$19.5 Million Settlement with Bristol-Meyers Squibb for Illegally Marketing Abilify

abilify-2California Attorney General Kamala D. Harris today announced that California, along with 42 other states and the District of Columbia, has reached a $19.5 million agreement with Bristol-Myers Squibb over allegations that the company illegally marketed the popular atypical antipsychotic drug Abilify.

In 2009, California and other states launched a multistate consumer protection investigation of Otsuka America Pharmaceutical, Inc., which manufactures Abilify, and Bristol-Myers Squibb, which is largely responsible for promoting Abilify.

The investigation found that Bristol-Myers Squibb engaged in off-label marketing by illegally promoting Abilify for therapeutic uses for which it was not approved, such as certain pediatric uses and to treat dementia. In addition to incentivizing sales representatives to engage in off-label marketing, the investigation found that the company misled doctors and patients about the drug’s risks and side effects and misrepresented the findings of scientific studies concerning the drug in marketing messages.

“These companies endangered and compromised the health and well-being of millions of Americans in order to turn a profit,” said Attorney General Harris. “This settlement makes clear that pharmaceutical companies using deceptive and unlawful tactics to promote drugs will not be tolerated in the United States.”

MDL created in October

Some 43 federal lawsuits against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc. are consolidated in MDL 2734, In re: Abilify Products Liability Litigation, created in October 2016 and supervised by US District Judge M. Casey Rodgers in the Northern District of Florida.

Plaintiffs allege that Abilify can cause compulsive gambling behaviors. All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

Abilify is approved by the Food and Drug Administration to treat schizophrenia, bipolar disorder, major depressive disorder, and Tourette’s disorder. Abilify, known as a blockbuster drug because of its popularity, generated $5.5 billion in sales in 2014, with Bristol-Myers Squibb receiving approximately $2.02 billion of that amount.

The settlement places strict rules on how Bristol-Myers Squibb can promote and market Abilify going forward, including prohibiting the company from promoting the drug for off-label uses, compensating health care providers for promotional activities without disclosing their connection to the company, using medical grants to promote the drug, and making unsubstantiated safety or efficacy comparisons between Abilify and other products.

In addition, under the terms of the agreement, Bristol-Myers Squibb must provide only accurate and scientifically balanced information about Abilify, conspicuously disclose risks, and take clear steps to ensure it is not creating financial incentives for promotion, sales, and marketing that would violate the law.

 

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New MDLs Consolidate Cases for Abilify, Roundup, Talc and Taxotere

Consolidating thousands of lawsuits involving Abilify schizophrenia drug, Roundup herbicide, Talc powder and Taxotere cancer drug, US Judicial Panel on Multidistrict Litigation (JPML) in Washington, DC, created new multidistrict litigation (MDL) dockets for the mass tort cases.

This is good news for plaintiffs. In due course the assigned courts will create short-form complaints and plaintiff fact sheets, facilitating the filing of new actions. Each litigation will be led by a plaintiff’s steering committee appointed by the judge, who will set a discovery schedule and select representative cases for bellwether trials.

abilifyAbilify (Aripiprazole)

Responding to a motion from all the parties, the JPML created new MDL 2734, In re: Abilify Products Liability Litigation, supervised by US District Judge M. Casey Rodgers in the Northern District of Florida. The ruling consolidates 22 actions filed in 12 district courts against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.

Plaintiffs allege that Abilify, an atypical anti-psychotic medication commonly prescribed to treat schizophrenia, bipolar disorder, depression, and Tourette syndrome, can cause compulsive gambling behaviors. All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

For more information read FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

WHO-says-Roundup-probably-causes-cancerRoundup (Glyphosate)

Granting the plaintiffs’ motion, the JPML created the new MDL No. 2741, In Re: Roundup Products Liability Litigation, supervised by Judge US District Vince Chhabria in the Northern District of California. Monsanto opposed consolidation. There are 21 actions pending in 14 districts. Including the potential tag-along actions, there are now 37 actions pending in twenty-one districts. More than ten different law firms represent plaintiffs in these actions, which are spread across the country.

These actions share common factual questions arising out of allegations that Monsanto’s Roundup herbicide, particularly its active ingredient, glyphosate, causes non-Hodgkin’s lymphoma. Plaintiffs each allege that they or their decedents developed non-Hodgkin’s lymphoma after using Roundup over the course of several or more years. Plaintiffs also allege that the use of glyphosate in conjunction with other ingredients, in particular the surfactant polyethoxylated tallow amine (POEA), renders Roundup even more toxic than glyphosate on its own.

For more information read New Illinois Lawsuit Charges Monsanto’s Roundup Causes Cancer

talc johnson & johnsonTalcum Powder

The JPML created the new MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, supervised by US District Judge Freda L. Wolfson in the District of New Jersey. There are 10 actions in 8 districts.

The plaintiffs allege that they or their decedents developed ovarian or uterine cancer following perineal application of Johnson & Johnson’s talcum powder products (namely, Johnson’s Baby Powder and Shower to Shower body powder). Two of the actions are consumer class actions brought on behalf of putative classes of women who allege that defendants deceptively marketed the talcum powder products for feminine hygienic use without disclosing talc’s carcinogenic properties. All the actions involve factual questions relating to the risk of cancer posed by talc and talc-based body powders, whether the defendants knew or should have known of this alleged risk, and whether defendants provided adequate instructions and warnings with respect to the products.

For more information read Behind the $55 Million Talc Verdict: J&J Knew About Cancer Risks Since the 1970s

taxotere hair lossTaxotere (Docetaxel)

The JPML created new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation, supervised by Chief US District Judge Chief Judge Kurt Engelhardt in the Eastern District of Louisiana. The litigation consists of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

Plaintiffs in these actions each allege that they experienced permanent hair loss as a result of using Taxotere. All actions will require discovery regarding the design, testing, manufacturing, marketing, and labeling of Taxotere. The defendant is Sanofi-Aventis U.S. LLC.

All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.

For further information read FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

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More Risperdal Cases Set for Trial in Philadelphia

Derek T. Braslow
Derek T. Braslow

Eight cases involving the antipsychotic drug Risperdal are set for trial against Janssen Pharmaceuticals in the Philadelphia Court of Common Pleas, with the company settling cases even as it denies that the drug causes disfiguring gynecomastia in boys.

Risperdal, a prescription medication used to treat schizophrenia and bipolar disorder, has caused gynecomastia, or the development of female breast tissue, according to leading plaintiff’s lawyer Derek T. Braslow of Pogust, Braslow & Millrood in Conshohocken, PA. This condition resulted from elevated levels of the hormone prolactin in the plaintiffs – which they allege is from their use of Risperdal.

Read these updates:

Risperdal Docket in Philadelphia Court of Common Pleas

Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

New Judge Knocks Out Plaintiff’s Expert, Abruptly Dismisses Risperdal Case

$70 million Verdict against Janssen Pharma in Risperdal Breast-Growth Case

The litigation has been continuing for three years, with 2,000 plaintiff cases filed in Philadelphia and the next trial set for January.  Another 16,000 case are consolidated in California Superior Court in Los Angeles with the first trials set for July.  Three earlier trials have resulted in verdicts in favor of the injured plaintiff in the amount of $2.5 Million, $1.75 Million, and $500,000.  In all the trials, juries have found that J&J failed to adequately warn of the risks of gynecomastia.

Fined $2.2 Billion

Janssen, a subsidiary of Johnson & Johnson, never got approval to market the drug for minors. Johnson & Johnson was fined more than $2.2 billion in criminal and civil fines in November 2013. It settled accusations that it improperly promoted the  drug to older adults, children and people with developmental disabilities, according to the Justice Department.

Kentucky Attorney General Jack Conway announced a $15.5 million settlement in December 2015 with Johnson & Johnson regarding Risperdal. The consumer protection lawsuit charged that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers.

Former commissioner of the U.S. Food & Drug Administration (FDA) David Kessler testified in 2015 that the company hid information about the gynecomastia risk as early as 6 years before it changed the drug’s label to include the injury, which is characterized by abnormal breast tissue growth in adolescent boys and young men. He also told the jury that Janssen failed to inform physicians of the gynecomastia risk associated with the drug.

Scientific research supports claims that Risperdal may cause gynecomastia in boys. A study published in a 2006 issue of the Journal of Clinical Psychopharmacology indicated that risperidone, which is the generic of Risperdal, “administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”

Braslow said that J&J has been settling Risperdal cases, but the amounts are not disclosed. The highest settlements are for boys who undergo double mastectomy.  He advised plaintiff lawyers to focus on cases involving prescriptions written from 2000 to 2006.

Risperdal has carried a black-box warning by the FDA since September 2006 to warn about the increased risk of death in elderly patients with dementia-related psychosis. In addition to the increased risk of death in the elderly, Risperdal has added warnings associated with Tardive Dyskinesia, which is the development of abnormal facial, shoulder and limb movements that a patient cannot control.

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Abilify Patients Move to Consolidate Cases to Florida Federal Court

abilifyPatients who took Abilify and suffered compulsive sex, gambling and shopping side effects have requested that the US Judicial Panel on Multidistrict Litigation consolidate 26 federal lawsuits against the manufacturers into the US District Court for the Norther District of Florida.

A decision on the motion, filed on June 24, is expected soon, because the defendants are also seeking consolidation. An MDL would  centralize 26 Abilify cases filed by four different law firms, pending in 12 different federal district courts before 14 different federal judges. The case is In Re: Abilify Compulsive Behavior Products Liability Litigation.

In addition, 13 Abilify compulsive behavior lawsuits pending in New Jersey state court have been consolidated in one proceeding for pretrial coordination. In total, Plaintiffs’ counsel anticipate that hundreds of additional Abilify compulsive behavior cases will be filed.

24 million patients

Since its U.S. launch over 13 years ago, an estimated 24 million patients have used Abilify with sales in 2013 totaling $2.3 billion. Doctors widely prescribe it to treat patients with schizophrenia, bipolar disorder, and major depressive disorder. The defendants are Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.

The movants recommend the new MDL be supervised by Judge Margaret Catharine “Casey” Rodgers in Pensacola, FL, before whom two Abilify compulsive behavior cases are pending. There are no MDLs pending in the Florida courthouse.

Denise Miley and Brad Miley of Maple Grove, Minnesota, filed the first lawsuit on January 12, 2016, in the District of Minnesota, Miley v. Bristol-Myers Squibb Company, Case 0:16-cv-00067.

Abilify was introduced in 2002 as an atypical anti-psychotic prescription medicine discovered by Defendant Otsuka Pharmaceutical Co., Ltd. In November 2012, the European Medicines Agency required that the defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling.

Warnings since 2012

Agencies began issuing warnings in 2012:

  • In November 2012, the European Medicines Agency required that the defendants warn patients and the medical community in Europe that Abilify use included the risk of pathological gambling.
  • In November 2015 Canadian regulators concluded that there is “a link between the use of aripiprazole and a possible risk of pathological gambling or hypersexuality.”
  • On May 3, 2016, the FDA, in an “FDA Safety Communication,” announced that warnings about “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex” would be added to the Abilify label. From 2005 to 2013, an FDA report showed that Abilify accounted for at least fifty-four reports of compulsive or impulsive behavior problems, including thirty reports of compulsive gambling, twelve reports of impulsive behavior, nine reports of hypersexuality, and three reports of compulsive shopping.

Among the issues that must be decided in a case are:

  1. Whether and to what extent Abilify is a substantial factor in causing the alleged compulsive behavior.
  2. When Defendants learned of any such connection between Abilify and the alleged compulsive behavior.
  3. Whether, and for how long, Defendants concealed any such knowledge from prescribing physicians.
  4. Whether Defendants failed to provide adequate and timely warnings and instruction about the alleged relationship between Abilify and compulsive behavior.
  5. Whether Defendants engaged in fraudulent and illegal marketing practices including, but not limited to, making unsubstantiated claims about the effectiveness and superiority of Abilify.
  6. Whether Defendant Otsuka Pharmaceutical Co, Ltd. is subject to personal jurisdiction in the United States courts.

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