"As a result of Defendants' promotions, there was an enormous increase in sales revenues and profits for Defendants, their affiliates, and other commercial entities involved in the manufacturing and distribution chains of these anorectic pharmaceuticals."
The complaint also alleges that Wyeth's gross sales of Pondimin in the US increased from $3.7 million in 1993 to $150 million in 1996.
The lawsuit charges that the defendants knew that there were at least 41 reports of PPH associated with fenfluramine by the spring of 1994, and knew that the drug's label describing only four cases of PPH was false and misleading and that they intentionally concealed information, "in order to maximize sales and profits of Pondimin."
By 1996, the complaint says, defendants knew of at least 71 cases of PPH, including twelve deaths, while the Pondimin PDR entry continued to falsely state that there had been only four PPH cases, and only one case was fatal.
The complaint also alleges that the defendants deliberately decided not to submit proposed labeling changes to the FDA about the risk of PPH with Pondimin, to avoid any negative impact on the New Drug Application for Redux, pending before the FDA in 1995-96.
Defendants knew, it says, that PPH risks associated with Pondimin were relevant to the FDA's consideration of Redux because both drugs had the same active ingredient.
On December 10, 1997, the Judicial Panel on Multidistrict Litigation transferred all federal fen-phen lawsuits to the US District Court for the Eastern District of Pennsylvania for consolidated pretrial proceedings before the Honorable Louis Bechtle, Chief Judge Emeritus, and upon his retirement, on June 29, 2001, the litigation was reassigned to Judge Harvey Bartle III.
The first two fen-phen cases to go to trial turned out to be a disasters for Wyeth. One settled after several plaintiffs in Mississippi won over $100 million in compensatory damages and a Texas case resulted in a verdict that included high punitive damages.
On August 7, 1999, a Texas jury awarded 36-year-old Debbie Stone Lovett, $23 million. Legal experts said the verdict was significant being Wyeth tried the case believing that the facts were their favor. The case was reportedly settled during an appeal for $2.2 million.
In another 1999 trial in Oregon, Wyeth lost a $29.2 million verdict that eventually was settled for $15.5 million. In this case, Mary Linnen, took fen-phen for just 23 days before developing PPH.
A few months after she was diagnosed, Ms Linnen had to undergo surgery to insert a tube in her heart, so that she could inject a medication into her heart several times a day. Less than 3 months later she died and her family filed the first fen-phen wrongful death lawsuit against the company.
Legal experts say Wyeth was so alarmed over the large punitive damage awards that it was desperate to find a way to set a limit on what fen-phen litigation would cost the company.
Wyeth believed that a class action could alleviate the threat of enormous punitive damage awards providing that only a small number of patients decided to opt out of the class. Under the rules, people who rejected the class action outright could sue for punitive damages, but victims who did not opt out at the first stage, would be barred from seeking punitive damages if they later decided to sue Wyeth.
The company offered the plaintiffs a good reason to remain in the class by conceding causation so that class members who stayed would not have to prove that Pondimin or Redux caused their heart valve damage, only that they had valve damage after taking the drugs.
Wyeth also offered generous compensation to class members. At the high end of the payment schedule, plaintiffs with valve damage so severe that they had strokes, heart transplants or died could receive upwards of $1.3 million.
The low end of the schedule was about $7,500 for claimants whose medical testing showed evidence of significant valve damage but no other indication of serious heart disease.
The complaint also alleges that Wyeth's gross sales of Pondimin in the US increased from $3.7 million in 1993 to $150 million in 1996.
The lawsuit charges that the defendants knew that there were at least 41 reports of PPH associated with fenfluramine by the spring of 1994, and knew that the drug's label describing only four cases of PPH was false and misleading and that they intentionally concealed information, "in order to maximize sales and profits of Pondimin."
By 1996, the complaint says, defendants knew of at least 71 cases of PPH, including twelve deaths, while the Pondimin PDR entry continued to falsely state that there had been only four PPH cases, and only one case was fatal.
Defendants knew, it says, that PPH risks associated with Pondimin were relevant to the FDA's consideration of Redux because both drugs had the same active ingredient.
On December 10, 1997, the Judicial Panel on Multidistrict Litigation transferred all federal fen-phen lawsuits to the US District Court for the Eastern District of Pennsylvania for consolidated pretrial proceedings before the Honorable Louis Bechtle, Chief Judge Emeritus, and upon his retirement, on June 29, 2001, the litigation was reassigned to Judge Harvey Bartle III.
The first two fen-phen cases to go to trial turned out to be a disasters for Wyeth. One settled after several plaintiffs in Mississippi won over $100 million in compensatory damages and a Texas case resulted in a verdict that included high punitive damages.
On August 7, 1999, a Texas jury awarded 36-year-old Debbie Stone Lovett, $23 million. Legal experts said the verdict was significant being Wyeth tried the case believing that the facts were their favor. The case was reportedly settled during an appeal for $2.2 million.
In another 1999 trial in Oregon, Wyeth lost a $29.2 million verdict that eventually was settled for $15.5 million. In this case, Mary Linnen, took fen-phen for just 23 days before developing PPH.
A few months after she was diagnosed, Ms Linnen had to undergo surgery to insert a tube in her heart, so that she could inject a medication into her heart several times a day. Less than 3 months later she died and her family filed the first fen-phen wrongful death lawsuit against the company.
Legal experts say Wyeth was so alarmed over the large punitive damage awards that it was desperate to find a way to set a limit on what fen-phen litigation would cost the company.
Wyeth believed that a class action could alleviate the threat of enormous punitive damage awards providing that only a small number of patients decided to opt out of the class. Under the rules, people who rejected the class action outright could sue for punitive damages, but victims who did not opt out at the first stage, would be barred from seeking punitive damages if they later decided to sue Wyeth.
The company offered the plaintiffs a good reason to remain in the class by conceding causation so that class members who stayed would not have to prove that Pondimin or Redux caused their heart valve damage, only that they had valve damage after taking the drugs.
Wyeth also offered generous compensation to class members. At the high end of the payment schedule, plaintiffs with valve damage so severe that they had strokes, heart transplants or died could receive upwards of $1.3 million.
The low end of the schedule was about $7,500 for claimants whose medical testing showed evidence of significant valve damage but no other indication of serious heart disease.
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