JJ&R exaggerated claims that it had coded on behalf of emergency room physicians in Louisiana and California.  Also, JJ&R did not regularly follow Medicare’s coding rules for governing the submission of teaching physicians claims. Le Jeanne Harris, a former employee of JJ&R, came forward with the allegations and the lawsuit was filed under the FCA. U.S. Attorney’s Office for the Middle District of Louisiana, as well as HHS Office of the Inspector General (OIG) and the Commercial Litigation Branch – Fraud Section of the Justice Department’s Civil Division handled the matter.

Read more at: http://www.justice.gov/opa/pr/2011/September/11-civ-1129.html

For more information see:  http://www.csmonitor.com/USA/Justice/2011/0623/Supreme-Court-strikes-down-law-restricting-sale-of-prescription-drug-info.

The Lobbyists contend that these types of payments were completely legal and that discounts from manufacturers to healthcare providers ultimately reduce costs and promote competition.  The Department of Justice disputes these contentions, arguing that if the payments had been legal, then Omnicare would have disclosed them to the government.  It also pointed out that Johnson and Johnson made an additional $280 million in sales as a result of the scheme. 

For more information see: http://www.bnet.com/blog/drug-business/drug-lobbyists-argue-kickbacks-lower-the-cost-of-healthcare/6575

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

For more information see http://www.forbes.com/feeds/ap/2010/07/15/business-health-care-us-elan-settlement_7771887.html?boxes=Homepagebusinessnews

More information on the lawsuits can be found here:  http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Nov2009/OmnicarePR.html

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

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

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

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