Prosecutors' lawsuit says opioid drug makers deceived public

Friday, June 9, 2017, Vol. 41, No. 23

NASHVILLE (AP) — A new lawsuit invokes the plight of a baby born dependent on opioid drugs, as three Tennessee prosecutors and the baby's guardian accuse several drug manufacturers of unleashing an epidemic through deceptive marketing about the risks of addiction to painkillers.

"Baby Doe spent his first days in the neonatal intensive care unit writhing in agony as he went through detoxification," according to the suit filed Tuesday in the Sullivan County Circuit Court in Kingsport, Tennessee. The infant boy, who is not identified, was born in March of 2015.

The baby born to an addicted mother survived after spending 14 days in a neonatal intensive care unit, often crying uncontrollably and was given morphine to wean him from his dependency, the suit says. The child, the documents say, continues to suffer from numerous health and learning disabilities.

The lawsuit was filed by three district attorneys who represent parts of the east Tennessee mountains in Appalachia, which has been the epicenter of the prescription drug epidemic that has ravaged the country. It's among a growing number of lawsuits filed recently around the country against opioid drugmakers.

The lawsuit was announced at Niswonger Children's Hospital in Johnston City, Tennessee, about 25 miles (40 kilometers) south of the Virginia state line. The hospital recently added a new neonatal intensive care unit to treat babies with neonatal abstinence syndrome because it has been inundated with infants born dependent on opioids.

Standard treatment for babies born dependent on opioids is giving them small doses of morphine or methadone to help them cope with their withdrawal symptoms before weaning them from the drug.

Tennessee has the second highest statewide opioid prescription rate in the country outside West Virginia, said Barry Staubus, a district attorney who represents Sullivan County. Tony Clark and Dan Armstrong are the other prosecutors who joined in the suit against three drug companies and their subsidiaries.

The lawsuit targets Purdue Pharma, maker of OxyContin; Mallinckrodt PLC, which manufactures and sells multiple painkillers; and Endo Health Solutions, which develops and sells several painkillers, including Opana. The federal Food and Drug Administration recently called for Endo Health Solutions to remove Opana from the market, saying the risks of abuse outweigh the painkiller's benefits. The suit also names two convicted drug dealers and an alleged pill mill.

The lawsuit seeks to stop the flood of opioids in Tennessee and to recover an unspecified amount of money for the costs of combatting the epidemic, including medical expenses, drug treatment, and pain and suffering. The suit also seeks to invalidate a Tennessee law limiting the amount of punitive and non-economic damages that people can win in a lawsuit, saying the statute is unconstitutional.

Staubus said he, Clark and Armstrong plan to join with other prosecutors to pressure Tennessee lawmakers to control the explosion of pain clinics and overprescribing of opioids.

Tennessee House Speaker Beth Harwell, a Nashville Republican, asked the state's attorney general to consider suing painkiller manufacturers on behalf of the entire state after Ohio filed a lawsuit against five drug companies last month.

A spokesman for Endo Health Solutions did not immediately respond to a phone message seeking comment.

"We have broadly supported efforts to combat the opioid abuse health care crisis through a range of advocacy initiatives, direct lobbying campaigns, and charitable activities," a statement from Mallinckrodt said. "We take our responsibility as an opioid manufacturer very seriously." The statement said the company only makes generic drugs and does not promote them.

"While we vigorously deny the allegations in the complaint, we share public officials' concerns about the opioid crisis and we are committed to working collaboratively to find solutions," a statement from Purdue Pharma said. The statement said Purdue works "with policymakers, public health officials and law enforcement to address this public health crisis" to develop abuse-deterrent technology, advocate for prescription drug monitoring programs and support access to Naloxone.

Plaintiffs' attorney Gerard Stranch, managing partner in the Nashville firm Branstetter, Stranch and Jennings, said, "We expect this to be a long drawn out battle and we're ready."

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This story has been corrected to add information on condition of infant.