Blog Archives

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug Administration.  Companies

Tagged with: ,
Posted in FDA

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law.[1] Under the Federal Food, Drug,

Posted in FDA

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or

Posted in FDA

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of information on its labeling without adjacent

Posted in FDA

Bellwether Trials: What Manufacturers Can Learn from the GM Ignition Claim MDL

As product liability multidistrict litigation becomes more prevalent, it is important for manufacturers to understand how the bellwether trial process works and how to use it to their advantage.  The ongoing bellwether trials in the GM faulty ignition switch MDL

Posted in Automotive

Roadmap for a Successful Product Inspection

One of the tasks manufacturing companies frequently face is having their products inspected and tested as part of the pre-litigation or litigation process.  While this may sound routine, it is important to have a detailed roadmap for conducting a successful

Posted in Inspections
Subscribe to New Posts

Email:

Products Liability Prevention & Defense
Our attorneys represent foreign and domestic designers, manufacturers, and distributors of a diverse array of products, from food and drugs to industrial equipment and building materials. We help clients respond to major personal injury and property damage claims in the form of single-product cases, class actions, mass torts, and multidistrict litigation, as well as all types of congressional, regulatory, or criminal investigations. Our team works closely with corporate counsel to minimize a company’s overall liability and establish efficient protocols for fielding claims and advise on labeling, marketing, manuals and instructions, supply and distribution contracts, and insurance and indemnification issues.
Recent Comments
Cozen O’Connor Blogs