News & Analysis as of

A “Good” Deed Goes Unpunished

Alabama Supreme Court Rejects “Good Samaritan” Liability in Gray Market Case - Last month, I wrote about the “Good Samaritan” rule, codified in Restatement (Second) of Torts, section 324A, “Liability to Third Persons...more

GLOBAL: How to protect brand reputation and sales from the risks associated with a product recall

In the past decade or so, manufacturers in the developed world that would previously have created their entire product in their own country now outsource manufacture to other parts of the world. This has had significant...more

Protect Your Safety Investigations and Deliberations From Prying Eyes

Every day companies deal with an ongoing safety analysis of their own products. These Safety Teams are routinely interdepartmental. The Safety Teams must consider design changes, manufacturing issues, potential recalls,...more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

How to protect brand reputation and sales from the risks associated with a product recall

Q: I am in charge of risk management for a global organisation and have been asked to investigate product risk. What suggestions can you offer on managing global supply and distribution? A: in the past decade or so,...more

Do Not Pass Go: Federal Judge Orders Execs Jailed for Contempt of Recall Order

A recent federal decision has made clear that court-ordered recalls can have real teeth, not just for manufacturers but also their officers—especially when the court has reason to suspect a company’s execs are deliberately...more

Newest Addition To CPSC’s Enforcement Toolbox

Recently, the Consumer Product Safety Commission obtained an unprecedented ruling when Administrative Law Judge Dean Metry granted leave to Craig Zucker in an administrative complaint against Maxfield and Oberton Holdings...more

CPSC Seeks to Hold Former CEO Responsible for Buckyballs® Recall

Last week the Consumer Product Safety Commission (CPSC) obtained an unprecedented ruling when Administrative Law Judge (ALJ) Dean Metry granted leave to name Craig Zucker in an administrative complaint against Maxfield and...more

FDA Draft Guidance on Device “Product Enhancements” Could Lead to Increased Recalls

On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more

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