Rheinfrank v. Abbott Laboratories, Inc. (119 F. Supp. 3d 749, 2015)

Order Granting in Part and Denying in Part Defendants’ Motion for Summary Judgment and Denying Plaintiffs’ Motion for Partial. Summary Judgment

Judge Susan J. Dlott, United States District Court

This is a product liability case under Ohio law arising from Plaintiff Pamela Rheinfrank’s ingestion of the antiepileptic drug, , Depakote, during her pregnancy with her daughter, M.B.D. Defendants Abbott- Laboratories, Inc., Abbvie, Inc,, and Abbott Laboratories • (“Defendants” or “Abbott”) manufacture, market, and distribute Depakote. Plaintiffs allege that Rheinfrank’s ingestion of Depakote during her pregnancy with M.B.D. caused injuries to her daughter, giving rise to this lawsuit.

This matter is before the Court on Defendants’ Motion for Summary Judgment (Doc. 113) and Plaintiffs’ Motion for Partial Summary Judgment (Doc. 112). Both motions are contested. Several motions regarding the expert witnesses to be presented at trial are also pending. For the reasons that follow, Defendants’ Motion for Summary Judgment is GRANTED IN PART AND DENIED IN PART, and Plaintiffs’ Motion for Partial Summary Judgment is DENIED.

I. BACKGROUND

A. Facts

Plaintiff Pamela Rheinfrank was born September 11, 1974 and has suffered from epilepsy since childhood. Rheinfrank initially experienced seizures from infancy until age five. From age five to fourteen, Rheinfrank was seizure free; however, she began experiencing seizures again at age fourteen in 1988.

In 1988, Rheinfrank was prescribed both two antiepileptic drugs (“AEDs”), Depakote and Phenobarbital, to treat her seizures. Rheinfrank continued using De-pakote and Phenobarbital during her pregnancy with four other children prior to M.B.D.’s birth; those children were born in 1990, 1992, 1994 and 2002. Rhein-frank became pregnant with M.B.D. in November or December of 2003. During her pregnancy, Rheinfrank’s drug dosage was 500 milligrams of Depakote, three times per day, and 60 milligrams of Phenobarbital, two times per day. (Rheinfrank Dep. (July 1, 2014) at 7-8, Doc. 79 at PagelD 1445.)

M.B.D. was born on July 25, 2004 and has been diagnosed with congenital malformations, facial dysmorphisms, cognitive impairment, developmental delay, and Fetal Valproate Syndrome (“FVS”). Plaintiffs attribute M.B.D.’s developmental delay and other physical and cognitive injuries to Rheinfrank’s use of Depakote while pregnant with her from 2003-2004.

Although Rheinfrank has been treated by multiple doctors, the earliest medical records reflecting her treatment with De-pakote are Walgreens Pharmacy records showing consistent prescriptions for Depa-kote from 2000 until 2008. These records indicate that Dr. Dagmar Lemus prescribed Depakote and Phenobarbital during Plaintiff Rheinfrank’s pregnancy with M.B.D. At that time, Dr. Lemus was a resident of internal medicine at a clinic in Cincinnati’s Good Samaritan Hospital. Dr. Lemus has no recollection of Rheinfrank and testified that she would not have been the originating prescriber of Rheinfrank’s Depakote. (Lemus Dep. at 7, 10, 45, Doc. 83 at PagelD 3257-58, 3267.)

Depakote received Food and Drug Administration (“FDA”) approval on or about March 3, 1983. (March 10, 1983 Letter from Department of Health and Human Services, Doc. 113-10 at PagelD 13313-20.) As of 1988, Depakote was designated by the FDA as a Pregnancy Category D drug.

In 2003, a Black Box warning- was included in the label, and the “Teratogenicity” Section of the Black Box warning read:

TERATOGENICITY:

VALPROATE CAN PRODUCE TERA-TOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF DEPAKOTE TABLETS IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO- THE FETUS. THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY REVERSIBLE CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT INJURY OR RISK OF DEATH (E.G./ MIGRAINE) IS CONTEMPLATED. SEE WARNINGS, INFORMATION FOR PATIENTS. AN INFORMATION SHEET DESCRIBING THE TERA-TOGENIC POTENTIAL OF VALP-ROATE IS AVAILABLE FOR PATIENTS.

(2000 Package Insert, Doc. 113-14 at Pa-gelD 13347; 2003 Package Insert, Doc. 113-15 at PagelD 13367; 2001 PDR, Doc. 113-16 at PagelD 13387; 20Ó3 PDR, Doc. 113-17 at PagelD 13397.)

The label also included the following language in the “Usage and Pregnancy” Section of the label:

Usage in Pregnancy

ACCORDING TO PUBLISHED AND UNPUBLISHED REPORTS, VAL-PROIC ACID MAY PRODUCE TER-ATOGENIC EFFECTS IN THE OFFSPRING OF HUMAN FEMALES RECEIVING THE DRUG DURING PREGNANCY. THERE ARE MULTIPLE REPORTS IN THE CLINICAL LITERATURE WHICH INDICATE THAT THE USE OF ANTIEPILEPTIC DRUGS DURING PREGNANCY RESULTS IN AN INCREASED INCIDENCE OF BIRTH DEFECTS IN THE OFFSPRING. ALTHOUGH DATA ARE MORE EXTENSIVE WITH RESPECT TO TRIMETHA-DIONE, PARAMETHADIONE, PHE-NYTOIN, AND PHENOBARBITAL, REPORTS INDICATE A POSSIBLE SIMILAR ASSOCIATION WITH THE USE OF OTHER ANTIEPILEPTIC DRUGS. THEREFORE, ANTIEPI-LEPSY DRUGS SHOULD BE ADMINISTERED TO .WOMEN OF CHILDBEARING POTENTIAL ONLY IF THEY ARE CLEARLY SHOWN TO BE ESSENTIAL IN THE MANAGEMENT OF THEIR SEIZURES.

THE INCIDENCE OF NEURAL TUBE DEFECTS IN THE FETUS MAY BE INCREASED IN MOTHERS RECEIVING VALPROATE DURING THE FIRST TRIMESTER OF PREGNANCY. THE CENTERS FOR DISEASE CONTROL (CDC) HAS ESTIMATED THE RISK OF VALPROIC ACID EXPOSED WOMEN HAVING CHILDREN WITH SPINA BIFIDA TO BE APPROXIMATELY 1 TO 2%. OTHER CONGENITAL ANOMALIES (E.G., CRANIOFACIAL DEFECTS, CARDIOVASCULAR MALFORMATIONS AND ANOMALIES INVOLVING VARIOUS BODY SYSTEMS), COMPATIBLE AND INCOMPATIBLE WITH LIFE, HAVE BEEN REPORTED.' SUFFICIENT DATA TO DETERMINE THE INCIDENCE OF THESE CONGENITAL ANOMALIES IS NOT AVAILABLE. THE HIGHER INCIDENCE OF CONGENITAL ANOMALIES IN ANTIEPILEPTIC DRUG-TREATED WOMEN WITH SEIZURE DISORDERS CANÑOT BE REGARDED AS A CAUSE AND EFFECT RELATIONSHIP. THERE ARE INTRINSIC METHODOLOGIC PROBLEMS IN OBTAINING ADEQUATE DATA ON DRUG TERATO-GENICITY IN HUMANS; GENETIC FACTORS OF THE EPILEPTIC CONDITION ITSELF, MAY BE MORE IMPORTANT THAN DRUG THERAPY IN CONTRIBUTING TO CONGENITAL ANOMALIES.

(Doc. 113-14 at PagelD 13354; Doc. 113-15 at PagelD 13374; Doc. 113-16 at PagelD 13390; Doc. 113-17 at PagelD 13399.)

B. Procedural History

Plaintiffs filed this action on February 28,.2013, and many related cases are pending throughout the country. In their Amended Complaint, Plaintiffs assert statutory claims of strict liability under theories of design defect, inadequate warning, and nonconformance with representations under Ohio Rev. Code §§ 2307.75, 2307.76, and 2307.77, respectively; common law negligence; negligent misrepresentation and, fraud; breach of express warranty and implied warranties of merchantability and fitness; unjust enrichment; and loss of consortium. Defendants have raised myriad defenses, including the learned intermediary doctrine and preemption.

On January 15, 2015, Plaintiffs filed two Motions for Partial Summary Judgment, and Defendants filed a Motion for Summary Judgment. For reasons explained on the record, the Court denied these Motions as moot subject to refiling. Subsequently, on January 28, 2015, Plaintiffs filed a Motion for Partial Summary Judgment on Defendants’ Third Defense (Learned Intermediary) and Forty-Third Defense (Preemption) and Plaintiffs’ Second Cause of Action for Failure to Warn. (Doc. 112.) Defendants filed a Motion for Summary Judgment as to all of Plaintiffs’ claims. (Doc. 113.)

Thereafter, on February 17, -2015, the parties filed several Daubert Motions seeking to exclude or limit expert testimony. Plaintiffs filed a Motion to Exclude in Part Proffered Expert Opinions of Dr; Kwame Anyane-Yeboa, Dr. Anthony Scialli, Dr. Max Wiznitzer, and Dr. Stephanie Greene (Doc. 136). The same day, Defendants filed a Motion to Exclude Testimony of C. Ralph Buncher, Sc.D (Doc. 153), Motion to Exclude Testimony of David Madigan, Ph.D. (Doc. 154), Motion to Exclude Testimony of Michael Privitera, M.D. (Doc. 155), Motion to Exclude Testimony of Suzanne Parisian, M.D. (Doc. 156), and Motion to Exclude Testimony of Howard Saal, M.D. (Doc. 157). Although these Motions are fully ripe, the Court will defer ruling upon them unless they are necessary to the Court’s summary judgment order.

II. SUMMARY JUDGMENT STANDARD

Federal Rule of Civil Procedure 56 governs motions for summaryjudgment. Summary judgment is appropriate if “there is no genuine issue as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). The movant has the burden of showing that no genuine issues of material fact are in dispute. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986); Provenzano v. LCI Holdings, Inc., 663 F.3d 806, 811 (6th Cir.2011). The evidence, together with all inferences that can permissibly be drawn therefrom, must be read in the light most favorable to the nonmoving party. See Matsushita Elec. Indus. Co., Ltd., 475 U.S. at 585-87, 106 S.Ct. 1348; Provenzano, 663 F.3d at 811.

The movant may support a motion for summary judgment with affidavits or other proof or by exposing the lack of evidence on an issue for which the nonmoving party will bear the burden of proof at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 322-24, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). In responding to a summary judgment motion, the nonmoving party may not rest upon the pleadings but must go beyond the pleadings and “present affirmative evidence in order to defeat a properly supported motion . for summary judgment.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 257, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The Court’s task is not “to, weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.” Liberty Lobby, 477 U.S. at 249, 106 S.Ct. 2505. A genuine issue for trial exists when there is sufficient “evidence on which the jury could reasonably find for the plaintiff.” Id. at 252, 106 S.Ct. 2505. “The court need consider only the cited materials, but it may consider other materials in the record.” Fed. R. Civ. P. 56(c)(3).

“Where the parties have filed cross-motions for summary judgment, the court must consider each motion separately on its merits, since each party, as a movant for summary judgment, bears the burden to establish both the nonexistence of genuine issues of material fact and that party’s entitlement to judgment as a matter of law.” In re Morgeson, 371 B.R. 798, 800-01 (B.A.P. 6th Cir.2007).

III. ANALYSIS

Defendants moves for summary' judgment on all claims, whereas Plaintiffs move for partial summary judgment. As briefly outlined below and more fully expounded upon throughout this Order, the Court will grant in part and deny in part Defendants’ Motion for Summary Judgment and deny Plaintiffs’ Motion for Partial Summary Judgment.

The Court will first consider the strict liability and negligence failure to warn claims. Defendants assert.that Plaintiffs’ claim that Defendants failed to warn of the risks of developmental delay is preempted. Defendants also.contend that the Depa-kote label was adequate as a matter of law, Defendants were not required to provide language comparing Depakote to other drugs in its label, and the teratogenicity of Depakote is common knowledge. Defendants also assert they are entitled to summary judgment on the failure to warn claims because Plaintiffs cannot prove proximate cause. For the reasons discussed below, the Court will find that Plaintiffs’ claim, that Defendants failed to warn of the risk of developmental delay is preempted. As to Plaintiffs’ strict liability and negligence failure to warn claims, questions of fact as to the label’s adequacy and causation preclude summary judgment for the Defendants. Finally, although Defendants contend a variety of other claims rise and fall with the failure to warn claims, the Court is not so persuaded.

Plaintiffs move for summary judgment on Defendants’ strict liability failure to warn claim and on two of Defendants’ defenses to the failure to warn-claim: preemption and the-learned intermediary defense. The Court will consider Plaintiffs’ in support of their Motion for Partial Summary Judgment in conjunction with Defendants’ Motion for Summary Judgment. For the reasons discussed below, the Court will deny Plaintiffs’ Motion for Partial Summary Judgment in its entirety.

Following its analysis on the failure to warn claims, the Court will consecutively consider Defendants’ arguments that it is entitled to summary judgment on Plaintiffs’ remaining claims, which include: design defect, negligent misrepresentation and fraud, and unjust enrichment claim. Finding the Defendants’ arguments persuasive, the Court will find Defendants entitled to summary judgment on each of these remaining claims.

Finally, Defendants assert Plaintiffs are unable to recover punitive damages in this action. The Court finds that Plaintiffs may pursue punitive damages for its common law claim, but not for its statutory failure to warn claim.

A. Failure to Warn Claims

The Court will first consider Defendants’ Motion for Summary Judgment on Plaintiffs’ failure to warn claims and Plaintiffs’ Motion for Partial Summary Judgment on its statutory failure to warn claim and Defendants’ defenses of preemption and the learned’ intermediary. Defendants move for summary judgment on all of Plaintiffs’ claims that hinge upon the inadequate warning theory, under which “a product is in a defective condition unreasonably dangerous when it is not accompanied by warnings sufficient to allow users to avoid risks inherent in the product.” In re Mendia Prods. Liab. Litig., 328 F.Supp.2d 791, 810 (N-D.Ohio 2004) (internal quotations removed). Plaintiffs move for summary judgment on their second claim, strict liability for failure to warn under Ohio Rev. Code § 2307.76, as well as the defenses of preemption and the learned, intermediary.

Plaintiffs base their products liability claims on theories of both strict liability and- negligence. Strict products liability claims in Ohio are governed by Ohio Rev. Code §§ 2307.71-2307.80. Under Ohio statutory law, a manufacturer is subject to liability for compensatory damages based on a product liability claim if the Plaintiffs prove, by a preponderance of the evidence, that the label was defective due to inadequate warning or instruction and the defect was the proximate cause of M.B.D.’s injury. McConnell v. Cosco, Inc., 238 F.Supp.2d 970, 976 (S.D.Ohio 2003) (citing Ohio Rev. Code § 2307.73(A)). Under a negligent failure to warn claim, Plaintiffs “must show that the manufacturer had a duty to warn, that the duty was breached, and that [Plaintiffs’] injuries] proximately resulted from that breach of duty.” Id. (citing Hanlon v. Lane, 98 Ohio App.3d 148, 648 N.E.2d 26, 28 (1994)).

Plaintiffs allege Abbott failed to warn of the following: (1) the increased teratogen-icity risk associated with higher doses of Depakote; (2) the increased risk of congenital malformations when Depakote is prescribed as part of polytherapy; (3) increased risk of impaired cognitive function and neurodevelopmental delay, caused by in útero exposure to Depakote; (4) increased risk of teratogenic effects to, the developing fetus as compared, to other an-tiepileptic drugs, which are safer for women of childbearing age; and (5) the greater risk to the fetus caused by Depakote usage than no treatment for seizure disorder. Defendants contend that Plaintiffs’ failure to warn claim premised on the adequacy of Defendants’ developmental delay warning is preempted, and that Plaintiffs cannot prove that any alleged inadequacy caused M.B.D.’s injuries.

1. Strict Liability and Negligence Standards for Failure to Warn

Under Ohio Rev. Code § 2307.76, a product is defective due to inadequate warning or instruction if either of the following applies:

(1) It is defective due to inadequate warning or instruction at the time of marketing if, when it left the control of its manufacturer, both of the following applied:

(a) The manufacturer knew or, in the exercise of reasonable care, should have known about a risk that is associated with the product and that allegedly-caused harm for which the claimant seeks to recover compensatory damages;

(b) The manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided concerning that risk, in light of the likelihood that the product would cause harm of the type for which the claimant seeks to recover compensatory, damages and in light of the likely seriousness of that harm.

(2) It is defective due to inadequate post-marketing warning or instruction if, at a relevant time after it left the control of its manufacturer, both of the following applied:

(a) The manufacturer knew or, in the exercise of reasonable care, should have known about a risk that is associated with the product and that allegedly caused harm for which the claimant seeks to recover compensatory damages;

(b) The manufacturer failed to provide the post-marketing warning or instruction that a manufacturer exercising reasonable care would have provided concerning that risk, in light of the likelihood that the product would cause harm of the type for which the claimant seeks to recover compensatory damages and in light of the likely seriousness of that harm.

“A claim for negligent failure to warn has three basic elements: (1) a duty to warn against reasonably foreseeable risks; (3) breach of such a duty; and (3) injury that is proximately caused by the breach.” Reece v. Astrazeneca Pharm., LP, 500 F.Supp.2d 736, 751 (2007) (citing Graham v. American Cyanamid Co., Nos. C-2-94-423, C-2-94-425, 2000 WL 1911431, at *10 (S.D.Ohio Dec. 21, 2000)). “The manufacturer must give suitable warning of a dangerous propensity that may result from use of the product.” Id. (citing Graham, 2000 WL 1911431, at *11). “The warning necessary to satisfy the duty of ordinary care will vary based on the facts of each case.” Id. (citing Graham, 2000 WL 1911431, at *11): “Because- the standard for failure to warn requires that a manufacturer exercise reasonable care, the same standard applies for'both strict liability and negligence claims for inadequate warning.” McConnell v. Cosco, Inc., 238 F.Supp.2d 970, 976 (2003) (citing Crislip v. TCH Liquidating Co., 52 Ohio St.3d 251, 566 N.E,2d 1177, 1183 (1990)). Accordingly, the Court will analyze the failure to warn claims jointly.

a. Preemption

Whether Plaintiffs’ failure to warn claims are preempted is a threshold issue for both parties’ motions. In their Motion for Partial Summary Judgment, Plaintiffs assert they are entitled to summary judgment on the defense of preemption, whereas Defendants contend that Plaintiffs’ failure to warn of the risk of developmental delay is preempted. Defendants contend that it was impossible for Abbott to have given a warning regarding developmental delay prior to 2009. Abbott asserts that it sought the FDA’s approval to add a developmental delay warning to its Depakote labeling in 2005 and 2007, and the FDA declined to approve' the warning both times because, in ifs view, the scientific evidence was insufficient to support such a warning. Plaintiffs.argue Defendants .are unable to meet the high burden to establish preemption and that they are entitled to summary judgment on this defense.

Implied conflict preemption arises- when “it is either impossible for a private party-to comply with both state and federal requirements,” Sprietsma v. Mercury Marine, 537 U.S. 51, 64, 123 S.Ct. 518, 154 L.Ed.2d 466 (2002) (citing English v. General Elec. Co., 496 U.S. 72, 79, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990)), “or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Id. (citing Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 85 L.Ed. 581 (1941)). A failure to warn claim is preempted where the manufacturer of the drug proves that it was impossible to comply with state and federal law by submitting “clear evidence that the FDA. would not have approved a change” to the drug’s label. Wyeth v. Levine, 555 U.S. 555, 571, 129 S.Ct; 1187, 173 L.Ed.2d 51 (2009).

Although the Levine Court articulated that the impossibility preemption defense is “demanding,” it did not define the “clear evidence” standard, nor did it suggest the level of proof required. Id. at 571-573, 129 S.Ct; 1187; see Dobbs v. Wyeth Pharm., 797 F. Supp. 2d 1264, 1270 (W.D.Okla. 2011) (discussing-the fact that lower courts are left to determine what satisfies the “clear evidence” standard in each case). Rather, the Levine. Court found that the manufacturer offered no evidence that the FDA would have rejected the proffered warning. Levine, 555 U.S. at 571, 129 S.Ct. 1187.

Before marketing a new drug, the manufacturer must submit a New Drug Application to the FDA, which demonstrates by “substantial evidence” that the medication is efficacious. Mason, v. SmithKline Beecham Corp., 596 F.3d 387, 391 (7th Cir. 2010) (citing 21 U.S.C. § 355(d)(5)). “The FDA’s approval is then conditioned on the manufacturer’s use of the label it suggests.” Id. (citing 21 C.F.R. § 314.105(b)). “Even after the medication is approved, the FDA continues to have authority over it and its label.” Id. (citing 21 C.F.R. § 314.80-81). Under FDA regulations:

to change labeling (except for editorial and other minor revisions), the sponsor '‘must submit a supplemental application fully explaining , the basis for the change (§§ 314.70 and 601.12(f) (21 C.F.R. 314.70 and 601.12(f)))). The FDA permits two kinds of labeling supplements: (1) Prior approval supplements, which require FDA approval before a change is made (§§ 314.70(b) and 601.12(f)(1)); and (2) “changes being effected” (CBE) supplements, which may be implemented before FDA approval, but after FDA notification (§§ 314.70(c) and 601.12(f)(2)). While a sponsor is permitted to add risk information to the FPI without first obtaining FDA approval via a CBE supplement, FDA reviews all such submission and may later deny approval of the supplement, and the labeling remains subject to enforcement action if the added information makes the labeling false or misleading under section 502(a) of the act (21 U.S.C. 352). Thus, in practice, manufacturers typically consult with FDA prior to adding risk information to labeling.

Requirements on Contént and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922-01. “The CBE regulation allows a manufacturer to modify a label to ‘add or strengthen ,a contraindication, warning, precaution, or adverse reaction’ ... and to do so when it files its supplemental application, before the FDA has the opportunity to .consider whether or not it will accept the change.” Mason, 596 F.3d at 392 (citing 21 C.F.R. § 314.70(c)(6)(iii)(A), (C).

i. 2005 Attempt to Strengthen Label

The FDA approved Depakote (dival-proex sodium) in 1983. The drug was “indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, including petit mal. De-pakene may also be used adjunetively in patients with multiple seizure types which include absence seizures.” (Doc. 114 at Pa-gelD 13813.)

On April 18, . 2005, Abbott submitted a letter to Dr. Russell Katz of the FDA with the subject line “Supplement-Prior Approval Labeling.” (Doe. 113-31 at PagelD 13536-63.) The purpose of the Supplement was to provide an update to the approved Depakote Tablets’ label based on medical literature and a review óf post-marketing safety data. Abbott asserted that “[t]he proposed labeling provides revised information related to teratogenicity and additional information for developmental delay and includes revisions to the WARNINGS-Usage in Pregnancy and the Patient Information Leaflet sections.” (Id. at PagelD 13536) (emphasis in original). With its Supplement, Abbott included “[a]n outline of safety-related changes for tera-togenicity/developmental delay and DDI with topiramate” and “[n]ew information concerning the use of valproate in women of childbearing potential: teratogenicity and developmental delay.” (Id. at 13537.)

Along with other modifications, the suggested label revision included adding the following language in the “Usage in Pregnancy” section of the label:

THERE ARE DATA THAT SUGGEST AN INCREASED INCIDENCE OF CONGENITAL MALFORMATIONS ASSOCIATED WITH THE USE OF VALPROIC ACID DURING PREGNANCY WHEN COMPARED WITH SOME OTHER ANTIEPILEPTIC DRUGS. THEREFORE, VALPROIC ACID SHOULD BE CONSIDERED FOR WOMEN OF CHILDBEARING POTENTIAL ONLY AFTER THE RISKS HAVE BEEN THOROUGHLY DISCUSSED WITH THE PATIENT AND WEIGHED AGAINST THE POTENTIAL BENEFITS OF TREATMENT.

THERE HAVE BEEN REPORTS OF DEVELOPMENTAL DELAY IN THE OFFSPRING OF WOMEN WHO HAVE RECEIVED VALPROIC ACID DURING PREGNANCY.

(Id. at 13539-40.) Abbott also proposed adding the following language in its Patient Information Leaflet, under the section labeled, “Information For Women Who Could Become Pregnant:” “These medications have also been associated with other birth defects such as defects of the heart, the bones, and other parts of the body. Information suggests that birth defects may be more likely to occur with these medications than some other drugs that treat your medical condition. In addition, there have been reports of developmental delay in children bom to women taking these medications.” (Id. at 13542.) Abbott- supported its submission with a White Paper labeled “New information concerning the use of valproate in women of childbearing potential: teratogenicity and developmental delay.” (Id. at 13547.)

On February 7, 2006, the FDA responded by e-mail to Abbott’s PAS and stated the proposed sentence referencing developmental delay should not be incorporated into labeling. (Doc. 113-33 at PagelD 13582-83.) The e-mail stated:

The sentence “There have been reports of developmental delay in the offspring of women who have received valproic acid during pregnane/’ is based on two recent publications (Gaily E et al. Neurology 62(l):28-32, 2004 and Vintén J et al. Neurology 64(6):949-54, 2005) that attempted to correlate children’s performance on IQ assessments with maternal prenatal use of valproate but which did not adequately control for maternal IQ and maternal educational attainment. Maternal IQ and maternal educational attainment are known to strongly correlate with children’s performance on IQ assessments and thus would confound any attempt to draw a correlation to maternal prenatal valproate use. Given the studies’ inability to establish this correlation, the proposed sentence should not be incorporated into labeling. A similar proposed sentence in the Par tient Information Leaflet was removed in the Approval Letter for S-032 (January 11, 2006).

(Id. at 13582.)

ii. 2007 General Correspondence with FDA

On May 21, 2007, Abbott sent a letter to Dr. Katz of the FDA with the subject line “General Correspondence-Request for Advice regarding Developmental Labeling.” (Doc. 113-32 at PagelD 13566-79.) The letter attached a White Paper labeled “De-pakote Neurodevelopmental Delay White Paper” and stated that Abbott continued to monitor literature and spontaneous adverse drug events database for developmental delay associated with valproic acid. (Id.) The correspondence was intended to provide “an updated analysis of the occurrence of developmental delay in the attached white paper, which now includes more compelling data from the Neurode-velopment Effects of Antiepileptic Drugs (NEAD) study.” (Id. at 13566.) The correspondence also stated the interim results from the NEAD study were “the first data with adequate control for maternal IQ using a standard IQ measure and show a significant developmental delay in 185 two-year-old children exposed to valproic acid during pregnancy.” (Id. at 13566-67.) Abbott accordingly proposed that the following language be added to the “WARNINGS-Usage in Pregnane/’ subsection of its label with consistent language added to the Patient Information Leaflet section of the label: “There have been reports of developmental delay in the offspring of women who have received valproate during pregnancy.” (Id. at 13567.)

On March 3, 2008, the FDA Division of Neurology Products held a telephone conference with Abbott regarding the RFA. (Doc. 113-34 at PagelD 13586.) Abbott’s FDA Contact Report of the call states that “Dr. Katz stated they cannot approve this labeling change at this time,” because the data was “not ‘ripe’ for inclusion in labeling” as it was based on “interim data from Dr. K. Meador and the Neurodevelopment Effects of Antiepileptic Drugs (NEAD) Study group.” (Id.) The Report further states:

FDA feels that the sample size with VPA compared to other agents is small, some of the data for the 2 year old IQ evaluation was imputed, and there are too many confounding factors to believe the data is reliable at this timepoint in the study. Dr. Katz stated that they want to wait until the study is complete at the six-year time point. Dr. Embres-cia then commented that there have been a number of cases of developmental delay reported through our post-marketing safety surveillance program, and asked whether that might not warrant the change in labeling. Dr. Katz asked for the number of cases we have, and Jim responded that at the time we submitted the proposed labeling change we had 240 reported cases, although many of those cases are confounded by other congenital abnormalities the patients have or other medications they.were on. Dr. Katz indicated he thought these cases were probably too confounded to assess and that he believes this is the type of event where they want investigation in a formal setting to confirm.

(Id. at 13586-87.)

iii. 2009 Correspondence

On April 30, 2009, Abbott requested advice from the FDA about adding developmental delay warnings to the Depakote label. (Doc. 88-4 at PageID 5828-900.) Abbott’s letter to the FDA states that since its requests on April 18, 2005 and May 21, 2007, Abbott monitored literature and post-marketing reports with respect to developmental delay and autism/autism spectrum disorder associated with in úte-ro exposure to valproic acid. (Id. at 5828.) Abbott explained that since that time, “Dr. Meador et al. (2009) has released results of an interim analysis of 3-year IQ assessments from children with in utero AED exposure at an academic conference and published them recently in the New England Journal of Medicine.” (Id.) Additionally, “three (3) publications have recently been issued on the subject: Eriksson et al. (2005), Rasalam et al. (3005) and Nicolai et al. (2008).” (Id. at 5829.) Abbott requested the FDA to review the new information and “provide advice on the acceptability of these data for use to support an amendment to the current label regarding the risk of developmental delay and/or autism/autism spectrum disorder with intrauterine exposure to valproate.” (Id.)

On September 18, 2009, the FDA held a teleconference with Abbott regarding Abbott’s April 30, 2009 submission. (Doc. 88-4 at PageID 5825.) The FDA advised Abbott that it had requested data from Dr. Meador and planned to “independently review the data.” (Id.) The FDA noted its statisticians “have raised concerns with [Dr. Meador’s] study and the methodology for the collection of data.” (Id.) “[B]efore taking regulatory actions with labeling, [the FDA] needed time to evaluate the data.” (Id.) As a result, “[the FDA] stated that they were not ready to sign off on labeling language.” (Id. at 5825-26.)

In response to Abbott’s inquiry as to whether the FDA “would be open to [Abbott’s] proposal for labeling language in the interim while the [FDA] completes its review[,]” the FDA advised that Abbott would be “well within [its] rights to submit a CBE but that [the FDA] would not take action until reviewing the data.” (Id. at 5826.) Subsequently, on November 18, 2009, Abbott submitted a CBE-0 to add developmental delay warnings for Depakote. (Doc. 163-33 at PageID 22020-23.)

iv. Failure to Warn of Developmental Delay Claim is Preempted

Defendants argue that the FDA’s 2006 and 2008 rejections of Defendants’ attempt to add a developmental delay warning to the Depakote label constitute clear evidence that the FDA would have not have approved a developmental delay warning prior to M.B.D.’s injury in 2003-2004. Plaintiffs, on the other hand) contend that Defendants cannot meet the high burden required to raise a preemption defense for three primary reasons: (1) the FDA did not approve Abbott’s PAS because of Abbott’s own omissions and failure to research the teratogenicity of Depakote, (2) Abbott failed to produce relevant documents, and (3) Abbott could have unilaterally added a warning with a CBE-0 at any time, but chose not to do so until 2009.

Preemption is- warranted because there is clear evidence the FDA would not have approved a change to the Depakote label adding a developmental delay warning prior to M.B.D.’s injury. The Court finds the FDA’s February 2006 decision that developmental delay warnings “should not be incorporated into [Depakote] labeling” and the FDA’s 2008 belief that “the data do not provide sufficient evidence to support [Depakote] labeling changes at this time” constitute “clear evidence” -that when confronted by the issue-in 2003, the FDA would have rejected an attempt to add a developmental delay warning. (Doc. 113-33 at PageID 13582-83; Doc. 113-34 at PageID 13586-87.) See Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 873 (7th Cir.2010) (finding clear evidence that the FDA would not have approved a label change because the FDA did not approve “a reference to SJS/TEN on the label of over-the-counter drugs containing ibuprofen, when it had been asked to do so in the submission to which the agency was responding”); Kaleta v. Abbott Laboratories, Inc., No. 14-cv-S47-NJR-SCW (S.D.Ill. Feb. 20, 2015) (order granting motion in limine to exclude evidence, testimony, and argument about preempted labeling issues) (examining the same FDA decisions at issue in this case ,and finding that the. FDA’s 2006 and 2008 rejections of Abbott’s attempts to add a developmental delay warning constitute-clear evidence the FDA would have rejected a similar change to the 1999 Depakote label); In re Fosamax, 951 F.Supp.2d 695, 703 (D.N.J.2013) (finding clear evidence the FDA would not have approved a label change prior to the plaintiffs injury where FDA had rejected prior attempts to strengthen the relevant label); Dobbs v. Wyeth Pharm., 797 F.Supp.2d 1264, 1276-77 (W.D.Okla.2011) (finding clear, evidence that the FDA would have rejected an expanded warning for Effexor after the FDA rejected the warning added by the defendant). See also Levine, 555 U.S. at 571-72, 129 S.Ct. 1187 (holding that Wyeth “failed to demonstrate that it was impossible for it:to comply with both federal and state requirements” and reasoning that it “offered no such evidence” and never argued “that it attempted to give” a warning but “was prohibited from doing so by the FDA”).

Although there have been a limited number of courts to rule on what constitutes clear evidence in determining whether ■ a failure to warn - claim is preempted, this Court is guided by Judge Rosensten-gel’s well-reasoned ruling on a motion in limine to exclude evidence, testimony, and argument about preempted labeling issues in Kaleta, No. 3:14-cv-847-NJR-SCW (ruling on motion in limine). In analyzing whether the motion should be granted, the Kaleta court examined the same 2006 and 2008 rejections to Abbott’s attempts to add a developmental delay warning presently before this Court to. determine whether those rejections constituted clear evidence the FDA would not have approved a 1999 developmental delay warning. Finding ..the evidence conclusive on the issue of preemption, the court held:

The Court finds that there is clear evidence that the FDA would- not have -approved a change to the 1999 label to include a warning of developmental delay. -As stated Above, Abbott tried, on various occasions, to secure approval of a developmental, delay warning, and its requests were twice denied by the FDA (See Docs. 162-4; Doc. 162-5; Doc. 162-7; Doc. 162-8). In light of the fact that the FDA rejected the developmental delay warning in 2006 because it did not find that the available scientific evidence at that time supported the addition of such a warning, it is highly unlikely that the available scientific evidence, seven years prior to. that date in 1999, would have supported the addition of such a warning. Notably, the FDA did not actually approve this developmental delay language until 2011.

Id. at *6-7. On this basis, the court granted the Abbott’s motion in limine. Although the Court recognizes there are differences between the present case and the Kaleta case, the Kaleta court’s ruling is persuasive.

The Court will briefly address the arguments raised by Plaintiffs, many of which were considered and rejected by the Kale-ta court. First, Plaintiffs argue Abbott failed to conduct or sponsor published scientific research on Depakote and developmental delay, which constitutes deliberate inaction and a failure to press its position despite evidence to’ the contrary. Plaintiffs reason that if Abbott had funded or conducted studies that generated subsequently published data, those' studies would have generated the same data sooner, and by 2003, the FDA would have allowed the developmental delay warnings based on that data. This reasoning is speculative. For example, in December 2004, Dr. Meador, who was a researcher running a pregnancy exposure registry to study multiple AEDs, including Depakote, presented interim registry data showing “possible developmental delay in some children exposed to VPA in útero.” (Doc. 113-35 at PagelD 13588-608.) When the Meador data was available in 2009, Dr. Katz of the FDA was concerned about methodological issues with the data and wanted to independently review the results. (Doc. 88-4 at PagelD 5825.) Thus, the FDA’s 2006 and 2008 rejections of a developmental delay warning based on the then-available scientific evidence demonstrates it was highly unlikely that years prior, the scientific evidence would have supported such a warning and the FDA would have approved it in 2003-2004. See.Kaleta, No. 3:14-cv-847-NJR-SCW, at *6-7.

Plaintiffs also argue that Abbott submitted misleading or incomplete information with its 2005 and 2007 applications to the FDA. Plaintiffs support their position with proffered expert testimony of four experts who have reviewed and opined on allegedly misleading information in Abbott’s White Papers submitted with Abbott’s 2005, 2007, and 2009 correspondences with the FDA. Plaintiffs’ argument that Abbott withheld certain information or misrepresented the results of studies in its 2005 and 2007 submissions to the FDA appears to be a fraud-on-the-FDA theory, which is preempted. In re Fosamax, MDL No. 2243, 2014 WL 1266994, at *17 (D.N.J. Mar. 26, 2014) (citing Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001)). As the Supreme Court held in Buckman, “state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law.” Buckman, 531 U.S. at 348, 121 S.Ct. 1012.

Regardless, an expert’s opinion that the FDA would have reacted differently if the submissions to the FDA in 2005 and 2007 had been supported by different evidence is speculative. Confronted with a similar argument in In re Fosamax, in which the court found that the plaintiffs claim against drug manufacturer Merck preempted, Judge Pisano reasoned:.

[Wjhat Merck could have or should have done is immaterial because we know what Merck did. Similarly, Wyeth v. Levine provides for preemption where there is clear evidence that the FDA would have rejected a label change, and, again, we know that the FDA did reject it. Thus, any expert testimony relating to what Merck could have or should have done, and what the FDA would have done in response to the same is purely speculation and does not rise to the level of being a genuine fact dispute.

In re Fosamax, 2014 WL 1266994, at *9 (emphasis in original).

The same logic applies here. Testimony about what Abbott could have and should have researched or stated to the FDA in its applications is speculative, and does not serve as the basis for a genuine issue of material fact. Thus, as was the case in In re Fosamax, the Court finds that Plaintiffs’ fraud-on-the-FDA theory is either preempted or based on speculation. See In re Fosamax, 2014 WL 1266994 at *17 (citing Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001)). See also In re Trasylol Products Liab. Litig., No. 08-MD-01928, 2010 WL 4259332, *12 (S.D.Fla. Oct. 21, 2010) (“[An expert] may not speculate as to what the FDA would have done in hypothetical circumstances.”); Webster v. Pacesetter, Inc., 259 F.Supp.2d 27, 37 (D.D.C.2003) (“Nor can plaintiffs create an issue of fact regarding their defective warning claim by speculating that if the FDA had known of the delayed perforation and tamponade incidents during the clinical trials and if defendant had investigated all the adverse incidents, the FDA would have either recalled the [product] or placed it on alert.” (emphasis in original)).

Plaintiffs argue that the FDA’s rejections of Abbott’s PAS and RFA do not foreclose that the FDA would have accepted a CBE-0, had Abbott filed one. A CBE allows a manufacturer to immediately add a warning unilaterally, which is then subsequently reviewed by the FDA. 21 C.F.R. § 314.70(c). Plaintiffs argue that the FDA employs a different, more lenient standard for a CBE-0. Specifically, Plaintiffs point to Abbott’s notes from a September 18, 2009 teleconference between Abbott and the FDA, during which the FDA advised Abbott that Abbott would be “well within [its] rights to submit a CBE but that [the FDA] would not take action until reviewing the data” to argue this option was available at any time and that the changes to the label would have been accepted. (Doc. 88-4 at PagelD 5826.)

Plaintiffs’ argument that an earlier-filed CBE-0 could have been filed at any time to add a developmental delay warning is unpersuasive to demonstrate clear evidence that the FDA would have approved a developmental delay warning prior to M.B.D.’s injury. Although the option is available to submit a unilateral change through a CBE, the FDA must still ultimately approve and review that change. Kaleta, No. 3:14-cv-00847-NJP-SCW, at *8; 21 C.F.R. § 314.70(b)(3), (c)(4); 71 Fed. Reg. 3922 (The FDA reviews all such CBE submissions and “may later deny approval of the supplement, and the labeling remains subject to enforcement action if the added information makes the labeling false or misleading under section 502(a) of the act (21 U.S.C. 352)”); see also Mason v. SmithKline Beecham Corp., 596 F.3d 387, 392 (7th Cir.2010). Moreover, “[t]he FDA applies the same standards to evaluate both PAS and CBE supplements.” Kaleta, No. 3:14-cv-00847, at *8. As the Kaleta court noted, the Seventh Circuit has held:

The ability to make CBE labeling changes underscores a central premise of federal drug regulation: A ‘manufacturer bears responsibility for the content of its label at all times.’ Levine, 129 S.Ct. at 1197-98. While it is important for a manufacturer to warn of potential side effects, it is equally important that it not overwarn because overwaming can deter potentially beneficial uses of the drug by making it seem riskier than warranted and can dilute the effectiveness of valid warnings. Therefore, warnings may only be added when there is ‘reasonable evidence of an association of a serious hazard with the drug.’ 21 C.F.R. § 201.57 (2003). It is technically a violation of federal law to propose a CBE that is not based on reasonable evidence. 18 U.S.C. § 1001.

Kaleta, No. 3:14-cv-00847-NJP-SCW, * 8 (citing Mason v. SmithKline Beecham Corp., 596 F.3d 387, 392 (7th Cir.2010)). In this case, Abbott has come forward with sufficient evidence that because the FDA rejected Abbott’s 2005 PAS, it likely would have rejected an earlier-submitted CBE seeking to add the same language to the label, that it eventually rejected in, the PAS. See Kaleta, No. 3:14-cv-00847, at *8; Fosamax, 951 F.Supp.2d at 704 (“Thus, since the FDA rejected Defendant’s PAS, it would not have approved a CBE seeking to add the same language to the label that it just rejected in the PAS.”).

Finally,' Plaintiffs argue that the FDA initially approved Abbott’s proposed developmental delay warnings during a November 17, 2005 teleconference. This assertion arises from an internal Abbott FDA Contact Report regarding a November 2003 CBE application to the FDA:

[FDA’s John Feeney] stated that FDA was in agreement with the latest wording provided to them regarding the mul-tiorgan-hypersensitivity, teratogenicity and developmental delay, and the topira-mate drug interaction. They noted that we had removed a sentence about developmental delay from the Patient Information Leaflet, and said that was OK However, they wanted to know our rationale for removing it (ie. annotation to the removal).

(Doc. 114 at PagelD 13919.) After Abbott submitted its 2005 PAS; the FDA advised Abbott that its S-032, which the FDA had not yet approved, was approvable, but asked Abbott to respond to various cona-ments. (Doc. 163-18 at PagelD 21638-42.) On .July 1, 2005, Courtney Calder of the FDA advised Abbott to “pull the patient information leaflet changes from 033 and put it in 032 (state in the cover letter you are withdrawing it [sic] form 033).” (Doc. 163-27 at PagelD 21944.) On July 21, 2005, Abbott submitted a letter to the FDÁ stating that it was removing the proposed text from the Patient Information Leaflet of Prior Approval Supplement to S-0S3, dated April 18, 2005. (Doc. 163-19 at PagelD 21643-46.) Thus, this evidence makes clear that the FDA did not advise Abbott about or otherwise determine the acceptability of developmental delay warnings for the De-pakote Prescribing Information before February 2006. (Doc. 163-24 at PagelD 21934-35.) Plaintiffs’ argument that the November 2005 FDA Contact Report therefore indicates that Abbott removed a developmental delay warning from its 2003 CBE application is inconsistent with the July correspondence between the FDA and Abbott. Thus, the argument that Abbott is either concealing documents or has a rationale document that could demonstrate Abbott advocated against its own request to add a developmental delay warning cuts against the evidence before the Court, which is that the FDA refused to ‘include a developmental delay warning in 2006 and again, later, in 2008.

' Thus, for these reasons, Plaintiffs’ claim that Defendants failed to warn of the risk of developmental delay is preempted. Plaintiffs’ motion for summary judgment on the defense of preemption is accordingly denied.

b. Adequacy of Warning and Duty to Warn

Having determined that Plaintiffs’ allegation that Defendants failed to warn of the risk of developmental delay is preempted, the Court will next consider the parties’ remaining arguments on the failure to warn claims. The Court will first turn to the Defendants’ remaining three central arguments in moving for summary judgment: that the Depakote label was adequate as a matter of law, that Defendants were not required to provide language comparing the risks of Depakote to other AEDs in its label, and that the tera-togenic risks of Depakote were common knowledge. The Court will next consider Plaintiffs’ central argument in their Motion for Partial Summary Judgment that Defendants failed to adequately warn both Rheinfrank and her physician of the risks of Depakote, rendering the learned intermediary defense inapplicable. As expounded upon below, the Court finds questions of fact preclude summary judgment for either party on the failure to warn claims.

The Court will first consider whether the Depakote label was adequate as a matter of law. The parties dispute whether the warnings provided on the De-pakote label were adequate in content and strength and whether they were required to be provided to Rheinfrank’s physician or Rheinfrank directly. Generally, whether a particular warning is adequate is a question of fact for the jury. In re Meridia Products Liability Litigation, 328 F.Supp.2d 791, 812 (N.D.Ohio 2004). “The fact finder may find a warning to be unreasonable, hence inadequate, in its factual content, its expression of the facts, or the method.or form in which it is conveyed.” Seley v. G.D. Searle & Co., 67 Ohio St.2d 192, 423 N.E.2d 831, 837 (1981). A warning’s adequacy is measured by “what is stated” and “the manner in which it is stated.” Id. “A reasonable warning not only conveys a fair indication of the nature of the dangers involved, but also warns with the degree of intensity .demanded by the nature of the risk.” Id. Thus, a warning may be found to be inadequate if it is “unduly delayed, reluctant in tone or lacking a sense of urgency,” or where the “existence of a ‘risk,’ i.e., causal relationship between use of the product and resulting injury, has not been definitely established.” Id.

Defendants argue their warnings are adequate as a matter of law. As of 1988, Depakote was designated by the FDA as a Pregnancy Category D drug. Abbott also asserts it sent “Dear Doctor” letters in 1983 to the medical community to inform them of the risk of spina bifida among those exposed prenatally to valproic acid. (Doc. 113-12 at PageID 13326-40.) In addition, Abbott incorporated a Black Box warning about teratogenicity in 1996. (Doc. 113-14; 113-15; 113-16; 113-17.)

Federal regulations do not limit drug manufacturers from strengthening their warnings to reflect new developments and comply with state laws. Wyeth v. Levine, 555 U.S. 555, 568-69, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) (citing 21 C.F.R. §§ 314.70(c)(6)(iii)(A), (Q). As the Supreme Court has explained, “it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.” Id. at 570-71, 129 S.Ct. 1187. While the Pregnancy Category D and Black Box warning highlight important' risks associated with the use of Depakote, they also direct the reader in some manner to consult additional sections of the warning label containing more information related to these risks in order to allow for a risk-benefit analysis, which Plaintiffs assert is inadequate.

In reviewing Plaintiffs’ evidence offered in support of its contention that Abbott’s 2003 label is inadequate, the Court finds summary judgment for Defendants is not warranted. Thus, the Court is not persuaded that the mere fact that the label listed Depakote as a Pregnancy Category D drug and included a Black Box warning indicates that the label was adequate as a matter of law. See Kaleta, 3:14-cv-00847-NJR-SCW, at *11-12 (S.D. Ill. Feb. 14, 2015) (granting in part and denying in part Abbott’s motion for summary judgment) (finding the mere fact that the label listed Depakote as a Category D drug and included a Black Box warning did not indicate that the' label was adequate as a matter of law). Rather, there is a question of fact as to whether the 2003 Depakote warning was adequate. Plaintiffs have identified a number of alleged inadequacies in Abbott’s warning, primarily through proffered testimony of multiple experts, the admissibility of which is disputed through Daubert motions. For example, Dr. Michael D. Privitera, M.D. a tenured Professor of Neurology at the University of Cincinnati Medical Center, Director of the Epilepsy Center of the UC Neuroscience Institute and a clinician with University Neurology, Inc., opines that the Depakote label that existed in 2003 when Rheinfrank became pregnant failed to provide adequate information to physicians and/or patients. (Doc. 109-1 at PageID 11711, 11718.) Such deficiencies include the label not stating that birth defects are greater with valproate than with other AEDs and the lack of warning that women of childbearing years should use contraception while taking valproate or not get pregnant while taking the drug. (Id. at 11718.)

i. Admissibility of Dr. Privitera’s Opinion

Through a Daubert motion, Defendants argue Dr. Privitera is not qualified to testify about the adequacy of the Depakote label. (Doc. 155.) The Court will narrowly consider the admissibility of Dr. Privitera’s opinion about the adequacy of the 2003 Depakote warning. Dr. Privitera is board certified by the American Board of Clinical Neurophysiology and American Board of Psychiatry and Neurology. (Id. at 11711.) He earned his B.A. in Biology from Johns Hopkins University and M.D. from State University of New York Medical Center. (Id.) Dr. Privitera is the author of numerous scientific peer-reviewed publications. (Id. at 11724-61.) The Court finds that Dr. Privitera is well-qualified based on this experience and education.

Defendants contend that Dr. Privitera’s testimony regarding whether Defendants should have included additional or different warnings in the Depakote label and the adequacy of submissions to the FDA concern regulatory matters that are beyond the scope of Dr. Privitera’s expertise. As Defendants point out, Dr. Privitera lacks specialized FDA product-labeling knowledge, skill, experience, training or education, and counsel admitted as much in his deposition. (See Doe. 109 at PagelD 11625-26) (Ms. Abaray stating, “He’s not a regulatory expert.”)

Two cases are particularly instructive here. First, in In re Gadolinium-Based Contrast Agents Prods. Liab. Litig., MDL No. 1909, No. l:08-GD-50000, 2010 WL 1796334, at *1 (N.D.Ohio May 4, 2010), the court considered omnibus generic Daubert motions filed by the parties relating to the admissibility of experts in a products liability case in which plaintiffs alleged different agents in magnetic resonance scans caused a rare disease known as Nephrogenic Systemic Fibrosis (“NSF”). The court considered, among other issues, whether Dr. Fine, who was not a regulatoiy expert with expertise to opine on FDA regulations and the regulatory process or whether defendants complied with those regulations or processes, could, based on his “background as a nephrologist and his review of [defendants’] renal studies, internal documents and the published literature at the time” offer opinions about the adequacy of the defendants’ warnings regarding the risks of the product at issue. Id. at *19. The court concluded that Dr. Fine was qualified to interpret and offer opinions about defendants’ renal studies and therefore could offer opinions on whether the labeling information or Dear Doctor letters contained adequate information, or inaccuracies or omissions that could deprive or mislead physicians like himself who treat renally impaired patients about the risks associated with the administration of the product at issue. Id.

Second, in In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prods. Liab. Litig., No. MDL 1203, 2000 WL 876900, at *11 (E.D.Pa. June 20, 2000), the court considered whether the defendant pharmaceutical company adequately warned about the risks associated with the defendants’ diet drugs. The defendants did not challenge the qualifications of the doctors to opine on their respective disciplines. Id. The court did not permit the doctors to testify as to regulatory requirements for labels or warnings, but did allow the experts to offer opinions concerning medical facts and science regarding the risks of the drugs in question, and to compare that knowledge with what was provided in the drug label and warning. Id. Specifically, the doctors were “qualified to render an opinion as to the labels’ completeness, accuracy, and — it follows from that — the extent to which- any inaccuracies or omissions could either deprive a reader or mislead a reader of what the risks and benefits of the diet drugs in issue are or were at the time the labeling was published.” Id.

The same is the case here. The parties do not dispute that Dr. Privitera is qualified as a neurologist, and his credentials establish his -expertise in the field. However, Dr. Privitera is not qualified to opine on the regulatory aspects of the case, including whether Abbott was' required to send a patient' package leaflet directly to patients or whether Abbott’s submissions to the FDA should have included certain materials. Similarly, testimony about what Defendants should have included in the label or what materials should have been submitteid to the FDA falls outside the scope of his expertise, as it falls under the regulatory component and is speculative.'Thus, Dr. Privitera also may not testify about whether Depakote should have been contraindicated for all women of childbearing years. On the other hand, testimony in which Dr. Privitera opines on the medical facts and science regarding the risks and benefits of Depa-kote and compares that knowledge with what was provided in the text of the labeling is admissible.

c. Comparative Label

Having found that questions of fact exist as to the adequacy of Depakote’s label’s warnings, the Court will now consider Defendants’ argument that they were not obligated under Ohio law to provide language in its label comparing the risks of Depa-kote to other AEDs. Specifically, Plaintiffs allege that Defendants’ label was inadequate because it improperly compared Depakote to other AEDs, but the risks associated with Depakote were greater, including the increased risk of congenital malformations when Depakote is prescribed as part of polytherapy and the increased risk of teratogenic effects to the developing fetus as compared to other an-tiepileptic drugs, which are safer for women of childbearing age.

Defendants argue that Plaintiffs’ allegation that its label failed to -adequately warn of the increased risk of teratogenic effects to the developing fetus. as compared to other antiepileptic drugs, which are safer for women of childbearing age, fails as a matter of law. Alternatively, Defendants argue .that the voluntary duty rule, under which one who gratuitously undertakes a voluntary act assumes the duty to complete with due care under the circumstances, does not apply here. Finally, Defendants contest the evidence Plaintiffs rely upon for the proposition that Depa-kote was more harmful than other AEDs.

To support their argument that Defendants were under no obligation to provide a comparative warning, Defendants argue that the Sixth Circuit in Ackley v. Wyeth Laboratories, Inc., has held that a manufacturer is “obligated to make a reasonable disclosure of all the risks inherent in its own drug,” but “[i]t is not obligated to provide a comparison of its drug with others[’].” 919 F.2d 397, 405 (6th Cir.1990) (citing Seley v. G.D. Searle & Co., 67 Ohio St.2d 192, 423 N.E.2d 831 (1981)). Defendants contend that the portion of the label upon which Plaintiffs rely does not offer a comparison between Depakote and other AEDs.

Plaintiffs argue Ackley is distinguishable, and the Court agrees. As other courts have acknowledged, the Ackley case did not involve warnings that included comparative information. See, e.g., J.B. v. Abbott Laboratories, Inc., No. 13-cv-326-DRH-SCW, 2014 WL 1464204, at *5 (S.D.Ill. April 14, 2014) (distinguishing Ackley and other cases on the basis that they “do not .appear to involve warnings that included comparative information”); Schedin v. Ortho-McNeiL-Janseen Pharms., Inc., 776 F.Supp.2d 907, 914 (D.Minn.2011) (Ackley did not apply because information “on comparative drugs was germane to the