LexisNexis® Legal Newsroom
2 Drug Makers To Pay $214.5 Million For Off-Label Marketing Of Zonegran

BOSTON - (Mealey's) Drug maker Elan Corp. PLC on Dec. 15 pleaded guilty to misdemeanor branding for the off-label marketing of the epilepsy drug Zonegran and will pay more than $203.5 million in criminal and civil penalties ( United States of America v. Elan Pharmaceuticals, Inc. , No. 10-10431,...

U.S. Sues Boston Scientific Over Guidant Heart Devices

MINNEAPOLIS - (AP) The U.S. government sued Boston Scientific Corp. on Thursday, alleging its Guidant unit knew some of its implantable heart devices were defective but continued to sell them anyway, putting patients' lives at risk. In a complaint filed in federal court in Minnesota, the government...

R. Scott Oswald Elected President Of MWELA

WASHINGTON, D.C. - R. Scott Oswald , managing principal of The Employment Law Group law firm, has been elected to serve as the 2011-2012 president of the Metropolitan Washington Employment Lawyers Association (MWELA). MWELA is the 300-lawyer Washington, D.C., metropolitan area affiliate of the National...

High Court Says FOIA Request Cannot Be Used In Lawsuit

WASHINGTON, D.C. - (AP) The Supreme Court says a Freedom of Information Act request cannot be used to trigger a False Claims Act lawsuit. The court on Monday voted 5-3 to agree with arguments by Schindler Elevator Corp., which sought to get a lawsuit against it dismissed. Daniel Kirk, a former employee...

Foley & Lardner Alert: Government's False Claims Act Complaint Against Major Financial Institution Alleges False Certifications Of Compliance With HUD Underwriting Rules

On May 3, 2011, the U.S. Attorney for the Southern District of New York, Preet Bharara, filed a False Claims Act (FCA) suit against Deutsche Bank AG and its subsidiary, MortgageIT, Inc., for making allegedly false statements and certifications of compliance with HUD rules requiring due diligence in underwriting...

Novo Nordisk Pays $26.7 Million To Settle Off-Label, Improper Payment Lawsuits

(Mealey's) Danish drug and biologics maker Novo Nordisk will pay a total of $26.7 million to settle separate False Claims Act lawsuits that include allegations that it paid military doctors to use a hemophilia drug off-label on wounded soldiers and paid retail pharmacists for the names of diabetic...

Firm Once Known As Blackwater Faces Another Lawsuit

ALEXANDRIA, Va. - (AP) A current worker and a former employee of the security contractor previously known as Blackwater have filed a whistleblower lawsuit against the company, the second such suit filed against the firm, according to documents unsealed Thursday. The lawsuit i n U.S. District Court alleges...

Medtronic Escapes Fraud Claims In Off-Label Stent Litigation

BOSTON - (Mealey's) Finding that two whistle-blowers' False Claims Act (FCA) allegations failed to meet federal pleading requirements for fraud, a Massachusetts federal judge on July 27 dismissed claims that Medtronic Inc. promoted biliary stents for off-label use ( United States of America,...

Judge: Lawsuit Against Former Blackwater 'Hangs By A Thread'

ALEXANDRIA, Va. - (AP) A jury will continue to hear a civil lawsuit alleging fraud by the security contractor once known as Blackwater, but a judge said Tuesday the case "hangs by a thread." Lawyers for Blackwater, now known as Xe Services, asked the judge to dismiss the case. It alleges Blackwater...

Virginia Jury Rules In Favor Of Blackwater In Lawsuit

ALEXANDRIA, Va. - (AP) A jury ruled Friday in favor of the security firm once known as Blackwater, rejecting two former employees' claims that the company overbilled the State Department for its work in Iraq and Afghanistan. Ex-employees Brad and Melan Davis alleged that Blackwater, now known as...

Scios To Plead Guilty, Pay $85 Million For Off-Label Marketing Of Natrecor

SAN FRANCISCO -- The Scios Inc. subsidiary of Johnson & Johnson has agreed to plead guilty to a misdemeanor charge related to the off-label marketing of its Natrecor heart drug, to pay an $85 million fine and to serve three years' organizational probation, according to a brief filed Sept. 14...

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...