(WASHINGTON) —  The Federal Trade Commission (FTC), along with the United States Department of Justice, announced it is seeking to fine online contact lens retailer Hubble $3.5 million for business practices that were both deceptive and dangerous to patients. The fine – $1.5 million in civil penalties and $2 million in redress – would be imposed because Hubble failed to properly verify patients’ contact lens prescriptions with their eye doctor, as required by law, among other things. The FTC reports it is the largest fine ever imposed for breaking the Contact Lens Rule (CLR).
 
According to the Department of Justice’s court filing, “Hubble did not ensure that consumers received lenses with the correct prescription, and did not actively confer with prescribers for the vast majority of customer orders. Instead, Hubble sent flawed and often incomprehensible verification messages to prescribers, and then, when the prescribers failed to respond with a denial within eight business hours, treated the order as passively verified and sent consumers lenses they had never been fitted for. Regardless of the quality of Hubble’s verification requests, Hubble promised more than passive verification—it promised that it would ensure that customers would receive the right prescription—and this it made no effort to do.”
 
“The findings by the Federal Trade Commission on Hubble’s dangerous and reckless business practices are deeply troubling, especially as they severely compromised patient health and vision safety for years,” said Dr. David Cockrell, OD, Chairman of the Health Care Alliance for Patient Safety. “We appreciate the Federal Trade Commission’s thorough investigation into this clear violation of the Contact Lens Rule, but this case makes it clear that immediate congressional action is needed in order fix the broken passive verification process, which allowed for Hubble to continue sending inaccurate and unverified prescriptions to patients for years.”
 
A bipartisan bill introduced in both the U.S. House of Representatives and U.S. Senate could have prevented these types of business practices that jeopardized patients’ health and safety. The Contact Lens Prescription Verification Modernization Act (H.R. 3353/ S.1784) modernizes the contact lens prescription verification process and makes it simpler and safer for millions of contact lens wearers.  
 
“Flagrant abuse of the Contact Lens Rule’s passive verification process makes it clear that Congress must act quickly in taking up and passing the Contact Lens Prescription Verification Modernization Act,” said U.S. Representative Bobby Rush (D-IL01), who introduced the legislation (H.R. 3353) in the House of Representatives. “This bill would give patients a much-needed safeguard by allowing eye doctors to clearly verify the accuracy of prescriptions and providing online retailers with the means to more safely and efficiently serve their customers.”
 
The bill increases patient safety by prohibiting prescription verification made via robocall and establishes clear verification processes. It requires that online sellers like Hubble use direct communication – e-mail, live phone call, or fax – to confirm prescriptions. This verification process would ensure patients are receiving their prescribed lenses rather than a substitution not approved by an eye care provider that could put their eye health and vision at risk. The bill also requires online sellers to develop HIPAA-compliant methods for patients to electronically transmit contact lens prescriptions.
 
Improper lens usage, which can result from the substitution of lenses not as prescribed by the patient’s doctor or using an outdated prescription, can lead to serious health complications, including infections and other sight-threatening conditions, such as microbial keratitis, corneal edema, ulcers, and neovascularization.
 
More than 45 million Americans rely on contact lenses – U.S. Food and Drug Administration (FDA) Class II and Class III regulated medical devices – for safe and effective vision correction. Contact lenses are more complex than they appear, having more than 10 different structural and chemical features that represent over 160 different brands to meet the needs of each individual patient. There are no generic contact lenses.
 
For more information, please visit www.PatientSafetyToday.com.