Medical Standards Seen from the Perspective of Changes in Academic Society Themes: Investigation of a Lawsuit Concerning the Prevention of Venous Thromboembolism

Abstract

Objective: To determine whether a violation of the standard of care for prevention of pulmonary embolism by preventing deep vein thrombosis occurred in 1999.

Materials and methods: Themes from past general meetings of the three societies that comprise the Japanese Board of Cardiovascular Surgery that pertained to venous thromboembolism from 1999 to 2006 were examined and analyzed for an appeal hearing to determine whether a violation had occurred.

Results: The first pertinent session on a method for the prevention of pulmonary embolism was presented in 2006 by the Japanese Society for Vascular Surgery. Thus, the medical treatment performed in this case did not violate the standard of care in 1999.

Conclusion: The “standard of medical treatment at the time”, can be discerned by tracing consensus agreement at session meetings. If the consensus from each session is recorded, a more detailed analysis can be made of the agreement reached by board members.

Introduction

The judicial system must make many decisions on whether or not a medical procedure performed at a defending institution strayed from the expected “standard of medical care of the time”. Since legal judges are not medical experts, serious consideration is given to the written opinions of the plaintiff, the defendant’s doctors, or the official judgment of an impartial third party. These written opinions and judgments must give a true and unbiased evaluation based on the medical standards of the time. However, medicine continues to develop daily; it is a process of reflection and renewal, and thus treatments themselves are fluctuating entities. For this reason, each medical judgment is different. As medical standards shift, an ambiguity in judgment arises, and this leads to a distrust of medical care.

The establishment of medical standards should be based on the consensus of the medical community. Themes (session theme) that are recurrently adopted at medical conventions provide suitable material for the consideration of medical standards. Repetition of a theme is a good indicator of the value of a theme’s investigation. Consensus opinions reached on debated themes reflect the standard of medical care of the time (of course, dissenting opinions often exist).

In order to analyze the standard of medical care, it is imperative to understand this progression of themes. How they originate, how they are selected, how problems are presented, and how themes are accepted by the societies’ members.

Materials and Methods

Selection of Session Theme

Sessions pertaining to the direct connection between deep vein thrombosis and pulmonary embolism were investigated. Further, sessions reviewed were those in which a medical society consensus could be formulated. These were: symposiums, workshops, consensus meetings, plenary sessions, president demanded sessions, debate sessions and panel discussions, all given at general assemblies. All other sessions were omitted.

The Societies Focused Upon

The majority of Japanese venous disease patients are cared for by vascular surgeons, with most practitioners belonging to the Japanese Society for Vascular Surgery.Licensing in this specialty is handled solely by the Japanese Board of Cardiovascular Surgery. The three bodies that compose this board−namely, the Japanese Society for Vascular Surgery, the Japanese Society for Cardiovascular Surgery and the Japanese Association for Thoracic Surgery–were the objects of this study. The time span of this investigation was from 1999 to 2006.

Outline of the Case Judged and Judgment Method

The central point of the case being appealed was whether or not the measures employed for prevention of pulmonary embolism at the time were appropriate. In 1999, the patient was admitted to a local general hospital for surgery. The patient’s obesity and a long surgical procedure posed a risk for deep vein thrombosis, however, no swelling of the lower extremities existed and the patient displayed no deep vein thrombosis. Post-surgery, the patient suddenly developed a pulmonary embolism. The expert opinion written for the plaintiff stated that this was caused by the hospital’s negligence in not following preventative measures as per the guidelines of 1999. The courts then compared the open prevention measures policy of the defendant hospital and the actual level of practice provided, with those of other local hospitals of comparable status.

There was little objective data reflecting the “standard of medical care of the time” for the defendant hospital and those of comparable scale. Therefore, “pulmonary embolism prevention concepts” that would create the “standard of medical care” of the time were examined. The preventative strategies for pulmonary embolism included the “early diagnosis and treatment of deep vein thrombosis” and “the prevention of deep vein thrombosis itself”. The former had been hastily established by Japanese pulmonary specialists of the time. The latter was a method practiced in the western world, however the designated appropriate dosage amounts for heparin differed for Japan and the west. Analysis of the results of session themes as objective data was used to determine which method was the “standard of medical care” in 1999. This result was given to the court.

Results

Session Themes

Themes from the General Assembly’s collections with the phrases “deep vein thrombosis” or “pulmonary embolism” in the title were examined. The Japanese Association for Thoracic Surgery had no relevant topics, and the Japanese Society for Cardiovascular Surgery had one session from 2005 entitled “Guidelines for Treatment of Venous Thromboembolism”. The Japanese Society for Vascular Surgery had five sessions in which the prevention, diagnosis and treatment of pulmonary embolisms were dealt with (Table 1).

Also, of these three societies, the first and only to have a session theme on “deep vein thrombosis prevention” as a means of pulmonary embolism prevention was the Japanese Society for Vascular Surgery (“Inspection and Problems of the Guidelines for Venous Thromboembolism”). It became clear that prior to this, the Japanese Society for Vascular Surgery was vigorously centered on the established method of “early diagnosis and treatment of deep vein thrombosis” and that this was the standard method for prevention of pulmonary embolism (Table 1).

Conclusion of Suit

It was clear that the 1999 “standard of medical care” for prevention of pulmonary embolism was, the “early diagnosis and treatment of deep vein thrombosis”. The investigation into “prevention of pulmonary embolism through the prevention of deep vein thrombosis” was not undertaken by the medical community until 2006. Further, the first guideline relating to the prevention of venous thrombosis, created by the Japanese Circulation Society in 2004, did not exceed a translation of western guidelines and was not born of the structure of Japanese illness.¹⁾ This did not gain consensus from the medical community, and could only be regarded as falling within the confines of an informational reference. It follows that prior to 2004, even though the writing referred to as a guideline in 1999 touched on the “prevention of pulmonary embolism through the prevention of deep vein thrombosis”, this did not reflect the “standard of medical care” of the country at the time.

Summarily, preventative measures for pulmonary embolism in 1999 were the “early diagnosis and treatment of deep vein thrombosis”, and not the “prevention of pulmonary embolism through the prevention of deep vein thrombosis”. The suit concluded that it could not be said that the “defendant hospital was liable for the development of the pulmonary embolism” through not taking measures to prevent deep vein thrombosis at the time.

Discussion

Features of a Society’s Specialty

Of the three associations that focus on the specialty of venous diseases and compose the Japanese Board for Cardiovascular Surgery, much activity is centered on the Japanese Society for Vascular Surgery. However, there are many specialists who, due to many restrictions, are unable to obtain a position on the Japanese Board for Cardiovascular Surgery. This is a reflection of the thought that society expects someone other than cardiovascular surgeons to be specialists in vascular disease.

Standard of Medical Care

From a medical viewpoint, the “Standard of medical care”, is not the average level of care, nor is it a minimal level that hospitals must maintain. Rather, it is a provisional goal used by the judicial system designed to raise the level of care provision of all members of the medical society to the highest level”.

Incidentally, the judicial system defines “standard of medical care” as “the standard of medical treatment claimed by the medical institution (at the time) based on contractual medical care (at the time)”. Medicine must continually improve, and “the expectation held by patients that the medical institution through its nature seeks to improve binds (patients and hospitals to) a medical contract”. Through this premise, the “standard of medical care” is fixed until such time as there is a medical association presentation or addendum report. The famous Supreme Court decision of Heisei 7 (1995) (a case concerning the photocoagulation procedures on infants with retinopathy) used this type of basic understanding in its ruling.¹⁾ In that instance, the conscientious “cooperative aim” towards the improvement of medicine legally became a “cooperative duty”. However, through legal findings, the judicial system continues to demand a clarification of the “standard of medical care” from the medical world and the judicial system further demands “the conscious use of legal findings in medical reports”.²⁾ Furthermore, the only reason that messages from the medical profession do not reach judicial ears is that there are doctors that continue to deliver erroneous messages.^{3, 4)} Therefore medical experts (not board certified medical experts), must return to the judicial system the most common medical understanding of the field based on current objective data. Session theme analysis is useful for this process.

The Significance of Session Themes

Session theme analysis holds more utility than just the clarification of guideline problems. From the results of session theme analysis it could be seen that neither the Japanese Association for Thoracic Surgery nor the Japanese Society for Cardiovascular Surgery held themes on venous disease, and that such knowledge was not jointly accumulated by the members of these associations. Conversely, with respect to the Japanese Circulation Society’s 2004 “Guideline Pertaining to Pulmonary Embolism and Deep Vein Thrombosis Diagnosis, Treatment and Prevention”, the Japanese Association for Thoracic Surgery and the Japanese Society for Cardiovascular Surgery are both listed as joint research associations. The Japanese Society for Vascular Surgery, however, is not. Associations operate by obtaining member consensus. The public must see that an association is part of a joint research effort, and that an association bears responsibility to the guidelines decided, and that the members of the association abide by these same guidelines. The only guideline definition supported by the Japanese Society for Vascular Surgery clarified here, received consensus from members of the society.

Conclusion

From investigation of the progression of session themes, the society’s members’ understanding of the standard of medical care of the time and the society’s transformation over time became clear. It is believed that the recording of each future session’s progressive conditions, problem points, resources, and reasons for discontinuation, would assist better understanding of societies’ opinions based on their member consensus.

Note From the Author

The preceding material first appeared in Japanese: Kawasaki, Tomio. 2008. Gakkai seshion no tehma hensen kara mita iryou suijyun−joumyaku kessensyou ni okeru iryousosyou no kentou [Standards of Medical Treatment Seen from the Standpoint of Changes in Academic Society Session Themes: Settlement of a Lawsuit Concerning Medical Treatment of Venous Thrombosis]. Jpn J Vasc Surg. 17, 7–12, 2008.