$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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Plaintiffs Settle Risperdal Case with Johnson & Johnson in Philadelphia Court

Risperdal causes gynecomastia, or enlarged breasts, in men.
Risperdal causes gynecomastia, or enlarged breasts, in men.

The parties in a case charging that a boy who took Risperdal, causing him to grow female breasts, settled for an undisclosed amount with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Meanwhile, appeals continue over when the statute of limitations begins to run for victims of the Risperdal side effects.

  • A total of 2,085 Risperdal products liability cases are pending in the Complex Litigation Center of the Philadelphia Court of Common Pleas.
  • Another 300 cases are pending in the Superior Court of Los Angeles.

J&J Suppressed Science

In the Philadelphia case that settled, the plaintiff started taking Risperdal at age six for Asperger’s syndrome. N.F. v. Janssen Pharmaceuticals, Case No. 13500998. It would have been the sixth case to go to trial over evidence that Janssen hid a scientific link between the antipsychotic drug and male breast growth, or gynecomastia.

Jason Itkin of Arnold & Itkin in Houston, TX.
Plaintiff attorney Jason Itkin of Arnold & Itkin in Houston, TX.

Risperdal was approved by the U.S. Food and Drug Administration in 2002 to treat schizophrenia, but was not cleared for use in children until 2006.

Evidence that the company lied  about the scientific link and hid it from the Food and Drug Administration led to a $70 million jury verdict against Janssen on July 1. The case is Andrew Yount v. Janssen Pharmaceuticals Inc. et al., case number 1304002094, in the Court of Common Pleas of Philadelphia County, Pennsylvania. 

The jury in the Yount case found that J&J intentionally falsified, concealed, or destroyed material evidence,” states a press release from Arnold & Itkin.

“During trial, evidence that became known in the case as ‘Tab 4,’ was publicly revealed for the first time. Tab 4 includes scientific data showing a link between Risperdal and gynecomastia. The lawyers made a case that J&J intentionally kept Tab 4 secret- withholding it from the FDA and keeping it out of published scientific studies,” the press release states.

Janssen knew about a key safety analysis since 2002, but failed to give it to the FDA, as they should have, when looking to get Risperdal approved for children, according to New Brunswick Today.

In 2013 the Department of Justice penalized Johnson & Johnson for more than $2.2 billion to resolve criminal and civil investigations allegations include off-label marketing and kickbacks to doctors and pharmacists relating to Risperdal.

Appeal over Statute of Limitations

A appeals panel of the Pennsylvania Superior Court may decide in three cases whether plaintiffs should have been reasonably aware that Risperdal caused breast enlargement as of June 30, 2009, starting the statute of limitations.

In January 2015 Judge Arnold L. New, the Coordinating Judge of the Complex Litigation Center, ruled that plaintiffs had two years to file a claim starting from the 2009 date. In Re: Risperdal Litigation, case numbers 576 EDA 2015, 590 EDA 2015 and 2451 EDA 2015, in the Superior Court of the State of Pennsylvania.

Judge New said the potential connection between Risperdal and gynecomastia had been revealed in several medical journals and media reports, and added to the drug’s warning label.

In oral arguments in September, plaintiff attorneys argued to the appeals court that the trial judge had improperly attempted to set a global accrual date for Risperdal claims that didn’t conform to the individual experiences of the two men whose cases served as a springboard for the ruling.

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

risperdal-infographicA jury in Philadelphia ruled on July 8 that the antipsychotic drug Risperdal caused a Tennessee boy to grow breasts and imposed a $70 million verdict on its manufacturer, Janssen Pharmaceuticals.

Lawyers for the boy argued that scientists for the company were well aware of the risks and sought to downplay them. The company disputed that allegation during the Common Pleas Court trial and said that physicians were fully informed of potential side effects.

It was the fifth Risperdal lawsuit tried in Philadelphia, and by far the largest verdict so far. Earlier verdicts ranged from $500,000 to $2.2 million. the jury also found that Janssen “intentionally falsified, destroyed or concealed records.” That finding is necesdsary for plaintiffs to recover more than the $750,000 damages cap that Tennessee law imposes on noneconomic damages.

The products liability action, Case C.P. Philadelphia No. 130402094, was heard before Judge Paula Patrick.

Gynecomastia

Plaintiffs Counsel was Jason Itkin, Arnold & Itkin in Houston. Defense Counsel was David Abernethy, Drinker Biddle & Reath in Philadelphia. A spokeswoman for Janssen said the verdict went against the evidence, and the company will seek an appeal.

Lawyers for the plaintiff demonstrated that Janssen, a subsidiary of pharmaceutical giant Johnson & Johnson, attempted to downplay the risks of the drug causing gynecomastia, a condition in which boys develop female breast tissue. While the drug was initially approved for a small market, those suffering from bipolar and schizophrenia related disorders, Janssen reportedly worked to expand doctors’ recommendations of the drug to include treatments for dementia, behavioral problems, and autism. At the time the plaintiff began taking the drug the Food and Drug Administration (FDA) had only approved it for adult use.

Follow our continuing coverage:

Plaintiffs 3-for-4 in Philadelphia Risperdal trials, confident punitive damages will be reintroduced

Kentucky AG Settles Risperdal and OxyContin False Marketing Cases for $39.5 Million

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