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Janssen Pharmaceutical Products, L.P. v. Hodgemire
Citations: 49 So. 3d 767; 2010 Fla. App. LEXIS 11781; 2010 WL 3191767Docket: No. 5D09-30
Court: District Court of Appeal of Florida; August 13, 2010; Florida; State Appellate Court
Appellants, Janssen Pharmaceutical Products, L.P. and ALZA Corporation, appeal a jury verdict favoring Appellee Scott Hodgemire, representing the estate of his deceased wife, Susan Hodgemire. They contest several pre-trial, trial, and post-trial rulings but affirm all except for a trial court ruling related to a setoff. The case involves the Duragesic transdermal patch, which delivers fentanyl, a potent synthetic opiate. Susan Hodgemire was prescribed a 75 µg patch after spinal surgery, and her dosage was later increased due to ongoing pain. Soon after, she experienced nausea and vomiting, leading to a call to the hospital for advice. Following instructions from an on-call physician’s assistant, she returned to bed and was found dead the next day. An autopsy determined her death was due to fentanyl toxicity, with a postmortem blood level of 22 ng/ml. Three claims were presented: medical negligence against the physician's assistant, strict liability against the Appellants for defective manufacturing and inadequate warnings regarding Duragesic, and negligence in manufacturing and warning. The primary trial issue was if her fentanyl level could be attributed to properly functioning patches. Appellee argued there was a defect in the patch's design, causing an overdose. Expert testimony indicated that the expected fentanyl from properly functioning patches would range from 3.4 to 9.8 ng, based on Appellants’ own data in the package insert. The experts considered postmortem redistribution when evaluating blood fentanyl levels, using both a published journal article and an updated affidavit from its author, which discussed fentanyl-related deaths in Los Angeles County. The affidavit indicated that the average postmortem redistribution ratio of fentanyl between central and femoral blood was 1:1.2. Utilizing this ratio, the Appellee’s experts calculated that properly functioning Duragesic patches would yield a maximum fentanyl concentration of 7.44 ng/ml for two patches or 11.16 ng/ml for three patches in Mrs. Hodgemire, while her actual postmortem level was 22 ng/ml. Consequently, they determined her death resulted from a lethal dose of fentanyl due to a malfunctioning patch. In contrast, the Appellants’ expert asserted that a user of 150 g of Duragesic would exhibit blood fentanyl levels between 1.5 to 13.5 ng/ml, emphasizing that blood drawn three days postmortem would have undergone redistribution, potentially inflating levels by two to seven times. This expert argued that the postmortem fentanyl level alone could not reliably indicate the level prior to death. Ultimately, the jury ruled in favor of the Appellee, attributing 80% liability to the Appellants and 20% to Wood. The Appellants' primary contention on appeal concerned the trial court’s rejection of their motion to exclude expert testimony regarding the calculation of Mrs. Hodgemire’s antemortem fentanyl level based on her postmortem level, which they claimed did not satisfy the Frye standard for admissibility. The court reviewed this issue de novo and sought supplemental briefs on whether the issue was preserved for appeal. Appellants argued that they preserved the issue through a pre-trial motion in limine, whereas the Appellee contended that it was not preserved due to the lack of an explicit request for a Frye hearing. The court clarified that a specific objection to the expert's testimony based on the unreliability of novel scientific evidence is necessary for preservation, and a pre-trial challenge is generally preferred. Appellants' motion aimed to exclude expert calculations of antemortem levels, citing scientific unreliability, but the trial court ultimately denied the motion, finding the testimony did not require a Frye analysis. Appellants' motion and arguments indicated a challenge to Appellee's experts based on Frye standards, which assess the general acceptance of scientific principles underpinning expert testimony. Although Appellants did not explicitly request a Frye hearing, they adequately preserved the issue for review. However, the court determined that Frye did not apply to Appellee's experts' testimony, as it is only relevant when an expert's opinion is based on new or novel scientific techniques. Appellants contended that Appellee's experts improperly extrapolated Mrs. Hodgemire's antemortem fentanyl blood level from her postmortem level of 22 ng/ml by accounting for postmortem redistribution. The court found this argument unconvincing, clarifying that Appellee's experts compared the postmortem level against expected levels from properly functioning Duragesic patches, rather than using back-extrapolation. Additionally, Appellants challenged the scientific basis of the experts' assertion that the average postmortem redistribution ratio for fentanyl was 1:1.2, arguing that medical literature does not support this figure and indicates individual variability. However, this challenge did not raise a Frye issue, as the underlying theory and methodology of postmortem redistribution were generally accepted by both parties. Consequently, the court concluded that Appellee's experts did not need to demonstrate general acceptance for their specific opinions regarding postmortem redistribution amounts. Appellants argue they are entitled to a setoff from Jewett's settlement with Appellee, calculated based on the jury's established ratio of economic damages to total damages, claiming a setoff amount of $55,775. Appellee conceded error during oral arguments, leading to a remand for a corrected judgment. Appellants' other arguments on appeal were rejected. The court affirmed in part, reversed in part, and remanded the case. Judges Torpy and Evander concurred, while Judge Cohen concurred specially, stating that the affirmation made it unnecessary to address issues from Appellee’s cross-appeal. Complications arose from the absence of Duragesic patches removed from Mrs. Hodgemire, as they were not retained by the medical examiner. Disputes included whether she was using two or three patches at her death, and the understanding that more fentanyl may leech back into the heart than the femoral artery. Due to the unpredictable nature of fentanyl-related deaths, studies on postmortem redistribution are limited to postmortem fentanyl blood analysis. The evidence presented was considered extreme compared to Appellants’ package insert and Appellee’s expert testimony. Unlike this case, the trial in Battle v. Gold Kist had substantial studies on blood measurement reliability in postmortem redistribution for cannabis, whereas the current trial only included counsels' arguments.