NEW YORK, Jan 14 (Reuters) – Three personal injury lawsuits were filed against Pfizer Inc (PFE.N) on Thursday, claiming its smoking cessation drug Chantix caused attempted suicides and death.

The lawsuits, filed in New York State Supreme Court in Manhattan, claim that at the time the plaintiffs took Chantix, Pfizer did not tell doctors and patients about dangers it allegedly knew were related to the drug, including depression and thoughts of suicide.

Although Pfizer subsequently added warnings to its package insert, the law firm that filed all three lawsuits alleged the drug’s label is still inadequate.

Pfizer introduced Chantix in the United States in 2006, hoping it would become a multibillion-dollar product and revive flagging profits. The drug’s sales have fallen off as concerns about side effects increased.

Chantix sales fell 15 percent to $155 million in the third quarter of 2009.

Attorney Marc Grossman alleged in the lawsuits that the company “intentionally, recklessly, and/or negligently concealed, suppressed, omitted, and/or misrepresented the risks, dangers, defects and disadvantages of Chantix.”

Grossman is with Sanders Viener Grossman LLP in Mineola, New York.

Two lawsuits claim the plaintiffs tried to kill themselves as a result of using Chantix. The third is a wrongful death lawsuit filed on behalf of Indiana resident Annette Pine, claiming she committed suicide after using Chantix.

The lawsuits seek trials by jury, punitive and compensatory damages, medical and legal expenses, and, in Pine’s case, funeral expenses.

Pfizer issued a statement defending the drug, approved in some 86 countries as a smoking cessation aid.

“At all times, Pfizer has clearly communicated important information about the safe use of Chantix, which is available only with a prescription,” Pfizer spokeswoman Sally Beatty said in the statement.

“We intend to vigorously defend this medicine,” she said, adding that Chantix has helped many smokers to quit.

The lawsuits claim that each of the plaintiffs used the drug properly. They also claim that in each case the plaintiffs and their doctors were “not aware and through diligent efforts were not able to discover the risk of serious injury, and/or depressed mood and/or suicide associated with and/or caused by Chantix.” (Reporting by Ransdell Pierson and Bill Berkrot; editing by Carol Bishopric)

By Duff Wilson, NY Times

Published: November 20, 2009

Legal experts predict that thousands of tobacco lawsuits could gain momentum in Florida after a Fort Lauderdale jury ordered Philip Morris USA to pay $300 million to a former smoker who says she needs a lung transplant.

 If it survives an appeal, the verdict late Thursday would be the nation’s largest award of damages to an individual suing a tobacco company and could encourage thousands of plaintiffs who have filed similar cases in Florida, according to Clifford E. Douglas of the University of Michigan Tobacco Research Network.

A state supreme court ruling in Florida a few years ago made it easier to pursue tobacco lawsuits there than in other states. But the tobacco industry, which plans to appeal, appeared unfazed. Tobacco companies have considered product liability suits as little more than a cost of doing business since the seven biggest companies agreed to pay $206 billion in a master settlement agreement with 46 states in 1998.

Florida, despite being one of those states, had a major legal ruling in 2006 that lowered a plaintiff’s burden of proof against a tobacco company.

The Florida Supreme Court rejected a class-action verdict and a $145 billion award to plaintiffs, saying smokers would have to sue individually. But the court said plaintiffs would not have to prove some key elements that had been upheld in the first stage of the class action: that nicotine is addictive, that smoking causes diseases, and that cigarette companies fraudulently hid those facts.

“That makes these cases in Florida unique,” Mr. Douglas said. Smokers in other states are still suing cigarette makers, he said, but they have higher legal hurdles.

A spokesman for the Altria Group, the Virginia-based parent company of Philip Morris USA, indicated it would appeal the verdict and said the Florida rules were “fundamentally unfair and unconstitutional.”

Shares of Altria, which had been up more than 27 percent this year, dropped 1.2 percent Friday, to $18.98.

Lucinda Naugle, the 61-year-old sister of a former Fort Lauderdale mayor, was awarded $56 million in compensatory damages and $244 million in punitive damages Thursday after a three-week trial and three hours of jury deliberation in Broward County Circuit Court.

Ms. Naugle, an office manager, had started smoking when she was 20 and quit when she was 45 years old, her lawyer, Robert W. Kelley of Fort Lauderdale, said in a telephone interview Friday. She now has severe emphysema and needs a lung transplant she cannot afford, he said.

The jury assigned her 10 percent of the liability for her smoking and disease, and Philip Morris 90 percent.

“She’ll get paid, I would hope, within a year or two,” Mr. Kelley said. “The question is will she live long enough.”

Mr. Kelley said about 25 more cases were lined up for trial in Florida next year. In all, more than 9,000 people from the former class action filed individual suits in various courts in Florida against tobacco makers by January 2008, the deadline set by the state Supreme Court.

About 4,000 of those cases were filed in federal court and have been stayed, pending a review scheduled in January by the United States Court of Appeals for the 11th Circuit, in Atlanta.

Brendan J. McCormick, a spokesman for Altria, said Friday that the company expected the federal appellate court to reject the standards of proof set by the state Supreme Court. “What you have is a defined number of cases in Florida with unique issues that will ultimately be resolved on appeal,” he said.

David J. Adelman, a tobacco analyst for Morgan Stanley, said the Florida case and, separately, forthcoming class-action lawsuits over light cigarette claims pose an “undeniable” increase in the industry’s legal risk “which had previously declined to an unprecedented low point.”

In an interview, Mr. Adelman noted that there were no jury trials in cigarette cases all of last year, and that other states had decertified class-action suits in ways more favorable to the tobacco industry. Further, Mr. Adelman said, the major legal threats to the industry were removed by the 1998 settlement with states. And since then, the industry has fended off calls in court and Congress for a huge disgorgement of its profits.

Even in light of the Florida verdict, Mr. Adelman said the tobacco industry could afford several hundred million dollars a year in legal losses if it had to. “That is a financially manageable issue,” he said.

Of more concern, he said in the interview and a note to investors, is a coming round of cases claiming fraud and damages from past marketing of so-called light cigarettes.

Those products have been shown to be no less harmful than regular cigarettes because smokers inhale them more deeply. Congress, in landmark tobacco legislation earlier this year, prohibited the use of the terms “light,” “low” or “mild” in all cigarette labeling and marketing, effective June 22, 2010.

The first of the “light cigarette” class-action cases is scheduled in Minnesota next October, followed by Missouri in January 2011.

By MARYCLAIRE DALE (AP)

Published October 14, 2009

PHILADELPHIA — A jury ordered GlaxoSmithKline to pay $2.5 million to a woman whose son was born with serious heart defects after she took the antidepressant Paxil during her pregnancy.

The closely watched verdict handed down Tuesday in Philadelphia was the first of about 600 similar cases pending across the country that blame Paxil for heart problems and other birth defects.

The jury found GlaxoSmithKline guilty of negligence but not outrageous conduct, and rejected punitive damages. The company vowed to appeal.

“The adverse events started to come in the late 1990s, early 2000. The evidence was overwhelming and alarming,” said lawyer Jamie Sheller, who represented plaintiff Michelle David. “They could have known this way, way before they did, way before they changed the label in 2005.”

Paxil was classified as a drug with no known link to increased birth defects from its introduction in 1992 through 2005. The Food and Drug Administration began warning in September 2005 that Paxil may be associated with birth defects and strengthened the warning four months later.

David, 28, of Bensalem delivered her full-term son, Lyam Kilker, in October 2005.

He was diagnosed with heart defects two months later and spent five months in a Philadelphia hospital, undergoing surgery to repair two holes in his heart, lawyer Jamie Sheller said Wednesday. He also has a third, separate heart defect and will need at least one more surgery as he grows, she said.

David, a dance teacher and former Philadelphia 76er cheerleader, has no history of heart defects in her family, her lawyer said.

GlaxoSmithKline argues that birth defects occur in 3 to 5 percent of all live births, whether or not the mother took medication during pregnancy.

“The scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition,” the drugmaker said in a statement. “Once approved for use, the company acted properly in marketing the medicine, including monitoring its safety, updating pregnancy information in the medicine’s labeling as new information became available, and in communicating important safety information to regulatory agencies, the scientific community and the public.

Plaintiffs lawyers will continue to pursue punitive damages in the hundreds of remaining cases, the next of which is set for trial in Philadelphia in November.

“We’re starting to chip away at this story, but even as we speak, we’re still fighting them, documents are still being produced, depositions are still being taken,” Sheller said.

Sales of Paxil totaled $849 million last year.

Paxil has competed fiercely in the marketplace at times with rival antidepressant blockbusters like Eli Lilly’s Prozac and Pfizer’s Zoloft. The drug no longer has patent protection and now competes against cheaper generic versions.

By RADHA CHITALE
ABC News Medical Unit
Sept. 3, 2009

At $2.3 billion, it’s a record-breaking settlement that includes the largest fine ever levied in U.S. history, but drug industry experts say that the hefty sum Pfizer agreed to Wednesday will do little to curb highly profitable, unethical marketing behaviors by some companies. The sum folds in civil and criminal penalties related to illegal prescription drug marketing, bringing the investigation of the pharmaceutical behemoth by the U.S. Department of Justice to a close.

Associate Attorney General Tom Perrelli, center, Health and Human Services Secretary Kathleen Sebelius, left, and Assistant Attorney General for the Civil Division Tony West, take part in a news conference to announce Pfizer will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions on Wednesday, September 2, 2009 in Washington.

The settlement includes $1.3 billion in criminal fines related to promoting the arthritis and menstrual pain drug Bextra for uses and in doses not approved by the FDA, putting patients at increased risk for heart attack and stroke. Pfizer voluntarily removed Bextra from the market in 2005.

But promoting off-label drug use to physicians is commonplace. Ethics experts and policy makers say more stringent government oversight is necessary, but that as long as the profits are bigger than the penalties, drug companies are unlikely to revise their marketing model.

“This suit shows that Pfizer controlled what physicians and consumers believed to be the effectiveness and safety of Bextra in ways not supported by the real science Pfizer had done and was not approved by the FDA,” said Dr. Jon Abramson, a pharmaceutical safety and ethics expert at the Harvard Medical School. “Those are the necessary ingredients of blockbuster drugs.”

Pharmacia and Upjohn Company, Inc., a subsidiary of Pfizer, will plead guilty to one criminal count of violating the U.S. Food, Drug, and Cosmetic Act in promoting off-label Bextra use.

Lavish Trips for Prescribing Doctors

Part of Pfizer’s marketing campaign included lavish “consultant meetings” in exotic locations that physicians were paid up to $1,500 to attend, in the hopes that they might increase the number of prescriptions they wrote, according to a lawsuit filed by John Kopchinski, a former Pfizer sales representative.

“At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives,” Kopchinski said, in a statement. “I couldn’t do that.”

Department of Health and Human Services Secretary Kathleen Sebelius called the settlement today “historic,” not only because of its size but because Pfizer agreed to a Corporate Integrity Agreement, which she said would offer some transparency in how the company researches and markets its drugs, including what kind of financial incentives the company offers doctors who prescribe Pfizer drugs.

Published August 21, 2009: 09:22 AM ET by CNNMoney

Drug maker Eli Lilly & Co. (LLY) has agreed to pay $22.5 million to settle a lawsuit in which West Virginia’s attorney general accused Lilly of improperly promoting the antipyschotic Zyprexa.

It’s the latest Lilly payout for Zyprexa. In recent years, the company has agreed to pay at least $2.6 billion to settle various personal-injury lawsuits and government investigations of its marketing practices related to the drug. Zyprexa is Lilly’s best-selling drug, generating $2.3 billion in sales for the first half of 2009.

The massive litigation stems largely from allegations that use of Zyprexa caused high blood sugar and diabetes in users, and that Lilly improperly warned of these risks. In addition, Lilly marketed the drug for unapproved uses such as helping nursing-home patients fall asleep, which authorities say caused improper reimbursement claims for the drug to be submitted to government health-insurance programs.

Indianapolis-based Lilly reached the settlement with West Virginia in late July and the pact was unsealed by a court Thursday. In the second quarter ended June 30, Lilly booked a pretax charge of $105 million to cover anticipated settlements with various U.S. states. Lilly is in advanced discussions with several states, the company said.

The West Virginia payout comprises $15.75 million to the state, plus $6.75 million to its outside attorneys, said spokeswoman Marni Lemons. Non-monetary terms of the deal include Lilly’s commitment to proper promotional practices, dissemination of Lilly’s funding of continuing-medical education for doctors, and disclosure of Zyprexa clinical trial data.

Lilly didn’t admit any wrongdoing under the agreement.

The states with pending cases against Lilly are Arkansas, Connecticut, Idaho, Louisiana, Mississippi, Minnesota, Montana, New Mexico, Pennsylvania, South Carolina and Utah.

This week, a U.S. judge in Brooklyn who is overseeing the Zyprexa litigation sent letters to some state judges urging that the remaining state and federal cases be resolved in a coordinated settlement.

Published August 21, 2009  beaumontenterprise.com

By: Margaret Toal

Twelve people in Orange County are listening to engineers, looking at police photos and following computer graphics that seek to explain the death of a 13-year-old and the possible role of a Yamaha Rhino.

And there’s a crowd with them in District Court Judge Dennis Powell’s courtroom as more than a dozen lawyers and legal assistants take notes, type on laptop computers or check their Blackberries.

Sometime, perhaps as early as next week, the jury will be asked to decide where the responsibility for this accident lies.

Eddie Ray, 13, riding a Yamaha Rhino for fun while out of school for Hurricane Humberto when he died of a head injury after the four-wheel vehicle that resembles a souped-up golf cart flipped over.

Almost 500 legal cases have been filed against Yamaha regarding injuries connected with rollovers in the Rhino, which first hit the market in 2003. The case in Orange is the first in the nation to go to trial, said plaintiff’s lawyer Tim Malony of San Antonio.

Malony said the lawsuit is not asking for a specific amount of money in damages. The goal, he said, “is to get this product off the market.”

The U.S. Consumer Product Safety Commission reports 59 deaths have been associated with the vehicle that is considered an “off-road vehicle” rather than an all-terrain vehicle.

Eddie Ray was a seventh-grade student at West Orange-Stark Middle School when he died after being injured on Sept. 13, 2007.

Published August 13, 2009 by zeenews.com

New York: The family of the first fatal swine flu victim in New York has filed papers in court with the intention of suing the local government for $40 million, news reports said on Wednesday.

Assistant principal Mitch Wiener at a Queens school succumbed to the influenza virus H1N1 in May, the first death, while several schools in New York City were ordered closed to prevent a further spread of the disease that struck mostly young children.

The CBS television network said Wiener’s wife and three sons plan to sue City Hall and its health and education departments for not taking faster steps in closing more schools.

CBS said the lawsuit claimed City Hall was negligent in failing to quickly report the influenza outbreak and failing to warn Wiener that he had been exposed to the H1N1 virus.

“The city didn’t do anything wrong,” CBS quoted Mayor Michael Bloomberg as saying. Bloomberg said the city had the obligation to keep schools open and he was sorry that Wiener died.