Six women are suing Allergan Inc., claiming the Irish pharmaceutical giant “buried” reports that its now-recalled textured silicone breast implants were linked to a rare form of cancer to hide possible safety risks from the public.
In a potential national class-action suit filed in federal court last month, the women allege that Allergan failed to properly file safety reports in the Food and Drug Administration’s public database, as reported by Law360. Instead, Allergan registered the reports as “alternative summary reports,” delaying their discovery with an “intent to deceive,” according to a press statement from consumer-rights law firm Fegan Scott, which represents the women.
The reports — and the knowledge of the serious injuries they contained — only came to light in 2017 when the FDA tightened its reporting requirements, according to Law360.
In September, the FDA asked Allergan to issue a sweeping recall of its Biocell Natrelle textured breast implants, warning of an increased “risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system.”
But the six plaintiffs claim that Allergan knew as far back as 2006 that the Biocell implants posed a significant risk of BIA-ALCL, according to the Fegan Scott statement.
“For decades, Allergan knew that its recalled implants were six times more likely to cause BIA-ALCL, but it continued to market these products, seemingly with little regard for the well-being of its users,” plaintiffs’ attorney Beth Fegan said.
The women are asking Allergan to fund a medical monitoring program to detect BIA-ALCL and other diseases.
As it stands today, women with the recalled implants can use a manufacturer’s warranty to replace their implants with other, supposedly safer Allergan implants. But Allergan has so far “refused to help the women who simply wanted to take the implants out or make medical monitoring possible to guard against developing cancer later,” Fegan said.
The potential class-action suit is the latest since the recall, as Law360 reported. A similar suit filed in September also alleges Allergan suppressed problems with its implants rather than reporting possible safety concerns to the FDA in a public, searchable database called Manufacturer and User Facility Device Experience (MAUDE).
In 2017, after the FDA enacted more rigorous reporting requirements, the number of breast implant-related adverse events soared from 200 to 4,567 in 2017 and reached 8,242 in the first six months of 2018, as Law360 reported.
Originally published December 6, 2019
By Nicole Knight
Nicole Knight is a freelance writer based in Southern California. A former reporter for the Orange County Register, she most recently covered issues related to women’s health and economic justice for the nonprofit site Rewire.News. Her bylines have appeared in outlets ranging from Pacific Standard to Parents.com, reflecting her varied interests. She is a member of the Association of Health Care Journalists and the American Society of Journalists and Authors. Follow her on Twitter @nicolekshine.