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.

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Read More

Motion for New Infant/NAS Opioid Dependant MDL 2872 Filed With JPML on September 20, 2018

A group of plaintiff attorneys have filed a new motion for consolidation of an “Infant/NAS Opioid Addicted Baby MDL” to be separate from the existing Opiate Prescription MDL 2804 due to the lack of “individuals/baby cases” being offered a prominent role in MDL 2804

 

 

 

 

 

 

 

 

 

September 20, 2018 Motion and Brief in Support Filed With the Joint Panel on Multidistrict Litigation:

BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION

IN RE: CHILDREN BORN                                                           MDL – 2872

OPIOID-DEPENDENT

 

MOTION FOR TRANSFER OF ACTIONS PURSUANT TO 28 U.S.C. §

1407 FOR COORDINATED OR CONSOLIDATED PRETRIAL PROCEEDINGS

 

Plaintiffs[1] respectfully move that the Judicial Panel on Multidistrict Litigation (“Panel”), pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Panel, transfer the actions on behalf of children born opioid-dependent listed in the attached Schedule of Actions and subsequent tag-along actions to a separate MDL before the Southern District of West Virginia.  Alternatively, Plaintiffs request transfer to the Southern District of Illinois.  Transfer is appropriate for the following reasons:

  1. Movants seek transfer and coordination or consolidation of all cases filed on behalf of opioiddependent infants into a separate MDL for the reasons laid out in the Doyle plaintiffs’ recently filed Motion to Vacate CTO-47 (JPML 2804 Rec. Doc. 2398).[2] As discussed therein, the cases of the opioiddependent infants are unique, and further, Movants have grave concerns that the due process rights of opioid-dependent infants are not being protected in MDL 2804 and that the interests of the governmental and corporate parties represented by the MDL leadership are fundamentally in conflict with those of these infants. The question now posed to the Panel, argued in the accompanying brief in support of this Motion, is not whether these cases should be held outside of the MDL as presently structured (they must be), but whether they should be consolidated in a separate MDL.
  2. Presently, there are substantially similar class action suits filed on behalf of opioid-dependent infants pending in the Southern District of West Virginia, the Southern District of Ohio, as well as eight cases currently caught up in MDL 2804 in the Northern District of Ohio. Undersigned counsel anticipates that several more substantially similar opioid-dependent infant class action suits will be filed across the country in the coming months.
  3. The actions on behalf of the opioid-dependent infants assert substantially similar claims and seek substantially similar relief. These suits seek to establish a fund for medical monitoring, damages related to acute neonatal abstinence syndrome (NAS) treatment and long-term treatment of these innocent victims of the Opioid Crisis.
  4. The convenience of the courts, witnesses, parties, and counsel will all be served by transfer of these cases to the Southern District of West Virginia, or in the alternative, the Southern District of

Illinois.

  1. Absent transfer, the opioid-dependent infants’ unique interests will remain unprotected and these young victims risk losing the opportunity to achieve a productive adulthood.
  2. In support of this Motion, Movants file:
    1. A Brief supporting their Motion;
    2. A numbered Schedule of Actions providing (i) the complete name of each action involved, listing the full name of each party included as such on the district court’s docket sheet; (ii) the district court and division where each action is pending; (iii) the civil action number of each action; and, (iv) the name of the Judge assigned to each action;
    3. A copy of all complaints and docket sheets for all actions listed on the schedule;
    4. Statement Regarding Oral Argument; and,
    5. Proof of Service.

WHEREFORE, Movants respectfully request that the Panel grant their motion and transfer these cases, for coordinated and consolidated pre-trial proceedings, to the Southern District of West Virginia. Alternatively, Plaintiffs request transfer to the Southern District of Illinois.

Respectfully submitted,

/s/ Scott R. Bickford

MARTZELL, BICKFORD & CENTOLA

Scott R. Bickford (LA 1165)

Spencer R. Doody (LA 27795)

338 Lafayette Street

New Orleans, LA 70130

Telephone: 504-581-9065 Facsimile: 504-581-7635 sbickford@mbfirm.com srd@mbfirm.com

usdcndoh@mbfirm.com

CERTIFICATE OF SERVICE

             I HEREBY CERTIFY that on this 19th day of September, 2018, a true and correct copy of the foregoing has been electronically filed with the Clerk of Court using the CM/ECF system, which provides an electronic service notification to all counsel of record registered as CM/ECF users.

/s/Scott Bickford___________________________

Scott Bickford

 

[1] Movants are: Deric Rees and Ceonda Rees, individually and as next friend and guardian of Baby T.W.B. on behalf of themselves and all others similarly situated (Illinois Class); Darren and Elena Flanagan, individually and as adoptive parents and next friends of Baby K.L.F., on behalf of themselves and all others similarly situated (Tennessee Class); Rachel Wood, individually and as next friend and adopted mother of Baby O.W., on behalf of themselves and all others similarly situated (Missouri Class); Melissa Ambrosio, individually and as next friend of Baby G.A., and on behalf of themselves and all others similarly situated (California Class); Shannon Hunt, individually and as next friend of Baby S.J., on behalf of themselves and all others similarly situated (Maryland Class); Bobbi Lou Moore on behalf of Baby R.R.C., and all other similarly situated (West Virginia Class); Walter and Virginia Salmons, individually and as the next friend or guardian of Minor W.D. and on behalf of all others similarly situated (National Class).

[2] All arguments in Motion to Vacate CTO-47 (JPML 2804 Rec. Doc. 2398) are adopted in support of this Motion.

 

___________________________________________________________________________________________________________________________________

BEFORE THE UNITED STATES JUDICIAL PANEL ON MULTIDISTRICT LITIGATION

IN RE: CHILDREN BORN                       MDL – _________

OPIOID-DEPENDENT

 

BRIEF IN SUPPORT OF PLAINTIFFS’ MOTION FOR TRANSFER OF

ACTIONS PURSUANT TO 28 U.S.C. § 1407 FOR COORDINATED OR

CONSOLIDATED PRETRIAL PROCEEDINGS

Plaintiffs[1] respectfully move that the Judicial Panel on Multidistrict Litigation (“Panel”), pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Panel, transfer the actions on behalf of children born opioid-dependent listed in the attached Schedule of Actions and subsequent tag-along actions to a separate MDL before the Southern District of West Virginia.; alternatively, Plaintiffs request transfer to the Southern District of Illinois.

I.        Children Born Opioid-Dependent Need A Separate MDL From MDL 2804

Movants seek transfer and coordination or consolidation of all cases filed on behalf of opioiddependent infants into a new MDL for the reasons laid out in the Doyle plaintiffs’ recently filed Motion to Vacate CTO-47 (JPML 2804 Rec. Doc. 2398).[2] As discussed therein, Movants bring unique claims on behalf of opioid-dependent infants, distinct from the claims of the government and corporate plaintiffs in MDL 2804. These suits bring direct claims on behalf of innocent victims for past and future damages suffered, in contrast to claims for reimbursement. Plaintiffs’ claims do not wholly sound in public nuisance but also in state medical monitoring and product liability causes of action. Further, Movants have grave concerns that the due process rights of opioid-dependent infants are not being protected in MDL 2804 and that the interests of the governmental and corporate parties represented by the MDL leadership are fundamentally in conflict with those of these infants.

Movants established in their Motion to Vacate that concerns for due process, conflicts of interest, and the protection owed to children under the law compel this Panel to exclude such claims from MDL 2804 as it is presently structured.  Movants have also established that despite their counsel’s numerous attempts to address these concerns with the leadership of the MDL, the status quo remains.  Absent a structural change within the MDL, the question before the Panel is not whether these cases should be held outside of the MDL (they must be), but whether they should be consolidated in their own MDL.

The prospect of a separate MDL for a non-governmental plaintiff group was explicitly and favorably discussed at this Panel’s November 30, 2017 hearing:[3]

JUDGE BREYER: Well, there’s another option that maybe your colleagues can address for you which is they all go to Judge X. There are common issues. Judge X conducts the discovery with respect to the common issues. And Judge X has the option of addressing the panel, one way or another, or the lawyers do, to create another MDL with this group or that group because the issues aren’t really amenable to the MDL that they are in.

  1. TELLIS: I think that is a fine idea.

JUDGE BREYER: You like that idea?

  1. TELLIS: I like that idea.

JUDGE BREYER: I’m glad you came up with that idea.

JUDGE VANCE: It’s not infeasible to think there could be a personal injury MDL or a third-party payor.

It has become abundantly clear that MDL 2804 is not amenable to the issues affecting opioid dependent infants, making a separate MDL for this group of innocent, injured plaintiffs necessary.

Presently, there are substantially similar opioid-dependent infant class action suits pending in the Southern District of West Virginia, the Southern District of Ohio, as well as eight cases currently caught up in MDL 2804 in the Northern District of Ohio. These state by state class actions filed to date conservatively represent approximately 40% of the children born opioid-dependent in the country. Undersigned counsel anticipates that several other substantially similar opioid-dependent infant class action suits will be filed across the country in the coming months. The actions on behalf of the opioid-dependent infants assert substantially similar claims and seek substantially similar relief.

These suits seek to establish a fund for medical monitoring, damages related to Neonatal Abstinence Syndrome (NAS) treatment and long-term treatment of these innocent victims of the Opioid Crisis.

The medical issues involved in the opioid-dependent infant cases and the relief sought are distinct from those of the governmental and corporate cases of MDL 2804.  The unique issues of these infants’ cases require discovery to be undertaken in areas including the following:

  • Studies regarding the effect of Defendants’ opioid products upon the health of pregnant mothers and their children in utero, and effects after birth.
  • Knowledge regarding the effects of methadone (and other addiction treatment drugs) taken by pregnant mothers on their children in utero.
  • Studies regarding which medications are appropriate for pregnant mothers dealing with opioid addiction.
  • Knowledge of the diversionary opioid market’s impact on pregnant mothers.
  • Discovery relevant to Movants’ products liability claims.

 

To the extent there is overlap of factual allegations and common issues regarding the opioid drug manufacturers’ and distributors’ conduct between the opioid-dependent infant lawsuits and the suits in MDL 2804, Movants envision that discovery in the infants’ MDL would be coordinated with Judge Polster in MDL 2804 in accord with 28 U.S.C. § 1407.

Absent transfer to a separate MDL, the opioid-dependent infants’ unique interests will remain unprotected and these innocent young victims risk losing the opportunity to achieve a productive adulthood.

II. The Southern District of West Virginia is the Most Appropriate Forum for Transfer and Consolidation or Coordination

 

The Southern District of West Virginia, where the suit of Bobbi Lou Moore on behalf of Baby R.R.C. v. Purdue Pharma L.P., No. 2:18-cv-01231 (S.D.W. Va.) is currently pending, is the most appropriate forum for Multidistrict Litigation. Southern West Virginia is the epicenter of the Opioid Crisis– where it began and where its most profound impacts are being felt. West Virginia has some of the highest rates of fetal opioid exposure and Neonatal Abstinence Syndrome (NAS) in the country.

The West Virginia Department of Health and Human Resources (DHHR) recently released data for

2017 showing the overall incidence rate of NAS was 50.6 cases per 1,000 live births (5.06%) for West

Virginia residents, with the rate as high as 106.6 cases per 1,000 live births (10.66%) in one county.[4]  According to the CDC, there are many more opioid prescriptions than people in West Virginia– 138 prescriptions for every 100 people.[5] A congressional investigation revealed that from 2008 to 2012, pharmaceutical distributors sent more than 780 million pills of hydrocodone and oxycodone to West Virginia, a state with only 1.8 million people.[6] Southern West Virginia was especially hard hit: 20.8 million opioid pills were shipped from 2006 to 2016 to Williamson (population 2,900).[7] One pharmacy in Kermit (population 400) ranked 22nd in the U.S. in the number of hydrocodone pills it received in 2006.[8] The grave impact of this flood of prescription opioids on southern West Virginia and the children born there cannot be overstated.

The Courts of the Southern District of West Virginia have a proven track record in administering Multidistrict Litigation, as demonstrated by the Pelvic Repair System Products Liability Litigation. The Southern District of West Virginia provides a well-prepared, well-staffed, and overall top-notch staff and Clerk’s office. As discussed below, the District’s judges have a wealth of experience in complex litigation, particularly pharmaceutical litigation. The convenience of the courts, witnesses, parties, and counsel will all be served by transfer of these cases to the Southern District of West Virginia.

Judge Robert C. Chambers has the requisite experience to manage this complex litigation.  He previously served as Chief Judge for this District from 2012-2017, and has presided over 500 cases involving pharmaceutical companies.  Judge Chambers is currently presiding over products liability actions involving claims against the manufacturer of prescription anticoagulant drugs.[9]  He has also presided over a case featuring complex pharmaceutical litigation, W. Virginia ex rel. Morrisey v. Pfizer, Inc., 969 F. Supp. 2d 476, 479 (S.D.W. Va. 2013).  Prior to being appointed to the federal bench by President Clinton, Judge Chambers was in private practice in Charleston for twenty years, and served as legal counsel to the West Virginia State Senate.

Senior Judge David A. Faber, appointed to the federal bench in 1991 by President George H.W. Bush, served as Chief Judge at the Southern District of West Virginia from 2002 to 2007. He has served as a Senior Judge in the district since 2008. He has handled 79 cases involving pharmaceuticals, including several opioid cases.[10] Senior Judge Faber also presided over a case involving medical products liability.[11] Prior to becoming a federal judge, Senior Judge Faber worked in both private practice and served in the military as a JAG, and achieved the rank of Colonel. He attended Yale for law school where he was a National Law Scholar, and holds an L.L.M. degree from the University of Virginia.

Chief Judge Thomas E.  Johnston in the Charleston Division has over a decade of experience as a federal judge. He oversees some of the suite of cases collected in the MDL related to the Pelvic Repair System Products Liability Litigation.[12]  Chief Judge Johnston has extensive experience presiding over medical cases, including 216 cases involving health care, and 28 cases specifically involving pharmaceuticals, as well as products liability claims.[13] He had previously served as U.S. Attorney for the Northern District of West Virginia from 2001 to 2006 before being appointed to the bench by President George W. Bush.

In the alternative, Movants would propose transfer and consolidation in the Southern District of Illinois before the Judge Staci M. Yandle. Judge Yandle was appointed to the federal bench in 2014 after an illustrious career in private practice and a distinguished record of public service, including serving on the Illinois Advisory Committee to the United States Commission on Civil Rights. This Panel has previously commended the Southern District of Illinois as convenient due in part to its geographically central location.[14]

III.     Conclusion

For the above-stated reasons and the reasons stated in the Motion to Vacate filed by the Doyle plaintiffs, Movants respectfully request that the Panel transfer the actions on behalf of opioid dependent infants recited on the attached Schedule and all subsequently filed tag-along cases for coordinated and consolidated pretrial proceedings in a separate MDL in the Southern District of West Virginia. Alternatively, Movants request transfer to the Southern District of Illinois, and assignment to Judge Staci M. Yandle.

 

Respectfully submitted,

 

/s/ Scott R. Bickford

MARTZELL, BICKFORD & CENTOLA

Scott R. Bickford (LA 1165)

Spencer R. Doody (LA 27795)

338 Lafayette Street

New Orleans, LA 70130

Telephone: 504-581-9065 Facsimile: 504-581-7635 sbickford@mbfirm.com srd@mbfirm.com

usdcndoh@mbfirm.com

 

 

/s/ Celeste Brustowicz

COOPER LAW FIRM, LLC

Celeste Brustowicz (LA 16835)

Barry J. Cooper, Jr. (LA 27202)

Stephen H. Wussow (LA 35391)

Victor Cobb (LA 36830)

1525 Religious Street

New Orleans, LA 70130

Telephone: 504-399-0009 Cbrustowicz@sch-llc.com

swussow@sch-llc.com

 

 

/s/ Kevin W. Thompson

THOMPSON BARNEY LAW FIRM

Kevin W. Thompson David R. Barney, Jr.

2030 Kanawha Boulevard, East

Charleston, WV 25311

Telephone: 304-343-4401

Facsimile: 304-343-4405

Kwthompsonwv@gmail.com

 

 

/s/ James F. Clayborne

CLAYBORNE, SABO & WAGNER, LLP

Sen. James F. Clayborne (IL 45627)

525 West Main Street, Suite 105

Belleville, Il 62220

Telephone:  618-239-0187

Facsimile:  618-416-7556

jclayborne@cswlawllp.com

 

 

/s/ Jack W. Harang

LAW OFFICES OF JACK W. HARANG

Jack W. Harang (LA 15083)

2433 Taffy Drive

Kenner, LA 70065 Telephone: 504-810-4734

jwharang@gmail.com

 

 

/s/ Kent Harrison Robbins

THE LAW OFFICES OF KENT HARRISON

ROBBINS, P.A.

Kent Harrison Robbins (FL 275484)

242 Northeast 27th Street

Miami, FL 33137

Telephone: 305-532-0500

Facsimile: 305-531-0150

Primary: Khr@khrlawoffices.com

Secondary: ereyes@khrlawoffices.com

Tertiary: assistant@khrlawoffices.com

 

 

/s/ Donald Creadore

THE CREADORE LAW FIRM, P.C.

Donald Creadore (NY 2090702)

450 Seventh Avenue – 1408

New York, NY 10123

Telephone: 212-355-7200

Facsimile: 212-583-0412

Primary: donald@creadorelawfirm.com

Secondary: donald@aol.com

 

 

/s/ Warren Perrin

PERRIN, LANDRY, deLAUNAY

Warren Perrin

251 La Rue France

  1. O. Box 53597

Lafayette, LA 70505

Telephone: 337-233-5832

[1] Movants are: Deric Rees and Ceonda Rees, individually and as next friend and guardian of Baby T.W.B. on behalf of themselves and all others similarly situated (Illinois Class); Darren and Elena Flanagan, individually and as adoptive parents and next friends of Baby K.L.F., on behalf of themselves and all others similarly situated (Tennessee Class); Rachel Wood, individually and as next friend and adopted mother of Baby O.W., on behalf of themselves and all others similarly situated (Missouri Class); Melissa Ambrosio, individually and as next friend of Baby G.A., and on behalf of themselves and all others similarly situated (California Class); Shannon Hunt, individually and as next friend of Baby S.J., on behalf of themselves and all others similarly situated (Maryland Class); Bobbi Lou Moore on behalf of Baby R.R.C., and all other similarly situated (West Virginia Class); Walter and Virginia Salmons, individually and as the next friend or guardian of Minor W.D. and on behalf of all others similarly situated (National Class).

[2] All arguments in Motion to Vacate CTO-47 (JPML 2804 Rec. Doc. 2398) are adopted in support of this Motion.

[3] JPML 2804 Rec. Doc. No. 382 at 16-17, Transcript of November 30, 2017 Hearing.

[4] https://dhhr.wv.gov/News/2018/Pages/DHHR-Releases-Neonatal-Abstinence-Syndrome-Data-for-2017-.aspx

[5] CDC, “Opioid Use Disorder Documented at Delivery Hospitalization – United States 1999-2014,” August 10, 2018, at 2. “West Virginia, for example, had a prescribing rate estimated at 138 opioid prescriptions per 100 persons in 2012, suggesting that individual persons might receive more than one opioid prescription per year.”

[6] https://www.usnews.com/news/politics/articles/2018-05-08/hill-panel-probing-opioids-abuse-targets-distributorfirms

[7] Id.

[8] Id.

[9] Knight v. Boehringer Ingelheim Pharm., Inc., 2018 WL 3037442 (S.D.W. Va. June 19, 2018).

[10] See, e.g., City of Huntington v. AmerisourceBergen Drug Corp., No. CV 3:17-01362, 2017 WL 3317300 (S.D.W. Va. Aug. 3, 2017); The Town of Clendenin, West Virginia v. AmerisourceBergen Drug Corporation et al., No. 2:18-CV-01284, (S.D.W. Va.

Sept. 10, 2018); Adkins v. Purdue Pharma, L.P. et al., No. 18-CV-00477, (S.D.W. Va. Mar. 23, 2018).

[11] Walker v. Medtronic, Inc., No. CIV.A. 2:07-00317, 2010 WL 4822135 (S.D.W. Va. Nov. 24, 2010), aff’d, 670 F.3d 569 (4th Cir. 2012).

[12] See MDL No. 2187, In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation.

[13] See, e.g., Raab v. Smith & Nephew, Inc., 150 F. Supp. 3d 671 (S.D.W. Va. 2015).

[14] In re: Pradaxa (dabigatran etexilate) Prod. Liab. Litig., 883 F. Supp. 2d 1355, 1356 (U.S. Jud. Pan. Mult. Lit. 2012) (“The Southern District of Illinois’ geographically central location and accessibility also commend it for this nationwide products liability litigation.”).

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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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Zostavax MDL 2848 (Shingles Vaccine) Consolidated In USDC ED Pennsylvania

Zostavax MDL 2848 Puts Merck Back on the MDL Hotseat

By Mark A. York (August 14, 2018)

 

 

 

 

 

 

 

The JPML has created the Zostavax MDL 2848 and assigned the lawsuits filed related to Merck’s shingles vaccine to the United States District Court of Pennsylvania and Judge Harvey Bartle III. See Mass Tort Nexus Zostavax brief case: ZOSTAVAX-(Zoster-Vaccine-Live)-MDL-2848-USDC-Eastern-District-of-Pennsylvania.

Shingles is a rash on the side of the face or body, usually affecting persons over 50. The U.S. Food and Drug Administration approved Zostavax as a shingles vaccine in 2006.

The August 2, 2018  order by the U.S. Judicial Panel on Multidistrict Litigation consolidates Zostavax MDL 2848 in the US District Court of Pennsylvania (Eastern District) in front of U.S. District Judge Harvey Bartle, who has been hearing one of the initial Zostavax cases filed in  016. The lawsuits, filed in courts across the country including, Pennsylvania, New Jersey, New York, Wisconsin and Massachusetts, allege that Merck failed to warn that the virus in the vaccine caused shingles, brain damage and death, among other things.

In a move not often seen, defense counsel for Merck had moved for an MDL assigned to Judge Bartle in Pennsylvania or U.S. District Judge James Moody of the Middle District of Florida.

“Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Zostavax are common to all actions,” wrote the JPML chairwoman, Sarah Vance. “Seven actions are pending in this district, and they are the earliest filed and most advanced actions in this litigation.”

Lead Counsel Comments

“My cases pending before Judge Bartle are the most advanced in the Zostavax litigation,” said Mark Sadaka of The Law Offices of Sadaka Associates in Englewood, New Jersey, a plaintiffs lawyer who supported sending the cases to Bartle. “Merck has already produced millions of pages of documents in my cases in the Easter District of Pennsylvania. Judge Bartle has already decided two summary judgment motions. I look forward to working together with other plaintiffs counsel to finally move our cases to trial.”

Other plaintiffs lawyers had formally opposed creation of an MDL.

Marc J. Bern & Partners in New York, a firm with by far the most individual plaintiffs in the country—over 5,000 Zostavax clients stated “we will be looking to be leaders in this MDL” and “certainly, Judge Bartle is a judge with long experience, has handled successfully other MDL’s” said name partner Marc Bern.

Merck Previously Admits Shingles Vaccine Can Cause Eye Damage and Shingles

Two important FDA approved changes to the warning label of Merck Pharmaceutical’s shingles vaccine, Zostavax, have been made since the controversial drug was introduced in 2006.  The first was in August 2014, when, in addition to potentially causing chickenpox, another side effect was added: shingles! That’s right. The vaccine that had been – and continues to be — aggressively marketed to prevent seniors from contracting this excruciating condition was found to actually cause shingles in some individuals.

The FDA approved a label change to warn those who prescribe the Zostavax vaccine of another potential side effect: “Eye Disorders: necrotizing retinitis.”

According to the authors of a Health Sciences Institute (HSI) article in January, 2016, “UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up.”  While Merck claims Zostavax is 50% effective, in the placebo group, 3.3 percent of the study participants developed shingles, compared to 1.6 percent in the vaccine group. So, while that is a 50% difference, the real, absolute risk reduction is just 1.7 percentage points.

The case criteria generally include the following injurie:

  • Autoimmune disorders, including Guillain-Barre Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Meniere’s Disease
  • Bell’s Palsy (facial paralysis)
  • Cardiovascular event
  • Congestive heart failure
  • Death
  • Hearing loss
  • Herpetic Neuralgia (disorder in the nerves)
  • Myelitis (spinal cord inflammation)
  • Pneumonia
  • Postherpetic neuralgia, or PHN (pain continuing after shingles blister subside)
  • Serious neurological diseases or disorders, including brain inflammation (encephalitis)
  • Stroke
  • Vasculitis
  • Vision problems, including blindness, eye infections, retinal damage, acute retinal necrosis

The JPML was aware of certain issues related to creation of MDL 2858, may delay cases for some plaintiffs, many of whom are older, but coordination of the  litigation would help resolve all the cases, “even if some parties might experience inconvenience or delay.”

The JPML order does not apply to lawsuits brought on behalf of 300 plaintiffs in California state court and 800 plaintiffs in New Jersey state court.

One of the lawsuits filed by female plaintiff Joria Bentley from Nevada, claims she suffered high blood pressure, an eye injury and other side effects from Merck & Co.’s Zostavax shingles vaccine in Zostavax litigation filed in the Philadelphia’s Court of Common Pleas. Ms. Bentley claims in her complaint that the patient information sheet, label and prescribing information that accompanied the vaccine did not provide any warning of the risk of viral infection and cites to the many instances of adverse events and other reports on medical issues caused by Zostavax.

Patients who received the injections are filing product liability lawsuits against Merck, alleging the company produced and sold an “unreasonably dangerous vaccine” that caused serious injuries after vaccination. Hailing from a range of states including Louisiana, South Carolina, Tennessee, Michigan and Wisconsin, the plaintiffs filed their suit in Merck’s home state of New Jersey. Instead of preventing shingles, Zostavax caused the plaintiffs to “contract a persistent strain of herpes zoster,” according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases.

The common allegations in all complaints are negligence, defective design, failure to warn, breach of express and implied warranties, misrepresentation involving risk of physical harm and unjust enrichment.

“Merck knew, or should have known, that its product caused viral infection, and was therefore not safe for administration to consumers,” the suits claim. There are “thousands of complaints” yet to be filed according to one of the lead plaintiff attorneys, adding “I think Merck has failed terribly to warn about the very serious side effects and the failure of the vaccine to do what they claim it does” as Merck continues to profit from

National Vaccine Information Center

NVIC provides links and resources such as the manufacturer product information inserts for Zostavax and shingles.

What is Shingles?

  • This information is for educational purposes only and is not intended as medical advice.

What is Zostavax?

Zostavax is a vaccine made by pharmaceutical giant Merck, and approved by the U.S. Food and Drug Administration in 2006. It was the only approved shingles vaccine in the United States until late 2017, which allowed the company to earn as much as $749 million in sales from the vaccine in 2016, according to reports.

This vaccine is designed to reduce the risk of getting herpes zoster — a painful and debilitating condition commonly known as “shingles” — in individuals ages 50 years and older, who are at increased risk of developing the virus. Zostavax is typically recommended for people aged 60 years and older by the U.S. Centers for Disease Control and Prevention, and doctors commonly give the vaccine in a one-dose shot.

Zostavax differs from some vaccines in that it contains a live, but weakened form of the herpes zoster virus (this is officially referred to as a “live, attenuated virus”). People with weakened immune systems cannot receive these types of vaccines.

 

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The Case for Individual Opioid Claims

Individual Opioid Claims 

Attend the July 20-22, 2018 Mass Tort Nexus Opioid Crisis Summit, to learn more about what your firm can do to help individual victims of the opioid epidemic.

The Opiod Crisis Summit will provide information related to the types of claims that may be brought against the opioid defendants on behalf of individual plaintiffs. Additionally, you will receive the proven criteria questions to obtain these clients, as well as vital information related to the complex issues related to qualifying clients for each category of opioid injury.

To register for the Opioid Crisis Summit contact Jenny Levine at 954-530-9892 or email at jenny@masstortnexus.com.

You can also register online at  https://www.opioidcrisissummit.com

Many of your firms’ past P.I. clients may have claims against the opioid defendants

If your personal injury firm is not reaching out to its past clients and engaging in “public awareness marketing,” to obtain opioid clients, you are missing out on an opportunity to help the several hundred thousand individuals and families, that have potential claims against the opioid litigation defendants.

Personal Injury firms are in a unique position to help individuals harmed by the opioid epidemic, as many of these potential clients will have been previously represented by your firm.  The first opioid prescription issued to an individual often occurs after a personal injury, such as an auto accident or work place injury. If your firm does not reach out to its past clients and offer to represent them in their potential claim against the opioid defendants, you can rest assured that other firms will eventually sign these cases.

Misconceptions about the Learned Intermediary Doctrine

Numerous firms have expressed concerns related to opioid individual cases being eviscerated by the Learned Intermediary Doctrine. This concern may arise from opioid individual cases from over a decade ago, that resulted in defense wins based on learned intermediary doctrine arguments.

Despite the defense Learned Intermediary Doctrine wins from over a decade ago, the researchers at Mass Tort Nexus and many others do not believe the Learned Intermediary Doctrine will be a significant factor in individual opioid cases filed now or in the future.

Why?

Much has occurred since the defense “Learned Intermediary Doctrine” wins of the past.

  1. The FDA has issued multiple new Black Box Warnings for all opioid products and more are expected.
  2. The FDA, CDC, NIH and even State Medical Boards have issued new guidelines for opioid prescribing and even stricter guidelines are expected in the future.

Considering all that is now known, it is unlikely that any physician would testify that he/she would continue to prescribe opioids, in the same manner as the past.

This is what the Surgeon General had to say

The current U.S. Surgeon General, Jerome Adams and immediate past U.S. Surgeon General, Vivek Murthy have issued statements containing language like the excerpt below, from a letter sent by Mr. Murphy to every prescriber in the United States:

Nearly two decades ago, we were encouraged to be more aggressive about treating pain, often without enough training and support to do so safely. This coincided with heavy marketing of opioids to doctors. Many of us were even taught – incorrectly – that opioids are not addictive when prescribed for legitimate pain.”

It is worth noting that the current Surgeon General Jerome Adams has been personally impacted by the opioid crisis. His brother is one of the many victims.

The Bottom Line

The learned intermediary was not “learned” in the past, doctors were misinformed or incorrectly “learned.” Defendants would face great challenges in succeeding in arguments sounding in the Learned Intermediary Doctrine given all that is now known.

New Black Box Warnings

In June of 2018, the FDA required new Black Box Warnings be added to the prescribing labels of all instant release opioid products partially because prescribers were miseducated by the opioid defendants, their front groups and key opinion leaders.

New Black Box Warning requirements were imposed on all opioid instant release products, as of June 2018. The intent was to ensure that previously miseducated doctors (learned intermediaries) gain an understanding of current proper opioid prescribing standards and cease prescribing opioids based on the past misinformation (incorrect learning) they received over the past several decades.

 

 

 

 

 

 

Mass Tort Nexus invites you to attend our July 20-22 Opioid Crisis Summit and hopes that your firm will join the fight on behalf of the hundreds of thousands of individual opioid victims needing legal representation.

To register for the Opioid Crisis Summit contact Jenny Levine at 954-530-9892 or email at jenny@masstortnexus.com.
You can also register online at  https://www.opioidcrisissummit.com

 

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New York And Other State Court Opioid Litigation Moves Forward Along With Federal Opiate Rx MDL 2804

“LAWSUIT FLOOD VERSUS ENTIRE OPIOID INDUSTRY IS GETTING BIG PHARMA’S ATTENTION”

By Mark A. York (June 11, 2018)

 

 

 

 

 

 

Opioid litigation in New York and other state courts, where hundreds of counties and cities have filed lawsuits against opioid manufacturers and distributors,  are now moving forward even with the explosion in the Federal Opiate Litigation MDL 2804 OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where more than 500 states, counties, cities as well as unions, hospitals and individuals have filed lawsuits against the opioid industry as a whole.

At one point, the opiate industry attempted to raise arguments stating that the Food and Drug Administration hasn’t yet determined whether narcotic painkillers are unnecessarily dangerous – a central question in any litigation, which was quickly denied and seems to show that Opiate Big Pharma is once again attempting to hide behind the FDA shield.

In a two-page order issued in March by Judge Jerry Garguilo of the Suffolk County Supreme Court, New York where he ruled that there is “no compelling reason to impose a stay of proceedings” until the FDA completes its own review of the benefits and risks of opioids. The lawsuits by most of the counties in New York, which have been consolidated in Garguilo’s court, are “backward-looking” toward allegedly fraudulent marketing materials and tactics the drug companies used to convince doctors and patients their products had low risk of addiction.

In another state court, the first of many opioid litigation trials to be scheduled is now set in Oklahoma, where Cleveland County District Judge Thad Balkman set May 28, 2019 for the start of the trial. ate has been set for a lawsuit by a state against pharmaceutical companies over the opioid epidemic, according to Oklahoma‘s attorney general. See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

Oklahoma, one of at least 20 states besides New York that have opioid lawsuit dockets against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

The New York state court lawsuits are joined by another somewhat unique group of plaintiffs in the legal battle over the opioid-epidemic with class actions filed by consumers who claim they’re seeing skyrocketing health insurance costs as a result of the crisis.

The suits, filed in New York and four other states, were brought by individual persons against opioid manufacturers and distributors, and are among the few class actions filed against drug makers and marketers. The vast majority of cases have been separate actions brought by government entities like cities and counties.

The plaintiffs in this new wave of cases have filed across the country in federal courts in  USDC SD New York (Complaint) , a New Jersey Complaint,  a Massachusetts Complaint, an Illinois Complaint as well as a California Complaint  where they’ve filed lawsuits on behalf of those who paid increased health insurance costs–including higher premiums, deductibles and co-payments–because of effects attributable to the opioid epidemic.

The proposed classes include businesses and individuals who paid for health insurance as part of employer-sponsored plans.

“We don’t know anyone who in the litigation is addressing the private sector harms to consumers and businesses from increased premiums and other insurance costs that flow to anyone in the health insurance market as a result of the fact that insurers are paying more for addictions,” said Travis Lenkner, one of the plaintiffs attorneys filing the cases.

The opioid cases add a new type of plaintiff into the wide-reaching opioid litigation, which have also includes states, Native American tribes, pension funds and hospitals.

John Parker, senior vice president of the Healthcare Distribution Alliance, speaking on behalf of distributors AmerisourceBergen Drug Corp., Cardinal Health Inc. and McKesson Corp., all named as defendants, called the opioid epidemic a “complex public health challenge.”

“Given our role, the idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated,” he said in a statement. “Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation.”

Purdue Pharma spokesman Bob Josephson noted that his company’s products account for less than 2 percent of all opioid prescriptions. Johnson & Johnson’s Janssen Pharmaceuticals defended the labels on its prescription opioids and called the allegations “baseless and unsubstantiated.”

Representatives of the other manufacturing defendants, which include Endo Health Solutions, Teva Pharmaceutical Industries and Insys Therapeutics Inc., did not respond to requests for comment.

It is now fairly common knowledge in the legal world that there is more than enough data that links increased health insurance costs to the opioid epidemic as well as the overall catastrophic impact of the flood of opioids into the America marketplace.

The suits cite statistics. In California, for instance, health insurance premiums for family coverage increased 233.5 percent from 2002 to 2016. Monthly premiums for the plaintiff in that case, Jordan Chu, jumped from $160.52 in 2016 to $240.76 this year. New Jersey residents with private health insurance spent $5,081 in insurance premiums in 2014, up from $2,454 in 2001. And an average family plan in New York with annual costs of $9,439 in 2003 had jumped to $19,375 in 2016.

Plaintiff counsel stated that they will be filing suits in more states and fight any attempts to transfer these cases to the Northern District of Ohio, where U.S. District Judge Dan Polster is overseeing the opioid multidistrict litigation, MDL 2804, even though the cases were filed in federal courts. A damaging discovery win for the plaintiffs was the order of May 18, 2018, see DEA ARCOS Database Access Order May 8, 2018 MDL 2804, where Judge Polster ordered the DEA to turn over distribution data for all 50 states based on the revelations in a prior DEA related order where the Opioid Drug distribution data provided very solid information on all the parties involved in creating the opioid crisis over the last 15 years.

The New York court docket parallels the federal and many other opioid based complaints, filed in state courts across the country where parties have decided to pursue their claims in their state courts versus the federal docket. These filings in both state and federal courts, will only increases the pressure on manufacturers and wholesalers to either win dismissal of these cases or prepare for an accelerated trial schedule.

There are currently more than 500 of the nation’s 3,200 counties have sued and plaintiff lawyers hope to soon get that number to 1,500, which some lawyers consider critical mass for a settlement.

The defendant companies argue they can’t be held liable for selling a legal product sold only with a doctor’s prescription whose distribution was controlled and overseen, from manufacturing to retail sales, by federal and state regulators.

The plaintiffs argue manufacturers used a variety of tactics, including misleading marketing materials and highly paid physician-influencers, to convince prescribing physicians their products were safe for treating chronic pain when, in fact, they were highly addictive.

In the March order, Judge Garguilo rejected the defendants’ claim that the FDA has exclusive authority to determine whether, in effect, opioids should be sold for anything other than relieving the pain of terminal illness. Regardless of what the FDA determines, the judge said, the municipal plaintiffs have the right to seek redress for their costs associated with addiction.

“Because the focus of this lawsuit is on the state of scientific knowledge that existed when the defendants made their marketing claims, there is no risk of inconsistent rulings, and none of the current studies will have any bearing on whether the defendants’ representations were misleading when made,” the judge wrote. The court isn’t being asked to decide the risks and benefits of opioids but whether the defendants misrepresented those risks and benefits, he added.

In case the defendants didn’t grasp the judge’s ultimate goal, the judge restated his “previously expressed desire” for a “prompt resolution of this matter.” The federal judge overseeing multidistrict litigation in Ohio, Judge Dan Aaron Polster, has similarly urged defendants to engage in settlement talks, although a global resolution of the litigation could prove difficult to negotiate.

In addition to hundreds of cases consolidated in federal court, the defendants face a wave of litigation in state court, like the New York cases, as well as lawsuits and investigations by 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 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.

For those looking to tap into the opioid litigation or learn what the current status is in both state and federal court opioid litigation, please visit www.opioidcrisissummit.com where Mass Tort Nexus is hosting national political leaders and lead opiate counsel who are active in the day to day opioid crisis and have the most up to date case information during the two day event taking place July 21-22, 2018 in Fort Lauderdale.

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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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Zinbryta Emerging Litigation

Emerging Zinbryta Litigation

 

 

 

 

 

 

 

 

Zinbryta (daclizumab) is made and marketed by Biogen and AbbVie. Zinbryta first received FDA approval pursuant to Biologic License Application (BLA: 761029) in May of 2016.  Zinbryta is a humanized monoclonal antibody that is self-administered as an injection for the treatment of Multiple Sclerosis.

In March of 2018 Biogen published a letter directed towards physicians and surgeons giving notice that Zinbryta would be withdrawn from the market and would no longer be available as of April 30, 2018.

Biogen Withdrawal Letter link: Biogen – AbbVie Notice of Withdrawal of Zinbryta in USA – March 12, 2018

Additional media related to withdrawal of Zinbryta:

https://www.zinbryta.com/content/dam/commercial/multiple-sclerosis/zinbryta/pat/en_us/pdfs/zinbryta-withdrawal-patient-letter.pdf

Adverse events potentially associated with Zinbryta include:

Serious Liver Damage

Inflammatory Brain Disease

Encephalitis

Onset of Seizures secondary to adverse reactions.

Death secondary to adverse reactions.

To Learn More About the Emerging Zinbryta Litigation:

The emerging Zinbryta Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

 

 

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

Course attendees will receive the benefit of a step by step analysis of the emerging Zinbryta Litigaton, using these primary metrics:

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including James Onder, of The Onder Firm in St. Louis, MO>

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

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Viberzi Emerging Litigation   

 Emerging Viberzi Litigation  

Viberzi Litigation

   

 

 

 

 

 

 

 

 

 

Viberzi made by Allergan received FDA approval subsequent to New Drug Application (NDA:206940) in May of 2015.

Since its approval the makers of Viberzi have flooded the media with advertisements, primarily directed toward women, featuring a now familiar female character wearing a jumpsuit featuring print depicting a portion of the human gastro-intestinal system.

 

FDA Communication Excerpt on Viberzi:

“FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns.

Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.”

Viberzi Emerging Litigation

Gallstone disease is one of the most common of all digestive diseases. The U.S. Centers for Disease Control and Prevention estimates that 6.3 million men and 14.2 million women in the United States have gallbladder disease. There is marked variation in the prevalence between ethnic groups

Approximately 700,000 individuals in the U.S.  have their gallbladder removed each year.

How to Learn More About the Emerging Viberzi Litigation

The emerging Viberzi Litigation will be used as a case study in the May 18 – 21, 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” to register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

 

Course attendees will receive the benefit of a step by step analysis of the emerging Viberzi

Litigation, using these primary metrics:

 

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

See endorsements below of some of the top mass tort trial lawyers in the country who’ve attended the Mass Tort Nexus Immersion Course>

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

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