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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.

Colorado Unveils New Weapon in Fight Against Prescription Drug Abuse

By Carole C. Schriefer, R.N., J.D., The Health Law Firm

In the United States, Colorado ranks among the highest in prescription drug abuse. Prescribing practices have contributed to both the overuse as well as the illegal use of controlled substances. Recently, the Colorado Medical Board in collaboration with the Colorado Dental Board, Colorado Board of Nursing, Colorado Board of Pharmacy, and the Nurse-Physician Advisory Task Force for Colorado Healthcare, passed a policy for prescribing and dispensing opioids. This is the first time that all four Colorado licensing agencies have worked together to formulate a common policy for health care providers.

The new guidance sets the tone for how complaints involving prescribing and dispensing controlled substances will be viewed by these regulatory boards.

To read the new policy in its entirety, click here.

An Overview of the Prescribing and Dispensing Policy.

The new policy aims to reduce prescription drug abuse by better managing opioid prescribing and dispensing. The policy states that providers working with patients who are prescribed opioids should:

– Follow the policy for prescribing and dispensing opioids;
– Be informed about evidence-based practices for opioid use in health care and risk mitigation;
– Collaborate with the integrated health care team to decrease overprescribing, misuse and abuse of opioids;
– Use the Colorado Prescription Drug Monitoring Program (PDMP) when initially prescribing medication and with each refill;
– Use caution when dispensing to new or unknown patients, filling weekend or late day prescriptions, and when filling prescriptions issued by a provider far from the location of the pharmacy; and
– Educate patients on appropriate use, storage and disposal of opioids, risks and the potential for diversion.

Red Flags.

The new policy describes certain “red flags” health care providers should look for when prescribing and dispensing opioids. It alludes to certain prescription amounts and types that will likely be considered substandard in the absence of a compelling reason for the prescription. For example, the policy advises opioid doses greater than the equivalent of 120 mg morphine are dangerous. The policy also advises against opioid treatment that exceeds 90 days. It’s suggested that prescribers should consider discontinuing opioid therapy when:

– The underlying painful condition is resolved;
– Intolerable side effects emerge;
– The patient’s quality of life fails to improve;
– Functioning deteriorates; or
– There is aberrant medical use.

Tread Lightly When Prescribing Opioids.

Whether you are a physician, nurse, dentist, pharmacist or other health care provider practicing pain management, you should read the entire policy and strictly follow its guidance. Keep detailed records of your pain patients’ care, including copies of PDMP data. As a professional dealing with pain patients, you should also feel comfortable referring appropriate patients to addiction and pain management specialists at any sign of abuse. Failure to follow the new policy may lead to disciplinary action against your license.

For more tips to protect yourself from being accused of overprescribing, click here for a previous blog.

Comments?

What do you think of Colorado’s policy for prescribing and dispensing opioids? Do you think this new policy will make an impact on the prescription drug abuse throughout the state? As a health care provider, will you follow the new policy? Please leave any thoughtful comments below.

Contact A Lawyer Experienced in the Representation of Health Care Professionals in Pain Management Defense.

The Health Law Firm attorneys represent physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities and other health care providers in different cases involving allegations of overprescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), complaints against professional licenses, and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and administrative hearings at both the state and federal level.

Call (970) 416-7456 now or visit our website www.TheHealthLawFirm.com.

About the Author: Carole C. Schriefer is a nurse-attorney with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456.

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 © 1999-2014 The Health Law Firm. All rights reserved.