Chapter 34 Guideline and Lawsuit
In this book, I’ve repeatedly mentioned that the Japanese Dermatological Association guideline has no reference to addiction and rebound.
How does the guideline bind doctors who give medical care? I’d like to introduce two forms of literature that may answer this question.
“How to treat and utilize Practice Guideline”
By T Nakayama (associate professor, Kyoto University Dept. of Health Informatics)
In the Teaching Guideline for New Residency Training Programs
---------- Excerpt ----------
In applying the practice guideline in each clinical situation, it is essential to deliberately read and construe the contents and combine the experience as a medical expert, even though the guideline expressly shows evidence. It is not always right blindly complying with the guideline and it is not always forbidden or taken into court doing what is not instructed in it. On the other hand, medical activity largely deviated from the guideline will be increasingly required to identify the actual treatment and reasons in medical records.
----- End of excerpt -----
Another one was written by a professor of the Obsterics and Gynecology Department of Tsukuba University.
A Standard for Medical Care and Clinical Practice, EBM and Practice Guidelines
By H Yoshikawa published in the Journal of Obsterics and Gynacology, Vol. 58, No. 1(2006)N-3~N-7
----- Excerpt -----
Once the guideline is published, applicable clinical doctors should obey it in principle. If they choose or think it better not to obey, they are obliged to explain patients the reasons. Provided, however that, guideline authors will not take the responsibilities for the bad results due to incompliance. I hear that guideline authors were once sued in the U.S. and the NCCN guideline always states in the premise that the guideline instructions may not be applicable for all the cases, and guideline authors are not liable for treatment results. The guideline authors are obliged to review the guideline every three years and are not allowed to take an inattentive attitude. In obsterics and gynecology, it is important to make the guideline as a means to reduce medical disputes. In the U.S., doctors are accused less as long as following the guideline and lawyers are targeting medical malpractice resulting from non-obedience to the guideline. If it is recorded that treatment followed the guideline, doctors rarely lose in the suit even though the treatment outcome was bad. But it’s like putting the cart before the horse to make the guideline to justify the current medical practice in order to reduce the number of lawsuits. Lawyers think much of the guideline because it describes the standard practice based on reasonable grounds.
----- End of excerpt -----
The above literature indicates that the guideline does not clinically bind doctors, but deviation from it needs to be explained and identified in medical records. Dr. Yoshikawa also says that practice according to the guideline is seldom taken into court and likely to win if put on trial.
By the way, I searched the case where guideline authors were sued in the U.S. and found the following material that contained the applicable case story.
The Impact of Clinical Guidelines and Clinical Pathways on Medical Practice: Effectiveness and Medico-legal Aspects
By T S Cheah published in the Ann Acad Med Singapore 1998; 27:533-9
----- Excerpt -----
On the flip side of the issue, it could be quite possible that guideline developers could be held negligent if a patient suffered injury as a result of inadequate or erroneous guidelines. This was illustrated in the US case of Wickline versus State of California in 1986. In this landmark case, the California Medicaid (Medi-Cal) program refused a doctor’s request for additional days of patient monitoring on the basis that they were not required under the clinical algorithms developed by Medi-Cal. The patient was discharged and subsequently developed complications. Cost-saving reasons had overridden the doctor’s better clinical judgment. The patient in turn sued Medi-Cal for medical negligence in requiring the doctor to discharge the patient against the doctor’s better judgment for cost-containment reasons. The court warned that doctors could be held liable where they disregard good clinical judgment by following cost-containment guidelines when the outcome may adversely affect the patient.
----- End of excerpt -----
I also downloaded and read the NCCN Guideline’s preface, which repeatedly mentioned about indemnity at the end.
----- Excerpt -----
Disclaimer: These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no representations or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way.
----- End of excerpt -----
It seems a guideline legally protects clinical doctors to some extent as long as they follow it, and to fulfill this object, the guideline itself has to be properly prepared for the principle purpose of patient protection. If the guideline descriptions are apparently wrong, guideline authors could be held liable unless they are not specifically indemnified. The guideline is reliable because they are prepared under such strict rules.
Please look at the following statement a dermatologist introduced in Chapter 23 made on the clinic website.
----- Excerpt -----
■Big lie 3~Will rebound occur?■
1) One of the big lies we frequently hear is that topical corticosteroid (TCS) application may induce rebound. But what is called “rebound” is just a primary disease aggravation due to TCS discontinuation. For example, if TCS is discontinued while treating a rash at the discretion of patients even though it has not resided yet, the rash will naturally get worse. Not a few people consider it rebound phenomenon. Treatment should be continued till their dermatologist says that there’s no need to apply TCS any more.
2) It’s no use to retrieve medical studies from all over the world with the keywords of “topical corticosteroids” and “rebound. All we can hit are reviews on systemic steroids. In foreign countries, “rebound” means the one resulted from systemic steroid.
3) As seen from the above, it is a complete hogwash that TCS application may cause rebound. So don’t worry.
4) Don’t pay attention to doctors, pharmaceutists and friends around you who give you wrong information.
5) Please see your local dermatologists approved by the Japanese Dermatological Association if you have questions about TCS.
----- End of excerpt -----
The item 2) is definitely wrong. When a patient who got addicted to TCS due to long-term application tries to put a doctor on civil trial, the biggest obstacle is to prove the doctor’s negligence. What if this patient might be diagnosed as a steroid addict at another hospital or clinic?
As it is generally difficult to prove what kind of explanation a doctor made for a patient or which doctor’s prescription caused addiction, patients cannot usually prove the negligence on the side of doctors. But this dermatologist voluntarily notifies his own negligence on the clinic website. I think the copy of this URL page, the prescription record at the clinic and medical certificate of steroid addiction by another doctor are enough to prove the negligence of this doctor.
To prevent such a thing from happening, the Japanese Dermatological Association needs to specify the risks of addiction and rebound induced by prolonged application of TCS in its guidelines and to inform all members of such side effects as early as possible.
In this book, I’ve repeatedly mentioned that the Japanese Dermatological Association guideline has no reference to addiction and rebound.
How does the guideline bind doctors who give medical care? I’d like to introduce two forms of literature that may answer this question.
“How to treat and utilize Practice Guideline”
By T Nakayama (associate professor, Kyoto University Dept. of Health Informatics)
In the Teaching Guideline for New Residency Training Programs
---------- Excerpt ----------
In applying the practice guideline in each clinical situation, it is essential to deliberately read and construe the contents and combine the experience as a medical expert, even though the guideline expressly shows evidence. It is not always right blindly complying with the guideline and it is not always forbidden or taken into court doing what is not instructed in it. On the other hand, medical activity largely deviated from the guideline will be increasingly required to identify the actual treatment and reasons in medical records.
----- End of excerpt -----
Another one was written by a professor of the Obsterics and Gynecology Department of Tsukuba University.
A Standard for Medical Care and Clinical Practice, EBM and Practice Guidelines
By H Yoshikawa published in the Journal of Obsterics and Gynacology, Vol. 58, No. 1(2006)N-3~N-7
----- Excerpt -----
Once the guideline is published, applicable clinical doctors should obey it in principle. If they choose or think it better not to obey, they are obliged to explain patients the reasons. Provided, however that, guideline authors will not take the responsibilities for the bad results due to incompliance. I hear that guideline authors were once sued in the U.S. and the NCCN guideline always states in the premise that the guideline instructions may not be applicable for all the cases, and guideline authors are not liable for treatment results. The guideline authors are obliged to review the guideline every three years and are not allowed to take an inattentive attitude. In obsterics and gynecology, it is important to make the guideline as a means to reduce medical disputes. In the U.S., doctors are accused less as long as following the guideline and lawyers are targeting medical malpractice resulting from non-obedience to the guideline. If it is recorded that treatment followed the guideline, doctors rarely lose in the suit even though the treatment outcome was bad. But it’s like putting the cart before the horse to make the guideline to justify the current medical practice in order to reduce the number of lawsuits. Lawyers think much of the guideline because it describes the standard practice based on reasonable grounds.
----- End of excerpt -----
The above literature indicates that the guideline does not clinically bind doctors, but deviation from it needs to be explained and identified in medical records. Dr. Yoshikawa also says that practice according to the guideline is seldom taken into court and likely to win if put on trial.
By the way, I searched the case where guideline authors were sued in the U.S. and found the following material that contained the applicable case story.
The Impact of Clinical Guidelines and Clinical Pathways on Medical Practice: Effectiveness and Medico-legal Aspects
By T S Cheah published in the Ann Acad Med Singapore 1998; 27:533-9
----- Excerpt -----
On the flip side of the issue, it could be quite possible that guideline developers could be held negligent if a patient suffered injury as a result of inadequate or erroneous guidelines. This was illustrated in the US case of Wickline versus State of California in 1986. In this landmark case, the California Medicaid (Medi-Cal) program refused a doctor’s request for additional days of patient monitoring on the basis that they were not required under the clinical algorithms developed by Medi-Cal. The patient was discharged and subsequently developed complications. Cost-saving reasons had overridden the doctor’s better clinical judgment. The patient in turn sued Medi-Cal for medical negligence in requiring the doctor to discharge the patient against the doctor’s better judgment for cost-containment reasons. The court warned that doctors could be held liable where they disregard good clinical judgment by following cost-containment guidelines when the outcome may adversely affect the patient.
----- End of excerpt -----
I also downloaded and read the NCCN Guideline’s preface, which repeatedly mentioned about indemnity at the end.
----- Excerpt -----
Disclaimer: These guidelines are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network makes no representations or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way.
----- End of excerpt -----
It seems a guideline legally protects clinical doctors to some extent as long as they follow it, and to fulfill this object, the guideline itself has to be properly prepared for the principle purpose of patient protection. If the guideline descriptions are apparently wrong, guideline authors could be held liable unless they are not specifically indemnified. The guideline is reliable because they are prepared under such strict rules.
Please look at the following statement a dermatologist introduced in Chapter 23 made on the clinic website.
----- Excerpt -----
■Big lie 3~Will rebound occur?■
1) One of the big lies we frequently hear is that topical corticosteroid (TCS) application may induce rebound. But what is called “rebound” is just a primary disease aggravation due to TCS discontinuation. For example, if TCS is discontinued while treating a rash at the discretion of patients even though it has not resided yet, the rash will naturally get worse. Not a few people consider it rebound phenomenon. Treatment should be continued till their dermatologist says that there’s no need to apply TCS any more.
2) It’s no use to retrieve medical studies from all over the world with the keywords of “topical corticosteroids” and “rebound. All we can hit are reviews on systemic steroids. In foreign countries, “rebound” means the one resulted from systemic steroid.
3) As seen from the above, it is a complete hogwash that TCS application may cause rebound. So don’t worry.
4) Don’t pay attention to doctors, pharmaceutists and friends around you who give you wrong information.
5) Please see your local dermatologists approved by the Japanese Dermatological Association if you have questions about TCS.
----- End of excerpt -----
The item 2) is definitely wrong. When a patient who got addicted to TCS due to long-term application tries to put a doctor on civil trial, the biggest obstacle is to prove the doctor’s negligence. What if this patient might be diagnosed as a steroid addict at another hospital or clinic?
As it is generally difficult to prove what kind of explanation a doctor made for a patient or which doctor’s prescription caused addiction, patients cannot usually prove the negligence on the side of doctors. But this dermatologist voluntarily notifies his own negligence on the clinic website. I think the copy of this URL page, the prescription record at the clinic and medical certificate of steroid addiction by another doctor are enough to prove the negligence of this doctor.
To prevent such a thing from happening, the Japanese Dermatological Association needs to specify the risks of addiction and rebound induced by prolonged application of TCS in its guidelines and to inform all members of such side effects as early as possible.