Manous v. Mylan Pharmaceuticals Inc.

982 F. Supp. 2d 1277, 2013 U.S. Dist. LEXIS 165956, 2013 WL 6086025
District Court, W.D. Oklahoma·Decided August 23, 2013·No. No. CIV-11-1330-R·Published·Cited by 1 cases

Opinion

ORDER

DAVID L. RUSSELL, District Judge.

This matter comes before the Court on the Defendant’s Motion to Exclude the testimony of James Bartling, Pharm.D. and Brief in Support. Plaintiff responded in opposition to the motion. The Court conducted a hearing pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), on August 21, 2013. Having considered the parties’ submissions and arguments, the Court finds as follows.

This Court acts as a gatekeeper with regard to the admissibility of expert testimony. Bitler v. A.O. Smith Corp., 400 F.3d 1227, 1232 (10th Cir.2004). Rule 702 of the Federal Rules of evidence governs the admission of expert testimony:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.

The Court must determine whether the proffered expert’s opinion will assist the trier of fact, in this case, the jury, in understanding or determining a fact at issue in the case. Daubert, 509 U.S. at 592, 113 S.Ct. 2786. The Court’s analysis is intended to ensure that the expert testimony is both reliable and relevant. Id. at 589, 113 S.Ct. 2786. Plaintiff, as proponent of the expert, bears the burden of establishing the foundational requirements for admissibility of his expert’s testimony, in this case the testimony of James Bartling, Pharm.D.

This case involves the alleged manufacturing defect in a fentanyl transdermal patch distributed by Defendant Mylan Pharmaceuticals. Mrs. Manous died on March 12, 2010, and the medical examiner determined the cause of death was acute fentanyl toxicity.1 Mr. Manous thereafter filed this lawsuit alleging a products liability claim, whereby he will be required to prove that the Mylan patches at issue herein caused Mrs. Manous’ death, that the patches were defective when they left Defendant’s control, and that the defect [1280]*1280made the patches unreasonably dangerous to Mrs. Manous. See Kirkland v. General Motors Corp., 521 P.2d 1353, 1363 (Okla.1974). To that end, Plaintiff retained and listed Dr. Bartling, a pharmacist, as an expert, indicating he “will testify in accordance with his report that the Mylan Fentanyl Transdermal System Fentanyl patches at issue were defective and unreasonably dangerous and caused Carol Ann Manous’s death.” Doc. No. 36. Defendant challenges Plaintiffs attempt to rely on Dr. Bartling, arguing he is not qualified to provide the testimony Plaintiff contends he will offer, that his opinions are not reliable, and that his opinions are not relevant to this case.

There is no dispute that Dr. Bartling is a licensed pharmacist who serves as the Dean of Admissions for the Mercer University School of Pharmacy and dispenses prescription medication, although not opiates, at a free clinic in Georgia. There is similarly no dispute that this case does not involve the standard of care owed by a pharmacist to a person filling a prescription. Dr. Bartling opines in his report that because of Mrs. Manous’ medical history, including a diagnosis of painful multiple sclerosis, that she would be the type of consumer expected to use and be affected by the Fentanyl Transdermal System, that the system was intended to deliver a therapeutic dose of Fentanyl to the patient, and that the evidence establishes that Mrs. Manous was using the system as dispensed. He opines that an end user of the Mylan Fentanyl Transdermal System would not expect death to occur if the patches were used correctly, that Mrs. Ma-nous died despite her proper usage, and that “Mrs. Manous died as a result of the Mylan Fentanyl Transdermal System unexpectedly delivering an overdoes of Fentanyl to Mrs. Manous.” Bartling Affidavit, ¶ 35. He opined that the Fentanyl concentration in Mrs. Manous’ blood should not have exceeded 10 ng/ml, and that the amount of Fentanyl in her blood postmortem, 28.1 ng/ml, could not be accounted for solely as a result of post-mortem redistribution.

First, the Court finds that Dr. Bartling is not qualified to act as an expert in this matter in the manner Plaintiff seeks to utilize his testimony. Plaintiff correctly contends that Dr. Bartling was not required to have ever designed or manufactured a transdermal delivery system in order to act as an expert in this matter. Be that as it may, however, Dr. Bartling has no background related to any issues relevant in this case. Dr. Bartling admitted that he lacked expertise in the areas of toxicology, the postmortem redistribution of drugs, the design and manufacture of transdermal medication delivery systems, and he could not identify anything in particular that could have been defective with regard to the two patches Mrs. Manous was wearing at the time of her death.2 Dr. Bartling lacks a background in pharacokineties or pharmacodynamics. He admits that had has no basis to evaluate the manufacturing process. Bartling deposition, p. 148. In short, from the Court’s perspective, Dr. Bartling would perhaps be an appropriate expert to testify regarding the duty of care owed by a pharmacist to a customer. He is not, however, the appropriate expert to opine that the fact that the medical examiner determined that Mrs. Manous’ postmortem blood concentration of Fentanyl was 28.1 ng/ml and caused her death was correct, was not based on postmortem redistribution or that it was the [1281]*1281result of a defect in the Mylan Transdermal Fentanyl patches that Mrs. Manous was wearing at the time of her death.

The Court also finds that there is no method utilized by Dr. Bartling from which it can determine that his testimony is reliable. To determine the reliability of expert testimony, courts assess “whether the reasoning or methodology underlying the testimony is scientifically valid.” Daubert, 509 U.S. at 592-93, 113 S.Ct. 2786.

In Daubert, the Court listed four factors that, while not an exclusive list of considerations for a trial court, will often be important in making this assessment: (1) whether the opinion has been subjected to testing or is susceptible of such testing; (2) whether the opinion has been subjected to publication and peer review; (3) whether the methodology used has standards controlling its use and known rate of error; (4) whether the theory has been accepted in the scientific community.

Truck Ins. Exchange v. MagneTek, Inc., 360 F.3d 1206, 1210 (10th Cir.2004) (citing Daubert, 509 U.S. at 590, 113 S.Ct. 2786.)

From the Court’s perspective, there simply is no method or scientific information upon which Dr. Bartling relied that can be assessed by the Court. As noted above, the issues in this case do not involve Dr. Bartling’s particular area of expertise. Second, Dr. Bartling’s testimony appears to be the product of assuming that because Mrs.

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Manous v. Mylan Pharmaceuticals Inc., 982 F. Supp. 2d 1277, 2013 U.S. Dist. LEXIS 165956, 2013 WL 6086025 (W.D. Okla. 2013).

982 F. Supp. 2d 1277 (Manous v. Mylan Pharmaceuticals Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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