Tag Archives: defense attorneys

Florida Hospice to Pay $1 Million to Settle Whistleblower Lawsuit Over False Billing Claims

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

The Hernando-Pasco Hospice (HPH Hospice) in Hudson, Florida, agreed to pay $1 million to resolve allegations that it violated the False Claims Act by submitting false claims for services to the Medicare and Medicaid Programs. According to the U.S. Attorney’s Office for the Middle District of Florida, the hospice allegedly admitted patients that did not meet the requirements for end-of-life care. This lawsuit was originally filed in 2010, by two former hospice employees. The announcement was made on July 22, 2013.

Click here to read the entire press release from the U.S. Attorney’s Office for the Middle District of Florida.

Hospice Accused of Admitting Ineligible Patients to Meet Targets.

HPH Hospice is accused of admitting ineligible patients in order to meet targets imposed by the management team, according to federal authorities. The settlement also resolves allegations that the hospice billed the government at higher rates than it was entitled to receive. It’s also accused of providing illegal kickbacks by giving services to skilled nursing facilities at no cost, in exchange for patient referrals.

Two former employees of the hospice first stepped forward with these allegations. The employees were longtime social workers at HPH Hospice. They filed a lawsuit alleging the facility’s management instructed the staff to make false or misleading statements in patients’ medical records to make them appear eligible for hospice care. The two former employees will share $250,000 of the settlement.

HPH Hospices Claims No Wrongdoing.

According to the Tampa Bay Times, the HPH Hospice spokesperson said the allegations were completely false. The organization stated that the settlement was the better option for patients and staff. As a result of these allegations, HPH Hospice said that it has hired three registered nurses to review and monitor all admission documentation, according to the Tampa Bay Times.

To read the entire Tampa Bay Times article, click here.

Under the False Claims Act, Whistleblowers Can Come Out on Top.

Whistleblowers stand to gain substantial amounts, sometimes as much as thirty percent (30%), of the award under the False Claims Act (31 U.S.C. Sect. 3730). Such awards encourage employees to come forward and report fraud.

You can learn more read our two part blog on whistleblowers. Click here for part 1, and click here for part 2.

Contact Health Law Attorneys Experienced with Medicaid and Medicare Qui Tam or Whistleblower Cases.

In addition to our other experience in Medicare, Medicaid and Tricare cases, attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblowers cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

To learn more on our experience with Medicaid and Medicare quit tam or whistleblower cases, visit our website. 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 this settlement agreement? Do you think settling was a better option for the hospice? Please leave any thoughtful comments below.

Sources:

Department of Justice. “HPH Hospice to Pay $1 Million to Resolve False Claims Act Allegations.” Department of Justice. (July 22, 2013). From: http://www.justice.gov/usao/flm/press/2013/july/20130722_HPH.html

Tillman, Jodie. “Hernando-Pasco Hospice Agrees to Pay $1 Million to Settle False Billing Cliams.” Tampa Bay Times. (July 22, 2013). From: http://www.tampabay.com/news/health/hernando-pasco-hospice-agrees-to-pay-1-million-to-settle-false-billing/2132592?utm_source=twitterfeed&utm_medium=twitter

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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Sarasota Sheriff Wants Patients to Waive HIPAA Privacy Rights

By Danielle M. Murray, J.D.

Law enforcement has been working hard to bust pill mills and stop prescription drug abuse. Pharmacists and pain management doctors are under intense scrutiny by various law enforcement agencies, including the Drug Enforcement Administration (DEA) and the Department of Health (DOH), for their role in giving out controlled substances.

“Doctor shopping” is a common phrase used to describe patients who see multiple doctors in a short period of time in an attempt to dupe doctors into giving them prescriptions for controlled substances. Doctors have been hampered somewhat by HIPAA privacy laws and have been unable to report suspicious patients to law enforcement agencies.

Sarasota County has a solution for that. According to the Sarasota Herald-Tribune, the county has devised a form, entitled “Authorization for Release of Protected Health Information,” and distributed it to pain management physicians. This form is to be signed voluntarily by patients and would allow doctors to discuss concerns with law enforcement. According to the sheriff’s office, the form intended to be limited to the patient’s name and the doctor’s concerns, and not to allow the release of medical records or other protected information.

To see the form for yourself, click here.

Physicians Not In Favor of the Form.

Critics say that the form is a blatant violation of patient rights and is simply a way for law enforcement to get around constitutional protections, such as search warrants.

It appears that some physicians agree with the critics. Not a single waiver has been returned to the Sarasota Sheriff’s Office.

In a Sarasota Herald-Tribune article, a pain management clinic owner states that his clients sign a contract that waives their rights if the clinic is approached by an investigator. He states “I understand HIPAA and am a firm believer in their rights, but if they’re doing something illegal, they’re jeopardizing my license.”

To see the full article from the Sarasota Herald-Tribune, click here.

Providers are at Risk.

The clinic owner is correct. Providers are at risk for their patients’ inappropriate prescription use. We have seen cases where providers are faced with criminal and civil liability when a patient overdoses on medication, whether intentional or not.

Click here to read a previous blog post on one Florida doctor who gave up his license due to allegations of malpractice and overprescribing pills.

In Orlando, Florida, a drug trafficking ring used fake prescriptions to access drugs at pharmacies around the city, and the responsible pharmacists are now facing disciplinary action for filling those prescriptions. There is a major crackdown underway to stop pill mills.

Recently the Polk County Sheriff’s Office issued 25 arrest warrants in connections to a pill mill investigation (click here to read the blog on this story). The big pharmacy chains are getting hit as well. A Walgreens distribution center in Florida was recently served with an immediate suspension order from the DEA (click here for that blog), and the DEA also pulled the controlled substance licenses from two Central Florida CVS Pharmacies (click here to read more).

Do Not Violate HIPAA.

Providers must be careful not to violate HIPAA. HIPAA violations may also result in administrative and civil action against you and your license, especially if the patient can prove they were damaged by the leak. A patient who was arrested due to the provider’s HIPAA violation would likely be able to show damages and cause action against the provider’s license.

You can read more on HIPPA violations on our two-part blog series. Click here to read part one and click here to read part two.

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 do you think of the “Authorization of Release of Protected Health Information” form? Do you think it goes too far? Please submit any thoughtful comments below.

Source:

Williams, Lee. “Sheriff wants doctors to have patients sign away rights.”  Sarasota Herald-Tribune. (October 1, 2012). From: http://www.heraldtribune.com/article/20121001/ARTICLE/121009975/2416/NEWS?p=all&tc=pgall 

About the Author: Danielle M. Murray 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.

 

“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.

Patients Like to Read Doctors’ Notes Online

By Danielle M. Murray, J.D.

According to the Orlando Sentinel, a study published in the Annals of Internal Medicine shows that patients like to read their doctors’ notes.  In the study, published in April of 2012, doctors put their notes online, and gave patients online access to the file.  While some patients had privacy concerns, ninety-nine percent (99%) of them requested to keep access to the file after the study was over.

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

Doctors Did Not Feel Overwhelmed by Having to Put Notes in Computer.

Patients interviewed for the study felt that the notes reiterated important points that they had discussed with their doctors.  Study participants were able to be reminded of key information, and many said they felt that they were more compliant with the doctors’ recommendations.

Doctors didn’t report feeling limited or overwhelmed by having to take notes in the computer system used for the study, and they continued to allow access to the notes following the study.

Non-Electronic Options for Doctors’ Offices.

If a doctor does not feel comfortable using an online system, or simply does not have the time or money to convert to an electronic system, the article suggests that doctors can simply add a new procedure to their current, handwritten record-keeping system.  Doctors can have staff routinely make a copy of the patient’s notes and mail the notes, or have the notes picked up by the patient, within a set time after the visit.

Keep in Mind Your Responsibilities as A Doctor.

As a health attorney advising physicians, medical groups and medical facilities, I have to look at the legal risks of such arrangements.

While putting records online or even creating an app for patients to access records is convenient, such an arrangement can inadvertently allow the records to fall into the hands of third parties.  I don’t know of many doctors’ offices with in-house staff to manage their document server and online secure servers for such an undertaking.  Even so, streamlining the process generally requires special software, which was created by and likely monitored by a third-party software developer.

I would first suggest that any health professional looking to digitize or allow remote access to records have a contract ready for their technology associate to sign.  The contract should clearly state the obligations of each party, and it should incorporate all Health Insurance Portability and Accountability Act (HIPAA) privacy and security responsibilities.  I would not suggest piecing something like this together on your own; seek counsel, such as experienced health law attorneys, to do this for you.

If you are unsure about HIPAA privacy rights, click here for part one and click here for part two of a blog series on possible violations.

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, dentists, pharmacists, psychologists, health facilities and other health providers in Department of Health (DOH) investigations, OCR HIPAA audits, breach of privacy investigations, HIPAA risk assessments, 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 professional, do you make notes available to your patients? Does putting such notes online worry you? Please leave any thoughtful comments below.

Source:

Pittman, Genevra. “Patients Like Reading Their Doctors’ Notes: Study.” Orlando Sentinel. (October 1, 2012). From: http://www.orlandosentinel.com/health/sns-rt-us-patients-like-reading-their-doctors-notes-stbre-20121001,0,925182.story

About the Author: Danielle M. Murray 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

 
“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.

Remedies for Violation of HIPAA Privacy Rights and Medical Confidentiality – Part 2

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

I receive many questions and e-mails about possible violations of the Health Insurance Portability and Accountability Act’s (HIPAA) Privacy Regulations and Security Regulations, and breaches of confidentiality of medical records and medical information. 

More detailed information on HIPAA Privacy Regulations and Security Regulations, can be found at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html

There is no private cause of action allowed to an individual to sue for a violation of the federal HIPAA or any of its regulations.  This means you do not have a right to sue based on a violation of HIPAA by itself.  However, you may have a right to sue based on state law. 

To read the first part of this blog, click here. To continue learning more on HIPAA Privacy Rights and Medical Confidentiality, see below.

4.  State Laws and Law Suits (Civil Recovery).

If there was a violation or breach of patient confidentiality or medical records confidentiality, this may also be a violation of the state’s laws on patient or medical records confidentiality.  In most states this would give you a legal cause of action for invasion of privacy or for negligence.

The biggest problem usually encountered in this type of case and the reason most attorneys will not even consider taking one is the lack of documented  provable damages (again, I emphasize the words “documented” and “provable”).

5.  The Key is Documented, Provable Damages.

Unless you have actual bills and receipts, you don’t have this.  In most cases, unless you can prove that you have suffered actual damages by proof such as:

a.  Doctors’ bills you have paid

b.  Mental health counseling fees you have paid

c.  The purchase of credit protection insurance

d.  The purchase of identification theft insurance

e.  The costs you have paid because your identity was stolen

f.   Lost pay from time off (with the pay stubs, W-2 forms, etc., to prove the amount)

g.  Lost pay from a lost job (with the pay stubs, W-2 forms, etc., to prove the pay lost)

h.  Attorney’s fees paid as a direct result of the breach of privacy (key word being “direct result”)

i.  Other actual out-of-pocket expenses, you may have a difficult time proving a case in a court of law

If you have these keep good, detailed documentation.  Obtain good, legible receipts for everything.

Unless you have these, you will have great difficulty in finding a plaintiff’s attorney to take such a case.  It is doubtful that you would have a provable case, as well.  There are exceptions to every case, however.

If you do feel that you have a valid case with documented damages, we urge you to contact and retain a plaintiff’s attorney to file suit on your behalf as soon as possible.  You have only a short period of time to bring up such a case, after which your rights to do so will be extinguished forever.

We would urge you to consider carrying out actions #1, #2 and #3 in Part 1.  If these organizations do not find in your favor, then it is even less likely that a judge or jury would find in your favor.

The Difference Between Hourly Attorney vs. Contingency Fee Attorney.

Our statements above hold true mainly because most attorneys who would take such a case are plaintiff’s attorneys who take cases for a contingency fee (a percentage of the amount they win).  In such a case, if an attorney spends 100 hours preparing for trial (actually a low number), wins your case, and you only have $500 worth of provable damages (if the contingency fee agreement is for 40%, a fairly standard amount) then that attorney only gets $200, or $2.00 per hour.  I don’t know any attorney who will work for that amount.  (This is a very simplistic illustration to make the point; it does not even take into account the legal costs involved, which the client is usually responsible for paying.)

An attorney who charges by the hour may be more likely to take the case (but he/she may also be hard to find for this type of case), and may require a retainer fee of $5,000 to $15,000 paid up front just to get started.

If you have a civil case for liability, you only have a short, limited time to file it.  You must do so within the applicable time period or you will lose the right to do so forever.

Remember, there is only a short time in which to take any action that may be necessary and if you fail to do so, your rights may be lost forever.

Again, this is not legal advice, just general information.

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.

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.

Remedies for Violation of HIPAA Privacy Rights and Medical Confidentiality – Part 1

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

I receive many questions and e-mails about possible violations of the Health Insurance Portability and Accountability Act’s (HIPAA) Privacy Regulations and Security Regulations, and breaches of confidentiality of medical records and medical information.  I will attempt to explain and clarify this issue a little in this short blog.

More detailed information on HIPAA Privacy Regulations and Security Regulations, can be found at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html

There is no private cause of action allowed to an individual to sue for a violation of the federal HIPAA or any of its regulations.  This means you do not have a right to sue based on a violation of HIPAA by itself.  However, you may have a right to sue based on state law.  See below.

1.  File a HIPAA Privacy Complaint with the Office of Civil Rights (OCR).

As a first step, you may desire to file a HIPAA Privacy Complaint with the federal government.  These are usually required to be filed within 180 days of the event (there are limited exceptions).  They are usually all taken and fully investigated.  If it is an egregious or a repeat violation, it may even result in an investigation by the Federal Bureau of Investigation (FBI) and criminal charges being filed against those responsible.  However, in most cases if there is a valid complaint, the federal government will assess administrative fines against those responsible.  In almost all cases, a report will be made back to you of what is found and what actions have been taken.

If you decide to file a HIPAA Privacy Complaint, this is done with the Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (DHHS).  You may do this online.  The Complaint form is found at: http://www.hhs.gov/ocr/privacy/hipaa/complaints/index.html

If you follow this process and receive a finding that verifies the violation, you may find it easier to retain an attorney to take your case.  Please note, there is only a very short period of time in which you are allowed to file such a complaint after you have discovered it.  So be sure to do this right away.

2.  File a Complaint Against the Physician Involved with the Florida Department of Health (DOH).

The Florida Department of Health (DOH) licenses all physicians, nurses and health professionals in the state of Florida.  It is also responsible for investigating complaints against them.  The various professional boards (Board of Medicine, Board of Nursing, etc.) are under the DOH.

If there was a violation or breach of patient confidentiality or medical records confidentiality, this may also be a violation of the state’s laws on patient or medical records confidentiality. This is true in most states, not just Florida.

If there was a violation or breach of patient confidentiality by a licensed health care professional, you may also file a complaint with the appropriate state licensing board or agency about this, as well.  In Florida, for example, if a licensed health professional did this, you may decide to report this to the Florida DOH.  If they are licensed in a different state, you may have to follow that state’s procedure for filing a complaint.

For Florida, you may call the Florida DOH at (888) 419-3456 or (850) 245-4339, or you may use the online complaint form found at: http://www.doh.state.fl.us/mqa/enforcement/enforce_csu.html

The Florida DOH will investigate the complaint and will usually have an expert witness review it.  If there is a finding against the physician (or other licensed health professional) you can ask for a copy of the DOH expert’s report.  This may result in your obtaining a free expert witness review of the case.  The expert witness might even agree later to testify as an expert witness if there is a civil lawsuit filed (however, this is something your attorney would have to work out with the expert witness).

3.  File Grievance or Report to Third Party Payer (Medicare, Tricare, VA, Insurance Co.).

If you are a Medicare patient, TRICARE/CHAMPUS patient, Veterans Administration (VA) patient, Public Health Service patient, or military patient, you may also report this to the Office of the Inspector General (OIG) of that specific agency.

If you are a member of a managed care plan or have health insurance, you may desire to file a member grievance or complaint with the insurance company.  Every physician who accepts Medicare is subject to the Medicare Program’s peer review system.  You may file a complaint directly with Medicare and ask for it to be reviewed by the Medicare peer review program.

More on HIPPA Violations to Come.

In a future blog, I will continue to explain and clarify HIPPA violations.

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.

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.

 

Hospice of the Comforter Inc., Faces Whistleblower Lawsuit

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

On September 6, 2012, the Department of Justice (DOJ) announced it will join in a whistleblower lawsuit alleging false Medicare billings against Hospice of the Comforter Inc., (HOTCI). The hospice is located in Altamonte Springs, a suburb of the Orlando area, and provides hospice services to local patients.

To read the entire whistleblower complaint filed, click here.

Allegations in the Lawsuit Against HOTCI.

According to the DOJ, the lawsuit was filed by the former vice president of finance for HOTCI. The case alleges HOTCI submitted false claims to Medicare for hospice care patients who were not terminally ill. The lawsuit also claims an executive at the hospice told employees to admit Medicare recipients for hospice care even before there had been a determination that the patients were eligible for the hospice benefit.

Initial Medicare Audit Allegedly Triggered Discharges.

In an Orlando Sentinel article, the plaintiff states that in an initial audit, in 2010, the government found HOTCI had a billings error rate of eighteen percent (18%), which triggered a second review. The plaintiff is accusing HOTCI of then creating an internal committee to review the eligibility of its Medicare patients. The committee discharged at least 150 patients between 2009 and 2010 as being ineligible for the Medicare hospice benefit.

According to the Orlando Sentinel, a representative from HOTCI said the discharges show that the hospice was taking actions to resolve of the situation on its own and only indicates some hospice patients should have been discharged at a previous point in time – not that they shouldn’t have been admitted at all.

To read the entire Orlando Sentinel article, click here.

Details of the Medicare Hospice Benefit.

According to the DOJ, the Medicare hospice benefit is available to patients who choose palliative treatment (medical care focused on providing patients with relief from pain and stress) for a terminal illness, and are expected to live six months or less. When an individual is admitted to a hospice facility, that individual is no longer entitled to receive services designed to cure the illness, or curative care.

Under the False Claims Act, Whistleblowers Can Make a Profit.

Should the government win this case, HOTCI could face up to $33 million in penalties, according to the Orlando Sentinel.

Whistleblowers stand to gain substantial amounts, sometimes as much as thirty percent (30%), of the award under the False Claims Act (31 U.S.C. Sect. 3730). Such awards encourage employees to come forward and report fraud.

You can learn more on the False Claims Act on the DOJ website.

Contact Health Law Attorneys Experienced with Medicaid and Medicare Qui Tam or Whistleblower Cases.

In addition to our other experience in Medicare, Medicaid and Tricare cases, attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblowers cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

To learn more on our experience with Medicaid and Medicare quit tam or whistleblower cases, visit our website.

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

Sources:

Santich, Kate. “Feds Join Whistleblower Lawsuit Against Hospice of the Comforter” Orlando Sentinel. (August 28, 2012). From: http://articles.orlandosentinel.com/2012-08-28/health/os-whistleblower-lawsuit-hospice-of-the-comforter-20120828_1_hospice-board-members-hospice-care-hospice-founder

Department of Justice. “United States Intervenes in False Claims Act Lawsuit Against Orlando, Florida-area Hospice.” DOJ. (September 6, 2012). From: http://www.justice.gov/opa/pr/2012/September/12-civ-1080.html

U.S. ex rel. Stone v. Hospice of the Comforter, Inc., No. 6:11-cv-1498-ORL-22-AAB (M.D. Fla) United State District Court for the Middle District of Florida Orlando Division. (September 12, 2012), available at http://www.thehealthlawfirm.com/uploads/US%20v%20Hospice%20of%20the%20Comforter.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.

Consequences of Clinical Research Fraud and Misconduct

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

Medical and clinical researchers, whether in an academic community or in a practice setting, spend years on clinical trials and investigations in hopes of contributing to their respective fields. Many of these researchers, however, find themselves defending their reputation after being accused of research fraud or research misconduct.


Why Researchers are Accused of Misconduct.

Although accusations of research fraud and misconduct have been present for decades, the number of complaints is on the rise, according to the FDA. In many cases, the researcher accused of such misconduct may actually be the victim of one or more unscrupulous individuals who make the complaint for his or her own ulterior motives. Some researchers may be targeted by an academic institution or the government. Other cases may involve a “whistle blower” who may just have misunderstood the situation.

Researchers Face Many Difference Accusations.

The most common accusations against researchers include: manipulating or concocting research data, failing to disclose financial interest or not properly disclosing conflict of interest, plagiarizing, failing to present data that contradicts one’s own previous research, overlooking the use of flawed data, and circumventing certain minor aspects of human-subject requirements. Researchers also face an enormous amount of pressure from funding sources. That influence on a researcher can lead to these accusations: changing the design, methodology or results of a study to meet a funding source’s expectations, ignoring details or cutting corners to meet a deadline, fabricating, falsifying or mishandling of data to gain some form of reward or benefit.

A Person and Professional Reputation can be Tarnished.

An accusation, even if later proven to be unfounded, may unfairly tarnish the personal and professional reputation of the researcher, cause the researcher to lose grants, bonuses and promotions, his or her employment may be terminated, or may even face criminal prosecution for fraud, theft or other applicable crimes.

To learn more on clinical research fraud and misconduct, click here.

Well-Known Cases of Research Fraud and Misconduct.

One of the most notorious recent cases of research misconduct involved a stem cell researcher in South Korea who claimed to have cloned human embryonic stem cells. However, the researcher was later accused of fabricating crucial data and charged with fraud and embezzlement. The fraud charges were eventually cleared, but not before the researcher’s reputation was destroyed.

From 1992 to 2002 a former research professor in Vermont falsified and fabricated data in numerous federal grant applications and academic articles. He used two million dollars in government grants – taxpayer money – for studies to perpetrate his fraud. He pled guilty to falsifying 17 grant applications to the National Institutes of Health (NIH) and fabricating data in 10 of his papers. He was ordered to serve one year and a day in federal prison, permanently barred from ever receiving more federal research grants, and ordered to write letters of retraction and correction to a number of scientific journals.

A prominent Massachusetts anesthesiologist admitted to fabricating 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked. This data used in the studies was published in several anesthesiology journals between 1996 and 2008. This doctor was sentenced to six months in prison, followed by three years of supervised release. He was ordered to pay a $5,000 fine, forfeit $50,000 to the government and make $360,000 in restitution to pharmaceutical companies. The plea deal effectively ended his career as a physician.

Visit the Office of Research Integrity (ORI) website to learn more on research fraud and misconduct.

Contact Health Law Attorneys Experienced in Clinical Research Fraud and Misconduct.

The Health Law Firm and its attorneys have experience in representing researchers, investigators, academicians and clinicians who are the subject of clinical research fraud and misconduct. The Health Law Firm and its attorneys also have experience in representing students, employees, researchers, investigators and “whistle blowers” who report such matters including those who become the victim or reprisals and retaliation by the person against whom the report is made.

Don’t wait. Obtain the advice and counsel of experienced attorneys who are familiar with such matters and can assist you before it is too late.

If you are facing research misconduct or research fraud accusations, please visit our website for more information at www.TheHealthLawFirm.com or call The Health Law Firm at (407) 331-6620 or (850) 439-1001.

Sources:

“Grantee Misconduct: Dr. Eric T. Poehlman.” National Institutes of Health. (March 7, 2012). From: http://www.nih.gov/news/granteemisconduct.htm

Arak, Joel. “Menopause Doc Fudged Data.” CBS Evening News. (February 11, 2009). From: http://www.cbsnews.com/2100-18563_162-703359.html

Interlandi, Jeneen. “An Unwelcome Discovery.” The New York Times. (October 22, 2006). From: http://www.nytimes.com/2006/10/22/magazine/22sciencefraud.html?pagewanted=all

Winstein, Keith and Armstrong, David. “Top Pain Scientist Fabricated Data in Studies, Hospital Says.” The Wall Street Journal. (March 11, 2009). From: http://online.wsj.com/article/SB123672510903888207.html

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.

Michael L. Smith, J.D., R.R.T.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.