Biocell Breast Implant Manufacturer Seeks To Dismiss Suits

Biocell Breast Implant Manufacturer Seeks To Dismiss Suits

Introduction

Allergan, Inc. filed a motion on August 7 in the U.S. District Court for the District of New Jersey involving its Biocell textured breast implant, seeking dismissal of lawsuits on pre-emption grounds, claiming that the company should not be held liable over the failure to warn claims.

The company contends that the lawsuits brought under state laws impermissibly challenge the design, manufacture, labeling, and post-sale reporting for the FDA-approved devices. However, the federal regulators are investigating the reason behind rare cancer in the tissue surrounding certain breast implants.

The motion asserts that the company should be immune from the claims as the FDA’s review of medical devices is exhaustive enough to allow it to escape responsibility for risks associated with the device, even when the manufacturer knew or should have known about the problems.

Lawsuits against Allergan Biocell breast implants are rising in numbers, following the nationwide recall. Each lawsuit has a similar allegation that the textured surface of the implant may increase the risk of a rare type of cancer in the tissue surrounding it, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

In June, the parent company of Allergan, AbbVie Inc., announced to launch a new awareness campaign to inform women implanted with the recalled Allergan Natrelle Biocell breast implants, who might be unaware of the risks associated.

Currently, Allergan faces at least 150 product liability lawsuits and class action lawsuits over breast implant cancer problems. The lawsuits have been consolidated to form multidistrict litigation (MDL) before U.S. District Judge Brian R. Martinotti in the District of New Jersey under MDL No.: 2921. Also, lawsuits filed in New Jersey are consolidated as part of multicounty litigation (MCL) in the New Jersey Superior Court for Bergen County, where the claims will be presided by Judge Rachelle Harz for coordinated discovery and pretrial proceedings.

Earlier, on June 8, Acting Administrative Director of the Courts, Glenn A. Grant, issued a Notice To The Bar, stating that all Allergan Biocell breast implant lawsuits filed in New Jersey will be consolidated as part of multicounty litigation (MCL) in the New Jersey Superior Court for Bergen County, where the claims will be presided by Judge Rachelle Harz for coordinated discovery and pretrial proceedings.

Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality).

Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received approval from the U.S Food & Drug Administration (FDA) on 11/17/2006.

The popular product, its textured implants, is linked to a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The disease is a type of non-Hodgkin lymphoma. 

The consolidation of the cases is designed to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial schedules from different judges, and serve the convenience of the common parties, witnesses, and the judicial system.

The MCL works similarly to the federal multidistrict litigation (MDL) but at the state-court level. The cases will continue as individual lawsuits, where the judge would schedule a series of early test trials known as bellwether cases. If no settlement is reached through the bellwether process, then the cases will eventually be tried as individual claims in the New Jersey state court system.

Last year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated the Allergan Biocell lawsuits in the Federal court system before U.S. District Judge Brian R. Martinotti in the District of New Jersey under MDL No. 2921.

Lawsuits against Allergan Biocell breast implants are rising in numbers, following the nationwide recall. Each lawsuit has a similar allegation that the textured surface of the implant may increase the risk of a rare type of cancer in the tissue surrounding it, which is now known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Recently, the parent company of Allergan, AbbVie Inc., announced to launch a new awareness campaign to inform women implanted with their recalled Allergan Natrelle Biocell breast implants, who might be unaware of the risks associated.