Oxervate Lawsuit | 2025 Latest Updates

Oxervate Lawsuit Overview

The eye drops solution Oxervate (cenegermin-bkbj), which is used to treat an eye condition called neurotrophic keratitis (NK), has recently been linked to an increased risk for the development of plaques on the eye, which can lead to corneal ulcers and potential blindness.

Oxervate is a topical recombinant human nerve growth factor (rhNGF) medicine used to treat neurotrophic keratitis, an eye condition in which damage to the trigeminal nerve supplying the surface of the eye causes loss of sensation and defects that do not heal naturally.

Because the number of patients with NK is low, the disease is considered ‘rare’, and Oxervate was designated an ‘orphan medicine’ (a medicine used in rare diseases) in December 2015. Oxervate is manufactured and marketed by Dompé U.S. Inc.

Oxervate is a topical recombinant human nerve growth factor (rhNGF) medicine used to treat neurotrophic keratitis, an eye condition in which damage to the trigeminal nerve supplying the surface of the eye causes loss of sensation and defects that do not heal naturally [1]. – European Medicine Agency.

Latest Oxervate Lawsuit Updates

• August 9, 2024 – Latest article update by C.L. Mike Schmidt, providing comprehensive information about Oxervate lawsuits.
• August 28, 2023 – A study published in Expert Opinion on Drug Safety identified 3288 cases of Oxervate-related ocular adverse events and 56 positive ocular-related signals in the FDA pharmacovigilance database. Fifty unexpected signals of ocular adverse events were also identified [2].
• November 2023 – A study published in Cornea looked at a report of corneal superficial plaque formation after topical recombinant human nerve growth factor treatment for a non-healing epithelial defect in a 72-year-old patient [3].
• January 2022 – A case report published in the medical journal Cornea looked at incidences of corneal deposits occurring in patients treated with Oxervate for neurotrophic keratopathy [4].
• September 2022 – A study published in the American Journal of Ophthalmology Case Reports reported for the first time an incidence of drug precipitate deposit formation on both the ocular surface and bandage contact lens in a patient treated with topical Oxervate [5].

We report the rapid onset of a corneal opacity after initiation of treatment with cenegermin in patients with stage 2 or 3 NK, consistent with acute calcific band keratopathy.  We recommend close monitoring of patients receiving cenegermin therapy because the opacity may be irreversible and may require keratoplasty for visual rehabilitation.- Dr. Craig A. White, Ophthalmologist at the Loma Linda University Eye Institute in California.

Reports and Statistics on Oxervate

According to research published in Expert Opinion on Drug Safety:

• 3288 cases of Oxervate-related ocular adverse events were identified.
• 56 positive ocular-related signals were detected.
• Eye ulcer was classified as a designated medical event.
• Twenty adverse events, including corneal perforation, eye infection, corneal deposits, and eye inflammation, were recognized as important medical events.

For a clinical study reported in Cornea in January 2022:

• 5 patients from 3 institutions were discovered to have developed a white opacity in different layers of the cornea, indicating calcium deposition, while undergoing treatment with Oxervate.
• The opacity appeared rapidly, evolving over a few weeks following treatment initiation.

Treatment outcomes varied among affected patients:

• One patient underwent a successful superficial keratectomy with ethylenediaminetetraacetic acid chelation.
• Another patient required penetrating keratoplasty.
• A third patient received a Boston keratoprosthesis.

Instead, Oxervate labels only state that  The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation [6].- Dompé U.S. Inc., the U.S. subsidiary of Dompé farmaceutici S.p.A.

Oxervate Risks & Safety Concerns

Serious side effects of Oxervate may include:

• Eye plaques
• Eye ulcers
• Eye infections
• Corneal ulcers
• Corneal deposits
• Corneal perforation
• Acute Calcific Band Keratopathy
• Drug Precipitate Deposit Formation
• Blindness

Although the successful resolution of the persistent epithelial defect with rhNGF administration was notable, the development of the unusual epithelial overgrowth emphasizes the importance of vigilant monitoring and evaluation when using rhNGF in complex ocular conditions. Making informed decisions on the timing of discontinuing rhNGF can lead to desirable effects of the drug while mitigating additional side effects when managing such challenging cases. – Pier Luigi Surico، Department of Ophthalmology, Massachusetts Eye and Ear Institute, Harvard Medical School, Boston, MA.

Other, less severe side effects of Oxervate eye drops may include [7]:

• Mild to moderate eye discomfort
• Eye pain
• Blurred vision
• Corneal deposits
• Feeling of having something in the eye
• Enlarged blood vessels in the white of the eyes
• Swelling of the eye
• Sensitivity to light
• Increase of tears
• Headache 

Neurotrophic keratitis is caused when the nerves that serve (innervate) the cornea do not function properly; these nerves carry impulses that help the cornea function by eliciting the blink reflex, promote wound healing and increase tear production [8].- National Organization for Rare Disorders.

Do You Qualify for an Oxervate Lawsuit?

You may qualify for a lawsuit if:

• You or a loved one suffered complications after using Oxervate eye drops.
• You have medical records linking the product to health complications.
• You incurred financial or physical harm due to these side effects.
• You can document your use of the product and subsequent injuries.

If you or a loved one suffered complications after using Oxervate eye drops, you should contact us immediately for a free consultation.

You may be entitled to financial compensation for medical costs and lost wages by filing a lawsuit and our law firm can help.

The safety information on the label is incomplete, and the adverse reactions noted are mostly mild and tolerable. However, the occurrence of painful epithelial plagues and irreversible corneal deposits after cenegermin usage have been reported. – Yunfei Li, Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China.

Evidence Required for an Oxervate Lawsuit

Supporting evidence may include:

• Medical records showing your use of Oxervate
• Documentation of the side effects experienced
• Expert testimony linking your condition to the medication
• Proof of financial damages incurred as a result of the injuries

Medical records are especially crucial. They help keep track of the diagnosis, treatment, and any hospitalization related to complications from Oxervate use.

Damages You Can Recover

Compensation may include coverage for:

• Medical expenses
• Pain and suffering
• Lost wages
• Other damages related to the side effects caused by Oxervate

In a lawsuit, damages commonly fall into two categories: economic and non-economic. Economic damages cover financial losses, while non-economic damages pertain to intangible harm, such as pain and suffering.

Oxervate Recall Information

Currently, there is no information about an official Oxervate recall in the materials provided. However, ongoing safety monitoring and studies continue to assess the risks associated with this medication.

Topical cenegermin can produce extensive drug precipitate deposits on both the ocular surface and contact lens when used in conjunction with a bandage contact lens. – Pier Luigi Surico، Department of Ophthalmology, Massachusetts Eye and Ear Institute, Harvard Medical School, Boston, MA.

Statute of Limitations for Oxervate Lawsuits

While specific statute of limitations information for Oxervate lawsuits is not provided in the materials, product liability cases typically have time limits that vary by state.

It’s important to consult with an attorney promptly to ensure your claim is filed within the applicable time frame.

Related Articles:

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• AMO Complete® MoisturePlus Acanthamoeba Keratitis Recall Lawsuit
• LightEyez MSM Eye Drops Lawsuit

FAQs

1. What legal actions can I take against the manufacturer?

Legal actions that you can take against the manufacturer include civil lawsuits for damages, and in some cases, class-action lawsuits may be pursued if multiple individuals have experienced similar complications.

2. Do I need proof that Oxervate caused harm?

You do need proof that Oxervate caused harm. Medical records, documentation of side effects, and expert testimony linking your condition to the medication can support your claim.

3. How long do I have to file a lawsuit?

The amount of time you have to file a lawsuit can vary by state, but most product defect lawsuits must be filed within a few years of the injury or its discovery.

4. What kind of compensation can I receive?

The kind of compensation you can receive can include medical costs, lost wages, pain and suffering damages, and other expenses related to your injuries.

5. What should I do if I developed eye problems from Oxervate?

If you have developed eye problems from Oxervate, you should document the issue, retain proof of purchase, seek medical attention, and consult a lawyer specializing in pharmaceutical litigation.

6. Will my case go to trial?

Your case may not go to trial. Many cases settle out of court, but some proceed to trial if a settlement is not reached.

7. Are there ongoing investigations into Oxervate risks?

There are ongoing investigations into Oxervate risks. Several studies continue to investigate complications associated with Oxervate, including the development of corneal deposits and plaques.See all related product liability lawsuits our attorneys covered so far.

Get A Free Oxervate Lawsuit Evaluation From Our Lawyers

Time is limited to pursue legal action. It’s crucial to be aware of your legal rights and determine if you qualify for a lawsuit.

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case

Reach out to Schmidt & Clark, LLP today for a comprehensive evaluation of your Oxervate case. Allow us to be your trusted partner in navigating this complex situation.

References:

1. https://www.ema.europa.eu/en/medicines/human/EPAR/oxervate#:~:text=Oxervate%20is%20a%20medicine%20used,with%20moderate%20or%20severe%20disease.
2. https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml
3. https://pubmed.ncbi.nlm.nih.gov/38015976/
4. https://pubmed.ncbi.nlm.nih.gov/34582138/
5. https://www.sciencedirect.com/science/article/pii/S2451993622003309?utm_source
6. https://www.schmidtandclark.com/wp-content/uploads/2023-OXERVATE-Prescribing-Information_10.30.23.pdf
7. https://oxervate.com/about-oxervate/
8. https://rarediseases.org/rare-diseases/neurotrophic-keratitis/