A Medical Device Daily

Cardinal Health (Dublin, Ohio) said it has reached an agreement with the FDA on an amended consent decree regarding the company's infusion pump products.

Cardinal Health has operated under a consent decree since February 2007 for its Alaris SE pumps, which resulted in the company implementing a new quality system on April 2, 2008.

Under the amended agreement, which is subject to approval by the U.S. District Court for the Southern District of California, Cardinal Health will conduct a thorough review of its broader line of infusion pump products within 60 days and submit a corrective action plan to the FDA that outlines all planned modifications to any infusion pump products.

Within 100 days, the company will have an independent expert inspect and certify whether the company's infusion pump operations are in conformity with the Quality System Regulation and certain other provisions of the Federal Food, Drug, and Cosmetic Act.

Also within 100 days, the company said it will have an independent expert inspect and certify whether its recall procedures and all ongoing infusion pump recalls are in compliance with the Act and determine whether additional remedial action should be taken.

The FDA alleges in the amended consent decree that based on a January 2008 inspection, certain Cardinal Health infusion pumps do not satisfy the standards of the act. The amended agreement does not impact the company's ability to market and sell its broader line of infusion pump products, except for the Alaris SE pump.

In other legalities:

• Align Technology (Santa Clara, California) reported that it has been notified of a purported declaratory judgment action filed against it on February 17, 2009 by ClearCorrect (Houston) in U.S. District Court for the Southern District of Texas. Align Technology became aware of the filing on Feb. 17, but said it has not been served with a copy of the complaint.

In the complaint, assigned case #H-09-470 and captioned "ClearCorrect, Plaintiff, vs. Align Technology, Defendant," ClearCorrect alleges that a "controversy exists between Align and ClearCorrect concerning the validity of Align's patents that relate to the manufacture and sale of a clear aligner therapy system" and regarding "the infringement of Align's patents" by ClearCorrect. The complaint seeks a judgment declaring that unidentified Align patents are invalid and unenforceable and that ClearCorrect does not infringe the unidentified Align patents.

Align Technology said that it is not currently involved in any litigation with ClearCorrect, nor has Align previously communicated with ClearCorrect regarding the subject matter of the complaint or any of Align's 165 issued patents.

It said ClearCorrect's complaint is unrelated to a previous lawsuit filed by Align Technology against Dr. Willis Pumphrey, ClearCorrect's CEO, for breach of contract, trademark infringement and copyright infringement. That lawsuit was settled to Align's satisfaction in 2007 by the payment of more than $330,000 to Align by Pumphrey and a stipulation by the parties that Pumphrey was decertified by Align and is no longer authorized to treat patients with Invisalign products.

Align said it has reviewed the allegations contained in the ClearCorrect filing and believes they are without merit. It said it intends to vigorously defend itself against the complaint.

• CVS Caremark Corp. (Woonsocket, Rhode Island) reported that it has entered into an agreement with the U.S. Federal Trade Commission and the U.S. Department of Health and Human Services Office for Civil Rights (OCR) concerning disposal of patient information at its retail pharmacy stores. The agreement resolves an investigation prompted by media reports from 2006 about alleged incidents of inadvertent disposal of patient information in dumpsters at a limited number of CVS/pharmacy locations in a manner that was inconsistent with the company's waste disposal procedures.

The investigation was initiated prior to the merger between CVS and Caremark, involved CVS/pharmacy retail locations only and did not relate to the PBM business. The company responded to these reports by promptly enhancing its retail waste disposal policies and training programs, and instituted a chain-wide shredding program for confidential waste to further guard against inadvertent disposal of confidential information in the regular trash.

CVS Caremark is not aware of any consumer harm arising out of, or related to, the alleged incidents. Per the agreement with the FTC and the OCR, the company has expressly denied engaging in any wrongful conduct and agreed to settle the matter in order to avoid the time and expense of further legal proceedings.

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