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the Reporter TEXAS MEDICAL LIABILITY TRUST Special issue: Ophthalmology 2007 NEGLIGENCE IN PRESCRIBING OPHTHALMOLOGY CLOSED CLAIM STUDY by Barbara Rose, Senior Risk Management Representative The following closed claim study is based on an actual malpractice claim from TMLT. This case illustrates how action or inaction on the part of physicians led to allegations of professional liability, and how risk management techniques may have either prevented the outcome or increased the physician’s defensibility. The ultimate goal in presenting this case is to help physicians practice safe medicine. An attempt has been made to make the material less easy to identify. If you recognize your own claim, please be assured it is presented solely to emphasize the issues of the case. Clinical presentation A 45-year-old woman came to the emergency department (ED) complaining of pain, blurry vision, and sensitivity to light in the left eye. Examination confirmed a corneal abrasion. The patient was given an antibiotic eye drop and instructions to follow up with the defendant ophthalmologist. She was seen the next day in the defendant’s practice. At that time, the history revealed that the patient had not filled the oral antibiotic prescription. She also had not administered the topical antibiotics as instructed by the ED physician. Physician action Visual acuity was 20/200 in the left eye. A corneal ulcer with an infiltrate was diagnosed. The defendant started the patient on topical Tobradex, a combination antibiotic and corticosteroid medication. The patient was instructed to return the next day for repeat evaluation. At that visit, she reported less discomfort and improved vision. On examination, the visual acuity had improved to 20/80 and the infiltrate was still present but improved. Tobradex was continued as well as Ciloxan that had been prescribed by the ED physician. A return appointment was made in five days. On the appointment date, the patient came to the same ED and was instructed to see the defendant as scheduled. She did not keep this appointment, but was seen the next day. The patient reported an increasing foreign body sensation in the affected eye. Visual acuity had decreased to 20/200 and an infiltrate was still noted. A therapeutic bandage contact lens was inserted and the patient was advised to continue Ciloxan and Tobradex and return in two days. At this appointment the patient complained of increased pain and decreased vision in the left eye. She informed the physician that she thought a piece of asphalt had flown into her eye the first day she went to the ED. Visual acuity was 20/400 and the infiltrate was larger, involving the inferior cornea. The bandage contact lens was exchanged and Ancef and Atropine drops were added to the topical medications. The patient was seen the next two days (Saturday and Sunday) by the defendant. No improvement was noted. On Sunday, the patient was referred to a corneal specialist. The defendant paged the on-call specialist for the corneal group and that physician agreed to see the patient on Sunday at a medical center. The patient was examined in the ED and appropriate cultures were done. On Monday, the corneal specialist recorded a corneal abrasion 4mm by 6mm that had not increased from the earlier measurements. Two days later, the abrasion had decreased in size to 3mm by 5mm. The final results of the cultures were determined five days later (April 16th), and were positive for a fungal corneal ulcer. Amphotericin B was started and Cosopt for increased intraocular pressure. A return visit with the corneal specialist on April 21st listed Amphotericin B, Vancomycin, Gentamycin, continued on page 2 continued from page 1 and Cosopt as the medication regimen. Demerol was also prescribed for pain. The patient reported hand motion vision. Pressure had increased to 42, and the infiltrate was described as light blocking and dense, about 5 mm. The plan was to continue therapy and see the patient in five days. On April 26th the patient described less pain and vision to count fingers. The impression indicated some improvement in the fungal infection, and an order to decrease the anti-fungal medication to every two hours. A return appointment was scheduled in four days. From April 30th to June 16th, the patient was seen 12 times with the indication that the ulcer was responding to treatment and continued therapy recommended. Amphotericin, Cosopt and Atropine were continued. At an appointment on June 16th with the corneal specialist, his findings indicated increasing pain despite Demerol every three hours, light perception only, pressure of 34, 75% hypopyon, filamentary keratitis and continued infiltrate. The fusiform ulcer was not responding to medical treatment. Xalatan was added for pressure reduction. Surgery was scheduled for a corneal graft. The transplant was done on June 18th. In spite of aggressive follow up and care, the transplant subsequently failed. She is legally blind in the left eye. Allegations The general ophthalmologist was sued and the plaintiff alleged negligence in prescribing both an antibiotic and steroid concurrently as it helped promote the growth of the infection. The plaintiff further alleged that the defendant should have added other antibiotics and an anti-fungal medication earlier thus causing a delay in treatment and the need for corneal transplant. Legal implications Physician consultants for the defense described the ophthalmologist’s care and treatment as reasonable and meeting the standard of care. They felt it was appropriate to treat a mild corneal ulcer without cultures in the beginning. When the patient’s condition did not respond to treatment, an emergent referral on a Sunday demonstrated the defendant’s concern. The physicians who reviewed this case consistently acknowledged that fungal corneal infections are difficult to detect in their early stages. It was also noted that most ophthalmologists may see only one to two fungal infections in their entire careers. One reviewer emphasized that there were no apparent signs of fungal infection during the time the defendant treated the patient. He felt strongly that no physician could have identified this infection any sooner, and there was no requirement on the part of the defendant to perform a culture earlier, as alleged by the plaintiff. With regard to causation, the corneal specialist who cared for the patient stated that upon first examining her, the eye did not appear to have a fungal ulcer present. He also agreed that the type of fungal infection the patient had is rare and very difficult to treat. This physician further opined that fusarium is a particularly nasty strain of fungal ulcer and generally results in the outcome this patient experienced regardless of the treatment. The plaintiff’s expert stated that the standard of care had been breached by the defendant because he prescribed a steroid (Tobradex) in combination with antibiotic drops (Ciloxan). The expert did agree that ophthalmologists may differ in their opinions regarding the use of Tobradex. The Physician’s Desk Reference lists treatment of corneal abrasions with Tobradex as appropriate and its use does not breach the standard of care. During deposition this expert also acknowledged that fungal infections are rare and the fusarium infection was even more rare. He agreed these infections are generally not diagnosed until the later stages and that patients often lose their eyesight. This physician went on to describe the characteristics of a fungal lesion and admitted to defense counsel that at no time under the defendant’s care were these findings present. Disposition This case was taken to trial and the jury returned a unanimous verdict in favor of the defendant. Risk management considerations It is satisfying to present a claim in which the defendant physician is exonerated at trial. It is also noteworthy to add that none of the physician consultants or experts participating in the review of this claim expressed any criticisms about the defendant’s practice protocols or quality of the medical record. Barbara Rose can be reached at [email protected]. Want more closed claim studies? Case Closed: A collection of TMLT closed claim studies, Volume 1 and Volume 2 are currently available. Each book contains closed claim studies based on actual TMLT claims. Physicians can earn 4 hours of CME — including 1 ethics hour — by completing the CME activity included in Case Closed. TMLT policyholders who complete this activity will earn a 3% premium discount (maximum $1,000) applied to their next eligible policy period. Request a free copy of Case Closed Volume 1 or Volume 2 by emailing [email protected]. Please include your name and mailing address in your email. 2 Ophthalmology 2007 risk management 101 The FDA in 2007: criticism, caution, and confusion by Barbara Rose and Anna Tauzin It seems safe to say that many physicians and a well-informed segment of the population have experienced confusion and sometimes distrust regarding the actions of the Food and Drug Administration (FDA) in recent years. Drugs and devices have been approved as safe and subsequently withdrawn, sometimes in quick succession to the dismay of physicians and patients. In the case of silicone gel-filled breast implants, the implants were approved, pulled off the market, and then approved again. This article will address the mission, responsibility, and decisions of the FDA in recent years; its impact on the delivery of health care, physician confidence, and patient safety; and ways to stay informed and react in a timely manner when the care of your patient(s) requires a change. History Following the exposure of hazards in the meat-packing industry, Congress passed the Federal Food and Drugs Act in 1906. The law required adequate labeling of food and drugs, specifically that the label could not be incorrect or misleading. However, deceptively packaged products continued to materialize. A more stringent act was introduced in 1938, bringing cosmetics and medical devices under the FDA’s control. It required drug labels to provide directions for safe use. The act also required that new drugs meet pre-market approvals, forcing manufacturers to prove to the FDA that their products were safe before being approved for public use. 1 In the last quarter-century, regulation of food on planes, radiation-emitting products, and pre-market licensing for therapeutic agents have been added to the list of FDA responsibilities. The administration is also accountable for post-market monitoring and recall authority of medical devices. Through decades of change, the FDA strives to adhere to it’s mission statement, found at www. fda.gov. “The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” 2 Recent issues Disrepute has tainted the FDA in recent years. Critics have asked if the FDA is losing sight of its responsibility to the public. Is the FDA too anxious to push certain drugs or products through the approval process without sufficient research? The most recent and media-saturated issue involves Merck and their anti-inflammatory drug Vioxx (rofecoxib). A companysponsored trial from 2004 showed that patients who took the medication for more than 18 months were at an increased risk for a heart attack or stroke. Following this trial, Merck voluntarily recalled the drug. However, later evidence suggested that the FDA knew about the increased risk long before Merck’s recall. 3 According to Dr. Richard Horton, editor of The Lancet, “In the case of Vioxx, the FDA was urged to mandate further clinical safety testing after a 2001 analysis suggested a ‘clear-cut excess number of myocardial infarctions.’ It did not do so. This refusal to engage with an issue of grave clinical concern illustrates the agency’s in-built paralysis, a predicament that has to be addressed through fundamental organizational reform.” 4 In June 2006, longtime FDA critic Senator Charles Grassley of Iowa said, “I’m fed up with resistance from the bureaucracy. It’s been one excuse after another. Practices and policies have changed from one day to the next. Files available one day become ‘confidential’ overnight. A line agent isn’t allowed to tell his story, even though line agents have been made available in other cases.” 4 (Line agents are domestic representatives to foreign pharmaceutical companies. The FDA requires that all foreign pharma- ceutical companies who import drugs into the U.S. appoint a domestic representative through whom all communication with the FDA takes place.) Senator Grassley, in a follow-up letter from September 2006, expressed concern about the FDA’s handling of pre-market review and post-market surveillance of drugs, biologics, and devices. Grassley is not the only one who has noticed a problem within the FDA. Scientific journals, the Government Accountability Office (GAO), the Institute of Medicine, and current and former FDA employees have all expressed their dissatisfaction with the FDA’s leadership. Said Senator Grassley, “The FDA needs to distance itself from the industry and return to its role as regulator, not a facilitator. Despite findings from a Merck study that heart attacks were five times higher for Vioxx patients than for patients on another drug, nearly two years passed before label changes were made. The overriding concern of the FDA should have been the health and safety of the American people. However, while the FDA was negotiating label changes with the company, patients and doctors remained largely unaware of the cardiovascular risks.” 5 Risk management considerations How do physicians manage the almost daily reports regarding FDA actions, notices to pharmaceutical companies, alerts, recalls, etc.? Ultimately, the responsibility for understanding and keeping up with this information falls squarely on the shoulders of physicians, who may not be given enough information to help patients make informed decisions. With this in mind, the following risk management practices may help avoid patient harm and possible litigation related to the prescription and use of FDA-approved products. • Physicians need to be proactive and stay informed on a daily basis. If you have not done so, sign up to receive the FDA’s MedWatch notices via email or RSS feed. (Visit http://www.fda.gov/medwatch/ for complete instructions.) Open all of your mail. For example, GE Healthcare mailed a letter continued on page 4 Ophthalmology 2007 3 Pre-sorted Standard U.S. Postage PAID Permit No. 90 Austin, Texas the Reporter TEXAS MEDICAL LIABILITY TRUST P.O. Box 160140 Austin, TX 78716-0140 800-580-8658 or 512-425-5800 E-mail: [email protected] www.tmlt.org Editor Jane Holeman Managing editor Barbara Rose the Reporter is published by Texas Medical Liability Trust as an information and educational service to TMLT policyholders. The information and opinions in this publication should not be used or referred to as primary legal sources or construed as establishing medical standards of care for the purposes of litigation, including expert testimony. The standard of care is dependent upon the particular facts and circumstances of each individual case and no generalizations can be made that would apply to all cases. The information presented should be used as a resource, selected and adapted with the advice of your attorney. It is distributed with the understanding that neither Texas Medical Liability Trust nor Texas Medical Insurance Company are engaged in rendering legal services. © 2007 TMLT. continued from page 3 to physicians in December 2006 informing them of the reports on nephrogenic fibrosing dermopathy after imaging studies with Gadolinium. • Require a comprehensive medical history from patients including their use of illegal drugs, prescription pain medications, and OTC products (analgesics, vitamins, herbs, weight loss products). Patients may be poor historians or may consider their use of herbal medications unimportant. (For example, use of St. John’s Wort is contraindicated in patients who will be undergoing general anesthesia.) • Review all current information about drugs, medical products, and devices that are part of your practice. It is unwise to base treatment recommendations on the abbreviated information provided by a marketing representative. • When discussing treatment decisions and options with patients, remember to include the most current information available along with the known risks. Document this exchange and the patient’s informed choice in the medical record. Sources 1. Swann JP. History of the FDA. 1998. Available at http://www.fda.gov/oc/history/ 4 Emergency Medicine 2007 historyoffda/default.htm. Accessed January 15, 2007. 2. U.S. Food and Drug Administration. FDA mission statement. Available at http:// www.fda.gov/opacom/morechoices/mission.html. Accessed January 15, 2007. 3. Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA. Lancet. December 4, 2004;364:1995-1996. Available at http://www.thelancet.com/journals/ lancet/article/PIIS0140673604175235/fulltext. Accessed January 15, 2007. 4. United States Senate Committee on Finance. Grassley Comments at the Department of Health and Human Services Regarding Access to Information About the FDA and The Antibiotic Drug Ketek. June 14, 2006. Available at http://finance.senate. gov/sitepages/grassley2006.htm. Accessed January 30, 2007. 5. Grassley C. Senator Grassley comments on the Institute of Medicine’s Assessment of the U.S. drug safety system. Available at http://grassley.senate.gov/ index.cfm?FuseAction=PressReleases. Detail&PressRelease_id=5180. Accessed January 30, 2007. Barbara Rose can be reached at barbara-rose@ tmlt.org. Anna Tauzin can be reached at [email protected]. Sample alerts from MedWatch The FDA communicates their safety and recall information to physicians through several channels, including emails to those who subscribe to the MedWatch e-list. The following is a sample of notices sent out in 2006 and early 2007: • failure of implanted cardiac defibrillator (ICD) devices; • gadolinium used in imaging studies and reports of nephrogenic fibrosing dermopathy; • recall of the Davol/Bard Composix Kugel large patch; • an alert about the antibiotic Ketek and links to severe liver damage; • potential side effects of antidepressant drug use in children and adolescents generating a Black Box warning; • an alert about drug-eluting stents; and • the dangers of several over-thecounter drugs (analgesics, antipyretics, cough and cold medications) for infants and children.