At least four lawsuits have been filed this month against Franck’s Compounding Lab, alleging that individuals suffered severe eye infections that were caused by contaminated doses of Brilliant Blue G, an eye surgery dye.
The product liability lawsuits accuse the compounding pharmacy of distributing contaminated and unsafe drugs, which led to their eye infections.
As a result of problems from Brilliant Blue G surgical dye, plaintiffs allege that they suffered debilitating eye injuries and permanent blindness in some cases.
The complaints were filed by Howard McMaster (PDF) and Brenda Hess (PDF) in the U.S. District Court for the District of Nevada, and by Eldon McKinley (PDF) and Bernice Tharp (PDF) in the U.S. District Court for the Northern District of Indiana.
Each of the lawsuits indicate that the plaintiffs received Brilliant Blue G during an eye procedure in November 2011, including cataract surgery and vitrectomy procedures.
Brilliant Blue G Recall Issued Due to Contamination
Brilliant Blue G is a compounded medication that was sold by Frank’s Compounding Lab to opthalmologists, who were told the product was safe to inject into the patient’s eyeball during surgery to help the doctor achieve desired results during the procedure.
In March 2012, Franck’s Compounding Pharmacy issued a Brilliant Blue G recall, following multiple reports of eye infections.
About two months later, the FDA issued a safety alert announcing the recall for all sterile human and veterinary prescriptions distributed by the pharmacy after investigators discovered microorganisms and fungal growth in areas of the facility that were supposed to be sterile.
According to a report by the U.S. Centers for Disease Control and Prevention (CDC) in May 2012, more than 30 confirmed or probable cases of fungal endophthalmitis were identified among patients who underwent eye surgery that involved products distributed by the pharmacy. Brilliant Blue G was linked to 20 of those cases.
Endophthalmitis is an eye infection that results in inflammation of the eye and can lead to vision loss and the loss of the entire eye in some cases. Antibiotics are usually applied via intravitreal injection (an injection into the eye itself), but in some cases eye removal is required.
The recently filed complaint alleges that the compounding pharmacy knew or should have known that the batches of Brilliant Blue G were unsafe for use, pursuing claims under theories of negligence, strict liability, failure to warn and breach of warranty.
The cases come as compounding pharmacies nationwide are undergoing intense scrutiny following a nationwide fungal meningitis outbreak that killed nearly 50 people and sickened more than 700. That outbreak was linked to epidural steroid injections distributed nationwide by the New England Compounding Center (NECC). Later investigations by the FDA discovered fungal contamination of drugs at that facility as well.
NECC also faces a growing number of fungal meningitis outbreak lawsuits, which drove the company into bankruptcy.