Legal Review & Commentary: Acid mixture mix-up results in severe facial burns and $500,000 Kentucky verdict
Legal Review & Commentary
Acid mixture mix-up results in severe facial burns and $500,000 Kentucky verdict
By Jan J. Gorrie, Esq. Buchanan Ingersoll PC, Tampa, FL
News: A change in how trichloroacetic acid (TCA) was packaged translated to a patient being seriously burned and disfigured while undergoing a chemical peel to "touch up" her face-lift. The physician and pharmacist — in what was identified as a second incident for each of them— failed to appreciate the fact that the TCA had been repackaged and required a new formula for achieving the correct dosage. The patient was awarded $500,000, which was apportioned between the supplier (30%), pharmacist (40%), and physician (30%).
Background: The 47-year-old consulted her plastic surgeon regarding "touch-up" work on a prior facelift. The surgeon suggested a chemical peel, a relatively common procedure that involved the application of a mixture containing TCA. The patient was told she would need three to four days to recover.
The plastic surgeon regularly obtained TCA from a single pharmacy, which in turn relied upon getting TCA from a single supplier that provided the chemical in a 35% solution.
Unfortunately, in the months prior to the plaintiff's procedure, the supplier switched its measurement of TCA mixtures. It changed from weight-to-volume measurement to weight-to-weight measurement. Apparently, the pharmacist did not appreciate the change and did not adjust his formula accordingly. The result was that when the plaintiff underwent her procedure, she received a much more powerful 54% solution of TCA. As a result, she sustained swelling and burns that required a complex course of treatment, which included steroid injections, laser treatments, and wearing a silicon bandage on her face for six months.
Permanent scarring resulted. The plaintiff claimed that the physician was negligent in using the "old" formula a second time, as another patient of the physician's had suffered from similar burns prior to her incident. The plaintiff also faulted the pharmacy for changing the mixture without appropriately notifying the physician. She claimed the supplier failed to provide adequate instructions on such a significant change in packaging.
The supplier in turn faulted the pharmacist for not paying attention to the change. The pharmacist countered that he relied upon the supplier and its expertise with the product. With regard to the first incident, the pharmacist claimed that once he learned of the injury to the first patient, he adjusted his formula and advised the physician to destroy the "old" formula. The physician claimed that he relied upon the pharmacy to provide the proper mixtures in the concentrations he specified.
A $500,000 verdict was awarded to the plaintiff. Fault was apportioned 40% to the pharmacy and 30% each to the physician and the supplier.
What this means to you: "As noted in the Institute for Safe Medication Practices Medication Safety Alert! Nov. 4, 2004 (volume 9), ‘Labeling, packaging, and nomenclature issues admittedly play a role in about half of all medication errors reported to MedWatch, according to Janet Woodcock, head of the U.S. Food and Drug Administration, Center for Drug Evaluation and Research.' The blame game that was played by the physician, pharmacist, and supplier in defending this lawsuit is a classic case in which no one involved took responsibility for reading the label," notes Cheryl Whiteman, RN, MSN, HCRM, clinical risk manager for Baycare Health System in Clearwater, FL.
"All three defendants had opportunities to prevent this injury. First, the supplier could have notified the pharmacy of the change in concentration of TCA due to their packaging changes, assuming that the manufacturer had notified the supplier at the outset. Second, the pharmacist, in all likelihood, saw a package that appeared to be unchanged. Without a warning label or notice from the supplier, the unsuspecting pharmacist probably assumed that the TCA was no different than it had been in the past, which resulted in the incorrect mixture being supplied to the plastic surgeon. Finally, the plastic surgeon may have been able to defend his position, had another patient not suffered burns from the mixture previously, as it would appear that the plastic surgeon neglected to have the first incident investigated, which allowed the second event to occur," Whiteman explains.
"Recognizing that labeling, packaging, and nomenclature are problematic, the facility risk manager or alternatively physician in this setting would be charged with educating all staff and making them aware of these risks. Several publications provide warnings and information that should be shared in an ongoing medication safety forum, as an element of establishing a culture of safety within the organization. Specifically with regard to this case, the physician would have perhaps been well served if staff members had been more familiar with frequently used medications and solutions, for it appears that he used TCA on a routine basis," notes Whiteman
"When untoward medication events do occur, the risk manager and health professionals should be responsible for reporting such via MedWatch so that warnings continue to be disseminated among caregivers and patients. While this incident did not result in the patient's death, given the role that the supplier played in the distribution of a product that is likely FDA-regulated, this likely falls into a mandatory reporting event as opposed to voluntary, although voluntary reporting by consumer and health professionals is highly encouraged ‘to keep effective drugs and devices available and on the market.' Regardless, health facilities should have procedures in place for the mandatory reporting process," Whiteman adds.
"Interesting to note is that use of TCA as a chemical peel is relatively common, and patients even can order TCA in varying concentrations over the Internet and subsequently self-administer chemical peels. Presumably, the TCA obtained through these channels is of a concentration that ‘gets the job done,' whether that be as advertised removal of fine lines, age spots, acne scars, ice pick scarring, or hyperpigmentation, but after the results in this case both to the patient and monetarily to the three defendants, it does make one wonder what the warning labels say and if there are releases involved in the on-line TCA products, which leads to me believe that perhaps this patient's scarring was rather severe," notes Whiteman.
Reference
• Kenton County (KY) Circuit Court, Case No. 01-1771.
News: A change in how trichloroacetic acid (TCA) was packaged translated to a patient being seriously burned and disfigured while undergoing a chemical peel to "touch up" her face-lift. The physician and pharmacist in what was identified as a second incident for each of them failed to appreciate the fact that the TCA had been repackaged and required a new formula for achieving the correct dosage. The patient was awarded $500,000, which was apportioned between the supplier (30%), pharmacist (40%), and physician (30%).Subscribe Now for Access
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