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J.C. v. Pfizer, Inc.

Supreme Court of West Virginia

May 15, 2018


          Submitted: March 6, 2018

          Appeal from the Mass. Litigation Panel Circuit Court of Kanawha County Civil Action Nos. 12-C-146 & 13-C-229 Honorable James P. Mazzone, Lead Presiding Judge In Re: Zoloft Litigation Civil Action No. 14-C-7000

          Benjamin L. Bailey, Esq. Counsel of Record Ryan McCune Donovan, Esq. J. Zak Ritchie, Esq.

          Michael J. Farrell, Esq. Counsel of Record Erik W. Legg, Esq. Megan E. Farrell, Esq.

          Bailey & Glasser LLP Charleston, West Virginia Counsel for Petitioners

          Farrell, White & Legg PLLC Huntington, West Virginia Counsel for Respondents

          JUSTICE KETCHUM, deeming himself disqualified, did not participate in the decision in this case.

          JUDGE WILKES sitting by special assignment.


         1."A circuit court's entry of summary judgment is reviewed de novo." Syl. Pt. 1, Painter v. Peavy, 192 W.Va. 189, 451 S.E.2d 755 (1994).

         2. "The determination of whether a defendant's efforts to warn of a product's dangers are adequate is a jury question." Syl. Pt. 4, Ilosky v. Michelin Tire Corp., 172 W.Va. 435, 307 S.E.2d 603 (1983).

         3. "[Compliance with the appropriate regulations is competent evidence of due care[.]" Syl. Pt. 1, in part, Miller v. Warren, 182 W.Va. 560, 390 S.E.2d 207 (1990).

         4. "It is the general rule that in medical malpractice cases negligence or want of professional skill can be proved only by expert witnesses." Syl. Pt. 2, Roberts v. Gale, 149 W.Va. 166, 139 S.E.2d 272 (1964).

         5. "'Where an injury is of such a character as to be obvious, the effects of which are reasonably common knowledge, it is competent to prove future damages either by lay testimony from the injured party or others who have viewed his injuries, or by expert testimony, or from both lay and expert testimony, so long as the proof adduced thereby is to a degree of reasonable certainty.' Syllabus Point 11, in part, Jordan v. Bero, 158 W.Va. 28, 210 S.E.2d 618 (1974)." Syl. Pt. 9, Ilosky v. Michelin Tire Corp., 172 W.Va. 435, 307 S.E.2d 603 (1983).

         6."In medical malpractice cases where lack of care or want of skill is so gross, so as to be apparent, or the alleged breach relates to noncomplex matters of diagnosis and treatment within the understanding of lay jurors by resort to common knowledge and experience, failure to present expert testimony on the accepted standard of care and degree of skill under such circumstances is not fatal to a plaintiff's prima facie showing of negligence." Syl. Pt. 4, Totten v. Adongay, 175 W.Va. 634, 337 S.E.2d 2 (1985).

         7. The determination of whether expert testimony is necessary to sustain the burden of proof in complex cases involving matters of science, medicine, engineering, technology and the like is made on a case-by-case basis. When the issues involved are beyond the common knowledge and experience of the average juror, expert testimony shall be required.


          LOUGHRY, Justice:

         The petitioners (plaintiffs below), J.C., a minor by and through his mother and next friend Michelle C., and I.H., a minor by and through her mother and next friend, Angela H., appeal the order of the Mass. Litigation Panel ("Panel") entered on February 15, 2017, through which summary judgment was granted in favor of the respondents (defendants below), Pfizer, Inc., Roerig, a division of Pfizer, Inc., and Greenstone, LLC f/k/a Greenstone, Ltd. (collectively "Pfizer"). The petitioners assert that the Panel's decision was erroneously based on the absence of expert testimony to support their claims that Pfizer failed to adequately warn of the risks of a prescription medication. The petitioners further assert that even if expert testimony were required, summary judgment was erroneous because Pfizer's experts could supply the necessary testimony. Upon our review of the parties' briefs, the arguments of counsel, the appendix record submitted, and the applicable law, we affirm the Panel's summary judgment ruling.

         I. Facts and Procedural Background

         This litigation commenced on July 11, 2012, when a complaint alleging products liability and negligence claims was filed by several unrelated mothers on behalf of their respective minor children. The petitioners alleged that the children had suffered birth defects that were proximately caused by their mothers' ingestion of the drug sertraline hydrochloride (brand-name "Zoloft") while they were pregnant. [1] Zoloft is a prescription antidepressant manufactured and marketed by Pfizer.[2]

         In seeking to recover damages, the petitioners alleged that Pfizer failed to adequately warn of the risks of birth defects from the use of Zoloft while pregnant and that adequate warnings would have prevented their injuries. The petitioners do not dispute that the federal Food & Drug Administration ("FDA")[3] has evaluated the safety of Zoloft for decades and that it remains approved as safe and effective.[4]

          FDA regulations require prescription medicine manufacturers to include one of five warnings in a drug's label which reflect the potential of a drug to cause birth defects if used during pregnancy.[5] Based upon information supplied by Pfizer, [6] the FDA determined that Zoloft should carry a Category C warning, which is required when animal studies show some risk in use of the drug during pregnancy; when there are no adequate, well-controlled studies in humans; and when the potential benefits of use during pregnancy may outweigh the potential risks. In 2003, when the petitioner mothers took Zoloft, the label stated:

Pregnancy-PregnancyCategoryC - Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. These doses correspond to approximately 4 times the maximum recommended human dose (MRHD) on a mg/m2 basis. There was no evidence of teratogenicity at any dose level. [7] When pregnant rats and rabbits were given sertraline during the period of organogenesis, delayed ossification was observed in fetuses at doses of 10 mg/kg (0.5 times the MRHD on a mg/m2 basis) in rats and 40 mg/kg (4 times the MRHD on a mg/m2 basis) in rabbits. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in the number of stillborn pups and in the number of pups dying during the first 4 days after birth. Pup body weights were also decreased during the first four days after birth. These effects occurred at a dose of 20 mg/kg (1 times the MRHD on a mg/m2 basis). The no effect dose for rat pup mortality was 10 mg/kg (0.5 times the MRHD on a mg/m2 basis). The decrease in pup survival was shown to be due to in utero exposure to sertraline. The clinical significance of these effects is unknown. There are no adequate and well-controlled studies in pregnant women. ZOLOFT (sertraline hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

         Pfizer also included in the Zoloft label that patients should "notify their physician if they become pregnant or intend to become pregnant during therapy."[8]

          The petitioners alleged that Pfizer negligently failed to adequately warn them of the risk of birth defects through the ingestion of Zoloft during pregnancy.[9] In their expert witness disclosure filed on March 16, 2016, the petitioners designated Adam C. Urato, M.D., as their expert on the adequacy of the Zoloft label in 2003, specifically as it related to the use of Zoloft during pregnancy. The petitioners disclosed that Dr. Urato would offer opinions concerning the label to "a reasonable degree of medical and scientific certainty, as an expert in Maternal-Fetal Medicine and based on his education, training, experience, review of the relevant literature, and specialized knowledge[.]"[10]

          Although Dr. Urato was scheduled for deposition on June 13, 2016, he became unavailable due to unspecified health reasons. Dr. Urato's unavailability prompted Pfizer to file a motion to exclude him from testifying as an expert witness in this matter. The petitioners opposed the motion, arguing that their labeling expert was a critical witness and their "key liability expert" without whom they would be severely prejudiced. The petitioners asserted that Dr. Urato was

an extremely well qualified and important liability witness for Plaintiffs. He has produced a 46[-]page expert report that explains his opinions, and the bases for his opinions, in great detail. He has done a great deal of work on this case in connection with his expert report and to form the opinions stated therein.

         The petitioners advised the Panel that should Dr. Urato's medical situation prevent him from testifying, they would "seek to designate a new expert in his place, considering the importance of the liability topics on which he is designated to opine[.]"

         During an August 8, 2016, hearing, the petitioners' counsel reiterated that "Doctor Urato is a key liability expert of ours. . . . We also want a trial to go forward with our key liability expert. We shouldn't be hamstrung and not have our key liability expert."[11]Although the Panel ordered that Dr. Urato's deposition be taken no later than August 29, 2016, the petitioners remained unable to produce him for deposition. Thereafter, the petitioners filed a motion seeking leave to designate a replacement expert, again describing Dr. Urato as their key liability expert without whom the plaintiffs would be prejudiced. In response, the Panel ordered the petitioners' counsel to file under seal, no later than September 7, 2016, an affidavit from Dr. Urato's treating physician that contained, inter alia, a medical diagnosis for Dr. Urato and an affirmation that he was not medically able to sit for deposition. By letter dated September 7, 2016, the petitioners' counsel advised the Panel that "we have had very limited contact with Dr. Urato and he has not supplied us with the affidavit from his treating doctor."

         Through its September 9, 2016, order, the Panel found that the petitioners' counsel were aware, no later than June 9, 2016, that Dr. Urato was unable to be deposed, and that counsel had failed to either make Dr. Urato available for deposition on August 29, 2016, or submit an affidavit from Dr. Urato's treating physician, as previously ordered. Determining that good cause had been shown, the Panel granted Pfizer's motion to exclude Dr. Urato as an expert in these cases "due to his inability to appear for deposition in these cases now or anytime in the foreseeable future." The Panel further found that although the petitioners' counsel had "failed to ascertain Dr. Urato's medical condition, determine whether Dr. Urato was able to testify in these cases, and request a replacement in a timely manner[, ]" it "would be unfair to punish the litigants for their counsel's lack of diligence." Accordingly, the Panel granted the petitioners' motion for leave to designate a replacement expert and ordered that the replacement expert be designated no later than September 16, 2016.

         In compliance with the Panel's deadline, the petitioners filed a supplemental disclosure of experts in which they identified David A. Kessler, M.D., as their expert on failure to warn issues. Dr. Kessler is a nationally known expert and former Commissioner of the FDA.[12] Dr. Kessler's deposition was noticed for November 17, 2016. The petitioners filed a motion seeking to limit Dr. Kessler's deposition to no more than three hours, asserting that Pfizer was well aware of his opinions. They referenced Dr. Kessler's 116-page report detailing his opinions and his deposition that was taken in 2015 in a federal Zoloft multi-district litigation case-MDL No. 2342. See In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation, MDL No. 2342, 26 F.Supp.3d 449, 452 (E.D. Pa. 2014) (granting motion to exclude expert witness). The petitioners stated that

Dr. Kessler has been designated to testify regarding whether Pfizer adequately warned about the risks associated with exposure to Zoloft, including the adequacy of its Zoloft labeling . . . . Dr. Kessler is also expected to provide testimony regarding the specific regulatory procedures and regulations with which pharmaceutical manufacturers must comply when developing and marketing drug products in the United States and communicating safety information. He is expected to explain a pharmaceutical manufacturer's responsibility to update its labeling when new information that (sic) causes the labeling to become inaccurate, false or misleading. Dr. Kessler is also expected to explain the different ways a pharmaceutical manufacturer can convey new safety information, including updated labeling, publications, verbal communications, advertisements, medical information letters, and the dissemination of Dear Health Care Professional letters.

         On November 14, 2016, the Panel entered an order denying the petitioners' motion to limit the length of Dr. Kessler's deposition and ordered the petitioners to produce Dr. Kessler for deposition on November 17, 2016. Two days before the deposition was to be taken, the petitioners filed a supplemental expert disclosure in which they withdrew Dr. Kessler as their labeling expert without explanation.

         Inasmuch as the petitioners no longer had their self-proclaimed key liability expert, Pfizer filed a motion for summary judgment, arguing that the petitioners could not meet their evidentiary burden on the alleged inadequacy of the 2003 Zoloft label. The petitioners filed a response in which they maintained that they could meet their evidentiary burden with Pfizer company documents that allegedly show Pfizer was aware of the risks associated with the use of Zoloft during pregnancy yet failed to provide an adequate warning of such risks on its label. They further argued that to the extent expert testimony was required on the applicable warning and labeling standards, it could be provided through Pfizer witnesses. Pfizer filed a reply, arguing, inter alia, that "[i]n the place of testimony from a qualified expert on the adequacy of the Zoloft label, Plaintiffs seek to substitute their attorneys' interpretation of internal company documents on complex scientific subjects and, thereby, present such evidence not through a scientist, but an advocate not subject to cross-examination."

         In its unanimous order entered on February 15, 2017, the Panel awarded summary judgment in favor of Pfizer. The Panel observed that whether the failure to adequately warn claim is based in strict liability or negligence, "the question is whether [Pfizer] acted reasonably under the circumstances."[13] Relying upon this Court's precedent, the Panel noted the importance of having an expert witness in failure to warn cases, particularly when there are "complex technical, scientific, and medical issues beyond the common knowledge and experience of the average person." The Panel found that "[w]hether Pfizer behaved as a reasonably prudent manufacturer would when warning about the use of

          Zoloft during pregnancy involves complex issues of science and medicine"; that "this is not a case where the label is silent regarding the alleged risk" because the label during the relevant time carried the Category C pregnancy warning; that "the FDA has repeatedly approved Zoloft's label"; that "numerous independent organizations have concluded that the evidence does not support a causal link between Zoloft and birth defects"; that the "inclusion of warnings that are not supported by the science can lead to unintended and adverse consequences for the patient"; and that the petitioners' "prior statements regarding the importance of their labeling expert and the prejudice to their case without such an expert are inconsistent with any assertion that they do not need such an expert because the alleged inadequacy of the Zoloft label is 'obvious.'"

         The Panel also found that the subject matter of the documents cited by the petitioners in opposition to summary judgment, namely animal studies, epidemiology, adverse event reports, Core Data Sheets, [14] and FDA regulations, were "not within the common knowledge and experience of the average juror[.]" The Panel further found that "such evidence cannot substitute for expert testimony on the adequacy of the Zoloft label" and that "[n]either the interpretation of such studies nor the appropriate method for distilling such lengthy and complex information into a prescription drug label is within the ordinary knowledge and experience of the average juror." The Panel ruled that under the facts of this case, the adequacy of Zoloft's label required expert testimony. Because ...

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