James v. Diva Int'l, Inc.

• Decision Date: 18 March 2011
• Docket Number: Case No. 1:10–cv–0527–TWP–TAB.
• Citation: 803 F.Supp.2d 945
• Parties: Sarah JAMES and Gerrad James, Plaintiffs, v. DIVA INTERNATIONAL, INC., Defendant.
• Court: U.S. District Court — Southern District of Indiana

803 F.Supp.2d 945

Sarah JAMES and Gerrad James, Plaintiffs,

v.DIVA INTERNATIONAL, INC., Defendant.

Case No. 1:10–cv–0527–TWP–TAB.

United States District Court,S.D. Indiana,Indianapolis Division.

March 18, 2011.

John Michael Antrim, Samuel Roy Robinson, Church Church Hittle & Antrim, Noblesville, IN, for Plaintiffs.

Elizabeth H. Getches, Eric B. Liebman, Moye White LLP, Denver, CO, Kyle Andrew Lansberry, Theresa Renee Parish, Lewis & Wagner, Indianapolis, IN, for Defendant.

ORDER ON DEFENDANT'S MOTION TO DISMISS

TANYA WALTON PRATT, District Judge.

This matter comes before the Court on Diva International Inc.'s (“Diva” or “Defendant”), Motion to Dismiss [Dkt. 15]. Plaintiff, Sarah James (“James” or “Plaintiff”) and her husband Gerrad James (collectively, “Plaintiffs”) filed suit in this Court alleging that a menstrual product manufactured by Defendant caused James to develop Toxic Shock Syndrome. Plaintiffs have alleged negligence and violations of two state statutes, Ind.Code §§ 34–20–4–1 and –2, for failure to warn and sale of a defective product. Diva filed the instant Motion to Dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), based upon failure to state a claim with specificity, and federal preemption as required by the Medical Device Amendments to the Food, Drug and Cosmetic Act, 21 U.S.C. § 360c et seq. For the reasons set forth below, Defendant's Motion to Dismiss [Dkt. 15] is DENIED in part and GRANTED in part.

I. BACKGROUND

For the following factual background, the Court accepts Plaintiff's well-pleaded allegations as true and draws all favorable inferences for Plaintiffs. See Killingsworth v. HSBC Bank, 507 F.3d 614, 618 (7th Cir.2007). With this standard in mind, the Court will recite the pertinent facts of the case.

A. Factual Background

Diva is the manufacturer and upstream distributor of the DivaCup Menstrual Solution (“DivaCup®”) model 1, which is the subject of this action. The DivaCup® is an alternative to traditional tampons and pads. The DivaCup® is manufactured in Ontario, Canada and sold in this instance, in Indiana. On or about March 26, 2008, James purchased and used the DivaCup® in accordance with its intended use and allegedly sustained injuries from Toxic Shock Syndrome. Through Plaintiffs' Amended Complaint (“Amended Complaint”), it is alleged that: (1) Diva failed to properly package or label the DivaCup® to give reasonable warnings of danger to James about the product even though Diva, by exercising reasonable diligence, could have made such warning available to James; and (2) at the time of purchase, the product was in a defective condition. [Dkt. 23 at 3]. The Amended Complaint alleges claims for “Negligence,” “Product Liability; Strict Liability in Tort,” and “Loss of Consortium” stemming from James' subsequent hospitalization after her use of the DivaCup®.

B. Medical Device Amendments to the Food, Drug and Cosmetic Act

As a medical device, the DivaCup® is governed in the United States by the Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 360c et seq. This means that the DivaCup® is subject to regulations and requirements as set out by the Food and Drug Administration (“FDA”). In 1976 Congress enacted the MDA as a system of regulation for all medical devices in which the FDA classifies each medical device intended for human use. 21 U.S.C. § 360c(a)(1). The three classifications the FDA utilizes establish an ascending order of control and oversight. Dow v. Baxter Healthcare Corp., 899 F.Supp. 822, 824 (D.Mass.1995).

Class I consists of devices which require only general control. Id. Class II includes devices which require compliance with both general controls and applicable performance standards promulgated by the FDA. Id. The FDA has classified the DivaCup® as a Class II medical device. Id. The performance standards of Class II devices include annual registration, labeling requirements, prohibitions against misbranding and adulteration, and good manufacturing practices. 21 U.S.C. § 360c; 21 U.S.C. § 360k; 21 C.F.R. § 860.3(c)(1)-(2). Finally, Class III includes devices which pose potential unreasonable risks of injury. The controls exercised over Class II devices are insufficient to determine safety or effectiveness of Class III devices; accordingly, Class III devices must be generally approved prior to being marketed through a premarket authorization procedure. See 21 U.S.C. § 360e and § 360c(a)(2)(C).

Some devices, however, enter the market through Section 510(k) of the MDA. This section applies to any device which the manufacturer submits as, and the FDA finds to be, “substantially equivalent” in design and function to a “predicate device” (i.e., a device which was on the market prior to the effective date of the MDA or was lawfully sold as a substantially equivalent device). 21 U.S.C. § 360c(f) and (i); 21 C.F.R. § 814.80. This is the process which allowed the DivaCup® to enter into the market. The “substantially equivalent” process has been described as follows:

Under section 510(k), devices that are shown to be substantially equivalent to a device on the market before the MDA [was] passed (a “predicate” device) can gain approval without submitting to the type of premarket approval required for a new device. At least ninety days before marketing its device, a manufacturer must submit to the FDA information that the device has the same intended use as a pre-Amendment device and that it has the same technological characteristics. Alternatively, a device may satisfy the 510(k) process even if it has different technological characteristics, as long as these characteristics do not raise different questions of safety and effectiveness from the predicate device. If a device meets the equivalence requirement, it can enter the marketplace without further scrutiny.

Dow, 899 F.Supp. at 824–25. The FDA may also request additional information in an effort to determine whether the device is substantially equivalent to a predicate device. 21 C.F.R. § 807.100. Additionally, the FDA regulations govern the form and substance of the information required for a submission under Section 510(k), including proposed labeling. 21 C.F.R. §§ 807.87 and 807.92.

II. LEGAL STANDARD

Pursuant to Federal Rule of Civil Procedure 12(b)(6), the Court must take the facts alleged in the complaint as true and draw all reasonable inferences in favor of the Plaintiff. Mosley v. Klincar, 947 F.2d 1338, 1339 (7th Cir.1991). The complaint must contain only “a short and plain statement of the claim showing that the pleader is entitled to relief,” Fed.R.Civ.P. 8(a)(2), and there is no need for detailed factual allegations. Pisciotta v. Old Nat'l Bancorp, 499 F.3d 629, 633 (7th Cir.2007) (citation omitted). Nevertheless, the statement must “give the defendant fair notice of what the claim is and the grounds upon which it rests” and the “[f]actual allegations must be enough to raise a right to relief above the speculative level.” Id. (citations and quotations omitted). “Although this does ‘not require heightened fact pleading of specifics,’ it does require the complaint to contain ‘enough facts to state a claim to relief that is plausible on its face.’ ” Killingsworth, 507 F.3d at 618 (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)).

III. DISCUSSION

Defendant asserts that James' claims fail due to insufficient pleading, as well federal preemption by the Medical Device Amendments to the Food, Drug and Cosmetic Act, 21 U.S.C. § 360c et seq. The Court will address each allegation in turn.

A. Pleading Requirements

“While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the ‘grounds' of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 1964–65, 167 L.Ed.2d 929 (2007) (internal citations omitted).

The Seventh Circuit addressed the difficulty of pleading regarding a manufacturing issue on a medical device in Bausch v. Stryker Corporation, and determined that so long as the plaintiff alleges facts sufficient to meet the “plausibility” standard then pleading is sufficient. Bausch v. Stryker Corp., 630 F.3d 546, 558 (7th Cir.2010); See Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (to survive a motion to dismiss, the complaint “must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face’.... A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.”) (emphasis added). Ashcroft, 129 S.Ct. at 1949 (citing Twombly, 550 U.S. at 570, 127 S.Ct. 1955). We give the plaintiff “the benefit of imagination, so long as the hypotheses are consistent with the complaint.” Bausch, 630 F.3d at 559 (emphasis added) (quoting Bissessur v. Indiana Univ. Bd. of Trs., 581 F.3d 599, 603 (7th Cir.2009)).

In deciding whether a complaint can survive a motion to dismiss, the Seventh Circuit has consistently said: “As a general rule ... notice pleading remains the standard.” Id. at 559 (quoting Windy City Metal Fabricators & Supply, Inc. v. CIT Tech. Financing Services, 536 F.3d 663, 667 (7th Cir.2008)). “Together, these rules ensure that claims are determined on their merits rather than on pleading technicalities.” Christensen v. County of Boone, 483 F.3d 454, 458 (7th Cir.2007).

According to James' Amended Complaint, the Defendant is identified as the manufacturer and seller of the Class II medical device DivaCup®. Plaintiff pled that on or about March 26, 2008, she purchased the DivaCup® and used it in accordance with its intended use. James' Amended Complaint further alleged that the...