Wallace v. Pharma Medica Research, Inc.

District Court, E.D. Missouri·Decided December 22, 2020·No. 4:18-cv-01859·Unknown

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MISSOURI EASTERN DIVISION

IAN WALLACE, ) ) Plaintiff, ) ) v. ) Cause No. 4:18-cv-01859-PLC ) PHARMA MEDICA RESEARCH, ) INC., et al., ) Defendants. )

MEMORANDUM AND ORDER This matter is before the Court on the “Daubert Motion to Strike Testimony and Opinions of Dr. Harry Hull” [ECF No. 102] filed by Defendants Pharma Medica Research, Inc. (“Pharma”), Tris Pharma, Inc. (“Tris”), Roxane Laboratories, Inc. (“Roxane”), Hikma Labs, Inc. (“Hikma”), and West-Ward Columbus, Inc. (“West-Ward”) (collectively, “Defendants”). Plaintiff Ian Wallace opposes the motion. This case arises from Plaintiff’s infection with hepatitis C virus. Plaintiff participated in medical research studies at Pharma’s facility in St. Charles, Missouri from March 23, 2016 through April 23, 2016 and June 10, 2016 through June 14, 2016. The studies, which were sponsored by Tris and Roxane,1 required Plaintiff to undergo frequent blood draws, which were performed by Pharma staff. In late June 2016, Plaintiff was hospitalized and diagnosed with acute hepatitis C.

1 Plaintiff alleges that Roxane “has been succeeded by West-Ward . . . and/or by Hikma . . . .” [ECF No. 76 at ¶ 4.] In his second amended complaint, Plaintiff alleges that he contracted the hepatitis C virus during the blood drawing process in one of the two studies at Pharma’s facility. [ECF No. 76.] Plaintiff brings claims of negligence and res ipsa loquitor against all Defendants. [Id.] Plaintiff designated Dr. Harry Hull, an epidemiologist, as one of Plaintiff’s experts. Dr. Hull opined “to a reasonable degree of medical and epidemiologic certainty” that:

1. [Plaintiff] developed an acute hepatitis C infection with onset of symptoms sufficient to seek medical care on June 25, 2016. 2. [Plaintiff] spontaneously cleared hepatitis C virus from his blood and does not have chronic hepatitis C infection. 3. It is more likely than not that the source of [Plaintiff]’s hepatitis C infection is an unrecognized unsterile needlestick during monitoring while he was participating in drug studies at Pharma Medica Research, Inc. in St. Charles, Missouri during March, April, and June 2016.

Dr. Hull’s report at 6 [109-2] and as supplemented [ECF Nos. 109-3, 109-4, 109-5].

Pursuant to Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993), Defendants move to exclude Dr. Hull’s report and opinions “relating [to] the causation of Plaintiff’s Hepatitis C.” Defendants argue Dr. Hull’s report and opinions do not satisfy the reliability requirements set forth in Rule 702 and Daubert. I. Legal Standard Rule 702 governs the admission of expert testimony. See Fed. R. Evid. 702; Hirchak v. W.W. Grainger, Inc., 980 F.3d 605, 608 (8th Cir. 2020). “Under Federal Rule of Evidence 702, testimony in the form of an expert opinion must be ‘based on sufficient facts’ and ‘help the trier of fact’ by applying the expert’s ‘specialized knowledge’ and ‘reliable principles and methods.’” Hirchak, 980 F.3d at 608 (quoting Fed. R. Evid. 702). See also Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir. 2001) (Rule 702 “codifies Daubert and its progeny”). “[T]he district court must … function as a gatekeeper who separates expert opinion evidence based on good grounds from subjective speculation that masquerades as scientific knowledge.” Adams v. Toyota Motor Corp., 867 F.3d 903, 916 (8th Cir. 2017) (quotation omitted). While decisions concerning the admission of expert testimony “lie within the broad discretion of the trial court,” Anderson v. Raymond Corp., 340 F.3d 520, 523 (8th Cir. 2003), “cases are legion that, correctly, under Daubert, call for the liberal admission of expert testimony.”

Johnson v. Mead Johnson & Co., LLC, 754 F.3d 557, 562 (8th Cir. 2014). “An expert’s opinion should be excluded only if that opinion is so fundamentally unsupported that it can offer no assistance for the jury.” Synergetics, Inc. v. Hurst, 477 F.3d 949, 956 (8th Cir. 2007) (quotation omitted). “Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.” Robinson v. GEICO Gen. Ins. Co., 447 F.3d 1096, 1100 (8th Cir. 2006) (quoting Daubert, 509 U.S. at 595). II. Discussion Defendants argue that Dr. Hull’s opinion relating to the causation of Plaintiff’s hepatitis C

infection is unreliable because Dr. Hull: (1) based his opinion on conjecture and improperly discounted other potential causes; and (2) is not qualified to render an opinion regarding hepatitis C. [ECF No. 103.] Plaintiff counters that Dr. Hull’s education and experience qualify him as an expert and his methodology was sound. [ECF No. 109] A. Dr. Hull’s Causation Opinion Plaintiff retained Dr. Hull to render an opinion on the source of Plaintiff’s hepatitis C infection. According to his curriculum vitae, Dr. Hull earned his medical degree at Johns Hopkins University in 1973 and is a “[p]hysician epidemiologist with 40 years of experience in infectious disease control.” [ECF No. 109-1 at 1.] He is licensed to practice medicine in Minnesota, certified by the American Board of Pediatrics, and a fellow of the American Academy of Pediatrics. [ECF No. 109-1 at 1-2.] Dr. Hull has worked as an epidemiologist at the: Centers for Disease Control and Prevention (CDC), New Mexico Health and Environment Department, and Minnesota Department of Health. [Id. at 1.] He also taught epidemiology at the University of Nevada School of Medicine, the University of Minnesota School of Medicine, and the University of Minnesota

School of Public Health. [ECF No. 109-2] Dr. Hull’s bibliography, which is attached to his curriculum vitae, lists 130 articles he authored or co-authored on topics including enteric diseases, poliomyelitis, measles, AIDS, and infectious diseases generally. [ECF No. 109-1 at 4-10.] Prior to completing his initial report, Dr. Hull reviewed various medical journal articles about hepatitis C, reviewed Plaintiff’s medical records and information relating to medical research studies that Plaintiff screened for and/or participated in, and examined and interviewed Plaintiff. [ECF No. 109-2.] In his initial report, Dr. Hull provided a narrative summary of Plaintiff’s medical research study participation for 2016. [ECF No. 109-2]. In particular, Dr. Hull reported that Plaintiff participated in a Pharma drug study from January 12, 2016 to February 1,

2016. He was screened on January 4, 2016, and found to have normal liver function, as well as negative tests for hepatitis C antibodies and drugs.

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Wallace v. Pharma Medica Research, Inc., (E.D. Mo. 2020).

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