The U.S. Judicial Panel on Multidistrict Litigation has agreed to centralize all federally filed lawsuits involving Allergan, Inc’s recently recalled Biocell textured breast implants before a single judge in the U.S. District Court, District of New Jersey.
“Allergan USA Inc. has its headquarters and principal place of business in this district, and represented at oral argument that significant common evidence, including witnesses, will be located there,” the Panel’s chair wrote in a Transfer Order dated December 19th.
About 30 breast implant lawsuits have been filed in various federal courts on behalf of women who claim Biocell’s textured implants increases the risk for a rare form of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Allergan recalled the devices in July, at the request of the U.S. Food & Drug Administration.
Plaintiffs had proposed centralization in October, asserting that coordinated pretrial proceedings would increase judicial efficiency and benefit the courts, parties and witnesses involved in the growing litigation.
All of the Allergan breast implant lawsuits claim that the company was aware of the link between Biocell textured devices and BIA-ALCL from performing extensive decades-long clinical studies, reviewing scientific studies and literature, FDA communications, government reports, and complaints from consumers, among other sources. Yet this information was never disclosed to the public or medical community.
Plaintiffs further note that Allergan has not agreed to pay for removal surgery and associated medical expenses, or to cover the cost associated with the ongoing medical monitoring now required of Biocell textured breast implant recipients.
The FDA asked Allergan to recall Biocell textured breast implants and tissue expanders after an analysis found that 84% of the 573 cases of BIA-ALCL reported worldwide involved those devices, as did 12 of the 13 deaths for which the implant manufacturer was known. The FDA determined that the risk of developing BIA-ALCL was six times higher with Allergan’s Biocell devices compared to textured implants from other manufacturers.
BIA-ALCL is not breast cancer, but a rare form of lymphoma that develops in the scar capsule surrounding breast implants. Symptoms typically include:
BIA-ALCL is very treatable when DETECTED EARLY, and usually requires removal of the breast implants and surrounding tissue. However, chemotherapy and radiation may be needed if the cancer has spread beyond the scar capsule.
According to the FDA, women with Biocell textured breast implants can allow the devices to remain in place, so long as they are not experiencing any BIA-ALCL symptoms. However, all breast implant patients should continue regular follow-up care and report any changes to their doctor immediately, especially persistent pain or swelling in their breast.