Products Liability Lawsuits Filed Over Brilliant Blue G Surgical Dye Made By Franck’s Compounding Lab

Monday, July 1, 2013
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Franck’s Compounding Lab in Ocala, Florida, may be closed, but that isn’t stopping patients affected by the lab’s contaminated products from filing lawsuits against the compounding pharmacy. According to an article on About Lawsuits, at least four products liability lawsuits were filed against Franck’s just in March of 2013. All of the lawsuits allege that the plaintiffs suffered severe eye infections that were caused by contaminated doses of Brilliant Blue G, an eye surgery dye made at Franck’s Compounding Lab.

You may remember, in May 2012, Franck’s issued a recall for its compounded prescriptions. The prescriptions impacted by this recall included all sterile human and veterinary compounded prescriptions distributed by Franck’s from November 21, 2011 to May 21, 2013. This recall included Brilliant Blue G. To read previous blogs on the recall, click here and here.


Brilliant Blue G Allegedly Gave Patients Eye Infections.

Plaintiffs allege they suffered serious eye injuries or even permanent blindness because of the dye. Each of the lawsuits indicated that the plaintiffs received Brilliant Blue G in November 2011, during an eye procedure, according to About Lawsuits. Click here to read the About Lawsuits article.

To read the complaints filed in the U.S. District Court for the District of Nevada, click here and here. To read complaints filed in the U.S. District Court for the Northern District of Indiana, click here and here.


Lawsuits Allege Franck’s was Negligent.

According to the lawsuits, the patients state that the compounding pharmacy knowingly distributed contaminated and unsafe drugs. The plaintiffs accuse Franck’s of negligence, strict liability, failure to warn, and breach of warranty.


Deficiencies Common in Pharmacy Inspections.

Since the widespread fungal meningitis outbreak in the fall of 2012, compounding pharmacies have fallen under heightened scrutiny. The FDA and state Department of Health (DOH) agencies are paying surprise visits to compounding pharmacies around the country.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1.  Pharmacy technicians not properly identified with name tags and identified as
    pharmacy technicians (as opposed to pharmacists);

2.  Pharmacy technicians not supervised by pharmacist;

3.  Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4.  Controlled substances not accurately recorded on appropriate forms; and

5.  Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recent blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.


Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.


The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm's attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


Comments?

What do you think of all the products liability cases against Franck’s? Please leave any thoughtful comments below.


Sources:

Kirk, Austin. “Motion Filed to Centralize Brilliant Blue G Eye Surgery Dye Lawsuits in MDL.” About Lawsuits. (April 23, 2013). From: http://www.aboutlawsuits.com/brilliant-bluy-g-eye-surgery-dye-lawsuit-mdl-motion-45101/

Jackson, Irvin. “Brilliant Blue G Eye Infection Lawsuits Filed Over Recalled Surgical Dye.” About Lawsuits. (March 29, 2013). From: http://www.aboutlawsuits.com/brilliant-blue-g-eye-infection-lawsuits-42987/



About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.


Tag Words: pharmacy, pharmacist, Franck's, Franck's pharmacy, compounding, eye infections, compounded prescription, fungal eye infections,  Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), Florida Department of Health (DOH), Drug Enforcement Administration (DEA), pharmacy lawsuit, products liability lawsuit, Brilliant Blue G, eye surgery dye, eye procedure, ophthalmologist, pharmacy deficiencies, drug recall, contaminated drugs, unsafe drugs, negligence, strict liability, failure to warn and breach of warranty, pharmacy investigation, pharmacist investigation, defense lawyer, defense attorney, pharmacy lawyer, pharmacy attorney, pharmacist attorney, pharmacist lawyer, The Health Law Firm


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7/1/2013

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