The original motion for issuance of a preliminary injunction, requiring nearly all prescriptions for opioids to women of child-bearing age be written only after the woman tests negatively for pregnancy, as currently required with other medicines which damage fetuses, was denied earlier this year in Cleveland, Ohio. However, that denial was appealed to the 6th Circuit.
A split-decision by three judges of the Circuit Appeals Court, with a strong dissenting opinion by Judge Amul Thapar, encouraged the attorneys to seek the en banc hearing.
“This extraordinary crisis can and must be stopped,” said Attorney Scott Bickford. “This aggressive first step costs the pharmaceutical companies nothing and saves potentially thousands of children from facing life-long disabilities. Indeed, it may save the taxpayers of this country millions upon millions of dollars and stop yet another generation of effected children.”
The case by Plaintiffs Amanda Hanlon and Amy Gardner is supported by sworn declarations from prominent physicians who give witness to the fact that opioid intake while pregnant has been determined to have long-lasting effects on exposed embryos. Recent studies have confirmed that in utero exposure can cause physical birth defects, such as cleft palate, heart, head and gastro-intestinal deformities, as well as development delays in speech, learning, walking and other motor skills.
Plaintiff Amanda Hanlon said, "I have seen with my own eyes that prescription opioids hurt babies, moms, and their families. If I could tell every woman, like me who is at risk for hurting their unborn babies, of how bad opioids are, I would. This injunction will tell every woman what they need to know, right when they need to know it with their doctor present. I hope the motion is approved."
Attorneys Scott Bickford and Celeste Brustowicz said even one birth of an opioid-dependent child born to a prescription opioid-using mother is a national failure.
“Action must be taken now. This preventable condition must be stopped,” said Mr. Bickford.
The incidence of NAS births is now estimated by organizations like the Centers for Disease Control to be every 15 minutes in the U.S., they added.
“This request is not unlike other programs established by drug manufacturers, distributors, pharmacies, and the FDA to successfully protect fetal development,” said Ms. Brustowicz. “The Accutane Program which requires the same of child-bearing women with acne is evidence that institutional requirements like those sought here do protect babies from fetal injuries.”
A major part of the Accutane Program requires urine pregnancy tests and communications between the prescribing physician and the dispensing agent, such as a pharmacy, with the support of the drug manufacturers and distributors, according to the filing.
The attorneys seek a court order to require major opioid pharmaceutical manufacturers like Purdue, Teva, Cephalon, Johnson & Johnson, Janssen, Endo, and Allergan to implement a program which, except in limited circumstances, will require a doctor to prescribe only seven days of an opioid-based prescription to a child-bearing-age woman after a negative pregnancy test. Physician renewal of a second prescription can occur only after a second negative test.
“There is an unprecedented epidemic of opioid addiction sweeping across the U.S.,” said Dr. Anand. “Newborn babies are the most vulnerable citizens, their lives and developmental potential are disrupted by Neonatal Abstinence Syndrome (NAS), but arrangements for their short-term and long-term care have been ignored.”
As of September 30, 2016, child and family assistance spending related to the epidemic was about $6.1 billion, according to various reports tracking the problem, though Attorneys Bickford and Brustowicz believe the problem is not sufficiently tracked and reported.
“The only realistic means of reducing these types of birth is prevention,” said Mr. Bickford.
Nearly one-third of all pregnant women in the United States are prescribed opioids, according to recent Centers for Disease Control reports. Neonatal Abstinence Syndrome (NAS) is a group of medical conditions faced by babies born dependent on opioids from their exposure in the womb due to their mothers’ usage. Between 2000 and 2009, the National Institute on Drug Abuse reported a five-fold increase of infants born with NAS. Data from multiple states that track NAS births continue to show growing numbers of newborns afflicted with it, and it is estimated that tens of thousands of NAS babies are born every year.
"This would be a huge step forward to push the medical field to use alternative methods and, in the long-term, limit the epidemic of NAS births in our country," said Ms. Brustowicz
PETITION FOR REHEARING EN BANC
UNDISPUTED MATERIAL FACTS SUPPORTING MOTION FOR PRELIMINARY INJUNCTION
DECLARATION OF DR. KANWALJETT S. ANAND
DECLARATION OF AMANDA M. HANLON