McLaughlin v. Bayer Corp.

• Decision Date: 22 March 2016
• Docket Number: 14-7317,14-7318,14-7316,CIVIL ACTION NOS. 14-7315,15-384
• Parties: Helen McLaughlin v. Bayer Corporation, et al. Ruth Ruble v. Bayer Corporation, et al. Melda Strimel v. Bayer Corporation, et al. Susan Stelzer v. Bayer Corporation, et al. Heather Walsh v. Bayer Corporation, et al.
• Court: U.S. District Court — Eastern District of Pennsylvania

172 F.Supp.3d 804

Helen McLaughlin

v.Bayer Corporation, et al.

Ruth Ruble

v.Bayer Corporation, et al.

Melda Strimel

v.Bayer Corporation, et al.

Susan Stelzer

v.Bayer Corporation, et al.

Heather Walsh

v.Bayer Corporation, et al.

CIVIL ACTION NOS. 14-7315

14-7316

14-7317

14-7318

15-384

United States District Court, E.D. Pennsylvania.

Signed March 22, 2016

James J. McEldrew, III, Thomas A. Dinan, McEldrew Young Law LLC, Philadelphia, PA, Justin R. Parafinczuk, Marcus J. Susen, Koch Parafinczuk & Wolf, Fort Lauderdale, FL, for Helen McLaughlin.

Heather Reardon Olson, Albert G. Bixler, Leslie A. Hayes, Mark C. Levy, Eckert Seamans Cherin & Mellott LLC, Philadelphia, PA, Elizabeth C. Curtin, Maja C. Eaton, Sidley Austin LLP, Chicago, IL, for Bayer Corporation, et al.

MEMORANDUM

Padova, Judge.

Five individual Plaintiffs have initiated separate actions against Bayer Corp., Bayer Healthcare LLC, Bayer Essure, Inc., Bayer Healthcare Pharmaceuticals and Bayer A.G. (collectively, “Bayer”). Each action asserts twelve claims for relief, seeking compensation for injuries that the Plaintiff suffered in connection with her use of Bayer's female birth control device known as “Essure.” The five cases were consolidated for resolution of pre-trial motions. In each of the five cases, Bayer has filed the same Motion for Judgment on the Pleadings Under Federal Rule of Civil Procedure 12(c), asking that we dismiss all of Plaintiffs' claims either as expressly preempted, as impliedly preempted, because they fail to state a plausible or cognizable claim under Federal Rule of Civil Procedure 12(b)(6), or because they fail to plead fraud with particularity as required by Federal Rule of Civil Procedure 9(b). We held oral argument on January 11, 2016. For the following reasons, we now grant the Motion in part and deny it in part, and also grant Plaintiffs the opportunity to file amended complaints.

I. BACKGROUND

The First Amended Complaint in the McLaughlin case (“Compl.”) describes Essure as a female birth control device that “is intended to cause bilateral occlusion (blockage) of the fallopian tubes by the insertion of micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage.”¹ (Compl. ¶ 13.) “The micro-inserts are comprised of two metal coils which are placed in a woman's fallopian tubes via Defendants' disposable delivery system and under hysteroscopic guidance (camera).” (Id.¶ 34.) The Complaint alleges that, instead of working as intended, “the device migrates from the tubes, perforates organs, breaks into pieces, and/or corrodes.” (Id.¶ 13.)

Each Complaint details specific injuries that the Plaintiff suffered after she had Essure implanted. In all five cases, the Essure device migrated from the Plaintiff's fallopian tubes to the Plaintiff's uterus, rectum or colon. In four of the five cases, the Plaintiff had to have a hysterectomy

and, in the fifth case, the Plaintiff not only had her fallopian tubes removed, but also delivered a baby with birth defects. All five Plaintiffs also experienced various additional symptoms, including severe pelvic or abdominal pain, bleeding, rashes, hair loss, insomnia, night sweats, fever, limb numbness, weight gain, vision problems, and/or fainting spells.

Essure is a Class III medical device that required premarket approval by the Food and Drug Administration (the “FDA”). (Id.¶¶ 46, 49.) The FDA separates medical devices into three categories, depending on their level of risk, and Class III devices receive the most federal oversight. Riegel v. Medtronic, Inc., 552 U.S. 312, 316–17, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008).

The Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. (the “MDA”), which amended the Food, Drug and Cosmetic Act (“FDCA”), require new Class III devices to undergo a rigorous premarket approval process, which includes review of all known studies and investigations of the device's safety and effectiveness. Riegel, 552 U.S. at 316–18, 128 S.Ct. 999. The FDA “grants premarket approval only if it finds that there is a ‘reasonable assurance’ of the device's ‘safety and effectiveness.’ ” Id. at 318, 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(d) ). Because the FDA weighs “ ‘any probable benefit to health from the use of the device against any probable risk of injury or illness from such use,’ ” it “may...approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.” Id.(quoting 21 U.S.C. § 360c(a)(2)(C) ).

Following its review, the FDA may either grant approval, deny approval, or “condition approval on adherence to performance standards, restrictions upon sale or distribution, or compliance with other requirements.” Id. at 319, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d), and 21 C.F.R. §§ 814.82, 861.1(b)(3) ). “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specification, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id.(citing 21 U.S.C. § 360e(d)(6)(A)(i) ). Indeed, “the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that approved form provides a reasonable assurance of safety and effectiveness.” Id. at 323, 128 S.Ct. 999.

The Complaint alleges that the Essure device was first designed and manufactured by Conceptus, Inc. (Compl. ¶ 43.) Because it is a Class III medical device, Essure underwent the above-described scientific and regulatory review by the FDA to evaluate its safety and effectiveness. (Id.¶ 49.) On November 4, 2002, Essure received conditional premarket approval (“PMA”) from the FDA. (Id.¶ 15; 11/4/02 PMA letter (“PMA Ltr.”).² ) The PMA authorized Conceptus to begin commercial distribution of Essure in accordance with certain specified conditions, including that (1) the device be restricted to prescription use, (2) the labeling specify the requirements that apply to the training of practitioners that use the device, and (3) the sale, distribution and use not violate 21 U.S.C. § 352(q) and (r), which, inter alia, prohibit the use of false or misleading advertising and require all advertising or other descriptive matter to include certain information, such as all relevant warnings, precautions, and side effects. (PMA Ltr. at 1.) The PMA also required Conceptus to conduct studies and collect data regarding pregnancies and outcomes, as well as adverse events, and to report its findings to the FDA annually. (Id. at 1-2.) In addition, it required Conceptus to conduct a study to document the bilateral placement rates for newly trained physicians, to permit an evaluation of training procedures and to update product labeling. (Id. at 2.)

On April 28, 2013, Conceptus merged with Bayer, and Bayer now manufactures, sells, distributes, markets and promotes Essure. (Id.¶¶ 44, 46.) Bayer also trains physicians on how to use the device and how to implant the device using hysteroscopicequipment. (Id.¶¶ 47, 67.) Bayer's training program included creation of a physician training manual; creation of a simulator called EssureSim; the organization of training courses, during which Bayer observed physicians until it believed they were competent; and creation of a Procedures Equipment Supplies checklist. (Id.¶ 70.) Bayer also represented to Plaintiffs that “[p]hysicians must be signed-off to perform Essure procedures” and that Bayer kept training records of physicians who had been “signed-off” to perform the procedure. (Id.¶¶ 70, 72.)

The Complaint further alleges, among other things, that Bayer's training of physicians was inadequate and that Bayer provided the hysteroscopic equipment to implanting physicians who were not qualified or competent to use the equipment. (Id.¶ 66.) The Complaint further alleges that Bayer engaged in an unreasonably dangerous distribution plan aimed solely at capturing market share, insofar as it, inter alia, provided unqualified physicians with specialized hysteroscopic equipment and required implanting physicians to purchase two Essure kits a month, whether or not they used the kits. (Id.¶¶ 77-80.)

According to the Complaint, Bayer made several statements about Essure, in several different contexts, that were false and/or misleading and which constituted warranties. For example, on its website, Bayer falsely stated that Essure is “Worry free: once your doctor confirms that your tubes are blocked, you never have to worry about unplanned pregnancy,” and that only skilled operative hysteroscopists would be trained to implant Essure. (Id.¶ 103(e), (j).) Likewise, in its advertisements, Bayer falsely stated, among other things, that, “[i]n order to be identified as a qualified Essure physician,” a physician must perform “a minimum of one Essure procedure...every 6-8 weeks.” (Id.¶ 104(b).) Bayer also prepared a brochure for Essure that included false statements, including that Essure is “Worry free,” stays secure, and is made from “the same trusted, silicone free material used in hearts stents.” (Id.¶ 111(a)-(c).).

The Complaint also alleges that Bayer failed to report all adverse events to the FDA, as the PMA required. Among other things, the Complaint alleges that Bayer failed to report eight perforations that occurred, instances of migration, and 16,047 unspecified complaints about the device. (See, e.g., id.¶¶ 58(c)-(d), (g), 59(e), 111(a)(vi), (b)(ii).) It also alleges that Bayer had notice of 168 perforations but only disclosed 22 to the FDA. (Id.¶ 60(b). The Complaint further alleges (and purports to document with an exhibit) that, on multiple occasions in 2010, Bayer failed to timely report to the FDA incidents involving perforation, the Essure coil breaking into pieces, and Essure migration. (Id.¶¶ 60(a), 111(a)(viii), and Ex. F).)

Each of the five Complaints asserts twelve causes of...