Align Technology, Inc. Investor Investigation In Connection With FDA Warning On Possible Side Effects

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Company Name(s): 
Align Technology
Affected Securities: 

After Align Technology, Inc announced on Nov. 30 that it received a warning letter from the FDA on Nov. 18 in connection with reactions by patients of its popular Invisalign invisible braces an investigation on behalf of investors of Align Technology, Inc. (NASDAQ:ALGN) concerning possible breaches of fiduciary duties was announced.

The investigation by a law firm concerns whether certain officers and directors at Align Technology, Inc. (Public, NASDAQ:ALGN) breached their fiduciary duties in connection with the recent U.S. Food and Drug Administration (FDA) warning letter and the recent ALGN stock decline.

Align Technology, Inc. designs, manufactures, and markets the Invisalign system, a method for treating malocclusion, or the misalignment of teeth. Invisalign corrects malocclusion using a series of clear, nearly invisible, removable appliances that gently move teeth to a desired final position. As early as Oct 21, 2010 Align Technology, Inc. (Public, NASDAQ:ALGN) announced that it has received regulatory approval from the Chinese State Food and Drug Administration (SFDA) to market and sell the Invisalign system as a Class II medical device for the treatment of malocclusion. Shares of Align Technology, Inc. (Public, NASDAQ:ALGN) traded during October as high as $21.08 per share but fell to under $17 in response to Align Technology, Inc. announcement of its Q4 2010 Guidance below Analysts' Estimates ALGN shares recovered during November to $18.50 per share.
Then on Nov. 30, 2010 Align Technology, Inc announced in a statement that it received a Warning Letter from the FDA as early as November 18, 2010 requesting additional documentation relating to written implemented corrections and corrective actions in complaint handling and Medical Device Reporting procedures taken by Align following an on-site inspection of Align's corporate headquarters in San Jose, California between June 29 and August 9, 2010. Align Technology, Inc said the FDA inspection resulted in the issuance of a Form 483 Notice which contained four observations and Align Technology already submitted a written response on August 26 and an additional written response on November 8, as well as a written response to the Warning Letter on November 22.
The warning letter accused Align Technology, Inc of failing to comply with federal requirements to report serious side effects associated with medical devices. The FDA warning letter stated three instances in which patients complained about their experience with the braces. On November 2, 2007, a patient reported “swollen, irritated, and sore” lips and gums; on March 17, 2008, a patient received steroids for the treatment of adverse events which occurred subsequent to the use of the Invisalign System; and on May 11, 2010, a patient reported “a burning tongue sensation, sore throat, ulcerations in the mouth, and swollen lymph nodes.” The FDA stated that those patient experiences should have been reported to the FDA no later than 30 days after the day that Align Technology became aware of those events.but instead none of these reactions were - timely - reported.
Roger E. George, vice president and general counsel of Align Technology said in the Nov. 30 Align Technology response to the FDA warning letter that "it appears that at the time the FDA issued the Warning Letter, it may not have fully reviewed the actions Align has completed and plans to complete to address the observations contained in the Form 483 Notice. We believe our response of November 8, 2010 may have crossed in the mail with the FDA's Warning Letter and we are working with the FDA to quickly resolve this matter with minimal impact on the Company."