Just because a silicone breast implant ruptures does not give the patient the right to sue, a federal appeals court ruled Friday.
A three-judge panel of the 9th Circuit Court of Appeals acknowledged testimony from the doctor of Nicole Weber that one of her silicone implants she had obtained following a mastectomy in 2009 at age 53 had bled and lost about 2.8 percent of its mass.
The doctor said that caused health issues, including significant vision loss. And Weber, in her lawsuit, said even after removal she still has severe visual and immune system problems.
But appellate Judge John Owens said there was no evidence that Allergan Inc., which made the implant, had violated the manufacturing standards imposed by the U.S. Food and Drug Administration. And, absent that, the judge wrote, the company was immune to product liability lawsuits.
Owens said it comes down to the fact that the FDA, in granting approval to a company to market implants and other similar items “does not guarantee that every device manufactured in that process will work.”
“Rather, the FDA performs a cost-benefit analysis and approves devices knowing that they sometimes will fail,” the judge wrote. But he said that Congress, in enacting the laws giving the FDA oversight − and precluding other lawsuits − “struck a balance” between the benefits of making potentially risky devices available and “the cost to the few” who would be precluded from filing suit.
In filing suit, Weber said that the Allergan implants were not use defective and/or unreasonably dangerous but that the labeling was insufficient for anyone to make informed decisions regarding its selection and use. She also claimed that the company failed to warn users of the inherent dangers in using the product.
Owens, however, said her claims are precluded by federal laws dealing with medical devices.
The judge said the FDA “rigorously reviews” these kinds of devices.
“This includes a risk-benefit assessment of the device and an analysis of the adequacy of the manufacturer’s label,” he wrote. And he said the law allows the FDA to approve devices that present great risks “if they nonetheless offer great benefits in light of available alternatives.”
More to the point, once a device is approved, federal law says states cannot impose different or additional requirements related to safety.
Put simply, Owens said it would be legal for Weber to sue in state court if she was alleging that Allergan had violated FDA regulations related to the implant. But absent a showing of a violation — like the company changing the manufacturing process after it had been FDA approved — the judge said there is no right to sue.
And in this case, Owens said, there was no such showing to the trial court. He also said that evidence that some other implants produced by Allergan were defective does not indicate the company did not comply with FDA good manufacturing processes.
There was no immediate response from her attorney.