Fen-phen settlement becomes final!

Parties Will Submit Order For Approval Of AHP Settlement In Diet Drug Litigation

PHILADELPHIA -- When Jan. 3 came and went without challenge to the Third Circuit U.S. Court of Appeals' decisions upholding the American Home Products settlement, the company declared that final judicial approval had occurred. 

The parties will nevertheless submit to U.S. Judge Harvey Bartle III of the Eastern District of Pennsylvania a stipulated order confirming final approval, according to the Web site of the AHP Settlement Trust. A source told Mealey Publications that order is expected within days and would include a schedule of deadlines for those applying for benefits.

The source said members of the class have until Aug. 1 to apply for a Fund A refund or register for echocardiogram screening. The screening period ends Jan. 3, 2003, the source said, and the blue form seeking Matrix benefits must be submitted by May 3, 2003. 

Those dates also govern some aspects of opting out. Initial opt outs, those who filed their intent by the March 30, 2000, deadline, must obtain echocardiograms by the end of the screening period and file claims within one year of final approval. Intermediate opt outs, according to an attorney, must also obtain echocardiograms by the end of the screening period and have until May 3 to file for an intermediate opt out, subject to numerous restrictions, including the waiver of punitive damages. Intermediate opt outs must also not have been diagnosed before Sept. 30, 1999, with valvular injury. 

The back-end opt out is available to people who are diagnosed with mild mitral regurgitation during the screening period and progress to a matrix level injury in the following 14 years or were FDA positive before Sept. 30, 1999, and reached a matrix level injury after that date. Copyright 2002, Mealey Publications - A LexisNexis Company

Fen-phen settlement becomes final

TRENTON, New Jersey (AP) -- A $3.75 billion settlement for thousands of people who took the recalled fen-phen diet drug combination is now final because no one challenged it by last week's deadline, drug maker American Home Products said Thursday. 

Until January 2, plaintiffs or their health insurers could have asked the U.S. Supreme Court to review the settlement, which currently includes about 295,000 people. No one did so. 

"That means the settlement is finally approved by the courts," said Doug Petkus, a spokesman for Madison-based AHP. 

The company made Pondimin, the fenfluramine half of fen-phen, and Redux, a chemical cousin. About 6 million people took the drugs before they were pulled off the market in 1997 amid concerns they caused heart-valve damage in some patients. 

Phentermine, the other drug in the combination, was not implicated in the problems. 

Final court approval means people who used the drugs and want to file a claim must do so by August, according to attorneys for plaintiffs and the trust administering the settlement. 

AHP, one of the country's biggest drug makers, has taken a total of $13.2 billion in charges to cover the settlement and lawsuits brought by plaintiffs who chose to pursue individual cases, company spokesman Lowell Weiner said. 

As of September 30, the company has paid about $11 billion to claimants, including some in the settlement, people who settled individually with the drug maker, those who won jury awards and dozens who developed a potentially fatal lung condition, Weiner said. 

So far, the trust has paid out $591.6 million. That includes $531.4 million, or an average of $403,000, to 1,309 people with significant heart damage, said Joe Foley, the trust's chief financial officer. 

Another $32 million went to 5,542 people who had minor heart valve damage and accepted $3,000 to $6,000 each to cover future medical costs. 

Copyright 2002 The Associated Press. All rights reserved. 

AHP's Fen-Phen Settlement Clears Final Appeals Hurdle (Update1)

Madison, New Jersey, Jan. 10 (Bloomberg) -- American Home Products Corp. won final approval of a $3.75 billion settlement of fen-phen lawsuits after the deadline for filing legal appeals expired, company officials said. 

The 3rd U.S. Circuit Court of Appeals in May approved the settlement, which includes $1 billion for future medical checkups and another $2.34 billion to settle individual suits over the company's withdrawn fen-phen diet drug combination. 

Consumers and health providers had until last week to ask the U.S. Supreme Court to review the agreement. No requests were filed, American Home said in a news release. 

Officials of Madison, New Jersey-based American Home now face a new wave of fen-phen lawsuits from users who decided to opt out of the settlement, plaintiffs' lawyers say. Final approval of the settlement starts a 16-month period in which such suits can be filed. 

"Final approval means more people will now get compensation under the settlement and can get checked to see if they've developed heart problems from taking this drug", said Michael Fishbein, a Philadelphia lawyer who represents consumers. "It provides a very tangible benefit for a large number of people." 

American Home's shares, which have risen 9 percent over the last 12 months, rose 60 cents to $61.82. 

1999 Settlement 

The company created the national settlement plan in 1999 to resolve suits by users of the company's Pondimin and Redux diet drugs. Consumers say the combination damaged their heart valves. 

American Home executives pulled the drugs off the market in 1997 after they were linked to heart problems and a fatal lung disease. The drugs were taken with the generic drug phentermine to make up the so-called fen-phen combination. 

American Home has been forced to set aside a total of $13.2 billion to resolve fen-phen litigation after failing to win a single case that came to trial over the last four years. That reserve includes the $3.75 billion national settlement. 

As part of the settlement, former fen-phen users unhappy with the amount of compensation they are scheduled to receive under the plan can opt to file new suits against American Home until April 2003, Fishbein said. 

The consumers are barred from seeking punitive damages in opt- out cases under the settlement. Other former users have been awarded millions in actual damages by juries in Texas and Oregon. 

An Oregon man and his mother were awarded nearly $4 million in actual damages in 2000 in a fen-phen lawsuit against American Home, for example. 

"There could be as many as 200,000 opt-out cases", Fishbein said. "No one knows at this point how many of those people will actually file, though." 

American Home officials weren't immediately available to comment on how many opt-out cases the company may face. 

"I expect the trials of the opt-out cases will be quicker and will result in substantially smaller verdicts", Fishbein added.

Fen-Phen's - Littlest Victim? 
Diet drugs are being blamed for an infant's heart defect 

Dawn Serina puts her 3-month-old son, Nicholas, into his tiny crib and winds a Noah's Ark mobile above his head. From the first chimes of "Lullaby and Good Night" he is flashing a wide, toothless grin each time the tiny elephant and zebra pass by. It's one of the few moments in her day when Dawn can see her son as a "regular baby." 

"I try, but it's hard," explains the 34-year-old Patchogue, L.I., woman, "because he's not a regular baby." 

Nicholas was born missing the crucial heart valve that pumps blood to the lungs and oxygen to the body, and his mother believes feels that her son is paying the price for her own terrible mistake: For two months before realizing she was pregnant, Dawn was taking fen-phen - the diet drug combination of fenfluramine and phentermine that the U.S. Food and Drug Administration pulled off the market last month after linking it to serious heart and lung disease in more than 100 adults. 

"In my heart, I know I did not cause this, but it's hard to tell your brain that," Dawn says with a sigh. "I took the pills, I went to the doctor. I didn't know I was pregnant - I thought this was safe." 

Going to Court 

Last Friday, Dawn Serina and her husband, Robert, 27, filed a $62 million lawsuit against the Nutri/System diet clinic that prescribed the pills, for failing to warn her of the risks. Four drug manufacturers and two local pharmacies were also named. 

Nutri/System's Joseph DiBartolomeo declined to comment on the lawsuit but said: "There's a very strong warning that she [Serina] had to read and sign, whether she was pregnant or she was trying to get pregnant." Other parties named in the lawsuit declined to comment. 

"If you look at all the variables out there, everything points to fen-phen," says the family's Manhattan attorney, Ronald Benjamin. "I am confidant that we will prove it in court." 

Meanwhile, the FDA is investigating at least three reports of children - including Nicholas - born with heart defects to women who had taken some combination of fen-phen or another diet drug, dexfenfluramine (Redux), during the first trimester of pregnancy. The valve that never developed in Nicholas' chest is the one found to be damaged in some adults taking fen-phen. 

These reports are the first signs that the damage only recently associated with adults might be passed along from mother to child. 

Joy at Firstborn 

When Nicholas was born June 21, Dawn and her husband Robert were thrilled to have their first child together. (Dawn has an 11-year-old daughter, Cassandra Sanchez, from a previous marriage.) 

"To look at him, he was perfect," recalls Serina. "You check all the fingers and check all the toes, you know? I didn't see anything." 

Nicholas looks like any other infant - adorable. He flirts with strangers, showing off that toothless smile, then turns suddenly shy. The only time he cries is when Dawn unbuttons his green striped jumper to point out the 4-inch-long, pencil-thin scar on his soft chest - a souvenir of open-heart surgery at the age of 2 months. 

At a cost of $55,000, the Serinas flew with Nicholas to Mott Children's Hospital in Ann Arbor, Mich., where surgeons inserted a flexible, medically treated Dacron conduit into the baby's heart to facilitate blood flow and increase his oxygen level. 

The medical term for Nicholas' condition is pulmonary atresia, a birth defect that occurs in less than 1% of newborn infants. In lay terms, it's also called "blue baby syndrome," and his mother must regularly check Nicholas' nose, upper lip or toes to be sure they aren't turning purplish-blue from lack of oxygen. As Nicholas outgrows the conduit, he'll need surgery to repair or replace it. 

So far, Nicholas' doctors can't pinpoint any reason for his birth defect, but "of the kids that have congenital cardiac defects, we're only able to find some link in about 8%," explains Dr. Thomas Biancaniello, director of pediatric cardiology at Stony Brook University's School of Medicine, where Nicholas receives treatment. 

Some can be traced to genetics, others to environmental toxins to which women might have been exposed during pregnancy. But the vast majority are never explained, and there is no reason automatically to assume that fen-phen is the cause, Biancaniello says. 

"I think that's a giant leap," he argues. However, all the major organs form between the fifth and 10th weeks of pregnancy, points out Dr. Nabil Husami, an obstetrician/gynecologist at Columbia-Presbyterian Medical Center. If a drug were to have a negative impact on the fetus, "this is where it could have the worst effect," he says. 

"All my life, I've been overweight," Dawn says. And all her life, she has struggled with diets. 

But five months into Nutri/System's fen-phen weight-loss program, Dawn was already down 47 pounds. Though she doesn't want to reveal her weight, Dawn's goal was to lose 120 pounds. 

Just a few weeks after Nicholas was born the news broke about a Mayo Clinic study linking fen-phen to heart and lung disease. Dawn reported his condition to the Mayo Clinic and, a few weeks later, she says, the FDA called and asked for Nicholas to be part of the agency's study. 

So far, Nicholas' doctors report that he's doing very well. But his troubles aren't over yet. Nicholas must undergo two more open-heart surgeries in the next year, and Dawn estimates the medical expenses have run close to $150,000 already. 

More worrisome, the Serinas will lose their health insurance in January: Dawn gave up her job as a legal secretary to stay home with Nicholas and Robert, a chef, isn't covered. 

Meanwhile, the Serinas are waiting for their Medicaid application to be reviewed. Robert's mother held a raffle to raise $4,000 to send Nicholas to Michigan, but that won't begin to cover the hospital bills. 

Still, the Serinas say finances aren't the only impetus for filing a lawsuit. "We keep asking ourselves, why did this happen? And nobody can give us an answer," Robert says. 

"It's not about the money," Dawn says. "Because if my son dies when he's 30, what good is money going to

Leflaw's Fen-Phen E-sources

• View the documents AHP didn't want you to see! 
• Free echo program at http://reduxlitigation.com 
• Fen Phen Victim Form at http://fenfenlitigation.com 
• Opt-Out Qualifier Program 
• Settlement Matrix Analyzer at http://settlementanalyzer.com 
• Free Echo Assistance Program at http://reduxsettlement.com 
• new and improved bulletin board at http://noticenetwork.com 
• FenPal Scrapbook 
• MDL Order 2152 Re 9% Fee 
• Exhibit A-Example 
• Memo & Order 467 
• Order 467 
• Order 517
• Phila Court Of Common Pleas Update 
• Fen Phen II information at http://fenfenclassaction.com

Fen-Phen - Diet drug doesn't cause birth defects, Feds say.

The federal government is denying any link between fen-phen, the diet drug combo banned last month, and birth defects in babies born to women who took the drugs during pregnancy, the Daily News learned yesterday. 

The U.S. Food and Drug Administration reached the conclusion after studying reports of at least three infants, including a Long Island boy who now suffers from congestive heart failure, born to women who used some combination of fenfluramine and phentermine during pregnancy. 

Those reports were the first that claimed heart and lung damage linked to adults taking fen-phen might be passed along during pregnancy. However, the FDA now maintains that the infant's birth defects are coincidental and "unlike the kind seen in [adult] patients taking fen-phen," said spokeswoman Marian Segal. 

The FDA also cited an ongoing University of California, San Diego, study of 64 pregnant women who took fen-phen during the first trimester. So far, none of the group's children have heart defects. 

The news comes as Nicholas Serina, the Long Island boy born without a crucial heart valve after his mother, Dawn, took fen-phen, was admitted to University Hospital in Stony Brook yesterday suffering congestive heart failure. Dawn Serina's attorney, Ronald Benjamin, said 4-month-old Nicholas will likely face emergency open heart surgery to unblock an artificial heart valve. 

Serina is suing Nutri/System and the makers of the diet drug combo, saying the medication caused her son's heart defect. 

Meanwhile, AnnMarie Mannino, 25, of Staten Island, another pregnant woman who took fen-phen at the time of conception, filed a $21 million lawsuit this week claiming emotional distress because she does not know if her baby will have heart problems.