Willet v. Johnson & Johnson

• Citation: 465 F.Supp.3d 895
• Decision Date: 03 June 2020
• Docket Number: No. 1:12-cv-00034-JAJ-RAW,1:12-cv-00034-JAJ-RAW
• Parties: Elizabeth J. WILLET and James E. Willet, Plaintiffs, v. JOHNSON & JOHNSON and Ethicon, Inc., Defendants.
• Court: U.S. District Court — Southern District of Iowa

465 F.Supp.3d 895

Elizabeth J. WILLET and James E. Willet, Plaintiffs,

v.JOHNSON & JOHNSON and Ethicon, Inc., Defendants.

No. 1:12-cv-00034-JAJ-RAW

United States District Court, S.D. Iowa, Western Division.

Signed June 3, 2020

Daniel B. Shuck, Shuck Law Firm, Sioux City, IA, Andrew N. Faes, Pro Hac Vice, Jeffrey M. Kuntz, Pro Hac Vice, Thomas P. Cartmell, Pro Hac Vice, Wagstaff & Cartmell LLP, Kansas City, KS, for Plaintiffs.

Nancy J. Penner, Robert D. Houghton, Shuttleworth & Ingersoll P.L.C., Cedar Rapids, IA, Jordan N. Walker, Pro Hac Vice, Butler Snow LLP, Ridgeland, MS, for Defendants.

OPINION AND ORDER REGARDING DEFENDANTS' MOTION FOR SUMMARY JUDGMENT and MOTION TO EXCLUDE EXPERT TESTIMONY

JOHN A. JARVEY, Chief Judge

This products liability action, involving the Ethicon Prosima pelvic mesh repair system, was remanded to this court on April 26, 2019, from the Multidistrict Litigation Panel. It is now before the court on the defendants' April 13, 2020, Supplemental Motion For Summary Judgment [Dkt. No. 56] on the plaintiffs' remaining claims relating to defective design. The plaintiffs filed their Memorandum In Opposition To Defendants' Supplemental Motion For Summary Judgment [Dkt. No. 63] on May 4, 2020, and the defendants were granted leave to file their overlength Reply [Dkt. No. 68] on May 11, 2020. This action is also before the court on the defendants' April 13, 2020, Motion To Exclude The Case-Specific Testimony Of Ralph Zipper, M.D. [Dkt. No. 57]. The plaintiffs filed their Memorandum In Opposition To Defendants' Motion To Exclude Certain Testimony Of Ralph Zipper, M.D. [Dkt. No. 61], on April 27, 2020, and the defendants filed their Reply [Dkt. No. 65] on May 6, 2020. For the reasons stated below, the defendants' April 13, 2020, Supplemental Motion For Summary Judgment [Dkt. No. 56] and the defendants' April 13, 2020, Motion To Exclude The Case-Specific Testimony Of Ralph Zipper, M.D. [Dkt. No. 57] are both GRANTED .

I. INTRODUCTION

This case has been the subject of prior orders and opinions. Thus, the summary of the factual and procedural background, here, is limited to issues that are either necessary for context or determinative of the pending motions.

A. Factual Background

Unless otherwise indicated, the facts stated, here, are undisputed. The court has also, at times, recast the parties' statements of facts to present them to the extent they are undisputed. Furthermore, because the pending motions include a challenge to the opinions of plaintiff's expert, Dr. Zipper, additional factual allegations concerning his opinions are drawn from the submissions concerning that challenge.

1. The parties

Plaintiff Elizabeth Willet is a resident of Moville, Iowa, where she lives with family members including her husband of 52 years, plaintiff James Willet. Defendant Ethicon, Inc., is the designer and manufacturer of the Prosima pelvic mesh device at issue in this case. Ethicon is a subsidiary of defendant Johnson & Johnson.

2. Mrs. Willet's surgeries and subsequent problems

In approximately late 2009 or early 2010, Mrs. Willet began experiencing a condition called pelvic organ prolapse (POP), which means, in essence, that her bladder had dropped into her vaginal region. Mrs. Willet's primary physician sent her to Dr. Michael Woods, a pelvic floor surgeon who also was a consultant for Ethicon from 2002 to 2013. On May 27, 2011, Dr. Woods implanted a Prosima mesh device to treat Mrs. Willet's POP.

Prosima was designed for the purpose of treating POP. Dr. Woods testified that, before implanting Prosima, he considered other procedures for treating Mrs. Willet's prolapse, including reinforcement surgery using either native tissue or biological grafts, but that, in discussion with Mrs. Willet, Prosima was chosen. Prosima used a synthetic mesh material called Gynemesh PS. Prosima was not a "fixed" device and did not require suturing to certain areas. Dr. Woods testified that Prosima "worked" for his patients and that there was no increased recurrence rate or increase in failures, although the Willets contend that there are no additional records to support Dr. Woods's conclusion that Prosima "worked" in his patients. Ethicon stopped selling Prosima in mid-2012, but it was not withdrawn from the market by the FDA or recalled by Ethicon.¹

Over the two years following the implantation of her Prosima device, Mrs. Willet required thirteen separate procedures. Five of those surgeries were to remove portions of the Prosima mesh. The first procedure following implantation occurred on October 6, 2011, when another physician, Dr. Zafar, diagnosed Mrs. Willet with an erosion of mesh into her bladder. An attempt to remove the erosion failed. The other procedures included a diagnostic laparoscopy

, a cystogram, and five cystoscopy procedures. The last of these thirteen procedures, on May 9, 2013, was a laparotomy with cystotomy and partial excision of the mesh, during which Mrs. Willet states the medical team "took out as much as they could" of the mesh. The defendants contend that Mrs. Willet's history of surgeries is not relevant to the issues on summary judgment, but the court concludes that Mrs. Willet's medical history provides context to the pending motions.

3. Dr. Zipper's opinions

The Willets designated Dr. Ralph Zipper as their case-specific expert in this case. The defendants contend that Dr. Zipper's opinions are not relevant, reliable, or otherwise admissible evidence in support of the Willets' remaining claims based on a design defect. The court concludes that Dr. Zipper's opinions provide context for the pending motions, whether or not the court ultimately finds them admissible.

a. Opinions on safer alternatives

Applying a differential diagnosis as to each of her injuries, Dr. Zipper opines that the Prosima mesh caused Mrs. Willet to suffer from erosion of the mesh into her bladder; multiple re-surgeries; pelvic pain; untreated compartment failure; dyspareunia

/decreased libido; urethral caruncle ; frequency, urgency, and urge incontinence; urinary tract infections and vaginal dysbiosis; chronic kidney disease ; and fecal incontinence. The Willets point to Dr. Zipper's Expert Report, 99-145, as laying out these opinions and explaining his differential diagnosis to support each of them. See Pl.s' Resp. [Dkt. No. 61], Ex. A.² Dr. Zipper opines, further, that defects in Prosima, including the "deficient pore size of the mesh, the unique tendency of the Ethicon mesh to destroy connective tissue, and unique tendency of the Ethicon mesh to erode deeply into tissue and the method defects of the PROSIMA device" were "the predominant causes of the PROSIMA GyneMesh PS bladder erosions suffered by Ms. Willet." Id. at 109. Dr. Zipper also opines that "the defective PROSIMA device and method have placed Mrs. Willet at a risk of future resurgeries greater than that which would be associated with safer alternatives defined elsewhere herein," that is, elsewhere in his Expert Report. Id. at 113. Dr. Zipper identified three purportedly "safer alternative designs" for the Prosima used in Mrs. Willet's treatment: (1) native tissue repair, (2) allograft or xenograft surgery, and (3) a product Ethicon began developing in 2010 called "Prosima+M."

The parties agree that native tissue surgical repairs, which use tissue from the patient's body, can fail, leading to increased scarring. The Willets point out, however, that Dr. Zipper testified that native tissue surgical repairs are still safer than Prosima, citing his Expert Report at page 113. It is not clear, however, what is the basis for that opinion, as the Willets do not identify any part of Dr. Zipper's Expert Report citing supporting authority, such as peer-reviewed studies, or any principled methodology that demonstrates such grafts are safer than Prosima.

Allografts

and xenografts are made of natural donor tissue—human cadaver donors, in the case of allografts, and animal donors, in the case of xenografts. The Willets assert that the main difference between Prosima and allografts

or xenografts is synthetic mesh versus natural materials. The defendants deny that this is the "main difference," because, biologic products are in a different class from synthetic mesh products and are a different method of addressing prolapse and incontinence. The Willets contend that allografts and xenografts could not cause mesh erosions, but the defendants point to studies indicating that, although they are not mesh products, they still can cause erosions. Dr. Zipper opines that "[t]hese biograft repairs provide similar subjective improvements and are not associated with persistent and recurrent erosions, chronic vaginal dysbiosis, and the high rate of dyspareunia know[n] of transvaginal mesh surgery." Id. at 151. Again, there is no citation to any authority or any principles or methodology supporting this opinion, while the defendants point to studies disputing this opinion.

Dr. Zipper attributed many of the problems with Prosima and Gynemesh PS to the small pores in the mesh and asserted that a safer alternative was Prosima+M, which was also a synthetic mesh product. Ethicon was developing in 2011, but never sold, Prosima+M, which was similar to Prosima, but was made from an absorbable mesh called UltraPro instead of the Gynemesh PS used in the Prosima. Ethicon denies that development of Prosima+M was ever completed. It is undisputed that a Prosima+M product was never marketed to patients, never submitted for FDA approval, and never approved by the FDA, as required for a Class II medical device. The defendants point out that the pore size design for Prosima was 2.5 mm at the time of implant and that the pore size for the Prosima+M concept was also 2.5 mm at implant, although it increased to 3.5 mm after absorption.

The Willets assert that Dr. Zipper opined that the Prosima+M could have been designed, approved by the FDA, and produced at a reasonable cost. The portion of Dr. Zipper's Expert Report cited by the...