This guest post is by Tom Hurney at Jackson Kelly, a genuine West Virginia lawyer who leaped at the opportunity to write about a recent favorable decision of his home state’s highest court and to give you a taste of what West Virginia is like. We were happy to oblige. So here’s a discussion of why plaintiffs really need expert witnesses in their West Virginia cases. As always, our guest posters are 100% responsible for what they say – they deserve all the credit (and any blame) for their analysis.
West Virginia is a great state. If you come to West Virginia, you, like Anthony Bourdain, will meet gracious and kind people, see nature’s beauty and have some great meals. In his “Parts Unknown” field notes on West Virginia, here, Bourdain said he was “intensely grateful for the kindness, hospitality, and patience the people of West Virginia showed to this ignorant rube from New York City who arrived with so many of the usual preconceptions, only to have them turned on their head.” Bourdain tried squirrel, learning how to skin, gut and quarter, here, and had mortgage lifter tomatoes on salt-rising bread, salt trout, chow chow and vinegar pie, here. We were glad to have him, although we would have included on his culinary tour some West Virginia hot dogs (with mustard and cole slaw and onions if you want them), beans and cornbread, pepperoni rolls and perhaps a few of our superior craft beers like Devil Anse IPA, Wild Trail Pale Ale, and Bridge Brew Ale. We would have suggested pizza at Pies & Pints in Charleston, Morgantown or Fayetteville or DiCarlo’s in Wheeling or Lola’s in Charleston; sandwiches at the Secret Sandwich Society in Fayetteville; lunch or dinner at Stardust Café or Jim’s Drive In (great burgers) in Lewisburg; Italian at Oliverio’s in Morgantown or Bridgeport, Muriales in Fairmont, Fazio’s or Soho’s in Charleston; great steaks at the Char in Beckley or Boyd’s in Martinsburg or Chop House in Charleston; and Seafood at Tidewater Grill in Charleston, unless you just want a big fish sandwich, then go to the Fresh Seafood Co. at Capitol Market. There are a bunch of other great places we don’t have room to mention.
We tell you all this because if you aren’t from here or haven’t visited (and many D&D Blog readers have) you might have the wrong impression of West Virginia. You should rethink that stereotype, like Anthony Bourdain, because in West Virginia it is now clear that plaintiffs need experts to prove warning cases in West Virginia.
On the heels of its 3-2 opinion rejecting “innovator liability” in McNair v. Johnson & Johnson, the Supreme Court of Appeals of West Virginia issued J.C. v. Pfizer, Inc., 2018 WL 2293297 (W. Va. May 15, 2018), where the plaintiffs appealed a summary judgment ruling from the West Virginia Mass Litigation Panel (, arguing 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.”
Here is the new syllabus point from the case, which as West Virginia lawyers (or our National Big Law friends who come down to visit frequently) know, is the binding precedent from the opinion:
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.
This isn’t a Daubert deal (or in West Virginia, a Wilt deal) – it doesn’t analyze the admissibility of expert testimony because there wasn’t any. That’s right. Basically, after losing their designated expert (detail on that below) Plaintiffs argued they could proceed without an expert in a case where they alleged “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.” Plaintiffs “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’) has evaluated the safety of Zoloft for decades and that it remains approved as safe and effective.” In furtherance of that claim, plaintiffs “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.” They 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[.].” So far, so good, right?
We digress for a moment to point out that before you go off on West Virginia and the rejection of learned intermediary in State ex rel Johnson & Johnson v Karl, let’s take a moment and note the action by the Legislature in 2016 to adopt the doctrine, as noted in footnote 9 of the opinion:
In 2016, the Legislature enacted West Virginia Code § 55-7-30, which provides, in part, that it is the “intention of the Legislature in enacting this section to adopt and allow the development of a learned intermediary doctrine as a defense in cases based upon claims of inadequate warning or instruction for prescription drugs or medical devices.” This Court had previously declined to adopt the doctrine. See Syl. Pt. 3, State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 647 S.E.2d 899 (2007) (“Under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers. We decline to adopt the learned intermediary exception to this general rule.”). Because the case at bar was filed in 2012, the doctrine has no application here.
So, consistent with the separation of powers in the Mountain State, the Legislature stepped in to change a substantive opinion of the Court, which is how checks and balances are supposed to work. Anywhoo, back to our discussion of J.C. v. Pfizer, which includes the Supreme Court’s careful recitation of the thorough analyses of the case by the Mass Litigation Panel.
Plaintiffs’ first expert, Dr. Urato was unable to appear for deposition “due to unspecified health reasons.” With Urato a no-show, Pfizer moved to exclude him. Plaintiffs’ opposition (which would come back to haunt them) “their labeling expert was a critical witness and their ‘key liability expert’ without whom they would be severely prejudiced.” After noting the “great deal of work” he had done, plaintiffs “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.’” They argued at the hearing on the motion, ““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.” Although the MLP ordered the deposition to proceed by a date certain, the plaintiffs “remained unable to produce him,” and instead moved for leave to designate a replacement again describing Dr. Urato as their “key” liability expert without whom the plaintiffs would be prejudiced. The MLP directed plaintiffs to provide an affidavit under seal containing “a medical diagnosis for Dr. Urato and an affirmation that he was not medically able to sit for deposition.” But, plaintiffs advised the Panel “we have had very limited contact with Dr. Urato and he has not supplied us with the affidavit from his treating doctor.”
Even though the MLP found plaintiffs, knew by June 9 the expert could not be deposed, did not provide an affidavit and did not timely determine Dr. Urato’s medical condition, whether he was able to testify in these cases, or request a replacement in a timely manner[,]” the MLP found good cause to name a new expert finding it “would be unfair to punish the litigants for their counsel’s lack of diligence.” Plaintiffs named their new expert, David A. Kessler, M.D., purportedly “a nationally known expert and former Commissioner of the FDA.” They then moved to limit Dr. Kessler’s deposition “to no more than three hours” arguing that Pfizer was already “well aware of his opinions,” because he issued a “116-page report detailing his opinions [gave a] deposition … in 2015 in a federal Zoloft multi-district litigation case….” The Panel denied the motion to limit the length of the deposition and ordered plaintiffs to produce him. “Two days before the deposition was to be taken, the petitioners filed a supplemental expert disclosure in which they withdrew Dr. Kessler.”
Pfizer moved for summary judgment “arguing that the petitioners could not meet their evidentiary burden on the alleged inadequacy of the 2003 Zoloft label.” Plaintiffs responded that they could meet their evidentiary burden with Pfizer documents and, if expert testimony was necessary, they could get it from Pfizer’s witnesses. The MLP granted summary judgment.
The MLP 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.” Relying on West Virginia precedent, the MLP 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 MLP 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 MLP also found that the documents plaintiffs claimed proved their warning case – “animal studies, epidemiology, adverse event reports, Core Data Sheets, and FDA regulations” – were “not within the common knowledge and experience of the average juror…[and that] such evidence cannot substitute for expert testimony on the adequacy of the Zoloft label. Further, “[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 MLP concluded “the adequacy of Zoloft’s label required expert testimony. Because the petitioners had withdrawn their warning/label expert, the Panel concluded they could not meet the burden of proof on an essential element of their claim.”
After detailing plaintiffs’ argument – essentially, they didn’t need an expert because evaluation of the warning was an issue within its common knowledge of the jury – and Pfizer’s argument – you need an expert to prove a warning claim – the Supreme Court of Appeals of West Virginia stated it was plaintiffs’ burden to prove an inadequate warning or “to prove that Pfizer acted unreasonably regarding the pregnancy warning on its 2003 Zoloft label, i.e., the Category C warning mandated by the FDA, as well as the additional warning that patients should ‘notify their physician if they become pregnant or intend to become pregnant during therapy[,]’ and that the failure to adequately warn proximately caused their alleged injuries.” Recognizing that the FDA approval of the label was evidence of reasonableness, the Court stated “our precedent reflects that expert testimony will be necessary to sustain an evidentiary burden when the matters involved are beyond the common knowledge and experience of the average juror.”
The Court noted particularly that plaintiffs resisted Pfizer’s motion to disqualify their first expert, arguing that his testimony “was critical to their claim,” and explaining in detail why. The Court expressed some amazement at the withdrawal of the second expert and stated “[n]otwithstanding the petitioners’ u-turn after they voluntarily withdrew their key liability expert, evaluating whether the language in the 2003 Zoloft label was adequate based upon the scientific and medical information that was available at that time, including the science related to the risks of untreated depression during pregnancy, is well beyond the ken and experience of the average juror.” After a detailed discussion of West Virginia precedent on the need for expert testimony and the common knowledge exception, the Court concluded “[o]ur consideration of the complex issues in the case at bar concerning what should and should not be included in a drug label demonstrates that this is a case where expert testimony is necessary…,” and “[t]o find otherwise, following our consideration of the facts, claims, and circumstances of this case, would be to invite an unsound, unintelligent, and speculative verdict based upon matters beyond the cognition and experience of the average juror.” (Here, we just have to interject Justice Neely’s separate opinion in Totten v. Adongay, 337 S.E.2d 2 (1985) (Neely, J., concurring), West Virginia’s seminal case on the “common knowledge” exception to the requirement of expert testimony: “The reason that I have taken the time to concur in part and dissent in part in a case that appears to be of little moment is simply to point out that it is stupid to try any malpractice case, no matter how outrageous, without the help of an expert witness.”).
The Court further rejected plaintiffs’ argument that the warning case could be proven with Pfizer documents and testimony. After a detailed review of the documents and Pfizer witness testimony, the Court concluded “[t]he foregoing deposition testimony shows that the petitioners cannot sustain their evidentiary burden with Pfizer’s witnesses…,” because “rather than supporting the petitioners’ claim, these witnesses each testified that the U.S. Zoloft label adequately conveyed the essential information in the Core Data Sheet, including the benefit/risk assessment to be conducted by the prescribing physician and the patient for use during pregnancy.” Again, the Court recounted the plaintiffs fought to keep their expert even though they had “‘significant material evidence’ that would obviate the need for expert testimony…. As the petitioners previously represented, the advanced education, experience, and expertise of Dr. Urato, and later Dr. Kessler, were necessary for an intelligent consideration and analysis of this “significant material evidence” and the myriad of factors involved in the formulation of the Zoloft label. The petitioners’ argument that they do not need their key liability expert but can sustain their failure to adequately warn claim with Pfizer witnesses is plainly untenable.”
Last, the Court rejected plaintiffs’ argument that requiring expert testimony would be “unfair”: “Importantly, requiring a party to meet his or her evidentiary burden with expert testimony – where necessary – ensures that a jury’s verdict has a sound evidentiary basis and has been intelligently rendered.”
The Court therefore affirmed the MLP’s order granting summary judgment.