Metropolitan News-Enterprise


Friday, November 29, 2019


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Ninth Circuit:

State Law Claims Against Maker of Saline Breast Implants Are Barred

Opinion Says Causes of Action Under California Law Could Be Maintained Only If the Plaintiff Pointed to Violation of Parallel Federal Requirements


By a MetNews Staff Writer


A woman who claims she suffered illnesses resulting from defective values in her saline-filled breast implants causing leaks failed to state claims under California law, the Ninth U.S. Circuit Court of Appeals has declared, because she has pointed to no deviation by the manufacturer from federal requirements.

Anita Laux’s action against Mentor Worldwide, LLC, a unit of Johnson & Johnson, was brought on Dec. 29, 2015, in Ventura Superior Court. She claimed she experienced pain throughout her body, numbness, fatigue, and respiratory congestion which doctors determined was traceable to the implants which contained debris and bio-toxins from mold.

Her action was removed by Mentor to the U.S. District Court for the Central District of California based on diversity of citizenship. Judge Otis Wright II granted summary judgment to the defendant on Nov. 8, 2017.

Federal Legislation

Wright explained that Mentor’s saline breast implants are devices of a sort that must be approved by the Food and Drug Administration (“FDA”). Under the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act, state actions are barred if they erect requirements which differ from those set by the FDA, he said.

Congress enacted the MDA in 1976, the judge noted, to tighten federal control of such devices.

“Plaintiff fails to plead a manufacturing defect or negligence claim that parallels federal requirements because Plaintiff does not allege that Defendant deviated from any specific manufacturing requirement imposed by the FDA,” Wright wrote.

Ninth Circuit Opinion

Affirming, the Ninth Circuit held, in a memorandum opinion filed Tuesday:

“Summary judgment was proper for Mentor on each of Laux’s state law claims because Laux failed to raise a genuine dispute of material fact as to whether Mentor violated a Food and Drug Administration…requirement, and therefore her state law claims are expressly preempted under the Medical Device Amendments…to the Food. Drug, and Cosmetic Act.”

The case is Laux v. Mentor Worldwide, LLC, 17-56832.


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