What triggers a CPSC recall of a defective product?

When a product poses a “substantial hazard” Every U.S. manufacturer, importer, distributor, and retailer of consumer products are obligated to report potential product defects to the U.S. Consumer Products Safety Commission. This doesn’t necessarily result in a CPSC-ordered recall of…

Cybersecurity for Medical Devices

Getting to the heart of the matter The FDA has issued a warning about potential cyber risks related to certain cardiac devices. The warning concerned implantable devices and transmitters that monitor and communicate data directly from patients to the doctors….

Which Products Need FDA Approval?

It’s not just for food and drugs Many of my current and potential clients are entrepreneurs marketing cosmetics, foods, dietary supplements and other products they’ve created for human and pet use and consumption. When discussing their insurance needs, I often…

Robotics and Product Liability

Medical technology and the law Surgical robots have been assisting surgeons for years now. However, we’re on the cusp of a new era in which fully-autonomous surgical robots will be actually conducting the surgery, not assisting. The goals are less…

Are Nanobots Really Already Here?

The effects of rapid technological advancement I read an article on the Next Big Future about nanobots currently being used to treat a terminally ill leukemia patient.  Without the DNA nanobot treatment, the patient would only be expected to live…

Advances in 3D bioprinters

Progress in medical technology mean better quality of life   “Hey, Doc, I need a tune-up.” This may be a common request doctors receive from athletes and arthritic patients in the near future. What is a 3D bioprinter? 3D bioprinters…

3D Printers Will Change the World as We Know It

 And what risks do 3D printers pose to businesses? 3D printing (or additive manufacturing) is a technology that will change society so profoundly it defies the imagination. Reading “The Printed World” showed me the possibility innovation where it will be just…

State-to-State Variability: Statute of Repose

Statute of Repose is another state law that can vary from state to state. This law specifically deals with the time allowed after the sale of a product a product liability lawsuit can be brought to the courts.

The Pre-emptive Defense for Medical Products

What will Obama do? Many journalists are convinced that President Obama’s administration is out to completely strike down pre-emption as an effective medical liability defense by medical manufacturers. In 2009, the Supreme Court ruled in Wyeth v. Levine that state juries…