The legal matters involving pharmacies and pharmacists are many. Learn more about pharmacist involvement in investigations by the Department of Health, local investigative agencies, the Medicaid Fraud Control Unit (MFCU) and the Drug Enforcement administration (DEA)concerning complaints, including allegations of license violations, prescription fraud, and other types of disciplinary infractions.

New Anti-Prescription Drug Abuse Campaign in Pinellas County

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

Pinellas County has started a new billboard campaign aimed at curbing prescription drug abuse. The billboard message reads, “We’re shutting down Pill Mills in Pinellas County.” The first two billboards were erected on April 1, 2012. Several smaller boards will be put up in the next few weeks, with even more planned for the future. This continues the long-standing battle by Pinellas County law enforcement authorities against pain management clinics that they describe as “pill mills.”  Pinellas County includes the cities of St. Petersburg, Clearwater and Seminole.

The billboard message is a statement from local coalition groups who have partnered with Pinellas […]

Specialty Pharmacy Agrees to Pay A $11.4 Million Settlement in Whistleblower Case

Lance Leider headshotBy Lance O. Leider, J.D., and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Department of Justice (DOJ) announced on December 27, 2012, that a specialty pharmacy, based in San Diego, California, has agreed to pay a $11.4 million settlement. That payment is to resolve allegations that the company used kickbacks to persuade doctors to write prescription for its products. The allegations came from a whistleblower lawsuit filed by a former employee.

Click here to read the press release from the DOJ.

Specialty Pharmacy Allegedly Used Expensive Kickbacks to Bribe Doctors.

An article […]

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 […]

Number of Oxycodone-Related Deaths Down in Florida

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

It looks like Florida’s prescription drug legislation, the statewide prescription drug monitoring database and the prescription drug crackdowns by law enforcement may be working, according to the Florida Department of Law Enforcement (FDLE). The FDLE states in its semi-annual report, oxycodone-related deaths statewide dropped between January and June of 2012, compared to the same period of time in 2011. A look at the national numbers shows that the number of people abusing prescription drugs is also down.

Florida and National Numbers.

In the first half of 2012, there were 759 oxycodone-related deaths in Florida, according […]

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, […]

Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Drug Enforcement Administration (DEA) agents along with local police and sheriffs’ deputies raided a Longwood, Florida, pain management clinic on June 14, 2013. According to the Orlando Sentinel, agents searched for evidence at the clinic associated with multiple doctors. DEA agents stated the clinic was operating as a “pill mill” and allegedly diverting legal prescriptions for illegal purposes. No one was arrested during the raid. Longwood is a suburb of Orlando.

Investigation Spreads to South Florida.

According to WESH-TV, during the raid agents took everything from the clinic that could help them build a criminal prosecution. […]

The DEA’s War on Pain Management

The Health Law Firm George F. Indest III HeadshotWithin the last few years, raids on pain management clinics, as well as pharmacies, have been increasingly commonplace. The doctors, pharmacists, nurses and other health care professionals involved are carted away in handcuffs and must defend their practice.

According to the St. Petersburg Times, a South Florida pain management clinic has recently been shut down under emergency action by the Florida Department of Health (DOH). Several health care professionals at the clinic were arrested, their licenses revoked.

In this instance, the charges against these health care employees are not completely unwarranted. Patients confessed to authorities that members of […]

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. […]

Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law George F. Indest III, Board Certified by The Florida Bar in Health Law

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

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is […]

New Florida Drug Database Aimed at Preventing Drug Abuse

Recently, Florida pharmacists, physicians and pain management clinics have received negative attention over frequent Drug Enforcement Administration (DEA) raids. Now, Florida is once again in the spotlight as the state has launched a drug database in an attempt to reduce drug abuse perpetuated by visits to the doctor.

According to the Orlando Sentinel, this database will allow physicians and pharmacists to review a patient’s prescription history before issuing prescriptions for painkillers like OxyContin and other powerful drugs.

These preventative measures are not new to Florida health care providers. After garnering a reputation for frequent drug trafficking, proliferated by pain management clinics, the state passed legislation banning many doctors from dispensing dangerous controlled substances in their offices.

Currently, use of the database […]

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