Whistleblower News

The Whistleblower  |  False Claims Act  | Qui Tam Litigation 
  Pharmaceutical Fraud  |  Whistleblower News

January 2, 2011
Whistleblower Tells 60 Minutes about GSK’s Bad Manufacturing Practices at Puerto Rico Plant

On January 2, 2011, 60 Minutes aired a program titled "Bad Medicine: The Glaxo Case" which focused on Cheryl Eckard and her experience as a former employee at GlaxoSmithKline (GSK) turned whistleblower.  Ms. Eckard will receive an estimated $96 million award of the $750 million settlement reached with GSK. The large sum will settle civil and criminal charges claiming that GSK engaged in faulty manufacturing practices and sold the resulting adulterated medications to various government health plans.

October 26, 2010
GSK to Pay Record $750M to Settle Whistleblower Suit

Pharmaceutical giant GlaxoSmithKline (GSK) has agreed to pay a whopping $750 million to settle criminal and civil claims alleging the company engaged in faulty manufacturing practices.  GSK will also plead guilty to a criminal charge for manufacturing contaminated pills at its Puerto Rico plant and distributing them to the public.  The plant has since been shut down.  The government’s probe found that some of the adulterated medications made at the plant, such as the antidepressant Paxil and diabetes medication Avandia, posed safety risks to patients.

June 21, 2010
U.S. High Court Rejects J&J Appeal to Stop Qui Tam Lawsuit

The U.S. Supreme Court denied an appeal made by Ortho Biotech Products, a Johnson & Johnson unit, to stop a qui tam lawsuit by a former sales representative who alleges the drug company paid kickbacks that led to inflated reimbursements under the Medicare program for the elderly and disabled. The J&J unit appealed on grounds that similar allegations had previously been disclosed during an earlier lawsuit.

The federal appeals court in Boston sided with whistleblower, Mark Eugene Duxbury, stating that he could pursue his qui tam lawsuit since he is an “original source” of the allegations. Because Duxbury provided the government with his insider information before he filed suit, according to the court, he is able to continue pursuing his qui tam lawsuit against J&J, a lawsuit that was filed in November 2003.

May 18, 2010
U.S. Department of Justice
Justice Department Makes Pharmaceutical Companies
High Priority Targets in Fraud Investigations

The Justice Department announced in May that it has settled nearly $150 million in a number of qui tam lawsuits. The $150 million settlements came from whistleblower suits against pharmaceutical companies and an additional $26 million settlement was reached during qui tam litigation involving a private lender, Ciena Capital LLC.

One of the recently settled qui tam claims involved Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corp. for the alleged illegal and off-label marketing of the cystic fibrosis drug TOBI. According to the suit, the marketing of unapproved uses of the drug led to the submission of false claims to federal health care programs. The Department of Justice settled the suit for over $72 million, of which nearly $8 million will be awarded to the qui tam whistleblowers who brought the fraud to light. A second settlement from Ortho-McNeil-Janssen Pharmaceuticals Inc., a recovery of $75 million, resolved allegations of illegal promotion by the company of its epilepsy drug Topamax.

The Justice Department has recovered over $3 billion in False Claims Act lawsuits since January 2009, of which $2.3 billion stemmed from pharmaceutical or healthcare fraud cases.

May 11, 2010
FDA Press Release
FDA Launches ‘Bad Ad’ Program Aimed at Better Detection and
Reporting of Misleading Drug Ads

The Food and Drug Administration has launched an educational outreach program dubbed the “Bad Ad Program,” that the agency hopes will encourage health professionals to recognize and report misleading prescription drug advertising and promotion. The program will raise awareness in the health care industry through medical conventions and educational materials in order to strengthen the already existing surveillance program of inappropriate and misleading drug advertising practices. The educational effort will be administered by the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) in the FDA’s Center for Drug Evaluation and Research.

“The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” said director of DDMAC, Thomas Abrams.

September 2, 2009
New York Times
Pfizer Settles Qui Tam Case Over Off-Label Marketing for Highest Fine in History

Pfizer has settled a whistleblower lawsuit for a record $2.3 billion over allegations that it illegally marketed certain prescription drugs. The settlement is the largest ever paid to settle a health care fraud case and the largest criminal fine in history. Pfizer was charged with illegally marketing a number of their medications, including Bextra, a painkiller that has since been withdrawn.

This is Pfizer’s fourth settlement since 2002 involving illegal marketing. Former Pfizer sales rep John Kopchinski, the whistleblower who helped spark the case, will be sharing $102 million with six other relators involved in the qui tam action.

January 15, 2009
Wall Street Journal
Eli Lilly Settles Qui Tam Claim over Zyprexa Marketing for a Record $1.4 Billion

On January 15, 2009 Eli Lilly settled a qui tam lawsuit over off-label marketing of their antipsychotic medicine Zyprexa for a record $1.415 billion. The Department of Justice announced the massive settlement as the largest amount paid by a single defendant in the department’s history.

Of the $1.415 billion settlement, $615 million will be paid for a criminal charge over the marketing of Zyprexa for unapproved uses, including the promotion of the drug’s side effects and its benefits to some patients. The remaining $800 million will be paid for civil claims regarding the payment for off-label uses by government insurance. Nine whistleblowers, or relators, will share $79 million of the recovered amount for their participation in the qui tam litigation.