Gannon v. Bayer Healthcare Pharm., Inc. (In re Yasmin & Yaz (Drospirenone) Mktg., Sales Practices & Prods. Liab. Litig.), 3:09-md-02100-DRH-PMF
| Court | United States District Courts. 7th Circuit. Southern District of Illinois |
| Writing for the Court | David R. Herndon |
| Docket Number | 3:09-md-02100-DRH-PMF,MDL No. 2100 |
| Parties | IN RE YASMIN AND YAZ (DROSPIRENONE) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION This Document Relates to: Gail Gannon v. Bayer Healthcare Pharmaceuticals, Inc., et al. No. 3:13-cv-10143-DRH-PMF |
| Decision Date | 23 April 2014 |
IN RE YASMIN AND YAZ (DROSPIRENONE) MARKETING, SALES PRACTICES
AND PRODUCTS LIABILITY LITIGATION
This Document Relates to:
Gail Gannon v. Bayer Healthcare Pharmaceuticals, Inc., et al. No. 3:13-cv-10143-DRH-PMF
3:09-md-02100-DRH-PMF
MDL No. 2100
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF ILLINOIS
Date: April 23, 2014
HERNDON, Chief Judge:
Before the Court is defendant Teva Pharmaceuticals USA's ("Teva") motion to dismiss under Fed.R.Civ.P. 12(c) (Doc. 23). Teva moves for judgment on the pleadings and dismissal of plaintiff Gail Gannon's ("plaintiff") claims against it. Plaintiff has filed a response in opposition (Doc. 28), to which defendant has replied in accordance with Local Rule 7.1(c) (Doc. 29). Teva contends that the plaintiffs allegations fail under Iqbal/Twombly and/or are pre-empt under federal law. The Court finds that the plaintiff's claims are adequately pled. Accordingly, the Court's order focuses on the issue of federal pre-emption. For the following reasons, defendant's motion is GRANTED IN PART AND DENIED IN PART.
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Plaintiff, a citizen of Illinois, directly filed her complaint in this Court on February 15, 2013, based on diversity of citizenship (Doc. 1). The plaintiff filed her first amended complaint on September 30, 2013 (Doc. 20). According to the pleadings, plaintiff purchased and ingested the brand-name combination oral contraceptive Yaz (drospirenone; ethinyl estradiol) in November 2009. Shortly thereafter, in June 2010, the plaintiff began using Gianvi, a generic iteration of Yaz (drospirenone; ethinyl estradiol) (Doc. 20 ¶ 3). Plaintiff contends that as a result of using Gianvi she suffered an acute bilateral pulmonary embolus on or about March 12, 2011 (Doc. 20 ¶ 3).
Plaintiff asserts claims against Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG (collectively, "Bayer") and Teva Pharmaceuticals USA ("Teva"). In her complaint, the plaintiff alleges that Bayer is the designer, developer, manufacturer, and seller of YAZ (Doc. 20 ¶¶ 3-21, 25, 60). The plaintiff further alleges and Teva admits that it is the distributor of Gianvi (Doc. 20 ¶ 24, 61).
The question of which entity manufactured the Gianvi ingested by the plaintiff is not a question that can be resolved by the Court at this stage in the litigation. The allegations appropriately considered by the Court at this time indicate the Gianvi ingested by the plaintiff was manufactured by either Bayer or a third entity not named as a defendant in this complaint - Barr Laboratories Inc ("Barr"). Barr is an entity that has entered into agreements with Bayer pursuant to
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which Bayer supplied Barr with generic versions of both Yaz (Gianvi) and Yasmin.1 Barr has been a wholly owned subsidiary of Teva since December 2008 (Doc. 63 ¶ 64). Barr submitted an Abbreviated New Drug Application ("ANDA") for a generic version of Yaz (distributed under the trade-name Gianvi), which was approved on March 30, 2009 (Doc. 23 p. 14 citing publically available records on the FDA's website). The Gianvi under Barr's ANDA is associated with national drug code numbers 0093-5661-58 and 00093-5661-28 (Doc. 23 p. 14 citing publically available records on the FDA's website).
Bayer has also manufactured Gianvi. The authorized generic version of YAZ (sold under the trade-name Gianvi) manufactured by Bayer is associated with national drug code numbers 0093-5423-58 and 0093-5423-28 (Doc. 20 ¶ 67, Doc. 22 ¶¶ 68-70).
Teva has distributed Gianvi under Barr's ANDA (i.e. associated with national drug code numbers 0093-5661-58 and 00093-5661-28) and under Bayer's NDA for the authorized generic version of Yaz (i.e. associated with national drug code numbers 0093-5423-58 and 0093-5423-28). Teva announced the introduction and availability of Gianvi under Barr's ANDA in June of 2010 (Doc. 20 ¶ 64). The "start marketing date" associated with Teva's distribution of
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Gianvi under Bayer's NDA for Yaz is March 30, 2011 (Doc. 23 p. 14 citing publically available records on the FDA's website).
Based on the above, Teva contends that it did not distribute an authorized generic version of drospirenone; ethinyl estradiol under Bayer's NDA prior to April 2011 and therefore, the Gianvi ingested by the plaintiff was necessarily Gianvi distributed by Teva under Barr's ANDA for drospirenone; ethinyl estradiol.2 The plaintiff has alleged that some Gianvi prescriptions filled before April 1, 2011 contain national drug code numbers 0093-5423-28 and 0093-542358, the national drug code numbers associated with Gianvi manufactured by Bayer and distributed by Teva (Doc. 20 ¶ 69). Accordingly, the plaintiff contends, it is possible that Bayer-manufactured Gianvi was available prior to April 1, 2011.
The plaintiff has also alleged that the Gianvi distributed by Teva under Barr's ANDA for drospirenone; ethinyl estradiol was made with drospirenone supplied by Bayer (See Doc. 20 ¶¶ 61-66) (alleging that pursuant to an agreement, Bayer supplied Barr with the product for Gianvi since December 2010). The plaintiff contends that this alleged agreement establishes that Bayer and Teva acted in concert to market, manufacture and supply Gianvi.
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Based on the above the Court finds that a question of fact exists with regard to which entity manufactured the Gianvi ingested by the plaintiff. However, in any of the alternative scenarios presently before the Court, Teva's involvement amounts to that of a generic distributor.3 Accordingly, the Court's analysis proceeds under the assumption that Teva is the entity that distributed the Gianvi ingested by the plaintiff.4
Federal Rule of Civil Procedure 12(c) allows a party to move for judgment on the pleadings, which include the complaint, the answer, and any written instruments, including contracts, that are attached as exhibits. N. Ind. Gun & Outdoor Shows, Inc. v. City of S. Bend, 163 F.3d 449, 452-53 (7th Cir. 1998). In reviewing a Rule 12(c) motion, a court applies the same standards applicable to a Rule 12(b)(6) motion seeking dismissal for failure to state a claim. See Buchanan-Moore v. County of Milwaukee, 570 F.3d 824, 827 (7th Cir. 2009). Thus, a court accepts as true all well-pled factual allegations and draws all reasonable inferences in the plaintiff's favor. See Rujawitz v. Martin, 561 F.3d 685, 688 (7th Cir. 2009). Only when it appears beyond a doubt that the plaintiff cannot prove any facts to support a claim for relief and the moving party
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demonstrates that there are no material issues of fact to be resolved will a court grant a Rule 12(c) motion. Brunt v. Serv. Employees Int'l Union, 284 F.3d 715, 718-719 (7th Cir. 2002) ( citing N. Indiana Gun & Outdoor Shows, Inc. v. City of South Bend, 163 F.3d 449, 452 (7th Cir.1998)). Although the court should accept as true all well-pleaded allegations and should view the complaint in a light most favorable to the plaintiff, the "[f]actual allegations must be enough to raise a right to relief above the speculative level." Twombly, 550 U.S. at 555.
If the Court considers evidence outside the pleadings, a motion for judgment on the pleadings is treated as one for summary judgment. FED. R. CIV. P. 12(d). However, a district court may take judicial notice of matters of public record without converting a Rule 12 motion into a motion for summary judgment. Gen. Elec. Capital Corp. v. Lease Resolution Corp., 128 F.3d 1074, 1080 (7th Cir.1997). Further, a court may consider "documents attached to a motion to dismiss * * * if they are referred to in the plaintiff's complaint and are central to his claim." Brownmark Films, LLC v. Comedy Partners, 682 F.3d 687, 690 (7th Cir.2012) (internal quotation omitted).
A. Preemption
Teva asserts that it is entitled to judgment on the pleadings because the plaintiff's state tort claims are preempted by federal law. The Supremacy Clause states that federal law "shall be the supreme Law of the Land ... and any Thing in
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the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. Implied preemption, the type of preemption at issue in this motion, occurs when it is "impossible for a private party to comply with both state and federal requirements." Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995). In other words, when state law requires what federal law forbids, state law must give way. See Wyeth v. Levine, 555 U.S. 555, 583, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009).
Federal preemption is an affirmative defense upon which the defendants bear the burden of proof. Village of DePue, III v. Exxon Mobil Corp., 537 F.3d 775, 786 (7th Cir. 2008).
B. The Hatch-Waxman Act
The labeling of prescription drugs is governed by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301, et seq. Pursuant to the FDCA, before bringing any new drug to market, approval must be obtained by filing a New-Drug Application ("NDA") with the U.S. Food and Drug Administration...
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