On April 5, the Court of Appeals for the Eighth Circuit wiped out a jury verdict in a products liability action and $13 million punitive damages award against a manufacturer and its wholly owned subsidiary on the basis that the…
Blog Archives
8th Circuit Reverses to Uphold Successor Liability Defense, Highlighting The Importance of Consistent, Clear Descriptions Of Acquisitions To Avoid the de facto Merger Exception
Posted in Successor Liability
FDA releases draft guidance on expansion of abbreviated 510(k) Program
On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that a new medical device meets certain performance…
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…
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New FDA Draft Guidance on Updates to Certain Generic Labeling
On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or…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
