The filings were 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.
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 this single action should abate the incidence of opioid-dependent children born to prescription opioid-using mothers. Relatively recent scientific confirmation that in-utero exposure to opioids causes teratogenic birth defects prompted the legal action, the attorneys said. 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 injunction seeks 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.
“Our organization Love on Wheels works to help children born with opioid-addiction at birth to opioid-addicted parents,” said Dr. Kathy Kunkel, a founder of this organization that deals with foster children. “We support actions, such as these, which would help reduce the number of births of children born with Neonatal Abstinence Syndrome, thus addressing a part of the problem caused by prescription opioid abuse and its impact on women and families.”
“Anything a pregnant woman ingests or breathes that enters the bloodstream is transmitted to her baby by the placenta, and opioids pass the mother’s placenta with ease,” said Ms. Brustowicz. “In-utero opioid exposure subjects the fetus to addiction as well as brain and other organ injury.”
Ms. Brustowicz and Mr. Bickford are currently leading a team of attorneys working on behalf of NAS children who were harmed by prescription opioids. They have filed eight state class actions and one nationwide class action seeking to recover medical monitoring costs, epidemiological studies, medical and social welfare treatment, and damages on behalf of the prescription opioid NAS babies and children.
“The efforts by the Federal Drug Administration, the National Institutes of Health and other government agencies have been focused on abating addiction and crime, but there is no particular focus on opioid-dependent babies and children,” said Attorney Scott Bickford. “This injunction is an extraordinary remedy to an extraordinary national crisis.”
Moreover, Attorney Bickford as well as Dr. Kanwaljeet Anand, the former chief of pediatrics at Stanford University, said the costs of caring for such children born dependent on opioids threaten the budgets of every family with such a child and every political subdivision in the country.
“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 until now. Babies with NAS must receive essential medical care and rehabilitation. On average, one infant with NAS is hospitalized every hour in the U.S.”
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.
“The proposed injunction provides a pragmatic approach to avoid NAS and congenital malformations related to opioid use, while providing responsible exceptions for surgical and other acute/chronic pain relief during pregnancy,” added Dr. Anand. “Since opioids can alter fetal development, preventing in-utero opioid exposure is key to reducing lifelong disabilities in the affected child. Every baby should be given the best chance to the best health. “
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 Abusereported 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.
“It will cost billions to evaluate, treat, and monitor these infants and children as they grow into adulthood,” said Mr. Bickford. “These babies not only require expensive after-birth care but exhibit life-long problems, including profound learning disabilities and propensity toward future addictions. Thus, the fight continues for these babies.”
“Individuals and health professionals are still woefully uneducated of the potential long-term impacts of first-time opioid exposure for themselves, especially expecting mothers,” said Greg Williams, a national addiction health policy expert and former Executive Vice President and Co-Founder of Facing Addiction."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."
UNDISPUTED MATERIAL FACTS SUPPORTING MOTION FOR PRELIMINARY INJUNCTION
DECLARATION OF DR. KANWALJETT S. ANAND
DECLARATION OF AMANDA M. HANLON
About the Opioid Justice Team
The Opioid Justice Team (OJT) is a group of attorneys working with doctors and national and local nongovernmental organizations fighting to end our nation’s opioid epidemic by identifying real solutions to the crisis. The OJT seeks not only compensation for damages for their clients but also a comprehensive settlement that will address the root causes of the opioid crisis. For more information, please visit http://opioidjusticeteam.com/.
|MEMORANDUM IN SUPPORT OF PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION|
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|UNDISPUTED MATERIAL FACTS SUPPORTING MOTION FOR PRELIMINARY INJUNCTION|
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