Orchidectomy - Casr Report

CLINICAL NEGLIGENCE CASE REPORT

LOSS OF FERTILITY – UNNECESSARY ORCHIDECTOMY AND FAILURE TO PRESERVE AND FREEZE SEMEN

J GG –V- SALFORD ROYAL HOSPITALS NHS TRUST

Background to Clinical Negligence Claim

The Claimant (dob 22.7.57) has Congenital Adrenal Hyperplasia ("CAH") diagnosed early in his life, for which he was seen regularly in the Endocrine Department at Hope Hospital, ("the Hospital") where he was treated with oral steroid medication.

In November 1999, the Claimant attended an appointment at the Endocrinology Department at the Hospital. Amongst other matters, he presented with swelling of his left testicle, which he thought had come on fairly quickly, four months previously. It was suspected that the swelling was cystic in origin. An MRI scan of both testicles was performed and reported by a Consultant Radiologist, (who was aware of the Claimant's clinical history), as showing masses in both testes, not typical of testicular tumours, raising the diagnostic possibility of hyperplasic adrenal rests.

On the 2nd March 2000, the Claimant was seen again in the Endocrinology Department, by Dr New, Consultant Endocrinologist, who altered the Claimant's Prednisolone dose, with a view to reducing the size of the masses in both testicles.

On the 24th April 2000, the Claimant was seen again in the Endocrinology Clinic. Despite taking higher doses of Prenisolone, his testicular masses had not regressed and were aching. He was referred by Dr New to Mr Clarke, Consultant Urologist at the Hospital. The referral letter contained the information that the Claimant had CAH, and that his testicular swellings were secondary to adrenal rests.

On the 18th May 2000, the Claimant attended as an out-patient at the Urological Clinic. It was known that he had CAH left testicular pain and that he had undergone an MRI scan. The Claimant's case was to be discussed in due course with Mr Clarke who was not available. However, the Claimant was advised that he would probably need to have his left testicle removed.

Following a Urology Clinic on the 20th July 2000, Mr Clarke wrote to Dr New noting the finding on the MRI scan, and suggested abnormalities on both sides of a nonspecific type. The right testicle was noted to be unremarkable, whereas the left testicle definitely had an indurated area in the mid region of his testes at the junction between the body of the testes and the epididymis, which was tender. Mr Clarke was suspicious that this might be a seminoma and he arranged for the Claimant to return the following week for a left radical orchidectomy (removal of testicle) and to biopsy the right testicle.

On the 25th July 2000, the Claimant underwent a left orchidectomy. Testicular biopsy of the right testicle was performed through the scrotum and sent for Histology. Prior to the operation, the Claimant was not informed that if he wished to have children in the future, he would need to provide a specimen of semen for freezing and storage.

Following the operation, the Histopathologist reporting on the excised left testicle, and the biopsy of the right testicle was not informed that the Claimant had CAH, nor that the Claimant had bilateral testicular masses.

The Histopathologist concluded that the left orchidectomy was a leydig cell tumour. He noted that the right testicular biopsy showed normal sperm and no evidence of neoplasia.

Mr Clarke, subsequently wrote to Dr New advising that the results of the Histology showed leydig cell tumour. Amongst other things, he observed that the malignant potential was difficult to ascertain, on the basis of the Histology, but that in a small percentage of cases, they did have a tendency to metastasise and that the Claimant would require an abdominal CT scan.

On the 28th September 2000, the Claimant was seen by Mr Clarke who advised him that he should have his right testicle removed as well, due to suspicion that this also contained a leydig cell tumour. On the basis of this advice, the Claimant agreed to undergo further surgery to remove his right testicle.

The following day, the Claimant advised Dr New in Clinic that he was keen to save some sperm to store in a sperm bank, to enable him to have the chance of fathering children in the future. The Claimant provided his sample of semen, which he understood was for freezing / storage purposes. Unfortunately, Dr New did not advise the Claimant that the sample was for analysis only and that if the sample was otherwise satisfactory, a further sample would have to be provided for freezing / storage purposes.

The Claimant underwent a right radical orchidectomy on the 17th October 2000. At no time prior to this surgery was the Claimant asked to provide a further specimen of semen for freezing / storage. He was asked whether he had provided semen for storage at St Mary's Hospital, and the Claimant confirmed that he had done so, honestly believing that the sample previously provided to Dr New had been for this purpose. In fact the sample provided to Dr New had been used for analysis, but had never been frozen / stored for fertility purposes.

Following the right orchidectomy, a Histopathologist, who was still unaware of the Claimant's medical history of CAH, reported on the Histology of the left testicle, to the effect that the appearances were of leydig cell tumour.

Progress of Litigation

Initially, the issues that required investigation centered upon :-

1. the initial decision to proceed to a left orchidectomy, without first arranging a biopsy,
   
   
2. whether the right orchidectomy was necessary, given that the biopsy of the right testis was noted to be normal and,
   
   
3. the failure to arrange for the preservation of a semen sample, for the purposes of preserving the possibility of the Claimant fathering children in the future.

Having notified the Trust's Solicitors of the proposed claim, there then followed a rather unusual sequence of events in that the Claimant was asked to attend an appointment with Mr Clarke at the Hospital, when he was advised that a mistake had been made in relation to the diagnosis and in fact, the correct diagnosis was not leydig cell tumour but rather, testicular tumour of the adreno genital syndrome (TTAGS). The Defendant's solicitors subsequently confirmed that the Histology samples had been re-examined by David Ansell, a Histopathologist based in Nottingham, and Professor Young, based at Harvard University, USA, who both confirmed the diagnosis of TTAGS.

As a result of this development, the basis of the proposed claim shifted considerably and the issues that then required investigation related to :-

1. The apparent failure on the part of the Urologists, to notify the Pathologist of the underlying condition of CAH and
   
   
2. whether, as has been suggested, had this diagnosis been communicated to the Pathologist, the correct diagnosis would have been reached and
   
   
3. if so, what the appropriate treatment would have been.

Reports were obtained from Professor Grossman, Professor of Endocrinology at St Bartholomew's Hospital and from Mr Agarwal, Consultant Urologist at Hammersmith Hospital, following which the allegations of negligence were formulated as follows :-

1. Failing on the occasion of the left orchidectomy to perform a biopsy of the right testicle with reasonable care, given the radiological evidence that there were bilateral testicular masses. A surface biopsy was performed but such a biopsy was done in a way to exclude carcinoma in situ, rather than to biopsy the tumour itself. Therefore, the tissue sample obtained was not representative. It was asserted that the biopsy should have been performed by soft clamping the blood supply to the testes, bivalving the right testicle and visualising the lesion and then performing a biopsy. In the event, the biopsy of the right testicle was reported as normal, whereas had it been performed as it should have been, it would/should have been realised that the Claimant was presenting bilaterally with the same type of tumour and that the overwhelming likelihood was that the Claimant had TTAGS, rather than bilateral leydig cell tumours.
   
   
2. Failing, following the first operation, to ensure that the Histopathologist knew that the Claimant had CAH, and that MRI scanning had detected bilateral testicular masses. Had this been known to the Histopathologist, he would or should have suspected a diagnosis of TTAGS, which could then have been confirmed if necessary by referral to an expert in the field.
   
   
3. Failing, after the Histopathologist had reported that investigation of the left testicle removed at the first operation showed a leydig cell tumour, (and when Dr New and Mr Clarke were aware that the Claimant had CAH, and that the Consultant Radiologist had reported in 1999 that the bilateral testicular masses could be related to CAH), to conclude ultimately that the underlying condition was in fact related to CAH, was quite benign and that there was no evidence of malignancy, such that the Claimant did not require further surgery. They should have instituted further investigations as to the adequacy of the clinical information supplied to the Histopathologist.
   
   
4. Failing, following the first operation to appreciate the significance of the pathological findings of a leydig cell tumour, given the reported appearances on the MRI scan of 1999, of bilateral testicular changes, and failing to discuss the matter further with the Pathologist, providing him/her with all relevant clinical information and ultimately to advise against the need for removal of the remaining right testicle.
   
   
5. The Histopathologist and/or Dr New and/or Mr Clarke should have performed a literature search in relation to CAH and, had they done so, they would have noted that bilateral testicular tumours are more likely to be TTAGS rather than leydig cell tumours. These are the only two differential diagnoses with testicular tumours. Only 3% of leydig cell tumours develop bilaterally, in contrast to 83% of bilateral tumours associated with TAGS.
   
   
6. Failure by Mr Clarke to contact the Histopathologist before proceeding to the right orchidectomy, having regard to the report of the 1999 MRI scan of bilateral testicular masses and failing to ensure that the radiologist had all relevant clinical information, in case this might affect the radiologist's conclusion.
   
   
7. A failure by Mr Clarke and/or Dr New to consider and investigate further the differential diagnosis of TTAGS which they should have made or suspected.
   
   
8. Failing to discover prior to the second operation, that the histology of the left testicle removed at the first operation showed that the Claimant had TTAGS and not a leydig cell tumour and failing to advise the Claimant that his condition was amenable to treatment and that he did not require a right orchidectomy.
   
   
9. Failing prior to the second operation to ensure that a specimen of the Claimant's sperm was frozen / stored for fertility purposes.
   
   
10. Wrongly performing a right radical orchidectomy and subjecting the Claimant to unnecessary surgery, notwithstanding the reported radiological findings that the Claimant had bilateral testicular changes. The presence of a leydig cell tumour in the right testicle or otherwise, should have been appropriately excluded, prior to the performance of the right orchidectomy.

So far as causation was concerned, it was asserted that but for the breaches of duty identified the Claimant would have avoided a right orchidectomy and that he would have been treated medically with sustained high dose medication, such that the right testicle mass would eventually have shrunk and the Claimant would not now be aspermic. Had the Defendants taken appropriate care to ensure that a specimen of the Claimant's semen had been frozen / stored, the Claimant would not have lost the opportunity to father children. In addition, the Claimant suffered psychiatric injury and embarrassment, having undergone an unnecessary operation and he now requires life long hormone replacement therapy and testicular implants.

Following service of a letter of claim in September 2003, the Defendant's letter of response which was received in January 2004 confirmed the following :-

• The left orchidectomy and right testicular sampling procedure ought to have led to him being diagnosed with TAGS. The Trust further conceded that the excised testicle and biopsy was mis-diagnosed because the urological surgeons, did not, when requesting pathological examination of the specimens, effectively communicate to the Histopathologists the fact that the Claimant had CAH. They admitted that their investigations had led to the conclusion that if the Histopathologist had been notified of the Claimant's pre-existing CAH, then the diagnosis of TTAGS would in fact have been reached. The Trust further acknowledged that the Claimant's condition was mis-diagnosed due to a communications failure, without which the Claimant would not have undergone a right orchidectomy.
  
  
• Interestingly, the Trust also advised that a number of organizational matters had been amended in the light of the Claimant's case and in particular, as at the relevant time, the Urological Surgery Department routinely maintained a separate volume of medical records, specifically restricted to Urological Surgery. As a consequence, clinicians who came to treat a patient when referring to their medical records would on occasion, not have immediate access to the entirety of that patient's medical records. This meant that in practical terms, when the Claimant attended Urology Clinics, his treating clinicians might not have been as fully aware of his Endocrine status and treatment as they ought to have been.
  
  
• In addition, the Trust admitted that no multi disciplinary meeting took place between the Radiologist, Histopathologist, Endocrinologist and Urologists. Although the Trust did not admit negligence in relation to the failure to undertake such a multi disciplinary meeting, it did admit that it could be liable to criticism for having undertaken a surgical procedure in the absence of a full meeting of all the senior clinicians involved in the Claimant's care.
  
  
• As a consequence, the Trust confirmed that its practices had been amended in a number of respects. In particular, a single set of medical records is now held in respect of each patient and in particular, separate urological surgery records are no longer kept by the Trust. In addition, the Trust organizes multi-disciplinary team meetings to discuss cases such as the Claimant's and they have become more prevalent in all areas, in the hope of avoiding a situation such as had affected the Claimant.
  
  
• So far as the failure to preserve a semen sample is concerned, the Trust acknowledged that the failure to store sperm, was as a result of insufficient discussions and co-ordination between the Physicians and Urologists. The Trust admitted that a sample should have been retained and that the Claimant should have been told by a member of staff at the Hospital for certain that his semen had not been retained for storage, prior to the second orchidectomy.

Settlement of Clinical Negligence Claim

The Claimant's claim was limited to general damages only and following negotiation, the claim settled for the sum of £30,000.00. It was noted that the JSB guidelines (Sixth Edition) gave a bracket of between £10,000.00 to £72,500.00 for cases of male sterility. In the case of the Claimant, at the date of the matters complained of, he was forty three years old, unmarried and suffering from erectile dysfunction. He also had a history of psychiatric problems.

The Claimant also received a written apology from the Trust.

Submitted by Sally Leonards, Claimant's Solicitor, of JMW Solicitors, Manchester.

Counsel

for the Claimant: David Heaton Byrom Street Chambers Manchester

Solicitor for the Defendant: Simeon Bower

Hill Dickinson
Manchester

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