331 (6th Cir. 2017) (citing NILAC Int'l Mktg. Grp. v. Ameritech Servs., Inc. , 362 F.3d 354, 358 (6th Cir. 2004) ). "When applying Kentucky's choice of law rules, ‘a strong preference exists in Kentucky for applying Kentucky law.’ " Brass Reminders Co. v. RT Eng'g Corp. , 462 F. Supp. 3d 707, 716 (E.D. Ky. 2020), aff'd, 844 F. App'x 813 (6th Cir. 2021) (citing Asher v. Unarco Material Handling, Inc. , 737 F. Supp. 2d 662, 667 (E.D. Ky. 2010) ). For tort claims, Kentucky law will apply if there is significant contact. Foster v. Leggett , 484 S.W.2d 827, 829 (Ky. 1972) ; Bell v. Kokosing Indus., Inc. , No. CV 19-53-DLB-CJS, 2020 WL 4210701, at *11 (E.D. Ky. July 22, 2020). Because Plaintiff, a Kentucky resident, had her implantation surgery in Kentucky, the state with the most significant relationship is Kentucky. Additionally, Plaintiff does not dispute that Kentucky substantive law applies. [See Plaintiff's Response In Opposition to Summary Judgment, DE 225 at 7].

1. VOLUNTARILY DISMISSED CLAIMS

Plaintiff agrees this Court's recent case involving Ethicon's Pelvic Mesh Products, Chasity Sexton v. Ethicon, Inc. , 2021 WL 4138399 (E.D. Ky. Sept. 10, 2021), should be adopted where applicable. [DE 225 at 1]. Therefore, Ms. Thacker voluntarily dismisses the following causes of action: Manufacturing Defect (Count II), Defective Product (Count IV), Fraud (Count VI), Fraudulent Concealment (Count VII), Constructive Fraud (Count VIII), Negligent Misrepresentation (Count IX), Negligent Infliction of Emotional Distress (Count X), Breach of Express Warranty (County XI), Breach of Implied Warranty (Count XII), Violation of the Kentucky Consumer Protection Act (Count XIII), and Unjust Enrichment (Count XV). However, several claims remain.

2. FAILURE TO WARN (COUNT III)

To maintain her claim for failure to warn, Ms. Thacker must show Ethicon (1) had a duty to warn, (2) Ethicon provided inadequate warnings, and (3) the inadequate warnings were the proximate cause of her injuries. See Manuel v. Traditional Sporting Goods, Inc. , No. 5:09-cv-406, 2011 WL 6091710, at *6 (E.D. Ky. Dec. 7, 2011) (citing Stewart v. General Motors , 102 F. App'x 961, 964 (6th Cir. 2004) ). Under Kentucky law, which applies the learned intermediary doctrine, the manufacturer is relieved of its duty to warn the patient if the manufacturer provides an adequate warning to the prescribing physician "regardless of how or if the physician warns the patient." Larkin v. Pfizer, Inc. , 153 S.W. 3d 758, 765 (Ky. 2004).

Defendants assert that Ms. Thacker's claim must fail because she cannot establish proximate causation for three independent reasons. [DE 159-1, at 4]. Kentucky law applies the substantial factor test for proximate causation where the Court asks, "was the defendant's conduct a substantial factor in bringing about plaintiff's harm?" Cutter v. Ethicon, Inc. , No. CV 5:19-443-DCR, 2020 WL 109809, at *7 (E.D. Ky. Jan. 9, 2020) (citing Morales v. American Honda Motor Co., Inc. , 71 F.3d 531, 537 (6th Cir. 1995) ). Circumstantial evidence may be used to prove causation, but "in that situation the evidence must be sufficient to tilt the balance from possibility to probability." Id.

First, Defendants argue proximate cause is not met because Plaintiff cannot show Dr. Guiler relied upon Ethicon's warnings via the Instructions for Use ("IFU") in making his treatment decision for Ms. Thacker. Instead, Defendants claim Dr. Guiler became aware of the risks involving the TVT-Secur and Prolift through his own experience and research. [James Michael Guiler, M.D. Deposition, DE 159-2 at 70:16-71:10]. Defendants further refute reliance on the IFU because even though Dr. Guiler "probably" reviewed the IFUs at his initial training [Id. at 7:25-8:18; 114:21-115:1], he does not review the IFU before every surgery [Id. at 114:16-20], does not remember the last time he reviewed the IFU [Id. at 115:7-9], did not review the IFU with Ms. Thacker as a part of her risk analysis because he was already aware of the listed complications [Id. at 115:15-116:1], and he did not rely on the words in the IFU in making his recommendations. [Id. at 116:25-117:12].

Under Kentucky law to prove the causation element in a failure-to-warn claim, the doctor must have relied on the manufacturer's warning in accessing risks and making treatment decisions. At the summary judgment stage, failure-to-warn claims have survived as long as some reliance on the IFU is shown, even if it is not the main consideration. Sexton , 2021 WL 4138399, at *3. Precedent illustrates that if the doctor never reviewed the IFU, reliance is impossible and proximate cause cannot be established requiring summary judgment to be granted. Cutter v. Ethicon, Inc. , 2020 WL...