A new lawsuit filed against Hubble’s parent company, Vision Path, by a patient who lost her eye highlights the need for FTC enforcement to protect patient safety.
(WASHINGTON) – Following the loss of a woman’s eye, Hubble parent company Vision Path faces legal woes concerning alleged product liabilities. In the lawsuit, the plaintiff alleges that she purchased Hubble contact lenses using a glasses prescription. The plaintiff also alleges that the prescription and provider information were not required to be provided to the company, and she received no contact lens care instructions. The plaintiff noted severe pain and injury after using the lenses for only a few weeks in her left eye, with persistent symptoms eventually leading to the loss of her right eye. This case emphasizes the need for public agencies, such as the Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA), to enforce current patient protection regulations already in place and to do more to respect the doctor-patient relationship.
David Cockrell O.D., Chairman of the Health Care Alliance for Patient Safety (HCAPS), said, “the doctor-patient relationship is the cornerstone of safe, high-quality care. Any business practices that undermine this relationship and lead to potential prescription replacements that put our patients at risk is completely unacceptable. HCAPS is committed to taking steps to stop these activities and uphold the doctor-patient relationship.”
HCAPS Executive Director, Ralph Kohl, emphasized the need to protect patient safety stating, “Tactics, such as the use of robocalls to verify contact lens prescriptions or substitute a medical device, can undermine decisions that doctors make based on a patient’s history and needs and put patients at undue risk. This lawsuit puts a clear and important spotlight on the need for patient-first guardrails in the contact lens market.”
The Alliance is calling on Congress to ban robocalls in the prescription verification process and pass the Contact Lens Prescription Verification Modernization Act (H.R. 2748). Passing this bill is critical in increasing the safety of the more than 45 million Americans that rely on contact lenses – FDA Class II and Class III regulated medical devices – for safe and effective vision correction.
The passage of this bipartisan legislation could mitigate, reduce, or stop improper lens usage, which can result from the substitution of lenses not as prescribed by the patient’s doctor or using an outdated prescription. This improper usage can lead to serious health complications, including infections and other sight-threatening conditions, such as microbial keratitis, corneal edema, ulcers, and neovascularization.
The Health Care Alliance for Patient Safety has made it a priority to close loopholes within the existing verification process and prevent improper substitution of lenses that can put patients at risk.
Stay up to date on all regulatory and policy news impacting patient safety by joining HCAPS.
HCAPS was founded in 2018 to advocate for patient safety and to protect and defend the doctor-patient relationship – the essential foundation of personalized health care decision making. The Alliance is made up of patient safety advocates, eye doctors, and contact lens manufacturers. HCAPS is supported by our Partners, the American Optometric Association, Johnson & Johnson Vision, EssilorLuxottica, Alcon, and CooperVision.
For more information, please visit www.PatientSafetyToday.com.