Liability Issues with RFID for Drug Security?

The FDA has indicated that they want drug companies to provide an electronic chain of custody that shows where drugs have traveled from manufacturer to patient, to reduce the risk of counterfeiting. RFID has been identified as the FDA's preferred technology for achieving that, although their rule does not specifically require RFID.

One of the unresolved policy issues associated with that move, and I've talked to folks on Capital Hill about it, is who carries liability for the accuracy of the report? If a patient takes a counterfeit drug, and the electronic record is inaccurate for some reason, does the liability and insurance risk fall on the patient? On the drug manufacturer? Their delivery network? The RFID provider? Insurance companies might have an interest in that question.

Same as with manufacturing issues -- RFID is increasingly being used to track expensive or critical parts for airplanes and cars. One reason is to reduce the risk of counterfeit and inferior parts being put on a plane. If the system fails and a plane crashes, who holds the risk? The airline? The RFID system? An insurance company perspective on these questions would be great.