Contact Lens Recall Spurs Lawsuit

The new year isn’t starting out so happy for The Cooper Companies Inc. The Pleasanton, Calif.-based medical device firm is facing a class action lawsuit over a massive contact lens recall issued earlier this year by one of its subsidiaries.

The complaint filed Nov. 28 in U.S. District Court for the Northern District of California seeks class action status to represent investors who purchased Cooper stock between March 4 and Nov. 15, 2011. The deadline for joining the class action suit is Jan. 27.

The lawsuit accuses company executives of downplaying problems with the recalled lenses in order to boost Cooper stock and then failing to properly inform the public about the recall. In addition to those missteps, senior executives and board members allegedly sold $47 million worth of personally-held stock during the eight-month class action period, the lawsuit charges. Specifically, President and CEO Robert Weiss and the company’s chief financial officer made $14 million by selling their shares of stock at inflated prices, the lawsuit contends.

Cooper’s legal troubles intensified in August, when its subsidiary, CooperVision Inc., issued a recall of the Avaira Toric contact lens. The product had been on the market for only four months when CooperVision issued a voluntary recall on Aug. 19 with a “limited number of lots” in the U.S. market that may have been contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain. About a week after issuing the voluntary recall, CooperVision executives informed the U.S. Food and Drug Administration (FDA) about its decision.

The FDA, however, accused CooperVision of issuing a “stealth recall” that left many consumers unaware of the potential problems associated with the Avaira Toric brand contact lens—namely, hazy vision, pain and torn corneas. The FDA issued a Class 1 recall warning about the lens (the most serious kind of recall) and pressured the company in October to inform more people about the 780,000 Toric lenses in circulation on the market. Just a few weeks later, CooperVision added its Avaira Aquaform Sphere soft contact lenses to the recall, bringing the total number of affected lenses to more than 7 million (a spokeswoman claimed 6.6 million Avaira Sphere lenses are affected by the recall, but only 4.9 million were shipped to stores such as Costco, Lenscrafters and Wal-Mart.

CooperVision officials claim the recall is limited only to the Avaira Toric and Avaira Sphere brands (both products use silicone oil in their manufacturing process). The company expects to set aside about $9 million for the expanded recall and $23.2 million on both recalls, according to a news release.

Some of that money most likely will be used to fund CooperVision’s extensive outreach program to consumers. According to an official statement, CooperVision’s recall efforts include:

• Sending worldwide recall notifications to Avaira Sphere CooperVision customers;
• Issuing a press release about the recall of limited lots of CooperVision Avaira Sphere lenses;
• Posting information on the CooperVision website so lens wearers can check their lot numbers against those affected by the recall (www.coopervision.com/international-recall);
• Posting an information notice on www.coopervision.com;
• Creating a toll-free consumer hotline (1-855-526-6737 hours of operation 9:00-5:00pm EST Monday-Friday);
• Providing retailers and distributors access to patient communications materials;
• Providing support and detailed information to eye care practitioners to remove recalled lots of Avaira Sphere lenses from the market; and
• Offering customer care resources to answer questions from patients.

“The company is confident we found the problem and have taken corrective action to fix the problem,” said Christine Moench, Vice President, Global Regulatory Affairs and Quality Assurance. “The health and safety of our customers is our top priority.”

The Cooper Companies operates through two business units, CooperVision and CooperSurgical. CooperVision is headquartered in Pleasanton, Calif., while CooperSurgical is located in Trumbull, Conn.