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Richardson v. Bayer HealthCare Pharmaceuticals Inc.

United States District Court, D. Idaho

August 30, 2016

BRIAN RICHARDSON and SUSAN RICHARDSON, husband and wife, Plaintiffs,
v.
BAYER HEALTHCARE PHARMACEUTICALS INC., CONCEPTUS, INC., ESSURE, ESSURE PROMISE, and JOHN DOE CORPORATIONS I-X, Defendants.

          MEMORANDUM DECISION AND ORDER

          B. Lynn Winmill Chief Judge United States District Court

         INTRODUCTION

         The Court has before it Defendants Bayer HealthCare Pharmaceuticals Inc. and Bayer Essure Inc.'s (collectively, “Bayer”) Motion for Judgment on the Pleadings (Dkt. 13), and Plaintiffs Brian and Susan Richardson's Motion to Amend/Correct Amended Complaint (Dkt. 14). Bayer asserts that Plaintiffs' state law claims are expressly and impliedly preempted by federal law.

         From a procedural standpoint, this case is a bit convoluted. Bayer provided substantial briefing in support of their original Motion for Judgment on the Pleadings. Plaintiffs' only substantive “response” was their motion to amend the amended complaint, which includes a copy of their Proposed Second Amended Complaint. See Motion to Amend, Dkt. 14; Supplement to Motion to Amend, Dkt. 16. Plaintiffs' Proposed Second Amended Complaint is extensive, detailed, and almost brief-like, including at least one case citation. Id. at ¶ 12. Plaintiffs' actual “response” to the motion was a simple one-page “brief” that cited their Proposed Second Amended Complaint.

         Bayer then responded to Plaintiffs' motion to amend with more substantial briefing, essentially making the same arguments as to the Proposed Second Amended Complaint that they made against the Amended Complaint. Plaintiffs failed entirely to respond to Bayer's opposition brief, which was filed on March 4, 2016. Plaintiffs' failure to respond to Defendants' arguments has placed this Court in a somewhat difficult position, particularly given the complexity of the legal arguments involved.

         Rule 15 of the Federal Rules of Civil Procedure provides that leave to amend “shall be freely given when justice so requires.” Fed.R.Civ.P. 15(a). In the interest of efficiency and thoroughness, the Court will grant Plaintiffs' Motion to Amend (Dkt. 14), and will address Bayer's arguments as they apply to the Second Amended Complaint. Thus, the Court essentially has before it a second motion for judgment on the pleadings or motion to dismiss the Second Amended Complaint. And the Court will note that Plaintiffs have been given an opportunity to respond to Bayer's arguments as they apply to both complaints. Accordingly, to the degree the Court grants dismissal, the Court will not give Plaintiffs yet another chance to amend - that right has already been granted by allowing the Second Amended Complaint, which Plaintiffs filed after having the opportunity to review Defendants' briefs.

         BACKGROUND

         The Richardsons' claims arose after Susan Richardson had the birth control device, Essure, implanted in her fallopian tubes on or around December 27, 2011 to prevent future pregnancies. Proposed Am. Complaint, at ¶ 4, Dkt. 16-1. About a year later, Plaintiffs discovered that Susan was pregnant despite the procedure. Id. at ¶ 6. An ultrasound later revealed that she was pregnant with twins. Id. Plaintiffs' Second Amended Complaint alleges ten state common-law causes of action asserting liability for the negligent and defective manner in which Essure was “manufactured, designed, formulated, tested, packaged, labeled, produced, created, made, constructed, assembled, marketed, advertised, distributed and sold.” Id. at ¶ 75. Bayer is responsible for the manufacturing and distribution of the Essure birth control device. Id. at ¶ 3.

         Plaintiffs' claims arise in the context of an extensive federal regulatory scheme. Medical devices are regulated by the FDA pursuant to the Food, Drug, and Cosmetics Act (“FDCA”) and the Medical Device Amendments of 1976 (“MDA”). 21 U.S.C. § 360c et seq. Pursuant to the MDA, Essure is conditionally designated as a Class III medical device, which means its design, manufacturing process, and labeling underwent the rigorous scrutiny of the FDA's premarket approval process (“PMA”). See Second Am. Compl. at ¶ 33, Dkt. 16; see also 21 U.S.C. § 360e. Essure's “conditional” status is conditioned on further trial testing, but the device is still regulated under the MDA statutory scheme until such status is otherwise revoked. See Am. Compl. at ¶ 42. A device is classified under Class III (and therefore subject to PMA) when the less stringent classifications cannot provide reasonable assurance of its safety and effectiveness, and the device is used either “in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health” or it “presents a potential or unreasonable risk of illness or injury.” 21 U.S.C. § 360c(a)(1)(C).

         A Class III device may only win PMA status and be marketed if the FDA finds, based on detailed investigations into the safety and effectiveness of the device and its labeling, that there is a “reasonable assurance of safety and effectiveness of [that] device....” 21 U.S.C. § 360e(d); see also Riegel v. Medtronic, Inc., 552 U.S. 312, 317-18 (2008) (describing PMA in detail). The determination of the safety and effectiveness of a device is made in part by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” 21 U.S.C.A. § 360c. In addition to regulating the device's actual design and application, the FDA must approve its labeling, including whether it is false or misleading under § 360e(d)(1)(A), and requires post-approval clinical investigations, scientific studies, and periodical reports to the FDA. See 21 C.F.R. § 814.84(b)(2).

         Because Essure is a Class III device subject to the FDA's PMA process, all relevant regulations under the FDCA and MDA are applicable. Bayer's motion is based on the assertion that Plaintiffs' state law claims are both expressly and impliedly preempted by the federal statutory scheme encompassed in the FDCA and the MDA.

         LEGAL STANDARD

         FRCP 8(a)(2) requires only “a short and plain statement of the claim showing that the pleader is entitled to relief, ” to “give the defendant fair notice of what the ... claim is and the grounds upon which it rests.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). While a complaint attacked by an FRCP 12(b)(6) motion to dismiss “does not need detailed factual allegations, ” it must set forth “more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Id. at 555. To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to “state a claim for relief that is plausible on its face.” Id. at 570. 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. Id. at 556. The plausibility standard is not akin to a “probability requirement, ” but it asks for more than a sheer possibility that a defendant has acted unlawfully. Id. Where a complaint pleads facts that are “merely consistent with” a defendant's liability, it “stops short of the line between possibility and plausibility of ‘entitlement to relief.'” Id. at 557.

         Rule 15 of the Federal Rules of Civil Procedure provides that leave to amend “shall be freely given when justice so requires.” Fed.R.Civ.P. 15(a). Indeed, while the decision to grant leave to amend is within the Court's discretion, the Court “must be guided by the underlying purpose of Rule 15 to facilitate decision on the merits rather than on the pleadings or technicalities.” U.S. v. Webb, 655 F.2d 977, 979 (9th Cir.1981). This “policy of favoring amendments to pleadings should be applied with extreme liberality.” Id. (internal quotation marks omitted).

         To determine “whether justice requires granting leave to amend, ” courts consider “the presence or absence of undue delay, bad faith, dilatory motive, repeated failure to cure deficiencies by previous amendments, undue prejudice to the opposing party and futility of the proposed amendment.” Moore v. Kayport Package Express, Inc., 885 F.2d 531, 538 (9th Cir.1989) (citing Foman v. Davis, 371 U.S. 178, 182 (1962)). “Generally, this determination should be performed with all inferences in favor of granting the motion.” Griggs v. Pace Am. Group, Inc., 170 F.3d 877, 880 (9th Cir.1999) (citing DCD Programs, Ltd. v. Leighton, 833 F.2d 183, 186 (9th Cir.1987)). Nevertheless, the “general rule that parties are allowed to amend their pleadings. . .does not extend to cases in which any amendment would be an exercise in futility or where the amended complaint would also be subject to dismissal.” Steckman v. Hart Brewing, Inc., 143 F.3d 1293, 1298 (9th Cir.1998) (citations omitted). Futility alone can justify a court's refusal to grant leave to amend. See Bonin v. Calderon, 59 F.3d 815, 845 (9th Cir.1995).

         ANALYSIS

         1. Express and implied preemption under the MDA and FDCA

         Under the MDA, many state law claims asserting liability for allegedly faulty medical devices are expressly preempted by federal law. See 21 U.S.C. § 360k(a); see also Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Additionally, even claims not expressly preempted by the MDA may be impliedly preempted under the FDCA's greater enforcement scheme. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 348 (2001).

         A. Express preemption under the MDA

         Unless a state seeks a specific exemption available under the statute, the MDA provides that no state may establish or enforce any requirement that ...


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