ER Call: Another Layer of EMTALA Liability

By Tamara R. Fountain, MD

Digest, Fall 2006

Dr. Fountain is a member of OMIC’s Audit, Finance, and Insurance/Marketing Committees. This article, originally published in the Digest in 2001, has been updated to reflect current law.

Fans of the hit television series, ER, are familiar with this scenario: a patient is rushed to the ER in need of life-saving treatment but the specialist on call, be it an OB/GYN or CT surgeon, fails to answer the ER’s page. Drs. Weaver, Carter, and Company are then charged with cracking chests, doing stat sections, and taking other heroic measures to stabilize the patient—all in one entertaining hour, including commercials.

Even Hollywood knows that transferring an unstable patient is against the law. That federal mandate, the Emergency Medical Treatment and Active Labor Act (EMTALA), is part of the Comprehensive Omnibus Budget Reconciliation Act (COBRA) passed by Congress in 1986. This well-intentioned piece of legislation was enacted to discourage hospitals from turning away patients based on their ability to pay. Widening legal interpretation of EMTALA provisions has created a host of accountability and risk management issues for physicians who provide emergency room coverage.

Under EMTALA, any patient who presents to a hospital ER must be afforded an “appropriate medical screening examination to determine the presence of any emergency medical condition.” EMTALA defines emergency medical condition as one in which “the absence of immediate medical attention would…result in placing the person’s health in serious jeopardy, cause serious impairment to bodily functions or cause serious dysfunction to any bodily organ or part.”1   An appropriate medical screening examination need satisfy only two elements to be compliant with EMTALA standards: (1) it should be reasonably expected to identify an emergency medical condition; and (2) it need be directed only at the signs and symptoms described by the patient or identified by the physician—NOT signs and symptoms the physician is not made aware of or might otherwise overlook.2

If the ER physician determines that an emergency medical condition exists (or cannot be ruled out), he or she may refer the patient to the appropriate physician on call for evaluation and management. The on-call physician is not only obligated to answer a page in a “timely fashion” (the definition of which is usually buried in one’s medical staff bylaws) but to evaluate the patient in the ER if requested to do so by the ER physician. The on-call physician must never try to talk the ER doctor out of a request to evaluate the patient. It may sound like the most routine, unequivocal case of conjunctivitis to you over the phone at one o’clock in the morning, but if the ER doctor asks you to come in, you must do so. (By the way, in the real world, those on-call OB/GYN and CT surgeons who failed to respond to their pagers in the ER episode would be subject to EMTALA fines of up to $50,000 each.)

Appropriate Patient Transfers

So you leave your daughter’s piano recital to see a patient in the ER. You diagnose an open globe with vitreous presenting at the wound— a qualifying emergency medical condition. But the hospital’s vitrector is being repaired and there is no surgical eye team available. What should you do? If the hospital’s facilities or ancillary staff are inadequate to treat a patient with an emergency medical condition, a transfer must be effected.

Since EMTALA was enacted to prevent indiscriminate transfer of patients to other facilities, one would expect strict guidelines on what constitutes an acceptable transfer. Federal law defines an appropriate transfer as one in which: (1) the patient has been treated within the capacity of the transferring hospital, thereby minimizing the risks of transfer; (2) a hospital with the space and personnel to care for the patient has been identified and has agreed to the transfer; (3) all records are sent, including informed consent, the transferring doctor’s certification that transfer is in the best interest of the patient, and, if applicable, the name and address of any on-call physician who refused or failed to evaluate the patient; and (4) qualified personnel, equipment, and transportation are utilized to effect the transfer.

Under most state laws, hospitals that are legally obligated to provide emergency care are also obligated to accept a patient transferred from another facility. Not as widely recognized, however, is an EMTALA provision affectionately known as the “snitch rule.” This whistleblower statute obligates the receiving hospital to report any inappropriate transfers to federal authorities. Failure to report such an infraction may invoke the same penalties for the receiving hospital (fines of up to $50,000 and exclusion from Medicare) as are levied on the hospital that initiated the transfer.

While this covers the primary areas of EMTALA’s impact on ER call physicians, there are many gray areas not addressed by its statutes (see Frequently Asked Questions About ER Call and this issue’s Risk Management Hotline, which elaborates on follow-up duties). As legal interpretations and provisions vary from state to state and hospital to hospital, OMIC recommends that ophthalmologists seek the counsel of their hospital medical staff office or our risk management department for further guidance.

1.42 C.F.R. §489.24(b)

2.Reynolds v. Maine General Health 1st Cir, 2000
218F.3d78.

Frequently Asked Questions About ER Call

Q: Do I have to take call at my local hospital if most of my cases are handled in an ASC?

A: It depends. Federal laws do not mandate taking calls, but whether you volunteer, take call as a requirement of medical staff bylaws, or independently contract your services to an ER, once you enter into a formal agreement to provide emergency coverage, you must comply with EMTALA regulations. Some ophthalmologists need hospital privileges as a condition of being a provider in a managed care contract and end up with call coverage as a result of those privileges.

Q: My hospital’s ER is poorly equipped to evaluate and manage eye emergencies. Do I have to come in if I know the patient will be transferred anyway?

A: Yes. You are still obligated to stabilize the patient within the available capabilities of the hospital’s staff and facilities. Once the risks of transfer have been minimized and if you determine that the benefits of transfer outweigh the risks on an unstable patient, you must effect a transfer. Later, you may want to discuss with your department chair or the ER department the need for adequate equipment to properly evaluate and manage common eye emergencies.

Q: I’m on call during a busy clinic day and get called to see a patient in the ER. Wouldn’t it be easier to have the patient come to my office for an evaluation?

A: Yes, but only easier for you. The ER doctor is asking you to come in to see the patient and, instead, you are proposing that the patient come to your office solely for your convenience.

If the patient deteriorates enroute, you will effectively have authorized, by phone, an inappropriate transfer under EMTALA laws. If, however, the ER doctor determines that no emergency medical condition exists, then the patient can be safely discharged from the ER to follow up in your office.

Q: I am an oculoplastics specialist. Do I have to come in for a retinal detachment?

A: Yes. Staff bylaws may spell out the scope of your clinical privi- leges and expertise, but if you take call, it is assumed that you are capable of evaluating ocular problems even if you’re not qualified to treat them.

Again, your job as an on-call doctor is to stabilize the patient and arrange appropriate consultation as needed. Some hospitals arrange call schedules so that various subspecialists provide back-up coverage. If a patient must be transferred to another facility, document that the benefits of a transfer outweigh the risks.

Q: The ER doctor calls and tells me a patient has conjunctivitis and, while I don’t need to come in, the ER doctor wants the patient to follow up in my office. The patient presents the next day with a corneal ulcer, not conjunc- tivitis. Am I in violation of EMTALA laws?

A: No. If you were not asked to come in, the ER doctor is effectively saying that he or she has ruled out (albeit incorrectly) an emergency medical condition based on a screening examination. Case law generally holds that a hospital and its ER physicians are not in violation of EMTALA for failing to treat an emergency medical condition if the facts demonstrate the hospital had no knowledge of the condition despite an appropriate screening examination. The ER doctor still may be liable for failure to diagnose and delay in treatment under regular malpractice laws, however, and such situations may expose the ophthalmologist to malpractice claims. Thus, it is critical to properly document and retain a record of your discussion with the ER doctor.

Q: If I am called in to treat a patient emergently, do I have to provide follow-up care?

A: The emergency transfer laws do not address the issue of follow- up care to patients who have been treated and stabilized in the ER and then discharged. However, a common law duty to the patient may arise since, arguably, a doctor-patient relationship is established by your treatment of the patient in the ER, giving rise to the expectation by that patient that you will provide follow-up care. You should consult your medical staff bylaws, as some specifically address this issue. Some bylaws establish a duty and require the on-call physician to see the patient in follow up and through- out the course of the illness that brought the patient to the ER.

Q: A patient is evaluated and treated in the ER while I’m on call but no one notifies me. The ER doctor discharges the patient to follow up with me the next day. Am I required to see this patient?

A: Not from an EMTALA standpoint. While there would be no EMTALA violation since the patient was presumably stabilized and discharged by the ER, your medical staff bylaws may require you to see the patient. When in doubt, you should accept a patient who presents to your office if the patient was treated in the ER while you were on call. Work with your hospital to establish a protocol for follow-up care.

Q: The ER doctor calls me one night and based on his or her description, I decide to wait to see the patient in my office the next morning. Is this an EMTALA violation?

A: It depends. If the ER doctor asks you to see the patient, you must do so when called, not the next morning. If the ER doctor feels the patient is stabilized and can wait until the next morning and the patient’s condition deteriorates because of the delay, the primary malpractice liability rests with the ER doctor. (EMTALA does not apply in this case because the patient was discharged in stable condition.) If the ER doctor cannot rule out an emergency medical condition, you as the on-call specialist cannot do so over the phone, as an appropriate medical screening exam has not technically been performed. As always, it is critical to document your discussion with the ER doctor.

Q: It’s bad enough that I can be fined by the federal government for EMTALA violations. Can I be sued by the patient too?

A: The federal government may fine both hospitals and individual physicians for EMTALA violations. Additionally, a patient may sue a hospital for EMTALA infractions. A patient may NOT sue a physician for breaking EMTALA laws. However, any doctor or hospital providing emergency room care is subject to civil claims of negligence and medical malpractice.

Discuss Potential Side Effects of Eye Drops

 By Richard A. Deutsche, MD

Argus, January, 1992

Before routine eye examinations and refractions, what should you tell patients about cycloplegic or mydriatic eye drops? When should this information be given? How important is it from a risk management standpoint?

Fortunately, there have not been many liability actions related to the use of dilating drops, but in this litigious age it is wise to avoid surprising patients with even mildly distorted vision that they may blame as the cause of a problem after an eye examination.

A small, informal survey of ophthalmologists found that most do not discuss possible side effects of cycloplegic drops with their patients prior to instilling the drops. From a risk management point of view, however, I have found it prudent in my own practice to discuss the potential effects of glare, lack of accommodation and possible blurred vision, particularly with patients who drive to the office for their eye examination.

In my experience, most individuals have no problem driving following dilation as long as sunglasses are worn on bright days. However, if a patient is at all uncomfortable with the prospect of driving after dilation, I suggest to the patient that he or she reschedule the dilation or make other arrangements to get home. One way to avoid the inconvenience of rescheduling is to have your receptionist alert each patient at the time the appointment is made that dilation may cause side effects which might make driving difficult. This way the patient can arrange to have a friend or family member do the driving to and from the appointment.

Before instilling cycloplegic or mydriatic drops, it is also important to ask each patient about potential allergic reactions and, if there is a shallow anterior chamber, precautions should be taken to avoid acute glaucoma.

As with any aspect of patient care, each person should be treated as you would like to be treated yourself. Patients do not appreciate an unpleasant surprise. Malpractice actions can be avoided when new patients are properly informed.

Medication Errors Result in Costly Claims for Ophthalmologists

By Dean C. Brick, MD

Digest, Winter, 1995

Surveys indicate that medication errors are a frequent cause of medical malpractice claims. Not surprising given the fact that prescribing medication is the most common therapeutic service provided by physicians. The National Center for Health Statistics (NCHS) reported in 1992 that new or continued medications are ordered or provided at 63% of visits to a physician’s office. For ophthalmologists, the figure is 41%, i.e., medications are ordered or provided at more than 19 million patient visits a year.

Claims Frequency

A review of data collected on 117,000 claims and lawsuits by the Physicians Insurers Association of America (PIAA) reveals that medication errors are the second most frequent reason for claims against physicians and result, cumulatively, in the second highest indemnity paid behind faulty diagnosis and evaluation. The high frequency and severity of claims involving medication errors prompted the PIAA to study the problem in 1993. This article will cite some of the findings from that study.¹

Jerome W. Bettman’s review of Seven Hundred Medicolegal Cases in Ophthalmology indicates that medication errors are the third most frequent complaint against ophthalmologists following claims arising from cataract surgery and treatment of retinal detachments.²

Although medication errors account for only 2% (10 claims) of all claims against OMIC insureds, they have been expensive to defend and more often than not have resulted in an indemnity payment.

Claims Severity

OMIC analyzes the severity, or impact, of a particular type of claim by examining the average indemnity payment, average defense costs, large losses (cases over $100,000), cumulative indemnity payments and defense costs, and frequency of indemnity payment to the plaintiff.

The average indemnity paid by OMIC for a medication error is $115,000 compared to $95,000 for all other types of claims. The largest single medication error-related payment by OMIC was $500,000; the lowest was under $20,000. Medication errors have also been costlier to defend and more likely to result in indemnity payments. It costs OMIC twice as much to defend claims involving medication errors as it does to defend all other types of claims ($22,000 versus $11,000). Of the eight closed claims involving medication errors, seven closed with an indemnity payment to the plaintiff. (Overall, less than one out of four OMIC cases closes with an indemnity.) Medication errors represent only 2% of all OMIC claims; however, 4% of all defense costs and 12% of all indemnity payments go toward these cases.

The PIAA, Bettman, and OMIC claim reviews indicate that corticosteroids and antibiotics are the medications most often implicated in claims against ophthalmologists. The following closed OMIC claims are representative of cases involving the misuse of these two medications and that of another drug, silver nitrate.

Case One: Glucocorticoids

A 35-year-old obese male presented to the insured in June 1986 with a history of severe chronic uveitis that had been treated by another ophthalmologist two months earlier with systemic and topical prednisone. When seen initially by the insured, the patient’s VA was 20/400 OU. Bilateral subtenon’s injections of Depo-Medrol were given with hourly topical steroids and cycloplegics. Systemic prednisone was added when this regimen failed to control the uveitis. While on systemic steroids the patient’s vision improved; however, attempts to withdraw the systemic prednisone resulted in a worsening of the patient’s vision and uveitis. Although a workup was performed for the uveitis and a chest x-ray showed calcified granulomas, the ophthalmologist never made a specific diagnosis.

The ophthalmologist followed the patient over a period of several years during which he tried varying doses of systemic prednisone to control the uveitis. Numerous side effects and complications developed, and in January 1987, the patient was referred to an internist to monitor the steroid’s effects because of obvious weight gain and borderline diabetes. The patient underwent bilateral cataract extractions in 1988, but despite continuing therapy, achieved a VA of only 20/70 OD and 20/40 OS. An attempt to switch the patient to chlorambucil failed due to side effects. The ophthalmologist also attempted to refer the patient to the National Institutes of Health for treatment with cyclosporin, but the patient declined to be involved in the study.

In late 1989, the patient developed frank diabetes and hypertension. Treatment with systemic steroids continued until 1991 when the patient was admitted to the hospital with adult respiratory distress syndrome (ARDS) and died. The cause of death was systemic candidiasis and ARDS probably caused by steroid therapy. The autopsy also revealed the patient was HIV positive. The patient’s family sued the insured ophthalmologist for wrongful death caused by negligent prescription management of steroid therapy. The case was settled prior to trial for less than $20,000.

Discussion

A number of issues make this case instructive. On the surface it appears the insured ophthalmologist did all he could to treat and monitor the patient appropriately, and in fact, most of the experts who were deposed in this case were not critical of the insured’s treatment. However, there are a number of things that ophthalmologists in these types of situations might do to minimize the risk of such claims.

First, when treating a patient with a severe recalcitrant disease, it is a good idea to bring in a consultant to help monitor the systemic effects of the treatment. It also is important to consult with an expert in the subspecialty involved to confirm that your course of treatment is the best one and that all other avenues of treatment have been explored. In this case, a confirmatory consult by a uveitis specialist would have further supported the prolonged treatment with high dose steroids. A referral back to the subspecialist after one or two years would have further shown that the insured was monitoring the need for continued treatment.

Second, document in the patient’s chart the reasons for the prolonged treatment and indicate that the side effects and complications of treatment have been discussed with the patient. This rebuts later claims by the patient or the patient’s family that they were not told of possible adverse reactions and outcomes related to a prescribed course of treatment. The PIAA Medication Error Study found that after “incorrect dose,” communication failure between physician and patient was the most common error associated with glucocorticoid therapy.

Although a written informed consent document signed by the patient may not be necessary, the physician should document that a discussion took place regarding the potential side effects of a prescribed drug and the consequences of not using the drug. If pamphlets and fact sheets describing the risks of longterm drug therapy are given to the patient, this should be documented.

The same applies when prescribing a drug with potentially severe and generally recognized complications (e.g., systemic steroids and immunosuppressive drugs). Obtain a second opinion to confirm that the drug is indeed the best choice for the patients in question and discuss the potential side effects of the medication with the patient, documenting that you did so.

Third, use established criteria to judge the response to therapy and record it in the patient’s record. If, after a sufficient trial of therapy, there is inadequate or no response, consider a second opinion or another form of therapy. Your best protection is evidence that you consistently acted in a timely and appropriate manner in the best interest of the patient.

Fourth, when co-managing patients with internists, such as rheumatoid patients on Plaquenil, orbital cellulitis patients, or patients in treatment for tuberculosis, make sure that the individual areas of responsibility are clearly documented in the patient’s record (e.g., who is managing the dosage and monitoring the response or complications). Report all test results to the co-managing physician, either in written form or with a documented phone call. Make sure the patient understands your role and any important symptoms that should be reported to you.

Case Two: Corticosteroids

A 65-year-old male, who had been followed by the insured for many years and had previously undergone a successful cataract and implant surgery in the right eye, presented to the insured with complaints of glare when looking at a distance and difficulty reading. Best corrected vision OS had decreased to 20/60. The insured elected to perform cataract surgery in the left eye.

Surgery was uncomplicated, and at the end of the surgery Celestone and Garamycin were injected subconjunctivally. The following day vision was limited to light perception and examination revealed a whitish area with hemorrhage in the retina. The ophthalmologist thought that some of the Celestone may have been inadvertently injected into the vitreous cavity and immediately referred the patient to a retinal specialist. A pars plana vitrectomy was performed and white crystalline matter was removed. The retina remained attached, but vision was limited to light perception initially and later diminished to no light perception as optic atrophy became evident.

The patient initiated a claim against the ophthalmologist, alleging negligence in injecting coricosteroid into the vitreous and causing irreparable damage to the eye. This case was settled for $50,000.

Discussion

The risk of an intraocular injection is always present, and extreme care must be used when giving injections around the eye. There can be a tendency to relax and lose concentration, or “let down your guard,” after completing the difficult part of a surgery or a procedure. This is dangerous. Any injection around the eye must be administered carefully and preferably where the tip of the needle is visible, or with a large bore needle which is less likely to penetrate the globe.

Case Three: Antibiotics

The patient was a 37-year-old male who presented with complaints of left lower lid swelling of three days duration. The patient’s written history noted that he was not on any medications, but had a known penicillin allergy. The ophthalmologist diagnosed a hordeolum and prescribed warm compresses and ampicillin 250 mg TID for five days. After two doses of ampicillin, the patient called the ophthalmologist’s office to complain of skin rash and generalized itching. He was instructed to discontinue the ampicillin and was switched to tetracycline 500 mg TID for five days. Meanwhile, the patient went to an employee health clinic and was treated with Benadryl and a Medrol Dose-Pak.

Five days after seeing the ophthalmologist, the patient was admitted to the hospital with confluent, erythematous rash over his entire trunk and extremities and was treated with intensive IV steroids, H1 and H2 blockers, and topical steroids. He improved rapidly and was discharged three days later on tapering doses of oral steroids, topical steroids, and Benadryl with instructions to avoid the sun for one month. Subsequently, the patient developed severe episodes of skin rashes and had a skin biopsy showing nonspecific chronic dermatitis.

The patient sued the insured ophthalmologist, alleging negligence in prescribing ampicillin to a patient with a known penicillin allergy, which resulted in the patient requiring hospitalization. The patient further alleged that he had residual dermatological photosensitivity and an increased risk of severe anaphylactic reaction if exposed to penicillin again. The case settled for $25,000.

Discussion

The prescription of a medication to a patient with a documented allergy to that medication is one of the most common causes for medication error claims. For this reason, all allergies to common medications used in the practice of ophthalmology should be recorded in a prominent place on the front of the chart, or in another location that will not be concealed by lab reports, etc. Before writing out a prescription, ask again if the patient has any known drug allergies. Since many prescriptions are handled by phone, train your assistants always to check for drug allergies in the patient’s chart or verbally with the patient prior to finally issuing a prescription over the phone. That telephone conversation and prescription should then be documented in the medical record.

Case Four: Silver Nitrate

A fifty-eight-year old male consulted the insured ophthalmologist for an opinion concerning the insertion of punctal plugs for a dry eye condition. Examination revealed a best corrected vision of 20/30 OU. External examination revealed no evidence of thyroid ophthalmology and slit lamp examination demonstrated hyperemia of the superior bulbar conjunctiva OU and papillary hypertrophy of the superior tarsal conjunctiva OU. The cornea demonstrated some fluorescein staining and a few corneal filaments superiorly. The ophthalmologist diagnosed superior limbic keratoconjunctivitis OU and proceeded to treat the right eye with silver nitrate, a procedure he had never performed before. Dacriose was used to dilute the silver nitrate on the end of a silver nitrate stick. The stick was applied to the everted upper lid of the right eye, the lid was allowed to return to normal position, and a “silver sheen” to the cornea was noted. When the patient complained of burning, the insured immediately irrigated the eye with dacriose for at least one minute.

Later that day, the patient was seen in a clinic with severe eye pain OD and referred to a hospital ER where the insured ophthalmologist saw the patient and diagnosed a severe chemical burn. The insured continued to treat the patient for several months until the patient left his care. The insured’s final examination of this patient revealed a visual acuity of 20/200 OD with a hazy cornea and moderate conjunctival injection.

The patient brought suit and alleged that the ophthalmologist negligently administered silver nitrate to his right eye, causing a severe corneal burn and loss of vision OD. The case was settled with a large indemnity payment.

Case Five: Silver Nitrate

The patient was a 35-year-old male who presented with complaints of a sandy itchy sensation in both eyes and decreased vision. The ophthalmologist diagnosed keratitis sicca and superior limbic keratoconjunctivitis, and treated the patient with a moistened silver nitrate stick applied to the conjunctiva at 12 o’clock. A drop of the silver nitrate dripped on the cornea, immediately causing a chemical burn which the ophthalmologist treated with lavage, cycloplegia, and antibiotics.

After the incident, the ophthalmologist followed the patient at regular intervals. He tried treating the SLK with Tobradex, but this caused increased IOP and was discontinued. Silicone plugs were inserted to treat the keratitis sicca. Eventually, a small posterior subcapsular cataract developed in the right eye. The patient was referred to a corneal specialist, who was able to alleviate the SLK with a conjunctival resection on both eyes. Currently, the patient is being evaluated for photorefractive keratectomy to remove the anterior stromal scar. A claim brought by the patient against the insured ophthalmologist was settled for $20,000.

Discussion

Diagnosis of SLK is sometimes missed by the general ophthalmologist. In the cases cited here, the ophthalmologists promptly and accurately diagnosed SLK; however, the poor outcome and resultant claims were allegedly related to the techniques used to treat the problem. To help avoid such claims, general ophthalmologists should take the time to review the proper technique for using silver nitrate. When doing a procedure for the first time or one that you have not done since your residency years ago, especially if it is a procedure that carries a significant risk, check and double-check the proper technique before proceeding. If indicated, ask a colleague who is experienced in the procedure to assist you the first several times you do it. Our profession recognizes the need to document recent training in new procedures such as laser sclerostomy and ALK, but sometimes fails to be equally cautious about procedures that are not normally a routine part of general practice.

Medication-related errors can cause serious injury and result in costly claims. Drug therapy is an integral aspect of ophthalmology and cannot be avoided. However, the following risk management suggestions may help prevent medication maloccurrences and provide a strong defense if a claim arises:

• Be humble enough to use consultants and to obtain second opinions when appropriate.
• Be vigilant in all procedures, including the administration of medications and injections and what may seem to be innocuous procedures or prescriptions.
• Consistently and conspicuously post medication allergies in the patient’s chart, and review the chart before prescribing any medication.
• Discuss the potential side effects of drug therapy with the patient and document that this discussion occurred.
• Make it easy for you and your staff to avoid medication errors by making patient medication information and informed consent documents readily available. Train and oversee your staff to ensure that medication guidelines and precautions are followed.

Notes:

1. Medication Error Study. Physician Insurers Association of America, Washington, DC. June 1993.
2. Bettman JW. Seven Hundred Medicolegal Cases in Ophthalmology. Ophthalmology. 1990;97: 1379-84.

When FDA Leaves Doctors to Their Own Devices

By Kimberly Wittchow, JD

Ms. Wittchow is a staff attorney with OMIC’s Risk Management/Legal Department.

Digest, Spring 2003

To view the two tables referenced in this article, go to the link http://www.omic.com/new/digest/DigestSpri_03.pdf

With the constant development of new devices in the global health care marketplace, ophthalmologists in the U.S. are privy to various treatment alternatives, many of which are tested and employed by their peers around the world long before they are approved for use in the U.S. What are the liability risks and risk management issues that arise if American doctors opt to use devices not yet approved by the Food and Drug Administration (FDA)?

Off-label use—the practice of using an FDA-approved drug or device for a purpose that the FDA has not approved—was explored in “Medicolegal Implications of Using Off-label Drugs and Devices,” (OMIC Digest, Winter 1996). The FDA states that doctors, in the exercise of their best judgment, may use approved drugs or devices off-label if they are well informed about the product, base its use on firm scientific rationale and sound medical evidence, and maintain records of its use and effects.

A related, riskier issue—the use of unapproved devices—was recently brought to OMIC’s attention by an insured who inquired about the soft tissue filler, Restylane, an injectable, gel-like substance containing hyaluronic acid that is currently used throughout Europe and Canada for lip augmentation and facial contouring. The FDA has received the results of US clinical trials of Restylane and is expected to approve it this summer (2003).

Compared to the FDA position on off-label use, the appropriateness of unapproved use is less clear. To understand the liability risks of using a device not approved by the FDA, it is necessary to understand the FDA device approval process. The Food, Drug and Cosmetic Act (FDCA) states that if a device is labeled, promoted or used in the US, it will be regulated by the FDA and is subject to pre-marketing and post-marketing regulatory controls to assure safety and effectiveness. Devices are broken down into three classes. Like collagen, Restylane, used for purposes similar to dermal collagen implants, is a Class III device (the most stringent regulatory category). Pre-market Approval (PMA) is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Clinical trials using un- approved medical devices on human subjects are performed under an Investigational Device Exemption (IDE). They must be approved by the FDA and by an Institutional Review Board (IRB) before the study can begin. The IDE allows the device to be used in order to collect the safety and effectiveness data required to support the PMA application to the FDA. Ophthalmologists must be aware that gathering new information on multiple patients for publication purposes, or to obtain approval for a new device or new use of an approved device, probably constitutes research and will require an IDE. However, if the use is based on firm scientific rationale and sound medical evidence, it is probably the practice of medicine, which is theoretically unregulated.

While the FDA approves and regulates the production, sale, and clinical research of medical devices, it does not directly regulate the practice of medicine. OMIC’s recent inquiries of FDA staff in the ophthalmic devices division reiterated this posi- tion. However, some courts will look for exceptions to a completely “hands off” position. For instance, the Pennsylvania Superior Court held that since the FDA had never approved the use of liquid silicone injections, the trial court erred when it gave a jury the instruction that the FDA has no authority to regulate the practice of medicine. The court noted that this instruction gave the jury the incorrect impression that a physician “can use any drug he wants, irrespective of whether it has been approved or disapproved by the FDA.”

Whether the FDA can or will regulate physicians using unapproved devices may be less important than the consequences resulting when a physician uses such a device to treat a patient and the patient files a malpractice lawsuit or disciplinary action with a state licensing board. The crucial question then becomes whether the physician met the standard of care based upon what reasonable physicians in the same specialty would do at the same time under similar circumstances.

Case law has shown that violating the FDCA may be evidence of a breach of the standard of care and consequently result in a determination that malpractice has occurred. A plaintiff attorney could argue that the use of an unapproved device constitutes negligence per se (negligence per se or legal negligence is negligence established as a matter of law, usually arising from a statutory violation). If state laws are stricter than the federal FDCA and specifically prohibit the use of unapproved devices, it would be easier for the plaintiff to prove a violation of the law and argue either negligence per se or breach of the standard of care.

In order to provide the best alterna- tive to the patient and stay one step ahead of the market competition, ophthalmologists may be tempted to offer the very latest in products or services. Before deciding whether to use the newest device available, several factors should be considered (see Questions to Ask Before Using a Non-FDA Approved Device). The analysis for non-FDA approved devices is based upon the same exer- cise of professional judgment that should be used in determining whether to use approved or off-label treatment alternatives. Physicians

should take special care before using a device for an elective cosmetic procedure. Defense attorneys postulate that juries more closely scrutinize the care of the physician when problems arise in an elective procedure, rather than in an emergency or life-saving procedure. A 2001 OMIC survey found that 73% of ophthalmologists polled believed that elective surgery patients are more likely than other patients to sue their surgeon. Given the higher risk that elective procedures pose, ophthalmologists should consider additional factors in order to make sound decisions to use non-FDA approved devices (see Additional Questions to Ask Before an Elective Cosmetic Procedure).

Applying this risk analysis to three different devices shows how fact- dependent the outcome of the analysis can be. First, in the case of Restylane, it appears that its use prior to FDA approval would be difficult to defend in a lawsuit. Even though physicians throughout Europe and Canada have been using Restylane with positive results since the mid-1990s, surgeons in the U.S. will need to gather data based on larger numbers of patients over extended periods of time in order to determine its long-term safety and efficacy. Patient expectations also will have a profound influence on the risk of using Restylane. Web sites already tout Restylane as a method that is “fast and safe and leaves no scars or other traces on the face.” Because the efficacy of Restylane is dependent on many variables, such as age, skin type, lifestyle, and muscle activity, patients with unrealistic expectations may be disappointed if they do not achieve the volume, smoothness, or long-lasting effects they anticipated. These factors create an especially risky environment in which to use a non-FDA approved device; prudent physicians would be well advised not to use Restylane (outside of an approved clinical trial) until it is approved by the FDA. A disappointed patient and plaintiff attorney will not have to look hard for theories of liability or experts to support a lawsuit against an ophthalmologist who injects this “unproven” material.

The second device group assessed for use prior to FDA approval is cap- sular tension rings, Class III devices marketed by Morcher and Ophtec and currently undergoing pre-market approval review with the FDA. These devices are being used in cataract surgery with some regularity and ophthalmologists are sharing their results with their peers. Because these devices are being used therapeutically for medical treatment, some of the patient expectation variables that arise in cosmetic pro- cedures are avoided. Nevertheless, because they are relatively new to the market, ophthalmologists should use them with caution.

The final example is cyanoacrylate adhesive, used by ophthalmologists for the medical treatment of corneal perforations. One variant of this product, Dermabond Topical Skin Adhesive (2-octyl cyanoacrylate), was approved by the FDA in 2002 to seal out infection-causing bacteria. Yet cyanoacrylate adhesives have been used in the US for wound repair as an alternative to sutures since the Vietnam War in the mid- 1960s. Even before Dermabond’s FDA approval, variations of this adhesive had a long and proven track record and near universal acceptance in the ophthalmic community. Because of its wide-spread peer use and longevity, ophthalmic use of cyanoacrylate adhesive for the treatment of small perforations or leaks would most likely be considered standard medical practice in the community even when applying the most conservative analysis criteria.

After review, if the ophthalmologist decides that there is sound medical evidence and it is in the patient’s best interest to use a non-FDA approved device, he or she should conduct and document a thorough and careful informed consent discussion. The patient should be informed of the nature of the technique or device being used, its scientific basis, its benefits, and any possible drawbacks or criticisms from other practitioners. Especially with cosmetic procedures, other options should be discussed, and the patient should be encouraged to seek a second opinion before proceeding.

If the unapproved device in question is used under an IDE, the federal government requires that the physician have a special, detailed informed consent discussion with the patient which addresses its unapproved status. If the device is not being used under an IDE, physicians should consult with legal counsel about whether state law requires them to disclose the device’s unapproved status to the patient as part of the informed consent discussion. Regardless of state or federal law, from a risk management perspective, it is always advisable to respect the patient’s right to obtain the information needed to make reasoned decisions about his or her own health care. If the physician reasonably believes that the approval status of the device to be used in the patient’s treatment will be a factor in the patient’s decision to undergo the procedure, this information should be disclosed.

Finally, ophthalmologists should always check with the Underwriting Department of their professional liability carrier to ensure that they will be covered for any off-label or non-FDA approved procedure they are contemplating.

Message from the Chairman discusses FDA and Allergan’s Trivaris drug

I have often used this Message to point out the many services OMIC provides to its policyholders, and indeed our profession, that other professional liability carriers cannot. Here is another very recent example of the prompt, specialty-specific advice OMIC is poised to provide.

Within days of the 18 June 2008 announcement in the American Academy of Ophthalmology’s Academy Express that the FDA had approved an injectable triamcinolone acetonide suspension (TA) for ophthalmic use, OMIC began to revise its consent form and anticipate associated medicolegal issues.

Trivaris,TM manufactured by Allergan Inc., is the second approved drug; it joins Alcon’s Triesence.TM These drug approvals come just 18 months after ophthalmologists received a “Dear Doctor” letter from Bristol-Myers Squibb advising them that KenalogTM was not approved for ocular use. In 2006, OMIC policyholders called our confidential Risk Management Hotline to ask if their policy would cover them if they still administered Kenalog.TM OMIC reassured ophthalmologists and assisted them by preparing and distributing a sample consent form to help patients understand that the use of an approved drug in an “off-label” fashion is a legal and often necessary aspect of the practice of medicine.

As a result of the limited indications for which TriesenceTM and TrivarisTM were approved, much ophthalmic use of these forms of TA will continue to be “off-label.” Moreover, now that there are approved formulations of TA, policy- holders are calling the Hotline again to ask, “Can I still use KenalogTM?” Why would physicians want to use a drug off-label if it was available in an approved, single dose form? Retina specialists whose patients were being successfully treated with bevacizumab (Avastin TM) grappled with this issue when Genentech got approval for another of its own products, ranibizumab (LucentisTM).

The answer then and now is related to the topics addressed elsewhere in this issue of the Digest: the cost of health care and the vagaries of reimbursement. Pharmaceutical companies devote years and considerable capital to research and manufacture new drugs. Thus, it is not surprising that freshly approved drugs are generally more expensive than ones already in use. The dilemma for physicians and patients alike, however, is that these drugs may not now—or ever—be included in the formularies of the patient’s health insurance plan. If an ophthalmologist feels the medication is indicated but learns that the cost won’t be borne by the insurance company or can’t be paid by the patient, what should he or she do?

OMIC’s board and committee members are ophthalmologists; we know it is our ethical and professional responsibility to put the patient’s interests above our own and provide what we feel is the most appropriate care. So our answer to our policyholders remains the same: discuss the situation openly with your patient, use your medical judgment, document your decision-making process, and know that OMIC will support you if your care is challenged. Be sure to call our Hotline to discuss particular concerns, and download

the TA consent form and risk management recommendations at www.omic.com.

Our ability to support your care may, however, be jeopardized if you do not properly evaluate and reduce the risks associated with other health care products, such as Medispas, cosmetic skin care, and forensic consulting. While you may gain needed revenue from this type of professional activity, it may come at too high a cost. Indeed, these services raise a number of questions that are addressed in detail in this Digest. Some legal issues can only be resolved by contacting your medical board, practice attorney, or the requesting party. Some malpractice claims coverage questions have clear cut answers, others will depend upon your relationship with the patient and the specific allegations. This issue of the OMIC Digest will at least help you begin your risk assessment.

Joe R. McFarlane Jr., MD, JD OMIC Chairman of the Board