Post-Riegel, non-preemption arguments for the proposition that FDCA-based causes of action are not viable under state law will be much more important.

But the following point stands out based on the facts as summarized:

The manufacturer did, indeed, violate FDA manufacturing standards. The FDA itself successfully brought suit against manufacturer on that basis. So, deliberately or otherwise, this device was not in compliance with FDA at the time it was implanted. The FDA said so in their own suit.

Thus, it seems to me that a version of Buckman figures in somewhere. If FDA itself finds a problem of this sort, can a suit go forward? If the problem was deliberate fraud, the Buckman precedent would suggest “no.” Ironically, then, this seemingly lesser negligence (relative to felony fraud) may be in a different category as judged here.

The other issue that arises is how much plaintiffs’ actions were themselves the trigger for FDA’s eventual suit. The decision notes: “Bionics assured Plaintiffs that the device conformed to manufacturing specifications and was not malfunctioning. However, in September of 2004,Bionics issued a voluntary recall of all HiRes90k devices containing Astro Seal feed-thrus. Although the recall covered only non-implanted devices, Plaintiffs elected to have B.P. undergo
surgery to remove his two cochlear implants. Bionics tested those units and determined that the moisture levels in them were 2.159% and 3.0312%—well above the maximum moisture level of .5% provided in the manufacturing specifications and approved by the Food and Drug Administration (“FDA”).”

Was this, I wonder, the basis of FDA’s own suit? If so, a further example of how FDA, on its own, is unlikely to catch problems of this kind.