Florida Compounding Pharmacy Pays $3.7 Million in Tricare False Claims Settlement

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration (FDA). This decision came after a finding of a significant increase in compound drug prescriptions reimbursed by Tricare over the last year.

In April 2015, just four months into the fiscal year, it was already determined that total costs for compound drug prescriptions filled for Tricare recipients were likely to come close to $1 billion. If the trend continues, the Defense Health Agency expects it may need to reallocate funds at the end of this year to cover the prescription drug benefit, which is currently set at $8.25 billion.

For more on this new screening process and its effect on compound medication prescriptions, click here.

With prescription drug costs at an all-time high, the government is cracking down on health care fraud. This includes the implementation of data mining for fraud detection and prevention.

It was during one of these routine mining expeditions of reimbursement data that the United States Attorney’s Office identified MediMix, a compounding pharmacy in Jacksonville, Florida, as the top-biller of compounding pain prescriptions. More importantly, upon further investigation, it was found that Ankit Desai, M.D. was the top referring physician for MediMix.

The significance in the correlation between the two is that, according to reports, Dr. Desai happens to be married to one of the top executives (Senior Vice President) of Medimix.

To read the press release on this story, click here.

Anti-Fraud Laws Prohibit Certain Physician Referrals.

Health care providers are generally prohibited from referring patients to another medical-related business in which they hold a financial interest of some kind, if there are payments made with federal funds.

The prohibition on certain physician referrals is established under Section 1395nn, 42 United States Code (otherwise known as the Stark Law). The Stark Law was specifically enacted to place limitations on physician referrals so as to avoid:

(1) conflicts of interests;

(2) self-referrals;

(3) overutilization of services;

(4) increased health care costs;

(5) a limit on competition by other medical providers;

(6) to prevent ineffective and unsafe treatment; and, ultimately-

(7) fraudulent practices.

Click here for more information on the most common Federal fraud and abuse laws in health care.

The Stakes are High for Non-Compliance.

MediMix reached a settlement agreement with the government which has avoided a determination of liability. However, the Jacksonville-based compounding pharmacy did not get off without a significant penalty. The settlement will cost MediMix an impressive $3,775,458.

Click here to read more about the government cracking down on what they determine to be “a significant threat to the [Department of Defense] DoD healthcare system.”

The FCA has been highly effective in exposing fraudulent practices of pharmaceutical companies. Whistleblower cases brought under the FCA have assisted the government in recovering more than $19 billion in stolen funds due to varying pricing, billing and marketing schemes.

To read more about the importance of complying with Stark and other anti-fraud laws, read one of our previous blogs here.

Avoiding False Claims Violations.

Here are the most common pharmaceutical practices that can result in allegations of FCA violations:

(1) Off-label marketing of drugs;

(2) Illegal kickbacks;

(3) Inflating the price of pharmaceuticals;

(4) Best price fraud; and

(5) Pharmaceutical benefits manager fraud.

If you find yourself in a tricky situation with possible allegations of a FCA violation, it’s best to contact an experienced health attorney immediately to properly evaluate your case and inform you of your rights.

For more about your right to consult with a lawyer prior to speaking with an investigator, please read one of our previous blogs here.

Comments?
Are you currently engaged in a questionable financial relationship? Do you agree with the law on prohibiting certain referrals in which there is a financial interest? Why or why not? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, 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:

Department of Justice, The United States Attorney’s Office, Middle District of Florida. Press release. “United States Settles False Claims Act Allegations Against Jacksonville-Based Compounding Pharmacy.” 1 June 2015. Web. 11 Sept. 2015.

Kime, Patricia. “Tricare to Start Screening Compound Medications Friday.” Military Times. A TEGNA Co., 1 May 2015. Web. 10 Sept. 2015.

“Pharmaceutical Fraud” Web blog post. False Claims Act Resource Center. Pietragallo Gordon Alfano Bosick & Raspanti, LLP, 2015. Web. 11 Sept. 2015.

Rumph, Alan, and Donna Lee Yesner. “When Referrals And Marriage Don’T Mix: MD, Pharmacy Settle Case.” Report on Medicare Compliance. Washington: Atlantic Information Services, Inc., 8 June 2015. Web. 11 Sept. 2015.

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

Keywords: False Claims Act defense attorney, FCA, pharmaceutical fraud, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, whistleblowers lawyer, FCA violations, fraud detection, data mining, financial interest in physician referrals, Stark Law, Department of Defense, DoD, Tricare fraud attorney, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, conflict of interest in physician referrals, compound medication prescriptions, compounding pharmacy lawyer, prescription reimbursement, qui tam attorney, financial relationship with physician

“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 © 1996-2015 The Health Law Firm. All rights reserved.

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Pharmacies May be Liable for Filling Valid Prescriptions

Lance Leider headshotBy Lance O. Leider, J.D.

Florida pharmacies have had their potential liability significantly expanded by the Fifth District Court of Appeal. In its recent decision, Oleckna v. Daytona Discount Pharmacy, the appellate court held that a pharmacy owes a duty to its patients that go beyond following the prescribing physician’s directions and properly dispensing the medication.

The court defined the pharmacy’s duty to use due care in filling a prescription to mean more than what it called “robotic compliance” with the instructions of the prescribing physician.

From the court’s decision and some others from around the state it would seem that Florida pharmacists are now under an obligation to question the quantity, frequency, dosage, combination, and possibly even the purpose of a valid prescription. Florida pharmacies are no longer simply a conduit for validly prescribed prescription medications. They are now an integral part of the health care system where trained professionals are expected to act as a check and balance on physicians and other prescribers.

This decision is in keeping with recent Florida Board of Pharmacy cases dealing with narcotic pain medications. The Board has interpreted Section 465.003(6), Florida Statutes, and Rule 64B16-27.820, Florida Administrative Code, to place a duty on a pharmacist to use his or her skill and experience to evaluate the propriety of every prescription presented on a global level.

While courts and the Board are more than willing to expand the scope of a pharmacist’s duty to his or her patients, unfortunately, neither have provided any prospective guidance on how to fulfill the duty.

Suggestions for Compliance.

Below are some suggestions for ensuring your pharmacy is fulfilling its obligation to its patients. This list is by no means exhaustive and is only intended to offer some basic guidance.

1. Know the physician and verify the credentials of an unfamiliar one;
2. Check the Prescription Drug Monitoring Program (PDMP);
3. Do not fill prescriptions that are more than 30 days old without verifying them with the prescribing physician;
4. Question higher than normal dosages and more frequent administration instructions;
5. Do not provide early refills without verifiable documentation and contact the physician when the patient is seeking an early refill on a medication with a high potential for abuse (the physician is usually in the best position to recognize drug seeking behaviors);
6. Flag concerning prescriptions for mandatory counseling prior to dispensing to give you an opportunity to discuss the risks with the patient;
7. Check the patient’s profile for interactions and discuss them with the patient and, if necessary, the prescribing physician;
8. Periodically check with the prescribing physician on long term medications;
9. Document everything done to verify the propriety of a prescription in the patient’s record; and
10. Most importantly, don’t be afraid to refuse a fill.

In addition to these steps, you should also be conducting regular staff meetings and routine reviews of your processes to ensure that they remain functional and able to be followed.

Comments?

Do you think a pharmacy or pharmacist should be held liable for filling valid prescriptions? How do you verify you or your employees are in compliance? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA 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 and visit our website at www.TheHealthLawFirm.com.

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 Ave., 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 © 1996-2015 The Health Law Firm. All rights reserved.

Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

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

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at a hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either gets legal representation on little or no advance notice, or has to suffer the consequences of having no legal representation.

Be Aware that Administrative Proceedings Can be Complex.

In some cases individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases it may even be possible to obtain a change in forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

Comments?

Have you ever had an informal or formal hearing before the Board of Pharmacy? What was the experience like? Please leave any thoughtful comments below.

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.

 

 

 

Jury Awards Walgreens Customer $1.44 Million Over HIPAA Violation

LOL Blog Label 2By Lance O. Leider, J.D., The Health Law Firm and  George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

An Indiana jury awarded a Walgreens customer $1.44 million on July 26, 2013, over a Health Insurance Portability and Accountability Act (HIPAA) violation, according to the Indianapolis Star. The Walgreens pharmacist was found to have violated the customer’s privacy by looking up and sharing the customer’s prescription history with others. The lawsuit alleged that there was a relationship between the pharmacist, her husband and the husband’s ex-girlfriend (who was the customer). The customer/ex-girlfriend was the plaintiff in the lawsuit.

Click here to read the entire article from the Indianapolis Star.

Details of the Lawsuit.

According to the American Bar Association, the lawsuit alleged the pharmacist was married to the customer’s ex-boyfriend at the time the pharmacist viewed her prescription records. The pharmacist admitted to showing the confidential information to her husband, who shares a child with the customer/plaintiff. In doing this, the pharmacist breeched her statutory and common law duties of confidentiality and privacy.

Click here to read the entire article from the American Bar Association.

Walgreens Found Negligent.

The jury found Walgreens negligent in training and supervising the pharmacist. The pharmacist admitted she was aware of the pharmacy’s privacy policy and knew she was violating it. Walgreens claims the pharmacist has been appropriately disciplined.

Deadline to Comply with Omnibus Rule Close-Are You Ready?

The Department of Health and Humans Services (HHS) released stronger rules and protections governing patient privacy on January 17, 2013. This omnibus rule strengthens the privacy and security protection established under HIPAA. Physicians, hospitals, clinics, health care providers and their business associates need to take into account the corrections as they work to update business associate agreements, policies, practices and training to comply with the rule changes by the September 23, 2013, deadline. To learn more on the omnibus rule changes, click here to read a previous blog.

Be Proactive-Get a HIPAA Risk Assessment.

A HIPAA risk assessment can significantly reduce, if not entirely eliminate, your exposure to regulatory and litigation sanctions.  It will identify areas for improvement and allow them to be corrected before an auditor finds the issue and causes unwanted problems for you and your practice.

HIPAA laws have most likely changed since you last edited your privacy forms and procedures. Many health providers simply don’t have the time to re-review their policies and revise documents. In a perfect practice, this would be done every six months.

To learn more on HIPAA risk assessments, click here.

Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

The attorneys of The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in investigating and defending alleged HIPAA complaints and violations and in preparing Corrective Action Plans (CAPs).

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Comments?

What are your thoughts on this HIPAA violation? Do you think Walgreens failed to train and supervise the pharmacist? Please leave any thoughtful comments below.

Sources:

Neil, Martha. “Walgreens Must Pay Customer $1.44M After Pharmacy Shared Her Prescription Records.” American Bar Association. (July 29, 2013). From: http://www.abajournal.com/news/article/jury_says_walgreens_must_pay_1.44m_because_pharmacist_gave_her_husband/

Evans, Tim. “Walgreens Must Pay Woman $1.44 Million Over HIPAA Violation.” Indianapolis Star. (July 26, 2013). From: http://www.indystar.com/article/20130726/NEWS/307260079/

About the Authors: 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.

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.

The Government’s Use of Civil Forfeiture to Combat Health Care Fraud and Pill Mills in Florida

CEB Blog Label2By Christopher E. Brown, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Recently we have seen government prosecutors and agencies, including the Medicaid Fraud Control Unit (MFCU), the U.S. Attorney General’s (AG) Office, and local sheriff and police departments use the Florida Contraband Forfeiture Act against health professionals and health facilities in health-related cases.

A prompt, aggressive defense to these actions may recover the property or funds seized and, more importantly, a good defense can be used to help resolve any pending criminal charges.

Civil Forfeiture of Property is Used to Fight Alleged Criminal Activity.

The civil forfeiture of property has become a popular tool for state and federal agencies to combat alleged criminal activity.  In Florida, the Florida Contraband Forfeiture Act, Sections 932.701 through 932.706, Florida Statues permits the government to seize personal property if there is probable cause to believe that property is either an instrumentality or the proceeds of criminal activity. In federal cases, such as Medicare fraud cases, the Federal Forfeiture Act can be found at 18 U.S.C. §983.Typically, a forfeiture action begins when personal property is seized as a result of a violation or arrest.  The owner of the personal property is then entitled to a notice within five (5) days of the seizure.

Remember If You Are The Subject of a Seizure, Ask For:

1.  An inventory of the seized items.

2.  A Receipt.

3.  The business cards or names, addresses, titles and phone numbers of each official or agent involved.

What is The Adversarial Preliminary Hearing?

Your most important right after a seizure is the right to an adversarial preliminary hearing.  This request must be made in writing within fifteen (15) calendar days of receipt of the notice. Sometimes the notice is given at the time the property is seized; it is important not to lose or misplace it.

When an adversarial preliminary hearing is held, the Court will review the verified affidavit and any other supporting documents and take testimony to determine whether there is probable cause to believe that the seized property was used, is being used, was attempted to be used, or was intended to be used in violation of the Florida Contraband Forfeiture Act.

While the burden of proof at this initial stage favors the government, the adversarial preliminary hearing is one of the fastest and most effective ways to fight for the return of the property and assert any defenses that exist in the case.  Even if unsuccessful at this hearing, the property owner is still entitled to a later civil forfeiture trial in which the government must prove by a preponderance of the evidence that the property was used in the commission of or obtained through the proceeds of criminal activity. Often it is unable to do this and far more defenses are available for use at the trial.

The key to success in civil forfeiture actions is to immediately consult with an experienced attorney after the property has been seized. Your best defense is to act as quickly as possible.

Use of Adversarial Preliminary Hearing to Obtain Information for Defense.

The Adversarial Preliminary Hearing is also a tool by which a defendant can obtain early, detailed discovery on his or her case. During the hearing the law enforcement authorities will be required to testify under oath and produce any documentary evidence. This can prove invaluable to the criminal defense attorney in later criminal proceedings.

Did the Government Exceed the Bounds of Propriety?

Although the government would contend otherwise, we believe the main purpose in the government’s use of civil forfeitures is to shut down the alleged criminal and make it so he or she cannot hire an attorney to defend the person(s) accused. This does, unfortunately, often work.

However, there are defenses and often the government exceeds the bounds of propriety in its overzealousness. We have successfully defended, for example, cases in which:

–  A sheriff’s office seized a spouse’s personal car for which she had traded in her old car.

–  A teenage daughter’s college account that had in it only money she had earned from her part-time job.

–  Money from a business owner’s purse which had been given to her by her mother to pay for her hospital labor and delivery charges.

–  Money from a roll-over IRA account which had been invested long before any criminal activity was alleged to have occurred.

–  Money from a family member’s account which had come from social security payments made for that person.

Every Person Should File a Claim.

If a spouse or other family member has an interest in the property, especially if that person is named on the account or title, that person should file a separate claim for return of the property and demand a Preliminary Adversarial Hearing. Even if the initial hearing is not successful in achieving an early return of the property, such defenses should prevail at the trial of the case.

Contact Health Law Attorneys Experienced in Civil Forfeiture Cases.

The Health Law Firm routinely represents physicians, nurses, pharmacists, dentists, mental health counselors and other health providers in investigations, regulatory matters, licensing issues, litigation, civil forfeitures, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), 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.

What Do You Think?

What do you think of the Civil Forfeiture Act being used against health care professionals and health facilities? Please leave any thoughtful comments below.
About the Authors: Christopher E. Brown, J.D., is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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


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

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

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

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

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

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

Steroid Injections Recalled.

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

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

Patients in North Carolina and Illinois Allegedly Reacted to Injections.

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

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

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

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

Previous Florida Case of Contaminated Medication.

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

Congress Debating on Giving Authority Over Compounding Pharmacies to FDA.

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

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

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

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

Sound Off.

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

Sources:

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

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

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

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999. 

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

Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council for Pharmacists

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

Often we learn after the fact that a health professional such as a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) insurance, has had a legal problem, and has not been able to locate an attorney or law firm that accepts this type of insurance. We have offices in Florida and Colorado, but we have attorneys licensed in Florida, Colorado, Louisiana, the District of Columbia, Virginia and other states.

Additionally, we can provide legal advice and representation in license investigations and administrative proceedings in many other states.

If you have HPSO Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it. Contact us, and we will help you.

We Will Work with Your Insurance Company.

Call us first. We can assist you in determining if your legal problem is covered by your insurance, and we can help you file a claim to have your legal defense expenses and costs covered. In most cases, we will accept the assignment of your insurance so that you do not have to worry about legal bills while your case is going on.

Contact Experienced Health Law Attorneys That Will Work with Insurance Companies.

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.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. We will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company, if your insurance company will allow this. Many of these insurers will pay our firm to represent you in the legal defense of an investigation or complaint against your professional (nursing, medical, dental, psychology, mental health counselor) license or for an administrative hearing involving professional discipline.

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

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.
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