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The case of a diet drug plaintiff in Philadelphia was recently bumped out of court at a preliminary stage after the drug’s manufacturer, Wyeth Corp., made a successful argument based on the learned intermediary doctrine. It’s not the first time Wyeth has won summary judgment in a fen-phen case by citing the doctrine, but, with the North Carolina plaintiff’s appeal to the Pennsylvania Superior Court, Common Pleas Judge Norman Ackerman has written an opinion explaining why he believes the plaintiff failed to meet her burden in Lineberger v. Wyeth. Patricia R. Lineberger of Lincolntown, N.C., filed her lawsuit against Wyeth in 2002. She alleged that taking the diet drugs Pondimin and Redux caused her heart valves to leak and that Wyeth failed to provide an adequate warning about the association between the drugs and valvular heart disease, according to the opinion. Lineberger’s case was one of thousands of individual cases pending in state court in Philadelphia against Wyeth, which used to market Pondimin and Redux. The corporation, then known as American Home Products, withdrew the diet-drug compound from the market in 1997 after medical studies reported it could cause heart trouble. Generally, the Philadelphia plaintiffs have met certain requirements for opting out of a massive nationwide settlement, but they cannot collect punitive damages against the corporation. In February, Wyeth moved for summary judgment, arguing that Lineberger was unable to establish that its failure to warn was the proximate cause of her alleged injuries. Ackerman concluded that Lineberger didn’t have sufficient evidence to show that her doctor wouldn’t have prescribed the drugs to her had he received a different warning from the drug’s manufacturer — one that specifically mentioned the drugs’ association with valvular heart disease. “Absent proof that a more thorough or explicit warning would have prevented plaintiff’s use of the drug, she cannot establish that defendants’ alleged failure to warn was the proximate cause of her injuries,” Ackerman wrote. Pennsylvania courts do not impose strict products liability on manufacturers of prescription drugs, and, therefore, the only recognized basis of their liability is a manufacturer’s neglect to warn of dangers associated with prescription drugs, Ackerman observed. That duty to warn does not run to the patient or the general public but to the prescribing physician, who judges the utility of the drug in light of knowledge of an individual’s medical history, Ackerman wrote. Thus, Wyeth’s duty to warn ran directly to Lineberger’s prescribing physician, John Lafferty, Ackerman explained. But Lafferty testified at deposition that he still would have prescribed the diet drugs to his patient even if Wyeth had provided a warning including the risk of valvular heart disease, according to the opinion. Describing the rationale behind the learned intermediary doctrine, Ackerman quoted a 1996 Superior Court case, Demmler v. SmithKline Beecham Corp.: Assuming a plaintiff established both the manufacturer’s duty and its failure to warn, the plaintiff “‘must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.’” That is, proximate cause is not assumed even when the failure to warn has been established, Ackerman noted. “Thus, where defendant has moved for summary judgment, in order to proceed to trial, the burden is on the plaintiff to come forward with evidence to show that a different warning would have caused her physician to change his prescribing habits,” he wrote. Lineberger had not done so. Lafferty, Lineberger’s doctor, testified at deposition that he specifically included Lineberger among a group of patients that he determined were good candidates for the diet-drug treatment because they were at a low risk of having a cardiovascular event, according to the opinion. Lafferty also swore in an affidavit that, “Even if the words ‘valvular heart disease’ had been added to the ‘warnings’ section of the label of the Physician’s Desk Reference while Pondimin and/or Redux were still on the market, I probably would have prescribed both drugs depending on the level of risk.” Ackerman concluded, “Given Dr. Lafferty’s uncontroverted testimony, this court had no choice but to conclude that he still would have prescribed Lineberger the diet drugs even if Wyeth had provided a warning including the risk of valvular heart disease.” Lineberger contended she was entitled to the presumption that she or Lafferty would have heeded an adequate warning of the risk of valvular heart disease had one been provided. Ackerman rejected this argument, saying “heeding presumption” has been applied exclusively to strict liability claims in Pennsylvania. Because Lineberger’s was a negligence claim, her argument “flies in the face of Pennsylvania jurisprudence and, thus, fails.” Lineberger also argued that the conduct of Wyeth’s sales representatives (“detail men”) nullified the warnings or gave her doctor a false sense of safety by not providing the warning on valvular heart disease, according to the opinion. Ackerman reasoned that the “warning” about valvular heart disease couldn’t have been nullified because Lineberger claimed there was no warning. Also, Lafferty testified that he didn’t recall specifically what he and a Wyeth sales person discussed, Ackerman noted. Lineberger’s attorney, Robert Curran of Curran & Byrne in Media, Pa., declined to comment last week. Reed Smith attorney Mike Scott, who has defended Wyeth in several fen-phen trials in Philadelphia, was pleased with the ruling. “We think he correctly decided it and accurately stated Pennsylvania law,” Scott said. He estimated that Wyeth has won summary judgment in at least six cases by citing the learned intermediary doctrine.

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