Pharmacy | The Health Law Firm Blog

Florida Walgreens Pharmacies Issued Inspection Warrants by the DEA

The recent investigation of a Walgreens distribution center and six Walgreens pharmacy stores in Florida shows that the U.S. Drug Enforcement Administration (DEA) is continuing to attack pharmacies, including the largest pharmacy chains.

On Wednesday, April 4, 2012, the DEA issued inspection warrants to the Florida Walgreens distribution center and six pharmacies. According to the warrant, the DEA is investigating these Walgreens pharmacies in Florida to determine if the pharmacies are dispensing controlled substances outside the scope of their registration in violation of federal laws and regulation.

The warrant was filed in U.S. District Court, Middle District of Florida and also stated that under the U.S. Controlled Substances Act, a warrant may be issued for valid public interest and without the type of probable cause needed under criminal law.

The inspection warrants will allow DEA investigators to review pharmacy’ records and receipts. The pharmacies are not required to stop selling controlled substances, which include painkillers like oxycodone and hydrocodone, during the DEA’s inspection.

The inspection of Walgreens’ pharmacies in Florida is only one of the latest attacks against pharmacies and pain management clinics by the DEA. Earlier this year, the DEA suspended Cardinal Health’s license to distribute controlled substances from one of its distribution centers in Florida. Two CVS pharmacies in Florida were also targeted by the DEA and suspended from selling controlled substances. Both companies are currently fighting the orders in court.

If you own or work at a pharmacy or pain clinic, visit our website at www.TheHealthLawFirm.com to learn more about legal matters concerning pain management and prescribing.

By The Health Law Firm|2012-04-18T14:54:24-04:00June 1, 2018|Categories: In the News, Pain Management, Pharmacy, The Health Law Firm Blog|Tags: dea, inspection, pharmacists, pharmacy, walgreens|0 Comments

Osceola County Authorities Nab 29 People in Phony Prescription Ring

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

A sting on a prescription fraud ring netted 29 arrests in Osceola County, Florida. On December 13, 2012. Osceola County Investigative Bureau (OCIB) agents, along with the Osceola County Sheriff’s Office, Kissimmee Police Department and St. Cloud Police Department conducted an operation nicknamed “Rx Printshop,” according to a press release from the Osceola County Sheriff’s Department.

Click here to read the entire press release from the Osceola County Sheriff’s Department.

Alleged Criminals Getting Phony Prescriptions Filled at Legitimate Pharmacies.

According to the Osceola County Sheriff’s Department, operation “Rx Printshop” targeted a group of people who printed fake prescriptions for painkillers, including oxycodone. The individuals involved would fill the prescriptions at legitimate pharmacies. The pills would then be sold illegally on the streets, according to the sheriff’s department. The people filling the phony prescriptions would be paid with the fraudulently obtained pills for their roles in pretending to be patients.

Those filling the prescriptions are nicknamed “smurfs.” They are usually hired by a drug ring. They return the pills from the prescriptions they get filled back to the ring-leaders. To read a blog on a similar raid in Polk County, click here.

29 People Arrested – More to Come.

According to CF News 13, the phony prescriptions were written using the DEA numbers of unknowing physicians. The physicians apparently have nothing to do with the scheme.

Agents allegedly arrested 29 suspects on felony warrants. Most of them will be charged with conspiracy to traffic drugs, in addition to obtaining prescriptions by fraud, according to CF News 13. Agents are still looking for four suspects who have similar arrest warrants outstanding.

Click here to see a list of those arrested in operation “Rx Printshop,” and those suspects still on the run.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.
The attorneys of The Health Law Firm provide legal representation to physicians, pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, administrative hearings and other actions involving health professionals and providers.

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

Comments?

As a pharmacist, how do you verify prescriptions you receive are legitimate? As a physician, how do you keep your DEA number safe? Please leave any thoughtful comments below.

Sources:

CF News 13. “29 People Busted in Fake Prescription Sting.” CF News 13. (December 14, 2012). From: http://www.cfnews13.com/content/news/cfnews13/news/article.html/content/news/articles/cfn/2012/12/14/_29_people_busted_in.html

Weiner, Jeff. “Fake-Prescription Ring Busted in Sting.” Orlando Sentinel. (December 15, 2012). From: http://articles.orlandosentinel.com/2012-12-14/news/os-prescription-sting-arrests-osceola-20121214_1_prescription-fraud-fraudulent-prescriptions-oxycodone-and-other-drugs

Osceola County Sheriff’s Office. “OCIB Arrests 29 in Operation Rx Printshop.” Osceola County Sheriff’s Office. (December 14, 2012). From: http://www.osceolasheriff.org/sheriff/113-22016-0/ocib_arrests_29_in_operation_rx_printshop.cfm

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.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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 County in order to curb the area’s prescription drug abuse problem. In 2010, Pinellas County allegedly had the most occurrences of accidental overdose deaths from prescription drugs when compared to all other counties in Florida.

The intention of Pinellas County in establishing this billboard campaign may be aimed at stopping prescription drug abuse, but the billboards also shed negative light on legitimate pain management clinics and physicians. Although anti-prescription drug abuse campaigns are laudable, these efforts should focus on assisting those with actual prescription drug abuse history, rather than creating a scapegoat out of the pain management industry.

If you work in the pain management industry (physician, pharmacist, pain clinic, pharmacy, etc.) and feel that your medical license, pharmacy license, or business is at risk or is under investigation by the Drug Enforcement Administration (DEA) or Florida Department of Health (DOH), please visit our website at www.TheHealthLawFirm.com for more information about this.

Sources Include:

WFTS Staff, “County Sends Billboard-sized Message About Prescription Drug Abuse,” ABC Action News (Apr. 6, 2012). From: http://www.abcactionnews.com/dpp/news/state/county-sends-billboard-sized-message-about-prescription-drug-abuse

“We’re Shutting Down Pill Mills in Pinellas County,” Tampa Bay Newspapers (Apr. 10, 2012). From: http://www.tbnweekly.com/pinellas_county/content_articles/041012_pco-01.txt

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

By The Health Law Firm|2012-04-25T17:38:04-04:00June 1, 2018|Categories: In the News, Pain Management, Pharmacy, The Health Law Firm Blog|Tags: Administrative Hearing, Board of Pharmacy, Clinic Licensure, Drug Enforcement Administration (DEA), Florida Department of Health (DOH), investigation, medical license, Pain Management Clinic Enforcement, pharmacist, pharmacy, Pharmacy License, physician, Pill Mill Law Enforcement|0 Comments

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

By 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 in Modern Healthcare states that the specialty pharmacy allegedly used tickets to sporting events, concerts, plays, spa outings, golf games and ski trips to bribe doctors to write prescriptions for its products. The company also had representatives schedule paid “preceptorships,” where the reps would follow doctors in their offices in an attempt to increase prescriptions written for their products.

To read the Modern Healthcare article, click here.

Specialty Pharmacy Will Pay More Than $11 Million.

The specialty pharmacy company agreed to a forfeiture of $1.4 million to resolve the anti-kickback statue allegations. It will also pay $9.9 million to resolve false claims allegations, according to the DOJ. Representatives with the DOJ said that by entering the deferred prosecution agreement the company was able to avoid criminal and civil liability for the kickback and false claims violations.

Whistleblower Gets $1.7 Million Reward.

According to the DOJ, the settlement resolves a False Claims Act lawsuit that was filed by a former sales representative for the specialty pharmacy. As part of the resolution, that whistleblower will receive $1.7 million.

Whistleblowers stand to gain substantial amounts, sometimes as much as thirty percent (30%), of the amount the government recovers under the False Claims Act (31 U.S.C. Sect. 3730). Such awards encourage employees and contractors to come forward and report fraud. You can learn more on the False Claims Act on the DOJ website.

Contact Health Law Attorneys Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

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 the settlement agreement? As a health professional are you tempted with kickbacks? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Victory Pharma Inc. of San Diego Pays $11.4 Million to Resolve Kickback Allegations in Connection with Promotion of Its Drugs.” Department of Justice. (December 27, 2012). From: http://www.justice.gov/opa/pr/2012/December/12-civ-1547.html

Kutscher, Beth. “$11.4 Million Settlement in Pharma Kickback Case.” Modern Healthcare. (December 27, 2012). From: http://www.modernhealthcare.com/article/20121227/NEWS/312279957/

About the Authors: Lance O. Leider is an attorney with 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 Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

By The Health Law Firm|2013-01-02T14:25:13-05:00June 1, 2018|Categories: Pharmacy, The Health Law Firm Blog, Whistleblower|Tags: Anti-kickback statue, Department of Justice (DOJ), false claims act, health care fraud, health care scheme, kickback scheme, legal representation, pharmaceutical company, qui tam suits, specialty pharmaceutical company, whistleblower, whistleblower attorney, whistleblower lawyers, whistleblower protection|0 Comments

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 of eye procedure in which the Franck’s products were used. 23 patients have allegedly suffered some vision loss as a result of the infection.

The Florida Department of Health (DOH) has stated that it cannot divulge if Franck’s or any other pharmacy is being investigated at this time. If the pharmacy is believed to pose an immediate threat to patient safety, the DOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license.

Franck’s has released a statement saying that the pharmacy is fully cooperating with the DOH and FDA. Franck’s says it is currently cooperating to conduct product recalls and will assist in post-recall inspections to prevent future occurrences.

This is not the first time that this Central Florida pharmacy has made headlines. In 2009, the pharmacy was blamed for the deaths of over twenty polo horses in south Florida. This was also allegedly caused by a contaminated compound. Because of this case, the FDA tried to stop Franck’s from compounding veterinary products.

However, Franck’s won in U.S. District Court when United States v. Franck’s Lab, Inc. was decided in December 2011. In this case, the federal court ruled that the FDA does not have the authority to regulate the practice of pharmacists compounding veterinary prescriptions from bulk substances. The decision in favor of the pharmacy can be found here.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. It’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.

Sources Include:

Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012). From
http://www.foxnews.com/health/2012/05/04/cdc-links-eye-infections-to-troubled-florida-pharmacy/#ixzz1tvHCA4yg

CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012). From:
http://www.cbsnews.com/8301-504763_162-57427915-10391704/rare-fungal-eye-infections-tied-to-fla-pharmacy-cdc-warns/

Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012) From
http://www.gainesville.com/article/20120503/ARTICLES/120509811?tc=ar

United States v. Franck’s Lab, Inc., No. 5:10-cv-147-Oc-32TBS (M.D. Fla., Sept. 12, 2011).

WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012). From
http://www.wftv.com/news/news/local/ocala-pharmacy-blamed-dozens-people-suffering-visi/nNWCR/

By The Health Law Firm|2012-05-09T15:45:57-04:00June 1, 2018|Categories: Department of Health, Health Care Industry, In the News, Pharmacy, The Health Law Firm Blog|Tags: CDC, compounding, drug recall, emergency suspension order, ESO, eye infections, FDA, florida, Franck's. Franck's pharmacy, fungal eye infections, Ocala, pharmacist, pharmacy|0 Comments

Number of Oxycodone-Related Deaths Down in Florida

By 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 to the Orlando Sentinel. That number is down from 1,058 during the same time period a year before. The Orlando Sentinel states that nationwide 7 million people abused prescription drugs in 2010. By 2011, that number had dropped to 6.1 million. Studies also show prescription drug use among young adults ages 18 to 25 is also on the decline. The Metropolitan Bureau of Investigation Director believes these numbers are down because young people are realizing these drugs are dangerous and can be deadly.

Click here to read the entire article from the Orlando Sentinel.

Florida Cracks Down on Prescription Drug Abuse.

Previously, Florida was known as a state where drug addicts and dealers could easily find a pill mill or go doctor shopping to get prescription drugs. In the past two years, Florida state leaders and law enforcement officials have stepped up regulations and made serious crackdowns on doctors, pharmacists and pharmacies.

In April 2013, a Lake Mary doctor was sentenced to 25 years in prison for trafficking prescription drugs. Click here to read that story. In December 2012, a fake prescription drug ring was busted in Osceola County. To read that story, click here. In June 2012, the Drug Enforcement Administration (DEA) and Florida law enforcement announced operation “Pill Street Blues” targeting doctors and clinic owners across Florida. Click here to read more.

Health Care Professional Must Stay Ahead of Patients with Chronic Pain.

Even though the number of people abusing prescription drugs is down, state regulatory boards, private certification boards and federal agencies are not going to ease up. Many physicians in practice today are eschewing multi-disciplinary approaches to treating chronic pain in favor of monotherapies with narcotic medications.

These physicians do this at their own peril. In our practice we see many physicians in trouble with state medical boards and law enforcement officials because of their prescribing practices. If you treat patients with chronic pain it is imperative that you stay ahead of them. Click here to read a blog on legal tips for health care professionals to manage pain patients.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Comments?

Do you think the new legislation, the state prescription drug monitoring database and the crackdowns by law enforcement are making a difference in the war against prescription drugs? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “‘We Can Stop This Epidemic,’ CDC Boss Says at Rx-Drug Abuse Summit in Orlando.” Orlando Sentinel. (April 2, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-prescription-drug-abuse-summit-20130402,0,4693169.story

Pavuk, Amy. “Drug-Related Deaths Plunge in First Half of 2012.” Orlando Sentinel. (March 25, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-drug-deaths-down-20130325,0,6750345.story

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.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

By The Health Law Firm|2013-04-17T14:06:33-04:00June 1, 2018|Categories: DEA, Pain Management, Pharmaceutical Drugs, Pharmacy, The Health Law Firm Blog|Tags: accidental overdose, administrative hearings, administrative law attorney, administrative law lawyer, controlled substances, defense attorney, defense lawyer, Department of Health (DOH), doctor, Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Florida health care lawyer, Florida health law attorney, Florida Office of the Attorney General (AG), Florida prescription drug abuse, Florida prescription drug crackdown, legal defense for doctors, legal defense for physicians, legal representation for doctors, legal representation for physicians, Medicaid Fraud Control Unit (MFCU), Medical negligence, opioid misuse, opioid use, oxycodone, pain management, pain pills, pharmacists, physician, physicians, pill mill, pill mill laws, prescription drug trafficking, prescription pain pill, prescriptions|3 Comments

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, Franck’s Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.

Franck’s Pharmacy Urges Physicians to Assist in Recall Efforts.

Franck’s Pharmacy is seeking the assistance of physicians in alerting patients who may be impacted by the recall. Franck’s Pharmacy is also advising physicians to review and evaluate patient records to determine if any adverse events may have resulted from use of the recalled products. Any adverse events should be reported to Franck’s Pharmacy and the FDA’s MedWatch program.

Franck’s Pharmacy Ceases Production of Sterile Compounds.

Franck’s Pharmacy also announced that it will stop producing sterile compounds at its Ocala lab facility for the present. Franck’s Pharmacy made the announcement via e-mail on May 23, 2012. The e-mail also confirmed that several employees had been laid off. Allegedly, these employees were terminated due to the sterile compounding shutdown. Franck’s Pharmacy will continue to compound non-sterile human and veterinary medicine.

Franck’s Pharmacy Recently Linked to Eye Infection Outbreak.

Franck’s Pharmacy decided to cease sterile compounding after the Centers for Disease Control and Prevention (CDC) issued a warning urging physicians not to use sterile products made by Franck’s Pharmacy. The warning was issued after the CDC traced a rare fungal eye infection back to the pharmacy. The infection impacted at least 30 patients who allegedly had undergone some type of eye procedure in which Franck’s Pharmacy products were used. For additional information on this, click here.

Prior Deaths of 30 Polo Ponies.

In an earlier unfortunate incident in 2009, Franck’s Pharmacy’s compounding of veterinarian prescriptions allegedly led to the deaths of approximately 30 expensive polo ponies here in Florida. Click here for details. In the aftermath of that case, the FDA attempted to prevent Franck’s Pharmacy from any further compounding of pharmaceuticals for veterinary purposes. The FDA eventually lost the case heard by the U.S. District Court, Middle District of Florida, which ruled in favor of Franck’s Pharmacy. The decision can be seen here.

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.

Sources Include:

Franck, Paul. “Urgent: Compounding Prescriptions Recall.” Franck’s Pharmacy. Press Release. (May 23, 2012). From
http://www.francks.com/

Medina, Carlos E. “Franck’s Ceases Sterile Compounding Service.” Ocala.com. (May 23, 2012) From
http://www.ocala.com/article/20120523/ARTICLES/120529872/-1/entertainment02?template/

By The Health Law Firm|2012-06-04T17:39:25-04:00June 1, 2018|Categories: In the News, Pharmacy, The Health Law Firm Blog|Tags: CDC, compounding, drug recall, eye infections, FDA, florida, Franck's. Franck's pharmacy, fungal eye infections, Ocala, pharmacist, pharmacy|0 Comments

Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic

By 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. This included paper records, computer equipment and prescription drugs. DEA agents would not say how many people they were investigating, but they did say this raid was the result of a two-year long investigation.

In addition to the Longwood pain clinic, DEA agents said they are also searching locations in Brevard County, Florida, where associates of the Longwood clinic allegedly live.

To watch the WESH-TV report, click here.
Two Doctors Associated With the Longwood Clinic Allegedly “Blacklisted” by Pharmacy.

According to the Orlando Sentinel, two doctors associated with the Longwood clinic were allegedly “blacklisted” in 2011, by CVS Pharmacy. This means that CVS notified those physicians that the pharmacy chain would no longer fill prescriptions they wrote for certain drugs such as oxycodone, due to suspiciously high prescribing rates. To read a previous blog on the CVS blacklist, click here.

Click here to read the entire Orlando Sentinel article.

The Longwood pain clinic is currently closed. Whether this will be temporary or permanent is unknown at this time.

Different Clinic, Similar Storyline.

This raid on the Longwood clinic is just one of the many we’ve recently seen in Florida. DEA agents and local law enforcement officials are not slowing down in their fight against illegal pill mills, and illegal prescribing and dispensing practices. To read a blog on two Orlando-area pharmacists recently arrested on charges of alleged drug trafficking, click here. Even the biggest pharmacy chains are not immune to investigations. Walgreens just agreed to pay $80 million to settle a DEA investigation into the chain’s dispensing practices of prescription drugs. To read more, click here.

Contact Health Law Attorneys Experienced with DEA Cases and Licensing Actions.

The Health Law Firm represents physicians, pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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 about all of these raids on pharmacies and pain clinics? Please leave any thoughtful comments below.

Sources:

McDaniel, Dave. “Agents Raid Longwood Pain Clinic.” WESH-TV. (June 14, 2013). From: http://www.wesh.com/news/central-florida/seminole-county/agents-raid-longwood-pain-clinic/-/17597106/20572512/-/item/0/-/afpnwwz/-/index.html

Pavuk, Amy. “Agents Raid Longwood Pain Clinic.” Orlando Sentinel. (June 14, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-professional-pain-care-raid-20130614,0,3826330.story#tugs_story_display
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.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

The DEA’s War on Pain Management

Within 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 the clinic knew they were shopping for drugs, and an employee revealed that he was asked to recruit patients by promising powerful drugs.

However, it is not uncommon for a pain management clinic or related practice to face investigation, especially in Florida. Federal and state agencies are doing everything and anything they can to prevent drug farming, which means a crackdown on health care providers. Dubbed “Operation Pill Nation,” this strict enforcement means more worries for health care professionals, who now must monitor patient needs under the DEA’s close watch.

If your medical practice specializes in pain management or a similar area, have a plan in place in the event that the DEA comes knocking on your door. Be aware of health lawyers that are familiar with these cases and can defend you in the event of a DEA raid. These proceedings are often very complicated, and you’ll want an experienced team of health law attorneys to properly defend you from criminal charges.

At The Health Law Firm, our team of lawyers specialize in the representation of doctors, nurses, pharmacists, physicians assistants, nurse practitioners and other health care professionals involved in Department of Health, Diversion Control and Drug Enforcement Administration in Florida and throughout the United States. For more information about our knowledge in the practice of health law and DEA cases read our article on Pain Management and the DEA.

By The Health Law Firm|2018-06-25T19:03:56-04:00June 1, 2018|Categories: In the News, Pain Management, Pharmacy, The Health Law Firm Blog|Tags: dea, department of health, drug enforcement administration, florida, florida health attorney, health law attorney, pain management, pill mills|0 Comments

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. Investors pursued the fraud claims in a case filed in 2009 in U.S. District Court in St. Louis. In the lawsuit, investors allege that they suffered $1.5 billion in losses. The investors claim that the loss was suffered because KV allegedly misled the FDA in its compliance reports. KV then shut down its manufacturing operations in 2009.

Investors Allege KV Was Not Honest About FDA Compliance.

The lawsuit focused on FDA inspections of KV facilities over a six-year period. Results of those inspections were reported to the company’s management on a document called a Form 483. Investors alleged that information on the forms about KV’s compliance with FDA regulations contradicted statements KV made to investors. Allegedly, the forms stated that KV was not in compliance with FDA regulations.

However, KV said that the forms did not show the FDA’s final determination. The district court agreed with KV and dismissed the suit.

Appeals Court Decision May Have Ramifications for Other Drug Manufacturers.

The appeals court reversed the dismissal of the lawsuit. According to the appeals court, investors could have considered the Form 483 reports significant given the company’s assurance that it was in compliance.

The appeals court decision could have implications for other drug manufacturing companies. The decision represents the first time a federal appeals court has determined that FDA’s issuance of a Form 483 can be considered material under federal securities laws.

KV Has Recently Experienced Several Setbacks in Addition to the Investor Lawsuit.

The appeals court decision is the latest setback for KV. Starting in 2008, the generic drug manufacturer was subject to a series of recalls and investigations by the U.S. Department of Justice and the FDA. The investigations were related to KV’s manufacturing and distribution of oversized morphine pills.

In 2010, KV’s former subsidiary Ethex Corp. pleaded guilty to two felony counts of criminal fraud. Ethex Corp. agreed to pay $27.6 million in fines and restitution related to the charges. To view a press release from the U.S. Department of Justice regarding the charges against Ethex, click here.

In 2011, KV’s former chief executive pleaded guilty to misdemeanor violations of the Food, Drug and Cosmetic Act. He was sentenced to 30 days in jail and ordered to pay $1.9 million in fines and forfeitures.

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.

Sources Include:

Harris, Andrew. “KV Pharmaceutical Must Face Suit Over Quality Assurances.” Bloomberg News. (June 4, 2012) From: http://www.businessweek.com/news/2012-06-04/kv-pharmaceutical-must-face-suit-over-quality-assurances

Raymond, Nate. “U.S. Court Revives KV Pharmaceutical Investor Suit.” Reuters. (June 4, 2012). From: http://www.msnbc.msn.com/id/47681167/ns/health/t/us-court-revives-kv-pharmaceutical-investor-suit/

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.

By The Health Law Firm|2012-07-02T13:57:41-04:00June 1, 2018|Categories: In the News, Pharmacy, The Health Law Firm Blog|Tags: criminal fraud, drugs, enforcement, FDA, FDA compliance, federal securities law, Food and Drug Administration, inspections, investigation, investors, KV Pharmaceuticals, lawsuit, pharmacy, securities fraud class action, shareholders|2 Comments