Mongeon v. Ethicon, Inc., CIVIL ACTION NO. 4:20-40024-TSH

456 F.Supp.3d 298

Sheila MONGEON, Plaintiff,

v.ETHICON, INC., Ethicon, LLC, and Johnson & Johnson, Defendants.

CIVIL ACTION NO. 4:20-40024-TSH

United States District Court, D. Massachusetts.

Filed April 27, 2020

Braden R. Lepisto, Pro Hac Vice, Christopher A. Gomez, Lee B. Balefsky, Pro Hac Vice, Michelle L. Tiger, Pro Hac Vice, Amanda L. Kurecian, Pro Hac Vice, Kline & Specter, P.C., Philadelphia, PA, Michael J. Harris, Crowe & Mulvey, LLP, Boston, MA, for Plaintiff.

Christy D. Jones, William M. Gage, Butler Snow LLP, Ridgeland, MS, David B. Thomas, Philip J. Combs, Susan M. Robinson, Thomas Combs & Spann, Charleston, WV, James M. Campbell, Campbell, Campbell, Edwards & Conroy, PC, Kathleen M. Guilfoyle, Campbell Conroy & O'Neil P.C., Boston, MA, Kari L. Sutherland, Butler Snow, Oxford, MS, for Defendants Ethicon Inc., Johnson & Johnson.

Philip J. Combs, Susan M. Robinson, Thomas Combs & Spann, Charleston, WV, William M. Gage, Butler Snow, Ridgeland, MS, for Defendant Ethicon LLC.

Ethicon LLC, pro se.

MEMORANDUM AND ORDER ON DEFENDANTS’ MOTION FOR PARTIAL SUMMARY JUDGMENT (Docket No. 21)

HILLMAN, D.J.

Sheila Mongeon ("Plaintiff") filed the instant action as part of an MDL against, inter alia , Ethicon, Inc., Ethicon, LLC, and Johnson & Johnson (collectively, "Defendants"). She seeks to recover for complications associated with the implantation of Defendants’ TVT-Secur mid-urethral sling. Defendants move for partial summary judgment. For the reasons set forth below, the Court grants in part and denies in part their motion (Docket No. 21).

Background ¹

Plaintiff suffers from stress urinary incontinence. In 2008, Dr. C. Scott Koenig ("Dr. Koenig") recommended that Plaintiff have a TVT-Secur mid-urethral sling (a "TVT-S") surgically implanted to treat the condition. He generally discussed the risks and complications of the procedure with Plaintiff.² Plaintiff consented to it, and on February 9, 2009, Dr. Koenig performed surgery to implant a TVT-S in her urethra. Five years later, Dr. Christine Carey observed erosion in the TVT-S where it had penetrated Plaintiff's vaginal mucosal tissue. Plaintiff had the device removed, and her surgeon reported that the TVT-S had completely penetrated her vaginal mucosal tissue.

Plaintiff filed the instant action in the MDL on January 8, 2015. She raises the following claims: 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); common law 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 (Count XI); breach of implied warranty (Count XII); violation of consumer protection laws (Count XIII); gross negligence (Count XIV); unjust enrichment (Count XV); punitive damages (Count XVII); and discovery rule and tolling (Count XVIII).

The parties deposed Dr. Koenig in September 2018. At the time, Dr. Koenig testified that, even accounting for everything he had since learned about the potential risks and benefits of TVT-S, he stood by his decision to recommend it to Plaintiff in 2009. (Docket Nos. 21-1 at 18, 26, 49; 23-5 at 12, 20, 43). He further stated that he believed he had adequately disclosed the risks and benefits to Plaintiff—including the risk of mesh erosion and dyspareunia. (Docket Nos. 21-1 at 22, 26; 23-5 at 16, 20). During cross-examination, however, Dr. Koenig admitted that, although he was aware of these risks, he did not view them as significant. (Docket Nos. 21-1 at 41, 23-5 at 35). And he stated that, had the Instructions for Use for TVT-S identified mesh erosion or permanent dyspareunia as a significant risk, he would have disclosed that information to Plaintiff. (Docket Nos. 21-1 at 41, 23-5 at 35). Dr. Koenig also indicated that he would not have used a TVT-S in Plaintiff's case if he had known about the inferior patient reported outcomes and higher reoperation rates experienced by other doctors. (Docket Nos. 21-1 at 44, 23-5 at 38).

In her deposition, Plaintiff denied being informed of the risk of mesh erosion, chronic pain, or dyspareunia prior to her surgery. (Docket No. 23-4 at 42–43, 44). She testified that, if she had known that TVT-S could cause these conditions, she would not have agreed to the procedure.³ (Docket No. 23-4 at 42–43).

On October 16, 2018, Defendants moved for summary judgment on Counts II, III, IV, V, VI, VII, VIII, IX, X, XII, XIII, and XV⁴ and for partial summary judgment on Counts I and XIV. (Docket No. 21).

Legal Standard

Under Federal Rule of Civil Procedure 56, a 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." An issue is "genuine" when a reasonable factfinder could resolve it in favor of the nonmoving party. Morris v. Gov't Dev. Bank of P.R. , 27 F.3d 746, 748 (1st Cir. 1994). A fact is "material" when it may affect the outcome of the suit. Id.

Discussion

1. Negligence (Counts I and XIV)^{5 ,6}

"In Massachusetts,^{[7 ]} a manufacturer can be found liable to a user of the product if the user is injured due to the failure of the manufacturer to exercise reasonable care in warning potential users of hazards associated with use of the product." Laaperi v. Sears, Roebuck & Co. , 787 F.2d 726, 729 (1st Cir. 1986) (footnote omitted). "In the ordinary course, the manufacturer of a product that is dangerous in nature or is in a dangerous condition has a duty to warn consumers or others who will foreseeably come in contact with the product." Tersigni v. Wyeth-Ayerst Pharm., Inc. , No. 11-10466, 2013 WL 6531118, at *5 (D. Mass. Dec. 13, 2013). The learned intermediary rule, however, carves out a middleman exception in context of medical products.⁸ See Tersigni , 2013 WL 6531118, at *5 ; see also Knowlton v. Deseret Med., Inc. , 930 F.2d 116, 120 n.12 (1st Cir. 1991). It relieves "manufacturers of the duty to warn a patient of the possible side effects of a [product] where it has adequately informed the prescribing physician of any associated risks." Haughton v. Hill Labs., Inc. , No. 06-11217, 2007 WL 2484889, at *2 (D. Mass. Aug. 30, 2007) (citing MacDonald , 394 Mass. at 135, 475 N.E.2d 65 ).

Defendants suggest that Plaintiff cannot establish causation in this case given the applicability of the learned intermediary rule. To determine whether a plaintiff can make a prima facie case of negligence despite imposition of the learned intermediary rule, courts uses a burden-shifting framework. See Liu v. Boehringer Ingelheim Pharm., Inc. , 230 F. Supp. 3d 3, 8 (D. Mass. 2017). Under this framework,

(1) the plaintiff carries the initial burden of producing sufficient evidence that the defendant manufacturer failed to warn of a non-obvious risk about which the manufacturer knew or should have known; (2) assuming the plaintiff raises a triable issue on this question, a rebuttable presumption arises that the physician would have heeded an adequate warning; (3) defendant must then come forward with sufficient evidence to rebut that presumption; and (4) once the presumption is rebutted, plaintiff must produce sufficient evidence to create a triable issue on the question of causation.

Id. at 8–9 (citations and internal quotation marks omitted).

Here, Plaintiff has met her initial burden. Defendants indisputably did not include any information on the risk of dyspareunia or mesh erosion in the Instructions for Use for the TVT-S. (Docket Nos. 21-1 at 41, 23-5 at 35). Plaintiff is therefore entitled to a rebuttable presumption that Dr. Koenig would have heeded an adequate warning if Defendants had provided one.⁹ See Garside v. Osco Drug, Inc. , 976 F.2d 77, 82 (1st Cir. 1992).

Defendants offer enough evidence to rebut this presumption. Dr. Koenig testified that, even accounting for everything he had subsequently learned about TVT-S, he stood by his decision to recommend it to Plaintiff in 2009. (Docket Nos. 21-1 at 26, 49; 23-5 at 20, 43). A reasonable juror could determine from this statement that Dr. Koenig would not have heeded additional warnings.

Summary judgment is inappropriate, however, because Plaintiff has produced enough evidence "to create a triable issue on the question of causation." See Liu , 230 F. Supp. 3d at 9. Plaintiff offers evidence casting doubt on the credibility of Defendant's rebuttal evidence. Dr. Koenig admitted, for example, that he would not have used a TVT-S implant on Plaintiff if he had known about the inferior patient reported outcomes and higher reoperation rates associated with the implant. (Docket Nos. 21-1 at 44, 23-5 at 38). He also conceded that, while he was aware of the risk of mesh erosion and dyspareunia through other sources, he did not view them as significant. (Docket Nos. 21-1 at 41, 23-5 at 35). Under the circumstances, a reasonable juror could conclude that Dr. Koenig's testimony does not reflect how he would have acted if he had received an adequate warning from Defendant.

And in any event, even if Dr. Koenig would still have recommended TVT-S to Plaintiff, Plaintiff suggests that she would not have accepted that recommendation if she had known of the risk of mesh erosion, chronic pain, or dyspareunia. And because Dr. Koenig stated that he would have disclosed any risks identified in the Instructions for Use to Plaintiff (Docket Nos. 21-1 at 41, 23-5 at 35), a reasonable jury could find that Plaintiff would not have undergone the procedure if Defendants had provided an adequate warning to Dr. Koenig, i.e., that the failure to warn caused her injuries.¹⁰ The Court accordingly denies Defendants’ partial motion for summary judgment as to Counts I and XIV.¹¹

2. Breach of Implied Warranty (Count XII)¹²

A merchant who sells good implicitly warrants that his goods "are fit for the ordinary...