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

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
www.SurgicalEyes.org/CanYouSue.htm

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,
without
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
you
have undergone, you must establish, to the standard set by the state
in which you were injured, the failure or failures which have
resulted
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
result
of refractive surgery gone badly, consult with an attorney who will
work with you to get an opinion from an independent medical expert
and
to evaluate whether actionable fault (something for which you can
sue)
resulting in your injury appears to exist.
DECEPTIVE ADVERTISING


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
generally
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
marketplace.
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
ad
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
implies.


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
how
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.


FAILURE TO OBTAIN A VALID INFORMED CONSENT


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
be
designed to educate the patient in terms that they can understand.
Therefore, informed consent language and its documentation
(especially
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
process.


Statutes define lack of informed consent as meaning the failure of
the
person providing the professional treatment to disclose to the
patient
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
the
information provided to secure your consent was insufficient. You
next
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
caused
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
surgeons.
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
to
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
goal.


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
surgical
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
suit
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
for
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
contained:


An explanation of the medical condition which warrants the proposed
procedure
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
side
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
the
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
presented
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
with
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
anyone,
to review and digest the information which should properly contained
therein in the limited time period provided let alone them being
asked
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
for
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
make
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
from
"move" patients from lower priced to higher priced surgeries.
Frequently informed consent documents are presented as "just
something
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
informed
consent either just to try to calm an apprehensive patient or to keep
business in the office. Particular attention should be paid to how
and
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
customers
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
common
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
the
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
determine
if there is any significance to the form you may have signed.


THE COMMISSION OF MEDICAL MALPRACTICE


While there are various types of medical malpractice claims,
generally
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
departure
from that standard was what caused the injury the patient now sues
for.


It must be understood that the standard against which the surgeon
will
be judged varies depending on where the doctor is practicing. A
doctor
has a duty to give his patients proper medical care within a
reasonable standard set by doctors within the same medical field.
This
"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
in
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
particular
specialty.


The determination as to whether the standard of care has been
breached
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
is
concerned. This expert doctor will review your medical records and
may
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
to
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
areas:


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
in
situ keratomileusis for the correction of myopia. Ophthalmology
1999).
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
sharp
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
ablation


Technical problems with complex and finicky automated diamond cutting
devices


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
only
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
course
of medical care, medical negligence is proved if the injured person
or
his or her family shows that the care received was below accepted
medical standards.


INADEQUATE POST-OPERATIVE CARE


First, you should have been given a set of instructions regarding
what
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,
etc.


No sports for one week


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


INADEQUATE PATIENT FOLLOW-UP


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
of
Optometry (O.D.) and you do not get to see your surgeon beyond the
first follow up appointment. You are sometimes required to discuss
all
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
care.


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".


DAMAGES


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
economic
damages resulting from the injury.


STATUTES OF LIMITATION


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
come
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
performed
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 BELIEVE THAT YOU CAN SUE


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
in
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
space

 

Whassamatter baby? Can't handle the FACT that people's lives are
being damaged by LASIK?

 

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.

 

Ah, you must be serebel. Nice to meet you, Neil. Ha ha ha aha
hahahahahah!!!!

 

news:...