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Archive for the ‘Pharmaceuticals’ Category
Thursday, July 22nd, 2010
Teva Pharmaceuticals, the Israeli generic pharmaceutical manufacturer, has settled, for $169 million, claims pending against it in Texas, California and Florida related to overpricing of its pharmaceutical products. Under the scheme, Teva had provided the drugs at issue to private pharmacies including Walgreens and Wal-Mart at steeply discounted rates, but reported higher prices to the states’ Medicaid programs. When Medicaid recipients were dispensed Teva products from the various pharmacies, the states reimbursed the pharmacies at higher rates than the pharmacies had actually paid, thus costing the taxpayers of those states significant unnecessary extra tax burden. Under the settlement, Teva does not admit liability. Texas will receive $51 million and Florida will receive $27 million. Additionally, the federal government and the State of California will divvy up the remaining $90 million contemplated by the settlement. Several other defendants remain as defendants to the lawsuits.
For more information, see the Texas Attorney General’s Press Release, available at http://www.oag.state.tx.us/oagNews/release.php?id=3413,
and the Florida Attorney General’s Press Release, available at http://www.myfloridalegal.com/newsrel.nsf/newsreleases/F45002F9757B9E478525776600519A18
Posted in Pharmaceuticals, State False Claims Acts | No Comments »
Thursday, July 22nd, 2010
Elan Corporation, plc, of Dublin, Ireland has agreed to settle claims related to the marketing of Zonegran, an anti-epileptic drug for which it sold the rights to a Japanese company in 2004. In January of 2006, Elan admitted that the the DOJ and the Department of Health and Human Services were looking into its marketing practices, but has since declined to elaborate. The product was approved for use in the United States in 2000. Under the agreement, reached with the United States Attorney for the District of Massachusetts, Elan will resolve all federal and state-based claims for $203.5 million. Elan Pharmaceuticals, Inc., a U.S.-based subsidiary, will plead guilty to a misdemeanor.
For more information see http://www.forbes.com/feeds/ap/2010/07/15/business-health-care-us-elan-settlement_7771887.html?boxes=Homepagebusinessnews
Posted in Federal False Claims Act, Pharmaceuticals, State False Claims Acts | No Comments »
Friday, November 20th, 2009
The United States Attorney’s Office for the District of Massachusetts announced the settlement of multiple false claims act cases against Omnicare, Inc. of Covington, Kentucky, for $98 million for soliciting and receiving multiple kickbacks. The first scheme involved Johnson and Johnson and kickbacks for recommending that physicians prescribe Risperdal, a J&J antipsychotic drug, to nursing home patients. The US also alleged that Omnicare regularly paid kickbacks to nursing homes by providing them with consultant pharmacist services at rates below Omnicare’s costs and below the fair market value for such services. The government alleged that Omnicare also solicited kickbacks from IVAX, and IVAX paid $8 million, in exchange for Omnicare’s agreement to purchase $50 million in drugs from IVAX. The US Attorney’s office settled related claims against IVAX for $14 million. Finally, the government alleged that Omnicare and several nursing home chains conspired to arrange for Omnicare to pay the chains $50 million in exchange for the right to continue providing pharmacy services to the nursing homes. As part of the settlements, Omnicare and IVAX agreed to enter into corporate integrity agreements with the OIG for the Department of Health and Human Services.
More information on the lawsuits can be found here: http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Nov2009/OmnicarePR.html
Posted in Healthcare, Pharmaceuticals, State False Claims Acts | No Comments »
Thursday, November 5th, 2009
Fourteen states and the District of Columbia have filed a false claims act suit against Amgen, accusing the biotech company of using kickbacks to sell its anemia drug Aranesp (darbepoetin alfa).
In court papers filed Oct. 30 in U.S. District Court for the District of Massachusetts, the states and D.C. alleged that the Thousand Oaks, Calif.-based company used cash and a fraudulent billing scheme to entice physicians to prescribe Aranesp. The 12-count suit stems from claims made by a former Amgen employee who turned whistleblower in 2006.
The whistleblower, who worked for the company from 2002 until 2005, claims that the company deliberately overfilled shipments of Aranesp and then encouraged physicians to bill government health care programs for the overage, a practice referred to as a “liquid kickback.” The whistleblower also contended that Amgen had strong ties to a professional organization called the International Nephrology Network and used medical conferences sponsored by the group as a chance to wine and dine physicians and office managers, often giving sizeable honoraria to those attending. Office managers who promoted the drug to administrators at other physician practices could receive additional honoraria as well, the suit claimed.
Participating in the suit are California, Delaware, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Nevada, New Hampshire, New York, Tennessee, Virginia and the District of Columbia.
For more information: http://www.mass.gov
Posted in Federal False Claims Act, Healthcare, Pharmaceuticals, State False Claims Acts | No Comments »
Wednesday, November 4th, 2009
AstraZeneca PLC announced that it has reached an agreement “in principle” to pay $520 million settle an investigation by the United States Department of Justice into the company’s marketing of schizophrenia drug Seroquel.
The U.S. Attorney’s Office in Philadelphia has been leading an investigation into AstraZeneca’s marketing of Seroquel, including allegations that the company promoted the drug for uses for which is not approved by the Food and Drug Administration (FDA).
Pharmaceuticals and other drugs are highly regulated by numerous federal and state laws and regulations. Before any drug can be approved for use in the United States, it must first be approved by the Food and Drug Administration (“FDA”). The FDA determines precisely which medical conditions a drug may be used to treat. This determination is known as the drug’s “label” or “indication.” The label or indication is critical to pharmaceutical companies because federal law restricts pharmaceutical companies to marketing or promoting drugs only for the uses or indications approved by the FDA. Physicians, by contrast, generally may prescribe drugs to treat numerous medical conditions even if the drug has not been approved by the FDA to treat those conditions. This practice is known as “off-label” use of a drug because it goes beyond those uses specifically approved by the FDA.
One common scheme by pharmaceutical manufacturers has been to market or promote their drugs to physicians for an off-label or unapproved use. Although physicians may prescribe a drug for an off-label use, pharmaceutical companies violate federal law, including the False Claims Act, when they market, promote or encourage physicians to use their drugs in an off-label or non-FDA approved manner. Pharmaceutical companies that have engaged in illegal off-label marketing or promotion of their drugs have paid the Government hundreds of millions of dollars as a result of Federal False Claims Act cases, often times brought by pharmaceutical sales representatives, sales managers, compliance officers, other pharmaceutical company employees, physicians, nurses and/or employees of hospitals or physician practices.
AstraZeneca said its net profit rose 22% in the third quarter to $2.12 billion from $1.73 billion a year earlier, while revenue increased 5.4% to $8.2 billion from $7.7 billion.
For more information see: http://online.wsj.com/article/SB10001424052748703363704574503022289816510.html?mod=googlenews_wsj
Posted in Federal False Claims Act, Healthcare, Investigations, Pharmaceuticals | No Comments »
Friday, October 16th, 2009
In an attack on the regulation of drug marketing, Allergan, the makers of the antiwrinkle shot Botox, as well as popular Ophthalmic drugs Restasis and Lumigan, have filed a free-speech lawsuit against the federal government. In the Complaint, filed in federal court in Washington, Allergan charged that restrictions on promoting unapproved uses of Botox for medical conditions like spasticity violate the company’s First Amendment rights to speak freely and truthfully with doctors about its drug products. Allergan is suing the Food and Drug Administration (FDA), which is responsible for regulating drug promotion, and the Justice Department, which has prosecuted companies for unlawful drug promotion.
The Food and Drug Administration approves medicines for specific therapeutic indications. Once a drug is approved for a specific use, doctors are then free to use their medical judgment to prescribe the drugs for other nonapproved, or off-label, uses. Manufacturers, however, are prohibited from promoting off-label uses to medical providers or advertising such uses directly to the public.
Companies that violate off-label marketing rules face prosecution and fines. Last month, for example, Pfizer agreed to pay fines of $2.3 billion to settle charges that the company had illegally promoted several drugs, including the painkiller Bextra, which has been withdrawn.
Allergan is seeking in its lawsuit invalidate federal regulations which prohibit drug manufacturers from promoting their drugs for off-label uses to medical providers or advertising such uses directly to the public. The lawsuit filed by Allergan comes in the wake of a Department of Justice probe of Allergan’s alleged off-label marketing of Botox, which has reportedly already cost the company $7.4 million.
Although Allergan denies that there is any connection between its suit against the FDA and the Justice Department investigation, the timing is certainly curious. Allergan’s broad assault on the FDA’s core authority, especially given the ongoing Justice Department probe, raises the serious question of whether there is far greater, yet undisclosed, off-label promotion of drugs going on at Allergan.
For more information on the Allergan lawsuit: http://www.nytimes.com/2009/10/03/business/media/03drug.html
Posted in Healthcare, Pharmaceuticals | No Comments »
Thursday, October 8th, 2009
Eli Lilly & Co. agreed to settle a lawsuit brought by South Carolina claiming the company improperly marketed its antipsychotic Zyprexa, averting a trial in which the state planned to seek $6 billion. South Carolina sought reimbursement for the costs of Zyprexa prescriptions and alleged Zyprexa-related illnesses. The state claimed Lilly pushed doctors to prescribe the medication and withheld information about Zyprexa’s side effects such as weight gain.
Zyprexa, Lilly’s best-selling drug, has been the subject of federal and state investigations into marketing practices, including “off-label” marketing. Lilly, the largest maker of psychiatric drugs, resolved a marketing investigation in January with the U.S. Justice Department, promising to pay $1.42 billion, including about $362 million to more than 30 states.
Pharmaceuticals and other drugs are highly regulated by numerous federal and state laws and regulations. Before any drug can be approved for use in the United States, it must first be approved by the Food and Drug Administration (“FDA”). The FDA determines precisely which medical conditions a drug may be used to treat. This determination is known as the drug’s “label” or “indication.” The label or indication is critical to pharmaceutical companies because federal law restricts pharmaceutical companies to marketing or promoting drugs only for the uses or indications approved by the FDA. Physicians, by contrast, generally may prescribe drugs to treat numerous medical conditions even if the drug has not been approved by the FDA to treat those conditions. This practice is known as “off-label” use of a drug because it goes beyond those uses specifically approved by the FDA.
One common scheme by pharmaceutical manufacturers has been to market or promote their drugs to physicians for an off-label or unapproved use. Although physicians may prescribe a drug for an off-label use, pharmaceutical companies violate federal law, including the False Claims Act, when they market, promote or encourage physicians to use their drugs in an off-label or non-FDA approved manner. Pharmaceutical companies that have engaged in illegal off-label marketing or promotion of their drugs have paid the Government hundreds of millions of dollars as a result of Federal False Claims Act cases, often times brought by pharmaceutical sales representatives, sales managers, compliance officers, other pharmaceutical company employees, physicians, nurses and/or employees of hospitals or physician practices.
The case is State of South Carolina v. Eli Lilly & Co., 2007-CP-42-1855, Common Pleas Court of South Carolina, Seventh Judicial Circuit (Spartanburg). For more information:
http://www.bloomberg.com/apps/news?pid=20602085&sid=aN.rgzI8E4bY
Posted in Federal False Claims Act, Pharmaceuticals | No Comments »
Monday, October 5th, 2009
Welcome to the False Claims Act – Whistleblowers Blog. The Federal and State Governments spend trillions of dollars each year to fund a wide variety of programs and to purchase vast amounts of goods and services. Some of the larger government programs include: Medicare, Medicaid, Department of Defense-Military Spending, the Troubled Assets Relief Program (”TARP”), Federal Emergency Management Agency (”FEMA”) Spending, Department of Education Grants; Department of Energy Grants and Mining and Gas Royalties; and General Services Administration (”GSA”) Spending.
Each of these government programs is a frequent target for fraudulent schemes and false claims. The Government does not have the resources necessary to protect every dollar of taxpayer spending. The Government has come to rely upon Whistleblowers, often referred to as “Qui Tam Relators,” to blow-the-whistle on businesses and individuals who attempt to defraud the Government.
This blog is devoted to providing information and resources to those interested in: whistleblowers; fraud by government contractors; the Federal False Claims Act; State False Claims Acts; Government Investigations; Qui Tam Actions; Qui Tam Relators; Pharmaceutical Industry Fraud; Defense Contracting Fraud; Healthcare Fraud; Financial Industry Fraud; Construction Industry Fraud; Energy Industry Fraud; Grant Fraud; Disaster Recovery Fraud; and Government Procurement Fraud.
We welcome you to this Blog, and hope that you find the information and resources useful and enlightening.
Posted in Construction, Defense Industry, Federal False Claims Act, Financial Industry, Government Contracts, Healthcare, Investigations, Pharmaceuticals, State False Claims Acts | No Comments »
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