Rheinfrank v. Abbott Labs., Inc.

• Decision Date: 10 August 2015
• Docket Number: Case No. 1:13–cv–144
• Citation: 119 F.Supp.3d 749
• Parties: Rheinfrank, et al., Plaintiffs, v. Abbott Laboratories, Inc., et al., Defendants.
• Court: U.S. District Court — Southern District of Ohio

119 F.Supp.3d 749

Rheinfrank, et al., Plaintiffs,

v.Abbott Laboratories, Inc., et al., Defendants.

Case No. 1:13–cv–144

United States District Court, S.D. Ohio, Western Division.

Signed August 10, 2015

Barry David Jacobson Levy, O'Connor Acciani & Levy, Calvin S. Tregre, Jr., Janet Gilligan Abaray, Melanie Sue Bailey, Sanna-Rae Taylor, Burg Simpson Eldredge Hersh & Jardine PC, Cincinnati, OH, for Plaintiffs.

Kathleen F. Sullivan Hardway, Andrea S. Andrews, Dino S. Sangiamo, James E. Gray, Jason C. Rose, Jason Sayers, John A. McCauley, Michael B. MacWilliams, Paul Farrell Strain, Stephen E. Marshall, Thomasina E. Poirot, Venable LLP, Baltimore, MD, Brian J. Mooney, Gordon & Rees LLP, San Francisco, CA, Jeffrey Daniel Geoppinger, Ulmer & Berne LLP, Cincinnati, OH, for Defendants.

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

,¹ during her pregnancy with her daughter, M.B.D. Defendants Abbott Laboratories, Inc., Abbvie, Inc., and Abbott Laboratories² ("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. BACKGROUND³

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 Depakote 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. Rheinfrank 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 PageID 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 Depakote

are Walgreens Pharmacy records showing consistent prescriptions for Depakote 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 PageID 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 PageID 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 TERATOGENIC 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 TERATOGENIC POTENTIAL OF VALPROATE IS AVAILABLE FOR PATIENTS.

(2000 Package Insert, Doc. 113-14 at PageID 13347; 2003 Package Insert, Doc. 113-15 at PageID 13367; 2001 PDR, Doc. 113-16 at PageID 13387; 2003 PDR, Doc. 113-17 at PageID 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, VALPROIC ACID

MAY PRODUCE TERATOGENIC 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 TRIMETHADIONE, PARAMETHADIONE, PHENYTOIN, AND PHENOBARBITAL, REPORTS INDICATE A POSSIBLE SIMILAR ASSOCIATION WITH THE USE OF OTHER ANTIEPILEPTIC DRUGS. THEREFORE, ANTIEPILEPSY 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 CANNOT BE REGARDED AS A CAUSE AND EFFECT RELATIONSHIP. THERE ARE INTRINSIC METHODOLOGIC

PROBLEMS IN OBTAINING ADEQUATE DATA ON DRUG TERATOGENICITY

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 PageID 13354; Doc. 113-15 at PageID 13374; Doc. 113-16 at PageID 13390; Doc. 113-17 at PageID 13399.)

B. Procedural History

Plaintiffs filed this action on February 28, 2013, and many related cases are pending throughout the country.⁴ 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 summary judgment. 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...