In re Allergan Biocell Textured Breast Implant Prod. Liab. Litig.
| Decision Date | 04 May 2021 |
| Docket Number | CASE NO. 634,MASTER CASE NO. BER-L-5064-20 |
| Parties | IN RE: ALLERGAN BIOCELL TEXTURED BREAST IMPLANT PRODUCT LIABILITY LITIGATION |
| Court | New Jersey Superior Court |
Superior Court of New Jersey, Law Division
Bergen County Justice Center
10 Main Street, Chambers 359
Hackensack, New Jersey 07601
(201) 221-0700
Prepared by the court
OPINIONBefore this court in this Multi-County Litigation ("MCL") is Defendants Allergan, Inc. and Allergan USA, Inc.'s (collectively, "Allergan" or "Defendants") Motion to Dismiss Plaintiffs' Master Long Form Complaint on Preemption Grounds ("Motion") pursuit to R. 4:6-2 predicated on 21 U.S.C. § 360(k) and 21 U.S.C. § 337(a).1 Plaintiffs opposed the Motion and Defendants replied, This court has carefully considered the parties' submissions. Oral argument was held on March 12, 2021. For the reasons set forth below and for good cause having been shown, Defendants' Motion is GRANTED IN PART and DENIED IN PART.
This action arises out of Allergan's BIOCELL product line of textured breast implants and tissue expanders (collectively, "BIOCELL Product Line") that allegedly caused Plaintiffs to develop, or become at risk of developing, breast-implant associated anaplastic large cell lymphoma ("BIA-ALCL"), a subtype of non-Hodgkin's lymphoma. Allergan's breast implants havetextured surfaces, by design, and are filled with either saline or silicone gel. (Compl. ¶ 3.) Tissue expanders are temporary inflatable implants that stretch skin and muscle to create space for breast implants. (Id. ¶¶ 4, 8, 41.) Like Allergan's breast implants, the tissue expanders also have textured surfaces. (Id. ¶¶ 4; 34.)
In 1987, Allergan, through its predecessor, introduced its first textured breast implants, the McGhan RTV Saline-Filled Mammary Implants ("McGhan RTV"). (Id. ¶¶ 3, 36.) The McGhan RTV implants were originally cleared for use through the 510(k) regulatory process. (Id. ¶¶ 3, 5.) In August 1999, the Food & Drug Administration ("FDA") issued a final rule requiring all saline-filled implants to receive Premarket Approval ("PMA") rather than clearance through the 510(k) process. (Id. ¶ 40.) Allergan's predecessor filed a PMA application to reclassify the McGhan RTV implants. (Id.) In May 2000, FDA approved the application and granted PMA for the McGhan RTV implants. (Id.)
In May 2000, FDA also granted PMA for the first segment of textured BIOCELL implants, the saline-filled breast implants. (Id. ¶¶ 40, 47.) In November 2006, FDA granted PMA for the second segment of textured BIOCELL implants, the silicone-filled breast implants. (Id. ¶ 57.) In February 2013, FDA granted PMA for the third segment of textured BIOCELL implants, the highly cohesive anatomical shaped silicone-filled breast implants. (Id. ¶ 59.) According to Plaintiffs, the PMAs for the BIOCELL implants included Conditions of Approval. (Id. ¶¶ 48-62.) The Conditions of Approval include specific obligations—such as requiring long-term post-approval studies for assessment of safety data and clinical performance—and general obligations—such as compliance with federal disclosure requirements and medical device reporting regulations. (Id.)
Allergan also manufactured McGhan BioDimensional Silicone-Filled BIOCELL Textured Breast Implant Style 153 ("Style 153"). (Id. ¶¶ 34, 39.) FDA granted Allergan an Investigational Device Exemption ("IDE") for the Style 153 implants to be studied in FDA-regulated clinical trials. (Id.) The Style 153 implants never received FDA approval and were discontinued before being marketed. (Id.) Allergan also manufactured two tissue expanders. Both products are Class II medical devices that were granted 510(k) clearance by FDA in 2011 and 2015, respectively. (Id. ¶¶ 5, 41.)
In 2013, a warning related to anaplastic large cell lymphoma was added to the BIOCELL implants label. (Id. ¶¶ 63, 64.) In July 2019, Allergan announced a global recall of its BIOCELL Product Line and discontinued its marketing and sale of the products. (Id. ¶¶ 2, 31.) The announcement followed a request by FDA to initiate the recall based on the emerging risk of BIA-ALCL associated with the BIOCELL Product Line. (Id. ¶ 31.) According to FDA, "the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S." (Id.) In May 2020, FDA issued a warning letter to Allergan regarding its failure to comply with PMA post-approval study requirements. (Id. ¶¶ 66-68.)
In sum, Plaintiffs' Master Long Form Complaint raises allegations involving five different breast implants and two different tissue expanders. Three of Allergan's breast implants received PMA, one received IDE, and one was reclassified to PMA after initially being cleared through the 510(k) process. Both of Allergan's tissue expanders were cleared through the 510(k) process. Plaintiffs bring the following Counts: (1) manufacturing defect; (2) failure to warn; (3) breach of express warranty; (4) design defect; (5) negligence; (6) consumer fraud; (7) wrongful death; and(8) loss of consortium.2 Allergan now moves to dismiss all claims based on federal preemption. Before addressing the parties' arguments on all counts, this court will first discuss the governing regulatory framework applicable to medical devices.
The Medical Device Amendments ("MDA") of 1976, 21 U.S.C. § 360c et. seq., to the Food, Drag, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et. seq., "imposed a regime of detailed federal oversight" that authorized FDA to regulate medical devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Under the MDA, medical devices are categorized into one of three regulatory classes—Class I, Class II, or Class III—based on their level of risk and the controls needed to reasonably assure their safety and effectiveness. 21 U.S.C. § 360c. Class III medical devices are subject to Premarket Approval, a comprehensive and rigorous process that receives the highest level of regulatory scrutiny and arduous federal oversight compared to that of other medical devices. Id. §§ 360c(a)(1)(C); 360e. The PMA regime imposes federal requirements specific to individual devices. See Riegel, 552 U.S. at 323 (). In contrast, Class II medical devices receive clearance through the Section 510(k) process, a "limited form of review" with a far less exhaustive submission process. See Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 767 (3d Cir. 2018) (citing 21 U.S.C. § 360(k); 21 C.F.R. § 807.87). FDA clearance of a Class II device rests on a finding that the device is"substantially equivalent" to an approved preexisting medical device. Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996).
As part of the PMA process, a manufacturer must provide FDA with, among other requirements:
full reports of all studies and investigations of the device's safety and effectiveness that have been published or should reasonably be known to the applicant; a 'full statement' of the device's 'components, ingredients, and properties and of the principle or principles of operation'; 'a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation of, such device'; samples or device components required by the FDA; and a specimen of the proposed labeling. § 360e(c)(1). Before deciding whether to approve the application, the agency may refer it to a panel of outside experts, 21 CFR § 814.44(a) (2007), and may request additional data from the manufacturer, § 360e(c)(1)(G).
Riegel, 552 U.S. at 318. FDA grants PMA only if the manufacturer has provided "reasonable assurance" that the device is safe and effective under the conditions of use included on the label and determined that the proposed label is not false or misleading. 21 U.S.C. § 360e(d)(2). "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 the approved form provides a reasonable assurance of safety and effectiveness." Riegel, 552 U.S. at 323.
Even after receiving PMA, "FDA may impose postapproval requirements." 21 C.F.R. § 814.82(a). Manufacturers must comply with certain Medical Device Reporting ("MDR") requirements, 21 U.S.C. § 360i(a)(1); 21 C.F.R. § 803.50(a), including:
1) inform the FDA of new clinical investigations or scientific studies concerning the device about which the manufacturer knows or reasonably should know, 21 C.F.R. § 814.84(b)(2); and 2) report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that wouldlikely cause or contribute to death or serious injury if it recurred, 21 U.S.C. § 803.50(a).
Cornett v. Johnson & Johnson, 211 N.J. 362, 381-82 (2012) (citing Riegel, 552 U.S. at 319-20). Manufacturers must also submit adverse events reports, which are made publicly available through an online database called the Manufacturer and User Facility Device Experience ("MAUDE").3 21 C.F.R. §§ 803.10; 803.50. Moreover, "FDA has the power to withdraw [PMA] based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling." Cornett, 211 N.J. at 382 (citing Riegel, 552 U.S. at 323); 21 U.S.C. §§ 360e(e)(1); 360h(e). Further, "[o]nce approved, the device may be manufactured, advertised, and distributed to the public, but those marketing activities may not be done in a manner 'inconsistent with . . . the [premarket] approval order for the device.'" Shuker, 885 F.3d at 766 (citing 21 C.F.R. § 814.80).
In addition, a manufacturer may seek an IDE to conduct clinical studies and collect data on a medical device prior to obtaining approval. Se...
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