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Journal of the Royal Society of Medicine Volume 85 October 1992
Cardiac injury and electrocution
F C Forrest FCAnaes P R Saunders FCAnaes M McSwinney FCAnaes M A Tooley PhD CEng MIEE Sir Humphry Davy Department of Anaesthesia Bristol Royal Infirmary, Upper Maudlin Street Bristol BS2 8HW Keywords: electrocution; cardiac damage The heart is the most susceptible organ to electrical injury and a wide range of abnormalities from arrhythmias to structural damage may be seen. We present a case of high voltage electrocution and discuss the factors that influence the degree of injury and some of the consequences.
Case report A 19-year-old man was dismantling scaffolding when he accidentally received a 6.5-kV a.c. shock from an overhead power cable. During the next-howr he was taken to the local hospital for initial resuscitatkn` and then transferred to our hospital for intensive care. Dluring this time he repeatedly went into ventricular fibrillation (VF) and received continuous cardiopulmonary resuscitation (CPR) including d.c. countershock. On admission to the intensive care unit (ITU) he had a rapid supraventricular tachycardia with superimposed ventricular arrhythmias. The electrocardiogram (ECG) showed changes consistent with an anterolateral infarct (Figure 1). At the time of son tolTU the muscle and specific cardiac enzymes were raised, -CPK 20400 (< 195 iu), MB 560 (< 10), LDH 2184 (it)ility the fibrillation threshold is reduced. durations ( 500 mA) in order to cause VF. Our patient received a very high voltage a.c. shock and this not surprisingly he was found in VF. Previous authors have sugges that electricity causes patchy myocardial necrosis: wdic leads to continuing cardiac instability manifest as'atrhythmias or ventricular wall dysfunction. The patchy nereis has been demonstrated on endomyocardial bio ifm patients accidentally electrocuted2. Myocardial ibtion dagnosed by ECG and enzyme changes may relate to the endomyocardial changes, myocardial contusion associated with CPR or the;electric shock causing coronary artery spasm. Certainly- myocardial infarction in the presence of normal coronary angiograms, or in our case postmortem findings, has been reported34 making the theory of coronary artery spasm more attractive. It is worth mentioning that d.c. countershock itself can make the myocardium more arrhythmogenic and therefore influence the time over which arrhythmias may be seen5. Echocardiographic changes following a.c. injury have shown left ventricular dysfunction with reduced fractional shortening as well as global hypokinesis. Both these changes have returned to normal by one year". Similar findings following high voltage injury were- reported but with some degree of permanent dysfunction7. In the light of previous reports of electrocution and the severity of the electric shock our patient received, it is perhaps surprising that our patient had a normal echocardiogram despite definite evidence of myocardial damage. References 1 Guide to effects ofcurrentpassing through the human body. British p Standards Institute. PD 6519:Part 1:1988 and PD 6519:Part 2:1988 2 Jensen PJ, Thomsen PEB, Bagger JP, Norgaard A, Baandrup U. Electrical injury causing ventricular arrhythmias. Br Heart J 1987;57:279-83
0141-0768/92 100642-02/$02.00/0 i 1992 The Royal Society of Medicine
Journal of the Royal Society of Medicine Volume 85 October 1992 3 Chang-Sheng Ku, Shoa-Lin Lin, Tsui-Lieh Hsu, Shih-Pu Wang, Mau Song Chang. Myocardial damage associated with electrical injury. Am Heart J September 1989;118:621-4 4 Walton AS, Harper RW, Coggins GL. Myocardial infarction after electrocution. Med J Aust 1988;148:365-7 5 Lown B, Neuman J, Amarasingham R, Berkovits BV. Comparison of alternating current with direct current electroshock across a closed chest. Am J Cardiol 1962;10:223-3
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6 Lewin rF, Arditti A, Sclarovsky A. Non-invasive evaluation of electrical cardiac injury. Br Heart J 1983;49:190-2 7 Homma S, Gillam LD, Weyman AE. Echocardiographic observations in survivors of acute electrical injury. Chest 1990;97:103-5
(Accepted 30 December 1991)
Meeting reports
Product liability and medicines Keywords: product liability; product labelling; product licensing; consumer protection; medicines regulation
A small but select audience was privileged to hear an enlightening discussion of medical product liability which was led by representatives from the pharmaceutical industry, a firm of solicitors and the media.
Pharmaceutical industry Dr Anthony Grace (Head of Registration of Pfizer Central Research) covered four aspects of product liability in the pharmaceutical industry: the labelling of licensed medicines; the unlicensed use of licensed medicines; product liability in clinical trials, and unlicensed medicines. The term 'labelling' was used in its American sense of total information about a pharmaceutical preparation as it appeared in data sheets, package inserts, labels and the prescribing information given in advertisements and promotional items. International pharmaceutical companies develop a master labelling document for universal use containing all the important prescribing information which evolved from in-house development and which was culled from the global medical literature. This latter point was considered to be important since the omission of any side-effects, or drug interaction, which had been mentioned anywhere in the world might weaken a state-of-the-art defence in any subsequent product liability litigation, defensive medicine by the orginator of the medicine as protection against prospective litigation. Similarly, the pharmaceutical industry spent considerable time and effort monitoring and evaluating reported adverse events to maintain state-of-the-art labelling on side effects. However, confusion could be engendered by changes being made to documents at different times in different countries, sometimes because of differing regulatory procedures by the various licensing authorities. It was Dr Grace's view that an archive of all prescribing documents should be maintained for a period of not less than 10 years. A pharmaceutical company is. not liable for the misuse of its products unless its 'labelling' is confusing or unclear. Therefore, in normal circumstances, a pharmaceutical company can not be held responsible for the consequences of the unlicensed use of its products. Dr Grace's advice to pharmaceutical
companies was that any response to enquiries about the use of a product for an unlicensed indication, or by an unlicensed route of administration, should be in writing, should clearly state the regulatory status and should advise against any proposed unorthodox use: more defensive medicine. Contravention of Part I of the Consumer Protection Act 1987 incurred civil liability but of Part II, criminal liability. Licensed medicines were exempt from Part II of the Act so breaches could not be a criminal offence, that is, subject to the provisions of the Medicines Act 1968. However, clinical trial medicines were subject to both Parts I and II, although a pharmaceutical company was unlikely to lay itself open to criminal liability if it followed Good Clinical Research Practice (GCRP) standards. For unlicensed medicines, a pharmaceutical company had three options: to provide a service by supplying such medicines while attempting to minimize its potential liability; not to provide any unlicensed medicines; to provide unlicensed medicines without taking any precautions and accepting the high potential risk of product liability. A company's liability could be lessened, although not eliminated, by producing the medicine to Good Manufacturing Practice (GMP) standards, issuing it in distinctive packaging and labelling it clearly with its unlicensed status, and including a package insert containing detailed prescribing information and the reason for its unlicensed status.
Legal aspects of consumer protection Mr Ian Dodds-Smith (a Partner in McKenna & Co) discussed some of the legal aspects of consumer protection in the United Kingdom, how it differed in Europe and the trend towards harmonization. Anyone who has followed recent group actions against producers of medicines will appreciate that, in the United Kingdom, compensation is not awarded according to need. All of the cases included the allegation of failure by the company concerned to carry out adequate research and give appropriate warnings. In compensation and product liability it was a case of striking a balance between the plaintiff and the defendant. In litigation on liability for faulty products, the burden of proof was with the plaintiff; the defendant pleaded reasonable care. The 1985 European Directive on product liability sought to adjust the balance towards the plaintiff because of the increasing technical complexity of modern products and devices.
Report of meeting of Library (Scientific Research) Section, 28 May 1992
0141-0768/92 100643-02/$02.00/0 © 1992 The Royal Society of Medicine
Journal of the Royal Society of Medicine Volume 85 October 1992
Cardiac injury and electrocution
F C Forrest FCAnaes P R Saunders FCAnaes M McSwinney FCAnaes M A Tooley PhD CEng MIEE Sir Humphry Davy Department of Anaesthesia Bristol Royal Infirmary, Upper Maudlin Street Bristol BS2 8HW Keywords: electrocution; cardiac damage The heart is the most susceptible organ to electrical injury and a wide range of abnormalities from arrhythmias to structural damage may be seen. We present a case of high voltage electrocution and discuss the factors that influence the degree of injury and some of the consequences.
Case report A 19-year-old man was dismantling scaffolding when he accidentally received a 6.5-kV a.c. shock from an overhead power cable. During the next-howr he was taken to the local hospital for initial resuscitatkn` and then transferred to our hospital for intensive care. Dluring this time he repeatedly went into ventricular fibrillation (VF) and received continuous cardiopulmonary resuscitation (CPR) including d.c. countershock. On admission to the intensive care unit (ITU) he had a rapid supraventricular tachycardia with superimposed ventricular arrhythmias. The electrocardiogram (ECG) showed changes consistent with an anterolateral infarct (Figure 1). At the time of son tolTU the muscle and specific cardiac enzymes were raised, -CPK 20400 (< 195 iu), MB 560 (< 10), LDH 2184 (it)ility the fibrillation threshold is reduced. durations ( 500 mA) in order to cause VF. Our patient received a very high voltage a.c. shock and this not surprisingly he was found in VF. Previous authors have sugges that electricity causes patchy myocardial necrosis: wdic leads to continuing cardiac instability manifest as'atrhythmias or ventricular wall dysfunction. The patchy nereis has been demonstrated on endomyocardial bio ifm patients accidentally electrocuted2. Myocardial ibtion dagnosed by ECG and enzyme changes may relate to the endomyocardial changes, myocardial contusion associated with CPR or the;electric shock causing coronary artery spasm. Certainly- myocardial infarction in the presence of normal coronary angiograms, or in our case postmortem findings, has been reported34 making the theory of coronary artery spasm more attractive. It is worth mentioning that d.c. countershock itself can make the myocardium more arrhythmogenic and therefore influence the time over which arrhythmias may be seen5. Echocardiographic changes following a.c. injury have shown left ventricular dysfunction with reduced fractional shortening as well as global hypokinesis. Both these changes have returned to normal by one year". Similar findings following high voltage injury were- reported but with some degree of permanent dysfunction7. In the light of previous reports of electrocution and the severity of the electric shock our patient received, it is perhaps surprising that our patient had a normal echocardiogram despite definite evidence of myocardial damage. References 1 Guide to effects ofcurrentpassing through the human body. British p Standards Institute. PD 6519:Part 1:1988 and PD 6519:Part 2:1988 2 Jensen PJ, Thomsen PEB, Bagger JP, Norgaard A, Baandrup U. Electrical injury causing ventricular arrhythmias. Br Heart J 1987;57:279-83
0141-0768/92 100642-02/$02.00/0 i 1992 The Royal Society of Medicine
Journal of the Royal Society of Medicine Volume 85 October 1992 3 Chang-Sheng Ku, Shoa-Lin Lin, Tsui-Lieh Hsu, Shih-Pu Wang, Mau Song Chang. Myocardial damage associated with electrical injury. Am Heart J September 1989;118:621-4 4 Walton AS, Harper RW, Coggins GL. Myocardial infarction after electrocution. Med J Aust 1988;148:365-7 5 Lown B, Neuman J, Amarasingham R, Berkovits BV. Comparison of alternating current with direct current electroshock across a closed chest. Am J Cardiol 1962;10:223-3
643
6 Lewin rF, Arditti A, Sclarovsky A. Non-invasive evaluation of electrical cardiac injury. Br Heart J 1983;49:190-2 7 Homma S, Gillam LD, Weyman AE. Echocardiographic observations in survivors of acute electrical injury. Chest 1990;97:103-5
(Accepted 30 December 1991)
Meeting reports
Product liability and medicines Keywords: product liability; product labelling; product licensing; consumer protection; medicines regulation
A small but select audience was privileged to hear an enlightening discussion of medical product liability which was led by representatives from the pharmaceutical industry, a firm of solicitors and the media.
Pharmaceutical industry Dr Anthony Grace (Head of Registration of Pfizer Central Research) covered four aspects of product liability in the pharmaceutical industry: the labelling of licensed medicines; the unlicensed use of licensed medicines; product liability in clinical trials, and unlicensed medicines. The term 'labelling' was used in its American sense of total information about a pharmaceutical preparation as it appeared in data sheets, package inserts, labels and the prescribing information given in advertisements and promotional items. International pharmaceutical companies develop a master labelling document for universal use containing all the important prescribing information which evolved from in-house development and which was culled from the global medical literature. This latter point was considered to be important since the omission of any side-effects, or drug interaction, which had been mentioned anywhere in the world might weaken a state-of-the-art defence in any subsequent product liability litigation, defensive medicine by the orginator of the medicine as protection against prospective litigation. Similarly, the pharmaceutical industry spent considerable time and effort monitoring and evaluating reported adverse events to maintain state-of-the-art labelling on side effects. However, confusion could be engendered by changes being made to documents at different times in different countries, sometimes because of differing regulatory procedures by the various licensing authorities. It was Dr Grace's view that an archive of all prescribing documents should be maintained for a period of not less than 10 years. A pharmaceutical company is. not liable for the misuse of its products unless its 'labelling' is confusing or unclear. Therefore, in normal circumstances, a pharmaceutical company can not be held responsible for the consequences of the unlicensed use of its products. Dr Grace's advice to pharmaceutical
companies was that any response to enquiries about the use of a product for an unlicensed indication, or by an unlicensed route of administration, should be in writing, should clearly state the regulatory status and should advise against any proposed unorthodox use: more defensive medicine. Contravention of Part I of the Consumer Protection Act 1987 incurred civil liability but of Part II, criminal liability. Licensed medicines were exempt from Part II of the Act so breaches could not be a criminal offence, that is, subject to the provisions of the Medicines Act 1968. However, clinical trial medicines were subject to both Parts I and II, although a pharmaceutical company was unlikely to lay itself open to criminal liability if it followed Good Clinical Research Practice (GCRP) standards. For unlicensed medicines, a pharmaceutical company had three options: to provide a service by supplying such medicines while attempting to minimize its potential liability; not to provide any unlicensed medicines; to provide unlicensed medicines without taking any precautions and accepting the high potential risk of product liability. A company's liability could be lessened, although not eliminated, by producing the medicine to Good Manufacturing Practice (GMP) standards, issuing it in distinctive packaging and labelling it clearly with its unlicensed status, and including a package insert containing detailed prescribing information and the reason for its unlicensed status.
Legal aspects of consumer protection Mr Ian Dodds-Smith (a Partner in McKenna & Co) discussed some of the legal aspects of consumer protection in the United Kingdom, how it differed in Europe and the trend towards harmonization. Anyone who has followed recent group actions against producers of medicines will appreciate that, in the United Kingdom, compensation is not awarded according to need. All of the cases included the allegation of failure by the company concerned to carry out adequate research and give appropriate warnings. In compensation and product liability it was a case of striking a balance between the plaintiff and the defendant. In litigation on liability for faulty products, the burden of proof was with the plaintiff; the defendant pleaded reasonable care. The 1985 European Directive on product liability sought to adjust the balance towards the plaintiff because of the increasing technical complexity of modern products and devices.
Report of meeting of Library (Scientific Research) Section, 28 May 1992
0141-0768/92 100643-02/$02.00/0 © 1992 The Royal Society of Medicine
