Pharmaceutical Drugs | The Health Law Firm Blog

Drug Enforcement Administration Releases Details of Investigation into Two CVS Stores in Sanford, Florida

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

In September 2012, the Drug Enforcement Administration (DEA) revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. Details into the investigation were made public on October 12, 2012, in a final order released by the DEA.

The order explains how the stores operated, whom they prescribed painkillers such as oxycodone to, and identified Central Florida’s top-prescribing doctors.

To read the final order from the DEA, click here.

I previously wrote about the two Sanford CVS stores losing their controlled substance licenses, click here to read that blog.

Testimonies from Employees Allegedly Explained Pharmacies’ Operating System.

The final order reveals testimonies from pharmacy personnel. In a press release from the DEA the pharmacist-in-charge at one of the Sanford stores told drug agents the stores would set a limit each morning on the number of oxycodone prescriptions they would fill based on the inventory. Once the limit was reached, the pharmacy would tell customers they were “out of stock,” even when they had inventory. The pharmacist told agents the reserved inventory was for their “real pain patients.”

Warning Signs.

Employees told drug agents that their customers would ask for oxycodone using street slang such as “the M’s” or “the blues.” Oxycodone was also allegedly dispensed frequently to customers who lived out of state, obtained prescriptions from South Florida doctors, and had the prescriptions filled in Seminole County.

Click here to read the press release from the DEA.

More Stings May Be Coming.

The Walgreens distribution center in Jupiter, Florida, is currently fighting its own war with the DEA. On October 17, 2012, the biggest pharmacy retailer in Florida filed a petition

asking a federal judge to lift an immediate suspension order (ISO) banning the center from shipping controlled substances to its stores in Florida and on the East Coast. To read more on that story, click here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, 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 DEA’s decision? As a pharmacist how to do you regulate prescriptions for painkillers? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Rx for Danger: DEA Blasts CVS for Ignoring ‘Red Flags’ at Sanford Stores.” Orlando Sentinel. (October 28, 2012). From: http://www.orlandosentinel.com/health/os-cvs-dea-oxycodone-ban-20121028,0,5395839.story

Drug Enforcement Administration. “Holiday CVS Final Order Reveals Gross Negligence By

Two CVS Pharmacies in Stanford, Florida.” DEA.gov. (October 15, 2012). Press Release From: http://www.justice.gov/dea/divisions/mia/2012/mia101512.shtml

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

“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.

Osceola County Authorities Nab 29 People in Phony Prescription Ring

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

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

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

Alleged Criminals Getting Phony Prescriptions Filled at Legitimate Pharmacies.

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

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

29 People Arrested – More to Come.

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

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

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

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

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

Comments?

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

Sources:

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

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

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

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

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

Multiple States Move to Enact New Laws Related to Controlled Substances

By Lance O. Leider, J.D., The Health Law Firm

In reports from both coasts, three states have recently made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new actions. Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

Prescription Drug Monitoring Programs by State.

According to the Los Angeles Times, California is looking to utilize its prescription drug monitoring program CURES to find physicians who are a little too loose with the prescription pad. Lawmakers are contemplating mining the data compiled by CURES to find physicians who are overprescribing and take action against them. Click here to read the entire Los Angeles Times article.

The Pennsylvania house recently forwarded a bill from committee to the floor for a final vote. The bill would establish a monitoring program like those in California, Florida and Kentucky. This monitoring program would be used to combat abuse and doctor shopping by identifying patients that have already received an adequate supply of medications.

Kentucky, already the home of some tough prescription drug laws, is looking to fine tune its regulatory scheme. According to The Courier-Journal, the new bill would clarify existing regulations by providing medical exemptions for patients that would otherwise be wrapped up in the enforcement provisions. To learn more on the proposed changes to Kentucky’s prescription drug laws, click here.

You Can Run, But You Can’t Hide from Prescription Drug Monitoring.

Lawmakers in all three states cited laws and regulations from other states as inspiration for the moves to consider new laws to monitor prescriptions of controlled substances. What this means is that whatever state you may be in, you should be aware that lawmakers are looking around the country at what works and are implementing similar programs and laws in their governments.

Are Databases Just a Tool for Prosecution?

Enforcement of drug laws and prescribing regulations has been ever increasing in recent years. The implementation of these databases and corresponding regulations are going to provide more tools for law enforcement and state medical boards to crack down on physicians. In order to avoid trouble it is crucial that you take time to review your state’s prescribing and record keeping laws with an experienced health care attorney.

From experience, we have seen the database in Florida used mostly as a tool for prosecution of pain management physicians and pharmacists. Even in cases where the pharmacist has been the one to notify the authorities of suspected forged prescriptions and where the pharmacist has cooperated in prosecuting the criminals, I have seen this database cited as evidence against him or her. I do not believe this is what the legislation intended. Physicians and pharmacists should consider using whatever database is implemented in their respective states, or otherwise remaining vigilant to avoid being labeled an overprescriber.

To read legal tips to manage pain patients, click here.

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

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

Comments?

Does the state where you are located have a prescription drug monitoring program? Is it similar to any of programs we mentioned in this blog? What do you think of these programs? Are they necessary? Please leave any thoughtful comments below.

Sources:

Girion, Lisa and Glover, Scott. “Atty. Gen. Kamala Harris Urges Funding for Prescription Tracking.” Los Angeles Times. (March 3, 2013). From: http://latimesblogs.latimes.com/lanow/2013/03/attorney-general-kamala-harris-funding-prescription-database-.html

Wynn, Mike. “Kentucky Legislature Overhauls Prescription Drug Law.” The Courier-Journal. (March 4, 2013). From: http://www.courier-journal.com/apps/pbcs.dll/article?AID=2013303040093&nclick_check=1

Associated Press. “Lawmakers Mull Prescription Drug Monitoring.” Associated Press. (March 4, 2013). From: http://meadvilletribune.com/local/x986702017/Lawmakers-mull-prescription-drug-monitoring

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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.

Medical Negligence – An Accidental Overdose of Prescription Pain Pills Can Lead to Lawsuits

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

In February 2009, a 30-year-old male patient was prescribed, all together, 180 pills of Dilaudid and Xanax from a South Florida pain clinic. Sometime within the next 24 hours the patient died of what medical examiners ruled an overdose. According to the American Association for Justice, the patient’s family then sued the pain management clinic alleging the clinic’s physician prescribed a lethal overdose of the drugs and the defendant was liable for damages resulting from the patient’s murder. In the lawsuit, the jury awarded the plaintiff more than $5.33 million.

Physicians and Business Owners Liable for Medical Negligence.

According to an article in American Medical News, of the pharmaceutical-related overdoses in 2010, seventy-four percent (74%) were unintentional. As prescription drug overdoses rise across the country, we are seeing some physicians and business owners held liable for medical negligence.

For example, in May 2012, an Alabama jury ruled a widower to receive $500,000 after he sued his wife’s physician. His wife died of an accidental overdose after being prescribed a number of narcotic pain medications. In April 2012, a woman was awarded $1.9 million after she sued her family physician claiming he over prescribed her methadone, which led to brain damage after she stopped breathing, according to American Medical News.

Click here to read the entire article from American Medical News.

Protecting Your Business and License.

Health care professionals need to pay close attention to patients who request pain medication. Being proactive about prescription management can also deter lawsuits or help in doctors’ defense if they are sued. Physicians must make sure their records meet all requirements of state laws and regulations. In cases where a patient has been “doctor-shopping” in order to abuse pain pills, we see state disciplinary investigations initiated against each physician who prescribed that individual medication. In most cases, these physicians were unaware of the other prescribers. Disciplinary actions such as these can often be defended when the physician has taken the proper safeguards.

Click here to read legal tips for physicians to manage pain patients.

Drug Monitoring Programs are Here to Stay.

The growing epidemic has some states developing drug monitoring programs to track drug seekers.

In Florida, a bill that would require doctors to check with the state’s drug database before writing a prescription for addictive medications passed in a House panel on March 19, 2013. Recently, legislators in California, Pennsylvania and Kentucky are contemplating moves to tighten monitoring and prescribing of controlled substances. Click here to read a blog on the possible new actions in these states.

Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

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

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

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

Comments?

Do you think physicians and business owners should be held liable for medical negligence in cases of an accidental overdose? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Thirty-Two Indicted in Broward and Palm Beach Counties in Second Coordinated Pill Mill Takedown.” Department of Justice. (August 23, 2011). From: http://www.justice.gov/usao/fls/PressReleases/110823-04.html

Gallegos, Alicia. “Physician Liability: When an Overdose Brings a Lawsuit.” American Medical News. (March 4, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_Overdose%20Lawsuits.PDF

LaMendola, Bob. “Pain Clinic Boss Jeffrey George Pleads Guilty to Murder.” Sun Sentinel. (August 29, 2011). From: http://articles.sun-sentinel.com/2011-08-29/health/fl-hk-jeff-george-pleads-guilty-20110829_1_pain-clinic-cynthia-cadet-george-twins

About the Authors: 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.

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.

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.

Number of Oxycodone-Related Deaths Down in Florida

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

It looks like Florida’s prescription drug legislation, the statewide prescription drug monitoring database and the prescription drug crackdowns by law enforcement may be working, according to the Florida Department of Law Enforcement (FDLE). The FDLE states in its semi-annual report, oxycodone-related deaths statewide dropped between January and June of 2012, compared to the same period of time in 2011. A look at the national numbers shows that the number of people abusing prescription drugs is also down.

Florida and National Numbers.

In the first half of 2012, there were 759 oxycodone-related deaths in Florida, according to the Orlando Sentinel. That number is down from 1,058 during the same time period a year before. The Orlando Sentinel states that nationwide 7 million people abused prescription drugs in 2010. By 2011, that number had dropped to 6.1 million. Studies also show prescription drug use among young adults ages 18 to 25 is also on the decline. The Metropolitan Bureau of Investigation Director believes these numbers are down because young people are realizing these drugs are dangerous and can be deadly.

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

Florida Cracks Down on Prescription Drug Abuse.

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

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

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

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

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

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

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

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

Comments?

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

Sources:

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

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

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

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

The Health Law Firm2013-04-17T14:06:33-04:00June 1st, 2018|Categories: DEA, Pain Management, Pharmaceutical Drugs, Pharmacy, The Health Law Firm Blog|Tags: accidental overdose, administrative hearings, administrative law attorney, administrative law lawyer, controlled substances, defense attorney, defense lawyer, Department of Health (DOH), doctor, Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Florida health care lawyer, Florida health law attorney, Florida Office of the Attorney General (AG), Florida prescription drug abuse, Florida prescription drug crackdown, legal defense for doctors, legal defense for physicians, legal representation for doctors, legal representation for physicians, Medicaid Fraud Control Unit (MFCU), Medical negligence, opioid misuse, opioid use, oxycodone, pain management, pain pills, pharmacists, physician, physicians, pill mill, pill mill laws, prescription drug trafficking, prescription pain pill, prescriptions|3 Comments

Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic

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

Drug Enforcement Administration (DEA) agents along with local police and sheriffs’ deputies raided a Longwood, Florida, pain management clinic on June 14, 2013. According to the Orlando Sentinel, agents searched for evidence at the clinic associated with multiple doctors. DEA agents stated the clinic was operating as a “pill mill” and allegedly diverting legal prescriptions for illegal purposes. No one was arrested during the raid. Longwood is a suburb of Orlando.

Investigation Spreads to South Florida.

According to WESH-TV, during the raid agents took everything from the clinic that could help them build a criminal prosecution. This included paper records, computer equipment and prescription drugs. DEA agents would not say how many people they were investigating, but they did say this raid was the result of a two-year long investigation.

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

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

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

Click here to read the entire Orlando Sentinel article.

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

Different Clinic, Similar Storyline.

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

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

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

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

Comments?

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

Sources:

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

Pavuk, Amy. “Agents Raid Longwood Pain Clinic.” Orlando Sentinel. (June 14, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-professional-pain-care-raid-20130614,0,3826330.story#tugs_story_display
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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

Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

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

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

– “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

– “One who makes such a payment may be unable to explain and to justify it.”

– “Such a firm or individual may well possess market power derived from the patent.”

– “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

– “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

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 Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

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.

More than 30 People Charged with Pharmaceutical Drug Trafficking in Central Florida

By Dr. Thu Pham, O.D., Law Clerk, The Health Law Firm

Attorney General Pam Bondi along with special agent Mark R. Trouville of the Drug Enforcement Administration (DEA) and Longwood Police Chief Troy Hickson announced, on June 20, 2012, the execution of 37 arrest warrants stemming from state drug charges. The defendants all reside in Central Florida.

Click here to read the entire press release from the Florida Attorney General.

Charges are Being Handed Down to the Defendants.

The charges for the defendants ranged from first degree to third degree felonies. The defendants have been charged with acts such as conspiracy to traffic Oxycodone, solicitation to deliver Oxycodone, and possession of Hydromorphone with intent to sell or deliver.

Law enforcement authorities have been able to apprehend 33 of the 37 charged.

Click here to see our experience representing pharmacists and pharmacies.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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.

Sources:

myfloridalegal.com. “DEA: 37 Charged in Longwood Local Impact Drug Trafficking Conspiracy.” AG. (June 20, 2012). From Press Release:

http://www.myfloridalegal.com/newsrel.nsf/newsreleases/9E8D06F29BCB233B85257A230072572A.

Justice.gov. “Law Enforcement Dethrones “Queen” of Longwood, Florida.” DEA, Domestic Field Division. (June 20, 2012). From Press Release:

http://www.justice.gov/dea/pubs/states/newsrel/2012/mia062012.html

About the Author: Dr. Thu Pham, O.D., is a law clerk 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.

“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.

The Health Law Firm2012-09-18T14:28:27-04:00June 1st, 2018|Categories: DEA, In the News, Pharmaceutical Drugs, The Health Law Firm Blog|Tags: administrative law, Attorney General (AG), Central Florida, conspiracy, controlled substances, DEA investigation, DEA raid, defense attorney, defense lawyer, drug charges, Drug Enforcement Agency (DEA), drug trafficking, felonies, investigation, pharmaceutical, pharmacist, pharmacy, prescription drug trafficking|1 Comment

New Details Released on Drug Enforcement Administration’s Investigation of Central Florida Pain Management Clinic

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

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

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

Details of the Investigation.

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

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

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

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

– Used needles were found in nearby parking lots; and

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

Pain Management Clinic Physicians Made Millions.

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

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

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

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

Be Mindful of the Prescription Drug Monitoring Database.

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

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

The raid on the Longwood clinic is just one of the many we’ve recently seen in Florida. DEA agents and local law enforcement officials are not slowing down in their fight against illegal pill mills, and illegal prescribing and dispensing practices. I have represented a number of physicians who have been accused of “overprescribing.” Some of these were criminal investigations by local law enforcement authorities, such as a county sheriff’s office. Some were investigations by the DEA. Some were investigations by the state licensing agency, such as the Florida Department of Health (DOH).

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

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

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

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

Comments?

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

Sources:

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

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

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

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

Drug Enforcement Agency (DEA) Blocks Shipping of Controlled Substances at Walgreens Distribution Center in Florida

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

On September 14, 2012, the Drug Enforcement Agency (DEA) blocked the Walgreens distribution center in Jupiter, Florida, from shipping oxycodone and other controlled drugs to its pharmacies in Florida and the East Coast with an immediate suspension order, according to the DEA. In the press release, the DEA called the Walgreens distribution facility an “imminent danger” to the public.

To see the entire press release from the DEA, click here.

Back in April 2012, the DEA served an administrative inspection warrant at the same facility, as well as its six top retail Walgreens pharmacies in Florida. To see my blog post on that story, click here.

DEA Suspension Order Only Stops the Distribution of Controlled Substances.

The DEA said the Jupiter distribution center has been “the single largest distributor of oxycodone products in Florida” since 2009. The DEA issued the suspension order because it believes Walgreens failed to maintain proper controls to ensure its retailers didn’t dispense drugs to addicts and drug dealers.

The order only applies to the Jupiter distribution center and only suspends the distribution of controlled substances.

Whether or not bath salts fall into this category is unclear. The Florida Legislature recently banned the sale of bath salts and 90 other substances to help stop the big face-eating zombie outbreak in Florida. See my blog on bath salts and the zombie outbreak in Florida.

Recently, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. The two stores are accused of dispensing an inappropriate number of prescriptions for oxycodone and had a suspicious number of sales of other controlled substances. There is a blog on this story on our website, click here to read it.

Millions of Oxycodone Pills Purchased by Walgreens Stores.

According to a USA Today article, six of Walgreens’ Florida pharmacies allegedly ordered more than a million oxycodone pills a year. One pharmacy in Oviedo, Florida, went from ordering more than 80,000 oxycodone pills in 2009, to nearly 1.7 million in 2011.

Click here to read the USA Today article.

Continued War on Prescription Drug Abuse.

According to the DEA, this is an effort to curb Florida’s prescription drug epidemic. Special Agent Mark Trouville, with the DEA’s Miami Division, said all DEA licensees “have an obligation to ensure that medications are getting into the hands of legitimate patients. When they choose to look the other way, patients suffer and drug dealers prosper.”

Neither Agent Trouville nor the DEA was, apparently, requested to comment on the bath salts ban and its effect on the zombie outbreak, however.

Oxycodone Numbers Published for Shock Value.

I really do not see why the public or our elected representatives are shocked and awed by the meaningless numbers and statistics used in connection with these matters. The fact that Walgreens, the biggest pharmacy retailer in Florida, might distribute over a million oxycodone pills in a year, is a meaningless statistic by itself. If a doctor prescribes a pain management patient a prescription for three (3) pills a day, that is approximately 90 pills per month or 1,080 pills per year. If Walgreens has only 1,000 patients with such a prescription in a year throughout the entire state of Florida, that is in excess of one million (1,000,000) pills per year. I would venture to guess that many single Walgreens retail stores have more than 1,000 customers per day, much less all Walgreens stores throughout Florida.

My point is that any such statistics are meaningless out of context and are only meant to sound huge of one doesn’t stop and think about it.

Another concern is that many, if not the vast majority of the Walgreens customers who now will not be able to get their prescriptions filled, are legitimate pain management patients with legitimate prescriptions written by legitimate physicians.

Where Do Legitimate Chronic-Pain Patients Turn?

I am constantly being contacted by patients who are in dire straits, suffering because they cannot locate a pharmacy to fill their legitimate pain medicine prescriptions. These include injured military veterans, patients who are 100% disabled and on disability or social security, patients injured in automobile accidents and job-related accidents (whose medications are paid for by insurance, if they can find a pharmacy to fill it) and others with real chronic pain issues.

If the largest legitimate chains of pharmacies in the state and nation are not allowed to fill these prescriptions, where will these suffering patients turn? Are these actions driving our citizens into the hands of shady independent pharmacies that have fewer safeguards and less accountability? Are these actions driving our citizens to seek out illegal drug dealers and turn to illegal drugs to cope with their legitimate medical problems? I hope not.

Thank you. I will get off my soapbox now.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, 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:

Leinwand, Donna. “DEA Inspects Walgreens for Oxycodone Probe.” USA Today. (September 15, 2012). From: http://www.usatoday.com/news/nation/story/2012/09/14/walgreens-and-oxycodone/57782912/1

Pavuk, Amy. “DEA Blocks Controlled-Substance Distribution at Florida Walgreens Facility.” Orlando Sentinel. (September 14, 2012). From: http://articles.orlandosentinel.com/2012-09-14/news/os-walgreens-dea-suspension-20120914_1_distribution-center-dea-miami-field-division

DEA. “DEA Serves a Suspension Order on Walgreens Distribution Center in Jupiter, Florida.” DEA.gov. (September 14, 2012). From: http://www.justice.gov/dea/divisions/mia/2012/mia091412.shtml

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620. He does not own stock in Walgreens or any other pharmacy.

“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.