In re Mirena IUD Products Liability Litigation (169 F. Supp. 3d 396, 2016)

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 defect and negligence, and are seeking punitive damages.

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.”)), and supporting materials — are undisputed except where noted.

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. (Id. ¶ 6.) The 2009 label, 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.” 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 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 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 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); 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 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.

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 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 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) 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 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.)

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.)

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 or the instrument used to insert the IUD when the IUD is normally positioned within the uterine cavity. (Id.)

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

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 circumstances 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. (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. Plaintiffs’ argument that Dr. Collins ignored contradictory scientific literature is unfounded; she specifically addressed the leading study on which Plaintiffs rely — the Goldstuck study — 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 conflicting 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), 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 experience 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.) 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 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.) Plaintiffs do not cite any cases 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.

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.

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. The fact that Plaintiffs’ own experts agree on the 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’ testimony 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