A Medical Device Daily

Align Technology (Santa Clara, California), inventor of Invisalign, a method of straightening teeth without wires or brackets, reported that the company has been notified of a purported class action complaint filed against it, OrthoClear (San Francisco) and OrthoClear Holdings, in the U.S. District Court for the Northern District of New York on May 18. Align said it became aware of the filing on May 22 but has not been served with a copy of the complaint.

The complaint, captioned "Debra A. Weber, on behalf of herself and all others similarly situated, Plaintiff, against Align Technology Inc., OrthoClear Inc., and OrthoClear Holdings, Inc., d/b/a OrthoClear, Inc.," alleges that orthodontic treatments of the plaintiff dental patients "were interrupted, unduly prolonged or terminated as a result of defendants' unlawful conduct" relating to the OrthoClear settlement.

The complaint alleges two causes of action against the OrthoClear defendants and one cause of action against Align Technology for breach of contract. The cause of action against Align Technology references Align's agreement to make Invisalign treatment available to OrthoClear patients, alleging that Align failed "to provide the promised treatment to Plaintiff or any of the Class Members."

Align said it has reviewed the allegations contained in the complaint and said it believes they are "without merit."

After two years of marketing and patent disputes between Align and OrthoClear, the companies last fall settled their legal battles, with Align buying OrthoClear's intellectual property, including the company's patent portfolio related to the manufacturing of clear, removable aligners for $20 million (Medical Device Daily, Sept. 29, 2006). With the settlement, OrthoClear agreed to stop the importation of aligners into the U.S. and discontinue all aligner business operations worldwide.

Align said that, as a result, some OrthoClear patients may not have been able to complete their orthodontic treatment with OrthoClear. Thus, Align offered to help minimize treatment disruptions for those patients and their doctors by making Invisalign treatment available to OrthoClear patients at no additional charge from Align.

Following the OrthoClear settlement, Align launched the Patients First Program to provide new Invisalign treatment to former OrthoClear patients at no charge to patients or their doctors, the company said. As of May 21, Align said it had shipped about 23,400 of the 24,700 cases submitted under the Patients First Program, including all Invisalign aligners for the named Plaintiff. The remaining in-process cases are expected to ship in the second quarter, the company said.