Pharma 101 - Pharmaceutical Fraud » false claims

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

Nolan and Auerbach — Tue, 04 May 2010 14:25:43 +0000

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.S. Department of Justice (DOJ) announced April 29, 2010.

According to the agreement, Ortho-McNeil Pharmaceutical LLC has agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for the misbranding of Topamax in violation of the Food, Drug and Cosmetic Act. The Food and Drug Administration (FDA) approved Topamax as an anti-epileptic drug, for the treatment of partial onset seizures, but not for any psychiatric use.

The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for off-label psychiatric uses by hiring outside physicians to join sales representatives on their visits to health care providers’ offices, to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses.

In addition to the criminal fine, Ortho-McNeil-Janssen Pharmaceuticals will pay $75.37 million to resolve civil allegations under the False Claims Act that they illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programs. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.

The civil settlement resolves two lawsuits filed under the qui tam, or whistleblower provisions of the False Claims Act.

For the full press release, go to: http://www.justice.gov/opa/pr/2010/April/10-civ-500.html. For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Pfizer to Pay $2.3 Billion in Largest Healthcare Fraud Settlement in Government’s History

Nolan and Auerbach — Wed, 02 Sep 2009 19:48:06 +0000

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.

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to healthcare providers to induce them to prescribe these, as well as other, drugs.

Additional whistleblower lawsuits filed under the qui tam provisions of the False Claims Act are pending, according to a September 2 press release by the United States Department of Justice.

For the full press release, go to: http://www.usdoj.gov/opa/pr/2009/September/09-aag-900.html.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Pharma Group Says “No” To Expensive Gifts to Doctors Which Could Influence Their Drug Choices

Nolan and Auerbach — Fri, 05 Jan 2007 17:51:39 +0000

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), a worldwide trade group said that under their revised ethics code that as of January 1, 2007, they were no longer permitted to provide expensive gifts to doctors. This change to the ethics code was the first in the past 10 years. Members of this trade group are no longer permitted to give physicians money or expensive gifts such as stays in luxury hotels or trips to golf resorts that might influence their prescription drug selections. IFPMA members include Pfizer, GlaxoSmithKline, Sanofi-Aventis, Eli Lilly, AstraZeneca, Merck and Novartis. Here’s to more reform!

For more information click here.

Pharma Has Its Nose In Clinical Trials

Nolan and Auerbach — Tue, 05 Dec 2006 15:05:52 +0000

A survey published in the New York Journal of Medicine found that more than a third of experts who oversee clinical trials at both medical schools and research hospitals have financial ties to pharmacutical and/or medical device companies. It was further found that some experts had a direct conflict of interest under federal rules; voting on or discussing clinical trials sponsored by companies they had relationships with or competitors of those very same companies. These experts may be part of review boards who are supposed to be insuring the scientific validity of clinical trials and safeguarding the safety of patient participants. Susan L. Rose, executive director of University of Southern California’s Office for the Protection of Research Subjects, said academic institutions had been reassessing their policies and discussing the need for mandatory disclosures.

To read more click here.

Omnicare Really Did Not Care….A Cool $49.5 Million Settles Omnicare Drug Provider Case

Nolan and Auerbach — Tue, 21 Nov 2006 17:10:54 +0000

Omnicare has agreed to pay $49.5 million to settle Medicaid fraud claims. Omnicare, one of the country’s leading suppliers of pharmacy services to nursing homes, switched generic brands with more expensive versions of drugs which included Zantac, an antacid, and Prozac, an antidepressant, to avoid the price limits for Medicaid reimbursement. The complaint was filed by two former employees of Omnicare Inc. which is based in Covington, Kentucky.

To read more click here.