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holding that determining whether an alternative procedure or surgery was safer “is a matter of medical judgment of treating doctors, not whether there is a safer alternative design for the product”
Summary of this case from Leavitt v. Ethicon, Inc.Opinion
No. 1:12-cv-00034-JAJ-RAW
2020-06-03
Elizabeth J. WILLET and James E. Willet, Plaintiffs, v. JOHNSON & JOHNSON and Ethicon, Inc., Defendants.
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.
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.
A few years later, however, in 2016, the FDA reclassified surgical mesh intended for transvaginal repair of anterior compartment prolapse as "high risk" (class III), and on April 16, 2019, ordered the remaining manufacturers of such products to stop selling and distributing them. See https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants.
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. 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."
Although there are several versions of Dr. Zipper's Expert Report in the record, only this version matches the Willets' page citations in their briefing of the pending motions. Therefore, this is the only version of Dr. Zipper's Expert Report that the court will cite.
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 Willets in support, pages 17-18, however, states no such opinions. Rather, after explaining that Ethicon had considered using Prosima+M to replace Prosima, because Ethicon expected that it would have several benefits, Dr. Zipper's Expert Report states, in pertinent part, as follows:
Ethicon had already commercialized its +M, for similar reasons, for it[s] PROLIFT device. Ethicon's internal document from April of 2009 notes that its paid expert pelvic surgeon consultants refused to use PROSIMA until the GyneMesh PS was replaced by Ultrapro (PROSIMA+M). This same internal document notes that many of Ethicon's paid key opinion leader[s] who were using PROSIMA desired a change to +M.
Prior to its worldwide commercialization of PROSIMA, Ethicon had already introduced what it believed to be the safer version of its GyneMesh PROLIFT device, the PROLIFT+M. Although Ethicon believed that the replacement of the GyneMesh PS of its PROSIMA with Ultrapro (PROSIMA+M) would provide a safer alternative to PROSIMA, it opted not to commercialize PROSIMA+M.
Dr. Zipper's Expert Report, 17-18 (footnotes omitted). Thus, what this portion of the Expert Report states is Ethicon's belief that Prosmia+M might be safer and anecdotal information, also from Ethicon, that some surgeons would prefer a +M product, not Dr. Zipper's opinion that Prosima+M was safer or any scientific evidence suggesting that it was safer.
The Willets' belief that Prosima+M was both feasible and safer than Prosima is based on Ethicon's internal documents discussing plans to develop Prosima+M dating to 2010 and 2011, in which Ethicon targeted FDA approval for November of 2011. Id. at 17. Dr. Zipper does not, however, point to any peer-reviewed studies, scientific or testing evidence, or any principles or methodology as demonstrating that Prosima+M or Ultrapro would be safer than Prosima or Gynemesh PS; at most, the portions of his Expert Report on which Dr. Ripper and the Willets rely indicate only that the Gynemesh PS material of Prosima presented various risks, particularly because of its small pore size. See id. at 13-16. Indeed, the portions of Dr. Zipper's Expert Report on which the Willets and Dr. Ripper apparently rely sets out evidence that the small pore size of the mesh in Prosima was the cause of Mrs. Willet's injuries, from which they leap to the conclusion that use of Prosima+M would have reduced foreseeability of harm to Mrs. Willet. See Dr. Zipper's Expert Report at 109 (opining on cause of injuries to Mrs. Willet), 113 (same), 122-123 (same), 125-27 (same). Although such opinions concerning causation of injuries to Mrs. Willet, if based on adequate evidence, might suggest alternatives, including materials with larger pores, they do not substitute for adequate support for expert opinions that any alternative material, even one with larger pores, would have been a safer alternative, because an adequate expert opinion requires that the hypothesis be adequately investigated and tested, or based on adequate principles and methodology, even if it was not actually peer reviewed.
The Willets assert that a Prosima+M product was feasible, because Ethicon did market Prolift+M, a similar product using Ultrapro mesh rather than Gynemesh PS. The defendants dispute that Prosima+M could have been approved by the FDA, when it was only a concept and was never actually submitted for FDA approval. They also dispute that Prosima+M otherwise constitutes an available safer alternative, when it was never approved, marketed, or tested. The defendants argue that Prolift+M is a completely different product from Prosima or Prosima+M, because Prolift uses a differently shaped mesh, a different insertion technique, and a different method of attaching mesh to the patient's tissue. The Willets assert that Ethicon currently sells a product essentially identical to the Prolift+M, the Artisyn, which uses Ultrapro mesh. The defendants dispute that Artisyn is "essentially identical to Prolift+M," because it is shaped differently from the concept behind Prolift+M, implanted differently (abdominally, not transvaginally), has no arms like Prolift, and is attached to the body completely differently than the concept of Prolift+M.
The Willets also assert that Dr. Zipper supports his conclusion that Prosima+M was a safer alternative to Prosima "throughout his entire report." The problem with this citation is that it does not identify any specific parts of his Expert Report demonstrating a basis for this opinion, which shows that this opinion is what the Supreme Court in Gen. Elec. Co. v. Joiner , 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997), referred to as ipse dixit.
b. Opinion on informed consent
In his "Summary Opinion of Failure to Inform" in his Expert Report, Dr. Zipper opines as follows:
My opinion, to a reasonable degree of medical certainty, [is] that, more likely than not, Ethicon's failure to inform Dr. Woods of the defective nature of the PROSIMA GyneMesh material and method, resulted in the inability of Dr. Woods to adequately inform Ms. Willet of the risks and benefits of the PROSIMA surgery and, therefore, prevented Ms. Willet from making an informed consent for surgery.
Dr. Zipper's Expert Report at 149-150. It is not clear how this opinion is relevant to the Willets' remaining claims, however, assuming that Dr. Zipper is qualified to offer such an opinion and that it is reliable.
c. Opinion that Prosima was a "non-consented clinical trial"
In his Expert Report, Dr. Zimmer also opines as follows:
The PROSIMA was Experimental
As described in this monograph, the biased clinical data failed to provide reasonable evidence that PROSIMA was as safe and effective as other surgical methods. There was no level one evidence in support of the PROSIMA device and method. All evidence was in the form of uncontrolled observational data from financially incentivized investigators and authors or the manufacturer itself.
The only published study on the cleared PROSIMA device and method failed to reach its predetermined success end point. The only published study on the cleared PROSIMA device and method failed to demonstrate long term efficacy that was equal to or greater than existing devices and methods. There was level one data demonstrating that other devices and methods were more efficacious than PROSIMA. The FDA notified Ethicon of the need for level one data in support of the safety and efficacy of PROSIMA. Ethicon was unable to demonstrate the existence of such data. Ethicon opted not to initiate the necessary trials to demonstrate the safety and efficacy of PROSIMA. The commercialization of PROSIMA represented a non-consented clinical trial, an experiment, on the women of the world.
Dr. Zipper's Expert Report at 32 (emphasis added). Again, it is not clear how this opinion is relevant to the Willets' remaining claims and reliable, assuming that Dr. Zipper is qualified to offer such an opinion.
B. Procedural Background
The Willets filed their Complaint in this action on December 31, 2012, naming some additional defendants, besides Ethicon and Johnson & Johnson. They asserted the following claims: negligence in designing, manufacturing, marketing, labeling, packaging, and selling the Prosima in Count I; failure to warn in Count II; design defect in Count III; manufacturing defect in Count IV; breach of express warranty in Count V; breach of implied warranty in Count VI; negligent misrepresentation in Count VII; fraud in Count VIII; violation of the Iowa Consumer Fraud Act in Count IX; "punitive damages/willful and wanton conduct" in Count X; and loss of consortium in Count XI. This case was consolidated into multi-district litigation (MDL) by a certified conditional transfer order on January 29, 2013, but it was eventually remanded back to this court for individual disposition on April 26, 2019.
On April 30, 2019, the defendants filed their first Motion For Partial Summary Judgment, seeking judgment on several of the Willets' claims relating to defective warnings and defective manufacturing. In an Order filed September 30, 2019, this court granted the defendants' Motion as to Counts II, IV, VII, VIII, and IX of the Willets' original Complaint. As a result, the Willets' remaining claims are for negligence as to a design defect only, in Count I; design defect in Count III; breach of express warranty in Count V; breach of implied warranty in Count VI; and loss of consortium in Count XI; with a prayer for punitive damages set out in Count X.
The defendants' motions now before the court followed on April 13, 2020.
II. LEGAL ANALYSIS
The defendants' have asserted, as their first ground for summary judgment on the Willets' remaining claims, that all the Willets' remaining claims fail, if the court excludes Dr. Zipper's opinions. They have also filed a separate motion to exclude Dr. Zipper's case-specific opinions. The Willets do not contend that any of their remaining claims can survive summary judgment without Dr. Zipper's opinions. Therefore, the court will consider, first, the motion to exclude Dr. Zipper's opinions.
A. The Motion To Exclude Dr. Zipper's Case-Specific Opinions
In their Motion To Exclude The Case-Specific Testimony Of Ralph Zipper, M.D., the defendants seek exclusion of Dr. Zipper's opinions or testimony about the following: (1) "safer" alternative designs of Prosima that are not product designs or whose comparative safety and efficacy have not been quantified as required by Iowa law; (2) Mrs. Willet's purported lack of informed consent; and (3) subjective, inflammatory, accusations that Prosima was a "non-consented clinical trial, an experiment, on the women of the world." Before considering any of these opinions, however, the court will explain the necessity of expert testimony on the issues presented, here, and the standards for such testimony.
1. Expert Testimony
a. The necessity of expert testimony on design defect claims
As the parties recognize, the Iowa Supreme Court has adopted the RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY , §§ 1 and 2 (1998) ( RESTATEMENT ( THIRD )). See generally Wright v. Brooke Group, Ltd. , 652 N.W.2d 159 (Iowa 2002). With exceptions not present, here, "[t]he Third Products Restatement section 2, as adopted in Wright , requires plaintiffs in design defect cases to demonstrate the existence of a reasonable alternative design." Scott v. Dutton-Lainson Co. , 774 N.W.2d 501, 506 (Iowa 2009) (citing RESTATEMENT (THIRD) , § 2(b) ). "The plaintiff must also show that the alternative design could have been practically adopted at the time of sale or distribution and that the omission of the alternative design caused the product to be not reasonably safe." Nationwide Agribusiness Ins. Co. v. SMA Elevator Constr. Inc. , 816 F. Supp. 2d 631, 658 n.7 (N.D. Iowa 2011) (citing, inter alia , RESTATEMENT (THIRD) , § 2(b) ).
The Restatement (Third) of Torts: Products Liability also contains § 6, entitled "Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices." While that provision might appear to apply to the Prosima device at issue in this case, the Iowa Supreme Court has never expressly adopted § 6, and no party, here, has argued that § 6 should apply rather than the more general product defect provisions in §§ 1 and 2.
In a comment to § 2, the RESTATEMENT (THIRD) explains, by way of example, when expert testimony is required in a products liability case:
For example, when a manufacturer sells a soft stuffed toy with hard plastic buttons that are easily removable and likely to choke and suffocate a small child who foreseeably attempts to swallow them, the plaintiff should be able to reach the trier of fact with a claim that buttons on such a toy should be an integral part of the toy's fabric itself (or otherwise be unremovable by an infant) without hiring an expert to demonstrate the feasibility of an alternative safer design.
RESTATEMENT (THIRD) , § 2, cmt. f, at 23–24. As the undersigned has explained, "The question for the Court, then, is whether this case is a case of common experience—such as a stuffed toy with hard plastic buttons—or a case involving more technical and scientific issues, thus requiring an expert." Neilson v. Whirlpool Corp. , No. 3:10-CV-00140-JAJ-RAW, 2012 WL 13018693, at *8 (S.D. Iowa Jan. 3, 2012).
Other federal judges have recognized that expert opinion on a safer alternative design may be required in design defect cases under Iowa law. As Chief Judge Strand of the Northern District of Iowa most recently explained,
Iowa's appellate courts discussed the necessity of expert testimony in product liability cases on several occasions. Iowa does not categorically require expert testimony in all product liability cases. Housley v. Orteck Int'l, Inc. , 488 F. Supp. 2d 819, 828 (S.D. Iowa 2007) (citing Reed v. Chrysler Corp. , 494 N.W.2d 224, 226–27 (Iowa 1992) ). "Whether expert testimony is required ultimately depends on whether it is a fact issue upon which the jury needs assistance to reach an intelligent or correct decision." Reed , 494 N.W.2d at 226–27 (quoting Wernimont v. Int'l Harvestor Corp. , 309 N.W.2d 137, 141 (Iowa Ct. App. 1981) ); see also Giles v. Miners, Inc. , 242 F.3d 810, 813 (8th Cir. 2001) ("Although Iowa law does not appear to require expert testimony for recovery in a products liability action, the plaintiff must supply sufficient evidence to satisfy the trial court that the jury, with its common knowledge, could reasonably find an alternative design to be practicable and feasible.").
Mauer v. Icon Health & Fitness, Inc. , No. C18-2009-LTS, 2020 WL 1052521, at *4 (N.D. Iowa Mar. 4, 2020). Chief Judge Strand has also explained,
Technical issues requiring expert testimony include "engineering, metallurgical and medical principles." [ Benedict v. Zimmer, Inc. , 405 F. Supp. 2d 1026,] 1033 [ (N.D. Iowa 2005) ]. When such principles are at issue in a design defect case, expert testimony is necessary to establish a reasonable alternative design and the ability of such design to reduce the foreseeable harm of the challenged product—that is to say, expert testimony may be needed to establish the elements of breach and causation. Id.
Farm Bureau Prop. & Cas. Ins. Co. v. CNH Indus. Am. LLC , No. C16-3122-LTS, 2018 WL 2077727, at *17 (N.D. Iowa Feb. 5, 2018). Also, "[e]xpert testimony regarding reasonable alternative designs is subject to the same standard as any other expert testimony." Id. at *14 (citing Peitzmeier v. Hennessy Indus., Inc. , 97 F.3d 293, 297 (8th Cir. 1996) ).
Here, the issue is whether an alternative safer design existed for a medical device, which plainly involves medical principles. See id. at *17 (recognizing that cases involving medical principles require expert testimony). Indeed, this is a case well outside the common experience of jurors, such as a stuffed toy with hard plastic buttons, because it involves more technical and scientific issues. Neilson , 2012 WL 13018693, at *8. The defendants, here, contend that, in this case, Iowa law requires expert proof of an alternative design that is safer, cost-effective, and available at the time it was used by Mrs. Willets, and the Willets do not argue otherwise. That being so, "expert testimony is necessary to establish a reasonable alternative design and the ability of such design to reduce the foreseeable harm of the challenged product." Farm Bureau Pro. & Cas. Co. , 2018 WL 2077727, at *17. Consequently, the court turns to the standards for such expert testimony. Id. at *14.
b. Standards for expert testimony
As it did in a prior decision in this case on a motion to exclude expert testimony, this court begins with the same legal standard that Judge Goodwin applied in the MDL litigation:
Expert testimony is admissible if the expert is qualified and if his or her
expert testimony is reliable and relevant. FED. R. EVID. 702; see also Daubert [v. Merrell Dow Pharm., Inc.] , 509 U.S. [579,] 597, 113 S.Ct. 2786, 125 L.Ed.2d 469 [ (1993) ]. An expert may be qualified to offer expert testimony based on his or her "knowledge, skill, experience, training, or education." FED. R. EVID. 702.
Reliability may turn on the consideration of several factors: (1) whether a theory or technique can be or has been tested; (2) whether it has been subjected to peer review and publication; (3) whether a technique has a high known or potential rate of error and whether there are standards controlling its operation; and (4) whether the theory or technique enjoys general acceptance within a relevant scientific community. Cooper v. Smith & Nephew, Inc. , 259 F.3d 194, 199 (4th Cir. 2001) (citing Daubert , 509 U.S. at 592–94, 113 S.Ct. 2786 ). But these factors are neither necessary to nor determinative of reliability in all cases; the inquiry is flexible and puts "principles and methodology" above conclusions and outcomes. Daubert , 509 U.S. at 595, 113 S.Ct. 2786 ; see also Kumho Tire Co. v. Carmichael , 526 U.S. 137, 141, 150, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). Finally, and simply, relevance turns on whether the expert testimony relates to any issues in the case. See, e.g., Daubert , 509 U.S. at 591–92, 113 S.Ct. 2786 (discussing relevance and helpfulness).
At bottom, the court has broad discretion to determine whether expert testimony should be admitted or excluded. Cooper , 259 F.3d at 200.
In re: Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig. , No. 2327, 2016 WL 4493681, at *2–3 (S.D.W. Va. Aug. 25, 2016) ; see also Glastetter v. Novartis Pharm. Corp. , 252 F.3d 986, 988 (8th Cir. 2001) (applying the same standard).
This statement of the standards for expert opinions requires some further development in this case, where the opinions at issue are about alternative designs. "Testing is an important factor in analyzing the reliability of alternative design proposals." Ehlers v. Siemens Med. Sols., USA, Inc. , 251 F.R.D. 378, 385 (D. Minn. 2008). Even so, an expert does not need to test the proposed alternative to prove its feasibility, if it was successfully in use. See Green Plains Otter Tail, LLC v. Pro-Envtl., Inc. , 953 F.3d 541, 546 (8th Cir. 2020) (citing Young v. Pollock Eng'g Grp., Inc. , 428 F.3d 786, 791 (8th Cir. 2005) ). On the other hand, the need for testing is a long-standing principle in Eighth Circuit case law, when an alternative design is purportedly based on principles, such as engineering or medical principles, rather than on a working exemplar:
[In Peitzmeier v. Hennessy Indus., Inc. , 97 F.3d 293 (8th Cir. 1996),] [b]ecause the expert's proposed safety mechanisms had been neither designed nor tested, because his ideas had not been subjected to peer review, and because the expert presented no evidence regarding his theory's rate of error or its general acceptance, we upheld the trial court's exclusion of the proffered expert testimony. Id. at 297–98.
In Pestel [v. Vermeer Mfg. Co. , 64 F.3d 382 (8th Cir. 1995) ], another alternative design case, we similarly upheld the district court's exclusion of proffered engineering testimony, again citing relevant Daubert factors. We pointed out that the proposed safety device had not been tested or even developed. Pestel , 64 F.3d at 384. With regard to peer review, we noted that the expert had not consulted others in the industry or subjected the concept to any manufacturers, engineers, or professors for scrutiny. Id. We also noted that the plaintiff had presented no evidence regarding general
acceptance. Id. We expressly declined to consider the fourth Daubert factor—potential rate of error—because this factor did not appear to be relevant to our inquiry. Id.
Jaurequi v. Carter Mfg. Co. , 173 F.3d 1076, 1082 (8th Cir. 1999).
As the Supreme Court has explained, "[ Daubert ] made clear that its list of factors was meant to be helpful, not definitive.... [T]he trial judge must have considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable." Kumho Tire Co. v. Carmichael , 526 U.S. 137, 151-52, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). Consequently, a district court does not abuse its discretion in finding opinions about alternative designs unreliable, where the alternatives had not been made, based on the "lack of testing in conjunction with the lack of peer review, lack of general acceptance, and evidence that the theories were developed in the context of litigation." Wagner v. Hesston Corp. , 450 F.3d 756, 760 n.8 (8th Cir. 2006).
2. Discussion
a. Opinions on safer alternatives
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 defendants dispute the sufficiency of Dr. Zipper's opinions as to any of these alternatives.
i. Native and donor tissue repair
The defendants argue that native tissue and donor tissue surgical procedures are not relevant to a safer design of the Prosima mesh product and that such grafts do nothing to inform the jury about whether the benefits of Prosima's design outweigh its risks. They contend that Dr. Zipper's opinion about these procedures really takes issue with the treating physician's choice of the appropriate procedure, rather than identifying a safer alternative design of the product at issue.
The Willets concede that native tissue repairs do not qualify as "safer alternative designs," because they are not products, but they argue that allografts and xenografts do qualify, because they are products. See Pl.'s Brief [Dkt. No. 61], 4 n.1. The Willets argue that Dr. Zipper's opinions about allografts and xenografts are relevant to the risk-utility analysis required under Iowa law and to counter any evidence from Ethicon that Prosima was the safest and most effective means of treating POP. They argue that the main difference between allografts or xenografts and Prosima is that such tissue grafts use a natural material rather than a synthetic material.
This court agrees with the MDL court that, as a general matter, "alternative procedures/surgeries do not inform the issue of whether an alternative design for a product exists." In re Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig. , No. MDL 2327, 2017 WL 1264620, at *3 (S.D.W. Va. Mar. 29, 2017) ; accord Mullins v. Johnson & Johnson , 236 F. Supp. 3d 940, 942 (S.D.W. Va. 2017) ("I am convinced that an alternative, feasible design must be examined in the context of products—not surgeries or procedures.") (citing Talley v. Danek Med., Inc. , 179 F.3d 154 (4th Cir. 1999) ). This is so, because "[w]hether an alternative procedure could have been performed without the use of the [device] does nothing to inform the jury on the issue of an alternative, feasible design for the [device]." Mullins , 236 F. Supp. 3d at 943. The choice of a surgery over a device is a matter of medical judgment of treating doctors, not whether there is a safer alternative design for the product. Id. Thus, the Willets must provide "sufficient evidence to identify a comparable product or design concept" to generate a jury question on the sufficiency of the alternative, feasible design. Id. at 944. I agree with the defendants that allografts and xenografts are not "comparable products" or "comparable design concepts" to the Prosima device, when, for example, allografts are regulated by the FDA as human tissues for transplantation, see 21 C.F.R. Part 1271, and xenografts are regulated as biological products for transplantation, see FDA Guidance Document: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans at 7. Neither is classified as a medical device, like Prosima.
Thus, Dr. Ripper's opinions about allografts and xenografts are not relevant or reliable, because they do not relate to an alternative product or alternative design concept for a product. In re: Ethicon, Inc. , 2016 WL 4493681, at *2–3.
Dr. Zipper's opinions about native tissue repair, allografts, and xenografts as safer alternative designs are excluded.
ii. Opinions on Prosima+M
The last safer alternative design offered by Dr. Zipper is the "Prosima+M." As to this alternative, the defendants argue that Dr. Zipper does not support his opinion with any reliable scientific evidence that Prosima+M could be marketed at a reasonable cost, would have been effective, and would have reduced the foreseeability of harm to Mrs. Willet. More specifically, they argue that Dr. Zipper's opinion lacks any support from medical literature or testing, so that this opinion reflects nothing more than Dr. Zipper's personal belief and speculation. The Willets respond that a reasonable safer alternative design does not have to be commercialized but can be hypothetical. They also argue that the defendants ignore the additional 153 pages of Dr. Zipper's Expert Report, which lay out the rationale for his ultimate opinion that Prosima+M is a safer alternative design and was feasible.
As the Willets argue, the RESTATEMENT (THIRD) recognizes, "If the plaintiff introduces expert testimony to establish that a reasonable alternative design could practically have been adopted, a trier of fact may conclude that the product was defective notwithstanding that such a[n] [alternative] design was not adopted by any manufacturer, or even considered for commercial use, at the time of sale." RESTATEMENT (THIRD) , § 2, cmt. d (1998). Even so, the greatest problem with Dr. Zipper's opinion that the Prosima+M represents a safer alternative design is not that the Prosima+M design was not completed, or even that it was never approved by the FDA and never commercialized. See Bruesewitz v. Wyeth LLC , 562 U.S. 223, 238, 131 S.Ct. 1068, 179 L.Ed.2d 1 (2011) (pointing out that neither relevant statutes nor FDA regulations answered the question of whether manufacturers are liable only for failing to employ an alternative design that the FDA has approved for distribution, adding that such approval "takes years to obtain").
Rather, the greatest problem with Dr. Zipper's opinion that the Prosima+M represents a safer alternative design is the complete lack of scientifically adequate evidence to support a reliable expert opinion. The Willets' and Dr. Zipper's belief that Prosima+M was both feasible and safer than Prosima is based on Ethicon's internal documents discussing plans to develop Prosima+M dating to 2010 and 2011, in which Ethicon targeted FDA approval for November of 2011. Dr. Zipper's Expert Report at 17. Such a basis for an opinion satisfies none of the relevant considerations for determining the reliability of an expert's opinion about an alternative design. See In re: Ethicon, Inc. , 2016 WL 4493681, at *2. First, Dr. Ripper's theory that a Prosima+M product would be safer, while perhaps amenable to testing, has not been tested or, at least, Dr. Zipper cites no such testing. Id. Where, as here, the alternative is not in use, such testing is important to the reliability of the expert's opinion about it. See Wagner , 450 F.3d at 760 n.8 ; Jaurequi , 173 F.3d at 1082 ; Ehlers. , 251 F.R.D. at 385. Dr. Ripper cites peer reviewed publications about problems with small pore meshes, but none showing that Prosmia+M or a larger pore mesh would be safer. Id. ; Jaurequi , 173 F.3d at 1082 ; Ehlers. , 251 F.R.D. at 385 ; see also In re: Ethicon, Inc. , 2016 WL 4493681, at *2 (identifying peer review as a consideration under Daubert ). He also cites no evidence about the potential rate of error or failure of a Prosima+M device. In re: Ethicon, Inc. , 2016 WL 4493681, at *2 (identifying this consideration under Daubert ); but see Jaurequi , 173 F.3d at 1082 (noting that, in Pestel , 64 F.3d at 384, the court had not found this factor relevant, where the device had not been developed). Similarly, he does not argue that the Prosima+M enjoys general acceptance within the relevant medical community, see id. ; Jaurequi , 173 F.3d at 1082, but only internal documents providing anecdotal evidence that some of Ethicon's paid expert pelvic surgeon consultants refused to use PROSIMA until the GyneMesh PS was replaced by Ultrapro and many of Ethicon's paid key opinion leaders wanted a change to +M. Dr. Zipper's Expert Report at 17.
Failure to satisfy any of these considerations would not necessarily be fatal in the applicable "flexible" inquiry, if Dr. Zipper's Expert Report pointed to "principles and methodology" supporting his conclusions about and anticipated outcomes for Prosima+M. See In re: Ethicon, Inc. , 2016 WL 4493681, at *2. Unfortunately, he does not do so. Rather, Dr. Zipper's Expert Report cites numerous problems with the Prosima, not principles or a methodology demonstrating that Prosima+M would be safer. See Dr. Zipper's Expert Report at 109 (opining on cause of injuries to Mrs. Willet), 113 (same), 122-123 (same), 125-27 (same). Because Dr. Zipper simply leaps from the problems with the Prosima to the conclusion that the Prosima+M would be safer, without adequate support for an expert opinion that a product with any alternative material, even a material with larger pores, would have been a safer alternative for the design of the Prosima, he has established only a speculative hypothesis, not an adequately supported expert opinion.
Dr. Zipper's assertions that Ethicon marketed Prolift+M, and the Willets' contention that Ethicon now markets a product similar to Prolift+M, called Artisyn, both of which use Ultrapro mesh rather than Gynemesh PS, do not demonstrate the reliability of Dr. Zipper's opinion that Prosima+M would have been a safer alternative design to Prosima. The defendants argue, and the undisputed record reflects, that Prolift+M is a substantially and significantly different product from Prosima or Prosima+M, because Prolift uses a differently shaped mesh, a different insertion technique, and a different method of attaching mesh to the patient's tissue. More importantly, the Willets do not identify any specific parts of Dr. Zipper's Expert Report demonstrating a basis for his opinion that the Prolift+M shows that a product using Ultrapro mesh instead of Gynemesh PS produced better results. The Willet's attempt to support such an opinion with Dr. Zipper's "entire report" shows that this opinion is essentially speculation or ipse dixit. See Kumho Tire Co. v. Carmichael , 526 U.S. 137, 157, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999) ("[A]s we pointed out in [ General Electric Company v.] Joiner , ‘nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert.’ ") (quoting Gen. Elec. Co. v. Joiner , 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997) ).
Thus, Dr. Ripper's opinions about Prosima+M as a safer alternative design are not reliable and must be excluded. In re: Ethicon, Inc. , 2016 WL 4493681, at *2–3.
In short, Dr. Zipper's opinions about any alternative safer designs, including native tissue grafts, allografts, xenografts, and Prosima+M, are excluded.
b. Opinions about informed consent
The defendants also seek to exclude Dr. Zipper's opinion that Mrs. Willet was prevented from making an informed consent for surgery. Dr. Zipper's Expert Report at 149-150. The defendants point out that the court has already dismissed claims based on failure to warn; that the product label was not the only source of information about Prosima; Dr. Woods was aware of all the risks of Prosima that Dr. Zipper identifies; and a duty to warn does not encompass all the risks of the product. The Willets argue that Dr. Zipper's testimony is reliable and relevant to the question of whether alternative designs were "reasonable."
The court concludes, first, that an opinion on "informed consent" is not relevant to any issue remaining in the case, where remaining claims concern the existence of a reasonable alternative design, not failure to warn claims. In re: Ethicon, Inc. , 2016 WL 4493681, at *2 (explaining that an expert opinion must be both relevant and reliable). The "reasonableness" of alternative safer designs simply does not involve any issue of informed consent. Second, the court concludes that Dr. Zipper's professional qualifications do not necessarily make him an expert on what constitutes "informed consent." See FED. R. EVID. 702. Yet, even if he is qualified to offer such an opinion, his opinion falls well short of demonstrating that Mrs. Willet's medical care provider did not supply the type of information regarding the treatment such that Mrs. Willet did not have access to all information material to making a truly informed and intelligent decision concerning the proposed medical procedure. See Andersen v. Khanna , 913 N.W.2d 526, 536 (Iowa 2018) (citing Pauscher v. Iowa Methodist Medical Center , 408 N.W.2d 355, 359, 360–61 (Iowa 1987) ). Even if this opinion might be admissible as reliable expert opinion testimony, the court concludes that it presents too much potential for prejudice in the form of a decision on an improper basis, confusing the issues, and misleading the jury to be admissible. See FED. R. EVID. 403 ; Walker v. Kane , 885 F.3d 535, 540 (8th Cir. 2018).
This opinion is excluded.
c. Opinion that Prosima was a "non-consented clinical trial"
Finally, the defendants seek to exclude Dr. Zipper's opinion that Prosima was a "non-consented clinical trial." They contend that this opinion is unreliable, irrelevant, and unduly prejudicial. The Willets contend that Dr. Zipper's experience qualifies him to offer such an opinion and that he does not intend, at trial, to offer such an opinion in inflammatory terms.
The court concludes that this opinion, like the one concerning "informed consent," discussed just above, is not relevant to any issue remaining in the case, because no claims based on failure to warn remain at issue. In re: Ethicon, Inc. , 2016 WL 4493681, at *2 (explaining that expert opinions must be both relevant and reliable). Furthermore, while the Willets must prove that Prosima was defectively designed, an opinion that Prosima was a "non-consented clinical trial," in whatever words that opinion is cast, does not make it more or less likely that Prosima was defectively designed or that an alternative safer design exists. See FED. R. EVID. 401, 402. The court concludes that any digression into whether Prosima was a "non-consented clinical trial" or otherwise should not have been marketed or approved for marketing by the FDA presents too much potential for prejudice in the form of a decision on an improper basis, confusing the issues, and misleading the jury to be admissible. See FED. R. EVID. 403 ; Walker , 885 F.3d at 540.
This opinion is excluded.
3. Summary
For the foregoing reasons, the defendants' April 13, 2020, Motion To Exclude The Case-Specific Testimony Of Ralph Zipper, M.D., is granted in its entirety.
B. The Motion For Summary Judgment
The court now turns to consideration of the defendants' April 13, 2020, Supplemental Motion For Summary Judgment on the Willets' remaining claims relating to defective design. As mentioned, above, the defendants' first ground for summary judgment on the Willets' remaining claims is that all the Willets' remaining claims fail, if the court excludes Dr. Zipper's opinions. The Willets do not contend that any of their remaining claims can survive summary judgment without Dr. Zipper's opinions. The Willets also separately and expressly concede that there is a single claim for "Design Defect" under Iowa law, and no claim for negligent design, so they do not contest the dismissal of Count I. They also expressly consent to dismissal of Count V asserting breach of express warranty. Finally, the Willets acknowledge that their loss of consortium claim is "derivative" of Mrs. Willet's claims, so that the loss of consortium claim only survives summary judgment if other claims do, and that granting summary judgment on their other claims will moot their prayer for punitive damages.
Because the court has excluded Dr. Zipper's opinions on alternative safer designs for Prosima, the Willets have failed to meet their burden in resisting summary judgment to submit evidentiary materials that set out specific facts showing that there is a genuine issue for trial on the required safer alternative design element of the claims related to defective design. FED. R. CIV. P. 56(a) ; Mensie v. City of Little Rock , 917 F.3d 685, 688 (8th Cir. 2019). The Willets have also expressly conceded that other claims cannot survive summary judgment. In these circumstances, the record taken as a whole "could not lead a rational trier of fact to find for the [Willets]." Torgerson v. City of Rochester , 643 F.3d 1031, 1042-43 (8th Cir. 2011) (en banc) (internal quotation marks and citations omitted).
Therefore, the defendants' April 13, 2020, Supplemental Motion For Summary Judgment is granted in its entirety.
III. CONCLUSION
Upon the foregoing,
IT IS ORDERED that
1. The defendants' April 13, 2020, Supplemental Motion For Summary Judgment [Dkt. No. 56] is granted ; and
2. The defendants' April 13, 2020, Motion To Exclude The Case-Specific Testimony Of Ralph Zipper, M.D. [Dkt. No. 57] is granted .
The Clerk of Court shall enter judgment for the defendants.