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.

The United States alleges that J&J paid kickbacks to Omnicare to induce the nursing home pharmacy company to purchase and recommend J&J drugs, including the anti-psychotic drug Risperdal, for use in nursing homes. According to the complaint, J&J understood that Omnicare’s pharmacists reviewed nursing home patients’ charts at least monthly and made recommendations to physicians on what drugs should be prescribed for those patients. The government further alleges that J&J knew that physicians accepted the Omnicare pharmacists’ recommendations more than 80 percent of the time, and that J&J viewed such pharmacists as an “extension of [J&J's] sales force.”

The United States alleges that, in order to induce Omnicare and its pharmacists to recommend J&J drugs, the company paid kickbacks to Omnicare in numerous ways. First, the complaint alleges that J&J entered into agreements with Omnicare by which Omnicare was entitled to increasing levels of rebates from Johnson & Johnson so long as Omnicare implemented specific programs to increase the prescriptions of J&J drugs. Second, the complaint alleges that J&J paid Omnicare millions of dollars for “data,” much of which Omnicare never provided. According to the complaint, the true purpose of these payments was to induce Omnicare to recommend J&J drugs. Third, the complaint alleges that J&J made various other substantial kickback payments to Omnicare, calling the payments “grants” and “educational funding,” even though their true purpose was to induce Omnicare to recommend J&J drugs, according to the release.

For the full release, go to: http://www.justice.gov/opa/pr/2010/January/10-civ-042.html.

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

South Texas Health System, a McAllen, Texas-based hospital group, has agreed to pay the United States $27.5 million to settle claims that it violated the False Claims Act, the Anti-Kickback Statute and the Stark Statute between 1999 and 2006. The hospital group, owned by Pennsylvania-based Universal Health Services Inc., allegedly paid illegal compensation to doctors in order to induce them to refer patients to hospitals within the group, the U.S. Department of Justice (DOJ) announced October 30, 2009.

The settlement involved allegations that the defendants had entered into financial relationships with several doctors in McAllen in order to induce them to refer patients to the defendants’ hospitals. The government alleged that these payments were disguised through a series of sham contracts, including medical directorships and lease agreements.

The settlement resolves allegations raised against both the parent and the subsidiary in a qui tam or whistleblower lawsuit, according to the DOJ.

For the full press release, go to: http://www.justice.gov/opa/pr/2009/October/09-civ-1175.html.

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

BioVail Pharmaceuticals will also pay more than $2.4 million to the United States to resolve allegations that this conduct caused false claims to be submitted to the United States, according to a September 14, 2009 press release by the Massachusetts Department of Justice.

For the full press release, go to: http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Sept2009/BiovailPlea.html.

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

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.

The suit alleges that Wyeth knowingly failed to give the government the same discounts it provided to private purchasers, as required by Medicaid law. According to the release, between 2000 and 2006, Wyeth offered steep discounts to thousands of hospitals nationwide for the drugs Protonix Oral and Protonix IV, two proton pump inhibitors used to suppress stomach acid. This pricing arrangement required that the hospitals purchase both drugs together, under a so-called “bundled” arrangement and it offered them a steep discount for doing so. Wyeth did this in part to gain access to the far more lucrative retail outpatient market, intending that patients who used the intravenous version of Protonix in the hospital would later purchase Protonix Oral once discharged. Under the bundled arrangement, hospitals that placed both products on their formularies and attained certain market share requirements were entitled to up to a 94% discount off the list price of Protonix Oral and up to 80% off the list price of Protonix IV. Although Wyeth was required under the Medicaid Drug Rebate Program to determine the effective prices paid by hospitals under this arrangement and to pass along the benefit of the lowest prices to the state Medicaid programs, Wyeth allegedly failed to do so.

For more on this case, go to US DOJ website

For more information about Qui Tam law,  Medicare Fraud and Health Care Fraud , contact Nolan and Auerbach, PA.

The Department of Justice has filed a civil complaint against Forest Laboratories alleging that the pharmaceutical company intentionally concealed a clinical study containing negative results involving the drugs Celexa and Lexapro.  According to the complaint, several top executives at the company did not disclose the results of the study that showed that the drugs were not effective and could even pose risks to children.  In spite of this information, from 2001-2004 the company promoted clinical trials showing the effectiveness of the drugs while concealing the existence of the negative study to anyone including its own medical advisors or sales reps.  Further, the complaint alleges that Forest Laboratories paid pharmaceutical kickbacks including paying for vacations and other benefits to physicians to promote the drugs’ use by physicians.

Celexa and Lexapro are popular antidepressants approved by the FDA only for adults.  They are two versions of the same drug, Citalopram. Lexapro is Forest Labs’ blockbuster drug with sales of $2.8 billion in 2008.The company however actively improperly marketed these drugs for children even though in 2008 they sought approval from the FDA to use the drug to treat depression in adolescents.  While antidepressants approved for adults are used by physicians to treat children, Celexa and Lexapro now carry a prominent “black box” warning that these drugs could cause suicidal thinking or behavior in some children.

It appears that the Government has joined a whistleblower lawsuit filed by two former Forest Labs employees.  This follows what has clearly been a long-running federal investigation triggered by the filing of a qui tam lawsuit.

To read more click on http://www.nytimes.com/2009/02/26/business/26drug.html?emc=eta1

or if you think that you have a Medicare Fraud case click on http://www.whistleblowerfirm.com/medicare-fraud/

The 10th largest pharmaceutical company in the world, Eli Lilly & Co. admitted to off-label use of Zyprexa; specifically, the organization promoted the drug for dementia in elderly populations, a usage that was not approved by the Food and Drug Administration. Additionally, Lilly trained its sales force to disregard the law by promoting Zyprexa for off-label uses. Thus over a period of two years (September 1999-March 2001), Lilly earned “hundreds of millions of dollars” through consistent criminal violations of the Food, Drug, and Cosmetic Act.

Of the civil settlement, $438 million will go to the federal government and up to $362 million will be allocated to states included in the settlement.  As a component of its restitution, Lilly will undergo five years of U.S. monitoring against future lawbreaking.  Independent from the current settlement, the company also faces lawsuits across twelve states for improper and off-label drug marketing.

This monumental case was initiated by Lilly sales representatives who in 2003 filed complaints against Lilly under the terms of the federal False Claims Act.  For their actions, the whistleblowers will receive over $78 million— or 18 percent of the settlement— in addition to possible shares of state settlements.

To learn more go here. or if you have information about Pharmaceutical Fraud contact Nolan & Auerbach P.A.