FDA stops firm marketing unapproved cold medicines

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Posted on 10th April 2009 by Gordon Johnson in Uncategorized

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Date: 4/10/2009

WASHINGTON (AP) — Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.

The Food and Drug Administration said Friday that East Windsor, N.J.-based Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.

Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.

Neilgen, which also does business as Unigen Pharmaceuticals, is based in Westminster, Md.

“Consumers in possession of these products should discontinue using them and discuss FDA-approved treatments with their health care professional,” the FDA said in a statement.

Company executives Bharat Patel and Pragna Patel agreed to destroy their inventory of unapproved drugs, under a consent degree handed down in the U.S. District Court of Maryland. The agreement also bars the executives from manufacturing any new drugs without FDA approval and requires them to hire outside consultants to assess their operations before resuming production.

Company leaders did not immediately respond to calls for comment Friday afternoon.

Friday’s action comes the same week the FDA ordered a number of medical device manufacturers to submit data on products that were never approved. The devices, which range from pacemaker generators to dental implants, were released to market before the 1976 law which gave FDA authority to regulate new devices.

Copyright 2009 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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Lilly takes $1.4B charge related to investigation

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Posted on 21st October 2008 by Gordon Johnson in Uncategorized

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Date: 10/21/2008 10:31 AM

By TOM MURPHY
AP Business Writer

INDIANAPOLIS (AP) _ Eli Lilly and Co. will take a big bite out of its third-quarter earnings with a $1.4 billion charge related to a government investigation over marketing practices for the anti-psychotic Zyprexa.

The drug maker said Tuesday it would take a charge that equates to $1.29 per share because it was in advanced discussions with the U.S. Attorney’s Office for the Eastern District of Pennsylvania over U.S. marketing and promotional practices for the drug.

But a Lilly representative also cautioned that the company isn’t admitting it did anything wrong in selling the anti-psychotic, its top revenue producer.

“All we’re doing today is taking a charge to earnings, so there is no admission or settlement or anything beyond that,” spokeswoman Marni Lemons said. “We are in advanced discussions with the government, but we have not concluded those discussions, and they could take more time.”

Patty Hartman, a spokeswoman for the U.S. attorney’s office, declined to comment on Lilly’s announcement.

“We’re aware that Lilly has released the information to the public, and it’s premature for us to comment about any disclosure,” she said.

The U.S. attorney’s office launched its investigation in 2004, and Lilly received a grand jury subpoena for a range of documents late last year. Lemons said the investigation has been a distraction.

“Our primary motivation is to put this issue behind us and get back to focusing on providing medications for patients, caregivers and health care professionals,” she said.

The charge surpasses Lilly’s entire profit for last year’s third quarter, when the drug maker reported net income of $926.3 million, or 85 cents a share. Lilly shares rose 5 percent Monday to close at $34.10, but the stock price fell 50 cents to $33.60 in Tuesday morning trading.

Analysts generally will exclude this charge from their earnings calculations for Lilly, analyst Les Funtleyder of Miller Tabak and Co. said.

“I think Wall Street will understand it’s a one-time event, and maybe a positive at that, because we’ll get past it,” he said.

Zyprexa has been Lilly’s top-selling drug for years and brought in $4.7 billion in revenue last year. But it also has been the subject of reams of litigation.

Lilly has settled more than 31,000 product-liability claims against the drug since 2005, shelling out more than $1.1 billion in the process.

Earlier this month, Lilly announced a separate $62 million settlement with 32 states and Washington, D.C., over marketing practices.

Lilly paid $15 million to settle a lawsuit with the state of Alaska in March. The drug maker still faces litigation with 11 states, generally involving consumer protection issues or Medicaid reimbursement.

But Lemons said some of those cases may be affected by settlement talks with the U.S. attorney’s office.

A group of insurance companies, unions and others are suing Lilly for billions of dollars, saying the drug maker charged too much for Zyprexa and marketed the drug for off-label uses. A federal judge has recommended that Lilly settle that case and last month granted the plaintiffs class-action status.

Aside from that case, Lilly still faces lawsuits from about 1,600 plaintiffs, Lemons said.

Lilly is scheduled to report its third-quarter earnings Thursdsay.

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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$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.

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

Supreme Court will be looking at drug maker liability

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Posted on 4th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/4/2008 10:20 AM
By The Associated Press

The Supreme Court is back in session on Monday. One high-profile case they will be taking up involves drugmaker Wyeth.

—Drug maker liability: Vermont musician Diana Levine won a $6.8 million judgment against drugmaker Wyeth after having part of her right arm amputated in 2000 when an anti-nausea drug was injected improperly. Now Wyeth, backed by the Bush administration, wants the high court to rule that Food and Drug Administration regulation of prescription drugs — in this case, approval of warning labels for drugs — overrides state laws and makes it easier for companies to defend against consumers’ claims.


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