Leavitt v. Ethicon, Inc., Case No. 2:20-cv-00176

CourtUnited States District Courts. 2nd Circuit. District of Vermont
Writing for the CourtChristina Reiss, District Judge
Citation524 F.Supp.3d 360
Parties Jacinta LEAVITT and Paul Leavitt, Plaintiffs, v. ETHICON, INC. and Johnson & Johnson, Defendants.
Docket NumberCase No. 2:20-cv-00176
Decision Date09 March 2021

524 F.Supp.3d 360

Jacinta LEAVITT and Paul Leavitt, Plaintiffs,
ETHICON, INC. and Johnson & Johnson, Defendants.

Case No. 2:20-cv-00176

United States District Court, D. Vermont.

Signed March 9, 2021

524 F.Supp.3d 363

D. Michael Noonan, Esq., Shaheen & Gordon, P.A., Dover, NH, Kenneth J. Brennan, Esq., Pro Hac Vice, Steven D. Davis, Esq., Pro Hac Vice, Tyler J. Schneider, Esq., Pro Hac Vice, TorHoerman Law LLC, Edwardsville, IL, Maxwell S. Kennerly, TorHoerman Law LLC, Elkins Park, PA, for Plaintiffs.

Christy D. Jones, Esq., Pro Hac Vice, William M. Gage, Esq., Butler Snow, Ridgeland, MS, David B. Thomas, Esq., Susan M. Robinson, Esq., Thomas Combs & Spann, Charleston, WV, James M. Campbell, Esq., Kathleen M. Guilfoyle, Esq., Campbell Conroy & O'Neil P.C., Boston, MA, for Defendants.


Christina Reiss, District Judge

This case arises out of alleged injuries suffered by Plaintiff Jacinta Leavitt ("Plaintiff J. Leavitt") following the implantation of tension-free vaginal tape ("TVT") for the treatment of her stress urinary incontinence. Plaintiff Paul Leavitt ("Plaintiff P. Leavitt") is Plaintiff J. Leavitt's husband.

Plaintiffs assert eighteen counts against Defendants Ethicon, Inc. ("Ethicon") and Johnson & Johnson: (1) negligence (Count I); (2) strict liability for manufacturing defect (Count II); (3) strict liability for failure to warn (Count III); (4) strict liability for a defective product (Count IV); (5) strict liability for design defect (Count V); (6) common law fraud (Count VI); (7) fraudulent concealment (Count VII); (8) constructive fraud (Count VIII); (9) negligent misrepresentation (Count IX); (10) negligent infliction of emotional distress (Count X); (11) breach of express warranty (Count XI); (12) breach of implied warranty (Count XII); (13) violation of consumer protection laws (Count XIII); (14) gross negligence (Count XIV); (15) unjust enrichment (Count XV); (16) loss of consortium (Count XVI); (17) punitive damages (Count XVII); and (18) discovery rule and tolling (Count XVIII).

This case was originally filed on January 14, 2014 as part of a multi-district litigation in the United States District Court for

524 F.Supp.3d 364

the Southern District of West Virginia before the Honorable Joseph H. Goodwin. On November 3, 2020 the case was transferred to the United States District Court for the District of Vermont.

Pending before the court is Defendants’ motion for partial summary judgment filed on October 29, 2019 requesting judgment as a matter of law on all claims with the exception of Plaintiffs’ strict liability for design defect, loss of consortium, punitive damages, and discovery rule and tolling claims, as well as Plaintiffs’ negligence and negligent infliction of emotional distress claims to the extent that they are based on a design defect. (Doc. 28.) Plaintiffs opposed Defendants’ motion on November 15, 2019. Defendants did not file a reply. Oral argument was held on February 10, 2021, after which the court took the pending motion under advisement.

Plaintiffs are represented by D. Michael Noonan, Esq., Kenneth J. Brennan, Esq., Maxwell S. Kennerly, Esq., Steven D. Davis, Esq., and Tyler J. Schneider, Esq. Defendants are represented by James M. Campbell, Esq., and Kathleen M. Guilfoyle, Esq.

I. The Undisputed Facts.

At all relevant times, Plaintiffs were residents of Vermont. On August 28, 2009, Jane Lowell, MD, performed surgery on Plaintiff J. Leavitt in Vermont to implant TVT to treat Plaintiff J. Leavitt's stress urinary incontinence.

Plaintiff J. Leavitt testified that prior to the surgery she thinks she saw a TVT brochure but that she did not rely on that brochure in connection with her decision to undergo the surgery. When asked if she relied on the TVT brochure, she testified "[n]o. I relied on her[,]" (Doc. 29 at 2) referring to Dr. Lowell.

Dr. Lowell testified in deposition that she does not recall reading Defendant Ethicon's TVT Instructions for Use ("IFU") but that she might have looked at it "maybe once as a resident[.]" (Doc. 28-1 at 68.) She stated that "reading a really long thing that's put out by the manufacturer, you know, the reality is [it's] not super helpful." (Doc. 29 at 3) (alteration in original) (internal quotation marks omitted). She further testified:

Q. ... Plaintiff's counsel was asking you some questions about the instructions for use and I believe you testified, you know, you may have read it, but you don't remember the last time you read the IFU; is that right?

A. That's true.

Q. So you didn't rely on the IFU to discuss risks of the mesh procedure with Miss Leavitt?

A. No definitely not.

Q. Did you rely on any statements made by Ethicon to discuss risks with Miss Leavitt?

A. No. It would have all been based on what I had seen in my training.

(Doc. 28-1 at 74.)

Dr. Lowell acknowledged that she would typically give her patients the TVT brochure:

Q. Do you normally give patients a brochure about TVT?

A. Yes.


Q. Would you go over – you know would you hand that brochure to a patient and then go through it with her?

A. Yes. Not maybe with me standing there by the picture, but I'm a pretty descriptive person.


Q. ... Fair to say that any risk information that you get from any source is
524 F.Supp.3d 365
going to go into that pool of information that helps you as a physician to make an informed decision with your patient?

A. Yes.

Q. And that's true if you read the IFU about the risks in there?

A. Yes.

Q. And that's true about the risks that were in the brochures that you read when you handed them to your patients. Is that true?

A. Yes.

Id. at 58, 70, 75.

Sometime after implantation of the TVT, Plaintiff J. Leavitt underwent two surgeries to remove or revise the TVT, both of which were performed by Mary Wakamatsu, MD, in Massachusetts.

II. Conclusions of Law and Analysis.

A. Standard of Review.

Summary judgment must be granted when "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 fact is ‘material’ ... if it ‘might affect the outcome of the suit under the governing law.’ " Rodriguez v. Vill. Green Realty, Inc. , 788 F.3d 31, 39 (2d Cir. 2015) (quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ). "A dispute of fact is ‘genuine’ if ‘the evidence is such that a reasonable jury could return a verdict for the nonmoving party.’ " Id. at 39-40 (quoting Anderson , 477 U.S. at 248, 106 S.Ct. 2505 ). The court "constru[es] the evidence in the light most favorable to the nonmoving party and draw[s] all reasonable inferences in his favor." McElwee v. Cnty. of Orange , 700 F.3d 635, 640 (2d Cir. 2012).

The moving party always "bears the initial responsibility of informing the district court of the basis for its motion, and identifying those portions of the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett , 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) (internal quotation marks omitted). When the moving party has carried its burden, its opponent must produce "sufficient evidence favoring the nonmoving party for a jury to return a verdict for that party." Anderson , 477 U.S. at 249, 106 S.Ct. 2505. "A non-moving party cannot avoid summary judgment simply by asserting a ‘metaphysical doubt as to the material facts.’ " Woodman v. WWOR-TV, Inc. , 411 F.3d 69, 75 (2d Cir. 2005) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp. , 475 U.S. 574, 586, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) ). Moreover, not all disputes of fact are material, "[i]f the evidence is merely colorable, or is not significantly probative, summary judgment may be granted." Anderson , 477 U.S. at 249-50, 106 S.Ct. 2505 (citations omitted).

"The function of the district court in considering the motion for summary judgment is not to resolve disputed questions of fact but only to determine whether, as to any material issue, a genuine factual dispute exists." Kaytor v. Elec. Boat Corp. , 609 F.3d 537, 545 (2d Cir. 2010). "Credibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge." Proctor v. LeClaire , 846 F.3d 597, 608 (2d Cir. 2017) (internal quotation marks omitted). The court may, however, grant judgment as a matter of law if the essential elements of a claim have not been established or if a rational fact finder could not find in a party's favor. See Celotex Corp. , 477 U.S. at 323, 106 S.Ct. 2548 (holding that "[t]he moving party is entitled to a judgment as a

524 F.Supp.3d 366

matter of law [if] the nonmoving party [fails] to make a sufficient showing on an essential element of her case with respect to which she has the burden of proof") (internal quotation...

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    ...189, 197–98 (2d Cir. 2014) ) (alterations in Kovaco ) (internal footnotes and citations omitted). See also Leavitt v. Ethicon, Inc. , 524 F. Supp. 3d 360, 367 (D. Vt. 2021) (same); 598 F.Supp.3d 53 Bellegar de Dussuau v. Blockbuster, Inc. , No. 03 Civ. 6614 (WHP), 2006 WL 465374, at *7 (S.D......
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