Was hospital derelict in leaving saline in open bowl?

BREAST IMPLANT SURGERY IS RISKY. Some risks are not as apparent as others. Who would expect that sterile saline would be left in a bowl out in the open?

SOUTHEAST ALABAMA MEDICAL CENTER OPERATES DOTHAN SURGERY CENTER IN DOTHAN ALABAMA. The center was involved in several cases in which women who had saline implants that failed due to contaminated saline solutions. After an intensive investigation, including involvement by the Center for Disease Control (CDC), a determination was made that the saline solution in question had a common denominator. Prior to the saline solutions being inserted in the implants with sterile needles the saline had been allowed to sit out in the open. It was determined that at or about the time in question the hospital had a new air ventilation system installed. Authorities determined that it was quite likely that while the saline was sitting in a bowl out in the open was also exposed in a Microwave Warmer, which was constantly being opened and closed. Did the saline pick up mold spores in the air? The five patients, who initially sued the hospital for subjecting them to this risk, sought to have the case certified as a class action. The Houston Circuit Court certified the case as a class action. The hospital appealed.

THE SUPREME COURT OF ALABAMA REVERSED THE JUDGMENT OF THE TRIAL COURT, WHICH GRANTED THE PLAINTIFFS' MOTION TO TREAT THE CASE AS A 'CLASS ACTION.' The court held, inter alia, that as to the majority of claims certified for class action, the plaintiffs failed to carry their burden of proving their entitlement to class action certification. Accordingly, the trial court erred in certifying the class. The court vacated the certification and remanded the case back to the trial court for actions not inconsistent with the court's opinion. Editor's Note: The case, as reported by the court, focused on the issue of whether or not the case was one which qualified for class action status. The facts around which the that issue revolved are ones that every hospital should be cognizant of The case may have been triggered by a condition resulting from the installation of a new air vent system by the hospital. That, together with the fact that saline, which was to be injected into implant devices, was allowed to sit in a container, exposed to all of the contaminants in the air, until it was injected into implants, was, indeed, cause for concern!.

ONE OF THE PROPONENTS OF THE 'OPEN BOWL' PROCEDURE STATED THAT HE USED THE METHOD FROM THE TIME HE ARRIVED IN JANUARY 1999 UNTIL HE BEGAN USING A 'CLOSED SYSTEM' AFTER JANUARY 31, 2001. He acknowledged that the microscopic fungal spores found by investigating authorities in the air in the operating room could have gotten into the saline in the 'open bowl.' He had used all four of the operating rooms at the center. At the time of his June 1, 2002, deposition, he had performed 143 "explantations" on patients who returned with complaints. He further testified that all removed implants had been "clear" except for the original five. He explained that the only way to determine, (and other experts concurred), whether the implants were clear was to remove them. By the time of the class-certification hearing, more women who had CBAs at the center had elected to have their implants removed. The CDC tested all of the implants and provided culture reports, which reflected that only the second implant Dr. Baker had removed from the original patient tested positive for Curvularia. Dr. Bayard Tynes, an internist and professor of medicine and infectious diseases at University of Alabama, the plaintiffs' expert witness, conducted an inspection at the center on September 18, 2001, at which time the center had been closed for several weeks, and operating rooms 1, 2, and 3 had undergone extensive renovation.

THERE WAS EXPERT MEDICAL OPINION THAT ALL PATIENTS WERE "POTENTIALLY EXPOSED" TO THE RISK. Apparently, the moisture problems at the center and "high humidity problems" were conductive to mold growth and the negative pressure in two of the operating rooms meant that there was "a higher degree of outside organisms coming into the operating room rather than having a sterile condition inside and pushing these to the outside." Further, patients whose CBA had been performed in OR-2 were at greater risk for Curvularia. Last, but not least, there was a risk factor-the degree of which was dependent on the amount of time the "uncovered" bowl of saline solution was exposed to the air. The risk of serious health consequences resulting from a 'leak" in an implant, which some predict will happen "sooner or later." Authorities estimate that there is a 1% to 4% risk of a leak in the first 10 years post-op, and a 50% risk of a leak every year after 10 years post-op. Houston County Health Care Authority v. Williams, No. 1021253 (Ala/12/01/2006) So.2d -AL

Meet the Editor & Publisher: A. David Tammelleo, JD, is a nationally recognized authority on health care law. Practicing law for over 40 years, he concentrates in health care law with the Rhode Island firm of A. David Tammelleo & Associates. He has presented seminars on medical, nursing and hospital law throughout the United States. In addition to his writings as Editor of Medical Law's, Nursing Law's & Hospital Law's Regan Reports, his legal articles have been published in the most prestigious health law journals. A prolific writer, his thousands of articles, as well as his achievements as an attorney and lecturer, have won him recognition in Martindale-Hubbell's Bar Register of Preeminent Lawyers, Marquis Who's Who in american Law, Who's Who in America and Who's Who in the World.