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About POGO's Federal Contractor Misconduct Database (FCMD)
The government awards contracts to companies with histories of misconduct such as contract fraud and environmental, ethics, and labor violations. In the absence of a centralized federal database listing instances of misconduct, the Project On Government Oversight (POGO) is providing such data. We believe that it will lead to improved contracting decisions and public access to information about how the government spends hundreds of billions of taxpayer money each year on goods and services. Report an instance of misconduct »
Ranking: 102
GlaxoSmithKline
GlaxoSmithKline is one of the world's largest pharmaceutical companies with with an estimated seven percent share of the world's pharmaceutical market. It produces medicines that treat six major disease areas – asthma, virus control, infections, mental health, diabetes and digestive conditions. The company also markets over-the-counter medicines, dental products, smoking control products and nutritional drinks.
Federal Contract $: $ 512.4m
Total Number of Instances: 33
Total Misconduct dollar amount: $8803.8m
- Annual Report
- Ethics Page
- Lobbying Information
- Political Activity
- Press Page
- SEC Form 20-F
- Website
- Contracting Information
Instances of Misconduct
1. Hawaii Average Wholesale Price Litigation
The state of Hawaii settled with dozens of pharmaceutical companies, including Merck, Pfizer, GlaxoSmithKline and Novartis, which were accused of gouging Hawaii's Medicaid program for more than a decade by fraudulently inflating their prescription drug prices. The total amount of the settlements was $82.7 million. The companies did not admit any liability or wrongdoing.... more»
2. Nigeria Trademark Infringement
It was reported that a Federal High Court in Lagos, Nigeria awarded about N1.2 billion (US$7.9 million) in damages against GlaxoSmithKline Plc and two of its subsidiaries for infringing on a trademark owned and registered by Nigerian company Continental Pharmaceuticals Limited (CPL). The court found that CPL had registered the trademark in 1981 for its brand of analgesic, Conphamol, and that the trademark was infringed by GSK, Smithkline Beecham Plc, and Glaxo Group Limited in their packaging and sale of Panadol and Panadol Extra.... more»
3. Denture Cream Product Liability Litigation
Lawsuits were filed against GlaxoSmithKline alleging its Super PoliGrip denture adhesive cream causes severe neurological injuries to users. Plaintiffs attribute their injuries to a form of zinc contained in the product which causes copper depletion and serious adverse neurological effects. In a July 2010 financial filing, GSK reported that it had "reached agreement in principle to settle the vast majority of cases." It was reported in May 2011 that GSK had paid approximately $120 million to settle the lawsuits.... more»
4. Tobin v. SmithKline Beecham (Paxil Wrongful Death)
The relatives of Donald Schell, who killed his family and himself in February 1998, blamed his actions on his use of the anti-depression drug Paxil and filed a wrongful death lawsuit against the manufacturer, SmithKline Beecham (n/k/a GlaxoSmithKline). A jury found in plaintiffs’ favor and awarded a total of $8 million in damages, for which GSK was held 80 percent responsible. Later, during GSK’s appeal, the parties reached a confidential settlement of the case.... more»
5. Kilker v. SmithKline Beecham (Paxil Birth Defects)
Michelle David claimed her son’s heart defects were caused by GlaxoSmithKline’s anti-depression drug Paxil, which she took during her pregnancy. A jury found that GSK negligently failed to properly warn David’s physician of Paxil’s risk and that David’s use of Paxil was a factual cause of her son’s heart defects. The jury awarded $2.5 million in compensatory damages.... more»
6. Cunningham v. GSK (Paxil Wrongful Death)
Fourteen-year-old Scott Cunningham committed suicide two months after he began taking GlaxoSmithKline’s anti-depression drug Paxil. His parents sued Glaxo, attributing Paxil to their son’s death and alleging the company suppressed evidence that linked Paxil to an increased incidence of suicidal thoughts and behavior in some adolescent users. The parties settled in May 2009 for an undisclosed amount.... more»
7. U.S. Senate Investigation of Avandia
According to a Senate Finance Committee inquiry, GlaxoSmithKline, the manufacturer of the diabetes drug Avandia, failed to publish studies that found serious health risks associated with Avandia in a timely manner and actively promoted the drug despite the known safety concerns. Documents obtained by the committee showed that, as far back as 2000, GSK executives sought to downplay scientific findings which raised questions about Avandia’s safety. Additionally, the committee found Avandia was part of a “ghostwriting campaign,” a practice by which pharmaceutical companies disguise their role in publishing articles promoting their products in medical journals under the byline of purportedly independent doctors or scientists. In September 2010, the U.S. Food and Drug Administration severely restricted the sale of Avandia.... more»
8. Paxil Birth Defect Litigation
In June 2010, it was reported that GlaxoSmithKline entered into a confidential settlement with 190 families who claimed its antidepressant Paxil caused congenital birth defects. Most of the claims alleged that babies born to mothers taking Paxil suffered heart defects.... more»
9. FDA Review of Altabax Promotional Material
In April 2010, the U.S. Food and Drug Administration issued a warning letter to GlaxoSmithKline about the promotion of its Altabax skin infection ointment. The FDA reviewed a sales brochure known as a “slim jim” sales aid which discussed Altabax and found it “false or misleading.” The FDA said the brochure “broadens the indication of Altabax, makes unsubstantiated superiority claims, and omits and minimizes important risk information associated with Altabax. Thus, the slim jim misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act….These violations are concerning from a public health perspective because they suggest that Altabax is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience.”... more»
10. Kentucky Kytril and Zofran Average Wholesale Price Lawsuit
GlaxoSmithKline agreed to pay the Commonwealth of Kentucky $3.75 million to settle allegations of deceptive or false marketing of the anti-nausea drugs Kytril and Zofran. Kentucky alleged that GSK improperly inflated the average wholesale price (AWP) for the drugs, causing Kentucky’s Medicaid program to pay millions of dollars more in reimbursements than it should have. Despite the fact that GSK was found liable in an earlier trial, GSK was allowed to settle without admitting any liability or wrongdoing.... more»
11. Puerto Rico Drug Manufacturing Facility Settlement
SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, agreed to plead guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility. The resolution included a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act for $600 million. The drugs, manufactured at the plant between 2001and 2005, included Kytril, Bactroban, Paxil CR and Avandamet. The government alleged that SB Pharmco’s manufacturing operations failed to ensure that Kytril and Bactroban were free of microorganism contaminants; that SB Pharmco’s manufacturing process caused Paxil CR two-layer tablets to split, causing the potential distribution of tablets that did not have any therapeutic effect; that Avandamet tablets manufactured by SB Pharmco did not always have the Food and Drug Administration (FDA)-approved mix of active ingredients; and that SB Pharmco’s facility suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle.... more»
12. Relafen Antitrust Litigation
GlaxoSmithKline agreed to pay $175 million to settle an antitrust lawsuit filed in federal court in Massachusetts accusing the company of blocking cheaper generic forms of its arthritis drug Relafen. The lawsuit was filed on behalf of wholesale purchasers who bought Relafen directly from GSK and resold them to health plans, pharmacies and supermarkets. In August 2001, a court ruled that GSK’s patent covering Relafen was both invalid and unenforceable due to the company’s inequitable conduct.... more»
13. Paxil Multistate Litigation - NY Attorney General Settlement
The New York State Attorney General and GlaxoSmithKline reached a $14 million multi-state settlement resolving claims involving GSK's anti-depression drug Paxil. GSK was accused of fraudulently delaying generic competition for Paxil by filing frivolous patent infringement lawsuits. The settlement resolved claims by 49 states that charged their Medicaid programs had been gouged.... more»
14. Relafen Multistate Litigation - NY Attorney General Settlement
New York State Attorney General Eliot Spitzer reportedly reached a national settlement with GlaxoSmithKline for $10 million, resolving claims that GSK delayed generic competition by by filing frivolous patent infringement lawsuits over its arthritis drug Relafen.... more»
15. Average Wholesale Price (AWP) Drug Litigation
A class-action lawsuit was filed in federal court in Massachusetts against GlaxoSmithKline and 22 other pharmaceutical companies alleging consumers are harmed by the way the companies price their drugs. The companies set prices using the Average Wholesale Price (AWP) formula. The government uses average wholesale prices as reported by drug companies to set reimbursements from federal health programs. Plaintiffs claim drugmakers artificially inflated their prices as part of a scheme to overcharge consumers. In August 2006, GlaxoSmithKline agreed to a proposed $70 million settlement.... more»
16. Paxil New York Litigation
The New York State Attorney General sued GlaxoSmithKline in June 2004, alleging the company withheld negative information about its anti-depression drug Paxil. The suit alleged GSK suppressed the results of studies which failed to prove Paxil's effectiveness and which suggested a possible increased risk of suicidal thoughts and acts in certain individuals. GSK was further alleged to have failed to disclose this information in medical information letters it sent to physicians. The following August, a settlement was reached in which GSK agreed to pay $2.5 million in disgorgement and costs to the State of New York and to publicly disclose information on all clinical studies -- whether positive or negative -- of the safety and efficacy of its drugs.... more»
17. Augmentin Antitrust Litigation
GlaxoSmithKline agreed to settle nationwide antitrust class action lawsuits regarding Augmentin. GSK will pay $92 million to direct purchasers of the antibiotic product, including pharmaceutical wholesalers, and indirect purchasers such as consumers and third party payers. GSK was accused of fraudulently preventing generic versions of Augmentin from entering the market by obtaining fraudulent patents and pursuing sham litigation defending those patents, resulting in higher prescription prices.... more»
18. Zofran and Kytril False Claims Act Violations
GlaxoSmithKline paid over $150 million to settle allegations that it violated the False Claims Act through the fraudulent drug pricing and marketing of the anti-emetic drugs Zofran and Kytril. GSK allegedly engaged in a scheme to set and maintain inflated prices for Zofran and Kytril knowing that federal healthcare programs established reimbursement rates based on those prices, and thereby caused false and fraudulent claims to be submitted to Medicare and other federal healthcare programs. The government also alleged GSK engaged in a "double dipping" billing scheme with respect to Kytril by encouraging customers to pool leftover vials of Kytril to create an extra dose, which would then be administered to a patient and re-billed to government healthcare programs.... more»
19. Underreporting Profits
GlaxoSmithKline agreed to pay approximately $3.4 billion to settle charges by the IRS that the company under-reported profits to avoid paying U.S. taxes. The Internal Revenue Service accused GSK of a practice called "transfer pricing," by which a company claims most of its earnings belong in a country where taxes are low. The transactions at issue, which concerned the way GSK priced drugs for sale through its U.S. subsidiary, occurred between the years 1989 and 2005.... more»
20. Overcharging Medicaid
Bayer AG and GlaxoSmithKline simultaneously settled allegations they overcharged Medicaid. GSK agreed to pay the government a civil fine of $87.6 million for failing to give the Medicaid program the lowest price charged to any consumer for anti-depressant Paxil and nasal allergy spray Flonase. Both companies were accused of hiding their lowest prices from Medicaid by repackaging or relabeling their products under a middleman's name, who then sold them at a deep discount not reported to the government. All 50 states will share in the settlement.... more»
21. Relafen Consumer Litigation
In February 2002, a class-action lawsuit was filed in federal court in Massachusetts against GlaxoSmithKline PLC, SmithKline Beecham Corp, Beecham Group PLC, and SmithKline Beecham PLC, on behalf of consumers and third-party payors around the country who purchased the drug Relafen or its generic alternatives. The suit alleged the companies unlawfully obtained a patent which allowed them to enforce a monopoly over Relafen, causing consumers to pay inflated prices for the drug. A court in August 2001 ruled that GSK’s patent covering Relafen was both invalid and unenforceable due to the company’s inequitable conduct. In November 2004, the judge granted preliminary approval of a proposed settlement under which the defendant companies agreed to pay $75 million in damages.... more»
22. Paxil Class Action Litigation (Madison County, IL)
A class action lawsuit filed against GlaxoSmithKline in Madison County, Illinois claimed GSK withheld negative information about the safety and effectiveness of its anti-depression drug Paxil. A settlement was reached in October 2006 and was approved by the court the following April. Under the settlement, GSK, which did not admit any wrongdoing, was required to establish a fund of $63.8 million to compensate all U.S. consumers who bought Paxil or Paxil CR for a person under the age of 18.... more»
23. Puerto Rico Drug Manufacturing Facility Settlement – State AGs
GlaxoSmithKline agreed to pay nearly $41 million to settle charges brought by 38 state attorneys general that the company tried to sell drugs made in a Puerto Rican plant that failed to meet manufacturing standards. The attorneys general alleged that, between 2001 and 2004, GlaxoSmithKline and its SB Pharmco Puerto Rico subsidiary engaged in unfair and deceptive practices when they manufactured and distributed certain lots of Kytril, Bactroban, Paxil CR, and Avandamet, produced in a plant in Cidra, Puerto Rico. An investigation found certain batches were not sterilized or medication contained different dosages than indicated on the bottle. See related GlaxoSmithKline instance, “Puerto Rico Drug Manufacturing Facility Settlement.”... more»
24. South Korea Antitrust Fine
South Korea’s Fair Trade Commission fined GlaxoSmithKline three billion won (approx. US$2.6 million) for conspiring with a Seoul rival over the sale of drugs. According to the South Korean government, Glaxo in 2000 offered Dong-A Pharmaceutical the exclusive right to sell its anti-nausea drug Zofran and an anti-viral medication called Valtrex; in return, Glaxo demanded that Dong-A stop selling a cheaper generic version of Zofran and not produce or sell any drugs that could compete against Zofran and Valtrex.... more»
25. Current Good Manufacturing Practice Violations at Worthing, UK Facility
The U.S. Food and Drug Administration (FDA) issued a warning letter to SmithKline Beecham Limited that it had violated Current Good Manufacturing Practice (CGMP) regulations at its manufacturing facility in Worthing West Sussex, United Kingdom. The FDA found that the company did not establish appropriate written procedures designed to prevent microbiological contamination of drug products purported to be sterile, failed to follow laboratory control procedures, and that the quality control unit did not adequately exercise its responsibilities to approve procedures or specifications that may impact the identity, strength, quality, and purity of the drug product.... more»
26. 2011 Criminal and Civil Investigations Settlement
In November 2011, GlaxoSmithKline announced it would set aside $3 billion to resolve criminal and civil investigations into marketing practices with regard to its Avandia diabetes drug, a Department of Justice investigation of its Medicaid pricing practices, and a nationwide investigation into the sales and marketing of nine of its products from 1997 to 2004. Under the settlement, the terms of which were finalized in 2012, GSK agreed to pay $3 billion in fines and penalties and plead guilty to three criminal counts. GSK also executed a five-year corporate integrity agreement with the Department of Health and Human Services, Office of Inspector General (HHS-OIG) requiring GSK to implement major changes to the way it compensates its sales force and to implement greater transparency in its research practices and publication policies.... more»
27. Argentina Vaccine Trials Fine
The government of Argentina fined GlaxoSmithKline Argentina Laboratories Company 400,000 pesos (approx. US$93,000) for its handling of vaccine trials in Mendoza, Argentina in 2007 and 2008. According to media accounts, a government investigation found Glaxo and two trial investigators failed to heed proper informed consent procedures in a study called Protocol Compas, which tested the efficacy of the Synflorix pediatric pneumonia vaccine. GSK admitted in a January 2012 public statement that there were “some administrative irregularities in the process of obtaining informed consent from a small proportion of patients in the study.”... more»
28. Defrauding Louisiana’s Medicaid Program
Louisiana recovered $25.2 million from five pharmaceutical companies the state accused of defrauding Louisiana’s Medicaid program: Actavis Group HF, Boehringer Ingelheim GmbH, Dey Pharma LP, GlaxoSmithKline, and Schering-Plough. The companies allegedly misreported prescription drug price information, based on Average Whole Prices (AWPs), in order to increase Medicaid reimbursements. GlaxoSmithKline paid the state a total of $10 million.... more»
29. Avandia Marketing, Sales Practices and Products Liability Litigation
The family of Milagros Larosa sued GlaxoSmithKline (GSK), claiming its diabetes drug Avandia was responsible for Larosa’s fatal stroke in December 2005. The Larosas accused GSK of causing her wrongful death due to negligence, breach of warranty, fraud, and failing to warn about the risks of Avandia. In November 2007, the Food and Drug Administration (FDA) announced a second “black box” warning would be added to the Avandia label advising users of its cardiovascular risks. In 2008, Larosa’s case was transferred to a federal court in Pennsylvania and consolidated with a national class action. In May 2010, it was reported that GlaxoSmithKline settled with more than 700 plaintiffs for $60 million. In July 2010, it was reported that GSK settled approximately 10,000 additional lawsuits for $460 million. In February 2011, it was reported that GSK settled 5,500 additional lawsuits for $250 million. In February 2012, it was reported that GSK settled more than 20,000 more cases for an undisclosed amount.... more»
30. Release of TCE in Scottsdale, AZ
Motorola, Inc., Siemens Corp. and GlaxoSmithKline will collectively pay a $500,000 civil penalty for system failures that led to the release of trichloroethylene (TCE) into the public drinking water system in Scottsdale, Ariz. A quantity of TCE exceeding contamination limits was released from the Miller Road Treatment Facility on two separate occasions, in October 2007 and January 2008. According to the Justice Department, the companies “failed to properly treat groundwater for TCE at the site and further failed to alert proper authorities about the release despite being under an agreement to do both.”... more»
31. Relenza Litigation Settlement
GlaxoSmithKline settled a lawsuit filed by Australian biotech company Biota Holdings Limited over the commercialization of the flu drug Relenza (known generically as zanamivir). Under the terms of the settlement, GSK admits no liability but will make a payment of A$20 million (USD$19.5 million) to Biota. Biota developed Relenza and licensed it to GSK in 2000 which brought it to market, but it never became a top seller. Biota filed suit in May 2004, accusing GSK of failing to properly promote Relenza. Both companies will continue to market Relenza as per the initial agreement, which remains unchanged by the settlement.... more»
32. Medicines Australia Code of Conduct Violations
Medicines Australia, a pharmaceutical industry trade group, assessed fines on GlaxoSmithKline Australia for infractions of the group’s code of conduct. GSKA was the subject of complaints by rival companies and was made to pay $100,000 in two separate decisions for distributing misleading promotional material about its products. GSKA was also fined $210,000 for code violations in regard to three doctors' conferences sponsored by the company.... more»
33. Paxil Class Action (National)
GlaxoSmithKline settled a class-action lawsuit over its antidepressant Paxil by agreeing to pay insurers $40 million to reimburse health plans that paid for children and adolescents to receive the drug between 1998 and 2004. The lawsuit alleged GSK suppressed studies showing the drug was not safe or effective for the treatment of depression in children under the age of 18.... more»
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