Opinion ID: 1107705
Heading Depth: 1
Heading Rank: 4

Heading: The Class-Certification Hearing

Text: At the class-certification hearing convened on October 14, 2002, the plaintiffs presented expert testimony from Dr. Stephen Moser, an associate professor of pathology and associate director of the diagnostic microbiology laboratory at the University of Alabama at Birmingham (UAB) Health System; Dr. Bayard Tynes, an internist and professor of medicine and infectious diseases at UAB; and Dr. Paul Howard, an associate clinical professor of plastic surgery at UAB. Williams and Clevenger also testified, and they introduced the deposition of Dr. Baker. Additionally, the plaintiffs introduced every deposition that has been taken by either side, and the parties introduced over 140 exhibits, contributing to the voluminous record in this appeal. SAMC presented expert testimony from Dr. Trish Perl, an associate professor of medicine in infectious diseases and a hospital epidemiologist at Johns Hopkins Hospital in Baltimore, and Dr. Ronald Nichols, a professor of surgery and microbiologist at Tulane Medical School in New Orleans, with special expertise in surgical infection control. Dr. Baker testified that he had used the open bowl method from the time he arrived at the center in January 1999 until he began using a closed system after January 31, 2001. He acknowledged that microscopic fungal spores in the air in an operating room could have gotten into the saline in the open bowl. He had used equally all four operating rooms at the center. At the time of his June 1, 2002, deposition, he had performed 143 explantations on returning patients. All removed implants had been clear and apparently uncontaminated except for the second implant removed from one of the original five; it, like her first explanted implant, contained black particles in the saline. He further testified, and the other experts concurred, that the only way to determine whether fungal contamination is present in an implant is to remove the implant for examination. By the time of the class-certification hearing, more women who had had CBAs at the center had elected to have their implants removed. The CDC had tested all the implants and provided culture reports reflecting that only the second implant Dr. Baker had removed from one of the original five had tested positive for Curvularia. Out of a total of over 180 sets of implants removed following SAMC's December 5 notification letter and sent to the CDC for testing, all had tested negative for Curvularia except the second implant from one of the original five. Dr. Moser, retained by counsel for the plaintiffs, conducted an inspection of the center on September 18, 2001. By then it had been closed for several weeks, and operating rooms 1, 2, and 3 had undergone extensive demolition. In the report Dr. Moser submitted following the inspection, he noted that because of the demolition, the center at the time of his inspection was heavily contaminated with dust, precluding meaningful quantitative counts of airborne fungi. Dr. Moser did observe extensive evidence of mold contamination and [t]he presence of moisture on sheetrock [indicated] that this might be a longer-term problem. Based on the details provided by the CDC report and other information available to him, he believed that conditions conducive to fungal growth were more than likely consistent throughout [the time from 1998 until the center was closed] and the probability of exposure would be high. Dr. Moser opined that during that period of time it would be highly probable that organisms were in the environment and potentially could have exposed people in that environment. He acknowledged that the amount of fungi in the air to which patients might be exposed would differ according to the date and duration of the surgery, how long the saline sat in the open bowl, the amount of saline injected, and the humidity condition of the time of year. He also recognized that a woman undergoing a CBA in OR-2 would be at greater risk of exposure than if the CBA had been performed in another operating room. Dr. Moser's definition of exposure was whether or not the fungus was probably present in the environment at the time; he explained that the conditions, whether they be periodic or not, over this period of time favored that exposure. As to whether that created any risk to a particular patient, or what that risk would be, Dr. Moser indicated, you need to ask the physicians. Dr. Moser explained further that even if a fungal spore was present in implant saline when it was inserted, it might not persist and grow. Dr. Tynes testified that the moisture problems at the center and high humidity problems were conducive to mold growth and that 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. He believed that all the patients were potentially exposed to fungal spores, although the more recent CDC data shows that there are maybe less than we thought there might be initially. He agreed that a patient whose CBA had been performed in OR-2 was at greater risk for Curvularia; that the identity of the surgeon who did the CBA was a risk factor; and that the duration of the surgery and how long the saline bowl was left open were also risk factors. Dr. Tynes explained that sooner or later all breast implants will leak. He testified that breast-implant Curvularia could cause serious health consequences if a leak occurs, but it is also possible for Curvularia-contaminated saline to leak out of a breast implant and cause no health problems. The CDC report, introduced at the class-certification hearing, stated that if breast implants remain intact, the risk of local or disseminated disease should be minimal. However, the incidence of [implant] deflation through leakage is estimated to be 1% to 4% per year for the first 10 years. . . . The relative high leakage rate of [implants] is concerning because Curvularia spp. or other pathogens may escape during leakage and result in local soft tissue infection or disseminated disease. Dr. Howard testified that breast implants leak at the rate of 1 to 2 percent per year and that the chance of an implant rupturing after 8 to 10 years is probably greater than 50 percent. Dr. Howard therefore tells all his patients that they should have their implants replaced at that point in time. He has never used the open-bowl technique in performing a CBA. According to Dr. Howard, a woman having a CBA in an operating room contaminated by fungus would probably be okay if nothing was placed in her body that was contaminated with the fungus, but if the open-bowl technique was selected by the surgeon, I would say [contamination is] more likely. An implant is not contaminated just because there is fungus in the air; contamination occurs only if the fungus ends up in the implant. Dr. Howard testified that a decision to use the open-bowl technique is the surgeon's, but that the standard of care would dictate that the surgeon follow the manufacturer's instruction on use of the silicone implant, which usually recommends a closed system for the saline. A contaminated implant creates the possibility of future inflammation or infection, but, based on the latest CDC test results on the removed implants, Dr. Howard placed the risk of Curvularia infection at less than two percent. SAMC's two expert witnesses likewise viewed the risk of Curvularia contamination for any particular patient as quite low, in light of the negative test results reported by the CDC. Dr. Nichols characterized the risk for infection as very, very, a very low, believing it to be less than one percent. Dr. Perl testified that the risk of contamination [of a proposed class member] is extremely low, although I will admit that it probably varies from patient to patient. Given that only one of the six known cases of implant fungal contamination involved possible infection, Dr. Perl calculated the risk of infection for the class members to be .25 to .5 percent. Williams testified that after she received SAMC's letter she went to see Dr. Baker, and he recommended that she have her implants taken out and tested, explaining that there was no other way to determine if fungal contamination was present in them. He told her that SAMC would pay for the explantation. Because of the mistrust Williams had by then developed for Dr. Baker and SAMC, she elected to have her implants removed by another surgeon in Dothan on December 26, 2001, at her own expense. The removal surgery cost Williams $3,200. Williams testified concerning her emotional upset after she received SAMC's letter and the financial hardship imposed on her by the cost of the explantation surgery. Apparently, her removed implants were not sent to the CDC but rather were turned over to Dr. Moser. He testified that he tested them and found a fungus present in the left implant but not in the right one. He was unable to determine the type of fungus involved because it was a sterile isolate; he could classify it only as some sort of fungus, a mold, and he could not rule out the possibility that it was Curvularia. Clevenger testified that she telephoned Dr. Baker's office after she had received SAMC's notification letter, and Dr. Baker's office arranged a conference call between Clevenger and Dr. McClintock. He advised her that it would be in her best interest to have her implants removed and replaced and that he would have Dr. Baker call her back, but she never heard from Dr. Baker. As of the date of the hearing, she had not had her implants removed, although she testified that she wanted to have that done eventually. She knew that SAMC would pay for the procedure if she had Dr. Baker perform the explantation at the center, but she no longer trusted him or SAMC, and she wanted to have the procedure done in her hometown of Macon, Georgia. At the time of the hearing, however, she did not have the money to pay for the surgery. She testified that she has not yet experienced any signs or symptoms of any problems with her breasts.