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From the Gulf Coast to West Texas, pharmaceutical company Wyeth scored two defense wins recently in fen-phen cases in the Lone Star State. In one of those cases, Wyeth stipulated to its liability and still walked away a winner. Wyeth won Roork v. Wyeth, et al. in Beaumont March 20. On March 1, a jury in the U.S. District Court for the Western District of Texas in Midland also found for the drug company, in Geers v. Wyeth. In Roork, Wyeth and its related entities stipulated to liability. In Geers, it didn’t. The question for defense and plaintiffs lawyers is: Does such a stipulation help the company win? In both cases, the plaintiffs alleged they suffered heart-valve damage after taking diet drugs prescribed in the combination known as fen-phen. J. Scott Nabers, one of the attorneys representing Gail Roork, says the jury’s verdict for Wyeth in that case was due, in part, to the defense’s stipulation to its liability in the case. By stipulating, Wyeth focused on the individual and did not focus on its own deeds, says Nabers, a partner in Houston’s Blizzard, McCarthy & Nabers. Nabers says Wyeth has filed similar stipulations of liability in all the fen-phen cases he currently has scheduled for trial. Prior to a national settlement approved in 2002, fen-phen litigation provided steady business for many Texas plaintiffs lawyers for several years. Plaintiffs lawyers began filing fen-phen suits within a day after the Food and Drug Administration asked drug companies to withdraw fenfluramine, the “fen” part of the diet-drug duo, and the related drug dexfenfluramine, or Redux, from the market in September 1997. [ See "Fat City: The Fen-Phen Feeding Frenzy,"Texas Lawyer , Feb. 9, 1998, page 1.] According to a November 1997 report by the Centers for Disease Control and Prevention, the FDA had received 144 physician-initiated reports by Sept. 30, 1997, that linked fenfluramine or dexfenfluramine to valvular heart disease. Nearly nine years later, the jury in Roork returned its verdict for Wyeth in a venue usually considered friendly to plaintiffs. Lawyers tried the case in front of the same judge and in the same court in which the former Houston firm of O’Quinn, Laminack & Pirtle won a $1 billion verdict in Coffey, et al. v. Wyeth, et al. in 2004. The family of a woman who died after taking one of the fen-phen drugs filed Coffey. However, Coffey involved a different kind of illness; the woman had suffered from primary pulmonary hypertension (PPH), a deadly lung disorder that can lead to heart failure. In addition to Coffey, Beaumont also was the venue of Hayes v. American Home Products Corp., et al., another fen-phen suit, which resulted in a $1.3 million verdict in 2003. Wyeth stipulated its liability in Hayes, says Kenneth T. “Tommy” Fibich. But the strategy wasn’t successful for the drug maker in that suit, he says. Fibich, a partner in Houston’s Fibich, Hampton & Leebron, is one of the Texas lawyers who filed a fen-phen class action against American Home Products Corp., Wyeth’s predecessor, in 1997. Fibich wasn’t involved in Hayes but says he keeps an eye on fen-phen litigation. He says he believes that Wyeth’s stipulation of liability was good for plaintiffs lawyers, because they only have to try the cause of the plaintiff’s injury and the amount of damages. “It cuts down on the expense and time of trying cases,” Fibich says. But one of Roork’s lawyers disagrees. By stipulating, Wyeth took the issue of general liability out of the suit, says Zona Jones, Nabers’ co-counsel in Roork and a partner in Provost Umphrey in Beaumont. Roork’s Case Roork, 72, alleged in her second amended petition that she suffered damage to her heart’s mitral valve after taking Pondimin from Dec. 12, 1996, to July 1997. Pondimin is the product name under which Wyeth marketed fenfluramine. In the petition, Roork sought up to $1 million in damages. In her petition, Roork also alleged that Wyeth placed the drugs on the market “in a defective and unreasonably dangerous condition as designed.” But Roork couldn’t present evidence of any allegations about the company’s conduct to the jury, Jones says. In a March 7 order, 172nd District Judge Donald Floyd instructed the jury in Roork that it must accept Wyeth’s stipulation with regard to the following: 1. The company was negligent in its marketing, manufacturing and design of Pondimin. 2. The risks of Pondimin outweighed any benefits. 3. Because the risks outweighed any benefits, the company is strictly liable for damages if Roork proves that her injuries were caused by the drugs. 4. The company failed to give adequate warnings of the known risk of valvular heart disease with Pondimin. Under Floyd’s order, all the jury could decide was whether Roork proved that she took Pondimin and whether taking the drug caused her alleged mitral valve injuries. If the jury found that Pondimin caused Roork’s injuries, it would determine the amount of damages she would recover. Nabers says he has been involved in fen-phen litigation since 1998. “Millions and millions of dollars have been spent to prove up the liability in these cases,” he says.
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But, Nabers says, by stipulating its liability, Wyeth is able to keep out of trials a host of documents the company doesn’t want juries to see. “It should prevent the introduction of irrelevant evidence,” Fields Alexander, one of Wyeth’s attorneys in Roork, says of the company’s stipulation to liability. Alexander, a partner in Beck, Redden & Secrest in Houston, declines comment on the defense’s reason for stipulating to liability. “What we do and why we do it is a matter of privilege between us and our clients,” he says. Joe Redden, Wyeth’s lead counsel in Roork and a partner in Beck, Redden, points to other reasons the Beaumont jury found for his client. Redden says some people certainly sustained heart-valve injuries from taking the diet drugs. “But it’s a relatively small number of people,” he says. Redden says the verdict in Roork shows that juries are beginning to figure out that taking the drugs may not have caused a number of people who file fen-phen suits to have valvular heart regurgitation disease. Wyeth contended in its second amended answer that Roork’s ingestion of Pondimin wasn’t a substantial cause of the valvular problems for which Roork sought damages. Redden says none of the doctors who treat Roork testified that her use of the diet drugs caused her heart-valve condition. “They all felt she had a number of other medical problems that were the likely cause,” he says. “This was a particularly tough case because Mrs. Roork is an elderly lady, and she had a number of other cardiac-related problems and disease processes,” Jones says. “I think it was quite easy for the defense to sway the jury with the other problems.” Geers’ Suit Wyeth did not stipulate to its liability in the Midland case, says G. Sean Jez, one of the attorneys for Patricia Geers. “We tried the liability and damages cases,” says Jez, an associate with Houston’s Fleming & Associates. The 53-year-old Geers alleged in her original petition that she suffered serious injuries to her heart valves as a result of taking the weight-loss medications. Geers alleged in the petition that Wyeth’s labeling of Pondimin and Redux was “misleading and inaccurate” and that Wyeth misbranded the drugs. Geers further alleged that Wyeth failed to conduct adequate testing of the drugs before marketing them. In its marketing efforts, Wyeth negligently misrepresented facts regarding fenfluramine and/or dexfenfluramine and their association with pulmonary hypertension and valvular heart disease, she alleged. Jez says Geers sought $200,000 in economic damages and an unspecified amount of non-economic damages. Jez says he thinks the court’s charge to the jury was a factor in the verdict. “The court mixed a failure-to-warn charge with a design-defect charge,” Jez says. “It made our burden harder to prove.” Pat Mizell and Kathleen Gallagher, Wyeth’s lead attorneys in Geers and partners in Vinson & Elkins in Houston, did not return two telephone calls placed to each of their offices before presstime March 23. But Gallagher argued in her March 1 summation to the jury that Geers has only mild aortic regurgitation. “Not a single doctor has told (Mrs. Geers to restrict her activity, (that she is impaired or will be impaired,” Gallagher told the jury, according to a transcript of her summation. Roork and Geers are intermediate opt-outs, meaning that they joined the national fen-phen settlement class but later decided to pursue their own suits. U.S. District Judge Harvey Bartle III of Philadelphia oversees the settlement. The settlement covers heart-valve claims, not the PPH claim at issue in Coffey. Fibich says conditions of the settlement, which the 3rd U.S. Circuit Court of Appeals approved in 2002, have impacted subsequent cases that have gone to trial. “There’s no doubt these cases are getting harder to try because of limits on evidence imposed in the class action settlement,” Fibich says. As part of the settlement, American Home Products and its successor, Wyeth, agreed to waive statute-of-limitations issues, enabling plaintiffs to decide later to opt out and seek jury trials. But, in return, the plaintiffs give up their rights to seek punitive damages and must limit their claims to two heart-valve conditions allegedly caused by fen-phen. [ See "Houston Lawyer Fights Evidentiary Ruling in Fen-Phen Litigation,"Texas Lawyer , April 21, 2003, page 6.] “It limits evidence that can be entered as to punitive damages,” Fibich says. Charlie Parker, counsel for the settlement class and a partner in Locke Liddell & Sapp and in Hill & Parker, both in Houston, says many of the plaintiffs who are intermediate opt-outs underwent medical testing that their attorneys arranged, rather than the testing provided through the settlement. “These intermediate opt-out cases may not have faced the toughest scrutiny in screening,” Parker says. Fibich says he has six or seven fen-phen suits scheduled to go to trial this year and he remains optimistic that juries will continue to rule for plaintiffs in this kind of litigation. “Wyeth has had a nice little run of luck, but we think the cards are going to change,” Fibich says. “We’re just not going to quit.”

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