# In re Mirena IUD Products Liability Litigation

> District Court, S.D. New York · March 8, 2016 · 169 F. Supp. 3d 396

URL: https://www.frixlaw.com/law-library/cases/7236890

## Case

- **Full name:** IN RE: MIRENA IUD PRODUCTS LIABILITY LITIGATION This Document Relates To Danley v. Bayer, 13-CV-6586 Hayes v. Bayer, 14-CV-288
- **Court:** District Court, S.D. New York
- **Decided:** March 8, 2016
- **Citations:** 169 F. Supp. 3d 396; 2016 U.S. Dist. LEXIS 29752; 2016 WL 890251
- **Precedential status:** Published
- **Opinion:** Opinion of the court by Seibel
- **Judges:** Seibel
- **Cited by:** 98 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/7236890

## How later opinions describe it (automated extraction)

- stating that while an expert’s failure to analyze a certain piece of evidence was “fair game for cross-examination” and “seem[ed] to undermine [the expert’s] conclusion,” “in these circumstances his failure to discuss it in his report is not so glaring as to render his opinion…
- stating that criticisms of an expert's conclusion "go to the weight, not the admissibility, of his testimony and are best addressed on cross-examination"
- stating that “medical doctors do not need to be epidemiologists in order to testify regarding epidemiological studies”

## Opinion text

OPINION & ORDER
Seibel, United States District Judge.
Table of Contents
I.Background.. .408
A. Background Applicable to Both Cases.. .408
B. Background Related to Jennifer Dan-ley. . .410
C. Background Related to Christie Hayes.. .411
II. Discussion.. .411
A. Legal Standard.. .411
B. Defendants’ Clinical Experts.. .418
1. Experts’ Qualifications & Opinions. . .415
2. Opinions on Secondary Perforation. . .418
3. Opinions on the Mirena Label.. .422
4. Opinions on 2D Versus 8D Ultrasound. . :424
5. Opinions on Epidemiology.. .426
6. Conflicting Bayer Statements and Documents.. .426
C. Plaintiffs’ Causation Experts.. .427
1. Roger C. Young, M.D., Ph.D_427
2. John Jarrell, Ph.D., P.E... .437
3. Susan Wray, Ph.D_446
4. Richard Strassberg, M.D_456
D. Defendants’ Regulatory Experts ...461
1. David Feigal, M.D., M.P.H_461
2. Dena Hixon, M.D.... 468
E. Plaintiffs’ Regulatory Expert — Suzanne Parisian, M.D_474
F. Plaintiffs’ Epidemiological Expert— April Zambelli-Weiner, Ph.D... .482
III. Conclusion.. .488
Danley v. Bayer, 13-CV-6856, and Hayes v. Bayer, 14-CV-288, are the first two cases selected for trial in the In re Mirena IUD Products Liability Litigation multidistrict litigation (“Mirena MDL”). Plaintiffs have sued three related companies, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG and Bayer OY (“Bayer” or “Defendants”), alleging that Mirena, an intrauterine device (“IUD”) perforated Plaintiffs’ uteruses and caused them injuries, and that Defendants did not adequately warn Plaintiffs about the risks of Mirena. Plaintiffs Danley and Hayes have also brought claims alleging design *408 defect and negligence, and are seeking punitive damages. 1
Before the Court is Plaintiffs’ Omnibus Motion to Preclude the Expert Testimony of Defendants’ Experts Steven Goldstein, M.D., Jay Goldberg, M.D., M.S.C.P., Michael Policar, M.D., M.P.H., Michelle Collins, Ph.D., C.N.M., R.N.-C.E.F.M., Vanessa Dalton, M.D., M.P.H., Geri Hewitt, M.D., and Marcia Javitt, M.D., F.A.C.R., (Doc. 2702). Plaintiffs also move to preclude Defendants’ regulatory experts, Dena Hixon, M.D., (Doc. 2705), and David Feigal, Jr., M.D., M.P.H., (Doc. 2724). Also before the Court are Defendants’ motions to preclude the testimony of Plaintiffs’ causation experts Roger Young, M.D., Ph.D., (Doc. 2694), John Jarrell, Ph. D., P.E., (Doc. 2679), Susan Wray, Ph.D., (Doc. 2691), and Richard Strassberg, M.D., (Doc. 2688). Defendants have also moved to preclude Plaintiffs’ regulatory expert Suzanne Parisian, M.D., (Doc. 2685), and Plaintiffs’ epidemiological expert April Zambelli-Weiner, Ph.D., (Doc. 2697).
I. Background
A. Background Applicable to Both Cases
The following facts, which are based on the record generated by these motions and Defendants’ motions for summary judgment, (Docs.2756, 2762) - including Defendants’ Local Rule 56.1 Statements and Plaintiffs’ responses thereto, (Docs. 2851 (“Danley 56.1 Stmt. & Resp.”), 2854 (“Hayes 56.1 Stmt. & Resp.”)), 2 and supporting materials — are undisputed except where noted. 3
In 2000 the U.S. Food and Drug Administration (“FDA”) approved the Mirena, a plastic T-shaped IUD that measures 1.26 by 1.26 inches, as safe and effective for intrauterine contraception. (Danley 56.1 Stmt. & Resp. ¶¶ 1-2.) Mirena provides contraceptive protection for up to five years, and has a cylinder in its stem that continuously releases a dose of the hormone levonorgestrel (“LNG”), (id. ¶ 3), a synthetic progestin. (Declaration of Diogenes P. Kekatos in Support of Plaintiffs’ Omnibus Motion (“Kekatos Omnibus Deck”), (Doc. 2704), Ex. B, General Expert Report of Jay Goldberg, M.D., M.S.C.P. (“Goldberg Report”), at 8.) It must be prescribed and inserted by a healthcare professional. (Danley Stmt. & Resp. ¶ 4.) The Mirena has removal threads that permit the user to check its placement. (Id. ¶ 13.)
The Mirena label has undergone four changes to its warning regarding the risk of perforation since the FDA’s initial approval in 2000. 4 (Id. ¶ 6.) The 2009 label, *409 which was in effect at the time both Ms. Hayes’ and Ms. Danley’s Mirenas were inserted, included a “Highlights” section on the first page that stated: “Perforation may occur during insertion. Risk is increased in women with fixed retroverted uteri, during lactation, and postpartum.” (Id. ¶¶ 8-9; Hayes 56.1 Stmt. & Resp. ¶¶ 8-9.) The 2009 label also included a Warnings section that stated, “Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later ... Delayed detection of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal obstruction, abscesses and erosion of adjacent viscera.” (Danley 56.1 Stmt. & Resp. ¶ 10.) It further warned that surgical removal might be required if perforation occurred. (Id.) The label also instructed healthcare providers to teach patients that they should check the Mirena threads every month, and that a patient should contact her doctor if unable to feel the threads. (Id. ¶ 18.) The label additionally instructed healthcare providers to, prior to insertion, give each patient a copy of the “Patient Information Booklet” that is included with every Mirena, and to discuss potential side effects and how to feel the Mirena threads. (Id. ¶ 14.) The Patient Information Booklet states that “Mirena can cause serious side effects,” including embedment and perforation, without reference to the timing of these potential events. (Id. ¶ 15.) Beginning in 2005, the warning label for ParaGard, another IUD, included the sentence: “Spontaneous migration has also been reported.” (Id. ¶ 53.)
The parties agree that Defendants warned against the possibility of uterine perforation during insertion. (Id. ¶ 9.) They also agree that Defendants did not warn against the possibility that perforation could occur after and unrelated to insertion, which Plaintiffs call “secondary perforation” or “spontaneous migration.” 5 Whether such a possibility exists is at the heart of their dispute. Plaintiffs and their experts maintain that a properly placed Mirena, with no perforation related to insertion, is capable of later perforating the uterus and migrating out of it. (Id. ¶ 56; Declaration of Christopher J. Cook in Support of Defendants’ Motion to Exclude the Testimony of Roger C. Young, M.D., Ph.D. (“Cook Young Deck”), (Doc. 2696), Ex. B, General Causation Expert Report of Roger C. Young, M.D., Ph.D. (“Young Report”), at 6; Declaration of Christopher J. Cook in Support of Defendants’ Motion to Exclude the Testimony of Susan Wray, Ph.D. (“Cook Wray Deck”), (Doc. 2693), Ex. B, General Expert Report of Dr. Susan Wray, Ph.D. (“Wray Report”), at 22.) Defendants and their experts assert that Plaintiffs’ theory of secondary perforation has not been proven, and that perforation of the uterus can only occur upon insertion of a Mirena, although detection of perforation or migration can occur later. (Dan-ley 56.1 Stmt. & Resp. ¶ 56; Kekatos Omnibus Deck Ex. A, General Expert Report of Steven Goldstein, M.D. (“Goldstein Re *410 port”), at 23; Kekatos Omnibus Decl. Ex. F, General Expert Report of Geri D. Hewitt, M.D. (“Hewitt Report”), at. 24.) The expert reports and proposed expert testimony discussed below deal primarily with these issues.
The parties also dispute the significance and validity of the European Active Surveillance Study on Intrauterine Devices (“EURAS”) study. EURAS was a study of 61,448 women using Mirena or copper IUDs in six European countries who were followed between 2006 and 2013 to “identify and compare the incidence of uterine perforation and other medically adverse events associated with levonorgestrel-re-leasing intrauterine systems ... and copper intrauterine devices (IUDs) under routine conditions of use in a study population representative of typical users.” (Declaration of Christopher J. Cook in Support of Defendants’ Motion to Exclude the Testimony of April Zambelli-Weiner, Ph.D. (“Cook Zambelli-Weiner Deck”), (Doc. 2699), Ex. E, Klaas Heinemann et al., Risk of Uterine Perforation with Levonorges-trel-Releasing and Copper Intrauterine Devices in the European Active Surveillance Study on Intrauterine Devices, 91 Contraception 274, 274 (2015) (hereinafter “Heinemann 2015”).) The study concluded that uterine perforation was rare, and that there were no clinically significant differences in perforation rates between IUDs containing LNG and copper IUDs. {Id. at 274, 278-79.) EURAS was funded by Bayer, (Cook Zambelli-Weiner Decl. Ex. D, at 1), but overseen by an independent Safety Monitoring and Advisory Council consisting of “internationally acknowledged experts in the field,” which made “recommendations and final decisions in all scientific matters” and which approved all study materials, {id. at 26).
The parties also dispute the capacity of two-dimensional (“2D”) versus three-dimensional (“3D”) ultrasound in detecting proper placement of a Mirena and signs of perforation. Defendants claim that “[t]wo-dimensional ultrasound imaging cannot rule out damage to the myometrium or a partial perforation at insertion,” while Plaintiffs assert that Mirena’s label “tells medical providers that they can confirm proper placement of a Mirena by utilizing 2-D ultrasound.” (Danley 56.1 Stmt. & Resp. ¶ 60.)
B. Background Related to Jennifer Danley
Jennifer Danley used Mirena for contraception on two separate occasions. Her first Mirena was inserted on February 14, 2006 and removed without complication on March 4, 2010. (Danley 56.1 Stmt. & Resp. ¶¶ 16, 17, 26, 27.) Ms. Danley’s second Mirena was inserted by Victoria Roebuck, a nurse practitioner, on June 29, 2011. {Id. ¶ 31.) On that occasion Ms. Danley signed a consent form indicating that she had read Mirena literature and had her questions answered, but Plaintiffs allege that Ms. Danley was not provided the Patient Information Booklet, {id. ¶ 33), although they concede she had gotten it before her first insertion, {id. ¶ 25). Immediately after Ms. Danley’s second Mire-na was inserted, she underwent a 2D ultrasound, and the ultrasound report said the IUD was seen “HIGH/RT.” (Id. ¶¶35-36.) The parties dispute whether the ultrasound images show that Ms. Danley’s uterus was perforated at insertion. (Id. ¶ 39.)
On January 3, 2013, Ms. Danley went to her healthcare provider after a positive home pregnancy test. (Id. ¶ 41.) Ms. Roebuck could not locate the threads of Ms. Danley’s Mirena, and an ultrasound from that date showed no IUD in Ms. Danley’s uterus. (Id. ¶ 43.) Ms. Danley’s providers suspected that the IUD may *411 have perforated Ms. Danley’s uterus and ordered an X-ray. (Id. ¶ 44.) An X-ray from January 8, 2013 showed the IUD was within Ms. Danley’s abdominal cavity. (Id. ¶ 45.) Ms. Danley’s Mirena was removed on January 23, 2013 via laparoscopic surgery. (Id. ¶ 46.)
C. Background Related to Christie Hayes
Ms. Hayes’ Mirena was inserted by Dr. Merle Robboy on February 3, 2011. (Hayes 56.1 Stmt. & Resp. ¶ 17.) The parties dispute whether Ms. Hayes was provided with the Patient Information Booklet. (Id. ¶ 14.) Ms. Hayes was under anesthesia and conscious sedation during the insertion of her Mirena. (Id. ¶ 23.) Ms. Hayes presented to Dr. Robboy on September 29, 2011 for removal of her Mirena, and during the removal attempt the threads of Ms. Hayes’ Mirena, which were still visible outside her cervix, broke off. (Id. ¶ 24-25.) Dr. Robboy noted that the Mirena was likely embedded in the uterine wall. (Id. ¶ 25.) On October 1, 2011, Ms. Hayes presented to Dr. John McHugh for removal of the IUD via hys-teroscopy, which did not locate the Mirena inside Ms. Hayes’ uterus. (Id. ¶¶ 26-27.) On October 26, 2011, Ms. Hayes’ Mirena was found outside her uterus and removed via laparoscopic surgery. (Id. ¶ 36.)
II. Discussion
A. Legal Standard
The admissibility of expert testimony is governed principally by Rule 702:
A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.
Fed. R. Evid. 702. The party offering the testimony has the burden of establishing its admissibility by a preponderance of the evidence. See Fed. R. Evid. 702 advisory committee’s note; Bourjaily v. United States, 483 U.S. 171, 175-76 , 107 S.Ct. 2775 , 97 L.Ed.2d 144 (1987). The standard for admissibility is the same at the summary judgment stage as it is at trial. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 143 , 118 S.Ct. 512 , 139 L.Ed.2d 508 (1997) (“On a motion for summary judgment, disputed issues of fact are resolved against the moving party.... But the question of admissibility of expert testimony is not such an issue of fact.”).
Rule 702 represents a liberal standard of admissibility for expert opinions, as compared to the previous and more restrictive standard set out in Frye v. United States, 293 F. 1013, 1014 (D.C.Cir.1923). See, e.g., Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 588-89 , 113 S.Ct. 2786 , 125 L.Ed.2d 469 (1993) (Frye test of general acceptance in the scientific community superseded by the Federal Rules; “a rigid ‘general acceptance’ requirement would be at odds with the ‘liberal thrust’ of the Federal Rules and their ‘general approach of relaxing the traditional barriers to “opinion” testimony’”) (quoting Beech Aircraft Corp. v. Rainey, 488 U.S. 153 , 109 S.Ct. 439 , 102 L.Ed.2d 445 . 169 (1988)). “Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.” Id. at 596, 113 S.Ct. 2786 . Despite the liberal standard, however, the district court still must ensure *412 that “any and all scientific testimony or evidence admitted is not only relevant, but reliable.” Id. at 589 , 113 S.Ct. 2786 ; see Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 , 119 S.Ct. 1167 , 143 L.Ed.2d 238 (1999) (Rule 702 requires district courts to fulfill the “gatekeeping” function of “mak[ing] certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”).
First, the district court must determine whether an expert is qualified. Qualification “may be based on ‘a broad range of knowledge, skills, and training.’ ” In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164, 172 (S.D.N.Y.2009) (quoting In re TMI Litig., 193 F.3d 613 , 664 (3d Cir.1999)). Courts within the Second Circuit have “liberally construed expert qualification requirements.” In re Methyl Tertiary Butyl Ether (“MTBE”) Prods. Liab. Litig., No. 00-CV-1898, 2008 WL 1971538 , at *5 (S.D.N.Y. May 7, 2008) (internal quotation marks omitted).
Experts need not conduct studies of their own in order to opine on a topic; a review of other studies and scientific literature can be enough to qualify experts to testify and to make that proposed testimony reliable. See McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1042-43 (2d Cir.1995) (rejecting argument that because expert had “no experience performing or interpreting air quality studies” he was not qualified to testify); 6 see also Cedar Petrochemicals, Inc. v. Dongbu Hannong Chem. Co., 769 F.Supp.2d 269, 284 (S.D.N.Y.2011) (“Experts need not have actually collected the data on which they base their conclusions in order to be credible.”); In re Zyprexa Prods. Liab. Litig., 489 F.Supp.2d 230, 282 (E.D.N.Y.2007) (“If the expert has educational and experiential qualifications in a general field closely related to the subject matter in question, the court will not exclude the testimony solely on the ground that the witness lacks expertise in the specialized areas that are directly pertinent.”) (citing Stagl v. Delta Air Lines, Inc., 117 F.3d 76, 80 (2d Cir.1997)).
Next, the district court must evaluate the reliability of proposed expert testimony. Daubert enumerated a list of factors that, although not constituting a “definitive checklist or test,” a district court might consider in evaluating whether a proffered expert opinion has the required indicia of scientific reliability: whether a theory or technique had been and could be tested, whether it had been subjected to peer review, its error rate, and its degree of acceptance within the relevant scientific community. Daubert, 509 U.S. at 593-94 , 113 S.Ct. 2786 . Rule 702 also requires a sufficiently rigorous analytical connection between the expert’s methodology and conclusions. “[W]hen an *413 expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.” Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 266 (2d Cir.2002); see Joiner, 522 U.S. at 146 , 118 S.Ct. 512 (“[NJothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.”).
The Daubert factors “may or may not be pertinent in assessing reliability, depending on the nature of the issue, the expert’s particular expertise, and the subject of his testimony.” Kumho Tire Co., 526 U.S. at 150 , 119 S.Ct. 1167 (internal quotation marks omitted). Indeed, expert testimony may be based on “experience alone — or experience in conjunction with other knowledge, skill, training or education.” Fed. R. Evid. 702 advisory committee’s note. “In certain fields, experience is the predominant, if not sole, basis for a great deal of reliable expert testimony.” Id.; see Kumho Tire Co., 526 U.S. at 156 , 119 S.Ct. 1167 (“[N]o one denies that an expert might draw a conclusion from a set of observations based on extensive and specialized experience.”). In all cases, “the test of reliability is flexible,” and a district court has “the same broad latitude when it decides how to determine reliability as it enjoys in respect to its ultimate reliability determination.” Kumho Tire Co., 526 U.S. at 141-42 , 119 S.Ct. 1167 (emphasis in original and internal quotation marks omitted).
After determining that a witness is qualified to testify as an expert as to a particular matter and that the opinion is reliable, Rule 702 requires the district court to determine whether the expert’s testimony will “help the trier of fact.” Fed. R. Evid. 702. Although expert testimony can be very persuasive, see Nimely v. City of N.Y., 414 F.3d 381, 397 (2d Cir.2005), the testimony is still admissible if it is relevant and helpful. By definition, expert testimony that “usurp[s] either the role of the trial judge in instructing the jury as to the applicable law or the role of the jury in applying that law to the facts before it,” United States v. Bilzerian, 926 F.2d 1285, 1294 (2d Cir.1991), does not “aid the jury in making a decision”; rather, it “undertakes to tell the jury what result to reach,” and thus “attempts to substitute the expert’s judgment for the jury’s,” United States v. Duncan, 42 F.3d 97, 101 (2d Cir.1994) (emphasis omitted).
Plaintiffs seek to exclude nine of Defendants’ experts, and Defendants seek to exclude six of Plaintiffs’ experts. Each motion and expert is discussed separately below. 7
B. Defendants’ Clinical Experts
Plaintiffs move in one omnibus motion, (Doc. 2702), to preclude seven of Defendants’ experts from testifying on five subjects: (1) secondary perforation; (2) con-tractility 8 or weakening of the uterus from exposure to the hormone LNG; (3) 2D ultrasound’s ability to detect proper placement of Mirena inside the uterus; (4) Mirena labeling; and (5) epidemiological *414 studies including the EURAS IUD study. (Plaintiffs’ Omnibus Memorandum of Law In Support of Their Motion to Exclude Proposed Testimony of Defendants’ Experts (“Ps’ Omnibus Mem.”), (Doc. 2703), 2.) I first summarize the general contours of the issues.
• Secondary Perforation
Plaintiffs and their experts contend that secondary perforation is the phenomenon of an IUD perforating (puncturing) a uterus that occurs after, and is unrelated to, its insertion. (Ps’ Omnibus Mem. 2-8; Wray Report at 22.) Bayer and its experts opine that perforation can only occur in connection with the insertion of an IUD, although the perforation may be detected at a later time. (See, e.g., Goldstein Report at 27-28; Hewitt Report at 24-25.)
• Effect of LNG on the Uterus and Uterine Contractions
Plaintiffs and their experts allege that exposure to LNG, released by the Mirena as part of its contraceptive effect, causes the endometrium (the inner-most layer of the uterus) 9 to weaken and become more susceptible to perforation by an IUD. They posit that uterine contractions (which occur regularly apart from childbirth) help to propel an IUD through the uterine wall. (Wray Report at 19-20, 25-26; Young Report at 11-18.) Bayer’s experts dispute the effects of LNG on the uterus, state that LNG does not have a thinning or weakening effect on the myometrium (the middle, muscular layer of the uterus through which a migrating Mirena would have to pass), and maintain that uterine contractions could not force through that wall an IUD that has not at least partially perforated. (See, e.g., Kekatos Omnibus Deck Ex. D, General Expert Report of Michelle Collins, Ph.D., C.N.M., R.N.C.E.F.M. (“Collins Report”), at 23-25.)
• Ultrasound Imaging
Bayer’s experts have opined that although 2D ultrasound is still a commonly used method to detect whether a Mirena has been properly placed — in other words, to determine whether perforation or damage occurred at insertion — this type of imaging cannot rule out such damage, and 3D ultrasounds produce higher quality images capable of more detailed detection. (See, e.g., Kekatos Omnibus Decl. Ex. G, General Expert Report of Marcia C. Jav-itt, M.D., F.A.C.R. (“Javitt Report”), at 4.) Plaintiffs argue that Defendants’ experts should not be allowed to opine on the superiority of 3D imaging because 2D imaging is capable of detecting proper placement of an IUD; it is frequently used to ensure proper placement; and Bayer has never instructed or recommended that physicians use 3D ultrasounds to detect Mirena. (Ps’ Omnibus Mem. 3-4.)
• Mirena Label
Bayer’s medical experts opine that from a clinical perspective, the Mirena label has always been adequate to warn of its risks. (See, e.g., Kekatos Omnibus Deck Ex. C, General Expert Report of Michael Policar, M.D., M.P.H. (“Policar Report”), at 36.) Plaintiffs argue that Defendants’ Obstetrics and Gynecology (“OB/GYN”) experts *415 are not qualified to opine on the adequacy of the Mirena label because they have not worked in a regulatory capacity. (Ps’ Omnibus Mem. 4.)
• Epidemiological Studies
Bayer’s experts offer opinions regarding the scope and results of the EURAS IUD study. (See, e.g., Goldberg Report at 17-19.) Plaintiffs argue that Bayer’s OB/ GYN experts are not qualified to opine on the adequacy of the EURAS IUD study because they are not epidemiologists, bio-statisticians or medical scientists. (Ps’ Omnibus Mem. 4.)
Defendants’ experts’ qualifications and opinions are discussed below, followed by an analysis of each opinion that Plaintiffs seek to exclude.
1. Experts’ Qualifications & Opinions
a. Michelle Collins, Ph.D., C.N.M., R.N.-C.E.F.M.
Dr. Collins is an Associate Professor of nursing, specializing in nurse-midwifery, and a director of a nurse-midwifery education program at Vanderbilt University’s School of Nursing. (Collins Report at 1; Declaration of Christopher J. Cook in Support of Defendants’ Opposition to Plaintiffs’ Omnibus Motion (“Cook Omnibus Deck”), (Doc. 2773), Ex. 7, Curriculum Vitae of Michelle Collins (“Collins CV’).) She teaches courses that cover IUD content, including IUD insertion, and practices part-time in the nurse-midwifery clinical faculty practice. (Collins Report at 1.) Dr. Collins has prescribed and inserted “hundreds of IUDs,” including ParaGard and Mirena. (Id.) Dr. Collins wrote a doctoral dissertation examining the effect of progestins, and one study she used included women with Mirena IUDs. (Id.) She teaches, writes and makes presentations in her field, including authoring a textbook chapter on hormonal contraception. (Id.; Collins CV.)
Dr. Collins opines on the benefits and risks of various types of contraception, including Mirena. (Collins Report at 3-13.) She concludes that the benefits associated with Mirena use outweigh its risks. (Id. at 26.) Dr. Collins discusses shortcomings associated with 2D ultrasound imaging of IUDs. (Id. at 18-19.) She additionally concludes that there is no evidence supporting Plaintiffs’ theory of secondary or delayed perforation, and that perforation can only occur upon insertion of an IUD. (Id. at 22-25.) She dismisses several theories put forth to show that secondary perforation is possible, (id. at 23-25), and concludes that Mirena’s label has always adequately outlined the proper risks from a medical perspective, (id. at 25-26).
b. Vanessa Dalton, M.D., M.P.H.
Dr. Dalton is a tenured Associate Professor in the Department of Obstetrics and Gynecology, Division of Gynecology, at the University of Michigan. (Dalton Report at 1; Cook Omnibus Decl. Ex. 10, Curriculum Vitae of Vanessa Dalton (“Dalton CV’).) She holds undergraduate, medical and public health degrees. (Dalton Report at 1.) Dr. Dalton has researched reproductive health services, including contraception, and she has served on committees for the American Congress of Obstetricians and Gynecologists (“ACOG”). (Id.) Dr. Dalton leads a weekly family planning clinic and consultative service providing counseling and provision of contraception, and she supervises or personally places 5 to 10 IUDs in a typical month. (Id. at 2.) More than half of her clinical practice is in “family planning related services.” (Id.) She has studied and published on LNG-releasing IUDs and the possible complications from IUDs in post-partum women. (Cook Omnibus Deck Exs. 11,12.)
*416 In her report, Dr. Dalton describes the effectiveness of different types of contraception. (Dalton Report at 6-18.) She concludes that the EURAS-IUD study provides the best evidence to show rates of IUD-associated perforation' and notes that the study found similar rates of perforation between LNG-containing ÍUDs and copper IUDs. (Id. at 20-22.) Dr. Dalton concludes that Plaintiffs’ theory of spontaneous migration is not supported by evidence and dismisses possible mechanisms of non-insertion related perforation, including migration through the fallopian tubes, pressure necrosis, uterine contractions and thinning effects of LNG on the uterine wall. (Id. at 24-27.) In addition, Dr. Dalton opines that the Mirena label has always adequately conveyed the risks associated with Mirena. (Id. at 29-31.) She also opines that 2D ultrasound technology is not always capable of detecting whether a portion of an IUD has extended into the myometrium. (Id. at 23.)
c. Jay Goldberg, M.D., M.S.C.P., C.E.F.M.
Dr. Goldberg is a board certified obstetrician/gynecologist and holds leadership positions in obstetrics and gynecology at Einstein Medical Center in Philadelphia. (Goldberg Report at 1.) Dr. Goldberg practices full-time as an OB/GYN and sees many patients for family planning and contraception. (Id.) He personally inserts several Mirena IUDs per month, and sometimes as many as five per week. (Id. at 10; Cook Omnibus Decl. Ex. 20, Deposition of Jay Goldberg (“Goldberg Dep.”), at 57:11-18.) He has published dozens of peer-reviewed articles and is a manuscript referee for more than a score of medical journals. (Goldberg Report at 2; Cook Omnibus Decl. Ex. 6, Curriculum Vitae of Jay Goldberg (“Goldberg CV”).) Dr. Goldberg opines generally on the benefits of contraception and IUDs and the mechanisms by which IUDs function. (Goldberg Report at 4-10.)
Dr. Goldberg concludes, based on available evidence and the general consensus in the scientific community, that perforation occurs, or at least initiates, at the time an IUD is inserted. (Id. at 13-14.) Dr. Goldberg opines that IUDs cannot move independently and dismisses potential theories by which spontaneous migration could occur. (Id. at 13-14, 23-30.) He also opines on the limitations of 2D ultrasound in detecting uterine perforation. (Id. at 14-15.) Dr. Goldberg discusses the EURAS-IUD study, and disagrees with some criticisms levied against it. (Id. at 17-19.) In addition, Dr. Goldberg concludes that the Mirena label has always adequately conveyed to prescribing physicians the risks of Mirena. (Id. at 21-23.)
d. Steven Goldstein, M.D.
Dr. Goldstein is a tenured professor at New York University School of Medicine in the department of Obstetrics and Gynecology. (Goldstein Report at 1.) Dr. Goldstein is the Director of Gynecologic Ultrasound and Co-Director of Bone Den-sitometry and Body Composition. (Id.) He has a half-time private practice, seeing patients of all ages as a gynecologist, and counsels and places IUDs. (Id. at 1-2.) Dr. Goldstein has written and edited textbooks on ultrasounds of the female pelvis, and published articles on 2D-ver-sus-3D ultrasound, including specific discussions regarding the detection of IUD placement. (See, e.g., Cook Omnibus Decl. Ex. 44.) Dr. Goldstein opines generally on contraceptive methods, IUDs and the risk of perforation associated with IUDs. (Goldstein Report at 2-14.) Based on the EURAS-IUD study, he finds no statistically significant difference in the perforation rate of Mirena compared to other IUDs. (Id. at 10-14.)
*417 Dr. Goldstein opines that most perforations are not diagnosed until after insertion, (id. at 14-17), and concludes that Plaintiffs’ theory of secondary perforation, and the alleged mechanisms by which it might occur, are “unproven” and “implausible,” (id. at 23). Dr. Goldstein opines on the use of 2D and 3D ultrasound in detecting proper Mirena placement, and concludes that 2D ultrasound cannot rule out injury to or perforation of the myometri-um. (Id. at 17-18.) Dr. Goldstein also concludes that Mirena’s label has always adequately informed clinicians regarding the risks of perforation, and that the label’s varying statements have not impacted his decision on whether to prescribe Mire-na for a patient. (Id. at 19-23.)
e. Geri Hewitt, M.D.
Dr. Hewitt is an associate professor at Ohio State University College of Medicine in the OB/GYN and Pediatrics Departments. (Hewitt Report at 1.) Dr. Hewitt supervises and teaches residents and medical students on the gynecologic and labor and delivery services, and works in a practice providing the “full range of general adult OB/GYN, including well woman care, contraception and family planning, obstetrical services, and gynecologic surgery.” (Id.) Dr. Hewitt counsels patients on contraception, and “routinely placets]” IUDs. (Id. at 1-2.) She serves on committees and boards related to OB/GYN services. (Id. at 3.) Her teaching activities “include both educating trainees about the risks and benefits of IUDs, and training and supervising IUD placement.” (Id. at 2.) She is co-author of a 2005 article on pro-gestin-only contraceptives, including Mire-na. (Cook Omnibus Deck Ex. 9.)
Dr. Hewitt opines that spontaneous migration is not possible and that uterine perforation occurs or at least initiates at the time of insertion. (Hewitt Report at 18-20.) Dr. Hewitt dismisses theories espousing mechanisms by which a Mirena could spontaneously migrate. (Id. at 24-29.) She disagrees with Plaintiffs’ epidemiological expert, Dr. Zambelli-Weiner, regarding her criticisms of the EURAS-IUD study. (Id. at 15-16.) Dr. Hewitt also opines that, as a prescribing doctor, the Mirena label “has always adequately and appropriately informed clinicians about the known risk of uterine perforation.” (Id. at 30.)
f. Marcia Javitt, M.D., F.A.C.R.
Dr. Javitt is the Director of Medical Imaging at the Rambam Health Care Campus in Haifa, Israel, and served as the Section Head of Body MRI and of Genitourinary Radiology at Walter Reed Army Medical Center in Washington from 2002 to 2011. (Javitt Report at 1.) She is trained in Ultrasound, Computed Tomography and MRI, and has over 30 years of experience in radiology. (Id.) She has written textbooks, book chapters and peer-reviewed articles, focusing her research on imaging of the female pelvis. (Id.)
Dr. Javitt opines on the imaging of IUDs and the differences between 2D and 3D ultrasound technology. (Id. at 3-6.) She concludes that 3D ultrasound offers advantages over 2D ultrasound with respect to localizing IUDs within the uterine cavity. (Id. at 4.) Dr. Javitt opines that 2D ultrasound cannot always rule out that any portion of an IUD has entered the myometrium. (Id.) In addition, Dr. Javitt concludes that neither 2D nor 3D ultrasound can rule out injuries to the uterine wall caused by a uterine sound 10 or the instrument used to insert the IUD when the IUD is normally positioned within the uterine cavity. (Id.)
*418 g. Michael Policar, M.D., M.P.H.
Dr. Policar is a board certified OB/GYN. (Policar Report at 1.) He also has a Master’s degree in Public Health. (Id.) Since October 2014, Dr. Policar has worked part-time training and supervising OB/GYN residents, mentoring post-residency Family Planning fellows, and serving on committees at San Francisco General Hospital. (Id. at 3.) Dr. Policar has previously held senior positions at the Planned Parenthood Federation of America, and as the national Medical Director was “responsible for creating and updating the clinical Standards and Guidelines that clinicians in every Planned Parenthood affiliate in the United States were expected to follow.” (Id. at 1, 3.) He has had an extensive career in OB/GYN, including 34 years of clinical experience in family planning. (Id. at 1-3.) Dr. Policar is also a senior author of “Contraceptive Technology,” a textbook on family planning. (Id. at 3.) Dr. Policar has inserted and removed IUDs, including Lip-pes Loop, Copper 7, Progestasert, Para-Gard, Mirena and Skyla during his career, and he has supervised “between 2-4 Mire-na insertions per week over the last 13 years.” (Id. at 4.)
Dr. Policar opines that all perforations occur at the time of the IUD insertion procedure, although diagnosis may be delayed, and that it is an uncommon but possible scenario that an embedment that occurred at the time of placement progresses over time to form a complete perforation via which the IUD could be propelled into the abdominal cavity. (Id. at 20-21, 24.) Dr. Policar is unaware of any plausible mechanism by which an IUD could spontaneously migrate out of the uterus, and opines that such a concept is not accepted in the family planning corn-munity. (Id. at 20-21, 24.) In his report, Dr. Policar discusses the benefits of the EURAS-IUD study and writes that its “clinical import has been widely endorsed within the medical community.” (Id. at 27.) Dr. Policar additionally opines on the limitations of 2D ultrasound, noting that 2D ultrasound can fail to diagnose an em-bedment in some circumstances. (Id. at 32.) Dr, Policar also concludes that the “Mirena label[s] over time have adequately informed clinicians of the salient clinical information” and that his understanding of the risks of perforation remained constant despite changes to the label. (Id. at 36.)
2. Opinions on Secondary Perforation 11
Bayer’s experts’ opinions on secondary perforation, contractility of the uterus and weakening of the uterus by LNG are closely related and will be discussed together. Plaintiffs first argue that Bayer’s clinical experts lack the medical experience necessary to opine on these issues. A general thrust of Plaintiffs’ arguments is that Defendants’ experts have not personally studied uterine activity upon exposure to LNG or pointed to studies ruling out the possibility of secondary perforation. Not only is personal study not necessary, see McCullock, 61 F.3d at 1042-43 ; Cedar Petrochemicals, Inc., 769 F.Supp.2d at 284 ; In re Zyprexa, 489 F.Supp.2d at 282 , but Defendants do not dispute that their own experts have not personally conducted such studies. Further, given that Defendants’ experts are attempting to prove a negative — that secondary perforation does not exist — pointing to the absence of convincing studies or the weaknesses of studies on which Plaintiffs rely, and evaluating them in light of their clinical experience, training and research, is in these circum *419 stances a logical and valid approach. After all, perforation is, as Defendants point out, a clinical phenomenon. See Huskey v. Ethicon, Inc., 29 F.Supp.3d 691, 735 (S.D.W.Va.2014); Deutsch v. Novartis Pharm. Corp., 768 F.Supp.2d 420, 480-82 (E.D.N.Y.2011); DeKeyser v. Thyssenkrupp Waupaca, Inc., 747 F.Supp.2d 1043, 1050 (E.D.Wis.2010). With that in mind, I turn to each expert’s proposed testimony.
Dr. Collins has both academic and clinical experience related to contraception in general and IUDs in particular. She has the qualifications and expertise in the field of family planning and OB/GYN necessary to allow her to opine on the efficacy of the Mirena IUD and Plaintiffs’ theory of secondary perforation under Daubert’s admissibility standard. See Daubert, 509 U.S. at 589 , 113 S.Ct. 2786 . Furthermore, Dr. Collins’ academic research related to hormones and her dissertation topic indicate that she is qualified to testify regarding the effect of LNG on the uterus and uterine contractility. (See Collins Report 1.) Plaintiffs argue that all of Bayer’s experts, including Dr. Collins, “blindly state that there is no evidence that secondary perforation actually occurs,” (Ps’ Omnibus Mem. 11), but this is not so. Instead, Dr. Collins’ opinions on secondary perforation (like those of the other experts) are based on her experience as a clinician who has inserted and instructed others on the insertion of IUDs, and on a review of medical literature. 12 (Collins Report at 21-25.) Although Plaintiffs and their experts may disagree with Dr. Collins’ conclusions, these disagreements are best explored on cross-examination.
Plaintiffs additionally argue that Dr. Collins’ opinion on secondary perforation is not reliable because she ignored contrary scientific literature and Bayer’s own internal and public findings. (Ps’ Omnibus Mem. 13.) Potentially conflicting statements by Bayer personnel are irrelevant for purposes of this Daubert motion. 13 Plaintiffs’ argument that Dr. Collins ignored contradictory scientific literature is unfounded; she specifically addressed the leading study on which Plaintiffs rely — the Goldstuck study 14 — and found it to suffer “from multiple methodological and analytical flaws that render its conclusions inaccurate.” (Collins Report at 24.) The Court expresses no opinion on the validity of the Goldstuck study, but because the parties so vehemently disagree on its credibility, it is a suitable topic for cross-examination before a jury. While failure to consider contrary studies may undermine reliability, cf. In re Rezulin Prods. Liab. Litig., 309 F.Supp.2d 531, 563 (S.D.N.Y.2004) (discussing problems of admissibility when expert failed to consider two epidemiological studies addressing topic at hand that reached different conclusions from expert), Dr. Collins in fact analyzed conflict *420 ing arguments. Her opinions are also grounded in reliable sources, and because of the complicated medical nature of Mire-na and its effects, her testimony is helpful to a trier of fact and is not unduly prejudicial.
Dr. Dalton’s medical qualifications are sufficient for her to opine on the effect of LNG on the uterus and Plaintiffs’ theory of secondary migration. See In re Zyprexa, 489 F.Supp.2d at 282 . She has experience practicing as an OB/GYN and has had the opportunity to place and supervise the placement of many IUDs throughout her career. (Dalton Report at 2.) Although she has not performed any studies herself, this does not mean she is not qualified to give a medical opinion using her experience as well as a review of relevant scientific literature. See McCullock, 61 F.3d at 1042-43 . Plaintiffs criticize Dr. Dalton because, in the section of her report where she concludes that LNG does not cause thinning of the uterine wall, she states only that she has not seen literature to that effect, rather than citing any study showing that such thinning does not occur. (Ps’ Omnibus Mem. 17.) But her list of materials considered contains these studies, (Dalton Report app. B), 15 and a lack of specific citation in her report goes to the weight of her opinions, not their admissibility. The fact that these studies are listed shows a rehable foundation upon which Dr. Dalton based her opinions. See Amorgianos, 303 F.3d at 269 . Dr. Dalton’s report regarding spontaneous migration cites scientific literature to support her claim, and she specifically addresses the Goldstuck study on which Plaintiffs rely. Dr. Dalton’s opinions are sufficiently reliable to pass muster under Daubert, see Deutsch, 768 F.Supp.2d at 480-81 (allowing doctors to testify where they based their opinions on their own experiences and review of literature), and her medical testimony would be helpful to the trier of fact.
Plaintiffs move to exclude Dr. Goldberg’s testimony, arguing that like Defendants’ other experts, he is not qualified because he has not personally conducted studies related to secondary perforation and the effect of LNG on the uterus, and that his opinion on secondary perforation is not based on reliable scientific literature. (Ps’ Omnibus Mem. 10.) Dr. Goldberg opines generally on uterine perforation, (Goldberg Report at 12-20), and on theories of spontaneous IUD migration, which he concludes are “just speculative hypotheses, without any sound scientific basis,” (id. at 23). Dr. Goldberg’s experi *421 ence as a medical doctor specializing in OB/GYN and his familiarity and experience in placing and teaching how to place IUDs qualify him to opine on the effects of LNG on the uterus and on Plaintiffs’ theory of secondary perforation, and are indicative of the reliability of his opinions. See In re Fosamax, 645 F.Supp.2d at 181 (finding the “clinical experience of the PSC’s oral maxillofacial experts” to be “highly indicative of the reliability of their opinions”). As previously discussed, experts need not perform studies themselves to be qualified to testify. McCullock, 61 F.3d at 1042-43 . Moreover, Dr. Goldberg cites to studies to bolster his claims that LNG does not thin the myometrium, and he analyzes and finds fault with several studies Plaintiffs cite. (Goldberg Report at 24-29.) Although Plaintiffs and their experts may take issue with Dr. Goldberg’s conclusions, these criticisms go to the weight, not the admissibility, of his testimony and are best addressed on cross-examination. In re Zyprexa, 489 F.Supp.2d at 285 (“The mere fact that an expert’s testimony conflicts with the testimony of another expert or scientific study does not control admissibility.”) (citing Fed. R. Evid. 702 advisory committee’s note (2000)). In addition, Dr. Goldberg’s medical opinions are helpful to the trier of fact.
Dr. Goldberg may not, however, opine on the impact of “lawsuit-generated scientific misinformation.” (Goldberg Report at 29-30.) 16 The probative value of this opinion is substantially outweighed by its prejudicial effect. Fed. R. Evid. 403; see Nimely, 414 F.3d at 397 (“[T]he Supreme Court ... has noted the uniquely important role that Rule 403 has to play in a district court’s scrutiny of expert testimony, given the unique weight such evidence may have in a jury’s deliberations.”). Dr. Goldberg’s view on how lawsuits affect women’s contraceptive choices — assuming it would pass muster under Daubert (a dubious proposition) — is not relevant to either Plaintiffs’ or Defendants’ theories of these cases, would waste time, and would unfairly prejudice Plaintiffs.
Dr. Goldstein’s opinions related to the effects of LNG on the uterus, uterine contractions and the possibility of secondary migration are sufficiently reliable and pass muster under Rule 702 and Daubert . Dr. Goldstein’s clinical and academic experience qualify him to opine on whether LNG can contribute to uterine perforations and whether spontaneous migration can occur. See McCullock, 61 F.3d at 1043 . Dr. Gold-stein bases his opinions on his decades of experiences as a doctor and a review of scientific literature. See Deutsch, 768 F.Supp.2d at 482 . Dr. Goldstein cites several studies for the proposition that uterine perforations occur, or at least initiate, at the time of insertion. (Goldstein Report at 28.) In addition, in his materials list Dr. Goldstein refers to studies that lend support for the proposition that LNG does not have a thinning effect on the myome-trium, in that perforation rates do not differ between hormonal and copper IUDs. {See Goldstein Report app. C.) Dr. Gold-stein also confronts contradictory studies, including Goldstuck. Plaintiffs can cross-examine to challenge Dr. Goldstein’s credibility.
Dr. Hewitt is qualified to opine on the theory of spontaneous migration and potential effects of LNG on the uterus. Her opinion is “based on [her] education, training, experience, and [her] review of *422 the medical literature.” (Hewitt Report at 24.) She cites several publications to support her view that spontaneous migration cannot occur. {Id.) This passes muster under Daubert. See Deutsch, 768 F.Supp.2d at 480-81 . She also confronts conflicting reports and explains her reasoning for dismissing their conclusions. (Hewitt Report at 25-26, 28-29.) Cf. In re Rezulin, 309 F.Supp. at 563. In addition, her medical testimony is relevant to this case and helpful to the trier of fact. The appropriate way for Plaintiffs to challenge Dr. Hewitt’s opinions is through cross-examination.
Plaintiffs once again miss the mark in arguing that Dr. Policar is not qualified to testify regarding secondary perforation, uterine contractility or weakening of the uterus by LNG. (Ps’ Omnibus Mem. 10-13, 15-18.) Like Bayer’s other clinical experts, Dr. Policar is a distinguished practitioner with a long career in OB/GYN practice. He has co-authored a textbook on family planning titled “Contraceptive Technology,” which is in its twentieth edition. (Policar Report at 3; Cook Omnibus Deck Ex. 2.) Dr. Policar bases his opinions on his experience and also the “family planning literature over the past 25 years.” (Policar Report at 20.) His disagreement with Plaintiffs’ theories regarding perforation unrelated to insertion are grounded in his experience and in the literature, as is appropriate under Dau-bert. His testimony is also relevant to this case and helpful to the trier of fact. Plaintiffs may challenge Dr. Policar’s theories and opinions on cross-examination. See In re Zyprexa, 489 F.Supp.2d at 285 .
For the reasons stated above, Bayer’s experts have demonstrated the requisite qualifications, reliability and helpfulness to the trier of fact to pass muster under Rule 702 and Daubert with respect to Plaintiffs’ theory of secondary perforation, uterine contractility and the effects of LNG on the uterus. Plaintiffs’ motion to exclude these experts from opining on these topics is denied.
3. Opinions on the Mirena Label
Bayer’s clinical experts all share similar backgrounds as healthcare providers who have experience prescribing and inserting IUDs, and all offer opinions regarding the adequacy of the Mirena label from the perspective of a medical practitioner who is familiar with Mirena and similar products. {See Collins Report at 25-26; Goldstein Report at 19-23; Goldberg Report at 21-23; Policar Report at 34-37; Dalton Report at 29-31; Hewitt Report at 29-30.) Plaintiffs argue that none of Defendants’ experts are qualified to offer an opinion on labeling because they lack “any education or training with respect to FDA labeling.” (Ps’ Omnibus Mem. 19-20.) But none of Defendants’ experts opine on FDA regulations or on the adequacy of the Mirena warning from a regulatory perspective. Rather, they only describe how they as clinicians have perceived the label and its wording with respect to perforation, and how, if at all, that wording affects their practices. As Dr. Goldstein said during his deposition:
I would definitely offer an opinion on the label as it pertains to how I, as a clinician and one who teaches, you know, you graduate seven residents a year times 30 years, 210 now out-in-practice OB/ GYNs, how we do or do not utilize the label. But as far as from a regulatory point of view, that’s not my area of expertise.
(Cook Omnibus Decl. Ex. 19, Deposition of Steven Goldstein (“Goldstein Dep.”), at 76:1-10.) 17 Plaintiffs do not cite any cases *423 where a prescribing physician or medical practitioner has been excluded from opining on how a label is perceived from a clinical medical perspective. The cases they cite deal generally with the relevance of expert testimony in specialized fields. In Redman v. John D. Brush Co., 111 F.3d 1174 (4th Cir.1997), the court found the expert’s testimony regarding industry standards for burglar-deterrent safes unreliable because he did not rely on “information of a kind reasonably relied on by experts in the field.” Id. at 1179 . Barrett v. Atlantic Richfield Co., 95 F.3d 375, 382 (5th Cir.1996), and Nora Beverages, Inc. v. Perrier Group of America, Inc., 164 F.3d 736, 746 (2d Cir.1998), are similarly unhelpful for Plaintiffs because although they stand for the general proposition that an expert must be qualified in a field related to his expertise and have relevant experience in order to testify, Bayer’s clinical experts in the current case do have such relevant experience and expertise. See Watkins v. Cook Inc., No. 13-CV-20370, 2015 WL 1395773 , at *10 (S.D.W.Va. Mar. 25, 2015) (allowing doctor to opine on label based on knowledge and experience with product, but not on FDA regulations); Deutsch, 768 F.Supp.2d at 440 (doctors were qualified to “opine as to the adequacy of the labels from the perspective of oncologists and prescribing physicians” but not as to whether label complied with FDA regulations).
Plaintiffs argue that Defendants’ experts should not be allowed to “testify in the absence of knowledge of the risks of Mire-na,” and that because Bayer’s experts “ignore that secondary perforation is real, they are not equipped to offer an opinion on the adequacy of the Mirena labeling.” (Plaintiffs’ Reply Memorandum in Further Support of their Omnibus Motion (“Ps’ Omnibus Reply”), (Doc. 2843), 5.) This argument does not withstand scrutiny. Defendants’ experts do not ignore the argument that secondary perforation exists; rather, through their study of the literature and their own clinical experiences, they do not find the argument persuasive. The legitimacy of this claim is obviously hotly contested, and the Court does not offer an opinion on its validity, but it does not mean that Bayer’s experts should not be able to opine on whether the label is adequate from a physician’s perspective. It is precisely because Defendants’ experts believe secondary perforation is not a real phenomenon that they think the label, despite not warning against it, is adequate— in other words, that the label conveys the legitimate risks of the product. Because Bayer’s experts have based these opinions on a sound methodology, they have the requisite qualifications, and their testimony is helpful to the trier of fact, their views are admissible under Daubert. 509 U.S. at 590-91 , 113 S.Ct. 2786 . Should the jury be convinced that secondary perforation is possible, it will discount the experts’ opinions about the label accordingly.
Bayer’s clinical experts all have experience in inserting IUDs, including Mirena, and have familiarity with its label, how it is understood, and how it is discussed with patients. Plaintiffs’ motion to exclude Bayer’s clinical experts’ testimony regarding those aspects of the Mirena label is therefore denied. Defendants’ experts may not, however, opine on FDA regulations or whether the Mirena label complied with them, as these doctors are not qualified as experts on that subject.
*424 4. Opinions on 2D Versus 3D Ultrasound
Plaintiffs move to preclude all of Bayer’s experts’ opinions that 2D ultrasound is not capable of always accurately detecting the presence of a Mirena. Plaintiffs argue that Bayer has never instructed or recommended that 3D rather than 2D ultrasound is the preferred method of locating a Mirena. (Ps’ Omnibus Mem. 18-19; Ps’ Omnibus Reply 4-5.) In addition, Plaintiffs argue that “[t]here is no peer-reviewed literature to support the position that 2D ultrasound is incapable of detecting the presence of Mirena,” and cite Defendants’ experts’ reports as stating 2D ultrasound is reliable in the IUD/Mirena context. (Ps’ Omnibus Mem. 18.) These arguments mischaracterize Defendants’ experts’ reports and deposition testimony. 18
Bayer’s clinical experts opine generally that 2D ultrasound can show whether an IUD is present in the uterus, but not necessarily whether a portion of an IUD has extended (or has become embedded) into the patient’s myometrium. (See Collins Report at 18-19; Dalton Report at 23; Goldberg Report at 14-15; Goldstein Report at 17-18; Hewitt Report at 19-20; Policar Report at 32.) With the exception of Dr. Javitt, Defendants’ experts do not offer lengthy opinions on this topic. These experts do not, as Plaintiffs seem to claim, offer opinions that 3D ultrasound is the standard of care or that “2D ultrasound is incapable of ensuring Mirena placement,” (Ps’ Omnibus Mem. 19); they only opine as to the limitations of 2D ultrasound in detecting perforation of the myometrium. If Plaintiffs disagree with the conclusions of Bayer’s experts regarding those limitations, counsel may question them on cross-examination. But in doing so they must bear in mind that saying that 2D ultrasound cannot definitively rule out embedment or perforation is not the same thing as saying 2D ultrasound is unacceptable or 3D ultrasound is routinely required.
In addition, Plaintiffs characterize as “unsupportable” the experts’ views that 2D ultrasound is incapable of ruling out uterine perforation, (Ps’ Omnibus Reply 4), but this argument is unavailing not only because Defendants’ experts set forth reliable bases (including studies) for that opinion, (Javitt Report at 4), but also in light of the fact that several of Plaintiffs’ own experts have said the same thing. 19 The fact that Plaintiffs’ own experts agree on the *425 limitations of 2D ultrasound show Bayer’s experts’ opinions concerning imaging are, at the very least, supportable.
Dr. Javitt, whose opinion focuses on 2D versus 3D ultrasound, is an accomplished radiologist and has served in leadership positions for national and international radiology committees that draft practice guidelines. (Javitt Report at 1.) She opines on the differences between 2D and 3D ultrasound technology, and concludes that a 2D ultrasound may not always be able to rule out that a portion of an IUD has entered the myometrium. (Id. at 4.) Dr. Javitt also opines that if the IUD is properly placed in the uterine cavity ’even 3D ultrasound cannot rule out injuries to the uterine wall caused by other objects, such as a uterine sound or an IUD inserter. (Id.) Dr. Javitt reaches this conclusion by analyzing several studies that lend support to her claims. (Id.) She is sufficiently qualified under Daubert to opine on ultrasound, and her report and proposed testimony are sufficiently reliable because she bases her opinions on her experience as a radiologist and on scientific literature. See Amorgianos, 303 F.3d at 266-67 . Again, if Plaintiffs disagree with Dr. Javitt’s conclusions, they can take it up on cross-examination. Their criticisms do not undermine her reliability, but rather go to the weight that should be given to her testimony. See id. at 267 . In addition, Dr. Javitt’s proposed testimony regarding the technical nature of ultrasound imaging would be helpful to assist a lay person in understanding the ways in which placement of the Mirena and possible perforations can be detected.
Plaintiffs also argue that because Bayer has never suggested that 3D ultrasound is necessary to ensure the location of a Mire-na, it is “disingenuous” for Bayer’s experts to offer testimony that 2D ultrasound may not be able to rule out perforation at insertion. (Ps’ Omnibus Reply 4.) Although Plaintiffs are free to make this point during cross-examination, it does not warrant preclusion under Daubert . Plaintiffs do not cite any authority for the proposition that because Defendants never instructed patients or doctors to use one method, experts cannot opine on limitations of another method, or that their testimony should be excluded in such circumstances as “disingenuous.” Any discrepancy between Defendants’ statements and their experts’ views at trial may be fodder for questioning and argument by Plaintiffs, but does not undermine the admissibility of the opinions. Dr. Javitt acknowledges in her report that when properly conducted, “2D U.S. [ultrasound] can reliably assess whether an IUD is located in or near the uterine cavity.” (Javitt Report at 3.) She also points out, however, that even though 2D ultrasound can determine whether an IUD is in the uterine cavity, it cannot always rule out that an IUD located in the uterine cavity has also partially entered the myometrium. (Id. at 3-4.) This distinction seems entirely logical and does not undermine the reliability of Dr. Javitt’s report or the opinions of other experts regarding 2D versus 3D ultrasound.
Defendants’ experts, who are all experienced medical practitioners with academic and clinical expertise, are qualified to opine on the narrow issue of the limitations of 2D ultrasound in detecting perforation. In addition, they base their opinions on peer-reviewed studies. They thus pass muster under Daubert’s reliability standard. See Daubert, 509 U.S. at 593 , 113 S.Ct. 2786 . These opinions are also helpful to the trier of fact because they relate to a technical, medical issue that would be beyond the ken of a lay person. For the reasons stated above, Plaintiffs’ motion to exclude Defendants’ experts’ tes *426 timony on the subject of 2D versus 3D ultrasound is denied. For the same reasons, Plaintiffs’ motion to exclude Dr. Jav-itt’s expert testimony is also denied.
5. Opinions on Epidemiology
Plaintiffs move to exclude Bayer’s clinical experts’ opinions regarding epidemiological studies, including the EURAS IUD study, because they are not epidemiologists and therefore not qualified to testify as to these studies. (Ps’ Omnibus Mem. 21-22.) This level of expertise, however is not required under Daubert. See In re Zyprexa, 489 F.Supp.2d at 282 . Moreover, medical doctors do not need to be epidemiologists in order to testify regarding epidemiological studies. See, e.g., In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 11-CV-5304, 2013 WL 1558690 , at *6 (D.N.J. Apr. 10, 2013) (doctor qualified to opine on clinical trials even though he was not an epidemiologist); Lyman v. Pfizer, Inc., No. 09-CV-262, 2012 WL 2971550 , at *3 (D.Vt. July 20, 2012) (“A medical doctor does not have to be an epidemiologist in order to testify about epidemiological studies.”).
Bayer’s clinical experts’ medical qualifications in the field of OB/GYN, their familiarly with IUDs, and their experience evaluating (and in some cases conducting) epidemiological studies as part of their clinical work and research suffice under Daubert and qualify them to opine on epidemiological studies, including the validity and sufficiency of the EURAS study. See In re Yasmin & YAZ (Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig., No. 09-CV-10012, 2011 WL 6740363 , at *6 (S.D.Ill.Dec. 22, 2011) (doctor’s “extensive experiences qualife[d] him to give expert opinions] about the epidemiological studies that he ... reviewed”). Accordingly, Plaintiffs’ motion to exclude Defendants’ experts’ opinions as to epidemiological studies is denied.
6. Conflicting Bayer Statements and Documents
Plaintiffs next contend that Defendants’ experts’ testimony should be excluded under Daubert because it arguably contradicts statements made by Bayer employees. (Ps’ Omnibus Mem. 14-15.) Plaintiffs do not cite any authority for this proposition. The one case that Plaintiffs cite in this section of their brief, Hilaire v. DeWalt Industrial Tool Co., 54 F.Supp.3d 223, 234 (E.D.N.Y.2014), does not support Plaintiffs’ argument for exclusion based on alleged contrary statements made by a party. In fact, the court there remarked, echoing Daubert , that once testimony “has been found to be admissible, the adverse party is free to challenge any shaky or unreliable testimony,” id. (internal quotation marks omitted), before the jury using “ ‘vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof,’ ” id. at 235 (quoting Daubert, 509 U.S. at 596 , 113 S.Ct. 2786 ) (emphasis added).
Plaintiffs further criticize Defendants’ experts’ testimony as unreliable for failing to consider Bayer’s public positions and internal discussions related to secondary perforation. (Ps’ Omnibus Reply 3-4.) To support their argument, Plaintiffs cite only Nimely, 414 F.3d at 396-97 , which broadly states that when expert opinions are “based on data, a methodology, or studies that are simply inadequate to support the conclusions reached,” that testimony should be excluded. Although this is certainly true under Daubert , it does not mean that potentially conflicting statements made by a party necessarily render that party’s expert’s testimony unreliable. The statements and public positions of Bayer are not scientific literature that an expert would be expected to confront in the exercise of intellectual rigor in the field. See In re Rezulin Prods. Liab. Li *427 tig., 369 F.Supp.2d 398, 425 (S.D.N.Y.2005) (expert testimony unreliable if expert does not acknowledge or account for “relevant scientific literature ... tending to refute the expert’s theory”). Under Daubert and its progeny, it is the role of the district court to analyze the qualifications of experts, the reliability of the methods used by an expert, and whether expert testimony will assist the trier of fact, not to weigh conflicting evidence — let alone conflicting evidence of a non-scientific nature in the form of party admissions. See Amorgianos v. Nat'l R.R. Passenger Corp., 137 F.Supp.2d 147, 162 (E.D.N.Y.2001) (“In assessing the reliability of a proffered expert’s testimony, a district court’s inquiry under Daubert must focus, not on the substance of the expert’s conclusions, but on whether those conclusions were generated by a reliable methodology.”), aff'd, 303 F.3d 256 .
To whatever extent Defendants’ public or internal statements conflict with its experts’ opinions or its litigation positions in these cases, that will be a problem for Defendants that Plaintiffs may exploit via cross-examination and argument. But Defendants’ experts’ failure to confront alleged conflicting statements made by Bayer does not warrant exclusion under Dau-bert. See Huskey, 29 F.Supp.3d at 735 (“The plaintiffs also contend that [the expert’s] opinion is unreliable because he did not review internal [company] documents that refute his conclusion ... [the expert’s] failure to review particular documents goes to the weight of his opinion, not its admissibility.”).
For the reasons stated above, all seven of Defendants’ experts have the necessary qualifications and have utilized reliable methods in their opinions as required by Rule 702 and Daubert , and their testimony will assist the trier of fact. Accordingly, Plaintiffs’ omnibus motion to exclude Bayer’s clinical experts, (Doc. 2702), is DENIED.
C. Plaintiffs’ Causation Experts
Defendants move to preclude Drs. Young, Jarrell, Wray and Strassberg from offering opinions regarding general and specific causation. Each is discussed separately below.
1. Roger C. Young, M.D., Ph.D.
Defendants move to preclude Dr. Young’s expert testimony relating to his theory of how secondary perforation of an IUD can occur — his theory of general causation — on the grounds that the methodology upon which he bases his opinions is unreliable and that he takes impermissible speculative leaps in forming his conclusions. Dr. Young’s general causation expert report and proposed testimony are offered by Plaintiffs to show a mechanism by which perforation of an IUD unrelated to insertion — in other words, secondary perforation or spontaneous migration— could occur. Dr. Young also offers a specific causation opinion that secondary perforation did occur in Ms. Danley’s case. (Cook Young Deck Ex. C, Expert Report of Roger C. Young, M.D., Ph.D. (“Young Danley Report”).) For the reasons stated below, Defendants’ motion is GRANTED with respect to both Dr. Young’s general causation opinions and his specific causation opinions.
a. General Causation
i. Opinions
In his general causation report, Dr. Young opines on “potential mechanisms of secondary perforation of Mirena IUDs.” (Young Report at 2.) He sets forth a “[biologically plausible mechanism for IUD uterine perforation” that consists of four steps. {Id. at 10-11.) The mechanism *428 assumes (at “Step 0”) that the IUD is correctly placed within the uterine cavity. (Id. at 11.) At Step 1 of Dr. Young’s mechanism, there is “delayed embedding” of the IUD in the uterine wall, which occurs unrelated to the insertion procedure. (Id.) Dr. Young opines that this “delayed embedding” is facilitated by “chemical changes of the lining on the uterus caused by locally high concentrations of levonorgestrel [LNG],” which serves to thin the endometrium, exposing the underlying musculature and leading to an enhanced foreign body reaction (“FBR”). (Id. at 12.) According to Dr. Young, this thinning and FBR leads to a “greater likelihood that the Mirena will experience delayed embedding” in the uterine wall. (Id.) Step 2 in Dr. Young’s mechanism refers to “penetration of the IUD into the uterine wall to a deeper level than embedding,” with one part of the IUD “lead[ing] the way” as the IUD penetrates the uterine wall. (Id. at 13.) Again, at this stage Dr. Young attributes the softening of the connective tissue near the IUD, caused by LNG, as a significant contributing factor to IUD penetration. (Id.) Dr. Young asserts that uterine contractions also contribute to penetration of the uterine wall. (Id.)
Step 3 in Dr. Young’s mechanism refers to perforation of the uterus by the IUD, which is the “phase where the IUD actively penetrates the uterine wall until some portion of the IUD protrudes through the wall into the abdominal cavity.” (Id. at 14.) Dr. Young opines it is likely that the Mirena penetrates the uterus “by mechanical and chemical mechanisms.” (Id. at 15.) The chemical mechanisms relate to the softening of the uterine tissue discussed at Steps 1 and 2, and the mechanical mechanisms refer to uterine contractions and the force required for the Mirena to perforate on its own. (Id.) Dr. Young acknowledges that the Mirena actually tends to reduce contractions, but finds that because it does not eliminate them, they can still contribute to secondary perforation. (Id.) Dr. Young estimates the amount of force created by the effect of uterine contractions on the Mirena using the size of Mirena and the force quantities found in one study examining the uterus and in another examining the heart. (Id. at 15-16.) The final stage in Dr. Young’s analysis, Step 4, refers to “[transmigration of IUD into abdominal cavity,” which is when the IUD exits the uterus. (Id. at 16.) Dr. Young opines that once the IUD has partially penetrated, complete penetration is “accomplished when uterine contractions occur in response to the presence of a foreign body.” (Id.) Dr. Young’s mechanism is thus based upon the effects of LNG on the uterus, which he concludes enhances the risk of secondary perforation, and the forces generated by uterine contractions. (Id.) He additionally concludes that knowledge of “mechanisms of secondary perforation are well-known” in medical literature. (Id.)
ii. Qualifications
Dr. Young is an experienced doctor specializing in OB/GYN. Dr. Young completed a residency in OB/GYN in 1986, and has since practiced obstetrics and gynecology in an academic setting. (Young Report at 3.) Dr. Young has served as a professor at the University of Vermont School of Medicine, Dartmouth Medical School, the Medical University of South Carolina and Duke University. (Id.) He is currently a professor at the University of Tennessee Health Sciences Center. (Id.) Dr. Young also has clinical experience in OB/GYN that has included caring for patients, supervising residents and teaching clinical medicine to medical students. (Id. at 4.) Dr. Young has learned, and subsequently taught, “how to place and remove copper 7, copper T, ParaGard and Mirena IUDs.” (Id. at 6.) *429 Over the course of his 27 years of clinical practice, Dr. Young has placed or supervised the placement of approximately 300 IUDs. (Id.) When Dr. Young was the Director of the Division of General Obstetrics and Gynecology at the University of Vermont, he “created a didactic, a practicum, and brief written test that each resident was required to complete prior to being able to place an IUD as the primary operator.” (Id.) In addition, Dr. Young has researched “subcellular, cellular, tissue-level, and organ-level uterine physiology” with a focus on the “[development of function with the hormonal effects of pregnancy, pre-labor changes, and labor.” (Id. at 3.) He has “written and published 50 articles or book chapters in peer-reviewed journals, including mathematical simulation computer programs that describe uterine contractions in pregnancy.” (Id.) Dr. Young has also extensively researched the functioning of the uterus. (Id.)
Defendants argue that Dr. Young has “no specialized knowledge or experience concerning Mirena, perforation, or the biomechanics of the non-pregnant uterus.” (Memorandum of Law in Support of Defendants’ Motion to Exclude the Testimony of Roger C. Young, M.D., Ph.D. (“Ds’ Young Mem.”) 3.) Dr. Young’s academic and clinical background in obstetrics and gynecology, however, as well as his specific research on the functioning of the uterus, including effects of hormones and uterine contractions, make him qualified to opine on the issue of whether an IUD such as Mirena is capable- of perforating a uterus unrelated to insertion. See In re Zyprexa, 489 F.Supp.2d at 282 . The Court must now determine whether Dr. Young’s opinion and methodology meet Daubert’s standards of reliability. See Daubert, 509 U.S. at 589 , 113 S.Ct. 2786 ; Amorgianos, 303 F.3d at 266 .
iii. Reliability
Defendants move to exclude the testimony of Dr. Young on the grounds that it is unreliable. (Ds’ Young Mem. 6-9.) Dr. Young’s report and proposed testimony — which purport to be scientific, and thus the sort of expert testimony to which the four DaUbert reliability factors apply, see Daubert, 509 U.S. at 592-93 , 113 S.Ct. 2786 — fail to meet any of those four factors. First, Dr. Young’s mechanism has never been tested or studied in human patients, nor has it undergone animal or in vitro 20 testing. (8/19/15 Young Dep. at 137:7-10, 137:22-138:2.) Dr. Young acknowledged that it would be very difficult to test his mechanism because one cannot rule out, using standard techniques, disruption to the endometrial layer or trauma to the stroma upon insertion, yet the absence of such injury is assumed at Step 0 of his theory. (Id. at 159:15-160:20.) Second, Dr. Young’s mechanism has not been “subjected to peer review and publication,” Daubert, 509 U.S. at 593 , 113 S.Ct. 2786 , nor has it been scrutinized by the scientific community, (8/19/15 Young Dep. at 138:3-10). Dr. Young has shared his theory only with lawyers, not with other medical researchers or experts. (8/19/15 Young Dep. at 138:11-17.) Third, Dr. Young’s mechanism has produced no “known or potential rate of error,” Daubert, 509 U.S. at 594 , 113 S.Ct. 2786 , because it has not been tested, (8/19/15 Young Dep. at 137:7-10, 137:22-138:2). Finally, Plaintiffs have not shown that Dr. Young’s proposed mechanism has gained “general acceptance” *430 within the scientific community. Daubert, 509 U.S. at 594 , 113 S.Ct. 2786 . Dr. Young acknowledged that he is unaware of anyone in the scientific community who agrees with his mechanism of perforation, (8/19/15 Young Dep. at 228:16-24), and he only began to investigate his theory in the context of this litigation, (id at 188:8-10, 163:21-164:6). See In re Pfizer Inc. Sec. Litig., No. 04-CV-9866, 2010 WL 1047618 , at *6 (S.D.N.Y. Mar. 22, 2010) (expert testimony regarding mechanism of causation permitted where “deemed plausible and credible in the relevant medical literature”), as amended (Mar. 29, 2010).
Expert testimony developed solely for litigation can weigh against reliability. See Eghnayem v. Bos. Sci. Corp., 57 F.Supp.3d 658, 670 (S.D.W.Va.2014); In re Rezulin, 369 F.Supp.2d at 420, 424 . In addition, although the factors outlined in Daubert are not a “definitive checklist or test,” Daubert, 509 U.S. at 593 , 113 S.Ct. 2786 , “when an expert is offering testimony that is presented as a scientific conclusion and the expert’s method fails to satisfy any of the factors identified in Daubert , a court should pause and take a hard look before allowing a jury to consider it,” In re Methyl Tertiary Butyl Ether (MTBE) Prods. Liab. Litig., 593 F.Supp.2d 549, 564 (S.D.N.Y.2008), on reconsideration in part (June 26, 2008) (emphasis in original). Because Dr. Young’s mechanism does not meet any of the criteria listed in Daubert , the Court carefully scrutinizes Dr. Young’s proposed testimony and concludes that it lacks a reliable methodology.
Expert testimony “must be supported by appropriate validation — i.e., good grounds, based on what is known.” Daubert, 509 U.S. at 590 , 113 S.Ct. 2786 (internal quotation marks omitted). Moreover, an expert, “whether basing testimony upon professional studies or personal experience, [must] employ[] in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co., 526 U.S. at 152 , 119 S.Ct. 1167 . In the scientific community, “[s]cientific methodology ... is based on generating hypotheses and testing them to see if they can be falsified.” Daubert, 509 U.S. at 593 , 113 S.Ct. 2786 . Dr. Young, however, was given a conclusion by lawyers and worked backwards to hypothesize a mechanism by which it might occur. {See Young Report at 2) (“I have been asked to offer an opinion as to the potential mechanisms of secondary perforation of Mirena IUDs.”). No testing of the hypothesis was conducted. This exercise does not seem to have involved any scientific methodology, but rather consisted of reverse-engineering a theory to fit the desired outcome. This does not rise to the level of intellectual rigor employed in the medical or scientific field, see Kumho Tire Co., 526 U.S. at 152 , 119 S.Ct. 1167 , and alone would warrant exclusion. See Faulkner v. Arista Records LLC, 46 F.Supp.3d 365, 381 (S.D.N.Y.2014) (“[M]ethodology ... aimed at achieving one result ... is unreliable, and ... must be excluded.”); In re Accutane Prods. Liab., 511 F.Supp.2d 1288, 1296 (M.D.Fla.2007) (“While [the expert’s] biological theory may be exactly right, at this point it is merely plausible, not proven, and biological possibility is not proof of causation.”); Golod v. La Roche, 964 F.Supp. 841, 860-61 (S.D.N.Y.1997) (“[Although [the expert’s] theory may be biologically plausible, it does not constitute ‘scientific knowledge’ within the meaning of Daubert . Instead, it is, at most, scientifically-grounded speculation: an untested and potentially untestable hypothesis. Although there may be circumstances in which a scientific hypothesis that is, practically speaking, untestable, would nevertheless be admissible, perhaps because of *431 general acceptance in the scientific community, this is not such a case.”). Indeed, “the courtroom is not the place for scientific guesswork, even of the most inspired sort. Law lags science; it does not lead it.” Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996). Dr. Young’s expert testimony is therefore inadmissible.
Furthermore, apart from the requirement that the opinion constitute “scientific knowledge,” as opposed to hypothetical speculation, an expert’s analysis must be “reliable at every step.” Amorgianos, 303 F.3d at 267 . Defendants argue that Dr. Young’s mechanism theory is unreliable because each step requires a “[speculative [l]eap[ ].” (Ds’ Young Mem. 918.) At Steps 1 through 4 of his mechanism, Dr. Young cites studies and publications that he alleges support his theory of the mechanism for secondary perforation. A closer look, however, shows that Dr. Young draws impermissibly speculative conclusions from these studies that “exceed the limitations the authors themselves plaee[d] on the[se] studfies].” In re Accutane Prods. Liab., No. 04-MD-2523, 2009 WL 2496444 , at *2 (M.D.Fla. Aug. 11, 2009), aff'd, 378 Fed.Appx. 929 (11th Cir.2010).
As part of Step 1 of his mechanism, Dr. Young opines that the IUD embeds into the uterine wall — the myometri-um — after, and unrelated to, insertion. (Young Report at 11-12.) Dr. Young says this is possible due to the uterus’s reaction to the IUD, a foreign body, being inside it, and the effect of LNG on the uterus. (Id.) Dr. Young relies on the Phillips study 21 to bolster his argument that a FBR takes place when an IUD is present in the uterus, (Young Report at 12), and cites to several studies that discuss the effects of LNG on the endometrium, (id. at 11-12; see Compendium Exs. 4, 6, 17, 18). 22 As Dr. Young conceded at his deposition, however, none of these studies, including Phillips, discusses effects that LNG might have on the myometrium, the layer of muscle beyond the endometrium through which an IUD must puncture for perforation and migration to occur. (See Young Report at 11-12; 8/19/15 Young Dep. at 182:7-21.) The distinction matters because, by his own account, the endometri-um and myometrium are distinct anatomical features: the former is a “thin layer,” (Young Report at 4), composed of “glandular tissue,” (8/19/15 Young Dep. at 112:15— 20), whereas the later is a 1.3-2 cm layer made up of muscular tissue, (id. at 112:2-14). Moreover, during his deposition Dr. Young could not point to an article or study that supported the notion that LNG has a foreign body effect on the myometri-um as opposed to the endometrium, (id. at 187:4-188:2; 191:22-194:1), and conceded that he was not aware of any evidence that LNG thins the myometrium, (id. at 114:9-11). Dr. Young opines, without explanation or analysis, that “[a]ny inflammation of the endometrium is going to extend into the myometrium,” based on the small distance (5 microns) and shared blood supply between the two. (Id. at 182:11-21.) He does not explain why this proximity means that an outer layer, made of muscle, will react the same way as an inner layer, made of a different type of tissue, to the presence of a hormone in the cavity the inner layer surrounds. This type of speculation, whereby the conclusions are linked to studies only by Dr. Young’s say-so, is *432 impermissible under Daubert. See Joiner, 522 U.S. at 146 , 118 S.Ct. 512 (where opinion “is connected to existing data only by the ipse dixit of the expert,” the “court may conclude that there is simply too great an analytical gap between the data and the opinion proffered”); see also McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1244-1245 (11th Cir.2005) (“The conclusions that [the expert] draws about ephedrine by analogy ... are very important to his opinions, but he did not show the reliability of each of his steps in deducing Metabolite's toxicity from this analogy. This is a fatal defect under Daubert.”). 23
Additionally, another important piece of Step 1 of Dr. Young’s theory is his conclusion that uterine cells grow around the IUD, or “remodel,” to attach it to the uterine wall. (8/19/15 Young Dep. at 172:10-173:8; Young Report at 11.) Dr. Young, however, disavowed the one article he cited to support this claim, and said that it does not actually support that proposition, (8/19/11 Young Dep. at 172:7-21, 177:24-178:2), and could not point to another study showing that uterine cells will grow around an IUD like Mirena, (id. at 172:22-173:20.) Dr. Young testified that he relied on two articles mentioned in his CV involving laboratory studies of cell growth on scaffolding. (Id. at 173:21-175:6.) Dr. Young’s report does not dis.cuss these studies, and during his deposition he did not explain why the growth of cells in these studies lends support to his theory that presence of an IUD leads to cell growth around it in the uterus. Indeed, he conceded that there are no studies that would support analogizing the two. (Id. at 176:13-22.) Dr. Young’s analysis in this regard does not rise to the level of intellectual rigor generally seen in the scientific community, and thus does not meet the requirements of Rule 702 and Daubert .
Step 2 of Dr. Young’s theory refers to penetration of the IUD into the uterine wall to a deeper level than embedding, a process helped by a softening in connective tissue due to the increased presence of LNG in the uterus. (Young Report at 13.) Dr. Young primarily relies on G.S. Anthony et al., Forces Required for Surgical Dilatation of the Pregnant and Non-Pregnant Human Cervix, 89 British J. Obstetrics & Gynaecology 913 (1982), (Compendium Ex. 2) (“Anthony study”), for the proposition that progestins such as LNG weaken uterine tissue. The authors of this study were analyzing the force required to dilate the cervix. The study specifically found no direct correlation “between circulating levels of [progesterone] and the cervical resistance in non-pregnant or early pregnant subjects.” (Id. at 915.) Despite this finding that seemingly contradicts the proposition for which he cites it, Dr. Young believes this study supports his theory because the authors state that the study found “patients receiving Depo-Provera showed a significantly lower level of cervical resistance ... than did the cycling group.” (Id. at 915.) Depo-Provera — a birth control shot that contains a progestin — is a different contraceptive than Mirena. The Anthony study did not attribute the weakening effect of Depo-Provera to progestin, and in fact *433 noted that another progestin-containing contraceptive (the combined oral contraceptive pill) had no such effect. (Id.) To conclude that Mirena would cause the same effect as Depo-Provera because they both contain progestin — particularly when other contraceptives also containing pro-gestin had the opposite effect, the effect of Depo-Provera was not attributed to pro-gestin, and the study found no correlation between progestin levels and that effect— is to impermissibly draw grossly “overreaching conclusions,” In re Accutane, 2009 WL 2496444 , at *2, which are connected solely to the data by Dr. Young’s say-so, see Joiner, 522 U.S. at 146 , 118 S.Ct. 512 ; see also Dunn v. Sandoz Pharm. Corp., 275 F.Supp.2d 672, 681 (M.D.N.C.2003) (“[Expert’s] assertion that because bromocriptine is an ergot alkaloid and may behave like other ergot alkaloids and cause vasoconstriction simply does not support the proposition that Parlodel causes stroke in postpartum women. Opinions merely expressing ‘possibilities’ do not suffice to support the admissibility of expert testimony.”) (citing Saldana v. Kmart Corp., 260 F.3d 228, 234 (3d Cir.2001)).
Moreover, at the end of his Step 2 analysis, Dr. Young acknowledges that LNG actually decreases the strength and frequency of uterine contractions, but argues that because they are not eliminated entirely, they still contribute to embedment. (Young Report at 13.) But he does not account for this diminishing effect in his analysis. “[A]ny theory that fails to explain information that would otherwise tend to cast doubt on that theory is inherently suspect.” In re Rezulin, 369 F.Supp.2d at 425 . The extrapolations and inferences Dr. Young makes at Step 2 of his analysis are just too speculative to suffice under Daubert .
At Step 3 of his analysis, Dr. Young relies in part on the Goldstuck study, supra note 14, to show that uterine contractions have sufficient force to penetrate the uterine wall. (Young Report at 14-15.) Although Goldstuck presents evidence relating to the force of uterine contractions in connection with an IUD, Dr. Young conceded that there were errors in the study’s methods and findings. (8/19/15 Young Dep. at 304:6-307:5.) He said an important value for measuring uterine contractions that the authors of Goldstuck attributed to another article did not actually appear in that other article, and described the Goldstuck authors as being “disingenuous.” (Id. at 304:15-305:11.) Nevertheless, Dr. Young continued to rely at least in part on the numbers generated by Goldstuck and said, without further explanation, that the author’s errors “made in one way tended to counterbalance other errors that [the author] made.” (Id. at 305:19-306:20.) Dr. Young seems to have performed some sort of calculation of his own to mitigate the errors he found in Goldstuck, (see id. at 303:4-8, 306:13-307:5, 318:10-323:5), but these calculations do not appear in his report nor were they apparent during his deposition. When asked to explain where he got some of the figures he used in that calculation, Dr. Young cited “just kind of my experience working with pregnant and nonpregnant tissue and just in terms of contractility of uterine tissue,” (id. at 320:23-321:2), and said that he derived these calculations from his “experience and talking with the people who have done the research, [who] seem to be getting those values,” (id. at 324:1-10.) 24 *434 This does not rise to the level of intellectual rigor of medical or scientific study, rendering this opinion unreliable. See Joiner, 522 U.S. at 146, 118 S.Ct. 512 ; In re Rezulin, 369 F.Supp.2d at 434 .
As in Step 2 of his theory, Dr. Young again does not account for the fact that Mirena actually decreases the strength and frequency of uterine contractions, even though he acknowledged that Gold-stuck did not involve uterine contractions in women with Mirena, further underscoring his unreliable methodology. See Rezulin, 369 F.Supp.2d at 425 . Dr. Young ultimately concludes that the contractile force of Mirena is 390'lbs/in2, which is sufficient to penetrate uterine tissue “compared to the amount of force required to penetrate heart muscle ... which is approximately ... 290 lbs/ in2.” (Young Report at 15.) The article that Dr. Young cited for the 290 figure involved a study of pig hearts, which Dr. Young said was an appropriate equivalent because he had “felt a lot of uteruses that ha[d] been taken out at the time of hysterectomy, and it feels remarkably like the pig hearts that my grandmother used to buy when I was a kid. So the softness of these two tissues are very similar.” (8/19/15 Young Dep. at 291:15-24.) 25 Such a subjective comparison of muscle of a pig heart to a female uterus creates “simply too great an analytical gap between the data and the opinion proffered” to pass muster under Rule 702 and Daubert. Joiner, 522 U.S. at 146, 118 S.Ct. 512 . But beyond that, Dr. Young corrected himself that it was chicken hearts he had felt as a child, and that he had no basis for comparing uterine tissue to pig hearts. (8/19/15 Young Dep. at 292:21-293:6.) So that aspect of Dr. Young’s testimony is not even connected to the data by ipse dixit. See Joiner, 522 U.S. at 146, 118 S.Ct. 512 .
iv. Assisting the Trier of Fact
In light of their failure to meet the Daubert factors, absence of methodology, reverse reasoning and analytical gaps, Dr. Young’s general causation opinions do not have sufficient indicia of reliability to pass muster under Daubert , and therefore they would not be helpful to a jury.
b. Causation Opinion in Danley
Dr. Young has also authored a case-specific causation opinion for Plaintiff Jennifer Danley, which Defendants move to exclude as contradictory and unreliable. Defendants also argue that because Dr. Young has not given a general causation opinion, or relied on another expert’s general causation opinion, he may not give a specific causation opinion. (Ds’ Young Mem. 20-21.) The records show that Ms. Danley’s Mirena was inserted on June 29, 2011. (Cook Young Decl. Ex. I.) An ultrasound was performed to check the position of the Mirena immediately following placement, and the technician noted that the IUD was seen “HIGH/RT.” 26 (Id. Ex. J.) On January 3, 2013, Ms. Danley went to her healthcare provider after she had a positive home pregnancy test. (Id. Ex. M.) On January 8, 2013, an X-ray was performed that revealed Ms. Danley’s IUD was located “overlying the left lilac bone.” *435 (Id. Ex. N.) On January 23, 2013, Ms. Danley’s Mirena was removed by a “diagnostic laparoscopy.” (Id. Ex. 0.)
i. Opinions
Dr. Young opines that Ms. Danley’s second Mirena was inserted on June 29, 2011 without complications and the Mirena was correctly located within the uterine cavity. (Young Danley Report at 2.) He concludes that Ms. Danley did not experience symptoms at the time of or immediately after insertion that would suggest that perforation occurred at that time. (Id.) He also opines that an IUD has little or no contraceptive effect if it is located outside the uterine cavity, and notes Ms. Danley did not become pregnant until 18 months after insertion. (Id.) Dr. Young reasons that had Ms. Danley’s uterus been perforated at the time of insertion, resulting in the Mirena’s placement directly into the abdominal cavity, it “is unlikely it would have taken 18 months for her to become pregnant.” (Id.) Dr. Young thus concludes that the Mirena entered Ms. Danley’s abdominal cavity during the fall of 2012 due to secondary perforation, requiring an abdominal laparoscopy to remove the- Mire-na, which she would not have otherwise needed. (Id.)
ii. Lack of General Causation
Defendants argue that Dr. Young’s specific causation is inadmissible because in his report on Ms. Danley, Dr. Young did not give a general causation opinion or rely on another expert’s general causation opinion. (Ds’ Young Mem. 20-21.) “ ‘General causation is whether a substance is capable of causing a particular injury or condition in the general population, while specific causation is whether a substance caused a particular individual’s injury.’ ” In re Rezulin, 369 F.Supp.2d at 402 (quoting In re Breast Implant Litig., 11 F.Supp.2d 1217, 1224 (D.Colo.1998)). 27 In the absence of evidence of general causation, evidence of specific causation is “irrelevant.” In re Rezulin Prods. Liab. Litig., 441 F.Supp.2d 567, 578 (S.D.N.Y.2006). 28 “[A] physician must have some reliable basis for believing that a particular substance is capable of causing the injury in question in relevant circumstances before concluding that the substance caused that injury in a particular case.” In re Rezulin, 369 F.Supp.2d at 438 . 29 Although *436 Dr. Young did not cite his mechanism theory for secondary perforation in his specific causation report, during his deposition he stated that he believed the “transmigration of [Ms. Danley’s] IUD occurred through [his] mechanism” and that the four steps of his mechanism occurred in Ms. Danley’s case. (Cook Young Decl. Ex. D, 8/20/15 Deposition of Dr. Roger C. Young (“8/20/15 Young Dep.”), at 472:17-473:3.)
But because I have found that Dr. Young’s general causation opinion is not based on a reliable methodology and is therefore inadmissible, his specific causation must also be excluded. See In re C.R. Bard, Inc., 948 F.Supp.2d at 605 (“[Expert’s] specific causation opinions are based on her general causation opinions. In other words, her opinion as to each bellwether plaintiff is that the plaintiff suffered nerve injuries through one or both of the general causation mechanisms ... Because I found that [the expert’s] general causation opinions are not based on reliable methodology and principles, her specific causations opinions — based on her general causation opinions — should also be excluded.”); Rezulin, 441 F.Supp.2d at 578 (excluding experts’ specific causation opinions for failing to offer opinions as to general causation). Dr. Young’s specific causation opinion is therefore inadmissible on this ground. 30
iii. Reliability
In any event, in addition to being inadmissible because of lack of evidence of general causation, Dr. Young’s methodology in reaching his conclusion that Ms. Danley experienced a secondary perforation of her Mirena is not based on a reliable methodology, warranting exclusion under Daubert . Dr. Young relies on the ultrasound that was taken following the insertion of Ms. Danley’s Mirena and a lack of any post-insertion symptoms to conclude that the Mirena “was correctly located within the uterine cavity at this time.” (Young Danley Report at 6.) That the IUD was in the uterine cavity, however, does not mean there was no injury upon insertion (whether from a sound, the inserter or the IUD). Further, Dr. Young acknowledged that 2D ultrasound cannot rule out the embedment of an arm of the *437 IUD in the myometrium, (8/19/15 Young Dep. at 168:6-17), and that many perforations are asymptomatic, (8/20/15 Young Dep. at 431:13-15). Dr. Young concludes that in Ms. Danle/s case it is more likely than not that secondary perforation occurred without explaining why hers is unlikely to be a case where 2D ultrasound missed an injury or where injury occurred without symptoms. This say-so does not rise to the level of reliability required under Rule 702 and Daubert .
Moreover, Dr. Young opines that Ms. Danley became pregnant in late 2012 because the Mirena was in place (producing its contraceptive effects) until it perforated her uterus at that time, but he fails to account for or consider alternative evidence that could explain why Ms. Danley did not become pregnant sooner. For example, Dr. Young admitted that he would not know whether Ms. Danley and her husband were having intercourse while Ms. Danley was ovulating. (Id. at 424:1-9.) Ms. Danley also used condoms as birth control from 2003 to 2013, which would include the time her second Mirena was implanted. (Cook Young Deck Ex. P, at JDanley-PFS-000080; Cook Young Decl. Ex. L, Deposition of Jennifer Danley (“J. Danley Dep.”), at 132:10-12.) Ms. Danley was also breastfeeding her baby for seven months following the insertion of her second Mirena, (J. Danley Dep. at 200:8-15), which Dr. Young acknowledged would have “some contraceptive effect,” although Dr. Young said the effect would not be “total,” (8/20/15 Young Danley Dep. at 426:10-15). Dr. Young also acknowledges that if an IUD’s drug reservoir is still within the myometrium it would have some reduced contraceptive effect, although he claims, without explanation, that this was not the case for Ms. Danley, (id. at 428:21-429:6), even though, according to him, it could take “[d]ays or weeks to years” for an IUD to penetrate into the uterine wall to a deeper level than embedding, (Young Report at 11). Dr. Young’s failure to give “reasonable explanation^]” for discounting or dismissing these alternative possibilities for why Ms. Danley did not become pregnant for 18 months undermines the reliability of his opinions. See Deutsch, 768 F.Supp.2d at 474 (“[E]ven though ‘an expert need not rule out every potential cause in order to satisfy Daubert , the expert’s testimony must at least address obvious alternative causes and provide a reasonable explanation for dismissing specific alternative factors identified by the defendant.’ ” (quoting Israel v. Spring Indus. Inc., 98-CV-5106, 2006 WL 3196956 , at *5 (E.D.N.Y. Nov. 3, 2006)).
Defendants’ motion to exclude Dr. Young’s proposed testimony regarding secondary perforation in the case of Ms. Danley is thus granted.
For the reasons stated above, Defendants’ motion to exclude the proposed testimony and opinions of Dr. Young in their entirety is GRANTED.
2. John Jarrell, Ph.D., P.E.
Defendants move to exclude the expert testimony of John Jarrell, Ph.D., P.E. on the grounds that he is not qualified to opine on the effects of LNG on the uterus, the “sharpness” of Mirena, or IUDs in general. (Memorandum of Law in Support of Defendants’ Motion to Exclude the Testimony of John Jarrell, Ph.D., P.E. (“Ds’ Jarrell Mem.”), (Doc. 2680), 3-7.) Defendants also move to exclude Dr. Jar-rell’s testimony on the grounds that it is unreliable and irrelevant. (Id. at 2-3.) 31 *438 For the reasons stated below, Defendants’ motion to exclude Dr. Jarrell’s testimony is GRANTED.
a. Opinions
Dr. Jarrell offers five opinions in his expert report. (Cook Jarrell Decl. Ex. B, General Expert Report of John D. Jarrell, Ph.D., P.E. (“Jarrell Report”), at 3-4.) First, Dr. Jarrell opines that the hormone that Mirena releases into the uterine cavity, LNG, causes a thinning of the endome-trium, the inner layer of the uterine wall. Second, Dr. Jarrell says the tips of the arms of the Mirena (the ends of the top of the “T” shape of the plastic device) are relatively sharp when compared to the smoother, adjacent surfaces of the Mirena. Third, he opines that although the Mirena generally has flexible arms, these arms become stiff and rigid when loaded in “constrained conditions,” causing the device to transfer pressures to the uterus in response to contractions, leading to necrosis (or dead tissue), embedment, and sometimes perforation. Fourth, Dr. Jarrell states that pressure on uterine tissue, generated by uterine contractions, and the presence of a rigid Mirena, create sufficient force to lead to the rapid development of pressure wounds and injury to cells. Finally, Dr. Jarrell opines that an inflammatory response and FBR occurs when polyethylene and silicone polymers (synthetic materials found in Mirena) come in contact with “compromised tissues,” enhancing damage and accelerating erosion in the uterus, and thus increasing the potential for migration. (Id. at 3-4.) In addition, during his deposition Dr. Jarrell opined that he found a manufacturing defect in the Mirena that he tested. (Jarrell Dep. at 190:18-191:12,196:24-197:3.)
b. Qualifications
Dr. Jarrell is a “multi-discipline engineer specializing in the analysis of complex designs and failures involving materials; mechanical and biological systems.” (Jarrell Report at 1.) Dr. Jarrell is “actively involved in engineering analysis, design, product development and research.” (Id.) Dr. Jarrell has Bachelor’s and Master’s of Science degrees in Materials Science and Engineering, as well as a Doctorate in Biology, Medical Science and Engineering from Brown University. (Declaration of Diogenes P. Kekatos in Opposition to Defendants’ Motion to Exclude the Testimony of John Jarrell, Ph.D., P.E. (“Kekatos Jar-rell Deck”), (Doc. 2775), Ex. A, Jarrell Report app. B (“Jarrell CV”), at 1.) He has authored “multiple peer-reviewed publications and abstracts on materials, toxicity, cell interactions with materials, bioma-terials, implants and coatings and a guide book on materials selection, friction and wear for medical device designers.” (Jar-rell Report at 2.) In addition, Dr. Jarrell has U.S. and foreign patents covering “ac *439 tive biomaterials, siloxane and metal oxide composites, active delivery and medical applications.” (Id.)
Although Dr. Jarrell seems to be an accomplished and experienced biomedical engineer — he has experience in certain biomaterials and implants — he has no previous experience with IUDs or hormonal contraception like Mirena. (Jarrell Dep. at 84:7-85:8.) 32 Nor does he have any particular familiarity with the anatomy of the uterus. (Id. at 75:16-77:11 (Dr. Jar-rell’s “training in uterine anatomy” occurred in connection with Mirena and mesh litigation).) Dr. Jarrell’s experience in engineering and biomaterials perhaps qualifies him to opine on a mechanism by which a Mirena might perforate a uterus, see In re Zyprexa, 489 F.Supp.2d at 282 , but he is not qualified to opine on the effects of LNG on the uterus because he is not a medical doctor nor does he • have relevant experience or expertise in hormonal contraception or the effects of hormones on uterine tissue. Dr. Jarrell’s only experience with LNG comes from reviewing a number of articles supplied to him by Plaintiffs’ counsel, which Dr. Jarrell subsequently copied and pasted into his expert report. (Jarrell Report at 14-18.) 33 This is not the level of rigor an expert in the field would apply and does not pass muster under Daubert. See Mancuso v. Consol. Edison Co. of N.Y., 967 F.Supp. 1437, 1443 (S.D.N.Y.1997) (finding expert unqualified because he relied on counsel to supply him with relevant scientific literature and “subsequently attempted, with dubious success, to qualify himself as [an expert] by a selective review of the relevant literature”); see also Prohaska v. Sofamor, S.N.C., 138 F.Supp.2d 422, 437 (W.D.N.Y.2001) (criticizing “litigation-driven expertise” where expert “relied upon the plaintiffs attorney to provide him with the relevant scientific literature”); cf. Arista Records LLC v. Lime Grp., LLC, No. 06-CV-5936, 2011 WL 1674796 , at *17 (S.D.N.Y. May 2, 2011) (allowing expert where conclusions were “not based on a selective review of a limited universe of sources strictly for the purposes of preparing to testify”).
c. Reliability
Although Dr. Jarrell is not qualified to opine on alleged thinning effects of LNG on the endometrium, see Amorgianos, 303 F.3d at 267 (expert testimony inadmissible if any step in the analysis is unreliable), assuming he would rely on Plaintiffs’ other experts for that proposition or that he does not intend to opine on this issue at trial, 34 the Court assesses the reliability of the subsequent steps of his analysis, and concludes that they do not have sufficient indicia of reliability under Daubert. See Joiner, 522 U.S. at 146 , 118 S.Ct. 512 (“[N]othing 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.”).
*440 i. Relative Sharpness of Mirena
Dr. Jarrell opines that the “tips of the Mirena arms contain relatively sharp edges compared to the smoother adjacent surfaces, based on [his] inspection under microscopy and with metrology.” (Jarrell Report at 18.) The substance of Dr. Jar-rell’s “experiment” seems to have consisted of him squeezing a Mirena with a .gloved hand and determining, based on his own tactile senses, that the tips are “relatively sharp” “compared to the smoother surfaces that are adjacent to the tips.” (Jarrell Dep. at 185:20-187:5.) Dr. Jarrell based this opinion on his “inspection and handling of the exemplar Mirena” during which time he observed “relatively sharp edges.” (Jarrell Report at 18.) Dr. Jar-rell relied primarily upon his own senses to determine the Mirena was “sharp” and compared it to itself, not to other IUDs (or even to other Mirenas to potentially argue that one Mirena in particular was sharper than others). This is not scientific and does not amount to rehable expert testimony. See In re C.R. Bard, Inc., 948 F.Supp.2d at 604-05 (general causation-opinion precluded when it was “based on nothing more than [the expert’s] personal, unscientific observation and opinion that ‘it’s obvious’ that mesh arms are sharp and can serrate or tear nerves” and finding such testimony to be “the type of subjective, conclusory approach that cannot reasonably be assessed for reliability and that Rule 702 is designed to exclude”) (internal quotation marks omitted); In re Rezulin, 309 F.Supp.2d at 544 (finding that allowing experts “to tender purely subjective views in the guise of expert opinions” would “border on the absurd”). Dr. Jarrell admitted at his deposition that individuals’ opinions as to whether the Mirena feels sharp could differ. (Jarrell Dep. at 188:12-20.) Dr. Jarrell was also unable to cite support, peer-reviewed or otherwise, that backs his theory that the Mirena IUD is sharp. (Jarrell Dep. at 184:22-185:2.) Dr. Jarrell’s methodology is devoid of objective standards that can be tested by others. Dr. Jarrell’s experiment has not been peer-reviewed or recreated in any other testing. See Daubert, 509 U.S. at 593-94 , 113 S.Ct. 2786 . It cannot be recreated or reviewed because he provides no standards by which he measured sharpness. Further, it was prepared solely for litigation, which by itself does not warrant exclusion, but weighs against reliability of an expert’s testimony. See In re Rezulin, 369 F.Supp.2d at 420 (courts may consider “whether an expert’s opinion was developed for litigation,” in addition to the four Daubert factors).
Plaintiffs try to salvage Dr. Jarrell’s opinions by pointing out that Dr. Jarrell performed “tactile analysis and evaluation” and “direct observation,” which they argue are “generally accepted methods used by experts in [Dr. Jarrell’s] field.” (Ps’ Jar-rell Opp. 13-14.) The quoted language apparently refers to Dr. Jarrell touching and looking at the Mirena, something the jury is capable of doing itself. 35 See Andrews v. Metro N. Commuter R.R. Co., 882 F.2d 705, 708 (2d Cir.1989) (expert testimony inadmissible if directed to “lay matter which a jury is capable of understanding and deciding without the expert’s help”). To support their argument that feeling an item is a reliable methodology, Plaintiffs cite a 1901 article with advice on how a surgeon should sharpen instruments. (Allen DeVilbiss, Care & Use of Instruments, 36 J. Am. Med. Ass’n 1099 (1901), Cook Jarrell Decl. Ex. F). While *441 this article does advise that the surgeon feel his instruments to see if they are sharp, the article nowhere suggests that doing so is a scientific exercise or otherwise indicates that touching an item would provide sufficient scientific rigor for expert testimony or is otherwise generally accepted as a method for engineers. Plaintiffs also cite the Mirena specifications as well as a long report on a copper IUD, neither of which assist them in addressing the entirely subjective and non-scientific nature of Dr. Jarrell’s “squeeze test.” 36 Because it does not bear indicia of reliability under Daubert , Dr. Jarrell will not be allowed to opine about the relative sharpness of the Mirena.
ii. In Vitro Mechanical Testing of Mirena
Dr. Jarrell also gives an opinion that the “Mirena design has generally flexible arms” but that they “become very stiff when loaded in constrained conditions,” which “causes the device to become very rigid at the tips, allowing the device to transfer high forces and pressures to the tissues in response to uterine contractions leading to tissue necrosis, embedment and in some instances, perforation and migration.” (Jarrell Report at 22.) Dr. Jarrell described a “constrained condition” as eor-responding to the top of the Mirena arms contacting the top of the fundus (the top portion of the uterus opposite the cervix) and the tips of the arms contacting the adjacent uterine surface. (Id.) Although Dr. Jarrell says the Mirena has “generally flexible arms,” he says that in a constrained position the arms are unable to flex and became much stiffer. (Id.) To measure the forces they transfer to uterine tissue in that position, he tested a Mirena in laboratory equipment apparently intended to mimic the uterus. (Id. at 10-11, 22.) Dr. Jarrell used double-sided tape to affix the tips of the Mirena’s arms to an “abutting block” across the top of the arms to apply pressure to the Mirena and hold it in place. (Id. at 11; Jarrell Dep. at 234: 2-14.)
Dr. Jarrell’s constrained testing conditions do not reliably replicate the conditions inside a woman’s uterus, and therefore render his methodology and the conclusions he draws from it unreliable. Dr. Jarrell admitted at his deposition that he did not have any basis to suggest that the way the Mirena became rigid in his experiment occurs in vivo (inside a human being). (Jarrell Dep. at 228:23-229:2, 318:10-14.) 37 Obviously, no *442 tape is used to affix the tips of the Mirena to the sides of the uterus — indeed, they are not affixed at all — and obviously the top of the arms does not meet the soft fundus the way it was pressed against the metal abutting block. This creates “too great an analytical gap between the data and the opinion proffered.” Joiner, 522 U.S. at 146 , 118 S.Ct. 512 ; see Winebarger v. Bos. Sci. Corp., No. 13-CV-28892, 2015 WL 1887222 , at *17 (S.D.W.Va. Apr. 24, 2015) (testing that produced certain results at very high temperatures that could not be replicated in human body, “without [expert] providing any explanation or support for his opinion,” did not fit facts of case and was therefore irrelevant and unhelpful). It seems apparent that without affixing the tips of the arms to the pressure plates of his apparatus and pressing down on the tops of the arms with a hard surface, Dr. Jarrell could not obtain the force numbers he needed for his theory, so he used that method despite an absence of correlation to any real-life conditions. This strikes the Court as exactly the sort of unreliable “science” the Daubert test was intended to weed out. See In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prods. Liab. Litig., No. 14-MN-2502, 145 F.Supp.3d 573, 588 , 2015 WL 7422613, at *12 (D.S.C. Nov. 20, 2015) (excluding testimony where expert “played around” with various scenarios until desired result was reached).
Similarly, Dr. Jarrell’s manual pressure plate testing, which he utilized to get a “numerical value” for the forces that the Mirena’s arms could resist, (Jarrell Dep. at 223:20-224:19), also does not satisfactorily replicate conditions inside a uterus as it appears Dr. Jarrell held the Mirena and pushed it against the pressure plate. 38 Dr. Jarrell does not provide a convincing explanation for why his in vitro experiment is a suitable replica for a uterus, and therefore there is too great of an analytical gap between his mechanical testing and the environment inside a woman’s uterus, making his testimony both unreliable and unhelpful to a jury. See Joiner, 522 U.S. at 146 , 118 S.Ct. 512 .
Defendants also criticize Dr. Jarrell’s report and proposed testimony because his mechanical test has not been tested by others, let alone peer reviewed, and he does not cite other support for his methodology or conclusions. (Ds’ Jarrell Mem. 13-14.) Although peer-review and studies supporting a methodology are not always necessary, see Kumho Tire Co., 526 U.S. at 156 , 119 S.Ct. 1167 , here these factors, when added to the unreliability of Dr. Jarrell’s in vitro mechanical testing, further weaken the reliability of Dr. Jarrell’s experiment. See Daubert, 509 U.S. at 593 , 113 S.Ct. 2786 . Plaintiffs’ broad claims that engineers are qualified to opine generally on mechanisms and their citation to the Reference Manual on Scientific Evidence are unavailing. See McClain, 401 F.3d at 1244 (finding expert testimony speculative and inadmissible when based upon “broad principles of pharmacology”); Moore v. Ashland Chem. Inc., 151 F.3d 269, 276 (5th Cir.1998) (“The expert’s assurances that he has utilized generally accepted scientific method *443 ology is insufficient.”)- 39 Moreover, although Dr. Jarrell’s experiment may be reproducible, this does not alleviate the unreliability caused by the fact that the testing conditions were unlike those present in a uterus.
In addition, Defendants argue that Dr. Jarrell’s report and testimony are unreliable because his mechanical testing amounted to an ad hoc test with no written protocol. (Ds’ Jarrell Mem. 14-15.) Although not necessarily dispositive, the fact that Dr. Jarrell did not have a written protocol prior to testing the Mirena, (Jarrell Dep. at 56:13-17) — he apparently created it after the fact, a short time before his deposition, (id. at 133:25-184:22) — again weighs against admissibility. See Hall v. Bos. Sci. Corp., No. 12-CV-8186, 2015 WL 868907 , at *12 (S.D.W.Va. Feb. 27, 2015) (noting expert’s “failure to adhere to testing standards or a written protocol” in finding methodology unreliable). Dr. Jarrell’s mechanical testing of the Mirena is not sufficiently reliable to withstand Daubert scrutiny, and he may not opine on this topic,
iii. Pressure Wound Theory
Without his force calculations, Dr. Jar-rell cannot opine that Mirena transfers enough force to cause pressure wounds. Putting that aside, however, there are other problems with his proposed pressure-wound testimony.
Dr. Jarrell opines that “[s]us-tained pressures between human tissues and rigid objects can lead to the rapid development of pressure wounds” and that “[t]he rigidity and geometry at the tips of the Mirena and pressures generated by uterine contractions are sufficient to cause rapid degradation to soft tissues.” (Jarrell Report at 24.) He also finds that “[a]n inflammatory response and foreign body reaction occurs when polyethylene (and silicone polymers) come in contact with compromised tissues and during embedment and migration,” which “enhances damage and breakdown of surrounding tissues and accelerates erosion and perforation of tissues, enhancing the potential for migration.” (Id. at 29.) Dr. Jarrell, albeit a qualified and impressive engineer, is not qualified to opine on pressure wounds in the uterus based on studies and patent filings he has read. (Id. at 29-32). In his report, to support his pressure wound opinion, Dr. Jarrell quotes portions of a study “evaluating] uterine and serum concentrations of LNG,” (id. at 29), a patent filing by Bayer stating the shape of an IUD should have “ blunt surfaces and gentle curves,” (id. at 31) (emphasis in original), and two articles that relate to a foreign body response and host reactions, (id. at 31-32). Dr. Jarrell does not offer any analysis as to why these sources support his pressure wound theory or tie them to Mirena, nor has he the relevant expertise to undertake such an analysis See Ellis v. YMCA Camp Mohawk, Inc., 615 Fed.Appx. 697, 698 (2d Cir.2015) (“Federal Rule of Evidence 702 requires expertise based on specialized knowledge and experience, not a mere understanding derived *444 from others’ publications.”). Dr. Jarrell is not a physician nor does he claim to have clinical experience with IUDs. (Jarrell Dep. at 75:3-6, 75:16-18, 82:23-83:5, 84:7-24.) His Ph.D. in biology, medical science and engineering and his research in bioma-terials do not suffice to render him an expert in how the uterus responds to the presence of Mirena.
Furthermore, because Dr. Jarrell had never heard of perforation before being contacted about this case, it is safe to say his theory of IUD perforation was created for purposes of this litigation. (Jarrell Dep. at 85:5-8.) Although a methodology or experiment that is created for litigation does not automatically require exclusion, such an origin is a factor in assessing reliability. See In re Rezulin, 369 F.Supp.2d at 420 (listing whether an expert’s opinion was developed for litigation as factor for consideration in Daubert analysis); see also Amorgianos, 137 F.Supp.2d at 190-91 (excluding experts after finding that they had not “tested [the] hypothesis in any way or subjected it to peer review. Instead, plaintiffs experts have aired their hypothesis only in the courtroom and have elected not to share their ideas on this subject with their peers in the medical and industrial hygienic communities.”). Here, Dr. Jarrell had very limited experience and exposure to IUDs prior to this litigation, and drafted his report based upon at least one important study (Goldstuck, see swpra note 14) that he received from Plaintiffs’ counsel and of which he had not heard before being retained. (Jarrell Dep. at 266:1-11.) This is not the level of academic rigor that would be expected of an engineer or doctor in the field. In addition, Dr. Jarrell’s pressure wound hypothesis has not been tested or peer reviewed, (Id. at 295:19-296:3), and Dr. Jarrell does not point to any convincing evidence of acceptance within the scientific community. See Golod, 964 F.Supp. at 860 (excluding an expert because his theory did “not constitute ‘scientific knowledge’ within the meaning of Daubert . Instead, it is, at most, scientifically-grounded speculation: an untested and potentially untestable hypothesis.”). 40
Plaintiffs argue in their Opposition that the Zakin study 41 shows that Dr. Jarrell’s pressure-wound theory is supported within the scientific community. (Ps’ Jarrell Opp. 21.) That study, however, appears to discuss pressure necrosis from an already-embedded IUD, not secondary perforation as Plaintiffs posit in this case. More fundamentally, even assuming the Zakin study could lend some support to Dr. Jarrell’s theory, Dr. Jarrell does not cite this study in his report, nor is it on his list of documents on which he relied. (Kekatos Jarrell Decl. Ex. A app. A.) It is not the district court’s purview to analyze the validity of the expert’s conclusions based on the universe of scientific knowledge, but rather to determine whether the expert’s methodology was reliable and stands up to the intellectual rigor of the expert’s field. See Kumho Tire, 526 U.S. at 152 , 119 S.Ct. 1167 . That, unbeknownst to the expert, a study exists that may support his conclusions does not render his methodology any stronger.
*445 Defendants also argue that Dr. Jarrell’s opinion is unreliable because he based his opinion on uterine contractions on studies of women not using Mirena or a similar progestin-releasing IUD. (Ds’ Jarrell Mem. 17-19.) Although this by itself might not warrant exclusion if there were a scientific basis for applying these studies to women using Mirena, fatal to Dr. Jar-rell’s opinion is his inability to even explain why these studies would be applicable to Mirena users. When asked where he got the baseline number measuring force of uterine contractions, Dr. Jarrell stated, “I had to look at the existing literature to get from an engineering standpoint the ranges of pressures that I could use for calculations, so these were the numbers that were available in the published literature.” (Jarreü Dep. at 268:12-23). Dr. Jarrell acknowledged that those figures arose from a study of women not using Mirena, (id. at 268:8-11), and that he did not know how use of a Mirena would affect them, (id. at 269:9-11 (“How a Mirena influences those [numbers], I didn’t see the literature giving me numbers of that.”); see id. at 269:14-15 (“If I had those numbers, I would have used them.”); id. at 292:18-19 (“I don’t know what the pressures are under Mirena.”)). His lack of access to reliable data does not justify use of unreliable data, and militates against admission under Daubert. See In re Rezulin, 369 F.Supp.2d at 426 (“A crucial consideration in evaluating the admissibility of expert testimo

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/7236890. Public record. Not legal advice.