Compounding Pharmacy’s Drug| Accused of Blinding Patients

LOS ANGELES (CN) - A compounding pharmacy in Florida sold contaminated surgical dye to eye surgeons that blinded patients or damaged their eyes, according to five federal complaints.

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.

The lawsuits began on Sept. 28, 2012; three have been filed this calendar year.

The allegations in this article come from the most recent one, from Jim Hermanson, filed last week in Los Angeles.

Hermanson also sued Paul W. Franck; Anthony James Campbell, a lead chemist for Franck's Lab; and Wells Pharmacy Network, also of Florida.

Hermanson claims that Franck's dye, "tainted with filth, putrid, or decomposed substances," gave him an infection, leaving him blind in his left eye.

Franck's recalled the dye after "numerous reports" of eye infections and blindness, and the Food and Drug Administration cautioned doctors about it, according to the complaint.

Hermanson claims it's not the first time around for Franck's. He says in the complaint that the compounding pharmacy was responsible for the deaths of 21 poloponies in 2009 in Palm Beach.

Compounding pharmacies may mix drugs themselves, rather than using only finished, prepared drugs.

New England Compounding Center, of Framingham, Mass., has been blamed for an outbreak of fungal meningitis that has killed 48 people and made more than 700 people sick. That outbreak was noticed just days after the first lawsuit was filed against Franck's.

The cases are unrelated, but are sure to bring a closer look at regulation of compounding pharmacies. Hermanson says in his complaint that compounding pharmacies are "largely unregulated."

Brilliant Blue G (BBG) helps physicians see transparent tissues in the eye during surgery. The dye is not approved by the FDA, Hermanson says in his complaint. He claims that the FDA issued a warning letter to Franck's on July 9, 2012, specifically warning it that its Brilliant Blue G was adulterated.

"Investigations by numerous state, county and federal health agencies concluded that Franck's BBG was adulterated and not sterile and that the defendants had violated numerous federal rules and regulations," the complaint states.

Hermanson claims the FDA warning letter told Franck's that it had misbranded the drug as "sterile," and stored it in "unsanitary conditions whereby they may have been tainted by filth."

The FDA has confiscated samples of Brilliant Blue G which contain the same bacteria and microorganisms found in patients' eyes, Hermanson says in the complaint. HE claims the FDA also found so-called "'clean rooms'" in Franck's laboratories with multiple bacteria and "other species of microorganisms."

"The FDA investigators observed numerous instances of unsanitary and inappropriate practices by compounding technicians who left and re-entered clean rooms without changing lab coats, who were touching non-sterile items while wearing their sterile gloves and then returned to compounding activities," the complaint states.

Brilliant Blue G "products were misbranded insofar as they were labeled as being sterile, and they contained filthy, putrid, or decomposed substances," the complaint adds.

Hermanson had retinal surgery late last year. Afterward, he says, he "experienced blurred vision and severe pain in his left eye."

He tried antibacterial eye drops, steroid drops, injections in his eye, and underwent two more surgeries, but the infection from the dye left him blind in one eye, he says.

He claims that Franck's knew that its practices "could result in complications, including fatal ones."

"In 2009, Franck's compounded cocktails that were given to prized polo horses from the Venezuelan-owned Lechuza Caracas team in preparation for championship matches near West Palm Beach, Florida. Twenty-one of these prized polo horses died from errors committed by Franck's in compounding these cocktails," the complaint states. "The FDA investigation following the incident with the polo horses led the agency to conclude that the defendants were mixing brews outside of federal guidelines and were utilizing drugs that had not been approved for use in the United States.

"Tragic complications of the patients who ended up receiving injections of the adulterated and non-sterile BBG are just one example of the problems in the largely unregulated area of compounding pharmacies. Recently, hundreds of patients who underwent steroid injections were stricken with meningitis due to the adulterated steroid fluid with the fungus Aspergillus."

Hermanson seeks punitive damages for strict products liability, negligent products liability, breach of warranty loss of consortium.

He is represented Gregory Bentley with Shernoff Bidart Echeverria Bentley of Claremont.

Paul Franck did not immediately respond to a request for comment left on Wells Pharmacy Network's voicemail.

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