The largest healthcare fraud settlements in U.S. history have each cost a single company between roughly $1 billion and more than $8 billion, with Purdue Pharma’s 2020 opioid resolution topping $8.3 billion and GlaxoSmithKline’s $3 billion deal in 2012 long considered the benchmark pharmaceutical settlement.1 Most were brought under the federal False Claims Act and resolved allegations of off-label drug marketing, kickbacks to physicians, inflated Medicare billing, or fraudulent pricing against Medicaid. The list below runs from the biggest down, with the opioid distributor settlements treated separately because they sit outside the traditional False Claims Act framework.
Purdue Pharma — Over $8.3 Billion (2020)
Purdue Pharma’s 2020 resolution with the Department of Justice is the largest in raw dollar terms, though collectability was complicated by the company’s bankruptcy. Purdue pleaded guilty to three felony counts: conspiracy to defraud the United States, conspiracy to violate the Food, Drug, and Cosmetic Act, and two counts of conspiring to violate the federal Anti-Kickback Statute. The criminal fine came to $3.544 billion, with another $2 billion in criminal forfeiture. A separate $2.8 billion civil settlement under the False Claims Act covered conduct between 2010 and 2018 in which Purdue caused false claims to be submitted to Medicare, Medicaid, TRICARE, and other federal programs by promoting unsafe and medically unnecessary opioid prescriptions.
Members of the Sackler family, who owned Purdue, separately agreed to pay $225 million to resolve their own civil liability under the False Claims Act. No family members received criminal releases. The deal also required Purdue to dissolve in its existing form and transfer its assets to a public benefit company tasked with donating overdose-rescue drugs and addiction treatment medications. The DOJ called the criminal penalties the largest ever levied against a pharmaceutical manufacturer.
GlaxoSmithKline — $3 Billion (2012)
GlaxoSmithKline’s $3 billion settlement in July 2012 remains the largest conventional healthcare fraud resolution. GSK pleaded guilty to three criminal counts: two for introducing misbranded drugs into interstate commerce and one for failing to report safety data to the FDA. The criminal fines and forfeiture totaled roughly $1 billion. The remaining $2 billion resolved civil False Claims Act allegations.
The criminal charges focused on Paxil and Wellbutrin. From 1998 to 2003, GSK promoted Paxil for pediatric use without FDA approval for children and pushed misleading clinical trial data. During the same window, it promoted Wellbutrin for unapproved uses including weight loss, sexual dysfunction, and ADHD. A separate count covered GSK’s failure to report safety concerns about the diabetes drug Avandia to the FDA between 2001 and 2007.
On the civil side, $1.043 billion resolved allegations that GSK promoted Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label uses and paid kickbacks to physicians. Another $657 million addressed false safety claims about Avandia, and $300 million resolved fraudulent Medicaid drug pricing dating back to 1994. GSK entered a five-year corporate integrity agreement that required eliminating sales-based bonus targets for its sales force and adding executive compensation clawbacks.
Pfizer — $2.3 Billion (2009)
Pfizer’s $2.3 billion settlement resolved criminal and civil investigations into the illegal promotion of Bextra, a painkiller marketed for uses and dosages the FDA never approved. Pfizer subsidiary Pharmacia & Upjohn pleaded guilty to a federal felony charge of misbranding Bextra, which had been promoted for pain relief after knee surgery although its approval was limited to rheumatoid arthritis, osteoarthritis, and menstrual pain. Sales representatives were also instructed to push 20-milligram doses to rheumatologists and orthopedists when only 10-milligram doses were approved for arthritis. Pfizer withdrew Bextra from the market in April 2005 at the FDA’s request after safety reviews revealed risks of rare and sometimes fatal skin reactions.
The breakdown was $1.3 billion in criminal recoveries and $1 billion in civil recoveries. The civil portion also addressed broader off-label promotion and kickbacks to doctors in the form of entertainment, cash, travel, and meals to induce prescriptions for Lipitor, Norvasc, Viagra, Zithromax, and Zyrtec. The case started with a 2003 whistleblower lawsuit filed by former Pfizer sales representative John Kopchinski.
Johnson & Johnson — $2.2 Billion (2013)
Johnson & Johnson paid more than $2.2 billion in November 2013 over the off-label promotion of three drugs: the antipsychotic Risperdal, its successor Invega, and the heart failure drug Natrecor. J&J subsidiary Janssen Pharmaceuticals pleaded guilty to a single misdemeanor charge related to Risperdal promotion.
From 1999 to 2005, the company promoted Risperdal to elderly dementia patients for aggression and anxiety and to children and individuals with disabilities for behavioral disturbances, even though the drug was only FDA-approved for schizophrenia at the time. J&J deployed a dedicated “ElderCare” sales force to target nursing home operators and paid representatives bonuses on total sales volume rather than prescriptions for approved uses. The DOJ also alleged that J&J funneled millions in kickbacks to Omnicare, the largest pharmacy serving nursing homes, disguised as “educational funding.” The resolution included $485 million in criminal fines and forfeiture and $1.72 billion in civil settlements with federal and state governments. J&J denied civil liability.
HCA — $1.7 Billion (2000–2003)
The fraud case against HCA, formerly Columbia/HCA, was at the time the largest multiagency investigation of a healthcare provider in U.S. history. The hospital chain’s penalties accumulated over several years. In December 2000, two HCA subsidiaries pleaded guilty to criminal charges including conspiracy to defraud the government and violating the Medicare Anti-Kickback Statute, producing $840 million in combined criminal and civil payments. The $745 million civil portion covered upcoding patient diagnoses to inflate Medicare reimbursements ($403 million), fraudulent home health visit billing ($106 million), outpatient lab billing violations ($95 million), fraudulent charges tied to home health agency purchases ($90 million), and disguising marketing costs as reimbursable expenses ($50 million).
In June 2003, HCA agreed to pay another $631 million in civil penalties and damages, plus $250 million to the Centers for Medicare and Medicaid Services for overpayment claims. The combined total reached $1.7 billion. Nine whistleblower lawsuits fueled the investigation. James Alderson, a CPA and former hospital CFO who filed his qui tam suit in 1993 after being fired for refusing to include inflated claims in a cost report, together with co-relator John Schilling, received $100 million. Total whistleblower awards reached $151.6 million, the highest combined qui tam payout in U.S. history at the time. HCA entered an eight-year corporate integrity agreement requiring independent audits, employee training, and the divestiture of the subsidiaries that pleaded guilty.
Abbott Laboratories — $1.5 Billion (2012)
Abbott Laboratories agreed in May 2012 to pay $1.5 billion over off-label promotion of Depakote, a seizure medication the company pushed for unapproved uses including agitation and aggression in elderly dementia patients, schizophrenia, depression, and anxiety. From 1998 to 2006, Abbott trained a specialized sales force to market Depakote directly to nursing homes, claiming the drug could help facilities avoid regulatory burdens under the Omnibus Budget Reconciliation Act of 1987, which restricted antipsychotic use. Internal clinical trials for Depakote in schizophrenia had failed, and the company had discontinued a 1999 dementia trial after adverse events including excessive drowsiness, dehydration, and loss of appetite.
Abbott pleaded guilty to a criminal misdemeanor for misbranding and paid $700 million on the criminal side, including a $500 million fine and nearly $200 million in asset forfeiture. The $800 million civil settlement was split between the federal government and participating states. Whistleblowers in four qui tam lawsuits received $84 million. Abbott was placed under five years of court-supervised probation and entered a corporate integrity agreement requiring board-level compliance reviews.
Eli Lilly — $1.415 Billion (2009)
Eli Lilly’s $1.415 billion settlement in January 2009 resolved allegations that the company illegally marketed Zyprexa, an antipsychotic, for the treatment of dementia in elderly populations including Alzheimer’s patients. Zyprexa was not approved for that use. From 1999 to 2003, Lilly targeted nursing homes and primary care physicians with marketing materials for off-label uses and trained sales staff to sidestep legal restrictions on promoting unapproved applications.
The company pleaded guilty to a misdemeanor charge of distributing misbranded drugs. The $515 million criminal fine was the largest individual corporate criminal fine in U.S. history at the time, with another $100 million in asset forfeiture. Up to $800 million in civil payments resolved False Claims Act allegations, split roughly $438 million to the federal government and $362 million to the states. Four qui tam lawsuits filed by former Lilly sales representatives drove the case, and the relators received nearly $79 million. A five-year corporate integrity agreement required annual compliance certifications and public disclosure of payments to physicians.
Other Notable Billion-Dollar Resolutions
- Tenet Healthcare paid $900 million in 2006 to settle civil allegations that it inflated hospital charges to secure excessive “outlier” payments from Medicare, paid kickbacks to physicians for patient referrals, and assigned unsupported diagnosis codes. The settlement was paid over four years and stemmed from multiple whistleblower lawsuits.
- TAP Pharmaceutical Products paid $875 million in 2001 after pleading guilty to conspiracy to violate the Prescription Drug Marketing Act over the fraudulent marketing and pricing of the prostate cancer drug Lupron. TAP had offered physicians free drugs, trips to resorts, medical equipment, and grants worth up to $100,000 to induce Lupron prescriptions, then conspired with doctors to bill Medicare for free samples. The case was triggered by a former TAP vice president and a physician who went undercover.
- Wyeth, later acquired by Pfizer, paid $784.6 million in 2016 to settle allegations that it hid deep hospital discounts on the acid reflux drugs Protonix Oral and Protonix IV from Medicaid between 2001 and 2006, avoiding hundreds of millions in required Medicaid rebates. Whistleblowers received more than $98 million.
- Reckitt Benckiser, the parent company of Indivior, reached a $1.4 billion global resolution in 2019 over Suboxone marketing, including a $700 million civil settlement and $647 million forfeited under a non-prosecution agreement. The government alleged that between 2010 and 2014, the company promoted Suboxone for unsafe and medically unnecessary uses, made misleading safety claims about its film formulation, and filed a fraudulent FDA petition to delay generic competition.
- Novartis paid $678 million in 2020 to settle allegations that it used over 100,000 sham speaker programs between 2002 and 2011 to funnel bribes to doctors who prescribed its cardiovascular and diabetes drugs. Events often took place at expensive restaurants where no educational presentation occurred, with per-person costs sometimes exceeding $500. The company agreed to shift future physician education to virtual-only formats and stop holding events at restaurants.
- AmerisourceBergen settled in 2018 for $625 million in civil penalties and $885 million in total exposure over allegations that its subsidiaries illegally repackaged injectable chemotherapy-support drugs by pooling leftover medication from vials into pre-filled syringes manufactured in unsanitary conditions, then double-billed federal health programs. A subsidiary had already pleaded guilty to criminal misbranding and paid $260 million.
Opioid Distributor Settlements: A Separate Track
The opioid crisis produced a parallel line of litigation that dwarfs most of the figures above but operates mostly outside the False Claims Act. In February 2022, Johnson & Johnson and the three largest U.S. drug distributors finalized a combined $26 billion settlement to resolve thousands of civil lawsuits filed by state and local governments and Native American tribes beginning in 2014. The individual commitments were McKesson at $7.4 billion, AmerisourceBergen at $6.1 billion, Cardinal Health at $6 billion, and J&J at $5 billion. The companies admitted no wrongdoing. Payments run over 18 to 20 years, with funds earmarked for drug treatment and harm-reduction programs. The agreement includes a monitoring system to flag excessive shipments of high-risk medications to communities.
Purdue Pharma’s federal criminal and civil resolution, listed above, sits apart from these broader civil settlements. Separate negotiations with the Sackler family are expected to produce payouts topping $6 billion. The overall structure of the opioid deals has been compared to the $246 billion tobacco settlement of the 1990s, but the opioid agreements were specifically designed to prevent funds from being diverted to unrelated government projects.
Recent Record-Breaking Cases
Enforcement has continued to escalate. In fiscal year 2025, the DOJ reported $6.8 billion in total False Claims Act recoveries, the highest annual figure in the statute’s history, with more than $5.7 billion from healthcare cases. Since the False Claims Act was strengthened in 1986, total recoveries have exceeded $85 billion.
A $556 million settlement with Kaiser Permanente affiliates in January 2026 resolved allegations of a scheme running from 2009 to 2018 to inflate the diagnoses of Medicare Advantage enrollees in California and Colorado. The DOJ alleged that Kaiser affiliates added thousands of invalid diagnostic codes to patient records, often months after visits and unrelated to the care actually provided, to secure higher government reimbursements. Physicians were reportedly pressured through financial bonuses tied to diagnostic targets. Two former Kaiser employees who blew the whistle are set to receive $95 million. Kaiser admitted no wrongdoing.
In March 2025, a federal judge in New Jersey backed a jury verdict ordering Janssen Products, a J&J unit now known as Johnson & Johnson Innovative Medicine, to pay $1.6 billion for off-label promotion of the HIV drugs Prezista and Intelence. The figure comprised $1.28 billion in per-claim penalties and $360 million in treble damages. The case, brought by former Janssen employees in 2012, proceeded to trial after the DOJ declined to intervene. The jury found that the company’s marketing caused nearly 160,000 false claims to be submitted to Medicare, Medicaid, and the AIDS Drug Assistance Program. Janssen is appealing to the Third Circuit, with oral arguments scheduled for March 2026.
Other significant 2024–2025 settlements included Endo Health Solutions at $476 million for opioid marketing, Teva Pharmaceuticals at $450 million for kickbacks and generic drug price-fixing, Rite Aid at $410 million for improperly dispensing controlled substances plus a separate $121 million for failing to report drug rebates to Medicare, and Gilead Sciences at $176 million for using speaker programs to induce prescriptions. The DOJ’s June 2025 national healthcare fraud takedown charged 324 defendants across 50 federal districts in connection with more than $14.6 billion in alleged fraud, the largest such operation in DOJ history.
Why the False Claims Act Drives These Cases
Nearly every settlement above traces back to the False Claims Act, a Civil War-era statute that Congress modernized in 1986. The law lets the government recover up to three times its actual damages plus a mandatory civil penalty for each false claim submitted, so a company that submitted thousands of fraudulent Medicare claims faces heavy exposure before treble damages are even calculated.
The statute’s qui tam provision lets private citizens, usually company insiders, file lawsuits on behalf of the government. A whistleblower files under seal in federal court, giving the DOJ time to investigate before deciding whether to take over the case. If the suit succeeds, the whistleblower receives between 15 and 30 percent of what the government recovers. Whistleblower-initiated cases have driven the majority of False Claims Act recoveries since 1986. In fiscal year 2025, qui tam actions produced over $5.3 billion of the $6.8 billion recovered. That share, consistent across decades, explains why most of the largest healthcare fraud settlements began with a single employee walking into a lawyer’s office.