Priest v. Sandoz Inc.MOTION for Summary Judgment and Incorporated Memorandum of LawW.D. Tex.September 22, 2017- i - 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 DEFENDANT SANDOZ INC.’S MOTION FOR SUMMARY JUDGMENT AND INCORPORATED MEMORANDUM OF LAW Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 1 of 39 - ii - TABLE OF CONTENTS I. INTRODUCTION ................................................................................................................. 1 II. PROCEDURAL BACKGROUND ................................................................................... 4 III. STATEMENT OF UNDISPUTED FACTS ...................................................................... 5 A. THE FDA-APPROVED LABELING FOR SANDOZ’ AMIODARONE CLEARLY WARNED OF A RISK OF PULMONARY TOXICTY. ................................................. 5 B. SANDOZ’ MEDICATION GUIDE WAS THE SAME AS THE MEDICATION GUIDE FOR CORDARONE® AND AT ALL TIMES CONTAINED A WARNING ABOUT A RISK OF SERIOUS LUNG PROBLEMS. .................................................... 6 C. SANDOZ DISTRIBUTED MEDICATION GUIDES FOR AMIODARONE AND ALSO MADE THEM AVAILABLE, AS REQUIRED BY 21 C.F.R. § 208.24. ........... 8 D. THE KROGER PHARMACY AUTOMATICALLY PRINTED A MEDICATION GUIDE FOR AMIDOARONE WHEN FILLING MR. PRIEST’S PRESCRIPTIONS. 10 E. MR. PRIEST’S PRESCRIBING PHYSICIAN WAS FULLY AWARE OF THE RISKS ASSOCIATED WITH AMIODARONE. ........................................................... 13 F. PLAINTIFF HAS NOT PUT FORTH RELIABLE EXPERT TESTIMONY THAT SANDOZ AMIODARONE CAUSED MR. PRIEST’S ALLEGED INJURIES. ........... 13 1. The Medical Records Show Mr. Priest Had Significant Heart Disease Prior to Taking Amiodarone. ................................................................................................................. 13 2. Plaintiff’s Experts Did Not and Cannot Exclude Other Possible Diagnoses or Confirm Amiodarone Toxicity as the Cause of His Death. ........................................................ 14 3. Sandoz’ Experts Concluded Mr. Priest Did Not Have Amiodarone Induced Pulmonary Toxicity. ....................................................................................................................... 16 IV. ARGUMENT ................................................................................................................... 17 A. STANDARD FOR SUMMARY JUDGMENT .............................................................. 17 B. THE UNDISPUTED EVIDENCE DEMONSTRATES SANDOZ DID NOT BREACH ANY DUTY AND ENTITLES SANDOZ TO JUDGMENT AS A MATTER OF LAW. ........................................................................................................ 18 1. The Undisputed Evidence Shows Sandoz Provided Both Sufficient Numbers of Medication Guides and the Means to Obtain Medication Guides to Distributors and Authorized Dispensers, in Full Compliance with Federal Law. .................................. 18 Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 2 of 39 - iii - 2. Plaintiff’s Claims Alleging Failure to Provide Medication Guides Are Impliedly Preempted, Because There Is No Private Right of Action to Enforce This Exclusively Federal Duty. ................................................................................................................ 21 C. THE UNDISPUTED EVIDENCE SHOWS THERE IS NO GENUINE ISSUE OF MATERIAL FACT AS TO CAUSATION AND SANDOZ IS ENTITLED TO JUDGMENT AS A MATTER OF LAW. ....................................................................... 24 D. PLAINTIFF CANNOT PUT FORTH THE CLEAR AND CONVINCING EVIDENCE NEEDED TO MEET HER HEIGHTENED BURDEN OF PROOF TO SUPPORT A CLAIM FOR GROSS NEGLIGENCE AND PUNITIVE DAMAGES. ........................ 28 V. CONCLUSION ................................................................................................................... 30 Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 3 of 39 - iv - TABLE OF AUTHORITIES Page(s) Federal Cases Acosta v. Amoco Oil Co., 978 F. Supp. 703 (S.D. Tex. 1997) ....................................................................................... 29 Black v. Food Lion, Inc., 171 F.3d 308 (5th Cir. 1999) ................................................................................................ 26 Boudreaux v. Swift Transp. Co., 402 F.3d 356 (5th Cir. 2005) ................................................................................................ 18 Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) ............................................................................................................. 22 Celotex Corp. v. Catrett, 477 U.S. 317 (1986) ............................................................................................................. 18 Copley v. Smith & Nephew, No. Civ A.H-97-2919, 2000 WL 223404 (S.D. Tex. Feb 2, 2000) ...................................... 26 Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) ............................................................................................................. 26 Dreher v. Wyeth Pharm., Inc., No. 2:14-CV-00280-KOB, 2015 WL 3948961 (N.D. Ala. June 29, 2015) ......................... 23 Ebel v. Eli Lilly & Co., 536 F. Supp. 2d 767 (S.D. Tex. 2008) .................................................................................. 23 Exxon Corp. v. Baton Rouge Oil & Chem. Workers Union, 77 F.3d 850 (5th Cir. 1996) .................................................................................................. 18 Hicks v. Brysch, 989 F. Supp. 797 (W.D. Tex. 1997) ............................................................................... 17, 18 Little v. Liquid Air Corporation, 37 F.3d 1069 (5th Cir. 1994) ................................................................................................ 18 McNabney v. Lab. Corp. of America, 153 Fed. Appx. 293 (5th Cir. 2005) ..................................................................................... 26 Myriad Dev., Inc. v. Alltech, Inc., 817 F. Supp. 2d 946 (W.D. Tex. 2011) ................................................................................ 28 Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 4 of 39 - v - Newton v. Roche Labs., Inc., 243 F. Supp. 2d 672 (W.D. Tex. 2002) ................................................................................ 26 PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) ................................................................................................... 6 Retzlaff v. De La Vina, 606 F. Supp. 2d 654 (W.D. Tex. 2009) ................................................................................ 29 Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir.1974) ............................................................................................... 23 Samuel v. Johnson & Johnson, No. 1:14-CV-473, 2015 U.S. Dist. LEXIS 123482 (E.D. Tex. Aug. 13, 2015) ............................................................................................................................... 26, 28 Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp. 3d 1246 (N.D. Ala. 2014) .................................................................................. 19 EEOC v. Texas Instruments, 100 F.3d 1173 (5th Cir. 1996) ........................................................................................ 18, 19 State Cases Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) ................................................................................................ 23 Ford Motor Co. v. Ledesma, 242 S.W.3d 32 (Tex. 2007) .................................................................................................. 25 Ford Motor Co. v. Ridgway, 235 S.W.3d 598 (Tex. 2004) ................................................................................................ 26 Havner v. E-Z Mart, 825 S.W.2d 456 (Tex. 1992) ................................................................................................ 25 HEB Grocery Co. v. Galloway, 2014 WL 2152128 (Tex. App. May 22, 2014) ..................................................................... 25 Houston Lighting & Power Co. v. Brooks, 161 Tex. 32, 336 S.W.2d 603 (1960) ................................................................................... 25 Prudential Ins. Co. v. Jefferson Assocs., 896 S.W.2d 156 (Tex. 1995) ................................................................................................ 25 Santa Rosa Medical Center v. Robinson, 560 S.W.2d 751 (Ct. App. Tex. 1997) .................................................................................. 25 Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 5 of 39 - vi - Travis v. City of Mesquite, 830 S.W.2d 94 (Tex. 1992) .................................................................................................. 25 U-Haul Int’l, Inc. v. Waldrip, 380 S.W.3d 118 (Tex. 2012) ................................................................................................ 29 Federal Statutes 21 U.S.C. §337(a) ............................................................................................................. 3, 22, 23 21 U.S.C. § 355(j)(2)(A) .............................................................................................................. 5 State Statutes Tex. Civ. Prac. & Rem. Code § 41.001(11) ............................................................................... 29 Tex. Civ. Prac. & Rem. Code § 41.001(11)(B) .......................................................................... 30 Tex. Civ. Prac. & Rem. Code § 41.003(b) ................................................................................. 29 Tex. Civ. Prac. & Rem. Code § 41.003 § 41.003(a)-(b) ............................................................. 28 Federal Rules and Regulations Fed. R. Civ. P. 56 .......................................................................................................................... 1 Fed. R. Civ. P. 56(a) ................................................................................................................... 17 Federal Rule of Evidence 702 .................................................................................................... 26 21 C.F.R. § 208.1 .................................................................................................................... 6, 19 21 C.F.R. § 208.1(a) ..................................................................................................................... 6 21 C.F.R. § 208.1(b) ..................................................................................................................... 6 21 C.F.R. §208.3 ......................................................................................................................... 19 21 C.F.R. § 208.3(a) ............................................................................................................... 8, 19 21 C.F.R. § 208.20(a) ................................................................................................................... 6 21 C.F.R. § 208.20(b)(8)(i) ........................................................................................................... 6 21 C.F.R. § 208.20(h) ................................................................................................................... 6 21 C.F.R. § 208.24 ........................................................................................................................ 8 21 C.F.R. § 208.24(b) ........................................................................................... 8, 10, 20, 21, 22 Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 6 of 39 - vii - 21 C.F.R. §208.24(d) .............................................................................................................. 8, 19 63 Fed. Reg. 66,378 ...................................................................................................................... 6 63 Fed. Reg. at 66,379 .................................................................................................................. 6 Local Rules Local Rule CV-5.2 ........................................................................................................................ 1 Local Rule CV-7(h) .................................................................................................................... 30 Tex. Adm. Code Rul. 291.33(c)(1) ............................................................................................. 24 Tex. Adm. Code Rul. 291.33(c)(1)(A)(i) ................................................................................... 24 Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 7 of 39 Defendant Sandoz Inc. (“Sandoz”), by its undersigned counsel, respectfully moves this Court for summary judgment pursuant to Fed. R. Civ. P. 56. In support of its Motion, Sandoz submits herewith this incorporated Memorandum of Law and states as follows: I. INTRODUCTION This products liability lawsuit has been pending for over two years and has proceeded through multiple rounds of pleading and motions to dismiss, extensive fact and expert discovery, and full exploration of Plaintiff’s sole remaining theory of liability: that Sandoz somehow failed to comply with federal regulations that Plaintiff argues required Sandoz to ensure delivery of a Medication Guide to her Decedent, Mr. Noel Priest (“Decedent” or “Mr. Priest”). Despite all of this unnecessary effort and expense, Plaintiff still has no evidentiary support for her claims that Mr. Priest did not receive a Medication Guide due to some failure by Sandoz to fulfill a regulatory obligation, nor does she have a competent and qualified expert who can establish that any act or omission of Sandoz caused any injury to Mr. Priest at all. Mr. Priest had a long and complicated medical history that included a prior heart attack and bypass surgery, pulmonary fibrosis, and removal of a portion of his stomach. See Deposition of Dr. Saleemi (“Saleemi Dep.”), excerpts of which are attached as Exhibit A, at 15, 28.12 In June 2013, Dr. Anees Saleemi, M.D. (“Dr. Saleemi”) administered amiodarone to Mr. Priest in the emergency room to treat his ventricular tachycardia and other cardiac complications. Saleemi Dep. at 69.3 Dr. Saleemi also prescribed amiodarone to Mr. Priest upon his discharge from the hospital on July 2, 2013. Kroger Pharmacy (“Kroger”) dispensed amiodarone manufactured by Sandoz to Mr. Priest on two occasions—August 9, 2013 and 1 Exhibits referenced herein contain confidential patient information or confidential company information. As such, all exhibits referenced herein are attached to Sandoz’ Motion to Seal Exhibits to Defendant’s Motion for Summary Judgment pursuant Local Rule CV-5.2. 2 See also ENT Office Visit by James F. Leffingwell, MD, attached as Exhibit B. 3 There is no allegation and no evidence that the amiodarone given in the hospital was manufactured by Sandoz. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 8 of 39 - 2 - September 1, 2013—and dispensed amiodarone manufactured by other manufacturers to Mr. Priest both before and after Sandoz’ amiodarone. See Kroger Pharmacy Records, attached as Exhibit C. Dr. Saleemi discontinued Mr. Priest’s amiodarone on October 22, 2013. Mr. Priest was hospitalized in January 2014 and again in February 2014 after he aspirated some stomach contents and required resuscitation. See Pre-Op History and Physical by Mark Batrice, MD, attached as Exhibit D; Pulmonology Consultation by Michael M. Makary, MD, attached as Exhibit E. He thereafter became septic and remained in the hospital until he died on March 14, 2014 at age 79, following a long and complex medical course. See Death Summary by Mark P. Batrice, M.D., attached as Exhibit F. Plaintiff alleges Mr. Priest’s death was the result of amiodarone-induced pulmonary toxicity, though his death certificate does not reference amiodarone and instead lists the causes of death as medullary failure, cardiac arrest, multiorgan failure and pneumonia. See Death Certificate of Noel Priest, attached as Exhibit G. Plaintiff’s First Amended Complaint (“FAC”) pled a theory of liability for negligence per se premised upon Sandoz’ alleged failure to deliver Medication Guides to patients, as Plaintiff alleged federal regulations required Sandoz to do, and which she alleged prevented Mr. Priest from learning of the risks of amiodarone that would have caused him to refuse to take the drug. FAC ¶¶ 123, 124. Fact discovery in this case conclusively demonstrated that Sandoz included Medication Guides with every shipment of amiodarone in the two years prior to Mr. Priest’s prescriptions, and also demonstrated that any Medication Guides affixed to the bottles of Sandoz amiodarone were discarded by the Kroger pharmacy, who opted instead to set up a system that automatically printed electronic Medication Guides at the point of sale for dispensing to patients. Thus, the undisputed record and all evidence before the Court Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 9 of 39 - 3 - conclusively refutes Plaintiff’s remaining theory of liability in her First Amended Complaint.4 Sandoz is therefore entitled to summary judgment for three reasons: First, the undisputed factual record makes clear that: (1) Sandoz shipped every batch of amiodarone from which Mr. Priest’s prescriptions could have been filled with adequate numbers of Medication Guides and otherwise made the Medication Guide available to pharmacies electronically and by phone, in full compliance with FDA requirements; (2) the evidence from the dispensing pharmacy Kroger is that it routinely and automatically printed and provided the Medication Guide at the point of sale to patients filling prescriptions for amiodarone and has no reason to believe it deviated from this routine practice any time Mr. Priest filled his prescriptions; and (3) Mr. Priest received accurate and adequate printed warning information about the risks of amiodarone toxicity from his pharmacist. These uncontroverted facts establish as a matter of law that Sandoz fulfilled its duties under federal regulations with respect to Medication Guides—duties that Plaintiff is prohibited by 21 U.S.C. §337(a) from attempting to privately enforce, which are subject to preemption, and which are contrary to Texas state law recognizing the learned intermediary doctrine. Second, the undisputed record further demonstrates that Plaintiff cannot meet her burden of proof on causation, because Plaintiff lacks any qualified and reliable expert opinion that Mr. Priest’s death was caused by Sandoz’ amiodarone, and the reliable medical opinions of Defendant’s experts and the treating physician at the time of Mr. Priest’s death conclusively refute Plaintiff’s unsubstantiated assertion that amiodarone caused Mr. Priest’s demise. There 4 Plaintiff has attempted at the eleventh hour via the testimony of an expert revamp her claims into attacks on the format and layout of Sandoz’ Medication Guide and argument that federal regulations obligated Sandoz to conduct a nationwide pharmacy education and validation program to ensure delivery of Medication Guides for amiodarone. These allegations are nowhere in Plaintiff’s Amended Complaint, and surfaced for the first time during expert discovery. However, as noted in Sandoz’ Motion to Exclude Daniel Buffington, Pharm.D. in part, incorporated herein by reference, these new theories are both unmoored from any factual or evidentiary support and are offered by an expert not qualified to give them and with no basis to support them. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 10 of 39 - 4 - is no competent evidence to support the critical element of medical causation, and without such evidence this claim must fail and summary judgment must be granted. Third, Plaintiff has not satisfied the heightened burden of proof to come forward with clear and convincing evidence to support her gross negligence cause of action or her claim for punitive damages, and so summary judgment is also appropriate on these claims. For each of these independent reasons, summary judgment is appropriate in this case as to all claims, and the Court should enter judgment with prejudice on all claims. II. PROCEDURAL BACKGROUND Plaintiff filed her original Complaint on September 14, 2015. (Dkt. 1). Sandoz moved to dismiss on January 13, 2016. (Dkt. 22). In lieu of responding, on February 10, 2016 Plaintiff filed her FAC alleging claims for wrongful death, gross negligence, off-label marketing, and failure to provide a Medication Guide. Sandoz moved to dismiss the FAC on March 7, 2016. (Dkt. 28). Following briefing, on December 29, 2016 Magistrate Judge Lane issued a Report and Recommendation that all remaining claims be dismissed except those premised on alleged failure to provide Medication Guides. (Dkt. 65). After objections, on January 31, 2017 the Court adopted the Magistrate’s Report and Recommendation, dismissing Plaintiff’s claims for wrongful death (count A) and off-label marketing (count C), but allowing claims for gross negligence (count B) and negligence per se (count D) alleging failure to provide a Medication Guide to proceed. (Dkt. 67). Accordingly, Sandoz’ alleged failure to provide a Medication Guide is now the sole theory of liability pled in Plaintiff’s current operative pleading. By agreement of the parties, fact discovery in this case closed on May 31, 2017. On June 5, 2017, Plaintiff disclosed three expert witnesses: radiologist Pamela Kulback, M.D., cardiologist Richard Friedlander, M.D., and pharmacist and pharmacologist Daniel Buffington, Pharm.D, MBA, and also served written reports of each expert. See Plaintiff’s Expert Witness Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 11 of 39 - 5 - Designation. (Dkt. 80). Defendants disclosed six expert witnesses on July 6, 2017: pulmonologist Carl Dahlberg, M.D., cardiologist John Dieck, M.D., gastroenterologist Pradeep Kumar, M.D., Texas pharmacist Jay Ashworth, R.Ph., FDA/regulatory expert Nicholas Fleischer, R.Ph., Ph.D., and pharmacokinetics expert Richard Klabunde, Ph.D, and also served written reports of each expert. See Sandoz’ Designation and Disclosure of Expert Witnesses. (Dkt. 81.) All of the parties’ experts have now been deposed and discovery is now closed. III. STATEMENT OF UNDISPUTED FACTS A. THE FDA-APPROVED LABELING FOR SANDOZ’ AMIODARONE CLEARLY WARNED OF A RISK OF PULMONARY TOXICTY. Amiodarone is a prescription pharmaceutical indicated for treatment of recurrent ventricular arrhythmias when other treatments are ineffective or have not been tolerated. See Expert Report of Richard Klabunde (“Klabunde Rep.”), attached as Exhibit H, at 8. Wyeth Pharmaceuticals, Inc. first manufactured and sold amiodarone under the brand name Cordarone® in 1985. FAC ¶ 26. Since it was first approved by the FDA in 1985, the labeling for Cordarone has included a black box warning about the risk of pulmonary toxicity. Id. Eon Labs Manufacturing, Inc. obtained approval to manufacture generic amiodarone on December 23, 1998. See Affidavit of Greg Seitz (“Seitz Aff.”), attached as Exhibit I, at ¶ 14. In order to gain approval to market generic amiodarone, Eon was required to submit an Abbreviated New Drug Application (“ANDA”) (No. 75-315) to FDA, which demonstrated that Sandoz’ amiodarone was both bioequivalent to Cordarone® and had proposed labeling that was materially identical to Cordarone®. See 21 U.S.C. § 355(j)(2)(A). As part of the ANDA approval process, FDA specifically reviewed and approved the proposed package insert, which like the package insert for Cordarone® included a black box warning about the risk of pulmonary toxicity. Seitz Aff. at ¶ 16. Following ANDA approval, federal law required Eon Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 12 of 39 - 6 - and later Sandoz5 to keep the labeling and design of its amiodarone the same as the approved labeling and design for Cordarone®. See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2577 (U.S. 2011). Eon and/or Sandoz made all required changes to amiodarone’s labeling following any changes to Cordarone®’s labeling. Seitz Aff. at ¶ 24. The FDA-approved package insert for amiodarone at the time of Mr. Priest’s 2013 prescriptions contained a black box warning about pulmonary toxicity. Id. at ¶ 23; see also Package Insert, attached as Exhibit J. B. SANDOZ’ MEDICATION GUIDE FOR AMIODARONE WAS THE SAME AS THE MEDICATION GUIDE FOR CORDARONE® AND AT ALL TIMES CONTAINED A WARNING ABOUT A RISK OF SERIOUS LUNG PROBLEMS. The purpose of a Medication Guide is to provide patients with information in clear layperson’s language about pharmaceuticals that pose a “serious and significant” concern, including information “necessary to patient’s safe and effective use of drug products,” such as serious known side effects. Medication Guide Requirements, 63 Fed. Reg. 66,378; 21 C.F.R. § 208.1(b).6 Medication Guides are a form of patient labeling, the need for which is determined by the FDA, and the wording and format of which require FDA’s prior approval before distribution. Medication Guide Requirements, 63 Fed. Reg. at 66,379; 21 C.F.R. § 208.1(a). Medication Guides must be “written in English, in nontechnical, understandable language, and shall not be promotional in tone or content.” 21 C.F.R. § 208.20(a). They are considered part of the labeling for a prescription drug product, and do not replace the physician-directed package insert. 21 C.F.R. § 208.20(h); 21 C.F.R. § 208.20(b)(8)(i). Because a Medication Guide is part of the labeling under federal law, it is subject to the same duty of sameness as all other labeling. See Expert Report of Dr. Nicholas Fleischer (“Fleischer Rep.”), attached as Exhibit K, at 10; see also Mensing, 131 S. Ct. at 2577. 5 Sandoz acquired Eon Labs on July 21, 2005. 6 See also Medication Guides for Certain Prescription Products, FDA.gov, http://www.fda.gov/ForConsumers/ ConsumerUpdates/ucm107825.htm#top. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 13 of 39 - 7 - In December 2004, FDA first notified Wyeth that it would require a Medication Guide for Cordarone®. Fleischer Rep. at 13-14. FDA notified Eon of the new Medication Guide requirement for amiodarone on January 21, 2005, and on January 24, 2005, Eon submitted a Changes Being Effected letter to FDA with its proposed Medication Guide, which was the same in terms of content as Wyeth’s Medication Guide. Id. at 14. Like Cordarone’s labeling, Sandoz’ proposed Medication Guide labeling submitted in January 2005 included (1) a separate Medication Guide document; (2) a physician package insert that referenced the Medication Guide in the Precautions section and included the entire Medication Guide at the end; and (3) a bottle label. FDA approved Eon’s Medication Guide on February 18, 2005, and the Medication Guide requirement and labeling carried over after Sandoz’ acquisition of Eon. Id. The FDA-approved Medication Guide contains information responsive to each of the following headers, written for the patient’s understanding: What is the most important information I should know about Amiodarone Hydrochloride Tablets? Amiodarone Hydrochloride Tablets can cause serious side effects that can lead to death including: lung damage. … What are the possible or reasonably likely side effects of Amiodarone Hydrochloride Tablets? Amiodarone Hydrochloride Tablets can cause serious side effects that lead to death including lung damage… See January 2005 Changes Being Effected letter, attached as Exhibit L. Plaintiff does not dispute that Sandoz’ Medication Guide contained these headers and related information. Importantly, the Sandoz Medication Guide also read: “This Medication Guide may have been revised after this copy was produced. For more information and the most current Medication Guide, please visit www.eonlabs.com or call our customer service department toll-free at 1- 800-526-0225.” Id. Further, the label affixed to the Sandoz bottle read: “PHARMACIST: Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 14 of 39 - 8 - Each time drug is dispensed, please provide patient with a Medication Guide.” Id. The content of Sandoz’ Medication Guides in place at the time of Mr. Priest’s amiodarone prescriptions in 2013 matched the Medication Guides for Cordarone® and contained the same warnings regarding a serious risk of lung damage. Seitz Aff. at ¶ 34. Similarly, the Sandoz Medication Guides in place in 2013 made clear they were also available online. Id. In addition, at the time of Mr. Priest’s amiodarone prescriptions, each bottle of Sandoz amiodarone had a label on the outside instructing pharmacists to provide a Medication Guide with each amiodarone prescription. Id. C. SANDOZ DISTRIBUTED MEDICATION GUIDES FOR AMIODARONE TO AUTHORIZED DISPENSERS AND ALSO MADE A MEANS AVAILABLE TO PRODUCE THEM, EITHER OF WHICH FULFILLED 21 C.F.R. § 208.24. Under 21 C.F.R. § 208.24(b), the manufacturer of a drug product for which a Medication Guide is required must either provide, “Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers” or “the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers.” Once authorized dispensers receive or produce Medication Guides, it is their exclusive duty to provide a Medication Guide to each patient receiving a prescription for the drug product. 21 C.F.R. §208.24(d). An “authorized dispenser” is “an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice,” in other words a pharmacy. See 21 C.F.R. § 208.3(a). Sandoz is not an authorized dispenser under this regulation. Id.; see also Fleischer Rep. at 17. Its duties under this statute are fulfilled by either providing Medication Guides in sufficient numbers to distributors or authorized dispensers or by making a means available to distributors and authorized dispensers to produce them. Id. Sandoz, unlike a pharmacy or authorized dispenser, does not have a duty (or the practical means) to provide Medication Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 15 of 39 - 9 - Guides directly to each patient who receives a prescription filled with Sandoz amiodarone. Id. Mr. Priest received prescriptions that were filled with amiodarone 200 mg tablets manufactured by Sandoz on August 9, 2013 and September 1, 2013 at Kroger, as evidenced by the pharmacy records showing he received amiodarone bearing National Drug Code (“NDC”) 0185-0144-60, which corresponds to Sandoz’ amiodarone. Fleischer Rep. at 16; see also Kroger Pharmacy records. Contrary to Plaintiff’s allegations in the FAC, all batches of amiodarone that Sandoz manufactured and shipped between August 2011 and September 2013, comprising all of the batches from which Mr. Priest’s prescriptions could have been filled, contained adequate numbers of Medication Guides, as is documented in Sandoz’ packaging batch records for each batch. See Deposition of Lisa Tinsley (“Tinsley Dep.”), excerpts of which are attached as Exhibit M at 155-159; Fleischer Rep. at 17. The batch records reflect the many checks and balances that Sandoz performed to ensure and verify satisfaction of the Medication Guide requirements, including incoming receipt of the folded Medication Guide “outserts,” issuing them to the packaging lines, adhering them to the bottles, and reconciling and destroying the extras at the end of packaging. Tinsley Dep. at 47-49. For each batch of amiodarone that Sandoz manufactured and shipped between August 2011 and September 2013, Sandoz conducted careful inspections and completed documentation to ensure that all parts of the labeling, including the Medication Guides, were included with each batch in specified numbers. Id. at 35. Verification that each shipment includes the appropriate labeling, including Medication Guides, is documented in records for every batch of amiodarone. See Deposition of Gregory Seitz (“Seitz Dep.”), excerpts of which are attached as Exhibit N at 51-52; Tinsley Dep. at 92-95. During discovery, Sandoz produced all packaging batch records for all batches of amiodarone distributed between August 2011 through September 2013, which necessarily including all Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 16 of 39 - 10 - shipments from which Mr. Priest’s Sandoz amiodarone could have come. Lisa Tinsley, Sandoz’ Director of Compliance and Auditing, also personally reviewed every packaging batch record for all shipments of amiodarone during this time, approximately 200 batch records, and testified about them at her deposition. Tinsley Dep. at 154-155. Her review confirmed each batch of amiodarone during this time was accompanied by Medication Guides attached to each bottle in the four-part folded “outsert.” Id. at 156-158. Thus, the undisputed evidence shows every shipment of Sandoz’ amiodarone from which Mr. Priest’s amiodarone could have come contained adequate numbers of Medication Guides when they left Sandoz’ control, and Sandoz therefore complied with all FDA regulations and industry standards for distribution of Medication Guides to distributors and pharmacies. Id. Additionally, at the time of Mr. Priest’s Sandoz amiodarone prescriptions in 2013, Sandoz also made Medication Guides available electronically through its website and/or the National Institutes of Health’s DailyMed website, thereby making them available to pharmacies for distribution to patients per the alternative method of compliance with 21 C.F.R. 208.24(b). Fleischer Rep. at 17. The Medication Guides themselves in place at the time of Mr. Priest’s prescriptions pointed patients and pharmacists to the Sandoz website. Id. Sandoz therefore complied with both methods permitted under FDA regulations for distributing Medication Guides or making them available to distributors and/or pharmacies. Id. D. THE KROGER PHARMACY AUTOMATICALLY PRINTED A MEDICATION GUIDE FOR AMIDOARONE WHEN FILLING MR. PRIEST’S PRESCRIPTIONS. The undisputed evidence from Kroger confirms its pharmacist would have provided Mr. Priest Medication Guides for his Sandoz amiodarone prescriptions, based on its routine and automatic Medication Guide printing practices at the time. Kroger produced uncontroverted evidence on this point in the form of: (1) an affidavit explaining Kroger’s policy and practice to Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 17 of 39 - 11 - dispense automatically printed Medication Guides;7 (2) the testimony of the pharmacist about his personal practice to always dispense Medication Guides with amiodarone; and, (3) the record of Mrs. Priest’s initials that she actually received counseling from the pharmacist, attached as Exhibit Q. Kroger further provided uncontroverted evidence that it is Kroger’s corporate practice to discard hard copy Medication Guides received from manufacturers when amiodarone arrives at its distribution center, and instead use an automated printing system to provide Medication Guides to patients. See Deposition of Kahlil Mohamad, R.Ph. (“Mohamad Dep.”), excerpts of which are attached as Exhibit R, at 66. Mr. Mohamad testified: Q. … You mentioned and talked about the labeling. And medications come with other materials. How is the -- you took me through the actual on-the-bottle label. How did the other required information, such as the prescribing information, get to the patient? … A. At the verification, once I verify the prescription, the computer prints automatically. Once I’m done with it, it will print two things. If it’s required, a receipt and any med guide necessary for that medicine, and that automatically prints. We package these two together with the medicine and we put them in a plastic bag and we keep them there until the patient comes. Q. So -- and I just want to be sure I understand. When you fill a particular prescription, if other materials are required, does that software automatically print that out? A. Yes. Q. So once you enter in that you’re filling that, then it immediately just comes out on your printer? A. Yes. Mohamad Dep. at 23-25 (emphasis supplied.) Mr. Mohamad further testified: Q. Do the majority of the prescription medications that you dispense come with additional printed materials other than the label? A. Only certain medicine that requires med guide. Q. So only the medicines that require Medication Guides receive other printed materials? So there’s not what I would call a monograph or prescribing information or anything else like that? A. It prints on the receipt. 7 A true and correct copy of the Affidavit of Kroger Pharmacy Procurement Manager Britt Turner (“Turner Aff.”) is attached as Exhibit O. A clarifying Affidavit of Britt Turner is attached as Exhibit P. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 18 of 39 - 12 - Q. On the receipt? A. Yes. Q. Okay. Help me understand that process. So take me through that, please. A. Sure. Once we verify the prescription and I put my scan and say everything is okay, it’s ready to go, the computer automatically print a receipt where it has the amount that patient has to be charged. It has the information on it of the patient information, name, address, telephone number. It has the doctor information. It has the drug name, the quantity, the NDC, National Drug Code, and it has a monograph that says what the medicine is for, what side effect and what -- what like drug interaction, with other drug interactions. All the information on the drug. It prints on the other side of it. So you have the receipt, and you have on the side of it on the bottom or on the back, information about the drug, the uses, the monograph. The uses, side effects, what the drug is for and all this. And then if you have another one that requires med guide, you have an extra one that prints out, the Medication Guide. Q. Okay. So in the Kroger nomenclature, the receipt itself is where all other information other than Medication Guide is provided to the patient. In other words, on that receipt he gets all the prescribing information or any other detail he needs about the medication? A. Correct. Mohamad Dep. at. 25-26 (emphasis supplied). According to Mr. Mohamad, Kroger provided Medication Guides to patients when required by FDA at all times. Id. at 29. It did so by automatically printing the Medication Guides from its software system for all drugs having Medication Guides, including amiodarone. Id. at 34, 45. Kroger does receive hard copy Medication Guides from manufacturers, but uses its software system to print Medication Guides for customers instead. Id. at 36. Mr. Mohamad’s testimony makes clear he knows of no reason why Kroger would not have provided Mr. Priest with the Medication Guide as required on any of the occasions on which he filled an amiodarone prescription at Kroger, much less all four. Id. at 25-36, 45. Britt Turner, Pharmacy Procurement Manager for Kroger, further stated in an affidavit that in 2013 the Kroger pharmacy in Grand Prairie, Texas, used a subscription service with First Databank, Inc. to print out Medication Guides for customers for all prescriptions requiring Medication Guides. Turner Aff., Exhibit O at pg. 2. No Medication Guides for amiodarone Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 19 of 39 - 13 - were shipped to the Grand Prairie Kroger pharmacy from the Kroger distribution facility in 2012 or 2013, as Kroger personnel would have instead provided customers with Medication Guides printed from the documents provided to Kroger by First Databank Inc. for any prescription that required Medication Guides, including amiodarone. See Turner Clarifying Aff., Exhibit P, at ¶ 7. These Medication Guides would have been automatically printed as Mr. Mohamad testified. Plaintiff has offered no contrary evidence, because there is none, that Mr. Priest’s 2013 prescriptions filled by Kroger were not accompanied by Medication Guides. E. MR. PRIEST’S PRESCRIBING PHYSICIAN WAS FULLY AWARE OF THE RISKS ASSOCIATED WITH AMIODARONE. Dr. Saleemi, Mr. Priest’s treating cardiologist, first prescribed amiodarone to Mr. Priest on July 1, 2013. Saleemi Dep. at 52. At the time, Dr. Saleemi was familiar with the warnings for amiodarone, including those related to pulmonary toxicity. Id. at 69. He knew of these risks when deciding to prescribe amiodarone to Mr. Priest. Id. at 71. Dr. Saleemi found the benefits outweighed the risks for Mr. Priest and it was the appropriate agent to treat him. Id. at 65-67. F. PLAINTIFF HAS NOT PUT FORTH RELIABLE EXPERT TESTIMONY THAT SANDOZ AMIODARONE CAUSED MR. PRIEST’S ALLEGED INJURIES. 1. The Medical Records Show Mr. Priest Had Significant Heart Disease Prior to Taking Amiodarone. Long before being prescribed amiodarone, Mr. Priest suffered from many long term medical problems including multiple cardiac arrhythmias, severe coronary artery disease, peripheral vascular disease, severe obstructive airways disease due to long term smoking, hypertension, hyperlipidemia, and musculoskeletal problems. See Expert Report of Dr. John Dieck (“Dieck Rep.”), attached as Exhibit S, at p. 4; Deposition of Dr. Tacka (“Tacka Dep.”), excerpts of which are attached as Exhibit T at pp. 57-58. Mr. Priest had a prior heart attack and had required both a bypass surgery and placement of a stent. Dieck Rep. at 5. Mr. Priest’s Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 20 of 39 - 14 - history of treatment by Dr. Saleemi for heart conditions dates back to 2002. Saleemi Dep. at 26. Mr. Priest suffered recurring complaints of atrial fibrillation (“AFib”), as well as new and separate diagnoses of frequent premature ventricular contractions and episodes of non- sustained ventricle tachycardia. Saleemi Dep. at 54-55. After Mr. Priest’s June 2013 admission to the emergency room, Dr. Saleemi prescribed amiodarone to Mr. Priest for the treatment of ventricular tachycardia. Saleemi Dep. at 69. Between July 2013 and the date of his final admission on March 27, 2012, Mr. Priest had increasingly complex PVCs (multiformed couplets, triplet PVC’s) and runs of consecutive PVCs highly suspicious for ventricular tachycardia. Saleemi Dep. at 55; Dieck Rep. at 4. Dr. Batrice, Mr. Priest’s attending physician during this admission, testified he did not treat Mr. Priest for pulmonary toxicity, and did not order any specific tests for amiodarone-induced pulmonary toxicity. See Deposition of Dr. Mark Batrice (“Batrice Dep.”), excerpts of which are attached as Exhibit U, at 38-39. As noted previously, Mr. Priest’s death certificate does not list amiodarone-induced pulmonary toxicity and instead lists his causes of death as “medullary failure, cardiac arrest, multiorgan failure and pneumonia.” Death Certificate, Exhibit G. 2. Plaintiff’s Experts Did Not and Cannot Exclude Other Possible Diagnoses or Confirm Amiodarone Toxicity as the Cause of His Death. Plaintiff engaged experts with the intention of supporting her claims that amiodarone- induced pulmonary toxicity (“AIPT”) caused the injuries that led to the death of Mr. Priest. See Plaintiff’s Designation and Disclosure of Experts (Dkt. 80). Plaintiff has identified cardiologist Richard P. Friedlander, M.D. (“Dr. Friedlander”), and radiologist Pamela Kulback, M.D. (“Dr. Kulback”) to opine on medical causation. Yet the purported causation testimony of these experts is fatally flawed and cannot support a claimed material factual dispute on causation for several reasons. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 21 of 39 - 15 - Dr. Friedlander lacks the requisite education, training and experience to offer an opinion as to Mr. Priest’s alleged pulmonary diagnosis, much less the necessary experience to opine about the “natural sequelae” of AIPT, or that AIPT caused his death. At deposition he admitted he reviewed none of Mr. Priest’s prior medical records, nor any of the radiology films he ostensibly relies upon. See Deposition of Dr. Friedlander, excerpts of which are attached as Exhibit V, at 108-109. He further admits he reviewed none of the depositions of Mr. Priest’s treating physicians, and thus was unaware of their diagnoses and explanations for Mr. Priest’s sickness and demise. Id. at 122, 240. The scant literature he relied upon was provided by Plaintiff’s lawyers and he conducted no independent research to determine if his opinion was supported by peer reviewed literature. Dr. Friedlander’s expert opinion is neither medically sound nor legally admissible. Dr. Friedlander’s opinions are simply ipse dixit and lack the hallmarks of a valid medical diagnosis. Thus, Sandoz has filed a Motion to Exclude Dr. Friedlander’s causation opinions (Dkt. 88), which is incorporated herein by reference. Dr. Kulback’s causation opinion was not disclosed in her report, and she likewise lacks the education, training, or experience to proffer medical causation opinions. Dr. Kulback is admittedly not a pulmonologist or a cardiologist, has never prescribed amiodarone, and has never treated a patient diagnosed with alleged AIPT. See Deposition of Dr. Kulback, excerpts of which are attached as Exhibit W, at 237, 276. Her testimony does not indicate she followed any generally accepted or reliable methodology in reaching her conclusions about the cause of Mr. Priest’s lung condition, and ultimately his aspiration and death, and instead confirms her opinions are classic ipse dixit lacking in any scientific or medical support or reliable methodology. Furthermore, Dr. Kulback never reviewed Mr. Priest’s medical history, as any clinician would do before making a diagnosis. Id. at 304. Thus, Sandoz has filed a Motion to Exclude Dr. Kulback’s causation opinions (Dkt. 86), which is incorporated herein by reference. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 22 of 39 - 16 - 3. Sandoz’ Experts Concluded Mr. Priest Did Not Have Amiodarone Induced Pulmonary Toxicity. In contrast to Plaintiff’s retention and disclosure of experts unqualified to testify about medical causation, Sandoz engaged qualified expert physicians including a cardiologist and pulmonologist, to evaluate Mr. Priest’s medical history and amiodarone use, and to provide opinions about medical causation to a reasonable degree of medical probability concerning Mr. Priest symptoms and diagnosis, including the cause of death, if known. See Sandoz’ Designation and Disclosure of Experts (Dkt. 81). Copies of these expert reports are attached as Exhibits H, K, S, Y, Z, and BB and incorporated as if set forth fully herein. Dr. John Dieck is an expert in cardiology, arrhythmias, ventricular tachycardia, and medical management of arrhythmias. See Dieck Rep., Exhibit S, at 2 for additional qualifications. He not only prescribes amiodarone often and manages patients taking amiodarone, but has diagnosed amiodarone induced pulmonary toxicity and participated in treatment of AIPT in his patients. See Deposition of Dr. John Dieck (“Dieck Dep.”), excerpts attached as Exhibit X, at p. 58. Dr. Dieck explained that AIPT is a diagnosis of exclusion, as there are numerous potential causes of interstitial lung disease. Dieck Rep. at 4. To reach a diagnosis of AIPT, other causes must be ruled out by history, examination, and testing. Id. Dr. Dieck reviewed all of the medical and pharmacy records of Mr. Priest from 2002 through 2014, and concluded that without more evidence and a lung biopsy, it is simply not possible to say to a reasonable degree of medical probability that Mr. Priest more likely than not had AIPT, as opposed to some other cause of his lung disease. Id. at 7; see also Dieck Dep. at 128. Dr. Carl Dahlberg is a pulmonologist, with expertise in diagnosing and treating interstitial lung disease, including interstitial lung disease secondary to amiodarone toxicity. See Dr. Dahlberg Expert Report (“Dahlberg Rep.”), attached as Exhibit Y, at 2. Dr. Dahlberg Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 23 of 39 - 17 - also reviewed all of Mr. Priest’s medical and pharmacy records from 2002 through 2014 and performed a differential diagnosis in his evaluation of the cause of Mr. Priest’s interstitial lung disease. Id. Given the information in the medical record, Dr. Dahlberg opined to a reasonable degree of medical probability that a diagnosis of amiodarone pulmonary toxicity cannot be established. Id. at 3. Instead, it is Dr. Dahlberg’s opinion to a reasonable degree of medical probability that amiodarone did not cause or contribute to Mr. Priest’s alleged injuries or death. Id. Further, the duration and cumulative dose of amiodarone that Mr. Priest received are not sufficient to cause pulmonary toxicity. Id.8 Plaintiff’s experts are not qualified to and cannot offer any reliable opinions disputing these conclusions, and thus Plaintiff cannot sustain her burden of proving medical causation through competent expert testimony. IV. ARGUMENT A. STANDARD FOR SUMMARY JUDGMENT Summary judgment is appropriate “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). “Federal summary judgment procedure requires the court to ‘pierce through the pleadings and their adroit craftsmanship to reach the substance of the claim.’” Hicks v. Brysch, 989 F. Supp. 797, 806 (W.D. Tex. 1997) (citing Tacon Mechanical Contractors v. Aetna Casualty and Surety Company, 65 F.3d 486, 488 (5th Cir. 1995)). “While the party moving for summary judgment must demonstrate the absence of a genuine issue of material fact, he need not negate the essential elements of the nonmovant’s case.” Little v. Liquid Air Corporation, 37 F.3d 1069, 1075 (5th Cir. 1994) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986)). “Once a properly supported motion for summary judgment is presented, the burden 8 Sandoz also presented a qualified expert in gastroenterology to explain why another medical cause of Mr. Priest’s aspiration and sepsis–medullary failure resulting in dysphagia--was a more likely cause of his injuries and death than amiodarone. See Expert Report of Pradeep Kumar, M.D. (“Kumar Rep.”), attached as Exhibit Z at p. 3. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 24 of 39 - 18 - shifts to the non-moving party to set forth specific facts showing that there is a genuine issue for trial.” Exxon Corp. v. Baton Rouge Oil & Chem. Workers Union, 77 F.3d 850, 854 (5th Cir. 1996) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986)). The nonmoving party “cannot discharge this burden by referring to the mere allegations or denials of the nonmoving party’s pleadings; rather, that party must, either by submitting opposing evidentiary documents or by referring to evidentiary documents already in the record, set out specific facts showing a genuine issue as to a material fact exists.” Hicks, 989 F.Supp. at 807; Celotex, 477 U.S. at 324. Plaintiff’s burden to show a dispute of material fact “will not be satisfied by some metaphysical doubt as to the material facts, by conclusory allegations, by unsubstantiated assertions, or only a scintilla of evidence.” Boudreaux v. Swift Transp. Co., 402 F.3d 356, 540 (5th Cir. 2005). If there is no genuine issue of material fact, then the moving party is entitled to a judgment as a matter of law. EEOC v. Texas Instruments, 100 F.3d 1173, 1179 (5th Cir. 1996). B. THE UNDISPUTED EVIDENCE DEMONSTRATES SANDOZ DID NOT BREACH ANY DUTY AND ENTITLES SANDOZ TO JUDGMENT AS A MATTER OF LAW. 1. The Undisputed Evidence Shows Sandoz Provided Both Sufficient Numbers of Medication Guides and the Means to Obtain Medication Guides to Distributors and Authorized Dispensers, in Full Compliance with Federal Law. Plaintiff rests her sole remaining theory of liability in this case on what have now conclusively been shown by undisputed evidence to be groundless assertions regarding Defendant’s purported failure to provide the Medication Guides for amiodarone to Mr. Priest. FAC ¶ 126, 133. Plaintiff incorrectly alleges that Defendant had a duty to “provide each patient prescribed Defendant’s amiodarone with a Medication Guide.” Id. Sandoz is under no such duty as a matter of law to provide a Medication Guide directly to patients, and Plaintiff’s allegations thus hinge on a fundamental mischaracterization of federal law, while the undisputed facts demonstrate Sandoz fully complied with all its obligations under federal law. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 25 of 39 - 19 - FDA requires that certain drug products be accompanied by Medication Guides when dispensed to patients. See 21 C.F.R. § 208.1. But the duty to provide those Medication Guides directly to patients does not rest upon the manufacturer. Rather, the manufacturer of a drug product has a duty to provide either “Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers” or “the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers.”9 Once the authorized dispensers obtain these Medication Guides from the manufacturer or from a distributor who received them from the manufacturer, it is then their exclusive duty “to provide a Medication Guide to each patient receiving a prescription for the drug product.” 21 C.F.R. § 208.24(d). Sandoz is not an “authorized dispenser” under this regulation, as it is not “an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice.” See 21 C.F.R. § 208.3(a). An “authorized dispenser,” in short, is a pharmacy or pharmacist, not a manufacturer like Sandoz, which is not licensed to provide drug products by prescriptions to patients in the course of a professional practice, and which does not have any direct interaction with patients themselves. Thus, Sandoz owed no duty to provide a Medication Guide directly to Mr. Priest. See Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp. 3d 1246, 1252 (N.D. Ala. 2014) (“[the] regulations require that Medication Guides be provided by a manufacturer to the distributor of a medication, not the end user”). Sandoz fulfilled its duties under 21 C.F.R. §208.24(b) by both providing sufficient numbers of Medication Guides to authorized dispensers with each shipment of amiodarone, and also providing a means to obtain Medication Guides to distributors or authorized 9 As defined in 21 C.F.R. §208.3, authorized dispenser means an individual licensed, registered, or otherwise permitted by the jurisdiction in which the individual practices to provide drug products on prescription in the course of professional practice. Id. Distributor means a person who distributes a drug product. Id. Packer means a person who packages a drug product. Id. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 26 of 39 - 20 - dispensers. The record establishes beyond material factual dispute that Sandoz did provide Medication Guides in adequate numbers to authorized distributors with all shipments of amiodarone from which Mr. Priest’s amiodarone prescriptions could have been filled. See Stmt. of Facts § III.C, supra; Tinsley Dep. at 155-159. Sandoz also produced batch records establishing its compliance with 21 C.F.R. § 208.24(b)(1) for all batches of amiodarone from which Mr. Priest’s prescriptions could possibly have come, which showed that Medication Guides were shipped in adequate numbers with each such shipment. Tinsley Dep. at 155-159. Plaintiff has no evidence to dispute this documentation or testimony of Sandoz’ compliance. Second, during the relevant time period, Sandoz also made Medication Guides available online and through a system where dispensers could call to request Medication Guides. See Stmt. of Facts § III.C, supra; Fleischer Rep. at 17. Similar to providing Medication Guides directly to distributor, packers, or authorized dispensers, the means of providing Medication Guides is not directed to patients but rather to the authorized dispenser, who is tasked with utilizing those means to provide Medication Guides to patients. Plaintiff has never addressed this alternative mechanism for providing Medication Guides to authorized dispensers and the record is devoid of any evidence Sandoz failed to provide adequate means to produce Medication Guides to authorized dispensers. The evidence therefore shows that Sandoz did provide a means to produce Medication Guides to authorized dispensers. Fleischer Rep. at 17. Even though Sandoz’ duty as described in 21 C.F.R. §208.24(b) concluded with its transmittal of sufficient numbers of Medication Guides to distributors and authorized dispensers, or alternatively with its provision of the means to produce Medication Guides to authorized dispensers, the record in this case goes ever further because the undisputed evidence demonstrates that Kroger would have provided a Medication Guide to Mr. Priest with his amiodarone prescription based on its routine and automatic practices at the time. Kroger Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 27 of 39 - 21 - pharmacist Kahlil Mohamad made clear at his deposition that it was Kroger’s routine practice and policy to automatically print a Medication Guide with every amiodarone prescription, affixed to the receipt provided to the patient, and that it would have been followed in this instance as to Mr. Priest’s prescriptions. See Stmt. of Facts § III.D, supra. Plaintiff lacks any evidence that Kroger deviated from its routine practice and policy and failed to provide Mr. Priest with a Medication Guide accompanying his prescription even once, much less all four times Mr. Priest filled a prescription for amiodarone at Kroger. Thus, Plaintiff has no evidentiary basis, in light of the undisputed factual record, to substantiate her assertions that Mr. Priest did not receive a Medication Guide and the warnings contained within it.10 Summary judgment should issue as to this sole remaining claim on this basis alone. 2. Plaintiff’s Claims Alleging Failure to Provide Medication Guides Are Impliedly Preempted, Because There Is No Private Right of Action to Enforce This Exclusively Federal Duty. Even if Plaintiff could point to some evidence that Sandoz violated its federal regulatory duties with respect to Medication Guides, Sandoz would still be entitled to judgment as a matter of law because claims premised upon violations of federal duties are impliedly preempted under Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). The Supreme Court in Buckman, citing 21 U.S.C. § 337(a), held “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for 10 Plaintiff’s only purported expert on the distribution of Medication Guides does not dispute the sufficiency of the numbers of Medication Guides distributed by Sandoz to authorized dispensers, but rather attempts to create additional requirements for manufacturers not described in the regulations. See Deposition of Dr. Buffington ( “Buffington Dep.”), excerpts of which are attached as Exhibit AA, at 246-247. Dr. Buffington admits that other than his opinion, there is no legal source such as “a regulation, a guidance, a statute” that requires a manufacturer to educate pharmacists regarding the manufacturer’s Medication Guides. Id. 272. Dr. Buffington opines this duty exists based solely on the existence of the word “ensure” in the regulations, which he interprets broadly to require both education of pharmacies nationwide and validation that they are distributing Medication Guides. Id. at 91-93. He claims the duty to carry out this educational program is “embodied in the two-prong pathways, and it’s embodied in the intent and rigor, and it’s underscored by the FDA.” Id. 272. Sandoz has filed a Motion to Exclude the testimony of Dr. Buffington (Dkt. 90), because he is not qualified to offer such opinions, these opinions are not supported by facts in the record or reliable methodology, and these opinions are impermissible legal conclusions. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 28 of 39 - 22 - noncompliance with the [law].” Id. at 349 n.4.11 Plaintiff bases her sole remaining claim for failure to provide a Medication Guide on Sandoz’ alleged violation of the Medication Guide regulations, which, as discussed in the preceding section, defines the manufacturer’s duty to provide Medication Guides to authorized dispensers. 21 C.F.R. § 208.24(b). This regulation on its face does not require manufacturers to ensure that Medication Guides are then distributed by authorized dispensers to patients, despite Dr. Buffington’s unique and completely unsupported interpretation of this regulation. This Court can see on the face of the regulation itself that Sandoz’ duty ends when it distributes adequate numbers of FDA-approved Medication Guides to authorized dispensers or makes available to them a means to distribute Medication Guides. But even if the record were not clear that Sandoz had complied with the duties contained with these regulations, Plaintiff would not be able to recover on a tort claim that is entirely premised upon an alleged violation of an FDA regulation. The purported duties Plaintiff seeks to enforce with this claim arise directly under the FDCA, which only the federal government may enforce, and consequently, the claims are impliedly preempted under Buckman and 21 U.S.C. §337(a). That this claim is inherently federal in nature is made clear by the lack of a Texas law counterpart to Plaintiff’s alleged violation of federal law that even arguably could permit Plaintiff to evade Buckman preemption. Rather, under Texas law and the learned intermediary doctrine, Sandoz is required to provide adequate warnings only to a patient’s prescribing physician. Ebel v. Eli Lilly & Co., 536 F. Supp. 2d 767, 772 (S.D. Tex. 2008) aff’d, 321 F. App’x 350 (5th Cir. 2009). As explained by the Fifth Circuit, “the learned intermediary doctrine is a products liability defense that explains ‘[p]harmaceutical companies ... [that] sell [] prescription drugs are required to warn only the prescribing physician, who acts as a ‘learned 11 The FDCA is the Federal Food, Drug and Cosmetic Act, which was passed by Congress in 1938 giving authority to the FDA to oversee the safety of among other things, prescription drugs. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 29 of 39 - 23 - intermediary’ between the manufacturer and consumer.’” Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir.1974) (citation omitted); see also Ebel, 536 F. Supp. 2d at 772 (“In the case of prescription drugs, a patient does not have access to the medication absent a prescription from a physician, therefore a manufacturer need only warn the physician.”). Nor may Plaintiff argue that FDA’s decision to require a Medication Guide for amiodarone that is intended to be delivered to patients somehow renders the learned intermediary doctrine irrelevant. In a similar context involving direct-to-consumer advertising of prescription drugs, the Texas Supreme Court still held there is no exception to the learned intermediary doctrine where a drug is marketed directly to patients. See Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 167 (Tex. 2012).12 Because no duty to warn patients directly of a prescription drug’s risks exists under Texas state law, even where the drug is directly marketed to patients, the duty Plaintiff seeks to enforce in this case necessarily arises under the FDCA and federal regulations promulgated thereunder, and runs afoul of 21 U.S.C. §337(a) and Buckman. See, e.g., Dreher v. Wyeth Pharm., Inc., No. 2:14-CV-00280-KOB, 2015 WL 3948961 (N.D. Ala. June 29, 2015) (allegations regarding failure to provide Medication Guides are “barred by either section 21 U.S.C. § 337(a) or the learned intermediary doctrine”); Purdue v. Wyeth, 209 F. Supp. 3d 847 (E.D. N.C. 2016) (same). And there is no record evidence to suggest Sandoz failed to warn Mr. Priest’s physicians of the risks associated with amiodarone; to the contrary, Dr. Saleemi was aware of the risks. See Stmt. of Facts § III.E, supra. Texas law also makes clear it is pharmacists, not manufacturers, who have a duty to 12 The Texas Supreme Court held: “[T]he [learned intermediary] doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product’s potential risks by providing an adequate warning to the prescribing physician. We further hold that the court of appeals erred by creating an exception to the learned intermediary doctrine for direct-to-consumer (DTC) advertising. Although the patient alleged various common law causes of action, all of the patient’s claims turn on the prescription drug manufacturer’s failure to warn. Therefore, the learned intermediary doctrine applies to all of the patient’s claims, and the patient was required to show that an inadequate warning to the prescribing physicians caused the patient’s injuries.” Centocor, 372 S.W.3d at 167. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 30 of 39 - 24 - communicate important drug information to patients. See Tex. Adm. Code Rul. 291.33(c)(1). Pharmacists are directed to counsel patients and provide them with: (i) name and description of the drug…; (ii) dosage form, dosage, route of administration, and duration of drug therapy; (iii) special directions and precautions for preparation, administration, and use by the patient; (iv) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; (v) techniques for self-monitoring of drug therapy; (vi) proper storage; (vii) refill information; and (viii) action to be taken in the event of a missed dose. Tex. Adm. Code Rul. 291.33(c)(1)(A)(i). Again, this duty is owed by Mr. Priest’s pharmacists, not Sandoz. Although Plaintiff alleges Mr. Priest did not receive the Medication Guide from Kroger because Sandoz failed to provide them to pharmacies, FAC ¶ 81, the undisputed evidence shows Sandoz provided Medication Guides to authorized dispensers with shipments of amiodarone, and also provided a means to produce Medication Guides to authorized dispensers, who have the ultimate duty of providing Medication Guides directly to patients under federal regulations and Texas law, and who the evidence shows did supply Medication Guides to Mr. Priest. See Stmt. of Facts §§ III.C-D, supra; see also Dr. Ashworth Expert Report (“Ashworth Rep.”), attached as Exhibit BB, at 5, 7-9. Simply stated, there is no evidence in the undisputed factual record to support Plaintiff’s theory of liability that Sandoz violated any duty owed to Mr. Priest under federal law with respect to Medication Guides. Even if there were, such a duty would arise entirely under federal law, and would be dependent upon alleged violation of federal regulations that only the federal government may enforce, and would therefore be impliedly preempted. C. THE UNDISPUTED EVIDENCE SHOWS THERE IS NO GENUINE ISSUE OF MATERIAL FACT ON CAUSATION AND SANDOZ IS ENTITLED TO JUDGMENT AS A MATTER OF LAW. Sandoz is also entitled to judgment as a matter of law because the record is devoid of any evidence to support Plaintiff’s theory of causation in this case. Plaintiff has offered no Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 31 of 39 - 25 - reliable medical evidence attributing Mr. Priest’s alleged injuries to Sandoz’ amiodarone. In fact, the record conclusively demonstrates Mr. Priest’s alleged injuries were not, to a reasonable degree of medical probability, caused by amiodarone. Under Texas law, Plaintiff bears the burden of proving the evidence and its logical inferences support the reasonable probability that Sandoz’ acts or omissions were a substantial factor in bringing about the injury complained of, and without said act or omissions the harm would not have occurred. See, e.g., Prudential Ins. Co. v. Jefferson Assocs., 896 S.W.2d 156, 161 (Tex. 1995); Travis v. City of Mesquite, 830 S.W.2d 94, 98 (Tex. 1992); HEB Grocery Co. v. Galloway, 2014 WL 2152128, at *5 (Tex. App. May 22, 2014). To prove Sandoz’ amiodarone somehow proximately caused Plaintiff’s injury, Plaintiff bears the burden of proving by a preponderance of the evidence that: (1) it was a substantial cause of his injury, and (2) it was a but-for cause, “namely one without which the event would not have occurred.” Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 46 (Tex. 2007); see also Havner v. E-Z Mart, 825 S.W.2d 456, 460 (Tex. 1992). As the Texas Supreme Court stated, “[i]n this state it is now a settled doctrine that anticipation of consequences is a necessary element in determining not only whether a particular act or omission is actionably negligent, but also whether the injury complained of is proximately caused by such act or omission.” Houston Lighting & Power Co. v. Brooks, 161 Tex. 32, 38, 336 S.W.2d 603, 606–07 (1960); Santa Rosa Medical Center v. Robinson, 560 S.W.2d 751, 757 (Ct. App. Tex. 1997). Plaintiff cannot meet her burden in this case because her experts are not qualified to offer medical causation opinions to a reasonable degree of medical probability as required under Texas law, and their opinions are unreliable and unsupported by evidence in the record. Proof of a causal connection between a plaintiff’s alleged injuries and the conduct complained of must be based upon reasonable medical probability, not mere conjecture, speculation or Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 32 of 39 - 26 - possibility. See Black v. Food Lion, Inc., 171 F.3d 308, 310 (5th Cir. 1999). The nature and function of prescription drugs fall outside the common understanding of a layperson, and thus expert testimony is required to establish causation. Samuel v. Johnson & Johnson, No. 1:14- CV-473, 2015 U.S. Dist. LEXIS 123482 at *13 (E.D. Tex. Aug. 13, 2015). If Plaintiff’s proffered experts cannot both identify a specific defect that they allege proximately caused the injury, and also rule out other possible causes of injury, Plaintiff will not have met her burden of proof on proximate causation. See Ford Motor Co. v. Ridgway, 235 S.W.3d 598, 600-01 (Tex. 2004); see also McNabney v. Lab. Corp. of America, 153 Fed. Appx. 293, 295 (5th Cir. 2005) (“medical causation experts must have considered and excluded other possible causes of injury” for their opinions to be admissible); Copley v. Smith & Nephew, No. Civ A.H-97-2919, 2000 WL 223404, at *4 (S.D. Tex. Feb 2, 2000) (district court excluded testimony of purported causation expert who “failed to perform a differential diagnosis to exclude other potential causes of Plaintiff’s pain.”); Newton v. Roche Labs., Inc., 243 F. Supp. 2d 672 (W.D. Tex. 2002) (excluding specific causation opinions where expert failed to rule out other potential causes.) As explained in detail in Sandoz’ Motions to Exclude Dr. Friedlander and Dr. Kulback’s causation opinions, Plaintiff’s two medical experts can do neither. Plaintiff’s experts do not meet the basic qualification or admissibility requirements of Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), for their medical causation opinions. Dr. Friedlander could not properly rule out a wide range of alternative diagnoses and causes. See Friedlander Dep. at 230. He also not only admitted he was not a pulmonology expert, but also deferred to a pulmonologist as to the causes of Mr. Priest’s interstitial lung disease. Id. at 94-95. Dr. Friedlander provided several potential alternative diagnoses that also could have caused Mr. Priest’s lung problems and his death, rather than amiodarone. Id. at 230, 235, 277. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 33 of 39 - 27 - As for Dr. Kulback, she admits she is not a pulmonologist or a cardiologist, has never prescribed amiodarone to any patient, and has never treated a patient diagnosed with suspected AIPT. Kulback Dep. at 237, 276. Additionally Dr. Kulback never reviewed Mr. Priest’s medical history, rendering any diagnostic opinion baseless and unsupported. Plaintiff’s attempt to use a radiologist who is wholly unqualified to opine on medical causation further underscores the lack of any evidence that Mr. Priest even had AIPT, let alone that it caused his injuries and death. While Plaintiff’s experts fail to provide competent and reliable medical causation opinions, in contrast Sandoz’ expert reports from its highly qualified and well-supported experts definitively conclude Mr. Priest did not have AIPT. See Stmt. of Facts § III.F.iii, supra.13 Instead, Sandoz’ experts conclude with ample basis that other medical causes that predate and bear no relationship to Mr. Priest’s use of amiodarone caused his aspiration event, which led to his sepsis and eventual death. Id. Dr. Dieck concluded, following a review of all of Mr. Priest’s medical records and pharmacy records, that without more evidence and a lung biopsy, it is simply not possible to say to a reasonable degree of medical probability that Mr. Priest more likely than not had AIPT, as opposed to some other cause. Id.; see also Dieck Rep. at 6. Additionally, Dr. Dahlberg concluded to a reasonable degree of medical probability that amiodarone did not cause or contribute to Mr. Priest’s alleged injuries or death. Stmt. of Facts § III.F.iii, supra; see also Dahlberg Rep. at 3. Thus, because she lacks competent expert testimony on medical causation that creates a genuine dispute of material fact, Plaintiff cannot 13 Dr. Dahlberg’s expert report concludes that “[a]lthough the plaintiff claims that amiodarone induced lung toxicity was responsible for Mr. Priest’s increased breathlessness beginning in July, 2013 and his subsequent respiratory failure and death in March, 2014, the duration and doses of amiodarone that Mr. Priest received are not sufficient to have caused pulmonary toxicity. Additionally, multiple other medical conditions and comorbidities were present during that time that were ultimately responsible for Mr. Priest’s breathlessness, respiratory failure and death. There were insufficient diagnostic studies performed on Mr. Priest to make a diagnosis of amiodarone- induced pulmonary toxicity, and it is not apparent that amiodarone-induced pulmonary fibrosis was responsible for the findings on his computed tomography scan of November 22, 2013 or his increased shortness of breath and his clinical pulmonary decompensation from July through October of 2013.” Dahlberg Rep. at 3. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 34 of 39 - 28 - carry her burden to survive a motion for summary judgment as to causation. Finally, Ms. Priest is the only witness with alleged first-hand knowledge of what Mr. Priest did or did not receive with his amiodarone prescriptions filled in 2013. Separate and apart from whether her testimony is reliable from a factual standpoint, her testimony alone cannot sustain her burden of proof on medical causation without competent expert support. Samuel, 2015 LEXIS 123482 at *13. Because Plaintiff cannot show a dispute of material fact on the necessary element of medical causation, summary judgment should be granted in full. D. PLAINTIFF CANNOT PUT FORTH THE CLEAR AND CONVINCING EVIDENCE NEEDED TO MEET HER HEIGHTENED BURDEN OF PROOF TO SUPPORT A CLAIM FOR GROSS NEGLIGENCE AND PUNITIVE DAMAGES. Finally, as to Plaintiff’s gross negligence claim seeking punitive or exemplary damages, Texas law provides that exemplary damages may be awarded to a plaintiff only if he proves specified elements of such damages by clear and convincing evidence. See Tex. Civ. Prac. & Rem. Code § 41.003 § 41.003(a)-(b). “Exemplary damages may not be awarded unless the claimant proves by clear and convincing evidence that the harm results from fraud, malice or gross negligence.” Myriad Dev., Inc. v. Alltech, Inc., 817 F. Supp. 2d 946, 980 (W.D. Tex. 2011). “Gross negligence consists of both objective and subjective elements. Plaintiff must prove by clear and convincing evidence that: 1) when viewed objectively from the defendant’s standpoint at the time of the event, the act or omission involved an extreme degree of risk, considering the probability and magnitude of the potential harm to others and 2) the defendant had actual, subjective awareness of the risk involved, but nevertheless proceeded with conscious indifference to the rights, safety, or welfare of others.” U-Haul Int’l, Inc. v. Waldrip, 380 S.W.3d 118, 137 (Tex. 2012) (internal citations omitted.) This burden of proof may not be shifted to the defendant or satisfied by evidence of ordinary negligence or even bad faith. See Tex. Civ. Prac. & Rem. Code § 41.003(b); see also, e.g., Acosta v. Amoco Oil Co., 978 F. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 35 of 39 - 29 - Supp. 703, 705 (S.D. Tex. 1997) (the standard and quantum of proof required to recover punitive damages under Texas law is quite stringent) (citing Transp. Ins. Co. v. Moriel, 879 S.W.2d 10, 21, 31 (Tex. 1994) (defining “gross negligence” as requiring the existence of an extreme risk and subjective awareness by the defendant as he proceeds with conscious indifference in the face of that risk). In this case, Plaintiff’s demand for punitive damages is based on Sandoz’ alleged gross negligence in failing to provide the “FDA-required Medication Guide.” FAC ¶ 125. “Gross negligence” means an act or omission: (A) which when viewed objectively from the standpoint of the actor at the time of its occurrence involves an extreme degree of risk, considering the probability and magnitude of the potential harm to others; and (B) of which the actor has actual, subjective awareness of the risk involved, but nevertheless proceeds with conscious indifference to the rights, safety, or welfare of others. Tex. Civ. Prac. & Rem. Code § 41.001(11). Here, the record is wholly devoid of any suggestion that Sandoz failed to fulfill its federal regulatory obligations with respect to providing Medication Guides to authorized dispensers, and in fact establishes beyond material factual dispute that Sandoz met and exceeded its obligations. See § IV.B, C, supra; see also Retzlaff v. De La Vina, 606 F. Supp. 2d 654, 658 (W.D. Tex. 2009) (where plaintiff “has not raised an issue of material fact in support of any of his causes of actions, he certainly would not be entitled to exemplary or punitive damages.”). Even if Plaintiff was somehow able to put forth such evidence in response to this Motion, she could not produce evidence that Sandoz acted “with conscious indifference to the rights, safety, or welfare of others,” and there certainly is not clear and convincing evidence that Sandoz was grossly negligent with respect to its amiodarone Medication Guides. Tex. Civ. Prac. & Rem. Code § 41.001(11)(B). Plaintiff cannot prove by “clear and convincing evidence” Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 36 of 39 - 30 - that Sandoz’ conduct warrants exemplary damages in this case, and summary judgment should issue on this claim. V. CONCLUSION Because there is no genuine dispute of material facts in this case, Sandoz is entitled to summary judgment on all claims. The undisputed evidence shows (1) Sandoz fulfilled its obligations under federal law with respect to Medication Guides, by shipping Medication Guides with every batch of amiodarone from which Mr. Priest’s Sandoz prescriptions could have been filled and otherwise making them available to pharmacies; and (2) his pharmacy would have given Mr. Priest a Medication Guide and other warning information with his amiodarone through their own means. Moreover, Plaintiff’s claims for violation of a purely federal duty to distribute Medication Guides are impliedly preempted under Buckman, which this Court may decide as a matter of law. In addition, Plaintiff can offer no competent expert evidence to meet her burden of proof as to medical causation of Mr. Priest’s lung injuries and death, because her disclosed experts cannot properly opine about medical causation as required by Texas law and Fed. R. Evid. 702. Finally, Plaintiff cannot demonstrate through “clear and convincing” evidence that Sandoz was grossly negligent, as is required to support a claim for punitive damages. Sandoz therefore respectfully requests that this Court enter summary judgment in its favor and dismiss Plaintiff’s claims with prejudice, and grant Sandoz any other relief the Court deems just and proper. Because the factual, legal and medical issues presented by this Motion are complex, Sandoz respectfully requests a hearing on this Motion pursuant to Local Rule CV-7(h). Respectfully submitted this 22nd day of September, 2017. Case 1:15-cv-00822-LY Document 92 Filed 09/22/17 Page 37 of 39 - 31 - /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 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 92 Filed 09/22/17 Page 38 of 39 - 32 - CERTIFICATE OF SERVICE I hereby certify that this document was served via mail and email on this 22nd day of September, 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 92 Filed 09/22/17 Page 39 of 39
