MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'false claims'. Sat, 03 Sep 2011 02:27:36 +0100 http://www.medworm.com/index.php?rid=5062497&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeTMnwRl80K0%2F Last month, a federal court ruled that a drug or device maker remains liable under the False Claims Act even when a pharmacy or hospital was unaware that a kickback was made to a doctor to induce the sale of a product for which reimbursement was sought from Medicare and Medicaid. The decision was seen as a game changer, because dismissing whistleblower lawsuits would likely become more difficult. Until then, courts had ruled the False Claims Act could not have been violated if a pharmacy does not know that a prescription was only written because a drugmaker gave a kickback to a doctor. Whistleblowers have argued, however, that a violation occurs once reimbursement is sought from Medicaid or Medicare. But the US Court of Appeals for the First Circuit disagreed. Not surprisingly, the same co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5062497 Mon, 25 Jul 2011 22:24:53 +0100 5062497 http://www.medworm.com/index.php?rid=4921749&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FG-5n30HMlGE%2F The Danish drugmaker has agreed to pay $25 million to settle a whistleblower lawsuit to settle charges of off-label marketing its NovoSeven treatment to stop bleeding. As part of the settlement, Novo Nordisk has entered into a five-year Corporate Integrity Agreement and will have to beef up its compliance procedures, according to a statement from the drugmaker. The lawsuit - which was filed jointly by a Oscar Montiel, a former Novo Nordisk medical liasion, and Ian Black, a former US Armed Forces physician in federal court in Maryland - alleges the medication was promoted improperly for treating unapproved uses such as blood trauma, intercranial hemorrhage and various surgeries, according to a source familiar with the case. The charges included improper payments made to Army personnel (here... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921749 Fri, 10 Jun 2011 15:52:08 +0100 4921749 http://www.medworm.com/index.php?rid=4921754&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkjRXkJtSLLo%2F Yet another drugmaker has been tagged for illegal marketing. This time, the US subsidiary of Belgium’s UCB has agreed to pay more than $34 million to resolve civil and criminal charges surrounding off-label promotion of its Keppra epilepsy drug, the US Department of Justice disclosed. Under the terms of the plea agreement in the US Court for the District of Columbia, UCB pleaded guilty to a misdemeanor in connection with misbranding of Keppra, which was approved for treating seizures in adults and children. But Keppra is not approved for the treatment of migraine, headache, psychiatric conditions or pain conditions. And guess what UCB promoted Keppra for treating? That’s right. The feds alleged that UCB promoted off label by creating and distributing posters indicating the drug... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921754 Thu, 09 Jun 2011 17:57:19 +0100 4921754 http://www.medworm.com/index.php?rid=4653605&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Figh8X5xxjNM%2F A provision of the False Claims Act that prevents whistleblower lawsuits from being unsealed does not violate the First Amendment and, therefore, the public’s right to access the documents, a federal appeals court has ruled. In a 2-to-1 vote, the US Court of Appeals for the 4th Circuit upheld an earlier decision that shot down the argument whistleblower lawsuits should be unsealed after a 60-day period because this would allow the public to learn as soon as possible about corporate wrongdoing. The rationale for requiring these lawsuits to remain sealed for at least 60 days is to allow the feds, who are permitted to seek extensions beyond that initial period, to investigate the allegations. During the seal period, the whistleblower is not supposed to discuss the suit or its contents. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653605 Tue, 29 Mar 2011 11:55:34 +0100 4653605 http://www.medworm.com/index.php?rid=4540739&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fy-ozTQgTevA%2F Five former Amgen execs have ‘taken the Fifth’ in depositions that were conducted as part of a False Claims Act lawsuit scheduled to go to trial in federal court in Boston later this year. And the former Amgen sales rep and product manager who brought the lawsuit is fighting to have the depositions filed in court and made public. At issue are allegations that Amgen provided free ‘overfills’ of its Aranesp anemia medication and encouraged doctors to bill Medicare and Medicaid for the extra amounts. The lawsuit, which was filed by Kassie Westmoreland, also charges the biotech offered kickbacks to doctors in the form of fictitious consulting arrangements and weekend getaways in order to steal market share from Johnson & Johnson, which sells the rival Procrit treat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4540739 Thu, 03 Mar 2011 03:02:31 +0100 4540739 http://www.medworm.com/index.php?rid=4522289&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgDRs3Vo3RaA%2F A former Johnson & Johnson sales manager accused the health care giant of concocting various schemes to defraud federal and state Medicaid programs in a lawsuit that was filed in 2005, but only recently unsealed amid a transfer of the litigation from a federal court in Pennsylvania to another in Massachusetts. The lawsuit was filed by Scott Bartz, a New Jersey resident who worked as a sales compensation manager from 1999 until 2007, when he alleges he was terminated in retaliation for repeatedly complaining about illegal marketing practices. His lawsuit also names the Omnicare nursing home operator and McKesson, the pharmaceutical wholesaler. In his complaint, Bartz charged J&J manipulated sales data; reported false prices to various government health programs, and paid kickback... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4522289 Fri, 25 Feb 2011 13:13:03 +0100 4522289 http://www.medworm.com/index.php?rid=4512613&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc--MjGyqugU%2F Earlier this month, a Medicaid managed care provider in Ohio agreed to pay $26 million to settle a whistleblower lawsuit brought by former employees, who alleged that assessments of adults and children with special needs were never conducted, but data was submitted anyway to the state Medicaid program for reimbursement. What has this episode to do with drugmakers? Well, the state of Ohio collected $10 million of the total $26 million paid by CareSource, the managed care provider. And Ohio attorney general Mike DeWine then bemoaned publicly that the state would have received more money if there was a False Claims Act statute on its books (look here). In general, such a law would allow Ohio to collect a bigger payday each time it participates in a whistleblower settlement. And in an era of i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512613 Wed, 23 Feb 2011 16:28:43 +0100 4512613 http://www.medworm.com/index.php?rid=4411723&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCJkmCAQ7CCQ%2F Earlier this week, the US Department of Health & Human Services trumpted its track record in recovering $4 billion from investigations of healthcare fraud, some of which was made possible thanks to qui tam, or whistleblower lawsuits alleging violations of the False Claims Act (you can read the report here). Many drugmakers were targets and paid big fines, (back story) and the implication offered was that more such settlements are in the offing. But how many investigations are actually under way? The answer came just a couple of days later courtesy of US Senator Chuck Grassley, who referenced some data the HHS provided him in a Jan. 24 letter that was written in response to a request he made last month for a breakdown of the fraud probes. And so we now learn that, as of Jan. 4, there w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4411723 Fri, 28 Jan 2011 13:20:11 +0100 4411723 http://www.medworm.com/index.php?rid=4294633&cid=t_99798_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fabout-scar-prevention-and-treatment%2F2010.12.27 I saw a Scarguard product on sale at a drugstore locally. The claims on the packaging were over the top as usual: 1. “Guards against new scars forming” – Difficult to prove. 2. “Flattens and shrinks old scars” – Not really. 3. “Scarguard is the #1 choice of plastic surgeons” – Really? Nobody asked me. Scar treatment is pretty simple. Avoid wounding if you can. If you have plastic surgery, seek a skilled surgeon who will spend the time to do the best. After surgery avoid sunlight and smoking, and consider scar massage as directed by your surgeon. This “Scarguard” product is not going to make a bad scar much better unless it is applied early, and even then the results are debatable. - John Di Saia, M.D. *This blog post was originally published at Trut... Better Health blogs http://www.medworm.com/rss/comments.php?id=4294633 Mon, 27 Dec 2010 15:00:30 +0100 4294633 http://www.medworm.com/index.php?rid=4266261&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2Iy2JFsVBl4%2F Once upon a time, defense contractors were considered the biggest hucksters. You know, the US Defense Department would pay $10 for a pencil. Now, though, drugmakers have surpassed every other industry when it comes to defrauding the US government, according to a new analysis by Public Citizen, which calls for stiffer penalies and increased criminal prosecution of pharma execs. The findings: Of 165 settlements comprising $19.8 billion in penalties during the past 20 years, 73 percent of the settlements and 75 percent of the penalties - representing $14.8 billion - have occurred in just the past five years. And four drugmakers - GlaxoSmithKline, Pfizer, Eli Lilly, and Merck’s Schering-Plough -accounted for 53 percent, or $10.5 billion, of all financial penalties. The chart below shows ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266261 Fri, 17 Dec 2010 14:44:48 +0100 4266261 http://www.medworm.com/index.php?rid=4139336&cid=t_99798_114_f&fid=34646&url=http%3A%2F%2Foig.hhs.gov%2Foei%2Freports%2FOEI-01-10-00140.pdf The U.S. Department of Health and Human Services, Office of Inspector General (OIG) has issued a resource and educational guide for new physicians to help them better understand the key Federal fraud and abuse laws.As a health care attorney who often deals with physicians on fraud and abuse related matters, I applaud the OIG's effort to provide educational information to help raise the level of understanding on these issues and increase the transparency of these federal laws. This guide won't just be useful for "new" physician but for all physicians to gain a better understanding of the very complex legal/regulatory structure of fraud and abuse laws in the United States.The new OIG document is titled, "Roadmap for New Physicians: Avoiding Medicare and Medicaid Fraud and Abuse." The physici... Health Care Law Blog blogs http://www.medworm.com/rss/comments.php?id=4139336 Fri, 05 Nov 2010 15:31:01 +0100 4139336 http://www.medworm.com/index.php?rid=4134255&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrFuvnfgIfB4%2F After months of reviews and meetings, the US Securities and Exchange Commission has proposed a whistleblower program that was mandated by Congress as part of the Dodd-Frank Wall Street Reform and Consumer Protection Act. And the agency describes its approach as “a simple, straightforward procedure for would-be whistleblowers” to provide information. To be considered for an award, the SEC says that a whistleblower must “voluntarily provide the agency with original info about a violation of federal securities laws that leads to the successful enforcement by the SEC of a federal court or administrative action in which the SEC obtains monetary sanctions totaling more than $1 million.” The issue is of concern to the pharmaceutical industry, given that many drugmakers hav... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4134255 Thu, 04 Nov 2010 13:41:59 +0100 4134255 http://www.medworm.com/index.php?rid=4106063&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKtFErbiCVU8%2F There have been numerous headlines lately about healthcare fraud and whistleblowers whose lawsuits eventually prompted huge settlements with the federal government. The latest tally, however, shows that the US Department of Justice recovered over $3.1 billion in fraudulent claims in the 2010 fiscal year that can be traced to lawsuits filed under the federal False Claims Act. Specifically, there were 145 FCA cases settled in the 2010 fiscal year and the 10 largest settlements involved health care fraud, with eight involving drugmakers, according to Taxpayers Against Fraud, a non-profit that supports whistleblower lawsuits. The 10 largest cases accounted for $2.7 billion recovered. Although fiscal year 2009 actually recovered a larger pot of money - $5.6 billion. It also worth that health ca... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106063 Mon, 25 Oct 2010 12:32:03 +0100 4106063 http://www.medworm.com/index.php?rid=4027355&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fxjmjpk1it7w%2F Hello, everyone. Nice to see you again. We hope the weekend was refreshing and restful. Now, of course, the time has come to resume the routine as those meetings and deadlines await. So please join us as we reach for the mandatory cups of stimulation (yes, we are two-fisted drinkers here at the Pharmalot corporate campus) and scan the news of the world. Have a good day and stay in touch… Sanofi Begins Hostile Bid For Genzyme (Associated Press) Reata Pharmaceuticals Adds Jobs After Abbott Deal (Dallas Business Journal) J&J Warns Concerta Sales Reps About Layoffs (The Wall Street Journal) Will Lilly Bid For MannKind? (The Indianapolis Star) Sihuan Pharma Sets $700M IPO (Reuters) South Africa Researches Plant That Lifts Moods (Associated Press) Antipsychotics, Illegal Marketing And... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4027355 Mon, 04 Oct 2010 11:49:48 +0100 4027355 http://www.medworm.com/index.php?rid=4003434&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpYWhwlZl3PU%2F Earlier this year, a former Pfizer exec amended his whistleblower lawsuit accusing the drugmaker of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines; using misleading educational programs for doctors, and unlawful sampling kickback schemes that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare. Jesse Polansky, who was director of outcomes management from April 2001 until July 2003, claims “thousands of physicians have prescribed Lipitor to millions of patients for whom drug therapy is not recommended, and for whom the medication could be dangerous. Millions of those improper prescriptions were ultimately paid for by various government healthcare plans, the suit charges. And in a newly filed brie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003434 Mon, 27 Sep 2010 15:28:45 +0100 4003434 http://www.medworm.com/index.php?rid=3976709&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKdHrZGFxZoY%2F After several years of legal sparring, a federal judge has dismissed the whistleblower lawsuit that Peter Rost filed against Pfizer. For those who do not recall, Rost is the controversial former Pfizer exec who allegated that Genotropin, a human growth hormone, was marketed for unapproved uses, such as combating aging in adults and treating short stature in children. The drug was initially marketed by Pharmacia, which is where Rost worked before the company was bought by Pfizer. The US Justice Department failed to join his lawsuit, but Rost last year succeeded in winning the right to proceed on a narrower basis by attempting to cite numerous instances in Indiana and Kentucky in which Genotropin marketing may have violated the federal False Claims Act. Specifically, he argued Pfizer engaged... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3976709 Thu, 16 Sep 2010 15:22:11 +0100 3976709 http://www.medworm.com/index.php?rid=3959926&cid=t_99798_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fcoffee-grounds-to-combat-cellulite%2F2010.09.11 Last week a popular TV talk show featuring a bunch of doctors (I’m not naming names) discussed how coffee grounds can improve cellulite. They explained how rubbing coffee grounds into your skin imparts caffeine into the cellulite thereby improving the circulation and drawing the toxins out. This is a great tip, except that rubbing coffee grounds on your skin does not impart any caffeine into it, and there are no toxins in cellulite. Cellulite is a normal secondary sex characteristic of women. It is the result of thin connective tissue in women’s skin. Massaging the cellulite (with coffee, tea, grapes, cream cheese, or chocolate frosting) pushes the fat back into the skin, temporarly improving the appearance. There is no science behind using coffee to treat this normal condition. Scient... Better Health blogs http://www.medworm.com/rss/comments.php?id=3959926 Sat, 11 Sep 2010 20:00:26 +0100 3959926 http://www.medworm.com/index.php?rid=3718695&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRnVigrnX3FU%2F Since the passage of the False Claims Act in 1986, the federal government has recovered about $22 billion through qui tam, or whistleblower lawsuits and a fair number of these have emanated from the pharmaceutical industry. An untold number of such lawsuits are always in the wings, as people who work with or for drugmakers attempt to expose alleged wrongdoing. There have been accusations that some whistleblowers are only in it for the money (see this), but life as a whistleblower has its challenges (see here). And so concerned that the pharmaceutical industry may not be doing enough to educate employees about whistleblowing protection, US Senator Chuck Grassley has written 16 big drugmakers to provide information about their programs. The letters went to Abbott Labs, Amgen, AstraZeneca, Br... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718695 Thu, 01 Jul 2010 14:34:30 +0100 3718695 http://www.medworm.com/index.php?rid=3687360&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9usn_RX90Yk%2F The US Supreme Court rejected an appeal by Johnson & Johnson’s Ortho-McNeil unit, which sought to stop a whistleblower lawsuit brought by Mark Duxbury, a former sales rep, who claimed the drugmaker gave kickbacks to docs and hospitals to induce them to prescribe the Procrit anemia med. These alleged kickbacks included free samples; off-invoice discounts; rebates; consulting fees; educational grants; payments to participate in studies, and advisory board fees. He also charged Ortho-Biotech inflated Procrit’s average wholesale price; promoted higher dosing than what was approved by the FDA, which generated larger government reimbursements to health care providers; and ran “sham drug trials” to falsify Medicare reimbursement for off-label use (background here and here). The l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3687360 Tue, 22 Jun 2010 12:02:45 +0100 3687360 http://www.medworm.com/index.php?rid=3534101&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJchNP4f8488%2F Two units of the big drugmaker - Novartis Vaccines & Diagnostics and Novartis Pharmaceuticals - agreed to pay the $72.5 million fine in order to resolve civil False Claims Act charges over the marketing of the TOBI cystic fibrosis medicine that took place between January 2001 and July 2006. The US Justice Department charged Novartis and Chiron, which Novartis purchased in 2006, caused false claims to be submitted to federal health care programs for off-label uses and for patients who shouldn’t have received the drug (here is the settlement). The federal government will get $43.5 million and various states will receive $29 million. Meanwhile, three former Chiron employees – Robert Lalley, Courtney Davis and William Manos – who filed whistleblower, or qui tam lawsuits, will re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3534101 Wed, 05 May 2010 12:19:10 +0100 3534101 http://www.medworm.com/index.php?rid=3534093&cid=t_99798_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F05%2Fqui-tam-states-in-yellow.html http://www.taf.org/statefca.htmGo to the link - the map there is interactive. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3534093 Wed, 05 May 2010 08:16:00 +0100 3534093 http://www.medworm.com/index.php?rid=3530028&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk9HNoSpWCpM%2F Three years ago, a federal law was enacted that provided incentives to states to pass their own versions of the False Claims Act, which allows people who are not affiliated with the government to file lawsuits against federal contractors claiming fraud against the government. There have been a spate of these whistleblower, or qui tam, lawsuits in the pharma world lately (see here, here and here). The Department of Health and Human Services and the Department of Justice were chartered with overseeing whether the states are meeting the qualifications that would allow them to receive a share of any proceeds recovered. And so last week, Senator Chuck Grassley, the ranking Republican on the Senate Finance Committee, who regularly probes drugmakers, wrote the agencies because only 14 states are... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3530028 Tue, 04 May 2010 15:44:30 +0100 3530028 http://www.medworm.com/index.php?rid=3519712&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZl8_IqGwlEA%2F The health care giant’s Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals subsidiaries are ponying up $81 million in order to resolve criminal and civil lawsuits charging the units with illegally promoting the Topamax epilepsy drug. This is one of three such agreements the Justice Department announced this week. Also today, Schwarz Pharma will pay $22 million for failing to tell the Centers for Medicare and Medicaid Services that two unapproved drugs didn’t qualify for coverage under federal health care programs. And earlier this week, AstraZeneca agreed to pay $520 million for off-label promotion of the Seroquel antipsychotic (see here). Unlike the J&J charges, these two oher cases didn’t involve criminal charges. One thing all three settlements h... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3519712 Thu, 29 Apr 2010 18:12:55 +0100 3519712 http://www.medworm.com/index.php?rid=3119060&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9PxBnlm0vaY%2F For those who may not remember, Peter Rost is the controversial gadfly and former Pfizer exec who is locked in a whistleblower lawsuit with the big drugmaker over his allegations that Genotropin, a human growth hormone, was marketed for unapproved uses, such as combating aging in adults and treating short stature in children. Rost worked for Pharmacia, which was bought by Pfizer. Although the US Justice Department failed to join his lawsuit, Rost is pressing on and his case is being closely watched. Last year, he cited numerous instances in Indiana and Kentucky in which Genotropin marketing may have violated the False Claims Act. Providing such detail was needed for the case to proceed and his efforts may serve as a template for other whistleblowers who are stymied by federal judges seekin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3119060 Thu, 24 Dec 2009 13:46:39 +0100 3119060 http://www.medworm.com/index.php?rid=3101066&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FErvcBYlFz9k%2F The deal resolves allegations the drugmaker “deliberately inflated” the price of its Albuterol asthma med and other drugs, causing California’s Medicaid (Medi-Cal) program to overpay millions of dollars in pharmacy reimbursement, according to California attorney general Jerry Brown. “With healthcare costs spiraling out of control, it’s unconscionable that a Fortune 500 pharmaceutical company deliberately inflated its drug prices to cheat California’s public healthcare system out of millions of dollars,” Brown says in a statement. “This is a company that made more than $12 billion in profits last year, yet still raided the pockets of California taxpayers.” The case began with a lawsuit filed by a whistleblower against several drugmakers... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3101066 Thu, 17 Dec 2009 19:37:18 +0100 3101066 http://www.medworm.com/index.php?rid=3063472&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXa2P72eCFck%2F A new court ruling may have a significant impact on whisteblower lawsuits that focus on off-label marketing. Last Friday, the US Court of Appeals for the Eleventh Circuit in Atlanta upheld a dismissal of a 2004 lawsuit filed by two Solvay Pharmaceuticals sales reps, who alleged the drugmaker caused the federal government to overpay by promoting off-label use of its Marinol treatment for chemotherapy patients (background). Specifically, the court ruled the reps’ lawsuit was lacking because they failed to offer specific examples showing Solvay actually caused the federal government’s Medicaid program to overpay by millions of dollars based on an alleged off-label marketing. Instead, the reps argued there was an obvious increase in Marinol scrips and a subsequent rise in federal g... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3063472 Mon, 07 Dec 2009 13:43:46 +0100 3063472 http://www.medworm.com/index.php?rid=2970418&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FH3evCBwKRAw%2F As they say: another day, another probe into a drugmaker. The latest - the US Department of Justice is investigating Abbott’s sales and marketing activities of the pill, which is used to treat bipolar disorder, seizures and migraines, according to its quarterly filing with the US Securities and Exchange Commission for Depakote. The government wants to know whether the drugmaker violated civil and/or criminal laws, including the Federal False Claims Act, the Food and Drug Cosmetic Act, and the Anti-Kickback Statute in connection with Medicare and/or Medicaid reimbursement to third parties. An Abbott spokeswoman tells Dow Jones that the drugmaker is cooperating, but declined further comment. And a spokesman for the US Attorney in the Western District of Virginia, which is handling the prob... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2970418 Fri, 06 Nov 2009 19:58:32 +0100 2970418 http://www.medworm.com/index.php?rid=2056345&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F490574990%2F A federal court in Chicago has dismissed a federal False Claims Act, or qui tam, lawsuit filed by former Aventis sales rep, who charged the drugmaker with off-label promotion of its Lovenox blood thinner and, in doing so, induced and doctors and hospitals to submit fraudulent Medicare claims. In their 2003 suit, Katy Kennedy, who also filed a retaliation claim, and Frank Matos, allege Aventis, now owned by Sanofi, prompted docs to prescribe Lovenox for atrial fribillation, acute myocardial infarction, mechanical heart valve replacement and other conditions for which the FDA had not approved use. They also charged Aventis paid $34,000 to one pharmacist for speaking engagements and hiring him to keep Lovenox on hospital formularies under his control. In addition, Aventis allegedly gave vari... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2056345 Sat, 20 Dec 2008 14:08:35 +0100 2056345 http://www.medworm.com/index.php?rid=1852734&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F410538397%2F Last February, the controversial gadfly and former Pfizer exec cleared a hurdle in his ongoing whistleblower lawsuit against Pfizer. In a filing, Rost cited approximately 200 instances in Indiana in which Genotropin, a human growth hormone, was marketed by Pharmacia (which was bought by Pfizer) for unapproved uses, such as combating aging in adults and treating short stature in children. Providing such detail was needed for the case to proceed. And the move signaled two potentially significant developments. One is the long-term implication for Pfizer, should Rost ultimately prevail. The other is that his efforts may serve as a template for other whistleblowers who are similarly stymied by federal judges seeking details that are, otherwise, very hard to come by. Interestingly, the Departme... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1852734 Fri, 03 Oct 2008 19:35:15 +0100 1852734 http://www.medworm.com/index.php?rid=1686527&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F357360853%2F A federal magistrate judge has recommended that a federal court dismiss a whistleblower lawsuit brought by two former Solvay reps, who contended the drugmaker concocted an illegal scheme to promote a drug for off-label use and, consequently, caused the federal government’s Medicaid program to overpay by millions of dollars. The drug in question was Marinol, which was originally approved to treat nausea and vomiting for chemo patients who failed to respond to standard meds and, later, anorexia for AIDS patients who suffer considerable weight loss. But Jim Hopper and Colin Hutto alleged Solvay improperly promoted Marinol off-label as an appetite stimulant, because the FDA-approved market was too small. However, in a 27-page report, Magistrate Judge Thomas Wilson of the US District Cou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1686527 Wed, 06 Aug 2008 12:27:46 +0100 1686527 http://www.medworm.com/index.php?rid=1575643&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F325745675%2F More than 900 cases alleging that government contractors and drugmakers have defrauded taxpayers out of billions of dollars are languishing in a backlog that has built up over the past decade because the Justice Department cannot keep pace with the surge in charges brought by whistleblowers, The Washington Post reports. The issue is drawing renewed interest among lawmakers and nonprofit groups because many of the cases involve the wars in Iraq and Afghanistan, rising health care payouts, and privatization of government functions - all of which offer rich new opportunities to swindle taxpayers, the Post writes. Since 2001, 300 to 400 civil cases have been filed each year by employees charging their companies defrauded the government. But under the cumbersome process that governs these cas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1575643 Thu, 03 Jul 2008 12:14:26 +0100 1575643 http://www.medworm.com/index.php?rid=1556510&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F323223098%2F That’s the question raised in a motion filed by the drugmaker’s lawyers in a whistleblower lawsuit in federal court in New Jersey. The case, which has actually been kicking around a few years, was recently unsealed and centers on the fatal side effects associated with a neuromuscular blocking agent known as Raplon that Organon withdrew in 2001. (Here’s the background). A former Organon employee alleges that Organon failed to disclose to the FDA concerns about serious bronchospasm that were cited by Raplon clinical trial investigators prior to the drug’s launch in 1999. And the employee, Jeff Feldstein, has added Schering-Plough as a defendant since the drugmaker recently paid $14.3 billion to acquire Organon. Here is the Schering-Plough motion. In arguing the suit shoul... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1556510 Mon, 30 Jun 2008 12:54:36 +0100 1556510 http://www.medworm.com/index.php?rid=1440007&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F289484147%2F Last February, the controversial gadfly and former Pfizer exec cleared a hurdle in his ongoing whistleblower lawsuit against Pfizer. In a filing, Rost cited approximately 200 instances in Indiana which Genotropin, a human growth hormone, was marketed by Pharmacia (which was bought by Pfizer) for unapproved uses, such as combating aging in adults and treating short stature in children. Providing such detail was needed for the case to proceed. And the move signaled two potentially significant developments. One is the long-term implication for Pfizer, should Rost ultimately prevail. The other is that his efforts may serve as a template for other whistleblowers who are similarly stymied by federal judges seeking details that are, otherwise, very hard to come by. Pfizer, however, last month tu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1440007 Tue, 13 May 2008 14:53:49 +0100 1440007 http://www.medworm.com/index.php?rid=1399359&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F277754849%2F The suit was brought by Laurie Simpson, a former Bayer strategic research analyst who joined the drugmaker just after the controversial cholesterol pill was launched in 1998, and she accuses Bayer of violating the federal and state False Claims Act. The suit was initially filed last year in US District Court in Newark, New Jersey, and was just unsealed. [WHOOPS: We initially wrote the feds joined the suit, but in fact, the US Attorney has declined to do so.] The lawsuit alleges that over a three-year period, prior to its withdrawal from the market, Bayer engaged in illegal and deceptive marketing practices in selling the Baycol cholesterol pill, which was later withdrawn due to side effects, predominantly rhabdomyolysis, a severe weakening of the muscles. Numerous death and 1,600 injuries ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1399359 Fri, 25 Apr 2008 17:41:10 +0100 1399359 http://www.medworm.com/index.php?rid=1268593&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F243446269%2F Two former Wyeth employees accused the drugmaker of making false claims to the government in connection with alleged manufacturing problems with its Prevnar vaccine. Anthony Sokol and Mark Livingston filed a whistleblower lawsuit against Wyeth in November 2006 in federal court in Virginia, according to Wyeth’s annual report (see page 62). The lawsuit alleged false claims were made to the government from 2000 through 2005 in connection with the manufacture of Prevnar, a vaccine given to children to prevent meningitis and other infections. Prevnar had $2.4 billion in sales in 2007. A Wyeth spokesman told Dow Jones that company policy is not to comment on pending litigation. The lawsuit had been filed under a federal law that allows whistleblowers to collect a portion of any settlement ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1268593 Fri, 29 Feb 2008 18:02:27 +0100 1268593 http://www.medworm.com/index.php?rid=1215492&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F231102471%2F The drugmaker failed to pay the appropriate rebates to Medicaid and other goverment health care programs, and also paid kickbacks to doctors and hospitals to induce them to prescribe various meds. The allegations were brought in two separate lawsuits filed by whistleblowers under the False Claims Act. Merck has also agreed to a Corporate Integrity Agreement, which means good behavior is now required for the next five years. “Not only is the combined recovery in these two cases one of the largest healthcare fraud settlements ever achieved by the Justice Department,” says Attorney General Michael Mukasey, in a statement, “it reflects our continuing effort to hold drug companies accountable for devising pricing schemes that deliberately seek to deny federal health care programs the same... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1215492 Thu, 07 Feb 2008 20:41:47 +0100 1215492 http://www.medworm.com/index.php?rid=1200757&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F228967876%2F Last November, the controversial former Pfizer exec won a significant victory when a federal appeals court ruled that his whistleblower lawsuit against the drugmaker should proceed. A federal judge had previously dismissed the case because Rost “failed to plead his fraud claims with sufficient specificity,” a reference to rule 9b, a provision of the False Claims Act that requires particular info about false claims submitted to the government for payment. This might include amounts charged, drugs prescribed, patient diagnosis and individuals involved in billing. Given the level of detail required, however, winning the reinstatement looked like the easy part, because the info contained in Medicaid databases may compromise patient privacy. Last week, for instance a whistleblower lawsu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1200757 Mon, 04 Feb 2008 16:08:32 +0100 1200757 http://www.medworm.com/index.php?rid=999551&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F178725568%2F Drugmakers aren’t the only ones, of course. But the Justice Department says it obtained $2 billion in settlements in fraud cases during fiscal year 2007, with most of the recoveries resulting from whistleblower lawsuits, the Associated Press reports. Approximately $1.45 billion of the settlements resulted from whistleblower lawsuits in fiscal year 2007, which ended Sept. 30, the department said. The individuals who filed suit were awarded $177 million. Under the False Claims Act, whistleblowers can sue companies or individuals that they believe have filed fraudulent claims with the federal government and, if successful, they can receive from 15 percent to 30 percent of the proceeds, the AP notes. Health care fraud accounted for most of the settlements, with $1.54 billion stemming fro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=999551 Fri, 02 Nov 2007 13:17:05 +0100 999551 http://www.medworm.com/index.php?rid=878189&cid=t_99798_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F157715186%2F The state and city of New York today filed a lawsuit against the drugmaker for allegedly hiding the heart risks associated with the painkiller. The lawsuit, filed in New York State Supreme Court, seeks damages, penalties and restitution for “tens of millions of taxpayer dollars wrongfully spent on Vioxx prescriptions,” New York State Attorney General Andrew Cuomo says in a statement. The suit, which was joined by New York City Mayor Michael Bloomberg, claims that many Vioxx scrips never would have been written if docs were properly informed of the risk of heart attack or stroke. Six other states have filed similar complaints. “Merck’s irresponsible and duplicitous conduct endangered the health of New Yorkers and wasted our tax dollars,” Cuomo says. “As a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=878189 Mon, 17 Sep 2007 18:50:07 +0100 878189 http://www.medworm.com/index.php?rid=462963&cid=t_99798_114_f&fid=34646&url=http%3A%2F%2Fhealthcarebloglaw.blogspot.com%2F2007%2F03%2Ffalse-claims-act-recent-changes.html Discussion and Analysis, administrators at CMS recognized that the best way to cut Medicare and Medicaid spending and maintain the integrity of the programs was to reduce Medicare and Medicaid fraud and abuse. For example, the Department of Health and Human Services reports that it collected almost $2.3 billion in 2006 from false claims suits. By implementing and actively enforcing anti-fraud compliance laws, the government can recover more money and, thus, curb the amount of Medicare and Medicaid spending. In order to further combat health care fraud and abuse, Congress enacted the Deficit Reduction Act of 2005 (“DRA”), P.L. 109-171. The DRA contains provisions to slow mandatory spending in Medicare and Medicaid. Furthermore, the DRA includes a provision, § 6032, that requires health... Health Care Law Blog blogs http://www.medworm.com/rss/comments.php?id=462963 Tue, 06 Mar 2007 11:42:00 +0100 462963 http://www.medworm.com/index.php?rid=480170&cid=t_99798_114_f&fid=34963&url=http%3A%2F%2Fwww.symtym.com%2Findex.php%3F%2Fsite%2Farticle%2Ffalse_claim_act%2F (Source: symtym) symtym blogs http://www.medworm.com/rss/comments.php?id=480170 Tue, 26 Dec 2006 05:00:00 +0100 480170