FDA | The Health Law Firm Blog

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 injections traced back to the lab caused the infections. These ophthalmic products contained multiple fungal and bacterial species, according to the CDC. The products have now been recalled, but were in use for over a year before the recall. The CDC has also issued a warning to avoid any product labeled sterile from Franck’s.

The patients impacted by the contaminated products had all undergone some type […]

By The Health Law Firm|2024-03-14T10:00:30-04:00June 1, 2018|Department of Health, Health Care Industry, In the News, Pharmacy, The Health Law Firm Blog|

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 see the recall click here.

Recall Based on FDA Findings of Fungal Growth in Pharmacy’s Clean Room.

The recall was apparently prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, […]

By The Health Law Firm|2024-03-14T10:00:31-04:00June 1, 2018|In the News, Pharmacy, The Health Law Firm Blog|

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 on June 4, 2012.

To view the appeals court ruling in Public Pension Fund Group v. KV Pharmaceutical Company, click here.

Appeals Court Ruling Revives Securities Fraud Class Action Lawsuit.

The appeals court has revived a securities fraud class action that was dismissed by a trial court in 2010. […]

By The Health Law Firm|2024-03-14T10:00:32-04:00June 1, 2018|In the News, Pharmacy, The Health Law Firm Blog|

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 General on July 2, 2012. This is the largest healthcare fraud settlement in U.S. history.

Settlement Resolves Allegations Against GSK Related to Healthcare Fraud.

The settlement resolves allegations that GSK:

Marketed the depression drug Paxil for off-label uses, such as use by children and adolescents;
Marketed the depression drug Wellbutrin for off-label uses, such as for […]

By The Health Law Firm|2024-03-14T10:00:32-04:00June 1, 2018|In the News, The Health Law Firm Blog|

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 with practicing medicine without a license. According to Reuters, the unlicensed health professional could also be facing charges of manslaughter if investigators confirm that a woman’s death was related to treatments received from the imposter.

Click here to read the entire article from Reuters.

If convicted, the fake health care professional could spend up to […]

By The Health Law Firm|2024-03-14T10:00:53-04:00June 1, 2018|Fake Health Care Professionals, In the News, The Health Law Firm Blog|

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 all types of prescription drugs, will give patients the option of mailing unused prescriptions to an authorized collector using packaging provided by the pharmacy.

Hopefully this will help to eliminate many of the problematic situations that pharmacists and physicians found themselves in when they accumulated returned or unused medications from patients for destruction.

This move intends to address […]

By The Health Law Firm|2024-03-14T10:01:40-04:00May 15, 2018|Pain Management, Pharmacist, Pharmacy, Pharmacy Law|

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 class of frontline treatment for type 2 diabetes. It was approved in 2013 and quickly gained popularity among health care providers and patients. Other drugs in the class include Invokament, Jardiance, Xigduo XR, Farxinga and Glyxambi. These drugs, known as SGLT2 inhibitors, are intended to improve glycemic control in patients with type 2 diabetes by blocking […]

By The Health Law Firm|2024-03-14T10:01:18-04:00May 15, 2018|Pharmacy Law Blog|

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 stems from FDA regulations that do not permit the holder of an approved ANDA to change labeling to add new safety information the generic company becomes aware of until and unless the brand name company that holds the NDA for the reference listed drug (RLD) modifies the labeling. This interpretation was affirmed by the U.S. Supreme Court in 2011 in the Pliva, Inc. […]

By The Health Law Firm|2024-03-14T10:01:40-04:00May 15, 2018|Pharmacy Law|