Navigation Links
AstraZeneca Pays $520 Million to Settle Seroquel Whistleblower Claims
Date:4/28/2010

Kenney & McCafferty Represent Whistleblower Dr. Stefan Kruszewski

(PRWEB) April 28, 2010 -- AstraZeneca has agreed to pay $520 million in civil fines, penalties and damages to settle allegations that the company defrauded Medicare, Medicaid and other government-funded health care programs in connection with its marketing and promotional practices for the blockbuster atypical antipsychotic Seroquel (U.S. ex rel. STEFAN KRUSZEWSKI, MD v. ASTRAZENECA PHARMACEUTICALS, LP., Eastern District of Pennsylvania, C.A. No. 06-4004.). This is the largest settlement of off-label marketing claims brought under the False Claims Act to date that involved civil-only fines. The $520 million settlement resolves a qui tam lawsuit filed by whistleblower Dr. Stefan Kruszewski, one of two relators to file a case. Dr. Kruszewski was represented by Brian Kenney and Tavy Deming of the Kenney & McCafferty law firm, along with William Leonard of Obermayer, Rebmann, Maxwell & Hippel.

Seroquel, a potent atypical antipsychotic, was FDA-approved only for two narrow uses in adults, schizophrenia and manic episodes associated with bipolar I disorder, at the time that Dr. Kruszewski filed his complaint. Harvard-trained psychiatrist Dr. Kruszewski alleged, however, that AstraZeneca engaged in an egregious, long term off-label marketing scheme by specifically targeting children and the elderly when those uses were never properly tested or approved by the FDA and that AstraZeneca marketed the drug for a litany of off-label uses, including depression, anxiety, ADHD and insomnia.

Dr. Kruszewski's complaint further alleged that AstraZeneca arranged for clinical trials that embellished efficacy data and also downplayed the drug’s serious side effects. Dr. Kruszewski alleged that AstraZeneca used these studies to stifle physician concerns about the drug's serious treatment-emergent side effects, including type II diabetes, hyperglycemia, cardiovascular complications, heart attacks, stroke, and, in some cases, an increase in the risk of mortality.

“The manipulation and misuse of Seroquel scientific data to support AstraZeneca’s off-label marketing campaign was the most disturbing aspect of the case to me,” Dr. Kruszewski said. “There were strong indications from AstraZeneca’s earliest clinical trials that Seroquel increased the risk of diabetes and induced profound sedation out of proportion to its weak antipsychotic effects.”

Kruszewski added that “rather than properly warning doctors and the public, AstraZeneca intentionally covered up the evidence on diabetes and other serious side effects and used the sedative property of Seroquel as a selling point.” “In the elderly population, they basically marketed Seroquel as an expensive sleeping pill and put hundreds of thousands of patients at risk for serious medical complications, premature cardiovascular disease, pneumonias, and premature death.”

“This was a well thought out marketing campaign that operated on many levels,” stated Brian Kenney. “AstraZeneca orchestrated scientific studies, ghost written articles, and the payment of large fees to academic psychiatrists to act as ‘thought leaders’ to promote the drug off label. The success can be seen in the huge numbers the campaign generated with 4.9 billion in sales in 2009.” “It’s particularly disconcerting that AstraZeneca successfully co-opted large portions of psychiatric academic community,” added Mr. Kenney.

“From the outset of this case, Dr. Kruszewski was passionate about bringing to light AstraZeneca’s concealment of unfavorable Seroquel studies as well as the company’s’ improper use of what he deemed to be flawed scientific studies to promote the drug off label,” said Tavy Deming.

The U.S. Attorney's Office for the Eastern District of Pennsylvania conducted the federal investigation into AstraZeneca's Seroquel marketing practices under the direction of U.S. Attorney Michael Levy, Assistant U.S. Attorneys Virginia Gibson and Colin Cherico.

U.S. ex rel. STEFAN KRUSZEWSKI, MD v. ASTRAZENECA PHARMACEUTICALS, LP., Eastern District of Pennsylvania, C.A. No. 06-4004.

Call Tavy Deming or Brian P. Kenney at 610-940-0327 to arrange availability for the complete news release or other public material related to the case.

About Kenney & McCafferty, P.C. (http://www.quitam-lawyer.com)

Kenney & McCafferty ("K&M") specializes in qui tam and tax whistleblower litigation. K&M represents whistleblowers nationwide and has recovered more than $4 billion for the government in False Claims Act and tax whistleblower cases. Recent K&M pharmaceutical False Claims Act settlements include Pfizer, Inc./Geodon; Eli Lilly/Zyprexa; and Cephalon, Inc./Actiq, Provigil and Gabitril..

Brian P. Kenney, Esq.
Tavy Deming, Esq.
Kenney & McCafferty, P.C.
3031C Walton Road, Suite 202
Plymouth Meeting, PA 19462
610-940-0327
www.quitam-lawyer.com

###

Read the full story at http://www.prweb.com/releases/2010/04/prweb3937374.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved

Related medicine news :

1. Angel.com Launches Caller First IVR Solutions with AstraZeneca
2. PharmaSmart International, Inc and AstraZeneca Canada Enter Into Strategic Partnership to Elevate Pharmacy Based Hypertension Management
3. Freedland Russo Announces $520 Million Settlement Against AstraZeneca
4. Kaiser Permanente Gives $5 Million to Childrens Healthcare of Atlanta
5. RadioShack Customers Donate $1.3 Million to LIVESTRONG
6. Michael J. Fox Foundation Awards $2.8 Million to Drive Development of Parkinsons Disease Biomarker Pipeline
7. Human Rights Denied: Obama Leaves 75 Million Children Behind
8. NVHR: Administrations 2011 Budget Proposal Shortchanges Five Million Americans Afflicted with Chronic Viral Hepatitis
9. State $200 Million Behind in Payments to Agencies Providing Care to Thousands of Older Illinoisans
10. Prominent Beverly Hills Law Firm Awarded $16.5 Million Medical Malpractice Jury Verdict
11. Esperanza Health Center Receives $6.5 Million in Stimulus Funds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... While it’s often important to take certain medications ... from Austin, Texas, has identified a solution. , She developed a prototype for MOTION ... As such, it eliminates the need to turn on a light when taking medication ...
(Date:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & Associates ... special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to date ... elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded by ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Global Healthcare ... scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare ... activity. The fun run is geared towards children of all ages; it is ...
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... introduction of an innovative new design of the shoulder pad. The shoulder pad ... comfort while controlling your pain while using cold therapy. By utilizing ice and water ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... Sept. 18, 2017 EpiVax, Inc. ... bioinformatics and immune engineering, today announced a ... A (H7N9) vaccine. ... seasonal influenza and presents a challenge for ... exposure to be effective. Using state-of-the-art bioinformatics and ...
(Date:9/12/2017)... 12, 2017   EcoVadis , the leading platform for environmental, social ... annual edition of its Global CSR Risk and Performance Index. The report ... based on Scorecard Ratings that analyzed nearly 800,000 data points across the ... ... ...
(Date:9/12/2017)...  ValGenesis Inc., the global leader in Enterprise ... announce the appointment of Dr. Ajaz Hussain ... Directors and Chairman of Advisory Board beginning September ... to manage their entire validation lifecycle process electronically ... process. Furthermore, ValGenesis VLMS enables rigorous compliance, helps ...
Breaking Medicine Technology: