{"id":886259,"date":"2015-12-30T11:27:01","date_gmt":"2015-12-30T18:27:01","guid":{"rendered":"https:\/\/www.myconstructionexpert.com\/blog\/?p=886259"},"modified":"2015-12-30T11:27:01","modified_gmt":"2015-12-30T18:27:01","slug":"getting-past-the-gatekeeper-no-shoes-no-shirt-no-service","status":"publish","type":"post","link":"https:\/\/www.myconstructionexpert.com\/blog\/getting-past-the-gatekeeper-no-shoes-no-shirt-no-service\/","title":{"rendered":"Getting Past the Gatekeeper: &#8220;No Shoes, No Shirt, No Service&#8221;"},"content":{"rendered":"<p>Annie Dike, Esq. | Bullseye | December 29, 2015<\/p>\n<p>\u201cNo shoes, no shirt, no service.\u201d\u00a0 How long has it been since you\u2019ve seen a sign like that?\u00a0 Does it still ring true?\u00a0 Apparently so, when it comes to admissibility of <a href=\"https:\/\/www.myconstructionexpert.com\/blog\/what-exactly-was-excluded-proffering-expert-opinions-to-preserve-daubertfrye-challenges\/\" target=\"_blank\">expert opinions<\/a> in federal court.\u00a0 A recent opinion in the numerous Cymbalta labeling cases proves in order to make it through the gate, your experts need to be dressed to impress.<\/p>\n<p><strong>No Shoes<\/strong><\/p>\n<p>When testifying as an <a href=\"https:\/\/www.myconstructionexpert.com\/blog\/work-product-protection-extends-to-dual-purpose-expert\/\" target=\"_blank\">expert<\/a>, one has big shoes to fill\u2500literally.\u00a0 Not only must you testify to your own knowledge and understanding of the issue, but you must also step into the shoes of the players <img loading=\"lazy\" decoding=\"async\" class=\"alignright\" title=\"Locked Gate\" src=\"https:\/\/imsexpertservices.blob.core.windows.net\/cmsroot-appservices\/imsexpertservices\/media\/ims-media\/blog\/locked-gate.jpg\" alt=\"Locked Gate\" width=\"284\" height=\"189\" \/>involved and testify to their capacity as well.\u00a0 For instance, in the Cymbalta matter, one of the plaintiffs\u2019 experts, Dr. Morris, a social scientist, was brought in to testify that Cymbalta\u2019s label was inconsistent with FDA guidelines and was misleading to physicians.\u00a0<em>Hexum v. Eli Lilly &amp; Co.<\/em>, No. 2, 2015, U.S. Dist. LEXIS 106153, (C.D. Cal. Aug. 10, 2015).\u00a0 Now, you could call Dr. Morris an FDA labeling guru.\u00a0 He had worked at the FDA for twenty years and held prominent positions such as Acting Director of the Division of Drug Advertising with responsibilities that focused specifically on evaluating consumer-oriented advertising materials.\u00a0 It would seem Dr. Morris was the quintessential person to speak on FDA labeling issues.\u00a0 But, let\u2019s think on that for a moment.\u00a0 Dr. Morris was an expert in evaluating labels directed at <em>consumers<\/em>, yet one of the opinions he was offering was whether the label was misleading to<em>physicians<\/em>.\u00a0 The judge was quick to close the gate on this.\u00a0 Specifically, the court found Dr. Morris\u2019 \u201clack of experience as a prescribing doctor\u201d rendered him incapable of testifying as to a<em> doctor\u2019s<\/em> interpretation of the label.<\/p>\n<p>The lesson here: make sure your expert can fill the right shoes.\u00a0 Dr. Morris was clearly an expert in FDA labeling.\u00a0 He was not, however, a prescribing physician and that was the specific role he needed to fill to be able to testify as to a physician\u2019s impressions.\u00a0 While someone may have significant expertise in an area\u2500twenty years in the upper echelon of the regulating agency even\u2500that will not allow him to step into and opine on a role in the process in which he has no experience or has not studied.<\/p>\n<p><strong>No Shirt<\/strong><\/p>\n<p>If the goal is \u201cdress to impress\u201d you probably want your expert in a button-down.\u00a0 While imagining your <a href=\"https:\/\/www.myconstructionexpert.com\/blog\/paper-experts-how-a-cv-can-create-apparent-expertise\/\" target=\"_blank\">expert<\/a> walking into court bare-chested probably makes you cringe, if he takes the stand with bare opinions that are void of sufficient support and reliable methodology, the impact to your case would likely be worse.\u00a0 In the Eli Lilly opinion, the judge prevented another of the plaintiffs\u2019 experts, Dr. Glenmullen, a clinical psychiatrist, from testifying that Eli Lilly obscured the results of its clinical trials by publishing them in a medical journal that was not widely read in the United States because the court found the opinion was completely bare.\u00a0 Dr. Glenmullen failed to cite any relevant authority or study to support these opinions.\u00a0 It was merely his stated assertion.\u00a0 An expert opinion must be buttoned down, <em>i.e.<\/em>, adequately supported by reliable data, research and methodologies.<\/p>\n<p>While a completely \u201cbare\u201d opinion, void of scientific support, may be easy to spot and avoid, sometimes a supported opinion can be excluded if the methodology is not the right fit.\u00a0 For instance, the court additionally struck Dr. Morris\u2019 opinion that Eli Lilly could have altered its label to more accurately reflect information published in a 2005 medical journal because it found Dr. Morris failed to show the FDA typically reviews published articles summarizing raw data rather than the raw data itself.\u00a0 In other words, Dr. Morris\u2019 process did not match that of the FDA\u2019s which meant his methodology was ill-fitting.<\/p>\n<p><strong>No Service<\/strong><\/p>\n<p>The judge in this case certainly stepped into his role as \u201cgatekeeper\u201d in&#8230;<\/p>\n<p><a href=\"http:\/\/www.ims-expertservices.com\/bullseye\/december-2015\/getting-past-the-gatekeeper-no-shoes-no-shirt-no-service\/\" target=\"_blank\">To finish reading this article<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Annie Dike, Esq. | Bullseye | December 29, 2015 \u201cNo shoes, no shirt, no service.\u201d\u00a0 How long has it been since you\u2019ve seen a sign like that?\u00a0 Does it still ring true?\u00a0 Apparently so, when it comes to admissibility of expert opinions in federal court.\u00a0 A recent opinion in the numerous Cymbalta labeling cases proves&hellip; <a class=\"more-link\" href=\"https:\/\/www.myconstructionexpert.com\/blog\/getting-past-the-gatekeeper-no-shoes-no-shirt-no-service\/\">Continue reading <span class=\"screen-reader-text\">Getting Past the Gatekeeper: &#8220;No Shoes, No Shirt, No Service&#8221;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2}},"categories":[7],"tags":[17],"class_list":["post-886259","post","type-post","status-publish","format-standard","hentry","category-expert-witness","tag-expert-witness-2","entry"],"jetpack_publicize_connections":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Getting Past the Gatekeeper: &quot;No Shoes, No Shirt, No Service&quot; 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