To cover its end of the deal, Wyeth agreed to ante up $2.55 billion for claimants who qualified for the larger payments, and another $1 billion for the smaller cash benefits and medical services for people with less severe heart damage.
On May 2, 2000, the US District Court in Pennsylvania held a hearing to determine whether the proposed Settlement Agreement was fair, adequate, and reasonable and held another hearing on August 10, 2000, to hear evidence on the fairness of changes contained in the Agreement.
On August 28, 2000, Judge Bechtle issued Memorandum and Pretrial Order approving the Agreement and the four amendments. A Settlement Trust was established on September 1, 2000, to administer the provisions of the Agreement, and to process the claims of class members.
In the end, Wyeth put up $3.75 billion to manage the litigation and was forced to add another $1.3 billion to the pot in 2004.
However, before the ink even had a chance to dry on the class action agreement, a new nightmare began for Wyeth when about 50,000 victims decided to opt out. The prospect of 50,000 punitive damage awards was an extremely frightening thought for Wyeth, given the results of the jury trials in 1999.
Legal experts say this looming threat prompted Wyeth to attempt settle the opt out cases as quickly as possible for whatever amount necessary and when the word got out, the whole mess quickly turned into a feeding frenzy for litigants.
Experts say news about previous large settlements may have prompted many victims to opt out. For instance, on July 22, 1999, the Dallas Morning News reported a case where the company paid more than $3 million to settle a lawsuit with a 70-year-old Texas woman. The agreement, the newspaper said, was at least the 12th settlement involving former fen-phen users, but was the first in a Dallas County court case.
A month before the $3 million settlement was reported, the article said, the company agreed to pay between $6 and $7 million to settle a case in Harris County, Texas that linked a woman's death to fen-phen.
Adding to the risk of trying cases before a jury, is the fact that more documents keep surfacing that prove useful in court. For instance, an internal FDA e-mail dated about a year before the agency issued the fen-phen advisory, written by former FDA reviewer, Leo Lutwak, to a colleague says the serious side effects linked to fen phen and the drugs' marginal benefits "should be brought out."
"The company has gotten away with much manipulation these past 3 years, of the public, of the press, of the FDA," Mr Lutwak wrote. "I started getting upset about this drug in '93 or '94 and was running into a lot of blocks from the FDA and from the drug company," he said.
Although other injuries associated with fen-phen include PPH and neuropsychological damage, only persons with heart valve damage are allowed to participate in a national class action settlement.
Persons suffering from neuropsychological damage that can include depression, mood swings, memory loss, behavioral changes, and psychotic breakdowns, must sue separately.
According to the FDA, PPH has been reported to occur in about 1 in 25,000 people using the appetite suppressants for more than 3 months. Close to half of all PPH cases result in death. The Pulmonary Hypertension Association defines the condition as:
"Pulmonary hypertension ("PH") is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life threatening.
"Symptoms of pulmonary hypertension include shortness of breath with minimal exertion, fatigue, chest pain, dizzy spells and fainting.
"When pulmonary hypertension occurs in the absence of a known cause, it is referred to as primary pulmonary hypertension (PPH). This term should not be construed to mean that because it has a single name it is a single disease. There are likely many unknown causes of PPH. PPH is extremely rare, occurring in about two persons per million population per year."
On May 2, 2000, the US District Court in Pennsylvania held a hearing to determine whether the proposed Settlement Agreement was fair, adequate, and reasonable and held another hearing on August 10, 2000, to hear evidence on the fairness of changes contained in the Agreement.
On August 28, 2000, Judge Bechtle issued Memorandum and Pretrial Order approving the Agreement and the four amendments. A Settlement Trust was established on September 1, 2000, to administer the provisions of the Agreement, and to process the claims of class members.
In the end, Wyeth put up $3.75 billion to manage the litigation and was forced to add another $1.3 billion to the pot in 2004.
Legal experts say this looming threat prompted Wyeth to attempt settle the opt out cases as quickly as possible for whatever amount necessary and when the word got out, the whole mess quickly turned into a feeding frenzy for litigants.
Experts say news about previous large settlements may have prompted many victims to opt out. For instance, on July 22, 1999, the Dallas Morning News reported a case where the company paid more than $3 million to settle a lawsuit with a 70-year-old Texas woman. The agreement, the newspaper said, was at least the 12th settlement involving former fen-phen users, but was the first in a Dallas County court case.
A month before the $3 million settlement was reported, the article said, the company agreed to pay between $6 and $7 million to settle a case in Harris County, Texas that linked a woman's death to fen-phen.
Adding to the risk of trying cases before a jury, is the fact that more documents keep surfacing that prove useful in court. For instance, an internal FDA e-mail dated about a year before the agency issued the fen-phen advisory, written by former FDA reviewer, Leo Lutwak, to a colleague says the serious side effects linked to fen phen and the drugs' marginal benefits "should be brought out."
"The company has gotten away with much manipulation these past 3 years, of the public, of the press, of the FDA," Mr Lutwak wrote. "I started getting upset about this drug in '93 or '94 and was running into a lot of blocks from the FDA and from the drug company," he said.
Although other injuries associated with fen-phen include PPH and neuropsychological damage, only persons with heart valve damage are allowed to participate in a national class action settlement.
Persons suffering from neuropsychological damage that can include depression, mood swings, memory loss, behavioral changes, and psychotic breakdowns, must sue separately.
According to the FDA, PPH has been reported to occur in about 1 in 25,000 people using the appetite suppressants for more than 3 months. Close to half of all PPH cases result in death. The Pulmonary Hypertension Association defines the condition as:
"Pulmonary hypertension ("PH") is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life threatening.
"Symptoms of pulmonary hypertension include shortness of breath with minimal exertion, fatigue, chest pain, dizzy spells and fainting.
"When pulmonary hypertension occurs in the absence of a known cause, it is referred to as primary pulmonary hypertension (PPH). This term should not be construed to mean that because it has a single name it is a single disease. There are likely many unknown causes of PPH. PPH is extremely rare, occurring in about two persons per million population per year."
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