JOHNSON CITY, TENN. — As a team of nurses unwrap baby Jayden from the comfort of his swaddling cloth, he wails. His tiny feet shake. His hands clench and unclench.
His suffering is obvious. Born dependent on opiates, the month-old boy and thousands like him are the smallest victims of the opioid epidemic.
Drug manufacturers sued on behalf of opioid-dependent babiesPlay Video - 4:56
Drug manufacturers sued on behalf of opioid-dependent babiesPlay Video - 4:56
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Scenes like this now play out every day in hospitals across the country, as increasing numbers of women of childbearing age struggle with opioid addiction. Nationally, the rate of American children born with neonatal abstinence syndrome, a set of symptoms experienced by babies exposed to drugs in the womb, has quadrupled over the past 15 years. In East Tennessee the number of infants born with NAS has skyrocketed, with some counties reporting rates eight times the national average.
The problem is so bad that eight of the region’s district attorneys general are suing opioid manufacturers on behalf of local babies born with NAS. The suits are two of the latest to be filed in a mounting nationwide effort to drag drug-makers and distributors into courtrooms.
Sullivan County District Attorney General Barry Staubus, a plaintiff in one of the suits, said the flood of prescription opioids into the region has had a “tragic” effect.
“When you see those babies scream, you see them claw, you see them shake, it makes the problem real,” Staubus said. “It’s not an abstract policy problem. It’s not a lawsuit. It’s a baby that never had a chance.”
‘This Is a Much Bigger Problem’
Dr. Shawn Hollinger, neonatologist at Niswonger Children’s Hospital, cradled baby Jayden’s head in an effort to comfort him. After 35 days in the neonatal intensive care unit, Jayden was ready to go home.
The number of children needing intensive treatment for NAS has become so overwhelming that the hospital opened a new ward this year just to care for them. Since 2009, hospital staff have treated over 1,800 babies with NAS. In the past 12 months, Dr. Hollinger has seen 351 infants with NAS come through the NICU.
“It’s hard to explain the magnitude of what the problem is right now,” said Hollinger.
A recent analysis by the Centers for Disease Control estimated that nearly six out of every 1,000 infants born in the U.S. are now diagnosed with NAS. However, experts say that rate is likely higher, as not all states regularly collect such data.
Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.
The state has been hit particularly hard by the opioid epidemic, now considered the worst drug crisis in U.S. history. For years, Tennessee has had some of the nation’s highest opioid prescription and overdose rates. Women of childbearing age have not been exempt from the scourge of opioid addiction, and recent research has found that the number of pregnant women in the state who use opioids is more than twice the national average. Until recently, under a much-criticized and now-expired law, Tennessee women could be prosecuted for using drugs while pregnant.
After birth, children exposed to drugs in the womb experience a multitude of symptoms, including tremors and seizures. Even after being released from the hospital, some children may still have to be treated with medication and physical therapy. It can cost upwards of $60,000 to treat one baby.
Not enough is known about the long-term effects of NAS, Hollinger said. Children with NAS may experience developmental delays, or attention problems later in life. Some research has found that children with NAS are more likely to end up in the foster care system.
“[It’s not] something that is going to be easily fixed,” Hollinger said.
After birth, baby Jayden was kept in a quiet, dark room and given physical therapy to soothe his symptoms. But the pain of withdrawal was severe enough that Hollinger had to give him small doses of morphine for five weeks, slowly weaning him off the medication.
“When I was first just seeing one or two babies at a time with this condition, my natural reaction was, ‘How could this mom let this happen?’,” he said, as Jayden whimpered in his bassinet. “How could she put her baby through this?”
“When we’re seeing the numbers that we’re seeing right now, it’s very clear to me that this is not an individual problem,” he added. “This is a much bigger problem.”
'I want them to be held accountable'
The new wave of opioid-related lawsuits mirrors the legal efforts against major tobacco companies in the 1990s. Dozens of counties, cities and states – including Missouri, Kentucky, Ohio, Mississippi, and New Mexico – have filed suit against manufacturers and distributors of prescription opioids. In late September,a coalition of 41 state attorneys general sent subpoenas to drug companies like Endo International and Purdue Pharma.
Staubus, a veteran prosecutor with a slow drawl, likened the litigation effort to a David-and-Goliath-style fight taken up by communities struggling to cope with the opioid epidemic.
“The public expects me, when we have a drug problem in the community, to do something about it,” said Staubus. “And I’m not going to defer to some federal agency somewhere else, somebody I don’t know, and I’m not going to defer to somebody that’s made a bunch of money, telling me what I can and can’t do. I’m going to do everything legally, ethically and policy-wise that I can do. And that’s what I’m doing.”
The East Tennessee suits against opioid manufacturers allege that the companies engaged in a “concerted effort” to “mislead doctors and the public about the need for, and addictive nature of, opioid drugs.” The suits also name local drug dealers and pain clinics as defendants.
In statements to NBC News, the companies said they are troubled by the opioid crisis and continue to make efforts to stop people from abusing their products.
Mallinckrodt Pharmaceutical said that it does not promote opioid products and intends to file a motion to dismiss the Tennessee cases. A spokesperson said the company has “deep sympathy for the mothers impacted by opioid addiction, and we empathize with the anguish and worry they have related to the impact of their disease on their babies.”
In a statement, Teva Pharmaceutical Industries told NBC News they are “committed to the appropriate use of opioid medicines” and that they “comply closely with all relevant federal and state regulations.”
A spokesperson for Endo said the company does not comment on pending litigation, but noted that safety is a priority for them and that the company is balancing “supporting the needs of patients with chronic pain while preventing misuse.”
Purdue is also trying to strike that balance, according to a spokesperson. While it denies the allegations in the suits, the spokesperson said, Purdue is “dedicated to being part of the solution” and is making efforts to work with law enforcement and prevent the abuse of its products. The company also said that its painkiller OxyContin represents only 1.7 percent of opioids prescribed nationally, and 1.6 percent of opioid prescriptions in Tennessee.
Opioid manufacturers, including Purdue, have paid millions in fines and settlements over the years. This summer, Mallinckrodt entered into a $35 million settlement with the Department of Justice, to resolve allegations that it ignored its responsibility to report the diversion of its oxycodone pills to the black market – some of which ended up in Tennessee. The company did not admit wrongdoing in the settlement.
Also this summer, the Food and Drug Administration asked Endo to remove its opioid painkiller Opana ER from the market, saying that the benefits no longer outweighed the risks. It was the first time the agency had ever moved to pull an opioid medication from sale.
“I want them to be held accountable in my county, where I live, where this damage is done,” Staubus said. “I want them to pay not just financially but I want them to pay in the fact that there’s going to be an accounting, legally, that they did this and they harmed the community, and they’re at fault.”
‘Who’s going to step up and admit that they were wrong?’
Libby Harris, 45, of Claiborne County, Tennessee, said she doesn’t think her son or daughter realized how far-reaching the consequences would be when they used opioid pills for the first time.
Her daughter became hooked after using them recreationally, Harris said. For years, she struggled with addiction. Then she became pregnant. And the consequences trickled down to Bella, her 17-month-old granddaughter, who was born dependent.
“It’s hard to explain how devastating it is, knowing that here’s this precious baby coming into this world,” Harris said. “And she’s gonna have so much to overcome, just from being born.”
There were so many hard parts. Overcoming the anger she felt at her daughter, coming to terms with the facts of addiction.”That’s what people need to understand,” Harris said. “They think it’s just you can lay it down and walk away. You can’t do that. It doesn’t work like that.”
And there were her granddaughter’s unrelenting cries. “It was unfair to her,” she said.
Claiborne County, on the Kentucky border, has one of the highest rates of NAS in Tennessee. Harris said nearly every family in this community of green pastures and rolling mountain ridges has dealt with the opioid epidemic in one way or another.
“You have to also look to what’s going to happen to all these kids when there’s nobody to take care of them,” she said. “It’s not exaggerating to say there’s going to be a generation of orphans.”
“Who’s going to step up and admit that they were wrong about a product that caused this?” she added. “People made a choice. But I don’t feel that they knew the force they were dealing with.”