Many healthcare qui tam cases involve a whistleblower seeing to report pharmaceutical fraud. Below are some examples of cases alleging pharmaceutical fraud.
Off-Label Marketing of Pharmaceuticals and Kickback Cases
Pfizer Settles Pharmaceutical Fraud Qui Tam for $491 Million
Year/Settlement Amount: 2012/$491 Million
Description of the Case: A whistleblower who filed a qui tam complaint to report pharmaceutical fraud alleged Pfizer promoted an organ transplant drug (Rapamune) for off-label uses. In addition, the whistleblower alleged the defendant targeted marketing to African American patients even though this was considered a high-risk population. The whistleblower also alleged that the defendant paid kickbacks to doctors.
Forest Laboratories Settles Pharmaceutical Fraud Qui Tam Case for $462 Million
Year/Settlement Amount: 2010/$462 Million
Description of the Case: In another pharmaceutical fraud case, the whistleblower alleged Forest Laboratories illegally distributed an unapproved drug product, Levothroid. The whistleblower also alleged the company promoted “off-label” uses for the drug Celexa. The complaint further stated that Forest caused false claims to be submitted to federal health care programs for Levothroid, Celexa, and another drug, Lexapro. Finally, the whistleblower alleged that it paid kickbacks to induce physicians to prescribe Celexa and Lexapro. The whisteblower who filed a qui tam case to report fraud received a relator share of the $462 million settlement.
Glaxosmithkline Settles Pharmaceutical Fraud Case for $3 Billion
Year/Settlement Amount: 2012/$3 Billion
Description of the Case: In one of the largest qui tam cases to date a whistleblower reported pharmaceutical fraud against GSK utilizing the False Claims Act. The whistleblower alleged GSK provided unlawful kickbacks and promoted certain prescription drugs off-label. The qui tam complaint also alleged that GSK failed to report drug safety data and falsely reported drug prices.
Other Qui Tam Off-Label Marketing Settlements
In the past, the largest qui tam settlements where whistleblowers sought to report pharmaceutical fraud involved off-label marketing allegations.
- $1.415 Billion Qui Tam Settlement: Eli Lilly and Company was prosecuted for promoting the antipsychotic drug Zyprexa for uses not approved by the FDA. This pharmaceutical fraud case resolved four related qui tam lawsuits brought by former sales representatives.
- $520 Million False Claims Act Settlement: Astrazeneca settled claims that it illegally marketed the anti-psychotic drug Seroquel for non-FDA-approved off label uses.
- $81 Million Qui Tam Settlement: Subsidiaries of J&J settled criminal and civil allegations for marketing Topamax, an epilepsy drug, for unapproved uses and doses.
- $72 Million False Claims Act settlement: Novartis settled pharmaceutical fraud claims that it marketed its cystic fibrosis drug TOBI for unapproved uses.
- $80 Million Whistleblower Settlement: Boehringer settled a qui tam complaint to resolve allegations of off-label drug promotion and illegal kickbacks involving four of its prescription drugs.
- $202.9 Million Qui Tam Settlement: Elan Corporation settled claims brought by a whistleblower seeking to report pharmaceutical fraud. More specifically, the whistleblower alleged that the company illegally promoted an epilepsy drug.
- $422.5 Million False Claims Act settlement: Novartis settled a pharmaceutical fraud qui tam case alleging it illegal marketed certain drugs.
- $600 Million Whistleblower Settlement: Allergan settled claims that it illegally marketed its drug Botox for “off-label” uses.
- $1 Billion Qui Tam Settlement: Merck Sharp & Dohme settled pharmaceutical fraud claims that it illegally promoted and marketed Vioxx.
- $1.5 Billion Whistleblower Settlement: Abbott settled qui tam claims that it illegally promoted Depakote.
- $762 Million False Claims Act Settlement: A whistleblower seeking to report pharmaceutical fraud alleged Amgen (biotechnology company) promoted the use of the anemia drug for off-label doses. Moreover, the government intervened and alleged that the company specifically instructed its sales representatives to create a smokescreen of “reactive marketing” by inducing doctors to ask about off-label uses. This case settled for hundreds of millions.
- $2.2 Billion Qui Tam Settlement: A qui tam case alleged that J&J engaged in off-label marketing and paid kickbacks to boost sales of two pharmaceutical products.
- $192.7 Million Whistleblower Settlement: Endo Pharmaceuticals and Endo Health Solutions settled a pharmaceutical fraud case alleging off-label promotion of certain drugs. More specifically, the company allegedly misbranded one of its products by instructing sales representatives how to encourage the use of the product for treatments not approved by the FDA. As part of the settlement, the company admitted that it intended its product to be used for unapproved indications.
Report Pharmaceutical Fraud Committed Against Private Insurance Companies
If an individual is seeking to report pharmaceutical fraud by filing a qui tam case related to Medicare/Medicaid, then the whistleblower’s lawyer should also investigate if private insurance companies were defrauded by the same conduct. in sum, ff private insurance companies are also defrauded, the whistleblower might have a case under the California Insurance Fraud Prevention Act or CIFPA. Examples of cases brought under the CIFPA to report pharmaceutical fraud can be instructive.
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