Florida Pharmacist Gets More Than Six Years in Prison For Role in Compounding Fraud Scheme

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

On November 29, 2018, a Florida pharmacist was sentenced to six and a half years in prison and ordered to pay $3.4 million, for her role in a scheme to defraud the government. Marjorie Robinson pled guilty one count of conspiracy to commit health care fraud for submitting fraudulent claims to Tricare, Medicare and private insurance programs for compounded creams that were not necessary.

The Fraud Scheme.

According to the U.S. Department of Justice (DOJ), Robinson was one of three owners of ASC Pharmacy Inc., a now defunct compounding pharmacy in Miami. Under her direction, the pharmacy made compounded creams that were made to maximize reimbursement from government and private insurance programs, not for patients needs, according to the plea deal. Click here to read the press release from the DOJ.

The other owners were charged separately and have also pled guilty.

This isn’t the first time a Florida pharmacy has defrauded government programs like Tricare, click here to read one of my prior blogs on a similar case.

Health Care Fraud Should Not Be Taken Lightly.

We have been consulted by many individuals, both before and after criminal charges were brought for fraud or related offenses. In many cases, those subject to Medicare and Medicaid fraud audits and investigations refuse to acknowledge the seriousness of the matter. Some may even decide not to spend the money required for a highly experienced health attorney to defend them.

Click here to read one of my previous blog posts regarding Medicare and Medicaid audits.

The government is serious about combating health care fraud. It created a Medicare Fraud Strike Force in March of 2007, in an effort to further prevent and eliminate fraud and abuse of government health care programs. False claims are a growing problem in the program, costing the government billions of dollars each year. Accordingly, punishments for defrauding the system can be quite severe.

If you are accused of Medicare or Medicaid fraud, realize that you are in a fight for your life. Your liberty, property/possessions and profession are all at stake. Often it is possible to settle allegations of fraud by agreeing to pay civil monetary penalties and fines. If given such an opportunity, the provider should consider whether it is worth the risk of facing decades in prison. Be prepared to give up whatever you need to in order to avoid a conviction and preserve your liberty.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The attorneys of The Health Law Firm represent pharmacists and healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also defend pharmacists, physicians, pharmacies and medical groups in actions by Tricare, Medicare, Medicaid and private insurers to recoup overpayments, obtain civil fines and penalties and take other actions against them. They represent pharmacies and pharmacists in DEA actions and administrative (Order to Show Cause ) hearings, Medicare Fraud Control Unit (MFCU) investigations, and administrative and civil litigation, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Sources:

Bolado, Carolina. “Fla. Pharmacist Gets 6½ Years For Bogus Claims For Creams.” Law360. (November 29, 2018). Web.

“South Florida pharmacist sentenced to more than six years in prison for role in $3.4 million compounding pharmacy scheme.” MD Linx. (November 30, 2018). Web.

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.

KeyWords: Legal representation for pharmacists, pharmacy lawyer, legal representation for pharmacies, pharmacists lawyer, legal representation for healthcare fraud, health care fraud representation, healthcare fraud defense lawyer, legal representation for submitting false claims to the government, False Claims Act defense attorney, FCA legal counsel, FCA defense lawyer, Anti-Kickback Statute (AKS) defense attorney, FCA representation, legal representation for allegations of violating Anti-Kickback Statute, AKS representation, TRICARE false claims legal defense attorney, TRICARE physician representation, legal representation violating False Claims Act, pharmaceutical fraud lawyer, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, Medicare audit defense attorney, ZPIC audit defense lawyer, RAC audit defense legal counsel, pharmacy Tricare audit defense attorney, Medicare pharmacy defense lawyer, Medicaid audit of pharmacy defense counsel, pharmacy defense attorney for overpayment demand, pharmacy civil fine defense attorney, pharmacy DEA defense attorney, pharmacy Order to Show Cause (OTSC) defense lawyer, Medicare Fraud Control Unit (MFCU) investigation defense legal counsel, pharmacy administrative and civil litigation attorney, health care fraud defense legal representation, TRICARE fraud attorney, health law defense attorney, health care fraud defense attorney, The Health Law Firm, representation for health care fraud investigations, compounding pharmacy lawyer, prescription reimbursement representation, pharmacy defense attorney, pharmacist defense lawter, representation for pharmacies, representation for pharmacists, legal representation for health care facilities, representation for health care professionals, legal defense of TRICARE providers, U.S. Department of Justice (DOJ) investigation representation, DOJ defense attorney, representation for DOJ matters, attorney reviews of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.

By |2018-12-26T19:49:51-05:00December 26th, 2018|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Two More Compounding Pharmacies Recall Drugs

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

Recall Upgraded in New Jersey.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Eye Infections from Georgia Compounding Pharmacy Products.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Florida Compounding Pharmacy in Hot Water Due to Fungal Growth.
We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Harsher Regulations on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Common Deficiencies We See in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recently blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

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.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer 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.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

New Requirements Released for Physician Medical Records Related to Compounded Medications

MLS Blog Label 2By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 5, 2013, the Florida Board of Medicine and the Florida Board of Osteopathic Medicine published new requirements for medical record documentation related to compounded medications administered to patients in an office setting.  These standards become effective September 9, 2013. The standards are contained in Florida Administrative Code Rules adopted by each board.

We believe the updated requirements are a result of the recent recalls of tainted compounded medications that have spread across the country and infected thousands of patients. These new standards will make it easier for health care professionals to trace drug reactions and spot tainted batches of medications quickly. The new changes apply to the exact documentation required anytime a compounded medication is administered to a patient.

For the Florida Board of Medicine this is an update to Rule 64B8-9.003, Florida Administrative Code. For the Florida Board of Osteopathic Medicine this is an update to Rule 64B15-15.004, Florida Administrative Code.

New Medical Records Standards.

According to the Florida Board of Medicine and the Florida Board of Osteopathic Medicine, when compounded medications are administered to a patient in the office the medical record documentation must contain, at a minimum:

1.  The name and concentration of medication administered;
2.  The lot number of the medication administered;
3.  The expiration date of the medication administered;
4.  The name of the compounding pharmacy or manufacturer;
5.  The site of administration on the patient;
6.  The amount of medication administered; and
7.  The date the medication was administered.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented about a year after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Click here to read our previous blog. Florida is no stranger to allegations of tainted compounded products. In May 2013, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

It’s likely these updated requirements are a direct result of the recent issues with compounded medications and compounding pharmacies. In the event a health care professional’s office receives a batch of tainted compounded medicine, these medical record standards will help the health care professional track which patients received the tainted medications. Also, authorities, such as the Department of Health (DOH) and U.S. Food and Drug Administration (FDA), will be able to easily track and send recalls to the offices that receive tainted compounded medications.

Contact Health Law Attorneys Experienced in the Representation 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?

Had you heard of these updates? Do you think these requirements will help officials track tainted medications? Please leave any thoughtful comments below.

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He 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 Ave., Altamonte Springs, FL 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.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

New England Compounding Pharmacy Linked to Meningitis Outbreak Suspected of Violated License

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

The compounding pharmacy behind the meningitis outbreak was allegedly not following the requirements of its state license, according to the Massachusetts Department of Health (DOH) in a released statement on October 10, 2012.

To read the entire statement from the Massachusetts DOH, click here.

The New England Compounding Center (NECC) shipped more than 17,000 vials of a steroid to pain clinics in 23 states, including Florida. The Centers for Disease Control and Prevention (CDC) is now reporting 214 cases of meningitis and 15 deaths associated with the fungal infection. NECC has surrendered its license and has recalled all medications. To see a blog I previously wrote about the recall and compounding facility shutting down, click here.

Under Law NECC Was Only Suppose to Produce Medication for Patient-Specific Prescriptions.

The Massachusetts DOH representative said under state law the NECC was only supposed to produce medications for patient-specific prescriptions. It is believed the company violated state law governing those pharmacies.

Apparently the DOH has had issues with the NECC prior to the outbreak. According to the statement, in 2006 the NECC received a warning letter from the Massachusetts DOH. The letter stated the company was operating more like a drug manufacturing firm than a compounding pharmacy.

All Compounding Pharmacies Now Under the Microscope.

On October 10, 2012, the Board of Pharmacy sent out an alert to all compounding pharmacies in Massachusetts to reinforce the state rules. The Board also issued an order requiring that all compounding pharmacies in the state sign an affidavit attesting compliance with all laws and regulations. The Massachusetts DOH officials do not believe any other pharmacies are operating outside of the rules, but said the alert was a precautionary measure.

Click here to see the alert from the Board of Pharmacy.

Compounding Pharmacy in Florida Faced Fungal Outbreak.

Florida has seen its share of fungal outbreaks. I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

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.

Comments?

What do you think of this story? Please leave any thoughtful comments below.

Sources:

Smith, Michael. “Meningitis: Pharmacy in Outbreak Violated License.” MedPage Today. (October 11, 2012). From: http://www.medpagetoday.com/Neurology/GeneralNeurology/35276?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news

Biondolillo, Madeleine Dr. “Statement of Dr. Madeleine Biondolillo Director of the Bureau for Health Care Safety and Quality.” Department of Public Health Massachusetts (October 10. 2012). From: http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy-necc-biondolillo-statement.doc

Associated Press. “CDC: US Meningitis Outbreak Growing, 14 Dead.” Florida Today. (October 11, 2012). From: http://www.floridatoday.com/viewart/20121011/HEALTH/121011041/CDC-US-meningitis-outbreak-growing-14-dead?odyssey=tab%7Ctopnews%7Ctext%7CLocal%20News

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.

Boca Raton Compounding Pharmacy Shuts Its Doors After Receiving an Emergency Suspension Order

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

On October 26, 2012, the Florida Department of Health (DOH) issued an emergency suspension order (ESO) against a Boca Raton compounding pharmacy, according to a number of sources. The DOH in a press release called the conditions in the pharmacy so “deplorable” that nothing short of immediately shutting down the pharmacy would suffice.

Click here to read the press release from the DOH.

Rodent Feces, Dead Bugs and a Sink Full of Dirty Water all Found at Compounding Pharmacy.

On October 12, 2012, a state inspector arrived at the Boca Raton compounding pharmacy for an inspection. According to an article on Health News Florida, rodent feces, dead bugs and a sink full of dirty water were discovered. A film of powder covered surfaces in the drug-compounding area, where containers of drugs were open. Information on patients and prescriptions was missing, and drug labels were missing important information on the dose, lot number and prescribing physician.

Apparently the compounding pharmacy had been cited in past inspections for similar issues.

To read the Health News Florida article, click here.

All Compounding Pharmacies Are Now Under Pressure.

The compounding pharmacy can have a DOH hearing before final action is taken. The suspension is in effect until final disciplinary action, until the suspension is lifted or the case is appealed.

This inspection and ESO occurred in the wake of a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. I previously wrote a blog on the Massachusetts compounding pharmacy shutting down. To read more click here.

It’s believed because of the meningitis outbreak, all compounding pharmacies are under the microscope.

Another Florida Compounding Pharmacy in Trouble Due to Fungal Growth.

I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog I wrote on this.

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.

Comments?

Do you think the Boca Raton compounding pharmacy was unfairly served with an ESO due to the meningitis outbreak? Or do you think it is better for the Florida DOH to be safe rather than sorry? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “State Finds Pharmacy Conditions ‘Deplorable,’ Suspends License.” Health News Florida. (October 26, 2012). From: http://wusfnews.wusf.usf.edu/post/state-finds-pharmacy-conditions-deplorable-suspends-license

Florida Department of Health. “Department of Health Takes Action Against Florida Pharmacy.” DOH. (October 26, 2012). Press Release From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2011/08/102612RejuviESO.pdf

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.

Meningitis Cases in Florida Continue to Rise – Doctors Getting Sued

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Department of Health (DOH) confirmed another case of fungal meningitis in Florida on November 19, 2012. A 56-year-old man allegedly received a contaminated steroid injection at Florida Pain Clinic in Marion County, Florida. This brings the state’s total number of fungal meningitis cases up to 24, including three deaths.

To read the entire press release from the Florida DOH, click here.

Meningitis Numbers Around the U.S. 

As of November 19, 2012, the Florida DOH reported the number of fungal meningitis cases nationwide is up to 480 with 33 deaths in 19 states.

The meningitis outbreak is reportedly linked to contaminated steroids made at the New England Compounding Center (NECC) in Framingham, Massachusetts, which is now closed. The compounding pharmacy was allegedly not following the requirements of its state license, according to the Massachusetts DOH. Under Massachusetts state law the NECC was only supposed to produce medications for patient-specific prescriptions, but it is believed the compounding pharmacy was preparing drugs in bulk. I previously wrote a blog on the reports related to the compounding pharmacy violating its license. Click here to read that blog.

Victims Sue Physicians.

Victims of the meningitis outbreak are starting to file lawsuits against the physicians and clinics that administered the tainted steroids. In a Business Insurance article released on October 28, 2012, I was quoted as saying liability might be established to the extent that the physicians were aware that the steroids distributed by the NECC violated regulations on compounding prescription medications. To read the entire article from Business Insurance, click here.

Florida and Fungal Outbreaks.

 Florida has seen its share of fungal outbreaks. I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

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.Jameson. Marni. “Florida Health Officials Confirm State’s 24th Case of Fungal Meningitis.” Orlando Sentinel. (November 19, 2012). From: ttp://www.orlandosentinel.com/news/local/breakingnews/os-florida-fungal-meningitis-20121119,0,3451600.story

Comments?

What do you think of the lawsuits again the physicians and clinics that administered the tainted steroid shots? Please leave any thoughtful comments below.

Sources:

Hiers, Fred. “Man Who Received Injection Locally Confirmed to Have Fungal Meningitis.” Ocala Star Banner. (November 19, 2012). From: http://www.ocala.com/article/20121119/ARTICLES/121119679/1412?Title=Man-who-received-injection-locally-confirmed-to-have-fungal-meningitis

Greenwald, Judy. “Meningitis Lawsuits Target Physicians.” Business Insurance. (October 28, 2012), From: http://www.businessinsurance.com/article/20121028/NEWS07/310289984?tags=|75|303

Hammonds, Jessica. “Florida Department of Health Uncovers Case of Fungal Meningitis.” Florida Department of Healht. (November 19, 2012). From: ttp://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2012/11/111912MeningitisUpdateonecase.pdf

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.

Florida Department of Health (DOH) Shuts Down Boca Raton Compounding Pharmacy

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

On October 26, 2012, the Florida Department of Health (DOH) issued an emergency suspension order (ESO) against a Boca Raton compounding pharmacy, according to a number of sources. The DOH in a press release called the conditions in the pharmacy so “deplorable” that nothing short of immediately shutting down the pharmacy would suffice.

Click here to read the press release from the DOH.

State Inspector Finds Feces, Bugs and Much More in Compounding Pharmacy.

On October 12, 2012, a state inspector arrived at the Boca Raton compounding pharmacy for an inspection. According to an article on Health News Florida, rodent feces, dead bugs and a sink full of dirty water were discovered. A film of powder covered surfaces in the drug-compounding area, where containers of drugs were open. Information on patients and prescriptions was missing, and drug labels were missing important information on the dose, lot number and prescribing physician.

Apparently the compounding pharmacy had been cited in past inspections for similar issues.

To read the Health News Florida article, click here.

Compounding Pharmacy Can Have a Hearing Before Action is Taken.

The compounding pharmacy can have a DOH hearing before final action is taken. The suspension is in effect until final disciplinary action, until the suspension is lifted or the case is appealed.

This inspection and ESO occurred in the wake of a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. I previously wrote a blog on the Massachusetts compounding pharmacy shutting down. To read more click here.

It’s believed because of the meningitis outbreak, all compounding pharmacies are under the microscope.

Read About Another Florida Compounding Pharmacy Accused of Distributing Medications with Fungal Infection.

I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog I wrote on this.

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.

Comments?

Do you think the Boca Raton compounding pharmacy was unfairly served with an ESO due to the meningitis outbreak? Or do you think it is better for the Florida DOH to be safe rather than sorry? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “State Finds Pharmacy Conditions ‘Deplorable,’ Suspends License.” Health News Florida. (October 26, 2012). From: http://wusfnews.wusf.usf.edu/post/state-finds-pharmacy-conditions-deplorable-suspends-license

Florida Department of Health. “Department of Health Takes Action Against Florida Pharmacy.” DOH. (October 26, 2012). Press Release From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2011/08/102612RejuviESO.pdf

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.

Negligence Will Determine the Success or Failure of the Meningitis Lawsuits Against Doctors and Clinics

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The victims and survivors of the meningitis outbreak are now filing lawsuits against the physicians and clinics that administered the tainted steroids. According to an article in The Tennessean, on January 29, 2013, a husband who lost his wife to fungal meningitis filed the first lawsuit against a Nashville outpatient clinic. It’s believed hundreds of people were injected at the same clinic with the tainted steroids. The man is now seeking $12.5 million in damages.

Click here to read the entire article from The Tennessean.

This lawsuit is just one in what is expected to be a series of lawsuits, in not just Tennessee, but across the country.

Compounding Pharmacy Allegedly Behind the Meningitis Outbreak is Out of Business.

The meningitis outbreak was at a peak in the fall of 2012. Contaminated steroid injections were allegedly made at the New England Compounding Center (NECC) in Framingham, Massachusetts. NECC is accused of shipping thousands of vials of tainted drugs across the country. There are allegedly 45 deaths nationwide from the steroids. The company shut down in October 2012, and filed for bankruptcy in December, according to an article in American Medical News.

Tennessee Complaint Alleges Outpatient Clinic Put Money Before Patients.

The man suing the Nashville outpatient clinic believes, among other things, that officials at the clinic put the company’s bottom line before patient care. The lawsuit specifically alleges:

1. The outpatient clinic ignored important information when it chose NECC to purchase thousands of vials of steroids,
2. That clinic officials failed to properly notify the victim that she had been injected with a potentially contaminated steroid,
3. That clinic officials failed to recommend the victim should receive treatment,
4. The clinic chose to purchase drugs from NECC because it was a cheaper than the safer alternatives.

Click here to read the entire complaint.

The Responsibility of Doctors and Clinics.

Negligence is the most common claim used against doctors in cases of defective medication. The assumption is that the physician breached the standard of care because he or she knew or should have known that NECC was not meeting applicable standards in compounding the medications. Another legal theory is that the physician should have known that certain medications should not have been compounded, but rather obtained directly from a manufacturer. I believe the liability of physicians and clinics might be established to the extent that the physicians were aware that the steroids distributed by NECC violated regulations on compounding prescription medications.

It’s imperative physicians and clinics are sure of the credentials of all vendors and suppliers.

I was recently quoted in an American Medical News article about physicians and clinics that are entangled in tainted drugs lawsuits. To read the entire article, click here.

Florida Compounding Pharmacy No Stranger to Fungal Outbreaks.

Florida has seen its share of fungal outbreaks. I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

Pharmacists Need to Obtain Good Professional Liability Insurance.

Many pharmacists, especially those who work for state agencies, large hospitals, pharmacy chains or other large institutions, scrimp on their purchase of professional liability insurance. Many mistakenly believe their employer will cover any legal defense expenses. This is not true and is often found out too late.

A pharmacist should always carry his/her own professional negligence insurance. It is inexpensive and can cover many types of legal actions other than just civil negligence cases. Always, always, always be sure your insurance includes at least $25,000 in professional license defense coverage. Get this in writing!

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.

Comments?

What do you think about the lawsuits against these doctors and clinics? Who do you think should be help responsible: the compounding pharmacy that shipped the contaminated steroids, or the doctors and clinics that administered the steroid shots? Please leave any thoughtful comments below.

Sources:

Roche Jr., Walter. “Meningitis Outbreak: Victim’s Husband Sues Saint Thomas Clinic.” The Tennessean. (January 31, 2013). From: http://www.tennessean.com/apps/pbcs.dll/article?AID=2013301300211&nclick_check=1

Wayne A. Reed v. Saint Thomas Outpatient Neurosurgical Center. Case Number 13C-417. Complaint. (January 29, 2013). From: http://www.thehealthlawfirm.com/uploads/Reed%20v.%20St.%20Thomas%20Outpatient.pdf

Gallegos, Alicia. “Physicians Entangled in Tainted Drugs Lawsuits.” American Medical News. (February 11, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_PhysicianLawsuits.PDF

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.

Food and Drug Administration (FDA) Recalls Products from Two Different Compounding Pharmacies

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

All Products from Med Prep Consulting Recalled.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Products from Georgia Compounding Pharmacy Allegedly Causing Eye Infections.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Franck’s Compounding Pharmacy in Florida  Caused Fungal Growth.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Compounding Pharmacies Under the Microscope.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding pharmacies, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Deficiencies That are Common in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recent blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

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.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer 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.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Recall Alert: FDA Warns Steroid Injections Compounded by Tennessee Pharmacy May Be Contaminated

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. So far, seven patients have allegedly suffered adverse reactions from the medications. The FDA says it is working with the Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate. The steroid injections were allegedly sent to 13 states, including Florida.

To read the press release from the FDA, click here.

Steroid Injections Recalled.

According to an article in the Associated Press, officials have not yet confirmed the products are contaminated. The FDA is treating all sterile products from Main Street Family Pharmacy as if they were contaminated as a precaution. The pharmacy has agreed to recall all of its sterile products. Click here to read the Associated Press article.

The injections in question allegedly contain the same drug at the center of the October 2012, deadly fungal meningitis outbreak. More than 55 people, including five in Florida were killed and 740 others were sickened after receiving contaminated injections from a Massachusetts compounding pharmacy. I previously blogged about that outbreak. To read more, click here.

Patients in North Carolina and Illinois Allegedly Reacted to Injections.

Federal authorities have allegedly identified seven cases of patients who have suffered complications after being injected with the potentially contaminated medications. There are five cases in Illinois and two cases in North Carolina. The Illinois patients supposedly have skin infections and one patient in North Carolina allegedly suffered from a fungal infection.

Florida Department of Health Working to Contain Allegedly Tainted Injections Statewide.

According to the Florida Department of Health (DOH), at least three Florida facilities received the drugs under investigation. Two of the facilities are in Melbourne, Florida, and one is in Chipley, Florida. The Florida DOH says it is not aware of any local cases of infections from these drugs.

To read the press release from the Florida DOH, click here.

Previous Florida Case of Contaminated Medication.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Congress Debating on Giving Authority Over Compounding Pharmacies to FDA.

Currently, compounding pharmacies are regulated by state pharmacy boards. There is currently legislation moving through Congress that would give the FDA direct authority over the compounding manufacturers. The goal is to prevent any national outbreaks tied to compounded medications.

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.

Sound Off.

Do you think each state should be responsible for regulating compounding pharmacies, or do you think the FDA should be responsible? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “FL Got Drugs Linked to New Outbreak.” Health News Florida. (May 24, 2013). From: http://health.wusf.usf.edu/post/fl-got-drugs-linked-new-outbreak

Kelly, Christopher. “FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections from Main Street Family Pharmacy in Tennessee.” Food and Drug Administration (May 24, 2013). From: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm

Stobbe, Mike and Loller, Travis. “FDA Warns of Infections Tied to Tennessee Pharmacy.” The Associated Press. (May 24, 2013). From: http://www.npr.org/templates/story/story.php?storyId=186473297

Florida Department of Health. “The Florida Department of Health Partners with Federal and State Health Organizations to Ward of Adverse Reactions Associated with Steroid Injections.” Florida Department of Health. (May 24, 2013). From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2013/05/052413CDCinfection.pdf

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.

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