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October 22 2008

Tort Litigation and Federal Regulation of Medical Devices

JAMA. 2008;300(16):1881-1882. doi:10.1001/jama.2008.506

To the Editor: In his Commentary on Riegel v Medtronic Inc, Mr Gostin1 provides what we consider to be a one-sided prolitigation viewpoint inconsistent with the interests of US physicians and their patients. Those interests are more accurately represented by the policies embodied in the Medical Device Amendments of 1976 and the opinions of 8 of the 9 justices of the United States Supreme Court. The opinion in Riegel highlighted that the plaintiff had a heavily calcified right coronary artery, 5 attempts were made to dilate that artery, and the recommended maximal pressure of 8 atmospheres was exceeded by using 10 atmospheres of pressure. The catheter balloon ruptured on the fifth attempt, leading to complications enumerated by Gostin.2