Florida Pharmacy Allegedly the Cause of Eye Infection Outbreak
The Centers for Disease Control (CDC) has allegedly traced a rare fungal infection to an Ocala pharmacy, according to media reports. As reported, Franck’s Compounding Lab is believed to be at least partially responsible for spreading a rare fungal eye infection to over 30 patients across the U.S. The CDC reports that eye drops and […]
Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service
Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To […]
Investors can Continue to Bring Claims Against KV Pharmaceutical
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The U.S. Eighth Circuit Court of Appeals ruled that investors can continue to bring claims against KV Pharmaceutical Co. (KV) for making false or misleading statements to the U.S. Food and Drug Administration (FDA). The ruling was reached […]
Settlement Reached in GlaxoSmithKline Healthcare Fraud Case
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law GlaxoSmithKline (GSK), a prescription drug manufacturer, will pay $3 billion in fines to resolve allegations of healthcare fraud. The settlement was announced by federal prosecutors on July 1, 2012, and in a press release from the Florida Attorney […]
Fake Doctor in Texas Accused of Injecting Patients with Silicone Instead of Botox
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law A South Texas woman was charged on October 31, 2013, for allegedly injecting people with silicone, that she claimed was Botox. The phony health professional, described in some media reports as an “unlicensed plastic surgeon,” has been charged […]
FDA Issues New Warning for Popular Type 2 Diabetes Drug
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Food and Drug Administration (FDA) recently warned that a new class of type 2 diabetes drugs may cause a serious condition and can lead to hospitalization. Included in that warning is Invokana, the first in a new […]
Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases
Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application). Federal preemption […]
DEA Offers New Prescription Drug Return Policy
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering […]