The U.S. Supreme Court refused to revive a lawsuit brought by two women against Johnson & Johnson unit Mentor Worldwide LLC, which they claim produced leaky breast implants that caused them to develop a myriad of health issues.
Amber Brooks and Jamie Gale had asked the high court to rule Mentor had a duty to warn that its MemoryGel Silicone breast implants could cause health problems.
Gale received her implants in 2008 and had them removed in 2017 after a host of medical issues she claims were caused by manufacturing defects in the product.
Brooks, who had augmentation surgery in March 2016, was hospitalized for sepsis and a life-threatening infection six months later caused by the MemoryGel.
The women initially filed suit in February 2019, accusing Mentor of negligence for its failure to warn and for defects in manufacturing. Their claims relied on the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.
They argued Mentor could have warned doctors and the public about negative side effects if the company had conducted follow-up studies and reported those findings to the U.S. Food and Drug Administration.
However, a Kansas federal judge tossed their lawsuit in September 2019, noting it was attempting to enforce the MDA when only the government had that power.
Further, the district court said there’s no federal law that would have required Mentor to warn patients. The judge also said manufacturers’ duty to warn extends to prescribing physicians, not patients, under the learned intermediary doctrine adopted by Kansas and Missouri, the states the women lived in.
The women appealed to the Tenth Circuit, which affirmed the dismissal. The panel said Brooks and Gale needed to point to a state law Mentor violated independent of the federal law in order to survive a motion to dismiss.