Merck's omission, suppression, and concealment of this important information enabled Vioxx to be sold to, and purchased, or paid for by, the End-Payors at a grossly inflated price.
Merck intentionally, recklessly, and/or negligently concealed, suppressed, omitted, and misrepresented the dangers, defects, and disadvantages of Vioxx, and advertised, promoted, Case 2:05-md-01657-EEF-DEK Document 64784 Filed 01/03/14 Page 2 of 28
Corporate conductAllegation
Merck is accused of introducing Vioxx for unapproved rheumatoid arthritis use
Merck is accused of introducing and delivering Vioxx for an unapproved use in treating rheumatoid arthritis, violating the FDCA.
11(c)(1)(C) (the "Plea Agreement") to an Information to be filed in United States of America v. Merck Sharp & Dohme Corp., Criminal Action No. [to be assigned] (District of Massachusetts) (the "Criminal Action"), that will allege a violation of Title 21, United States Code Sections 33l(a), 333 (a)(1), 352(f)(1), to wit, that Merck introduced and caused the delivery for introduction into interstate commerce of quantities ofVioxx® for an unapproved use, namely the treatment of rheumatoid arthritis, which drug was misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act ("FDCA").
Workplace equityConfirmed
Merck pays pregnant female reps less
Merck is accused of systematically paying female sales reps less than male employees, especially those who are or were pregnant.
Plaintiffs’ also claim that Merck has systematically paid female sales representatives , particularly those who were, are or had been pregnant, less than similarly situated male employees in all forms of compensation, including base pay, salary increases, and incentive compensation.
Corporate conductSettlement
Merck settles for $58 million over deceptive TV drug ads
Merck reaches $58 million settlement to address deceptive TV drug advertising claims.
Mr Corbett said that in 1999 Merck had launched “an aggressive and deceptive advertising campaign which misrepresented the safety and improperly concealed the increased risks associated with Vioxx.” Hundreds of thousands of consumers demanded prescriptions for the drug before doctors had a chance to understand the side effects, he added.
“Merck’s aggressive television advertising convinced hundreds of thousands of consumers to seek Vioxx prescriptions before the drug’s risk were fully understood,” Attorney General Brown said.
$58 Million Merck Settlement To Change Deceptive TV Drug Adv…
$58 Million Merck Settlement To Change Deceptive TV Drug Advertisements
$58 Million Merck Settlement To Change Deceptive TV Drug Advertisements | State of California - Department of Justice - Office of the Attorney General
Corporate conductSettlement
Merck was fined $650 million for fraudulent price reporting
Merck fined $650 million for fraudulent price reporting | Healthcare Finance News.
In addition to the monetary recovery, Merck has entered into a Corporate Integrity Agreement with the United States Department of Health and Human Services which will govern its future dealings with the Medicare and state Medicaid programs.
Merck fined $650 million for fraudulent price reporting | Healthcare Finance News
Under two whistleblower settlement agreements, the Merck Company will pay more than $650 million to the U.S. Department of Justice and 49 individual states.
Merck fined $650 million for fraudulent price reporting
Merck has entered into or will be entering into separate settlement agreements, described in Paragraph l(b) below (hereinafter referred to as the "Medicaid State Settlement Agreements") with certain states and/or the District of Columbia in settlement of the Covered Conduct and the State Alleged Medicaid Conduct.
The United States also contends that it has certain administrative claims against Merck as specified in Paragraphs 3 through 5 below, for engaging in the Covered Conduct.
By Ben James ( February 7, 2008, 12:00 AM EST) -- Merck & Co. will pay more than $650 million to settle False Claims Act suits that accused the company of overcharging Medicare and paying kickbacks to doctors to get them to dispense the drugs Mevacor, Vioxx, Zocor and Pepcid....
Merck To Pay $650M To Settle Kickback, Pricing Suits - Law360
Pennsylvania’s water pollution rules have been a source of frustration for Merck since at least the mid-2000s, when the drugmaker had a chemical spill at its West Point facility and had to pay millions of dollars as part of a civil settlement with the U.S. Justice Department.
Corporate conductRecall
Merck recalls BANAMINE® due to particulate matter
Merck voluntarily recalled three lots of BANAMINE®-S injection in the U.S. due to presence of particulate matter.
Merck Animal Health Issues Voluntary Recall for Three Lots of BANAMINE® / BANAMINE®-S (Flunixin Meglumine Injection) in the U.S., Due to Presence of Particulate Matter
Merck Animal Health Issues Voluntary Recall for Three Lots of BANAMINE® / BANAMINE®-S (Flunixin Meglumine Injection) in the U.S., Due to Presence of Particulate Matter | FDA
1, 2023 – Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA. (NYSE:MRK), is voluntarily recalling three batches of BANAMINE®/BANAMINE®-S (flunixin meglumine injection) 50 mg/mL in the United States, used for injection in cattle, swine and horses to the consumer level due to the presence of particulate matter.
Corporate conductRecall
Merck recalls BANAMINE® due to particulate matter
Merck voluntarily recalled four additional lots of BANAMINE®-S injection over particulate matter concerns.
29, 2023 – Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), is voluntarily recalling four additional batches of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) 50 mg/mL in the United States, used for injection in cattle, swine and horses due to the presence of particulate matter.
Merck Animal Health Expands Voluntary Recall with Four Additional Lots of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) in the U.S., Due to Presence of Particulate Matter | FDA
Merck Animal Health Expands Voluntary Recall with Four Additional Lots of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) in the U.S., Due to Presence of Particulate Matter
Climate & energySettlement
Merck agreed to pay $1,857,395 to settle allegations that the Kelco facility exceeded air pollution limits
In addition, Merck, the former owner of Kelco, has agreed to pay penalties of $1,857,395 to settle allegations that the facility exceeded air pollution limits for several years.
In addition, Merck, the former owner of Kelco, has agreed to pay penalties of $1,857,395 to settle allegations that the facility exceeded air pollution limits for several years.
(San Francisco) -- Merck and Co. Inc. has agreed to pay more than $1.8 million in penalties and Monsanto Co.
Climate & energySettlement
Merck & Co. agreed to pay a $1.5 million civil penalty to settle alleged violations of federal environmental laws at its pharmaceutical manufacturing facilities in Riverside
The settlement involving Merck & Co. concerns environmental violations.
Merck & Co., Inc. Settlement | Enforcement | US EPA
Merck will pay a civil penalty of $1.5 million to the United States within 30 days of the entry of the Stipulation.
Department of Justice today announced that Merck & Co. has agreed to pay a $1.5 million civil penalty to settle alleged violations of federal environmental laws at its pharmaceutical manufacturing facilities in Riverside and West Point, Pa.
Merck will pay a civil penalty of $1.5 million to the United States within 30 days of the entry of the Stipulation.
Department of Justice today announced that Merck & Co. has agreed to pay a $1.5 million civil penalty to settle alleged violations of federal environmental laws at its pharmaceutical manufacturing facilities in Riverside and West Point, Pa.
(Washington, DC - September 28, 2011) The U.S. Environmental Protection Agency and the U.S. Department of Justice today announced that Merck & Co. has agreed to pay a $1.5 million civil penalty to settle alleged violations of federal environmental laws at its pharmaceutical manufacturing facilities in Riverside and West Point, Pa.
: : STIPULATION AND ORDER BETWEEN PLAINTIFF UNITED STATES OF AMERICA AND DEFENDANT MERCK & CO., INC. WHEREAS, Plaintiff United States of America, on behalf of the United States Environmental Protection Agency (“EPA”), has filed a complaint in this action (“Complaint”) pursuant to Sections 309(b) and (d) and Section 311(b)(7) of the Federal Water Pollution Control Act, as amended by the Clean Water Act of 1977 and the Water Quality Act of 1987 (the “Clean Water Act” or “CWA”), 33 U.S.C.
By Kaitlin Ugolik ( September 28, 2011, 5:09 PM EDT) -- Merck & Co. Inc. agreed Wednesday to pay a $1.5 million civil penalty to settle claims that it failed to prevent and report discharges of hazardous materials at two pharmaceutical manufacturing facilities in Pennsylvania, in violation of federal environmental laws....
Corporate conductConfirmed
FDA's Arthritis Advisory Committee convenes for Vioxx label change
In February 2001, the FDA's Arthritis Advisory Committee convened to consider Merck's request to update the Vioxx label with VIGOR's gastrointestinal findings.
In February 2001, the FDA’s Arthritis Advisory Committee convened to consider Merck’s request that the Vioxx label be changed to reflect VIGOR’s positive gastrointestinal findings.
Corporate conductSettlement
Merck agreed to pay $399 million plus interest to settle the Medicaid Rebate
Merck agreed today to pay $399 million plus interest to settle the Medicaid Rebate as well as the kickback allegations.
Merck agreed today to pay $399 million plus interest to settle the Medicaid Rebate as well as the kickback allegations.
These programs primarily consisted of excess payments to physicians that were disguised as fees paid to them for �training,� �consultation� or �market research.� In fact, the government alleged that these fees were illegal kickbacks intended to induce the purchase of Merck products.
Media & the pressRuling
A Minnesota jury found Merck liable in a mesothelioma lawsuit
A Minnesota jury has found Merck and several cosmetic talc manufacturers liable in a mesothelioma lawsuit.
Mr Corbett said that in 1999 Merck had launched “an aggressive and deceptive advertising campaign which misrepresented the safety and improperly concealed the increased risks associated with Vioxx.” Hundreds of thousands of consumers demanded prescriptions for the drug before doctors had a chance to understand the side effects, he added.
The civil settlement ends investigations by 29 US states and the District of Columbia into Merck’s previous advertising practices for the drug.
In a statement published this week Merck acknowledged that it had reached civil settlements “to resolve previously disclosed investigations under state consumer protection laws related to past activities for Vioxx.” The company said that it had “acted in good faith and that the company’s activities in support of Vioxx were intended to fully comply with relevant regulations.”
Corporate conductRecall
Merck recalls Temodar and Temozolomide bottles
Merck recalled Temodar and Temozolomide bottles with cracked caps due to child-resistant closure failure.
The FDA sent Merck a warning letter released to the public on September 21, 2001.
Workplace equityAllegation
Employees of Merck filed discrimination charges with the Equal Employment Opportunity Commission
Procedural Background Allegations of racial discrimination against Merck were initially part of a proposed class action, which began on July 6, 1998, when Julius Webb and Ernest Thomas, two Merck employees, filed charges with the Equal Employment Opportunity Commission (“EEOC”).
Procedural Background Allegations of racial discrimination against Merck were initially part of a proposed class action, which began on July 6, 1998, when Julius Webb and Ernest Thomas, two Merck employees, filed charges with the Equal Employment Opportunity Commission (“EEOC”).
Corporate conductAllegation
Merck is accused of anticompetitive behavior
Merck is accused of anticompetitive behavior in a class-action lawsuit.
The first court case, United States v. Merck & Co., stems from claims by two former Merck scientists that Merck "fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act]."
These fraudulent activities, say the whistleblowers, were designed to produce test results that would meet the FDA's requirement that the mumps vaccine was 95 per cent effective. To the whistleblowers' delight, the judge dismissed Merck's objections to the case proceeding, finding the whistleblowers had plausible grounds on all of the claims lodged against Merck.
According to the whistleblowers' court documents, Merck's misconduct was far-ranging: It "failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment describe herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government was purchasing."
I would also affirm because, even without considering Merck’s petitioning activity, a reasonable jury could still conclude that Merck engaged in anticompetitive conduct by maintaining misrepresentations on its vaccine ’s label to protect its monopoly in the mumps vaccine market.1 18 Because we hold that Merck is shielded by Noerr-Pennington immunity, we need not address whether there is a genuine dispute of material fact about antitrust injury.
-35a- unlawful anticompetitive behavior .9 In short, the record, viewed in Plaintiffs’ favor, shows that (1) Merck’s MMR- II label was approved in the 1970s and was continually used thereafter; (2) decades after the label was approved, Merck learned that the public-facing label may not be accurate with respect to the seroconversion rate 10 and potency/shelf-life claims,11 and withheld that information from the public;12 and (3) Merck was reluctant to modify the claims on its approved label because doing so would make it easier for its competitor, GSK, to enter the market and cut into Merck’s monopoly and profits.
Because Merck’s conduct “consist[ed] of making intentional misrepresentations,” the mere fact that it succeeded would not have entitled it to absolute immunity.
I would also affirm because, even without considering Merck’s petitioning activity, a reasonable jury could still conclude that Merck engaged in anticompetitive conduct by maintaining misrepresentations on its vaccine ’s label to protect its monopoly in the mumps vaccine market.1 18 Because we hold that Merck is shielded by Noerr-Pennington immunity, we need not address whether there is a genuine dispute of material fact about antitrust injury.
Because Merck’s conduct “consist[ed] of making intentional misrepresentations,” the mere fact that it succeeded would not have entitled it to absolute immunity.
-35a- unlawful anticompetitive behavior .9 In short, the record, viewed in Plaintiffs’ favor, shows that (1) Merck’s MMR- II label was approved in the 1970s and was continually used thereafter; (2) decades after the label was approved, Merck learned that the public-facing label may not be accurate with respect to the seroconversion rate 10 and potency/shelf-life claims,11 and withheld that information from the public;12 and (3) Merck was reluctant to modify the claims on its approved label because doing so would make it easier for its competitor, GSK, to enter the market and cut into Merck’s monopoly and profits.
-35a- unlawful anticompetitive behavior .9 In short, the record, viewed in Plaintiffs’ favor, shows that (1) Merck’s MMR- II label was approved in the 1970s and was continually used thereafter; (2) decades after the label was approved, Merck learned that the public-facing label may not be accurate with respect to the seroconversion rate 10 and potency/shelf-life claims,11 and withheld that information from the public;12 and (3) Merck was reluctant to modify the claims on its approved label because doing so would make it easier for its competitor, GSK, to enter the market and cut into Merck’s monopoly and profits.
"Merck misled regulators to preserve its monopoly, blocking competition and driving up prices for an essential vaccine," Gupta said.
WASHINGTON (Reuters) -The U.S. Supreme Court declined on Monday to hear a bid by a group of physicians and healthcare providers to revive their antitrust lawsuit accusing drugmaker Merck of misleading federal regulators to maintain a decades-long monopoly over the mumps vaccine market.
Corporate conductConfirmed
Merck discontinues U.S. antibiotic
Merck discontinued an important antibiotic from the U.S. market.
In an unexpected move, Merck discontinued an important antibiotic from the U.S. market earlier this month, underscoring concerns about the commitment large pharmaceutical companies are willing to make to a field that is crucial to public health.
Corporate conductConfirmed
Merck — Resolution Chemicals
Infringement Fines - Lundbeck Fines – generic companies Merck KGaA / Generics [UK] agreements Merck KGaA: € 21 411 000 of which jointly and severally with Generics [UK] Limited: € 7 766 843 Arrow agreements Arrow Group ApS: € 9 975 000 of which jointly and severally with Arrow Generics Limited: € 9 360 000 of the latter amount of which jointly and severally with Resolution Chemicals Limited: € 823 735 Alpharma agreement Zoetis Products LLC and Xellia Pharmaceuticals ApS jointly and severally: € 10 530 000 of which jointly and severally with A.L.
Infringement Fines - Lundbeck Fines – generic companies Merck KGaA / Generics [UK] agreements Merck KGaA: € 21 411 000 of which jointly and severally with Generics [UK] Limited: € 7 766 843 Arrow agreements Arrow Group ApS: € 9 975 000 of which jointly and severally with Arrow Generics Limited: € 9 360 000 of the latter amount of which jointly and severally with Resolution Chemicals Limited: € 823 735 Alpharma agreement Zoetis Products LLC and Xellia Pharmaceuticals ApS jointly and severally: € 10 530 000 of which jointly and severally with A.L.