The Trouble with the Curve: Manufacturer and Surgeon Liability for “Learning Curves” Associated with Unreliably-Screened Implantable Medical Devices

Authors

• Frank Griffin

Abstract

Implantable medical devices have a considerable effect on the health and finances of Americans. The rate of success of the implantation of the medical device depends upon device design and physician experience. New devices are often associated with an increased rate of complications during the first few years the device is on the market as doctors learn how to better implant the device and as device companies make modifications to the device. This phenomenon is known as the “learning curve”.

During the learning curve period, the complication rate for the new device is often higher than for the established device being replaced. Risk-utility balancing can be used to determine whether or not the manufacturer (or surgeon) acted negligently by releasing (or using) the device with a learning curve.

It is inherently unreasonable for patients to be subjected to a learning curve for a device that promises worse and more expensive outcomes than an established device. Under simple risk=benefit analysis for both the individual patient and society as a whole, where an unreliably-screened, implantable, medical device (USIMD) offers no proven benefit, no additional risk over an established device should be accepted. Patients injured during the learning curve for a USIMD have at least two potential routes to recovery under current law: (1) defective design under products liability law, and (2) informed consent doctrine under medical malpractice law.

Recommended Citation

Frank Griffin, The Trouble with the Curve: Manufacturer and Surgeon Liability for “Learning Curves” Associated with Unreliably-Screened Implantable Medical Devices, 69 Ark. L. Rev. 755 (2016).
https://doi.org/10.54119/alr.jiog1798
Available at: https://scholarworks.uark.edu/alr/vol69/iss3/4