Qui Tam

DOJ Announces $1.3 Billion Health Care Fraud Enforcement Action

Posted on July 13, 2017
The Department of Justice has announced that charges have been filed against 412 defendants, across 41 districts, to recoup approximately $1.3 billion in false billings to the Medicare, Medicaid and TRICARE programs. Defendants include doctors, nurses, pharmacists and other licensed medical professionals...

Nationwide Study of OIG Home Health Fraud Cases Reveals Hotspots

Posted on May 09, 2017
Home health care has long been seen as a program area vulnerable to fraud, waste, and abuse with physicians playing a central role. The Medicare home health benefit covers skilled nursing care, home-based assistance, and therapeutic services for qualifying homebound individuals...

Drexel University Study Shows Two Thirds of US Patients See Physicians Paid by Drug Companies

Posted on March 31, 2017
In a recently released study conducted by Genevieve Pham-Kanter, PhD , an assistant professor in Drexel?s Dornsife School of Public Health, 65% of patients visited a physician within the last year who had received payments or gifts from pharmaceutical or medical device companies; yet only 5 percent of those surveyed knew that their doctor had […]

Walgreen Accepts Responsibility for $50 Million Kickback Case

Posted on March 24, 2017
The United States Attorney for New York, Preet Bharara announced a settlement of $50 million against Walgreen Co. (?Walgreens?), the national retail drug chain which owns and operates thousands of retail stores across the United States. The settlement resolves allegations that Walgreens violated the federal Anti-Kickback Statute and False Claims Act by providing government beneficiaries […]

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Update on Pharmaceutical Company Insys Kickback Investigation

Posted on March 21, 2017
On June 25, 2015, the New York Times reported that Heather Alfonso, a Connecticut advanced practice registered nurse, had pled guilty to federal charges of accepting $83,000 in kickbacks from Insys Therapeutics, an Arizona drug company that sells Subsys, a powerful painkiller used by cancer patients...

Government Uncovers TRICARE $100M Compounding Fraud Scheme

Posted on March 01, 2017
Recently, twelve defendants including doctors, pharmacy owners and marketers were charged in a $100 million TRICARE compounding fraud scheme according to John Parker, U.S. Attorney in the Northern District of Texas.  TRICARE is an insurance program for active-duty and retired military and their family members...

Baxter pays more than $18 million to resolve cGMP Criminal and Civil Liability

Posted on February 07, 2017
DOJ recently announced that Baxter Healthcare Corporation agreed to pay $18.158 million to resolve its criminal and civil liability arising from Baxter?s failure to follow current Good Manufacturing Practices (cGMP) when manufacturing sterile drug products in North Carolina...

Lab Fraud: Will a $256 Million Settlement Stop It?

Posted on January 17, 2017
In fiscal year 2016, Millennium Health (formerly Millennium Laboratories), agreed to pay the Government $256 million to resolve alleged violations of the False Claims Act.  The allegations included medically unnecessary urine, drug and genetic testing and as providing of free items to physicians who agreed to refer expensive laboratory testing business to Millennium in violation […]

The 2017 Healthcare Whistleblower: Agent of Change

Posted on January 13, 2017
New research by Jaron H. Wilde at the University of Iowa?s Tippie College of Business concludes that: ?after truth tellers come forward with information about wrong doing inside their operations? [and after investigation, there was a] sharp and lasting drop in financial wrongdoing? Part of Mr...

Kickbacks Crackdown Worldwide: Will Pharma Finally Get the Message?

Posted on August 29, 2016
The Wall Street Journal recently reported that six employees of Novartis have been indicted in South Korea amidst allegations that the company paid $2.3 million to physicians in order that they prescribe the company?s drugs. Although the company said, ?Novartis does not tolerate misconduct and we are already implementing a remediation plan in Korea based […]

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...

Pharmacy Settles Whistleblower Case Involving Drug-Recycling Allegations

Posted on January 06, 2011
Long-term care pharmacy Remedi Seniorcare, Inc. has agreed to pay $1,279,575 to settled a qui tam action, raising allegations that it illegally distributed misbranded and adulterated drugs in interstate commerce.  This was a unique and important whistleblower case, alleging that, instead of disposing unused medications, the pharmacy unlawfully recycled, repackaged, and redistributed thousands of drugs [...

FOLLOW THE MONEY: New Database Details Pharma Payments to Doctors

Posted on December 23, 2010
According to a new database compiled and published by ProPublica, a non-profit investigative journalism group, drug companies shelled out more than $250 million to some 17,000 doctors and nurses across the country in 2009 and 2010. While some of these payments may be legitimate, the aggregate amount certainly raises eyebrows, especially since several drug companies [...

Whistleblowers Needed to Expose Drug Manufacturing Deficiencies

Posted on December 21, 2010
Recently, we discussed GlaxoSmithKline?s False Claims Act settlement, in which the drug maker shelled out $750 million to quiet allegations about manufacturing deficiencies at its Puerto Rico. Based on a recently released FDA inspection report, it looks like another drug company?s Puerto Rican plant is having trouble following current Good Manufacturing Practices (cGMP)...

Drug Efficacy

Posted on December 13, 2010
On November 15, 2010, Scios, Inc. announced that the investigatory study of NATRECOR (ASCEND-HF trial)  demonstrated no statistically significant difference from placebo in the co-primary endpoints of dyspnea, measured at six and 24 hours, or in the composite of heart failure re-hospitalizations and death during the first 30 days following treatment...

Government Needs Help in Identifying Dishonest Pharma Executives

Posted on December 08, 2010
Last month, the influential legal advocacy group Washington Legal Foundation (WLF) called on the FDA to abandon its plans to criminally prosecute the corporate masterminds behind pharmaceutical fraud schemes. Specifically, in a letter to Eric Blumberg, Deputy Chief for Litigation in the FDA?s Office of Chief Counsel, WLF complained that increased criminal prosecution of pharmaceutical [...

Drug Company Settles Adulterated Drug Case, Highlighting Need for Courageous Whistleblowers

Posted on November 19, 2010
Recently, the United States Department of Justice announced the settlement of the first False Claims Act qui tam case predicated on current Good Manufacturing Practice (cGMP) violations. In this settlement, GlaxoSmithKline pled guilty and agreed to pay $750 million to resolve criminal and civil liability regarding manufacturing deficiencies at its Puerto Rico plant...

Supreme Court Refuses to Address Whether Pharma Sales Rep?s Severance Package Barred His False Claims Act Case

Posted on November 12, 2010
On Monday, the U.S. Supreme declined to hear a False Claims Act case in which the Fourth Circuit had ruled that a release contained in an employment separation agreement barred a former sales manager for Purdue Pharmaceuticals from bringing a qui tam action against the company...

Court Approves Allergan?s Criminal Plea Agreement

Posted on October 22, 2010
Last month, drug company Allergan, Inc. agreed to pay $225 million to resolve civil allegations that it unlawfully promoted its drug Botox® Therapeutic for unapproved uses and that it paid illegal remuneration to health care providers to induce them to prescribe the company?s products...

Novartis Whistleblower Cases Settle for Over $422 Million

Posted on October 15, 2010
For the third time in one month, we announced another substantial whistleblower recovery on behalf of their clients. Collectively, the cases have returned in excess of $1.4 billion to the US Treasury to reimburse America?s health care programs. During September, we also represented two whistleblowers in a $600 million overall settlement with Allergan, Inc...

GOVERNMENT CLARIFIES FCA?s USE AGAINST DECEPTIVE PHARMACEUTICAL MARKETING PRACTICES

Posted on October 11, 2010
From time to time, pharmaceutical companies have challenged the reach of the FCA, especially as it is applies to off-label pharmaceutical marketing schemes. Last week, the US Department of Justice weighed in on this debate, when it filed a Statement of Interest in an ongoing FCA case that alleges that Pfizer violated the FCA by [...

?Examples? of False Claims Are Sufficient

Posted on October 08, 2010
The government intervened in a qui tam action, alleging that a software company paid illegal kickbacks to resellers of its products and services. The company argued that the government did not sufficiently allege the facts of the case, for it did not provide details of every single alleged kickback payment...

Congress Looks to Ban Pharma Fraud Masterminds

Posted on October 06, 2010
In the opening article of this month?s issue of Nature Medicine, Nolan & Auerbach partner Jeb White advocated sending the masterminds of pharmaceutical fraud to prison. While this idea is still percolating on Capitol Hill, Congress is, at least, taking strides to prevent these masterminds from repeating their criminal mischief with other pharmaceutical companies...

Justice Department Intervenes in FCA Action Against Pfizer

Posted on September 24, 2010
Earlier this week, the federal government and nineteen state governments intervened in a False Claims Act qui tam action against Pfizer and its subsidiary Wyeth Pharmaceuticals, accusing the companies of illegally off-label marketing their drug Rapamune, a drug used to prevent rejection of kidney transplants...

Forest Whistleblower Cases Settle for Over $300 Million

Posted on September 21, 2010
Nolan & Auerbach, P.A. announces another successful whistleblower recovery by their courageous clients, whose cases continue to return hundreds of millions of dollars to the US Treasury for America?s healthcare programs. Two weeks ago, the firm represented two of the whistleblowers in a $600 million overall settlement with Allergan, Inc...

Botox Whistleblower Case Settles for $600 Million

Posted on September 07, 2010
Pharmaceutical manufacturer Allergan, Inc. has agreed to pay $225 million to resolve civil allegations that it unlawfully promoted its drug Botox® Therapeutic for unapproved uses and that it paid illegal remuneration to health care providers to induce them to prescribe the company?s products...

Out of the U.S. No Oversight Necessary?

Posted on June 23, 2010
Today the OIG posted “Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials” (OEI-01-08-00510). As all new investigational drugs and biologics must undergo clinical trials on human subjects to demonstrate safety and efficacy prior to approval for sale in the United States, pharmaceutical manufacturers sponsor trials involving investigators and patients both inside and outside [...

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