Shareholder Class Action Lawsuit Against Pfizer Inc.
December 16, 2004 07:36

Finkelstein, Thompson & Loughran has filed a securities fraud class action lawsuit in the United States District Court for the Southern District of New York, on behalf of investors who purchased or otherwise acquired the publicly-traded common stock of Pfizer, Inc. ("Pfizer" or the "Company") between November 1, 2000 and November 10, 2004, inclusive (the "Class Period").

The complaint alleges that, throughout the Class Period, defendants misrepresented and omitted material facts concerning the safety and marketability of Pfizer's Celebrex and Bextra products. Specifically, Plaintiff alleges that at all times during the Class Period, Defendants were aware of strong indicators that Celebrex and Bextra, drugs known as "Cox-2 Inhibitors," posed serious undisclosed health risks to consumers, that these undisclosed health risks would limit their marketability, and that the potential financial liability Pfizer faced from the harms these drugs caused posed a serious threat to the Company's finances. Nevertheless, Defendants concealed these facts from the investing public.

http://www.biospace.com/news_story.cfm?StoryID=18479120&full=1

NEW YORK, Dec. 17 /PRNewswire/ -- Wolf Haldenstein Adler Freeman & Herz LLP filed a class action lawsuit today in the United States District Court for the Southern District of New York, on behalf of all persons who purchased the common stock of Pfizer, Inc. ("Pfizer" or the "Company") [NYSE: PFE] between November 1, 2000 and December 16, 2004, inclusive, (the "Class Period") against defendants Pfizer and certain officers and directors of the Company. ADVERTISEMENT

The case name is Morabito v. Pfizer, Inc., et al. The complaint alleges that defendants violated the federal securities laws by issuing materially false and misleading statements throughout the Class Period that had the effect of artificially inflating the market price of the Company's securities. A copy of the complaint filed in this action is available from the Court, or can be viewed on the Wolf Haldenstein Adler Freeman & Herz LLP website at http://www.whafh.com .

The complaint arises out of defendants' false and misleading statements and omissions concerning the safety and marketability of Pfizer's Celebrex and Bextra products. At all times during the Class Period, defendants were aware that Celebrex and Bextra, drugs known as "Cox-2 inhibitors," posed serious undisclosed health risks to consumers. Defendants knew or recklessly disregarded that the undisclosed health risks posed by these drugs would limit their marketability, and that potential financial liability Pfizer faced from the harms these drugs caused posed a serious threat to the Company's financial condition. Nonetheless, defendants concealed these facts from the investing public, thereby damaging Plaintiff and the Class.

Toward the close of the Class Period, a series of factual revelations from several sources caused the market to gradually perceive the truth about Pfizer's Bextra and Celebrex products. On December 17, 2004, Pfizer issued a press release announcing the Company has discovered an increased risk of heart problems with patients taking its painkiller Celebrex. The press release came after a study revealed that the use of Celebrex in patients taking 400mg to 800mg of the drug daily were found to have a risk of 2.5 times greater of experiencing major heart problems than those who were not. This level of risk was even greater than the one found in patients taking Vioxx that led Merck to withdraw Vioxx from the marketplace.

If you purchased Pfizer common stock during the Class Period, you may request that the Court appoint you as lead plaintiff by February 14, 2005. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as "lead plaintiff." Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain Wolf Haldenstein, or other counsel of your choice, to serve as your counsel in this action.

Pfizer examining data that show higher risk of heart attack

With a new study that indicates the nation's leading arthritis painkiller could raise the risk of heart attacks, the Food and Drug Administration advised doctors Friday to consider "alternative therapy" to Celebrex.

Earlier Friday, drug giant Pfizer Inc. said it had no plans to pull the painkiller off the market despite the data that showed patients using the drug in a long-term cancer study had increased cardiovascular risks.

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

New data came to light Friday morning, showing that long-term use of Pfizer Inc.'s (PFE) painkiller Celebrex at high doses led to a much greater risk of a heart attack and stroke than a placebo did, according to the Food and Drug Administration.

This is the first time that Celebrex has shown to be that harmful, but the future of this whole class of drugs - Cox-2 inhibitors - is in question more than it has ever been.

Pfizer Chairman and Chief Executive Henry McKinnell told CNBC Friday he doesn't believe that the class of Cox-2 drugs is "doomed" with the new Celebrex data. McKinnell said the risks of the drugs must be compared to the rewards they provide. http://money.iwon.com/jsp/nw/nwdt_rt.jsp?cat=USMARKET&src=704&feed=dji§ion=news&news_id=dji-00113920041217&date=20041217&alias=/alias/money/cm/nw

Another blockbuster painkiller, Celebrex, has been found to raise the risk of heart attacks when taken in high doses, the drug's maker said yesterday.

But Pfizer Inc., which produces the nation's best-selling pain medication, said it did not plan to take the drug off the market because it has not been shown to increase the risk of heart attacks at lower doses.

The announcement came just two months after similar concerns forced Merck to pull its competing drug Vioxx off the shelves. Both drugs belong to a newer class of potent painkillers called cox-2 inhibitors - touted for causing fewer stomach problems than older anti-inflammatory drugs, such as aspirin or ibuprofen. http://www.nydailynews.com/front/story/263241p-225300c.html

News that the arthritis drug Celebrex may raise the risk of heart attacks sent the class of painkillers known as Cox-2 inhibitors from blockbuster to bust.

Federal health officials announced they were halting a colon-cancer-prevention study using Celebrex, reviewing the safety of scores of other trials involving Cox-2 inhibitors, and considering whether to add more warnings or even recall the drugs.

"We do not have a decision yet on the fate of the product," said Lester Crawford, acting commissioner of the Food and Drug Administration. "We do have a great deal of concern about this product and this class of products. We're telling consumers to check with their doctors, and telling doctors to consider alternative forms of therapy."Just from a practical perspective, it will be difficult to use Celebrex in trials because of the confusion and concern," said Charles Geyer, medical affairs director of the group, the National Surgical Adjuvant Breast and Bowel Project."

"Many of us thought the other shoe would drop," said Charles Burrows, a Doylestown orthopedic surgeon. "I do tell patients with a history of heart disease to get off" Celebrex.

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: FDA

"We?re leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," Acting FDA Commissioner Lester Crawford said Friday. "We do have great concern about this product (Celebrex) and the class of products."

"As a physician, you have to ask: Is the increased risk due to something common about all the drugs in that class or is it unique to that one medication? My personal opinion is that it is probably a class effect and that the whole class is probably suspect. And I don?t think this medication has that much more to offer than other traditional pain medications that are cheaper and probably safer," New Hampshire, state medical director, Dr. William Kassler, said.

"It?s on TV. It?s pushed by the pharmaceutical industry for everybody and clearly that is no longer the case. The FDA has tough decisions to make. Either take it off the market or determine it can be used appropriately for a small segment of the population for which it is clearly indicated," Kassler said.

"Both doctor and patient ought to be looking very carefully at this drug and weighing what we know are the potential risks against any potential benefits. . . . We?re going to have to pay attention to the science. We?re going to be hearing more about this in clinical and medical circles. This is just the beginning for this issue and it?s far from resolved," Kassler said.

"I think the trial concludes the controversy about whether there is a class effect of these drugs. Now there is clear evidence of it," said Dr. Garret A. FitzGerald, a cardiologist at the University of Pennsylvania. "You would need to believe the earth is flat if you thought this was just a coincidence."

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

One long-term cancer study found high doses (400mg - 800mg) of Celebrex over time more than doubled the risk of heart attack, but a second study found no increased risk at all. Celebrex was approved in 1998 by the Food and Drug Administration for doses of 100mg or 200mg. http://www.wistv.com/Global/story.asp?S=2707547

With yet more already-marketed medicines raising the ire of consumer advocates and regulators alike, momentum is building for reform of the government's drug approval and monitoring procedures.

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: Celebrex Recall

Crawford said the FDA would have more announcements about Celebrex in the next few days.

The NIH said it was reviewing all government grants for studying Celebrex and other COX-2 inhibitors.

If doctors do consider Celebrex appropriate for certain patients, they should prescribe the lowest possible dose, FDA officials said.

The drug industry has already been under fire for numerous high profile debacles: Merck & Co.'s withdrawal of Vioxx, the failure of Chiron Corp. to deliver half the country's flu vaccines, and disclosures that drug companies had stifled negative clinical trial data from studies examining anti-depressant use in children.

The National Cancer Institute, which was conducting the study for Pfizer, said patients in the clinical trial taking 800 milligrams of Celebrex had a 3.4 times greater risk of cardiovascular events compared to a placebo. For patients in the trial taking 400 milligrams of Celebrex the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.

In the 2,000 patient study, 15 individuals taking 400 mgs, 20 patients taking 800 mgs and 6 patients on placebo suffered either a cardiac-related death, heart attack or stroke.

Dr. Garret A. FitzGerald, who has been critical of cox-2 inhibitors said he believed the news has implications for cox-2 inhibitors such as those under development at Merck and Novartis. "I think the trial concludes the controversy about whether there is a class effect of these drugs. Now there is clear evidence of it," said FitzGerald. "You would need to believe the earth is flat if you thought this was just a coincidence."

http://www.reuters.co.uk/newsArticle.jhtml?type=businessNews&storyID=640773§ion=finance&src=rss/uk/businessNews

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

Continued risk for Celebrex users

Pfizer Inc. has halted new research on its popular pain drug Celebrex after finding an apparent increased risk of heart attacks in cancer patients.

The company announcement, made Friday morning, said a second, separate cancer trial found no increased risk of heart problems tied to the drug. But Pfizer urged that all patients "being treated with Celebrex should discuss appropriate treatment options with their health-care professionals." >

"In placing this new information in context, it is important to understand that the APC trial results differ from both the PreSAP cardiovascular results as well as the large body of data that we and others have accumulated over time, in which an increased risk of serious cardiovascular events in arthritis patients, even at higher-than-recommended doses, had not been seen," said Dr. Joseph Feczko, president of worldwide development for Pfizer.

Dr. James O'Dell, chief of rheumatology and immunology at the University of Nebraska Medical Center, said the Celebrex concerns stem from experimental uses of the drug at doses two to four times the 200 mg or less daily dose recommended for most patients.

"We have a vast amount of data on Celebrex that's been accumulated from double-blind clinical studies and very large observational studies that have looked very closely at the heart," said O'Dell, a nationally recognized rheumatoid arthritis expert.

The company said it has no plans to remove Celebrex from the market, but the disclosure on Friday sent Pfizer's shares tumbling because of fears that it could cripple sales of what had been the most-prescribed drug for treating arthritis.

In the 2,000 patient study, 15 individuals taking 400 mgs, 20 patients taking 800 mgs and 6 patients on placebo suffered either a cardiac-related death, heart attack or stroke.

"The challenge for Pfizer now is to show why this drug should be chosen," said FitzGerald, a cardiologist at the University of Pennsylvania.

"You can't say as a result of this study that doses under 400 milligrams are absolutely safe," said Dr. Eric Matteson, a professor of medicine in the division of rheumatology at the Mayo Clinic in Rochester, Minn.

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: ________

Celebrex is used by 26 million people, according to Pfizer, and is the latest COX-2 type pain drug to face controversy. Vioxx, made by the rival Merck and Co., was withdrawn in September because of the increased risk of heart attacks.

Three US doctors on Friday appealed for physicians to stop prescribing Bextra, another COX-2 painkiller, also made by Pfizer.

News of the Celebrex study sent Pfizer shares slumping but the US firm's chairman Hank McKinnell said the drug would not be withdrawn.

"Any decision to withdraw a drug has to be made in the context of all of the information," McKinnell told CNBC television.

"Until the study results became known to us late last night we saw a very acceptable safety profile for Celebrex."

"I don't think this one study, even though it is a large, well-controlled study, characterizes the drug in any significant way," McKinnell said.

A study into the use of Celebrex to prevent benign tumours, or adenomas, showed patients taking 400mg and 800mg of Celebrex daily had an approximately 2.5-fold increased risk of major cardiovascular problem compared to patients on a placebo, according to the National Cancer Institute (news - web sites).

Based on the "statistically significant" findings, the institute, which sponsored the trial, suspended the dosing of Celebrex. The news was given to Pfizer late Thursday.

A separate study into whether Celebrex can prevent polyps showed no increased risk to the heart.

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

"We're leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," said Crawford, during a press briefing. "We do have great concern about this product (Celebrex) and the class of products."

"Let's hope that Pfizer isn't falling into the same mind-set that Merck demonstrated when it stonewalled for years over the safety of its popular arthritis drug, Vioxx, only to yank it from the market when a convincing study found it raised the risk of cardiovascular problems. Yesterday Pfizer announced the results of a government-sponsored clinical trial, which showed that its own best-selling arthritis drug, Celebrex, more than doubled or tripled the risk of heart attacks, strokes and cardiovascular deaths, depending on the dosage" says a NY Times editorial.

It is all about profits. The editorial goes on to say, "Pfizer said it would not pull Celebrex off the shelves, a stance that is not surprising given the profits generated by the drug, and the widespread belief in the industry that Merck only compounded its legal and financial problems by withdrawing Vioxx. But if Vioxx was risky enough for Merck to remove from the market, one wonders why Celebrex should not be yanked as well."

Let me know what you think.

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC