Four women who were diagnosed with breast cancer and underwent breast reconstruction surgeries filed lawsuits this week against Roper St. Francis after they developed infections that they claim caused "severe, debilitating injuries."
Deane Pokodner, Mary Bull, Tesha Grant and Sharon Richie-Tiralois count themselves among more than two dozen women who became infected with non-tuberculous mycobacteria following procedures at Roper Hospital on Calhoun Street. Most of the victims were also diagnosed with breast cancer.
In Pokodner's lawsuit, she claims that the hospital did not immediately disclose that other patients had contracted the same infection, which required her to take months of antibiotics and to undergo follow-up breast procedures.
"Although the CDC decided she was likely to have contracted the infection at Roper Main, she was never informed of this by Roper or any treating physicians," the Pokodner complaint contends.
Her lawsuit also argues that Roper St. Francis continued to pay bonuses during this time to physicians and managers in lieu of making "necessary capital improvements ... to protect patients."
Todd Shuman, chief physician officer at Roper St. Francis, confirmed last week the water supply at Roper Hospital previously tested positive for non-tuberculous mycobacteria, but he explained the hospital system has since implemented a water management plan, as recommended by the state health department. Sterile water is used during surgical procedures, he explained, and it's not clear how these patients were exposed to bacteria found present in the regular tap water supply.
Ultimately, the Centers for Disease Control and Prevention and the S.C. Department of Health and Environmental Control were not able to pinpoint exactly how these patients became infected, he said.
"We were hoping ... they would say, 'This is the smoking gun. Do this, and you'll be done.' But they really didn't have that," he said.
On Tuesday, in a prepared statement, Shuman said, "Compassionate and excellent care are cornerstones of our mission, and we sincerely apologize to any patient whose experience hasn’t lived up to those standards."
He said the hospital system does not typically comment on pending litigation, "but we want to emphasize that it has been 11 months since any Roper Hospital patient undergoing an operative procedure has developed a mycobacterium infection. And each of the 27 women who developed an infection were treated successfully with antibiotics."
Roper St. Francis moved all breast reconstruction procedures to its Mount Pleasant Hospital last year.
The lawsuits filed this week in Charleston County circuit court highlight deficiencies noted by CDC officials, who observed during a surgical procedure at Roper that staff "wore improper surgical attire, including jewelry, wore their hair uncovered, improperly changed gloves, and often did not have their masks secured when entering the operating area. The CDC observed high volumes of unnecessary traffic into and out of operating areas in addition to non-scrubbed visitors entering and exiting surgical zones."
Shuman said last week these findings were unrelated to the bacterial infections, but correspondence between DHEC and Roper St. Francis suggests that some of the hospital's infection control practices, including the use of flash sterilization in the operating room, may have contributed to the problem.
Court records show, in an email dated May 23, 2017, DHEC attorney William Britt conveyed to Roper St. Francis attorney Greg Edwards that the state agency was "experiencing significant pressure" from the CDC "to make sure that these items have been addressed."
In his statement Tuesday, Shuman said Roper St. Francis "implemented all of their recommendations and took extensive steps that surpassed industry standards to filter and treat the water in Roper Hospital. At all times, we took the most reasonable steps and acted in the best interest of our patients’ health, and we always will. Our patients are safer because of what we’ve learned and done."
A lawyer at McGowan, Hood & Felder, who represents the plaintiffs, did not immediately return a message on Tuesday. Other victims are expected to file separate lawsuits.
A spokeswoman for the Medical University of South Carolina confirmed on Monday that two MUSC patients have been infected with non-tuberculous mycobacteria since 2016.
“When MUSC was informed by Roper about these concerns over a year ago, we immediately reviewed all cultures to identify patients with these infections, and to look for any commonalities or trends," said Dr. Danielle Scheuruer, MUSC's chief quality officer, in a statement.
"We have continued these reviews to date," she added. "Although there have been a very limited number of patients with these infections after surgical procedures, we cannot find any commonalities or trends related to specific procedures. We will continue to vigilantly monitor for these infections to ensure patient safety.”
A spokeswoman for the Ralph H. Johnson VA Medical Center said no patients have been infected at that facility.