In re Allergan Biocell Textured Breast Implant Prods. Liab. Litig.

Decision Date19 March 2021
Docket NumberMDL No. 2921,Case No. 2:19-md-2921-BRM-ESK
Citation537 F.Supp.3d 679
CourtU.S. District Court — District of New Jersey

Martinotti, District Judge

Before this Court are three motions by Defendants Allergan, Inc. and Allergan USA, Inc. ("Allergan"): (1) Motion to Strike/Dismiss Plaintiffs’ Consolidated Class Action Complaint ("CAC") (ECF No. 118) and every other class action complaint filed in a lawsuit that is part of this Multi District Litigation ("MDL") pursuant to Fed. R. Civ. P. 12(b)(6) and 12(f) (ECF No. 171-2); (2) Motion to Dismiss Plaintiffs’ complaints on preemption grounds pursuant to Fed. R. Civ. P. 12(b)(6) (ECF No. 171-1); and (3) Motion to Dismiss Plaintiffs’ Master Long Form Personal Injury Complaint ("PIC") (ECF No. 119) on non-preemption grounds and every other complaint filed in a lawsuit that is part of this MDL and alleges personal injury damages pursuant to Fed. R. Civ. P. 8(a), 9(b) and 12(b)(6) (ECF No. 171-3). Plaintiffs filed Oppositions to Allergan's Motions. (ECF Nos. 216, 219, 220.) Allergan filed a Notice of Supplemental Authority. (ECF No. 224.) Plaintiffs responded to Allergan's Notice. (ECF No. 225.) Allergan filed Replies in support of its Motions. (ECF Nos. 236, 237, 238.) Allergan filed a second Notice of Supplemental Authority. (ECF No. 246.) Plaintiffs responded to Allergan's second Notice. (ECF No. 250.) Having reviewed the parties’ submissions filed in connection with the Motions and having heard oral argument on December 14, 2020 (ECF No. 261),1 for the reasons set forth below and for good cause having been shown, Allergan's Motion to Strike/Dismiss CAC (ECF No. 171-2), Motion to Dismiss Plaintiffs’ complaints on preemption grounds (ECF No. 171-1), and Motion to Dismiss PIC (ECF No. 171-3) are GRANTED IN PART and DENIED IN PART .

For the ease of the reader, the Court has included a table of contents:


A. Rule 12(b)(6)...703
B. Rule 12(f)...704
C. Rule 23...704
A. Allergan's Motion to Dismiss on Preemption Grounds (ECF No. 171-1)...705
1. Failure to Warn Claims...708
2. PlaintiffsManufacturing Defect Claims Are Not Preempted...712
3. PlaintiffsNegligence Per Se Claims Are Not Preempted...714
4. Plaintiffs’ Claims Concerning Investigational Devices Used In An Approved Clinical Trial Are Preempted...715
5. Plaintiffs’ Negligent Failure to Warn Claims Alleging Allergan's Failure to Conduct Post-PMA Clinical Studies Are Preempted...716
6. PlaintiffsImplied Warranty Claims Are Not Preempted...717
7. Plaintiffs’ Claims for Negligent Misrepresentation, Breach of Express Warranty, and Breach of State Consumer Fraud and Deceptive Trade Practice Statutes Are Not Preempted...717
B. Allergan's Motion to Dismiss on Non-Preemption Grounds (ECF No. 171-3)...719
1. The Court Will Review the PIC with Leniency...720
2. The Court Will Not Scrutinize Whether Plaintiffs Have Sufficiently Alleged Present Injuries in the PIC...721
3. PlaintiffsManufacturing Defect Claims Should Not Be Dismissed...721 4. Plaintiffs’ Negligence Per Se Claims Are Not Viable in Some Jurisdictions...723
5. Plaintiffs’ Report-Based Failure to Warn Claims Are Not Viable in Some Jurisdictions...729
6. PlaintiffsNegligent Misrepresentation Claims...734
7. Plaintiffs Cannot Assert Warranty Claims in Some Jurisdictions...740
8. Summary for Allergan's Motion to Dismiss on Non-Preemption Grounds...751
C. Allergan's Motion to Strike/Dismiss Plaintiffs’ Class Allegations (ECF No. 171-2)...751
A. Factual Background

Plaintiffs and class members are patients who had Allergan's BIOCELL textured breast implants

and tissue expanders2 (together, "the BIOCELL implants") implanted into their bodies. (ECF No. 119 at ¶ 1.) Many of the Plaintiffs are breast cancer survivors or women having undergone prophylactic mastectomies, who were implanted with the BIOCELL implants in reconstructive surgery. (Id. at ¶ 8.) Plaintiffs allege the BIOCELL implants cause Breast-Implant Associated Anaplastic Large Cell Lymphoma ("BIA-ALCL"), a cancer of the immune system that develops in the area around an implant, often between the implant and the surrounding scar tissue. (Id. at ¶¶ 1, 27.) BIA-ALCL frequently presents as a late-onset seroma in the breast, which is an accumulation of fluid between the capsule and the implant, resulting in swelling of the breast. (ECF No. 118 at ¶ 138.) Left untreated, BIA-ALCL can spread through the body and be fatal. (Id. ) Symptoms of BIA-ALCL can arise even after the implant is removed. (Id. at ¶ 139.) Diagnostic procedures for detecting BIA-ALCL include computed tomography scans, magnetic resonance imagings, and fluid sampling. (Id. at ¶ 140.) BIA-ALCL is treated with the surgery to remove the implant and the surrounding capsule and tissue, and may require other treatments such as reconstructive surgery, chemotherapy, and radiation. (ECF No. 119 at ¶ 29.) Some of the Plaintiffs have been diagnosed with BIA-ALCL, others have had their implants removed, and others still have BIOCELL implants in their bodies. (Id. at ¶ 8.)

This case involves dozens of recalled models of the BIOCELL implants. (Id. at ¶ 41.) Many models were sold pursuant to three pre-market approvals ("PMAs") that Allergan received from the United States Food and Drug Administration ("FDA") on May 20, 2000, on November 17, 2006, and on February 20, 2013. (Id. at ¶ 53.) Plaintiffs allege these PMAs contained Conditions of Approval, requiring Allergan to (among other things) conduct studies of the devices’ safety, report adverse events to the FDA, and revise the labeling to add warnings when necessitated by new safety information. (Id. at ¶¶ 59–61.) Other models, including the BIOCELL tissue expanders

, were approved through the much less rigorous § 510(k) process. (Id. at ¶ 52.) Still others were approved for use in investigative studies under the Investigational Device Exemption ("IDE"). (Id. at ¶ 50.)

For over 20 years, Allergan and its predecessor companies marketed and sold the BIOCELL Implants. (ECF No. 118 at ¶¶ 112–37.) To texturize the implant shell, Allergan allegedly employed a "salt loss" manufacturing process. (Id. at ¶¶ 13, 167.) The process applies solid particles of cubic salt over the implant shell surface, embedding the particles within. (Id. ) The implant is then covered with another silicone layer, which is scrubbed off, and the shell is washed. (Id. ) Plaintiffs state the FDA-approved manufacturing specifications require all solid particles be scrubbed off and dissolved. (Id. at ¶ 168.) Plaintiffs allege Allergan performs the final scrubbing process manually, which leaves solid particles and other residues on the implants’ surface. (Id. at ¶ 169.) Plaintiffs claim these particles, residues, the implant's increased surface area resulting from the texturizing process, and the chronic friction that occurs between the body's tissues and the implant cause inflammation, increased T-cell activity, malignant T-cell transformation and, ultimately, BIA-ALCL. (Id. at ¶ 170.)

Allergan recalled the BIOCELL implants in July 2019 after the FDA found they posed a heightened risk of BIA-ALCL. (Id. at ¶¶ 138, 191–92.) Plaintiffs claim Allergan's textured implants increase the risk of BIA-ALCL by 3,000 times. (Id. at ¶ 158.) The FDA has concluded "the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers." (Id. at ¶ 193.) According to the FDA, 246,831 BIOCELL Implants have been recalled in the United States. (Id. at ¶ 386.)

As early as 1997, some women were reported to have developed BIA-ALCL after receiving the BIOCELL Implants. (Id. at ¶ 141.) Over the course of the next two decades, the number of reported cases of BIA-ALCL associated with the BIOCELL Implants continued to mount. (Id. at ¶¶ 141–45, 149, 154–57.) Through this period, Allergan allegedly concealed the risks of BIA-ALCL by failing to appropriately submit adverse event reports to the FDA or otherwise disclose to the public complete and accurate safety information regarding the BIOCELL Implants. (Id. at ¶ 209–20.)

On July 29, 2019, the FDA issued a Class I Recall notice. (Id. at ¶ 2.) According to the FDA, the continued distribution of the BIOCELL Implants "would likely cause serious, adverse health consequences and potentially death from BIA-ALCL." (Id. at ¶ 193.) Allergan refuses to pay the implants’ users for the cost of explant surgeries to remove the implants or for ongoing monitoring and testing for BIA-ALCL. (Id. at ¶ 198.)

B. Procedural History

This litigation began as a series of actions filed in judicial districts throughout the country. (ECF No. 144 at 1.) By Order dated December 18, 2019, the United States Judicial Panel on Multidistrict Litigation transferred several of those matters to the District of New Jersey, thereby creating MDL No. 2921. (ECF No. 1.) The Panel has continued to transfer cases since that time, and Plaintiffs have directly filed others, such that this MDL currently consists of more than 562 member cases. (ECF No. 144 at 1–2.)

On May 26, 2020, Liaison Counsel for Plaintiffs and Co-Lead PlaintiffsCounsel filed the PIC. (ECF No. 119.) The complaint asserts: claims for manufacturing defect, based on strict liability (Count I) and negligence (Count II); claims for failure to warn, based on strict liability (Count IV) and negligence (Count V); claims for general negligence (Count III) and breach of the implied warranty of merchantability (Count VII), primarily based on the...

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2 firm's commentaries
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    ...for the expenses of medical surveillance.”). Accord In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp. 3d 679, 762 (D.N.J. 2021) (including Delaware as a jurisdiction that “do[es] not allow a medical monitoring relief without a present physical injury......
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