For decades, GSK and its predecessor company concealed an internal study from 1982 showing that Zantac can break down into high levels of a cancer-causing compound called NDMA.
In October 2024, GSK agreed to pay up to $2.2 billion to 80,000 plaintiffs, resolving 93% of its remaining Zantac liability cases.
A 2023 news report exposed that GSK had known of the cancer risks for decades and intentionally withheld the findings of the internal study.
Corporate conductAllegationAgainst
GSK is accused of promoting exaggerated Paxil efficacy
GSK is accused of promoting a medical journal article it paid for, which exaggerated Paxil's efficacy while downplaying trial risks.
drive these promotional efforts, GSK touted a medical journal article that it paid to have drafted and that exaggerated Paxil's efficacy while downplaying risks identified during one of the trials.
COMPLAINT
Corporate conductSettlementAgainst
GSK settles for $600M over Puerto Rico manufacturing flaws
GSK agrees to a $600 million settlement over allegations of poor manufacturing practices at its Cidra, Puerto Rico facility.
The federal and state civil settlement, totaling $600 million dollars, resolves allegations of poor manufacturing practices in the GSK facility located in Cidra, Puerto Rico.
The United States contended that GSK sold certain batches, lots, or portions of lots of these drugs, in which the strength, purity, or quality was materially inferior to that specified in the drugs’ FDA applications or related documents, and that this resulted in false claims to Medicaid and other federal health care programs.
Corporate conductAllegationAgainst
GSK is accused of submitting false claims to federal health care programs
The United States alleges GSK submitted false or fraudulent claims to federal health care programs, seeking treble damages and civil penalties under the False Claims Act.
Avandia: In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs.
GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia.
As part of this global resolution, GSK has agreed to resolve its civil liability for the following alleged conduct: (1) promoting the drugs Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent, and Valtrex; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of congestive heart failure and myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia.
California, along with 44 other states and the federal government, alleged that GSK engaged in a pattern of unlawfully marketing certain drugs for uses for which they were not approved by the Food and Drug Administration (FDA); making false representations regarding the safety and efficacy of certain drugs; offering kickbacks to medical professionals; and underpaying rebates owed to government programs for various drugs paid for by Medicaid and other federally-funded healthcare programs.
The $3 billion settlement includes $2 billion in damages and civil penalties to compensate state and federal healthcare programs, including California’s Medi-Cal program, for harm allegedly suffered as a result of the illegal conduct. In addition, GSK has agreed to plead guilty to federal criminal charges related to drug labeling and FDA reporting and pay a $1 billion criminal fine.
“Patient care is undermined when pharmaceutical companies promote uses for drugs that have not been approved by the FDA or pay medical professionals to promote certain drugs,” Attorney General Harris said. “This settlement requires GSK to pay a significant penalty and imposes strong new rules designed to prevent future misrepresentations of GSK products.”
The state and federal governments alleged that GSK engaged in a pattern of unlawfully marketing certain drugs for uses for which the drugs were not approved by the FDA, making false representations regarding the safety and efficacy of certain drugs, offering kickbacks to medical professionals, and underpaying rebates owed to government programs for various drugs paid for by Medicaid and other federally- funded healthcare programs.
This settlement agreement reimburses the federal government and the participating states for the amounts paid by the Medicaid program as a result of GSK's conduct.
This promotional strategy was a targeted assault on the entire community of physicians whom GSK knew to be most likely to prescribe an antiemetic for treatment of 5 The generic master complaint includes the same three counts, but the fraudulent misrepresentation count is Count Five and the count alleging violations of state consumer protection laws is Count Six.
GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia.
GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA).
As part of this global resolution, GSK has agreed to resolve its civil liability for the following alleged conduct: (1) promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
Avandia: In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs.
The settlement resolved federal and state claims related to the sale of adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico manufacturing facility, to government healthcare programs.
(2) the United States' audit and civil and criminal investigation of the matters covered by this Agreement; (3) GSK's investigation, defense, and any corrective actions undertaken in response to the United States' audit and civil and criminal investigation in connection with the matters covered by this Agreement (including attorneys' fees); (4) the negotiation and performance of this Agreement, the Plea Agreement, and the Medicaid State Settlement Agreements; (5) the payments GSK makes to the United States or any State pursuant to this Agreement, the Plea Agreement, or the Medicaid State Settlement Agreements and any payments that GSK may make to Relators (including costs and attorncys' fees); (6) the negotiation of, and obligations undertaken pursuant to the CIA to: (i) retain an independent review organization to perform annual reviews as described in Section II of thc CIA; and (ii) prepare and submit reports to OIG-HHS.
As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Zofran to be submitted to, or caused purchases by Medicaid and the other Federal Health Care Programs. (6) Imitrex, Lotronex, Flovent and Valtrex: From January 1, 1999 through December 30, 2004, GSK paid illegal remuneration for speaker programs, mentorships, preceptorships, journal clubs, advisory boards (including Local and Regional Advisory Boards and Special Issues Boards), Reprint Mastery Trainings, and provided gifts (including entertainment, cash, travel and meals) to health care professionals to induce them to promote and prescribe the drugs Imitrex, Lotronex, Flovent and Valtrex, in violation of the Federal Anti-Kickback Statute, 42 U.S.C.
GSK caused claims for payment for the Covered Drugs to be submitted to the TRICARE program, 10 U.S.C.
This conduct includes repeatedly publishing and promoting false and misleading accounts of studies and treatment guidelines to convince physicians to use GSK drugs.
GSK's false and fraudulent statements, including with respect to the safety and efficacy, superiority, and medical necessity and appropriateness of its drugs, to the public, to patients, to physicians and directly to Medicaid and other federal health care programs, were material to the physician's decisions to prescribe these drugs and the United States’ decision to pay claims for these drugs and related services. 274.
I understand that payment of a claim by Medicare is conditioned upon the claims and the underlying transaction complying with such laws, regulations and program instructions (including, but not limited to Federal anti-kickback statute and the Stark law), and on the [provider's] compliance with all applicable conditions of participation in Medicare. C. GSK's False, Misleading and Illegal Marketing Caused the Submission of False and Fraudulent Claims to Federal Health Care Programs 269.
GSK's promotion of its drugs described above was both fraudulent and effective, utilizing false and misleading statements and claims and kickbacks to cause doctors to prescribe GSK's drugs and federal health care programs to pay millions of dollars in false and fraudulent claims.
As set forth above, GSK knowingly made and caused to be made or used false and/or fraudulent statements or records material to false and/or fraudulent claims and/or to get these claims paid or approved by the United States, in violation of 31 U.S.C.
should be paid to the United States. PRAYER FOR RELIEF WHEREFORE, the United States seeks against GSK the following: 1. On Counts One and Two under the False Claims Act, the amount of the United States' damages, trebled as required by law, and such civil penalties as are required by law, together with all such further relief as may be just and proper. 2. On Count Three for unjust enrichment/disgorgement, the damages sustained and/or amounts by which GSK was unjustly enriched or obtained illegally, plus interest, costs, aununel e ue u ues suee e. DEMAND FOR JURY TRIAL The United States demands a jury trial in this case. Respectfully submitted, TONY WEST ASSISTANT ATTORNEY GENERAL CARMEN M.
GSK presented false and misleading information directly to the Medicaid programs to block step edits and prior authorization requirements for Advair that would have restricted non-medically accepted off-label use—edits such as requiring a patient to try an ICS before a LABA-containing product, such as Advair, unless the physician diagnosed the patient as having moderate to severe asthma. 227.
As set forth above, GSK knowingly made and caused to be made or used false and/or fraudulent statements or records material to false and/or fraudulent claims and/or to get these claims paid or approved by the United States, in violation of 31 U.S.C. § 3729(a)(1)(B) and former 31 U.S.C. § 3729(a)(2)1, including (a) claims for drugs caused by GSK's illegal promotion of its products as set forth above, samples of which are set forth in Exhs.
GSK promoted these products for uses that the FDA had not approved as safe and effective (“off-label" or "“unapproved" uses), and for uses that were not medically accepted indications covered by federal health care programs.
GSK knowingly caused to be presented false or fraudulent claims for payment or approval to the United States in violation of 31 U.S.C. § 3729(a)(1)(A), including (a) claims for drugs caused by GSK’s illegal promotion of its products as set forth above, samples of which are set forth in Exhs.
GSK continued to direct its sales force in sales training to deliver this false and misleading message to physicians through at least the spring of 2010. H. GSK Made False and Misleading Statements to Medicaid Programs to Prevent Medically Appropriate Restrictions on Advair Reimbursement. 226.
§1320a-7b. 4. GSK's conduct, including its false and fraudulent statements, illegal promotion and payment of illegal inducements to prescribers, caused false or fraudulent claims to be submitted to federal health care programs for GSK's drugs, including claims for Advair, Paxil and WBSR, for uses that were not eligible for payment and for physician services relating to the prescribing of those drugs. I. THE PARTIES 5. The United States brings this action on behalf of the federal health care programs the Department of Health and Human Services (“HHS") and the Centers for Medicare & Medicaid Services (“CMS"), which administers the Medicare and Medicaid programs. 6. This is the United States' Complaint as to the claims as to which it has intervened 2
The United States brings this action to recover treble damages and civil penalties under the False Claims Act, damages and other monetary relief under common law and equity against the defendants GlaxoSmithKline plc and GlaxoSmithKline LLC (together "GSK") for causing the submission of false or fraudulent claims to federal health care programs.
By virtue of the false or fraudulent claims that GSK caused to be made, the United States suffered damages in an amount to be determined at trial. 74
TRENTON – Attorney General Jeffrey S. Chiesa announced today that New Jersey will receive a total of $22.1 million as the result of its participation in a global settlement with GlaxoSmithKline (GSK) that resolves allegations the company engaged in off-label marketing of certain drugs, underpaid on rebates it owed to state Medicaid programs and touted its diabetes drug, Avandia, as having certain health benefits despite a lack of adequate scientific supporting evidence.
As part of the settlement, GSK will pay to the states and the federal government a total of $2 billion in damages and civil penalties to compensate various federal healthcare programs, including Medicaid, for harm allegedly suffered as a result of the illegal conduct.
It was also alleged that GSK made false representations regarding the safety and efficacy of certain drugs, offered kickbacks to medical professionals and underpaid rebates owed to government programs for various drugs paid for by Medicaid and other federally-funded healthcare programs.
The participating states, and the federal government, alleged that GSK engaged in a pattern of unlawfully marketing certain drugs for uses for which the drugs were not approved by the Food and Drug Administration (FDA). It was also alleged that GSK made false representations regarding the safety and efficacy of certain drugs, offered kickbacks to medical professionals and underpaid rebates owed to government programs for various drugs paid for by Medicaid and other federally-funded healthcare programs.
The agreement resolves criminal and civil liabilities related to: an investigation begun by the US Attorney's office of Colorado in 2004 and later taken over by the US Attorney's Office of Massachusetts into GSK's sales and marketing practices for nine products; the U.S. Department of Justice's investigation of possible inappropriate use of the nominal price exception under the Medicaid Rebate Program; and the Department of Justice's investigation of the marketing and regulatory submissions of Avandia.
The SEC’s order finds that GSK violated the FCPA’s internal controls and books-and-records provisions.
GSK consented to the order without admitting or denying the findings, and agreed to pay a $20 million civil penalty.
3-17606 GlaxoSmithKline Pays $20 Million Penalty to Settle FCPA Violations September 30, 2016 – The Securities and Exchange Commission today announced that GlaxoSmithKline plc (“GSK”) has agreed to pay $20 million to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) when its China-based subsidiaries engaged in pay-to- prescribe schemes to increase sales.
3-17606 GlaxoSmithKline Pays $20 Million Penalty to Settle FCPA Violations September 30, 2016 – The Securities and Exchange Commission today announced that GlaxoSmithKline plc (“GSK”) has agreed to pay $20 million to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) when its China-based subsidiaries engaged in pay-to- prescribe schemes to increase sales.
The SEC’s order finds that GSK violated the FCPA’s internal controls and books-and-records provisions.
GSK consented to the order without admitting or denying the findings, and agreed to pay a $20 million civil penalty.
Corporate conductSettlementAgainst
A plaintiff filed a lawsuit against GSK, alleging that GSK violated antitrust laws through its settlement agreement with Teva over the Lamictal patent dispute
Plaintiff filed suit before this Court on February 27, 2023 against Defendants GlaxoSmithKline LLC (“GSK”), Teva Pharmaceutical Industries LTD., and Teva Pharmaceuticals USA, Inc. (jointly “Teva”) alleging that they violated antitrust laws through their settlement agreement to end a patent suit over GSK’s brand-name drug Lamictal and Teva’s generic form, lamotrigine.
Plaintiff filed suit before this Court on February 27, 2023 against Defendants GlaxoSmithKline LLC (“GSK”), Teva Pharmaceutical Industries LTD., and Teva Pharmaceuticals USA, Inc. (jointly “Teva”) alleging that they violated antitrust laws through their settlement agreement to end a patent suit over GSK’s brand-name drug Lamictal and Teva’s generic form, lamotrigine.
Climate & energySettlementAgainst
GSK agreed to pay a $317,550 penalty to settle alleged violations of hazardous waste regulations
GSK, located at 709 Swedeland Rd., has also agreed to pay a $317,550 penalty to settle the alleged violations of hazardous waste regulations.
The UK-headquartered companies and firms connected with such donations to Congress members after they tried to overturn the election results include PricewaterhouseCoopers, Deloitte, Ernst & Young, Grant Thornton, GSK (former name GlaxoSmithKline), AstraZeneca, BAE Systems, Rolls-Royce Holdings, BP, British American Tobacco, Imperial Brands, WPP, Diageo, Bacardi (headquartered in UK overseas territory Bermuda), Rio Tinto, RELX, HSBC, Barclays, National Grid, and InterContinental Hotels Group.
ManufacturingConfirmedYou decide
GSK commits $1.2 billion to U.S. manufacturing
GSK committed $1.2 billion to expand U.S. manufacturing, including a new biologics factory in Pennsylvania and advanced digital technology at existing sites.
GSK's $1.2 billion commitment to advanced manufacturing is set to include the construction of a new biologics factory in Pennsylvania to produce respiratory and cancer medicines, the company said, as well as the addition of advanced digital technology capabilities across GSK's existing five manufacturing sites in Pennsylvania, North Carolina, Maryland, and Montana.
“This week’s state visit brings together two countries that have led the world in science and healthcare innovation,” GSK chief executive officer Emma Walmsley said in a statement. Its US commitment includes a US$1.2 billion plan to build a biologics factory in Pennsylvania for developing respiratory and cancer treatments, and artificial intelligence (AI) development at its five US manufacturing sites.
EducationConfirmedYou decide
GSK selects STEM equity grantees for Philadelphia students
GSK selected STEM equity grantees to support educational and career pathways for Philadelphia students.
“The GSK STEM Equity grantees selected this year have demonstrated a commitment to increasing equity in STEM educational and career pathways and we are excited to support their work to benefit Philadelphia students,” she added.
Corporate conductRecallAgainst
GSK recalls Panadol Advance bottles
GSK recalled Panadol Advance bottles sold exclusively in Puerto Rico due to failure to meet child-resistant closure requirements.
GSK Recalls Panadol Advance Bottles Due to Failure to Meet Child-Resistant Closure Requirement; Sold Exclusively in Puerto Rico
GSK Recalls Panadol Advance Bottles Due to Failure to Meet Child-Resistant Closure Requirement; Sold Exclusively in Puerto Rico
Corporate conductConfirmedAgainst
GSK faces SEC enforcement proceedings
GSK must send payment documents with a cover letter identifying itself as a Respondent in these proceedings and forwarding them to Charles Cain, Division of Enforcement, Securities and Exchange Commission.
Payments by check or money order must be accompanied by a cover letter identifying GSK as a Respondent in these proceedings, and the file number of these proceedings; a copy of the cover letter and check or money order must be sent to Charles Cain, Division of Enforcement, Securities and Exchange Commission, 100 F St., NE, Mailstop 5631, Washington, DC 20549.
Corporate conductAllegationAgainst
GSK is accused of violating consumer protection laws
GSK is accused of violating state consumer protection laws by misrepresenting the uses and qualities of certain drugs.
The Complaint and Stipulated Judgment, submitted today to the San Diego County Superior Court, alleges that GSK violated state consumer protection laws by misrepresenting the uses and qualities of certain drugs.
Corporate conductConfirmedAgainst
GSK investigating promotion fraud allegations
GSK is investigating its promotion practices for potential improper promotion.
g) GSK's processes and pro cedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving improper promotion;
ManufacturingConfirmedYou decide
GSK employs 66,800 globally
GSK employs 66,800 people across 70 countries through 33 production sites.
A Securities Fraud Lawsuit Has Been Filed Against GSK plc And Investors With Losses Are Urged To Contact The Schall Law Firm
LOS ANGELES, CA / ACCESS Newswire / February 24, 2025 / The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against GSK plc ("GSK" or "the Company") (NYSE:GSK) for violations of 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.
Corporate conductSettlementAgainst
GSK settlement over faces bribery investigation
The police ministry announced last week GSK employees were under investigation for paying bribes that were passed through travel agencies.
The Securities and Exchange Commission announced the settlement of civil charges Friday with the British-based company, known as GSK. The company neither admitted nor denied the allegations of violating the Foreign Corrupt Practices Act, which prohibits bribery of foreign government officials or company executives to secure or retain business.
The SEC said that between 2010 and 2013, employees of GSK’s China-based subsidiary and a joint venture in the country channeled money and gifts to officials, including health care professionals.
Just three weeks later in July 2013, police announced accusations that top GSK managers in China had carried out a lengthy and widespread campaign of bribery.