PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.: "Pfizer - Genotropin: only one more hurdle for Rost to clear"
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PETER ROST: PHARMA MARKETING EXPERT WITNESS. AWP, MEDICAL DEVICE EXPERT.

Peter Rost, M.D., is a former Pfizer Marketing Vice President providing services as a medical device and drug expert witness and pharmaceutical marketing expert. Judge Sanders: "The court agrees with defendants' view that Dr. Rost is a very adept and seasoned expert witness." He is also the author of Emergency Surgery, The Whistleblower and Killer Drug. You can reach him on rostpeter (insert symbol) hotmail.com. Please read the terms of use agreement and privacy policy for this blog carefully.

"Pfizer - Genotropin: only one more hurdle for Rost to clear"

I figured I'd use PharmaGossip's headline so this didn't look self serving . . .

This is how PharmaGossip continued:

From Brandweek:

A Massachusetts U.S. District Court judge has dismissed former Pfizer marketing vp Peter Rost’s whistle-blowing case against his former employers, Pharmacia and Pfizer.

Rost had alleged that Genotropin, a human-growth-hormone brand, was sold illegally by Pharmacia to anti-aging quacks who falsely promised wealthy clients the fountain of youth. New York’s Pfizer acquired Pharmacia in April 2003 despite Rost’s warnings about the “off-label”—meaning legally unapproved—sales, he claims.

In the Aug. 31 ruling, Judge Joseph Tauro wrote that for his suit to succeed, Rost needed to show he had evidence that Pharmacia and Pfizer had orchestrated the submitting of bills to the government for reimbursement for “off-label” Genotropin treatments. For instance, it would be legal to bill Medicaid for a Genotropin prescription for a child suffering from stunted growth (an “on-label” use); but it would be illegal if Medicaid was billed by someone using the drug to jump-start their libido or get smoother skin.

Tauro wrote that Rost had no evidence—such as an actual false bill—of such a scheme. Therefore, Tauro ruled, the case must be dismissed in its entirety.

Pfizer on Thursday hailed the decision.

“Rost’s complaint fails to identify one actual false claim for reimbursement for an off-label use of Genotropin,” said Paul Fitzhenry, a Pfizer representative. “The court’s decision brings to a close the suit he filed and its allegations.”

Rost, as usual, was upbeat last week.

He noted that the suit had been dismissed only because he had failed to meet one technical test—evidence of a specific bill. On three other issues, the judge had agreed with Rost. (Those issues were: that Rost, not Pfizer, was the first to disclose the off-label sales; that Rost’s claims were based upon his own knowledge of Genotropin sales and not Pfizer’s disclosures to the government; and that Rost, not Pfizer, was the original source of the disclosures.)

As such, Rost said Thursday, he intends to amend his complaint to address the evidence deficiency and will appeal. “Pfizer has a database with all these claims in which they have refused to give to us. We can ask them to produce it,” he said.

Looks like the endgame approaches. It ain't over yet!

/End quote from BrandWeek/

As for me and my lawyers we are pleased. We have overcome the most difficult challenges Pfizer threw in our way and the Court has completely rebutted all the lies Pfizer told the press in December 2005. Now we need to present one false claims case . . .

Stay tuned.

5 Comments:

Anonymous Anonymous said...

Sore loser, aren't we. The government fails to back your bid, even though it would have been the biggest benficiary of a successful suit. And, now your case gets tossed out.

9/09/2006  
Blogger Peter Rost said...

Dear Anonymous: Thank you for visiting.

For your info, from Bloomberg News:

The fact the Justice Department won't join the suit doesn't
mean the end of Rost's case, said Patrick Burns, director of
communications for the Taxpayers Against Fraud Education Fund, a
Washington-based non-profit organization that assists
whistleblowers and their attorneys.
``The Department of Justice simply does not have enough
lawyers and investigators to handle the volume of false claims
act suits coming its way,'' Burns said in an interview. ``There
are right now 150 cases under seal and under investigation,
covering more than 500 drugs.''

Dear Anonymous, a case doesn't end until the legal process is completed. We are confident that we will prevail upon appeal. I don't think that makes me a "sore loser," I think that will make me a winner.

Let me give you guys some more details.

As you may remember, Pfizer had filed a motion to dismiss my complaint and had made four arguments, three of which the Court eloquently rebuked and the fourth is a technicality which will be relatively simple to handle based on additional information.

First, Pfizer claimed that Defendants disclosure to various government officials constituted a "public disclosure," which would require dismissal of my case. They had also claimed that my lawsuit was "parasitic." The Court grinds this argument to pieces, writing, "A plaintiff cannot take advantage of information in the public domain, when no such information exists. In other words a parasite cannot exist without a host. The present case is the paradigm example of this principle.”

Second, Pfizer contended that my lawsuit was “based upon” Pfizer’s disclosures to the government. The Court completely rejects this argument, and states, “Plaintiff’s Complaint derives from his own independent investigation of Defendant’s off-label marketing scheme, and from his personal knowledge of Defendants’ activities. Plaintiff, furthermore, had no knowledge of Defendants’ disclosures to various government officials.”

Third, Pfizer claimed that I was not the “original source” of the information in my complaint. An “original source” is someone who had direct and independent knowledge of fraudulent conduct. And here’s what the Court found to be factual and true: “In this case, Plaintiff is an original source. In his position as vice president of Pharmacia’s Endocrine Care unit, Plaintiff personally uncovered evidence of Pharmacia’s unlawful conduct. In response to his discoveries, Plaintiff diligently monitored the marketing, distribution, and sales of Genotropin, and repeatedly brought the issues to the attention of his superiors both at Pharmacia and Pfizer. Defendant, in fact, began their internal investigations, ultimately producing the voluntary disclosure to the government, only after Plaintiff came forward with the results of his persona investigation.”

Fourth, Pfizer had argued that I had “failed to plead fraud with sufficient particularity.” This means that we had to “identify actual false claims submitted to the government.” Problem here is that Pfizer has the data and we have not been allowed to start discovery. So, based on earlier decisions in the first Circuit, this Court wrote that “Plaintiff, therefore, must satisfy the strict heightened pleading requirements.” The Court then notes that “Plaintiff fails to identify one actual false claim that was submitted to the government for reimbursement of an off-label prescription of Genotropin.” And the Court concludes, “As Plaintiff has failed to plead fraud with sufficient particularity, Plaintiff’s Complaint is dismissed.”

Clearly, the Court has done a great job within the framework of case law within the first Circuit. Because of another recent case the Court had no other option.

As for the final concern, we will simply file an appeal, with additional information, including such a single case of a false claim, as well as case law from other Circuits related to “heightened pleading requirements” in which they have applied much more leniency. We have already overcome three of the four hurdles Pfizer threw in our way. So the case is moving forward.

And that makes me and my lawyers very pleased.

9/09/2006  
Blogger Peter Rost said...

O h m y dear!

I think I know who just made that first comment!

A PR agency down in DC . . .

Can't tell you more.

9/09/2006  
Anonymous Anonymous said...

Pfizer’s Corporate Terrorism: Kindler’s History of Highjacking the Truth

Way back on January 9th, 2002 the Wall Street Journal reported that Jeffrey Kindler, Esq. was behind Pfizer’s failure to respond to a request from the United States General Accounting Office (GAO), despite the voluntary compliance of ten other pharmaceutical companies. We all should have seen a pattern of highjacking the truth emerging back then.

As part of an ongoing investigation reports the WSJ, the General Accounting Office was attempting to investigate the prices that Medicaid pays for prescription drugs. Kindler, then Pfizer’s General Counsel, “says that Pfizer had declined to voluntarily provide sensitive information on drug prices to investigators because it was worried about the confidentiality of its data.” “The GAO is seeking detailed sales transaction data that would allow it to see if pricing information Pfizer sends the federal government is accurate.” Specifically, “the GAO is seeking sales transaction information for specific high-volume drugs.”

(WSJ helpful background: “ To participate in the Medicaid program, drug makers must submit pricing data, telling the government both the "best price" they charge any customer and the "average manufacturer price" for any prescription drug sold to state Medicaid recipients. Under a complicated drug-rebate system, those figures are used to help determine the eventual price paid by Medicaid for prescription drugs.”)

“SUBPOENAS FROM THE GAO ARE UNUSUAL, and have been used infrequently by the investigative agency, according to a person familiar with the investigation. The Medicaid drug-rebate law allows the federal government to request those data. The GAO tried to resolve Pfizer's concerns but the company still refused to voluntarily hand over the information, resulting in the subpoena, the person said.” (WSJ, 09-Jan-2002)

Hiding information from the government and from the paying public seems to be business as usual for Pfizer’s new CEO Jeffrey Kindler. Just ask Dr. Peter Rost. As was well-reported on Dr. Rost’s BLOG, http://peterrost.blogspot.com, one of Pfizer’s multi-million dollar Gulf Stream jets cannot be traced by the public, by members of Congress or by anyone else, beyond a limited number of just five individuals. As has been reported, when a Pfizer shareholder, let’s say, attempts to track this $30 million dollar private jet (owned by Pfizer shareholders after all), a message appears: THIS FLIGHT IS NOT AVAILABLE FOR TRACKING PER REQUEST FROM THE OWNER/OPERATOR (would this secretive ‘operator’ be Jeffrey Kindler, Esq. by any chance???). As an anonymous poster on Dr. Rost’s blog correctly points out, for $720 per person, friends, family and associates can be selectively "UNBLOCKED" and peek into the movements of this shareholder-owned aircraft (just not Pfizer shareholders or the public at large). Guess this time it’s not Medicaid price information being hidden from the government. This time Pfizer’s secretive new CEO has HIGHJACKED a shareholder-owned plane for the exclusive and personal use of himself, his wife and his two children! All in the name of 'security.' Has the public (or the IRS) seen the detailed security protocols required to allow this corporate Winnie the Pooh to stick his hand further into Pfizer's honey pot?

But wait, is there even more Kindler hides from the courts, the public and little old Pfizer shareholders everywhere? Just this past week it was learned that Dr. Rost’s lawsuit against Pfizer (Pharmacia) could not move forward in it's current state, although an appeal is planned. As Brand Week reported in its 20-Mar-2006 article Bad Medicine, Judge Tauro of the Massachusetts U.S. District Court “has dismissed the former Pfizer marketing VP’s whistle-blowing case against his former employers, Pharmacia and Pfizer. Dr. Rost had alleged that Genotropin, a human-growth-hormone brand, was sold illegally by Pharmacia to anti-aging quacks who falsely promised wealthy clients the fountain of youth.” What was required for Dr. Rost’s suit to go forward was “evidence that Pharmacia and Pfizer had orchestrated the submitting of bills to the government for reimbursement for 'off-label' Genotropin treatments.” As was reported by Brand Week, “…it would be illegal if Medicaid was billed by someone using the drug to jump-start their libido or get smoother skin.” “Tauro wrote that Rost had no evidence—such as an actual false bill—of such a scheme. Therefore, Tauro ruled, the case must be dismissed in its entirety.”

“In a nation obsessed with youth, [selling Genotropin to the perpetual-youth crowd in Florida] was a marketer's dream. There was just one problem: it is a federal crime to distribute Genotropin for [this purpose]. Pharmacia’s contract to sell Genotropin for this purpose ‘was one of about a dozen that the Peapack, N.J.-based company signed with businesses and pharmacies which appeared to be promoting fountain-of-youth therapies…’ Those contracts have potentially far-reaching consequences. They could expose Pharmacia's employees and customers to five years in federal prison—the punishment for dealing illegally in growth hormone, according to the statute and the Food and Drug Administration.” ”In October 2005, a rival growth hormone marketer, Serono, pled guilty and paid a $704 million fine for the illegal marketing of a similar drug.” (http://www.brandweek.com/bw/news/spotlight/article_display.jsp?vnu_content_id=1002199768)

Given that perhaps only Pfizer has this ‘smoking gun,’ for now this document becomes yet one more inconvenient piece of truth that Pfizer will keep well-hidden and away from the prying eyes of the government, shareholders and Wall Street. And as we have seen, like actual Medicaid prices and the personal flight activity of a $30 million dollar corporate-owned Gulf Stream jet, over the years Pfizer’s ‘Kindler and Co.’ have become well-versed in hiding facts and high-jacking the truth. Corporate terrorism as legal strategy. After Pfizer’s former CEO Hank McKinnel’ was thrown from Pfizer’s 42nd St. high-rise, securely floating back to Gazillionaire-land Greenwich, CT on an $83 million dollar platinum parachute (paid for by stockholders), Wall Street was hoping for some much-needed transparency from the new CEO.

As the Guardian reported this summer, Maria Bartiromo “has witnessed first hand some of the most extraordinary events in corporate history: the dotcom boom and the subsequent bust. As the tide went out, so frauds were uncovered at the likes of Enron and WorldCom.” Prosecutors in Ebbers trial used a CNBC interview with the CEO denying that his company was in trouble just months before WorldCom filed for the biggest ever bankruptcy. As Maria reported to the Guardian, “‘We said, look is there anything fraudulent going on at this company and he said absolutely not.’ Does it annoy her that she was lied to on air? ‘It wasn't a personal thing. They were doing what they do.’” (http://business.guardian.co.uk/story/0,,1820038,00.html)

Gotta love the Money Honey!

Sorry Wall Street, the only thing transparent about the new Pfizer seems to be that the Harvard-trained Kindler has a not-so-well-hidden history of secrecy and reticence with the truth. What else might we NOT be told until it’s too late for employees and retirees holding ‘blue-chip’ Pfizer stock, preparing for their golden years?

9/10/2006  
Anonymous Anonymous said...

Pfizer’s Corporate Terrorism: Kindler’s History of Highjacking the Truth

(Brand Week references corrected)

Way back on January 9th, 2002 the Wall Street Journal reported that Jeffrey Kindler, Esq. was behind Pfizer’s failure to respond to a request from the United States General Accounting Office (GAO), despite the voluntary compliance of ten other pharmaceutical companies. We all should have seen a pattern of highjacking the truth emerging back then.

As part of an ongoing investigation reports the WSJ, the General Accounting Office was attempting to investigate the prices that Medicaid pays for prescription drugs. Kindler, then Pfizer’s General Counsel, “says that Pfizer had declined to voluntarily provide sensitive information on drug prices to investigators because it was worried about the confidentiality of its data.” “The GAO is seeking detailed sales transaction data that would allow it to see if pricing information Pfizer sends the federal government is accurate.” Specifically, “the GAO is seeking sales transaction information for specific high-volume drugs.”

(WSJ helpful background: “ To participate in the Medicaid program, drug makers must submit pricing data, telling the government both the "best price" they charge any customer and the "average manufacturer price" for any prescription drug sold to state Medicaid recipients. Under a complicated drug-rebate system, those figures are used to help determine the eventual price paid by Medicaid for prescription drugs.”)

“SUBPOENAS FROM THE GAO ARE UNUSUAL, and have been used infrequently by the investigative agency, according to a person familiar with the investigation. The Medicaid drug-rebate law allows the federal government to request those data. The GAO tried to resolve Pfizer's concerns but the company still refused to voluntarily hand over the information, resulting in the subpoena, the person said.” (WSJ, 09-Jan-2002)

Hiding information from the government and from the paying public seems to be business as usual for Pfizer’s new CEO Jeffrey Kindler. Just ask Dr. Peter Rost. As was well-reported on Dr. Rost’s BLOG, http://peterrost.blogspot.com, one of Pfizer’s multi-million dollar Gulf Stream jets cannot be traced by the public, by members of Congress or by anyone else, beyond a limited number of just five individuals. As has been reported, when a Pfizer shareholder, let’s say, attempts to track this $30 million dollar private jet (owned by Pfizer shareholders after all), a message appears: THIS FLIGHT IS NOT AVAILABLE FOR TRACKING PER REQUEST FROM THE OWNER/OPERATOR (would this secretive ‘operator’ be Jeffrey Kindler, Esq. by any chance???). As an anonymous poster on Dr. Rost’s blog correctly points out, for $720 per person, friends, family and associates can be selectively "UNBLOCKED" and peek into the movements of this shareholder-owned aircraft (just not Pfizer shareholders or the public at large). Guess this time it’s not Medicaid price information being hidden from the government. This time Pfizer’s secretive new CEO has HIGHJACKED a shareholder-owned plane for the exclusive and personal use of himself, his wife and his two children! All in the name of 'security.' Has the public (or the IRS) seen the detailed security protocols required to allow this corporate Winnie the Pooh to stick his hand further into Pfizer's honey pot?

But wait, is there even more Kindler hides from the courts, the public and little old Pfizer shareholders everywhere? Just yesterday it was learned that Dr. Rost’s lawsuit against Pfizer (Pharmacia) could not move forward in it's current state, although an appeal is planned. Judge Tauro of the Massachusetts U.S. District Court “has dismissed the former Pfizer marketing VP’s whistle-blowing case against his former employers, Pharmacia and Pfizer. Dr. Rost had alleged that Genotropin, a human-growth-hormone brand, was sold illegally by Pharmacia to anti-aging quacks who falsely promised wealthy clients the fountain of youth.” What was required for Dr. Rost’s suit to go forward was “evidence that Pharmacia and Pfizer had orchestrated the submitting of bills to the government for reimbursement for 'off-label' Genotropin treatments.” As Brand Week reported in its 20-Mar-2006 article Bad Medicine,, “…it would be illegal if Medicaid was billed by someone using the drug to jump-start their libido or get smoother skin.” Brand Week reports this past week that Judge Tauro “wrote that Rost had no evidence—such as an actual false bill—of such a scheme. Therefore, Tauro ruled, the case must be dismissed in its entirety.” (http://www.brandweek.com/bw/news/recent_display.jsp?vnu_content_id=1003118863)

From Brand Week’s Bad Medicine report in March of this year, “In a nation obsessed with youth, [selling Genotropin to the perpetual-youth crowd in Florida] was a marketer's dream. There was just one problem: it is a federal crime to distribute Genotropin for [this purpose]. Pharmacia’s contract to sell Genotropin for this purpose ‘was one of about a dozen that the Peapack, N.J.-based company signed with businesses and pharmacies which appeared to be promoting fountain-of-youth therapies…’ Those contracts have potentially far-reaching consequences. They could expose Pharmacia's employees and customers to five years in federal prison—the punishment for dealing illegally in growth hormone, according to the statute and the Food and Drug Administration.” ”In October 2005, a rival growth hormone marketer, Serono, pled guilty and paid a $704 million fine for the illegal marketing of a similar drug.” (http://www.brandweek.com/bw/news/spotlight/article_display.jsp?vnu_content_id=1002199768)

Given that perhaps only Pfizer has this ‘smoking gun,’ for now this document becomes yet one more inconvenient piece of truth that Pfizer will keep well-hidden and away from the prying eyes of the government, shareholders and Wall Street. And as we have seen, like actual Medicaid prices and the personal flight activity of a $30 million dollar corporate-owned Gulf Stream jet, over the years Pfizer’s ‘Kindler and Co.’ have become well-versed in hiding facts and high-jacking the truth. Corporate terrorism as legal strategy. After Pfizer’s former CEO Hank McKinnel’ was thrown from Pfizer’s 42nd St. high-rise, securely floating back to Gazillionaire-land Greenwich, CT on an $83 million dollar platinum parachute (paid for by stockholders), Wall Street was hoping for some much-needed transparency from the new CEO.

As the Guardian reported this summer, Maria Bartiromo “has witnessed first hand some of the most extraordinary events in corporate history: the dotcom boom and the subsequent bust. As the tide went out, so frauds were uncovered at the likes of Enron and WorldCom.” Prosecutors in Ebbers trial used a CNBC interview with the CEO denying that his company was in trouble just months before WorldCom filed for the biggest ever bankruptcy. As Maria reported to the Guardian, “‘We said, look is there anything fraudulent going on at this company and he said absolutely not.’ Does it annoy her that she was lied to on air? ‘It wasn't a personal thing. They were doing what they do.’” (http://business.guardian.co.uk/story/0,,1820038,00.html)

Gotta love the Money Honey!

Sorry Wall Street, the only thing transparent about the new Pfizer seems to be that the Harvard-trained Kindler has a not-so-well-hidden history of secrecy and reticence with the truth. What else might we NOT be told until it’s too late for employees and retirees holding ‘blue-chip’ Pfizer stock, preparing for their golden years?

9/12/2006  

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