Pfizer Lawsuits: Depo-Provera, COVID Vaccines, and DOJ Settlements

Pfizer lawsuits span a wide range of claims, from a rapidly growing federal multidistrict litigation over the contraceptive Depo-Provera to state attorney general cases over the company’s COVID-19 vaccine, kickback settlements, antitrust class actions, and a long history of product liability suits over individual drugs. Since 2000, Pfizer and its subsidiaries have paid more than $11.2 billion in penalties across 108 recorded enforcement actions, according to the Good Jobs First Violation Tracker.¹ Below is a current picture of the most significant active cases and the historic settlements that shape the company’s legal record.

Depo-Provera Brain Tumor MDL

The largest active case against Pfizer involves Depo-Provera, the injectable contraceptive. Thousands of women say long-term use caused them to develop meningiomas, typically noncancerous but potentially debilitating tumors that grow near the brain and spine. The cases are consolidated as MDL No. 3140 in the Northern District of Florida.²

The docket has grown fast. Roughly 3,100 lawsuits were pending in the MDL as of March 2026, up from just 78 a year earlier, and projections suggest the total could eventually reach 5,000 to 10,000 cases.²³

Plaintiffs rely on a 2024 study in the British Medical Journal finding that patients using Depo-Provera for a year or more were roughly five times more likely to develop a meningioma requiring surgery, and a 2025 JAMA Neurology study confirming elevated risk among long-term users compared to women using other contraceptives.² In December 2025, the FDA approved a label change for Depo-Provera to include a specific warning about intracranial meningioma, reversing its 2024 position when it had rejected a proposed warning.⁴

The central unresolved question is Pfizer’s federal preemption defense. The company argues it was legally prohibited from updating the Depo-Provera label because the FDA had earlier rejected its proposed warning. The motion is fully briefed and under review; a ruling will apply to every case in the MDL.⁵ If the court denies preemption, a general causation hearing is set for late June 2026, with the first bellwether trial scheduled for December 7, 2026.⁴ Pfizer has not admitted liability and intends to contest the claims.

COVID-19 Vaccine Lawsuits by State Attorneys General

Two state attorneys general have sued Pfizer alleging the company misrepresented the safety and effectiveness of its COVID-19 vaccine. Both remain active in some form.

Texas

Texas Attorney General Ken Paxton filed suit in November 2023, alleging deceptive trade practices in Pfizer’s vaccine efficacy claims and asserting the company conspired with social media platforms to suppress criticism.⁶ In December 2024, U.S. District Judge Sam Cummings dismissed the case, ruling that Pfizer was shielded by the federal Public Readiness and Emergency Preparedness Act and that the challenged statements were not connected to consumer transactions.⁷ Paxton appealed in January 2025, and the case is pending before the Fifth Circuit.⁸

Kansas

Kansas Attorney General Kris Kobach filed suit in June 2024 in Thomas County, Kansas, alleging violations of the Kansas Consumer Protection Act. The complaint disputes Pfizer’s “safe and effective” marketing, specifically assertions that the vaccine was safe for pregnant women and posed no risk of myocarditis or pericarditis.⁹ Pfizer removed the case to federal court, but in May 2025, a federal judge sent it back to state court, where it continues.¹⁰ Pfizer maintains the claims lack merit and notes that the remand ruling addresses only jurisdiction.

Why Most Individual Vaccine Suits Fail: The PREP Act

The PREP Act, enacted in 2005, grants broad immunity from liability to companies involved in developing, manufacturing, and distributing medical countermeasures during public health emergencies. The only exception is for “willful misconduct,” which requires plaintiffs to file exclusively in the U.S. District Court for the District of Columbia and prove conduct exceeding mere negligence by clear and convincing evidence.¹¹ Courts have consistently relied on the PREP Act to dismiss COVID-19 vaccine injury claims against Pfizer.

The 2009 DOJ Settlement: $2.3 Billion for Off-Label Marketing

Pfizer’s single largest legal penalty came in September 2009, when the company agreed to pay $2.3 billion to resolve criminal and civil allegations of illegally promoting drugs for unapproved uses. It was the largest healthcare fraud penalty in history at the time.¹²

The criminal component involved a guilty plea by a Pfizer subsidiary, Pharmacia & Upjohn Company, to a felony charge of promoting the painkiller Bextra for uses the FDA had never approved, including post-surgical pain relief. The criminal fine was $1.3 billion.¹³ Bextra had already been pulled from the market in 2005 at the FDA’s request. The roughly $1 billion civil portion resolved allegations tied to off-label promotion of the antipsychotic Geodon (about $301 million), the antibiotic Zyvox (about $98 million), and the anti-epileptic Lyrica (about $50 million), along with smaller amounts for alleged improper payments to healthcare professionals.¹²

The investigation was triggered by a 2003 whistleblower suit from John Kopchinski, a former Pfizer sales representative who said he was directed to distribute unapproved dosages of Bextra to physicians.¹³ Pfizer entered a five-year corporate integrity agreement with the HHS Office of Inspector General and paid an additional $33 million to 42 states and the District of Columbia for consumer protection violations tied to Geodon.¹²

Other Major Settlements

Neurontin (2004) — $430 Million

In May 2004, Warner-Lambert, which Pfizer had acquired in 2000, pleaded guilty to two felony counts of violating the Food, Drug & Cosmetic Act for promoting the epilepsy drug Neurontin for uses the FDA had never approved. The total payment was $430 million: a $240 million criminal fine (the second-largest ever imposed in a healthcare fraud case at the time), about $152 million in federal and state Medicaid settlements, and $38 million in state consumer protection payments.¹⁴¹⁵ The case originated with a whistleblower suit from a former company employee, Dr. David Franklin.

Nurtec ODT Kickbacks (2025) — $59.7 Million

In January 2025, Pfizer agreed to pay nearly $60 million to resolve False Claims Act allegations that its subsidiary Biohaven Pharmaceutical had paid kickbacks to doctors to prescribe the migraine medication Nurtec ODT. The DOJ said that between 2020 and 2022, Biohaven hosted “speaker programs” at high-end restaurants where providers received honoraria and expensive meals — some speakers collected more than $100,000 — in exchange for prescribing the drug. The government alleged these programs had no genuine educational purpose and were sometimes attended by speakers’ friends and family.¹⁶ About $50.2 million went to the federal government and $9.5 million to state Medicaid programs; the whistleblower, former Biohaven employee Patricia Frattasio, received approximately $8.4 million.¹⁷ Pfizer, which acquired Biohaven in October 2022 for $11.5 billion, terminated the speaker programs after the acquisition. The settlement did not include an admission of liability.

EpiPen Pricing (2021) — $345 Million

Pfizer and two subsidiaries, Meridian Medical Technologies and King Pharmaceuticals, agreed in 2021 to a $345 million settlement resolving class action claims alleging anticompetitive conduct in EpiPen pricing. The suits, filed in 2016 and 2017, alleged that Pfizer as the device manufacturer and Mylan as the marketer conspired to inflate prices by offering rebates to pharmacy benefit managers conditioned on refusing to cover competing generics.¹⁸ A package of EpiPens had risen from roughly $100 when Mylan acquired the brand in 2007 to more than $600 by 2016. Pfizer’s settlement did not include an admission of wrongdoing and did not resolve claims against Mylan.

Generic Drug Price-Fixing (2025) — $33 Million

In 2025, Pfizer and its generic-drug subsidiary Greenstone agreed to pay $33 million as part of a proposed class action settlement in a sprawling generic drug price-fixing case consolidated in the Eastern District of Pennsylvania. The litigation alleges that multiple generic manufacturers conspired to fix prices, rig bids, and allocate customers and markets.¹⁹ A fairness hearing on final approval was scheduled for April 2026.

Product Liability Over Individual Drugs

Beyond the headline settlements, Pfizer has faced extensive product liability litigation over individual medications, with outcomes ranging from large payouts to complete dismissals.

Prempro. Pfizer settled most of the nearly 10,000 lawsuits alleging the hormone therapy caused breast cancer, paying more than $1 billion by 2012.
Chantix. Pfizer set aside roughly $288 million in 2013 to resolve about 3,000 lawsuits alleging the smoking-cessation drug caused suicidal thoughts and psychological disorders. In 2021, Pfizer recalled the entire U.S. distribution of Chantix after finding a cancer-linked nitrosamine impurity in the pills. A small number of class actions followed; the litigation has remained limited in scale.²⁰
Lipitor. More than 2,000 lawsuits alleging the cholesterol drug caused Type 2 diabetes were dismissed by a federal judge in early 2017, and the Fourth Circuit affirmed in 2018.
Zoloft. Hundreds of lawsuits alleging the antidepressant caused birth defects were consolidated into an MDL in the Eastern District of Pennsylvania. The first trial, in St. Louis in April 2015, returned a verdict for Pfizer. By mid-2017, the remaining federal cases were dismissed for insufficient scientific evidence linking the drug to the claimed injuries.
Trovan. Pfizer paid $700,000 to four families and established a $35 million fund in 2011 to settle claims arising from a 1996 clinical trial of the antibiotic in Nigeria, in which children with meningitis were given an unapproved drug. Eleven children died and others suffered disabilities.

Cases Pfizer Has Brought: Metsera and Paxlovid

Pfizer is also a plaintiff in significant pending litigation. In late 2025, after signing a $7.3 billion deal to acquire the obesity-drug biotech Metsera, Pfizer faced a competing bid from Novo Nordisk valued at up to $10 billion. Pfizer sued in Delaware Chancery Court alleging breach of the merger agreement, and separately in Delaware federal court alleging that Novo Nordisk’s bid violated federal antitrust laws by attempting to eliminate an emerging competitor in the GLP-1 drug market.²¹ In November 2025, Chancery Court denied Pfizer’s request for a temporary restraining order to block Novo’s bid, though the underlying breach-of-contract claims remain active.²² The FTC separately warned Novo Nordisk and Metsera that their deal structure could constitute “illegal gun jumping” under merger review laws.²³ Both lawsuits remained pending as of early 2026.

On the defense side of a patent fight, Pfizer prevailed against Enanta Pharmaceuticals, which had sued in 2022 in the District of Massachusetts alleging that nirmatrelvir, the active ingredient in Paxlovid, infringed an Enanta patent for antiviral peptide compounds. In December 2024, the court granted summary judgment for Pfizer, finding the patent invalid because Enanta could not establish an early enough priority date to predate Pfizer’s work.²⁴ Enanta has indicated plans to appeal to the Federal Circuit and has filed a parallel infringement case against Pfizer in Europe’s Unified Patent Court.²⁵

The Cumulative Penalty Picture

Pfizer’s legal exposure over the past quarter century is unusual even by pharmaceutical industry standards. According to the Good Jobs First Violation Tracker, the company and its subsidiaries have accumulated more than $11.2 billion in total penalties across 108 recorded enforcement actions since 2000. Drug safety violations account for about $5.6 billion across 15 cases, and healthcare-related offenses, predominantly off-label marketing, add about $3.4 billion across 11 cases. Government contracting violations, largely False Claims Act cases, account for another $1.2 billion, and competition-related offenses add roughly $1 billion more.¹ Those figures include penalties imposed on companies Pfizer later acquired, such as Wyeth, Warner-Lambert, and King Pharmaceuticals, whose legal liabilities transferred upon acquisition.

1
Good Jobs First. Pfizer Violation Tracker
2
Motley Rice. Depo-Provera Lawsuits
3
The Guardian. Pfizer Sued in US Over Contraceptive That Women Say Caused Brain Tumours
4
ICLG. Pfizer Faces 2026 Trial as Brain Tumour Claims Multiply
5
MDL Update. MDL 3140 Depo-Provera
6
Texas Attorney General. Attorney General Ken Paxton Continues Lawsuit Against Pfizer
7
Bloomberg Law. Pfizer Defeats Texas Lawsuit Over Covid Vaccine Effectiveness
8
U.S. Chamber of Commerce. Texas v. Pfizer Inc.
9
Kansas Attorney General. Kansas AG Kobach COVID-19 Vaccine Lawsuit
10
KCTV5. Case Filed Against Pfizer Covid Vaccine Marketing to Be Heard State Level
11
HHS ASPR. PREP Act
12
Pfizer. Pfizer Concludes Previously Disclosed Settlement Agreement With U.S. Department of Justice
13
ABC News. Pfizer Fined $2.3 Billion for Illegal Marketing
14
U.S. Department of Justice. Warner-Lambert to Pay $430 Million to Resolve Criminal and Civil Health Care Liability
15
AMA Journal of Ethics. Neurontin and Off-Label Marketing
16
U.S. Department of Justice. Pfizer Agrees to Pay Nearly $60M to Resolve False Claims Allegations
17
Connecticut Attorney General. Attorney General Tong Announces False Claims Settlement With Pfizer-Owned Biohaven
18
CNBC. Pfizer Subsidiaries Agree to Pay $345 Million in EpiPen Settlement
19
PR Newswire. NastLaw LLC and Direct Purchaser Plaintiffs Announce Additional Settlements
20
FDA. Pfizer Issues Voluntary Nationwide Recall of Chantix Tablets
21
Pfizer. Pfizer Files Federal Antitrust Claims in Second Lawsuit
22
Fierce Biotech. Judge Knocks Down Pfizer’s Efforts to Halt Novo Bid for Metsera
23
Pfizer. Pfizer Responds to Delaware Chancery Court Ruling
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GovInfo. Enanta Pharmaceuticals v. Pfizer, Memorandum and Order
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IP Fray. Pharma Patent Litigation Updates: Pfizer Faces New COVID UPC Suit