Silicone Contaminated Eye Injections
The Silicone Contaminated Eye Injections Litigation Group provides a forum for attorneys litigating against the manufacturers of ant-VEGF drugs, compounding pharmacies, and the manufacturers of the syringes used to inject the drugs directly into a patient's eye.
Age-related macular degeneration (AMD), diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization are all medical conditions that require drugs to be injected directly into patients’ eyes. One of the most common conditions, AMD, is a leading cause of vision loss in people older than 60. Neovascular (or “wet”) AMD is caused by “leaky” blood vessels in the eye. Wet AMD can be caused by a protein in the eye called vascular endothelial growth factor (VEGF).
Anti-VEGF drugs are available to treat wet AMD and other conditions that cause vision loss, but the drugs must be injected directly into the eye. There are four anti-VEGF drugs available to treat wet AMD. All four drugs are effective in treating wet AMD, but there is a huge disparity in cost. The costs per injection are roughly: $2,000 for Lucentis, $1,800 for Eylea, $800 for Macugen, and $50 for Avastin. Avastin is much cheaper because it is available in large doses to treat cancer.
Across the country, compounding pharmacies are repackaging Avastin into single-use syringes, which are manufactured with a silicone lubricant inside the barrel of the syringe. These syringes were not designed, tested, or approved for use in eye injections. The drugs can become contaminated with silicone oil droplets, and the droplets will be injected directly into the patient’s eye along with the drug. Improper shipping and handling of the repackaged syringes can increase the risk of silicone contamination.
Most of the syringes used for injecting Eylea, Lucentis, and Avastin into the eye are manufactured by Becton Dickinson and were never approved or designed for use in eye injections.
Silicone oil droplets being injected into a patient’s eye can severely interfere with a patient’s vision and/or cause a permanent increase in intraocular pressure, requiring additional treatments like ocular surgery to reduce or correct. If unaddressed, increased IOP can eventually be linked to inflammation, infection, sight complications, retinal tearing, retinal detachment, and blindness. Patients experience these silicone oil droplets/particles as black discs floating in – and obstructing – their field of vision.
It is possible for the body to absorb the silicone oil droplets/particles naturally after many months or they may permanently obstruct a person’s vision. The silicone oil droplets can only be removed by a vitrectomy. In this procedure, a doctor drains the vitreous gel entirely and replaces it with an artificial saline, which the body replaces with natural saline over the next 24-48 hours. Unfortunately, this surgery impairs the effectiveness of future treatment for macular degeneration, which means the patient will go blind much sooner.
The Litigation Group was formed in July 2017.
The Silicone Contaminated Eye Injections Litigation Group provides a forum for lawyers litigating cases to share knowledge, strategies, and educational resources. The Litigation Group has a secure, members-only list server and document library where members can share pertinent information and documents regarding the litigation. This Litigation Group holds regular meetings that are closed to members only to discuss current cases and important updates.
AAJ Annual and Winter Conventions, or as need by group members.