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Posts Tagged ‘whistleblower’
K&M Represents Whistleblower in $45 Million Settlement against Par Pharmaceutical Company, Inc.
Tuesday, March 5th, 2013
Kenney & McCafferty is proud to announce that it represents a key Par Pharmaceutical insider whose knowledge, information, and evidence were central to Par’s decision today to pay $45 million to settle civil and criminal allegations. The settlement resolves allegations that Par willfully defrauded Medicare, Medicaid, and other government funded health care programs in connection with the launch of a long-term care sales force to promote Megace ES for off-label uses, including weight loss in elderly patients.
Kenney & McCafferty represented whistleblower Christine Thompson, who filed a qui tam action against Par arising from this misconduct. As a result of her efforts in coming forward with this information as well as her assistance throughout the government’s investigation, Ms. Thompson is entitled to receive a percentage of the government’s civil recovery.
To read more about the Par case, including the complaint, click here.
Tags: health care, Healthcare, off-label marketing, Par, Par Pharmaceutical, Qui Tam, whistleblower
Posted in False Claims Act, government fraud, Press Release, Recent News | Comments Off
GSK Pleads Guilty and Pays $3 Billion to Resolve Allegations Brought under False Claims Act by Whistleblowers Represented by K&M
Monday, July 2nd, 2012
Philadelphia, July 2, 2012 – GlaxoSmithKline has agreed to pay $3 Billion in criminal and civil fines, penalties and damages to settle allegations that the company defrauded Medicare, Medicaid and other government funded health care programs in connection with its market practices for Advair, Wellbutrin, Paxil, Lamictal, Zofran, Imitrex, Lotronex, Flovent and Valtrex and Avandia. The settlement is the largest qui tam settlement in U.S. history. The settlement is the largest qui tam settlement in U.S. history.
Gregory Thorpe and Blair Hamrick, the first whistleblowers to file a qui tam action against GSK arising from this marketing misconduct nearly a decade ago, are represented by Kenney & McCafferty. As part of the record setting settlement, GSK agreed to pay $1.17 billion to settle claims brought by Thorpe and Hamrick. To read more about the settlement, click here.
To read the complaint filed on behalf of Thorpe and Hamrick, click here. Exhibits accompanying the complaint may be found here. Additionally, Thorpe’s internal report to compliance executives at GSK may be found within the Exhibits at 0000015-0000027.
To read the Complaint-in-Intervention filed by the United States, click here.
To read the Settlement Agreement, click here.
If you have knowledge of healthcare fraud and would like to discuss the possibility of a whistleblower award under the False Claims Act, please contact our whistleblower attorneys today. Kenney & McCafferty will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys regarding your case are confidential and protected by attorney-client privilege.
Tags: False Claims Act, FCA, fraud, GSK, health care fraud, pharmaceutical fraud, Qui Tam, reward, whistleblower, whistleblower award, whistleblower reward
Posted in False Claims Act | Comments Off
cGMP Violations Remain a Hot Topic under the False Claims Act
Monday, June 11th, 2012
As the world’s largest purchaser of prescription drugs under Medicare, Medicaid, the Veterans Administration, and other government healthcare programs, the United States government has a vested interest in ensuring that prescription drugs are safe and effective.
Current Good Manufacturing Practice (“cGMP”) regulations outline the requirements that drug manufacturers must follow for the manufacture, processing, packing, and holding of a drug. The regulations, which are enforced by the U.S. Food and Drug Administration (“FDA”), provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law. The government has taken the position that adulterated drugs, those whose strength materially differs from, or the purity or quality falls below, the strength, purity, or quality specified in the drug’s FDA-approved New Drug Application, the drug’s labeling, and/or the standards set forth in official compendium, are not eligible for payment by the government. Consequently, any claim for payment submitted for an adulterated drug may give rise to liability under the False Claims Act.
In October 2010, the Department of Justice announced its largest cGMP settlement to date, as SB Pharmco Puerto Rico – a subsidiary of GlaxoSmithKline – pleaded guilty to the manufacture and distribution of adulterated drug products. The company settled the False Claims Act allegations for $750 million, resulting in a $96 million payment to the whistleblower in the case.
Most recently, at an ABA conference, the government affirmed its position that cGMP violations can give rise to violations of the False Claims Act, particularly if the resulting drug products are unsafe, ineffective, and/or substandard.
If you have knowledge of cGMP violations and would like to discuss the possibility of a whistleblower award under the False Claims Act, please contact our whistleblower attorneys today. Kenney & McCafferty will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys regarding your case are confidential and protected by attorney-client privilege.
Tags: Adulterated drug, cGMP, cGMP violations, Good Manufacturing Practices, Healthcare Fraud, Medicaid fraud, medicare fraud, whistleblower
Posted in False Claims Act | Comments Off
Pfizer Pays $3.3M to Settle False Claims Allegations in Oregon
Wednesday, March 21st, 2012
Pfizer Inc. has agreed to pay Oregon more than $3.3 million to settle claims that the company used misleading statements and studies to market Zyvox. The settlement comes after a two-year state investigation into the marketing of the company’s drug, which is used to treat pneumonia and bacterial skin infections.
Oregon Attorney General John Kroger announced the settlement on Tuesday. The settlement follows a 2009 multistate settlement concerning Zyvox, as well as other drugs, which included $2.3 billion in fines against the company.
“Our investigation was aggressive, detailed, went placed that the federal settlement didn’t and provided additional settlement to the state of Oregon,” said David Hart, a senior AG who headed the investigation.
The complaint, filed in Marion County Circuit Court, alleged that Pfizer used “unreliable and unsubstantiated claims” in marketing Zyvox as a better alternative than its generic competitors.
Pfizer denied the allegations, yet released a statement saying it was “pleased to resolve this investigation and avoid the further time and cost of litigation.”
For more information on the settlement, see the full article in the Washington Post at http://www.washingtonpost.com/business/industries/pfizer-agrees-to-pay-oregon-33m-in-antibiotic-marketing-case/2012/03/21/gIQAfGx1QS_story.html.
If you have knowledge of Healthcare Fraud and would like to discuss the possibility of a whistleblower award under the False Claims Act, please contact our whistleblower attorneys today. Kenney & McCafferty will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys regarding your case are confidential and protected by attorney-client privilege.
Tags: False claims, False Claims Act, Qui Tam, reward, whistleblower
Posted in False Claims Act | Comments Off
Attorney General Warns: More Corporate Crime Charges Coming
Tuesday, March 13th, 2012
Those individuals involved in corporate fraud may soon find themselves in the crosshairs of the Department of Justice. According to Attorney General Eric Holder, the DOJ plans to take action against individuals responsible for corporate fraud, adding that fines against corporations are not a deterrent.
“It can’t simply be that you make billions of dollars and then you pay hundreds of millions of dollars in penalties. That’s not a disincentive,” Holder said. According to the Attorney General, “there have been far too many repeat offenders.”
Recently, the DOJ has been the target of strong criticism over its failure to bring actions against individual employees responsible for corporate fraud. In the past, the DOJ has generally brought cases against corporations.
With this new approach, the DOJ hopes to counter its critics.
“We’re gonna make some news with regard to holding individuals responsible for things we tend to think of as corporate crimes,” Holder said at a meeting of state attorneys general in Washington.
If you have knowledge of Corporate Fraud and would like to discuss the possibility of a whistleblower award under the False Claims Act, please contact our whistleblower attorneys today. Kenney & McCafferty will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys regarding your case are confidential and protected by attorney-client privilege.
Tags: corporate fraud, False claims, False Claims Act, whistleblower
Posted in False Claims Act | Comments Off
Blowing the Whistle on Foreign Corrupt Practices Act Violations
Tuesday, July 26th, 2011
The Securities and Exchange Commission (SEC) whistleblower program provides for rewards for individuals who provide the government with information about violations of the Foreign Corrupt Practices Act (FCPA) of 1977.
The FCPA was enacted in 1977 in an effort to end the practice of multinational corporations obtaining business abroad by bribing foreign officials. The Act covers any U.S. company or citizen doing business abroad. It covers foreign companies — and their directors, officers, stockholders, employees and agents — with reporting and registration requirements under the Securities and Exchange Acts as well as any foreign person or company acting within the United States.
The FCPA makes it unlawful to bribe a foreign government official to obtain or retain business. The Act prohibits U.S. companies and individuals from paying money or any other sort of inducement, including an offer or promise to pay money or anything of value, to a foreign official with the intent to influence a decision or action affecting that company’s business.
A foreign official is defined as “any officer or employee of a foreign government or any department, agency, or instrumentality thereof, or of a public international organization, or any person acting in an official capacity for or on behalf of such government or department, agency, or instrumentality, or for or on behalf of any such public international organization.”
The Department of Justice (DOJ) is the chief enforcement agency, with a coordinate role played by the SEC. The DOJ is responsible for all criminal enforcement and for civil enforcement of the anti-bribery provisions with respect to domestic concerns and foreign companies and nationals. The SEC, on the other hand, is responsible for civil enforcement of the anti-bribery provisions with respect to issuers.
The FCPA provides for criminal and civil penalties. The criminal penalties include fines on officers, directors, stockholders, employees and agents of up to $250,000 and up to five (5) years in prison. Meanwhile, corporations and other business entities can face criminal fines of up to $2 million, or alternatively twice the amount of ill-gotten profits. The civil fines under the FCPA include $10,000 against any violating company and individual. Moreover, the SEC may also require a disgorgement of profits.
In the past few years, prosecutions under the FCPA have dramatically increased. The SEC has established an enforcement unit, targeting violations of the FCPA by U.S. issuers. The DOJ has similarly assigned prosecutors and FBI agents exclusively to the FCPA. The federal authorities have also instituted more aggressive investigative tactics in their pursuit of FCPA violations.
The DOJ and the SEC recently settled with Johnson & Johnson (J&J) for $71 million. J&J agreed to pay $21.4 million in criminal penalties as part of a deferred prosecution agreement. J&J additionally settled a related matter filed by the SEC agreeing to more than $48.6 million in disgorgement of profits and pre-judgment interest. The $71 million aggregate settlement by J&J registers as just the 10th largest FCPA-related settlement since 2008.
The top nine FCPA related settlements are as follows: (1) Siemens for $800 million in 2008; (2) KBR/ Halliburton for $579 million in 2009; (3) BAE for $400 million in 2010; (4) Snamprogetti Netherlands B.V. for $365 million in 2010; (5) Technip S.A. for $338 million in 2010; (6) JGC Corp. for $218.8 million in 2011; (7) Daimler AG for $185 million in 2010; (8) Alcatel-Lucent for $137 million in 2010; and (9) Panalpina for $81.8 million in 2010.
If you have knowledge of an FCPA violation or other securities law violations and would like to discuss the possibility of a whistleblower award under the SEC or CFTC whistleblower programs, please contact our whistleblower attorneys today. Kenney & McCafferty will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys regarding your case are confidential and protected by attorney-client privilege.
Tags: Department of Justice, DOJ, FCPA, FCPA violation, Foreign Corrupt Practices Act, SEC, Securities and Exchange Commission whistleblower program, Securities law violations, whistleblower, whistleblower award, whistleblower reward
Posted in Uncategorized | Comments Off
SEC Whistleblower Program Rules Available
Thursday, May 26th, 2011
Look for this link on the SEC's home page.
Since the Commission’s 3-2 vote adopting the final rules yesterday, the SEC has made the document available on its website at ttp://www.sec.gov/news/press/2011/2011-116.htm
Kenney & McCafferty is carefully reviewing the document and determing how the new rules can benefit those reporting securities violations. For a free consultation about a potential claim of your own, please call K&M today.
Tags: abuse, corporate fraud, False Claims Act, fraud, government fraud, health care fraud, pharmaceutical fraud, retaliate, retaliation, Tax Fraud, tax whistleblower, waste, whistle blower, whistle blowing, whistleblower, whistleblowing, wrongful termination
Posted in corporate fraud, Corporate Tax Fraud, False Claims Act, government fraud, Money Laundering Tax Fraud, SEC Whistleblower Program, Uncategorized, Whistleblower Protection | Comments Off
SEC Adopts Final Whistleblower Program Rules
Wednesday, May 25th, 2011
Mary Schapiro presided over the vote approving the SEC whistleblower rules.
In a split vote, the SEC adopted final rules to implement the whistleblower program provisions enacted under Dodd Frank in July 2010. Chairman Mary Schapiro presided over the discussion, with Sean McKessy and Stephen Cohen of the SEC’s staff answering questions by the commissioners on the proposal.
Cohen said that the SEC had strengthened its Office of Market Intelligence to handle the incoming tips and would be adding a special Whistleblower page to a new Tips, Complaints, and Referrals section of the SEC’s webpage. McKessy said that they have not seen a significant increase in the number of tips to the SEC since the passage of Dodd Frank, but staff has seen an improvement in the number of high quality tips received.
Commissioners Walter and Aguilar praised the SEC staff for implementing a “robust public process” leading to the development of today’s rules. Commissioner Paredes dissented and said that he thought the rules did not adequately preserve the role of internal corporate compliance programs and the process for reporting of tips would be a deterrent to whistleblowers. Paredes also said he voted against the proposal because the rules as proposed would create an “undue risk of encouraging low quality submissions.” Paredes said the issue was not the merit of whistleblower programs, but anticipated problems created by this particular set of rules.
Schapiro called for the vote, and the final rules were passed 3 to 2.
Tags: abuse, corporate fraud, False Claims Act, fraud, government fraud, health care fraud, pharmaceutical fraud, retaliate, retaliation, Tax Fraud, tax whistleblower, waste, whistle blower, whistle blowing, whistleblower, whistleblowing, wrongful termination
Posted in Uncategorized | Comments Off
SEC Delays Whistleblower Rules
Thursday, April 28th, 2011
SEC wants to "get it right."
The SEC has postponed adoption of rules for its whistleblower program. According to the Dodd-Frank Act, final regulations for the whistleblower program were to be adopted by the SEC no later than April 21, 2011. Earlier this week, the SEC announced on its website that it is planning to adopt new rules some time between May and end of July. SEC spokesperson John Nester did not provide any specifics about the delay, commenting only that the SEC was crafting all the new rules for Dodd-Frank with an emphasis on “getting it right.”
The financial industry needs an effective fast-track incentive program for whistleblowers. The Dodd-Frank program augments the SEC’s 40 year old insider trading reward program that never realized its potential as a decentralized fraud enforcement mechanism. The SEC, under the old insider trading program, only paid out awards to whistleblowers four times. SEC watchers generally discount the insider trading program and are skeptical about the SEC’s interest in working with whistleblowers in general.
The new Dodd-Frank whistleblower program has generated considerable interest among would be whistleblowers and large companies. Frustrated employees and fraud fighters are delighted to have another program that incentivizes whistleblowers; large companies criticize the program because it encourages whistleblowers to report fraud directly to the government, bypassing internal corporate compliance procedures.
Whistleblowers could file SEC claims for rewards under the Dodd-Frank Act as of last July but will be expected to comply with the new rules once the new rules are adopted. Kenney & McCafferty, P.C. is happy to assist you in assessing your potential SEC whistleblower claim. Call K&M for a free consultation today
Tags: bank fraud award, banking whistleblower, banking whistleblower award, corporate fraud, corporate fraud whistleblower, corporate whistleblower award, finance industry fraud, market fraud, market fraud whistleblower, market whistleblower award, mortgage fraud, mortgage fraud whistleblower, mortgage whistleblower award, Sarbanes Oxley award, Sarbanes Oxley violation, Sarbanes Oxley whistleblower, Sarbanes Oxley whistleblower award, SEC whistleblower, SEC whistleblower award, SEC Whistleblower Program, SEC whistleblower reward, securities violations, securities violations reward, securities whistleblower, securities whistleblower award, SOX retaliation, SOX whistleblower, SOX whistleblower award, whistleblower
Posted in retaliation, SEC Whistleblower Program, Uncategorized, Whistleblower Protection | Comments Off
Senators Introduce Bill to Update Whistleblower Protection Act
Friday, April 8th, 2011
Earlier this week, a group of bipartisan Senators introduced the Whistleblower Protection Enhancement Act of 2011. The bill aims to update the Whistleblower Protection Act, which provides protection from retaliation for federal employees who expose waste, fraud, and abuse in federal agencies.
The bill is being spearheaded by Senator Daniel K. Akaka (D-Hawaii) and Senator Susan M. Collins (R-Maine). Among the sponsors of the legislation is Senator Charles Grassley (R-Iowa), who co-authored the 1989 Whistleblower Protection Act.
If successful, the legislation would:
•clarify that “any” disclosure of gross waste or mismanagement, fraud, abuse, or illegal activity may be protected, but not disagreements over legitimate policy decisions;
•suspend the Federal Circuit Court of Appeals sole jurisdiction over federal employee whistleblower cases for five (5) years;
•extend Whistleblower Protection Act coverage and other non-discrimination and anti-retaliatory laws to all employees of the Transportation Security Administration;
•clarify that whistleblowers may disclose evidence of censorship of scientific or technical information under the same standards that apply to disclosures of other kinds of waste, fraud, and abuse;
•codify and strengthen the anti-gag provision that has been part of every Transportation-Treasury Appropriations bill since 1988;
•allow jury trials under certain circumstances for a period of five years;
•provide the Merit Systems Protection Board with authority to consider and grant summary judgment motions in certain cases for a period of 5 years;
•clarify that employees protected by the Whistleblower Protection Act may make protected classified disclosures to Congress using the same process as intelligence community employees;
•establish protections for the intelligence community modeled on existing whistleblower protections for FBI employees;
•establish a process within the executive branch for review if a security clearance is allegedly denied or revoked because of a protected whistleblower disclosure;
•establish Whistleblower Protection Ombudsmen to educate agency personnel about whistleblower rights; and
•provide the Office of Special Counsel with the independent right to file “friend of the court” briefs, or amicus briefs, with federal court
According to Senator Akaka, the bill “strengthens the Whistleblower Protection Act and restores congressional intent that whistleblowers be protected from retaliation. This protection is crucial to efforts to improve government management, cut the deficit, protect public health and safety, and to secure the nation.”
Senator Collins added, “this [bill] should give federal workers the peace of mind that if they speak out, they will be protected.”
Tags: fraud, retaliation, whistleblower, Whistleblower Protection Act, Whistleblower Protection Enhancement Act
Posted in Uncategorized | Comments Off
