Tag Archives: ESO

New Details Released on Drug Enforcement Administration’s Investigation of 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

The Drug Enforcement Administration’s (DEA) investigation into a Longwood, Florida, pain management clinic continues. More details are being revealed about the case. DEA agents along with local police and sheriffs’ deputies raided the pain management clinic on June 14, 2013. Agents believe the evidence they have gathered suggests the clinic was operating as a “pill mill,” according to the Orlando Sentinel. Officials allegedly seized evidence at the clinic associated with at least ten (10) doctors and other clinic employees. No one has been arrested yet, but documents filed in federal court in Orlando suggest charges could be coming.

I previously blogged about this raid. Click here to read that blog.

Details of the Investigation.

According to the Orlando Sentinel, the DEA began surveying the alleged pill mill in January 2011, while investigating a doctor shopper. From July 2011 through May 2013, agents monitored the clinic. During the investigation, agents observed long lines outside the clinic, out-of-state license plates and groups of “patients” arriving at the clinic together. All of this behavior, according to authorities, is associated with pain clinics.

More concrete evidence against the pain management clinic, according to police officials, includes:

-  Patients stating that employees discussed selling pain pills and fake MRIs;

-  DEA agents observing drug deals made by patients coming from the clinic, in the vicinity of the clinic;

-  Used needles were found in nearby parking lots; and

-  Two of the clinic’s patients allegedly died from overdoses during the investigation.

Pain Management Clinic Physicians Made Millions.

It’s reported that the pain management clinic hired ten (10) doctors to write illegal prescriptions and employed others to falsify documents. For their willingness to participate in the illegal activity, the physicians allegedly made millions of dollars.

According to the Orlando Sentinel, the bank accounts of the clinic managers were analyzed as part of the investigation. From 2011 to 2013, more than $5.5 million in cash was deposited into the bank accounts of the clinic managers and physicians.

To read the entire article from the Orlando Sentinel, click here.

Keep in mind, at this point, these are just allegations made against the clinic and its employees and nothing has been proven by the state or federal government.

Be Mindful of the Prescription Drug Monitoring Database.

DEA agents used Florida’s prescription drug monitoring database to find out what types of pills and how many pills physicians at the Longwood pain clinic were prescribing. The prescription database was not intended to be used for criminal prosecution or law enforcement purposes. Yet it is routinely being used to prosecute physicians, pharmacists and pharmacies among others.

If You are a Health Care Professional Involved with Pain Management, Keep These Tips Handy.

The 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. I have represented a number of physicians who have been accused of “overprescribing.”  Some of these were criminal investigations by local law enforcement authorities, such as a county sheriff’s office. Some were investigations by the DEA. Some were investigations by the state licensing agency, such as the Florida Department of Health (DOH).

It is important physicians know how to protect themselves and their licenses from drug-seeking patients.  Click here to read tips I give to physicians I advise on this issue.

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:

Pavuk, Amy. “Rx for Danger: Pain Clinic Owners Made Millions, Hired 10 Doctors to Write Illegal Scripts, Feds Say.” Orlando Sentinel. (June 24, 2013). From: http://www.orlandosentinel.com/health/os-professional-pain-care-longwood-20130624,0,1172890.story

Indest, George. “Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic.” The Health Law Fir. (June 17, 2013). From: http://thehealthlawfirmblog.wordpress.com/2013/06/17/drug-enforcement-administration-agents-raid-central-florida-pain-management-clinic/

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.

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. 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.

Two Central Florida Physicians Connected to Statewide Pill-Mill Network

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

An Orlando and Jacksonville physician have been linked to a statewide pill-mill operation that brought in millions of dollars to pain clinic owners and doctors, according to the Orlando Sentinel. On June 27, 2012 seven doctors and seven pain clinic owners were arrested in the raid that was dubbed “Operation Pill Street Blues.” The two-year, multiagency investigation into the pill-mill operation spanned from Miami to Pensacola. The investigation included the Drug Enforcement Agency (DEA) and Florida law enforcement.

To view the DEA’s press release concerning the investigation, click here.

South Florida Firefighter Alleged Leader of Pill Mill.

Investigators named a 32-year-old Pompano Beach firefighter as the pill-mill’s ring leader. He allegedly used his image as a city firefighter and paramedic to develop a clean reputation with the local law enforcement.

He allegedly told his co-conspirators how to turn in other rogue doctors, pain clinics, and patients who abused drugs to authorities, so that their business would appear legitimate.

Millions of Oxycodone Pills were Prescribed in One Year.

Doctors recruited by the pill-mill network would allegedly write prescriptions to patients who did not have a medical need for the drugs or would prescribe excessive amounts of pills.

The seven doctors in the organization allegedly dispensed more than two million oxycodone tablets in one year. The Orlando and Jacksonville doctors allegedly prescribed more than 930,000 oxycodone pills between the two of them in a nine-month period.

Both Local Doctors Examined Undercover Detectives Posing as Patients During the Investigation.

Both doctors were visited by undercover detectives posing as patients. The Jacksonville doctor examined a detective who complained of minor back pain. She allegedly issued prescriptions for oxycodone and other drugs, even though the detective had no observable medical issues.

The affidavit details other undercover doctor visits, including those with the Orlando doctor at a pain management clinic in Fort Meyers. The initial exam between the doctor and the undercover detective allegedly lasted less than three minutes, before he gave the detective a prescription for oxycodone and other drugs.

Charges Vary from Racketeering to Manslaughter.

Those arrested for alleged involvement in the pill-mill scheme face charges ranging from racketeering, to trafficking of a controlled substance, to manslaughter.

On June 26, 2012, the day before authorities announced the charges, the Department of Health suspended the doctors’ licenses.

Pain management doctors click here to see if you’re in compliance with the recent changes to Florida’s pain management laws.

Patients with Severe Pain Speaking Out.

A former patient of a Vero Beach doctor arrested in the sting is one of hundreds who were prescribed strong narcotic pain medications at the alleged pill mills. Now she’s having a hard time finding the medications she needs to treat her conditions, including: a herniated disk, osteoarthritis and fibromyalgia. All of her conditions are listed in medical records and cause her severe pain. She is trying to find another doctor that is willing to prescribe her the medications she needs to function.

This situation is familiar to many patients in Florida with true medical need for prescription pain medications. These patients are finding it increasingly difficult to even locate a physician to treat them. Medical ethicists have commented on this problem, saying it is an issue that will become increasingly problematic for the foreseeable future.

To read more on operation “Pill Street Blue,” click here.

Contact Health Law Attorneys Experienced with DEA Cases.

The Health Law Firm represents 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.

Sources Include:

Pavuk, Amy. “Authorities Link Orlando doctor, Daytona Clinic to Pill-Mill Network.” Orlando Sentinel. (July 14, 2012). From: http://articles.orlandosentinel.com/2012-07-14/news/os-fernando-valle-pill-mill-network-20120714_1_pain-clinics-pill-mill-network-clinic-owners

Gordon, Lynn. “Former Patient of Vero Beach Doctor Arrested in Pill Mill Bust Talks.”WPEC-TV. (July 17, 2012). From: http://www.cbs12.com/news/top-stories/stories/vid_1092.shtml

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.

Recent Pill Mill Bust in Florida Dubbed “Operation Pill Street Blues”

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

A statewide pill mill bust that spanned several Florida cities was announced by the Drug Enforcement Administration (DEA) and Florida law enforcement on June 27, 2012. Seven doctors and seven pain clinic owners were arrested. The raid has been dubbed “Operation Pill Street Blues” by the DEA.

To view the DEA’s press release concerning the raid, click here.

Manslaughter and Trafficking Among Charges Against the Doctors and Pain Clinic Owners.

The doctors and pain clinic owners are facing a long list of charges. Some of the alleged offenses include: racketeering; conspiracy to commit racketeering; manslaughter; trafficking in a controlled substance; conspiracy to traffic in a controlled substance; delivery of a controlled substance; illegally prescribing a controlled substance by a practitioner; illegally prescribing a controlled substance (oxycodone hydrochloride) by a practitioner-trafficking amount; workers compensation fraud; and money laundering.

Investigation Unveiled Ring of Pill Mills Spanning Across Florida.

The arrests follow a two year investigation led by the DEA in conjunction with the Indian River County Sheriff’s Office, Vero Beach Police Department, and the Attorney General’s Office of Statewide Prosecution. The investigation began in Vero Beach in November 2010 after the DEA received complaints about a pain clinic that was allegedly writing a large amount of narcotics prescriptions.

During the investigation, DEA agents uncovered eight more pain clinics in Miami, Daytona Beach, Jacksonville, Sarasota, Gainesville and Pensacola that were allegedly involved in the same operation. DEA agents also learned that some of the pain clinics were allegedly owned by two active Pompano Beach firemen.

Pain Clinic Owners Allegedly Studied Other DEA Pill Mill Busts to Avoid Detection.

According to the DEA, the pain clinic owners allegedly researched public records relating to past DEA investigations such as Operation Pill Nation and Operation Oxy Alley. One of the pain clinic owners also allegedly educated others at the clinics on how to successfully report their competition to law enforcement.

Wire Intercepts, Informants, and Undercover Agents Used in Pain Clinic Investigations.

The investigation into the pain clinics involved the use of judicial wire intercepts, informants, and under cover visits to the pain clinics. Undercover agents allegedly visited each of the seven doctors charged. The agents were allegedly prescribed approximately 2,732 oxycodone tablets.

Law Enforcement Raids on Physicians, Pharmacists, Nurses and Other Health Providers Will Continue.

According to the DEA, Operation Pill Street Blues is an ongoing investigation. Additional arrests of co-conspirators, including other doctors and health providers, are forthcoming, according to the DEA. If you are a physician, pharmacist, nurse, or other health provider, ensure you are taking measures to protect yourself and your practice.

Contact Health Law Attorneys Experienced with DEA Cases.

The Health Law Firm represents 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.

Sources Include:

Ro, Mia. “Federal Investigation Takes Down New Breed of Pill Mills in Florida.” Drug Enforcement Administration. (June 27, 2012). Press Release. From: http://www.justice.gov/dea/pubs/states/newsrel/2012/mia062712.html

Roberts, John. “DEA, Florida Police Arrest 14 in Pill Mill Bust.” Fox News. (June 6, 2012). From http://www.foxnews.com/us/2012/06/27/statewide-pill-mill-bust-involves-florida-municipal-workers/#ixzz1zBvQuGgC

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.

Florida Cardiologist Receives Emergency Suspension Order Linked to Stem Cell Treatments

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

A Florida cardiologist recently had his medical license emergently suspended by the Florida Department of Health (DOH) for allegedly performing stem cell treatments on a patient. According to the emergency suspension order (ESO), the DOH had previously warned the doctor to stop performing these treatments in 2011. Now, his license is at risk of being revoked. To view the ESO click here.

Doctor’s License Suspended by the DOH for Allegedly Performing Stem Cell Treatments.

The DOH ordered the emergency suspension of the cardiologist’s medical license in March 2012. He is being accused of violating an emergency restriction order (ERO) against using stem cell treatments in Florida. He is also being accused of causing the death of a patient.

We want to be perfectly clear that these are just allegations being made by the DOH at this point in time. All persons are presumed to be innocent until found guilty in a court of law (or, in DOH licensure cases, in an administrative final order).

Stem Cell Treatment Allegedly Contributed to Patient’s Death.

According to the ESO, the doctor performed a stem cell treatment on a patient who had both pulmonary hypertension and pulmonary fibrosis. Both of these conditions restrict blood flow to the heart. According to the ESO, the stem cell treatment included harvesting adipose tissue from the patient’s abdomen and concentrating stem cells from the tissue in a lab. The concentrated stem cells were then infused into the patient’s bloodstream to help treat the patient’s pulmonary hypertension and pulmonary fibrosis. Allegedly, the cardiologist’s patient suffered a cardiac arrest and died during the treatment.

Doctor Now Awaits Administrative Hearing.

An administrative hearing regarding the doctor’s license suspension is scheduled for June 2012.

To view the administrative complaint issued by the DOH, click here.

To see a diagram or flow chart of the procedures followed by the Florida Department of Health, click here.

For an explanation of the differences between a formal administrative hearing and an informal administrative hearing under the Florida Administrative Procedure Act, Chapter 120, Florida Statutes, click here.

For the Florida Administrative Procedure Act, Chapter 120, Florida Statutes, click here.

Contact Health Law Attorneys Experienced with Emergency Suspensions and DOH Actions.

The attorneys of The Health Law Firm are experienced in handling all types of DOH cases, including emergency suspensions, administrative complaints, investigations, administrative hearings, investigations, licensing issues, settlements and more. If you are currently facing adverse action by the DOH contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at http://www.thehealthlawfirm.com/.

Sources:

Fitzpatrick, David and Drew Griffin. “Florida Suspends Doctor Accused of Illegal Stem Cell Therapy.” CNN. (Mar. 8, 2012). From: http://www.cnn.com/2012/03/08/health/stem-cell-doctor-suspension/index.html

Miller, Reed. “Flouting Warning, Florida Stem-Cell Cardiologist has License Suspended.” theheart.org. (Mar. 8, 2012). From: http://www.theheart.org/article/1368039.do

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.  http://www.thehealthlawfirm.com/  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Cardinal Health’s Settlement With the DEA Results in Shipment Suspension

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

Cardinal Health and the Drug Enforcement Administration (DEA) have reached a settlement which will suspend Cardinal Health’s ability to ship controlled substances from its Florida distribution facility for two years. The company will now supply controlled substances from its distribution center in Jackson, Mississippi.

Cardinal Health’s Settlement Does Not Prevent the DEA from Pursuing Civil Penalties.

The settlement was announced on May 15, 2012. It includes an Administrative Memorandum of Agreement (MOA), the terms of which will apply to all of Cardinal Health’s registered distribution facilities. The MOA will not prevent Cardinal Health from possible civil penalties related to the DEA’s case against the pharmaceutical distributor.

The obligations in the MOA will remain in effect for five years unless the DEA agrees to an earlier termination. Some of the terms require Cardinal Health to improve anti- diversion procedures and keep track of narcotics distributions.

Click here to view the Memorandum of Agreement between Cardinal Health and the DEA.

Cardinal Health’s History with the DEA.

On February 3, 2012, Cardinal Health’s Florida distribution center was served with an Immediate Suspension Order (ISO) from the DEA. The ISO alleged that the distribution center did not maintain effective safeguards against the diversion of controlled substance, including oxycodone.

According to the DEA, Cardinal Health’s Florida facility shipped a large quantity of oxycodone to four Florida pharmacies. The DEA alleged that Cardinal Health did not ensure that these drugs only went to legitimate patients.

The February 2012 ISO was not the DEA’s first action against Cardinal Health’s Florida distribution center. In 2007, the DEA issued an ISO at the facility because it allegedly distributed hydrocodone to illegitimate internet pharmacies. That action, and similar DEA actions at other Cardinal Health facilities across the United States, resulted in a $34 million fine.

Cardinal Health has been operating under an Administrative MOA with the DEA since October 2008. This MOA required Cardinal Health to maintain a compliance program designed to detect and prevent the diversion of controlled substances (as required under the Controlled Substances Act).

According to the DEA, Cardinal Health did not comply with the terms of the October 2008 MOA, which is partly why the agency issued the February 2012 ISO.

Cardinal Health Pursues Litigation Against DEA.

Cardinal Health had filed litigation to challenge the DEA’s decision to impose the ISO, shortly after it happened. Click here for a copy of the Complaint filed in Federal Court in Washington, D.C. Ultimately the federal courts ruled against Cardinal Health on February 29, 2012. For a copy of the Court’s decision against Cardinal click here.

Click here to view other blogs regarding the Cardinal Health case.

Contact Health Law Attorneys Experienced with DEA Cases.

The Health Law Firm represents pharmacists, pharmacies, physicians and other health provders in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its 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:

DEA Public Affairs. “DEA Suspends for Two Years Pharmaceutical Wholesale Distributor’s Ability to Sell Controlled Substances from Lakeland, Florida Facility.” United States Drug Enforcement Administration. Press Release. (May 15, 2012). From
http://www.justice.gov/dea/pubs/pressrel/pr051512.html

Milford, Phil and Tom Schoenberg. “Cardinal DEA Settlement Calls for Two-Year Shipping Halt.” Bloomberg. (May 15, 2012). From
http://www.bloomberg.com/news/2012-05-15/cardinal-dea-settlement-calls-for-two-year-shipping-halt.html

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.

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/

Emergency Suspension Orders and Medicaid Fraud

In the recent case of Mendelsohn v. State of Florida Department of Health, Mendelsohn’s license to practice medicine was suspended under an Emergency Suspension Order (ESO).

According to the ESO, Mendelsohn is licensed to practice medicine in Florida pursuant to the provisions of chapter 458, Florida Statutes. On December 9, 2010, he entered a plea of nolo contendere in federal court to a charge of conspiracy to commit fraud upon the United States in violation of 18 U.S.C. § 371. As a result of his conviction, the Florida Department of Health immediately suspended his medical license without a hearing pursuant to section 456.074(1), Florida Statutes (2010), which states:

(1) The department shall issue an emergency order suspending the license of any person licensed under chapter 458 . . . who pleads guilty to, is convicted or found guilty of, or who enters a plea of nolo contendere to, regardless of adjudication, to:

. . .

(b) A misdemeanor or felony under 18 U.S.C. s. 669, ss. 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s. 1349, or s. 1518 or 42 U.S.C. ss. 1320a-7b, relating to the Medicaid program.

Mendelsohn argued that his federal conspiracy conviction was not related to the Medicaid program, so the Florida Department of Health could not issue an ESO without establishing that his actions posed an immediate danger to public safety.

Florida law requires that an order directing the immediate suspension of a practitioner’s license contain “every element necessary to its validity . . . on the face of the order.” In general, an ESO will not be upheld unless the order on its face sets out the specific facts and reasons for finding an immediate danger to the public health, safety, or welfare, as well as the Florida Department of Health’s reasons for concluding that the procedure used is fair under the circumstances.

However, Section 456.074(1), Florida Statues, however, requires DOH issue an emergency order suspending a medical license in certain circumstances without regard to specific proof that a petitioner is acting in a way that poses an immediate danger to public safety.

But Mendelsohn asserted that the Florida Department of Health incorrectly found that his conviction required an ESO under section 456.074(1)(b). Section 456.074(1)(b) requires the Florida Department of Health to issue an ESO when a practitioner has been convicted of a “felony under 18 U.S.C. s. 669, ss. 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s. 1349, or s. 1518 or 42 U.S.C. ss. 1320a-7b, relating to the Medicaid program.”

Although Mendelsohn was convicted of a felony in violation of § 18 U.S.C. 371, he contended his conviction was not related to the Medicaid program, and thus, did not support the issuance of an ESO without further proof that he posed a threat to public safety.

The court ultimately agreed with Mendelsohn, deciding “the underlying facts do not qualify as one of those instances where the Florida Department of Health may issue an ESO without providing specific reasons why the suspension is necessary to prevent immediate harm to the public.”

Do not let the Florida Department of Health take away your license unless it is warranted. Contact a board certified health law attorney who is knowledgeable in handling these matters. For more information about Emergency Suspension Orders and other legal matters concerning healthcare providers visit www.TheHealthLawFirm.com.

George Indest is an attorney, board certified by the Florida Bar in Health Law, who represents health care professionals and providers, including pain management clinics and pain management physicians.