Pharmaceutical Bribery Prosecutions
1. United States v. Novartis Pharmaceuticals Corp. (2010–2012)
Facts:
Novartis, a multinational pharmaceutical company, was accused of bribing doctors and healthcare providers to promote its drugs, including Trileptal and Exjade. Bribes included cash, gifts, trips, and lavish dinners to influence prescription decisions.
Charges:
Violations of the False Claims Act (FCA) — submitting claims to federal healthcare programs based on illegally induced prescriptions.
Anti-Kickback Statute (AKS) — prohibiting remuneration to induce prescriptions under Medicare and Medicaid.
Outcome:
Novartis agreed to pay $678 million in settlement in 2010.
The settlement included civil and criminal components, holding the company liable without individual executives being criminally charged.
Impact:
This case reinforced that corporate bribery of healthcare professionals to influence prescriptions is a serious federal offense and can result in massive financial penalties.
2. United States v. GlaxoSmithKline (GSK) (2012)
Facts:
GSK was accused of bribing doctors in several U.S. states and overseas to prescribe its drugs, including Wellbutrin, Paxil, and Avandia. Bribes included free meals, paid travel, and continuing medical education (CME) events.
Charges:
FCA violations for submitting claims influenced by kickbacks.
AKS violations, including inducements to physicians for prescriptions covered by federal programs.
Marketing drugs for off-label uses, which is illegal.
Outcome:
GSK agreed to pay $3 billion in 2012, the largest healthcare fraud settlement in U.S. history at that time.
Criminal charges included misbranding drugs and promoting off-label prescriptions.
Impact:
This case sent a strong message that bribery combined with off-label promotion carries both civil and criminal liability.
Companies must implement strict compliance programs to avoid kickbacks.
3. United States v. Pfizer Inc. (2009–2010)
Facts:
Pfizer faced allegations of bribing doctors and healthcare organizations to prescribe its drugs, including Bextra and Geodon, for off-label uses not approved by the FDA. Bribes included consulting fees, speaking engagements, and lavish gifts.
Charges:
FCA violations for fraudulent claims to federal healthcare programs.
AKS violations — illegal remuneration to induce prescriptions.
Off-label marketing violations under FDA regulations.
Outcome:
Pfizer agreed to pay $2.3 billion in total fines and settlements, including $1.3 billion criminal fine.
Multiple executives were personally investigated, but no individual executives received long prison sentences.
Impact:
Reinforced that off-label promotion coupled with inducements is a serious criminal and civil offense.
Set precedent for corporate accountability in the pharmaceutical sector.
4. United States v. Teva Pharmaceuticals USA (2016)
Facts:
Teva Pharmaceuticals was accused of paying kickbacks to specialty pharmacies and doctors to favor Teva’s drugs, including multiple generic and specialty medications.
Charges:
AKS violations, including illegal remuneration to promote specific drugs.
FCA violations, due to the impact on federal healthcare reimbursements.
Outcome:
Teva agreed to pay $519 million in civil and criminal penalties.
Individual executives were fined but not imprisoned, highlighting the corporate focus of enforcement.
Impact:
Showed that generic drug manufacturers are also under scrutiny for bribery practices.
Highlighted the risk of indirect kickbacks via pharmacies.
5. United States v. Johnson & Johnson / Janssen Pharmaceuticals (2013)
Facts:
Janssen Pharmaceuticals, a J&J subsidiary, bribed physicians and nurse practitioners to prescribe antipsychotic drugs like Risperdal for unapproved uses in children and elderly patients.
Charges:
FCA violations for fraudulent claims to Medicare and Medicaid.
AKS violations, due to inducements to healthcare providers.
Off-label marketing and misbranding under FDA law.
Outcome:
Janssen agreed to pay $2.2 billion, including $1.2 billion criminal fine.
Criminal plea involved misbranding and bribery, setting a corporate liability precedent.
Impact:
Reinforced that off-label promotion plus bribery is heavily penalized.
Encouraged stricter internal compliance and monitoring in pharmaceutical marketing.
6. United States v. Endo Pharmaceuticals (2017)
Facts:
Endo Pharmaceuticals was accused of bribing doctors and pharmacists to prescribe oxycodone and other opioids. Bribes included bonuses, gifts, and incentive programs linked to prescription volume.
Charges:
FCA violations for influencing claims to federal healthcare programs.
AKS violations — direct and indirect remuneration to influence prescriptions.
Outcome:
Endo paid $200 million in criminal and civil settlements.
Some executives faced fines and probation, but no long-term imprisonment.
Impact:
Highlighted the intersection of bribery and the opioid crisis.
Emphasized enforcement focus on marketing practices that influence opioid prescriptions.
Key Legal Takeaways:
Anti-Kickback Statute (AKS) prohibits giving anything of value to influence prescriptions under federal programs.
False Claims Act (FCA) allows the government to recover payments made under fraudulent inducement.
Off-label promotion combined with bribery compounds liability.
Corporate settlements often involve billions in fines, but individual prosecutions are less common.
Bribery prosecutions cover both domestic and international operations of pharmaceutical companies.
Summary Table
| Case | Year | Defendant | Drug(s) | Allegation | Outcome |
|---|---|---|---|---|---|
| Novartis | 2010 | Novartis Pharma | Trileptal, Exjade | Bribery of doctors | $678M settlement |
| GSK | 2012 | GlaxoSmithKline | Wellbutrin, Avandia | Bribery & off-label promotion | $3B settlement |
| Pfizer | 2009–2010 | Pfizer Inc | Bextra, Geodon | Bribery & off-label promotion | $2.3B settlement |
| Teva | 2016 | Teva Pharma USA | Generic drugs | Kickbacks to pharmacies & doctors | $519M settlement |
| J&J / Janssen | 2013 | Janssen Pharma | Risperdal | Bribery & off-label promotion | $2.2B settlement |
| Endo | 2017 | Endo Pharma | Oxycodone | Bribery & prescription inducement | $200M settlement |
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