Franck’s Compounding Lab, of Ocala, has been sued twice in Los Angeles, once in Las Vegas, and twice in New Orleans, for its Brilliant Blue G, a stain used in eye surgery,
Courthouse News Service reports. In the most recent suit, filed this month in Los Angeles, the plaintiff claims that Franck’s dye, “tainted with filth, putrid, or decomposed substances,” caused an infection that left him blind in his left eye.
Brilliant Blue G (BBG) is a dye that helps physicians see transparent tissues in the eye during surgery. The dye is not approved by the U.S. Food and Drug Administration (FDA), Courthouse News Service said. In March 2012, the FDA issued a warning to physicians about the use of Brilliant Blue G and sent a letter to Franck warning that Brilliant Blue G was adulterated. Franck’s voluntarily recalled the product.
Pharmaceutical compounding involves individual mixing of drugs, typically when a patient cannot be treated with the standard FDA-approved medication. The patient may be allergic to inactive ingredients in the medicine or may need a different dose or form than is commercially available. Compounding pharmacies work outside of the statutory drug approval process, which means that compounded drugs are not typically FDA approved. The Los Angeles lawsuit alleges that Franck’s laboratories violated numerous federal regulations for the production of sterile drugs, resulting in the contamination of Brilliant Blue G.
Recent incidents have focused attention on compounding pharmacies and the need for oversight. Contaminated steroid medications produced by the New England Compounding Center (NECC)were blamed for last year’s multi-state outbreak of fungal meningitis and secondary infections, which, to date, have caused more than 700 illness and 50 deaths, according to the U.S. Centers for Disease Control and Prevention (CDC). This month, Med Prep Consulting Inc., a New Jersey pharmacy, recalled magnesium sulfate solution after fungal contamination was discovered. The company has temporarily halted all production at its facility.
Franck’s was previously investigated in 2009 after the deaths of 21 polo ponies that had been treated with drugs the company produced. The company acknowledged errors in the formula.