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New Treatment Options in Cancer Care

by Attorney Frank E. Reardon

September 2007

In the early to mid 20th century, rapid, significant advances were made in American medicine.  This was particularly true in relation to surgery and life prolonging technologies.
  Today, we are probably experiencing a similar expansion in treatment options in cancer care.  Patients and their families were presented with a panoply of treatment options that were never before confronted.   Also, many of these treatment options were being offered in large, academic medical centers where their long term, family doctor was no longer part of the decision process.  All of sudden, choices could not be made simply based on what the physician recommended but also had to consider what the patient elected to undergo.  And state statutes and laws were enacted to require that the health care profession respected this right to chose.  The most celebrated cases were in matters concerning decisions to refuse respirators and artificial feeding, even where those treatments had been initiated with patient consent and where the decision to discontinue would result in death.  As the court’s noted, a patient has the right to be free from the unconsented to invasion of his bodily integrity.  Clearly, quite grandiose language, which did strike at the heart of this developing issue.    
But there were other cases, as well.  For example: How much information must be provided to a pregnant women about her decision to deliver vaginally or c-section and the risks inherent in each approach?  If waiting to deliver vaginally following the rupture of membranes increased the possibility of infection, what would the law require she be told to arrive a truly informed decision?  Thankfully, Courts reviewing these issues have generally taken a practical approach.  Usually, the requirement is that the patient receive information that a reasonable person similarly situated would want and need to make an informed decision.  A one or two percent risk of infection may not be reasonable while a thirty per cent might.  Further, the seriousness of the injury that could result would correspondingly require that less likely, but more serious risks be disclosed.  As a result, in the later half of the century, the legal doctrine of informed consent in medical treatment was born.        Although much has been written in legal and medical journals, few malpractice judgments have been solely grounded upon allegations of insufficient informed consent.  Usually, these allegations will be accompanied by sufficient allegations that a negligent medical decision was made or that a procedure was conducted in a substandard manner. 

More often, such allegations have been utilized by sophisticated plaintiff’s attorney to imply to a jury that the health care provider was acting paternalistically and could not be bothered spending the time to speak with the patient. Thus, risk managers and lawyers have repeatedly taught that there must be a note in the chart that indicates a conversation occurred with the patient explaining the risks and benefits of alternative treatment decisions.  Note that this does not mean that such conversations were not happening in the past, merely that now notes that support the physicians assertion that informed consent was provided were important.  The law even recognized that the health care provider should be allowed to testify what his “custom and practice” would have been at the time of treatment regarding the information provided the patient.  So, in court proceedings, a provider could testify what his customary conversation with the patient would have been even though he could not recall the specifics of that conversation years later.  Many health care institutions adopted policies that required certain services to use written forms that needed to be signed by the patient and included in the chart before the procedure could go forward.  Two of these services were anesthesia and surgery.  All health care providers and many patients are familiar with the anesthesia forms that routinely talk about risks from death to tooth loss. Similarly with surgical consent forms, the preprinted risks were often accompanied by other information such as that house staff may participate in the treatment.  Additionally, in most of these forms, there is always a blank space where the provider can write any information he has provided to the patient about their special circumstances.  For example, if a patient has a cardiac condition that complicates the survivability of the procedure, this should be noted.  There has always been concern among opponents of informed consent forms that such pre fabricated documents would be an excuse not to have the traditional doctor patient discussion.   

However, the more common belief is that such forms require and trigger discussions rather than facilitate their avoidance. This past July, the federal government promulgated regulations that are more a recognition of this practice than the imposition of new practice requirements.  At one time, the regulations required that any house staff be identified in writing and their role be delineated.  Those requirements are no longer set forth which is a good change.  When a surgeon or other specialist is providing care with the assistance of other health care professionals, decisions regarding what care the other provider is allowed to perform is made during the course of treatment and is often not readily defined in advance of treatment.  The law has usually held the doctor overseeing the treatment responsible for the appropriateness of the decision to let the other professional perform rather than the manner in which they perform.  In other words, they are not responsible for substandard treatment by the assistant if the decision to let them proceed was appropriate.  Thus, the new regulations merely codify what has been the practice in most medical centers for the past decades.  However, to the extent certain facilities had not pursued these practices on their own, these regulations are an improvement. 
Particularly, the requirements that these documents and discussions be memorialized in the contemporaneous medical record.  The rapid progression of electronic medical records in hospitals should ease the implementation of these requirements and should facilitate the provision of sound and thoughtful medical advice to patients and their families.  Through these regulations and other legal requirements, the goal is to inform patients of their diagnosis, prognosis with and without the proposed treatments and the risks and benefits of such treatment.