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«Case 7:13-mc-02434-CS-LMS Document 135 Filed 10/22/15 Page 1 of 32 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK WHITE PLAINS DIVISION ...»

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Case 7:13-mc-02434-CS-LMS Document 135 Filed 10/22/15 Page 1 of 32

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF NEW YORK

WHITE PLAINS DIVISION

-----------------------------------------------------------------------x

IN RE:

13-MD-2434 (CS) 13-MC-2434 (CS)

MIRENA IUD PRODUCTS LIABILITY LITIGATION

-----------------------------------------------------------------------x

MEMORANDUM OF LAW IN SUPPORT OF DEFENDANTS’

MOTION TO EXCLUDE THE TESTIMONY OF

JOHN JARRELL, PH.D., P.E.

Case 7:13-mc-02434-CS-LMS Document 135 Filed 10/22/15 Page 2 of 32

TABLE OF CONTENTS

TABLE OF AUTHORITIES

I. INTRODUCTION

II. FACTUAL BACKGROUND

III. ARGUMENT

A. Dr. Jarrell’s Opinions About The Purported Effects Of Levonorgestrel Should Be Excluded

1. Dr. Jarrell Is Unqualified To Opine On The Purported Effects Of Levonorgestrel

2. Dr. Jarrell’s Opinions About The Purported Effects Of Levonorgestrel On The Endometrium Are Unreliable

B. Dr. Jarrell’s Opinion That Mirena’s Arms Are “Relatively Sharp” Should Be Excluded

1. Dr. Jarrell Lacks The Requisite Experience To Opine On Mirena’s Purported “Sharpness”

2. Dr. Jarrell’s Opinion That Mirena’s Arms Are “Sharp” Is Unreliable................ 7 C. Dr. Jarrell’s In Vitro Mechanical Testing Should Be Excluded

1. Dr. Jarrell’s Testing ConditionsAre Untethered From Clinical Reality........... 11

2. Dr. Jarrell’s Manufactured Test Condition Does Not Meet Daubert’s Reliability Standards

3. Dr. Jarrell’s Methodology Is An Ad Hoc Endeavor That Did Not Adhere To A Written Protocol

D. Dr. Jarrell’s Uterine Pressure Wound Theory Is Unsound And Requires Exclusion

1. Dr. Jarrell’s Uterine Pressure Wound Theory Ventures Far Beyond The Scope Of His Expertise

2. Dr. Jarrell’s Theory Does Not Satisfy Any Measure Of Reliability.................. 16

3. Dr. Jarrell’s Theory Is Plagued By Unexplained Analytical Gaps

4. Dr. Jarrell’s Extrapolations Exceed The Bounds Of His Cited Support............ 19

–  –  –

5. Dr. Jarrell’s Theory Does Not “Fit” The Facts Of This Case

E. Dr. Jarrell’s Held Opinions Are Ultimately Irrelevant

F. Dr. Jarrell Cannot Opine On A Safer Alternative Design

G. Dr. Jarrell Should Not Be Allowed To Opine About Alleged Manufacturing Defects

IV. CONCLUSION

–  –  –

Cases Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256 (2d Cir. 2002)

Amorgianos v. National R.R. Passenger Corp., 137 F. Supp. 2d 147 (E.D.N.Y. 2001)

Claar v. Burlington Northern RR. Co., 29 F.3d 499 (9th Cir. 1994)

Daubert v. Merrill Dow Pharm., Inc., 509 U.S. 579 (1993)

Devito v. Smithkline Beecham Corp., 2004 WL 3691343 (N.D.N.Y. Nov. 29, 2004)

Dodson v. Ford Motor Co., 2006 WL 2405868 (R.I. Super. Aug. 17, 2006)

Ellis v. YMCA Camp Mohawk, Inc., 2015 WL 5254913 (2d Cir. Sept. 10, 2015)

Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997)

Golod v. La Roche, 964 F. Supp. 841 (S.D.N.Y. 1997)

Hall v. Boston Scientific Corp., 2015 WL 868907 (S.D.W.V. Feb. 27, 2015)

In re Accutane Products Liab., 511 F. Supp. 2d 1288 (M.D. Fla. 2007)

In re Bausch & Lomb, Inc. Contact Lens Solution Products Liab. Litig., 2009 WL 2750462 (D.S.C. Aug. 26, 2009)

In re Bextra and Celebrex Marketing Sales Practices and Product Liab. Litig., 524 F. Supp. 2d 1166 (N.D. Cal. 2007)

In re Denture Cream Products Liab. Litig., 2011 WL 9375632 (S.D. Fla. July 22, 2011)

In re Rezulin Products Liab. Litig., 369 F. Supp. 2d 398 (S.D.N.Y. 2005)

–  –  –

In re Zyprexa Products Liab. Litig., 2009 WL 1357236 (E.D.N.Y. May 12, 2009)

Mancuso v. Consolidated Edison Co. of New York, 967 F. Supp. 1437 (S.D.N.Y. 1997)

McClain v. Metabolife Int’l, Inc., 401 F.3d 1233 (11th Cir. 2005)

Prohaska v. Sofamor, S.N.C., 138 F. Supp. 2d 422 (W.D.N.Y. 2001)

R.F.M.A.S., Inc. v. So, 748 F. Supp. 2d 244 (S.D.N.Y. 2010)

Rose v. Ciba-Geigy Corp., 78 F.3d 316 (7th Cir. 1996)

Ruggiero v. Warner-Lambert Co., 424 F.3d 249 (2d Cir. 2005)

Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347 (N.D. Ga. 2001)

Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 434 (W.D. Pa. 2003)

Tyree v. Boston Scientific Corp., 2014 WL 5486694 (S.D.W.V. Oct. 29, 2014)

Tyree v. Boston Scientific Corp., 54 F. Supp. 3d 501 (S.D.W.V. 2014)

U.S. ex rel. Gudur v. Deloitte Consulting LLP, 2007 WL 4322433 (S.D. Tex. Mar. 5, 2007).

United States v. Khan, 787 F.2d 28 (2d Cir. 1986)

Winebarger v. Boston Scientific Corp., 2015 WL 1887222 (S.D.W.V. Apr. 24, 2015)

Zaremba v. General Motors Corp., 360 F.3d 355 (2d Cir. 2004)

–  –  –

Rules Fed. R. Evid. 702

Other Authorities Carlo Bulletti, et al., Uterine contractility during the menstrual cycle, 15 (Suppl. 1) Human Reproduction 81 (2000)





Norman D. Goldstuck and Dirk Wildemeersh, Role of uterine forces in intrauterine device embedment, perforation, and expulsion, 6 Int’l J. of Women’s Health 735 (2014)

–  –  –

I. INTRODUCTION Plaintiffs designated Dr. John Jarrell, an engineer who has no expertise in uterine physiology and has zero professional experience with IUDs, to come up with a supposed plausible mechanism of how a Mirena could perforate a uterus outside of the insertion process.

In his report, Dr. Jarrell hypothesizes a four-part mechanism theory of perforation. Importantly, Dr. Jarrell does not purport to opine that the four steps he speculates about in his report relate to the actual perforation risk with Mirena. Instead, he candidly admits that he has no idea whether his “plausible” mechanism theory has anything to do with how IUDs like Mirena, in fact, perforate the uterus. Dr. Jarrell does not even claim to opine that the Plaintiffs’ alleged injury in this litigation – the supposed “secondary perforation” of Mirena − in fact occurs.

The fatal flaw to Dr. Jarrell’s theory is that it simply is made-up for litigation purposes and has no reliable support outside Dr. Jarrell’s unqualified ipse dixit and a contrived “experiment” Dr. Jarrell commissioned. See Amorgianos v. Nat’l R.R. Passenger Corp., 137 F.

Supp. 2d 147, 190 (E.D.N.Y. 2001) (finding experts’ opinions unreliable where, among other reasons, their hypotheses were first developed in the course of the litigation). Dr. Jarrell’s theory is not articulated in the peer reviewed scientific literature; it has not been described outside the litigation as a legitimate scientific hypothesis; and it has not been subjected to reliable scientific

testing. The following testimony illustrates how little support Dr. Jarrell has for his theory:

Q: Well, Doctor, you’ve posited a theory by which IUDs perforate the uterus by this pressure wound theory that you’ve come up with, right?

–  –  –

Case 7:13-mc-02434-CS-LMS Document 135 Filed 10/22/15 Page 8 of 32 Deposition Transcript of Dr. John Jarrell (“Jarrell Dep.”), Exhibit A, at 302:12-20. But the Federal Rules do not allow a witness to invent a new scientific theory that is totally devoid of any indicia of reliability and present it to the trier of fact. Consequently, this Court should exclude Dr. Jarrell’s testimony in its entirety because (1) he has no “specialized knowledge [that] will help the trier of fact;” (2) his testimony is not “based on sufficient facts or data;” (3) his testimony is not “the product of reliable principles and methods;” and (4) he has not “reliably applied the principles and methods to the facts of the case.” Fed. R. Evid. 702.

II. FACTUAL BACKGROUND

Dr. Jarrell is an engineer; he did not attend medical school and has never been involved in any aspect of patient care. Ex. A, Jarrell Dep. at 74:14-23, 75:3-6, 75:16-18. He has been retained by plaintiff lawyers in a wide variety of cases ranging from automobiles to massage chairs. See Dodson v. Ford Motor Co., 2006 WL 2405868, at *15-18 (R.I. Super. Aug. 17, 2006) (excluding Jarrell’s fire causation opinion as unreliable); Ex. A, Jarrell Dep. at 69:18-22.

But importantly for the issues in this case, Dr. Jarrell had no prior experience with IUDs before agreeing to serve as Plaintiffs’ expert in this case. Id. at 84:7-18, 84:20-85:4, 85:20-24.

III. ARGUMENT Dr. Jarrell’s purported mechanism theory rests on four different steps, each of which is a necessary part of his opinions. According to the first step in his analysis, levonorgestrelreleasing intrauterine systems (“LNG-IUS”), like Mirena, cause a thin, fragile endometrium with fragile vascularity. See General Expert Report of Dr. John Jarrell (“Jarrell Report”), Exhibit B, at 13-18. Second, he opines that Mirena’s arms have “sharp” tips, which can create a concentration of forces and increased pressures on the tissues in contact. See id. at 18-22. Third, when tested in a highly contrived in vitro experiment, Mirena’s arms become stiff and rigid. See id. at 22-24. The final step in Dr. Jarrell’s mechanism theory provides that the contact created by Case 7:13-mc-02434-CS-LMS Document 135 Filed 10/22/15 Page 9 of 32 Mirena’s arms in the constrained loading condition combined with uterine contractions leads to a pressure wound in the uterine wall. Dr. Jarrell speculates that through this four-step process, it is plausible that a Mirena can perforate. But nowhere in his report does he offer the opinion that Mirena in fact causes secondary perforation. In fact, Dr. Jarrell does not purport to opine that his hypothesized mechanism has anything to do with the actual perforation risk with Mirena. In that regard, as is explained in Section III.E infra, his opinions ultimately are irrelevant and would not aid the jury. The Second Circuit has made clear that when determining whether an expert’s opinion is reliable, the failure of any individual step renders the entire analysis void. See Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 267 (2d Cir. 2002) (“‘[A]ny step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony inadmissible.’”) (citation omitted, emphasis in original). Here, every step of Dr. Jarrell’s proposed theory falters and requires exclusion for a variety of reasons, rendering his made-upfor-litigation mechanism hypothesis unable to pass muster under Daubert v. Merrill Dow Pharm., Inc., 509 U.S. 579, 591 (1993).

–  –  –

Dr. Jarrell’s mechanism theory begins with his assertion that “LNG-IUS causes a thin fragile endometrium with fragile vascularity based on the published scientific literature.” Ex. B, Jarrell Report at 13. Dr. Jarrell’s proffered opinions about the supposed effects of Mirena on the endometrium should be excluded because: (a) he has no qualifications to offer such opinions;

and (b) the opinions are unreliable.

–  –  –

Federal Rule of Evidence 702 governs the admissibility of expert testimony and “requires that expert testimony come from someone who is ‘qualified as an expert by knowledge, skill, Case 7:13-mc-02434-CS-LMS Document 135 Filed 10/22/15 Page 10 of 32 experience, training, or education….’” Zaremba v. General Motors Corp., 360 F.3d 355, 359-60 (2d Cir. 2004) (quoting Fed. R. Evid. 702).

Dr. Jarrell is not remotely qualified to opine on the effects of the levonorgestrel in Mirena on the endometrium. He has never published or lectured on IUDs, levonorgestrel, or any other form of hormonal contraception. Ex. A, Jarrell Dep. at 84:20-85:4, 85:20-24. Dr. Jarrell freely admitted that prior to being retained as an expert in this litigation (which occurred in August

2014) he had no expertise in levonorgestrel:

–  –  –

Ex. A, Jarrell Dep at 169:24-170:2, 148:18-148:23. Rather than relying on his education, training, or experience to qualify him as an expert in this area, Dr. Jarrell claims that his expertise derives from reading scientific articles after his retention by the Plaintiffs. But a witness cannot manufacture expertise by reading a handful of scientific articles solely as part of his work in litigation. See Mancuso v. Consolidated Edison Co. of New York, 967 F. Supp.1437, 1443 (S.D.N.Y. 1997) (“We cannot help but conclude that [the plaintiffs’ expert] was not in fact an expert…when he was hired by the plaintiffs, but that he subsequently attempted, with dubious At one point in his deposition, Dr. Jarrell suggested that he had pre-litigation knowledge of levonorgestrel by virtue of the fact that “I have children. It’s a birth control item, I’ve been exposed to products because of that.” Ex. A, Jarrell Dep. at 146:5-16. Needless to say, general exposure to birth control methods in one’s family life does not imbue a witness with sufficient expertise to testify as an expert in this litigation.

Case 7:13-mc-02434-CS-LMS Document 135 Filed 10/22/15 Page 11 of 32 success, to qualify himself as such by a selective review of the relevant literature.”); see also Devito v. Smithkline Beecham Corp., 2004 WL 3691343, at *7 (N.D.N.Y. Nov. 29, 2004) (deeming proffered expert unqualified because he had previously conducted no research on the drug at issue and his first time reviewing relevant scientific literature was for his work as an expert in the litigation); Ex. A, Jarrell Dep. at 148:18-149:19. Like the excluded expert in Mancuso, Dr. Jarrell’s purported qualifications in this area derive solely from relying upon articles supplied by plaintiffs’ counsel. See Mancuso, 967 F. Supp. at 1445 (excluding expert based on, among other reasons, “his reliance upon plaintiffs’ attorney to provide him with the scientific literature he relied upon to support his opinion”); Ex. A, Jarrell Dep. at 156:4-10. Dr.



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