medical errors | The Health Law Firm Blog

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.

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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.

Quality of Care: New Study Finds That Medical Errors Are Third Leading Cause of Death in U.S.

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
A new study by patient safety researchers revealed that common medical errors are now the third leading cause of death in the U.S., after heart disease and cancer. Their analysis, published in the British Medical Journal (BMJ) on May 3, 2016, contends that “medical errors” in hospitals and other health care facilities are incredibly common and may now be the third-leading cause of death in the United States — claiming 251,000 lives every year, more than respiratory disease, accidents, stroke and Alzheimer’s.

The Blame Game: From Bad Doctors to Systemic Issues.

Dr. Martin Makary, a surgical director at the Johns Hopkins University School of Medicine who led the research in this case, said in an interview that the category of “medical errors” includes everything from bad doctors to more systemic issues such as communication breakdowns when patients are handed off from one department to another. Dr. Makary said rates for deaths related to “medical care gone awry” aren’t tracked in any standardized way. Because of this, deaths due to medical errors aren’t tallied in the same way as heart disease, cancer and other medical conditions when it comes to national statistics on causes of death.

The Findings.

The published findings come from an analysis of death rate records spanning eight years. Dr. Makary told CBS News that national mortality statistics are calculated using billing codes, which don’t have a built-in way to recognize incidence rates of mortality due to medical errors. To read his full interview with CBS on this study, click here.

For the study, Dr. Makary and his colleagues evaluated four separate studies that analyzed medical death rate data from 2000 to 2008, including one by the U.S. Department of Health and Human Services’ Office (HHS) of the Inspector General and the Agency for Healthcare Research and Quality. Based on 2013 data on hospitalization rates, they found that of 35,416,020 hospitalizations, that 251,454 deaths were attributable to a medical error. They said that adds up to 9.5 percent of all deaths a year in the U.S.

According to the Centers for Disease Control and Prevention (CDC) data, heart disease is the current leading cause of death in the U.S., killing more than 611,000 people per year. Cancer comes in second with more than 584,000 deaths. The new research would place medical errors at a solid third place–ahead of respiratory disease, which is responsible for almost 150,000 annual deaths.

The Many Forms of Medical Errors.

Medical errors can take a number of different forms, including diagnostic errors–missing the correct diagnosis due to inadequate evaluation of a patient–and drug mishaps. Additionally, unnecessary surgery, not calling in a specialist when one is needed, and missing the diagnosis of life-threatening conditions such as septic shock also feed into the problem. Most such instances reflect system-wide problems, such as poorly coordinated care and inconsistencies in insurance coverage, among other issues, and cannot simply be blamed on “bad” doctors.

“Human error is inevitable. But while we cannot eliminate human error, we can better measure the problem to design safer systems mitigating its frequency, visibility, and consequences,” Makary wrote in the study. To read further on the study from the BMJ, click here.

These Statistics Should Not Be a Shock.

Unfortunately, the results of this study should not be a shock to anyone. A similar study performed by the 1999 Institutes of Medicine (IOM) entitled “To Err Is Human: Building a Safer Health Care System” produced similar conclusions. What is shocking is that after all of these years, even with this knowledge, preventable medical mistakes costing tens of billions of dollars and tens of thousands of lives each year are still occurring.

For further discussions of the 1999 IOM report, click here and here.

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The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians in investigations and at Board of Medicine and Board of Osteopathic Medicine hearings. We represent physicians accused of wrongdoing, in patient complaints and in Department of Health investigations.

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Sources:

Nation’s Third Leading Cause of Death: Medical Errors, Study Finds.” AHLA. (May 6, 2016.) Web.

Cha, Ariana. “Researchers: Medical errors now third leading cause of death in United States.” The Washington Post. (May 5, 2016). Web.

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.

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