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The Legal Intelligencer A Philadelphia judge has upheld a $5 million verdict rendered over a 1-year-old’s death allegedly due to liver failure from an overdose of Infants’ Tylenol, in part because the judge said the makers of the over-the-counter drug filed a 29-point statement of matters in violation of Rule 1925(b). McNeil-PPC Inc. has appealed Judge Annette M. Rizzo’s decision in Dunson v. McNeil-PPC Inc. to the Pennsylvania Superior Court. Rizzo said the appeal should be quashed because the defense violated Rule 1925(b). “Appellant has attempted to overwhelm this court by filing a Rule 1925(b) statement that contains an excessive number of issues that could not possibly be raised on appeal due to briefing constraints of Pa.R.A.P. 2116,” wrote Rizzo in her Sept. 12 decision. “The five-page, 29-issue length of the instant statement of matters, unless significantly reduced, will surely result in a violative statement of questions involved. . . . Appellant’s conduct with respect to the statement of matters breaches the duty of good faith and fair dealing with the court.” She said the defendant made “very little effort” to refine the issues raised on appeal. “Appellant’s conduct with respect to the statement of matters breaches the duty of good faith and fair dealing with the court and constitutes a course of misconduct,” designed to undermine the appellate procedural rules, Rizzo said. According to the opinion, Marquis Dunson died March 2002 after being administered Infant’s Tylenol for three days to treat his cold symptoms. The plaintiffs argued that Dunson died from acetaminophen toxicity and that the warning labels and directions on the Infant’s Tylenol label were not clear that an overdose from acetaminophen, Tylenol’s active ingredient, can lead to liver toxicity. McNeil countered that Dunson’s death was from an unrelated viral hepatic injury and that the parents had failed to follow the medicine’s instructions and warnings. The Philadelphia jury sided with the plaintiffs’ argument in its July 2006 verdict that the Infant’s Tylenol warning labels were defective and contributed to Dunson’s death. Dunson’s parents, Martin and Lisa, testified they would not have given the medicine to their son if it included a warning that it could cause liver damage or death, Rizzo said. According to Rizzo, the defense failed to preserve at trial or in its motion for post-trial relief whether she erred in allowing the plaintiffs to purse a strict liability theory, rather than a negligence theory, among other issues. McNeil-PPC Inc., owned by Johnson & Johnson, renewed the argument in their appellate brief filed last week that Rizzo erred in ruling that federal law did not preempt the claim in the case, in allowing the plaintiffs to assert a strict liability theory rather than a negligence theory, in ruling that the lack of use of example warnings offered by the plaintiffs had “proximately caused the injury” and ruling that plaintiffs had sufficiently established for the jury to find that Infants’ Tylenol is “unreasonably dangerous,” among several other issues. McNeil argued in its brief that it preserved the issues raised on appeal. “McNeil first raised the insufficiency of plaintiffs’ proof of causation as to each of their warning theories in a motion in limine and its motions for nonsuit. . . . McNeil also asked the court to determine that Infants’ Tylenol is not unreasonably dangerous in its motions for nonsuit,” the brief said. “McNeil argued that negligence, rather than strict liability, standards should be applied to the case. . . . McNeil preserved its challenge to the court’s exclusion of evidence of the conclusions of the [Federal Drug Administration] by identifying the testimony and opposing plaintiffs’ pre-trial motion to exclude this evidence.” Bruce Clark, one of McNeil’s attorneys from Dechert LLP, deferred comment to Johnson & Johnson in-house attorney John Kim. Kim did not respond to a phone call Friday afternoon. During the trial McNeil argued Dunson’s liver problems were caused by a virus, but during closing arguments the defense shifted to arguing that Dunson’s parents also administered other cold remedies to their son and that combined use of other drugs with Infant’s Tylenol caused him unintended harm, Rizzo said. A. Roy DeCaro of Raynes McCarty, a plaintiffs attorney for the parents, praised Rizzo’s opinion and said that the defense shifted their legal theories both in the trial court and now at the appellate level. “I always think it’s a mistake to do a shotgun appeal,” DeCaro said. “They did it before the trial judge and now they’re doing it again before the Superior Court.” Rizzo said in her opinion ruling against McNeil that negligence concepts are firmly prohibited in products liability matters; that the defendants did not present any evidence that the FDA considered failure to warn claims to be pre-empted by federal law; and that the plaintiff theories of liability were supported by the introduced evidence. “Evidence was presented, however, to support appellees’ other theories of liability – that the Infant’s Tylenol was defective because it lacked any one of the following warnings that the use of the product could cause death; that use of the product could cause liver damage; and that the product was three times as potent as Children’s Tylenol. Said evidence, which was considered by the jury in its finding of both a defect and causation, was sufficient as to those specific theories which were submitted to the jury,” Rizzo said. The case is indicative of the trend of some drugs for infants being pulled off the market, DeCaro said. “Parents need to know about these baby and children’s drugs,” the plaintiff’s attorney said. The plaintiffs must file their appellate brief by Nov. 28. (Copies of the 31-page opinion in Dunson v. McNeil-PPC Inc. , PICS No. 07-1733, are available from The Legal Intelligencer . Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information. Some cases are not available until 1 p.m.)

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