Deadly bacteria: Pittsburgh family sues drug maker over contaminated laxative
They were supposed to grow up together, twins Ariana and Alivia Singleton born one minute and 2 pounds apart.
Ariana appeared to be the vocal, mischievous one.
Alivia, nicknamed “Livvy,” exhibited a personality as the strong, quiet one.
Now, only Ariana, 2, runs around the Singleton home in Hampton. Her sister's crib remains next to hers in their bedroom with a photo and pink painted imprints of Alivia's tiny feet.
Alivia Singleton died May 4, 2016, at Children's Hospital of Pittsburgh of UPMC. She was three months shy of her first birthday. She was born prematurely with a cleft palate and later diagnosed with severe acid reflux. The reflux caused fluid to become trapped in her lungs, which led to chronic lung disease.
She also had mysteriously contracted a type of bacteria called Burkholderia cepacia.
The family never heard of such an infection, but for several months before her death the bacteria invaded Alivia's breathing tube and catheter.
“We're asking, ‘What is that? Is it something you get at the hospital? Is it easy to get rid of?'” said Alivia's mother, Jocelyn Singleton.
Alivia's lung problems caused her to need breathing devices and her reflux caused the need for a feeding tube connected directly into her intestines. Doctors administered a laxative to offset a common side effect — constipation caused by some of her pain medication.
Suddenly, in February 2016 she developed a fever and became lethargic. Doctors detected the bacterial infection but couldn't figure out what caused it.
The infection came and went during Alivia's last few months.
“Every day was touch and go for the last month of her life,” Jocelyn Singleton said.
After Alivia's death, her mother learned of a nationwide recall of a liquid laxative that had been found to be contaminated with Burkholder cepacia. During her hospital stay, Alivia was administered the exact same laxative, called Dicoto Liquid, through her feeding tube to regulate her bowels.
Singleton and her husband, Lamont, sued the Florida-based laxative manufacturer, PharmaTech LLC, in U.S. District Court in Pittsburgh. The suit, filed late this summer, also names distributors, The Harvard Group and Rugby Laboratories, as defendants.
“The thing we want everybody to be aware of is even though our child was sick, there was a glimmer of hope that she was going to get better and come home for good,” Lamont Singleton, who works as a foreman for Rice Energy, told the Tribune-Review at his home. “It was a tumultuous ride and you wouldn't think that a laxative would be the culprit. The lack of not paying attention to details by these pharmaceutical factories is unreal. Things could have been different.”
In June 2016, a month after Alivia died, the Food and Drug Administration and the Centers for Disease Control and Prevention reported an investigation of multistate outbreaks of Burkholderia cepacia, or B. cepacia infections.
A month later, PharmaTech voluntarily recalled all of its Dicoto Liquid products. The FDA confirmed the laxative was contaminated with B. cepacia linked to infections in five states, including Pennsylvania.
“I'm thinking, ‘What?' Jocelyn Singleton said. “I'm reading this and Livvy had already passed away. I see the name of the bacteria, and I was so scared to tell my husband. Not only is it recalled, but it has the bacteria. It didn't sit right.”
PharmaTech to defend itself
PharmaTech's recall said the product “may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.”
Alivia, with her compromised immune system, was the perfect victim for such an infection.
“What is most concerning is the number of patients that were potentially affected by this,” said Pittsburgh attorney Brendan Lupetin, who is representing the family. “This type of stool softener is given to many patients that are hospitalized for extended periods of time, in particular when narcotic medication causes constipation.”
Lupetin, who is handling the case with attorney Jonathan Gesk, pointed out that UPMC is not a defendant in the lawsuit.
“UPMC was left in the dark like everyone else,” he said. “Its staff was given a defective product that was represented as the appropriate medication to regulate the bowels of the patient population.”
Children's Hospital pulled the laxative upon learning about the complications, Lupetin said.
PharmaTech, through its Pittsburgh attorney Donald H. Smith, said it plans on defending itself in court.
“While PharmaTech is defending against the allegations made by the Singletons and we look forward to our day in court, we cannot comment further at this time due to the ongoing nature of the litigation,” he said in a statement.
The other defendants did not return messages for comment.
In August, the FDA announced a more extensive recall: PharmaTech, because of the contamination, recalled all liquid products it manufactured. PharmaTech vacated its Davie, Fla., facility in June, according to the Sun Sentinel newspaper . The company website is no longer active and its Florida phone number is disconnected. A LinkedIn page said it employed an “experienced team of chemists, formulators, project coordinators and dynamic quality assurance team.”
A report regarding PharmaTech issued by the FDA in August 2016 cited complaints of mold contamination liquid products along with black flakes in others. A water sample collected from its water system tested positive for B. cepacia bacteria.
“Specifically, your firm does not have any written and approved documentation for ensuring consistent water quality for drug production and implementation of procedures for maintaining and monitoring the quality of the water,” the FDA wrote in its Aug. 9, 2016 report.
An ‘amazing' life
Alivia spent only five weeks at home during her nine months of life, from Thanksgiving 2015 through the New Year.
“It was the most amazing five weeks,” her mother said, while crying. “She finally got to be with her sister. She loved it and you could feel it.”
Throughout the ordeal with Alivia, the Singletons devoted attention to their beloved Ariana, nicknamed “Ari.” As Jocelyn Singleton recounted the horrific journey, she wept. Ariana crawled onto her lap several times and wiped her tears with her hands.
“You're crying,” she said to her mother, confused yet smiling.
The Singletons barely left medical facilities in nine months: whether it was Magee-Womens Hospital, where Alivia was born, The Children's Home of Pittsburgh & Lemieux Family Center, where she recovered after birth, or Children's Hospital, where she was baptized Catholic and where she died.
“People are like: how did you do it?” Jocelyn Singleton said. “We just had to. When you become a parent, you're like a superhero. We had to do what we had to do. Thank God for those nurses. They were our family.”
By May 4, 2016, the Singletons made the decision to take Alivia off breathing machines.
Jocelyn Singleton looked at her husband and said, “I want to hold her. I just want to hold her. They started taking everything off of her and made sure we were sure. Her oxygen was single digits. She wasn't there anymore.”
Nurses who had the day off drove to the hospital to comfort them.
“I did not want her to suffer anymore,” Jocelyn Singleton said.
Ben Schmitt is a Tribune-Review staff writer. Reach him at 412-320-7991, email@example.com or via Twitter at @Bencschmitt.