Allergan Seeks to Avoid Liability for Problems from Recalled Breast Implants

Allergan, Inc. has filed a motion seeking to dismiss breast implant lawsuits filed over recalled textured designs, arguing that they should not be held liable for failing to warn women about the risk of cancer that may develop in the surrounding tissue.

The manufacturer currently faces at least 150 product liability lawsuits and class action lawsuits over recalled Allergan Biocell textured breast implants, which were removed from the market last year after federal regulators linked the design to most reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

In addition to individual claims for women who developed ALCL from Allergan Biocell breast implants, often resulting in the need for removal of the devices, the litigation also includes complaints that seek class action status to pursue damages for all women who received the recalled implants, indicating that they will now require medical monitoring for the rest of their lives due to the increased risk of cancer.

Given similar questions of fact and law presented in complaints filed in District Courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided last month to consolidated the claims before U.S. District Judge Brian R. Martinotti in the District of New Jersey, to reduce duplicative discovery into common issues, avoid conflicting pretrial schedules and serve the convenience of the parties, witnesses and the judicial system.

In a motion (PDF) filed by Allergan on August 7, the company calls for the dismissal of all individual and class action complaints, indicating they should be able to escape any liability under a federal pre-emption defense.

Although federal regulators were investigating the reason some women developed the rare cancer in the tissue surrounding certain breast implants for years, the manufacturer is attempting to argue that because the FDA approved of the Biocell textured breast implant design, and Allergan did not deviate from that design, the company should be immune from litigation brought under state laws.

The motion implies that the FDA’s review of medical devices is exhaustive enough that it’s approval of such a device should allow manufacturers to escape responsibility for risks associated with the device, even when the manufacturer knew or should have known about the problems; an argument that has only rarely seen success in similar medical device litigation throughout the years.

Allergan Breast Implant Recalls

The lawsuits emerged after an Allergan Biocell breast implant recall was issued in July 2019, in response to an FDA determination that nearly all cases of BIA-ALCL have been linked to this one type of device.

Although there have been concerns about the link between textured breast implants and cancer for the past few years, the manufacturer continued to sell the product and failed to notify women about the potential risk that may be associated with the Biocell design, according to allegations raised in the litigation.

Last year, the FDA release data involving at least 573 known cases of breast implant ALCL diagnosed worldwide, including at least 33 deaths. Of those, 481 have been linked to breast implants sold by Allergan, which have been involved in at least 12 of the 13 deaths where the manufacturer of the breast implant was known.

Since the recall, there has been a sharp rise in the number of lawsuits filed against Allergan over the breast implants, each raising similar allegations that the textured design was unreasonably dangerous and defective.

All pretrial proceedings will be handled by one judge, but the cases will remain individual lawsuits. If a breast implant settlement agreement is not reached while the cases are pending before Judge Martinotti, each claim may later be transferred back to its originating District Court for trial.