First impression? Look at the facts (br. at 8-9). This is a borderline ridiculous product liability case. The device, a cardiac balloon catheter, was misused � and we�d have to say abused. It was inserted into a patient with a �heavily calcified� (from the medical records) coronary artery despite an explicit warning not to use this particular catheter on �calcified� blockages. Reading between the lines, we�d guess that the reason for that warning is that calcifications tend to be hard and have sharp edges. The business end of the device, after all, is still a balloon. On top of that, the surgeon then overinflated the device by two atmospheres.
The result? Predictable. The balloon burst.
From what the highly abbreviated facts indicate, we can see that there might be a malpractice case on such facts. That only a product liability suit was filed in Riegel speaks volumes about how out of control product liability truly is.
Beck and Herrmann give a phenomenal analysis of the preemption issues at stake and the defense-side briefs in Riegel v. Medtronic.