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In re Zofran (Ondansetron) Products Liability Litigation

United States District Court, D. Massachusetts

October 8, 2019

IN RE ZOFRAN (ONDANSETRON) PRODUCTS LIABILITY LITIGATION This Document Relates To: All Actions

          MEMORANDUM AND ORDER ON PLAINTIFFS' MOTION TO STRIKE EVIDENCE FROM GSK'S RENEWED MOTION FOR SUMMARY JUDGMENT BASED ON PREEMPTION

          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.

         On July 19, 2018, defendant GlaxoSmithKline LLC (“GSK”) moved for summary judgment based on federal preemption-in substance, on the ground that state-law claims of failure to provide an adequate warning label were preempted by federal law. Among other things, GSK contends that the federal Food and Drug Administration has twice rejected label changes containing warnings similar to those that plaintiffs contend should have been provided. The Court denied that motion on February 5, 2019, having concluded that the issue was one of fact for the jury to decide and that there were disputed issues of material fact precluding summary judgment.

         On May 20, 2019, the Supreme Court held in Merck Sharp & Dohme Corp. v. Albrecht, 139 S.Ct. 1668, 1679 (2019), that the issue of federal preemption in a pharmaceutical product liability case must be treated “not as a matter of fact for a jury but as a matter of law for the judge to decide.” This Court then vacated the relevant portions of its February 5 order.

         On July 22, 2019, GSK renewed its motion for summary judgment on preemption grounds.[1] When it renewed its motion, it submitted four witness declarations, which had not been submitted with its original motion, and 139 other exhibits consisting almost entirely of items such as deposition transcripts, internal GSK documents, journal articles, and documents from the FDA. Plaintiffs have moved to strike all evidence submitted with GSK's motion that was not previously part of the summary judgment record.

         For the following reasons, plaintiffs' motion to strike will be granted as to the declarations of Dr. Dena Hixon, Dr. Gary Shaw, and Dr. Patrick Wier, which are GSK's Exhibits 1, 3, and 4, and will otherwise be denied.

         I. Background

         A. The Preemption Issue Generally

         Zofran is an anti-emetic-that is, a drug that prevents or treats nausea or vomiting. It was initially approved by the Food and Drug Administration in 1991 for the prevention of nausea and vomiting induced by chemotherapy or radiation therapy and post-operative nausea and vomiting.

         Zofran was not approved, and never has been approved, for the prevention of nausea and vomiting in pregnancy. Nonetheless, Zofran has been prescribed off-label to pregnant women for many years. According to plaintiffs, that widespread practice was due in large part to unlawful marketing practices by GSK that sought to promote off-label usage.

         At some point, the FDA became aware that Zofran was being prescribed to pregnant women in significant numbers. In 2010, the FDA requested that GSK provide supplemental information concerning the safety of Zofran when used during pregnancy. In response, GSK provided an analysis of the then-available safety data. The FDA did not require any labeling changes. In 2013, a citizen petition requested that the FDA revise the Zofran label to indicate an increased risk to fetal safety if ingested during pregnancy. The FDA rejected that request. In 2015, the current manufacturer of Zofran, Novartis, submitted a proposed label change to provide, among other things, a warning that use in pregnancy could cause harm to the fetus and is not recommended. That, too, was rejected.

         In short, whether Zofran poses a risk to fetal safety has been considered, and rejected, by the FDA on multiple occasions since the drug's initial approval. Even today, it is not contraindicated for use during pregnancy, and its label contains no enhanced form of warning for such use. Indeed, the current label states that “[a]vailable data do not reliably inform the association of Zofran and adverse fetal outcomes.”

         Plaintiffs nonetheless contend that ingestion of Zofran during pregnancy in fact causes birth defects, that the label should contain such a warning, and that GSK's failure to provide such a warning should result in tort liability under state law. Plaintiffs contend that the FDA's initial approval of Zofran in 1991, and its subsequent rejection of label changes, were based on incomplete information-essentially, because GSK withheld certain data from the FDA and made material misrepresentations. GSK denies that it withheld information and contends that any state-law failure-to-warn claims are preempted by federal law.

         B. Procedural Background

         The present dispute principally concerns the filing of additional declarations by GSK in support of its renewed motion for summary judgment, which plaintiffs contend are untimely expert disclosures. A review of the procedural background is necessary to address that issue.

         On May 17, 2018, this Court issued MDL Order No. 25. Among other things, that order provided that discovery as to “Phase 3, ” which was defined as “discovery as to general causation and preemption issues, ” should conclude by June 29, 2018, and “may proceed” after that date “only by agreement of the parties or by leave of court upon good cause shown.” (MDL Order No. 25 (Docket No. 1006)). It further provided that “any motion for summary judgment based on preemption” should be filed by June 15, 2018. (Id.).

         MDL Order No. 25 also set a timetable for “[e]xpert discovery on general causation and general liability issues.” (Id.).[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, and that GSK was to do so by August 6, 2018. (Id.).

         On June 11, 2018, the Court extended the deadlines for GSK to file a summary judgment motion on preemption to July 2, 2018. (Docket No. 1030).

         On June 27, 2018, the Court extended the deadlines for expert disclosures concerning general liability issues. (Docket No. 1036). Under the revised deadlines, plaintiffs' expert disclosures were to be served by July 31, 2018, and GSK's were to be served by September 21, 2018. (Id.).

         On July 2, 2018, GSK timely filed its initial motion for summary judgment based on federal preemption. GSK submitted a number of exhibits with that motion, but did not submit any expert affidavits. (See Hill Decl. (Docket No. 1042)).

         On August 1, 2018, plaintiffs filed an opposition to GSK's motion for summary judgment. Plaintiffs submitted a number of exhibits with that opposition, but did not submit an expert affidavit on regulatory or preemption issues. (See Jenner Decl. (Docket No. 1105)).

         On August 6, 2018, GSK timely disclosed an expert report of Dr. Gary Shaw, one of its general causation experts. (GSK's Opp., Ex. J). Dr. Shaw's report did not directly touch on preemption issues.

         On August 15, 2018, GSK filed a reply memorandum, together with multiple exhibits, in support of its motion for summary judgment on preemption. Again, no expert report on regulatory or preemption issues was submitted. (See Hill Decl. (Docket No. 1126)).

         On September 11, 2018, plaintiffs filed a supplemental memorandum of law in opposition to GSK's motion for summary judgment, together with additional exhibits. Among the exhibits was an expert report from Dr. Brian Harvey dated August 30, 2018, addressing certain regulatory and preemption issues. (See Jenner Decl. (Docket No. 1155), Ex. 5).

         On September 13, 2018, the Court heard oral argument on the motion for summary judgment and took the matter under advisement.

         On September 21, 2018, GSK timely disclosed to plaintiffs an expert report of Dr. Dena Hixon, a regulatory expert, who addressed preemption issues. (GSK's Renew. Mot. for Summ. J., Ex. 17).

         On October 2, 2018, plaintiffs filed a revised version of Dr. Harvey's expert report. The revised version included an affirmation that it was signed under oath, without any change to the substance of the report.

         On February 5, 2019, the Court issued its opinion denying GSK's motion for summary judgment based on preemption. Among other things, the Court held that the preemption issue involved disputed issues of material fact that should be resolved by a jury.

         On February 26, 2019, the Court issued MDL Order No. 31. (Docket No. 1355). That order provided, among other things, that “GSK's case-specific expert disclosures under Fed.R.Civ.P. 26(a)(2), including expert reports, ” should be served by April 5, 2019. (Id.). The order further provided that the opposing party would be entitled to take the deposition of a “case-specific expert [who] appear[s] in more than one case for a party.” (Id.).

         On April 5, 2019, GSK made a case-specific expert disclosure to plaintiffs concerning Dr. Patrick Wier, a GSK employee. (Docket No. 1650, Ex. G). The disclosure was four pages long, and indicated that Dr. Wier would provide opinion testimony concerning Zofran animal studies at trial. (Id.). That disclosure was made as to the eight individual cases that were being prepared for the first trial group, not in the MDL proceeding as a whole. GSK had previously identified Dr. Wier in 2015 and 2016 as a fact witness concerning the effectiveness and safety of Zofran. (GSK's Opp. (Docket No. 1650), Exs. B, C). Based on those disclosures, plaintiffs had deposed Dr. Wier on March 28, 2018. (Wier Dep. at 1).

         On May 20, 2019, the Supreme Court issued its decision in Albrecht. In light of that decision, the Court permitted GSK to file a renewed motion for summary judgment based on federal preemption. (Docket No. 1575). In response to questions by the parties as to what types of materials they could submit, the Court expressed a desire to decide the preemption issue on a full factual record. (July 10, 2019 Hr'g Tr. at 44:5-12). However, the Court also noted that the parties could move to strike any supporting materials that they believed were improperly submitted. (Id.).

         On July 22, 2019, GSK filed its renewed motion for summary judgment on preemption. Attached were declarations by four witnesses: Dr. Dena Hixon, Dr. Luise Rogg, Dr. Gary Shaw, and Dr. Patrick Wier. (GSK's Renew. Mot. for Summ. J., Exs. 1-4). GSK also attached 139 other exhibits to its motion. (Id., Exs. 5-143).

         On August 26, 2019, plaintiffs moved to strike all four declarations and all 139 exhibits.

         II. Legal Standard

         A. Fed R. Civ. P. 26(a)(2)

         Fed. R. Civ. P. 26(a)(2) governs the disclosure of expert testimony. “[A] party must disclose to the other parties the identity of any [expert] witness it may use at trial to present evidence . . . .” Fed.R.Civ.P. 26(a)(2)(A). If the witness “is one retained or specially employed to provide expert testimony in the case or one whose duties as the party's employee regularly involve giving expert testimony, ” the party must also submit a “written report” with numerous detailed facts, data, exhibits, and other items. Fed.R.Civ.P. 26(a)(2)(B).[3] If the witness is not such a person, the party must nonetheless disclose “(i) the subject matter on which the witness is expected to present [expert] evidence . . .; and (ii) a summary of the facts and opinions to which the witness is expected to testify.” Fed.R.Civ.P. 26(a)(2)(C).

         “A party must make these disclosures at the times and in the sequence that the court orders.” Fed.R.Civ.P. 26(a)(2)(D). As with all disclosures made under Rule 26(a), parties must “supplement or correct” their expert disclosures “in a timely manner” if a party learns of an omission or error unknown to the other party or “as ordered by the court.” Fed.R.Civ.P. 26(e)(1). “For an expert whose report must be disclosed under Rule 26(a)(2)(B), the party's duty to supplement extends both to information included in the report and to information given during the expert's deposition.” Fed.R.Civ.P. 26(e)(2).

         B. Fed R. Civ. P. 26(a)(3)

         Fed R. Civ. P. 26(a)(3) requires parties to disclose the evidence that they may present at trial. “[A] party must provide to the other parties and promptly file . . .: (i) the name, and if not previously provided, the address and telephone number of each witness . . .; (ii) the designation of those witnesses whose testimony the party expects to present by deposition . . .; and (iii) an identification of each document or other exhibit, including summaries of other evidence . . . .” Fed R. Civ. P. 26(a)(3)(A). A party must make those disclosures at the times ordered by the court, or if the court sets none, then at least 30 days before trial. Fed.R.Civ.P. 26(a)(3)(B). As with all disclosures made under Rule 26(a), parties must “supplement or correct” those disclosures “in a timely manner” if a party learns of an omission or error unknown to the other party or “as ordered by the court.” Fed.R.Civ.P. 26(e)(1).

         C. Fed R. Civ. P. 37

         Rule 37 provides sanctions for violations of Rule 26. “If a party fails to provide information or identify a witness as required by Rule 26(a) or (e), the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless.” Fed.R.Civ.P. 37(c). “[T]he required sanction in the ordinary case is mandatory preclusion.” Poulis-Minott v. Smith, 388 F.3d 354, 358 (1st Cir. 2004) (alteration in original) (internal quotation marks omitted) (quoting Klonoski v. Mahlab, 156 F.3d 255, 269 (1st Cir. 1998)). But “preclusion is not a strictly mechanical exercise; district courts have some discretion in deciding whether or not to impose that onerous sanction.” Santiago-Díaz v. Laboratorio Clínicio y de Referencia del Este, 456 F.3d 272, 276 (1st Cir. 2006). In determining the proper sanction, the court should consider “(1) the party's justification for the late disclosure; (2) the opposing party's ability to overcome any prejudice; (3) the impact on the court docket; (4) the party's history of litigation abuse; and (5) the party's need for the late evidence.” Glass Dimensions, Inc. ex rel. Glass Dimensions, Inc. Profit Sharing Plan & Tr. v. State Street Bank & Tr. Co., 290 F.R.D. 11, 17 (D. Mass. 2013) (citing Harriman v. Hancock Cty., 627 F.3d 22, 30 (1st Cir. 2010)); see also Gagnon v. Teledyne Princeton, Inc., 437 F.3d 188, 191 (1st Cir. 2006).

         A party may avoid a Rule 37 sanction if it shows “that its failure to comply with the Rule was either justified or harmless and therefore deserving of some lesser sanction.” Wilson v. Bradlees of New England, Inc., 250 F.3d 10, 21 (1st Cir. 2001). A substantial justification, as used in Rule 37, “is one that ‘could satisfy a reasonable person.'” Pan American Grain Mfg. Co. v. Puerto Rico Ports Auth., 295 F.3d 108, 117 (1st Cir. 2002) (interpreting prior, similar version of Rule 37). Substantially justified “does not mean justified to a high degree, but only justified in substance or in the main-that is, justified to a degree that could satisfy a reasonable person.” Sheppard v. River Valley Fitness One, L.P., 428 F.3d 1, 12 (1st Cir. 2005) (internal quotations omitted). In weighing the justification for and harm caused by a disclosure violation, “[t]he Court must bear in mind the intent of the disclosure rules ‘to facilitate a fair contest with the basic issues and facts disclosed to the fullest practical extent.'” Jalbert v. Grautski, 2009 WL 3754698, at *4 (D. Mass. Feb. 12, 2009) (quoting Poulis-Minott, 388 F.3d at 358).

         III. ...


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