Tag Archives: emergency suspension order

Doctors and Nurse Practitioner Arrested in Prescription Drug Abuse Raid

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

A crackdown on prescription drug abuse by New York law enforcement has resulted in the arrests of 98 people. Two doctors and a nurse practitioner were among those charged.

A series of raids were carried out by Brooklyn federal prosecutors, the Drug Enforcement Administration (DEA), district attorney’s offices, and local law enforcement agencies. The raids began June 5, 2012 and resulted in the arrests.

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

Both Doctors Accused of Overprescribing.

One of the doctors is accused of conspiring to distribute oxycodone to patients that were not legitimate. Allegedly, the doctor surrendered his DEA registration. This terminated his authority to prescribe controlled substances such as oxycodone. However, he allegedly attempted to use other health care practitioners to continue to prescribe drugs, which the government contends is illegal.

Another doctor involved in the crackdown is charged with illegal distribution of oxycodone. During the execution of a federal search warrant at his offices on March 1, 2012, the doctor voluntarily surrendered his DEA registration. However, he allegedly continued to issue prescriptions to those whom he knew were not legitimate patients.

We continually warn against “voluntarily relinquishing” DEA registrations or medical licenses with any investigation pending as this is treated the same as a revocation in most cases. For an article we have written on this, click here.

Florida Has Experienced Similar Prescription Drug Abuse Crackdowns.

Starting around two years ago, Florida health providers involved in narcotics precribing became routine targets for law enforcement. This was part of a concerted effort by state and federal officials to crackdown on “pill mill” operations. Regulations increased. Lawmakers enacted severe penalties for doctors and other health professionals accused of over-prescribing. Most physicians were banned from dispensing drugs in their offices. The governor created a Florida drug “strike force” with a mission to eliminate any pain clinics that were found to be breaking the law. The Florida Surgeon General and the Board of Medicine made announcements about the “crackdown” on “over-prescribing.”

Since the implementation of the new pain management and prescribing laws, the Florida strike force has made thousands of arrests and seized millions of pills of narcotics. This has resulted in serious concerns by those in the pain management profession.

Law Enforcement will Continue to Pursue Physicians, Pharmacists, Nurses and Other Health Providers.

The recent raid in New York and ongoing actions in Florida demonstrate that law enforcement will continue to pursue health professionals who prescribe large amounts of narcotics.

Contact Health Law Attorneys Experienced with Overprescribing Charges and 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. 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:

Allen, Jonathon. “Doctors Arrested in New York Prescription Drug Crackdown.” Reuters. (June 7, 2012). From http://in.reuters.com/article/2012/06/06/usa-crime-painkillers-idINL1E8H6E3J20120606

CBS News. “98 Arrested in NY Prescription Drug Sweep.” CBS News. (June 6, 2012). From http://www.cbsnews.com/8301-201_162-57448268/dozens-arrested-in-ny-prescription-drug-bust/

McKenzie-Mulvey, Erin. “U.S. Attorney Lynch, District Attorneys, DEA, Other Law Enforcement Announce Prescription Drug Initiative.” Drug Enforcement Administration. (June 7, 2012). Press Release. From: http://www.justice.gov/dea/pubs/states/newsrel/2012/nyc060712a.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 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.