Letter: Medical devices in court

From Stacy Taylor

Your report of the US Supreme Court’s decision in Riegel vs Medtronic may create the erroneous impression that the court has given manufacturers of medical devices a free pass to sell defective products (1 March, p 6).

While the court did hold that the Riegels’ negligence claim was pre-empted by Food and Drug Administration approval of the catheter used, the scope of the ruling is limited to those medical devices that have undergone the full rigours of pre-market approval.

The court’s 1996 decision in Lohr vs Medtronic stands: claims can be asserted against medical devices that were approved by the FDA as being “substantially equivalent” to a previously approved device. In 2005, 3148 devices were approved in this way and only 32 devices underwent full pre-market evaluation and approval.

Claims that address issues not considered by the FDA, such as post-approval misuse of a device, may still be brought.

Poway, California, US