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Appeals court reinstates patient’s suit in breast implant case

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appeals court

A federal appeals court on Wednesday overturned a lower court and reinstated medical products liability litigation filed by a patient against a breast implant manufacturer, ruling state law did not preempt the lawsuit.

In January 2007, Dr. Lalitha E. Jacob was surgically implanted with MemoryGel implants manufactured by Irvine, California-based Mentor Worldwide LLC, according to the ruling by the 11th U.S. Circuit Court of Appeals in Atlanta in Lalitha E. Jacob, MD, v. Mentor Worldwide LLC.

Dr. Jacob alleged that after she received 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, at which time she discovered her left implant had ruptured, creating systemic “chemical and heavy metal toxicity that affected her entire body,” it said.

She filed suit against Mentor in U.S. District Court in Tampa, Florida, which dismissed the case, citing the Medical Device Amendments Act, which preempts state-law manufacturing defect claims except when parallel violations of state and federal law are alleged.

In overturning the ruling, a three-judge appeals court panel said Dr. Jacob has “plausibly 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 for liability,” and that a manufacturer may 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-conforming component parts and materials, in violation of Florida law’ and that the design was also inconsistent” with U.S. Food and Drug Administration regulations, the ruling said, in remanding the case for further proceedings.

Plaintiff attorney Thomas A. Burns, founding shareholder with Burns P.A. in Tampa, said in a statement, “We’re pleased with the ruling and delighted that Dr. Jacob will have the opportunity to continue pursuing her case in the district court.”

Mentor’s attorneys did not respond to a request for comment.