Federal Government Seizes Cyanide Antidote Kits from California Company

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California.
The seizure warrant was issued by the U.S. District Court for the Central District of California.

Marketed for use in cases of cyanide poisoning, Keystone distributes the kits primarily to hospitals in the United States and Canada. The products contain a Sodium Thiosulfate injection and a Sodium Nitrite injection in vials, along with components such as needles, tubing, and a syringe.

Most commonly, cyanide exposure occurs through inhaling smoke in residential fires, or through inhaling cyanide fumes during industrial accidents.

The cyanide antidote kits distributed by Keystone are unapproved new drugs under the Federal Food, Drug and Cosmetic Act and are therefore not permitted to be introduced into interstate commerce. The products have not been proven safe and effective for their intended use.

The kits also are misbranded because their labeling does not contain adequate directions for their use. Additionally, the seized products are adulterated because they were manufactured under conditions not in compliance with current Good Manufacturing Practice (cGMP) to assure that they meet the identity, quality, and purity standards they claim to possess.

“The FDA is taking this action because Keystone has refused to take these unapproved products off the market,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “This action is a significant step in protecting the public health.”

In October 2008, the FDA issued a warning letter to Keystone’s contract manufacturer, PrimaPharm of San Diego. That letter identified numerous cGMP violations and informed PrimaPharm that the Keystone Sodium Thiosulfate Injection and the Keystone Sodium Nitrite Injection were unapproved new drugs. The FDA also twice warned Keystone verbally that it should not distribute the unapproved drugs in the cyanide antidote kits.

After an FDA inspection of PrimaPharm between August and September 2009 found continuing cGMP violations, the contract manufacturer said it would no longer accept orders from Keystone to manufacture the injections or kits.

An FDA inspection of Keystone between September and October 2009 revealed that the firm had continued to distribute the unapproved drugs in the cyanide antidote kits still in inventory and did not intend to stop. Keystone was given numerous opportunities to come into compliance, but the company failed to cease distributing the unapproved new drugs.

The FDA advises hospitals or organizations that purchased these products to return the unapproved products to Keystone.

To date, the agency has not received reports of adverse reactions linked to the Keystone cyanide antidote products.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Haemonetics Files a New Legal Action to Stop Fenwal Inc.'s Continued Patent Infringement

/PRNewswire/ -- Haemonetics Corporation (NYSE:HAE) announced today that it has filed a new legal action to stop Fenwal Inc.'s continued patent infringement resulting from Fenwal's just released red cell collection kits, using a modified separation chamber. Fenwal allegedly modified its separation chamber to circumvent Haemonetics' patent and the injunction entered by the Court prohibiting Fenwal's continued sale of infringing products after December 1, 2010. According to statements made by Fenwal's counsel today in the United States District Court, Fenwal is determined to proceed with commercialization without 510(k) clearance from the U.S. Food & Drug Administration.

On December 7, 2009 Fenwal announced that it began shipping a red cell collection kit with a modified separation chamber, and that it is discontinuing sales of its original kit. Ten months ago, on January 31, 2009, a federal jury had determined that Fenwal's original collection kit infringes a Haemonetics patent, and found Fenwal liable to Haemonetics for over $15 million in damages. The United States District Court for the District of Massachusetts later added millions of dollars in pre-judgment interest and ordered the product removed from the market by December 1, 2010. The District Court also ordered that between January 31, 2009 and December 1, 2010, Fenwal must pay Haemonetics a 10% royalty on the offending product's sales. The damages have not been paid, and the royalties are being escrowed pending decision on Fenwal's appeal to the United States Court of Appeals for the Federal Circuit. A decision by the appellate court is not expected before late 2010 at the earliest.

Haemonetics filed a new lawsuit against Fenwal on account of the modified collection kit, requesting another jury trial that seeks multiple damages for willful infringement, and a permanent injunction. The new matter has been assigned to the same federal judge who issued the permanent injunction on Fenwal's original red cell kit.

Brian Concannon, Haemonetics' President and CEO said, "We commit to supporting blood collectors who wish to assure an orderly transition away from infringing product well in advance of the December 2010 injunction. It is our genuine desire to protect customers from involvement in this commercial dispute between competitors. As we continue to make multi million dollar investments to bring new technologies and blood management offerings to the blood community, we are likewise committed to protect our intellectual property, which is the foundation of the business we've built."

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page