Our courageous clients alleged that Allergan implemented a sophisticated marketing plan with the purpose of inducing physicians to prescribe Botox® Therapeutic for various off-label uses which were neither FDA-approved nor demonstrated to be safe and effective. According to the complaint, Allergan marketed Botox® Therapeutic as safe and effective for certain off-label uses, such as overactive bladder, adult spasticity, and headaches. The Complaint also alleged that Allergan regularly provided illegal kickbacks to physicians who prescribed Botox® Therapeutic for off-label use.

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

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.

Under this agreement, the proceeds from the settlement will be split between the federal government and various states. The settlement resolves a lawsuit brought by a whistleblower under the qui tam or whistleblower provisions of the False Claims Act, according to a DOJ press release.

For the full press release, go to: http://www.justice.gov/opa/pr/2010/March/10-civ-269.html. For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Today’s settlement stems from a lawsuit filed by a whistleblower against several pharmaceutical companies accused of Medicaid fraud. The case is still proceeding against Dey, Inc., Mylan Pharmaceuticals, Inc., Sandoz, Inc. and their parent companies. Schering-Plough recently merged with Merck, and is now known as Merck & Co.

The settlement resolves allegations that Warrick Pharmaceuticals, a subsidiary of Schering-Plough, deliberately inflated the Average Wholesale Prices (AWPs) it reported to California for Albuterol.

For the full press release, go to: http://ag.ca.gov/newsalerts/release.php?id=1842.

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

JAMA has been criticized “for taking five months to acknowledge that a study it published last year on the use of antidepressants in stroke patients was written by a University of Iowa psychiatrist who failed to disclose he had a financial relationship with the maker of the drug studied,” according to the article.

For the full article, go to: http://online.wsj.com/article_email/SB124700923018308521-lMyQjAxMDI5NDA3NzAwMDc5Wj.html.

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