Allergan plc faces extensive medical device litigation arising from its BIOCELL textured breast implants and tissue expanders. The proceedings include product liability claims involving breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) as well as separate non-cancer systemic injury allegations, which advance along distinct procedural and evidentiary tracks. After FDA approval in May 2000, regulators requested a voluntary recall in July 2019 following findings of disproportionately higher BIA-ALCL risk associated with BIOCELL products.
This analysis examines the regulatory history, MDL structure, and liability theories shaping the Allergan implant litigation within the broader medical device mass tort landscape.
Allergan BIOCELL Breast Implants: Product Background and FDA Approval
Allergan’s BIOCELL textured breast implants entered the U.S. market following FDA approval on May 10, 2000, at a time when textured implants represented a small fraction of overall breast implant usage. FDA data later showed that textured devices accounted for less than 5% of the U.S. breast implant market, a fact that would become relevant as post-market safety data developed.
The BIOCELL product line included Natrelle and McGhan 410 implants, as well as Natrelle 133 tissue expanders. Plaintiffs allege that the macro-textured surface design distinguished BIOCELL products from smoother alternatives and created conditions conducive to bacterial biofilm formation and chronic inflammation—mechanisms that later became central to cancer-related liability theories.
This product design backdrop framed how regulators and plaintiffs evaluated BIOCELL implants as safety concerns emerged over time.
Regulatory History and the FDA’s 2019 BIOCELL Implant Recall
Regulatory scrutiny of textured breast implants developed incrementally as post-market safety data accumulated over time. The FDA first identified a possible association between breast implants and anaplastic large cell lymphoma in June 2011, issuing early safety communications while continuing to monitor adverse event reporting rather than imposing immediate market restrictions.
By March 2018, the agency refined its assessment and publicly acknowledged a measurable lifetime risk associated with textured implants. At that stage, FDA estimates placed BIA-ALCL risk between approximately 1 in 3,817 and 1 in 30,000, reflecting growing concern as additional clinical and epidemiological data emerged.
As regulatory concern intensified, several developments converged and shifted the agency’s posture from monitoring to intervention, including:
- A sustained increase in adverse event reports submitted to the FDA and international regulators.
- Epidemiological signals suggesting disproportionate BIA-ALCL risk associated with specific textured implant surfaces.
- Heightened scrutiny and early action by foreign regulatory authorities.
On July 24, 2019, the FDA requested that Allergan voluntarily recall all BIOCELL textured implants and tissue expanders, marking the first time the agency sought market removal of a breast implant product. At the time of the recall, FDA data identified:
- 573 global cases of BIA-ALCL.
- 481 cases (approximately 84 percent) associated with Allergan implants.
- An estimated sixfold higher BIA-ALCL risk for BIOCELL products compared to other textured implants.
International regulators acted earlier. Health Canada suspended Allergan’s BIOCELL licenses on May 28, 2019, nearly two months before the FDA’s recall request, reinforcing the conclusion that BIOCELL products presented a disproportionate risk profile relative to other textured implants.
BIA-ALCL Product Liability Claims Against Allergan BIOCELL Implants
Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) is not breast cancer. The World Health Organization classifies the condition as a CD30-positive, ALK-negative T-cell lymphoma that arises in the fibrous capsule surrounding breast implants rather than in breast tissue itself.
Regulatory recognition of BIA-ALCL as a distinct implant-associated disease provided the foundation for plaintiffs to frame cancer-related claims around product design, warnings, and post-market surveillance obligations. Plaintiffs consolidated these allegations into a Master Complaint filed on May 26, 2020, asserting multiple product liability theories tied to Allergan’s BIOCELL implants.
Design Defect Claims
Plaintiffs allege that the macro-textured BIOCELL surface created an unreasonably dangerous product by promoting bacterial biofilm formation and chronic inflammation. These claims rely in part on FDA findings indicating a materially higher risk of BIA-ALCL associated with BIOCELL implants compared to other textured devices.
Failure-to-warn Claims
Plaintiffs contend that Allergan failed to adequately disclose known or emerging BIA-ALCL risks, emphasizing delays between the FDA’s initial safety communications in 2011 and subsequent labeling updates that began in 2013.
Post-market Surveillance Violations
The complaint alleges that Allergan failed to complete FDA-mandated post-approval studies evaluating long-term safety outcomes, including cancer risk, local complications, and device integrity. These allegations reference FDA Warning Letter No. 607690, issued on May 14, 2020.
Punitive Damages Theories
Plaintiffs argue that Allergan possessed actual knowledge of elevated BIA-ALCL risk through adverse event reporting, international regulatory actions, and internal safety data, yet continued marketing BIOCELL products without adequate corrective measures. Together, these theories anchor the cancer-related track of the Allergan implant litigation.
Allergan Breast Implant MDL 2921: Federal Multidistrict Litigation Structure
As BIA-ALCL claims expanded nationwide, the Judicial Panel on Multidistrict Litigation centralized federal actions on December 18, 2019, establishing MDL No. 2921 in the U.S. District Court for the District of New Jersey under Judge Brian R. Martinotti. The MDL structure reflects the litigation’s bifurcated nature, with cancer-related BIA-ALCL claims proceeding separately from non-cancer systemic injury allegations under distinct evidentiary and expert requirements. This division shapes discovery scope, motion practice, and the sequencing of case development across the docket.
On March 19, 2021, Judge Martinotti issued a mixed ruling allowing manufacturing defect, failure-to-warn, breach of express warranty, and negligence claims to proceed while dismissing certain theories on federal preemption grounds. The court clarified that FDA regulatory compliance does not categorically bar state-law claims alleging parallel violations or deviations from approved specifications. Under current case management orders, expert discovery closes on May 27, 2026, with the first surgical explant bellwether trial scheduled for October 19, 2026, marking the MDL’s initial phase of substantive liability testing.
Non-Cancer Systemic Injury Claims in the Allergan Breast Implant Litigation
The Allergan MDL maintains a clear procedural and evidentiary distinction between BIA-ALCL claims and non-cancer systemic injury allegations. While cancer-related claims benefit from FDA recognition and peer-reviewed epidemiological literature, non-cancer plaintiffs allege a range of autoimmune and systemic conditions following breast implant exposure.
This distinction is central to how the MDL evaluates claim viability, expert admissibility, and discovery scope across the two categories of allegations.
These non-cancer allegations commonly include claims involving:
- Sjögren’s syndrome.
- Rheumatoid arthritis.
- Systemic sclerosis and lupus.
- Chronic fatigue, cognitive dysfunction, and fibromyalgia.
Unlike BIA-ALCL, systemic injury claims face substantial evidentiary challenges. Courts have repeatedly cited the absence of epidemiological support and the lack of FDA validation linking breast implants to autoimmune disease. This posture is reinforced by precedent from the 1990s silicone implant litigation, including a 2017 Central District ruling excluding three plaintiff experts in breast implant–related autoimmune disease cases, which continues to shape expert admissibility disputes within the current MDL.
Settlement Activity and the Absence of Global Resolution in MDL 2921
Despite the size of the Allergan BIOCELL docket, the MDL has not produced publicly disclosed settlement benchmarks. No bellwether verdicts have established valuation reference points, and no court-approved global settlement program currently exists, leaving overall case valuation unresolved across the litigation.
This posture reflects the MDL’s current procedural stage rather than a lack of activity. With expert discovery continuing into 2026 and no liability findings yet tested through bellwether trials, resolution efforts have mainly remained individualized. International developments underscore this uncertainty, including a December 17, 2025, decision in which Amsterdam judges rejected a €900 million collective damages claim brought on behalf of approximately 60,000 women in the Netherlands.
Manufacturing Defect and Post-Market Surveillance Liability Theories
Manufacturing defect theories remain a central avenue of exposure in the Allergan BIOCELL litigation. In Beavan v. Allergan, the New Jersey Superior Court Appellate Division permitted expert testimony asserting that silicone particulate discharge from Allergan implants deviated from FDA-approved manufacturing specifications, reinforcing the viability of claims grounded in alleged departures from approved processes.
Regulatory findings further support these theories. The FDA’s May 14, 2020, Warning Letter documented Allergan’s failure to complete required 10-year post-approval studies assessing long-term safety outcomes, including:
- Local complications and implant-site conditions.
- Connective tissue, neurological, reproductive disorders, and cancer risks.
- MRI screening compliance and device integrity monitoring.
Courts have consistently held that scientific uncertainty surrounding BIA-ALCL does not insulate manufacturers from conduct-based liability. As a result, manufacturing defect claims and parallel state-law theories mirroring federal post-market surveillance obligations continue to survive federal preemption challenges.
Practice Implications for Counsel Evaluating Allergan BIOCELL Claims
The absence of completed bellwether trials leaves valuation benchmarks unsettled across the Allergan BIOCELL docket. As a result, case evaluation currently relies on comparative mass tort frameworks, developments emerging from MDL discovery, and plaintiff-specific variables such as cancer staging, treatment modality, and documented economic losses. These factors continue to drive wide variability in valuation assessments across claims.
Adverse event reporting data remains central to this analysis. FDA MAUDE submissions and related regulatory records are frequently used to establish manufacturer notice and knowledge timelines, while the evidentiary divide between BIA-ALCL claims and non-cancer systemic injury allegations shapes motion practice, expert admissibility disputes, and settlement dynamics across jurisdictions.
Procedural Posture and Forward Outlook of the Allergan BIOCELL Litigation
The Allergan BIOCELL litigation remains in active pretrial proceedings, with the first bellwether trial currently scheduled for October 19, 2026. To date, the MDL has produced significant rulings on claim viability, preemption limitations, and post-market surveillance obligations, but no verdicts establishing valuation benchmarks. The litigation continues to develop along bifurcated tracks for BIA-ALCL and non-cancer systemic injury claims, each presenting distinct evidentiary and procedural considerations.
As discovery advances, regulatory correspondence, adverse event reporting, and patient-specific medical histories remain central to case development. Comprehensive medical documentation and timeline reconstruction play a critical role in evaluating exposure, causation, and damages across implant-related claims, particularly in complex medical device litigation involving long latency periods and evolving regulatory standards.
.webp)
.webp)
