Pharma 101 - Pharmaceutical Fraud » Lawsuit

Eli Lilly has Fighting Words for W. Virginia Attorney General

Nolan and Auerbach — Wed, 10 Jun 2009 01:52:22 +0000

Attorneys representing Eli Lilly & Co. claim that the civil penalties sought by West Virginia Attorney General Darrell McGraw for the pharmaceutical manufacturer’s alleged mislabeling violations are inappropriate and unreasonable, according to a June 8, 2009 article by John O’Brien on LegalNewsline.com.

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.

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.

Off Label Marketing Costs Jazz Pharmaceuticals $20 Million

Nolan and Auerbach — Wed, 29 Aug 2007 15:46:46 +0000

Jazz Pharmaceuticals, Inc. (”Jazz”) has agreed to pay $20 million in order to resolve both criminal and civil investigations which were conducted by the United States Attorney’s Office for the Eastern District of New York. Specifically, Jazz Subsidiary Orphan Medical, Inc. plead guilty to the off label, illegal marketing of Xyrum (also known as “GHB”) and agreed to pay $17.2 Million in restitution and penalties. Both Jazz and Orphan were also to pay an additional $2.8 Million through a Civil Settlement Agreement.

The government’s investigation of the pharmaceutical fraud began as the result of a whistleblower lawsuit under the False Claims Act by a former sales representative for Orphan. Orphan engaged in a scheme to expand the market for Xyrum by marketing and promoting the drug to physicians for “off-label” use which included using a psychiatrist in promotional speaking engagements. The psychiatrist with the approval of Orphan sales personnel also showed physicians how to obtain reimbursement from Medicare and Medicaid for these unapproved uses. The criminal prosecution arose out of a criminal misbranding scheme by which physicians would write presciptions for Xyrum that were not reimburseable for Medicare and Medicaid.

“Pharmaceuticals manufactured under strict standards can still injure or kill if used for unapproved purposes. Here, the risk was not from willful abuse by users; it was from a concerted campaign by the manufacturer to push a drug for off-label uses. This posed a serious health risk and constitutes a serious crime,” said FBI Assistant Director-in-Charge, New York Field Office, Mark J. Mershon.
To learn more click here or contact Nolan & Auerbach.

Is Big Pharma Manufacturer Roxane Overcharging the Government?

Nolan and Auerbach — Tue, 06 Feb 2007 15:23:11 +0000

The United States Attorney’s Office announced on January 29, 2007, in Boston, Massachusetts that it is intervening in a whistleblower lawsuit filed against Boehringer Ingelheim Roxane, Inc. (”Roxane”) The allegations center around the contention that Roxane reported inflated prices for numerous pharmaceutical products knowing the federal health care programs would establish reimbursement rates based on these fraudulent prices. According to the Government’s complaint, these reported prices were in excess of 1,000 percent of the actual sales prices on several of the drugs it manufactures. It is alleged that damages to federal programs exceeds $500 million.

To read more about pharmaceutical fraud, click here.

Allegedly Tainted Blood Claims and Generous Medical Directorship result in 5.7 Million Dollar Settlement

Nolan and Auerbach — Tue, 24 Oct 2006 16:35:26 +0000

Northside Hospital located in Atlanta, Georgia, has agreed to pay $5.7 million to settle a whistleblower lawsuit alleging tainted claims were submitted to Medicare because they were the result of improper financial and referral relationships in violation of the Stark law. Two former employees of the Blood and Marrow Transplant Group of Georgia (BMTGA) filed a false claims act lawsuit; BMTGA, in affiliation with Northside Hospital, also operated a clinical transplant program for stem cell transplants and cancer treatment. The transplant physicians who own the transplant group also own Atlanta Blood Services, a clinical lab that provided services and blood products to Northside Hospital.

For more information click here.

Unapproved devices hit the FDA Radar Screen

Nolan and Auerbach — Fri, 13 Oct 2006 17:14:38 +0000

The FDA recently announced that it had filed for a permanent injunction against Endotec Inc. of Orlando, Florida to stop the illegal distribution of unapproved total joint replacement devices. The lawsuit alleges that the company has carried out the illegal distribution of the devices since March 15, 2002, despite the FDA’s warnings that these actions were illegal. This enforcement activity follows increased FDA awareness and resolve to take action against manufacturers of marketed unapproved new drugs. In 2003, after several decades without any apparent real enforcement, the FDA issued a Draft Compliance Policy Guide concerning marketed (but) unapproved drugs, declaring again that the drugs are illegal and that the FDA would exercise its enforcement discretion. There are hundreds if not several thousand prescription drugs on the market which have never obtained FDA approval in any form, yet year after year are unknowingly prescribed by physicians and taken by patients. Fortunately, the FDA in recent years has stepped up its enforcement efforts, even this month taking action against a manufacturer of unapproved dental drugs.