Informed consent represents the single most important issue in the delivery of health care.  Informed consent exists only when there is full disclose of known relevant information and known risk presented to the patient in a manner that they can understand. There are patients who did not understand that the "mastectomy" they agreed to have involved removal of their breast.  

In the "real world" in which we live there are often other procedural modifiers which influence the concept of full disclosure.  Some of these have legitimacy and some do not.  It is not unusual to see a court setting as the venue by which resolution of such issues is attempted.  An example of such a situation is the legally relevant issue as to whether a treatment or surgery being recommended is "accepted", "standard" or "approved" and to where the authority to determine this exists.  

The challenge in determining "informed consent" becomes even greater when it becomes apparent that there exists significant confusion in the definition of the terms noted above.  In fact because such confusion exists some have taken advantage of this to promote their own interests and agendas.  Medical malpractice cases based on informed consent issues (rather than negligence) often represent the "soft" side of forensic medicine.  Litigation is unquestionably an important "safety net" for society.  It has, unfortunately, in the area of informed consent sometimes been subject to serious abuse requiring attention and change. 

In recent years our courts have been busy with major litigation relating to the issue of fusion with pedicle screw instrumentation.  Pedicle screw systems have been, and continue to be, important modalities in spine care.  The major issue involved in this litigation has been that of informed consent.  It focused on whether the plaintiffs had been accurately informed, by their surgeons, as to whether or not the procedure was "investigational".  Even though the use of pedicle screw fixation systems in spine surgery was "standard practice" and considered to be so by most physicians the litigation was based on United States Food and Drug Administration (FDA) device classification which was confusing and was subsequently changed.  This did not, however,  stop the long courthouse parade.  Mealy's Litigation reported that, since December 17, 1993, in the United States, 7,000 plaintiffs with 1,650 complaints filed legal suits against manufacturers, surgeons and medical associations.  The cost of this exercise has to-date seen the expenditure of hundreds of millions of dollars based on these issues.  It has also resulted in the harassment of many of the United States' pioneering spine surgeons (and their families) who deserve better.  The message has been sent that informed consent litigation has now become big business and that procedural designations (valid or not) can serve to criminalize decent physicians.

To be candid, the practice of medicine does not (and never has) related to certainties. Treatment is based on best information.  This typically constitutes careful clinical observation and experience combined with the best scientific data available. The notion that there is no empirical basis upon which to draw valid inferences and render reasonable judgments in the treatment of patients is false. On the other hand there also exists important scientific information which never seems to make its way to physicians responsible for patient care.  As medicine progresses it becomes smarter and learns of risk factors which were previously unknown or unappreciated.  Sometimes this knowledge is privy to some who purposely do not release it or act, for personal gain, to obfuscate it.  Yet an important landmark in forensic medicine is "what was known, and when was it known" as a determinant of informed consent.

An interesting example of this is the issue of chronic respiratory disease related to exposure to asbestos fibers.  There is much litigation against manufacturers presently in progress.  For the most part exposure to asbestos occurred during a period of time when neither the manufacturers, the workers or their physicians were aware of asbestos toxicity.  Where is the benchmark?  How can we create expectations which are smarter than we are?

The phenomenon of "managed care" has introduced additional challenges to the concept of "informed consent".  In their quest to justify denial of coverage for their subscribers many third party payors, seeking an opportunity to say "no" to treatment being recommended for a patient, often use the term "not proven" or "experimental" as a means of denying coverage.  What is legal ramification of this to the physician recommending treatment?  What are the legal ramifications when care is denied and an alternative treatment goes "wrong".  Who has the legal responsibility?  Well, up-to-now the physician has been left "blowing in the wind" on this one.  The "worm ", however, is "turning".  Now that the unique immunity against legal suit provided by ERISA is being stripped away by the courts this "playing field" is finally becoming level.

A level playing field is particularly needed in the arena of informed consent because full disclosure of risk is taken to a medical "right" in the United States (as well as a primary "standard of care").  This is an interesting phenomenon because this concept varies considerably throughout the world as was demonstrated by the Burton Experience in the Soviet Union in the 1970s.  From this, and other experience,  it is evident that "rights" represent a conceptual phenomenon.  This publication must, at this point, make clear that it is a strong proponent of clear and complete disclosure of possible risks to patients by all health care providers.  Even though the United States is most visible as the world leader regarding disclosure of risk to patients there continue to be serious inadequacies and transgressions in this process which need to be addressed.  Without fair and complete disclosure true informed consent is not possible.  In addition, the issues of patient respect and consideration, from the health system also need mention.

In the real world of nature there are no "rights" for animals (astutely pointed out by Charles Darwin).  If each of us were placed naked in the center of a dense tropical jungle and we had to fend for ourselves we would discover what Darwin had in mind.  As the human race entered the scene on planet earth only those humans in possession of power had "rights".  In medieval times only the monarchs and the nobility of the world possessed "rights.  When the United States was young Thomas Paine and James Madison observed that rights were divided into "natural rights" (i.e. freedom of thought and speech) and "civil rights" (i.e. the right to trial by jury).  Informed consent is a civil right", more specifically a conceptual "patient right".

Unfortunately for Americans the concept of "rights" in the United States has burst asunder to finally reach a level of frivolity.  Perhaps this should not come as a surprise in a society where legal suits have become, as George F. Will has observed: simply a part of "a great American growth industry, litigation that expresses the belief that everyone has an entitlement to compensation for any unpleasantness".

When one considers all the attention which has been focused on the issue of informed consent over the past few years it may seem surprising to learn that important areas of medical diagnosis and treatment still exist where full disclosure of risk has never been provided in the past and has continued to be seriously deficient in the present.  Let's look at the record; only in recent years have the adverse effects of particulate radiation, exposure to toxic chemicals and cellular damage resulting from nicotine and carbon monoxide poisoning (from cigarette smoking) been disclosed.  It is important to note that most of this has occurred only as the result of litigation reflecting plaintiff rage and not because of governmental or medical concern.    

A good case in point is that of cigarette smoking.  From a medical standpoint, the toxic effects of smoking appear to represent the single most adverse known chronic health liability, from an external source, directed to the human body.  Remarkably, it has only been since 1997, when, as a direct response to legal actions, the actual ingredients of some cigarettes were finally disclosed to the public. Once again, were it not for the existence of legal process the release of this important information might never have occurred.

It is clear that there is no risk-free state in medicine. What then are the risks of surgery? In the field of spine surgery all patients run the risk of dying, being paralyzed, experiencing a nerve injury, wound infection, medical problem, drug reaction, etc. Actually most of these serious risks also exist when the patient drives to the hospital. The United States government reported that in 1998 alone 41,480 people died from auto accidents.

Most interested surgical patients in the United States today are reasonably cognizant of the associated risks and greater information continues to appear on the internet.  There are, however, a number of areas where informed consent remains, quite remarkably, almost absent.  In fact there are a number of examples of serious health risks which continue unabated over the years and decades.  Many of these are still unassociated with adequate public disclosure and few in the legal profession have yet "stepped up to the plate" to assist in assisting the public interest.  The most prominent example of this has been, and continues to be, those serious complications resulting from the introduction of foreign body substances into the subarachnoid space for the purpose of myelography and as a potential complication of epidural steroid injection. The complication is that of clinically significant adhesive arachnoiditis.  This particular entity represents one of the most flagrant examples of a still ongoing world-wide serious public health problem.  Patient suffering secondary to adhesive arachnoiditis serves as a frightening example of ill-advised therapy in an area where, as of year 2000 evidence suggests that not a single patient has ever been provided with   informed consent in the materials provided for review!  In association with this remain remarkable examples of continuing medical ignorance relating to commonly performed procedures.  Medical informed consent is unlikely when the usual material provided to the public, by their physicians, ignores the most significant risk factors?

From the standpoint of disability, incapacitation and suffering it is clear that the greatest dilemmas exist in the field of exposure to toxic substances and toxic radiation.  It is in these areas where the greatest numbers of harmed individuals are to be found.  Associated with this are also the greatest breakdowns in informed consent.   It takes a "brave heart" to acknowledge this given the reality of opening a "Pandora's box" followed by a deluge of lawsuits.  It is therefore important to acknowledge those who, like Raoul Wallenberg, have demonstrated extraordinary personal courage in their willingness to take on difficult challenges.  For the new Millennium the Burton Report® would like to acknowledge the valor of Cherie Booth, wife of British Prime Minister Tony Blair, for supporting Britain's Human Rights Act .  This long-overdue legislation will extend to all in England their very first Bill of Rights.

No area of informed consent is more important than that of medical research and the involvement of human subjects.  An important example of the many quandaries inherent in applying informed consent to medical research was illustrated by the death, in 1999, of a 18 year old volunteer in gene-therapy experiments at the University of Pennsylvania in Philadelphia and thus serve to open soul-searching philosophic inquiries.  On the basis of this death the United States Food and Drug Administration temporarily halted the University's genetic research in order to conduct a review.  It is alleged that the volunteer did not fully understand the risk factors relating to his involvement in this treatment program.  How can the patient know the risks when they are basically unknown to science as well as the medical profession?  Unquestionably, gene research will play a very important role in future medical therapy.  Gene therapy represents a challenging voyage into uncharted water where the benefits for all mankind may be historic.  How do we know what we don't know, and how does informed consent fit into this picture?

Summary:
Informed consent is an essential requirement for the well-being of any modern health care system in the 21st century.  Informed consent is based on full disclosure of known risk (the easy part).  Full disclosure of all "relevant information" is the murky component, particularly from the standpoint of jurisprudal  machinations and contrived governmental anomalies.  Informed consent litigation has created a great deal of "busy work" for attorneys.  Much of this litigation has wasted large amounts of time, talent and resource which could have been put to better use in the courtroom by pursuing more important areas of societal need.  The need for clearly defined requirement for patient protection taking into account the rapidly changing landscape is essential now.