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.

Published August 11, 2009 by aboutlawsuits.com

A fentanyl patch recall has been issued by Watson Pharmaceuticals, Inc. for one lot of their generic 100 mcg/hr pain patches, as manufacturing problems could cause the patches to leak the powerful fentanyl gel contained inside, potentially causing an overdose, respiratory depression or death.  

 The Watson pain patch recall was announced on Friday, for 100 mcg/hr Fentanyl Transdermal System patches shipped in the United States between April 2, 2009 and May 20, 2009, with the Lot Number 145287A. The lot number is located on the box or the foil patch, and any pouches covered by this recall should not be handled directly.

The fentanyl pain patch is a generic version of the Duragesic patch, and is designed for use by patients suffering from severe, chronic pain. The patch is supposed to release fentanyl, a powerful opioid that is 100 times more potent than heroine, over an extended period of time. However, if the fentanyl gel leaks out of the patch and comes in direct contact with the skin, it could cause a fatal fentanyl overdose.

Similar manufacturing problems have resulted in a number of prior recalls and hundreds of fentanyl pain patch overdose deaths have been associated with different versions of the patch since it was first introduced by Johnson & Johnson in 1994.

At least six different fentanyl patch recalls have been issued by Johnson & Johnson and companies manufacturing generic versions of the patch, raising questions about whether the powerful painkiller can be safely made.

Last year, in August 2008, another Watson fentanyl patch recall was issued for 75 mcg/hr pain patches due to the same risk of leaks and overdose.

Dozens of pain patch wrongful death lawsuits have been filed against manufacturers of the fentanyl patches, alleging that defects caused too much of the gel to be delivered into the users bloodstream. Out of the first four cases to go to trial against Johnson & Johnson, the plaintiffs have been successful in each case, receiving verdicts that combine to exceed $36 million.

By Steve Bousquet, Times/Herald Tallahassee Bureau
In Print: Friday, January 16, 2009

TALLAHASSEE — Facing a $3.5-billion deficit next year, Florida desperately needs all the money it can get. But millions more will disappear because the state has settled a lawsuit that affects millions of motorists.

The Legislature will spend $10.4-million to settle a class action lawsuit over allegations that the state illegally sold drivers’ personal information to marketing firms over a four-year period in violation of a federal law barring the practice. The state made $27-million each year on the deal, according to the lawsuit.

The settlement to drivers?

$1.

Drivers who held a license, car registration or state-issued ID from June 1, 2000, through Sept. 30, 2004, will get a one-time credit of $1 when they register or renew a registration between July 1, 2009, and June 30, 2010.

“Just one dollar?” Sen. Gary Siplin, D-Orlando, asked in a committee hearing on the settlement.

The four South Florida motorists who sued will get $3,000 each, and five law firms that pursued the case for more than six years will divide $2.85-million in legal fees, which is separate from credits paid to consumers.

Gov. Charlie Crist and the Cabinet approved the agreement in August, but the Legislature has to appropriate the money. The Senate Transportation Committee was briefed on the settlement Wednesday.

The personal information that was sold includes a driver’s photo, Social Security number, driver ID number, name, address, phone number and medical condition.

The preliminary settlement requires the state motor vehicle agency to post on its Web site a system to obtain names of the mass marketers that bought the personal information, as well as a reference on license and registration forms on state and federal disclosure laws.

The state formally denied any wrongdoing.

“No one’s hurt, no one’s injured, and we’re paying $10-million?” asked Sen. Larcenia Bullard, D-Miami.

“It’s $10-million or the potential is in the billions,” replied Steven Fielder, a lobbyist for the Department of Highway Safety and Motor Vehicles.

The state’s maximum liability was estimated at $39-million, based on a $2,500 penalty for each violation of the federal Drivers Privacy Protection Act.

Congress in 1999 amended the law to prohibit states from providing drivers’ personal information unless the state had drivers’ permission to do so.

But Florida, the lawsuit alleged, continued to market the data anyway. The Legislature passed a law in 2004 ending the practice.

Anyone affected by the settlement has until March 16 to file an objection with the court in Miami. The case is before U.S. District Judge Jose Martinez

Sen. Carey Baker, R-Eustis, said it looks to him as though consumers should have gotten more.

“The victim really doesn’t benefit very much, and the attorneys make out on attorneys’ fees.”

I think it is a fair assumption to say that most people who smoke wish they had never started.  Unfortunately, it is a very rare occasion to quit smoking on the first attempt.  I personally know of a woman who used cigarettes as a weight loss tool.  She died of emphysema at the age of 57.  The woman was my mother-in-law.  Not only is smoking debilitating to your health, it is just downright expensive.

            It is no wonder that the public was excited when Pfizer introduced Chantix and received approval by the F.D.A. in May, 2006 as a smoking cessation drug.  Here was medication that promised them freedom from their dependence on cigarettes.  Sadly, it didn’t take long to discover that Chantix had some potentially tragic side effects. 

            The United States Food and Drug Administration issued an Early Communication to the public and health care providers on November 20, 2007 that they were evaluating “…adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior…”  Tragically, this announcement came too late for some. 

            As I have said, I have seen the powerful grip that cigarettes can have and the desperation to break free.  I have also spoken to individuals who have taken Chantix and have experienced its heartbreaking effects.   If you or someone you love has been a victim of these side effects, you don’t need to go through this alone.  I would like to invite you to visit my website at www.dreamlegalteam.com.  Feel free to fill out an online consultation form or engage in a live chat.  Once again, the website is www.dreamlegalteam.com.  Don’t wait.

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