Tag Archives: florida

22 New Synthetic Drugs Outlawed in Florida: Citizens Keep an Eye Out for Zombies

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

On December 11, 2012, Attorney General (AG) Pam Bondi filed an emergency rule outlawing 22 new synthetic drugs, commonly known as “bath salts,” “K2,” and “Spice.” This emergency rule modifies Section 893.03(1)(c), Florida Statutes, by expanding the list of synthetic drugs in Schedule I of controlled substances of the Florida Comprehensive Abuse Prevention and Control Act.

Click here to view a copy of the emergency rule.

I previously wrote a blog on House Bill 1175 in July 2012, which originally outlawed 90 forms of synthetic drugs. Click here to read that blog.

Authorities Having a Hard Time Staying on Top of These Drugs.

The new law puts restrictions on those who manufacture, sell or deliver synthetic substances including certain synthetic cannabinoids and synthetic stimulants. Many of the synthetic substances are also commonly known as synthetic marijuana, bath salts, K2, potpourri, and incense. According to an article in the Orlando Sentinel many of these drugs look like snacks for children. One of these drugs is even marketed as a “Scooby Snack,” another looks like cotton candy. To read the entire article from the Orlando Sentinel, click here.

Florida’s officials are continuously updating the list of outlawed synthetic substances because the chemical compounds in these substances are easy to change. The ease of converting these substances into illegal drugs helps drug makers, users and sellers avoid arrest and prosecution.

Click here to see the entire list of outlawed controlled substances.

Anyone with These Drugs Asked to Voluntarily Surrender Supply.

The emergency rule by the AG makes it a third-degree felony for an individual to sell, manufacture or deliver these synthetic drugs.

These drugs are widely available in smoke shops, truck stops, convenience stores and on the internet. In a press release the AG and local law enforcement reached out to people handling these drugs, asking them to voluntarily surrender the substances or face action from law enforcement.

To read the entire press release from the AG, click here.

AG Wants a Zombie-Free Holiday.

This emergency rule is evidence of Floridians’ fear of zombies and cannibal attacks allegedly linked to the misuse of the outlawed substances. Florida has been linked to both in the national news, thus scaring away many of our tourists who usually flood the state. For an update on the zombie apocalypse in Florida, click here. Of course, there are those detractor who contend that face-chewing and other alleged zombie behavior is just natural behavior for Floridians, regardless of the chemicals imbibed.

Since Florida seems to be the only state infected with these flesh-eaters, we are taking a poll. Should Florida be renamed “the Zombie State?” Let us hear from you.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely 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.

Comments?

What do you think of this new list of outlawed synthetic drugs? Do you think sellers will voluntarily surrender their products? Will this new list keep the zombies away? Tell us, do you think we should rename Florida the Zombie state? Click here to vote in a poll on our Facebook page.

Sources:

Meale, Jenn. “Attorney General Pam Bondi Outlaws Additional Synthetic Drugs.” Office of the Attorney General. (December 11, 2012). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/C2FED4E8849E737685257AD1006EED54

Haughney, K. “Bondi Files Emergency Rule to Outlaw Additional Synthetic Drugs.” Orlando Sentinel. (December 11, 2012). From: http://blogs.orlandosentinel.com/news_politics/2012/12/bondi-files-emergency-rule-to-outlaw-additional-synthetic-drugs.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.
“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.

Central Florida Has Been Invaded By Zombies – No Twinkies Means No Food Source

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

You are already aware of Floridians’ fear of zombies, as shown by recent legislation against bath salts. Despite this, there continue to be reports of rampant zombie outbreaks across the Sunshine State. The zombie apocalypse has hit Central Florida, hard. As a citizen of Florida, you know you are not safe; not from zombies, not from British tourists, not from inability to count (notes in an election) and not from the state legislature. To make matters worse, Twinkies, the only food known to mankind that can survive a post-apocalyptic zombie outbreak (reference: Zombieland 2009) or a nuclear holocaust (reference: Family Guy, second season, third episode Dec. 26, 1999), may soon be out of production. Everyone knows Twinkies have a shelf life of 246 years.

Since Florida seems to be the only state infected with this flesh-eating disease, we are taking a poll. Should we be renamed “the Zombie State?”

A Run With the Living Dead in Clermont.

For those of your reading this blog from another state, you’re in luck. There is actual video footage of how bad the zombie outbreak has gotten in Florida. In Clermont, thousands of cardio-enthusiasts showed up to run a 5K course filled with numerous obstacles that forced participants to crawl in the sticky mud to avoid being pricked by barbed wire above and walking along an unstable beam of wood. Unfortunately, the runners were bombarded along the way by the living dead looking for a quick bite to eat. The participants had to protect their brains while running for their lives. Only the fastest survived.

To see video of attack, click here.

Zombies Take Over the University of Central Florida (UCF).

If you are in Florida and were hoping to take shelter on the campus of the University of Central Florida (UCF), you’re too late. From now until December 2, 2012, the campus will be crawling with zombies who have taken to the stage in a production called “Zombie Town: A Documentary Play.”

We’ve heard it’s not bad. Click here to read a review of the performance.

No Twinkies = No Hope.

By now you’ve heard Hostess, the maker of Twinkies, may be on its way to a complete shutdown. As you know, these delicious treats are the only food that can survive a zombie outbreak. If Hostess closes its doors, we are doomed for sure. Thank goodness Hostess and its striking union members are renegotiating. If Hostess does shut down, it’s rumored a Boca Raton, Florida, company will purchase the brand. We can only hope.

To read the latest on the Hostess debacle, click here.

Given the increasing number of zombie attacks in Florida, the price of Twinkies could soar into the hundreds of dollars each in Florida. Doomsday enthusiasts and disenchanted stock market investors are allegedly pouring funds into warehouse loads of Twinkies.

Is the Ban on Synthetic Drugs in Florida Working?

If you remember, Florida Governor Rick Scott signed House Bill 1175 on March 23, 2012. This bill outlawed more than 90 new forms of synthetic drugs. It modified Section 893.03(1)(c), Florida Statutes, by expanding the list of banned hallucinogenic substances in Schedule I of the Florida Comprehensive Abuse Prevention and Control Act. To view Florida HB 1175, click here. To read more on the ban, click here.

HB 1175 was in response to the first known zombie attack in Miami. This cannibalistic attack was allegedly because the one man was high on bath salts. It was rumored that one prominent Florida lawmaker stated that banning bath salts, smiles and other synthetic drugs should help to reduce the reported acts of cannibalism and zombie-like behavior in Florida.

And he was wrong, the walking dead are alive, sort of, and well in Florida.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely 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.

Comments?

What do you think about all the zombies around town? What are you doing to survive? Are you stocking up on Twinkies now? Tell us, do you think we should rename Florida the Zombie state? Vote in a poll on our Facebook page.

Sources:

Armstrong, Cassie. “Zombies Invade Clermont in 5K Challenge.” Florida 360. (November 17, 2012). From: http://www.orlandosentinel.com/multimedia/os-fla360-zombies-invade-clermont-in-5k-challenge,0,110644.story

Palm, Matthew. “Theater review: ‘Zombie Town: A Documentary Play’ from Theatre UCF.” Orlando Sentinel. (November 18, 2012). From: http://www.orlandosentinel.com/community/ucf/os-zombie-town-review-ucf-20121116,0,4007008.story

Hsu, Tiffany. “Hostess, Union to Give Talks Another Chance.” Orlando Sentinel. (Novemeber 2012). From: http://www.orlandosentinel.com/la-fi-mo-twinkies-hostess-union-mediation-20121119,0,4220893.story

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

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

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

New Popular Drug Called “Smiles” Outlawed in Florida – Zombie Attacks Still a Threat!

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

In previous blogs we’ve mentioned that Florida Governor Rick Scott signed House Bill 1175 on March 23, 2012. This bill outlawed more than 90 new forms of synthetic drugs and included bath salts, among others. It modifies Section 893.03(1)(c), Florida Statutes, by expanding the list of banned hallucinogenic substances in Schedule I of the Florida Comprehensive Abuse Prevention and Control Act. To see Florida HB 1175, click here. To see the entire list of banned substances, click here.

As you are no doubt aware, this was due, in part, to the recent outbreak of zombie attacks in the state of Florida. To see my prior blog on this, click here.

A new drug is popping up on the market with the name 2C-I or “smiles.” This drug is on the list of banned hallucinogenic substances, but has been linked to a number of deaths across the country.

Click here to learn more on the dangers of taking smiles.

Actor Thought to Have Taken Smiles Prior to Death.

According to CBS News, Johnny Lewis, an actor on the TV show “Sons of Anarchy,” is believed to have taken smiles before allegedly killing his landlady and falling to his death. Detectives believe the actor also had mental health issues.

To see the CBS News story, click here.

Florida’s Synthetic Drug Legislation Imposes Restrictions on Synthetic Substances.
The law that was passed in Florida put in place restrictions to prevent abuse of synthetic substances including certain synthetic cannabinoids and synthetic stimulants. Many of the synthetic substances are also commonly known as synthetic marijuana, smiles, bath salts, K2, potpourri, and incense.

The large quantities of synthetic substances are included in HB 1175 because the chemical compounds in these substances are easy to change. The ease of converting these substances into illegal drugs helps illegal drug makers, users and sellers to avoid arrest and prosecution. For example, one synthetic substance might be illegal under the Florida Comprehensive Abuse Prevention and Control Act, but a minor change in the molecular makeup might make the substance legal. Florida residents who desired to become zombies could just take one of these synthetic substances (don’t ask how). They no longer have to go to Haiti or watch “Weekend at Bernie’s” three times in a row.

Banning Synthetic Drugs Was An Attempt To Reduce Cannibalistic Attacks.

Who can forget the story of the Miami cannibal believed to have been on bath salts?

To refresh your memory, click here to see the story from CNN. Warning this does include actual video of the attack.

It was rumored that one prominent Florida lawmaker stated that banning bath salts, smiles and other synthetic drugs should help to reduce the reported acts of cannibalism and zombie-like behavior in Florida.

Manufacturers and Retailers, Watch Your Back.

The passing of HB 1175 could mean more issues for manufacturers and retailers of any products utilizing synthetic substances such as bath salts, herbal incense, or potpourri. If you manufacture or sell any product that is composed of synthetic substances you should regularly test your products to ensure that you are in full compliance with the new law.

On October 2, 2012, a Port Orange, Florida, store owner was charged with drug possession with intent to sell. Officials accused him of selling synthetic drugs, including marijuana and bath salts.

To see the Orlando Sentinel story on this arrest, click here.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely 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.

Comments?

What do you think about the ban on synthetic drugs? Do you think it is working or not working? Please submit any thoughtful comments below.

Sources:

Jaslow, Ryan. “‘Smiles’ Druge Implicated in Actor’s Death: What Are They?” CBS News. (September 28, 2012). From: http://www.cbsnews.com/8301-204_162-57522571/smiles-drug-implicated-in-actors-death-what-are-they/

Weiss, Piper. “2C-I or ‘Smiles’: The New Killer Drug Every Parent Should Know About.” Yahoo. (September 20, 2012). From: http://shine.yahoo.com/healthy-living/2c-smiles-killer-drug-every-parent-know-234200299.html

Hernandez, Arelis. “Store Owner Accused of Selling Synthetic Drugs, Bath Salts.” Orlando Sentinel. (October 2, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-bath-salts-arrest-20121002,0,7437907.story

CNN. “Security Video Shows Entire Miami ‘Zombie’ Attack.” CNN. (May 30, 2012). From: http://news.blogs.cnn.com/2012/05/30/security-video-shows-entire-miami-zombie-attack/

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.

Settlement Reached in GlaxoSmithKline Healthcare Fraud Case

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

GlaxoSmithKline (GSK), a prescription drug manufacturer, will pay $3 billion in fines to resolve allegations of healthcare fraud. The settlement was announced by federal prosecutors on July 1, 2012, and in a press release from the Florida Attorney General on July 2, 2012. This is the largest healthcare fraud settlement in U.S. history.

Settlement Resolves Allegations Against GSK Related to Healthcare Fraud.

The settlement resolves allegations that GSK:

  • Marketed the depression drug Paxil for off-label uses, such as use by children and adolescents; 
  • Marketed the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages; 
  • Marketed the asthma drug Advair for off-label uses, including first-line use for asthma;
  • Marketed the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions; 
  • Marketed the nausea drug Zofran for off-label uses, including pregnancy-related nausea; 
  • Made false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;
  • Offered kickbacks to healthcare professionals to induce them to promote and prescribe certain prescription drugs; and
  • Submitted incorrect pricing data for various prescription drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs.

GSK Will Also Plead Guilty to Criminal Charges as Part of Settlement.

As part of the settlement, GSK has will plead guilty to criminal charges that it violated the federal Food, Drug, and Cosmetic Act (FDCA). Allegedly, GSK introduced Wellbutrin and Paxil into interstate commerce when the drugs contained labels that were not in accordance with their FDA approvals. Additionally, GSK allegedly failed to report certain clinical data regarding Avandia to the FDA.

Florida to Receive Over $56 Million In Settlement.

Florida will receive more than $56 million as part of the settlement with GSK. Florida Attorney General, Pam Bondi, announced the state’s participation in the settlement on July 2, 2012.

Settlement Stems From Whistleblower Actions.

The settlement is based on four qui tam, or whistleblower, actions brought by individuals pursuant to state and federal false claims. To view the federal False Claims Act, click here. A National Association of Medicaid Fraud Control Units team, along with several other federal agencies, investigated the matter and conducted settlement negotiations with the defendants. Florida’s civil investigation was handled by the Attorney General’s Complex Civil Enforcement Bureau, which is part of the Medicaid Fraud Control Unit.

Contact Health Law Attorneys Experienced in Healthcare Fraud Cases.

The Health Law Firm represents physicians, medical practices, pharmacists, pharmacies, and other health providers in healthcare fraud cases, including investigations, regulatory matters, litigation, and audits involving government health programs (Medicare, Medicaid, TRICARE).

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:

Meale, Jenn. “Attorney General Bondi’s Office Reaches Historic Healthcare Fraud Settlement.” Florida Office of the Attorney General. (July 2, 2012). Press Release. From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/E494FDADFF113AC885257A2F0068F790

Schmidt, Michael S. and Katie Thomas. “GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement.” New York Times. (July 2, 2012). From: http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all

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.

411-PAIN Settles with Florida Attorney General

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

Florida Attorney General Pam Bondi announced that her office has reached a settlement with 411-PAIN. The settlement requires 411-PAIN to pay $550,000 and change its advertising practices for allegedly making misrepresentations to consumers. 411-PAIN is a Florida-based attorney and chiropractic referral service.

411-PAIN Allegedly Misrepresented Consumer Entitlements.

The Attorney General pursued action against 411-PAIN for the company’s alleged violation of Florida’s Deceptive and Unfair Trade Practices Act, Chapter 501, Part II, Florida Statutes. To view Florida’s Deceptive and Unfair Trade Practices Act, click here.

Allegedly, the company misrepresented that consumers could be entitled to $100,000 or more for injuries and lost wages as a result of accidents. The company also allegedly misrepresented that consumers could be entitled to more than $10,000 in personal injury protection compensation or benefits for injuries and lost wages. The alleged misrepresentations were made through the company’s advertising.

Additionally, 411-PAIN was accused of falsely stating that police officers require consumers to call 411-PAIN after calling emergency services following an auto accident. This was allegedly conveyed through the company’s advertisements which used actors dressed as police officers. The advertisements allegedly did not feature a disclosure that the individuals in the commercials were actors and not actual law enforcement officers.

Attorney Services Allegedly Misrepresented by 411-PAIN.

411-Pain also allegedly misrepresented attorney services to consumers. The company is accused of stating that consumers would be referred to a “qualified” attorney or “specialized” attorney who specializes in the type of injury or accident they sustained, when no such attorney specialization exists in Florida.

Settlement Restricts the Company’s Advertising.

The settlement reached by the state in Broward Circuit Court prohibits 411-PAIN from
 • Promising any monetary compensation in its ads; 
 • Saying it’s referring victims to a “specialized attorney;” 
 • Using images of law enforcement officers to suggest that officials are directing consumers to use 411-Pain after calling 911, unless the officer is labeled as a “paid actor.”

To view the full settlement, click here.

Sources:

Cohen, Bryan. “Florida AG Settles with 411-PAIN.” Legal Newsline. (June 5, 2012). From:
http://www.legalnewsline.com/news/contentview.asp?c=236354

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.

Franck’s Pharmacy Recalls Compounding Prescriptions and Shuts Down Sterile Compounding Service

Franck’s Pharmacy, Inc. located in Ocala, Florida, has issued a recall for its compounded prescriptions. The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck’s Pharmacy made the announcement on the company’s website on May 24, 2012. To see the recall click here.

Recall Based on FDA Findings of Fungal Growth in Pharmacy’s Clean Room.

The recall was apparently prompted by action by the U.S. Food and Drug Administration (FDA). The FDA notified Franck’s Pharmacy that environmental sampling of the pharmacy’s clean room revealed the presence of microorganisms and fungal growth. Because of the FDA’s findings, Franck’s Pharmacy decided to recall its sterile compounds to prevent any possible risk of infection to patients.

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

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

Franck’s Pharmacy Ceases Production of Sterile Compounds.

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

Franck’s Pharmacy Recently Linked to Eye Infection Outbreak.

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

Prior Deaths of 30 Polo Ponies.

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

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

Sources Include:

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

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

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/

The DEA Attacks Legitimate Pharmaceutical Distributors, Starting with CVS Pharmacy and Cardinal Health

Earlier in February 2012, the DEA accused both CVS Pharmacy, one of the nation’s largest drug store chains, and Cardinal Health, one of the nation’s largest legitimate distributors of pharmaceuticals, of endangering the public by selling excessive amounts of oxycodone to four Florida pharmacies. For Cardinal Health, the charges came in an immediate suspension order served Feb. 3, 2012, when the DEA suspended Cardinal’s license to distribute controlled substances from its Lakeland, Florida location, which serves four states, according to USA Today. Lakeland is located between Orlando and Tampa.

Cardinal immediately challenged the suspension in federal court denying the charges. The DEA’s suspension was temporarily lifted and a hearing was scheduled in the federal district court in Washington, D.C. In preparation for the hearing, the DEA and Cardinal filed hundreds of pages of documents that provide a look into how prescription painkillers have infiltrated the black market. We are attempting to obtain copies of some of these so that we can share them with other interested attorneys and individuals.

As reported in various media sources, the investigation into Cardinal’s operation began after a Cardinal investigator became aware of a rumor that a local pharmacy was selling oxycodone by the pill for cash. This Florida pharmacy was reported to be one of Cardinal’s biggest customers.

Over the next two years, Cardinal employees allegedly visited the same pharmacy at least four more times. Each time, they noted the following suspicious signs: Customers paid cash, oxycodone was the top seller, and young people came into the pharmacy in groups to have their prescriptions filled. The pharmacy allegedly dispensed 462,776 oxycodone pills over a two month period — which is what the DEA states is approximately seven times what the average pharmacy dispenses in a year. Additionally the pharmacy allegedly asked Cardinal for more. Cardinal filled the order for more oxycodone but terminated the pharmacy as a customer.

By the time Cardinal cut the pharmacy off in October 2011, police had arrested at least three doctors who were associated with or had their patients’ prescriptions filled at the pharmacy.  Law enforcement officials charged them with trafficking in oxycodone, racketeering and over-prescribing narcotics.

Then, in early February 2012, the DEA reportedly suspended the DEA registrations (sometimes called “DEA numbers” or “DEA licenses”) of four of Cardinal’s largest Florida customers. These suspensions demonstrate the DEA’s strategy to combat the country’s prescription drug abuse problem at the highest levels, regardless of the size or reputation of the company. After years of attacking doctors who dispense drugs from pain clinics, DEA agents are now targeting the legitimate pharmaceutical distributers — the top of the legitimate drug supply chain.

The number of overdose deaths involving prescription pain medications allegedly now exceeds deaths from heroin and cocaine combined, which motivates state and federal agents to be more aggressive in fighting against misuse of drugs.

Under the federal Controlled Substances Act, the DEA regulates every link in the supply chain for controlled substances such as oxycodone and hydrocodone, including manufacturers, distributors, doctors and pharmacies. According to the DEA, approximately 1.4 million entities have DEA registrations to handle controlled pharmaceuticals. The law requires pharmaceutical distributors, like Cardinal Health, to have systems to detect suspicious orders, which must then be reported to the DEA.  Additionally, federal regulations require that any thefts, losses or shortages of controlled medications be reported to the DEA.

In court documents filed in response to Cardinal’s challenge, the DEA said Cardinal ignored “red flags” raised to detect suspicious orders. However, Cardinal argues that volume alone is not enough to determine whether a pharmacy is diverting the drugs, because it does not account for a pharmacy’s location, the age and health of the population, and the proximity to hospitals, nursing homes and cancer centers.

The DEA routinely cites the volumes of drugs a pharmacy fills or the numbers of tablets of a certain type of medication for which a doctor writes prescriptions.  This is also a factor the DEA uses in cases we have seen where it seeks to suspend or revoke the DEA registrations of physicians and pharmacies in administrative cases.  However, some judges have expressed a reluctance to admit such “bean counting” or naked numbers as being irrelevant, when not supported by testimony or evidence placing the numbers into context with other factors, such as the physician’s practice, patient mix, standards of treatment, severity of illness, etc.

In the federal court case now pending, Cardinal has stated in papers filed that it has a “robust” detection system and has cut off more than 330 pharmacies, including 140 pharmacies located in Florida, over the past four years that it decided posed an unreasonable risk of diversion.

In a news article posted late on February 29, 2012, the Associated Press advised that federal Judge Reggie Walton had ruled against Cardinal Health earlier in the day.  Apparently Cardinal Health had originally obtained a “stay” (sometimes referred to as a “temporary restraining order” or “temporary injunction”) against the DEA’s suspension order.  However, after a hearing held on February 29 in which Cardinal Health sought an injunction against the DEA’s enforcement of its suspension, Judge Walton announced a decision form the bench.  He reportedly refused to grant Cardinal Health an injunction against the DEA, apparently agreeing with the DEA’s position.

This battle between Cardinal Health and the DEA is an important one as it demonstrates the DEA continued efforts to attempt to exert more control over pain clinics, pain management physicians, pharmacists, pharmacies, and now, pharmaceutical distributors. If you believe that the DEA is investigating you, your facility, your company or if you want to learn more about the legal implications of pain management, visit our website to learn more.

Sources for this article included; the Orlando Sentinel, Boston Globe, Associated Press, USA Today and Florida Today.

Suspected Florida Pill Mills Continue to Attract Investigations

According to the Orlando Sentinel, some of the worst alleged pill mills in Florida are located in Orlando. At a small pain clinic near downtown Orlando and an affiliated office, one doctor prescribed more oxycodone during a three-month period in 2010 than all doctors in the state of California combined. Details about the clinic from former employees span a nearly 200-page affidavit filed in Orange County Circuit Court in the racketeering case against doctors and management of this pain clinic. The documents offer a rare glimpse inside the investigation.

In this case, agents examined bank records, Crimeline tips and records from the Medical Examiner’s Office. Additionally, FDLE and Metropolitan Bureau of Investigation agents gathered prescribing data from the U.S. Drug Enforcement Administration, pulled state corporation filings and viewed Department of Health records. Agents obtained the prescribing histories for 75 patients who got their drugs at Walgreens and found that 64 had criminal records. Of those, 42 have been arrested for drug-related crimes.

In addition to exploring paper trails, agents and investigators employed more-traditional law enforcement tactics, including undercover investigations. Posed as patients, undercover MBI agents were prescribed painkillers with little or no medical assessment. While waiting for their turns to see the doctors in the clinics, they overheard patients in the lobby talk about selling drugs.

Undercover agents said there were other indications that this pain clinic was a pill mill. There were long lines outside; armed security guards; and signs that warned patients they needed to bring empty pill bottles and posted what medications were available and a price list for the pills. The pain clinics were a cash business. Insurance was not accepted, and employees told agents the price per visit ranged from $160 to $350.

The original target of this investigation was one of the doctors at the pain clinic, but as agents gathered intelligence, it became clear they needed to learn more about the owners and management.

According to the investigation, the management recruited doctors to work at the clinics, but court documents show they had a problem retaining them. A man who used to work at a nearby business told agents that one of the owners complained to him that doctors were quitting and suggested he would hire the man to pretend to be a doctor at the clinic. 

The investigation of this pain clinic resulted in the arrest of the owners and doctor involved in allegedly overprescribing narcotics. As federal, state, and local agencies continue their mission to eradicate pill mills, more pain clinics will be involved in investigations.

If you are concerned about your pain clinic, or if you are a doctor practicing pain management at a pain clinic, please call us today at (407) 331-6620 or (850) 439-1001.

What Does Proposed Liposuction Bill Mean For Florida Plastic Surgeons?

A new Florida bill aimed at making liposuction procedures safer is making its way through the Senate in Tallahassee. The bill was created as a result of the deaths of four South Florida mothers in their 30s during liposuction procedures, according to the Orlando Sentinel.

Present state rules say physician surgery offices must be inspected by the state Department of Health or accrediting organizations, unless the doctor performs procedures using only local sedatives that leave the patient awake. Cosmetic surgeons who perform liposuctions using local sedatives such as lidocaine do not have to have their offices inspected.

The bill says that any liposuction that removes more than 1 liter of fat can only be done in a regulated office. This would cover most liposuctions. It would force most liposuctions to be done in surgery offices inspected by the state, by doctors with life-support training, not in unregulated physician offices.

However, some doctors think that the legislation doesn’t go far enough. It does not ban liposuction in physician surgery offices, as some proposed. It does not force med-spas to be regulated, as Sobel proposed in bills that failed in the past. It does not force doctors to use an anesthetist for all liposuctions.

The bill has cleared the Senate Health Regulation Committee and now goes to the Senate Budget Committee, where it is expected to pass. A similar bill is pending in the state House and no opponents have come out against it so far.

The bill was filed by state Sen. Eleanor Sobel, D-Hollywood in reaction to four South Florida liposuction deaths since 2009.

Maria Shortall, 38, died when her bloodstream was blocked by fat sucked from her midsection and reinjected into her buttocks at an unregulated physician office. Kellee Lee-Howard, 32, died of drug interactions in the hours after a liposuction at the same office, and Rohie Kah-Orukotan, 37, died of an overdose of lidocaine given during liposuction at an unregulated medical spa. Another Miami woman was killed from a fat blockage after liposuction at a licensed surgery center.

Disciplinary action is pending against the doctor involved in the first two cases; the doctor in the third case has surrendered his medical license. No disciplinary action has been taken in the fourth case.

According to the Florida Society of Plastic Surgeons, which backs the bill, it won’t be expensive for the state to regulate these offices. Additionally, the Florida Society of Plastic Surgeons hopes inspections will detect doctors who may be using local sedatives, such as lidocaine, for extensive liposuctions that should warrant stronger sedatives and more safety measures. Those measures include advanced life-saving training and having an assistant give anesthesia.

While no one has come out vehemently opposing the bill, if passed it will have some consequences for plastic surgeons who don’t update their practice to comply.

For more information about this and other health law topics, please visit www.TheHealthLawFirm.com.