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Qui Tam

Pharma 101 - Pharmaceutical Fraud

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

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Last Entry: July 13, 2017 at 15:54:39

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...

Eli Lilly Pays Record Fine for Off-Label Drug Marketing

Posted on January 19, 2009

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...

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

Posted on November 04, 2008

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FDA Issues a draft Guidance for Dissemination of Information on Unapproved Uses of Medical Products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The U.S. Food and Drug Administration (FDA) last Friday issued a draft guidance on “Good Reprint Practices” for regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of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...

Big Pharma Pays $13.6 million for Price Inflation

FDA Issues a draft Guidance for Dissemination of Information on Unapproved Uses of Medical Products

Big Pharma Pays $13.6 million for Price Inflation

Posted on March 25, 2008

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...

Off Label Marketing Costs Jazz Pharmaceuticals $20 Million

Posted on August 29, 2007

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 [...

CRO?s Conflict of Interest

Posted on July 02, 2007

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...

Federal Judge Rules Drug Companies Engaged in Drug Price Deception

Posted on June 25, 2007

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...

Clinical investigator indicted for fraud in pharmaceutical trials of blockbuster drug

Posted on June 15, 2007

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 [...

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