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Kellington v. Bayer Healthcare Pharmaceuticals, Inc.

United States District Court, W.D. Virginia, Harrisonburg Division

August 30, 2016



          Elizabeth K. Dillon United States District Judge.

         This is a personal injury case in which plaintiff, Emily Kellington, seeks to hold defendants, Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma AG, and Bayer OY (collectively defendants or Bayer), liable for personal injuries she contends she sustained as a result of using Mirena, a levonorgestrel-releasing intrauterine system manufactured by Bayer. Pending before the court and addressed herein is Bayer's motion to exclude (Dkt. No. 95), which has been fully briefed and was argued before the court. For the reasons set forth in this opinion, the motion will be granted in part and denied in part.

         I. BACKGROUND

         In its motion to exclude, Bayer seeks an order excluding certain expert opinions and reliance materials under Federal Rule of Civil Procedure 37(c)(1) on the grounds that they were not timely disclosed, and also asks for monetary sanctions. (Bayer's Mot. to Exclude, Dkt. No. 95.) While all parties agree that plaintiff timely submitted expert reports pursuant to Rule 26(a)(2), Bayer takes issue with certain opinions expressed and documents used at the depositions of four experts. Specifically, Bayer asserts that two of plaintiff's experts, Drs. Ross and Maggio, provided completely new opinions and new bases for existing opinions at their depositions. A third expert, Dr. Fraunfelder, purportedly disclosed new reliance materials and testified that he had not finalized most of his opinions. And a fourth expert, Dr. Tang, revealed new reliance materials that served as the primary basis for one of her core opinions without ever producing those materials.

         Plaintiff counters that her experts clarified existing opinions; that counsel merely defended and rehabilitated, or bolstered, her experts; and that no disclosure rule was violated.[1]Alternatively, plaintiff states that the experts supplemented their reports through their testimony, and so she filed supplemental “expert reports, ” following the depositions, which merely incorporate each expert's deposition testimony. (Dkt. No. 96-13.) Plaintiff further asserts that even if she failed to disclose in violation of a rule, the nondisclosure was justified or harmless. As part of this final contention, plaintiff contends that Bayer had the opportunity to examine plaintiff's experts at the depositions and could have asked to take supplemental depositions of the experts.[2]


         A. Legal Standards Governing Expert Disclosures

         Rule 26(a) requires an expert witness to submit a written report that contains “(i) a complete statement of all opinions the witness will express and the basis and reasons for them; (ii) the facts or data considered by the witness in forming them; [and] (iii) any exhibits that will be used to summarize or support them . . . .” The report “should be a comprehensive document that, by itself, provides all the expert's opinions that will be offered at trial, along with the bases for those opinions.” Samsung Elecs. Co., v. Nvidia Corp., 314 F.R.D. 190, 198 (E.D. Va. 2016) (citations omitted). The report then “form[s] the basis for informed deposition-taking.” Id. There is also a duty to timely supplement expert reports if they are “incomplete or incorrect” “in some material respect” and “the additional or corrective information has not otherwise been made known to the other parties . . . .” Fed.R.Civ.P. 26(e)(1)(A). With regard to retained experts, the duty to supplement also includes information conveyed at the expert's deposition. Fed.R.Civ.P. 26(e)(2). The supplemental information is due no later than the deadline for pretrial disclosures under Rule 26(a)(3)-so thirty days before trial. Id.; Fed.R.Civ.P. 26(a)(3).

         Courts have distinguished between supplementation and “gamesmanship.” Disney Enters., Inc. v. Kappos, 923 F.Supp.2d 788, 795 (E.D. Va. 2013). Supplementation is appropriate to “add or correct information, ” but a party may not use Rule 26(e) supplementation “whenever [it] wants to bolster or submit additional expert opinions” or it would “amount to unlimited expert opinion preparation.” Campbell v. United States, 470 F. App'x 153, 157 (4th Cir. 2012). Put differently, the duty and ability to supplement “does not permit a party to make an end-run around the normal timetable for conducting discovery.” Colony Apartments v. Abacus Project Mgmt., Inc., 197 F. App'x 217, 231 (4th Cir. 2006); see also East West, LLC v. Rahman, 2012 WL 4105129, at *6 (E.D. Va. 2012) (quoting Abacus). Rather, supplementation is “only for the narrow purpose of correcting inaccuracies or adding information that was not available at the time of the initial report.” Minebea Co. v. Papst, 231 F.R.D. 3, 6 (D.D.C. 2005); Disney Enters., 923 F.Supp.2d at 795 (describing examples of “true supplementation” as “correcting inadvertent errors or omissions”).

         If there has been a failure to disclose timely all opinions or information, as required by Rule 26 or a pre-trial order, the court must determine whether the nondisclosure was substantially justified or harmless. If so, then no action is required by the court. Fed.R.Civ.P. 37(c). If not, then the party may not be allowed to use the witness or the information, or the court may impose “other appropriate sanctions” in addition to, or instead of, exclusion. Id. If the court finds a disclosure violation that is not substantially justified or harmless, it has “broad discretion to select an appropriate remedy in light of the totality of the circumstances.” S. States Rack & Fixture, Inc., v. Sherwin-Williams Co., 318 F.3d 592, 593 (4th Cir. 2003).

         B. Challenged Opinions and Materials

         With the law as stated above in mind, the court considers each of the experts whose opinions Bayer challenges. In this section, the court sets forth the eight items (allegedly new opinions and/or reliance materials) that Bayer seeks to exclude, the plaintiff's response regarding each of the eight items, and then provides the court's finding as to whether there was a nondisclosure. Within this structure, the court also provides a very brief summary of each expert's opinions. In a separate section that follows, the court considers whether-as to those materials or opinions that were not timely disclosed-the nondisclosure was harmless or substantially justified, and also determines any appropriate remedy.

         Dr. David Ross - regulatory expert

         By way of very brief summary, it appears from Dr. Ross's report that he concluded that there is a reasonable association between the use of Mirena and idiopathic intracranial hypertension (IIH), [3] and that there is reasonable evidence of a causative relationship. He stated that the reasonable evidence for an association was present at the time of Mirena's original approval, and the evidence supporting such a relationship has increased over time. He also concluded that the FDA-approved labeling for Mirena has never contained a summary of the relevant, essential scientific information regarding the relationship between use of Mirena and IIH. (Ross Report 2, Dkt. No. 96-1.) His report stated that an adverse reaction must be listed on a label, even if it has not shown to be caused by the drug, if there is a “reasonable association, whether causal or not, between the reaction and the use of the drug.” (Ross Report 30.)

         Bayer challenges four opinions or aspects of Dr. Ross's testimony as being “new” and/or raised for the first time at his deposition:

         1. New Opinion on Other Drug Labels.

         At his deposition, Dr. Ross testified as to the labels for a class of drugs called fluoroquinolones (antibacterial medicines) that warn of IIH, and analogized them to Mirena. (Ross Dep. 20-21, Dkt. No. 96-2 .) He pointed out that the labels for fluoroquinolones include information about reports of adverse events, even though there is not “absolutely proven, confirmed evidence of an association.” (Id. at 74.) Dr. Ross admitted, though, that he had not reviewed the full body of data on that class of drugs to see how it compared to similar data of adverse effect reports for Mirena (e.g., is there a stronger or weaker correlation). (Id. at 75-76.)

         Plaintiff's Response:

         Plaintiff characterizes Dr. Ross's testimony about fluoroquinolones not as a new opinion, but as a “good example of the threshold of evidence needed by the FDA in order to require PTC warnings.” (Pl.'s Resp. 14, Dkt. No. 104.) She points out that his report discussed this issue at length, citing to his report at 44-48. Plaintiff's counsel confirmed this characterization at the hearing.

         Court's finding and ruling:

         The court agrees that Dr. Ross was simply providing an additional example of his opinion that warning labels for “adverse events” can include information about adverse reports, even absent confirmed evidence of an association between the drug and the adverse reports. Thus, the court finds no violation of the disclosure rule.

         2. New Opinion on Clinical Trial Cases.

         Bayer claims that Dr. Ross's reliance on a chart created by plaintiff's counsel, which purportedly showed three cases of “generic intracranial hypertension reported during clinical trials of levonorgestrel-containing IUDs” was a new opinion. (See Ross Dep. 386-89.) Dr. Ross admitted in his deposition that he was not previously aware of these three cases, and he offered opinions at his deposition concerning what the three cases meant. In particular, he said that those three incidences were “very concerning” and “strengthen[ed] the opinions in [his] report.” (Ross Dep. 391.) Bayer then examined him about these three cases, at which point he testified that he may have missed them initially. (Id. at 442-43.)

         Plaintiff's Response:

         Plaintiff admits that Dr. Ross did not recall reviewing information on these three cases prior to his deposition, and she also does not dispute that the three cases were not discussed in his report. While the data containing the three cases was disclosed as being among the original materials considered by Dr. Ross (Pl.'s Resp. 15), he testified he was not aware of the cases, so he could not have considered them in forming his opinions.[4]

         Court's finding and ruling: The court finds that these cases were a new basis for Dr. Ross's opinion and were not properly disclosed.

         3. New Opinion on ...

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