Heart device infection: 'I was shutting down'
When Dwight Blake received a letter from WellSpan Health last year detailing a potential bacterial infection outbreak, he brushed it off, thinking there was no way he would be affected.
After all, the then-66-year-old Delta resident had bounced back from his December 2013 open-heart surgery, returning by April 2014 to work as a vendor, often moving and stocking heavy crates of tea.
"My doctor told me he'd never seen anyone bounce back from surgery so quickly," Blake recalled, pointing out that many in his family have lived past 90 years old.
But during the spring of 2016, Blake felt his body quickly deteriorating with no obvious explanation.
"One day, I came home from work, told my wife and son I just didn't have any push left and flopped down in my chair," he said, pointing to a recliner where he now spends much of his day, in front of a television. "I was shutting down."
After multiple doctor's visits and countless tests, Blake was eventually diagnosed with the nontuberculous mycobacteria, or NTM, infection that was outlined in WellSpan's October 2015 letter.
Device: WellSpan had sent letters to 1,300 patients after it discovered eight open-heart surgery patients at York Hospital with the NTM infection and linked it, with help from the state Department of Health and federal Centers for Disease Control and Prevention, to heater-cooler devices used during surgeries.
The heater-cooler device has since been linked to infections at two other Pennsylvania hospitals and hospitals in Iowa and Michigan.
A report published by The York Dispatch last month showed that health care facilities in at least six other states have filed reports to the U.S. Food and Drug Administration indicating that their heater-cooler devices tested positive for mycobacteria.
Recently, the CDC released the results of a study that indicates some of these devices might have been contaminated during manufacturing.
LivaNova, formerly Sorin Group, is the manufacturer implicated in the CDC's study, and the FDA had detailed this potential issue in a warning letter to the German-based company last December.
The device manufactured by LivaNova is used in approximately 60 percent of heart bypass procedures performed in the U.S., according to the CDC.
In its latest release, the CDC has urged hospitals and health care providers to identify and inform patients who might have been put at risk.
In June, the FDA held a panel on the devices in which they concluded that patient notification was not necessarily a priority unless two or more infected patients could be identified.
Blake was astounded and disappointed upon being told of the panel's recommendation, as he recalled how critical patient notification was in his own diagnosis.
Since WellSpan's letter was sent out, four additional patients have been diagnosed with the infections, and WellSpan has identified two patients likely infected with NTM who died before the issue was discovered.
Blake's medical records and communications with WellSpan, reviewed by The York Dispatch, indicate he is being treated for an NTM infection.
WellSpan spokesman Brett Marcy said the nonprofit health system does not comment on individual patient cases but added that it would be heartening to know a patient was able to detect the infection because of the outreach.
Marcy pointed out that, in the past year, WellSpan has built a robust patient support network, including a dedicated NTM clinic, in order to continue monitoring the health of patients potentially exposed.
Hospital stays: As Blake began feeling worse earlier this year, he started thinking back to that letter, he said, and suspected NTM may be the cause of his sudden ailments.
In July, he said he "was turning gray and looked like (he) was dying," so his primary care doctor sent him to the hospital.
Blake said hospital staff ran tests for "just about everything" except NTM, including AIDS and hepatitis, and he had a colonoscopy.
Only after they had ruled out every other possibility did they start treating him for NTM, Blake said. He ended up spending 18 days in the hospital during that stay and 15 more during a separate stay in August.
Blake said his time in the hospital was difficult for him to withstand, but it took a tougher toll on his wife and 17-year-old son.
"They had both given in to the fact that I was probably going to die," he said. "I could see it on their faces when they visited me."
Six of the 12 patients identified with the infection at York Hospital have died, but Blake believes he will survive the illness.
"I have a better attitude than a lot of people," he said, "and a lot of faith."
Diagnosis: Blake said he decided to reach out to the media because he's worried others at risk of contracting the infection don't fully understand how difficult it is to diagnose.
A WellSpan NTM patient information sheet given to Blake after he was diagnosed states that "there is no single test that is sensitive nor specific enough alone to diagnose NTM infection" and blood cultures, which take approximately eight weeks to review, can provide false-positive or false-negative results.
To date, none of Blake's blood cultures have tested positive for NTM, he said, but his health has vastly improved since being placed on NTM-fighting antibiotics.
Blake said he's worried that patients around the country will be given false assurances based on negative blood cultures and not realize their nonspecific symptoms — which include fevers, fatigue, night sweats and weight loss — still could mean they're infected.
Accountability: Blake was born in York Hospital, and he said he's had many doctors and nurses he's liked, but he's disappointed with the company's lack of accountability in this case.
WellSpan has said publicly that it will cover the costs of treatment for York Hospital patients discovered with NTM infections.
Blake said the health care system has covered the costs of his visits and four of his medications directly treating the NTM, including an IV he administers himself three times a week.
These medications have several serious side effects, including hearing and sight loss, which is why doctors are wary of prescribing them to patients as a preventative measure.
However, the delay in prescribing these medications — NTM infections can sit undiagnosed for years after surgery — led to serious issues with Blake's liver and kidneys, and he has received separate antibiotics to treat those problems.
Blake said WellSpan is refusing to cover the costs of those four additional medications, which he was not taking before being diagnosed with NTM.
"They said they aren't NTM-related, but I wouldn't be taking them if it wasn't for the NTM," he said. "It's all NTM-related."
The medications only add up to about $50 per month, he said, but his finances have been negatively impacted by the infection.
Since he can no longer work and is too old to collect disability, Blake is living on his Social Security check, which he said barely covers his house payment.
Six lawsuits have been filed jointly in York County against WellSpan and LivaNova related to these infections, according to court records.
Blake said he doesn't want to file a lawsuit, but it's looking more and more likely that he will have to in order to protect his family financially.
"I may end up with no choice," he said.