By v. Abbott Labs., Inc.

Z.H. by and through KEVIN HUTCHENS and CHRISTIN HUTCHENS,individually, and as parents and next friends of Z.H. Plaintiffs, v. ABBOTT LABORATORIES, INC. and ABBVIE, INC. Defendant.

CASE NO.1:14CV176

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION

September 30, 2016

JUDGE CHRISTOPHER A. BOYKO

OPINION AND ORDER

CHRISTOPHER A. BOYKO, J:

This matter is before the Court on the Motion for Summary Judgment by Defendants Abbott Laboratories, Inc. and Abbvie, Inc. (ECF # 57). For the following reasons, the Count grants, in part and denies, in part, Defendants' Motion.

Plaintiffs Kevin and Christin Hutchens, parents of Plaintiff Z.H., a minor, are Ohio residents. Defendant Abbott Laboratories is an Illinois corporation. Defendant AbbVie, Inc. is a Delaware corporation with its principal place of business in Illinois.

According to the First Amended Complaint, Z.H. was born in 2003 with a number of severe birth defects allegedly caused by Christin's use of Depakote, an anti-seizure medication formulated, tested, manufactured and marketed by Defendants during her pregnancy. Depakote has been approved and sold in the United States since 1978 for the treatment of certain forms of epilepsy. Depakote is promoted as an effective anti-epileptic drug ("AED"). However, Plaintiffs allege Depakote is defective and dangerous for its intended use because the primary compound in Depakote, valproic acid, is teratogenic (of, relating to, or causing developmental malformations) - i.e.- causes severe birth defects if taken during the first trimester of pregnancy. Among the birth defects known to be caused by first trimester exposure to Depakote are spina bifida, cleft palate, limb and digital deformities, facial dysmorphism, mental development delays, genitourinary malformations and heart defects. According to Plaintiffs, Depakote is riskier than other AEDs for women who are or may become pregnant and Defendants were aware of the heightened risks of birth defects from Depakote, yet they continue to market and distribute it in the United States without adequate warnings.

According to Plaintiffs, Defendants failed to communicate the heightened risk of birth defects to doctors and women but instead sought to minimize the risks and downplay the dangers in their product labeling. Defendants further marketed Depakote for off-label uses despite the knowledge of the risks. This is particularly troubling since the damage to the developing child is done often before a woman even knows she is pregnant.

Due to Defendants' alleged breaches of their duty of reasonable care, breaches of their express and implied warranties and their misrepresentations and omissions concerning the known risks of Depakote, Plaintiffs allege they have been injured. Z.H. was born with heart defects, hypospadias, limb defects and developmental delay, as well as other congenital malformations and birth defects. Plaintiffs allege Ohio state law claims, including Strict Products Liability for Design Defect under O.R.C. 2307.75, Strict Products Liability for Inadequate Warning under O.R.C. 2307.76, Strict Products Liability for Nonconformance with Representations under O.R.C. 2307.77, Negligence, Gross Negligence, Negligent Misrepresentation and Fraud, Breach of Implied Warranty, Breach of Express Warranty, Intentional Infliction of Emotional Distress, Negligent Infliction of Emotional Distress and Loss of Consortium.

Defendants have moved for summary judgment on all Plaintiffs' claims. Defendants contend Depakote packaging contained a Black Box warning on the Depakote label at the time Christin got pregnant in 2002. This Black Box warning was the strongest warning permitted under FDA regulations. Defendants further contend they provided physicians with sufficient warnings that reasonably disclosed the risks of birth defects. Relying on the Sixth Circuit decision in Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397 (6th Cir. 1990), Defendants argue that Ohio law does not require that a warning label provide a comparison of the dangers of Defendants' drug compared with other AEDs. Furthermore, even if Ohio law imposed such a duty on Defendants, Christin's physician would still have prescribed Depakote to Christin because the physician knew of the greater risks of Depakote from her study of relevant medical literature, yet still determined it was the best option for treating Christin's seizures.

Defendants challenge Plaintiffs' claims that Depakote caused Z.H.'s cognitive developmental delay because Plaintiffs lack competent medical evidence supporting such a causal relationship. Also, the FDA would not have permitted such a warning on the Depakote label because there was no clear scientific evidence supporting this conclusion back in 2002. This is supported by Defendants' attempts to have just such a warning added to its label in 2005 and 2007 and both times the FDA rejected Defendants' attempts to include the cognitive development warning. Thus, according to Defendants, federal law preempts Plaintiffs' state law claims arising from any alleged failure to warn of any cognitive development delay.

Defendants move for summary judgment on Plaintiffs' design defect claim, which alleges the Depakote warning label was defective. Defendants argue that the Depakote label adequately warned about the risks. Plaintiffs offer no evidence that the drug Depakote itself was defectively designed, in fact, Christin still takes Depakote because it has provided the best relief of her seizure symptoms with the fewest side effects. Furthermore, for Plaintiffs to prevail on a claim that Depakote is defective they must demonstrate by expert testimony that the risks of Depakote outweigh the benefits. Plaintiffs have offered no such testimony. Also, Plaintiffs cannot show a better alternative existed in 2002. Lastly, when the FDA approves a drug, federal regulations prohibit changes to formulation.

Defendants further challenge Plaintiffs' breach of warranty claims, contending that the "learned intermediary doctrine" insulates Defendants from liability. Even if the doctrine does not apply, Plaintiffs did not rely on any representation by Defendants but instead relied on the representations of Christin's physician. Defendants argue that all Plaintiffs' common law claims are abrogated by the Ohio Product Liability Act ("OPLA") and move for summary judgment on Plaintiffs' demand for punitive damages because the FDA has not found Defendants committed fraud and Plaintiffs cannot show conscious disregard for the rights and safety of Depakote users.

LAW AND ANALYSIS

Standard of Review

Summary judgment shall be granted only if "the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." See Fed.R.Civ.P. 56(a). The burden is on the moving party to conclusively show no genuine issue of material fact exists. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986); Lansing Dairy. Inc. v. Espy, 39 F.3d 1339, 1347 (6th Cir. 1994). The moving party must either point to "particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations, admissions, interrogatory answers, or other materials" or show "that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact." See Fed.R.Civ.P. 56(c)(1)(A), (B). A court considering a motion for summary judgment must view the facts and all inferences in the light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). Once the movant presents evidence to meet its burden, the nonmoving party may not rest on its pleadings, but must come forward with some significant probative evidence to support its claim. Celotex, 477 U.S. at 324; Lansing Dairy, 39 F.3d at 1347.

This Court does not have the responsibility to search the record sua sponte for genuine issues of material fact. Betkerur v. Aultman Hospital Ass'n., 78 F.3d 1079, 1087 (6th Cir. 1996); Guarino v. Brookfield Township Trustees, 980 F.2d 399, 404-06 (6th Cir. 1992). The burden falls upon the nonmoving party to "designate specific facts or evidence in dispute," Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50 (1986); and if the nonmoving party fails to make the necessary showing on an element upon which it has the burden of proof, the moving party is entitled to summary judgment. Celotex, 477 U.S. at 323. Whether summary judgment is appropriate depends upon "whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law." Amway Distributors Benefits Ass 'n v. Northfield Ins. Co., 323 F.3d 386, 390 (6th Cir. 2003) (quoting Anderson, 477 U.S. at 251-52).

Count I Strict Products Liability Design Defect O.R.C. 2307.75, Negligent Design and Breach of an Implied Warranty

Plaintiffs' First Amended Complaint alleges Depakote was defective in its design or formulation "because it when it left the hands of Defendants, the forseeable risks of the product exceeded the benefits associated with its design or formulation;" (FAC pg 9 at 34) and "it was more dangerous than an ordinary consumer would expect" (Id at 35) and there were alternative AEDs available with less teratogenic risks but comparable efficacy. O.R.C. 2307.75, in effect during the relevant time period, stated in pertinent part:

a product is defective in design or formulation if either of the following applies:(1) When it left the control of its manufacturer, the foreseeable risks associated with its design or formulation as determined pursuant to division (B) of this section exceeded the benefits associated with that design or formulation as determined pursuant to division (C) of this section;(2) It is more dangerous than an ordinary consumer

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