Ozurdex Injection Recall Lawsuit | Get the Right Lawyer

Ozurdex Injection Recall Lawsuit Details

​Ozurdex is a biodegradable intravitreal implant that delivers dexamethasone, a corticosteroid, directly to the vitreous humor of the eye. This targeted approach allows for sustained release of the medication over several months, effectively reducing inflammation and swelling associated with various retinal conditions. ​

Indications for Use:

Ozurdex is approved for the treatment of:

• Macular Edema Following Retinal Vein Occlusion (RVO): Swelling in the central retina due to blocked retinal veins. ​

• Diabetic Macular Edema (DME): Swelling of the macula in diabetic patients, particularly those with an artificial lens or when other treatments are ineffective or unsuitable. ​

• Non-Infectious Uveitis Affecting the Posterior Segment: Inflammation in the back part of the eye not caused by infection. ​

Administration:

The Ozurdex implant is injected directly into the vitreous humor using a specialized applicator. This procedure is performed by an ophthalmologist under sterile conditions to minimize the risk of infection.

What’s the Problem?

​Patients have initiated lawsuits concerning Ozurdex due to complications such as implant migration, corneal damage, and the necessity for surgical removal. The primary reasons include:​

1. Implant Migration and Corneal Damage:

• Anterior Chamber Migration: In certain cases, the Ozurdex implant has migrated from its intended position in the vitreous cavity to the anterior chamber of the eye. This migration is particularly prevalent in patients who are aphakic (lacking a lens) or have a compromised posterior lens capsule. Such displacement can lead to corneal edema and endothelial damage, potentially resulting in significant vision impairment. ​

• Risk Factors: Factors increasing the likelihood of migration include prior vitrectomy procedures and the absence or damage of the lens capsule.

2. Silicone Particulate Contamination:

• Manufacturing Defect: In December 2018, a recall of Ozurdex was initiated after the discovery of silicone particulates approximately 300 microns in diameter within the implants. These particles originated from the needle sleeve used during the injection process.

• Health Risks: The introduction of silicone particulates into the eye can cause complications such as retinal detachment, corneal damage, and may necessitate additional surgical interventions. ​

3. Necessity for Surgical Removal:

• Complication Management: When the implant migrates to the anterior chamber or when silicone contamination is detected, surgical removal becomes imperative to prevent further ocular damage. Such procedures carry inherent risks and can place additional physical and emotional burdens on patients.

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Ozurdex Injection Side Effects

Ozurdex has been linked to serious side effects, including (but not limited to):

• Migration
• Cornea damage / Corneal degradation / Corneal degeneration / Corneal decompensation
• Cornea epithelial cell damage
• Corneal edema
• Corneal lesions
• Blindness
• Accidental malpositioning
• Misdirected implant
• Ozurdex implant removal surgery
• Cornea transplant
• Conjunctival hemorrhage
• Glaucoma
• Cataract formation
• Retinal detachment
• Endophthalmitis
• And more

Ozurdex Recall

In December 2018, Allergan initiated a voluntary recall of 22 lots of its Ozurdex (dexamethasone intravitreal implant) after routine manufacturing inspections revealed the presence of silicone particulates approximately 300 microns in diameter within the implants.

Details of the Recall:

• Cause: The silicone particles were traced back to the needle sleeve, an integral component of the Ozurdex injection system. ​

• Scope: The recall affected Ozurdex units distributed in the U.S. between November 2016 and November 2018.

Potential Risks Identified:

The introduction of silicone particulates into the eye during injection posed several health risks, including:​

• Corneal Damage: If the particles migrated to the anterior chamber of the eye, they could cause corneal injury. ​

• Retinal Detachment: The presence of foreign particles could lead to retinal complications. ​

• Increased Intraocular Pressure: Potential elevation in eye pressure, leading to conditions such as glaucoma. ​

Regulatory Actions:

In response to the identified risks, regulatory agencies took the following steps:​

• United Kingdom: The Medicines and Healthcare products Regulatory Agency (MHRA) issued a Class 2 Medicines Recall for specific Ozurdex batches, advising healthcare professionals to cease use of the affected products and arrange for their return.

• United States: Allergan communicated directly with healthcare providers through an Urgent Drug Recall letter, detailing the issue and providing guidance on managing patients who had received the affected implants.

Ozurdex Eye Damage Studies

​Several studies have investigated ocular complications associated with Ozurdex injections. Below is a summary of notable findings:​

1. Retinal Injury Post-Injection:

• Case Report: A patient developed retinal and vitreous hemorrhage following an Ozurdex injection intended to treat macular edema due to branch retinal vein occlusion. This incident highlights the potential for retinal injury, especially in vitrectomized eyes [1.].

2. Anterior Migration of Implant:

• Review Findings: A review identified that 83% of patients experiencing anterior migration of the Ozurdex implant suffered significant complications, primarily corneal edema, which can severely impact visual acuity and patient comfort [2.].

3. Complications and Risk Factors:

• Retrospective Study: An analysis of 1,241 patients revealed a 1.69% incidence of significant complications related to Ozurdex injections. These included implant migration into the anterior chamber, leading to corneal decompensation, and cases of endophthalmitis and retinal detachment. Identified risk factors encompassed prior complicated intraocular lens implantation, iris defects, and a history of vitrectomy. [3.]

4. Intralenticular Injection Incident:

• Case Study: An unintended intralenticular injection of Ozurdex occurred in a patient with a thicker lens and persistent fetal vasculature. The uveitis remained well-controlled without significant cataract development until seven months post-injection, when cataract progression necessitated surgical intervention [4.].

5. Intraocular Pressure Elevation:

• Study Results: Research indicates that repeated Ozurdex injections do not significantly increase the frequency of intraocular pressure spikes beyond 30 mmHg. However, monitoring is essential, as individual responses may vary [5.].

6. Long-Term Safety Profile:

• Real-World Data: Comprehensive evaluations suggest that, under a pro re nata (PRN) treatment strategy, the average duration of dexamethasone implant efficacy is close to five months. Approximately one-third of patients may experience intraocular pressure increases, emphasizing the need for regular monitoring.

Legal Actions Against AbbVie

• Basis for Lawsuits: Affected individuals are pursuing legal action against the manufacturer, alleging negligence in ensuring the product’s safety and failure to provide adequate warnings about potential risks. Claims focus on the physical harm suffered, the need for additional medical procedures, and the overall impact on quality of life. ​

• Case Example: In a notable case, a patient experienced blindness following an Ozurdex injection due to a silicone particle being introduced into the eye from a defective applicator.

These lawsuits underscore the critical importance of stringent quality control in medical device manufacturing and the necessity for comprehensive patient education regarding potential risks associated with implantable devices.

Get a Free Ozurdex Injection Lawsuit Evaluation With Our Lawyers

The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Ozurdex Lawsuits. We are handling individual litigation nationwide and currently accepting new personal injury cases in all 50 states.

Again, if you or a loved one experienced serious side effects after receiving an Ozurdex Injection, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our product liability lawyers can help.

References:

1. https://journals.sagepub.com/doi/10.1177/2474126420934238
2. https://journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-023-00513-5
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC7511382/
4. https://www.sciencedirect.com/science/article/pii/S2405844022035071
5. https://www.dovepress.com/the-effects-of-repeated-ozurdex-injections-on-ocular-hypertension-peer-reviewed-fulltext-article-OPTH