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Twelve patients and nine of their spouses have filed a civil lawsuit against WellSpan for its alleged role in exposing them to a potentially deadly bacteria during open-heart surgeries.

WellSpan first announced in October 2015 that it had discovered a link between medical devices it uses at York Hospital during open-heart surgeries and rare bacterial infections that have since been identified in 12 of its patients, six of whom have died.

The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have each issued alerts warning health-care providers nationwide about the connection between heater-cooler devices and nontuberculous mycobacteria, or NTM, infections.

Since WellSpan's announcement, five lawsuits have been filed against health-care provider by or on behalf of York Hospital patients claiming the infection. Those suits all include LivaNova, the manufacturer of the device, as a defendant.

Local attorney Donald Reihart is representing the 12 patients, who have not been diagnosed with the infection, and their spouses in the recent lawsuit.

Reihart said WellSpan failed in their responsibility of "patient safety supervision," a phrase he emphasizes throughout the 94-page complaint filed in the York County Court of Common Pleas.

Reihart pointed to a previous case settled in the state's Supreme Court that determined hospital owners have a legal obligation to: ensure the maintenance of safe and adequate facilities and equipment; select and maintain only competent physicians; oversee all persons who practice medicine within its walls; and formulate, adopt and enforce adequate rules and policies to ensure quality care for patients.

The complaint also emphasizes the phrase "known or should have known" with regard to the organization's knowledge of the risk the heater-cooler devices presented to the patients.

The FDA and CDC releases both state that the NTM infections from heater-cooler devices are a newly discovered risk because the devices do not come into direct contact with the patients.

The risk comes from unfiltered water traveling from the device's vents through the air and into the patient during operations.

Reihart said the knowledge that water can travel through a vent and carry airborne bacteria has been well known for some time, pointing to several cases of Legionnaires' disease being connected to similar circumstances.

Beyond that, the complaint points out that WellSpan admitted it didn't completely follow disinfection protocols distributed by the device's manufacturer.

The organization also admitted that it had received an alert regarding the risk of infection associated with the heater-cooler devices in August 2014 but failed to fully share it throughout the organization.

The complaint states that an additional 611 patients underwent open-heart surgery at York Hospital between the time it received that alert and late July 2015, when hospitals were ordered by the state Department of Health to replace the devices.

WellSpan spokesman Dan Carrigan could not confirm or deny that number because the organization will not comment on active or pending litigation, he said.

Four of the patients involved in the suit — Henry Dengler, of New Freedom; S. Jean Leiphart, of Red Lion; Anthony Cuffaro, of Dover; and Kenneth Hoke, of Dover — had their surgeries after WellSpan received the August 2014 alert, the complaint shows.

The other patients' surgeries occurred between July 2012 and July 2014.

None of the patients could be reached for comment, and Reihart said he instructed his clients not to speak with media until the suit is resolved.

While these patients don't currently have NTM infections, the complaint documents how each has displayed some of the many general symptoms of the infection, including night sweats, fatigue and weight loss.

"Patients put their trust in the hospital," Reihart said. "Now they have to wonder, 'Am I getting (an NTM infection) or just another cold?'"

Each plaintiff is seeking damages "exceeding the mandatory arbitration amount in Pennsylvania," which Reihart said means more than $50,000.

Carrigan said WellSpan's top priority has been and will continue to be remaining focused on the safety, care and well-being of its patients affected, or potentially affected, by this infection.

Since announcing the connection, WellSpan has set up dedicated nurses and phone lines to answer question regarding the infections and opened a clinic dedicated to treating and testing for the bacteria.

— Reach David Weissman at dweissman@yorkdispatch.com or on Twitter at @DispatchDavid.

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