The Opioid Epidemic and State Courts – Why some aren’t filing into Opiate MDL 2804

Florida, Texas, Nevada, North Carolina, North Dakota, Oklahoma, Tennessee, Massachusetts and others have started  their own Opioid Litigation in state courts across the country

By Mark A. York (December 10, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Opioid abuse has been steadily increasing in the United States, and now state courts are becoming the legal venue of choice for filing lawsuits against the “opioid industry” and there may be a need for partnerships with other organizations to confront this epidemic. Lawsuits have already been filed in federal courts and by 22 U.S. states and Puerto Rico against Opiate Big Pharma. 

For a look at the Federal Opiate Litigation MDL 2804 see “OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION” where states, counties, cities, indian tribes as well as unions, hospitals and individuals have filed more than 1000 lawsuits against the opioid industry as a whole.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

A NEW INFANT NAS MDL 2872

Kevin Thompson of the Opioid Justice Team, has filed a motion for a new prescription opiate related multidistrict litigation, which was heard in front of the JPML panel on November 28, 2018 in New York City, where the panel was requested to designate MDL No. 2872 (INFANTS BORN OPIOID-DEPENDENT PRODUCTS LIABILITY LITIGATION) as a new and separate litigation focused on infants born addicted to opiates and suffering from what’s commonly knows as Neonatal Abstinence Syndrome (NAS) and numerous other long-term medical issues.

The current Opiate MDL 2804 is not moving litigation related to individuals forward in any way. Thompson’s team is requesting that the infant cases be carved out from the sprawling lawsuit in Cleveland and transferred to a federal judge in West Virginia, one of the hardest hit states where roughly 5 percent of all babies are born dependent on opioids. The overall Infant NAS MDL 2872 docket can be viewed here MDL 2872 Infant NAS Re-infants-born-opioid-dependent-products-liability-litigation docket.

The misuse of opioids starting with the flood of prescription pain medicines, which has cast a wide net to now include heroin, fentanyl, morphine, and other drugs both legal and illegal is a serious national problem. In 2015 one in ten Americans reported using an illicit drug in the past 30 days.[1] Marijuana use and the misuse of prescription pain relievers account for the majority of illicit drug use. Of the 21.5 million Americans 12 or older who had a substance-use disorder in 2014, 1.9 million had a substance-use disorder involving prescription pain relievers, and 586,000 had a substance-use disorder involving heroin.[2]

 

Widespread use of opioids has had a devastating impact on many communities. In 2014, more people died from drug overdoses than in any year on record, with 78 Americans dying every day from an opioid overdose. Drug overdose now surpasses motor-vehicle crashes as the leading cause of injury death in the United States. Most opioid-related overdoses involve prescription painkillers, but a growing number are the result of a powerful combination of heroin and fentanyl, a synthetic opioid often packaged and sold as heroin. Some of the largest concentrations of overdose deaths were in Appalachia and the Southwest, according to county-level estimates by the Centers for Disease Control and Prevention.[3]

One contributing factor behind the opioid epidemic is the increase in the use of prescription painkillers nationally. From 1991 to 2011, the number of opioid prescriptions dispensed by U.S. pharmacies tripled from 76 million to 219 million.[4] This increase in the use of opioids is unique to America. The United States represents less than 5 percent of the world’s population but consumes roughly 80 percent of the world’s supply of opioid drugs.[5] There is also wide variation from one state to another in opioid-prescribing rates. In 2012 twelve states had more opioid prescriptions than people: Alabama (142.9 per 100 people), Tennessee (142.8), West Virginia (137.6), Kentucky (128.4), Oklahoma (127.8), Mississippi (120.3), Louisiana (118), Arkansas (115.8), Indiana (109.1), Michigan (107), South Carolina (101.8), and Ohio (100.1).[6]

The impact of the opioid epidemic touches every aspect of our public safety and judicial system. Drug-related arrests involving opioids are skyrocketing. In many communities, court dockets and probation caseloads are filled with individuals with opioid-use disorders. Access to treatment, particularly medication-assisted treatment combined with cognitive behavioral interventions, is limited—particularly in rural communities. This epidemic also comes at a price. In 2015 the Ohio Department of Mental Health and Addiction Services began providing substance-abuse treatment in Ohio’s prisons, spending an estimated $30 million per year on drug treatment in prisons, $4 million on housing for individuals in recovery, and $1 million over two years for naloxone to reverse drug overdoses. The Ohio State Highway Patrol spent over $2 million to expand and improve their crime lab to keep up with substance testing.

In addition to the impact of opioid abuse on the criminal courts, the nation’s family courts and child welfare system are being deeply impacted. A recent report by the Administration for Children and Families shows that after years of decline, the number of children in foster care is rising. Nearly three-quarters of all states reported an increase in the number of children entering foster care from 2014 to 2015. The largest increases occurred in Florida, Indiana, Georgia, Arizona, and Minnesota. From 2012 to 2016, the percentage of removals nationally due to parental substance abuse increased 13 percent to 32.2 percent.

In addition to hundreds of cases consolidated in federal court in Opiate MDL 2804, the defendants face a wave of litigation in state courts as well as civil and criminal investigations by numerous state attorneys general and the federal government. Any settlement would have to protect the defendant companies from future lawsuits over the same issue and that may be difficult to negotiate given all the concurrent litigation in different courts.

The primary federal litigation involving many cities and counties was consolidated by the JPML in December 2017 in a federal court in Cleveland, Ohio, in front of Judge Daniel Polster. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

The judiciary can play a critical role in addressing the opioid epidemic. In August 2016, representatives from the Kentucky, Illinois, Indiana, Michigan, Ohio, Pennsylvania, Tennessee, Virginia, and West Virginia courts convened for the first-ever Regional Judicial Opioid (RJOI) Summit. The judicial summit brought together multidisciplinary delegates from each state to develop a regional action plan and consider regional strategies to combat the opioid epidemic. RJOI member states continue to work both within their home states and regionally to share promising practices, as well as to implement the objectives of the regional action plan. Courts are encouraged to work with partners in similar ways to:

  • Invest in local, state, and regional multidisciplinary, system-level strategic planning to identify policies or practice changes that can improve treatment engagement and reduce the risk of overdose death. Judges are particularly effective at using their convening power to bring together a variety of agencies and community stakeholders. The sequential intercept model is an effective approach to identifying gaps and opportunities for diverting criminal-justice-involved people to treatment. Communities are encouraged to not focus singularly on heroin use but to focus on substance-use disorders in general. A recent CDC study found that nearly all people who used heroin also used at least one other drug; most used at least three other drugs.[7]
  • Implement law-enforcement diversion programs, prosecutor diversion programs, or both to deflect or divert individuals with substance-use disorders from the criminal justice system into treatment at the earliest possible point.
  • Expand court diversion and sentencing options that provide substance-abuse treatment as an alternative to incarceration. Problem-solving courts, such as adult drug courts or veterans treatment courts, are the most notable examples of effective approaches.  
  • Incorporate strategic screening questions designed to identify criminal-justice-involved individuals at high-risk for overdose death into all criminal-justice-agency intake forms. Specifically, research suggests that individuals with a history of non-fatal overdoses, individuals with a history of opioids in combination with benzodiazepines like Xanax (alprazolam) and Soma (Carisoprodol), and individuals with an opioid-use disorder recently released from a confined environment (e.g., residential treatment or incarceration) are at particular risk for overdose death. This population should be prioritized for treatment and overdose-prevention services, such as naloxone access.

On January 24, 2017, the Bureau of Justice Assistance released funding for a “Comprehensive Opioid Abuse Program.” Through this solicitation, courts and their partners may implement overdose outreach projects, technology-assisted treatment programs, and diversion and alternatives to incarceration.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

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[1] Center for Behavioral Health Statistics and Quality, “Key Substance Use and Mental Health Indicators in the United States: Results from the 2015 National Survey on Drug Use and Health” (HHS Publication No. SMA 16-4984, NSDUH Series H-51), report prepared for the Substance Abuse and Mental Health Services Administration, Rockville, Maryland, 2016. Retrieved from http://www.samhsa.gov/data/.

[2] Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health (Rockville, MD: Substance Abuse and Mental Health Services Administration, 2015).

[3] L. M. Rossen, B. Bastian, M. Warner, D. Khan, and Y. Chong, “Drug Poisoning Mortality: United States, 1999–2014,” National Center for Health Statistics, 2016.

[4] National Institute on Drug Abuse, “Prescription Opioids and Heroin,” Research Report Series, Department of Health and Human Services, National Institutes of Health, Washington, D.C., 2015. Retrieved from https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/rx_and_heroin_rrs_layout_final.pdf.

[5] L. Manchikanti and A. Singh, “Therapeutic Opioids: A Ten-Year Perspective on the Complexities and Complications of Escalating Use, Abuse, and Nonmedical Use of Opioids,” Pain Physician 11, 2nd supp. (2008): S63-S88.

[6] L. J. Paulozzi, K. A. Mack, and J. M. Hockenberry, “Vital Signs: Variation Among States in Prescribing Pain Relievers and Benzodiazepines—United States,” Center for Disease Control and Prevention, Atlanta, 2014.

[7] National Survey on Drug Use and Health, 2011-2013.

 

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A New Opiate MDL Was Requested For Benefit of Opioid Addicted Babies On September 20, 2018

THE JPML HAS BEEN REQUESTED TO CONSOLIDATE A NEW ADDICTED INFANT MULTIDISTRICT LITIGATION

By Mark A. York (September 21, 2018)

 

 

 

 

 

 

 

 

 

Have the most vunerable plaintiffs in the opiate litigation been underserved by firms primarily focused on representing governmental entities in Opiate MDL 2804 and state court consolidations? What about the epidemic of NAS affected babies who have been born addicted to prescription opiates?

Link to Mass Tort Nexus Briefcase Re: OPIOIDS-Children-Born-Opioid-Dependent-(NAS)-JPML-MDL-(PENDING)

(MASS TORT NEXUS MEDIA) Lawyers representing addicted infants in the opiate litigation have now filed a Motion for Transfer and Consolidation of Children Born Opioid Dependent with the JPML on September 21, 2018. To read the entire JPML Motion and Brief in Support, see our briefcase Re: masstortnexus.com/News/4335/Motion-for-New-Infant-NAS-Opioid-Dependant-MDL-Filed-With-JPML-September-20-2018.

Plaintiffs lawyers have also filed class actions in nine states on behalf of infants, and other “individuals” affected by opiate use and subsequent addiction, with very limited input into the federal litigation process. On May 21, 2018 a coalition of nine law firms filed court papers asking MDL 2804 Judge Dan Polster (USDC ND Ohio) for permission to request a separate discovery and litigation track for the baby cases, which was summarily denied without comment by the court on June 28, 2018.

Lawyers and public health officials have estimated that there could be more than 1 million babies diagnosed with “neonatal abstinence syndrome,” which occurs when infants are born to mothers who used opioids. There is a request seeking a trust of more than $1 billion to help pay for medical monitoring of the children over the next few decades.

“There has been no large-scale attempt to find out what happens to these children, and there are thousands at this time, perhaps over 1 million, progressing now through the school system and growing up,” said Scott Bickford, a principal at Martzell, Bickford & Centola in New Orleans. “Theoretically, these kids are born addicted and may stay addicts for life.”

Treatment and Prognosis for Opioid Addicted Newborns

The course of treatment will be determined by factors such as:

  • Baby’s gestational age, medical history, and health
  • Severity of the disorder and expectation of the effects it will have
  • Baby’s tolerance of the therapies, procedures, or medications
  • Parents’ preference

Immediate treatment for withdrawal effects focuses on comfort and thriving. Babies suffering from opioid withdrawal often have trouble resting and eating, so treatment involves:

  • Swaddling for comfort
  • Adding extra calories to account for energy used through restlessness and increased activity
  • Intravenous fluids for dehydration
  • Medication to relieve discomfort and eliminate symptoms like seizures

Long-term treatment involves treating physical and behavioral effects and can involve:

  • Monitoring and treating vision and hearing impairments
  • Therapy for behavioral problems
  • Language therapy
  • Treatment for chronic ear infections
  • Interventions for cognitive deficits
  • Treatment for sleep disturbance

Babies are the latest segment of the opioid epidemic to attempt to get a front-row seat in the legal case against manufacturers and distributors. More than 1,000 lawsuits have been coordinated in multidistrict litigation in Cleveland before U.S. District Judge Dan Polster of the Northern District of Ohio, who has allowed a limited amount of discovery to go forward, (see Mass Tort Nexus Briefcase OPIOID-National-Prescription-Litigation-MDL-2804-USDC-Northern-District-of-Ohio) for case docket information.

The vast majority of plaintiffs are cities and counties seeking to recoup the costs of medical treatment and law enforcement, but Native American tribes, hospitals and others have elbowed into the case. New plaintiffs are emerging, such as class actions—including eight filed this week—filed on behalf of individuals alleging the opioid epidemic caused their health insurance premiums to skyrocket.

At least 11 cases have been brought on behalf of babies, many of whom suffer from addiction and learning disabilities. Bickford said the cases are in states that have medical monitoring laws, which include New York and California. According to the case filed in New York Supreme Court for Niagara County, for instance, lifetime medical costs could include treatment of developmental, psychiatric, emotional or behavioral disorders associated with addiction.

THIS IS A MUCH BIGGER PROBLEM

Dr. Shawn Hollinger, neonatologist at Niswonger Children’s Hospital, cradled baby Jayden’s head in an effort to comfort him. After 35 days in the neonatal intensive care unit, Jayden was ready to go home.

The number of children needing intensive treatment for NAS has become so overwhelming that the hospital opened a new ward this year just to care for them. Since 2009, hospital staff have treated over 1,800 babies with NAS. In the past 12 months, Hollinger has seen 351 infants with NAS come through the NICU.

After birth, children exposed to drugs in the womb experience a multitude of symptoms, including tremors and seizures. Even after being released from the hospital, some children may still have to be treated with medication and physical therapy. It can cost upwards of $60,000 to treat one baby.

“The intent would be to construct a trust that would deliver financial assistance directly to the custodians of these children,” he said. Custodians could include other family members, foster parents or birth parents who have kicked the habit, he said.

The defendants in all the baby cases include opioid manufacturers Purdue Pharma, Johnson & Johnson, Endo Health Solutions and Teva Pharmaceuticals, as well as distributors McKesson Corp., AmerisourceBergen Corp. and Cardinal Health Inc. The New York complaint also named Insys Therapeutics Inc.

Johnson & Johnson spokeswoman Wanda Moebius wrote in an email: “Our actions in the marketing and promotion of these medicines were appropriate and responsible. The labels for our prescription opioid pain medicines provide information about their risks and benefits, and the allegations made against our company are baseless and unsubstantiated. In fact, our medications have some of the lowest rates of abuse among this class of medications.”

Endo spokeswoman Heather Zoumas Lubeski said, “We deny the allegations contained in these lawsuits and intend to vigorously defend the company.”

Representatives of the other defendants either did not respond or declined to comment.

It’s not the first time the coalition of law firms tried to get Polster to create a separate “baby track.” On June 28, the judge denied an earlier request.

“We’ve asked the court to reconsider our motion for a separate baby track for babies with neonatal abstinence syndrome,” Bickford said. “We don’t think the present MDL and the people in it who essentially represent state and local governments really have the children’s interests at heart.”

The plaintiffs’ executive committee in charge of the opioid MDL has refused to provide information about discovery and depositions, he said. His request described the discovery process as operating under a “cloak of secrecy” and included an attached email exchange in which executive committee member Jayne Conroy of Simmons Hanly Conroy called his request to monitor depositions “not necessary” and “burdensome.”

Conroy said in a statement: “All our legal efforts are directed at the companies who caused the opioid epidemic.  Any success will benefit all victims.”

Earlier this summer, the Judge charged with control over the federal MDL involving government entities’ claims against opioid manufacturers and distributors rejected a request for the inclusion of NAS baby cases within a special litigation track. The request would create a nationwide medical monitoring trust fund for NAS babies within the existing MDL litigation regarding prescription opioid

On May 31, 2018 counsel for the baby/NAS addicted plaintiffs filed a Motion for Leave to Establish a Separate Track for Opioid Baby Claims, with the court denying the request via text order entry below.

06/28/2018 Order [non-document] denying Motion for leave to File Motion for Order to Establish Separate Track for Opioid Baby Claims filed by Melissa Ambrosio, Darren Flanagan, Elena Flanagan, Ceonda Rees, Deric Rees, Virginia Salmons, Walter Salmons, Roxie Whitley, Rache l Wood(Related Doc # 540 ). Judge Dan Aaron Polster (MDL 2804) on 6/28/18.(P,R) (Entered: 06
Court Response to Previous Attempt to Get a Baby Track in Opiate MDL 2804

 Tens of thousands of infants born in the U.S. each year now have NAS, and a recent Centers for Disease Control report said the rate of NAS deliveries at hospitals quadrupled during the past 15 years.

The period of hospitalization for NAS infants averages 16 days and hospital costs for a typical newborn with NAS are $159,000$238,000 greater than those of healthy newborns, according to the attorneys representing the NAS babies.

Dr. Kanwaljeet J. S. “Sunny” Anand, the nation’s foremost expert on opioids in infants and a Professor of Pediatrics, Anesthesiology, Perioperative & Pain Medicine at Stanford University School of Medicine, is a medical expert to the legal team. “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 NAS, but arrangements for their short-term and long-term care have been ignored until now. These babies need strong advocacy and legal action to ensure that their rights are protected, and that they urgently receive essential medical care and rehabilitation. On average, one infant with NAS is hospitalized every hour in the U.S.”

Named as defendants in the class actions are an array of pharmaceutical manufacturers, distributors and retailers, all of whom netted billions of dollars due to unfair and deceptive trade practices that preyed on all Americans, including the unborn, say the attorneys.

“A medical monitoring fund would document and address the medical problems these children will have to face for a lifetime,” said Mr. Bickford. The filing today objects to current settlement negotiations engaged by the opioid MDL which ignore the NAS babies’ interests.

“Legal precedent recognizes the difference between present and future claims in negotiations of this magnitude,” said Mr. Bickford. “Without being at the table, the legal representatives of NAS babies and children will not be heard and the due process rights of these infants and children will be denied.”

The filing says only government, hospital and third-party payors are at the table in negotiating a settlement through the MDL, though no agreement has yet been reached. The attorneys representing the NAS babies have raised concerns that outcomes similar to the Tobacco MDL settlement, where money was diverted to state budget deficits instead of the intended victims, might happen here.

 Born to women addicted to drugs, newborns suffer through withdrawal

Babies suffering through opioid withdrawal have a distinct way of crying: a short, anguished, high-pitched wail, repeated over and over. It echoes through the neonatal therapeutic unit of Cabell Huntington Hospital in Huntington, West Virginia. A week-old girl has been at it, inconsolably, since six o’clock this morning. At 10 o’clock Sara Murray, the unit’s soft-spoken, no-nonsense nurse manager, sighs. “This may be a frustrating day,” she says.

The opioid epidemic in the United States is painfully evident in hospital newborn units across the country. In 2012 nearly 22,000 babies were born drug dependent, one every 25 minutes, according to the most recent federal data. As the opioid crisis has escalated dramatically over the past five years, those numbers have surely climbed.

West Virginia, at two and a half times the national average, has the highest rate of deaths from drug overdose—mostly from opioids. Cabell County, which averaged about 130 overdose calls to 911 annually until 2012, received 1,476 calls last year and is on pace to reach around 2,000 this year. Emergency workers saved many of those people, including an 11-year-old, but inpatient treatment programs have long waiting lists. At Cabell Huntington Hospital, one in five newborns has been exposed to opioids in the womb.

“What you’re seeing here is the tip of the iceberg of substance use,” says neonatologist Sean Loudin, the unit’s medical director.

In 2012 the neonatal intensive care unit became so overwhelmed by drug-dependent babies that it had to turn away newborns with other medical needs. The hospital opened this specialized unit to treat withdrawal. It typically has 18 babies. On this day there are 23.

The babies shake, sweat, vomit, and hold their bodies stiff as planks. They eat and sleep fitfully. Swaddled, they lie in bassinets or in the arms of nurses, parents, or volunteers. The place doesn’t have the hustle or beeping machinery of an ICU. Instead there are dim lights and hushed conversations because the babies need calm and quiet. Many also need methadone or other medication to relieve their symptoms. They are weaned from it over days or weeks.

“OK,” Murray whispers to a bleating 41-day-old boy. She gently lifts him to her chest, cradles him firmly, and places a green pacifier in his mouth. He sucks it fast and hard, like a piston.

Opioids pass readily from a pregnant woman’s bloodstream through the placenta and across the fetal blood-brain barrier. When birth abruptly shuts down the flow of the drug, the baby’s nervous system can trigger the agitating symptoms of withdrawal. Studies show that 55 percent to 94 percent of newborns exposed to opioids develop symptoms. Prenatal exposure to other widely used drugs, including benzodiazepines and certain antidepressants, also can lead to withdrawal shortly after birth.

The condition is called neonatal abstinence syndrome (NAS). Experts don’t consider it to be addiction, which, by definition, means a person persists in compulsive drug use despite terrible consequences. By the same logic, NAS is also a misnomer—abstaining, or just saying no, is different from experiencing the physical anguish of withdrawal. But medical experts have come to accept the NAS label because it’s less fraught with stigma than words like “addiction” and “withdrawal.”

In some cases the mothers themselves are in recovery. They didn’t misuse opioids during pregnancy but took methadone or buprenorphine, the frontline medications for treating opioid addiction. The American Congress of Obstetricians and Gynecologists recommends their use during pregnancy despite the risk of NAS, for the obvious reason that sobriety is safer and healthier for a woman than shooting heroin or popping painkillers or trying to go cold turkey on her own. It’s also much better for her child. But encouraging as it is, the growing use of medication-assisted addiction treatment means that even when the opioid crisis eases, hospitals like Cabell Huntington will continue to be swamped with babies in withdrawal.

To manage the condition, most hospitals use an assessment tool developed at the height of the heroin outbreak in the 1970s. Babies are rated every four hours on the severity of 31 symptoms, including excessive crying, sweating, tremors, and frequent yawning. The scores help doctors determine whether to put babies on methadone or other medication. In most cases the scores support drug therapy. Now some researchers are challenging that approach.

“It’s archaic,” says Elisha Wachman, a neonatologist at Boston Medical Center and an assistant professor of pediatrics at Boston University School of Medicine. “What ends up happening is that babies get overmedicated.” Too often, she says, they experience withdrawal from their treatment, which prolongs their misery and their hospital stay.

A handful of researchers around the country are revamping NAS treatment to rely less on medication and more on parental bonding. Wachman has abandoned the old score sheet for assessing the babies. “I couldn’t care less how many times they yawn,” she says. Instead, she evaluates them on just three measures: eating, sleeping, and being consoled. Rather than transfer babies to an ICU or a specialty unit, Boston Medical Center keeps them with their moms throughout their stay. Wachman encourages the women to breastfeed and clutch their babies skin to skin. One hundred fifty volunteers—most of them medical students and hospital employees—put in two-hour shifts as cuddlers. The waiting list to hold babies has 200 names.

Before the hospital changed its approach, 86 percent of the babies with NAS it treated received medication. Now it’s 30 percent. The babies generally spend nine days in the hospital, down from 19 days under the old protocol. The average cost of a hospital stay for a baby with NAS is $19,655 at Boston Medical Center, compared to a national average of $67,000.

Wachman says sound treatment for the babies must go hand in hand with compassionate, comprehensive care for their mothers. The medical center runs a prenatal clinic for women with addiction. The obstetricians prescribe buprenorphine and prepare women for the possibility that their babies will have NAS. The clinic also offers counseling, social services, psychiatric help, peer support, and education about infant care. “When the moms come in to deliver, they’re in the best shape they can be,” Wachman says. In July the medical center opened a clinic that provides pediatric care for babies born with NAS and addiction services for their mothers.

It’s not clear how opioid exposure affects long-term brain development. Surprisingly little research has been done, and most of it predates the current crisis and the widespread use of highly potent synthetics, such as fentanyl. Some studies show subtle cognitive and behavioral differences among children who were exposed to opioids before birth, but the problems are less severe than the intellectual and attention deficits associated with fetal alcohol exposure. The studies don’t answer a key question: Do the neurodevelopment issues stem from drug exposure or poverty or other chronic stresses? Some researchers believe that social factors and a stable environment are bigger influences on a child’s future than NAS.

“We keep hearing about the babies, and that it is important, but there needs to be much more of a focus on women and making sure they’re taken care of well,” says Uma Reddy, a maternal-fetal medicine expert at the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

Mass Tort Nexus will provide updates on the Infant NAS MDL request to the JPML as well the Opiate Prescription MDL 2804 on a daily basis.

For the most up to date information on all MDL dockets and related mass torts visit www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.

To obtain our free newsletters that contain real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

 

 

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Has California Rules Change In Novartis AG Litigation Changed Lawsuits Over Generic Drug Injuries?

Will Big Pharma Change Labeling Today-If They Have To Pay Tomorrow?

By Mark York (August 15, 2018)

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media) In December of 2017, California’s Supreme court ruled that consumers are now able to file lawsuits against Novartis AG and other makers of brand-name pharmaceutical products over injuries blamed on generic versions of the drugs manufactured by other companies.

The California Court’s ruling broke with the recent legal leanings nationally to the contrary and created potentially massive exposure for brand-name drugmakers who could be sued in the state for failing to warn users about the risks of cheaper, generic versions of their drugs. This has generally been an area of law that name brand drugmakers have been excluded from and now it seems that the litigation flood gates may open wide, at least in the State of California.

Generic Drug Opinion in T.H. (a Minor) vs. Novartis-Pharmaceuticals (California S.Ct. December 2017)

Leslie Brueckner, the plaintiffs’ lawyer, said this decision was the only current one where a state’s top court ruled in favor of consumers who were prescribed generic drugs, and have legally been prevented from filing suit against generic drugmakers for not warning about their products’ risks.

“This is just a huge victory for public health and safety, and this victory will be felt nationwide,” she said.

Novartis, whose appeal had the support of industry groups including the U.S. Chamber of Commerce, said it disagrees with the court’s decision to potentially hold it responsible for an injury caused by a different company’s product. This has been the primary defense of Big Pharma when defending themselves, from legal claims against generic makers of the products that Big Pharma brought to the marketplace originally, Big Pharma has had a get out of jail free card in play for years.  In many medical circles the view is, generics are based on the formula and R&D developed by Big Pharma labs, so why shouldn’t they be held responsible for their pharmaceutical progeny, which they created.

The decision came in a lawsuit centered on two twin children who were diagnosed with developmental delays and autism after their mother while pregnant took a generic version of Brethine to suppress premature labor. This may open a floodgate of litigation in many other states where the same medical issues are considered to be caused by Novartis designed drugs.

MASSACHUSETTS SUPREME COURT JOINS CALIFORNIA

Federal law prevents people injured by generic drugs from suing generic drugmakers, but in another recent court ruling plaintiffs injured by generic drugs can sue makers of the brand-name versions.

The rulings apply to people harmed by generic drugs in Massachusetts and California. Brand-name drugmakers may be liable for injuries caused by generic drugs they did not manufacture or sell.

Generic drugs can cause the same side effects as the brand-name drugs they’re copying. Generic drugs must carry the same label as the brand-name versions. Only makers of brand-name drugs may add warnings to drug labels without approval from the FDA.

The U.S. Supreme Court says courts may not order generic drugmakers to violate the law by changing their labels. So, federal law bars lawsuits that accuse generic drugmakers of failing to warn of dangerous side effects, based on preemption.

Now two state supreme courts said brand-name drugmakers may be responsible for problems caused by generic drug labels. They ruled to allow people harmed by generic drugs in the two states to sue the brand-name companies.

The latest ruling came March 16, 2018, from the Massachusetts Supreme Court. The case involved a generic version of Merck’s drug Proscar.

The court ruled patients who take generics may sue brand-name drugmakers when they intentionally fail to warn of dangers. Patients can also sue if a maker of a brand-name drug fails to warn when it should have known of serious danger. Lawsuits can’t just claim negligence, a lesser standard, the court said.

The Massachusetts ruling comes just three months after the December 2017 California Supreme Court ruling, which involved the Novartis drug Brethine.

In 2007, a pregnant woman with twins, who is unnamed in the lawsuit, was prescribed the generic version of the drug Terbutaline in order to prevent premature labor. Although Terbutaline is an asthma medication, it has been used “off-label” in order to prevent premature births. She claims that it caused the two children to suffer brain injuries that led to developmental problems, including autism.

Terbutaline was sold by the pharmaceutical company, Novartis, under the name Brethine until it sold the rights to the drug in 2001. Studies from as far back as the 1970s have shown that Terbutaline should not be used by pregnant women, but the Plaintiff’s alleged that Novartis shucked all responsibility for the children’s injuries during the trial by stating that it could do nothing about the warnings on the generic-product’s label.

Currently, generic-drug’s labels must only match the brand-name’s. The court’s decision further states that the brand-name manufacturer is still liable for discrepancies between its label and the generic’s, even if the brand-name drug has stopped being manufactured. Generic medication manufacturers cannot change the warning labels on the drugs they produce without approval from either the FDA or current generic manufacturer.

The generic-drug manufacturer, however, is still liable for injuries if they purposefully change the label from that of the brand-name counterpart, if there is an issue in the manufacturing process, and if the generic manufacturer suggests a use different from that of its FDA approved functions.

Will these rulings have large implications for the pharmaceutical industry since the ruling was so close, and it deviated from decades of precedent. It is possible that if other state courts rule with the same mindset as the California Supreme Courts, they will pressure the US Supreme Court into reviewing the existing federal regulations.

Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels.

The father of the children, referred to in court papers as T.H. and C.H., instead sued Novartis, which made Brethine until 2001, and aaiPharma Inc, which bought the rights to it in 2007 while their mother was taking the generic version.

Novartis argued its duty to warn consumers did not cover those taking generics and that a contrary ruling would effectively make it the market’s insurer. Even though the genric maker uses the drug warning label developed and approved by Novartis.

The court disagreed. Justice Mariano-Florentino Cuéllar wrote that brand-name manufacturers are the only entities with the ability to strengthen a warning label. This seems correct since generic makers have zero ability to add warnings or change the label of a drug based on existing law. Perhaps now the long term view of Big Pharma and drug labelling may change if more states are holding them accountable tomorrow for their lack of ethical drug labelling conduct today.

“So a duty of care on behalf of all those who consume the brand-name drug or its bioequivalent ensures that the brand-name manufacturer has sufficient incentive to prevent a known or reasonably knowable harm,” Judge Cuéllar wrote.

The court also held 4-3 that Novartis could be sued despite divesting itself of Brethine because its failure to update the warning label before the sale could foreseeably cause the children harm.

The case is T.H. v. Novartis Pharmaceuticals Corporation, California Supreme Court, No. S233898

IN THE SUPREME COURT OF CALIFORNIA

(Dec. 21, 2017 Opinion Excerpt)

III. CONCLUSION

We do not doubt the wisdom of crowds in some settings. But the value of an

idea conveyed by or through a crowd depends not on how loudly it is proclaimed or

how often it is repeated, but on its underlying merit relative to the specific issue at hand.

Despite the impressive case authority Novartis has collected on its behalf,

none of it purports to interpret California law. Yet it is California law that we must construe

and apply in this case. In doing so, we find that brand-name drug manufacturers have a

duty to use ordinary care in warning about the safety risks of their drugs, regardless of

whether the injured party (in reliance on the brand-name manufacturer’s warning) was

dispensed the brand-name or generic version of the drug. We also conclude that a brand-

name manufacturer’s sale of the rights to a drug does not, as a matter of law,

terminate its liability for injuries foreseeably and proximately caused by

deficiencies present in the warning label prior to the sale.

We therefore affirm the Court of Appeal.

CUÉLLAR, J.

 

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HOW CAN WE SOLVE THE OPIOID CRISIS STARTING NOW? With An Opioid Crisis Summit Like No Other

A Definitive Opioid Crisis Solutions Event

By Mark A. York (May 29, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) It’s been called the most perilous drug crisis ever in the United States, the epicenter of the opioid epidemic, overdose deaths have quadrupled since 1999, killing more than 100 people every day. Pharmaceutical opiate pain relief is an essential clinical tool, but with physicians writing over 240 million opioid prescriptions to Americans every year, the potential for catastrophe is enormous. Now it seems to be coming into realization that the opioid crisis is here and the damage is catastrophic, gauged against the devastating impact on families and communities across the United States.  How can we get the message out that addiction is now  recognized as a medical, not a criminal problem, and new treatments are on the horizon. How do we protect the population from misusing opioids? An Opioid Crisis Summit featuring national leaders who are involved in the day to day efforts to fight this opiate crisis on all levels, including Ohio Lieutenant Governor Mary Taylor, Dr. Rahul Gupta, West Virginia Director of Public Health and others who are involved in providing real time solutions to the opiate epidemic as well as treating physicians and legal professionals who are active in offering solutions.

The Definitive Opioid Crisis Summit For All of America:

July 21-22, 2018

www.opioidcrisissummit.com

OPIOD CRISIS SUMMIT

By Mass Tort Nexus

Fort Lauderdale, FL

 How did the opioid crisis happen?

In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive. Opioid overdose rates began to increase. In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.1That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder (not mutually exclusive).

 What do we know about the opioid crisis?

  • Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.
  • Between 8 and 12 percent develop an opioid use disorder.
  • An estimated 4 to 6 percent who misuse prescription opioids transition to heroin.
  • About 80 percent of people who use heroin first misused prescription opioids.
  • Opioid overdoses increased 30 percent from July 2016 through September 2017 in 52 areas in 45 states.
  • The Midwestern region saw opioid overdoses increase 70 percent from July 2016 through September 2017.
  • Opioid overdoses in large cities increase by 54 percent in 16 states.

Quarterly rate of suspected opioid overdose, by US region
Source: Centers for Disease Control and Prevention.

This issue has become a public health crisis with devastating consequences including increases in opioid misuse and related overdoses, as well as the rising incidence of neonatal abstinence syndrome due to opioid use and misuse during pregnancy. The increase in injection drug use has also contributed to the spread of infectious diseases including HIV and hepatitis C. As seen throughout the history of medicine, science can be an important part of the solution in resolving such a public health crisis.

 The Opioid Crisis Summit Agenda

An unprecedented group of elected officials, political and medical experts, and academic leaders from around the country are set to examine the crisis and offer insight and solutions.

On July 21-22, 2018, the definitive Opioid Crisis Summit presented by Mass Tort Nexus will convene a symposium to present a firsthand account as to the depth and severity of the crisis. The research team at Mass Tort Nexus has brought together influential speakers including the Lieutenant Governor of Ohio, Mary Taylor; State Attorney for Palm Beach County Florida, Dave Aronberg, Esq.; Director of Public Health, State of West Virginia, Rahul Gupta, MD; Executive Director, Novus Medical Detox Centers, Kent Runyon; The Amy Winehouse Project Addiction Recovery Center, Susan Anderson and Blades Williamson; Opioid Crisis Advocate, Stephen Gelfand, MD and Opioid Crisis Expert, John Ray.  These speakers are coming together to give our attendees a firsthand look at just how dramatic the impact of the opioid crisis is within our communities.

Summit attendees including attorneys, elected officials and healthcare officials will be giving specific information regarding the legal aspects of the Opioid Crisis as well. This relates to the Opiate Prescription MDL 2804, where hundreds of counties, states and cities across the country have filed lawsuits against the opiate pharmaceutical industry as a whole. This includes key MDL 2804 leadership counsel who will discuss signing of both entity and individual cases, regarding case criteria, damage models and estimated timeframes for settlement. See MDL 2804 Opiate Prescription Litigation US District Court of Ohio, for the National Prescription Opiate Litigation docket information.

This level of professional expertise and real time awareness of the issues regarding the opioid crisis in the United States has never been assembled on a scale such as this and if you are wanting to get the most critical and complete information, please contact someone at Mass Tort Nexus before all seats are taken.

Media Contact: media@masstortnexus.com 954.870.7323, Mark A. York

Event Contact:

Barbara Capasso

Jenny Levine

954.530.9892

barbara@masstortnexus.com

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Johnson & Johnson Liable For Talc Mesothelioma Verdict Of $21.7 Million In Actual And $4 Million In Punitive Damages

Will Industrial Talc Litigation Become Another Asbestos? The Litigation Is Moving That Way!

By Mark A. York (May 24, 2018)

 

 

 

 

 

 

 

 

Is Industrial Talc Litigation The Next Major Mass Tort?

(MASS TORT NEXUS MEDIA) Johnson & Johnson lost another talcum powder cancer trial, when a California jury awarded $4 million in punitive damages on top of $21.7 million in compensatory damages on Wednesday May 23, 2018 to Joanne Anderson and her husband, Ms. Anderson is a 68-year-old woman who sued J&J alleging that he cancer was caused by asbestos in the company’s baby powder. The case is Anderson v. Borg Warner Corp., BC 666513, California Superior Court, Los Angeles County (West Covina).

The jury found that J&J (JNJ.N), was 67 percent responsible for her mesothelioma, a cancer linked to asbestos exposure. Anderson’s lawyers said she was exposed to baby powder laced with the carcinogen when she used it on her children and while bowling.

The verdict against J&J was linked to company documents produced in the trial, “When jurors are given the opportunity to see internal documents and conduct of J&J — things the FDA and government haven’t seen — there is only one choice in how to rule.” According to Chris Panatier, plaintiffs’ lawyer.

Anderson and her husband had sued J&J, a unit of Imerys SA (IMTP.PA), Cyprus Amax Minerals, a unit of Brenntag (BNRGn.DE), Honeywell International (HON.N) and other local talc suppliers, which are now becoming targets more and more in the emerging talc litigation exploding across the country.

J&J’s lawyers have stated that Anderson’s mesothelioma may not have been caused by asbestos in talc, but could have occurred “spontaneously.’’ They also said the woman had a family history of lung and breast cancer. Even though there has been ample evidence shown in court after court, both state and federal that J&J’s talcum powder products are known to be cancer causing. J&J and others have been diligent in suppressing the research and scientific studies showing the cancer links, going so far as to pay “ghost writers” to submit company sponsored “talc is a good product” papers as legitimate scientific materials to recognize medical journals. This conduct dates back to at least the mid-10970’2 when internal J&J consultants working on Talc R&D projects raised red flags on the dangers of talc and the link to cancer.

Hiding Data That Showed Potential Dangers: The standard complaints utilized in the prior trial allege that J&J knew about the risks of ovarian cancer as early as 1971. The complaints allege that “nearly all” of 23 known epidemiologic studies on cosmetic talc reported an associated risk with ovarian cancer, and assert alleged instances in which J&J “knowingly released false information” about the safety of talc in coordination with the Cosmetic Toiletry and Fragrance Association. Media reports suggest that, in post-trial interviews, jurors indicated that these allegations were part of the motivation for the large punitive damages award.

This is the second jury in less than two months to conclude J&J sold its iconic baby powder knowing it contained at least trace amounts of asbestos and posed a cancer risk to users. In April, jurors in J&J’s hometown of New Brunswick, New Jersey, ordered the company and a unit of Imerys SA, a talc supplier, to pay a total of $117 million to a banker who showed his cancer was tied to baby powder use. See For J&J $37 Million Talcum Powder Mesothelioma Verdict—Add $80 Million In Punitive Damages.

Litigation over J&J’s baby powder is accelerating. The company is facing claims by more than 9,000 plaintiffs, primarily connecting talc to ovarian cancer, according to a May 1 securities filing. J&J didn’t break out the number of ovarian cancer cases versus the number of mesothelioma cases allegedly tied to talc. See Johnson & Johnson Talcum Powder Litigation MDL 2738 (USDC New Jersey).

In MDL 2738 J&J is facing more than 6,000 cases claiming its baby powder caused ovarian cancer, but the talc litigation has taken a new focus in recent months with plaintiffs claiming the widely used product causes mesothelioma due to alleged asbestos contamination.  These casese are being in in US District Court of New Jersey, in front of Judge Freda Wolfson, who has not been perceived as a plaintiff friendly judge so far. But science is science and as more of the data is released and becomes accepted, J&J’s home court advantage in New Jersey courts will continue to

J&J, talc supplier Imerys  and retail seller incuding Rite-Aid pharmacy (RAD.N) are currently facing similar claims in a trial underway in South Carolina over asbestos talc allegations.

Anderson argued she used J&J’s talc products on her children in the 1970s and on herself in the 1980s and 1990s when she would powder her hands and feet while bowling. She claimed at one point, she went through two bottles a month.

Notable Cosmetic Talc/Asbestos Contamination Verdicts

Two recent verdicts for asbestos contamination demonstrate the risk to cosmetic talc defendants. In October 2016, a Los Angeles County jury awarded $18M to Philip Depolian against Whittaker, Clark & Daniels finding it 30% responsible for his mesothelioma due to his alleged exposure to various cosmetic talc products used at his father’s barbershops that contained asbestos. The jury apportioned liability against various cosmetic talc defendants that had settled and several other cosmetic talc product defendants that sold products including Old Spice, Clubman, Kings Men and Mennen Shave Talc.

In 2015, another Los Angeles jury awarded Judith Winkel $13M against Colgate-Palmolive for mesothelioma allegedly caused by exposure to talc in its baby powder. The jury rejected Colgate and its experts’ claims that the cosmetic talc at issue was not contaminated by asbestos and that the talc in question were non-fibrous “cleavage fragments” unlikely to be inhaled or embedded in the lungs. Although details of the trial are not readily verified, at least one report indicated that evidence presented at trial showed that the talc contained 20% asbestos fibers.

These cases are particularly important because the defendants were held responsible for cosmetic talc containing asbestos and for having caused mesothelioma and not ovarian cancer as in the J & J cases. Further, both juries found that the defendants acted with malice. However, the cases were confidentially settled before the respective punitive damage phases.

 Talc History

There are two types of talc: industrial talc which is used most frequently in rubber, plastics and ceramics; and cosmetic talc which is of a higher grade and is used in conjunction with products that involve direct human exposures such as cosmetics, pharmaceuticals and food additives.

Talc manufacturers and companies that have incorporated talc into their products have been, and continue to be, sued. Industrial talc defendants have been involved in litigation for decades. In lawsuits involving industrial talc, plaintiffs generally allege that the talc is contaminated with asbestos. The injuries alleged are mesothelioma, lung cancer and asbestosis. To date, there have been no claims against industrial talc defendants alleging that asbestos in the talc caused ovarian cancer. Industrial talc defendants have aggressively defended the cases and, although suffering some adverse verdicts, they won more cases than they have lost. However, will thousands of new industrial talc claims result in acceptance of litigation and pressure to settle as a suddenly arising “cost of doing business’, such as the view taken by pharmaceutical and medical device manufacturers who incorporate “litigation costs” into corporate filings and simply classify it as an expense of doing business?

Cosmetic talc cases fall into two distinct categories: 1) cosmetic talc alleged to cause ovarian cancer; and 2) cosmetic talc alleged to cause mesothelioma. The J & J verdicts were ovarian cancer cases. There was no claim that the talc was contaminated with asbestos.

While the J & J St. Louis verdicts received significant attention in the national media, cases alleging that asbestos-containing cosmetic talc caused an asbestos-related disease such mesothelioma have been percolating, and some recent notable verdicts have been obtained. In 2015, a Los Angeles jury awarded $13M to a woman who alleged talcum powder sold by Colgate-Palmolive was contaminated with asbestos causing her to contract mesothelioma.  These cases, if they emerge as viable litigation, could make cosmetic talc defendants targets by substituting them for insolvent asbestos defendants and anyone else who may be named, which would present an extreme and unforeseen threat to cosmetic talc defendants and affiliated industry.

Cosmetic Talc Litigation – Ovarian Cancer

Cases alleging injury from cosmetic talc are relatively new, as best exemplified by the recent high-profile J & J verdicts. These cases did not depend on asbestos contamination, nor did they allege mesothelioma. Instead, they alleged that talc itself causes ovarian cancer. The ovarian cancer talc cases indeed represent an entirely new class of toxic product liability litigation. The approximately 14,000 ovarian cancer deaths a year, in conjunction with the widespread use of talc in everyday products such as baby powder, renders these cases a serious threat to certain defendants and their insurers.
According to the National Institute of Health, there are 22,280 new ovarian cancer diagnoses each year in the U.S. and 14,240 women die of the disease every year. This is seven times the number of annual mesothelioma diagnoses.

The American Cancer Society estimates that there are only 3,000 new mesothelioma diagnoses a year,  with mesothelioma lawsuit filings being stable and not increasing. Like any other business, plaintiffs’ firms are always looking to maintain and grow revenue. Litigation against cosmetic talc defendants alleging ovarian cancer offers a way to substantially increase their bottom line. Indeed, “do you have ovarian cancer?” and “did you use talcum powder?” ads are commonplace on television.

Because everyone can credibly claim exposure to cosmetic talc, the primary issue that will be litigated is the science underlying the causal connection between talc exposure and ovarian cancer. While plaintiffs prevailed in the St. Louis actions, Imerys Talc and J & J persuaded a New Jersey trial court in 2016 to dismiss with prejudice two ovarian cancer cases after granting their motions to bar expert testimony due to inadequate science supporting their opinions. Apparently pressing their advantage, the defendants persuaded the federal talc MDL in New Jersey to conduct a “science day” in which the litigants would attempt to generally demonstrate that cosmetic talc does or does not cause ovarian cancer. The plaintiffs’ bar quickly responded with their own proposed “science day” in California state court, presumably where they perceive a jurisdictional advantage. The “science” of whether cosmetic talc causes ovarian cancer will be the field of battle on which the sustainability of these claims will live or die.

The sustainability of ovarian cancer talc cases will depend on how the courts resolve the science questions surrounding causation. This will depend in large part on the plaintiffs’ bar’s ability to persuade courts outside jurisdictions traditionally favorable to asbestos claimants of the merit of their claims.

Cosmetic Talc Cases Alleging Asbestos Contamination

In addition to the emergence of ovarian cancer cases, cosmetic talc defendants are also at risk of becoming responsible for mesothelioma cases alleging that their products were contaminated with asbestos. If plaintiffs can meet their burden of proving asbestos contamination in their products, the issue of product identification will largely be moot due to the ubiquitous use of talc in everyday products to which any plaintiff can presumably credibly claim exposure.

Allegations of asbestos contamination in talc have a long and disputed history. The FDA launched an investigation in 2010 based on reports that talc from South Korea and China contained asbestos. After extensive testing of various U.S. consumer products, the FDA found no asbestos contamination in the products. However, it described its results as inconclusive and only “informative” because it was unable to secure samples from all of the common talc suppliers.

The issue of whether cosmetic talc is contaminated by asbestos is disputed by the plaintiffs’ bar. The cosmetic talc defendants present an attractive target, especially given the declining pool of solvent asbestos defendants. In addition, while mesothelioma case filings have been relatively flat, the expected decline of mesothelioma claims has failed to emerge.

If mesothelioma cases do trend upward, plaintiffs’ lawyers will have additional incentive to identify new solvent defendants to satisfy the potential liabilities. Cosmetic talc defendants, generally not burdened by years of asbestos liabilities, make attractive defendants. In addition, because the traditional asbestos defendants that used and sold asbestos products have gone bankrupt, plaintiffs’ lawyers have increasingly struggled to demonstrate proximate cause against individual defendants and have been forced to make ever-more tenuous arguments that even de minimus exposures to asbestos caused their clients’ mesothelioma. The widespread use of cosmetic talc overcomes most traditional product identification, proximate cause defenses. Instead, the principal issue becomes only whether a particular product was contaminated with asbestos.
The plaintiffs’ bar will attempt to meet its burden of demonstrating asbestos contamination in cosmetic talc by arguing that traditional testing methods are not precise enough to detect it at low levels and that there is no safe level of asbestos exposure. In previous cases, plaintiffs have employed experts to challenge defendants that maintained talc samples. As these cases are being litigated in the same jurisdictions that handle most asbestos cases, these allegations will  be difficult for defendants to rebut.

Question: Will industrial and cosmetic “personal care” products made with talcum powder and the emerging confirmed links to “asbestos” and “mesothelioma” become the new long term mass tort resulting in thousands of complaints against nontraditional and unsuspecting defendants? Such as the Los Angeles County, California Superior Court lawsuits where a 2015 “cosmetic talc” trial resulted in an $18 million verdict award based on “cosmetic talc exposure in a barbershop” against Old Spice, Clubman, Kings Men and Mennen Shave Talc, as well as a prior 2015 trial verdict of $13 million against Colgate-Palmolive for exposure to talc in its baby powder.

 

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More States Are Now Filing Lawsuits Against Big Pharma’s Opioid Rx Cash Cow Industry

Florida, Texas, Nevada, North Carolina, North Dakota and Tennessee Join Opioid Litigation

 

 

 

 

 

 

(Mass Tort Nexus Media) Litigation against OxyContin maker Purdue Pharma LP and the rest of the Opioid Big Pharma industry just jumped significantly, as six more states have filed lawsuits against Purdue Pharma, et al. The ongoing allegations against the opioid pharmaceutical industry as a whole, where numerous governmental entities from across the country have asserted that the opiate makers have fueled a national opioid crisis. This is primarily based on corporate boardroom designed deceptive opioid marketing campaigns, designed to sell prescription opioids, and minimize the previously well-known medical risks, including addiction and overdose, while generating billions of dollars in sales.

For up to date information on the Opioid Litigation across the country see, OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION (https://www.masstortnexus.com/Briefcases/Drugs/254/)

Prescription and illegal opioids account for more than 60 percent of overdose deaths in the United States, a toll that has quadrupled over the past two decades, according to the U.S. Centers for Disease Control. Drug overdose deaths in 2015 far outnumbered deaths from auto accidents or guns.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

State attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee assert that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

Teva, in a statement, emphasized the importance of safely using opioids, while AmerisourceBergen said it was committed to collaborating with all stakeholders to combat opioid abuse.

The Healthcare Distribution Alliance, an umbrella group for drug distributors, said in a statement that accusations that distributors were responsible for the abuse of opioid prescriptions defied common sense and lacked understanding of the pharmaceutical supply chain.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

THE SACKLERS AND PURDUE

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country.  At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

PURDUE-OXYCONTIN HISTORY

On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What’s more, Purdue Pharma’s patent for the original OxyContin formula didn’t expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.

OxyContin’s ball-of-lightning emergence in the health care marketplace was close to unprecedented for a new painkiller in an age where synthetic opiates like Vicodin, Percocet, and Fentanyl had already been competing for decades in doctors’ offices and pharmacies for their piece of the market share of pain-relieving drugs. In retrospect, it almost didn’t make sense. Why was OxyContin so much more popular? Had it been approved for a wider range of ailments than its opioid cousins? Did doctors prefer prescribing it to their patients?

During its rise in popularity, there was a suspicious undercurrent to the drug’s spectrum of approved uses and Purdue Pharma’s relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller.

US DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

For criminal opioid cases see: Federal Venues and Courts Where Opioid Indictments Are Pending As Of July 2017

FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

Former President Bill Clinton pulled no punches as he focused directly on the opiate issues “Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game rests, which is one of the prime issues of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered. Clinton further commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

RURAL vs. BIG CITY OPIATES

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these states, with West Virginia numbers being, 780 million painkillers prescribed in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a point where Opiate Big Pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to assign a financial penalty for the alleged corporate opioid abuses.

FDA Failed to Cite Opioid Big Pharma

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

As the Opioid litigation expands across the country in both state and federal courtrooms, it remains to be seen if the anticipated payouts will surpass the $200 billion payday for governments in the 1998 Big Tobacco Litigation settlement.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

 

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Abilify, Taxotere and Ethicon Multi-Layered Hernia Mesh Lawsuits Being Consolidated in New Jersey State Court

New Jersey State Court MCL Designations: Is NJ the emerging state court mass tort venue for lawsuits against Big Pharma?

By Mark A. York (May 11, 2018)

(Mass Tort Nexus Media) In late 2017 plaintiffs and defendants in the Abilify litigation in New Jersey state court moved to have the litigation designated as a multicounty litigation (MCL) on December 27, 2017 and which was approved as an MCL on May 9, 2018, see links below for both court filings.

Abilify New Jersey State Court MCL Notice to the Bar December 27, 2017

Abilify New Jersey MCL Designation – Atlantic County May 9, 2018

 

 

 

 

 

 

 

The  New Jersey judiciary site provides multicounty litigation docket information where you will see there are more MCL dockets that parallel existing federal MDL’s being brought in Big Pharma’s backyard. These multicounty litigations involve large numbers of claims that are associated with pharmaceuticals and medical devices based in New Jersey, and there appears to be an emerging consensus that confronting J&J, Sanofi and others in their home state venue is now a very viable litigation option for mass tort firms across the country. The recently consolidated Abilify MCL is a prime example, as is the pending Taxotere MCL application.

There were nearly 50 Abilify cases filed in Bergen County in New Jersey Superior Court, with that number expected to rise over the next few months, with Superior Court Judge James DeLuca having been the initial judge handling the docket, both plaintiff and defense had agreed that the cases should remain with Judge DeLuca. However, the May 7, 2018 order designated Superior court Judge Nelson C. Johnson and the Atlantic county court as the Abilify New Jersey MCL venue, Abilify New Jersey MCL Designation Atlantic County May 7, 2018.

The motion for MCL designation was filed to ensure that any Abilify case filed in New Jersey will be transferred into the designated state court venue and remain there. There is already a multidistrict litigation (MDL) designation in the Abilify federal litigation, which is consolidated in Northern District of Florida, where the three upcoming bellwether trial were just settled, as well as pending “global settlement order, see Abilify MDL 2734 Global Settlement Order, where Judge Casey Rodgers ordered the parties to reach an agreement within 120 days of the May 1, 2018 order entry date.  The MDL for Abilify was consolidated in October 2016, before U.S. District Judge M. Casey Rodgers.

NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts, Ethicon Hernia Mesh Litigation MCL Notice – New Jersey State Court April 11, 2018. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

 

 

 

 

 

As a growing number of hernia mesh lawsuits continue to be filed against Johnson & Johnson and it’s Ethicon subsidiary in New Jersey state court, each involving complications allegedly caused by the design of multi-layered patch products sold in recent years, a request has been filed to centralize the litigation before one judge for coordinated pretrial proceedings.

On April 11, Glenn A. Grant, acting administrative director of New Jersey state courts, issued a Notice To The Bar (PDF), indicating that the state Supreme Court has received an application to create a multicounty litigation (MCL) for all product liability lawsuits over Ethicon multi-layered hernia mesh.

TAXOTERE EMERGING MCL

The most recent MCL application to be filed and listed by the New Jersey Courts is the Taxotere (docetaxel) cancer chemotherapy drug litigation against Sanofi-Aventis US, Sandoz, Inc. and Actavis, Inc with the MCL Notice posted on April 11, 2018 see Taxotere New Jersey MCL Notice To The Bar April 11, 2018.

There is already an existing Taxotere MDL 2740 in the US District Court ED Louisiana see Mass Tort Nexus Briefcase TAXOTERE-MDL-2740-(US-District-Court-Eastern-District-of-Louisiana, where there are more than 5,000 claims pending in front of the very soon to depart Chief Judge Kurt D. Englehardt, who recently received full US Senate approval to move up to the Forth Circuit Court of Appeals, replaced by sitting US District Court Judge, Jane Triche Milazzo.

 

 

 

 

 

How the New Jersey state court Taxotere MCL compares to the Taxotere MDL 2740 remains to be seen, but the New Jersey based pharmaceutical giants are now being forced to address mass torts more and more often in their home state courts, which previously was perceived as a venue of last resort for many plaintiff firms across the country.

With these three newest mass torts emerging in New Jersey state courts, along with the many pre-existing MCL’s that have been very successful there, will New Jersey now be considered the “go to” venue for filing litigation against Big PharMa?

 

 

 

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$35 Million In Punitives Added To Bard TVM Trial Verdict in NJ Court

“TOTAL VERDICT OF $68 MILLION IN SYNTHETIC SURGICAL MESH TRIAL”

Mark A. York (April 18, 2018)

SYNTHETIC MESH COMPANIES FACING THOUSAND OF LAWSUITS

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) C.R. Bard, Inc. was ordered to pay an additional $35 million in punitive damages, added to the $33 million the jury initially award for a total of verdict of $68 million in the first Transvaginal Mesh trial for Bard in New Jersey state court. Plaintiff Mary McGinnis was successful in her claims that Bard’s synthetic vaginal mesh implants are defective, asserting that Bard defectively designed the product, ignored warnings and related FDA notices about the numerous adverse events related to their synthetic surgical mesh products.

Bard, a subsidiary of global medical supplier Becton-Dickinson of Franklin Lakes, says it will appeal the verdict. In a statement, the company said McGinnis knew of the inherent risks in having the vaginal implants. This case docket can be found under Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The punitive damage award was added after the initial $33 million verdict was returned and the judge set a hearing to address the punitive damages award. The jury decided that there were grounds to award plaintiff Mary McGinnis and her husband the large verdict based on trial testimony and evidence that Bard was aware of the mesh product dangers and chose to ignore the thousands of adverse events reported related to post-surgery complications claimed by women across the country.

The Bard synthetic mesh products are designed to provide pelvic support for any number of medical issues primarily affecting women, with synthetic mesh recognized as often causing major medical complications and leaving patients in permanent pain. The jury held the company liable for two products that McGinnis had implanted in March of 2009: an Avaulta Solo mesh, and an Align Transobturator and Bard was forced to concede that both products have been taken off the market.

The verdict comes as Murray Hill, New Jersey-based Bard is pushing to a flood of litigation its surgical mesh implants , which have been criticized by women for damaging internal and often affecting or stopping normal sex lives. Bard has settled more than 13,000 cases since 2014, and as of September 2017, the company still faced more than 3,000 suits over allegedly defective synthetic mesh devices still in litigation. Those cases are part of the Bard-TVM-Litigation-MDL-2187 Briefcase, in front of Judge Goodwin, US District Court of West Virginia.  While Bard still faces another 150 lawsuits in New Jersey state court, which previously had been perceived as a favorable home court legal venue by the company.

McGinnis alleged Bard’s Avaulta and Align implants shrank after being implanted, causing nerve damage and leaving her unable to engage in sexual activity and that she was forced to undergo four surgeries in attempts to remove all the mesh from her body.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market.J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Bard has been accused in many lawsuits of using a form of polypropylene mesh in the devices, that their mesh supplier and manufacturer had warned wasn’t suitable for human implantation. Bard officials countered that the mesh was a safe substance from which to make the inserts, ignoring the safety sheet warning issued by the polypropylene mesh product maker.

Last year, C.R. Bard was acquired by medical-device company Becton, Dickinson & Co. $24 billion, combining two of the world’s biggest health-care suppliers.  How the thousands of remaining mesh lawsuits affect the company business model and potentially moves them towards serious settlement discussions remains to be seen.

This case can be found at: Mary McGinnis v. C.R. Bard, Inc., Docket No.: BERL1754314, Bergen County, New Jersey Superior Court (Hackensack).

 

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ETHICON, INC. AND J&J FACING THOUSANDS OF TVM AND HERNIA MESH LAWSUITS: WILL THEY SETTLE SOONER OR LATER?

“New Jersey State Court Opens Ethicon Hernia Mesh Consolidation”

Mark A. York (April 17, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Ethicon’s Pelvic Repair System litigation also known as Transvaginal Mesh (TVM) litigation, (see Mass Tort Nexus Ethicon TVM MDL 2327 Briefcase) and the more recent hernia mesh legal filings, are the latest in a series of ongoing legal battles facing Johnson & Johnson and its Ethicon subsidiary. Ethicon is facing over 50,000 mesh lawsuits in state and federal courts across the country where plaintiffs have filed suits over their synthetic mesh surgical implants. The numbers are increasing daily as the TVM plaintiffs are being joined by plaintiffs filing “hernia mesh” lawsuits, where the allegations are very similar to claims asserting that J&J’s failed to warn and choosing to ignore the thousands of FDA filed adverse events related to its hernia mesh products.

EMERGING NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

Ethicon TVM litigation has been underway for close to six years in MDL 2327, (MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation court link) currently pending in the U.S. District Court in West Virginia, where U.S. District Judge Joseph Goodwin is also overseeing seven other  multidistrict litigations (MDLs) established for cases against different manufacturers. When you add in other synthetic mesh manufacturer lawsuits besides J&J, there are more than 100,000 mesh lawsuits pending against Ethicon and other manufacturers, including Boston Scientific, C.R. Bard, American Medical Systems (AMS) acquired by Endo, Coloplast, Cook Medical, Neomedic and others.

Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

Only American Medical Systems, Inc has resolved substantially all of their claims over their mesh products, agreeing to pay about $1.6 billion to resolve more than 20,000 claims.

PRIOR MESH SETTLEMENTS

While manufacturers have had some success in defending the safety of the products in a handful of cases, most of the claims that have gone before a jury so far have resulted in substantial damage awards, suggesting that TVM settlements will likely cost the companies several billion dollars.  There have been settlements by some mesh makers including End International, Inc. on behalf of American Medical Systems, Inc, where Endo agreed to pay $775 million in August 2017 to resolve the remaining cases, where there had been over 22,000 lawsuits filed over its vaginal mesh implants. They had previously agreed to a $400 million settlement of more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. This has been part of Endo’s decision to exit “substantially all” the remaining lawsuits against its AMS unit, with the $400 million being in addition to $1.2 billion previously pledged by Endo to cover mesh litigation. Including its $830 million settlement to resolve thousands of mesh lawsuits (~40,000 per case) in May 2014. That settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny.

ETHICON TRIAL VERDICTS

Although Ethicon attempts to defer blame and causation for the often life altering medical conditions that occur post mesh implant surgery, they are often found liable at trial with verdicts being anywhere from $1.5 million to more than $100 million and often include major punitive damages. The punitive damages, which are designed to punish Ethicon for conducting its business with malice towards women who were implanted with the products, finding that the company knew that the synthetic mesh products caused severe complications, but failed to warn the medical community.

With Ethicon (Johnson & Johnson) facing more vaginal mesh lawsuits than any other manufacturer. Here are trial verdicts from lawsuits that have resulted in major losses for Ethicon/J&J again and again:

  • In March 2018, a jury in Indiana awarded $35 millionto Barbara and Anton Kaiser. They’d sued Ethicon (a subsidiary of Johnson & Johnson) after Barbara Kaiser’s Prolift mesh allegedly caused her pelvic pain. They awarded her $10 million in damages and hit Ethicon with $25 million in punitive damages.
  • In December 2017, a Bergen County, NJ jury awarded$15 million to Elizabeth Hrymoc. Ms. Hrymoc said she received a defective Prolift mesh implant in 2008, which left her in such pain that she had to have it removed and replaced. She cried as the jury announced their verdict.
  • In September 2017, a Philadelphia jury awarded $57.1 millionto Ella Ebaugh, who says she suffered chronic pain and incontinence because of two Ethicon pelvic mesh implants that eroded into her urethra. Ms. Ebaugh says she required three surgeries to remove the mesh. Ethicon vowed to appeal.
  • In April 2017, a Philadelphia jury awarded $20 millionto a woman who claimed she was in constant pain because of her TVT-Secur transvaginal mesh, a product of Johnson & Johnson subsidiary Ethicon. A spokesperson for Ethicon said the company would appeal the decision, but it was the fifth major loss over the mesh products since 2014.
  • $13.5 million verdict awarded to Sharon Carlino of New Jersey in February 2016. According to the lawsuit, Carlino received Ethicon’s transvaginal tape (TVT) for stress urinary incontinence and it left her with constant pain and discomfort. Two surgical attempts to fix the device did not rid her of pain. $10 million of the verdict came in the form of punitive damages. The jury said that Carlino’s doctor would not have used the Ethicon mesh had the device risks been known.
  • $4.4 million jury award to Florida resident Tessa Taylor in February 2016. The jury found that ObTape sling (made by J&J subsidiary Mentor) caused Taylor’s back pain, bladder pain, and difficulty urinating over a 7 year period. Taylor received the mesh to treat urinary incontinence, but she was re-diagnosed with the condition in spite of the device. $4 million of the verdict was for punitive damages to “discourage others from behaving in a similar way.”
  • J&J agreed to pay $120 million to settle 2,000-3,000 mesh lawsuitsin January 2016. The settlement marked the first serious attempt by J&J to settle a significant number of mesh lawsuits. A regulatory filing at the time showed that J&J still faced more than 42,000 mesh cases.
  • $12.5 millionverdict awarded to Indiana resident Patricia Hammons, including $7 million in punitive damages. Hammons was implanted with Ethicon’s Prolift device, which she says caused severe pain, sexual difficulties, and incontinence–even after corrective surgery.
  • $5 millionsettlement reached in September with plaintiff Pamela Wicker, implanted with Ethicon’s Prolift mesh device. Wicker claims that Prolift eroded inside of her and necessitated numerous surgeries to remove the device. A law professor said that the large settlement showed the costs of dealing with mesh litigation would be a lot higher than expected.
  • $5.7 millionverdict awarded to Coleen Perry in March 2015 by a California jury. Perry was implanted with the J&J/Ethicon TVT Abbrevo and says she expects to have pain the rest of her life. The jury found that the TVT Abbrevo has design problems and that Ethicon failed to warn about potential health risks. The verdict included $5 million in punitive damages for conduct that amounted to “malice.”
  • Two confidential settlementsinvolving 115 mesh victims were reached in January 2015. One of the settlements resolved 4 cases in Missouri over Ethicon’s Prolift mesh device and the other resolved 111 cases in Georgia over the ObTape Transobturator Sling (made by J&J subsidiary Mentor). The Missouri women claimed that the mesh in Ethicon’s Prolift insert shrinks and damages organs, causing constant pain and making sexual intercourse difficult, while the Georgia women alleged that ObTape causes permanent injuries.
  • $3.25 millionverdict awarded to plaintiff Jo Husky over the J&J/Ethicon Gynecare TVT-O mesh device. The verdict was reached by a West Virginia jury in September 2014 following a two-week trial. Jurors found that the TVT-O was faulty and that Ethicon failed to warn of side effects.
  • $1.2 millionverdict awarded to Linda Batiste, implanted with the Gynecare TVT Obturator (TVT-O) mesh sling (made by J&J unit Ethicon) in April 2013. The jury concluded that the device’s design was flawed.
  • $11.1 millionverdict (including $3.35 million in compensation and $7.76 million in punitive damages) awarded to Linda Gross of South Dakota, who was implanted with J&J’s Gynecare Prolift vaginal mesh device. A New Jersey jury reached the verdict in February 2013, saying that J&J fraudulently misled Gross about device risks.

ETHICON MESH LITIGATION

Judge Goodwin is overseeing coordinated pretrial proceedings for all federal vaginal mesh lawsuits, as the cases involve nearly identical allegations that the products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women are defectively designed and can cause severe and deforming complications, including infections, puncturing organs and eroding through the vagina.

The MDLs were established for cases against each manufacturer to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts. However, as hundreds of cases become “trial ready”, and manufacturers continue to make little progress in settling claims, Judge Goodwin faces the prospect of remanding large numbers of lawsuits back to U.S. District courts nationwide for individual trials, which could take decades to complete.

Plaintiff complaints against Ethicon all consistently assert that Ethicon was and is aware of the dangers posed by their synthetic mesh products, and choose to ignore the thousands of adverse event reports filed with the FDA as well as the fact that more than 50,000 plaintiffs have filed lawsuits over Ethicon synthetic mesh implants. The legal claims assert injuries due to the defective design of the most every synthetic mesh product made by Ethicon regarding its vaginal mesh, including mesh erosion, mesh contraction, inflammation, pain during sexual intercourse, urinary incontinence, chronic pain, and recurring prolapse of organs.

As a result of the post surgical complications, plaintiffs have been known to undergo as many as four operations to have the mesh removed, often resulting in massive levels of pain as well as financial impact of repeated surgeries and rehabilitation.  There are many instances where the the surgeons were unable to remove all the mesh due to the mesh adhesion to internal organs and surfaces within the body that were never intended as a post surgical complication.

While the outcome of the MDL cases and other trials are not binding on other cases in the vaginal mesh litigation, Ethicon and its parent Johnson & Johnson should gauge how juries have responded to certain evidence and testimony via recent major trial verdicts in most every mesh trial they’ve faced in both federal and state courts. How Ethicon counsel views the recent trial verdicts and the impact on the thousands of other cases they face, and the potential for the trial results to be repeated throughout these cases, would seem to have an impact on J&J’s views of starting substantive settlement negotiations. To date, this has not been a significant part of the Johnson & Johnson legal business strategy, potentially resulting in an ongoing windfall for the thousands of plaintiffs for years to come.

 

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Bard Loses $33 Million In Pelvic Repair Mesh Trial In New Jersey State Court: Punitive Damage Hearings Today

“New Jersey State Courts Not Legal Safe Haven Lately For Companies HQ’d There”

By Mark A. York (April 13, 2018)

C.R. Bard Avaulta Synthetic Surgical Mesh

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In another win for plaintiffs, a jury in Bergen County, New Jersey awarded plaintiff Mary McGinnis $23 million and her husband Thomas, an additional $10 million in actual damages, with a hearing taking place today on how much in punitive damages will be be added. This $33 million verdict in New Jersey state court, where defendant C.R. Bard is headquartered, closely follows the $117 million verdict of last week against another New Jersey company, Johnson & Johnson in a baby powder trial.  This was the first C. R. Bard case to go to trial in the Bard consolidated New Jersey state court docket, where Bard is facing hundreds of additional lawsuits over its defective pelvic mesh implants, also known as Transvaginal Mesh or TVM.

The jury directed the company to pay the $33 million in compensatory damages over claims the business knew its pelvic mesh products were unsafe and failed to warn doctors about potential risks related to devices that caused a woman debilitating pain and related inability to enjoy life as she did prior to the surgical implant of the synthetic mesh device.  Bard and others makers of both TVM and hernia mesh products are under highly increased scrutiny and being hot with major trial verdicts over claims they ignored the dangers of implanting synthetic mesh products, primarily made from polypropylene, the same product most fishing line is made from, into the human body. This case docket can be found under- Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14, Bergen County Superior Court, Judge James DeLuca.

The jury took less than a day to decide on the verdict following the four-week trial, after finding that Bard was responsible for a defective design of the Avaulta mesh product and failure to warn doctors or consumers of the defective design. . Of note is that Bard had removed the Avaulta mesh line from the market by 2016.

The jury found that Bard’s Avaulta and Align synthetic mesh products, which were  implanted to treat McGinnis’s bladder prolapse and stress urinary incontinence were defectively designed and caused incapacitating injuries as well as impacting her relationship with her husband. Bard claimed repeatedly that they tested Avaulta extensively as well as their other mesh products, and Mrs. McGinnis’ unrelated medical conditions caused her injuries

Hearings over punitive damages and how much they should be are scheduled to start this morning. Bard is probably keeping in mind the $80 million in punitive damages awarded last week in a similar state court punitive damages hearing in the J&J talcum powder cancer trial in New Brunswick, which is less than 50 miles from the Bergen County court.

Bard has historically been hit with ongoing verdicts over its synthetic mesh line of products in trial across the country, as far back as 2012 where a previous Avaulta mesh trial in California state court ended in a $5.5 million verdict and in a 2013 West Virginia federal court trial, a verdict was returned for  $2 million verdict against Bard and its Avaulta mesh.

TVM MESH IS SUBJECT TO MAJOR LITIGATION

Surgical Mesh Makers Facing Litigation

 

 

 

 

 

 

 

Major litigation against CR. Bard/Davol, Ethicon (J&J), Boston Scientific and other surgical mesh manufacturers has been ongoing for few years in both federal and state courts and will continue into the foreseeable future, based on the hundreds of thousands of synthetic mesh implants used in surgical procedures in the United States over the last 15 years.

Bard has been known to settle mesh cases, in the Wise v. Bard, bellwether case selection, that was set for trial back on February 18, 2015, settled a week before the trail start date for a confidential amount. The Wise lawsuit was part of the Bard MDL 2187, see Bard-TVM-Litigation-MDL-2187 Briefcase, where thousands of lawsuits are still pending against C.R. Bard, additionally there are other MDL’s where every other synthetic surgical mesh manufacturer in the US marketplace is facing more than 50 thousand lawsuits over their synthetic mesh surgical products.” See Ethicon (J&J) Pelvic Mesh Litigation MDL-2327-TVM Briefcase.

OTHER TVM MESH VERDICTS

 There were $26.7 million and $18.5 million mesh verdicts against Boston Scientific see  Boston-Scientific-TVM-Litigation-MDL-2362 Briefcase, in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include:

Transvaginal Mesh Adverse Events

Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement.

Complications and Adverse Events Include:

  • erosion through the vaginal tissue
  • mesh contraction
  • mesh extrusion
  • inflammation
  • fistula
  • infection and abscess
  • pain
  • blood loss
  • chronic and acute nerve damage
  • pudendal nerve damage
  • pelvic floor damage
  • scar tissue
  • chronic pelvic pain
  • urinary problems and/or incontinence
  • recurrence of prolapse
  • bowel, bladder, and blood vessel perforation
  • dyspareunia or pain during sexual intercourse

Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications.

In July 1, 2012, Bard stopped selling the Avaulta Meshin the United States because the FDA required additional clinical trials and testing.

On June 4, 2012: Johnson and Johnson/Ethicon withdrewfour mesh products from the US Market, including its controversialGynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.

History of Warnings

Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.

Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.

However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.

On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.

On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of lifeover other surgical methods.

On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.

Transvaginal Mesh Products & Manufacturers

Ethicon

  • Secure
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-SECUR (TVT-S)
  • TVT-Exact
  • TVT-Abbrevo
  1. R. Bard
  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex

American Medical Systems 

  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc

Boston Scientific

  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System

Coloplast

  • T-Sling-Universal Polypropylene Sling

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