Skip to content
June 25, 2013 / Scott Tillett

U.S. Government Sues Pharmaceutical Company for Distribution of Unapproved and Misbranded Drugs

US-FDA01

The Department of Justice (“DOJ”) has filed a lawsuit, on behalf of the Food and Drug Administration (“FDA”), against Sage Pharmaceuticals, Inc. (“Sage”) in the U.S. District Court for the Western District of Louisiana. The complaint alleges that Sage violated the Federal Food, Drug, and Cosmetic Act (“FDCA”) by manufacturing and distributing drugs that had not been approved by the FDA.

The FDA is charged with approving all drugs sold in the United States to ensure that they are safe and effective for use by consumers. Assistant Attorney General Stuart Delery commented that “those companies that undermine [the FDA’s] mission will be held accountable.”

This is not the first time that Sage has been under government scrutiny for the sale of unapproved drugs. In April 2000, the government obtained an injunction against Sage banning the sale of two unapproved cold and allergy medications, Palgic D and Palgic DS. As a result, Sage has been the subject of continued monitoring and FDA inspections, which now reveal that the company continues to distribute unapproved pain relievers and over-the-counter cold medications without first obtaining FDA approval.

Despite several warnings from the FDA, Sage has failed to comply with approval requirements for the sale and distribution of new drugs. The DOJ and the U.S. Attorney’s Office now seek a permanent injunction requiring Sage to cease the manufacturing, sale, and distribution of all pharmaceutical products until it has brought its operations into line with FDA regulations.

If you or someone you know has purchased drug products that have not been approved by the FDA, you may be entitled to relief. Please call Khorrami Boucher Sumner Sanguinetti, LLP for a confidential consultation.

About these ads

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Consumer Advocate Legal Update

Insight and Commentary on Consumer Legal Issues

Plaintiffs-Advocate

Insight and Commentary on Individual Rights

Fair Employment Legal Update

Insight and Commentary on Legal Employment Issues

KBSS News

Legal Updates and News About Khorrami Boucher Sumner Sanguinetti, LLP

Follow

Get every new post delivered to your Inbox.

Join 467 other followers

%d bloggers like this: