Case Study: Plaquenil Toxicity and Preventable Blindness

Background

A woman in her early 50s was diagnosed with lupus and arthritis. To manage her symptoms, her rheumatologist prescribed Plaquenil (hydroxychloroquine) at 400 mg per day. Plaquenil has been used for decades to treat autoimmune conditions, but it carries a well-documented risk of permanent retinal damage.

Medical guidelines — published by the FDA, the American College of Rheumatology (ACR), and the American Academy of Ophthalmology (AAO) — clearly warn that:

Daily doses above 400 mg increase the risk of toxicity.

Patients using Plaquenil for more than five years require annual screening with visual field tests and advanced imaging (such as OCT scans).

Any signs of visual changes should trigger immediate discontinuation of the drug.

To safeguard her vision, the patient was referred to an ophthalmologist for annual monitoring. Unfortunately, both her rheumatologist and ophthalmologist ignored these standards.

The Patient’s Story

2004–2006

The patient began Plaquenil treatment at 400 mg/day. Within two years, she reported problems on a vision test. Instead of ordering more sensitive exams, her ophthalmologist performed only a single baseline visual field test — and then waited nine years before repeating it.

In 2006, her rheumatologist increased the dose to 600 mg/day, far above safe levels. He admitted later that he never weighed the patient, never calculated safe dosing by body weight, and never considered cumulative exposure — all required for safe prescribing.

2007–2010

The patient continued to report vision problems, including blurred and doubled lines. Despite this, her ophthalmologist stuck with outdated “Amsler grid” tests that had already been deemed unreliable by professional guidelines. At no point did he stop the medication, even though the drug’s labeling explicitly required discontinuation at the first sign of visual changes.

By 2010, the patient had been on Plaquenil for six years — already beyond the five-year threshold where risk of toxicity sharply rises. Still, neither doctor conducted the required tests or reviewed her dosage.

2011–2012

The AAO issued updated standards in 2011, requiring annual visual field and OCT testing. Both doctors ignored these changes.

That same year, the patient’s lupus went into remission. Rather than reducing her medication, the rheumatologist left her at 600 mg/day. In 2012, he increased her dosage to 800 mg/day — double the safe limit. At this point, the patient had multiple risk factors: age over 60, long-term use, cumulative exposure above safety limits, and declining vision. Yet both doctors continued to approve the drug.

2013–2014

The patient repeatedly complained of worsening near and distance vision. Still, the ophthalmologist refused to run visual field or OCT tests. Instead, he routinely wrote to the rheumatologist that it was “ok to continue Plaquenil.”

2015

By March 2015, the patient reported fuzzy vision and loss of peripheral sight. Her ophthalmologist finally suspected toxicity — but instead of acting urgently, he delayed testing for months. When he eventually performed the proper tests in September 2015, the damage was severe and irreversible.

Around the same time, the patient switched to a new rheumatologist, who immediately cut her dosage in half. Shortly thereafter, Plaquenil was discontinued altogether.

The Consequences of the Doctors’ Mistakes

The damage had already been done. Despite stopping the drug, her vision continued to deteriorate due to Plaquenil’s long half-life in the body. She is now legally blind.

Her current eyesight is measured at 20/125 in one eye and 20/250 in the other. She cannot drive, read, shop, or perform daily tasks independently. Once an active grandmother, she now requires constant assistance and describes feeling like a “prisoner in her own home.”

The emotional toll has been profound. She struggles with depression, a loss of intimacy, and the grief of never being able to see her family’s faces again.

Our Role

Our case demonstrated that both physicians breached the standard of care:

The rheumatologist prescribed excessive doses, failed to monitor weight or cumulative exposure, and continued the drug even when the patient’s disease was in remission. In his deposition, he admitted he knew the dosage was far too high but “took the risk.”

The ophthalmologist ignored updated guidelines, failed to perform mandatory testing, never asked about dosage, and admitted in hindsight that more testing “should have been done.”

Shockingly, the two doctors never once communicated with each other about the patient in more than a decade of treatment. The “team” responsible for her care functioned in complete isolation — leaving the patient to fall through the cracks.

Why It Matters

This case shows how devastating the consequences can be when doctors ignore established safety standards for Plaquenil. Both the FDA and the AAO had long warned of the risks and required strict monitoring. Had either doctor followed the rules, the patient’s blindness almost certainly could have been prevented.

Instead, she faces the rest of her life with a permanent, progressive disability.

Our firm pursued this case to hold the providers accountable and to highlight the importance of proper Plaquenil monitoring. Patients deserve physicians who take these risks seriously — and when they don’t, the law provides a path to justice.