Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

In re Zofran (Ondansetron) Products Liability Litigation

United States District Court, D. Massachusetts

October 23, 2019



          Dennis Saylor IV United States District Judge

         This is a multi-district litigation (“MDL”) proceeding arising out of product-liability claims that the use of the drug Zofran (ondansetron) by pregnant women caused certain types of birth defects in their children.

         Defendant GlaxoSmithKline LLC (“GSK”) has moved to strike the second supplemental report of one of plaintiffs' expert witnesses on general causation, Dr. Bengt R. Danielsson. Dr. Danielsson previously filed an expert report in this matter in July 2018. In that report, he opined that, based on his review of the available medical literature, the use of Zofran by pregnant women can cause a variety of birth defects.

         Since Dr. Danielsson's initial report, three relevant studies-one by Huybrechts et al., one by Parker et al., one by Zambelli-Weiner et al.-have been published. Dr. Danielsson has twice supplemented his initial report to address the Parker and Zambelli-Weiner studies: once in a brief report on November 23, 2018, and a second time in a more detailed submission on February 28, 2019. As for the Huybrechts study, Dr. Danielsson has supplemented his initial report to address it only once, in his submission on February 28, 2019.

         The issue before the Court is whether that February 2019 report was timely under Fed.R.Civ.P. 26. For the reasons set forth below, the Court concludes that it was timely as to the Huybrechts study, but not as to the Parker and Zambelli-Weiner studies, and that exclusion of the untimely portion of the report is appropriate. Accordingly, GSK's motion to strike will be granted as to those portions of the February 2019 report.[1]

         I. Background

         Dr. Bengt. R. Danielsson, M.D., Ph.D. is a physician and teratologist. A focus of his research is how drug-induced alterations in the heart rhythms of human embryos can cause various birth defects. Plaintiffs have engaged Dr. Danielsson to opine on whether Zofran “is capable of causing birth defects such as congenital heart defects and orofacial clefts.” (Danielsson Report at 1).

         On May 17, 2018, this Court issued MDL Order No. 25. Among other things, that order set a timetable for “[e]xpert discovery on general causation and general liability issues.” (MDL Order No. 25 (Docket No. 1006)).[2] It provided that plaintiffs were to serve “expert disclosures under Fed.R.Civ.P. 26(a)(2), including expert reports, ” by July 16, 2018. (Id.). The order did not set a deadline by which the parties were required to supplement their expert disclosures. (See id.).

         On July 10, 2018, Dr. Danielsson submitted his initial expert report in this matter.[3] In that report, he concluded that Zofran “is capable of causing congenital heart defects and orofacial defects, both in animals and in humans, through the hERG-mediated mechanism of teratogenicity.” (Danielsson Report at 68). He wrote that in forming his opinion, he had considered “the totality of the available evidence, ” including, among other things, several epidemiological studies in humans. (Id. at 3-4). While he relied on at least one abstract from an epidemiological study, (Id. at 5 (Andersen et al., 2013a)), he apparently did not consider the abstracts from three epidemiological studies that were eventually published later in 2018: Huybrechts, Parker, and Zambelli-Weiner. (See Id. at References).[4]

         On August 27, 2018, Dr. Danielsson submitted a “Supplemental and Rebuttal Expert Report.” That report also did not address the Parker or Zambelli-Weiner studies.

         On October 12, 2018, GSK deposed Dr. Danielsson. Dr. Danielsson confirmed that he had neither reviewed the Parker study nor discussed it in either his initial or his rebuttal report. (Danielsson Dep. at 112:17-113:7). Counsel for GSK asked why he had not reviewed the study in order to prepare his rebuttal report even after GSK's own experts referred to it. (Id. at 120:21-122:16). He replied that he had not had the opportunity to read every study cited by GSK's experts, and that he was “on holiday” when the Parker study came out and could not spend “every day looking at the reference list.” (Id. at 121:14-17). He also had not reviewed an abstract for the Huybrechts study, which had not yet been published at that point. (Id. at 389:17-21).

         On November 23, 2018, Dr. Danielsson submitted an “Additional References Considered” list, which listed the Parker and Zambelli-Weiner studies. (GSK Mem., Ex. C). At the bottom of the list, Dr. Danielsson wrote that “[h]aving considered this additional material . . . my opinions from my expert report are unchanged.” (Id.).

         Dr. Danielsson's most recent report is dated February 28, 2019. (GSK Mem., Ex. F (“Danielsson 2019 Report”) at 3). It is three pages long. (Id.). GSK contends that it did not receive the report until March 15, 2019. (GSK Mem. at 3). In that report, Dr. Danielsson describes the Huybrechts, Parker, and Zambelli-Weiner studies; interprets their results; and concludes that they do not alter the opinion he offered in his initial report. (See id.). Curiously, he does not include the Parker article, which he discusses, on his list of additional references considered. (Id. at 3).

         GSK has moved to strike Dr. Danielsson's February 2019 report.

         II. Legal Standard

         A. Fed R. ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.