Tracheostomy Litigation Information For Medical Professionals and Risk Mitigators

Having performed a tracheostomy, or about to perform one, you may be concerned that a claim may be made against you, or you may already have had a claim made against you. Depending on your location, the consequences can lead from a claim of compensation from a patient or his or her family, for medical negligence, to a criminal prosecution.

Key Points:

  • Negligence arising from medical acts may result in a civil action by the injured party (claimant) or a criminal prosecution by the state.
  • Medical negligence is proved if all components of the three-part test are established on the balance of probabilities (civil suit) or beyond reasonable doubt (criminal prosecution).
  • The three-part test establishes that the doctor owed a duty of care to the patient, the duty of care was breached, and as a direct result of the breach the patient suffered harm.
  • Successful civil actions result in monetary compensation to the injured party or dependents which may be paid by the employing organization or the doctor’s defence organization.
  • Successful criminal prosecutions may result in a custodial sentence for the doctor and additionally, the possibility of being struck off. (no longer permitted to practice medicine)
  • It is essential to have proper record keeping and evidence that the tracheostomy was performed as a last resort, and was absolutely clinically necessary.

If it is established that a tracheostomy was not necessary, a claim by a Health Insurance Provider may also follow for recovery of the costs of the procedure and subsequent expense.

A claim for negligence (involving a tracheostomy) may be the result of:-

  • The procedure being performed when it was not necessary.
  • Insufficient explanation to the patient of potential complications and quality of life implications to have given informed consent
  • Death and complications and side effects that could have been avoided
  • Negligence of care post procedure
  • Not informing the patient, or trying all other available alternative forms of respiratory support.

The decision to perform a tracheostomy should clearly meet the following test;

  • that its clinical requirement is beyond doubt, or was the result of an emergency event, and;
  • all possibilities of alternative available forms of non-invasive ventilation have failed, or were not appropriate, and ;
  • the patient is fully aware of the life altering implications involved, and the potential complications that may result.

Failure to meet this test will clearly establish that negligence has occurred.

Clinical requirement

The clinical requirement for a tracheostomy is easily established, but limited. In order to demonstrate clinical necessity, the following must be established;

  • The lack of a viable airway, and/or;
  • Failure of both available forms available non-invasive ventilation (mask based, and biphasic cuirass ventilation), or;
  • Circumstance which would preclude either form of non-invasive ventilation from being attempted. This can include, contra-indications for use of either method of non-invasive ventilation (e.g, lack of patent or viable airway, bodily burns in the case of biphasic cuirass ventilation, facial trauma in the case of mask based ventilation.)

Where negligence is criminal

If negligence occurs as a result of carelessness, then where the carelessness has been so severe that it is judged to be ‘gross’, the doctor may be subject to a charge of criminal negligence. Although the requirement to prove criminal negligence is a much higher one (i.e. beyond reasonable doubt, the sanctions are considerably greater and may include a custodial prison sentence for any doctor found guilty of such an offence, in addition to being prohibited from practicing in the future).

Informed Consent

In order to clearly prove that informed consent has been given, the following test should be met;

  • The patient has been made aware of the complications and their prevalence, that can follow a tracheostomy e.g risk of infections, bleeding, damage to vocal cords, etc
  • The aftercare requirements following the procedure
  • Quality of life impact issues, e.g difficulties in talking, eating, etc
  • That both alternative forms of non-invasive ventilation are available and have either failed, or are contra-indicated or have been specifically declined.

Alternative Forms of Ventilation

Currently two mainstream forms of non-invasive ventilation are available.

NIPPV – Non-invasive Positive Pressure Ventilation
Non-invasive Positive Pressure Ventilation is very well proven, and is often used as an alternative to invasive ventilation. NIPPV may be used with either a mask or mouthpiece as an interface. There is a significant body of clinical evidence that illustrates its’ use as a safe effective alternative to invasive ventilation – available worldwide.

BCV – Biphasic Cuirass Ventilation
Biphasic Cuirass Ventilation is also very well proven, and used as an alternative form of non-invasive ventilation. BCV is used with a Cuirass, a semi rigid plastic shell as an interface. Biphasic Cuirass Ventilation also has a significant body of evidence that illustrates its’ use as a safe and effective alternative to invasive ventilation – available worldwide.

Both forms of ventilation have many hundreds of clinical publications supporting their use, and are used by thousands around the world. It is very well proven that where one method has failed, the other has proved effective.

Discussion

For many medical professionals, a tracheostomy procedure appears to be a rather simple, quick fix to assist patients in respiratory distress. It can indeed greatly simplify care of a patient requiring ventilation. In some cases, it has become a source of revenue for institutions. It is not uncommon for fees for this procedure and immediate respective care to exceed $250,000. This in itself raises alarm for many.

There is no question that at times, this procedure is not only necessary, but lifesaving.

However, what has become apparent is that tracheostomies have become too readily performed, despite their numerous and very serious complications which include risk of death, and need not have been performed.

In the United States alone, upwards of 150,000 tracheostomies are performed annually. This is a conservative estimate, and only of the adult population.

It is obvious a great many patients have been significantly harmed, and many may have died.

Where the tests for clinical necessity and informed consent have not been met, claims for negligence will inevitably follow, and harm easily established.