Failure to detect latex allergy leads to death, $4.7M verdict
Legal Review & Commentary
Failure to detect latex allergy leads to death, $4.7M verdict
By Radha V. Bachman, Esq., LHRM
Buchanan Ingersoll & Rooney
Tampa, FL
Leilani Kicklighter, RN, ARM, MBA, CHSP, CPHRM, LHRM
The Kicklighter Group
Tamarac, FL
News: A woman underwent a hysterectomy at a local hospital. After surgery, the woman woke up complaining of itching and nausea, and she had blisters on her lips. She was given over-the-counter drugs to assist with these symptoms. The woman later had trouble breathing and developed ventricular tachycardia. Four days after surgery, the woman died. A Mississippi jury returned a verdict in favor of the plaintiff in the amount of $4.7 million.
Background: A 29-year-old mother of two young sons received a hysterectomy and partial vulvectomy at the recommendation of her gynecologist. The surgery was performed by the woman's OB/GYN and his partner. The woman regained consciousness after surgery but complained of itching and nausea. She also had blisters on her lips and redness of the face. The woman was provided with Benadryl for the itching and another drug for her itching.
The night of the surgery, the woman's husband heard the woman gasping and making gurgling sounds. When she was unable to respond to him, the husband contacted the nurse who found the woman having trouble breathing. An emergency department (ED) physician immediately intubated the woman. Due to the intubation, the woman was unable to breathe on her own and was placed on a ventilator and transferred to the intensive care unit. Despite this intervention, the woman exhibited no neurological function following the cardiac arrest and was taken off the ventilator. She died four days later.
The woman's husband brought a wrongful death action against the hospital and alleged that the hospital and physicians were negligent in failing to discover that the woman was allergic to the latex gloves used by the surgeon. He asserted that the woman died as a result of the latex allergy, which caused her cardiac arrest.
At trial, the husband introduced the hospital's latex allergy policies and procedures which provided, in part, that "all patients should be assessed for [a] latex allergy." The policy also provided that patients should be questioned about certain items, including apple, banana, and chestnut allergies (ABC food allergies), which would indicate a patient was at high risk for such an allergy. The woman's allergy list included sulfa, Lorcet, dairy products, seafood, and adhesive tape. On the nursing admission history, prepared a week before surgery, the same allergies were listed. The form also included a section titled "Latex Allergy Alert" which did not appear to be adequately completed by the nurse despite the woman admitting to having an allergy to chestnuts (one of the ABC food allergies' foods). The doctor never was informed that the woman had several of the ABC food allergies.
Had an allergy been noted on the woman's chart, the hospital's policy would have required an allergy sticker on the chart, signage on the patient's door, notification to central supply and purchasing regarding any special supplies or products needed, and notification to food and nutrition to ensure servers not wear latex gloves when serving the patient's food. The nurse maintained during her testimony that the patient did not give her any information regarding being allergic to latex and that based on her understanding of the policy, notification was only required if the patient had affirmatively acknowledged a known allergy to latex.
Experts for the parties disagreed on whether the woman had a latex allergy. Ultimately, however, the jury returned a verdict in favor of the woman's husband in the amount of $4.7 million. The award was split such that $516,000 was paid to the wrongful death beneficiaries and $4.2 million to the woman's estate.
The hospital appealed the finding. The court of appeal rejected the hospital's contention that the verdict was inconsistent as a result of finding that the hospital was found to be at fault while the physician was not at fault. In its holding, the appellate court found that the nurses had a separate duty to assess the woman for a latex allergy or sensitivity and to notify the physician of any such allergy or sensitivity.
Additional information was provided which showed that the duties related to assessing for latex allergy were generally required and were not solely required by the hospital's policies. Evidence was shown that the nurses did not follow the policies. There was also no evidence to provide that had the nurses acted within the standard of care, the doctors would have heeded their warnings.
What this means to you: Latex comes from the rubber plant sap. Historically, all medical gloves were made of rubber. After each use, healthcare providers filled them with water to test for leaks. If a leak was found, the glove was discarded; if not, it was washed, inside and out, packaged in a surgical towel, and sterilized for reuse. Washing apparently reduced the latex concentration, as we recognized latex reactions were dramatically low.
Latex is a component of many household and office materials and tools, such as garden hoses, automobile hoses and connections, elastic bands in clothes, and elastic bands used to hold hair and papers. Many of the medical supplies and equipment used in hospitals and other healthcare facilities also contain latex including, for example, gloves, urinary catheters, facemasks, tourniquets, bandages, wound drains, injection ports, rubber syringe stoppers, bulb syringes, mattresses on stretchers, dental devices, and stethoscopes.
The powder in latex gloves also has latex, which a problem when the gloves are removed and the powder is disbursed into the air and into the air conditioning system. Powder containing latex has been found in the hair and beards of members of surgical teams in operating rooms that are supposed to be sterile environments. As a result, experts agree that facilities should attempt to schedule latex-sensitive patients undergoing surgery as the first case of the day, when aerosolized latex particles in the operating room and elsewhere are at their lowest. Generally speaking, however, latex allergies do not have a significant public presence.
Nevertheless, allergies are funny things. A person can eat tomatoes and ketchup every day and have no problem until one day the person develop hives, a rash, or an allergic reaction. Usually this reaction would not be attributed to tomatoes since tomatoes were consumed by the person regularly prior to the reaction. Often, individuals live with these allergy symptoms by taking an antihistamine until a significant reaction occurs and the person is forced to seek medical attention. Other times, these symptoms dissipate on their own, though they can suddenly exacerbate as well.
Latex allergies can play the same game, such as this patient who had an allergy to tape. The symptoms of this allergy probably were localized where the tape was placed and dismissed on that basis. From the facts provided here, there is no indication as to whether there was any further questions regarding the signs and symptoms of the tape reaction. Many people forget to mention food allergies unless it is known to be significant from the point of causing life-threatening issues such as respiratory difficulties.
Nurses and physicians/surgeons must be more cognizant of this failure to be forthcoming and specifically query about food, make-up, and other common non-medical type allergies. For example, in today's widespread use of propofol, an anesthetic agent that has a soy base, in surgical settings, it is particularly important to solicit if a patient has a sensitivity or allergy to soy or soy products. Should a patient in respond that they have or have had sensitivity or allergy to a substance, drug, or food, further discussion should be undertaken. This information is specifically brought to the attention of the physician/surgeon/nurse practitioner and, in the case of surgery, to the anesthesiologist as well. Documentation of such information sharing should be done as well. The affixing of the allergy sticker on the front of the chart and with the implementation of the electronic medical record (EMR), we soon will have no front of the chart is a policy and standard of practice. However, it is possible that it often is ignored and not addressed in the medical record.
In a healthcare setting, the two major strategies for management are one, prevention and treatment of occupational latex allergy in employees, and two, the safe care of the latex-allergic patient. The cornerstone of latex allergy treatment is avoidance. As a result of recognition of risk of latex allergy and the potential for anaphylaxis, there was a significant focus on the use of latex gloves and other medical equipment and supplies containing latex. In the late '90s and early 2000s many healthcare facilities went latex free and/or powder free. During the initial employment health screen, many facilities have a latex allergy screen that all employees must complete. This screen is updated annually as sensitivities can evolve as mentioned above. In many facilities, this screen is a component of the nursing intake history. Many facilities have pointedly made it a policy to purchase only latex-free equipment and supplies, and manufacturers have bowed to that pressure. Again, many facilities have a surgical latex allergy protocol for those patients with a known latex allergy. In 1998, the American Academy of Dermatology's Committee on Latex Allergy made suggestions in its position paper with respect to the use of latex.
The result in this unfortunate case is one that, in large part, was a result of the facility's own policy. Risk managers preach "policy must follow practice" and "practice must follow policy," and of course both must follow accepted standards. However, department staff don't always validate that statement is the case. One exception is the failure modes and effects analysis (FMEA) process a very involved but valuable evaluation tool which is not undertaken for each policy and procedure.
In addition to conducting a root cause analysis (RCA) of this event, the risk manager should review in detail the current policy and procedure(s) relating to latex allergies including the latex/powder-free program status. Based on these finding, the risk manager should undertake to convene a small group of frontline nursing staff members and a small group of physicians and surgeons to discuss the issues and how it can be addressed more effectively. Both groups can come together to collaborate on how best to address the issue in the best interests of the patient's safety in the facility. Changes identified then should be implemented and an educational program provided to all physicians and employees relating to latex allergies, signs and symptoms, and equipment and supplies that might contain latex. This issue is one that cannot be addressed once and then put on the shelf until a subsequent adverse incident occurs. The population in general, which includes the medical and facility staff, can be latex allergy-free one day and subsequently have a significant allergic reaction up to and including anaphylaxis. Emphasize the signs and symptoms of allergy. The physician from the ED who responded to the breathing difficulties apparently did not consider latex allergy reaction and anaphylaxis, even with face redness, lip blisters, itching, nausea, and difficult breathing after surgery. If he had, perhaps appropriate treatment could have been initiated. One wonders if the endotracheal (ET) tube placed by the ED physician was latex-free.
A part of the educational program to physicians/surgeons and nurses should include an emphasis on recognition of signs and symptoms of an allergic reaction and particularly those that show up after a surgical procedure. In this situation, one would question whether this was a latex-free facility and if staff members were using latex-free ET tubes throughout the facilities. With documentation of an allergy to tape, one would question if that allergy were taken into consideration when dressing the post-op wound, when taping the ET, or taping the Foley or intravenous line?
Another relevant question is what social and medical history was noted in this surgeon's office record. Did the surgeon review the patient's medical record in detail before commencing the surgical procedure? One wonders if the allergy to tape were noted as a part of the timeout process.
One very distressing comment in this scenario is the last one before the end of the fact pattern: "There was also no evidence to provide that had the nurses acted within the standard of care, the doctors would have heeded their warnings." This statement presents a significant challenge for risk managers, nursing, administrators, and members of healthcare facility boards. Specifically, the challenge is how to bridge this apparent disconnect, especially in the facility context. Is it possible that this disconnect might be more widespread throughout healthcare than recognized? This potential disconnect is a significant impediment to providing safe, trusted healthcare in each and every healthcare environment.
Reference
Mississippi, Court of Appeals, Case No. 2009-CA-01796-COA.
News: A woman underwent a hysterectomy at a local hospital. After surgery, the woman woke up complaining of itching and nausea, and she had blisters on her lips. She was given over-the-counter drugs to assist with these symptoms. The woman later had trouble breathing and developed ventricular tachycardia. Four days after surgery, the woman died. A Mississippi jury returned a verdict in favor of the plaintiff in the amount of $4.7 million.Subscribe Now for Access
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