LASIK Malpractice: Can You Sue? by Kenneth M Keith, JD

Discussion in 'Laser Eye Surgery' started by badlasik, Jan 30, 2007.

  1. badlasik

    badlasik Guest

    If you've had a bad outcome from LASIK or other refractive surgery,
    read this excellent article by (unfortunately) very experienced LASIK
    malpractice attorney Ken Keith.

    Can You Sue?
    by Kenneth M. Keith, JD

    There can be no doubt that refractive surgery can do harm. If you are
    viewing this on the Surgical Eyes website it may be because you have
    been injured by refractive surgery and you want to know if there is
    anything you can do about it. An old legal axiom "Mere injury,
    fault, will not stand" says it all for attorneys practicing in the
    field of medical malpractice. Simply put, it is not enough that you
    have been injured as a result of the refractive surgical procedure
    have undergone, you must establish, to the standard set by the state
    in which you were injured, the failure or failures which have
    in the injuries you have sustained. This article will attempt to
    identify those areas where the failure is most likely to occur, but
    every set of circumstances is different and every experience unique.
    Malpractice may exist beyond the scope explored here and this article
    is not intended to substitute for the advice of an attorney.
    Malpractice is differently viewed in every state and while this
    article attempts to be jurisdictionally neutral, a slight New York
    spin may be unavoidable as it is the jurisdiction in which the author
    practices law. If you believe you have sustained an injury as a
    of refractive surgery gone badly, consult with an attorney who will
    work with you to get an opinion from an independent medical expert
    to evaluate whether actionable fault (something for which you can
    resulting in your injury appears to exist.

    Unlike most other areas of medical malpractice, some claims against
    laser eye surgeons and the corporate giants behind them may stem from
    the manner in which they attracted you to refractive surgery
    and to them in particular. Refractive surgeons and the businesses
    surrounding them are competing in a manner that medical professionals
    never really have before, they are advertising. They find themselves
    having to fight for patients in an increasingly difficult
    Price competition all but ignores the question of whether a surgeon
    has the requisite skill and experience to perform an operation on
    anything as fragile and as important as one's eyes, but if the only
    criteria used in selecting a surgeon began and ended with a dollar
    sign, fault may well lie on both sides of the scalpel. Of greater
    interest from the point of view of attorneys are the promises made in
    the ads of refractive surgeons.

    Federal and local consumer protection laws govern the promises that
    are made in the ads and the nature of the promises contained in the
    may give you the ability to sue your surgeon even where you cannot
    otherwise seek redress for a failed refractive surgery procedure in a
    "traditional" medical malpractice lawsuit. Advertising is considered
    "deceptive" if it is likely to mislead "reasonable" consumers and if
    it is likely to affect consumers' conduct or decisions. A practice is
    "unfair" if it causes or is likely to cause injury to consumers that
    they could not reasonably avoid and that is not outweighed by the
    benefits. The Federal Trade Commission, basically, has three simple
    guidelines for all advertising:

    1. Tell the truth. Don't mislead consumers about the benefits or
    safety of your product by what you say expressly or by what your ad

    2. Tell all the truth. Don't omit information that is needed to keep
    what you say from being deceptive.

    3. Make sure it is the truth. Have adequate support for any objective
    claim, express or implied.

    The web sites of doctors providing laser surgery must, but
    occasionally don't, disclose risks and complications, as required by
    FDA rules, whenever a particular laser's benefits are mentioned in
    marketing materials.

    Each State has is own set of consumer protection legislation against
    which the promises made by refractive surgeons in their advertising
    and literature must be viewed. In many cases there is a fine line
    between mere "puffery" (just generally saying how good you are and
    good laser surgery is) and a deceptive advertisement (Perfect vision
    every time and guaranteed no night vision problems").

    Please note that the attorney who may represent clients in medical
    malpractice may not be the same attorney who pursues claims for
    deceptive advertising practices. They will, undoubtedly, be able to
    refer you to an attorney who may handle such matters.


    Informed consent is a process, not just the document your surgeon or
    his staff will ask you to sign at the time your surgery is to be
    performed. Information must be presented to enable persons to
    voluntarily decide whether or not to undergo the contemplated
    procedure. The procedures used in obtaining informed consent should
    designed to educate the patient in terms that they can understand.
    Therefore, informed consent language and its documentation
    explanation of the alternatives, risks and benefits) must be written
    in "lay language", (i.e. understandable to the people seeking the
    surgery). The consent document must be revised when deficiencies are
    noted or when additional information will improve the consent

    Statutes define lack of informed consent as meaning the failure of
    person providing the professional treatment to disclose to the
    such alternatives to the procedure and the reasonably foreseeable
    risks and benefits involved in the operation as a reasonable medical
    practitioner, under similar circumstances, would have disclosed, in a
    manner permitting the patient to make a knowledgeable evaluation. To
    succeed in a law suit based upon lack of informed consent you must
    first present expert medical testimony to support your belief that
    information provided to secure your consent was insufficient. You
    need to show both that a reasonably prudent person in your position
    (NOT YOU) would not have undergone the operation had they been fully
    informed AND that the lack of informed consent is what directly
    the injury upon which you have sued.

    The adequacy, or lack thereof, of the informed consent which is a
    necessary component of every surgical procedure may well be the most
    fertile area in which malpractice is committed by refractive
    As stated above, surgeons are now competing with their peers for each
    and every potential patient. The corporate world has involved itself
    in the practice of medicine in a way it never has before and, in many
    cases, seeks to groom the experience of the patient in a way designed
    to attract those who are considering the operation, to keep those who
    have decided to undergo the operation and to keep the image of
    refractive surgery as neat and clean as possible so as to be able to
    attract those who have not yet seriously thought about the operation.
    Simply put, they want to get you, once they get you they don't want
    scare you off and they want to make sure those leaving their offices
    have nothing bad to say. Corners are sometimes cut to achieve their

    Make no mistake about it informed consent was and is, primarily, a
    device used for the protection of doctors by doctors. They give it to
    you to protect themselves from law suits. That's not, obviously, how
    the document was intended but it, like many well intended things, has
    had its use perverted by those with a self serving agenda.

    Initially the Courts viewed the failure to provide adequate
    information upon which one could base their consent to have a
    procedure as negating the consent itself. It made sense. If someone
    doesn't give you all of the known information before you decide to go
    ahead, your decision to go ahead shouldn't be held against you. The
    Courts treated operations occurring with defective consents as an
    unconsented touching or a battery (in some states, an assault). In
    that way almost anything that happened could form the basis for a
    against a doctor. The Courts came to hold that this approach placed
    too great a burden on the medical profession (can you spell powerful
    lobby?). Today, the Courts almost unanimously treat lack of informed
    consent as another branch of medical malpractice and treat it as
    negligence for a physician to fail to disclose necessary information
    to a patient.

    The concept of informed consent is based on the principle that a
    physician has a duty to disclose to a patient information that allows
    the patient to make a reasonable decision regarding his or her own
    treatment. Although the exact content included in refractive surgery
    informed consent should vary from individual to individual as each
    individual is unique and approvals for lasers themselves are given
    differing prescriptions, physicians, generally, have one form that
    they give to all of their patients, which is intended, in theory, to
    serve the needs of all. Having reviewed close to 100 different
    informed consent forms in preparation of this article, Informed
    Consent documents range in length from barely three pages to over
    twenty-five. Now, while length is, clearly, never the factor to be
    used in determining adequacy, it is clear that the twenty-five page
    document must contain information not present in the three page
    version. There are those who believe that some Informed Consent forms
    are so overpowering (not necessarily thorough, however) that they
    serve to "Hide in plain sight" all of the risks and lead many to just
    skim and sign instead of fully digesting a more comprehensive, but
    compact, document.

    Contents of the Informed Consent

    The informed consent that you were given should, at a minimum, have

    An explanation of the medical condition which warrants the proposed
    An explanation of the purpose of the proposed procedure or treatment
    A description of the proposed procedure or treatment including known
    and/or anticipated side effects
    A discussion of the known risks (including all known conditions which
    might render the surgery inappropriate for a particular patient) and
    benefits of the proposed procedure or treatment, a presentation of
    alternatives to the procedure being contemplated and their known
    effects, risks and benefits
    A discussion of the consequences of not accepting the proposed
    procedure or treatment
    A statement that the procedure may involve risks to the patient which
    are currently unforeseeable
    A statement of the individual's right to withhold their consent to
    proposed procedure and a statement that such refusal will not impact
    on the individual's current or future right to receive continuing
    health care
    A statement that the individual may withdraw consent to the procedure
    at any time and that such withdrawal will not impact on the
    individual's right to receive continuing health care
    It is the responsibility of the physician to present all information
    necessary for informed consent to the individual and involved family
    members in a way that is understood by them. This includes the use of
    words, phrases and language that they understand. If necessary, an
    interpreter should be involved. In addition, other members of the
    health care team, such as nurses, may clarify information and answer
    questions regarding the information presented by the physician. It
    should be noted that some states follow the "prudent physician"
    standard to judge the reasonableness of an informed consent. That is
    to say, the question is not, "What would a reasonably prudent patient
    require by way of information," but rather, "What would a reasonably
    prudent physician provide?". There can be no question that within the
    area of informed consent there is far more gray than black or white.

    Presentation of the Informed Consent

    As important as the content of the Informed Consent document is, of
    equal importance is the manner in which the patient has been
    with the information.

    It is best if the patient has been provided with the informed consent
    at least a week in advance of the procedure. If you are presented
    the document as you are sitting in the waiting room waiting for your
    surgery, it can well be argued that no matter how complete the
    document it is difficult at best , and impossible at worst for
    to review and digest the information which should properly contained
    therein in the limited time period provided let alone them being
    to do so while they are working with the additional stress and
    distraction of their pending surgery.

    The mere presentation of the document is, again, insufficient for a
    surgeon to have met their responsibility to the patient. First and
    foremost the document must have been provided in an understandable
    format. Layman's English, not doctorspeak, is essential. If English
    isn't your first language the document should have been translated
    you, line by line, not paraphrased by an employee of the surgeon or
    the center and it should not be left to a friend or family member who
    may have come with you as they may well be no more familiar with the
    terms they are reading than you are. The surgeon or other members of
    the health care team, should have been available to review the
    document and to clarify information and answer all the questions you
    may have regarding the information presented in order for you to
    an informed decision about the contemplated surgery.

    It is of particular concern when the Informed Consent is negated by
    the manner in which it is presented. Laser centers have been known to
    give cash incentives to their employees to get a non-refundable
    deposit from potential patients and to "move" patients from lower
    priced to higher priced surgeries to get a non-refundable deposit
    "move" patients from lower priced to higher priced surgeries.
    Frequently informed consent documents are presented as "just
    we have to get you to sign" or with "Don't worry, none of this ever
    happens, we just have to put it all in". Informed consent forms for
    PRK have even been give to those undergoing LASIK. Sometimes well
    intentioned office employees will negate the substance of the
    consent either just to try to calm an apprehensive patient or to keep
    business in the office. Particular attention should be paid to how
    when you were given the informed consent documentation, who was
    present when you reviewed it and what role if any, they played in
    your execution of the document.

    the quote below is about Laser Vision Institute (LEVI), that required
    its counselors to "close a deal" with 75 percent of possible
    to qualify for bonuses, and the chain based commissions on how much
    the patient paid:

    "To ensure that patient counselors are performing adequately, LVI
    sends undercover evaluators acting as prospective patients. One
    question on the evaluation form, worth 35 of a possible 58 points,
    asks, "After giving the counselor a reason why you were not committed
    to leaving a deposit today, did they make a STRONG ATTEMPT to get you
    to change your mind? How many attempts did the counselor make to have
    you leave a deposit?"

    Some former LVI counselors said they sometimes used a technique
    in the selling of cars and appliances but nearly unheard of in the
    selling of medical services: the faked meeting with the manager."

    The above applies only to LVI but may well be systemic, extending to
    providers in addition to LVI, but not yet uncovered.

    An informed consent, executed under these circumstances, may well be
    subject to attack, giving you the right to sue where, on paper, it
    might appear that you were otherwise precluded.

    PLEASE NOTE: The mere fact that you have signed a consent form does
    NOT mean that you cannot sue for malpractice. A consent form does not
    give the health care provider a license to commit malpractice. While
    the execution of a typical consent form indicates acknowledgment of
    stated risks and complications associated with a given treatment or
    procedure, it does not relieve the health care provider from his or
    her duty of meeting the standard of care associated with such
    treatment or procedure. So many informed consent forms are deficient
    or are presented in such a manner as to devalue or negate entirely
    fact that they were presented at all that it is important for you to
    understand that only a qualified legal and medical professional, each
    reviewing the totality of the facts unique to your case, can
    if there is any significance to the form you may have signed.


    While there are various types of medical malpractice claims,
    speaking, you must usually show that a doctor patient relationship
    existed, that the doctor failed to perform to the appropriate medical
    standard, that the patient was injured and that the doctor's
    from that standard was what caused the injury the patient now sues

    It must be understood that the standard against which the surgeon
    be judged varies depending on where the doctor is practicing. A
    has a duty to give his patients proper medical care within a
    reasonable standard set by doctors within the same medical field.
    "standard of care" test is used to determine whether or not a doctor
    has committed medical malpractice by doing something he should not
    have done or failing to do something he should have done, resulting
    his medical care falling below the "standard" and thus constituting
    medical malpractice. If the medical professional fails to meet the
    standard of good medical practice and harm results to a patient, the
    medical professional may be liable for any resulting damages. In the
    case of a doctor who is a medical specialist, the standard of care is
    determined by the standard of good medical practice in that

    The determination as to whether the standard of care has been
    is not made by your lawyer. It can be made only by a doctor
    experienced in the area of medicine with which your potential claim
    concerned. This expert doctor will review your medical records and
    also examine you to evaluate your claim. It is this doctor who will
    advise your lawyer as to whether the standard of care has been
    breached and whether you have been harmed as a result and therefore
    can sue. Ideally, that doctor will also be prepared to serve as the
    expert you will need to prove your case because in order to win a
    medical malpractice case, you must have a doctor who will testify at
    trial that your physician violated the standard of care. The court
    will not accept your opinion, that of your lawyer or anyone else not
    qualified on this issue. Your surgeon will, in all likelihood, seek
    present their own expert testimony to establish either that the
    standard is not as high as your expert claims or that he has met that
    standard. Medical malpractice lawsuits often become battles in which
    each side has expert witnesses declaring different opinions as to the
    acceptable medical standards, leaving a jury to decide what should
    have been done and whether your surgeon did it. Medical malpractice
    occurring during the surgery generally comes within two general

    Device Failure

    A recent study showed that most LASIK complications were related to
    the surgeon's experience with the procedure (Stulting RD, Carr JD,
    Thompson KP, Waring GO, Wiley WM, Walker JG. Complications of laser
    situ keratomileusis for the correction of myopia. Ophthalmology
    The flap is created by a microkeratome (a surgical device that is
    affixed to the eye by use of a vacuum ring. When secured, a very
    blade shaves a small amount of the cornea at a predetermined depth).

    Flap complications include, but are not limited to:

    Failure of automated instrument to leave a hinge on the corneal flap,
    with the first incision

    Loss of the corneal flap during the operation.

    Loss of the corneal flap after the operation

    Slipping of the flap and healing off center

    First incision too deep (perforation of the eye) or too shallow,
    causing a hole in the flap

    Invasion of the surface tissue into the central tissue of the cornea.

    Infection of the cornea

    Loss of visual acuity - from scarring or from decentration of the

    Technical problems with complex and finicky automated diamond cutting

    The LASIK procedure is much more dependent upon surgeon's operating
    skills, than the computerized precision of the PRK procedure. Flap
    quality is affected by the performance of a microkeratome.
    Particularly notable is the adjustability of several features of some
    of the units, allowing the operator to develop parameters suitable to
    their own needs and experience. The obligation to select a proper
    microkeratome and to maintain it in proper working order clearly
    belongs to your surgeon. You may be able to sue both the doctor and
    the maker of the microkeratome in the event it becomes the cause of
    post-operative problems. It's sometimes easier to sue your doctor
    and leave the suit against the manufacturer to him in the event he
    believes it was a defect in the device that caused the injury.

    The second surgical device in use during refractive surgery is the
    Excimer laser. This is a high-energy "cold" laser that is used to
    sculpt the central zone, or visual axis, of the cornea. The laser
    emits a pulsating beam of ultraviolet light that ablates, or
    vaporizes, the corneal tissue to the degree designated and as guided
    by a computer within or connected to the laser system. Problems with
    the laser, the software which runs it or the computer which runs it
    all can all form the basis for post-refractive problems.

    Surgeon Error

    Medical malpractice is perhaps more accurately called medical
    negligence. In cases in which an injury has occurred during the
    of medical care, medical negligence is proved if the injured person
    his or her family shows that the care received was below accepted
    medical standards.


    First, you should have been given a set of instructions regarding
    you were to do following the surgery. You should have been instructed
    to bring someone with you to assist you in getting home. You should
    have been given, in writing, a list of do's and don'ts for the days
    after your operation. The list should have been something like this:

    Do not rub or squeeze your eyes for one week

    Use eye drops as instructed

    Wear sunglasses

    Wear the eye shield for the first three nights after the surgery.

    No make-up for one week

    Avoid smoke filled rooms and dusty environments for a few days.

    No water activities for 3-4 weeks including swimming, hot tubs,

    No sports for one week

    Call the office if you have severe pain that cannot be controlled
    over the counter pain medications


    Follow up visits must be scheduled. They should be set at reasonable
    intervals (usually around one day, one week and one month, three
    months, six months and one year following surgery). Additional visits
    are requested as necessary. Long term (at least annually) follow-up
    must also be stressed. The problem here is that frequently the
    post-operative care is left entirely to a staff or referring Doctor
    Optometry (O.D.) and you do not get to see your surgeon beyond the
    first follow up appointment. You are sometimes required to discuss
    post-surgical complications with the O.D. as a portal to the surgeon.
    This is a cause for many problems and it is an area upon which you,
    your attorney and the expert you have chosen must focus to determine
    if the imposition of a "chain of command" has amounted to an
    abandonment by your surgeon and has negatively impacted upon your

    Remember, medical malpractice lawsuits can be boiled down to the
    instructions that will generally be given to a jury at the end of a
    trial, just before they begin their assessment of what has been
    presented to them.

    "If you find that the defendant has complied with the accepted
    standard of medical care, then he/she is not liable to the plaintiff
    regardless of the result. On the other hand, if you find that the
    defendant has departed from the accepted medical standard, then you
    must determine whether such deviation or negligence was a proximate
    cause of any injury sustained or any loss incurred by the plaintiff".


    A person who is the victim of medical malpractice can sue for the
    injuries and all direct consequences of those injuries. "Direct
    consequences" include any mental or physical pain and suffering
    (including the full range of activities in which the injured person
    cannot engage and/or enjoy as a result of the injury) caused by the
    careless doctor and any lost wages, medical expenses or other
    damages resulting from the injury.


    All states have laws (Statutes of Limitation) which define the time
    periods within which a law suit must be started or the right to sue
    may be lost. There are differing rules as to when the time clock
    starts to run and what, if anything, stops (tolls) the clock from
    ticking. Depending upon whom you intend to sue some deadlines may
    mere months after surgery (especially true when a governmental entity
    or employee is the one being sued). If you believe, even remotely,
    that you may have a malpractice claim against the doctor who
    your surgery, you should immediately contact an attorney to confirm
    what the applicable Statute of Limitation is to make sure that your
    valuable right to sue is not lost.


    If you think that you have a valid medical malpractice lawsuit, it is
    wise to seek out an attorney who handles cases of the type you are
    seeking to commence. Medical malpractice is an extremely complicated
    area of law that raises many complex and intellectually difficult
    legal and medical issues. Due to the heavy reliance upon medical
    experts, the cost involved in bringing a successful medical
    malpractice suit is very high. Most attorneys will provide a free
    initial consultation to determine whether the case is worthy of
    further investigation. Most malpractice attorneys work with
    experienced experts who can determine not only whether the case is
    viable, but also how difficult the case will be to try before a jury.

    About the author. Kenneth M. Keith is a partner in the Law Firm of
    Keith, Shapiro & Ford. The firm maintains New York State offices in
    Nassau and Suffolk Counties and in the City of New York He served as
    Director of Legal Services to Surgical Eyes, a Not-for-Profit
    Foundation serving the needs of injured post-refractive surgical
    patients. His firm represents plaintiffs in actions for malpractice
    refractive surgical procedures.

    This page is not intended to replace the advice of an attorney. If
    you believe that you are the victim of medical malpractice contact a
    qualified attorney immediately

    Reply Reply to author Forward Rate this post: Text for clearing
    badlasik, Jan 30, 2007
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  2. Whassamatter baby? Can't handle the FACT that people's lives are
    being damaged by LASIK?
    LASIK Nightmare, Jan 30, 2007
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  3. badlasik

    Neil Brooks Guest

    Can handle it just fine, but ... anybody who does a two second Google
    will already have ALL the info they need without you spamming newsgroups.

    You have an axe to grind, clearly, but you aren't adding anything
    substantive to the dialog.

    Come to think of it ... have you met Otis? You two should talk.
    Neil Brooks, Jan 30, 2007
  4. Ah, you must be serebel. Nice to meet you, Neil. Ha ha ha aha
    LASIK Nightmare, Jan 30, 2007
  5. badlasik

    Scott Guest

    Scott, Jan 30, 2007
  6. badlasik

    Scott Guest

    Scott, Jan 31, 2007
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