Frey v. Novartis Pharmaceuticals Corp.

• Decision Date: 23 July 2009
• Docket Number: No. C-1-07-317.,C-1-07-317.
• Citation: 642 F.Supp.2d 787
• Parties: Amanda FREY, et al., Plaintiffs, v. NOVARTIS PHARMACEUTICALS CORPORATION, et al., Defendants.
• Court: U.S. District Court — Southern District of Ohio

642 F.Supp.2d 787

Amanda FREY, et al., Plaintiffs, v. NOVARTIS PHARMACEUTICALS CORPORATION, et al., Defendants.

No. C-1-07-317.

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

July 23, 2009.

COPYRIGHT MATERIAL OMITTED

Alissa Jacqueline Magenheim, Barry David Jacobson Levy, O'Connor Acciani & Levy, Cincinnati, OH, for Plaintiffs.

Michael L. Junk, Hollingsworth LLP, Eric G. Lasker, Katharine R. Latimer, Spriggs & Hollingsworth, Washington, DC, Rex A. Littrell, Ulmer & Berne, Columbus, OH, for Defendants.

ORDER

HERMAN J. WEBER, Senior District Judge.

Plaintiffs Amanda Frey, Sharon Lacy and Thomas Lacy bring this action against defendants Novartis Pharmaceuticals Corporation (Novartis) and John Does 1-10. The matter is before the Court upon Novartis' motion for partial dismissal of the amended complaint (doc. 24), plaintiffs' memorandum in opposition to the motion to dismiss and, to the extent the Court finds the complaint to be deficient, plaintiffs' motion for leave to file a second amended complaint (doc. 28), and Novartis' reply (doc. 30).

I. Introduction

Plaintiffs, residents of Ohio, originally filed this action in the Court of Common Pleas for Clermont County, Ohio. Defendants removed the action to this court based on the court's diversity jurisdiction. Plaintiffs subsequently filed an amended complaint in which they make the following allegations: Novartis, a pharmaceutical company incorporated under the laws of the State of New Jersey with its principal place of business in New Jersey, and John Does 1-10 designed, manufactured, marketed, distributed and sold Trileptal (oxcarbazepine) in interstate commerce, including in Ohio. Trileptal is in a class of drugs known as anticonvulsants or antiepileptics, which generally prevent seizures, but more specifically Trileptal contains oxcarbazenpine. Trileptal's predecessor was Tegretol, which was also manufactured by Novartis, and Novartis marketed Trileptal as the "new Tegretol." On January 14, 2000, the Food and Drug Administration (FDA) approved Trileptal for the treatment of epilepsy, including partial seizures in adults. Subsequent to FDA approval, Trileptal was marketed by Novartis as a safe and effective anti-seizure medication. Defendants downplayed the health hazards and risks associated with Trileptal. Trileptal has been linked to several severe and life-threatening medical disorders, including multi-organ hypersensitivity, whose manifestations may include lymphadonopathy, hepatitis, liver function abnormalities, hematological abnormalities, pruritis, nephritis, oliguria, hepato-renal syndrome, arthralgia and asthenia. Defendants did not disclose these known material risks to plaintiff.¹ A labeling change was made in or about March 2005, adding a precaution regarding multi-organ hypersensitivity. On or about April 18, 2005, Novartis sent a warning letter to physicians of the label change.

Plaintiffs further allege that plaintiff Amanda Frey ingested Trileptal from March 25, 2005, until April 23, 2005; as a proximate result, she suffered multi-organ hypersensitivity and multiple related complications; and had she known of the risks and dangers associated with Trileptal, she would not have taken it and would not have been subject to its side effects.

Based on these allegations, plaintiffs bring a claim for strict liability for defect in the manufacture of Trileptal under Ohio Rev.Code § 2307.74 (First Cause of Action). In support of this cause of action, plaintiffs allege as follows:

¶ 27. The product which was consumed by Plaintiff was defective in design and construction at the time it left the Defendants' control.

¶ 28. Defendants failed to design, manufacture, test, and control the quality of Trileptal such that when it left the control of the Defendant, it deviated in a material way from the design specifications, formula or performance standards of the manufacturer, or from otherwise identical units manufactured to the same design specifications, formula or performance standards.

¶ 29. As a direct and proximate result of the defect in manufacture or construction by Defendants, Plaintiff [ ] suffered the injuries [] and damages set forth herein.

Plaintiffs bring as their second cause of action a claim for strict liability for defect in design or formulation under Ohio Rev. Code § 2307.75. They claim that the risks created by Trileptal exceeded its benefits and that a practical and technically feasible alternative design was available which would have prevented the harm alleged without substantially impairing the product's usefulness or intended purpose.

Plaintiffs allege as their third cause of action a claim for strict liability for inadequate warning or instruction pursuant to Ohio Rev.Code § 2307.76. They claim that Trileptal was defective due to inadequate warning or instruction at the time of marketing and post-marketing because defendants knew, or in the exercise of reasonable care should have known, about a risk associated with the product that caused the harm alleged, and defendants failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided concerning that risk.

As their fourth cause of action, plaintiffs allege strict liability for failure to conform to representation under Ohio Rev.Code § 2307.77. Plaintiffs make the following allegations in support of this claim:

¶ 46. At the time that the product and its component parts left the control of the Defendants, the product did not conform to representation(s) made by Defendants.

¶ 47. Plaintiff relied on the representations of Defendants in consenting to consume Trileptal.

Plaintiffs bring a claim for liability of a supplier under Ohio Rev.Code § 2307.78 as their fifth cause of action. They claim that defendants "had a duty to exercise reasonable care in the sale, quality control and assurance, representations made regarding the performance and risks of failure of the product, conveyance, [and] sale and/or distribution of the product within the stream of commerce ..." Plaintiffs claim that defendants negligently made representations to plaintiff regarding the safety of Trileptal which did not conform to the representations made by defendants at the time the product left their control. Plaintiffs contend that "Defendants suppliers" are liable as if they were the manufacturer because: (1) the supplier in question owned, or when it supplied that product, owned, in whole or in part, the manufacturer of that product; (2) the supplier in question created or furnished a manufacturer with a design or formulation that was used to produce, create, make[,] construct, assemble or rebuild the product or a component of that product; (3)[t]he supplier in question altered, modified, or failed to maintain that product after it came into the possession of, or before it left the possession of, the supplier in question and the alteration, modification or failure to maintain the product rendered it defective; or (4) the supplier marketed the product under its own label.

Finally, plaintiffs assert as their sixth cause of action in the amended complaint a claim for punitive or exemplary damages under Ohio Rev.Code § 2307.80, which has since been dismissed on stipulation of the parties (doc. 23), and a claim to recover economic loss sustained by plaintiffs Sharon Lacy and Thomas Lacy under Ohio Rev.Code § 2307.71 (seventh cause of action).

II. Applicable Law

A. Standard for Rule 12(b)(6) Motion to Dismiss

A motion to dismiss pursuant to Rule 12(b)(6) operates to test the sufficiency of the complaint. The first step in testing the sufficiency of the complaint is to identify any conclusory allegations. Ashcroft v. Iqbal, ___ U.S. ___, 129 S.Ct. 1937, 1950, 173 L.Ed.2d 868 (2009). "Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Id. at 1949 (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). "[A] plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (citations and quotation marks omitted). Although the court must accept well-pleaded factual allegations of the complaint as true for purposes of a motion to dismiss, the court is "not bound to accept as true a legal conclusion couched as a factual allegation." Id.

After assuming the veracity of all well-pleaded factual allegations, the second step is for the court to determine whether the complaint pleads "a claim to relief that is plausible on its face." Iqbal, 129 S.Ct. at 1949, 1950 (citing Twombly, 550 U.S. at 556, 570, 127 S.Ct. 1955) (rejecting the traditional 12(b)(6) standard set forth in Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)). A claim is facially plausible when the plaintiff "pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. at 1949 (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955). The standard for plausibility is not akin to a "probability requirement," but it requires "more than a sheer possibility that a defendant has acted unlawfully." Id. (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955).

B. The Parties' Positions

Defendants move to dismiss plaintiffs' first, second and fifth causes of action on the grounds that (1) plaintiffs fail to allege facts sufficient to state a claim for manufacturing defect under Ohio Rev.Code § 2307.74 because plaintiffs rely on only a "formulaic recitation of the elements of a cause of action" and they actually allege that Amanda Frey's injuries arose from the purported effects of Trileptal as designed and not from a deviation in the manufacture of the specific tablets she ingested (2) a claim of design defect in an ethical drug under...