Pharma 101 - Pharmaceutical Fraud » qui tam

Forest Whistleblower Cases Settle for Over $300 Million

Nolan and Auerbach — Tue, 21 Sep 2010 14:18:23 +0000

Nolan & Auerbach, P.A. announces another successful whistleblower recovery by their courageous clients, whose cases continue to return hundreds of millions of dollars to the US Treasury for America’s healthcare programs. Two weeks ago, the firm represented two of the whistleblowers in a $600 million overall settlement with Allergan, Inc. This latest settlement marks the unsealing of its client’s case against pharmaceutical manufacturer Forest Laboratories, Inc., and its subsidiary Forest Pharmaceuticals, Inc., which have agreed to pay $42.5 million to resolve allegations that they illegally sold the drug Levothroid, even though the FDA had never proven the drug to be safe or effective at that time. These companies are the latest to settle allegations raised in a multi-defendant lawsuit, claiming that several drug companies have illegally marketed and sold unapproved drugs to Medicaid providers. This settlement also settles two other qui tam actions, which, in total, resulted in the $149 million recovery. In addition, Forest has agreed to pay a $150 million criminal fine, to forego $14 million in disputed payments and to plead guilty to a misdemeanor charge of introducing this misbranded drug into interstate commerce.

This is the third settlement this year by Nolan & Auerbach, P.A. involving unapproved drugs. Under the federal Food, Drug & Cosmetic Act, 21 U.S.C. § 301 et seq., every drug must be approved by the FDA for safety and effectiveness before it can be marketed to the public. However, the FDA acknowledged that there are thousands of unapproved drugs illegally on the market, posing serious health risks to patients, particularly Medicaid recipients, many of whom are elderly or disabled, and who have extensive healthcare needs.

The whistleblowers alleged that from August 2001 through December 2005, Forest repeatedly misrepresented to CMS that its drug Levothroid met the definition of a Covered Outpatient Drug. Forest made these false representations or omissions after the FDA had announced that all oral levothyroxine sodium products, including Levothroid, needed to obtain proper FDA approval for safety and efficacy.

According to the whistleblower lawsuit, Forest nearly doubled its illegal sales of Levothroid after the FDA required the phased-down distribution of all unapproved oral levothryoxine sodium products, including Levothroid. All the while, Forest submitted quarterly reports to CMS, falsely stating that Levothroid qualified as a Covered Outpatient Drug.

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

Botox Whistleblower Case Settles for $600 Million

Nolan and Auerbach — Tue, 07 Sep 2010 22:27:52 +0000

Pharmaceutical manufacturer Allergan, Inc. has agreed to pay $225 million to resolve civil allegations that it unlawfully promoted its drug Botox® Therapeutic for unapproved uses and that it paid illegal remuneration to health care providers to induce them to prescribe the company’s products. In addition, the company has agreed to pay a $375 million criminal fine and to plead guilty to a misdemeanor charge of introducing this misbranded drug into interstate commerce. Nolan & Auerbach, P.A. represented two of the key whistleblowers in this case, which was brought under the qui tam, or whistleblower, provisions of the False Claims Act. This settlement also resolves two other qui tam actions raising similar allegations.

Our courageous clients alleged that Allergan implemented a sophisticated marketing plan with the purpose of inducing physicians to prescribe Botox® Therapeutic for various off-label uses which were neither FDA-approved nor demonstrated to be safe and effective. According to the complaint, Allergan marketed Botox® Therapeutic as safe and effective for certain off-label uses, such as overactive bladder, adult spasticity, and headaches. The Complaint also alleged that Allergan regularly provided illegal kickbacks to physicians who prescribed Botox® Therapeutic for off-label use.

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

Out of the U.S. No Oversight Necessary?

Nolan and Auerbach — Wed, 23 Jun 2010 19:22:13 +0000

Today the OIG posted “Challenges to FDA’s Ability To Monitor and Inspect Foreign Clinical Trials” (OEI-01-08-00510).

As all new investigational drugs and biologics must undergo clinical trials on human subjects to demonstrate safety and efficacy prior to approval for sale in the United States, pharmaceutical manufacturers sponsor trials involving investigators and patients both inside and outside the United States. The data in support of a particular product’s approval therefore comes from both U.S. and foreign clinical trials. The FDA, as mandated by the Food, Drug and Cosmetic Act is charged with the responsibility of ensuring the rights, safety and well-being of subjects who participate in these trials and of verifying that the clinical trial data collected are both accurate and reliable.

In the Report, the FDA found that 80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials. Further, over half of clinical trial subjects and sites were located outside the United States. Astonishingly, the FDA inspected clinical investigators at less then 1 percent of foreign sites!

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

Johnson & Johnson Subsidiaries to Pay More Than $81 Million to Resolve Allegations of Off-Label Promotion of Topamax

Nolan and Auerbach — Tue, 04 May 2010 14:25:43 +0000

American pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, have agreed to pay more than $81 million to resolve criminal and civil liability arising from the off-label promotion of the epilepsy drug Topamax, the U.S. Department of Justice (DOJ) announced April 29, 2010.

According to the agreement, Ortho-McNeil Pharmaceutical LLC has agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for the misbranding of Topamax in violation of the Food, Drug and Cosmetic Act. The Food and Drug Administration (FDA) approved Topamax as an anti-epileptic drug, for the treatment of partial onset seizures, but not for any psychiatric use.

The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for off-label psychiatric uses by hiring outside physicians to join sales representatives on their visits to health care providers’ offices, to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses.

In addition to the criminal fine, Ortho-McNeil-Janssen Pharmaceuticals will pay $75.37 million to resolve civil allegations under the False Claims Act that they illegally promoted Topamax and caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not medically accepted indications and therefore not covered by those programs. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.

The civil settlement resolves two lawsuits filed under the qui tam, or whistleblower provisions of the False Claims Act.

For the full press release, go to: http://www.justice.gov/opa/pr/2010/April/10-civ-500.html. For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

AstraZeneca Agrees to $520 Million Settlement

Nolan and Auerbach — Wed, 28 Apr 2010 18:27:54 +0000

Attorney General Eric Holder announced April 27, 2010, that AstraZeneca has agreed to pay $520 million to federal and state taxpayers to settle claims that it illegally marketed the anti-psychotic drug Seroquel for uses that were not approved as safe and effective by the Food and Drug Administration. As part of this scheme, AstraZeneca was accused of illegally promoting Seroquel to physicians off label and in violation of the federal Anti-Kickback statute, all in furtherance of supporting the drug’s use for a host of illnesses for which it was never approved, according to the U.S. Department of Justice. This pharmaceutical fraud settlement is the largest amount ever paid by a company in a civil- only settlement of off-label marketing claims. The federal government will receive $302 million, and states will share up to $218 million.

For the full announcement, go to: http://www.justice.gov/ag/speeches/2010/ag-speech-100427.html.

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

FDA Warns Pfizer About Pediatric Trials of Geodon

Nolan and Auerbach — Mon, 26 Apr 2010 16:08:05 +0000

On April 9^th, the FDA issued a Warning Letter to Pfizer, Inc. concerning its conduct during a clinical trial for one of its prescription drugs on the market. According to a Wall Street journal article (“FDA Warns Pfizer About Pediatric Trials of Geodon,” April 21, 2010) the drug (name redacted in the Warning Letter) is Geodon, which is FDA-approved to treat schizophrenia and bipolar disorder in adults. The FDA admonished Pfizer over its failure to properly monitor the clinical trials resulting in excessive doses given to pediatric subjects. The Warning Letter reads “dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.” Geodon does not have a pediatric indication.

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

Alpharma to Pay $42.5 Million to Resolve False Claims Act Allegations

Nolan and Auerbach — Tue, 30 Mar 2010 16:13:38 +0000

Pharmaceutical manufacturer Alpharma, Inc. has agreed to pay $42.5 million to resolve False Claims Act allegations in connection with the marketing of the morphine-based drug, Kadian, the U.S. Department of Justice (DOJ) announced Tuesday, March 16, 2010. The settlement resolves allegations that, between January 1, 2000 and December 29, 2008, Alpharma paid health care providers to induce them to promote or prescribe Kadian, and made misrepresentations about the safety and efficacy of the drug, which is used to treat chronic moderate to severe pain. Alpharma is now a wholly-owned subsidiary of Bristol, Tennessee-based King Pharmaceuticals, Inc.

Under this agreement, the proceeds from the settlement will be split between the federal government and various states. The settlement resolves a lawsuit brought by a whistleblower under the qui tam or whistleblower provisions of the False Claims Act, according to a DOJ press release.

For the full press release, go to: http://www.justice.gov/opa/pr/2010/March/10-civ-269.html. For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Texas Hospital Group Pays $27.5 Million for False Claims Act Allegations

Nolan and Auerbach — Thu, 05 Nov 2009 02:10:58 +0000

South Texas Health System, a McAllen, Texas-based hospital group, has agreed to pay the United States $27.5 million to settle claims that it violated the False Claims Act, the Anti-Kickback Statute and the Stark Statute between 1999 and 2006. The hospital group, owned by Pennsylvania-based Universal Health Services Inc., allegedly paid illegal compensation to doctors in order to induce them to refer patients to hospitals within the group, the U.S. Department of Justice (DOJ) announced October 30, 2009.

The settlement involved allegations that the defendants had entered into financial relationships with several doctors in McAllen in order to induce them to refer patients to the defendants’ hospitals. The government alleged that these payments were disguised through a series of sham contracts, including medical directorships and lease agreements.

The settlement resolves allegations raised against both the parent and the subsidiary in a qui tam or whistleblower lawsuit, according to the DOJ.

For the full press release, go to: http://www.justice.gov/opa/pr/2009/October/09-civ-1175.html.

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

FDA’s Postmarketing Studies and Clinical Trials Draft Guidance Gets Supported By Public Citizen

Nolan and Auerbach — Mon, 02 Nov 2009 22:07:32 +0000

In an October 13 letter to the FDA, the well respected consumer advocacy organization Public Citizen, gave a strong endorsement to the FDA Draft Guidance on Postmarketing Studies and Clinical Trials. In letter, Public Citizen’s Deputy Director Peter Lurie MD, MPH, and Sidney M. Wolfe, MD, wrote: “Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach. The guidance makes a sensible distinction between studies that are for efficacy purposes only (“postmarketing commitments….”) and those that have any significant safety element (“postmarketing requirements….”). The categories of studies that can fall under postmarketing requirements (observational studies, clinical trials, animal studies, in vitro studies, pharmacokinetic studies, and interaction/bioavailability studies) are appropriately broad. We urge you to resist any efforts to weaken the draft guidance.” (Emphasis supplied)

To review the draft guidance, go to: http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809f1ed1.

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