Priest v. Sandoz Inc.REPLY to Response to MotionW.D. Tex.October 20, 2017 IN THE UNITED STATES DISTRICT COURT WESTERN DISTRICT OF TEXAS AUSTIN DIVISION MARGARET HALTON PRIEST, Individually and as Representative of the Estate of Noel Lajoie Priest, Plaintiff, vs. SANDOZ INC., Defendant. ) ) ) ) ) ) ) ) ) ) ) CIVIL ACTION NO. 1:15-CV-00822-LY SANDOZ INC.’S REPLY IN SUPPORT OF MOTION TO EXCLUDE TESTIMONY OF DANIEL BUFFINGTON, PHARM.D. IN PART Case 1:15-cv-00822-LY Document 113 Filed 10/20/17 Page 1 of 8 -1- Sandoz Inc. (“Sandoz”) files this Reply in support of its Motion to Exclude Testimony of Daniel Buffington, Pharm.D., in Part (the “Motion”) (Dkt. 90), and replies to Plaintiff’s Response (“Response”) (Dkt. 100), as follows: I. INTRODUCTION Plaintiff fails to meet her burden to demonstrate Dr. Buffington’s qualifications, reliable methodology, or that his opinions are relevant to and fit this case. As set forth in the Motion, Dr. Buffington is a pharmacist and pharmacologist with no real training or experience in federal Medication Guide regulations, and his challenged opinions should be excluded because: (1) he is unqualified to offer them under Fed. R. Evid. 702; (2) they lack support and are unreliable under Daubert; and (3) his “compliance” opinions are impermissible legal conclusions. (Dkt. 90 at 5- 20). The Response incorrectly attempts to re-cast the Motion as a mere criticism that Dr. Buffington’s expertise “is not laser-focused on regulation[.]” (Dkt. 100 at 2), when in fact the Motion made clear Dr. Buffington has almost no experience or training in federal regulation of pharmaceutical manufacturers with respect to Medication Guides. The Response also fails to address any of Sandoz’ grounds for the exclusion of Dr. Buffington’s opinions regarding drug manufacturers’ regulatory obligations for Medication Guides and whether Sandoz complied. The Response not only fails to meet the substance of these arguments, but it essentially concedes every point. Plaintiff posits that Dr. Buffington will opine regarding whether Sandoz’ method of distributing Medication Guides was designed to “achieve the purpose” of the Medication Guide program, “regardless of the legal interpretation of the regulations” governing Medication Guides. (Dkt. 100 at 2). That position neatly encapsulates the entire problem with Dr. Buffington’s opinions. He is not qualified to opine about the Medication Guide regulations, and his opinions show he does not understand those regulations, yet he still seeks to offer his Case 1:15-cv-00822-LY Document 113 Filed 10/20/17 Page 2 of 8 - 2 - “expert” legal opinion – actually a legal conclusion properly left for this Court and the jury to decide – that Sandoz’ method of distributing medication guides “was not compliant with federal requirements and was negligent.” (Id.). Rule 702 and the Daubert gatekeeper function exist for just these circumstances, to exclude unfounded and unreliable expert testimony. II. ARGUMENT A. Plaintiff Fails to Meet Her Burden of Establishing That Dr. Buffington Is Qualified to Offer His Opinions and That His Opinions Are Reliable. Plaintiff bears the burden of establishing that her expert’s opinions are qualified and reliable under Fed. R. Evid. 702 and 703, as well as Daubert and its progeny.1 Little v. Tech. Specialty Prod., LLC, 940 F. Supp. 2d 460, 467 (E.D. Tex. 2013). Yet, her Response does not even mention the Daubert standard and completely fails to meet this burden. 1. Plaintiff Fails to Show Dr. Buffington Has the Requisite Qualifications, Training or Experience to Opine About Federal Medication Guide Regulations. The Response wholly fails to establish that Dr. Buffington has any expertise on the topics on which he offers opinions. The Response asserts without support that Dr. Buffington’s “broad expertise in the prescription drug industry” renders him qualified “by knowledge, training, and experience” to testify as to Sandoz’ compliance with federal Medication Guide regulations. (Dkt. 100 at 2). Plaintiff offers no authority supporting her proposition that his unrelated experience with pharmacy “information distribution systems” somehow qualifies him to testify about the requirements of 21 C.F.R. §208.24 and whether Sandoz complied with them. Whatever Dr. Buffington’s experience in pharmacy and pharmacology, Plaintiff has not shown he is qualified to interpret Medication Guide regulations or opine on whether Sandoz complied with them. Plaintiff insists that Sandoz’ “narrow visions of a qualified expert is, thankfully, not 1 The Response fails to respond to Sandoz’ argument that Dr. Buffington’s opinion that FDA does not regulate authorized dispensers (pharmacies) and any regulations directed to pharmacies are mere requests rather than obligations. The Motion clearly establishes otherwise, and the Response does not dispute and thus concedes this. Case 1:15-cv-00822-LY Document 113 Filed 10/20/17 Page 3 of 8 - 3 - supported by the law.” (Dkt. 100 at 2). Yet the Response offers no law whatsoever – not a single citation to a case or to Fed. R. Evid. 702 or 703 – to support Plaintiff’s permissive view of subject matter expertise under the federal rules. An expert’s experience must be sufficiently related to the particular issue on which the expert is intended to testify. Houston-Hines v. Houston Indep. Sch. Dist., No. CIV. A. H-04-3539, 2006 WL 897209, at *2-*3 (S.D. Tex. Apr. 4, 2006). Plaintiff misconstrues Sandoz’ position as demanding an expert who worked as a regulator. While a person with a regulatory background may be qualified to testify on regulatory compliance, Dr. Buffington simply has no relevant training or experience on this topic. Dr. Buffington seeks to opine on whether Sandoz was compliant with federal requirements under FDA’s Medication Guide regulations. His general experience as a pharmacist and pharmacologist who admits to only the barest familiarity and experience involving Medication Guides is simply not sufficiently related to the subject matter of his opinions. See Tyree v. Boston Sci. Corp., 54 F. Supp. 3d 501, 551 (S.D.W. Va. 2014) (excluding as unqualified a distinguished urogynecologist seeking to testify as to “product warnings and FDA compliance” where he never drafted a warning and only knew information he would give his patients, despite having “taken a course on the FDA process” and reviewed internal documents); Frederick v. Swift Transp. Co., 616 F.3d 1074 (10th Cir. 2010) (affirming exclusion of a trucking safety and regulation compliance expert whose opinion went beyond his experience and into accident reconstruction); McClellan v. I-Flow Corp., 710 F. Supp. 2d 1092, 1127 n.28 (D. Or. 2010) (excluding testimony of three physicians as unqualified on FDA regulations). 2. Plaintiff Fails to Show Dr. Buffington’s Compliance Opinions Are Reliable. Plaintiff’s Response also fails to address the fatally inadequate methodology employed by Dr. Buffington. Dr. Buffington opines that Sandoz’ distribution system failed to comply with the Medication Guide regulations because it lacked an education system—or, as the Response Case 1:15-cv-00822-LY Document 113 Filed 10/20/17 Page 4 of 8 - 4 - frames it, “process validation” (Dkt. 100 at 3)—and that Sandoz’ four-part cut-away Medication Guide is non-compliant. The Response fails to discuss, much less demonstrate the reliability of, the methodology by which Dr. Buffington reached these legal conclusions. As discussed in the Motion, Dr. Buffington’s so-called “process validation” opinion erroneously relies upon an out- of-context statement plucked from an FDA presentation and subsequent letters, yet the governing regulations, guidance, confidential correspondence between FDA and Sandoz, and industry interpretations all clearly contradict his interpretation. (Dkt. 90 at 13-15). Expert opinions founded on incorrect assumptions are inherently unreliable. Whitney Nat. Bank v. Air Ambulance by B & C Flight Mgmt., Inc., 516 F. Supp. 2d 802, 816-817 (S.D. Tex. 2007). Plaintiff, by arguing a “distinction” between regulatory and compliance opinions, (Dkt. 100 at 3) deploys a smoke screen to conceal the fact that Dr. Buffington’s opinions, whether they’re about regulations or compliance, lack any kind of methodology and are therefore unreliable. Likewise, Dr. Buffington’s opinion regarding the four-part cut-away Medication Guide rests on a fatally incorrect assumption that Sandoz did not make FDA aware of the layout of its Medication Guide or how it would be distributed. Yet Sandoz’ numerous CBE submissions show otherwise, as even Dr. Buffington was forced to admit. (Dkt. 90 at 10). Because Plaintiff cannot explain away Dr. Buffington’s erroneous assumption, the Response instead insists that CBEs do not matter, because there is no evidence that FDA “approved or took notice of more than the wording” of the Medication Guide. (Dkt. 100 at 3). The Response’s rank speculation that FDA failed to perform the regulatory task assigned to it in reviewing changes to Sandoz’ Medication Guide hardly provides a basis to disregard Dr. Buffington’s admittedly false assumptions. B. THE RESPONSE DOES NOT REFUTE, AND THUS CONCEDES, THAT DR. BUFFINGTON’S OPINIONS ARE IMPERMISSIBLE LEGAL CONCLUSIONS. Finally, the Response futilely attempts to draw a non-existent and irrelevant distinction Case 1:15-cv-00822-LY Document 113 Filed 10/20/17 Page 5 of 8 - 5 - between the legal conclusions Dr. Buffington seeks to offer and potentially permissible “compliance” testimony. Dr. Buffington bases his interpretation of the regulation upon the inclusion of one word – “ensure.” (Dkt. 90 at 15). He offers a legal interpretation of the duty he believes is encompassed by this word. However, the question of whether a statute or regulation gives rise to a particular duty or obligation is fundamentally a legal opinion. Experts may not testify regarding the legal interpretations of regulations or offer legal conclusions. Silverman v. Watson Pharm., Inc., 2013 WL 1413782, at *3 (S.D. Tex. Apr. 8, 2013). Even former FDA employees with experience regulating the pharmaceutical industry have been precluded from providing similar opinions. Stanley v. Novartis Pharm. Corp., No. CV1103191JGBOPX, 2014 WL 12573393, at *4 (C.D. Cal. May 6, 2014) (excluding expert opinion about whether the defendant “was in regulatory compliance with the FDA”); Lopez v. I-Flow Inc., No. CV 08- 1063-PHX-SRB, 2011 WL 1897548, at *10 (D. Ariz. Jan. 26, 2011) (excluding opinion that defendants “disregarded their duties an obligations to protect public safety and ensure compliance with regulatory safeguards”). Because the questions of what 21 C.F.R. §208.24(b) required of Sandoz and whether Sandoz met such obligations are ultimately legal conclusions for this Court to decide, permitting an expert to offer opinions on these ultimately legal questions in the guise of expert testimony would be improper. Other than a minimal reference in a header, Plaintiff fails to address this argument in her Response, and thus she has necessarily conceded it. III. CONCLUSION For the foregoing reasons, Sandoz respectfully asks this Court to exclude the expert opinions of Dr. Buffington in part as outlined in the proposed order submitted with the Motion. Sandoz requests a hearing, per L.R. 7(h), because of this motion’s complex issues. Respectfully submitted, this 20th day of October, 2017. Case 1:15-cv-00822-LY Document 113 Filed 10/20/17 Page 6 of 8 - 6 - /s/ Sara K. Thompson Elizabeth Ross Hadley State Bar No. 24063085 E-Mail: hadleye@gtlaw.com GREENBERG TRAURIG LLP 300 West 6th Street, Suite 2050 Austin, Texas 78701 Telephone: (512) 320-7200 Facsimile: (512) 320-7210 OF COUNSEL: Lori G. Cohen E-Mail: cohenl@gtlaw.com Sara K. Thompson E-Mail: thompsons@gtlaw.com GREENBERG TRAURIG, LLP 3333 Piedmont Road, NE Suite 2500 Atlanta, Georgia 30305 Telephone: (678) 553-2100 Facsimile: (678) 553-2212 Attorneys for Sandoz Inc. Case 1:15-cv-00822-LY Document 113 Filed 10/20/17 Page 7 of 8 - 7 - CERTIFICATE OF SERVICE I hereby certify that this document was served via mail and email on this 20th day of October, 2017: Jesse Z. Weiss Guy Hohmann jesse@hbslawyers.com guyh@hbslawyers.com Hohmann, Brophy & Shelton, PLLC 210 Barton Springs Road, Suite 250 Austin, TX 78704 Jay C. English Steve Weinberg jenglish@englishpllc.com sweinberg@englishpllc.com English Law Group, PPLC Merit Tower 12222 Merit Dr., Suite 1200 Dallas, TX 75251 Emil Lippe emil@texaslaw.com Lippe & Associates 600 N. Pearl Street, Suite S2460 Dallas, TX 75201 E. Kirk Wood kirk@woodlawfirmllc.com Wood Law Firm, LLC 2001 Park Place North, Suite 1000 Birmingham, AL 35203 Kathryn Snapka ksnapka@snapkalaw.com Jack E. Urquhart jurquhart@snapkalaw.com The Snapka Law Firm 606 N. Carancahua, Suite 1511 P.O. Box 23017 Corpus Christi, Texas 78403 Telephone: (361) 888-7676 Facsimile: (361) 884-8545 /s/ Sara K. Thompson Sara K. Thompson Case 1:15-cv-00822-LY Document 113 Filed 10/20/17 Page 8 of 8
