“For the first time, the dirty secret regarding prescription opioids prescribed to women of child-bearing age is revealed,” said Legal Strategist Stuart Smith. “Our research shows that though the federal agencies documented the link between in-utero exposure to prescription opioids and birth defects, a timely black box warning on opioid prescriptions given to women by their doctors and gynecologists could have and should have been made before 2014, when the first warning in opioid labeling was made.”
These cases now present a legal model for replication in all cases, Mr. Bickford said. The suits were filed seeking to protect the rights of babies born opioid-dependent and their guardians because these children will face life-time medical needs related to educational, physical, and developmental disabilities.
“The responsible parties who should have warned prescribers of opioids to women of childbearing age, never undertook a Risk Evaluation and Mitigation Strategy (REMS) similar to other proven teratogens,” said Mr.Bickford. “These cases are an important public warning to women and their babies because they were left unprotected during decades of widespread distribution, marketing and medical use of these drugs.”
The four amended cases in West Virginia, California, Tennessee and Ohio document the birth defects and complications children born before 2014 to mothers using prescription opioids are now facing, along with the scientific links alleging the mechanism of action by which this class of prescription opioid drugs caused these debilitating injuries.
The amended briefs include research conducted by Toxicological Pathologist Dr. Vyvyan Howard of Ulster University and Neo-Natal Abstinence Syndrome (NAS) Expert Dr. Kanwaljeet Anand of Stanford University. The teratogenic effects of opioids on a developing fetus range from physical deformities such as heart, brain and gastroenterological defects, including mal-formed heads, cleft palates or lack of complete bowel systems, as well as neurological, motor and cognitive defects such as inability to walk, talk or complete basic skills.
“The hard work of these independent researchers has uncovered the sorry details of this public health crisis, but we remain concerned that these facts will get lost in the fights over bankruptcies and counter lawsuits,” said Mr. Bickford. “This information must get out to every doctor and pharmacy, and a REMS program instituted to protect every woman of child-bearing age who might be prescribed these risky drugs.
“Hundreds of thousands of Opioid Dependent Children have been born in the last 20 years. These children face educational and developmental hurdles, and many may face future addiction since they were born addicted. We continue to push aggressively in the federal court system and before Judge Polster presiding over the Multi-District Litigation for a specific NAS track because of the severe and enduring impact this epidemic has and will have on our nation’s children.
Table 1 Association between maternal opioid analgesic treatment and specific major birth defects in National Birth Defects Prevention Study of 17449 cases and 6701 controls . Significance is starred * in the usual way. Odds ratios were adjusted for maternal age, race/ethnicity, education, pre-pregnancy obesity, smoking.
Statistics compiled by the Centers for Disease Control estimate that first-year Medicaid costs for opioid-exposed infants average approximately $238,000 and the additional cost burden on hospital Neo-natal Intensive Care Units has increased five-fold in less than a decade.
“These estimates do not cover costs borne by family caregivers or foster-care institutions responsible for the infants once released from the hospital. The guardians and parents who take these infants home frequently believe that once the child is weaned from their opioid-dependency, there will be no long-term impact on the child. Data shows that is unfortunately almost never the case,” said Mr. Bickford.
The 34 states represented in the NAS legal filings are:
Alabama, Arkansas, Arizona, California, Colorado, Delaware, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Utah, Virginia, Washington, West Virginia, Wisconsin.