9/8/16
By: Michael Bruyere and Amanda Hall
On August 8, 2016, the FDA issued draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Current regulations provide that a manufacturer of a medical device must …
Category: Life Sciences
2/25/16
By: Amanda K. Hall
On January 25, 2016, researchers at Harvard University and The University of Illinois Urbana-Champaign detailed their creation of “4D-Printed” structures –made by mimicking the way orchids and other plants move and twist – that could ultimately …
MDL Procedures At-Risk For Closer Scrutiny Going Forward
1/21/16
By: Ryan Babcock
For years, the resolution of large-impact product defect and personal injury litigation has been shifting away from class actions in favor of Multidistrict Litigation cases that are consolidated in front of one judge in the federal and …
Insurance Application Omissions Not Enough to Rescind Policy
1/19/16
By: Kristian Smith
Insurers may need to pay closer attention to insurance applications. A Pennsylvania jury recently ruled that an insurer knew (or should have known) about omissions on an insurance application, preventing the insurer from rescinding the policy.
In …
Drug Distributors May Find Themselves Without a Defense
12/23/15
By: Michael Bruyere and Kristian Smith
Rising prescription drug abuse has put drug distributors under scrutiny in the last few years. Now, pharmaceutical companies are being sued for the economic costs associated with the epidemic, but they may not be …
FDA Approves First Drug Made by 3D Printing
9/1/15
By: Mike Bruyere
Additive manufacturing, or 3D printing, reached a significant milestone this month when the FDA approved the production of an epilepsy medication that will be marketed under the name Spritam. The new drug, developed by Aprecia, controls seizures …