Navigation Links
Grant & Eisenhofer Represents Whistleblowers in Justice Dept. $257 Million Civil Settlement with Wyeth over Unlawful Marketing of Rapamune
Date:7/30/2013

WASHINGTON, July 30, 2013 /PRNewswire/ -- Leading whistleblower law firm Grant & Eisenhofer P.A. represented two key whistleblowers behind a $257.4 million settlement announced today between drugmaker Wyeth Pharmaceuticals, a subsidiary of Pfizer, and the U.S. Department of Justice stemming from alleged marketing abuses of Wyeth's powerful immunosuppressant drug Rapamune. The case was originally brought by Grant & Eisenhofer clients Marlene Sandler and Scott Paris, both of whom were sales representatives for the company.

Today's blockbuster settlement of the whistleblower case was originally panned by the Justice Department, but raised the ire of a Congressional oversight committee in 2010. 

The case, filed under seal in 2005 in U.S. District Court for the Eastern District of Pennsylvania, led to an investigation by the Justice Department and multiple states into abusive marketing practices related to Rapamune, which is primarily approved by the FDA for individuals following kidney transplants to help the body prevent organ rejection.  On Dec.3, 2006, the DOJ filed a formal notice with the Eastern District declining to intervene in the case.

Grant & Eisenhofer continued to move forward with the case, and filed an amended complaint on behalf of the whistleblowers on May 24, 2010  ─ which spurred a formal inquiry by the U.S. House of Representatives Committee on Oversight and Government Reform, then chaired by U.S. Representative Edolphus Towns.

On Sept.21, 2010, the Justice Department intervened in the case and transferred it to the U.S. the District Court for the Western District of Oklahoma in Oklahoma City, where an investigation was initiated with regard to claims brought by a third whistleblower.

The settlement agreement notes the broad scope of Wyeth's alleged unlawful marketing of Rapamune for well over a decade, spanning from September 1999 to December 2011:

Wyeth (a) knowingly promoted the sale and use of Rapamune for uses for which it had not been approved by the United States Food and Drug Administration (FDA), including for use in connection with solid organ transplant patients other than kidney transplant patients, which were not medically-accepted indications (as defined in 42 U.S.C. § 1396r-8(k)(6)), and were not covered by Medicare, Medicaid and other Federal health care programs; and (b) knowingly promoted the sale and use of Rapamune in treatment regimens that had not been approved by the FDA including the use of Rapamune with transplant patients who used another immunosuppressant drug before using Rapamune and the use of Rapamune in combination with certain types of products other than cyclosporine and corticosteroids. 

Ms. Sandler and Mr. Paris were represented by Grant & Eisenhofer director Reuben Guttman and Senior Counsel Traci Buschner.  Mr. Guttman is one of the country's preeminent whistleblower lawyers, having representing individuals in some of the largest pharmaceutical and financial services cases on record.

"Pfizer subsidiary Wyeth joins a parade of other pharma giants to plead guilty and pay significant penalties for unlawfully marketing their drugs," said Mr. Guttman. "The abuses related to illicit marketing of Rapamune paint a disturbing portrait. Wyeth leadership placed a highly vulnerable patient population at serious health risk.  Exposing those whom drug makers have pledged to heal to increased risk merits immediate congressional oversight.  Hopefully, the settlement will prompt Congress to take action."

Mr. Guttman continued: "Over the past five years, at least half a dozen pharma giants have paid fines for conduct that places patients in harm's way, yet not a single individual has been held accountable. Our nation can no longer afford the expenditure for drugs that don't work, cause additional harm and saddle the country with the long-term of obligation of paying for the medical care of victims. These cases are reported in terms of dollars but they are more about conduct that impacts patients and taxpayer."

Grant & Eisenhofer is one of the nation's leading high-impact litigation firms. In the last two years, its False Claims Litigation Group has had unprecedented success representing lead whistleblowers in the government's $1.6 billion settlement with Abbott (2012); its $1.04 billion settlement with GlaxoSmithKline (2012); and its $24.9 million dollar settlement with Amgen (2013).  The firm also represented whistleblower Lynn Szymoniak, who first reported claims of robo-signing to 60 Minutes and whose allegations led to a $95 million settlement as part of the government's historic $25 billion settlement with the country's four largest banks (2012).

Mr. Guttman and Ms. Buschner currently represent several relators in an ongoing case, in which the government has intervened, against defense contractor LockheedMartin regarding alleged environmental noncompliance and mishandling of hazardous waste at the Paducah Kentucky Gaseous Diffusion Plant.

About Grant & Eisenhofer

Grant & Eisenhofer P.A. represents plaintiffs in a wide range of complex financial litigation.  G&E's clients include institutional investors, whistleblowers and other stakeholders in bankruptcy litigation, securities class actions, derivative lawsuits, consumer class actions, antitrust suits, and cases involving the False Claims Act. G&E has recovered more than $13 billion for investors in the last five years and has consistently been cited by RiskMetrics for securing the highest average investor recovery in securities class actions. Grant & Eisenhofer has been named one of the country's top plaintiffs' law firms by The National Law Journal for the past eight years. For more information, visit www.gelaw.com.

Contacts:
Allan Ripp, 212-262-7477, arippnyc@aol.com
Elise Martin, 302-622-7004, emartin@gelaw.com


'/>"/>
SOURCE Grant & Eisenhofer P.A.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt
2. National Institute of Justice Awards Bode Technology Missing Persons Grant
3. Trevena Granted Key Composition of Matter Patent for TRV027 in U.S.
4. CorMedix Granted Extension of NYSE MKT Listing
5. Avanir Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
6. Voices Against Brain Cancer Awards Grant to Tocagen to Support Investigation of Toca 511 & Toca FC in Patients with Recurrent Brain Cancer
7. QRxPharma Granted US Patent On Hybrid Opioids
8. Agnitio Grants 10,000 New Licenses Globally this Financial Year
9. Misonix, Inc. Announces the Grant of Patent by the United States Patent and Trademark Office
10. Tunitas Therapeutics Awarded Phase II SBIR Grant to Advance Asthma Program
11. FDA Grants Soligenix "Fast Track" Designation for SGX942 for the Treatment of Oral Mucositis in Patients with Head and Neck Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... 25,2016 FDA 510(k) clearance ... platform for urological and surgical applications ... of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) ... the US with the 12 th 510(k) ... (FDA). This new FDA clearance covers Confocal Miniprobes ...
(Date:5/25/2016)... May 25, 2016  Zymo Research Corp. announced ... new reference materials that help researchers obtain the ... to analyses. The rapid growth of the study ... to have standard methods to improve the reproducibility ... inherently exist at every step of the measurement ...
(Date:5/25/2016)... , May 25, 2016  Granger Diagnostics today announced ... for wounds and infections. This test ensures discovery ... select viruses. The test requires only a simple swab ... David G. Bostwick , MD, Chief ... facilitate wound healing: "We are excited to make ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... 2016 , ... There are many ways to cook a hot dog, but ... Americans prefer their dogs straight off the grill. Of the 90 percent of Americans ... to cook a hot dog, far outpacing other cooking methods such as steaming (12 ...
(Date:5/26/2016)... ... May 26, 2016 , ... Intalere, ... members and suppliers for its inaugural Member Conference at the Paris Hotel in ... elevating the operational health of America’s healthcare providers. , The conference was highlighted ...
(Date:5/26/2016)... ... 26, 2016 , ... On Memorial Day, Hope For Heroes and ... military battle for the country. The nonprofit Hope For Heroes partnered with the ... empower independence for disabled military veterans, as well as police, firemen, and EMS professionals ...
(Date:5/26/2016)... ... 2016 , ... There are nearly 14.5 million people living with and beyond ... Sunday, June 5, 2016, communities around the world will gather to recognize these cancer ... Cancer Survivors Day® is an annual worldwide Celebration of Life that is held on ...
(Date:5/26/2016)... ... May 26, 2016 , ... Dr. James Maisel will ... Long Island Chapter on June 4, 2016, 1:30-3:30 pm at the Farmingdale Public ... Retina Group of New York , is a Board Certified ophthalmologist who ...
Breaking Medicine News(10 mins):