Informed Consent in the Legal System

gavel and stethoscopeA common call that we receive comes from a patient who feels that she did not receive “informed consent” from her physician.  The patient had a procedure or took a prescribed medication, and something went wrong.  There was a complication or side effect, the patient doesn’t feel the doctor told her this might happen, and now she’s very unhappy.

That unhappiness does not necessarily translate into a successful medical malpractice claim, even if the patient truly wasn’t told about the complication or side effect.  That’s because informed consent in a legal sense means something more than a lack of information.  Each state has slightly different legal requirements, but in Massachusetts, a patient bringing a claim for lack of informed consent must prove four things: 1) that he wasn’t informed about a risk or complication; 2) that the risk or complication is something that a reasonable patient in his position would want to know about; 3) that the risk or complication actually occurred; and 4) that if the patient had known about the risk or complication, neither he nor a reasonable patient in his position would have agreed to the treatment, procedure or medication in question.

That last part is a major stumbling block in many cases.  Most patients understand that surgeries carry certain risks, and that medications may have side effects.  Yet every day, patients have surgery and take medications, fully understanding that the outcome may not always be what they hope or expect.  Informed consent, in the legal sense, provides a remedy only if the patient can prove that she wouldn’t have had the treatment or taken the medication if she’d been aware of the risks.  The patient’s word isn’t enough; the patient also has to prove that a reasonable patient wouldn’t have had the treatment either.  And in many cases, that’s quite difficult.

The purpose of the legal cause of action for informed consent is not to guarantee that no complications will occur, or even to provide compensation if a there is a complication.  It is simply to make sure that patients understand what might go wrong when they get medical treatment, and have the opportunity to decide whether the anticipated benefit of the treatment outweighs the possible risks.  As a practical matter, unless the risks are very great, or the potential benefits very small, most patients would choose the treatment.

A cause of action for informed consent is most likely to be successful when there are reasonable and legitimate alternatives to the doctor’s chosen course of treatment.  Some examples include situations where a proposed surgery is truly elective or cosmetic, where there are options for both medical and surgical treatment, or where something about the patient’s individual situation makes a usual treatment less appealing.

A final note:  in most jurisdictions, the doctor’s obligation to inform the patient applies not just to surgical procedures.  Doctors must tell patients about the different treatment choices or medications available to them, including the alternative of no treatment, or doing nothing.  This principle often becomes important during certain labor and delivery situations, where the mother may need to decide whether to have labor induced, whether to undergo a trial of labor, or whether to allow labor to continue in the face of fetal heart rate abnormalities.  Patients have the right to make these decisions in an informed manner.

Informed Consent in a Medical Setting

patient signing ICMost doctors and patients have heard about informed consent, but very few of them have a clear understanding of what it means.  Part of the confusion stems from the fact that the concept of informed consent has different meanings in different settings.  When doctors speak of informed consent, they mean the process by which patients are given medical information about their condition and treatment.  When lawyers use the same phrase, they mean a legal cause of action that has specific proof requirements that vary from state to state.  The difference is important if you are thinking about a medical malpractice claim.  It’s not as simple as proving that the doctor didn’t tell you something.

Historically, doctors made decisions about a patient’s medical treatment without consulting the patient.  The rationale was that the doctor had the medical training, the doctor knew best, and that a patient would not think to question a doctor’s judgment.  Over time, that has changed, particularly where there is more than one reasonable course of action: whether to treat with medication or surgery, whether to watch a condition or treat it, whether to perform an elective surgery, among others.  Doctors now understand–and the law recognizes–that patients, not doctors, have the right to make those types of decisions.

Many organizations have attempted to help patients and doctors through the process of shared decision making.  One independent research group, the Informed Medical Decisions Foundation, has created a series of  “decision aids” to help doctors focus on what’s important to patients in making treatment decisions, including what may be the effect of particular choices on a patient’s quality of life.  The American Medical Association emphasizes to physicians that the informed consent process is not just a formality.

Despite these efforts and warnings, many in the medical profession have lost sight of the purpose of informed consent, and often treat the important process of shared decision-making as just one more item to be checked off the list.  Doctors and hospitals have developed standard forms that contain vague and general listings of the worst risks imaginable–paralysis, brain damage, death–as well as more common complications such as organ injury or infection.  For the most part, these forms are used for a wide variety of patients and treatments, and there is little, if any, effort to tailor the form (or the information) to the particular patient or treatment at hand.  They look like exactly what they are: an attempt to avoid legal liability, rather than a genuine effort to inform the patient.

Patients, too, have become desensitized to the process, as they become accustomed to signing forms full of fine print, often containing both medical and financial information, without reading the form or questioning the health care provider.  If the treatment goes smoothly and the patient does well, this wink-and-a-nod approach to informed consent goes unnoticed.  But when something goes wrong, the health care provider may find that it doesn’t have the legal protection it would like, while the patient, quite understandably, may feel that the informed consent process was given short shrift.

And when that happens, the patient often calls a lawyer.  That’s where the disconnect between medicine and law comes into play.  Even if the patient was truly unaware of a potential risk or complication, that’s not necessarily enough to bring a claim for lack of informed consent.  Check back later this week for a discussion of informed consent in the legal sense.

Robotic Surgery… the Rest of the Story

davinci roboticWant to avoid a large surgical incision and scar?  Want to spend the least amount of time in the hospital?  Want the least possible blood loss?  Least amount of pain?  Less narcotic medicine?  Want to recover from surgery as fast as possible?

These are the questions posed by a patient brochure distributed by Intuit Surgical, the manufacturer of the daVinci robot.  The robot is being used to perform a number of different prostate, gynecologic, urologic, cardiac and abdominal surgeries.  The doctor controls the surgical instruments from a console near the operating table.  And for some patients and some doctors, the results are good.   But for other patients, the complications can be extremely severe.

We recently met with a client who had suffered a serious nerve injury after undergoing robotic surgery on his prostate.  During his operation, the machine broke down, the surgery went much longer than planned, and eventually had to be converted to a standard open procedure.  Probably as a result of remaining too long in the surgical position, the man suffered a disabling nerve injury, and cannot work.

There is a growing body of medical literature documenting a number of specific complications of robotic surgery.  These range from nerve injuries and vision loss to brain damage or even death.  Many of these arise from prolonged time on the operating table, which is often attributed to the inexperience of the operating surgeon.  Despite evidence that there is a steep learning curve, requiring as many as 200 surgeries to become proficient, doctors are rushing to sign up patients for the new techology.   In addition, patients with certain medical conditions may be at higher risk for complications with the minimally invasive approach.

Researchers at Johns Hopkins Hospital in Baltimore have expressed concern that hospital websites may be misleading patients by making unproven claims about the safety and effectiveness of the robotic procedure.  Often using content and images provided by the manufacturer, and even providing a direct link to Intuit’s website, hospitals tout the benefits of surgery, overestimating the advantages and largely ignoring the risks.

Hospitals of all sizes are seeking to gain a larger share of the lucrative market in this area.  But especially at smaller hospitals, the volume of procedures may not be sufficient for the surgeons, anesthesiologists and operating teams to develop the expertise needed to use the robot safely and efficiently.   Individual surgeons, feeling pressure to compete with their peers, may rush to perform robotic surgery before they have developed true proficiency.

Despite the obvious appeal of shorter hospital stays and less pain, patients considering robotic surgery should carefully question their surgeons about the actual benefits and the doctor’s own experience with the procedure.  Otherwise, these patients may be trading short-term benefits for devastating long-term consequences.

Read More: Anesthetic considerations for robotic prostatectomy: a review of the literature.

Read More: daVinci Surgery Patient Flyer

Getting Your Medical Records

medical records wide viewIn Massachusetts and most other states, you have the right to get copies of your medical and hospital records.  In theory, the process is simple: just make a written request to your doctor, hospital, or other health care provider.  Include your name, address, date of birth, and a description of the records you want to receive.  A hospital is required to respond to your request within thirty days if the records are kept in the hospital, or sixty days if they are stored in an off-site location.  Many hospital websites provide specific information and authorization forms for use in requesting records from the facility.  It’s usually a good idea to call the provider before submitting your request to make sure you’re sending the right form to the right address.

If you are the parent of a minor child, you may request your child’s records.  If you are the administrator or executor of the estate of a deceased person, you may request records for the decedent.  Sometimes the provider will release the records of a deceased person to the surviving husband or wife, or to the person named in the will as executor, but many institutions require a formal probate court appointment.

In Massachusetts, the provider is permitted to charge you a reasonable fee, set by a statute, General Laws, Chapter 111, Section 70, for retrieving and copying the records, unless the records are for use in a Social Security claim, or for a federal or state needs-based program.  The provider may not withhold the records because you have not paid a bill for medical services.  A hospital is required to keep records for 20 years from the date the patient is last seen.  A doctor must keep records for seven years, or until the patient reaches age 18.

When requesting records, it is important to be specific about which records you are requesting.  Particularly where the records are voluminous, or cover a long period of time, a hospital may provide only a summary or abstract of the records.  Depending on the purpose of the request, this may or may not be sufficient.  You are also entitled to receive copies of x-rays, CT or MRI scans, and other imaging studies.   Many labs and hospitals will not release pathology slides directly to the patient or an attorney, but will send them to another health care provider.

Georgetown University has a website that attempts to track requirements and time limits for requesting medical records in each state.  This site includes specific information for Massachusetts, New Hampshire and Rhode Island.  The Massachusetts Board of Registration in Medicine also publishes a brochure to help patients understand their rights in this area.

If you’re considering a medical malpractice claim, you may want to consult a lawyer before requesting your medical records.  A lawyer will be able to help you determine which records are necessary to evaluate a potential case, and most lawyers will handle the requests for you.  Health care providers  tend to interpret medical record requests quite narrowly, and will normally respond only with copies of records they created, omitting information received from other providers, administrative and billing documents and similar material.  If the purpose of a request is to investigate a medical malpractice case, there may be other important documents in the provider’s file that must be specifically requested.  These may include correspondence, records from other health care providers, billing records, history or information forms completed by the patient, and phone messages.

Most patients–and even many lawyers–do not realize that there may be important information that a hospital will not include even in response to a request for the complete record.  An often overlooked category of records includes certain anesthesia and surgical monitoring documentation.  For some reason, many hospitals do not consider these documents to be part of the patient’s record, and will not include them even in response to a request for the complete hospital record.  In a case involving surgical or anesthesia negligence, this documentation may be critical, as it contains detailed information not found in any other record.

Mike Harris to Chair Educational Program for Lawyers

Mike Harrris is chairing a seminar to help lawyers who handle medical malpractice cases better serve their clients.  Mike has assembled a panel of noted local authorities, including lawyers for patients, lawyers for doctors and hospitals, and an experienced insurance claim representative. seminar room The program, to be held at Massachusetts Continuing Legal Education on Winter Place in Boston on January 14, 2013, will also be available for remote viewing over the internet, both during the live presentation and a week later.  MCLE will also produce audiotapes of the presentation for those who miss these sessions or who want a lasting reference.

Aimed at both experienced practitioners and lawyers wanting to get started in this rewarding field, the fast-paced program will cover all aspects of medical malpractice cases, from case selection and evaluation through trial.  Mike and his panel will devote special attention to the new notice requirements for filing medical malpractice cases in Massachusetts, and the prospect for better disclosure of adverse events to patients and the possibility of quicker resolution of claims.

The seminar will also feature wide-ranging panel discussions on alternative methods of resolving cases through settlement or arbitration, and will guide attendees through the most recent laws for dealing with Medicare and Medicaid liens and protecting settlement funds.

Agenda: Handling Medical Malpractice Cases

A Blog is Born… and Some Fine Print

My baptism in the blogosphere came at the hands of a doctor.  A doctor who called himself Flea.  Flea was the defendant in a medical malpractice case in which I represented the family of a young boy who had died of undiagnosed diabetes.  In addition to being a doctor, Flea was a prolific and–some might say–incorrigible blogger.  Long before Flea and I crossed paths, Flea blogged on a variety of interesting topics.  He was irreverent, provocative, and sometimes brutally honest about his patients and his profession.  If he’d stuck to writing about medicine, he might still be blogging.

Unfortunately, shortly before the malpractice trial started, Flea began blogging about his trial preparation sessions with his lawyers.  He moved on to me, and then to the judge and the jurors, all in quite unflattering tones.  Someone dropped an electronic dime on Flea, and I found his blog.  It was fascinating reading!  I won’t rehash all the details of the denouement, which have been well-chronicled by bloggers like Eric Turkewitz, Kevin MD, and Overlawyered, and even in The Boston Globe, with varying degrees of accuracy.  But in the course of combing Flea’s blog for statements that contradicted his trial testimony (there were several), and in reading commentary by various bloggers who followed the saga, I learned a lot about the blogosphere.  An endless array of people commenting on an infinite variety of topics.  I’d simply had no idea that all this existed.

blog letters

And somewhere in those days, another blogger was born–or at least conceived.  The urge to add my observations nagged at me like an itch I just couldn’t scratch.  There is just so much going on, in medical malpractice, in personal injury, in trial practice.  So finally, with the launching of our new website, I have a platform.

This blog is intended to be informative, thought-provoking, and, I hope, an accurate source of news and information for our clients and other lawyers.  But there is a little fine print:

1.    Unfortunately, the law can be complicated, is subject to frequent changes, and may vary according to the jurisdiction and the particular facts of a situation.  This blog cannot provide legal advice.  Individuals who have legal questions should consult their own lawyers.  TRANSLATION: We hope you find this helpful, but you may not rely on what’s written here as legal advice.  If you are a lawyer, we hope you find this helpful, but you’ll need to do your own research and reach your own conclusions about the law that applies to your case.

2.    On occasion, this blog may give examples from past cases handled by my firm or other firms.  These cases are intended as illustrations, and should not be used as a basis for predicting results or outcomes in other cases.  It is tempting to try to compare one case to another, but without a detailed understanding of the facts and the law in each case, these comparisons can be very misleading.  TRANSLATION: Just because your neighbor or your Aunt Tillie tells you what happened in her case doesn’t mean that your case will result in the same outcome.

3.    I have been privileged to work with some wonderful people on various committees, particularly my friends and colleagues on the Executive Committee of the Massachusetts Guide to Evidence and the Supreme Judicial Court’s Standing Advisory Committee on the Rules of Professional Conduct.  Any positions or opinions expressed here are my own individual thoughts, and not official statements of any group or organization.  TRANSLATION: Please don’t blame anyone else for what I write.