LOS ANGELES (Legal Newsline) – A California court has revived a lawsuit over breast implants that ruptured and derailed the career of a singer.
The Second Appellate District decided July 2 an issue of preemption in favor of plaintiff Rexina Mize, who sued Mentor Worldwide after her breast implants popped and allegedly caused various health problems.
The issue is whether her state law products liability claims were preempted by Medical Device Amendments to the federal Food, Drug and Cosmetic Act. They were not, because of the actions of the defendant, the court ruled.
“Mize sufficiently pled her manufacturing defect claims,” Justice Martin Tangeman wrote.
“She alleged that in the years leading up to her implant surgery Mentor failed to meet FDA-imposed manufacturing quality standards, destroyed evidence of its implants’ high rupture rates, sold contaminated implants and failed to comply with FDA-mandated design and materials specifications.
“She alleged that she later suffered a number of ailments that subsided once her implants were removed. That juxtaposition naturally gives rise to an inference that Mentor’s alleged manufacturing defects caused her injuries.”
Mentor Worldwide settled federal allegations in 1998 and agree to remedy the alleged violations. Mize had breast augmentation surgery two years later, receiving MemoryGel breast implants as part of a study.
Mize neither knew she was participating in the company’s study nor that she would not have qualified for it. Her implants had not been approved for sale by the FDA.
She suffered chronic fatigue, pain, joint swelling, stiffness, memory loss, numbness and worsened vision. She abandoned her music career after losing many business opportunities, the ruling says.
Three years after the surgery, a federal court dissolved Mentor’s consent decree with the FDA. In 2006, the FDA told Mentor to conduct six studies on its implants as a condition of approving them.
The company failed to properly perform the studies, the ruling says, by not fully reporting all of the negative events like silicone toxicity and ruptures.
Mize ended up having the implants for 16 years, when an MRI revealed that they had ruptured. Her lawsuit said Mentor failed to design its implants in a manner approved by the FDA while the company made a preemption argument.
A trial court sided with Mentor.
“These injuries are clearly those the MDA and FDA regulations sought to prevent, and Mize is in the class the FDA sought to protect,” Tangeman wrote.