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Archive for September, 2010

C DIFFICILE

C. Difficile (Clostridium) is a species of gram-positive spores producing bacteria which are present in 2-5% of healthy people’s guts.  It survives in the gut usually asymptomatically.  It is passed by faecal. 

In 2007 in the United Kingdom, 8,324 people died from C. Difficile.  This compares to 1,593 who died from MRSA in the same year.  

The C. Difficile Bacterium has two forms, an active infectious form that cannot survive in the environment for prolonged periods and a non active, non-infectious form called a spore that can survive in the environment for prolonged periods. 

C. Difficile spores are found frequently in -  

  • Hospitals.  
  • Nursing Homes. 
  • Extended Care Facilities.                        
  • Nurseries for newborn infants.           

 

They can be found on bedpans, furniture, toilet seats, linen, telephones, fingernails, rings, floors and infants rooms.  Therefore these environments are a ready source for infection with C. Difficile.                       

Q.1      WHAT IS CLOSTRIDIUM DIFFICILE (C. Difficile) COLITIS?                            

Antibiotic associated C. Difficile Colitis is an infection of the colon caused by C. Difficile that occurs primarily in individuals who have been using antibiotics.  It is the most common infection acquired by patients while they are in hospital. 

More than 3 million C. Difficile infections occur in hospitals in the United States each year.  After a stay of only 2 days in hospital, 10% of patients will develop infections of C. Difficile.  It may also be acquired outside of hospitals in the community.    

Q.2      WHAT DOES C. DIFFICILE CAUSE?    

  • If it overgrows in the colon, it causes Pseudomembranous Colitis – infection of colon causing diarrhoea.                                             

 

Q. 3     WHAT ARE THE SYMPTIOMS OF C. DIFFICILE COLITIS?                            

Patients with mild C. Difficile Colitis may have:  

  • A low grade fever.       
  • A mild diarrhoea (5-10 watery stools a day).                                                                   
  • Mild abdominal cramps and tenderness.                                                                                                         

 

Patients with severe C. Difficile Colitis may have:                      

  • High temperatures of between 102F – 104F.     
  • Severe diarrhoea with blood.       
  • Severe abdominal pain and tenderness.        

 

Not everyone infected with C. Difficile develops colitis.

C. Difficile spores lie dormant inside the colon until the person takes an antibiotic.  The antibiotic disrupts the other bacteria that are normally living in the colon and preventing C. Difficile from transforming into an active disease, causing bacterial form.  As a result, C. Difficile transforms into an infectious form and then produce toxins (chemicals) that inflame and damage the colon. 

The inflamination results in an influx of high blood cells to the colon.  The severity of the colitis can vary.  In the most severe cases, the toxins kill the tissue of the inner lining of the colon and the tissue falls off.  The tissue that falls off is mixed with white blood cells (puss) and give the appearance of a white membranous patch covering the inner lining of the colon.  This severe form of D. Difficile is called pseudomembranus Colitis because the patches appear like membranes, but they are not true membranes.                   

Q.4      WHAT KILLS C. DIFFICILE?        

  • Metronidazole.        
  • Vancomycin. 
  • Linezolid.   

 

Q.5      WHAT DOES NOT KILL C. DIFFICILE?   

  1. Alcohol based hand rubs.   
  2. Many disinfectants (but bleach is effective).   
  3. Broad spectrum antibiotics (which kill competing gut flora).                       

 

Q.6      WHAT AGGREGATES C. DIFFICILE? 

  1. Continued prescription of broad spectrum antibiotics.      
  2. Diarrhoea treatment (which slows the progress of toxins through the colon).          

 

Q.7      HOW IS ITS SPREAD PREVENTED?   

  1. Prudent use of Broad spectrum antibiotics.   
  2. Isolation and barrier nursing of infected patients.        
  3. Effective cleaning of toilets and other environments with bleach to kill off spores.    
  4. Good hand hygiene of healthcare workers.  

 

Q.8      THOSE AT RISK FROM C. DIFFICILE?  

  • The elderly, particularly those in hospitals and nursing homes. 
  • Post-surgical patients.        
  • Immuno suppressed patients. 
  • Those on broad spectrum antibiotics.      

 

In the United Kingdom in 2008, there were 40,705 instances of C. Difficile hospital infections with 5,931 deaths arising therefrom.       

Typical Injuries – C. Difficile            

  1. Death – Usually of the elderly.            
  2. Colectomy – Surgical resection of any extent of the large intestine.   
  3. Diarrhoea and prolonged hospital admission.   

 

Negligent Acquisition      

Failures in barrier nursing -  

  1. Did any other persons on the ward have C. Difficile or have isolation notices above their beds?    

 

  1. Did any other patients have severe diarrhoea?             

                      

  1. Were the toilets or any other areas contaminated with diarrhoea?                  

           

  1. Prior to treating you and giving you medication or food, did health care staff either wash their hands or use alcohol rub?      

 

  1. Did staff wash or use alcohol rub after treating one patient and then treating the next?              

 

  1. Were there sinks and soap dispensers nearby and notices advising visitors to use them?     

 

After being diagnosed with C. Difficile were you….    

a)      Moved to a side room or otherwise into isolation (and how long was this after your diarrhoea commenced).   

b)      Identified as having C. Difficile by an isolation notice and treated as such.        

c)      Provided with your own toilet facilities.     

d)      Permitted to interact with other patients.

HSE and DePuy Orthopaedics Face Multiple Claims Arising from Hip Implant Defects

The HSE and DePuy Orthopaedics – a division of Johnson and Johnson – who recently issued a recall of two of its hip replacement products, may face thousands of lawsuits from affected patients.   

The products which were recalled were the ASR Xl Acetablur System and the ASR Hip Resurfacing System.  The ASR devise is a large diameter, monoblock hip resurfacing and replacement device.

 The DePuy ASR Hip Resurfacing System was introduced in 2003 and is only approved for use outside of the USA.  The ASR Excel Acetabular System was first launched in 2004 and has since been available worldwide.  It is estimated that 93,000 of these devices have been implanted worldwide.                        

Shortly after the ASR Resurfacing System was introduced, DePuy Orthopaedics began receiving a number of complaints of problems and complications associated with early failure for the metal hip implants.  The hip replacement can fail with only a few years of surgery, causing pain and leading to complicated and expensive replacement surgery.  Most of these complications required additional surgery to replace the hip implants.    

The DePuy ASR Acetabular Cup System is a metal- on- metal hip component.  DePuy withdrew the ASR hip in the Australian market in December 2009 and indicated a plan to phase the devise out worldwide in 2010.  It is believed that a design flaw with the DePuy metal hip implants exist which makes them difficult to implant at the proper angle.  If the metal on metal hip replacement is improperly positioned, it can cause small particles of metal to cause inflammatory reactions, impacting the surrounding tissue in the hip joint and loss of bone.  This can cause complications and leave patients with lasting problems and the surgery to remove the hip implant can be more complex. 

Individuals with small statures, such as women and those with weak bones may be more susceptible to failure of the DePuy ASR hip implants.  

The company will face legal claims for liability for manufacturing a defective product, failing to warn these patients and doctors of problems with the implants and negligence in the design, manufacture and sale of the product.   

Approximately 70,000 hip replacements have taken place in Ireland since July 2003, when this product first became available in this Country.  Approximately 5% of these may be affected by this recall, as figures from the company itself indicate that 3,516 implants were sold in Ireland.  However, this figure has not yet been confirmed as accurate. 

In March 2010, DePuy discontinued the cup and sent a letter to Doctors that month warning that data from the Australian Medical Device Registry showed a “higher than expected” failure rate than traditional hip replacement, especially in smaller patients and those with weak bones.  These moves followed two years of reports that the implant was prone to early failure.

The HSE may also have a legal liability to compensate affected patients if it can be proven that they were aware of the defective nature of the implants but continued to use them in their hospitals.  Since 2008 the problems with these implants had become apparent.

While the primary liability may be with the manufacturer in these cases, the HSE may also have a liability problem. If the HSE continued to purchase these devices from DePuy Orthopaedics during the period in which it was clear that these products were defective, then the HSE could be held partially liable and may end up paying millions of euro in compensation to effected patients.          

Patients with hip replacements have reported that they have experienced pain and swelling of the hip, even mouths after the surgery.    If the device becomes loose, it could potentially break some bones in the area around the hip socket.  There have also been numerous patient complaints of crippling pain experienced following the implantation with this defective device.                      

Between 2006 and 2009, reports of problems with the DePuy model ASR hip replacement device rose sharply.  Of the problems reported in 2009, over 90% required replacement.                               

The FDA has received approximately 300 reports of failure since 2008.  The majority of these individuals required expensive and painful operations to remove the device.

MEDICAL NEGLIGENCE

Question:      

I was in hospital recently for an operation and during my stay I contracted MRSA.  I was very sick for a number of months and continue to have some ongoing complaints.  I don’t know how to find out if I have a case for compensation against the hospital concerned.  What steps would I have to take to try and establish if I have a case?         

Answer:            

Medical negligence cases are difficult.  The Irish test for professional medical negligence was established in a landmark case called Dunne –v- The National Maternity Hospital.  This case set out four separate tests that have to be met by any injured patient before they can succeed in proving negligence against a hospital and/or a doctor.  Two of these tests are as follows:  

  1. A practitioner is negligent in diagnosis of treatment only if guilty of such failure as no other practitioner of equal specialist or general status or skill would be guilty of if acting with ordinary care.  

 

  1. An injured patient establishes negligence against a medical practitioner by proving his deviation from a general and approved practice, only upon proving also that the course taken was one which no other medical practitioner of like specialisation and skill would have followed when taking the ordinary care required from a person of his qualification.      

 

In summary, these are difficult tests to establish and usually involve all of a patients medical notes, records, scans and x-rays being obtained from the hospital and doctors concerned and then being sent to the appropriate expert in the United Kingdom for them to provide an opinion as to whether the doctor and/or hospital concerned were negligent (using the Dunne Test).   

 

What is MRSA?   

 

MRSA – Methicillin Resistant Staphylococcus Aureus.  

  1. Frequently part of the skin flora found in the nose and on skin but can live on plastic, paper and metal.  

 

  1. About 20% of the population are long term carriers of S. Aureus.      

 

  1. Most hospital infections are spread by direct patient to patient contact via healthcare staff or via contaminated environment.  

 

What does MRSA cause?  

  • Pimples. 
  • Boils. 
  • Infected eczema.   
  • Septicaemia, if it gets into the blood stream.         
  • Septic arthritis.        
  • Endocarditis.             
  • Cellulitis 
  • Osteomyelitis  (Infection of the bone)

 

What does not kill MRSA?                           

  • Broad Spectrum Antibiotics.                                              
  • Methicilin
  • Penicillin.                       
  • Potentially any Antibiotics.                                                    

 

When you consult a Solicitor, you should immediately, having obtained your notes and records from the hospital’s concerned also provide information in relation to the following concerning your treatment and stay in the hospital:            

 

  1. (a)  Prior to the surgery had you spent any time in hospitals and/or care homes?                                

                  

(b) Was your skin swabbed prior to the surgery to test for MRSA and if so, do you recall the result?    

(c) Was any action taken as a result?   

2.   From the date of admission to hospital until diagnosis was made with MRSA, can you recollect if any other patients on the ward had MRSA or had “isolation” notices above their beds?    

3.   Can you commend whether and over what period you had: 

 (a) Any major open or closed wounds.  

             (b) Any wires or bolts through the skin into fracture sites.      

             (c) Any intravenous lines regarding foods or fluids or medication or any injections.       

4.    Do you remember if prior to touching any wounds, wires, bolts or intravenous lines whether the health care staff either washed their hands or used alcohol rub ?

5.    Did health care staff wash their hands or use alcohol rub after treating one patient and before treating the next e.g. those taking blood pressures, giving medicine, giving blood etc.    

6.   Were there sinks, soap dispensers, alcohol rub dispensers nearby and were the dispensers full?            

7.    Do you have any other comments or information about the state of cleanliness or hygiene on the ward?   

8.  When were your first symptoms of infection (e.g. fever, puss from wounds?).    

9.    How long after this were swabs taken and how long did it take before you were informed of your diagnosis?   

10.  After being diagnosed with MRSA, were you or your family member:  

(a) Moved to a side room or otherwise into isolation and how long was this after the diagnosis?   

     (b) Identified as having MRSA by an isolation notice?      

     (c) Provided with your own toilet facilities?       

     (d) Permitted to interact with other patients?              

11.  Did you notice any change in how you were treated after diagnosis and what were those changes? 

The answers to the above questions are very important in assisting the expert who will be retained by your Solicitor so that the expert can establish whether you have a claim for medical negligence.

When the experts report is obtained, your Solicitor will then be able to advise you as to whether a case should be taken against the hospital concerned. 

It is very important to ensure that any proceedings against the hospital are issued within 2 years from the date upon which you contracted MRSA as this is the Statute of Limitations period.  Any proceedings that are issued outside of this period may become statute barred.

HIGH COURT JUDGEMENT MAY LEAD TO HUNDREDS OF GARDAI BEING REFUSED COMPENSATION

A landmark High Court decision dealing with the operation of the Garda Siochana compensation scheme may result in Gardai who sustain minor injuries on duty being refused compensation.   

A recent test case dealing with the Garda Siochana Compensation Act in which three Gardai sought compensation for injuries maliciously inflicted on them, established that the Minister for Justice could refuse to allow compensation claims from Gardai to proceed where the Minister concluded that the injuries were “minor in nature”.

The Gardai claimed that they had sustained anxiety disorders which their Consultant psychiatrists confirmed were recognised psychiatric injuries.  These cases are more commonly referred to as “fear of diseases” cases.                 

Judge Mary Irvine found that in a large number of cases the transmission risk of disease was zero and that consequently Doctors should not be testing Garda when there is a negligible or zero risk of infection – such as a splash of blood onto intact skin or cases involving saliva only. 

She said that in many cases blood testing over a three and six month period was unnecessary and as a result, if Gardai attended the appropriate infectios disease specialisst for advice, any anxiety suffered by Gardai would be confined to a very short period of time. 

In her Judgement, she recommended that the Garda authorities prepare an advisory pamphlet setting out the nature of the viruses, how they are transmitted, when testing should be done, when the imposition of restrictions on a persons sexual and sporting life are warranted and suggested the immediate availability of treatment, such as prophylaxis to all gardai

She recommended that they be made available in every Garda station so that in the event of an assault causing a member to fear infection, they could immediately refer to these pamphlets for reassurance. 

If accurate information and adequate reassurance could be provided to members of the Gardai as to the nature of these infections diseases and the minimal risks of infection, even in cases where blood testing may be justified and even allowing for a members private life being restricted over a 6 months period, that these injuries would be classified as best as minor in nature and insufficient to force the Minister to grant authorisations for leave to apply for compensation before the High Court.  

In awarding damages of €6,000.00, €7,000.00 and €15,000.00 to the three Gardai the Judge also clarified the law in relation to how damages are to be assessed.  The Judge stated that there was nothing in the Act which suggested that the Court should not approach compensation in the same manner as it would approach the issue of damages in an ordinary personal injury claim.

The Judge accepted in all three cases that the Gardai had suffered from anxiety disorders and physical injuries and therefore the awards would therefore appear to be quite low.

An award of €6,000.00 does not even exceed the District Court Jurisdiction and would be open to criticism.  The Judge indicated that all Gardai have a duty to mitigate their loss and that if a Garda is assaulted and had a fear that he may have been affected with HIV and/or hepatitis that they should immediately try and ascertain the disease status of their assailant and that if they failed to do so that this could be taken into account by the Court in the assessment of damages. 

This would appear to be an unfair burden to be placed on Gardai who in many cases have no ability to force their attackers to provide blood tests. 

The State heavily contested this test case and it would appear that future Garda Siochana Compensation claims coming before the High Court will be vigorously contested, both in relation to the issues of liability, causation and damages. 

Gardai will feel aggrieved by this Judgement, which on the one hand confirms that their cases are to be dealt with in the same manner as ordinary personal injuries claims, but on the other hand, they are not being awarded the same levels of compensation. 

They also face the prospect of future claims for compensation being refused at first instance by the Department of Justice.  This may lead to further litigation in that many Gardai may decide to challenge the Ministers decision by way of Judicial Review.

All in all, this Judgment has raised more questions than it has answered.                                              

Section 6(b) of the Garda Siochana Compensation Act 1941 provides:-     

If the injuries are of a minor character sustained in the course of ordinary duties, the Minister must refuse the application.       

Notes for the Editor         

The State has paid more than 30 million in the past 2 years in compensation and legal fees for injuries suffered by Gardai during the course of their duties.  All cases are initially dealt with by the Department of Justice, to whom the injured member applies for compensation.  The minister for Justice, then exercises powers conferred under the Garda Siochana (Compensation) Act 1951 authorises the applicants to apply to the High Court for compensation once he is satisfied that the injuries companied are not minor in nature.