LASIK malpractice lawsuits establish European beachhead

Suing ophthalmologists over refractive surgery is no longer just an American phenomenon. New evidence from Britain’s largest medical defence company shows that LASIK and PRK malpractice lawsuits have established a beachhead in Europe. According to the Medical Defence Union, lawsuits for laser procedures now account for one-third of all claims against its UK-based ophthalmologists. In the last six years alone, the number of refractive surgery claims has risen by 166%.

In financial terms, the claims experience of refractive surgery has translated into Europe’s highest malpractice premium for refractive surgeons: £22,000, or about E31,500. The figure represents a two-fold loading on the standard UK ophthalmic surgery premium of £9,155, or about E13,000. When compared to other specialties, the new refractive surgery premium is one of the highest in all of Britain: for instance, neurosurgeons, who practice in one of the riskiest surgical specialties, pay £16,495, or about E24,000.

About the only UK-based specialists who pay more than refractive surgeons are obstetricians. UK Obstetricians pay £35,950 or about E51,000 a year for malpractice coverage. "Our experience shows that although ophthalmology as a whole has traditionally been a low risk specialty, negligence claims in laser eye surgery are increasing rapidly," says Matthew Robson, MRCP, clinical risk manager at the Medical Defence Union. Some rise in claims was expected.

Any time surgeons perform an operation they expose themselves to at least some risk of a lawsuit. Multiply that risk times the estimated 60,000 to 100,000 refractive procedures performed in the UK each year and it’s easy to understand how ophthalmologists are facing substantially more claims. There are however, some things that refractive surgeons in the UK – and in the rest of Europe – can do to reduce the risk of being sued however.

Unrealistic expectations a factor One prime way to reduce the risk of being sued is to remind every patient that refractive surgery isn’t for everyone, isn’t always successful, and isn’t a panacea even when it does work, the Medical Defence Union urges. "While some of the claims are as a result of faulty surgical technique, an underlying feature in many more cases is patients’ unrealistic expectations about what can or cannot be achieved by surgery," Dr. Robson says.

"It is important for the doctor who is performing the surgery to counsel possible patients about the risks of the procedure and the possibility of an imperfect result and other complications in order to obtain proper consent." Dr. Robson explains that what the patient expects and what refractive surgery delivers is often quite different. "There appears to be a climate of unrealistic expectations out there," he observes. And, he adds, those unrealistic expectations may have little to do with the ophthalmologist who actually performs the surgery.

For instance, many patients will have viewed Internet advertisements that would otherwise be illegal or unethical in Europe. "Whether or not your clinic advertises realistically or unrealistically the patient has been exposed to unrealistic expectations," Dr. Robson says. "As a result you need to devote that much more time to reminding patients about the limits of refractive surgery." Those reminders should always include warnings that patients may have to continue using eyeglasses after surgery, he says. Patients will have seen advertisements saying, ‘You can throw your glasses away and have 100 percent perfect eyesight,’ Dr. Robson explains.

What actually happens after LASIK surgery isn’t so clear, however. As refractive surgeons know well, a proportion of patients will continue to need their old glasses or obtain a different prescription To reduce the risk of being sued, the Medical Defence Union recommends that any ophthalmologist who performs refractive surgery must be properly trained and stay up-to-date with developments in refractive surgery. "Doctors must have the necessary skills, training and experience to carry out the procedure and these skills must be kept up to date through continuous professional development," according to the Medical Defence Union.

Part of continuous professional development includes what Dr. Robson describes as "reflective practice." In other words, ophthalmologists should continually audit their own results and compare them to those of other ophthalmic surgeons. "This is a specialty where doctors can easily compare their results with others," Dr. Robson says. He noted that such practice statistics as flap complication rates can inform ophthalmologists about their technique and how to improve it.

"It’s an excellent area where doctors can compare their results with others," Dr. Robson says. If an ophthalmologist finds that his or her flap complication rate exceeds those of peers, the ophthalmologist should change the technique or undergo training to reduce the complication rate, Dr. Robson advises. Patients want what they pay for Not all risks are within the ophthalmologist’s control, however. One contributing factor to a patient’s decision to sue appears to be money, Dr. Robson notes.

Many patients believe they should get a better service because they pay – and often pay a lot – for it, says Dr. Robson. "When patients are paying for a service, they are more likely to complain than when they are not." In other words, if patients pay E1500 out of their pocket for a refractive procedure and don’t get what they expect, they will react a bit differently to disappointment from their GP’s services, which fee may be fully covered by insurance.

Dr. Robson adds that ophthalmologists should remember a lesson that plastic surgeons learned some time ago: that fixing what ain’t broke brings its own risks. If a procedure is elective and cosmetic, a person can say "I was fine before it," particularly if the outcome isn’t what the patient expected, Dr. Robson says. It can often be a case of a patient suing because something that wasn’t broken is now broken. That’s a lot different from a patient who needs emergency surgery for a burst appendix," he says. In that case, the patient doesn’t mind when the scar is slightly lopsided."

Avoid lawsuits by taking the time to explain what LASIK can – and can’t do Ophthalmologists can minimise the risk of a patient suing them for malpractice if they take the time to help patients understand what refractive surgery can – and can’t – do for them, according to the Medical Defence Union. "Patients must be given sufficient time to ask questions, take in and digest the information before making a decision," says the Matthew Robson, MRCP, clinical risk manager at the MDU. "They must be reminded of the other options available to them, such as continuing to wear spectacles or contact lenses, and the benefits and risks of the procedure when compared to these options." All such discussions about the risks and benefits of refractive surgery – as well as the alternatives to such surgery – must be clearly documented in the patient’s record, Dr. Robson advises. "Merely obtaining a signature on a consent form is unlikely to be considered satisfactory," he notes. Also, the person who discusses the risks of the surgery – and obtaining the consent to the procedure – should be the refractive surgeon who is carrying out the procedure, not a nurse or technician. Dr. Robson notes that the UK physician licensing body, the General Medical Council, advises that the person obtaining the patient’s consent should ideally be the surgeon who is carrying out the procedure. If this is not practicable, the Council says "you may delegate these tasks provided you ensure that the person to whom you delegate: is suitably trained and qualified; has sufficient knowledge of the proposed investigation or treatment and understands the risks involved." In other words, delegate the consent process at your own peril. Any advertising of services must also comply with the standards of the ophthalmologists’ licensing body and the appropriate advertising standards authority, Dr. Robson adds. In the UK, for instance, the General Medical Council advises that patient information "must not make unjustifiable claims about the quality of your services" and "must not, in any way, offer guarantees of cures." And if a patient asks specifically about an ophthalmologist’s flap complication rate, the ophthalmologist should be able to inform the patient, says Dr. Robson, noting guidelines of the UK's General Medical Council. Also, if a patient asks about how an ophthalmic surgeon compares against other surgeons – and the surgeon knows – the surgeon is under an obligation to tell the patient. If UK ophthalmologists are asked by patients how their results compare with other doctors or clinics, the General Medical Council guidelines require them to be completely honest: "You must answer such questions as fully, accurately and objectively as possible," the guidelines read. In other words, if a surgeon has a 2% flap complication rate and he or she knows that the national rate is 1%, the ophthalmologist is under an obligation to tell any patient who asks about the comparative rates, Dr. Robson says. World Medical Association Box 63 01212 Ferney-Voltaire Cedex France Telephone: +33 450 407 575 Fax: +33 450 405 937 Email: wma@wma.net Website: www.wma.net

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