Regulation of risk management of medical devices and the role of litigation

Patient health often depends on medical devices and implants. Thanks to these advancements, trust in and expectations of medical technology are high. But history shows critical device failures of heart valves, breast implants, hip prostheses and heart stimulators occurring under the regulatory system for such devices which certifies their efficacy and safety similar to the drug regulation process. Thus, questions remain regarding the effectiveness of the regulatory system to minimize risk. Differences between device regulation in Europe and the USA are shown, basically entailing that Europeans have quicker access to new technology but at the price of greater risk of harm. Given the investments to develop new devices and implants and the assumed thoroughness of the regulatory system, a certified device in Europe is considered safe and meeting the state-of-the-art standards of technology. Therefore, passing successfully the road map to certification, the certificate exempts the manufacturer of liability in case the device fails. Recently, it was revealed that regulation may fail due to underestimation of risks when used in patients, mainly due to lack of impartial and effective knowledge on the part of experts involved in the certification process. Conflicts of interest of experts and clinical investigators may also result in unacceptable exposure of patients to risk of device failure. Trust and good faith still play an important role in order to make a justified risk-benefit balance and to accept 'earn as you learn' as a leading principle. The past shows that thanks to litigation and class actions, legislation can be adjusted and compliance with regulations realized. The complexity of the system and restriction of patients' rights to be compensated for harm due to risky exposure to unproven but certified technology makes criminal and civil litigation still indispensible.