GUARDIANS OF OPIOID-DEPENDENT BABIES SEEK MDL CLASS CERTIFICATION BEFORE JUDGE POLSTER
 
Leading medical experts testify that in-utero opioid exposure causes birth defects
 
(CLEVELAND, OHIO) Attorneys representing America’s most innocent victims in the nation’s prescription opioid crisis took a significant step today within the Multi-District Litigation before Judge Daniel Polster in Cleveland, Ohio by seeking class certification of the guardians responsible for children injured by in-utero exposure to opioids and diagnosed with Neo-Natal Abstinence System or drug dependence.
 
States, cities, municipalities, hospitals and Native Americans have already gained such class certification status. Those classes do not include guardians of children who were born with Neo-Natal Abstinence Syndrome or drug dependent. 
 
This would be the first-time children diagnosed with Neonatal Abstinence Syndrome, due to the opioid use of their birth mothers, would finally have redress of the lifelong physical and development disabilities and defects these children do and will experience, said Attorney Scott Bickford. 
 
Mr. Bickford, who has argued on behalf of children with NAS for nearly two years before Judge Polster, said his team is being expanded by the legal expertise of Marc Dann, the former Attorney General of Ohio, and class-action experts Kelly and Tom Bilek.
 
“These children are the most vulnerable and blameless victims of the opioid crisis and will need lifelong medical monitoring and surveillance, as well as medical and social support services,” said Mr. Dann.
 
“This generation of children is not yet lost but will be without substantial intervention. For two years, their needs have been subordinated to the less urgent needs of government entities which do not have the legal ability to bring claims for these children, do not owe the duty of care to them and will never guarantee their on-going needs are met. Nevertheless, the child’s guardian will surely face and bear the fiduciary responsibility,” Dann added.
 
The legal filing, with supporting evidence from leading medical experts in the areas of NAS and the scientific relationship between in-utero opioid exposure and birth defects, puts forth studies and testimony to support these arguments, making these main points:
 
·      The nation is vastly undercounting the number of NAS babies, and data shows the number of babies with NAS babies born in the U.S.--now estimated at one every 15 minutes by the Centers for Disease Control– are far greater than the official government count because of flaws in how this information is gathered.
 
·      Babies are sent home from hospitals to guardians with little awareness of what the child and caregiver will face. While physical deformities may be evident when a baby is born, the growing medical science in the NAS area shows opioid exposure in the womb impacts brain size and development which results in long-term developmental effects such delays in walking, talking, hyperactivity, impulsive behaviors, aggression, learning disabilities and other problems which won’t demonstrate until the child ages.
 
·      Governments, schools and other institutions don’t understand the needs of these children because there is no registry of babies with NAS. Thus, families have no roadmap for the challenges ahead. Such a map can only be provided by establishing a registry and providing long-term medical monitoring and research. “This will allow for the program to reach out to the impacted families at the appropriate times,” wrote West Virginia Dr. Charles Werntz III, and also help identify the most hard-hit regions.
 
Certification of a nationwide class of guardians of NAS children must occur in 2020, the attorneys argue in today's filing on behalf of families in 34 state class actions. This is underscored by the fact that nationwide, one of every five pregnant women on Medicaid has been prescribed opioids, the filing claims. 
 
“In addition to medical monitoring claims to the guardian, plaintiffs seek to ensure that money needed to pay for testing and epidemiology is actually spent for the direct benefit of children born with NAS.  More urgently, intervention and education of doctors and women of child-bearing age is required to immediately stop the possibility of more such births by educating them and the public that opioids cannot be used during pregnancy,” said Mr. Dann.
 
The link to the filing and supportive statements is here: ​
​nas_opioid_2020_01_07_ts__motion-brief-appendix-proposed_order-declaration_with_exhibits.pdf

Attorneys fighting to stop opioid prescription-related Neonatal Abstinence Syndrome (NAS) births filed a petition seeking a hearing before the entire U.S. Court of Appeals for the 6th Circuit in Cincinnati, Ohio because of the emergency nature of the opioid issue to all women of childbearing age in the United States. 

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
 
ADDITIONAL DOCUMENTS:
PETITION FOR REHEARING EN BANC
UNDISPUTED MATERIAL FACTS SUPPORTING MOTION FOR PRELIMINARY INJUNCTION
DECLARATION OF DR. KANWALJETT S. ANAND
DECLARATION OF AMANDA M. HANLON
​

Four of the 34 statewide class actions pending before Judge Dan Polster’s Multi-District Litigation have been amended with evidence pleading the causal connection between in-utero prescription opioid use and birth defects in exposed fetuses, said Lead Counsel Scott Bickford.

“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 [2]. Significance is starred * in the usual way. Odds ratios were adjusted for maternal age, race/ethnicity, education, pre-pregnancy obesity, smoking. 

“The lawsuits seek creation of a medical monitoring trust fund for these children funded by the prescription drug defendants directly, rather than relying on local governments with competing priorities,” Mr. Bickford said, illustrating the gravity of the situation by estimating that an opioid-dependent child is being born every 15 minutes in the United States.  
         
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.

Book gives a full picture of the gunman’s character from the point of view of a psychologist            
 
Author John D. Williams calls the nexus of Lee Harvey Oswald, Lyndon B. Johnson and President John F. Kennedy in the 1960s a “fatal triangle”, and in his book Lee Harvey Oswald, Lyndon Baines Johnson and the JFK Assassination, he uses his skills as a psychologist, statistician and researcher to give a fuller portrait of the men forever starring in one of America’s greatest tragedies.

Amazon.com has already rated the book its #1 seller in new releases on 1960s American History.

“The Warren Commission characterization of Lee Harvey Oswald is simply false. They hide his relationships to the CIA and the FBI. It addresses his relationship with Jack Ruby, as well as Oswald’s income, which was much greater than previously reported,” said Author Williams. “It simply paints a fuller picture of the real man that does not fit the profile of him developed by the Warren Commission, i.e. the lone gunman seeking greatness through the assassination of a President.”

This is Dr. Williams’ first book after nearly two decades of writing and publishing scholarly analyses of the JFK assassination as a Doctor of Psychology for various universities, including the University of Northern Colorado. 

“Dr. William’s book isn’t just another summary of other authors’ works but is a fresh approach to understanding the JFK assassination. This new synthesis is made possible because of the extensive interviews Professor William’s conducted with Dr. Ernst Titovets, Judyth Vary Baker, Madeleine Brown and many others,” writes Gary Severson, a JFK researcher who like Dr. Williams has spent a great deal of time tracing Oswald’s links to the mid-west, especially North Dakota. “This in-depth analysis of Lee Harvey Oswald’s pre-November 22, 1963 life gives us a very unique view of Oswald that has not previously been available in one book.”

The book will fascinate JFK assassination theorists with new details linking Oswald to critical witnesses and his New Orleans girlfriend Judyth Vary Baker, as well as new information about Oswald’s trips to Mexico. His analysis uses statistics and facts to draw conclusions in an easy and clear writing style, reflecting his college-level teaching expertise, said TrineDay Publisher Kris Millegan.

Dr. Williams will present his book which becomes available on Amazon.com on November 1 at the JFK Assassination Conference in Dallas Nov. 21-24 at the Market Center Doubletree Hotel. His presentation is Friday, Nov. 21, 8 a.m.. For more details, see: https://www.facebook.com/JFKDallasConference/; Registration information: https://www.eventbrite.com/e/the-7th-annual-jfk-assassination-conference-tickets-69381185995?aff=ebdssbeac
 
FOR DR. WILLIAMS’ PRESS INFO/INTERVIEWS: Kris Millegan (800) 556-2012
 
BOOK INFO: 
HISTORY 
336 PAGES, 6 X 9 
FORMATS: TRADE PAPER, MOBIPOCKET, EPUB 
$24.95 (US $24.95) (CA $33.95) 
ISBN 9781634242684
TRINE DAY (NOV 2019)

Author Christopher Fulton to make rare speaking appearance at the JFK Conference in Dallas on Saturday, Nov. 23, 4 pm CST, Doubletree Market Center, 2015 Market Center Blvd., Dallas; contact (800) 556-2012 for interviews

Christopher Fulton, a successful American developer in Vancouver, Canada, was labeled a threat to U.S. national security, placed on the FBI’s most wanted list, arrested, extradited, and interrogated without counsel; he was then viciously prosecuted and federally incarcerated. Christopher Fulton is the last survivor of the U.S. government’s ongoing attempt to finalize the suppression of Robert Kennedy’s unsecured evidence from JFK’s assassination, as detailed in the book, The Inheritance.

Christopher Fulton unwittingly unlocked some of the mysteries that have surrounded JFK’s life and death for more than 55 years when he acquired personal items JFK’s secretary, Evelyn Lincoln, had kept locked away for years, at the request of Robert Kennedy. These included JFK’s secret Oval Office recordings. 

These non-secured materials, including a Cartier watch JFK had on at the time of his assassination, had the ability to alter the course of U.S. politics and history, according to Mr. Fulton. Following Mrs. Lincoln’s passing and the transfer of these materials to Mr. Fulton and his subsequent meeting with JFK Jr. who had plans to acquire the evidence and expose the truth about JFK’s death, the U.S. Government intervened, and put Christopher Fulton right in the middle of the Assassination Records Review Board’s investigation under President Bill Clinton. Though promised by President Donald Trump to be released, the files related to Mr. Fulton’s experience remain sealed or missing. 
Now a free man, Christopher Fulton tells his story and how this experience has impacted his professional and family life, how being brutally attacked and incarcerated brought him face-to- face with the nation’s cruel penal system, and how a political agenda can overrule justice. While there is much discussion in the nation about a “Deep State”, Christopher believes he came up against it by accidentally, opening a hidden chapter in U.S. history. 

ABOUT CHRIS FULTON: Christopher Fulton was born in 1965, just outside Washington, D.C., into a family with rich military history. He was on his way to being accepted to the U.S. Naval Academy at Annapolis but chose a career in commercial construction. His discipline and diligence took him to the top of the high-rise construction industry in Vancouver, British Columbia, where at age 33, during the height of his success, he was extradited and spent years in federal prison for his possession of the physical evidence related to JFK’s assassination. His wife, Michelle Fulton, helped him write a memoir of the experience, called The Inheritance: Poisoned Fruit of JFK’s Assassination (Trine Day, ISBN#: 978-1-63424- 217- 2). The Fultons reside in California with their two children and rescue dogs. 
​
For more information or interviews:
Kris Millegan (800) 556-2012; ramillegan@aol.com
Julia W. Brown (619) 888-7956 

REUNION:                 Wednesday, Oct. 16, 1-3 p.m.
WHERE:                     New Orleans
                                    Historic New Orleans Williams Research Center
                                    410 Chartres St.
CONTACT:                Jeanne and Jeff Geoffray (214) 850-4584
                                    431exchange@gmail.com
MEDIA:                      Heather Harper/the Brylski Company (504) 897-6110 or
                                    (504) 289-0499; hharper@h2nola.net
 
            In December, 1965, a small vocational school known as the Adult Education Centerwelcomed an integrated class of mostly black underemployed women to begin training to become the first secretaries who would integrate the all-white businesses of New Orleans. 
            The effort caused an uproar at the time. The first pilot program was shut down after neighbors in uptown New Orleans objected to the school’s integrated student population. After the pilot program closed, the founders went looking for a new home. In the process, 60 landlords turned them down. Finally, one brave landlord, James J. Coleman, agreed to rent them a space in a series of converted bars on Exchange Place in the French Quarter. 
            During its period of operation from 1965 to 1972, the school placed 94 percent of its 431 graduates in jobs with salaries above the national average, thus making it one of the most successful programs of its kind in the War on Poverty. 
            The program was not without controversy for teaching English as a second language and for teaching African-American history and culture. The school published the first textbook on teaching English as a second language to native English speakers. It also pioneered teaching African-American makeup and hairstyles to help prepare its students for working in some of the city’s most high profile offices. Last, but not least, the school was a champion of taking a humanistic approach to vocational education. So, in addition to typing and shorthand, the students worked on writing, speaking and communication skills to help strengthen their critical powers and self-image.  
            The school was shut down a second time in 1967 for political reasons. But a group of New Orleans businessmen and leaders rallied to keep the school alive. The school was brought back to life in 1968 as a private / government partnership that was unique in its day and became a model for other such partnerships around the country. The story of the school closing and reopening was the subject of an Emmy Award winning documentary entitled, “The School That Would Not Die” written and narrated by Mel Leavitt. Eventually, the program’s success gained recognition from President Lyndon B. Johnson and a U.S. Senate committee welcomed Dr. Alice Geoffray, the school’s director, and three students to testify in Washington about the reasons why the school was so successful when so many other jobs programs in the War on Poverty failed. The late Congressman Hale Boggs, the father of Cokie Roberts, who recently passed away, was a great supporter of the school.
            Dr. Geoffray documented the successes of her students, many who went on to earn advanced degrees and become prominent New Orleans change agents. These stories are celebrated at the reunion by survivors and their families, as well as used to encourage new generations of success by the award of scholarships to local students. 
 
            See student biographies here: https://www.431exchange.com/our-stories
            Read about the center here: https://www.431exchange.com/history
​

German attorneys took a recent French court ruling against Dow and its subsidiaries to the next level this week by gaining court approval to seize nearly $ 4 billion (21.210 shares) in capital of Dow Olefinverbund GmbH in order to compensate more than 1245 former Central American plantation workers and their families for damages caused by knowing corporate use of a ‘sperm killer’ pesticide at its fruit plantations.
 
“Companies acting on an international basis should quickly learn that there are no safe places left to hide from liability for environmental and human rights incompliance,” said Berlin attorney Christoph Partsch. “The French court decision and the German exequatur decision form a formidable precedence to that end.”
 
Nicaraguan courts previously ordered compensation to these workers, which Dow claimed was unenforceable but the French courts last month agreed to hear cases of previously uncompensated workers in a Paris trial early in January, 2020. The case is about the corporate giants’ continued use of the banned pesticide in Central America well into the 1980s after it had been banned in the U.S. during the previous decade. 
 
According to Mr. Partsch, the French court of Bobigny first issued an injunction to seize the property of Dow to protect the enforcement of the Nicaraguan decision. With this French decision in hand, Dr. Partsch and his legal partner Jana-Maria Wernitzki petitioned the Merseburg court in Germany to grant exequatur pleading under the European Brussel Convention obliging European member states to recognize the legal decisions from another member states. 
 
 
The seizure allowed by the German court was served by German bailiff to Dow Olefinverbund GmbH which holds the so-called Buna complex, a giant chemical plant built in 1930s and sold by Germany to Dow for about 3 billion € in 1995. The legal move conserves and protects the options of the plaintiffs, according to the attorneys.

The multinational legal team for the plaintiffs include Berlin-based German attorneys Mr. Partsch and Ms. Wernitzki, French Supreme Court Attorney Francois-Henri Briard, former Chair of the Paris Bar Attorney Pierre-Olivier SUR, Nicaraguan Attorneys Tony Lopez and Gustavo Lopez Jr., and internationally-known environmental American Lawyers Stuart H. Smith and Robert McKee.
 
“Finally, these plantation workers will collect damages from Dow and its subsidiaries,” said Mr. Smith. “These companies knowingly poisoned people and then left without any penalty, knowing these workers would be denied a normal family life.” Mr. Smith also called attention to the fact that Dow has hidden a multibillion-dollar liability from its stockholders and the U.S. Securities and Exchange Commission, since the Nicaraguan Courts ordered a $805 million payout, which the companies continue to ignore.
 
Mr. Briard said, “Our German colleagues did a fantastic job; it is clear that brave European Judges, French and German, are now on the way to provide justice to these men and women of Nicaragua poisoned by American companies. One should not be surprised that in a world where companies act globally victims do cross borders. I am confident that we will get French Trial Court exequatur with provisional execution very soon; with seizures done, especially the German one, we will be able to sale shares in good conditions for our clients.”