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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

Consequences of Pharmaceutical Fraud Settlements: Off-Label Marketing Continues?

Posted on June 08, 2010
Reporter Susan Todd wrote a fine article in the June 6, 2010 Star ?Ledger about off-label marketing. ?There are very few companies that haven?t had their turn in the wheelhouse to get a spanking,? according to a quote in the article by Ira Loss, an independent analyst who follows the pharmaceutical industry...

GI Drug Overhyped, Warns FDA

Posted on May 10, 2010
On May 5th, the FDA posted a letter sent to Shire Development, Inc. regarding the marketing of LIALDA, an oral sustained release multimatrix formulation of mesalazine approved in 2007. LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis...

Johnson & Johnson Subsidiaries to Pay More Than $81 Million to Resolve Allegations of Off-Label Promotion of Topamax

Posted on May 04, 2010
American pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, have agreed to pay more than $81 million to resolve criminal and civil liability arising from the off-label promotion of the epilepsy drug Topamax, the U...

AstraZeneca Agrees to $520 Million Settlement

Posted on April 28, 2010
Attorney General Eric Holder announced April 27, 2010, that AstraZeneca has agreed to pay $520 million to federal and state taxpayers to settle claims that it illegally marketed the anti-psychotic drug Seroquel for uses that were not approved as safe and effective by the Food and Drug Administration...

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FDA Warns Pfizer About Pediatric Trials of Geodon

Posted on April 26, 2010
On April 9th, the FDA issued a Warning Letter to Pfizer, Inc. concerning its conduct during a clinical trial for one of its prescription drugs on the market. According to a Wall Street journal article (?FDA Warns Pfizer About Pediatric Trials of Geodon,? April 21, 2010) the drug (name redacted in the Warning Letter) is [...

Alpharma to Pay $42.5 Million to Resolve False Claims Act Allegations

Posted on March 30, 2010
Pharmaceutical manufacturer Alpharma, Inc. has agreed to pay $42.5 million to resolve False Claims Act allegations in connection with the marketing of the morphine-based drug, Kadian, the U.S. Department of Justice (DOJ) announced Tuesday, March 16, 2010...

Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA

Posted on March 01, 2010
Medical device manufacturer Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was charged Feb. 25, 2010 with criminal violations of the Federal Food, Drug, and Cosmetic Act related to safety problems with some of its implantable defibrillators, according to a U...

U.S. Files Suit against Johnson & Johnson for Paying Kickbacks to Nation?s Largest Nursing Home Pharmacy

Posted on January 19, 2010
The United States has filed a civil False Claims Act complaint against drug manufacturer Johnson & Johnson (J&J) of New Brunswick, N.J., and two of its subsidiaries, Ortho-McNeil-Janssen Pharmaceuticals Inc. and Johnson & Johnson Health Care Systems Inc...

Attorney General Announces $21.3 Million Medi-Cal Fraud Settlement with Schering-Plough

Posted on December 17, 2009
Attorney General Edmund G. Brown Jr. announced December 17, 2009 a $21.3 million settlement with Schering-Plough Corporation, resolving allegations the company deliberately inflated the price of Albuterol and other drugs, causing California’s Medicaid (Medi-Cal) program to overpay millions of dollars in pharmacy reimbursement...

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...

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

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...

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 [...

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

Posted on February 20, 2009

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