on the  $1.1billion included in the recovery Act for comparative effectiveness research.  The funds requested will continue efforts to produce state-of-the-science information on what medical treatments work best for a given condition.

Not only will these  findings enhance medical decision-making by patients and their physicians,  they will likely  close the door a little bit more to the success of off-label marketing of pharmaceuticals for indications that have little to no science to back up the claims of efficacy. Physicians will hopefully have a readily available source from which to compare treatments and drugs.

West Virginia is asking $2 billion under the state’s Consumer Credit and Protection Act, related to the drug company’s dissemination of an alleged inadequate label on its Zyprexa antipsychotic product. The lawsuit claims that Eli Lilly should be punished for disseminating the inadequate label.

Eli Lilly claims West Virginia is overstepping its bounds and into those of the FDA.

According to the article, the motion also says that penalizing Eli Lilly $5,000 for each Zyprexa prescription distributed from Feb. 28, 2002-Oct. 2007 (which is about 400,000 with the alleged improper labeling) would “lead to a grossly disproportionate punishment” under the U.S. Constitution.
In January, Eli Lilly agreed to pay $1.4 billion to settle federal civil and criminal claims. The payment also benefited the Medicaid programs of more than 30 states that collectively received approximately $362 million, according to the article on LegalNewsline.com.

To read the article in its entirety, go to: http://www.legalnewsline.com/news/221408-eli-lilly-w.vas-claim-for-civil-penalties-inappropriate-greedy.

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.

Senators backing the bill say it would help to improve Health and Human Services’s (HHS’s) detection methods and place billing statements under increased scrutiny.

If it becomes law, HHS would identify the 50 counties most vulnerable to fraud and take a watch dog approach to carefully monitoring these designated “high-risk” fraud areas.

Among the many things it would do, the legislation would require that HHS establish a tracking system for certain durable medical equipment, and change the current system of using social security numbers as the Medicare Beneficiary Identifier used on Medicare cards.

To learn more about the bill, go to http://www.govtrack.us/congress/bill.xpd?bill=s110-3164&tab=summary or http://www.opencongress.org/bill/110-s3164/show.

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

In the letter, addressed to Frank M. Torti, MD, MPH, Grassley writes: “While I appreciate the fact that some information, including certain business trade secrets, needs to be protected from unauthorized disclosures, I have serious concerns that your memorandum goes beyond legitimate privacy concerns and appears to run contrary to many statutes protecting executive branch communications with members of Congress.

Specifically, your memorandum notes that certain information acquired from businesses and industry is protected as confidential and may only be disclosed in limited circumstances. Your memorandum cited the Food, Drug, and Cosmetic Act, the Freedom of Information Act (FOIA), the Trade Secrets Act, and the Privacy Act, as well as FDA regulations as the controlling authority for determining when a document or information may be disclosed. You added that FDA employees who violate these provisions may face disciplinary sanctions and criminal liability.”

Grassley’s concern is that FDA employees should have the right to talk to Congress and to provide Congress with information free and clear of FDA agency influence. Further, these employees have the right to be free from fear of retaliation or reprisal, he writes.

For the letter in its entirety, go to http://www.iowapolitics.com/index.iml?Article=153174. For more information about qui tam law and health care fraud, including pharmaceutical 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 government agency issued warnings to Ranbaxy late last year for more than 30 of the pharma giant’s generic drugs, produced at two plants in India. According to Inside Washington Publishers’ October 10, 2008 FDA Week, FDA sued Ranbaxy last summer, stating that the company was likely selling adulterated drugs in the U.S.

But FDA may have dropped the ball–some say, knowingly. FDA Week reports that FDA did not begin blocking Ranbaxy imports until September, even though the agency knew about the problems as early as 2005.

The Department of Justice is investigating claims that Ranbaxy produced HIV medication that contained insufficient active ingredients or was adulterated with other ingredients.

To read more click on
http://content.nejm.org/cgi/content/full/360/8/824

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.

For further information click here or if you think you have a False Claims Act case contact Nolan & Auerbach, P.A.