Florida Man Sentenced to Prison for Role in Florida Hospital Data Theft

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

A Davenport, Florida, man was sentenced to four years in prison for paying off two Florida Hospital employees to illegally access patient records, according to the Department of Justice (DOJ). A judge sentenced Sergie Kusyakov on April 10, 2013. He was charged with conspiracy and wrongful disclosure of individual identifiable health information.

Click here to read the press release from the DOJ.

Ex-Employees Sold Patient Information to a Co-Conspirator.

Mr. Kusyakov’s sentence stems from a privacy breach at Florida Hospital back in October 2011. The breach involved thousands of patient records that were illegally accessed between 2009 and 2011. Apparently Mr. Kusyakov was paying hospital employee Dale Munroe and his wife to illegally access thousands of records of patients treated at multiple Florida Hospital locations. Mr. Munroe was sentenced in January 2013. Click here to read a previous blog on that story.

Mr. Munroe was allegedly fired in July 2011, after it was learned he accessed the records of a doctor fatally shot in a parking garage. Investigators then found that Mr. Munroe had accessed more than 700,000 patient records, most of whom had been involved in vehicle accidents. Mr. Munroe then sold the records to Mr. Kusyakov, who was associated with two chiropractic clinics. The information was then used to solicit the patients for lawyers and chiropractors. After Mr. Munroe was fired, his wife began stealing patient information. She will be sentenced in July.

HIPAA Privacy Complaints Do Result in Action.

The act of accessing patient records is a direct violation of the Health Insurance Portability and Accountability Act (HIPAA). Many individuals whose privacy is breached fail to realize how effective a HIPAA Privacy Complaint can be. These complaints, which can be filed online to the Office of Civil Rights (OCR), a federal agency, are fully investigated. Stiff civil fines and even criminal prosecutions may result. In serious cases, the FBI investigates them.

Since the time period is short for filing these (180 days), the first step you should take, if your medical privacy is breached, is to file a HIPAA Privacy Complaint with the OCR. Also file a complaint with the hospital or health care provider and with the state agency that licenses the health care provider.

Contact Health Attorneys Experienced in the Confidentiality of Medical Records.

Our attorneys provide advice and legal opinions on confidentiality of medical records and medical information, including HIPAA Privacy Regulation, and are available to testify as expert witnesses on these issues.

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

Comments?

What do you think of Mr. Kusyakov’s sentence? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Man Sentenced to Federal Prison for Role in Florida Hospital Theft.” Orlando Sentinel. (April 11, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-florida-hospital-patient-data-theft-20130410,0,3261544.story

Department of Justice. “Davenport Man Sentenced to 4 Years in Prison of Theft of Patient Information.” Department of Justice. (April 10, 2013). From: http://www.justice.gov/usao/flm/press/2013/apr/20130410_Kusyakov.html

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

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

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

Colorado Surgeon Accused of Botching Multiple Robotic Arm Surgeries

By 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.

Tips for Medical Students and Medical Residents Accused of Irregular Behavior on the USMLE

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

We frequently receive calls for consultations from students who receive a letter from the National Board of Medical Examiners (NBME) accusing the medical student or medical resident of “Irregular Behavior” on the United States Medical Licensing Examination (USMLE). In many cases these are graduates of foreign medical schools who have applied through the Examination Committee for Foreign Medical Graduates (ECFMG).

Irregular behavior can consist of many different things before, during or after taking the USMLE.  What you must know is that, in effect, you are being accused of cheating.

Examples of What The USMLE Defines  as “Irregular Behavior.”

Examples of the types of conduct which we have seen before include:

-  Attending a commercial USMLE preparation course that provides some of the actual examination questions.

-  Soliciting information on the contents or questions on the examination.

-  Using a cell phone during the examination.

-  Talking with another person during the examination.

-  Sharing information on the types of questions or cases that were on your examination with another person or on a blog over the internet.

These are just a few.  For more examples, please see an article I wrote on this by clicking here.

When Accused of Irregular Behavior Don’t Do  The Following.

We have represented students accused of irregular behavior by consulting with them before and after USMLE hearings and on appealing the results. We have represented a number of examinees at the hearings held before the NBME at its headquarters in Philadelphia, Pennsylvania.

From our experience in such cases, the following are the errors that most of you will make when accused by the USMLE of irregular behavior.

1.  You will fail to obtain an attorney experienced with such cases immediately upon receipt of a letter from the NBME accusing you of irregular behavior.  Take this as a formal charge accusing you of, in effect, cheating.  THIS IS SERIOUS.

2.  You will telephone, write or e-mail the NBME and explain “your side of the story.”  This will be full of admissions that will help prove the case against you and you will not even understand this.  (Please note that under U.S. law any statements you make, oral or written, can be used as evidence against you in any civil, criminal or administrative proceeding.  This is not the case with statements that your attorney makes on your behalf.)

3.  If you submit documents or statements to the NBME in support of your case, these will not be well-organized, well-labeled and in a form simple and easy to understand.  In many instances, you will not even understand the legal issues you are facing or how to refute them.

4.  You will fail to request or attend in person the hearing before the NBME Committee on Irregular Behavior (“The Committee”) in Philadelphia, Pennsylvania.

5.  You will fail to take an attorney experienced in such medical administrative hearings to represent you at The Committee hearing in Philadelphia.

6.  You will not know how to properly present your evidence or present your own position to The Committee, if you do attend the hearing.

7.  You will not know when or what kind of witnesses, including expert witnesses, you need to use to prove issues in your case before The Committee.

8.  You will fail to understand and correctly respond to the questions that the many different Committee members (usually 15 or more) will ask you during the hearing.

9.  You will fail to correctly follow all procedures in order to preserve your rights in the proceedings.

10.  You will falsely believe that if you lose at The Committee hearing you can win on appeal or somehow sue in court and prove you are right; this is almost never correct.  You will have only one chance at proving your case and this is at The Committee hearing in Philadelphia.

11.  You will incorrectly believe that even if you are only suspended from taking the USMLE again for a short period of time, this will have no effect on your education or career.  (Note:  Your USMLE transcript will note this fact and this will probably prevent you from ever getting into a good residency program.  See #1 above.)

 

This Is a Serious Matter, Don’t Think Otherwise.

You and your family have invested tens of thousands, if not hundreds of thousands of dollars, on your education so that you can become a physician.  You have spent years of sacrifice and studying in order to become a physician.  This is not the time to be cheap and to think that the cost of hiring an experienced legal counsel is too high.  You could lose everything you and your family has invested in this. Do not be “penny wise and pound foolish.”  You will need professional help if you are to get through this successfully.  If you don’t care about these matters or you don’t believe this is a serious matter worthy of an investment for attorney’s fees, then go ahead and ignore this advice.

If you are not reading this until after you have lost the case and been found to have committed “irregular behavior” by the USMLE Committee on Irregular Behavior, I am sorry for you, but it is probably too late to do anything about it.

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? 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.

Two National Recalls Prompt Food and Drug Administration (FDA) to Update Metal-on-Metal Hip Implant Safety Concerns

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

On January 17, 2013, the Food and Drug Administration (FDA) issued an updated public health communication about hip replacement components that have both a metal ball and a metal socket, or metal-on-metal hip devices. This comes after two recent hip replacement recalls that are sparking thousands of lawsuits. Click here to read the FDA communication.

In August 2010, Johnson and Johnson’s DePuy Orthopaedics implemented a DePuy ASR hip recall, withdrawing more than 93,000 hip implants from the market. (Click here to read the press release on the recall from DePuy.) In July 2012, Stryker Orthopaedics implemented a similar recall on the Rejuvenate and ABG II modular neck components. (Click here to read the Stryker recall press release.)

Updated Information on Metal-on-Metal Hip Implants From the FDA. 

According to the FDA, in metal-on-metal hip implants, metal can be released into the body when two connecting components slide against each other. This can happen during daily activities. Metal release will cause some tiny metal particles to wear off of the device and into the space around the implant. Wear and corrosion at the connections may also occur. Some of the metal ions from the implant can enter the bloodstream. If this happens, patients can suffer from muscle, nerve and bone damage.

Click here to read more on metal-on-metal hip implants from the FDA.

Second Trial Over DePuy Hip Implant in Progress.

The president of DePuy testified during the second DePuy ASR hip trial. According to an article in Bloomberg News, the DePuy president said that the metal-on-metal hip implants were recalled because of a high rate of corrective surgeries required in patients, not because the device’s design was defective. Click here to read the Bloomberg article.

You may remember on March 8, 2013, in the first ASR hip recall trial, a California jury awarded the plaintiff $8.3 million in compensation damages after finding the ARS’s design defective. This result will have significant impact in the 10,750 other lawsuits against DePuy. Click here to read a previous blog on the first trial over the DePuy hip implants.

Stryker Orthopaedics Facing Similar Lawsuits.

As of February 2013, more than 80 lawsuits against Stryker have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey. Stryker is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on any patient who had implants installed. Click here to read a previous blog on the Stryker lawsuits.

We’ve also learned some Stryker patients are being contacted by Broadspire. This company is trying to discuss settling with these patients. We want to encourage any metal-on-metal hip implant recipients to contact and experience attorney first, because there is still time to file a claim for injuries.

Contact an Attorney Experienced in Products Liability Litigation.

Although The Health Law Firm represents predominantly physicians and other health care providers, we are involved in products liability litigation. The Health Law Firm has recently undertaken plaintiffs’ products liability cases against the manufacturers of defective hip implants. We are now representing plaintiffs in a number of products liability cases involving both the DePuy hip and the Stryker hip implants. We are able to combine our knowledge of the health law industry with our litigation experience for the benefit of patients.

If you received a DePuy or Stryker hip replacement and have experienced pain, swelling, high levels of metal in your blood, a corrective revision surgery, or other complications, we may be able to help you.

To learn more about your legal rights, contact The Health Law Firm for a consultation by calling (407) 331-6620 or (850) 439-1001 or visit our website at www.TheHealthLawFirm.com.

Comments?

What are your thoughts on these recalls? Are you a Stryker or DePuy hip implant recipient? Please leave thoughtful comments below.

Sources:

Harris, Andrew and Voreacos, David. “J&J’s Ekdahl Says Hip Recalled for Clinical Reaons.” Bloomberg. (March 13, 2013). From: http://www.bloomberg.com/news/print/2013-03-13/depuy-chief-questioned-over-records-calling-asr-defective.html

Hooks, Beau. “Stryker Hip Replacement Lawsuits.” Drug Watch. (February 2013). From: http://www.drugwatch.com/stryker/lawsuit-hip-replacement/

Guilfoyle, Jeanine. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems.” Stryker. (July 6, 2012). From: http://www.stryker.com/stellent/groups/corporate/documents/web_prod/147504.pdf

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

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

 

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

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

Why You Should Not Voluntarily Relinquish Your Medical License or DEA Registration Number

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

I am often contacted by clients who are health professionals or own businesses in the health care industry who have been approached by government agents or investigators regarding possible complaints or charges. In many cases, the individuals involved do not think to consult with an attorney until many months later, and this may be too late to save the business or professional practice involved. This holds for physicians, dentists, nurses, pharmacists, pharmacies, pain management clinics, physician assistants, group homes, assisted living facilities (ALFs) and home health agencies, among others.

“Voluntary” Relinquishment Treated the Same as a Revoked License.

We have seen a trend recently, especially here in Florida, of investigators immediately offering the person being investigated the option to voluntarily relinquish his or her professional license. This is offered as an option to being investigated, even in the event of very minor or frivolous complaints. The problem is that once an investigation has been opened, then a voluntary relinquishment of a license is treated the same as if it were revoked for disciplinary reasons. It will be very difficult, if not impossible, to ever get a new license under the circumstances.

Furthermore, if the professional has other licenses or similar licenses in other states, then this will be reported to the other states and disciplinary action will probably be initiated against those other licenses.

We have heard horror stories of investigators, accompanied by police or sheriff’s deputies or Drug Enforcement Administration (DEA) agents, making all sorts of threats against a health professional in order to intimidate him or her into giving up a DEA registration number or professional license, including medical licenses, nursing licenses and pharmacy licenses.

In the case of such an incident occurring in Florida, the “voluntary” relinquishment must still be presented to the applicable professional Board and voted on at a scheduled meeting, since it is considered to be disciplinary. It may be possible to withdraw the “voluntary” relinquishment before it is voted on, so all may not be lost.

Think Long and Hard About Relinquishing DEA Registration Number.

However, in the case of the DEA, a DEA registration number is considered gone as soon as the “voluntary” relinquishment paper is signed. This is one of the reasons it is crucial to talk with a knowledgeable health law attorney before making such a decision. The ones putting pressure on you to do this will do everything they can to persuade you not to talk to an attorney. But it is your right to do so. Don’t be rushed or intimidated into making a foolish decision you will regret.

We have represented clients attempting to obtain a new DEA registration number or a new professional license many years after they did a voluntary relinquishment. In most cases, it is an extreme uphill battle and is often not successful.

Additional Consequences of Voluntary Relinquishment of a Professional License or DEA Registration Number.

The following are some of the additional consequences of voluntary relinquishment of professional license or DEA number after notice of an investigation:

1. Disciplinary action will be commenced against any other professional licenses in the state.

2. Disciplinary action will be commenced against any similar licenses in other states.

3. The matter will be reported to any national certification boards of which you are a member and they will most likely commence action against you to revoke your national certification.

4. You will be placed on the Office of the Inspector General’s (OIG) List of Excluded Entities and Individuals (LEIE) and excluded from the federal Medicare Program.

5. You will be terminated from the state’s Medicaid Program, if you are a Medicaid provider.

6. You will be terminated from the panels of any health insurers or managed care plans of which you are a provider member.

There are many other possible repercussions to such actions, so it is extremely important to be prepared if such an event occurs. To prepare you can:

1. Purchase professional licensing defense insurance coverage through Lloyd’s of London, Healthcare Provider’s Service Organization (HPSO), Nurses Service Organization (NSO) or one of the other reputable insurance companies that provide such coverage.

2. Have the names, telephone numbers and other information on good, reputable criminal defense and health law attorneys at hand at all times. Make sure your practice manager has this information as well.

3. Call as soon as an investigator walks in. Don’t wait.

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 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?

Have you ever been approached by government agents or investigators about possible complaints or changes? 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.

First Trial Over DePuy Hip Implants Finished – Plaintiff Receives $8.3 Million

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

On March 8, 2013, a California jury ruled that Johnson and Johnson’s DePuy unit designed a defective metal-on-metal ASR XL hip implant and was negligent, according to Bloomberg News. The plaintiff in this case was awarded $8.3 million in compensation damages, after the jury found that the design of the hip implant was the reason behind the plaintiff’s injuries. This is the first trial, out of 10,750 lawsuits filed against DePuy’s ASR XL hip implant. Click here to read more on the first trial against DePuy from Bloomberg News.

In August 2010, DePuy recalled 93,000 ASR XL hip implants after 12 percent (12%) failed within five years. Last year, 44 percent (44%) allegedly failed in Australia within seven years. (Click here to see the press release on the recall from DePuy.) We recently blogged on similar problems with Stryker brand hip implants and similar litigation. Click here to read that blog.

Hip Implants Allegedly Sold with Design Flaws.

During the trial, attorneys for the plaintiff argued DePuy knew that the design flaws in the defective device could cause it to shed particles into patients.

Almost all the patients who filed lawsuits complain that DePuy’s ASR XL hip implants have caused them constant pain and follow-up surgeries, according to Bloomberg News.

DePuy Believes Product is Solid.

During the trial a DePuy spokeswoman said the company believes the ASR XL was properly designed and that the actions they took concerning the product were appropriate.

According to Bloomberg News, an attorney for DePuy said three things have to work well for a successful surgery: a doctor who does his/her job; a device that works properly; and a patient whose body responds to the implant. The attorney went on to say that the bodies of some patients with existing medical conditions did not react well to the implants, and they do not know why.

Second Lawsuit in Court in Illinois.

On March 12, 2013, a second trial began in Illinois. This time a nurse claims her DePuy hip failed after three years and she needed a replacement surgery. Click here to read more on the second trial.

DePuy has a long road ahead. The company faces about 500 lawsuits in state court in Illinois, about three-quarters of the total lawsuits were consolidated in the federal court in Ohio and more than 2,000 are in the state court in California. The next trial is scheduled for May in Ohio federal court.

DePuy Cases Very Similar to Those Against Stryker Orthopaedics.

As of February 2013, more than 80 lawsuits have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey against Stryker Orthopaedics. Patients claim the company’s Rejuvenate and ABG II modular-neck femoral hip systems are defective, according to a number of news sources. The case is on track to becoming one of the largest mass-tort litigations in the country.

In July 2012, Stryker issued a voluntary recall of the Rejuvenate and ABG II modular-neck femoral hip systems. (Click here to see the press release from Stryker.) The company is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on patients who had implants installed. Click here to read a letter from Stryker to a surgeon.

Contact a Health Law Attorney Experienced in Products Liability Cases.

Since the implants were recently recalled, it’s expected that there are many more cases out there.  Many of the people who have already filed lawsuits claim Stryker marketed and sold a defective device and failed to warn the public, among other issues.

If you or a family member received a Stryker Rejuvenate or ABG II hip implant and suffered complications, you don’t have to face the medical issues alone. Contact an experienced attorney that is board certified in health law. Before you talk about settling, please call an attorney. Our 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 DePuy and Stryker lawsuits? Have you experienced complications for a hip implant? Please leave thoughtful comments below.

Sources:

Possley, Maurice, Voreacos, David and Pettersson, Edvard. “J&J Must Pay $8.3 Million Over Defective Hip, Jury Says.” Bloomberg. (March 8, 2013). From: http://www.bloomberg.com/news/2013-03-08/j-j-must-pay-8-3-million-in-suit-over-defective-hip-jury-says.html

Harris, Andrew and Voreacos, David. “J&J Faces Second Trial Over Recalled Hip After Loss.” Bloomberg. (March 12, 2013). From: http://www.bloomberg.com/news/2013-03-11/j-j-faces-second-trial-over-recalled-hip-after-losing-first-case.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.

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

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

Zone 4 Program Integrity Contractor (ZPIC) for Medicare and Medicaid Programs is Health Integrity, LCC

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

Health Integrity, LCC, was named the Zone 4 Program Integrity Contractor (ZPIC) for the Medicare and Medicaid programs. As the ZPIC for Zone 4, Health Integrity has been performing benefit integrity activities aimed to reduce fraud, waste and abuse in Medicare and Medicaid data matching programs.

A ZPIC is a business entity that contracts with Medicare and Medicaid and works with state Medicaid agencies, the Centers for Medicare and Medicaid Services (CMS), and law enforcement officials to identify improper billing and utilization patterns throughout Zone 4.

ZPIC Zone 4 includes Texas, Colorado, New Mexico, and Oklahoma.

What is a ZPIC?

ZPICs are private companies contracted by the CMS, used to conduct audits for Medicare and Medicaid overpayments. ZPICS also detect, investigate and gather evidence of suspected fraud and abuse to be turned over to the Office of Inspector General (OIG) for criminal or civil prosecution.. When you hear “ZPIC,” think “fraud.”

ZPIC audits are initiated by:

1. Whistleblower or qui tam lawsuits,
2. Probe audits,
3. Other audit agency findings,
4. Beneficiary/patient complaints,
5. Hotline complaints, or
6. Complaints and notices from other government programs.

How to Handle a ZPIC Audit.

When a physician, medical group or other health care provider receives a notice of an audit and site visit from a ZPIC, things happen fast with little opportunity to prepare. A ZPIC will routinely fax a letter to the practice shortly before the end of a business day the day before a site visit/audit to that practice. Auditors will request to inspect the premises, will photograph all rooms, equipment, furniture, and diplomas on walls. They will usually request copies of several patient records to review later. They will request copies of practice policies and procedures, treatment protocols, all staff licenses and certifications, drug formularies, medications prescribed, and medications used in the office. ZPIC auditors will inspect any medication/narcotic lockers or storage cabinets and will request drug/medication invoices and inventories. You will usually be contacted for follow-up information and documentation after the audit and will eventually be provided a report and, possibly, a demand for repayment of any detected overpayments.

For a checklist on what to do after you receive initial notification of a ZPIC audit, read our two-part blog. Click here for part one and click here for part two.

The Health Law Firm’s Success in a North Carolina Medicaid Action.

In October 2012, The Health Law Firm assisted a North Carolina Medicaid provider in reducing an overpayment demand made by the North Carolina Medicaid program by more than ninety-eight percent (98%). We were brought on to assist the provider in challenging an initial audit. We assembled and submitted documents to the auditor and assisted the client in presenting evidence at the hearing. The final result of the hearing reduced the Medicaid overpayment amount from $1.4 million to just $24,083. To read more on this successful Medicaid action, click here.

State Included in Zone 4.

ZPIC Zones are broken up by state. Health Integrity serves as the Zone 4 ZPIC. As indicated above Zone 4 includes Texas, Colorado, New Mexico, and Oklahoma.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Comments?

Have you ever received notification of a ZPIC visit or audit? 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.

Stryker Orthopaedics Facing Dozens of Hip Implant Lawsuits

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

As of February 2013, more than 80 lawsuits have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey against Stryker Orthopaedics. Patients are claiming the company’s Rejuvenate and ABG II modular-neck femoral hip systems are defective, according to a number of news sources. The case is on track to becoming one of the largest mass-tort litigations in the country.

In July 2012, Stryker issued a voluntary recall of the Rejuvenate and ABG II modular-neck femoral hip systems. (Click here to see the press release from Stryker.) The company is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on patients who had implants installed. The letters state that Stryker will compensate patients for any tests or work that has to be done.

Click here to read a letter from Stryker to a surgeon.

Unfortunately, for some, this notice is too late. Hundreds of patients are already experiencing pain from the Stryker hip implants, which has forced them to have the implants removed. Even after surgery some patients alleged they have permanent damage and are demanding compensation.

Early Lawsuit Filed from Florida Patient.

According to the Palm Beach Post, one of the first lawsuits against Stryker came from a Boca Raton retiree. Her replacement came with a promise to last for decades. The device allegedly failed within months. Click here to read the patient’s entire story.

According to Drug Watch, most patients who received Stryker’s devices allegedly suffered from muscle, nerve and bone damage as the metallic components of the device rub against each other, causing metallic elements to be released into the body and be absorbed into the blood stream and body tissue. To read the entire article from Drug Watch, click here.

More Lawsuits to Come – Contact an Experienced Health Lawyer.

Since the implants were recently recalled, it’s expected that there are many more cases out there.

Many of the people who have already filed lawsuits claim Stryker marketed and sold a defective device and failed to warn the public, among other issues.

If you or a family member received a Stryker Rejuvenate or ABG II hip implant and suffered complications, you don’t have to face the medical issues alone. Contact an experienced attorney that is board certified in health law. Before you talk about settling, call an attorney.

Stryker Lawsuits Similar to DePuy.

According to an article in The Records, similar mass-tort cases in New Jersey include hundreds of lawsuits filed against DePuy Orthopaedics. More than 2,500 plaintiffs in that case alleged similar complaints due to a metallic hip part. DePuy’s product, ASR, was recalled by the company in August 2010. The cases being heard involve potentially hundreds of millions of dollars in settlements or verdicts. Click here to read the entire article from The Records.

Contact Experienced Health Law Attorneys.
If you or a family member received a Stryker Rejuvenate or ABG hip implant and suffered complications you don’t have to face the medical issues alone. Our attorneys are available seven days a week to answer your questions. We can help you decide whether filing a lawsuit is the right option for you. Our attorneys include those who are board certified by The Florida Bar in Health Law, as well as licensed health professionals who are also attorneys.

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

Comments?

Did you or someone you know have a Stryker Rejuvenate or ABG II modular-neck femoral hip implant? What has been your experience? Did you know about the recall? Are you in need of legal assistance? Please leave comments below.

Sources:

Markos, Kibret. “Mahwah-based Stryker Orthopaedics Faces Hip Implant Lawsuits.” The Records. (February 28, 2013). From: http://www.northjersey.com/mahwah/Over_80_lawsuits_on_hip_implants_filed_against_Mahwah-based_Stryker_Orthopaedics_.html?c=y&page=3

Singer, Stacey. “Artificial Hips Corrode, Poisoning Some Patients, Local Lawsuits Say.” The Palm Beach Post. (January 27, 2013) From: http://www.palmbeachpost.com/news/lifestyles/health/artificial-hips-corrode-poisoning-some-patients-lo/nT7jf/

Hooks, Beau. “Stryker Hip Replacement Lawsuits.” Drug Watch. (February 2013). From: http://www.drugwatch.com/stryker/lawsuit-hip-replacement/

Guilfoyle, Jeanine. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems.” Stryker. (July 6, 2012). From: http://www.stryker.com/stellent/groups/corporate/documents/web_prod/147504.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.

Multiple States Move to Enact New Laws Related to Controlled Substances

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

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

Prescription Drug Monitoring Programs by State.

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

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

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

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

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

Are Databases Just a Tool for Prosecution?

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

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

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

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

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

Comments?

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

Sources:

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

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

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

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

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

Lehigh University Student Sues Grad School for $1.3 Million for Bad Grade

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

While in school, we all received grades that we believed to be unfair or unwarranted. One graduate of Lehigh University in Pennsylvania, has taken her bad grade to court. She is suing the university over a “C+” grade. In the lawsuit, the student claims that if not for a zero she was given in participation for a fieldwork class in 2009, she would have gotten a “B.” That grade would have allegedly allowed the student to move on toward finishing her master’s in counseling and human services. The student claims the one bad grade prevented her from attaining her dream to become a licensed professional counselor. Now she is suing the university for $1.3 million, according to an article in The Morning Call.

Click here to read the entire article from The Morning Call.

Was the Grade Given for Unprofessional Behavior or in Retaliation of Student’s Activism?

According to an article in The Morning Call, the student claims she received the low grade because the teacher and the then-director of the degree program conspired to hold her back. The student allegedly claims they were unhappy she had complained after being forced to find a supplemental internship partway through the semester. The student also claims the teacher was biased against her (the student’s) activism for gay and lesbian rights.

Attorneys for the university argue the grade was given to the student in an effort to help her address the skills she needed to be a licensed professional counselor. It’s stated in the complaint that the student expressed unprofessional behavior during class, including outbursts of cursing and crying.

The student ended up graduating from Lehigh University with a master’s degree in human development. She now works as a drug and alcohol counselor, according to The Morning Call. The $1.3 million she is seeking represents the alleged difference in her earnings over her career if she was instead a state-certified counselor.

Can a Judge Change a Grade?

The judge in this case questions whether he has the legal authority to actually change a grade received by a student. He has looked at cases nationally and has been unable to find one in which a judge had done so. The student’s attorney believes the judge has a wide enough latitude to impose “equitable remedies,” according to The Morning Call.

From our experience with such matters, the courts are extremely reluctant to become involved in such academic matters. Absent convincing evidence of discrimination, it is doubtful the courts will decide in the student’s favor.

Legal Ramifications of this Case.

According to an article on Huffington Post, there have been a number of students who have sued their alma maters in grading conflicts. For example, two former Texas Southern University law students filed a lawsuit in 2012 against the university’s Thurgood Marshall School of Law because they received “Ds.” The bad grades led to their dismissal for not maintaining 2.0 GPAs and put a stop to their pursuit of becoming attorneys.

Click here to read more stories of students suing their schools.

Contact a Health Care Attorney that is Experienced in the Representation of Medical Students, Interns, Residents and Applicants.

The Health Law Firm and its attorneys represent medical school students in disputes with their medical schools, internship supervisors, and in dismissal hearings. We have represented residents, interns and fellows in various disputes regarding their academic and clinical performance, allegations of substance abuse, failure to complete integral parts training, alleged false or incomplete statements on applications, allegations of impairment (because of abuse or addiction to drugs or alcohol or because of mental or physical issues), because of discrimination due to race, sex, national origin, sexual orientation and on other matters.

To learn more about our experience in the representation of medical students, click here.

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 case? Do you think the judiciary should be injecting itself into the academic process? How do you think this lawsuit will end? Please leave any thoughtful comments below.

Sources:

Yates, Riley. “Judge decides quickly after request to dismiss Lehigh lawsuit over C+ grade.” The Morning Call. (February 13, 2013). From: http://articles.mcall.com/2013-02-13/news/mc-lehigh-university-student-sues-over-grade-0213-20130213_1_carr-and-nicholas-ladany-zero-in-classroom-participation-daughter-of-lehigh-finance

Kingkade, Tyler. “Megan Thode, Lehigh University Grad, Files $1.3 Million Lawsuit Over C+ Grade.” HuffingtonPost. (February 13, 2013). From: http://www.huffingtonpost.com/2013/02/13/megan-thode-lehigh-university-lawsuit_n_2671739.html?view=print&comm_ref=false

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. 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.