Abilify whistleblowers ask court to revive False Claims Act lawsuit

Aug. 22, 2016 – San Diego, CA Two former Big Pharma sales reps asked the Sixth Circuit Court of Appeals to revive their False Claims Act suit against Otsuka and Bristol-Myers Squibb, Law360 reported Friday.

Whistleblowers Jennifer Edwards and Joseph Ibanez, former sales representatives for pharmaceutical giant Bristol-Myers Squibb, filed a qui tam action in January 2011 under the False Claims Act against their former employee and Otsuka American Pharmaceutical Inc., the US subsidiary of the Japanese company Otsuka Pharmaceutical Co.

The suit alleged the two companies violated their corporate integrity agreements — which they entered into with the federal government after settling allegations of improperly promoting the antipsychotic drug Abilify — by including physicians on Abilify call lists who treated children, adolescents and geriatric patients, Law360 reported.

Qui tam actions allow whistleblowers who have evidence of past or present fraud committed against the federal government to bring lawsuits on the government’s behalf. Whistleblowers are rewarded financially if their lawsuits recover funds for the government.

A federal judge in Ohio district court dismissed all of the whistleblowers’ claims against Otsuka and all but retaliation claims against Bristol-Myers in March 2015.

On Friday, Edwards and Ibanez urged the Sixth Court to reverse the Ohio court’s dismissal of their 2011 qui tam suit, saying arguments made last month by Otsuka and Bristol-Myers against their claims were wrong. Specifically, Otsuka said in July that the Ohio district court was right to stop the whistleblowers from filing another amended complaint, since the edits to their accusations would have come from publicly available information, something that is not allowed under the False Claims Act, reported Law360.

The whistleblowers fought back against Otsuka’s argument, saying the information they included in their third amended complaint did not publicly disclose the allegations they made against the two pharmaceutical companies, as Otsuka claimed.

“Public information does not preclude the filing of a qui tam action unless it discloses the fraudulent transaction or the allegation of fraud underlying the action,” the plaintiffs reportedly said, adding that “the companies repeatedly mischaracterize [the whistleblowers’] argument regarding this point, incorrectly conflating information that is public with information that publicly discloses the allegations or transactions of fraud underlying a [whistleblower’s] complaint.”

Abilify is marketed jointly in the US by Bristol Myers-Squibb and Otsuka. Abilify is brand name aripiprazole, an antipsychotic medication used to treat certain mental health disorders in adults and children. It was one of the top-selling drugs of 2014, bringing in nearly $8 billion for the Big Pharma companies.

Abilify was originally approved to treat adults only. In 2007, Bristol-Myers paid $515 million to settle allegations it had illegally marketed the antipsychotic to treat children and the elderly and paid kickbacks to physicians who prescribed the drug. In 2008, Otsuka American agreed to pay $4 million to settle similar off-label marketing allegations.