Colorado Surgeon Accused of Botching Multiple Robotic Arm Surgeries

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

A Colorado surgeon allegedly faces 14 counts of unprofessional conduct associated with the use a robotic arm used during surgeries, according to the formal administrative complaint. The Colorado Medical Board filed the complaint on April 2, 2013, alleging that from 2008 until 2010, the surgeon cut and tore blood vessels, left sponges and other instruments inside of patients, injured patients through padding and positioning, subjected some patients to overly long surgeries and had to abort kidney donation procedures because of mistakes. The surgeon is also accused of not documenting the mistakes in patient charts.

According to the Colorado Board of Medicine’s administrative complaint, the surgeon was using the da Vinci robot, manufactured by Intuitive Surgical, Inc., for surgeries.

Click here to read the formal complaint from the Colorado Medical Board.

This complaint was filed around the same time as the U.S. Food and Drug Administration (FDA) launched a review of the robotic procedures.

A Number of Patients Speak Out On Surgeries.

The complaint lists 11 patient cases allegedly mishandled by the surgeon.

In one case, a 22-year-old woman wanted to donate a kidney to her brother. She was informed by the surgeon that the robot was the “gold standard” for kidney removals and transplants. During the surgery, the surgeon allegedly injured the patient’s aorta. To stop the bleeding, the surgeon allegedly converted to an open surgery, then aborted the kidney removal. After the attempted surgery, the patient allegedly went into post-operative distress and an X-ray showed a sponge that had been left inside the patient. The patient also alleges she was left with nerve damage after being improperly padded.

In another case, the surgeon allegedly used the robot on an 86-year-old man with metastatic cancer. The surgeon allegedly injured the patient’s aorta, and the robot arm moved when it should not have, causing another tear. The patient suffered kidney failure after the operation, and the family withdrew the patient’s life support.

Surgeon Suspended for Performing Robotic Surgeries.

In the complaint, the Colorado Medical Board is asking an administrative law judge to discipline the surgeon’s license to practice medicine. An article in The Denver Post states that the surgeon had his robotic-surgery privileges suspended for three months in 2010. The hospital would not say whether or not the surgeon received new training before allowing him to use the robotic arm after his suspension.

To read the entire article from The Denver Post, click here.

FDA and Other Medical Societies Leery of Robotic Procedures.

In March 2013, the FDA began interviewing surgeons about issues with the robotic surgery units, according to Fierce Health IT. The agency is allegedly trying to figure out why there has been an uptick in adverse event reports, including damaged organs and device failures, and whether these are a result of error or design problems.

For a list of other sources discussing possible adverse outcomes from robotic surgery, please see “references” below.

The American Congress of Obstetricians and Gynecologists and the Massachusetts Quality and Patient Safety Division are also warning health care professionals about the risks associated with robotic surgeries, according to Fierce Health IT. The American Congress of Obstetricians and Gynecologists said that these types of surgeries should not be the first or second choice for women undergoing routine hysterectomies. The Massachusetts Quality and Patient Safety Division sent a letter advising doctors of the safety concerns regarding robotic surgery.

Click here to read the entire article from Fierce Health IT.

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?

As a health care professional, does your facility use robotic arm surgeries? Do you believe they are the safer option? Do you think the FDA should take a closer look at these machines? Please leave any thoughtful comments below.

Sources:

Booth, Michael. “Colorado Charges Doctor in Problem-Plagued Robo-Surgeries at Porter.” The Denver Post. (April 10, 2013). From: http://www.denverpost.com/breakingnews/ci_22998041/colorado-charges-doctor-botched-robo-surgeries-at-porter

Hall, Susan. “Robo-Surgery Mistakes Land Physician in Hot Water.” Fierce Health IT. (April 15, 2013). From: http://www.fiercehealthit.com/story/robo-surgery-mistakes-land-physician-hot-water/2013-04-15

Colorado Medical Board v. Warren J. Kortz, M.D. Case Number ME 2013. Formal Complaint (April 2, 2013). From:http://www.thehealthlawfirm.com/uploads/Colo%20v.%20Warren%20Kortz%20MD.pdf

Gold, Ashley. “Health Officials Warn Complications Robotic Surgeries.” Fierce Health IT. (March 26, 2013). From: http://www.fiercehealthit.com/story/health-officials-warn-complications-robotic-surgeries/2013-03-26

Hall, Susan. “OBGYN Group: Robotic Surgeries Not Best Choice for Routine Hysterectomies.” (March 15, 2013). From: http://www.fiercehealthit.com/story/obgyn-group-robotic-surgery-not-best-choice-routine-hysterectomies/2013-03-15

Garde, Damian. “FDA Echoes Questions Over Intuitives’s Surgical Robot.” Fierce Medical Devices. (March 1, 2013). From: http://www.fiercemedicaldevices.com/story/fda-echoes-questions-over-intuitives-surgical-robot/2013-03-01

Bird, Julie. Much of Robo-Surgery Marketing ‘Unsubstantiated.’” Fierce Health IT. (July, 24, 2012). From”
http://www.fiercehealthit.com/story/much-robotic-surgery-marketing-unsubstantiated/2012-07-24

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

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

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

Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council in Florida

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.

Don’t Worry About Legal Bills While Your Case is Going On.

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

The Doctors Company (TDC) Attorneys, Lawyers and Defense Council in Florida

Indest

By 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 physicians, dentist and other health professionals has received The Doctors Company (TDC) 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 TDC Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it.
The Health Law Firm Will Work with You and 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.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses, dentists 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.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Medical Students and Residents Must Fight Allegations of “Irregular Behavior” on the USMLE Step Exams

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

I am constantly taking calls from medical students and residents (or future residents) relating to allegations brought against them of “irregular behavior” in connection with the United States Medical Licensing Examination (USMLE) exams. Although the term “irregular behavior” is equated by many with the word “cheating,” it is actually defined by the USMLE to mean:

Irregular behavior includes any action by applicants, examinees, potential applicants, or others when solicited by an applicant and/or examinee that subverts or attempts to subvert the examination process.

The notice that a person has been accused of irregular behavior may come in a letter from the USMLE, National Board of Medical Examiners (NBME), or Examination Committee for Foreign Medical Graduates (ECFMG). In serious cases, one might be approached by a private investigator or law enforcement authority, for example in the case of an alleged theft of an examination or illegal use of examination questions.

Regardless, any notice that you are suspected or accused of irregular behavior should be treated as an extremely serious matter that can suspend your medical education or residency and place your medical career on hold. You should immediately contact an attorney familiar with health and medical law and, especially, one familiar with USMLE, NBME and ECFMG proceedings.

Examples of What Not To Do.

A few examples of irregular behavior we have consulted on include:

1.  A student soliciting information about the contents of a USMLE step examination in an online blog.

2.  Individuals blogging online regarding a certain step exam preparation course they took when the course instructor allegedly used actual examination questions to teach it.

3.  An individual allegedly using an iPhone during a step examination.

4.  Someone setting a fire in a bathroom in the testing center where the examination was given.

5.  An individual who allegedly had written notes on his arm to use during the exam.

6.  Someone who wrote down notes about the exam on a piece of tissue paper after the exam was over.

No matter how trivial the matter may initially seem, it can have devastating effects. The reporting of your test results will be held up until the matter is completely resolved, thereby delaying entry into or continuation of a residency program or, in some cases, medical school graduation. Choice residencies can be lost and a promising medical career can be placed on hold.

If irregular behavior is confirmed, test scores will be voided, your transcript of USMLE tests will be annotated with the fact that you were found to have committed irregular behavior and you may not be allowed to retake the exams for a period of time. This can really screw up your life.

Ask for a Hearing and Be Prepared.

If you are accused of irregular behavior, you will be given the right to have a hearing before a committee of the USMLE which will hear evidence on the matter. Ask for the hearing! Do not waive it.

You will have the right to submit documents on your own behalf. Do this. Use any favorable document that supports your side of the story, shows your good character, shows your academic and clinical performance and mitigates from the seriousness of the alleged conduct.

Attend the hearing in person and with your attorney. You have this right. Do not expect to win a hearing if you do not attend it yourself to answer any questions the committee may have. These committee hearings are all held at MBE headquarters in Philadelphia, Pennsylvania, so it may be a challenge to attend. But you must do so; this may be the most important hearing of your life.

Retain expert witnesses to support you if appropriate. In matters where a statistical extrapolation is used against you, a statistics expert can be a valuable asset.

Many times the facts of the situation turn out to be far different from what the USMLE secretarial has initially reported. But you must avail yourself to the procedures and opportunity to prove this.

Don’t delay. At your first notice, contact an experienced attorney to represent you. The stakes are too high to gamble on handling it yourself.

Contact Experienced Health Law Attorneys Today.

The attorneys of The Health Law Firm provide legal representation to medical students, residents, interns and fellows in academic disputes, graduate medical education (GME) hearings, contract negotiations, license applications, board certification applications and hearings, credential hearings, and civil and administrative litigations.

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

Comments?

Have you faced the Committee? What was the experience like? Did you retain experienced legal counsel? 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.

Terrible Things That Can Happen after Discipline on Your Professional License or Resignation of a License after Notice of Investigation

Patricia's Photos 013By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Do you have a medical, pharmacy or nursing license in several different states?  Do you have a license in more than one health profession?  Have you been notified that an investigation has been opened against you?  Are you thinking about resigning your professional license or voluntarily relinquishing such a license?  Then you must be aware of the following.

First, you should never voluntarily relinquish or resign your license after you know that an investigation has been opened or that disciplinary action has been taken against you.  Such a resignation is considered to be a “disciplinary relinquishment” and is treated the same as if your license had been revoked on disciplinary grounds.

Second, this will be reported out to other states, agencies, to the National Practitioner Data Bank (NPDB), to any certifying bodies for certifications you have and to other reporting agencies (such as the National Council of State Board of Nursing, the National Association of Boards of Pharmacy or the American Board of Internal Medicine).  Other states and other professional boards will most likely initiate disciplinary action based upon the first one.

Protect Your License from These Adverse Actions.

The following is a list of some of the adverse actions that you can expect to be taken against you after discipline on your license or after you resign your professional license after receiving notice of investigation:

1.  A mandatory report to the National Practitioner Data Base (NPDB) which remains there for 50 years. Note: The Healthcare Integrity and Protection Data Bank or HIPDB recently merged into the NPDB.

2.  Must be reported to and included in the Department of Health (DOH) profile that is available to the public online (for those having one), and remains for at least ten years.

3.  Any other states or jurisdictions in which the nurse has a license will also initiate an investigation and possible disciplinary action against him or her in that jurisdiction.  (Note:  I have had two clients who had licenses in seven other states and all, even ones that were inactive or not renewed years ago, initiated action).

4.  The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) will take action to exclude the provider from the Medicare Program.  If this occurs (and most of these offenses require mandatory exclusion) the provider will be placed on the List of Excluded Individuals and Entities (LEIE) maintained by the HHS OIG.

a.  If this happens, you are prohibited by law from working in any position in any capacity for any individual or business, including hospitals, nursing homes, home health agencies, physicians, medical groups, insurance companies, etc., that contract with or bill Medicare or Medicaid.  This means, for example, you are prohibited from working as a janitor in a nursing home that accepts Medicare or Medicaid, even as an independent contractor.

b.  If this happens, you are also automatically “debarred” or prohibited from participating in any capacity in any federal contracting, and you are placed on the U.S. General Services Administration’s (GSA) debarment list.  This means you are prohibited by law from working in any capacity for any government contractor or anyone who takes government funding.  This applies, for example, to prevent you from being a real estate agent involved in selling property financed by a government backed loan, prohibited from working for an electrical company that bids on contracts for government housing projects, working as a school teacher in a public school, etc.

c.  If this happens, your state Medicaid Program is required to terminate you “for cause” from the state Medicaid Program.  In many states, this is also grounds for revocation of your license.

5.  Any profile or reporting system maintained by a national organization or federation (e.g., NURSYS profile maintained by the National Council of State Boards of Nursing, American Medical Association physician profile, or the Federation of State Board of Physical Therapy profile) will include the adverse action in it, generally available to the public.

6.  If you are a nurse practitioner or other professional with clinical privileges at a hospital, nursing home, HMO or clinic, action will be taken to revoke or suspend the clinical privileges and staff membership if you have such. This may be in a hospital, ambulatory surgical center, skilled nursing facility, staff model HMO or clinic.  This will usually be for physicians, physician assistants (PAs), advance registered nurse practitioners (ARNPs), certified registered nurse anesthetists (CRNAs), nurse midwives or certified nurse anesthetists (CNAs), podiatrists, clinical psychologist or clinical pharmacists.

7.  Third party payors (health insurance companies, HMOs, etc.) will terminate the professional’s contract or panel membership with that organization.

8.  The U.S. Drug Enforcement Administration (DEA) will act to revoke the  professional’s DEA registration if he or she has one.

9.  Many employers will not hire you or will terminate your employment if they discover your license has been disciplined in another state.

What Should You Do?

–  Don’t take the easy way out by immediately relinquishing your license if you are notified you are under investigation.

–  Don’t hide your head in the sand by thinking the case will just go away on its own.

–  Don’t take the easy way out.  If you are innocent of the charges, request a formal hearing and contest the charges; defend yourself.

–  Do not request an informal hearing or a settlement agreement in which you admit the facts alleged against you are all true.  If you do this, you are “pleading guilty.”

–  Do immediately seek the advice of an attorney who has experience in such professional licensing matters and administrative hearings.  They are out there, but you may have to search for one.  Do this as soon as you get notice of any investigation and especially before you have talked to or made any statement (including a written one) to any investigator.

–  Do purchase professional liability insurance that includes legal defense coverage for any professional license investigation against you, whether it is related to a malpractice claim or not.  This insurance is cheap and will provide needed legal assistance at the time when you may be out of a job and not have money to hire an attorney.  Beware of the insurance policy that only covers professional license defense if it is related to a malpractice claim.

Professional Liability Insurance.

We strongly encourage all licensed health professionals and facilities to purchase their own, independent insurance coverage.  Make sure it covers professional license defense under all circumstances.  Make sure you have enough coverage to actually get you through a hearing. $25,000 coverage for just professional licensure defense is the absolute minimum you should purchase;  $50,000 may be adequate but $75,000 or $100,000 may be what you really need in such a situation.  For a few dollars more (and I do mean only a few) you can usually purchase the higher limits.

Also, I will repeat, make sure it covers your legal defense in an administrative disciplinary proceeding against your license, even if there is no malpractice claim filed against you or likely to be filed against you.

We also recommend that you purchase coverage through an insurance company that allows you to select your own attorney and does not make you use one that the insurance company picks for you.

Companies we have encountered in the past who provide an inexpensive top quality insurance product for professional license defense costs include:  CPH & Associates Insurance, Nurses Service Organization (NSO) Insurance, Healthcare Providers Organization (HPSO) Insurance and Lloyd’s of London Insurance.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians, nurses, pharmacists, pharmacies, dentists, mental health counselors, massage therapists and other health providers in investigations, regulatory matters, licensing issues, litigation, 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.

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 Requirements Released for Physician Medical Records Related to Compounded Medications

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

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

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

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

New Medical Records Standards.

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

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

New Standards Most Likely Triggered by Tainted Compounded Medications.

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

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

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

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

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

Comments?

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

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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

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

Florida Doctor Faces Administrative Hearing Over Allegations of Torturing Patient

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

A Lake Worth, Florida, doctor accused of “punishment therapy” that included the use of whips, blindfolds, handcuffs and other instruments of torture could have his license revoked by the Florida Board of Osteopathic Medicine. At the meeting on November 15, 2013, the Board rejected a settlement that the Florida Department of Health (DOH) had negotiated with the doctor’s attorney. The settlement option included a $10,000 fine and two (2) years of probation. The doctor was not arrested or charged with a crime, but admitted to having an unusual and sexual relationship with his patient.

By rejecting the proposed settlement, the Board indicated that it was not satisfied with the agreed upon discipline. Instead , the Board stated that it wanted a revocation of the physician’s license.

The Florida DOH filed an administrative complaint against the doctor in July 2013, alleging inappropriate sexual conduct with a patient.

Click here to read the complete administrative complaint made against the physician.

According to the doctor’s attorney, it appears the case will head to an administrative hearing.

Punishment Therapy Allegedly Used to Help Patient’s Depression.

According to the Sun Sentinel, the doctor’s relationship with his patient was first reported in 2011. The patient told investigators that the doctor allegedly used “punishment therapy” on her to help her remedy depression. She reportedly told detectives she did not like the “therapy” which would usually take place in the doctor’s office after normal business hours. The patient claims she was repeatedly choked, whipped and tied up in a closet, according to the Sun Sentinel. The patient also alleges she never paid money for these sessions, but the doctor would give her free samples of medication.

The doctor alleges that he and his patient had a consensual sexual relationship that began after she was no longer a patient. However, according to the Sun Sentinel, investigators found evidence that the doctor prescribed medicine to the patient while they were in engaging in the “torture therapy” sessions.

Click here to read the Sun Sentinel article.

What Florida Law Says About Sexual Relationships Between Health Care Providers and Patients.

Sexual misconduct in the practice of health care is considered to be a violation of the doctor-patient relationship. This violation is grounds for discipline. The Board takes it seriously and can impose discipline up to and including revocation.

Florida law bans doctors and other health care providers from turning their patients into sexual partners because it is considered an abuse of power. Also, patients are presumed to be incapable of giving consent to a relationship with a health care provider.

To watch a short video on why a patient cannot consent to a sexual relationship with a health care provider, click here.

Don’t Wait Too Late; Consult with an Experienced Health Law Attorney.

Do not wait until action has been taken against you to consult with an experienced attorney in these matters. Few cases are won on appeal. It is much easier to win your case when there is proper time to prepare and you have requested a formal hearing so that you may actually dispute the facts being alleged against you.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians in investigations and at Board of Medicine and Board of Osteopathic Medicine hearings. We represent physicians accused of wrongdoing, in patient complaints and in Department of Health investigations. Call now or visit our website www.TheHealthLawFirm.com.

Comments?

Do you think this physician should have his license revoked? Do you think the settlement agreement would have been a sufficient punishment? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “Doctor Accused of Torturing Patient.” Health News Florida. (November 15, 2013). From: http://health.wusf.usf.edu/post/doctor-accused-torturing-patient

Department of Health v. David Simon, D.O. Case Number 2012-00680. Administrative Complaint. July 11, 2013. From: http://ww2.doh.state.fl.us/DocServiceMngr/displayDocument.aspx

Clarkson, Brett. “Doctor Used Whips, Choked Female Patient in ‘Punishment Therapy,’ Deputies Say.” Sun Sentinel. (November 20, 2013). From: http://www.sun-sentinel.com/news/palm-beach/fl-lake-worth-kinky-doctor-20131120,0,3297599.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.

Agency Attorney Prosecuting Case Should Not Also Be in Position of Advising The Agency; Possible Bias Denies Due Process

McAlpin appealed an order of the Criminal Justice Standards and Training Commission (“Commission”) suspending his law enforcement certification for eighteen months. The Commission filed an administrative complaint alleging misconduct during the course of a criminal investigation. A formal administrative hearing was held and a recommended order was issued.

At the Commission hearing to consider the recommended order, the attorney who prosecuted the case against McAlpin was present and offered advice to the Commission. The Commission’s staff had prepared a memorandum to the Commission recommending an increase in the recommended penalty to revocation of McAlpin’s license. It was not clear who prepared the staff memorandum. However, it was clear the prosecuting attorney had prepared exceptions to the recommended order for the agency.

On appeal, the court reversed and remanded for a new Commission hearing. While the Commission did not ultimately adopt the agency’s recommendation of an increased penalty, the court held that the staff attorney’s enhanced access to the Commission undermined the Commission’s function as an unbiased reviewer of the recommended order.

The court did note that it was not inherently inappropriate to consolidate investigative, prosecutorial and adjudicatory authority in a single agency. Each case must be considered on its unique factual background.

Source:

McAlpin v. Criminal Justice Standards and Training Comm’n, 120 So. 3d 1260 (Fla. 1st DCA 2013)(Opinion filed September 13, 2013).

About the Author: The forgoing case summary was prepared by Mary F. Smallwood, Esquire, of the Administrative Law Section of The Florida Bar. It originally appeared in the Administrative Law Section newsletter, Vol. 35, No. 2 (Dec. 2013).

 

After Investigation Has Ended, Even Investigator’s “Mental Impressions” Are Subject to Release Under Public Records Act

The foregoing case summary was prepared by Mary F. Smallwood, Esquire, of The Administrative Law Section of The Florida Bar.

The City of Avon Park (“City”) terminated Michael Rowan’s employment as Chief of Police. In the subsequent administrative hearing, at issue was Rowan’s investigation of certain city council members and alleged deletion of certain information from his work computer.

An investigator with the State Attorney’s Office was called in to investigate those issues; he prepared a report of his findings. The City subpoenaed the investigator to appear as a witness at the administrative hearing on Rowan’s termination, and to bring his report, which the City wanted to rely on. The State sought a circuit court order quashing the subpoena issued to the investigator. It also sought to prevent disclosure of portions of the report which constituted mental impressions of the investigator. The circuit court granted in part and denied in part the State’s petition. It concluded the investigator’s mental impressions were exempt from the Public Records Act and entered a protective order limiting the investigator’s testimony and protecting the mental-impression portions of the report.

The City appealed, arguing the report should be admissible in full and Rowan’s testimony should not be limited; Rowan cross-appealed, arguing that he should not be required to testify at all. The Second District Court of Appeal reversed the trial court’s decision excluding from evidence the portion of the report containing the investigator’s mental impressions. The court pointed to section 119.071(1)(d)1., Florida Statutes, which protects mental impressions from disclosure only until the conclusion of the litigation or adversarial administrative proceedings. In this case, the court concluded that the investigation had ended and no charges had been filed. Therefore, the investigator’s mental impressions were no longer protected.

Source:

City of Avon Park v. State of Florida, 117 So. 3d 470 (Fla. 2d DCA 2013) (Opinion filed July 17, 2013).

About the Author: The foregoing case summary was prepared by Mary F. Smallwood, Esquire, of The Administrative Law Section of The Florida Bar. It originally appeared in the Administrative Law Section Newsletter, Col. 36, No. 2 (Dec. 2013).

Burden of Proof in Administrative Cases Involving Discipline of a Health Professional’s License – Part 1

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

I am often asked about the burden of proof that must be met by the state Department of Health (DOH) in professional licensing disciplinary cases.  This could be a complaint against a physician, dentists, mental health counselor, nurse, psychologist, pharmacist or anyone else.  It also includes, for example, engineers, general contractors, school teachers, architects, cosmetologists, or any other professional holding a professional license in Florida.  However, since we routinely represent health professionals, I will concentrate on those licenses by the state DOH in this blog.

Overview.

What few people (even attorneys) know is that cases which involve discipline against a professional’s license are treated as “punitive” or “penal” cases.  This means the standards applied to them, at least in Florida, are the same that are applied to criminal cases.

Therefore, if the statute that is being charged is unclear or ambiguous, the courts apply a “strict scrutiny” standard.  If the language of the statute does not clearly prohibit the acts being charged or is unclear about being covered by the statute, then there should be a ruling in favor of the one charged.

Additionally, rights that apply in criminal cases, such as the right to have an attorney and the right to not be compelled to be a witness against oneself found in the Fifth Amendment of the U.S. Constitution, also apply to administrative cases involving discipline against a license holder.

The state has a higher burden of proof in an administrative licensure case, as well.  The burden of proof that applies in a civil case, “preponderance of the evidence” (also described as the greater weight of the evidence, the preponderance of the evidence or more than fifty percent), does not apply in administrative discipline cases.  Instead a higher burden, “clear and convincing evidence” applies.  Therefore, if the evidence supports the license holder’s position, just as much as it supports the state’s case, the state loses.

How Constitutional Rights Are Involved.

The Fifth Amendment of the United States Constitution provides individuals protection against self-incrimination, stating:

No person . . . shall be compelled in any criminal case to be a witness against himself, nor be deprived of life, liberty, or property, without due process of law. . . .

Note that in Florida, as in most states, a professional license is considered to be a property right which cannot be taken by the state without due process of law.

Article I, Section 9 of the Constitution of Florida also provides similar protections stating:

No person shall be deprived of life, liberty or property without due process of law . . . or be compelled in any criminal matter to be a witness against oneself.

In addition, case law in Florida has upheld as a protected right the individual’s ability to practice a profession of choice if otherwise so qualified.  To take away this right requires due process of law and reviewing courts will apply a strict scrutiny standard.

Under some states’ constitutions or state statutes there is a right to work or a right to practice the profession of one’s choice;  this further lends credibility to an argument that agency actions which take away this substantial right should require a greater burden than that required in a mere civil case (i.e., preponderance of the evidence”).  However, even without such a provision in the state constitution, a professional license (or the right to practice a profession) is a substantial right and to take it away should require a higher burden of proof (e.g., clear and convincing).

Supreme Court Gives More Protection In Cases That Are “Penal.”

The law is settled through U.S. Supreme Court cases that “penal statutes are to be construed strictly, Commissioner v. Acker, 361.U.S. 87, 80 S. Ct. 144, 4. L. Ed. 2d 127 (1959), Fed’l Comm. Comm’n v. Am.  Broadcasting Co., 347  U.S. 284, 296.  One “is not to be subjected to a penalty unless the words of the statute plainly impose it,” Keppel v. Tiffin Savings Bank, 197 U.S. 356, 362.  See, e.g., Tiffany v. National Bank of Missouri, 18 Wall. 409, 410;  Elliott v. RR Co., 99 U.S. 573, 576.

Penal statutes must be construed narrowly and are interpreted against the state.  Any part or term that is vague will not be enforced or will be stricken.  Warren v. State,  16 Fla. L. Week 1346 (Fla. 1991).  Accord, Riley v. Georgia,  219 Ga. 345, 133 S.E. 2d 367 (Ga. 1963);  State v. Morrison, 25 N.J. Super. 534, 96 A. 2d 723 (Essex Cty. Ct., N.J., 1953);  U.S. v. Ortiz, 24 M.J. 164 (CMA 1987), at 168.

Florida Courts Apply Criminal Law Rights and Protections to Cases Involving Administrative Penalties.

The Florida Supreme Court has affirmatively extended the proscription against self-incrimination to any administrative proceeding of a “penal” character.  This could be one in which the state seeks revocation or suspension of a license or one in which the state seeks a fine on a licensee.  Kozerowitz v. Fla. Real Estate Comm’n, 289 So. 2d 391 (Fla. 1974).

Any administrative proceeding in which the state seeks to inflict a penalty against the license or the licensee would invoke these rights.  An action to revoke a professional license is penal.  So, too, is an action which results in the loss of income or a fine.

More to Come.

Be sure to check our blog regularly to learn more on the burden of proof in administrative cases involving discipline of professional licenses. Part two of this blog series will be posted soon.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers. 

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings.

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.

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

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