Pharma 101 - Pharmaceutical Fraud » Pharmaceutical industry

Pharma Co. to pay more than $24 million for kickback, conspiracy charges

Nolan and Auerbach — Wed, 16 Sep 2009 01:06:30 +0000

Biovail Pharmaceuticals, LLC, has pled guilty to conspiracy and kickback charges and has been sentenced to pay a criminal fine of more than $22 million. These charges concern various actions by the New Jersey-based pharmaceutical company and its employees to carry out a program in which Biovaile paid or cause to be paid up to $1,000 to thousands of physicians and others in order to induce them to prescribe or recommend the drug Cardizem, L.A.

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 .

Grassley Probes into Ghostwriting Practices that May Result in Pharmaceutical Fraud

Nolan and Auerbach — Sat, 11 Jul 2009 14:39:51 +0000

United States Senator Charles E. Grassley of Iowa has asked eight leading medical journals to describe their ghostwriting policies and practices. The inquiry is part of his broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals, according to a July 2, 2009 press release by the senator. Such financial relationships can lead to pharmaceutical fraud practices, such as off-label marketing.

In December, Grassley wrote to Wyeth and DesignWrite, a medical education and communications company, regarding allegations that Wyeth hired DesignWrite to draft articles promoting the company’s hormone therapy products and seek academic investigators to sign on as the primary authors. Previously, Grassley had written to Merck and Scientific Therapeutics Information, a medical publishing company, regarding similar allegations reported in the Journal of the American Medical Association related to articles on Merck’s VIOXX studies.

He sent the letter on July 1 to the American Journal of Medicine, the Annals of Internal Medicine, the Annual Review of Medicine, the Archives of Internal Medicine, Nature Medicine, PLoS Medicine, The Journal of the American Medical Association and The New England Journal of Medicine. Grassley asked for the editors’ written responses by July 22, 2009.

For the full press release, go to: http://finance.senate.gov/press/Gpress/2009/prg070209.pdf.

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

Major Medical Journal No Longer to Silence Whistleblowers

Nolan and Auerbach — Fri, 10 Jul 2009 14:32:40 +0000

A recent move by a major medical journal could provide more timely disclosure of alleged undisclosed conflicts of interests between researchers and pharmaceutical companies. The Wall Street Journal reported July 7, 2009, that the Journal of the American Medical Association (JAMA) has softened its policy demanding that anyone filing a complaint about unreported conflicts of interest must not reveal the information to third parties or the media while the investigation is underway. In an editorial published early in July in JAMA, editors modified the policy so that it does not explicitly require silence during the investigation, according to the Wall Street Journal.

JAMA has been criticized “for taking five months to acknowledge that a study it published last year on the use of antidepressants in stroke patients was written by a University of Iowa psychiatrist who failed to disclose he had a financial relationship with the maker of the drug studied,” according to the article.

For the full article, go to: http://online.wsj.com/article_email/SB124700923018308521-lMyQjAxMDI5NDA3NzAwMDc5Wj.html.

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

Wyeth under Fire for Alleged Medicaid Fraud

Nolan and Auerbach — Thu, 21 May 2009 17:48:53 +0000

The U.S. government and 16 states have joined in two whistleblower suits against pharmaceutical giant Wyeth. The drug company allegedly failed to pay hundreds of millions in rebates to the Medicaid program, according to a May 18, 2009 release by the U.S. Department of Justice.

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.

Schering- Plough Pays $31 Million to Resolve Pharmaceutical Fraud Allegations

Nolan and Auerbach — Tue, 04 Nov 2008 17:18:43 +0000

The State of Missouri filed a lawsuit against Schering-Plough in May 2005 and alleged in its complaint that the company did not accurately report drug prices for drugs sold to pharmacies involved in the Missouri Medicaid program. This is the largest settlement figure the State of Missouri has ever recovered in a pharmaceutical pricing fraud. This is one of a number of lawsuits filed by state AG’s office against pharmaceutical companies alleging pharmaceutical fraud. They typically follow qui tam lawsuit fact patterns.

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

Big Pharma Pays $13.6 million for Price Inflation

Nolan and Auerbach — Tue, 25 Mar 2008 21:13:49 +0000

U.S. District Court Judge Patti Saris has ordered drug companies AstraZeneca and Bristol-Myers Squib to pay a total of $13.6 million in a Masachusetts case that alleged that they inflated the average wholesale price (AWP) of expensive and in some cases, life-saving drugs. Judge Saris also found that the companies “unfairly and deceptively caused to be published false” average wholesale prices of drugs and thus caused “real injuries to the insurers and the patients who were paying grossly inflated prices for critically important, often life-sustaining drugs.” Judge Saris said that she decided to double the assessed damages because the conduct was willful on the part of the companies. Judge Saris further stated that “The Defendants well understood the devastating impact the mega-spreads had on old and sick patients required to make co-payments they could ill afford.”

Bristol-Myers is maintaining that their pricing was fair and that they intend to appeal this decision.

Of note is the fact that Judge Saris remarked and doubled the damages due to the wilfulness on the part of the defendants. Further, this can expand to a nationwide class action lawsuit.

To read more click on:

http://www.boston.com/news/local/massachusetts/articles/2007/11/02/drugs_companies_ordered_to_pay_136_million_for_inflating_prices/ or to read more about pharmaceutical fraud go to www.whistleblowerfirm.com/pharmaceuticalfraud

Eli Lilly and Company in More Hot Water

Nolan and Auerbach — Thu, 17 May 2007 14:25:00 +0000

Montana is the latest state to sue Eli Lilly and Company, alleging that the company improperly and fraudulently marketed Zyprexa, an antipsychotic drug for unapproved uses. According to Montana Attorney General Mike McGrath, Eli Lilly improperly promoted Zyprexa for off label use and illegally paid kickbacks to physicians. Lilly created a sales force of 280 persons according to the State of Montana complaint, “to promote Zyprexa exclusively for off-label uses, specifically for long-term-care facilities to maximize off-label use of Zyprexa sales.” Under federal laws, pharmaceutical companies are prohibited from marketing their drugs for off-label or unapproved uses. Lilly’s worldwide sales of Zyprexa were $4.36 billion in 2006.

To read more click here.

Congress now has the power to shake up the FDA

Nolan and Auerbach — Fri, 26 Jan 2007 17:28:57 +0000

With the new Democratic-controlled Congress, how the FDA accomplishes enforcement will likely change, which may in turn effect the level of resources devoted to the investigation of qui tam complaint allegations. In June 2006, a government report was issued entitled “Prescription for Harm: The Decline in FDA Enforcement Activity”, as a result of the House Committee on Government Reform having commissioned an investigation to evaluate the FDA enforcement activities related to the pharmaceutical industry under the Bush administration. The Report did not present a well-oiled enforcement machine.

To see the full report, click here.

To read more about Pharmaceutical Fraud, click here.

Pharma Has Its Nose In Clinical Trials

Nolan and Auerbach — Tue, 05 Dec 2006 15:05:52 +0000

A survey published in the New York Journal of Medicine found that more than a third of experts who oversee clinical trials at both medical schools and research hospitals have financial ties to pharmacutical and/or medical device companies. It was further found that some experts had a direct conflict of interest under federal rules; voting on or discussing clinical trials sponsored by companies they had relationships with or competitors of those very same companies. These experts may be part of review boards who are supposed to be insuring the scientific validity of clinical trials and safeguarding the safety of patient participants. Susan L. Rose, executive director of University of Southern California’s Office for the Protection of Research Subjects, said academic institutions had been reassessing their policies and discussing the need for mandatory disclosures.

To read more click here.

$30 Million Off-Label Case

Nolan and Auerbach — Sun, 06 Aug 2006 16:28:44 +0000

The State of Mississipi has filed a sweeping lawsuit against the pharmaceutical company Eli Lilly (see www.lilly.com) alleging the pharmaceutical compay illegally marketed Zyprexa (an antipsychotic drug) for off label uses, thereby defrauding the state of Mississippi in excess of $30 million. For more information, click here.