PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: U.S. Gives Opinion On Qui Tam Pfizer Suit
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PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.

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U.S. Gives Opinion On Qui Tam Pfizer Suit

Portfolio Media, New York (May 13, 2008)--The government has weighed in on Pfizer Inc.'s bid to dismiss a whistleblower lawsuit filed by a former executive alleging that the company illegally marketed human growth hormone Genotropin.

Under the False Claims Act, a complaint need not allege that the defendants made a false statement but merely that they caused a third party to make a false statement to get a false claim paid, said the motion filed Monday in the U.S. District Court for the District of Massachusetts.

"A statement urging a physician to prescribe a drug for an unapproved, off-label use could well amount to a half-truth and satisfy the false statement requirement ... where, for example, the drug sales representative fails to mention that the evidence does not support the drug's efficacy for the use he or she is promoting or the FDA has specifically concluded that the drug is not safe or effective for that use," the complaint said.

The government also said Pfizer is seeking too rigid a pleading standard when it contends that the amended complaint fails because it doesn't make specific false claims or do so with sufficient particularity.

However, the motion said that the U.S. was submitting the brief only to put forward its position on how to interpret and apply certain aspects of the Medicaid Act and the FCA. The government was not taking a position on the sufficiency of the complaint.

The suit brought by Dr. Peter Rost was given new life in November when the U.S. Court of Appeals for the First Circuit said that while he didn't meet the proper pleading requirements in his qui tam lawsuit, he should have been given an opportunity to amend his complaint.

The U.S. District Court for the District of Massachusetts had tossed the qui tam case in September 2006 for lack of jurisdiction.

In the False Claims Act suit filed in June 2003, Rost, a former Pfizer marketing vice president, accused Pfizer and its unit Pharmacia Corp. of off-label marketing for Genotropin, which allegedly boosted the company's sales by as much as $50 million in 2002 alone.

Rost claimed many of those sales came at the expense of the government through Medicaid, which generally does not give reimbursements for off-label uses.

Rost based his case on information from Pfizer and Pharmacia's marketing methods, but the district court found that Rost's case was only speculation.

The circuit court agreed with the lower court, saying that Rost's original complaint did not meet the pleading requirements but he should have been given a chance to amend.

Rost did so in January.

Pfizer and Pharmacia promptly moved to dismiss the complaint again, saying the amended complaint largely repeated the allegations that were already held to be deficient.

The government's brief filed Monday was in response to wrangling over the pending dismissal motion. The judge in the case also just allowed the Washington Legal Center to file a motion in support of the defendants' dismissal bid.

Mark I. Labaton, a lawyer with Kreindler & Kreindler LLP and counsel for Rost, said that the government's brief supports their position and shows that the issues raised in the case are important from a public policy standpoint.

A lawyer for Pfizer didn't immediately respond to a request for comment Tuesday.

A hearing on the motion to dismiss is scheduled for Monday.

Rost's suit was unsealed in November 2005 after the U.S. decided not to intervene in the case. Rost, who began working for Pharmacia in 2001, based his claims on several alleged practices by the drug companies.

Rost was fired from Pfizer in December 2005 after his complaint was unsealed. His allegedly wrongful termination became the subject of a separate lawsuit filed the same month in the U.S. District Court for the Southern District of New York.

The suit also resulted in a criminal investigation conducted by the U.S. attorney's office in Massachusetts. In April 2007, the office announced that Pfizer would plead guilty and pay a fine for violating an anti-kickback statute through Genotropin-related payments to doctors.

Pfizer paid $34.7 million to resolve Genotropin-related investigations conducted by the Department of Health and Human Services, the Department of Justice and the FBI.

Genotropin is FDA-approved for the treatment of children with hormone-related growth failure or with Prader-Willi Syndrome, and adults with growth hormone deficiency.

Rost is represented in this matter by Kreindler & Kriendler LLP.

Pfizer is represented in this matter by Covington & Burling LLP.

The district case is USA v. Pfizer Inc. et al., case number 1:03-cv-11084, in the U.S. District Court for the District of Massachusetts.

--Additional reporting by Erin Marie Daly and Ron Zapata

1 Comments:

Anonymous Anonymous said...

Crime and Punishment: Enough for Corporate Wrongdoing?

Corporate crime should not be a new concept to many. However, it has evolved into more troubling ways- not only in regards to its severity, but the methods of deterrence now being implemented against corporations. So it may be becoming progressively worse for U.S. citizens as a result.
Rather than speak of all corporations, what will be discussed is government health care fraud. Fraud basically is deception with the potential to harm others. In the case of pharma companies, this may include improper promotion and marketing, meaning that such tactics are or may be deceptive misconduct that may be illegal. In addition, there are the crimes of kickbacks and lesser crimes of misbranding products. Probably more methods of wrongdoing as well do in fact exist and happen. Yet the point is that drug companies should not engage in such wrongdoing to enrich their faceless existence with profiting off those who are ill in illegal ways.
How is such conduct discovered? Typically by whistleblowers who worked for the described pharma company, and such people are rare for a number of reasons. The whistleblower then seeks legal agents and files what is called a qui tam false claims act with a district attorney’s office (Boston or Philadelphia, if you want prosecutors to take you seriously). After the case is filed, the whistleblower verbally acknowledges the charges and evidence to the chosen prosecutors and others.
Such cases usually take years for unclear reasons, yet in the past two years, the settlements from such cases has approached 2 billion dollars after investigations ended that took years, which is tax dollars returned to the American public with these settlements.
So, what has been happening once a pharma company is busted. Criminal indictment by the district prosecutor? Hardly, yet appropriate. Usually, the prosecutor’s objective is to dismiss the case, but give the impression that such activities will not be tolerated by our government. So Corporate Integrity Agreements are mandated to the pharma company, but not really taken seriously, as some have more than one of these agreements active still. It’s an invisible ankle bracelet. A pharma company can and have committed equal or worse crimes while under such an agreement. This Agreement is issued after the deferred or non prosecution agreement is sentenced to the law-breaking corporation, which basically is a pre-trial diversion. Essentialy, it’s just parole, which is supported by the DOJ and the administration. The criminals admit wrongdoing, but not guilt. And they pay a settlement in the neighborhood of hundreds of millions of dollars. Not that shocking, if you consider the income of big pharma companies. These agreements are relatively new and partially a result of suggestions from what was known as a Thompson memo, which basically was created by a DOJ guy as commandments for prosecuting corporations and variables to consider when doing so, which ultimately offered responses as to why a greater degree of punishment was not enforced.
We are one of three countries in the world with the most prisoners behind bars, yet those that do similar if not greater harm to others get out of jail free. Double standard, I would say. Is this behavior by our legal system towards corporations an effective deterrent? Most think not. It rather seems like tacit approval of their conduct. And health care fraud may be more damaging than other types in other industries, yet lack of regulation allows such crimes to continue.
Citizens should make the laws in our country. Justice would then finally exist.

“Corporations cannot commit treason, nor be outlawed, nor excommunicated, for they have no souls.”
---- Edward Coke

Dan Abshear

5/23/2008  

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