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Can You Sue?
As attorneys practicing in the field of
Opthamalogic malpractice barely a day goes
by in which
we are not asked this question.
Our decision to accept or to reject a matter presented to us is
weighed just as heavily as the decision to undergo the surgery was
weighed by our potential client. There can
be no doubt that refractive surgery can do harm. If you are
reviewing this 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 (see
Ebay auction as an example). 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 frequently don't,
disclose all the 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.
The
Standards
Once
you have shown that the information provided was insufficient you
will have to meet one of three standards to be able to sue:
1) Reasonable physician standard: what would a typical
physician say about this intervention? This standard allows the
physician to determine what information is appropriate to disclose
2)
Subjective
patient standard:
what
would this patient need to know and understand in order to make an
informed decision? This standard is the most challenging to
incorporate into practice as it would appear to require the
tailoring of information to each individual patient.
3)
Reasonable
person standard: Would a reasonably prudent
person in your position (NOT YOU) not have undergone
the operation had they been fully informed.
You
may then, depending on the jurisdiction where you sue, have to show
not only 1)that the information provided was not sufficient 2) That
you have met the applicable of the three standards above but also 3)
that the injury sustained was the injury for which inadequate
warning was given.
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.
From
an article in the Washington Post on Tuesday, September 4, 2001, the quote below is
about Laser Vision Institute (LVI), 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.
Surgical
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:
1.
Do not rub or squeeze your eyes for one week
2.
Use eye drops as instructed
3.
Wear sunglasses
4.
Wear the eye shield for the first three nights after the surgery.
5.
No make-up for one week
6.
Avoid smoke filled rooms and dusty environments for a few days.
7.
No water activities for 3-4 weeks including swimming, hot tubs,
etc.
8.
No sports for one week
9.
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. The damages are intended
to be such that they will place the injured party in the
position they were in immediately before the defendant's
negligent act. In other words, the plaintiff is to be
compensated for all past, present, and future harm caused by the
defendant's medical malpractice.
It is essential that an attorney
representing an individual injured in a refractive surgery
procedure understand the life changing effect of failed eye
surgery. Plaintiffs in these types of cases suffer the distinct
disadvantage of walking into a courtroom looking exactly as they
did prior to the surgery. There is no limp, no scar, no missing
limb to serve as a benchmark of the damage done. Juries are just
regular people and suffer from the same lack of understanding of
the consequences of a failed laser refractive surgery as do most
of the people we encounter in our day to day lives. An
individual who believes that they have been a victim of
malpractice at the hands of a refractive surgeon should
immediately begin maintaining a diary of their experiences.
Keeping daily notes of things they cannot do, things they can
only do with difficulty, their feelings and frustrations
could prove invaluable as the case moves forward through
discovery, settlement discussions and to trial. Trying to
remember it all, years later, is almost impossible and the doctors
and insurance companies know it. Preparation is the key to
success in all forms of litigation.
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.
If
you are interested in the background of your surgeon, summary
information of disciplinary actions taken against licensees by the
Board of Regents in New York State since January 1, 1994, together
with information about malpractice claims (NOT current or accurate)
and criminal convictions is available from the
New
York State Department of Health Office of Professional Conduct.
For other states, you can begin your search at the
Federation
of State Medical Boards, they even operate a pay service
for you to search out information about a doctor, but check with the
individual states first, as it may well be available for free.
This website 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
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