Informed Consent

February 8th, 2010

February 8, 2010

As a New York LASIK malpractice attorney, frequently, LASIK patients contact me and complain that they have suffered complications from their surgery. They quickly add that they fear that they signed papers (which they call a “release,” or more accurately, an informed consent form), prior to their surgery, preventing them from pursuing a lawsuit. However, signing an informed consent form does not prevent legal action. The doctor’s pre-operative informed consent form does not protect him from his own negligence.

In New York, the Pattern Jury Instructions, which a judge reads to a jury in a medical malpractice case, provide the following statement of the doctor’s duty of informed consent to his patient:

“Before obtaining a patient’s consent to an operation or invasive diagnostic procedure or the use of medication, a doctor has the duty to provide certain information concerning what the doctor proposes to do, the alternatives to that operation, procedure or medication and the reasonably foreseeable risks of such operation, procedure or medication. It is the doctor’s duty to explain, in words that are understandable to the patient, all the facts that would be explained by a reasonable medical practitioner so that when the patient does, in fact, consent, that consent is given with an awareness of:

  1. the patient’s existing physical condition;
  2. the purposes and advantages of the operation, procedure or medication;
  3. the reasonably foreseeable risks to the patient’s health or life which the operation, procedure or medication may impose;
  4. the risks involved to the patient if there is no operation, procedure or use of medication; and
  5. the available alternatives and the risks and advantages of those alternatives.” NY PJI 2:250A.

With LASIK surgery, it is customary for a patient to sign a multi-page typed form that purports to instruct the patient of all of the risks of surgery. According to TLC’s form, you may not be a candidate for LASIK surgery if you have:

“inflammation or infection, severely dry eyes, excessive corneal scarring, certain degenerations or dystrophies of the cornea, lazy eye, muscle imbalance, keratoconus or any condition which may affect healing; history of Herpes Simplex eye infections, uncontrolled vascular disease, uncontrolled diabetes, lupus, rheumatoid arthritis; a compromised immune system; a pacemaker or defibrillator; progressive nearsightedness or farsightedness; previous corneal surgery; corneal blood vessel growth; keloid formation; or have taken Accutane, Cordarone or Imitrex.”

TLC’s form also states that vision threatening complications include:

“excimer laser malfunction, causing permanent irregularity of the cornea leading to uncorrectable loss of vision; microkeratome or Pulsion-FS laser malfunction, causing an abnormal corneal flap leading to uncorrectable loss of vision;  decentered treatment causing permanent irregularity of the cornea, leading to uncorrectable loss of vision; irregular corneal healing which causes distortion, ghost images and scarring; epithelial healing defects, resulting in delayed healing, pain, light sensitivity, or infection; wrinkled, displaced or lost corneal flap; corneal infection; corneal inflammation; intractable glare and inability to function in a dark environment; retinal detachment, venous or arterial blockage of the retina, hemorrhage of the retina, cataract formation, total blindness or loss of the eye; and complications due to anesthetic drops or other medications used in conjunction with LASIK.”

Given the comprehensive nature of such forms, the patient wonders how he can sue when this fine print regrettably applies to him. First, the consent form does not protect the doctor from his own negligence. For example, if the patient initially was not a good candidate for surgery, if the doctor was negligent in performing the surgery, or if the laser malfunctioned, the informed consent form will not protect the doctor.

So, when might the informed consent form matter? A recent article in Cornea reports that 20% of LASIK patients suffer varying degrees of dry eye after LASIK surgery.  As a general rule, the complication or side effect of dry eyes is not due to any error or mistake by the doctor. It is generally considered to be a known and accepted risk of the surgery. The doctor tells you this so that you are not surprised if it happens to you. Dry eyes generally are not a sign of malpractice.  However, failing to inform a patient of this common side effect would constitute a breach of the duty of informed consent. (Bailey M.D., Zadnik K. “Outcomes of LASIK for myopia with FDA-approved lasers,” Cornea. 2007 Apr; 26(3):246-54.)

Informed consent is a process. It is not a piece of paper. The pre-printed informed consent form is prepared for the vast majority of refractive laser surgery patients. But if the patient is at higher risk because he has a pre-existing corneal condition or disease, such as keratoconus, is suspicion for ectasia, or has a thin cornea, the doctor has a duty to inform his patient.

Ideally, it would be appropriate for the doctor to give the patient the written form in advance of the day of the surgery, such as when the initial screening is performed. Then, the patient might actually be able to read and understand the form, and have a chance to ask the surgeon follow up questions. However, in some high volume LASIK surgery centers, patients have been given such forms after their eyes have been dilated, when they cannot read, or after they have given Valium as a sedative for the surgery, after which they may not fully comprehend what they are reading.

If you have had LASIK surgery and suffered a complication, you should contact a lawyer to investigate whether you have a malpractice claim. Your having signed an informed consent form does not prevent you from pursuing a valid claim of surgical negligence.

If you have not yet had surgery, you should insist on speaking to the surgeon, and not your optometrist, or “technician.” You should ask your eye surgeon to describe to you in terms that you can understand the risks, benefits and alternatives to surgery. The fact that LASIK surgery is customarily scheduled by the doctor in 15 minute increments, and takes just seconds to perform, does not mean that the doctor cannot give you 5 minutes of his time to talk to you, especially after having paid thousands of dollars for the surgery. Most importantly, you should acknowledge that you have read, or would like a chance to read, the written informed consent form, BUT you would like to know if there is any reason, particular to you, why the surgery may carry increased risks that do not apply to the general population. Given the elective nature of the surgery, if so, you may want to think long and hard about going forward with such surgery, and hope that you have surgeon who thinks the same way.

Related posts:

  1. THE STATUTE OF LIMITATIONS AND TIME BOMB OF POST LASIK ECTASIA
  2. Selecting A LASIK Surgeon
  3. How Safe is LASIK? The Tiger Woods of Medical Procedures?
  4. FDA To Study LASIK Patient Satisfaction
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