Pfizer agrees to pay $2.3 billion to settle qui tam and criminal charges

Pfizer Inc has agreed to pay a record settlement of $2.3 billion to resolve a qui tam case and to settle federal and criminal probes. According to the DOJ and several published reports, this involves the alleged Medicare/Medicaid fraud, and the illegal use off-label marketing of multiple drugs.

The fines in this case are $1.3 billion, which are the largest settlement ever paid for a health care fraud claim and a criminal case. In addition to Pfizer, Pharmacia & Upjohn Co, a Pfizer subsidiary was also involved with misbranding a pharmaceutical.

The settlement involves the marketing drugs not included in the label approved by the FDA. Two drugs included in this probe are antibiotic Zyvox and antipsychotic Geodon.

Pfizer has agreed to pay $400 million to settle whistleblower claims involving Zyvox and Geodon drugs. They will pay an additional $33 million for improper marketing with 42 states and the District of Columbia.

The whistleblowers involved in this case will receive over $100 million for their roles in bringing this fraud to light.
 

Federal Government Joins 16 States in Wyeth Whistleblower Lawsuit

New Jersey-based Wyeth, one of the nation's largest drug manufacturing companies recently had two qui tam lawsuits filed against them in federal court in Massachusetts. Pharma giant,  Wyeth - poised to be bought out by large pharmaceutical company Pfizer, Inc. later this year - is being accused of overcharging state Medicaid programs by failing to offer them the best price possible for the stomach acid drug Protonix. Sixteen states - as well as the Justice Department - have joined in on the lawsuits, which could result in millions of dollars in repayments to Medicaid, as well as settlements for the two whistleblowers.

The lawsuits allege that between the years 2000 and 2006, Wyeth offered very high discounts to hospitals around the country for Protonix, which is available in oral and injected forms. While these hospitals were able to take advantage of the deal for the brand name drug, the same deal was not offered to state Medicaid programs. Federal law mandates that the manufacturers of brand name prescription drugs must offer the same deal - or the "best price" - of the drugs they make to Medicaid programs and private hospitals alike.

According to to the DOJ, Tony West, Assistant Attorney General for the Justice Department's Civil Division stated,

“Our complaint charges that Wyeth created the Protonix bundle so they could increase their market share at the expense of the Medicaid program -- a program to provide the least advantaged Americans with necessary medical care and services. “By offering massive discounts to hospitals, but then hiding that information from the Medicaid program, we believe Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have.”

By failing to offer Medicaid programs the best price for Protonix, it is alleged that Wyeth avoided paying hundreds of millions of dollars in rebates. The presence of two whistleblowers in the two lawsuits suggests that people with insider knowledge into the goings-on at Wyeth have evidence that will be presented in court during these suits. As with other past whistleblower cases, these individuals have likely already disclosed a great deal of damaging information to the government regarding Wyeth's alleged practices.

Additionally, the lawsuits against Wyeth allege that the drug manufacturer bundled oral and intravenous versions of Protonix together in the hopes of making additional profits through outpatient sales. When combined with the rebate allegations being leveraged against the pharmaceutical company, these additional accusations of underhanded marketing tactics make this a case that is sure to be followed with great interest by watchdog groups around the country.

As expected, representatives for Wyeth have defended their methods. Spokesperson Doug Petkus issued a statement saying that Wyeth stands behind its pricing. However, if Wyeth is found guilty of defrauding Medicaid - a state program that aids poor citizens in their medical coverage - it could face steep fines as well as be held responsible for restitution. On top of that, Wyeth would likely have to pay damages to the two whistleblowers involved in the suits.

In addition to the Justice Department, 16 states have joined in the two lawsuits filed in Massachusetts. The states are: Florida, Delaware, California, Indiana, Illinois, New York, Massachusetts, Louisiana, Michigan, New Hampshire, Nevada, Tennessee, Virginia, Wisconsin, Texas and Washington, DC.
 

Pfizer settles kickback allegations for $34.7 million

Two subsidiaries of Pfizer Inc. have agreed to pay fines totaling $34.7 million for offering a kickback to recommend company drugs and for illegally promoting the human growth hormone product Genotropin for nonapproved uses, according to federal prosecutors in a Boston Globe article.

Prosecutors allege that Pharmacia & Upjohn Co. offered to overpay a subsidiary of a pharmacy benefit manager by $12.3 million in the hope the company would, in turn, recommend Pharmacia's drug products to its clients.

In a Press Release by the U.S. Attorney's Office in Massachusetts, U.S. Attorney Michael Sullivan, states that “It is important for the public to recognize that growth hormone has not been shown to be safe and effective for anti-aging, cosmetic or athletic uses, and it must not be promoted for such uses. Sullivan noted that Pfizer,  acted responsibly when it self-disclosed to various federal government agencies, in May 2003, PHARMACIA’s unlawful promotion of human growth hormone.

Whistleblower, Peter Rost, former Vice President at Pfizer had a different spin on the events. He told the Corporate Crime Reporter  "The Justice Department praised Pfizer for self-reporting; but Pfizer would have done nothing if I didn’t twist its arm. I was floored when I read the press release. They have one guy who lost his career, lost his job for doing the right thing. That would be me. And they praised the company that fired me?”