LexisNexis® Legal Newsroom
Go-It-Alone Whistle-Blowers Force $14.5M Pfizer Settlement For Off-Label Promotion

BOSTON - (Mealey's) Two whistle-blowers who went it alone in prosecuting a False Claims Act lawsuit against Pfizer Inc. in a Massachusetts federal court have forced a $14.5 million settlement for the off-label marketing of Detrol, according to announcements by the plaintiffs on Oct. 20 and a federal...

Orthofix Pleads Guilty, Pays $42 Million In Fines, Penalties For Medical Device Sales Tactics

BOSTON - (Mealey's) Orthofix Inc. on June 7 pleaded guilty to a federal felony count of obstructing a federal audit and agreed to pay nearly $42 million in criminal fines and civil penalties for illegal promotion of its bone-growth stimulators ( United States of America v. Orthofix, Inc. , No. 1...

Glaxo To Plead Guilty, Will Pay $3 Billion Stemming From Drug Marketing

BOSTON - (Mealey's) GlaxoSmithKline LLC (GSK) agreed June 2 to plead guilty and to pay $3 billion to resolve broad-ranging criminal and civil allegations in Massachusetts federal court regarding the promotion of several prescription drugs, failure to report safety data and alleged false-price reporting...

And The Beat Goes On. . . Medicaid Fraud Suits Continue Churning and Returning Taxpayer Money Paid To Medical Providers

In anticipation of the upcoming U.S. presidential election, the news cycle is heating up with discussions about federal and state budget deficits and funding for Medicare/Medicaid programs. Both the Republican and Democratic Parties are lining up and getting ready to pitch their proposals to the public...

U.S. Government Hits Bank Of America With $1 Billion Lawsuit Over Lending Program

NEW YORK - (Mealey's) The U.S. government on Oct. 24 filed a $1 billion lawsuit against Bank of America Corp., as successor for Countrywide Financial Corp., alleging that Countrywide violated provisions of the False Claims Act by engaging in a scheme to defraud Fannie Mae and Freddie Mac in connection...

Boehringer Ingelheim Pays $95 Million To Settle Off-Label, Kickback Claims In Civil Suit

BALTIMORE — Boehringer Ingelheim Pharmaceuticals Inc. will pay $95 million to the federal government to resolve civil allegations that it marketed three drugs for off-label uses, promoted high doses of two drugs and paid kickbacks to health care professionals, according to a settlement agreement...

William A. Ruskin: First Amendment Bars Pharmaceutical Company Prosecution

By William A. Ruskin The Second Circuit [on Dec. 3] rendered its much-anticipated decision in United States v. Caronia [ enhanced version available to lexis.com subscribers ], the most important Food Drug and Cosmetics Act enforcement case pending in the country. Not only did the court's 2-1 holding...

Foley & Lardner LLP: 7th Circuit Rejects Public-Disclosure Bar in Qui Tam Case

By Eric G. Pearson A cardinal rule of a qui tam action brought under the False Claims Act is that the relator must be the information’s original source. In United States ex rel. Heath v. Wisconsin Bell, Inc. , No. 12-3383 (7th Cir. July 28, 2014) , the Seventh Circuit grappled with this bar...

Foley & Lardner LLP: 8th Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

By Jacqueline N. Acosta In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for harmful off-label uses. United States ex rel. Paulos...

Stryker Subsidiary, Ex-CEO Plead Guilty, Pay $79 Million For Illegal Device Marketing

NEWARK, N.J. — (Mealey’s) Stryker Corp. subsidiary OtisMed Corp. and the former OtisMed chief executive officer on Dec. 8 pleaded guilty to marketing the unapproved OtisKnee Orthopedic Cutting Guide medical device after the Food and Drug Administration denied clearance for the device ( United...

Boston Scientific Pays $600 Million To Settle Guidant Contract Suit By Johnson & Johnson

MARLBOROUGH, Mass. — (Mealey’s) Boston Scientific Corp. on Feb. 17 announced that it has agreed to pay Johnson & Johnson (J&J) $600 million to settle a nine-year-old lawsuit alleging that Guidant Corp., which is now a Boston Scientific subsidiary, in 2006 interfered with J&J’s...

DLA Piper: 9th Circuit Joins Majority Of Circuits To Lower Barrier For Whistleblowers In False Claims Act Lawsuits

By Todd C. Toral and Greg Young The U.S. Court of Appeals for the Ninth Circuit, in a case likely heralding an increase in the number of qui tam False Claims Act lawsuits, has abrogated prior precedent and lowered the jurisdictional bar for whistleblowers in FCA cases. Repudiating 23 years of precedent...

DLA Piper LLP: Appeals Court Clarifies Attorney-Client, Work Product Privileges In Internal Investigation Context

By Jonathan W. Haray , Jeffrey D. Rotenberg and Lindsay R. Barnes In its latest review of the attorney-client and work product privileges in In re: Kellogg Brown & Root, Inc. (“ In re KBR ”), the US Court of Appeals for the DC Circuit again rejected the district court’s restrictive...

Cadwalader: D.C. Circuit Upholds Attorney-Client Privilege Again in In re Kellogg Brown & Root, Inc.

On August 11, 2015, the U.S. Court of Appeals for the D.C. Circuit granted a petition by Kellogg Brown & Root, Inc. (“KBR”) for a writ of mandamus in order to protect KBR’s assertion of attorney-client privilege over its prior internal investigation of alleged violations of the...