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.

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.

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.

“There are very few companies that haven’t had their turn in the wheelhouse to get a spanking,” according to a quote in the article by Ira Loss, an independent analyst who follows the pharmaceutical industry. “I tend to think the pressure put on these salesmen to hit targets and goals leads to misbehavior.”

Off-label marketing allows pharma companies to increase profit from their best-selling products. This illegal shortcut is alluring because the companies don’t invest in further FDA approvals. Pfizer generated $10 billion in about five years selling its seizure drug Neurontin for unapproved uses.

Doctors may prescribe medicines for unapproved uses, but pharma companies cross the line when their reps sell physicians on the idea of using drugs for off-label purposes, sometimes with inducements and misrepresentations.

These violations of the False Claims Act will continue, one expert said, as long as drug companies make more on off-label promoting than they lose in fines. But big financial penalties and the threat of having medicines taken off Medicare, Medicaid and other formularies could make the risk too great.

Frank Palumbo, executive director of the University of Maryland School of Pharmacy Center on Drug and Public Policy, said in the article: “I think companies are on notice at this point to make sure they’re in compliance. Adopting a corporate integrity agreement puts a company on notice that they need to be more proactive about their sales reps are doing.”

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

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

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.

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.

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

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.

DOJ filed the criminal information in connection with an agreement with Guidant to resolve the charges. A formal guilty plea agreement is expected to be filed with the court at a later date. Boston Scientific previously announced in a November 2009 press release that the company would pay $296 million on behalf of Guidant in connection with these charges, according to the release.

According to the information filed Feb. 25 in federal district court in St. Paul, Minn., Guidant concealed information from the U.S. Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices. The charges were filed following a four-year investigation into Guidant’s handling of short-circuiting failures of three models of implantable cardioverter defibrillators (ICDs): the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant issued safety advisories regarding the failures in June 2005.

Failure to report adverse events regarding medical devices or pharmaceutical products, as required by law, may be the basis of a False Claims Act case.

For the full release, go to: http://www.justice.gov/opa/pr/2010/February/10-civ-202.html.

For more information about qui tam law and health care fraud, contact us.