$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The settlement includes roughly 7,000 personal injury cases, mainly plaintiffs who took since-withdrawn Bextra, said plaintiff attorney Perry Weitz.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.


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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Florida sues Merck to recover money spent on Vioxx

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Posted on 2nd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/1/2008 4:46 PM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Florida has joined eight other states in suing drugmaker Merck & Co. over what the state alleges was deceptive marketing of its former prescription painkiller Vioxx.

In a lawsuit brought by Florida Attorney General Bill McCollum, the state is seeking restitution for all money spent by state health programs on Vioxx, plus interest.

Florida’s Medicaid program alone spent more than $80 million on Vioxx, once a blockbuster arthritis treatment, between 1999 and 2004. Merck pulled Vioxx from the market four years ago after its own research showed the pill doubled risk of heart attack and stroke.

The lawsuit alleges that “Merck’s costly promotional campaign was intended to convince purchasers that the drug was not only safe, but that they should demand it from their healthcare professionals for pain treatment,” according to a statement from the attorney general.

The suit also seeks civil penalties of up to $10,000 for each time that Merck’s advertising caused a Vioxx purchase to be made, an amount that a court would have to determine, according to a spokeswoman for McCollum.

“The company also allegedly tried to intimidate physicians and researchers who questioned the safety of Vioxx,” the statement adds.

Merck spokesman Ron Rogers said Tuesday that Merck acted responsibly.

The Whitehouse Station, N.J.-based company said in a statement that Vioxx was an effective pain reliever and that the company carefully studied the drug and consistently made results of its studies available to U.S. regulators and the medical community.

“We intend to defend ourselves against the complaint,” Rogers said.

Alaska, Louisiana, Michigan, Mississippi, Montana, New York, Texas and Utah have previously brought similar suits, as has New York City.

Except for the Texas case, all those suits currently are pending in New Orleans under U.S. District Judge Eldon Fallon, who is overseeing the bulk of the massive Vioxx litigation, according to Rogers.

The litigation includes a $4.85 billion settlement that will end about 50,000 lawsuits by people alleging Vioxx caused heart attacks or strokes. Several thousand other lawsuits filed by people claiming other types of injuries from Vioxx also are pending, and Merck faces two personal injury class-action suits in Canada and a class action suit by shareholders seeking to recover losses on Merck stock.

Merck has already paid out $58 million under a settlement reached in May to end allegations its ads for Vioxx deceptively downplayed health risks. That settlement ended investigations by 29 states and the District of Columbia and also required Merck to submit all new TV commercials for its drugs to the Food and Drug Administration for review.

Merck shares rose 53 cents, or 1.7 percent, at $32.09.

Copyright 2008 The Associated Press.


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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Cephalon to pay $425M for improper drug marketing

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Posted on 30th September 2008 by Gordon Johnson in Uncategorized

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Date: 9/29/2008 6:28 PM

By MARYCLAIRE DALE
Associated Press Writer

PHILADELPHIA (AP) _ Drug maker Cephalon Inc., completing a previously announced settlement, will pay $425 million for illegally marketing a highly addictive lollipop painkiller and two other drugs for non-approved uses.

Federal prosecutors also announced Monday that Cephalon, as planned, will plead to a criminal misdemeanor for its off-label marketing.

“This company … put patients at risk for nothing more than the bottom line,” Acting U.S. Attorney Laurie Magid said at a news conference.

Doctors can prescribe drugs for uses other than what has been approved by the U.S. Food and Drug Administration, but pharmaceutical companies cannot promote such “off-label” use in their marketing.

One of Cephalon’s drugs, Actiq, was marketed to doctors for maladies including migraines and injuries when the fentanyl lollipop is a highly addictive narcotic approved only for cancer patients with severe pain, authorities said.

Cephalon encouraged off-label marketing at lavish physician-education conferences and through its compensation and bonus structure, authorities said. The company also had its sales force call on doctors who would not normally prescribe the three drugs, they said.

The off-label use proved harmful and even fatal at times, Magid said. However, the settlement does not encompass any individual cases.

Cephalon disclosed the tentative settlement last November. The Frazer-based company has signed an agreement to plead guilty to one misdemeanor count of distribution of misbranded drugs.

Cephalon also marketed Gabitril, an anti-epilepsy drug, for anxiety, insomnia and pain, authorities said. Provigil, which is approved for narcolepsy, was marketed for fatigue, among other things, they said.

The $425 million settlement includes a $375 million civil settlement, a $40 million criminal fine and $10 million in criminal forfeiture, prosecutors said.

Whistleblowers — former Cephalon sales representatives disturbed by the company’s practices — will share $46.5 million from the settlement.

Much of the money recovered will be shared by state and federal Medicaid programs that paid the tab for many of the prescriptions. Sales of Actiq soared from $50 million to $500 million from 2001 to 2006, authorities said.

Prosecutors considered charging the company with a felony, but agreed to a misdemeanor in part to preserve the company’s ability to sell the drugs to patients who need them, Magid said.

“We are pleased to have these long-standing matters behind us, while preserving our ability to participate in all federal and state health care programs, thereby maintaining the access of patients in those programs to our medications,” Jerry Pappert, Cephalon’s executive vice president and general counsel, said in a statement Monday.

Cephalon will also pay an estimated $12 million in interest.

Copyright 2008 The Associated Press.


Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney