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In the late 1990s, Phyllis D. Hodges lost 50 pounds in eight months while taking the popular diet drug cocktail known as fen-phen. Her dieting success, however, was not without consequences. In April 2001, it was determined that Hodges’ heart valves were damaged and two months later doctors at the Mayo Clinic in Rochester, Minn., performed surgery to repair and replace the damaged valves. She’s now seeking damages against Madison, N.J.-based Wyeth Corp., the company that manufactured Pondimin, or the “fen” portion of the drug cocktail, and allegedly marketed the fen-phen combination as a safe, effective weight-loss remedy. Her case has moved to No. 1 on the list of 49 fen-phen complaints coming before Fulton State Court Judge Penny Brown Reynolds. The judge has devoted about 24 weeks of her 2005 calendar to the fen-phen cases and attorneys on both sides say they will try as many cases as they can over the next year. But, at least one defense attorney estimates it could take as long as six years to finish all 49 trials. Thus far, the only other fen-phen case to be brought before a jury in Georgia ended in November 2003 with a verdict for the drug company. But, Fulton Superior Court Judge Constance C. Russell granted a motion for new trial on Aug. 12 after the 3rd U.S. Circuit Court of Appeals revised the rules of evidence permitted in diet drug cases. Eichmiller v. American Home Products, 2002CV52077. (Fult. Sup. filed April 19, 2002) 53,000 REJECT SETTLEMENT DEAL The cases before Brown Reynolds are part of the nationwide diet-drug litigation. While Wyeth Corp. has entered into a national settlement agreement with most fen-phen users (some 5.8 million by the drug maker’s estimate), the company has taken a tougher stance against those, such as the litigants here, who’ve opted out of the settlement in search of higher awards. About 53,000 had filed fen-phen-related suits against Wyeth as of July 14, 2004. If these opt-out plaintiffs were expecting a simple negotiation to bring a larger check, they were wrong. After a string of headline-grabbing multi-million-dollar losses over the past five years, the drug company’s lawyers have been quietly collecting some verdicts of their own. So far this year, Wyeth’s attorneys succeeded at least eight times in persuading juries that fen-phen was not the cause of a plaintiff’s injuries. In one other Philadelphia case, five combined plaintiffs split a paltry award of just $4,000. That’s not to say 2004 has been all good news for the fen-phen defense. A jury in Beaumont, Texas, socked the drug maker last April with $113 million in compensatory damages and $900 million in punitives. However, unlike most of the fen-phen cases, the Beaumont trial was a wrongful death action. The only other trial to bring a seven-figure verdict this year was a Philadelphia case brought by four plaintiffs that ended in November with a verdict calling for aggregate damages of $2.1 million. The cases before Brown Reynolds will be unusual for Georgia because of the potential structure of the trials. As it has done in other jurisdictions, Wyeth is asking to split the trial into two parts and use a procedure called “reverse bifurcation.” In the first phase of the trial, the jury would decide the issues of causation and damages. In the second phase, liability would be decided. Lawyers on both sides of the case say they are not aware of reverse bifurcation being used before in Georgia. Whether reverse bifurcation will be used in the trials is up to former Court of Appeals Judge Marion T. Pope Jr., who has been assigned as a special master to resolve discovery and scheduling issues in the trials. Pope is expected to issue a ruling in December. DEBATING TRIAL PROCEDURE There’s an ostensible reason for using reverse bifurcation: the national settlement agreement bars opt-out plaintiffs from seeking punitive damages and the federal judge overseeing the agreement has warned of repercussions if “de facto” punitives become part of any state jury award. Judge Harvey Bartle III of the U.S. District Court for the Eastern District of Pennsylvania wrote in a September order he was “confident that the state court judges will see the wisdom” of using reverse bifurcation in fen-phen cases. “Moreover, if the state court judge proceeds in such a manner, any post-trial proceedings in this court to overturn an infected state court verdict, as alluded to by our [3rd Circuit] Court of Appeals, will likely be avoided,” Bartle wrote. Reverse bifurcation protects Wyeth from punitives because the damages have already been locked in at the front-end of the trial before any mention of the types of things that could presumably inflame the jury’s emotions. For instance, the jury would not hear about Wyeth’s marketing tactics and its negotiations with government regulators until the liability phase of the trial. Plaintiffs lawyers may not, at any point in the trials, discuss Wyeth’s size as a company, its sales, profits or financial condition. Besides preventing back-door punitives, the reverse-bifurcation process also could lead to earlier settlements, the drug company has argued. By knowing how much it’s on the hook for, Wyeth can decide relatively early whether it wants to go forward with the second phase of the trial once the jury comes up with a damages figure. So far in 2004, only one case using the reverse bifurcation method has made it all the way to the liability phase. At a hearing Nov. 19 in the Atlanta offices of Troutman Sanders, an attorney representing Wyeth, Phillip S. McKinney of Rogers & Hardin, argued that reverse bifurcation protects the drug company from punitives and leads to shorter trials while preserving the plaintiffs’ rights to present all of their evidence to the jury. “All of that evidence will get heard and it will get heard by the same jury,” he said. In addition to McKinney, Wyeth is being represented by Troutman attorneys Alan E. Lubel, N. Karen Deming and Kenneth Thompson Jr. Stephen M. Brooks and Stephen M. Lore of Nelson, Mullins, Riley & Scarborough, also are working for the defense. For their part, the plaintiffs’ attorneys don’t want to be the first to use reverse bifurcation in Georgia. In arguing against the unique trial procedure, Robert C. Buck of Schlueter, Buck & Childers said it would give Wyeth an unfair advantage in the trial by preventing evidence from being introduced in the first phase that is not specific to the plaintiff. Along with Buck, the plaintiffs in the Fulton State Court fen-phen cases are being represented by C. Andrew Childers, also of Schlueter, Buck & Childers, and Charles A. Mathis Jr. of The Mathis Law Firm. Buck said that in the Hodges case, he expects the drug company will attack his client’s medical history in a bid to show that the 49-year-old Memphis resident’s heart troubles may have stemmed from some other health ailment. According to an amended plaintiff’s fact sheet, Hodges has a history of obesity, depression and a half-pack-a-day cigarette habit. While those ailments will give the drug maker plenty of fodder to combat the causation issue, Buck said the reverse bifurcation process would prevent him from discussing in the first phase of the trial the “back story” of why Hodges’ doctors felt like the drugs were safe, what Wyeth knew about the dangers of fen-phen at that point and how the drugs were being marketed in spite of those dangers. “The evidence is what it is,” Buck said. “And we can’t help it if it makes Wyeth look bad and causes juries to be upset.” McKinney said it would be up to Brown Reynolds to decide if the “back story” as described by Buck would be relevant to the first phase of the trial. But, the lawyer noted at another point in the hearing that “Wyeth’s conduct has nothing to do with the plaintiffs’ medical expenses.” The other possible point of entry for punitives will be in the assessment of damages for mental pain and suffering. Again, using the Hodges case as an example, the plaintiff was initially diagnosed with a commonly fatal condition and naturally became upset upon hearing the news. The reasons for why doctors may have thought she had a fatal injury after using fen-phen will likely be part of the plaintiff’s case but the drug maker is attempting to block the introduction of such evidence because it could presumably lead to the jury learning that the drugs did lead to the deaths of several people, although none of them are related to the Hodges case. Hodges v. Wyeth, No. 2002VS 043365 (Fulton St. filed Dec. 30, 2002). DIET DRUG FAD QUICKENS The genesis of these drugs stretches back several decades before the ’90s diet drug fad came in full swing. In 1965, a fenfluramine forerunner to Pondimin was introduced in Europe under the trade name Aminorex. Medical evidence soon surfaced that Aminorex was associated with pulmonary hypertension and in 1972 the drug was removed from the European market. A year later, the U.S. Food and Drug Administration approved another fenfluramine drug, Pondimin, for use in the U.S. as an appetite suppressant by altering the serotonin level in the brain. However, according to the Fulton State Court suit, sales of the drug sagged because Pondimin causes lethargy. Decades later, the diet drug craze was unleashed when Dr. Michael Weintraub in 1992 published a series of articles in Clinical Pharmacology & Therapeutics describing his studies on fen-phen use and weight loss. Those articles failed to examine the safety of the drugs and instead focused on their effectiveness in managing obesity, the plaintiffs’ lawyers say. Nevertheless, Wyeth used Weintraub’s published studies to promote the drug cocktail to the public and, consequently, the fen-phen mania took off. Doctors prescribed fenfluramine along with an amphetmine-based diet drug, phentermine, to offset the sleepiness caused by Pondomin. The combo became known as “fen-phen.” While the FDA had approved both drugs individually, the combination of the two never received the government’s blessing. But, with the diet dreams of millions of obese Americans coming true, doctors fed the public’s desire for the drugs and in essence began a mass experiment of the combined use of fenfluramine and phentermine. Wyeth later introduced a variant of fenfluramine called dexfenfluramine. Upon the 1996 approval by the FDA, the drug was sold under the trade name “Redux.” TRAGIC RESULTS The results of the experiment were tragic. A Centers for Disease Control and Prevention report stated that approximately 14 million prescriptions for either fenfluramine or dexfenfluramine were written between 1995 and 1997. On July 8, 1997 the Mayo Clinic reported that it had discovered 33 cases of diet-drug users who developed heart valve problems. The FDA issued a health advisory the same day, warning doctors of the potential side effects associated with fen-phen. Then, at the urging of the government, Wyeth pulled Pondimin and Redux from pharmacy shelves on Sept. 15, 1997. In depositions, Phyllis Hodges said she felt “excited” when she began taking the popular diet drug cocktail known as fen-phen. A former employee at the DuPont chemical plant in Memphis, Tenn., Hodges stood 5-foot-4 and weighed about 250 pounds before taking fen-phen. In depositions, she blamed her weight problems on the inconsistent meal schedule forced on her by the “revolving” eight-hour shifts at the DuPont plant (one week of evenings, one week of overnight, one week of daytime). POPULARITY SPREADS In early 1996, she spoke with a co-worker who had lost a “ton” of weight and asked him his secret. He told her about the special diet medication. “All I remember him telling me is he took some diet pills, and I asked him what and he said ‘fen-phen,’” Hodges said in a deposition earlier this year. She spoke with her doctor who, in turn, informed Hodges that fen-phen, like all amphetamine-based diet pills at that time, was not available in Tennessee. So, Hodges joined the thousands of other Tennessee residents who sought out the diet drugs across state lines. In July 1996, she traveled close to two hours to a clinic in Paragould, Ark., where a doctor weighed her, measured her body fat and then wrote a prescription. She would lose 50 pounds before she stopped taking the drugs in July 1997 when the U.S. Food and Drug Administration issued its health advisory describing the results of the Mayo Clinic study. In October 1999, Hodges checked into an emergency room in Memphis coughing up blood and experiencing severe shortness of breath. The coughing subsided for a time but the shortness of breath continued. A year later, she visited a physician who left her with the impression that she had primary pulmonary hypertension, a commonly fatal condition in which the blood pressure in the arteries connecting the heart and lungs becomes abnormally high and eventually leads to cardiac failure. That prognosis was subsequently downgraded by the doctors at the Mayo Clinic who said she actually had heart valve trouble. In June 2001, Hodges underwent surgery at the Mayo Clinic where the doctors repaired and replaced her damaged valves. When the company entered into the national settlement agreement, it set up a system for awarding claims to diet drug users such as Hodges. According to Childers, one of Hodges’ attorneys, most of the opt-out plaintiffs would have received somewhere between $3,000 and $6,000 from Wyeth, depending on how long they used the drugs. If the diet drug user required surgery, the settlement amount was set according to the patient’s age and pre-existing conditions. The range of those awards stretch from $7,389 on the low end, to $1.48 million on the high-end. Childers noted that in order to receive the maximum, the diet drug user would have had to have died before age 24.

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