Exposing the LASIK Scam

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 Post subject: Doctors Are Being Coached On How To Prevent Being Sued...
PostPosted: Tue Jun 13, 2006 2:00 pm 
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http://www.ascrs.org/Meetings/Annual-Sy ... 20-401.doc

ASCRS
Course 20-401: Medicolegal Issues in Refractive Surgery

This course will have case presentations to illustrate some of the current problems and pitfalls in the medicolegal area as it relates to refractive surgery.

Neal A. Sher MD, FACS
Eye Care Associates and Phillips Eye Institute
Minneapolis, Minnesota
612 338 4861
drsher@mn.rr.com

William B. Trattler MD
Center or Excellence In Eye Care
Miami, Florida
305 598 2020

Wendy Zeller Esq
Robins, Kaplan, Miller and Ciresi LLP
Minneapolis, Minnesota
612 349 8586
WJZeller@rkmc.com

Introduction:

The medicolegal landscape for refractive surgery is shifting rapidly. The huge increase in refractive surgical procedures over the last 3-4 years has been followed by a large increase in filed and impending lawsuits. Richard L. Abbott, MD, of San Francisco and a consultant for OMIC, recently suggested the following reasons for the increase in claims resulting from LASIK:

(Audio Digest Ophthalmology, 1/7/02)

1. Large volume of cases
2. High patient expectations and elective procedures
3. Significant potential for pain, suffering
4. Significant economic harm
5. Lack of informed consent

Other reasons for the increasing number of cases may include:

1. Growing lay knowledge about refractive surgery
2. Websites devoted to refractive surgical complications, some of which encourage litigation
3. Low cost LASIK (slash for cash), unethical corporate chains and similar entities
4. Increase in attorneys specializing in this type of litigation
5. Lack of surgeon availability to discuss and treat complications. Surgeons ?fly in-fly out?
6. Co-management issues
7. Bilateral ?simultaneous? surgery: despite the statistical claims that this is safe and it is the standard of care, complications from bilateral ectasia to bilateral irregular astigmatism frequently trigger law suits.
8. Poor surgeon and technician training
9. Misleading advertising i.e. ?20/20 vision or your money back?
10. Emerging new areas of legal liability (see below)
11. Increasing expectations from uncritical media coverage

How to Avoid Litigation in Refractive Surgery

1. Patient Selection Issues:
a. Screen for difficult patients and personality types

2. Marketing Issues
Review all marketing copy, brochures
Unprofessional advertising
Inappropriate comments to patients (source: lasikdisaster.com)
?A blind man would kill for your vision??
?Just try not to notice the ghosts??
? If I look up complications in the dictionary, I would see your face?

Raffles for surgical procedures (pressure on surgeon to qualify raffle winner when patient may be marginal candidate.
Vanity or fake authorship of books

3. Informed Consent Issues:
a. Make sure your documents are up to date and reflect your latest practice and complication profile
b. Patients should optimally sign consent when not dilated and after taking home to review
c. Consents signed after sedation or at time of procedure may be considered invalid and coerced.
d. If there is a chance of surface ablation rather than LASIK as primary procedure, inform patient in advance and obtain prior consent for surface ablation
e. Informed consent should be obtained by operating surgeon
f. The OMIC website has some excellent informed consent documents (English and Spanish) for a variety of procedures (http://www.omic.com/resources/risk_man/forms.cfm#refsx)

4. Co-Management Issues
a. Training of co-managing individual
b. Blame among co-managing parties
c. Financial relationships closely examined at time of trial
d. Lack of relationship between surgeon and patient

5. Discuss/demonstrate monovision and presbyopia issues in advance

6. Medical Record Issues:
a. Do not alter records. Sign and date amendments.
b. Make notes on phone calls.
c. Do not use standard op notes when problems occur in procedure.
d. Review all previous relevant records.

7. Second Eye Same Day Surgery
a. Bilateral complications frequently lead to lawsuits.
b. Consent for second eye is dependent on complication free first eye. If a patient has a complication in first eye, they have not given consent for second eye.
c. Can you justify in court the reasons you performed bilateral surgery?

8. Preoperative Issues
a. Evidence of refractive stability
b. Follow newest guidelines for contact lens discontinuation
c. Look for anterior membrane dystrophy before anesthetic, IOP and Pach measurements
d. Preoperative significant dry eye

9. Screening for preoperative topographical abnormalities, FFKC, Terriens

10. Operative Issues

Certified for particular laser by manufacturer
Follow guidelines for refractive range. If ?off label? use, make sure consent is obtained
Triple check input and axis
Triple check patient wrist bands or other suitable patient identifiers,
Equipment maintenance and preoperative checklists
11. Bilateral LASIK and PRK Complications Which Have Lead to Litigation

? Laser input errors
? Bilateral flap complications
? Bilateral large epithelial defects
? Bilateral DLK
? Bilateral Infections
? Bilateral Ectasia
? Bilateral macula hemorrhages
? Bilateral laser calibration errors

12. Postoperative Issues:

Failure to diagnose and delay treatment of DLK, infections (PRK and LASIK).
Failure to diagnose elevated IOP.
Availability and abandonment issues.
Additional Thoughts:

Never Alter Medical Records

Surgeon should be Available and Responsible

Avoid Operating Second Eye Until Any Complication Encountered in First Eye is Stable

Update Your Informed Consent Documents and Obtain Consent Yourself

Follow FTC Guidelines for Advertising

Avoid Ads Similar to Used Car Salesman

Inform Patient of Off-label Procedures and Document

Use Objective Measurements for Pupil Size

Triple Check All Data Entered into Laser to Avoid Errors

Consider Consecutive Day Surgery rather than Bilateral Same Day Procedures

Deal Preoperatively With Issues with Monovision and Presbyopia

Use Patient Name Tags

Notify Your Malpractice Carrier of Any Incidents

Anatomy of a Medical Negligence Claim

1. Liability ? a health care provider acted negligently;
2. Damages ? an injury occurred; and
3. Causation ? the negligent act directly caused the injury.

Liability Defined

Care is negligent when the healthcare provider?s acts or omissions depart from accepted medical standard to be expected from specialists or practitioners similarly situated.

Liability Defined

Physician did something other physicians in the same specialty would not have done under the same circumstances.

Liability

? Acts must be viewed at the time they are taken, not in hindsight.
? Generally a national standard of care / but some states may still have a locality rule.

Liability

? Physician is not negligent simply because there is a bad outcome.
? Accepted alternative treatments.

Damages Defined

? Economic Costs
? Medical Bills
? Wage loss
? Loss of earning capacity
? Pain, suffering, emotional distress.
? Loss of consortium / relationship.

Damage Considerations

? Cost of proceeding with a medical malpractice case is significant.
? If the client?s damages are minimal, the cost of obtaining a recovery may be more than the recovery obtained.

Permanency

? Will it heal?
? Can it be fixed?

Proof Problems

? How will the jury recognize and understand the significance of the injury?

Causation Defined

? Negligent care played a substantial role in bringing about the injury.
? ?But For? test: But For the negligence, the injury would not have occurred.

Causation Considered

Scientific explanation of how the negligent care caused the injury /damages

Causation Considered

Multiple causes: Injury could have resulted from more than one cause, some of which are not negligent.

Causation Considered

Distinguish from recognized risks and complications of a procedure / treatment.

Claims Other Than Negligence

? Product Liability
? Statutory Violations

- Consumer protection

- False advertising

- Unfair business practices

Additional Material for Consideration:

The following material was supplied by Martin Everson Esq. and presented as part of Course 2306, Medicolegal Issues in Refractive Surgery, Sher, NA, Zeller, W, Everson, MJ, at the ASCRS Meeting, San Diego, CA May 2004.

Martin J. Everson, Esq.
Galloway, Lunches & Everson, PC
Walnut Creek, CA 94596

EMERGING LIABILITY ISSUES IN OPHTHALMOLOGY

I. Categories of traditional medical malpractice cases

A. Failure to diagnose:

Glaucoma, retinal tears or detachment, infection, pituitary and other tumors.

B. Surgical and treatment complications:

Cataract surgery, refractive surgery, other procedures, lack of informed consent.

II. Emerging liability issues

A. Two statutes were passed that affect malpractice cases

1. 1977: False Advertising and Unfair Business Practices Act (Business and Professions Code ??17200, et seq., and 17500, et seq.).

2. 1970: Consumer Legal Remedies Act (CLRA), Civil Code ?1770, et seq.,

3. The Statute are designed to:

a. Protect the public from unscrupulous business/merchants who falsely advertise their services and engage in unfair business practices.

b. Not regulate the practice of medicine; however, the statutes, in recent years, have been successfully pled against physicians and medical groups who aggressively advertise their services.

B. Aspects of ophthalmology make it susceptible to liability.

1. Ophthalmology involves routine, minimally invasive procedures that can be performed quickly and cost efficiently (i.e., cataract surgery, refractive surgery, laser retinal treatment), with low risk of adverse outcome or complication.

2. There are an increasing number of ophthalmologists who aggressively market their practice by advertising free screenings to the public in newspapers, magazines, and telephone directories, by hiring individual/firms to aggressively advertise and market their practice, identifying certain segments of the population (i.e., elderly) to solicit and advertise by direct mailing, seminars and advertising on television, radio and in newspapers.

3. Some physicians market their practices to the public and run the risk of being perceived as running a business, rather than a medical practice. In the event of an adverse outcome on a patient, the physician is potentially exposed to allegations of over-practice (i.e., unnecessary surgery), which may lead to a claim for punitive damages. (See unfair or deceptive acts which violate Civil Code ?1770(a))

III. Statutory provisions

A. Consumer Legal Remedies Act (Civil Code ?1770, et seq.)

1. Provides damages and injunctive relief to consumers damaged by specified, deceptive sales practices.

2. Provides for class action, which would not otherwise be available in a medical malpractice case.

3. The court shall award court costs and attorneys' fees to a prevailing plaintiff (Civil Code ?1780(d)); attorneys' fees may be awarded to a prevailing defendant upon a finding by the court that the prosecution of the action was not in good faith.

4. Actual damages are a prerequisite for standing.

5. Restitution/disgorgement of profits.

6. Punitive damages are allowed in the case of intentional misconduct.

7. Parties entitled to a jury trial on issue of damages.

8. Damages are not awarded if the defendant proves the violation was unintentional, that the violation has been corrected, and that reasonable procedures have been adopted to avoid the violation in the future.

9. Statement of legislative policy ? the Act is to be liberally construed and applied to protect consumers against unfair and deceptive business practices.

10. Consumers may not waive the Act.

11. Civil Code ?1770(a) specifies 23 unfair or deceptive acts which violate the statute, including:

a. Misrepresenting the affiliation, connection or association with or certification by another.

b. Representing that goods or services have sponsorship, approval, characteristics, ingredients, uses, benefits or characteristics which they do not, or that a person has a sponsorship, approval, status, affiliation or connection, which he or she does not have.

c. Representing that goods or services are of a particular standard, quality or grade, or that goods are of a particular style or model, if they are of another.

d. Advertising goods or services with intent not to sell them as advertised.

e. Inserting an unconscionable provision in the contract.

B. California False Advertising and Unfair Business Practices Act (Business and Professions Code ??17200, et seq. and 17500, et seq.)

1. B&P Code ?17200 prohibits any unlawful, unfair or fraudulent business act or practice.

2. B&P Code ?17500 prohibits any unfair, deceptive, untrue or misleading advertising.

3. A violation of the California False Advertising and Unfair Business Practices Act is a strict liability offense (i.e., not necessary to show an intent to injure anyone); instead, one need only prove that members of the public are likely to be deceived using a ?reasonable consumer? standard, which can be demonstrated by extrinsic evidence, such as consumer surveys.

4. Damages are not recoverable.

5. Remedies for violation of the statute include injunction and restitution.

6. Since only equitable remedies allowed ? court trial only.

7. An award of restitution involves disgorgement of profits, which requires plaintiff to prove that the defendant has profited from the deceptive advertising or practice.

IV. Cases in which the CLRA and False Advertising and Unfair Business Practices Act have been applied to physicians.

1. Of course, traditional malpractice from top.

2. Incorrect statement of board certification in telephone directory and medical brochures.

3. Class action lawsuit involving use of unhygienic technique in LASIK procedures and misrepresentations of same to public ? first class action lawsuit certified against physicians.

V. Management techniques to minimize risk of statutory claims

A. To prevent failure to diagnose: Rule out most serious diseases in arriving at diagnosis, comprehensive evaluation, appropriate diagnostic testing, referral to specialist as indicated, thorough documentation and close follow-up with patients when serious disease or injury has not been ruled out, detailed instructions to patient and need to return if vision deteriorates.

B. To prevent surgical and treatment complications: Sufficient documentation of patient complaints and diagnostic testing results to justify the need for surgery, provide patient with standardized brochures, use of standardized office consent forms to be signed by patient detailing risks of surgery, thorough documentation regarding indications for surgery and discussions with patient regarding the procedure and its benefits/risks, close follow-up during immediate postoperative.

C. Limit direct advertising to the public.

D. Do not oversell services, procedures or one?s experience and qualifications.

E. Include a disclaimer statement advising that there is a risk of vision loss, and there is no guarantee of a satisfactory result.

F. Same precautions mentioned above regarding traditional medical malpractice cases to minimize risk of lawsuit.


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 Post subject:
PostPosted: Tue Jun 13, 2006 3:52 pm 
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I see this course as a good thing and hope that it will raise the level of care in the industry.


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