The JPML has created an MDL for Allergan Biocell® Textured Breast Implant products and sent the cases to U.S. District Judge Brian Martinotti of the District of New Jersey for consolidated or coordinated pretrial proceedings. The New Jersey District selection by the Panel was strongly supported by Allergan, whose U.S. headquarters are in Madison, NJ, where significant common evidence, including witnesses, is expected to be located.
The implants were recalled by Allergan earlier this year, after an FDA determination that nearly all cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) were related to textured implants. According to the lawsuits, Allergan allegedly hid important product safety information that evidenced the cancer risk of their textured breast implants by omitting to report information on the FDA’s Manufacturer and End User Facility Device Experience (MAUDE) database. Instead, the company submitted alternative summary reports, which were not easily searchable or available to the public. In 2017, when the FDA revised their safety reporting requirements, the number of reports of breast implant associated injuries like BIA-ALCL rose from approximately 200 to over 4,500 in 2017 and over 8,000 in the first half of 2018.
The Panel order includes four actions pending in four federal districts and the Panel notes they have been informed of an additional 25 related federal actions pending in another 14 districts.