The lawsuit was filed by two anonymous women, A.B. and C.D., who have both been diagnosed with a rare immune system cancer known as Anaplastic Large Cell Lymphoma (ALCL).
Last month, Allergan recalled their textured breast implants due to a 6-fold increased risk of cancer. The women say they were forced to pay out-of-pocket to have their recalled breast implants removed.
The lawsuit also accuses Allergan of using a loophole in FDA regulation to avoid reporting cases of cancer linked to the implants.
When the FDA ordered stricter injury reporting requirements in 2017, the number of cases of ALCL skyrocketed. Of the 573 known cases of ALCL from breast implants, 84% involve Allergan’s recalled implants.
The FDA first warned about the risk in 2011. The lawsuit accuses Allergan of failing to warn women and their doctors for years, although the company knew about the link between their implants and ALCL.
The company is refusing to pay for surgery to have the implants removed. Instead, Allergan has offered to pay for new breast implants for women want the implants removed — but only until July 24, 2021.
The lawsuit is In RE: A.B. and C.D. et al. v. Allergan Inc. et al. — Case number 8:19-cv-01651 in the U.S. District Court for the Central District of California.