Crockett v. Luitpold Pharm.

KATHERINE CROCKETT, Plaintiff, v. LUITPOLD PHARMACEUTICALS, INC.; AMERICAN REGENT, INC.; DAIICHI SANKYO, INC.; DAIICHI SANKYO U.S. HOLDINGS, INC.; and VIFOR (INTERNATIONAL) AG, Defendant.

Civil Action No. 19-276

United States District Court, E.D. Pennsylvania

February 23, 2023

MEMORANDUM OPINION

WENDY BEETLESTONE, J.

This drug product liability case, one among many brought against Defendants by separate plaintiffs, arises out of the alleged injuries Plaintiff Katherine Crockett sustained after being administered Injectafer, an iron-replacement medication used to treat iron deficiency anemia. Plaintiff attributes her injuries to hypophosphatemia (“HPP”), a condition marked by low blood phosphorus levels. Plaintiff brings claims for negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, and fraud arguing, in relevant part, that the labeling for Injectafer failed to properly warn of the risks of HPP and that Defendants failed to exercise reasonable care in the testing monitoring, and pharmacovigilance practices associated with the product.

Defendants^[1]move to exclude the expert testimony of Plaintiff's expert George Samaras, Ph.D. pursuant to Federal Rule of Evidence 702 and Daubert v Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).

For the reasons below, Defendants' motion will be granted in part and denied in part.

I. FACTUAL BACKGROUND^[2]

Plaintiff's proposed regulatory expert George Samaras, Ph.D., is a biomedical scientist and interdisciplinary engineer whose “interest, expertise, and focus are medical product development across the full product lifecycle[.]” Samaras has two doctoral degrees, one in engineering management and another in physiology.^[3]He also has a number of licenses and certifications, including as to ergonomics and electrical/software engineering.

In his professional life, he has worked in different capacities on medical devices, including as to “health information systems and pharmaceutical container closure systems for combination medical devices.” He currently heads a private engineering practice “involved in software engineering, human factors^[4] engineering, computer systems validation, quality engineering, technical management consulting, expert testimony, and occupational & environmental health & safety research.”

Overall, he has “extensive experience (nearly four decades) working with regulated organizations,” during which he has assisted clients in developing quality management systems and obtaining premarket approvals from the FDA, as well as assisting them “in a variety of postmarket activities, with an emphasis on postmarket risk management.”

Samaras submitted a 156-page report, wherein he opines on, inter alia, the adequacy of Defendants' labeling for Injectafer and Defendants' pharmacovigilance system (i.e., the practices designed to manage the risks posed by the drug).^[5]Specifically, Samaras concludes the following:

• “Defendants did not engage in effective hazard communication for U.S. prescribers and U.S. consumers;”

• “Defendants did not implement an effective pharmaceutical risk management system to protect U.S. prescribers and U.S. consumers;”

• “Defendants did not use an effective pharmacovigilance system that would reliably manage serious and catastrophic injuries associated with the use of the Injectafer;” and

• “Defendants did not have an effective Quality Management System for marketing prescription-only medicines.”

II. LEGAL STANDARDS

Defendants' motion is governed by Daubert, 509 U.S. 579, which established a “gatekeeping role” for trial courts in admitting expert testimony. Oddi v. Ford Motor Co., 234 F.3d 136, 144 (3d Cir. 2000) (quoting Daubert, 509 U.S. at 597). The Daubert standard is codified in Federal Rule of Evidence 702, which provides:

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.

Fed. R. Evid. 702; see Durando v. Trustees of Univ. of Pennsylvania, 2022 WL 2467080, at *1 (E.D. Pa. July 6, 2022). The rule “embodies a trilogy of restrictions on expert testimony: qualification, reliability, and fit.” Durando, 2022 WL 2467080, at *1 (quoting Schneider ex rel. Est. of Schneider v. Fried, 320 F.3d 396, 404 (3d Cir. 2003)). The proponent of expert testimony has the burden of establishing its admissibility by a preponderance of evidence. Oddi, 234 F.3d at 144 (citing Daubert, 509 U.S. at 593 n.10).

A. Qualifications

To satisfy Daubert's qualification requirement, an expert must possess “specialized knowledge regarding the area of testimony.” Betterbox Comm'ns Ltd. v. BB Techs., Inc., 300 F.3d 325, 327 (3d Cir. 2002) (internal quotation omitted). “The basis of this specialized knowledge ‘can be practical experience as well as academic training and credentials.'” Waldorf v. Shuta, 142 F.3d 601, 625 (3d Cir. 1998) (citing American Tech. Resources v. United States, 893 F.2d 651, 656 (3d Cir. 1990); and Hammond v. International Harvester Co., 691 F.2d 646, 653 (3d Cir. 1982)). The qualification requirement is generally interpreted “liberally,” Pineda v. Ford Motor Co., 520 F.3d 237, 244 (3d Cir. 2008), and “a broad range of knowledge, skills, and training qualify an expert as such.” In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d Cir. 1994) (citation omitted). Nevertheless, an expert “must first be qualified by virtue of specialized expertise.” Moore v. State Farm Fire & Cas. Co., 2015 WL 5729266, at *1 (E.D. Pa. Sept. 30, 2015) (quoting Elcock v. Kmart Corp., 233 F.3d 734, 740-41 (3d Cir. 2000)).

B. Reliability

An expert's conclusions must “reliably flow from the facts known to the expert and the methodology used.” Oddi, 234 F.3d at 146 (citation omitted). “To satisfy the reliability requirement, ‘the expert must have good grounds for his or her belief,' not ‘subjective belief or unsupported speculation.'” T.N. Incorporation, Ltd. v. Fid. Nat'l Info. Servs., Inc., 2021 WL 5980048, at *2 (E.D. Pa. Dec. 17, 2021) (quoting In re Paoli R.R. Yard PCB Litig., 35 F.3d at 742). For testimony such as Samaras's, which does not involve the sort of strict “scientific knowledge” at issue in Daubert inasmuch as he opines on regulatory issues and risk management practices, reliability concerns typically “focus upon personal knowledge or experience.” Durando, 2022 WL 2467080, at *2 (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999)); cf. In re Paoli R.R. Yard PCB Litig., 35 F.3d at 742 n.8 (summarizing Daubert reliability factors typically applied to testimony involving scientific methods). The “reliability analysis applies to all aspects of an expert's testimony,” including “the link between the facts and the conclusion.” Heller v. Shaw Indus., Inc., 167 F.3d 146, 155 (3d Cir. 1999). “The reliability test is flexible and a district court enjoys ‘broad latitude when it decides how to determine reliability.'” Durando, 2022 WL 2467080, at *2 (quoting Kumho Tire, 526 U.S. at 142). When reliability questions go to the weight of an expert's proposed testimony rather than its admissibility, they become an issue suitable for the jury. See id. at *4.

C. Fit

“In assessing whether an expert's proposed testimony fits, [the question is] whether the expert testimony proffered is sufficiently tied to the facts of the case that it will aid the jury in resolving a factual dispute.” United States v. Schiff, 602 F.3d 152, 173 (3d Cir. 2010) (internal quotation, ellipses, and citation omitted). The fit of testimony goes “primarily to relevance.” Daubert, 509 U.S. at 591. Relevancy presents a “relatively low obstacle to clear.” Hausknecht v. John Hancock Life Ins. Co. of New York, 2022 WL 1664362, at *8 (E.D. Pa. May 25, 2022) (citing United States v. Ford, 481 F.3d 215, 219-20 (3d Cir. 2007)). “The Rules of Evidence embody a strong preference for admitting any evidence that may assist the trier of fact.” Pineda, 520 F.3d at 243 (citation omitted).

III. DISCUSSION

Defendants, while moving to exclude the whole of Samaras's testimony, focus on two topics of Samaras's report: the purported inadequacy of the Injectafer labeling and Defendants' pharmacovigilance program. Defendants argue that Samaras's testimony on these topics violates each of Rule 702's trilogy of requirements for admissibility.

A. Opinions Drawing Legal Conclusions Will Be Excluded

In addition to the two topics of testimony identified by Defendants as objectionable, there is preliminary issue to be addressed. Samaras draws a number of impermissible legal conclusions bearing on the issues in this case in his expert report. For instance, Samaras opines, inter alia that “US federal regulations controlling drug labeling were improperly followed”; “repeated failures to update the labeling, rendering it false & misleading . . . meets the definition of the regulatory term ‘misbranded'”; and “Defendants' activities, decisions, conduct, and omissions fall below the standard of care.” Expert witnesses are “prohibited from rendering a legal opinion.” Berckeley Inv. Grp., Ltd. v. Colkitt, 455 F.3d 195, 217 (3d Cir. 2006). “While Rule 704 allows experts to provide an opinion about the ‘ultimate issue' in a case, it prohibits experts from opining about the ultimate legal conclusion or about the law or legal standards.” Patrick v. Moorman, 536 Fed.Appx. 255, 258 (3d Cir. 2013) (citations omitted). ...