Pharma 101 - Pharmaceutical Fraud: Qui Tam

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Pharma 101 - Pharmaceutical Fraud

Straightforward information & insight on qui tam lawsuits based upon unlawful kickbacks, marketing & pricing conduct.

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Last Entry: November 04, 2009 at 22:10:58

Texas Hospital Group Pays $27.5 Million for False Claims Act Allegations

Posted on November 04, 2009
South Texas Health System, a McAllen, Texas-based hospital group, has agreed to pay the United States $27.5 million to settle claims that it violated the False Claims Act, the Anti-Kickback Statute and the Stark Statute between 1999 and 2006. The hospital group, owned by Pennsylvania-based Universal Health Services Inc...

FDA?s Postmarketing Studies and Clinical Trials Draft Guidance Gets Supported By Public Citizen

Posted on November 02, 2009
In an October 13 letter to the FDA, the well respected consumer advocacy organization Public Citizen, gave a strong endorsement to the FDA Draft Guidance on Postmarketing Studies and Clinical Trials. In letter, Public Citizen’s Deputy Director Peter Lurie MD, MPH, and Sidney M...

Biotech Company and Its Top Management Indicted for Illegal Promotion, Making False Statements to the FDA

Posted on October 30, 2009
The Federal Bureau of Investigation (FBI) Boston announced October 28, 2009, that Stryker Biotech and its top management had been indicted for illegal promotion of medical devices used in surgery. The Hopkinton, Mass.-based biotech and some of its employees were charged in federal court with participating in a fraudulent marketing scheme of medical devices used [...

Four Pharmaceutical Companies Pay $124 Million for False Claims Act Violations

Posted on October 26, 2009
Mylan Pharmaceuticals, UDL Laboratories, AstraZeneca Pharmaceuticals and Ortho McNeil Pharmaceutical have entered into settlement agreements for a total of $124 million to resolve claims that they violated the False Claims Act by failing to pay appropriate rebates to state Medicaid programs for ?authorized generics? paid for by those programs, the U...

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New GAO Report Uncovers Massive Pharmaceutical Fraud

Posted on September 30, 2009
The U.S. Government Accountability Office (GAO) released a report in September 2009 looking at fraud and abuse related to controlled substances paid for by Medicaid. According to GAO’s summary of the report, the government agency found tens of thousands of Medicaid beneficiaries and providers involved in potential fraudulent purchases of controlled substances, abusive purchases of controlled [...

Pharma Co. to pay more than $24 million for kickback, conspiracy charges

Posted on September 15, 2009
Biovail Pharmaceuticals, LLC, has pled guilty to conspiracy and kickback charges and has been sentenced to pay a criminal fine of more than $22 million. These charges concern various actions by the New Jersey-based pharmaceutical company and its employees to carry out a program in which Biovaile paid or cause to be paid up to [...

Pfizer to Pay $2.3 Billion in Largest Healthcare Fraud Settlement in Government?s History

Posted on September 02, 2009
Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. have agreed to pay $2.3 billion to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced September 2, 2009...

Small Case Nets Government $3.9 Million for Alleged Medicaid Fraud

Posted on August 15, 2009
Special Design Healthcare, a Cape Girardeau, Mo.-based pharmacy, has settled with the U.S. and states of Missouri and Illinois to pay $3.9 million for allegations of Medicaid fraud. According to an article in the August 13, 2009 Chicago Tribune, the pharmacy’s owner is charged with submitting false and fraudulent claims to the two states’ Medicaid [...

Quality Control Violation Reports Prompt Drug Maker Mylan to Halt Production, Launch Probe

Posted on July 28, 2009
While Mylan has not publically acknowledged serious problems at its generic drug manufacturing facility, the Pittsburgh Post-Gazette has obtained internal reports alleging that employees at the Morgantown, W. Va. plant have violated government-mandated quality control procedures...

Grassley Probes into Ghostwriting Practices that May Result in Pharmaceutical Fraud

Posted on July 11, 2009
United States Senator Charles E. Grassley of Iowa has asked eight leading medical journals to describe their ghostwriting policies and practices. The inquiry is part of his broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals, according to a July 2, 2009 press release by the senator...

Major Medical Journal No Longer to Silence Whistleblowers

Posted on July 10, 2009
A recent move by a major medical journal could provide more timely disclosure of alleged undisclosed conflicts of interests between researchers and pharmaceutical companies. The Wall Street Journal reported July 7, 2009, that the Journal of the American Medical Association (JAMA) has softened its policy demanding that anyone filing a complaint about unreported conflicts of [...

Effect on Off-Label Marketing in the 2010 Budget Details?

Posted on June 09, 2009
The Department of Health and Human Services recently released its budget proposal for 2010. As it relates to the FDA, HHS is looking to build on the� $1.1billion included in the recovery Act for comparative effectiveness research.� The funds requested will continue efforts to produce state-of-the-science information on what medical treatments work best for a given [...

Eli Lilly has Fighting Words for W. Virginia Attorney General

Posted on June 09, 2009
Attorneys representing Eli Lilly & Co. claim that the civil penalties sought by West Virginia Attorney General Darrell McGraw for the pharmaceutical manufacturer’s alleged mislabeling violations are inappropriate and unreasonable, according to a June 8, 2009 article by John O’Brien on LegalNewsline...

Wyeth under Fire for Alleged Medicaid Fraud

Posted on May 21, 2009
The U.S. government and 16 states have joined in two whistleblower suits against pharmaceutical giant Wyeth. The drug company allegedly failed to pay hundreds of millions in rebates to the Medicaid program, according to a May 18, 2009 release by the U...

STOP Act Charged with Curbing Medicare Fraud

Posted on May 21, 2009
National organizations, including AARP, are endorsing the bipartisan “Seniors and Taxpayers Obligation Protection (STOP) Act,” which is awaiting senate vote. Sponsored by Senators Mel Martinez (R-FL), Bill Nelson (D-FL) and John Cornyn (R-TX), this legislation is aimed at curbing the billions of dollars spent on Medicare fraud each year...

Senator Requests Clarification of Recent Memo to FDA Employees

Posted on March 25, 2009
U.S. Sen. Chuck Grassley wrote a letter on March 24, 2009 to FDA’s acting commissioner asking for clarification of a recent memo to FDA employees, warning agency employees of their obligations to keep certain information confidential. In the letter, addressed to Frank M...

Allegations of Pharmaceutical Fraud Lands Forest Labs in Hot Water

Posted on March 03, 2009

Progress and Deficiencies in the Registration of Clinical Trials

Posted on February 20, 2009
The New England Journal of Medicine just recently published an article which raises questions about the ethics and the science of increasingly conducting studies, or clinical trials, outside the United States — when the studies are meant to gather evidence for new drugs to gain approval in this country...

FDA approves Ranbaxy Laboratories? drugs despite allegations of fraud and more

Posted on February 20, 2009
FDA has approved 18 products, including generic versions of commonly used cholesterol and allergy medications, by pharmaceutical giant Ranbaxy Laboratories, even though the government has accused the company of serious violations. The government agency issued warnings to Ranbaxy late last year for more than 30 of the pharma giant?s generic drugs, produced at two plants in [...

Progress and Deficiencies in the Registration of Clinical Trials

Posted on February 14, 2009

Eli Lilly Pays Record Fine for Off-Label Drug Marketing

Posted on January 19, 2009
Philadelphia, Pennsylvania? Multiple news publications have confirmed that Eli Lilly & Co. will, in the largest United States-imposed criminal fine on an individual company, pay $1.42 billion for the off-label marketing of its drug Zyprexa.�� This record-breaking false claims case settlement was announced on January 16 by Acting U...

Schering- Plough Pays $31 Million to Resolve Pharmaceutical Fraud Allegations

Posted on November 04, 2008
The State of Missouri filed a lawsuit against Schering-Plough in May 2005 and alleged in its complaint that the company did not accurately report drug prices for drugs sold to pharmacies involved in the Missouri Medicaid program.� This is the largest settlement figure the State of Missouri has ever recovered in a��pharmaceutical pricing fraud...

Big Pharma Pays $13.6 million for Price Inflation

Posted on March 25, 2008
U.S. District Court Judge Patti Saris has ordered drug companies AstraZeneca and Bristol-Myers Squib to pay a total of $13.6 million in a Masachusetts case that alleged that they inflated the average wholesale price (AWP) of expensive and in some cases, life-saving drugs...

FDA Issues a draft Guidance for Dissemination of Information on Unapproved Uses of Medical Products

Posted on March 25, 2008
The U.S. Food and Drug Administration (FDA) last Friday issued a draft guidance on “Good Reprint Practices” for regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices...

FDA Needs Help

Posted on December 04, 2007
The rise in Qui Tam cases that we and other qui tam law firms have experienced is no doubt a result of the lax enforcement that has occurred over the years-as fraud has been allowed to increase.This month, consistent with the notion that the FDA has been under-resourced from a regulatory enforcement standpoint, the FDA?s [...

Off Label Marketing Costs Jazz Pharmaceuticals $20 Million

Posted on August 29, 2007
Jazz Pharmaceuticals, Inc. (”Jazz”) has agreed to pay $20 million in order to resolve both criminal and civil investigations which were conducted by the United States Attorney’s Office for the Eastern District of New York. Specifically, Jazz Subsidiary Orphan Medical, Inc...

CRO?s Conflict of Interest

Posted on July 02, 2007
St. Petersburg Reporter Chris Hundley wrote (July 1, 2007)� a well-written, balanced and comprehensive (as�can get in an article) about Contract Research Organizations (CRO’s). �The article points out the inherent conflict of interest for CRO’s to manage clinical trials pre-approval (for NDA submission) and at the same time substantially invest��in the pharmaceutical company that is [...

Federal Judge Rules Drug Companies Engaged in Drug Price Deception

Posted on June 25, 2007
In a class action lawsuit that claims drug companies unfairly adjusted prices of medication, the plaintiffs scored a major victory when Judge Saris found that defendants ?unfairly and deceptively caused false AWPs to be published knowing that payers and the government did not understand the truth and the severity of the markups...

Clinical investigator indicted for fraud in pharmaceutical trials of blockbuster drug

Posted on June 15, 2007
NEW ORLEANS — Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday...

Purdue Pharma Agrees to $19.5 Million Settlement Over Off Label Marketing of OxyContin

Posted on May 25, 2007
Purdue Pharma has agreed to settle claims by 26 states and the District of Columbia for marketing and promoting OxyContin for unapproved uses i.e. for use every 8 hours as opposed to the FDA approved dosage of every 12 hours.� The states alleged that FDA rules were violated by Purdue promoting OxyContin as the painkiller [...

Eli Lilly and Company in More Hot Water

Posted on May 17, 2007
Montana is the latest state to sue Eli Lilly and Company, alleging that the company improperly and fraudulently marketed Zyprexa, an antipsychotic drug for unapproved uses.� According to Montana Attorney General Mike McGrath, Eli Lilly improperly promoted Zyprexa for off label use and illegally paid kickbacks to physicians...

FDA Launches Draft Guidelines On Financial Ties With Drug Companies

Posted on March 23, 2007
If an outside expert has more than $50,000 in ties to drug and medical device companies regulated by the Food and Drug Administration he will be barred from advising the FDA under the new draft guidelines. The money calculations include corporate grants, contracts, consulting fees and/or company stock...

Aventis Aware of Fraudulent Data Regarding Ketek Says CRO Employee

Posted on February 22, 2007
A former staff member of the Pharmaceutical Product Development (PPD) has claimed that Aventis and PPD - the contract research organization (CRO) hired by Aventis- both knew of fraudulent data in a postmarketing trial for the antibiotic drug during a testimony before a US Congressional subcommittee last week...

Is Big Pharma Manufacturer Roxane Overcharging the Government?

Posted on February 06, 2007
The United States Attorney’s Office announced on January 29, 2007, in Boston, Massachusetts that it is intervening in a whistleblower lawsuit filed against Boehringer Ingelheim Roxane, Inc. (”Roxane”) The allegations center around the contention that Roxane reported inflated prices for numerous pharmaceutical products knowing the federal health care programs would establish reimbursement rates based on [...