A federal appeals court on Wednesday overturned a lower court and reinstated a medical product liability lawsuit filed by a patient against a breast implant manufacturer.
In January 2007, Dr. was implanted. Lalitha E. Jacob surgically with MemoryGel implants manufactured by Irvine, Calif.-based Mentor Worldwide LLC, according to the ruling by the 11th US Circuit Court of Appeals in Atlanta in Lalitha E. Jacob, MD, v. Mentor Worldwide LLC.
Dr. Jacob claimed that after receiving her implants, she developed “severely disabling and life-threatening medical problems” related to lupus-like syndrome, the ruling said.
She underwent surgery 12 years later, when she discovered her left implant had ruptured, creating systemic “chemical and heavy metal toxicity that affected her entire body,”; it said.
She filed a lawsuit against Mentor in US District Court in Tampa, Florida, which dismissed the case citing the Medical Device Amendments Act, which preempts state manufacturing defect claims, except when parallel violations of state and federal law are alleged.
In overturning the conviction, a three-judge panel of the appeals court said Dr. Jacob “arguably has pleaded parallel violations of state and federal requirements that survive Mentor’s motion to dismiss.”
Florida law “recognizes common law negligence claims based on a manufacturing defect theory of liability,” and that a manufacturer can be held strictly liable for an injury to its product’s user, it said.
“Jacob alleges that Mentor manufactured the implants using ‘improper and non-compliant components and materials, in violation of Florida law’ and that the design was also inconsistent” with US Food and Drug Administration regulations, the ruling said, as the case was remanded for further proceedings.
Plaintiff attorney Thomas A. Burns, founding shareholder of Burns PA in Tampa, said in a statement, “We are pleased with the verdict and pleased that Dr. Jacob will have the opportunity to continue to pursue her case in district court.”
Mentor’s attorneys did not respond to a request for comment.