Tag Archives: health care attorney

Watch Out for Legal Pitfalls Associated with Telemedicine

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

With all the new technologies, mobile medical applications, expansion of access to health care under the Affordable Care Act (ACA), and the emphasis on quality care, telemedicine is at the forefront of the health care industry.

Now is the time to educate yourself on the new opportunities in practicing telemedicine. As with any new health care business model, you also have to assess the risks and be sure you are complying with the ever increasing number of regulations.

Where Telemedicine Stands Today.

The Centers for Medicare and Medicaid Services (CMS) can be credited for the telemedicine revival. In 2011, CMS issued a final rule permitting a more flexible process for credentialing and privileging practitioners who provide telemedicine services. Telemedicine escalated in 2013, when federal and state legislation and major insurers expanded the types of reimbursable telemedicine services. Now in 2014, there are more partnerships between insurers and health care delivery systems to provide patients access to specialists through telemedicine programs.
For example, WellPoint, Inc., and Aetna, Inc., among other health insurers, are letting millions of patients schedule online visits with health care professionals. These insurance companies are working together with companies that offer virtual visits with doctors who, in some states, can prescribe drugs for anything from sinus infections to back pain. According to Bloomberg, this is a major advancement for telemedicine. To read the entire article from Bloomberg, click here.

The Current Status of Telemedicine in Florida.

In March 2014, the Florida Boards of Medicine and Osteopathic Medicine adopted updated standards for practicing telemedicine. The final rule, 64B8-9.0141, Florida Administrative Code, defines telemedicine as:

the practice of medicine by a licensed Florida physician or physician assistant where patient care, treatment, or services are provided through the use of medical information exchanged from one site to another via electronic communications. Telemedicine shall not include the provision of health care services only through an audio only telephone, email messages, text messages, facsimile transmission, U.S. mail or other parcel service, or any combination thereof.

The rule states that the standard of care shall remain the same regardless of whether a physician provides services in person or by telemedicine. Also, those providing telemedicine services are responsible for the safety, security and adequacy of their equipment.

Several other parts of the new Florida telemedicine rule are worth noting:

1. Telemedicine is sufficient to establish a physician-patient relationship;
2. All regulations regarding patient confidentiality and record keeping are applicable;
3. The rule specifically exempts medical advice given by emergency responders including EMTs, paramedics and emergency dispatchers;
4. The rule also does not apply to physicians or physician assistants providing emergency care under conditions requiring immediate medical care; and
5. Florida law presently prohibits prescribing controlled substances via telemedicine.


Telemedicine and the Potential Legal Issues.

As telemedicine grows, so will the oversight and scrutiny by state medical boards and federal and state regulatory agencies. Here are some areas to be mindful of:

- Reimbursement: This is continuously an issue with telemedicine. Medicare reimbursement for telemedicine services is limited and generally requires face-to-face contact between patients and providers. Medicaid reimbursement varies from state-to-state, and only about 20 states have enacted statutes that require reimbursement for certain telemedicine services. This means health care providers need to review Medicare and Medicaid reimbursement policies, state health insurance regulations, and provider payer contract requirements so that they are aware of the reimbursement requirements that may affect their billing. Educate yourself on what will and what won’t be reimbursed, and only submit compliant claims to avoid audits.

- Fraud and Abuse: As a telemedicine provider, you will most likely initiate business arrangements between distinct health care entities that may include the lease of equipment or the use of a product owned, in part, by physicians. Arrangements like this need to be written with federal fraud and abuse laws in mind, including the Anti-Kickback Statute and the Stark Law. For more advice on telemedicine-related fraud issues, review advisory opinions issued by the Office of the Inspector General (OIG).

- Medical Staff Bylaws: Health care organizations that depend on information from a distant-site hospital or telemedicine entity to credential and privilege telemedicine practitioners must revise their medical staff bylaws and policies to include criteria for granting privileges to distant practitioners, and a procedure for applying the criteria. Additions should also include what category of the medical staff distant-site telemedicine practitioners will join, the level of involvement they may have in medical staff committees, and what procedural rights they should be given.

- Credentialing and Privileging: Under CMS’ final rule, health care organizations may rely on the credentialing and privileging decisions of distant-site hospitals or the information provided by other telemedicine entities when determining privileges for distant-site practitioners who provide telemedicine services, as long as certain conditions are met, including a compliant written agreement.

- Patient Privacy: Providers are responsible for ensuring they have secure communication channels, implementing business associate and other confidentiality and privacy agreements, educating staff regarding the appropriate use of telemedicine, and understanding how and what patient information is being collected and stored.

- Compliance with State Requirements: Most states require physicians engaging in telemedicine to be licensed in the state where the patient is located. It would be wise for health care organizations to seek the legal guidance of an experienced health law attorney to navigate individual state requirements.

- Interactions with Pain Management Laws: Our practice has seen many physicians become the subject of some kind of government investigation or action resulting from the remote practice of medicine in a pain management setting. These telemedicine rules do not alter the status quo in pain management. Physicians are still required to see patients in a face-to-face encounter in order to prescribe controlled substances for the treatment of pain. There are discussions among the members of the Florida  Boards of Medicine and Osteopathic Medicine to permit limited prescribing of controlled substances through telemedicine. However, the boundaries of a future rule are unclear. Considering the hard-line stance the Boards have taken toward pain management in general, it is unlikely that any final rule would authorize the remote practice of pain management.

Health care providers need to stay mindful of the listed legal issues, and any others that may come up. It is important when practicing telemedicine to ensure your services are compliant, and you appropriately protect patient safety and privacy.

Comments?

Does your practice use telemedicine? In your opinion what are the benefits and what are the difficulties of telemedicine? Please leave any thoughtful comments below.

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

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

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings. To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.TheHealthLawFirm.com.

Sources:

French, Marie. “The Doctor Will Click on You Now.” Bloomberg. (July 13, 2014). From: http://www.bloomberg.com/news/2014-07-14/the-doctor-will-click-on-you-now.html

Kadzielski, Mark and Kim, Jee-Young. “Telemedicine: Many Opportunities, Many Legal Issues, Many Risks.” JD Supra. (July 30, 2014). From: http://www.jdsupra.com/legalnews/telemedicine-many-opportunities-many-l-18993/

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. http://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 © 1996-2014 The Health Law Firm. All rights reserved.

Fake Surgeon in Florida Accused of Performing Liposuction Without a License

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

A Kissimmee, Florida, man was arrested on December 18, 2013, on charges that he has been allegedly performing liposuction without a medical license in a Central Florida clinic. According to the Orlando Sentinel, the Metropolitan Bureau of Investigation (MBI) began investigating the phony surgeon about a year ago, after Florida Department of Health (DOH) received a complaint about the clinic in which the phony doctor worked. The clinic was called “Sculptural Orlando.”

Click here to read the article from the Orlando Sentinel.

Investigators Looking for More Victims.

According to the Orlando Sentinel, it is alleged the fake surgeon has been performing illegal liposuction surgeries for about a year and telling his patients he was a licensed medical doctor.

After further investigation, MBI agents discovered the clinic was licensed as a massage establishment and the fake surgeon did not hold a valid medical license in Florida. Several MBI agents visited the clinic undercover, posing as potential customers. The agents allege the fake surgeon performed evaluations on them and showed them before-and-after photos of his patients.

The DOH is still looking for victims or tips related to the fake surgeon and any unlicensed activity at the clinic.

Practicing Without a License Is a Crime.

This is by no means the first report we’ve heard of phony health care professionals operating on patients or injecting people with toxic chemicals. For some reason, Florida seems to get more than its fair share of these.

Practicing medicine without a license is a crime. Additionally, so is helping someone practice medicine without a license. As a licensed healthcare practitioner, you may be asked to supervise others or participate in a clinic or practice as a “medical director,” supervisor, or monitor. Remember that your license may be at stake with any wrongdoing by those subordinates under your supervision. Before you join a practice or agree to supervise others, check first with the DOH that the other providers have legitimate, active licenses. You can verify a license for free on the DOH’s website.

Also, remember that a license to practice medicine in Venezuela, Cuba, Mexico or anywhere else, is just that: a license to practice in that country. It does not allow a person to practice medicine in the United States or Florida. A license from the State of Florida is required to practice in Florida, except for certain military and government-employed physicians. Always check a physician’s license.

Additionally, a medical clinic that is not owned 100% by a licensed physician, podiatrist, chiropractor, physical therapist or nurse practitioner (or a few other specified medical professions) must have a separate Health Care Clinic License (HCCL) that is issued by the Agency for Health Care Administration (AHCA).

We have been consulted by many professionals who have found themselves caught working in illegal clinics. For example, a medical clinic cannot be owned by a deceased physician’s spouse who is not a licensed health professional, unless it has a HCCL. A clinic cannot be owned 50% by a CPA and 50% by a doctor, unless it has a separate HCCL. A dental clinic cannot be owned 20% by a non-dentist and 80% by a dentist; this is illegal and even a HCCL will not make it legal.

Always check out the credentials of a clinic, and its owners before you accept a job there or before you seek treatment there.

More Stories on Fake Physicians and Other Phony and Fraudulent Professionals to Come.

On this blog we will include additional articles on fake doctors and health care professionals, similar to those we have published in the past.

To see a blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking here. To read the story of a fake doctor in Texas accused of injecting patients with silicone instead of Botox, 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, 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 http://www.TheHealthLawFirm.com.

Comments?

What do you think of all of these news stories of phony health care professionals? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Man Accused of Performing Illegal Liposcutions.” Orlando Sentinel. (December 19, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-liposuction-without-license-arrest-20131219,0,7677863.story

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. 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.

Fake Doctor in Texas Accused of Injecting Patients with Silicone Instead of Botox

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A South Texas woman was charged on October 31, 2013, for allegedly injecting people with silicone, that she claimed was Botox. The phony health professional, described in some media reports as an “unlicensed plastic surgeon,” has been charged with practicing medicine without a license. According to Reuters, the unlicensed health professional could also be facing charges of manslaughter if investigators confirm that a woman’s death was related to treatments received from the imposter.

Click here to read the entire article from Reuters.

If convicted, the fake health care professional could spend up to ten (10) years in prison and have to pay up to $10,000 in fines.

Investigators Looking for More Victims.

Investigators say this phony health professional would travel to different spas and massage parlors along the Texas-Mexico border offering her services and leaving advertisements. She allegedly made injections in patients’ lips, buttocks and legs. The advertisements seized by authorities touted collagen treatments for $250.

According to Fox News, investigators learned of the underground practice when a victim allegedly received a series of injections in her legs in August 2013. The victim has allegedly been hospitalized since October 9, 2013. Authorities also say they are investigating the death of a woman who may have been a victim of the treatments. So far around 30 victims have been identified, but investigators say there could be more, according to Fox News.

To read the Fox News story, click here.

Underground Injections Happen All Over the Country.

This is by no means the first report we’ve heard of phony health care professionals injecting people with toxic chemicals.

In February 2013, a South Florida man was arrested for allegedly injecting people with silicone in a West Palm Beach motel room. According to police, this fake physician injected his patients with buttocks-enhancing silicone injections. He would then allegedly seal up the skin wounds with Krazy Glue. To read more on this, click here to read my previous blog.

As far as we know, there is no relationship between the Florida fake doctor and the Texas fake doctor. However, they could have attended the same medical school.

Practicing Without a License Is a Crime.

Practicing medicine without a license is a crime. Additionally, so is helping someone practice medicine without a license. As a practitioner, you may be asked to supervise or join a practice. Remember that your license may be at stake with any wrongdoing by your subordinates. Before you join a practice or agree to supervise others, check first with the Department of Health (DOH) that the other providers are legitimate. You can verify a license for free on the DOH’s website.

Also, remember that a license to practice medicine in Venezuela, Cuba, Mexico or anywhere else, is just that: a license to practice in that country. It does not allow a person to practice medicine in the United States. A specific license from the State of Florida is required to practice in Florida, except for certain military and federal physicians. Always check a physician’s license.

More Stories on Fake Physicians and Other Phony and Fraudulent Professionals to Come.

In the near future on this blog we will include additional articles on fake doctors and health care professionals.

To see a blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking 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, 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 http://www.TheHealthLawFirm.com.

Comments?

What do you think of all of these news stories of phony health care professionals? Please leave any thoughtful comments below.

Sources:

Taylor, Jared. “Phony Plastic Surgeon Accused of Using Silicone for Botox.” Reuters. (October 31, 2013). From: http://www.reuters.com/article/2013/10/31/us-usa-crime-texas-idUSBRE99U1CT20131031

Associated Press. “South Texas Woman Charged for Allegedly Injecting Client; Authorities Seek More Victims.” Fox News. (October 31, 2013). From: http://www.foxnews.com/us/2013/10/31/south-texas-woman-charged-for-allegedly-injecting-clients-authorities-seek-more/

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.

The American Academy of Family Physicians Releases Third List for Choosing Wisely Campaign

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

On September 24, 2013, the American Academy of Family Physicians (AAFP) released its third list of commonly prescribed tests and procedures that may not be necessary. This list is part of the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign.

The Choosing Wisely Campaign was initiated to give patients a catalog of procedures, tests and treatments that have been overused, misused or have been identified as ineffective. Since its launch in April 2012, more than fifty (50) medical specialty societies have created lists of procedures, tests and drug treatments that deserve to be questioned before a physician orders them or patients accept them.

The purpose is to help patients become more discriminating about what care they receive. Physicians and health care providers also need to use this information to review the latest research and use that information to help avoid any litigation.

I’ve previously written about the Choosing Wisely campaign. Click here for part one and here for part two.

AAFP’s Updated List of Commonly Prescribed Tests and Procedures That May Not be Necessary.

1. Do not prescribe antibiotics for otitis media in children aged 2-12 years with non-severe symptoms where the observation option is reasonable.

2. Do not perform voiding cystourethrogram routinely in first febrile urinary tract infection in children aged 2-24 months.

3. Do not routinely screen for prostate cancer using a prostate-specific antigen (PSA) test or digital rectal exam. Evidence suggests that PSA-based screening leads to an overdiagnosis of prostate tumors.

4. Do not screen adolescents for scoliosis. Potential harms include unnecessary follow-up visits resulting from false-positive test results.

5. Do not require a pelvic exam or other physical exam to prescribe oral contraceptive medications. Hormonal contraceptives are safe, effective, and well tolerated by most women.

Click here to read the AAFP’s previous recommendations.

Health Care Providers and Professionals’ Responsibility to Patients.

A doctor should have the knowledge, skill, training, and confidence to know when such tests and procedures are not warranted. Also, a health care professional or provider should not be swayed by increasing his/her personal bottom line. Specifically, physicians that work in a fee-for-service setting that rewards doctors for performing more procedures are at risk for ordering unnecessary tests or procedures. If a physician persists in ordering these tests solely for the means of increasing profits, he or she should be penalized. If not, the physician should be able to justify them.

Laws Protect Patients from Unnecessary Testing.

This situation may have the side effect of promoting additional litigation against doctors, healthcare clinics and hospitals that provide the unnecessary tests and procedures. Many states have laws that prohibit unnecessary tests and procedures and sanction those who provide them. For instance, Section 766.111, Florida Statutes, provides a private cause of action by a patient against a health provider who orders or furnishes such “unnecessary” diagnostic tests, but unlike other tort and medical malpractice statutes, it allows the prevailing party in such a case to recover attorney’s fees and costs. This law may by itself promote litigation in the face of the lists of tests produced by the specialty groups in the Choosing Wisely campaign.

Look for More Whistleblower/Qui Tam Cases.

As this list continues to grow, I believe that we will see more qui tam/whistleblower and false claims cases.

Qui tam cases have been brought under the federal False Claims Act for the recovery of Medicare payments from hospitals, physicians, nursing homes, diagnostic testing facilities, clinical laboratories, radiology facilities and many other types of healthcare providers. These cases allege that a false claim was submitted to the government. If the test or procedure was unnecessary, then it seems almost axiomatic that a claim for it is false. The plaintiff bringing such cases receives a percentage of the recovery, which often amounts to millions of dollars in successful cases.

Most states now have similar false claims act or qui tam laws providing similar causes of action and recoveries to individual plaintiffs in the case of state Medicaid payments as well.

Because medical necessity is a requirement for practically every Medicare and Medicaid service, as well as most services paid by private health insurers, the lists provided by the specialty may very well be exhibit one in future lawsuits.

We’ve recently written about a couple of whistleblower/qui tam cases stemming from unnecessary procedures. To read a blog on a group of Florida radiation oncology service providers accused of performing unnecessary and improperly supervised procedures, click here. To read a blog on Winter Park Urology’s settlement over allegations stemming from radiation therapy used to treat cancer patients, click here.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

As a health care professional or provider what do you think of the Choosing Wisely campaign? Please leave any thoughtful comments below.

Sources:

Hand, Larry. “AAFP Releases Third Choosing Wisely List.” Medscape. (September 25, 2013). From: http://www.medscape.com/viewarticle/811638

Carman, Diane. “Useless, Costly Medical Procedures Targeted by Choosing Wisely Campaign.” Health Policy Solutions. (October 15, 2013). From: http://www.healthpolicysolutions.org/2013/10/15/useless-costly-medical-procedures-targeted-by-choosing-wisely-campaign/

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

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

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

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

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

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

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

Protect Your License from These Adverse Actions.

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

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

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

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

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

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

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

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

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

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

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

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

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

What Should You Do?

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

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

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

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

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

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

Professional Liability Insurance.

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

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

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

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

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians, nurses, pharmacists, pharmacies, dentists, mental health counselors, massage therapists and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

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

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

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

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

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

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

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

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

Examples of What Not To Do.

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

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

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

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

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

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

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

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

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

Ask for a Hearing and Be Prepared.

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

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

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

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

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

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

Contact Experienced Health Law Attorneys Today.

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

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

Comments?

Have you faced the Committee? What was the experience like? Did you retain experienced legal counsel? Please leave any thoughtful comments below.

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

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

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

Lance Leider headshotBy 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

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

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

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

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

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

A Number of Patients Speak Out On Surgeries.

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

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

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

Surgeon Suspended for Performing Robotic Surgeries.

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

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

FDA and Other Medical Societies Leery of Robotic Procedures.

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

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

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

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

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

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

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

Comments?

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

Sources:

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

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

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

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

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

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

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

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

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

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

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

Patricia's Photos 013By 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

GFI Blog LabelBy 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.