Since some users of the diet drugs opted out of a class action decision, 800 suits have been filed in the Tampa Bay area.
By ANITA KUMAR
© St. Petersburg Times, published October 8, 2000
Saddled with extra weight and chronic fatigue, Pati Daniel sought out what many considered the 1990s miracle drug.
She shed 30 pounds, recaptured her youthful energy and couldn't have been more confident in the popular diet drug fen-phen.
But after 10 months, she discovered the little pills had a life-threatening side effect.
Mrs. Daniel began to have attacks in which she could feel her heart skip beats. Even after she stopped taking the pills, she had to catch her breath after walking across her small Brooksville home. Her blood pressure soared -- and so did her weight. She regained the 30 pounds she lost and packed on 40 more. At 5 feet 5, Mrs. Daniel now weighs 190.
"I was in shock," said Mrs. Daniel, now 40. "I haven't quit living, but I know this is going to shorten my life greatly. It's a nightmare."
Doctors and tests confirmed she had heart and lung problems -- similar to those plaguing thousands of other men and women who took fen-phen.
What began as a weight-loss craze quickly became a breeding ground for lawsuits when the drug was taken off the market in late 1997. Courts across the nation, including those in the Tampa Bay area, were bombarded with cases.
In late August, a federal judge approved the largest personal injury settlement in U.S. history -- a $3.75-billion class-action settlement to fen-phen users expected to end much of the nationwide litigation against the biggest marketer of the paired drugs.
But about 45,000 of the 6-million fen-phen users across the nation opted out of the settlement, many choosing to sue the drugs' distributor themselves.
Most of the 2,500 suits filed in Florida will be heard in about a half-dozen metropolitan centers. So far, 800 suits have been filed in Pinellas, Pasco and Hillsborough counties with the first cases set for trial in January.
Many say American Home Products of New Jersey knew of potential problems with the pills but continued to sell them anyway. Similar complaints have been lodged against the makers of tobacco and Firestone tires.
"It's worse than Firestone," said David Krathen, a Fort Lauderdale lawyer handling fen-phen cases. "It's as bad as you get."
Mrs. Daniel estimates she would have received about $6,000 from the nationwide settlement, less than she said she already has spent on medical expenses. So she sued individually.
"Six thousand dollars? You've ruined my life and that's it?" said Mrs. Daniel. "Somebody should at least take care of us. . . . These people will pay one day."
Only five years ago, doctors couldn't prescribe the fen-phen combination fast enough. It was dubbed a medical marvel for those who had tried countless diets and drugs but had never been successful losing weight.
The two drugs -- fenfluramine and phentermine -- were approved as weight-loss drugs as early as the 1960s but didn't become popular until a 1992 study showed dramatic results when the pills were taken together.
Weight-loss clinics heavily promoted fen-phen and, in turn, millions flocked to the appetite suppressants. It was intended to be used only for a few weeks by those who were severely obese but that didn't always happen.
Mrs. Daniel, who heard about the drug from her sister who was also taking the pills, took the combination for almost a year although at the time she was not considered seriously obese. Her sister has not experienced any health problems.
Krathen said some clients took the drugs to lose 3 or 4 pounds. About 6-million Americans were taking them when the "fen" drug was taken of the market in September 1997.
That's when the Food and Drug Administration, which initially approved the drugs, learned studies had linked fen-phen to leaky heart valves and an often fatal lung disease, pulmonary hypertension.
Scientific studies done since then concluded that people who took the drugs for short periods -- less than two or three months -- are unlikely to have serious injury. About 75 percent of fen-phen users fall into that category.
Following in the footsteps of large companies that marketed breast implants and other supposedly defective products, American Home Products agreed to a nationwide settlement.
The company will pay up to $2.8-billion for people who sustained injuries. Almost another billion would pay for the medical monitoring of those who took the drugs and have not shown any signs of damage.
The deal pays about 200,000 users, including 1,000 Florida residents, anywhere from a few hundred dollars to $1.5-million depending on a variety of factors, including injuries.
American Home Products spokesman Lowell Weiner declined to comment about any specific cases last week but said the company now faces an additional 11,000 lawsuits.
In August 1999, a Texas jury awarded nearly $23.4-million to a fen-phen user. In December 1999, a Mississippi jury awarded $150-million to another five people.
Just last week in Mississippi, American Home Products reached a $200-million settlement with fen-phen users who claimed to have suffered heart or lung damage. The settlement was reached Tuesday in the same Jefferson County court that last year yielded a nearly $400-million settlement involving a different set of plaintiffs and the drugmaker.
The company already has settled more than a dozen cases for undisclosed amounts between $500,000 and $7-million. Some cases already had been to trial but those who sued agreed to settle for less money so they could receive the award more quickly.
"Each time a jury has heard about what this company did, they get very angry," said Joseph Saunders, a St. Petersburg lawyer with about 100 fen-phen cases in Florida. "The company was telling everyone it was safe. They put profit over health."
Though some cases have been settled, most fen-phen users who filed suits continue to wait. Many continue to rack up medical bills or suffer further health problems.
Attorneys say some of their clients have had strokes or brain damage. Others have died.
Brenda Fulmer, a Tampa lawyer whose firm filed about 700 suits, said five of her clients have died from heart or lung problems.
Thousands of people opted out of the national settlement because they would rather have an attorney handle their claim than be locked into the settlement, said Scott Liotta, an Orlando lawyer whose office represents 600 fen-phen users.
Class-action suits, like the national settlement, give ordinary people the ability to take on big business by contributing little money. But once people are involved with one of these suits, they are stuck with the outcome.
Attorneys say their clients would have been shortchanged by the settlement if they have serious heart valve injuries or any lung problems.
"Its insulting," Fulmer said. "Some would not even be reimbursed for out-of-pocket medical expenses."
In Florida alone there are at least 2,500 individual claims. The Times contacted more than a dozen plaintiffs, but almost all declined to talk for fear of harming their cases or because of the stigma attached to being overweight and taking a diet drug.
All of Florida's plaintiffs are represented by only a handful of lawyers around the state because of the high cost. Lawyers do not receive any money for the cases unless there is a jury award or settlement.
The massive number of suits filed in Pinellas, Pasco and Hillsborough counties prompted Chief Judges Susan Schaeffer and Dennis Alvarez to assign one judge in each circuit to handle all pretrial motions.
Schaeffer and Alvarez both said it's easier for one judge to hear the pretrial motions because at this early stage the motions in all fen-phen cases would be similar. Also, they said they want to make sure there are consistencies from one case to another.
When it's time for trial, though, the cases would likely be divided among civil trial judges.
Hillsborough has dealt with this magnitude of cases before with silicone breast implants and asbestos, also having one judge handle all pretrial motions. But it's unprecedented in Pinellas.
Mrs. Daniel is one of those waiting for her day in a Pinellas court.
She quit her job and can't even fold laundry without wheezing. She uses a wheelchair when she takes her 11-year-old daughter to Sea World. She takes 14 pills a day and eventually may need open-heart surgery to replace leaky heart valves.
"It's a nightmare," she said. "The company is killing people. Where is the publicity? Where is the apology?"
- Times researcher Caryn Baird contributed to this report, which also includes information from Times wires.