Confidential Settlement
Six southern Illinois residents who claimed they suffered valvular heart disease after taking the diet drug fen-phen filed a products liability case in St. Louis City Circuit Court against American Home Products, now known as Wyeth Pharmaceuticals.
The plaintiffs — Russell Gaskins, Georgia McCuan, Selena McElvain, Gloria Smith, Larue Sumner and Connie Vance — ranged in age from 32 to 60. They all took fen-phen for more than 90 days, and claimed they developed either mild or moderate aortic insufficiency.
The plaintiffs originally participated in the national American Home Products settlement but were intermediate opt outs. As a result, they gave up their right to recover punitive damages.
In pretrial motions, AHP requested a reverse bifurcation at trial — that is, damages and causation would be tried first, and then liability. State court judges in Philadelphia have been trying fen-phen cases on a reverse bifurcation basis, and the federal judge overseeing the fen-phen multidistrict litigation has indicated this procedure will be used — in fact, defense attorneys have filed motions to enjoin all plaintiff's attorneys in state cases from arguing against reverse bifurcation.
The plaintiffs tried their St. Louis case under design defect and failure to warn theories. They contended that fen-phen, used for more than 90 days, caused plaque-like lesions to form on the heart valves, preventing them from closing completely and causing regurgitation of blood or leaky valves. Five of the plaintiffs had mild aortic regurgitation or insufficiency, and one had moderate insufficiency. Their experts claimed that AHP knew or should have known fen-phen caused valvular disease and failed to issue warnings before the product was taken off the market in September 1997.
The court applied the substantive law of Illinois, which allowed the plaintiffs to argue that there was an increased probability they would need valve replacement surgery — even though an expert could not testify to a reasonable degree of medical certainty that future surgery would be needed. The plaintiffs' expert said that the five individuals with mild aortic valvular insufficiency had a 5 to 10 percent increased risk of future valvular surgery, and that the individual with moderate insufficiency would more likely than not require valve replacement surgery.
He also testified that people with valvular heart disease have a two to five year decrease in life expectancy. In addition, he said they need annual echocardiograms and follow-up medical care such as prophylaxis antibiotic treatment before surgery or dental visits in order to avoid bacterial infection of the heart lining.
The defendants denied that the plaintiffs' valvular heart disease was caused by fen-phen or that valvulopothy caused by fen-phen is progressive. They introduced studies showing that many doctors believe valvulopothy decreases after fen-phen usage is stopped and that the need for valve replacement surgery is rare. In addition, they said there were other causes for the plaintiffs' aortic insufficiency.
The trial began on Sept. 13 and the plaintiffs completed their case in chief on Sept. 21. The defendants filed a motion for directed verdict as to all four counts. The plaintiffs agreed to drop their claim for breach of warranty in response to the defendants' motion, and the trial court denied the motion as to the other three counts.
In their case, the defendants pointed out that none of the plaintiffs had received echocardiograms until 2001, four years after the drug was removed from the market. They also noted that four of the plaintiffs did not have echocardiograms after 2001, and three of them never had one in their whole lives. The defendants argued that this showed the plaintiffs did not have any concern for their health.
The defendants said they were prepared to offer testimony from the plaintiffs' treating physicians that none of them had any restrictions on their activities, and there was no evidence, clinical or otherwise, that there was any change in their cardiac conditions in the seven years since they stopped taking fen-phen. According to the defendants, none of the treating cardiologists offered any testimony of a reduced life expectancy.
After the defense presented one day of evidence, the case was settled for a confidential amount on Sept. 22.
Type of Action: Products liability
Type of Injuries: Moderate aortic valvular insufficiency/regurgitation, mild aortic valvular insufficiency/re-gurgitation
Court/Case No./Date: St. Louis City Circuit Court/022-0268-B/Sept. 22, 2004
Caption: Gaskins, et al. v. American Home Products
Judge, Jury or ADR: Jury
Name of Judge: Jimmie Edwards
Special Damages: $120,000 to $350,000 future medical expense
Verdict or Settlement: Confidential settlement
Allocation of Fault: N/A
Last Offer: N/A
Last Demand: N/A
Attorneys for Plaintiff: John Carey and David Bauman, Carey & Danis, St. Louis; Jeffrey J. Lowe, Jeffrey J. Lowe PC, St. Louis; Mike O'Brien, Mike O'Brien PC, Houston, Texas; Andres Pereria, George Flemming & Associates, Houston, Texas
Attorneys for Defendants: Harvey Kaplan, Marie Woodbury and Matthew Keenan, Shook Hardy & Bacon, Kansas City
Insurance Carrier: None
Plaintiff's Experts: Cheryl Blume, Tampa, Fla. (pharmacologist, FDA expert); Dr. Harris Busch, Houston, Texas (pharmacologist); Dr. Grover Hutchins, Baltimore, Md. (cardiopathologist); Dr. Alan Maniet, St. Louis (cardiologist)
Defendant's Experts: Dr. Daniel Scharf, Overland Park, Kan. (cardiologist)
October 4, 2004
