update on risperdal mass tort litigation with robert mosier

RisperdalRobert A. MosierSanders Phillips Grossman, LLC2860 Michelle Drive, Ste 220Irvine, CA 92606Rmosier@thesandersfirm.com949-233-7002 Cell

Offices in CA, NY, WA, PR

Risperdal Basics

SANDERS PHILLIPS GROSSMAN, LLC.

What is Risperdal?

• It is a very powerful antipsychotic developed by Janssen Pharmaceuticals to treat schizophrenia in adults

• It works by blocking dopamine receptors in the brain (dopamine antagonist)

• However, it also has a serious side effect – by blocking dopamine, it causes prolactin to spike out of control (rises more than 10 times normal limits in first 1-3 hours) and prolactin remains elevated while on the drug

What is Prolactin?

• Prolactin is the hormone responsible for breast growth and lactation in pregnant women.

• Breast growth and lactation are wonderful for pregnant women and their newborns.

• However it is psychologically and physically damaging to young boys and men . . . .

So why are we here?• Because Janssen illegally marketed and

sold its powerful antipsychotic drug, Risperdal, to one of the most vulnerable segments of our society – our children – and hid this disfiguring side effect causing a generation of young boys and men to grow female breasts. (gynecomastia).

• PHOTOS

So why was Janssen illegally pushing this powerful antipsychotic on our children?

Because Janssen wanted more, a lot more…

More market share,

More sales,

More profits.

Janssen’s illegal marketing scheme worked

By 2008, Risperdal was a Billion Dollar Blockbuster drug.

• Janssen sold $3.4 Billion of Risperdal in 2008.

• Risperdal was Janssen’s #1 selling drug.

• It was drug giant Johnson & Johnson’s #2 selling drug worldwide.

But then they got caught….

• Because of J&J’s illegal marketing of Risperdal, Janssen pled guilty to criminal charges of off-label marketing – coupled with a contemporaneous False Claims Act action brought by the United States, and paid $2.2 Billion in criminal and civil fines – the third largest in US History.

Risperdal Label History

Risperdal Label and Approvals

• 1993 (Adult – psychotic disorder/schizophrenia)• 2006 (Child & Adolescent – Autism (Irritability))• 2007 (Child & Adolescent – Schizophrenia &

Mania Associated with BiPolar Disorder)• 2008 (Generic – Patriot)

1993 – 2006 Adult Label

1993 – 2006 Adult Only

15SANDERS PHILLIPS GROSSMAN, LLC.

2006/2007 LabelC&A Indication

2006 Risperdal Prescribing Information (PI) @ 11“INDICATIONS AND USAGE”

2006 Risperdal Prescribing Information (PI) @ 32“USE IN SPECIFIC POPULATIONS”

2006 Risperdal Prescribing Information (PI) @ 37

2006 Risperdal Prescribing Information (PI) @ 6

2007 Label

Approved Pediatric Indications- Summary

RISPERDAL

1993- October 2006 – NO PEDIATRIC INDICATION

October 2006 – Irritability associated with autistic disorder

December 2007 – Adolescent Schizophrenia and Mania

Associated with Bi-Polar disorder.

NEVER approved for ADD, ADHD, OCD, Tourette, Depression,

Conduct Disorder, etc.

Attempts to obtain C&A Indications and Off-Label Marketing prior to 2006

1993 – Risperdal Approved for Adults

By 1996, Janssen figured out it was missing a huge untapped and profitable market..

The child and adolescent market worth hundreds of millions of dollars

So they tried to get FDA approval…

1996 – FDA - Denied

• “you have not identified any pediatric indications for which you believe Risperdal could be approved and you have provided no data from adequate and well-controlled trials to support such approvals… To permit the inclusion of the proposed vague references to the safety and effectiveness of Risperdal in pediatric patients and the nonspecific cautionary advice about how to prescribe Risperdal for the unspecified target indication would only serve to promote the use of this drug in pediatric patients without any justification.”

Janssen did not care . . . They wanted more.

They knew the child and adolescent market was an untapped gold mine.

So they hatched a plan.

First, they tried to get approval from the FDA . . . again.

March 2000 – Denied - Again

“main concern is that RISPERDAL or any other product would be used as a chemical straight jacket.”

But they wanted more

So they decided self help was in order and turned to the Johnson & Johnson marketing machine – their sales force.

2001 Business Plan Focused on Pediatrics

• Concluded that the fastest growing market for Risperdal was pediatrics (19 and under)

• Use of Risperdal was “exploding” at a growth rate of 17%, for a total market share of $340M per year

2001 Business Plan - Call to Action• Key Business goal was to grow and protect share in the

child/adolescent market.• Instructed sales reps to call on child psychiatrists and

children’s mental health facilities• Instructed sales reps to market Risperdal as effective for

ADHD, OCD and autism• Sponsored advisory boards with child psychiatrists• Sponsored Speaker Programs for “Risperdal in Children and

Adolescents with Severe and Disruptive Behaviors and Below Average IQ”

2002 Business and Tactical Plans for Pediatric Market

• “Reach New Heights with Risperdal in 2002”

• 4 key business strategies:– Understand level of awareness of Risperdal in children– Educate health care providers on therapeutic options for

treatment childhood mental illness– Develop a child and adolescent PR and media

management plan

2002 - C & A Business Plan• RISPERDAL is the most prescribed of the atypical

antipsychotics; however, as is the case with the other atypicals, RISPERDAL is not currently indicated for use in children and adolescents. The business plan will focus on continued market understanding, medical education efforts, the drug commercialization efforts necessary to capitalize on the market opportunities for the brand in the child and adolescent segment.

• J&J has a unique opportunity in the child and adolescent psychopharmacology marketplace due to its product offerings across multiple operating companies.

A Building Block for Success• Promotional materials included

advertisements showing children playing with blocks and claiming:

• “potentially prolactin-related adverse events in patients treated with Risperdal were comparable to those with placebo.”

2002 J&J Center for Pediatric Psychopathology at Mass General

Thousands of dollars donated to the Hospital run by Dr. Joseph Beiderman.

“Mission of the Center is to create common ground for a strategic collaboration between J&J and the Pediatric Psychopharmacology Research Program… and move forward the commercial goals of J&J.”

Biederman later disciplined by Harvard

• “Biederman also courted funding from Johnson & Johnson by promising that his work at Mass. General would promote the use of its anti-psychotic Risperdal in children. Johnson & Johnson gave the hospital $700,000 for a Biederman-led research center that performed studies promoting Risperdal.”

More Promotions – 2003 M-Tabs

• District Managers encouraged contests and other incentives to promote quick dissolving Risperdal for kids “there is a very large market for M-Tabs for children”

• San Antonio – Back to School “bashing” parties - encouraged ice cream parties, snacks and lunches to promote M-Tabs

• Lollipops and Small toys to be included in the kit with a coupon and a one box sample. Great for child and adolescent psychiatrists

2003, 2004, 2005, 2006……

2003 – they submit another application for a child and adolescent indication.2004 – pending2005 – “not approvable”2006 – irritability associated with autism2007 – mania associated with bipolar and schizophrenia

NO OTHER C&A INDICATIONS WERE EVER GRANTED

DOJ Action - $2.2Billion

• Risperdal Qui Tam– In a separate action brought by the U.S. DOJ, J&J

agreed in November 2013 to pay more than $2.2 billion to federal and state governments and in penalties to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs, including Risperdal, for unapproved uses in children, seniors and disabled patients. Company pays $1.273 billion in civil penalties. http://www.justice.gov/opa/pr/2013/November/13-ag-1170.html

Philadelphia Litigation

• The Honorable Arnold L. New• Plaintiffs’ Liaison Counsel

– Christopher Gomez, Sheller, P.C., Philadelphia, PA– Thomas R. Kline, Kline & Specter, Philadelphia, PA

• Defendants’ Liaison Counsel– Kenneth R. Murphy, Drinker Biddle & Reath, LLP, Philadelphia,

PA• 1,300+ Cases Pending

Risperdal Timeline in Philadelphia

• First Complaint Filed in January 2010• Mass Tort Created in March 2010• Master Complaint Filed in June 2010• First Amend Master Complaint Filed in September

2010• Second Amended Master Complaint Filed in April

2012• Three Bellwether Trials begin in September/October

2012• Settlement of filed cases only

Case Management in Philadelphia

• CMO1 –Deadlines, Service, etc.• CMO3 –PFS, DFS, Authorizations, SFC• CMO4 - Protective Order• CMO5 – Appt. of a Discovery Master• CMO7 – Filing of Qualified Trust Motions• Proposed CMO10- Stay of Cases Affected By

SOL Winter Decision• http://courts.phila.gov/common-pleas/trial/

civil/clc.asp

Court Grants MSJ – No Punitive Damage Recovery

Court Grants MSJ on SOL Motion • No Discovery Rule tolling of SOL after June 30,

California Litigation

• The Honorable William Highberger• Plaintiffs’ Lead Counsel

– Robert A. Mosier, Sanders Phillips Grossman, Irvine, CA– Daniel S. Robinson, RCRSD, Newport Beach, CA

• Defendants’ Lead Counsel– Steven Selna, Drinker Biddle & Reath, LLP, San

Francisco, CA• 3,000+ Plaintiffs (batch complaints)

Risperdal Timeline in California

• First Complaint Filed in January 2014• Mass Tort (JCCP) Created in May 2014• First Hearing July 2014• Bellwether Trials set June 2016• Discovery proceeding

– Depositions– Third Party (Canadian Production)– RFP’s, ROG’s– Clinical Trial electronic data– Clinical Trial Master Files– CRF’s– Case Specific

Case Management in California

• CMO1 –Lead/Liaison Counsel• CMO2 – Plaintiff Steering Committee• CMO3 - Protective Order• CMO5 – PFS/DFS• CMO6, 7 – Discovery

St. Louis Litigation

• First Batch Complaint Remanded May 4, 2015 (64 Plaintiffs) – Driscoll Firm, St. Louis

• Defense Counsel– Richard P. Cassetta, Stephen Strauss and Stefan Mallen of

Bryan Cave in St. Louis.• Beginning phases of discovery• No Trial dates yet

Trials - Philadelphia

Recent Philadelphia Trials• Pledger Trial began January 2015 (Plaintiff

verdict)• Cirba Trial began February 2015 (Defense

verdict)• Both Pre-2006 label cases• Failure to warn only • Tom Kline & Chris Gomez for Plaintiff in both

cases• Diane Sullivan & Ken Murphy for Defense

(Pledger)• John Winter & William Essig for Defense (Cirba)• Next two trials to be scheduled for October

Defenses

Puberty Other CausesTiming

Defenses

Defenses: Puberty

• Physiological• Idiopathic• Illicit drug usage such as

marijuana• Drug exposures• Leydig cell tumor• Sertoli cell tumor• Adrenal tumors• HCG secreting tumors• Aromatase excess syndrome

(increases the conversion of testosterone to estrogen)

• Hyperthyroidism

• Hypergonadotropic Hypogonadism (such as Klinefelter Syndrome)

• Hypogonadotropic hypogonadism

• Hyperprolactinemia (only if it induced hypogonadotropic hypogonadism)

• Exposure to estrogens (such as lavender, and tea tree oils)

• Medication exposure• Klinefelter syndrome

Defenses: Other Causes

Defenses: Timing

PLEDGER - Evidence Plaintiff had breast growth while on Risperdal- Photos- Mother was a strong witness- Kessler live

CIRBA - little evidence Plaintiff had breast growth while on Risperdal- No Photos- Mother and son were not strong witnesses- 5 treating physicians – no adverse effects while on drug

Verdicts

Pledger:$2.5 MillionFailure to Warn onlyNo Punitives allowedDisfigurement

Cirba:Jury found Janssen NegligentJury found no Causation

Upcoming Trials

PHILADELPHIATrial settings October 2015 and Spring 2016

CALIFORNIATrial settings June 2016

Case Criteria

An A Case• Timeframe of use: minor used between 9/2001 and

10/2006 – When Janssen should have warned about association

between Risperdal and gynecomastia and did not• Diagnosis:– Mentioned in medical records– Must have gynecomastia while ON Risperdal

• Off-label use that remains off-label to date:– Anything other than schizophrenia, mania associated

with Bipolar I, and irritability associated with autism

Risperdal Screening Criteria• Children (2001 to present)

– Males only– Took Risperdal (off-label use preferred)– Breast growth while on drug – Took Risperdal for at least 30 days (90+ days preferable)– Name brand Risperdal– The generic brand Patriot - the Patriot generic is an “authorized

generic” pharmaceutical• Risperdal became generic in June 30, 2008; however, you will see

brand name prescriptions after this date• NDC codes - http://www.accessdata.fda.gov/scripts/cder/ndc/

– Photos of permanent breast growth

Adult Cases• Considerations: – Research findings of older men with increased risk

of gynecomastia in risperidone and paliperidone (Invega) users compared to nonusers (69% increased risk)• Mahyar Etminan, PharmD, et al., Antipsychotic May

Boost Gynecomastia Risk. Medscape. Mar 17, 2014 – Pre-2008 label = Rare – Less than .1%– Post-2008 label = Less than 1%

Questions?Robert A. Mosier

Sanders Phillips Grossman, LLC2860 Michelle Drive, Ste 220

Irvine, CA 92606Rmosier@thesandersfirm.com

949-233-7002 Cell

update on risperdal mass tort litigation with robert mosier

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