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.