MDL Sought For Allergan Biocell Breast Implant Lawsuits Over ALCL Risk

As a growing number of Allergan Biocell breast implant lawsuits continue to be filed by women who face a risk of anaplastic large cell lymphoma (ALCL) from the microtextured device, a group of plaintiffs are calling for complaints filed throughout the federal court system to be centralized before one U.S. District Judge for coordinated discovery and pretrial proceedings.

Over the past few years, there has been increasing evidence that certain Allergan breast implants with a textured surface may increase the risk of a rare cancer that may develop in the surrounding tissue, which is now increasingly referred to as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

In July, an Allergan Biocell breast implant recall was issued after the FDA determined that nearly all cases of BIA-ALCL have been linked to this one type of device.

At that time, the FDA indicated that there were 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 also been linked to at least 12 of the 13 deaths where the manufacturer of the breast implant was known.

Since then, a number of lawsuits have been filed against Allergan over the breast implants, each raising similar allegations that the textured design was unreasonably dangerous and defective.

In a motion to transfer (PDF) filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on October 3, several plaintiffs called for cases brought throughout the federal court system to be consolidated U.S. District Court for the middle District of Tennessee, as part of an MDL or multidistrict litigation.

According to the motion, five Allergan Biocell class action lawsuits have been filed nationwide, each in a different federal court district. Plaintiffs and Allergan breast implant lawyers expect that number to grow with additional class action, as well as individual complaints brought by women diagnosed with ALCL.

“There are thousands of women who similarly face significantly greater risks of developing BIA-ALCL. While Allergan has instituted a recall, it has not agreed to pay for the removal of BIOCELL implants and associated medical expenses, including costly surgical fees, or to cover the expenses associated with ongoing medical monitoring,” the motion states. “An expeditions resolution is therefore critical, and streamlining discovery, motion practice, and class certification will ensure that these cases do not face unnecessary delays.”

If the JPML agrees to consolidate the cases into a multidistrict litigation (MDL), all pretrial proceedings would be handled by one judge, but the cases would remain individual lawsuits. If a settlement agreement is not reached, the cases would be transferred back to their originating districts for trial.

For women who have the recalled Allergan breast implants, the FDA is not recommending removal of the device if they are not showing symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those diagnosed with ALCL typically require additional surgery to remove the breast implants and the surrounding scar capsule, according to the latest recommendations from health regulators.

While the complaints referenced in the motion to transfer involve class allegations, a number of individuals lawsuits are also being pursued for damages associated with a BIA-ALCL diagnosis, which the panel may decide to include in a single federal multidistrict litigation to avoid scheduling conflicts, duplicative discovery into common issues and serve the convenience of common witnesses and parties in the claims.