Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more
2/21/2023
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Industry Standards ,
Food and Drug Administration (FDA) ,
Hackers ,
Hospitals ,
Innovative Technology ,
Internet of Things ,
Manufacturers ,
Medical Devices ,
Popular ,
Regulatory Agenda ,
Regulatory Standards
Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have...more
“Public hazard” is not a label that any company would want associated with its product. Such a label can have far-reaching consequences for product manufacturers, especially if a product is involved in mass litigation....more
A proposed amendment to Rule 30(b)(6) of the Federal Rules of Civil Procedure raises the potential for problematic consequences that may lead to more discovery disputes, such as a new discovery obligation to discuss the...more
On February 28, 2017, the Missouri Supreme Court issued an opinion significantly limiting the state’s personal jurisdiction over corporations. This limitation on statewide jurisdiction includes the courts of the City of St....more
On May 10, 2016, FDA released a much-anticipated draft guidance (the “Guidance”) concerning medical devices that incorporate additive manufacturing (AM) technologies, a category which includes 3D printed devices. AM...more
On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more