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Qui Tam

Pharma 101 - Pharmaceutical Fraud

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

Post Frequency: 5.4/day

Last Entry: February 28, 2013 at 14:42:04

Fraud Hunting Season Remains Open for Off-Label Marketing Schemes

Posted on February 28, 2013
For weeks, the United States Department of Justice has signaled that it will continue to vigorously pursue illegal off-label marketing schemes deployed by dishonest pharmaceutical manufacturers. Recently, Zane Memeger, the United States Attorney for the Eastern District of Pennsylvania, made this point explicitly clear, when he stressed that False Claims Act off-label cases are ?a [...

Drugmakers Are Slow to Update FDA on Potentially Risky Drugs, Says HHS-OIG

Posted on February 22, 2013
According to a recent report from HHS-OIG, pharmaceutical manufacturers are playing games with the FDA when it comes to providing information about how patients and prescribers are using some of the riskiest drugs on the market. Adding insult to injury, there is nothing the FDA can do about it...

CMS ?Sunshine? Database Will Help to Deter Kickbacks from Pharmaceutical and Medical Device Industries

Posted on February 11, 2013
By its very nature, health care fraud thrives in the dark. Thus, the drafters of the Affordable Care Act tried to shine a light on health care kickbacks by including a so-called ?Sunshine? provision into the law. Just last week, CMS released a final rule implementing this legislation, which will require manufacturers of drugs, devices, [...

Are Specialty Pharmaceutical Companies Bribing Their Way into the Market?

Posted on January 16, 2013
In 2002, after several member-pharmaceutical companies paid out substantial fines for violating the federal Anti-kickback Statute, the industry trade association Pharmaceutical Research and Manufacturers of America (PhRMA) adopted a new marketing code for its members to aspire to abide...

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Sanofi Sales Representative Receives $18.5 Million

Posted on January 09, 2013
Closing out a record year for False Claims Act recoveries, pharmaceutical manufacturer Sanofi has agreed to pay $109 million to resolve allegations that it paid illegal kickbacks to health care providers. Specifically, it was alleged that Sanofi violated the federal Anti-kickback Statute by regularly giving physicians free units of its knee injection product Hyalgan to [...

Whistleblowers Assist Government in Recovering $762 Million in Ill-Gotten Gains from Biotechnology Giant Amgen

Posted on January 04, 2013
Amgen Inc. agreed to pay $612 million to resolve civil healthcare fraud allegations that the company unlawfully promoted its anemia drug Aranesp and other medications, and that it paid illegal kickbacks to physicians to induce them to prescribe the company?s products...

Boehringer Ingelheim Pharmaceuticals Pays $95 Million for Illegally Promoting Drugs for Unapproved Uses and Dosages

Posted on November 20, 2012
Another pharmaceutical giant recently agreed to return millions of dollars to federal and state governments for causing false claims arising out of off-label marketing its pharmaceutical products. In this latest False Claims Act qui tam settlement, Boehringer Ingelheim Pharmaceuticals paid $95 million to resolve allegations relating to its promotion of the stroke-prevention drug Aggrenox, the [...

Federal Judges Demand Harsher Punishments for Dishonest Pharmaceutical and Medical Device Makers

Posted on September 26, 2012
Federal judges have questioned sufficiency of Justice Department pharmaceutical and medical device manufacturers. First, in 2009, the pharmaceutical giant Pfizer paid over $2 billion to settle the largest health care fraud settlement in history. Half of this payment was to cover the largest criminal fine ever imposed in the United States...

When Pharmaceutical Companies Promote Unapproved Dosages and Market the Spread

Posted on August 10, 2012
Actress Mae West said, ?If a little is great, and a lot is better, then way too much is just about right!? Some pharmaceutical company executives have apparently bought into this view, for recent False Claims Act cases and settlements have detailed off-label promotions that touted higher, unapproved dosages of drugs...

GlaxoSmithKline Returns $3 Billion to Government in Largest Health Care Fraud Settlement in U.S. History

Posted on July 02, 2012
It has been announced today that a record $3 billion settlement has been reached between GlaxoSmithKline (GSK), a London-based pharmaceutical company,�and the United States government regarding the resolution of several investigations into GSK?s unlawful marketing and pricing tactics...

Drug Wholesaler McKesson Corporation Resolves False Claims Act Case for $190 Million

Posted on June 29, 2012
McKesson Corporation, a large drug wholesaler is paying more than $190 million to settle False Claims Act allegations against it for causing Medicaid to overpay for drugs due to McKesson?s inflation of pricing information.� This settlement resolves the federal share of the Medicaid overpayments...

Were Johnson & Johnson?s Risperdal Sales Inflated by Illegal Promotions?

Posted on June 11, 2012
In 1993, the FDA approved Johnson & Johnson?s drug Risperdal for the limited use of treating a few psychotic disorders, including schizophrenia. However, even with limited FDA approval, claims for Risperdal prescriptions increasingly flooded government health care programs, generating worldwide sales of $24...

Setting a Record: Abbott Labs Agrees to Pay $1.5 Billion for its Off-Label Marketing of Depakote

Posted on June 01, 2012
Resolving its criminal and civil liability with the Government is going to cost Abbott $1.5 billion as the result of its unlawful marketing of Depakote.� This payment represents the second largest healthcare fraud payment by a pharmaceutical company in a False Claims Act case and includes a criminal fine and forfeiture of $700 million and [...

CMS Delays Implementation of Physician Payments Sunshine Act

Posted on May 18, 2012
Late last year, the CMS published a proposed rule implementing the Physician Payments Sunshine Act. During the comment period, CMS received hundreds of comments lampooning the proposed rule, including dozens of letters from the pharmaceutical industry...

Abbott Labs Pays $1.5 Billion to Quiet Off-Label Promotion Allegations, Company Promises Not to Compensate Sales Representatives for Future Off-Label Sales

Posted on May 10, 2012
This week, the United States Department of Justice announced that Abbott Laboratories Inc. has pleaded guilty to a criminal misdemeanor and has agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company?s alleged off-label promotions of the prescription drug Depakote...

Dava Pharmaceuticals Whistleblower Case Settles for $11 Million

Posted on April 09, 2012
Recently, Nolan & Auerbach, P.A. announced the $11 million pharmaceutical fraud settlement of a whistleblower?s False Claims Act case against Dava Pharmaceuticals, Inc. Pharmaceutical labelers that want their products available to Medicaid beneficiaries under the Medicaid program must enter into a Drug Rebate Agreement...

KV Pharmaceutical Whistleblower Case Settles for $17 Million

Posted on December 16, 2011
The federal government has announced a $17 million settlement of a False Claims Act qui tam action with KV Pharmaceutical Company, the parent company of now-defunct Ethex Corporation. This is the latest settlement from a decade-old qui tam action by national whistleblower law firm Nolan & Auerbach, P...

Kickbacks to Providers from Pharmaceutical Companies Still Going Strong

Posted on November 18, 2011
Kickbacks from pharmaceutical companies cloud the medical judgment of health care providers and run afoul of federal and state anti-kickback laws. Most prominently, the federal Anti-kickback Act (AKS) was specifically designed to ensure that physicians prescribe drugs based on patient need, not personal greed...

FDA-Approved Targeted Drugs Are Ripe for Off-Label Marketing

Posted on September 13, 2011
The FDA at times gives its stamp of approval to drugs that only work in small subset of the patient population. For example, a few days ago, the FDA approved Pfizer?s lung cancer drug Xalkori, which was only proven effective in less than 7% of the lung cancer patient population...

Are Pharma Companies Using Foreign Research Studies to Boost Off-label Sales?

Posted on August 02, 2011
In this era of mega international pharmaceutical mergers, pending False Claims Act lawsuits oftentimes bubble to the surface at the closing table. Recently, as Teva Pharmaceuticals looked to wrap up its acquisition of Cephalon, Inc., it was revealed that the United States government was, once again, examining Cephalon?s marketing practices...

The Hefty Medicare Price Tag for the Off-Label Prescriptions

Posted on June 27, 2011
Recently,� the US Department of Health & Human Services Office of Inspector General found that, in the six-month period from January through June 2007, an astounding 51 percent of Medicare claims for atypical antipsychotics were off-label. This amounted to over $116 million in Medicare funds...

Off-Label Bonanza Detected by Hospital Records

Posted on May 26, 2011
Anyone interested in off-label cases should review the retrospective analysis recently published by researchers funded by the Agency for Healthcare Research and Quality. In the study, “Off-Label Use of Recombinant Factor VIIa in U.S. Hospitals: Analysis of Hospital Records,” Aaron C...

J&J Fined $70 Million for International Kickbacks

Posted on May 19, 2011
Pharmaceutical giant Johnson and Johnson has agreed to pay $48.6 million in disgorgement charges, and another $21.4 million in criminal charges as part of a settlement agreement. These fines are in response to allegations brought forward by the Securities and Exchange Commission contending J&J paid out kickbacks to foreign doctors, hospitals, and governments to gain [...

Whistleblowers Offered Substantial Rewards for Uncovering Pharmaceutical Manufacturing Problems

Posted on April 27, 2011
Increasingly, federal investigators have been turning their attention to manufacturing deficiencies at some of the world?s largest drug makers. According to one industry report, the number of FDA inspection reports has skyrocketed to an all-time high...

Drug ?Xenaderm? Under Fraud Microscope

Posted on April 22, 2011
The Department of Justice (DOJ) has intervened in a Nolan & Auerbach, P.A. qui tam suit against Xenaderm maker, DFB Pharmaceuticals, alleging the marketing company Healthpoint (owned by DFB) knowingly promoted and sold the drug under the premise that it could be billed to Medicare and Medicaid...

When it Comes to Off-Label Marketing, the Intended Audience Matters

Posted on April 07, 2011
In recent years, a number of drug companies have settled False Claims Act cases, alleging that the companies off-label marketed their products to children. Oftentimes, the offending marketing materials did not specifically mention the use of the products in the pediatric population...

Uncovering Pharmaceutical Manufacturing Problems

Posted on March 30, 2011
Increasingly, federal investigators have been turning their attention to manufacturing deficiencies at some of the world?s largest drug makers. According to one industry report, the number of FDA inspection reports has skyrocketed to an all-time high...

CNBC Runs Whistleblower Series

Posted on February 09, 2011
Throughout the week, CNBC is doing a special series on whistleblowers, and much of it concerns the False Claims Act. This morning, Recognizing that there is a huge ?cottage industry? out there, CNBC ?s Eamon Javers reported that pharmaceutical companies have changed their practices as a result of pharmaceutical fraud whistleblower lawsuits...

Drug Companies Pay $421 Million to Settle Inflated-Price Allegations

Posted on January 24, 2011
Recently, the U.S. Justice Department announced settlements with three pharmaceutical companies for a total of $421 million to settle allegations they reported “false and inflated prices” for pharmaceutical products knowing that government health care programs would use those reported prices to set payment rates...

Drug-maker Shells Out $41 Million to Settle Kickback, Illegal Promotions Lawsuit

Posted on January 14, 2011
Kos Pharmaceuticals, a subsidiary of Abbott Laboratories, has agreed to pay $41 million to quiet criminal and civil allegations that it violated the federal anti-kickback laws, when it allegedly bribed doctors, medical groups and managed care organizations to prescribe or recommend two of the company?s drugs, Advicor and Niaspan...

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