Judge Dismisses Off-Label and Kickback Allegations Against Bristol-Myers Squibb, But BMS Must Face Whistleblower Retaliation Suit

District Court Judge William Bertelsman recently dismissed False Claims Act (FCA) allegations against Bristol-Myers Squibb and Otsuka Pharmaceuticals brought by two former BMS sales reps. Despite finding the whistleblowers failed to show that the company engaged in either off-label promotion or kickbacks in violation of the FCA, however, Judge Bertelsman held that the whistleblowers adequately pled wrongful retaliation claims. According to the former sales reps, they tried to bring their compliance concerns up the company chain, but were instead punished with poor performance reviews. Both employees were terminated soon after without an opportunity to defend themselves, according to the complaint.  Joseph Ibanez and Jennifer Edwards filed suit against their former employer in January 2011, alleging that BMS and Otsuka engaged in a scheme to promote Abilify, an atypical antipsychotic, off-label to pediatric and geriatric patients, and also offered kickbacks to physicians to get them to prescribe the drug. Judge Bertelsman found the relators' claims to be insufficient on both counts due to lack of evidence connecting the manufacturers behavior to any specific false claim submissions. In dismissing the off-label allegations, the Judge found the whistleblowers' pleading did not raise a “strong inference” that BMS and Otsuka caused the submission of a false claim for payment "because such a conclusion requires no fewer than five sequential inferen...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs