Lawyer for Nigeria: Pfizer settlement close

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Posted on 26th February 2009 by Gordon Johnson in Uncategorized

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Date: 2/26/2009

By EDWARD HARRIS
Associated Press Writer

LAGOS, Nigeria (AP) — A lawyer representing Nigeria in multi-billion dollar lawsuits against Pfizer said Thursday that a settlement is close in the cases stemming from the pharmaceutical giant’s 1996 drug trial.

Nigerian authorities allege that Pfizer conducted illegal meningitis-drug experiments, resulting in deaths, brain damage, paralysis and slurred speech in many of the children involved in the 1996 study. Pfizer denies the charge and says its scientists acted lawfully and in keeping with professional standards.

Babatunde Irukera, the lawyer representing Nigeria, told The Associated Press that he was not at liberty to disclose the terms of any settlement. He said a deal could be announced within hours, although it would likely take several more days since Pfizer had yet to give the government any formal notification of a decision.

“It looks like we’re on the verge of an agreement. I have reason to believe that we’re very close,” said the lawyer, who is representing the Nigerian federal government.

Pfizer spokesman Chris Loder said the settlement process was continuing and that the company was willing to stay at the negotiating table until an agreement was reached.

“We continue to be interested in an amicable settlement that would help improve and expand health care for the people of Nigeria,” he told the AP in an e-mailed statement.

A case launched by Nigeria’s federal government is seeking $7 billion in damages, while a separate case stemming from the same study, brought by Kano state where the study took place, seeks $2 billion. Pfizer officials from the time of the study have also been subjected to criminal charges in Nigeria.

Irukera said any settlement would cover all parties to cases against Pfizer in Nigeria, and that negotiations were being led by former Nigerian military ruler Yakubu Gowon.

Last month, a New York-based court ruled that Nigerian families can sue Pfizer in U.S. courts, overturning rulings by a lower court judge who had tossed out the lawsuits in litigation that began in 2001. It was unclear if any settlement reached in Nigeria would include that legal challenge.

Pfizer treated 100 meningitis-infected children with an experimental antibiotic called Trovan. Another 100 children, who were control patients in the study, received an approved antibiotic, ceftriaxone — but the dose was lower than recommended, the family attorneys allege.

As many as 11 children in the study died, while others suffered physical disabilities and brain damage. Pfizer has insisted its records show that none of the deaths was linked to Trovan or substandard treatment, noting that the study showed a better survival rate for the patients on Trovan than those on the standard drug, and that mental damage and other serious disabilities are known aftereffects of meningitis.

Authorities in Kano state have blamed the Pfizer affair for widespread suspicion of government public health policies and for helping fuel a drive by local Islamic leaders who briefly halted polio vaccination efforts in northern Nigeria.

Copyright 2009 The Associated Press.

Pfizer completes part of painkiller settlement

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Posted on 23rd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/22/2008

NEW YORK (AP) _ Pfizer Inc. said Wednesday it finalized part of a larger, $894 million deal to settle lawsuits over its promotion of the painkillers Celebrex and discontinued Bextra.

The company made official a deal that would pay $60 million to settle investigations by 33 states and Washington, D.C., over Bextra, while also agreeing to adopt compliance measures. Various states alleged Pfizer promoted the painkiller for “off-label” uses, or uses it was not approved for. While a physician is allowed to prescribe drugs for off-label uses, a company cannot market them for unapproved uses.

States also alleged the company misrepresented the safety of the drug.

As part of the settlement, Pfizer denied that its promotional practices violated any laws.

Among other strictures, the settlement requires Pfizer to submit all consumer television advertisements to the FDA for approval, the New Jersey attorney general’s office said. Pfizer said such practice was already company policy.

Last week, the company said it would pay $745 million to settle personal injury cases, $60 million to cover settlements with attorneys general in the 33 states and Washington, D.C., and $89 million to cover consumer fraud class action cases over reimbursement for money spent on the two drugs.

In all, the company said the settlements would cover more than 90 percent of the pending legal actions.

“As we announced last week, these settlements avoid the disruption and expense of litigation and put these matters behind us,” Amy W. Schulman, senior vice president and general counsel of Pfizer, said in a statement.

Celebrex and Bextra came under scrutiny following lawsuits over a similar drug made by Merck & Co., called Vioxx. Merck has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming the drug caused heart attacks, ischemic strokes or death.

Bextra, like Vioxx, was a Cox-2 inhibitor.

“This medicine (Bextra) was rigorously studied and tested by the company and independent medical experts, and information about its benefits and risks was fully disclosed to the FDA,” Schulman said.

Celebrex is currently the only Cox-2 inhibitor on the market.

Pfizer has also agreed to other compliance measures regarding its promotional programs. The New Jersey Attorney General’s office, in a statement, said the settlement places strictures on such practices as companies “ghost writing” drug-related articles and studies, deceptively using scientific data when marketing to doctors, and awarding incentives to sales staff to increase off-label prescribing by doctors.

“This case should send a strong message to the industry at large that New Jersey does not tolerate deception and misleading claims in the promotion of prescription drugs,” Attorney General Anne Milgram said in a statement.

Copyright 2008 The Associated Press.

$894 million deal ends pain of Pfizer's lawsuits

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Posted on 17th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/17/2008 9:47 AM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Drug giant Pfizer Inc. has reached an $894 million deal to end most of the lawsuits over its two prescription pain relievers, the popular Celebrex and a similar drug, Bextra, no longer on the market.

The world’s biggest drugmaker said Friday it has agreements in principle to end more than 90 percent of personal injury lawsuits brought by people claiming the pills caused heart attacks, strokes or other harm.

The settlement includes roughly 7,000 personal injury cases, mainly plaintiffs who took since-withdrawn Bextra, said plaintiff attorney Perry Weitz. He represents nearly 2,000 claimants, about 10 percent of them relatives of people who died.

“It gives Pfizer closure and the claimants their money sooner, rather than later or never at all,” Weitz said.

Pfizer hopes to finalize claims covered by the settlement, which now includes up to 92 percent of plaintiffs, by year’s end. It also hopes to include many of the remaining claimants in the settlement and will fight any remaining personal injury suits with court motions or at trial, General Counsel Amy Schulman told The Associated Press.

“I don’t think either side has an interest in protracting this,” Schulman said in an interview.

Weitz said plaintiff lawyers will “have issues” with Pfizer “if their claimants aren’t paid before the end of the year.”

In early trading, Pfizer shares were down 47 cents, or 2.8 percent, at $16.50.

Schulman said the deal comes after two important court rulings — one by a New York state judge overseeing many of the state-level personal injury cases and the other by a federal judge in San Francisco coordinating pretrial steps in federal lawsuits over the drugs.

“We teed up some pretrial motions for a court ruling on whether there was significantly reliable evidence that would allow an expert to testify as to whether there was an increased risk of heart attack and stroke at the most common dose,” 200 milligrams, Schulman said. Both judges ruled that was not the case, she said.

The proposed deal also would end suits by insurers and patients seeking to recover what they spent on Bextra and Celebrex, as well as claims by 33 states and the District of Columbia that Pfizer improperly promoted Bextra.

Out of the total settlement, $745 million will go to settle personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs. Two additional states, Louisiana and Mississippi, still have pending cases regarding Pfizer’s promotion of the drugs.

New York-based Pfizer withdrew Bextra from the market in 2005, a year after Merck & Co. withdrew its Vioxx, a similar drug.

The Vioxx withdrawal, which triggered an avalanche of lawsuits against Merck, also raised concerns about the safety of other medicines in the same class, called Cox-2 inhibitors. They were heavily touted by their makers as superior to traditional nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen, because they block an enzyme involved in promoting inflammation but — unlike NSAIDs — don’t block an enzyme that protects the stomach from bleeding and other side effects.

Other NSAIDs, such as ibuprofen and naproxen, have also been linked to increased heart risks.

Celebrex is the only Cox-2 inhibitor that the Food and Drug Administration has allowed to remain on the U.S. market.

Attorney Christopher Seeger, a member of the plaintiffs steering committee, said he’ll “have no problem recommending” the settlement to the roughly 400 clients he represents.

“We’re very satisfied with the deal,” Seeger said.

Schulman said the company’s negotiations with opposing lawyers had been under way for some time but picked up in the late summer.

“Litigation can be distracting, and putting these matters behind us helps our shareholders and, most importantly, patients and doctors,” Schulman said.

Weitz noted that it took four or five years to get through trials for less than 20 cases in the massive Vioxx litigation, because the court system can only handle a limited number of cases at a time.

Pfizer will take a pretax charge of $894 million to its third-quarter earnings, which it is scheduled to report on Tuesday.

Merck, based in Whitehouse Station, N.J., has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming Vioxx cause heart attacks, ischemic strokes or death. It still faces other litigation over the former blockbuster arthritis treatment.

Copyright 2008 The Associated Press.