Johnson & Johnson unit in implant lawsuit
A Johnson & Johnson (J& J) unit is allegedly selling defective breast implants that are causing health problems for some women, including muscle pain and nausea, according to the first state-court lawsuit in California over the devices.
J&J’s Mentor Worldwide unit failed to conduct proper studies of its silicone-based implants’ health risks that were mandated by government regulators, lawyers for Rexine Mize said in the suit filed on Thursday in Los Angeles. Leaks from the devices are causing a variety of ailments for Mize and other women, she says in the complaint.
J& J spokesman Ernie Knewitz did not immediately return calls on Friday seeking comment on the lawsuit.
Mentor, Allergan and Sientra are the only companies authorised by the US Food and Drug Administration to sell silicone implants in the US after the agency lifted a 14-year ban on the devices in 2006.
The breast-implant market was about $635m in 2016 with 80% of women opting for the silicone-based version, according to the American Society of Plastic Surgeons.
Mize’s case may be a harbinger of another wave of silicone-implant suits, said Jaime Moss, a lawyer who filed the case against J&J. The devices were a frequent target of litigation in the 1980s and 1990s and prompted some companies to seek bankruptcy in an attempt to resolve claims.
PERVASIVE PROBLEM
“We believe the problems with Mentor’s silicone implant are pervasive and may have harmed thousands of women,” Moss said. “This suit may be just the tip of the iceberg.”
Mize’s complaint is the second filed in California over the implants. In September 2016, a Seattle woman sued Mentor and J& J in federal court in San Francisco claiming her implants made her sick. Sara Ebrahimi alleged her Mentor MemoryGel implants caused skin rashes, fatigue and left her bloodstream laced with heavy metals used to manufacture the devices.
J&J acquired Mentor in December 2008 for about $1.1bn after it became the first device maker to win approval to reintroduce silicone implants.
Mentor became part of J&J’s Ethicon unit, which sells medical devices for the world’s largest healthcare firm.
Regulators had banned the use of silicone-based breast implants in 1992 after women sued manufacturers of the devices, claiming they caused cancer and Rheumatoid arthritis. Hundreds of thousands of women sued Dow Corning, once the largest maker of implants, prompting the firm to seek bankruptcy protection in May 1995. The chapter 11 filing came after a proposed $4bn settlement covering all implant makers fell apart.
Dow Corning emerged from bankruptcy in 1999 under a plan calling for the manufacturer to pay $3.2bn to compensate implant recipients.
The lawsuit contends Mentor officials failed to warn Mize — who says she is suffering from pain, nausea, skin rashes and extreme fatigue — and her physician about “the risk of serious defects and life-altering complications” tied to the leaking implants.