Janssen Pharm. Products, L.P. v. Hodgemire
| Decision Date | 13 August 2010 |
| Docket Number | No. 5D09-30.,5D09-30. |
| Citation | 49 So.3d 767 |
| Parties | JANSSEN PHARMACEUTICAL PRODUCTS, L.P., et al., Appellants/Cross-Appellees, v. Scott David HODGEMIRE, Personal, etc., Appellee/Cross-Appellant. |
| Court | Florida District Court of Appeals |
William E. Lawton and Lamar D. Oxford of Dean, Ringers, Morgan & Lawton, P.A., Orlando, Barry Richard of Greenberg Traurig, Tallahassee, Charles C. Lifland of O'Melveny & Myers LLP, Los Angeles, and Ernest W. Auciello of Tucker Ellis & West LLP, Cleveland, OH, for Appellants/Cross-Appellees, Janssen Pharmaceutical Products, L.P., and ALZA Corporation.
Bard D. Rockenbach and Philip M. Burlington of Burlington & Rockenbach, P.A., West Palm Beach, Joseph M. Taraska and Harry Jacobs of Jacobs & Goodman, P.A., Altamonte Springs, and E. Clay Parker of E. Clay Parker, P.A., Orlando, for Appellee/Cross-Appellant.
Appellants, Janssen Pharmaceutical Products, L.P., and ALZA Corporation, appeal from a jury verdict in favor of Appellee, Scott Hodgemire, as Personal Representative of the Estate of Susan Hodgemire, his deceased wife. Appellants challenge a number of pre-trial, trial, and post-trial rulings. With the exception ofthe trial court's ruling on a setoff, we affirm in all respects.1
One of the products Appellants advertise, manufacture, and distribute is Duragesic. Duragesic is a prescription transdermal patch that delivers a time-released dose of fentanyl, an exceptionally potent synthetic opiate. Mrs. Hodgemire was initially prescribed one 75 µg 2 Duragesic patch following spinal fusion surgery performed by Jewett Orthopaedic Clinic (hereinafter "Jewett"). Her prescribing doctor, Dr. Villalobos, subsequently doubled her dose after she continued to experience pain.
Several nights after her dosage was increased, Mrs. Hodgemire awoke Appellee complaining of nausea and vomiting over several hours. At her request, Appellee called the hospital and he was advised to call Jewett. Doing so, Mrs. Hodgemire spoke to Kurt Wood, an on-call physician's assistant at Jewett. Wood instructed Mrs. Hodgemire to take anti-nausea medication and call her family doctor the following Monday. Complying with these instructions, Mrs. Hodgemire returned to bed and fell asleep. Although he repeatedly checked on Mrs. Hodgemire the following morning, Appellee discovered his wife dead in the early afternoon. Following an autopsy, the medical examiner concluded Mrs. Hodgemire died from fentanyl toxicity, based in part on her postmortem blood fentanyl level of 22 ng/ml.3
Three claims were presented to the jury for its consideration: medical negligence against Wood; strict liability against Appellants for defectively manufacturing, designing, and failing to warn of the dangers associated with Duragesic; and a claim against Appellants for negligently manufacturing and failing to warn of the dangers associated with Duragesic.4
The primary issue at trial was whether Mrs. Hodgemire's postmortem fentanyl blood level could have been caused by properly working Duragesic patches. Appellee asserted that there was a defect in the design and manufacture of the patch, such that Mrs. Hodgemire received too much of the drug too quickly. In support, Appellee presented expert testimony, complaints of defective Duragesic patches, testimony of manufacturing defects, as well as evidence of a recall. The jury heard sharply conflicting testimony about whether a properly working patch could explain Mrs. Hodgemire's postmortem fentanyl blood level.
Appellee's experts testified that the maximum amount of fentanyl Mrs. Hodgemire would have received from two or three 5 properly working patches ranged from 3.4 to 9.3 ng, accounting for the mean plus two standard deviations higher. This testimony was predicated on Appellants' published data in the package insert that was included with the Duragesic patches. The package insert stated the mean "Maximal Concentration" for a person using one 75 µg patch to be 1.7 ng with a standard deviation of .7. Because Mrs. Hodgemire's blood fentanyl level was measured afterdeath, the experts also accounted for postmortem redistribution.
Postmortem redistribution is the process by which drugs stored in the body's tissues are released back into the bloodstream upon death. It is calculated by measuring the amount of a drug in central (heart) blood and femoral blood. Under the theory that femoral blood more accurately represents the antemortem level of a drug in a person's body, the central blood level is compared to the femoral blood level to develop a ratio.6 This ratio represents the amount a drug redistributes after death.7
In rendering their opinion on postmortem redistribution, Appellee's experts relied on two sources. The first source was a published journal article. The second source was an affidavit; it was prepared by the author of the journal article for another case and updated the research from the article with additional case studies. The research looked at deaths from the Los Angeles County, CA coroner's office where the decedent's blood tested positive for fentanyl. Taking those cases that reported central and femoral blood fentanyl concentrations, the affidavit concluded that the ratio of postmortem redistribution between central and femoral blood averaged 1:1.2.
Adopting the 1:1.2 postmortem redistribution fentanyl ratio from the affidavit, Appellee's experts multiplied the ratio with the maximum level of fentanyl they testified properly working patches would produce. Accounting for postmortem redistribution, the experts testified that the maximum amount of fentanyl they would have expected properly working patches to produce in Mrs. Hodgemire was 7.44 ng/ml for two patches or 11.16 ng/ml for three patches. Comparing this number to her postmortem level of 22 ng/ml, the experts concluded that Mrs. Hodgemire died from a lethal dose of fentanyl due to a failure in the Duragesic patch.
In stark contrast, Appellants' expert opined that a person using 150 g of Duragesic would have a blood fentanyl level between 1.5 to 13.5 ng/ml. 8 Placing emphasis on the fact that blood was not drawn from Mrs. Hodgemire until three days after her death, Appellants' expert testified that postmortem redistribution would increase the level of fentanyl in her blood by two to seven-fold. He also testified that the postmortem level of fentanyl only indicated that Mrs. Hodgemire used fentanyl and could not be used to predict or reach conclusions about her fentanyl level before she died. After hearing this and a wealth of other testimony, the jury returned a verdict in favor of Appellee, apportioning liability eighty percent against Appellants and twenty percent against Wood.
The first issue in their brief and primary focus at oral argument was the trial court's denial of Appellants' motion to exclude expert testimony that calculated Mrs. Hodgemire's antemortem fentanyl blood level from her postmortem blood level. Appellants challenged the testimony on the basis that it did not meet the Frye9 standard of admissibility. We review this issue denovo. Hildwin v. State, 951 So.2d 784, 791 (Fla.2006).
Before addressing the merits of Appellants' Frye challenge, this court requested supplemental briefing on whether this issue was preserved for review. Appellants contend they preserved the issue by raising it in a pre-trial motion in limine and receiving an adverse ruling. Appellee argues the issue was not preserved because Appellants did not expressly request a Frye hearing.
A party may preserve a Frye challenge by making a specific objection at trial. Thus, generally objecting to the expert under section 90.702, Florida Statutes, is insufficient. See United States Sugar Corp. v. Henson, 787 So.2d 3, 12 (Fla. 1st DCA 2000). Objecting that the expert's opinion goes to the ultimate issue in the case or that the expert is not competent to testify is also insufficient. See Hadden v. State, 690 So.2d 573, 580 (Fla.1997). Rather, the objection must challenge the expert's testimony on the basis that the "novel scientific evidence is unreliable." Id.
A party may also raise a Frye challenge pre-trial. The supreme court has recognized this as the better procedure because it minimizes any inconvenience to the jury. Ramirez v. State, 651 So.2d 1164, 1168 n. 4 (Fla.1995). If raised pre-trial, courts have recognized that, normally, an evidentiary hearing should be held. See United States Sugar Corp., 787 So.2d at 21; Holy Cross Hosp., Inc. v. Marrone, 816 So.2d 1113, 1121 (Fla. 4th DCA 2001) (). However, an evidentiary hearing is not always required. See United States Sugar Corp., 787 So.2d at 21. This is particularly true when the face of the motion indicates that the expert's testimony is not subject to a Frye analysis.
In this case, Appellants' motion in limine sought to exclude any expert who would calculate Mrs. Hodgemire's antemortem blood fentanyl level from her postmortem blood level because it did not "pass muster under Frye." At the hearing scheduled to resolve the parties' motions in limine, approximately twenty-four in total, Appellants introduced their Frye motion by stating: The trial court subsequently denied the motion, concluding the testimony was not subject to Frye.
Both Appellants' motion and argument at the hearing put opposing counsel and the trial court on notice that Appellee's experts were being challenged based on Frye. Although Appellants did not specifically request a Frye hearing, we believe they sufficiently preserved it for this court's review. However, we conclude that Appellee's experts' testimony was not subject to Frye.
A Frye inquiry ensures that the scientific principles and methodologies underlying an expert's testimony are generally accepted in the scientific community....
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