Rusk et al v. Novartis Pharmaceuticals Corporation et al

MOTION for Summary Judgment and Incorporated Memorandum of Law

W.D. Tex.November 15, 2016

i IN THE UNITED STATES DISTRICT COURT WESTERN DISTRICT OF TEXAS AUSTIN DIVISION DEFENDANT SANDOZ INC.’S MOTION FOR SUMMARY JUDGMENT AND INCORPORATED MEMORANDUM OF LAW JOHN ANTHONY RUSK and JUDY RUSK, individually and as Administrator of the Estate of JOHN ANTHONY RUSK, Plaintiffs, vs. SANDOZ INC., Defendant. ) ) ) ) ) ) ) ) ) ) ) CIVIL ACTION NO. 1-14-CV-00549-LY Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 1 of 39 ii TABLE OF CONTENTS I. INTRODUCTION .................................................................................................................. 1 II. PROCEDURAL BACKGROUND ......................................................................................... 2 III. STATEMENT OF UNDISPUTED FACTS ........................................................................ 4 A. THE FDA-APPROVED LABELING FOR SANDOZ’ AMIODARONE WAS THE SAME AS CORDARONE’S LABELING AND WARNED OF A RISK OF PULMONARY TOXICTY. .................................................................................................................................. 4 i. Amiodarone Has Long Been Used for the Treatment of Atrial Fibrillation and the Labeling Has Long Warned of the Risk of Pulmonary Toxicity. ........................................... 4 ii. Sandoz’ Medication Guide was the Same as Cordarone® and at All Times Contained a Warning Related to a Risk of Serious Lung Problems. ....................................................... 5 B. SANDOZ DISTRIBUTED AND MADE AVAILABLE MEDICATION GUIDES WITH MR. RUSK’S AMIODARONE. ..................................................................................... 7 C. THE PHARMACIES WOULD HAVE DISPENSED MEDICATION GUIDES WITH MR. RUSK’S AMIODARONE PRESCRIPTIONS................................................................. 10 D. MR. RUSK’S PRESCRIBING PHYSICIANS WERE FULLY AWARE OF THE RISKS ASSOCIATED WITH AMIODARONE AND EXPLAINED THEM TO MR. RUSK. ............................................................................................................................... 11 E. PLAINTIFFS CANNOT MEET THEIR BURDEN OF PUTTING FORTH RELIABLE EXPERT TESTIMONY THAT SANDOZ AMIODARONE CAUSED MR. RUSK’S ALLEGED NJURIES. ............................................................................................... 12 i. The Medical Records Show Mr. Rusk Had Significant Heart Disease Prior to Taking Amiodarone........................................................................................................................... 12 ii. Mr. Rusk’s Treating Physicians Could Not Exclude Other Possible Diagnoses or Confirm Amiodarone Toxicity as the Cause of His Death. .................................................. 13 iii. Sandoz’ Experts Concluded Mr. Rusk Did Not Have Amiodarone Induced Pulmonary Toxicity. ................................................................................................................................ 15 IV. ARGUMENT ..................................................................................................................... 16 A. STANDARD FOR SUMMARY JUDGMENT. ............................................................ 16 B. THE UNDISPUTED EVIDENCE DEMONSTRATES SANDOZ DID NOT BREACH A DUTY AND ENTITLES SANDOZ TO JUDGMENT AS A MATTER OF LAW. ........... 17 i. 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 ii. Plaintiffs’ Claims Alleging Failure to Provide Medication Guides Are Impliedly Preempted, Because There Is No Private Right of Action to Enforce This Exclusively Federal Duty.......................................................................................................................... 20 C. THE UNDISPUTED EVIDENCE SHOWS THERE IS NO GENUINE ISSUE OF MATERIAL FACT AS TO CAUSATION AND ENTITLES SANDOZ TO JUDGMENT AS A MATTER OF LAW. ............................................................................................................. 23 Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 2 of 39 iii D. PLAINTIFFS CANNOT PUT FORTH THE CLEAR AND CONVINCING EVIDENCE NEEDED TO MEET THEIR HEIGHTENED BURDEN OF PROOF TO SUPPORT A CLAIM FOR GROSS NEGLIGENCE AND PUNITIVE DAMAGES. ........... 28 V. CONCLUSION ..................................................................................................................... 30 Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 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) ...................................................................................................24 Boudreaux v. Swift Transp. Co., 402 F.3d 356 (5th Cir. 2005) ...................................................................................................17 Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) ...........................................................................................................20, 21 Celotex Corp. v. Catrett, 477 U.S. 317 (1986) .................................................................................................................17 Copley v. Smith & Nephew, No. Civ A.H-97-2919, 2000 WL 223404 (S.D. Tex. Feb 2, 2000) .........................................25 Dreher v. Wyeth Pharm., Inc., No. 2:14-CV-00280-KOB, 2015 WL 3948961 (N.D. Ala. June 29, 2015) .............................22 Ebel v. Eli Lilly & Co., 536 F. Supp. 2d 767 (S.D. Tex. 2008) ...............................................................................21, 22 Exxon Corp. v. Baton Rouge Oil & Chem. Workers Union, 77 F.3d 850 (5th Cir. 1996) .....................................................................................................17 Hassan v. Lubbock Indep. Sch. Dist., 55 F.3d 1075 (5th Cir. 1995) ...................................................................................................17 Hicks v. Brysch, 989 F. Supp. 797 (W.D. Tex. 1997)...................................................................................16, 17 Hubble v. Am. River Transp. Co., No. 01-2361, 2002 WL 927782 (E.D. La. May 7, 2002) .........................................................28 Little v. Liquid Air Corporation, 37 F.3d 1069 (5th Cir. 1994) ...................................................................................................17 McNabney v. Lab. Corp. of America, 153 Fed. Appx. 293 (5th Cir. 2005) .........................................................................................25 Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 4 of 39 v Myriad Dev., Inc. v. Alltech, Inc., 817 F. Supp. 2d 946 (W.D. Tex. 2011)....................................................................................28 Newton v. Roche Labs., Inc., 243 F. Supp. 2d 672 (W.D. Tex. 2002)....................................................................................25 Petrucelli v. Bohringer & Ratzinger, 46 F.3d 1298 (3rd Cir. 1995) ...................................................................................................24 PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) ...................................................................................................5, 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) ..................................................................................................21 Samuel v. Johnson & Johnson, No. 1:14-CV-473, 2015 U.S. Dist. LEXIS 123482 (E.D. Tex. Aug. 13, 2015) ..........24, 25, 27 Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp. 3d 1246, 1252 (N.D. Ala. 2014) ...........................................................................19 Tabor v. E. J. Patterson, Inc., No. 98-2438, 1999 WL 52144 (E.D. La. Jan. 28, 1999) ..........................................................28 EEOC v. Texas Instruments, 100 F.3d 1173 (5th Cir. 1996) ...........................................................................................17, 18 State Cases Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) ....................................................................................................22 Ford Motor Co. v. Ledesma, 242 S.W.3d 32 (Tex. 2007) ......................................................................................................24 Ford Motor Co. v. Ridgway, 235 S.W.3d 598 (Tex. 2004) ....................................................................................................25 Havner v. E-Z Mart, 825 S.W.2d 456 (Tex. 1992) ....................................................................................................24 HEB Grocery Co. v. Galloway, 2014 WL 2152128 (Tex. App. May 22, 2014) ........................................................................24 Prudential Ins. Co. v. Jefferson Assocs., 896 S.W.2d 156 (Tex. 1995) ....................................................................................................23 Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 5 of 39 vi Puryear v. Porter, 262 S.W.2d 933 (Tex. 1953) ....................................................................................................24 Santa Rosa Medical Center v. Robinson, 560 S.W.2d 751 (Ct. App. Tex. 1997) .....................................................................................24 Travis v. City of Mesquite, 830 S.W.2d 94 (Tex. 1992) ......................................................................................................23 U-Haul Int’l, Inc. v. Waldrip, 380 S.W.3d 118 (Tex. 2012) ....................................................................................................29 Federal Statutes 21 U.S.C. § 337(a) ...................................................................................................................22, 23 21 U.S.C. § 355(j)(2)(A) ..................................................................................................................5 Federal Food, Drug and Cosmetic Act ..........................................................................................21 Federal Regulations 21 C.F.R. § 208.1 ...........................................................................................................................18 21 C.F.R. § 208.1(a).........................................................................................................................5 21 C.F.R. § 208.1(b) ........................................................................................................................6 21 C.F.R. § 208.3(a)...................................................................................................................8, 18 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 .....................................................................................................................7, 18 21 C.F.R. § 208.24(b) ..............................................................................................................18, 21 21 C.F.R. § 208.24(b)(1) ................................................................................................................19 21 CFR § 208.3 ..............................................................................................................................18 63 Fed. Reg. 66,378 .........................................................................................................................6 63 Fed. Reg. at 66,379 .....................................................................................................................5 Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 6 of 39 vii Federal Rules Fed. R. Civ. P. 26(a)(2) ..................................................................................................................25 Fed. R. Civ. P. 37(c)(1) ..................................................................................................................25 Fed. R. Civ. P. 56 .............................................................................................................................1 Fed. R. Civ. P. 56(a) ......................................................................................................................16 State Statutes and Rules 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 Tex. Adm. Code Rul. 291.33(c)(1) ................................................................................................22 Tex. Adm. Code Rul. 291.33(c)(1)(A)(i) .......................................................................................23 Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 7 of 39 1 Pursuant to Fed. R. Civ. P. 56, Defendant Sandoz Inc. (“Sandoz”) respectfully moves this Court for summary judgment. In support of its Motion, Sandoz states as follows: I. INTRODUCTION Plaintiffs’ sole remaining claim in this case, following the Court’s ruling on Defendant’s motion to dismiss, is that Sandoz failed to distribute or make available the patient medication guide for amiodarone, a generic anti-arrhythmia medication, and that but for this alleged failure John Anthony Rusk’s (“Mr. Rusk”) death would have been prevented. Following discovery, Plaintiffs have failed to develop any evidence to support this claim, and indeed the evidence conclusively refutes Plaintiffs’ theory. From 2006 to 2012, Plaintiffs’ decedent, Mr. Rusk, was prescribed amiodarone by numerous cardiologists for treatment of his atrial fibrillation, an irregular heartbeat, or arrhythmia that can lead to stroke, heart failure and other cardiac complications. Two different pharmacies dispensed amiodarone manufactured by Sandoz or its affiliate, Eon Labs, Inc., to Mr. Rusk on three occasions—December 29, 2006, January 22, 2007, and August 24, 2011—and dispensed amiodarone manufactured by other manufacturers to Mr. Rusk on numerous other occasions. Mr. Rusk died in May 2012 at age 84 following a long and complex medical course. Plaintiffs allege Mr. Rusk died of amiodarone pulmonary toxicity, a risk well-known by the medical community since the approval of Cordarone®, the brand name for amiodarone, in 1985. First, the undisputed record makes clear: (1) Sandoz shipped every batch of amiodarone from which Mr. Rusk’s prescriptions could have been filled with medication guides and otherwise made the medication guide available to pharmacies electronically and by phone; (2) the pharmacies would have given Mr. Rusk the medication guide; and (3) Mr. Rusk received warning information about the risks of amiodarone toxicity from his prescribing physicians and Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 8 of 39 2 from the pharmacies. These uncontroverted facts establish that Sandoz fulfilled its duty under federal law to provide medication guides—a duty that is in all events impliedly preempted by federal law (it also has no counterpart in Texas state law)—and that Mr. Rusk received warnings related to the exact risk at issue in this case. Second, the record further reflects Plaintiffs’ inability to meet their burden of proof on the element of causation because Plaintiffs have no reliable expert testimony to support their claims that Mr. Rusk’s death was caused by Sandoz’ amiodarone, and Defendant’s disclosed experts conclusively refute the element of causation. Third, Plaintiffs have not satisfied their heightened burden of proof to come forward with clear and convincing evidence to support their gross negligence cause of action and claim for punitive damages. For each of these independent reasons, summary judgment is appropriate in this case. II. PROCEDURAL BACKGROUND Plaintiffs originally filed this case in May 2014, and Sandoz moved to dismiss. This Court granted Sandoz’ motion in part and denied it in part, permitting re-pleading of two claims: off-label promotion and failure to provide a medication guide. The Court provided very clear instructions regarding what would be required to adequately replead such claims. (Dkt. 46). In November 2015, Plaintiffs filed their First Amended Complaint (“FAC”) (Dkt. 48), and Sandoz again moved to dismiss on the grounds that Plaintiffs’ claims failed to meet the Court’s instructions for re-pleading and on grounds of preemption. (Dkt. 50). On July 28, 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 both parties filed objections, on September 7, 2016, the Court adopted the Magistrate’s Report Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 9 of 39 3 and Recommendation, dismissing claims for wrongful death (count A) and off-label marketing (count C), but allowing claims from gloss negligence (count B) and negligence per se (count D) for failure to provide a medication guide to proceed. (Dkt. 71). Accordingly, Sandoz’ alleged failure to provide a medication guide is now the sole claim remaining in this case. While Sandoz’ second motion to dismiss was pending, discovery proceeded, including written discovery, document production, depositions of Mr. Rusk’s family members1 and treating physicians, and the deposition of Costco pharmacist Michael Boccieri. Despite the agreement of the parties that Plaintiffs’ expert disclosures and reports would be due September 15, 2016, Plaintiffs failed to serve any disclosures of their expert opinions (whether retained or non-retained) or any reports from expert witnesses.2 At the October 6, 2016 deposition of treating physician Harold Cain, M.D., Plaintiffs’ counsel for the first time indicated Plaintiffs intended to rely upon unnamed treating physicians as alleged experts to support their clams, although the identities of these physicians, the physicians’ opinions, or where the substance of such opinions may be located in either a disclosure or a medical record have not been disclosed. (See Dkt. 112, 113).3 Plaintiffs also have not supplemented their Rule 26 disclosures to include disclosure of any treating physician opinions on which they intend to rely. Notwithstanding Plaintiffs’ failure to disclose any expert witnesses or to produce any expert reports, on October 1, 2016, Sandoz served both its disclosures and written reports from six retained expert witnesses and disclosed non-retained expert witnesses, including treating 1 Plaintiffs have refused to make Ms. Rusk available for deposition based on her alleged mental health status and have recently moved for reconsideration of the Court’s Order granting Sandoz’ Motion to Compel as to the deposition of Ms. Rusk. Sandoz opposes this motion on the grounds that Plaintiffs argue that she is able to respond to deposition upon written questions but not an oral deposition based on her dementia. Ms. Rusk is the only identified witness with alleged first hand knowledge of what Mr. Rusk received or did not receive with his December 29, 2006, January 22, 2007 and August 24, 2011 Sandoz amiodarone prescriptions. 2 See Scheduling Order (Dkt. 59); Email to extend dates outlined in Scheduling Order (Dkt. 92-2). 3 Following the completion of the depositions of certain treating physicians on whom Plaintiffs may intend to rely, despite their failure to clearly disclose such an intention, Sandoz filed motions to exclude as to two such physicians- Harold Cain, M.D. and Stuart McKennon, M.D. (Dkt. 112, 113). Those motions are pending. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 10 of 39 4 physicians and company witnesses. Plaintiffs did not request depositions of Sandoz’ experts prior to the close of expert discovery on October 30, 2016. The opinions of Sandoz’ expert witnesses’ are therefore uncontroverted, and Plaintiffs lack any competent expert support on medical causation or the other necessary elements of their claims against Sandoz. III. STATEMENT OF UNDISPUTED FACTS A. THE FDA-APPROVED LABELING FOR SANDOZ’ AMIODARONE WAS THE SAME AS CORDARONE’S LABELING AND WARNED OF A RISK OF PULMONARY TOXICTY. i. Amiodarone Has Long Been Used for the Treatment of Atrial Fibrillation and the Labeling Has Long Warned of the Risk of Pulmonary Toxicity. Amiodarone is a prescription pharmaceutical product indicated for treatment of recurrent ventricular arrhythmias when other treatments are ineffective or have not been tolerated. See Ex. A, Affidavit of Gregory Seitz, II in Support of Sandoz Inc.’s Motion for Summary Judgment (“Seitz Aff.”), at Exhibit B (2011 amiodarone package insert). Wyeth Pharmaceuticals, Inc. first manufactured and sold amiodarone under the brand name Cordarone® in 1985. FAC ¶ 44. Amiodarone is widely recognized and employed as an antiarrhythmic agent for patients with atrial fibrillation like Mr. Rusk. See Ex. B, Dr. Stoddard Expert Report (“Stoddard Rep.”), at p. 5. The safety and effectiveness of amiodarone for the treatment of atrial fibrillation is well established in the medical literature and clinical experience. Id. The use of amiodarone for atrial fibrillation is also supported by guidelines published by recognized medical associations, including the American Heart Association and the American College of Cardiology. Id. Although the FDA-approved labeling for amiodarone does not list atrial fibrillation as an indicated use, prescription of amiodarone is the standard of care for atrial fibrillation for many patients and is a medically necessary treatment. Id. It is not uncommon for drugs to be widely used for an indication not included in the FDA labeling, if clinical literature and experience Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 11 of 39 5 supports its use for those indications. Id. Since it was first approved by the FDA in 1985, Cordarone® labeling has included a black box warning, the strictest type of warning, of the risk of pulmonary toxicity. Seitz Aff.¶ 14. Eon Labs Manufacturing, Inc. n/k/a Eon obtained approval to manufacture generic amiodarone on December 23, 1998.4 Id. ¶¶ 17-18. In order to manufacture generic amiodarone, Eon was required to submit an Abbreviated New Drug Application (“ANDA”) (No. 75-315) to FDA, which demonstrated both bioequivalence to Cordarone® and proposed labeling that was materially identical to Cordarone®. See 21 U.S.C. § 355(j)(2)(A). As part of the ANDA approval, FDA specifically reviewed and approved the proposed physician package insert, which like the package insert for Cordarone® included a black box warning of the risk of pulmonary toxicity. Seitz Aff. ¶¶ 15-16. Following ANDA approval, federal law required Eon and later Sandoz5 to keep the labeling and design 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 the labeling for their amiodarone products following changes to Cordarone®. Seitz Aff. ¶¶ 23-24. The FDA-approved package insert for amiodarone at the time of all three of Mr. Rusk’s Sandoz amiodarone prescriptions in December 2006, January 2007, and August 2011 contained a black box warning regarding pulmonary toxicity. Id. ¶ 22. ii. Sandoz’ Medication Guide was the Same as Cordarone® and at All Times Contained a Warning Related to a Risk of Serious Lung Problems. Medication guides are patient labeling for certain prescription drugs as determined by the FDA and require FDA’s prior approval of the wording and format before distribution. Medication Guide Requirements, 63 Fed. Reg. at 66,379; 21 C.F.R. § 208.1(a). The purpose of a 4 For the general regulatory framework for generic drugs, see Seitz Aff. ¶¶ 9-21. Also, Sandoz incorporates the background and fact sections from its motion to dismiss for additional regulatory history. (Dkt. 50). 5 Sandoz acquired Eon on July 21, 2005. Seitz Aff. ¶ 19. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 12 of 39 6 medication guide is to provide patients with information regarding drugs that pose a “serious and significant” concern, including additional information about serious known side effects. Medication Guide Requirements, 63 Fed. Reg. 66,378.6 More specifically, the purpose of the medication guide is to provide patients with information “necessary to patient’s safe and effective use of drug products.” 21 C.F.R. § 208.1(b). 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 label under federal law, it is subject to the same duty of sameness as all other labeling. See Seitz Aff. ¶¶ 12, 28; Mensing, 131 S. Ct. at 2577. In December 2004, the FDA required that Cordarone® include a medication guide. Seitz Aff. ¶ 25. FDA notified Eon of the new medication guide requirement on January 21, 2005, and on January 24, 2005, Eon submitted a Changes Being Effected letter to FDA with its proposed medication guide that was the same as Cordarone’s labeling. Seitz Aff. ¶ 30. Like Cordarone’s labeling, Sandoz’ proposed medication guide labeling 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. The FDA approved Eon’s (this was before Sandoz’ acquisition of Eon) medication guide labeling on February 18, 2005. Id. This FDA-approved medication guide provided in pertinent part: What is the most important information I should know about Amiodarone Hydrochloride Tablets? 6 See also Medication Guides for Certain Prescription Products, FDA.gov, http://www.fda.gov/ForConsumers/ ConsumerUpdates/ucm107825.htm#top. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 13 of 39 7 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… Seitz Aff. ¶ 31. Importantly, the medication guide also made clear that it was available both online and by telephone: “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. ¶ 32. Further, the label affixed to the bottle read: “PHARMACIST: Each time drug is dispensed, please provide patient with a Medication Guide.” Id. The medication guides in place at the time of Mr. Rusk’s Sandoz amiodarone prescriptions in December 2006, January 2007, and August 2011 matched that of Cordarone® and contained the same warnings regarding a serious risk of lung damage. Id. ¶ 33. Similarly, the medication guides in place in December 2006, January 2007 and August 2011 made clear that they were available online and by telephone. Id. In addition, the labels on the bottles at the time of Mr. Rusk’s prescriptions instructed pharmacists to provide the medication guide with each amiodarone prescription. Id. B. SANDOZ DISTRIBUTED AND MADE AVAILABLE MEDICATION GUIDES WITH MR. RUSK’S AMIODARONE. Under 21 C.F.R. § 208.24, 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 Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 14 of 39 8 or produce medication guides, it is their exclusive duty “to provide a Medication Guide to each patient receiving a prescription for the drug product.” See id. ¶ 34. 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. Seitz Aff. ¶ 37. Its duties are therefore fulfilled by either providing medication guides in sufficient numbers to distributors or authorized dispensers or 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 to provide medication guides directly to patients. Id. Mr. Rusk filled prescriptions for 200 mg amiodarone tablets on December 29, 2006 and January 22, 2007 at a Costco pharmacy, which filled the prescriptions with amiodarone bearing National Drug Code (“NDC”) 0185-0144-60, which corresponds to Sandoz amiodarone. Seitz Aff. ¶ 20. Mr. Rusk also filled a prescription for 200 mg amiodarone tablets on August 24, 2011 via CVS/Caremark mail order pharmacy, which filled the prescription with amiodarone bearing NDC 0185-0144-05 that corresponds to Sandoz. Id. Contrary to the FAC’s assertions, the amiodarone Sandoz manufactured, packaged and shipped to authorized dispensers that was dispensed to Mr. Rusk in 2006, 2007 and 2011 all contained adequate numbers of medication guides. See Ex. C, Declaration of Cynthia Pitt (“Pitt Dec.”), at ¶ 17; Seitz Aff. ¶ 40. Proper labeling is extremely important and is therefore treated with a high level of scrutiny. Pitt Dec. ¶ 13. There are many checks and balances performed from incoming receipt of the labels to issuing them to the packaging lines, to adhering them to the bottles, to reconciling and destroying the extras at the end of packaging. Id. For each batch Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 15 of 39 9 distributed between January 24, 2005 and August 2011 (that may have contained Mr. Rusk’s prescriptions), Sandoz/Eon conducted careful inspections of each batch of amiodarone to ensure that all part of the labeling, including the medication guides were included with each batch. Id. ¶¶ 13. Verification that each shipment includes the appropriate labeling, including medication guides, is documented in records for every batch of amiodarone (“batch records”). Pitt Dec. ¶ 13. Sandoz produced all of the batch records for all batches of amiodarone distributed between December 2004 and December 2008, and between August 2009 and August 2011 from which Mr. Rusk’s Sandoz amiodarone would have come. Cynthia Pitt, Director of Quality Systems and Compliance and/or Flavia Hoffman, Executive Director, Quality at the Wilson Site, personally reviewed every batch record for all shipments of amiodarone during these time periods, which necessarily included the shipments of amiodarone from which Mr. Rusk’s prescriptions came.7 In total, they reviewed approximately 540 batch records. Pitt Dec. ¶ 16. Their review confirmed that each batch of amiodarone distributed during these time periods was accompanied by medication guides either (1) affixed to each bottle as part of the twinsert; (2) provided in printed tear-away pads; or (3) included as part of the physician package insert. Pitt Dec. ¶ 17. Thus, the undisputed evidence demonstrates every shipment of Sandoz’ amiodarone at issue contained adequate numbers of medication guides and Sandoz complied with all FDA regulations and industry standards. Id. ¶ 21. Additionally, in 2006, 2007, and 2011, at the time of Mr. Rusk’s Sandoz amiodarone prescriptions, Sandoz made medication guides available through its website and/or the National 7 Prescription records reflect that the dates Mr. Rusk’s amiodarone prescriptions were filled with Sandoz amiodarone were December 29, 2006, January 22, 2007, and August 24, 2011. Because Sandoz’ amiodarone 200 mg tablets have a two year expiration date, for purposes of evaluating shipments of amiodarone that may have included the amiodarone dispensed to Mr. Rusk on these dates, Sandoz collected, reviewed and produced all batch records created in the two year period prior to each date of prescription. There is no evidence whatsoever that Mr. Rusk’s amiodarone was dispensed more than two years after it was manufactured, and thus it is undisputed for purposes of this Motion that the amiodarone dispensed to Mr. Rusk was manufactured and shipped within the two- year periods for which batch records were produced and reviewed, and incorporated into the Pitt Declaration. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 16 of 39 10 Institutes of Health’s DailyMed website, thereby making them available to pharmacies for distribution to patients. Seitz Aff. ¶ 41; Pitt Dec. ¶¶ 21, 13. The medication guides themselves in place at the time of Mr. Rusk’s prescriptions pointed patients and pharmacists to the Sandoz website and a phone number. Seitz Aff. ¶ 41. Sandoz therefore complied with not only one, as required under federal law, but all FDA regulations for distributing medication guides and making them available to wholesalers and/or pharmacies. Id.; Pitt Dec. ¶ 21. C. THE PHARMACIES WOULD HAVE DISPENSED MEDICATION GUIDES WITH MR. RUSK’S AMIODARONE PRESCRIPTIONS. The undisputed evidence from Mr. Rusk’s pharmacies confirms that they would have provided him with medication guides for his Sandoz amiodarone prescriptions. Both the Costco pharmacy filling his prescriptions in 2006-2007 and the CVS/Caremark mail order pharmacy filling his prescription in 2011 produced uncontroverted evidence on this point. Plaintiffs deposed Costco pharmacist Michael Boccieri on October 25, 2016. Mr. Boccieri testified: Q. But the intent of Costco, would it be to provide Mr. Rusk with the medication guide with this patient counseling information? A. Yes, sir. Q. If the pharmacist that dispensed the medication to Mr. Rusk did everything right, they would have provided the medication guide as well as this patient counseling information? A. Yes. MS. FINCHER: Object to form. MR. WILLIAMS: Objection; form. Q. (BY MR. MERRELL) Would it have been a requirement of Costco that the pharmacist provide the medication guide with this patient counseling information? A. Yes. Deposition of Michael Boccieri (“Boccieri Dep.”), excerpts of which are attached as Ex. D, at 64-65. According to Mr. Boccieri, Costco provided medication guides to patients when required by FDA at all times. Id. at 50. Costco either printed the medication guides from an electronic format beginning around 2007 or 2008, or received them with the drug from McKesson, a Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 17 of 39 11 distributor, who in turn had received them from the manufacturers. Id. at 50-51. Providing medication guides was important to Costco and it made every effort to make sure patients received the medication guides. Id. at 51-52. The testimony of Mr. Boccieri makes clear that he knows of no reason why Costco would not have provided Mr. Rusk with the medication guide as required. Id. at 81-82; see also id. at 71-72. Mr. Boccieri testified paragraph 84 of the FAC, in which Plaintiffs allege a Costco pharmacist said Costco did not provide medication guides for amiodarone because it did not receive them from Sandoz, is inaccurate. Id. at 66-67. Furthermore, Plaintiffs have no evidence to support their claim that CVS or Caremark did not provide Mr. Rusk with a medication guide. Caremark does not maintain specific copies of the documents given to a patient with their prescription. See Caremark’s Resp. and Obj. to Def. Subpoena., Resp. 2, attached as Ex. E. However, Caremark believes that a counseling sheet and FDA medication guide would have been included. Id. CVS also asserts that it does not maintain specific copies of the document given to a patient with their prescription. See CVS’s Resp. and Obj. to Def. Subpoena., Resp. 2, attached as Ex. F. Plaintiffs have no contrary evidence that either the 2006-2007 prescriptions filled by Costco or the 2011 prescription filled by CVS/Caremark were not accompanied by medication guides.8 D. MR. RUSK’S PRESCRIBING PHYSICIANS WERE FULLY AWARE OF THE RISKS ASSOCIATED WITH AMIODARONE AND EXPLAINED THEM TO MR. RUSK. Dr. Robert Canby, Mr. Rusk’s treating cardiologist, first prescribed amiodarone to Mr. Rusk on December 28, 2006. See Deposition of Robert Canby (“Canby Dep.”), excerpts of 8 Additionally, Mr. Rusk’s stepdaughter Rachel Reeves testified he likely would have reviewed and thrown away the package insert or twinsert, which contained a Medication Guide, after receiving his prescriptions of amiodarone. See Deposition of Rachel Reeves (“Reeves Dep.”), excerpts of which are attached at Ex. G, at 111-112. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 18 of 39 12 which are attached as Ex. H, at 52. Dr. Canby is familiar with the black box warning for amiodarone including those related to pulmonary toxicity. Id. at 76, 78. He knew of these risks when deciding to prescribe amiodarone to Mr. Rusk. Id. at 79. It is his practice to specifically warn patients about the risk of lung toxicity, and to tell them to look it up and contact him if the patient has any questions. Id. at 85–86. Dr. Canby found the benefits outweighed the risks for Mr. Rusk and it was the appropriate agent to treat him. Id. at 66. Mr. Rusk’s other prescribing physicians similarly testified they knew of the risk of pulmonary toxicity, were aware of the black box warning, and discussed the potential for toxicity with Mr. Rusk, and also testified they decided in his case the benefits outweighed the risks. Pulmonary toxicity is one of the risks Dr. Sanchez addressed with Mr. Rusk when discussing risks and benefits of amiodarone. Deposition of Javier Sanchez (“Sanchez Dep.”), excerpts of which are attached as Ex. I, at 32, 82. Dr. Wozniak re-started Mr. Rusk on amiodarone on June 23, 2009, and he discussed the risks and benefits of amiodarone with Mr. Rusk. Deposition of Robert Wozniak (“Wozniak Dep.”), excerpts of which are attached as Ex. J, at 124-125.9 E. PLAINTIFFS CANNOT MEET THEIR BURDEN OF PUTTING FORTH RELIABLE EXPERT TESTIMONY THAT SANDOZ AMIODARONE CAUSED MR. RUSK’S ALLEGED NJURIES. i. The Medical Records Show Mr. Rusk Had Significant Heart Disease Prior to Taking Amiodarone. Mr. Rusk was first diagnosed with atrial fibrillation (“AFib”) in May 2006. May 24, 2006 Dr. Wozniak History & Physical Report, attached as Ex. K. Despite initial treatment with a different medication, Mr. Rusk suffered recurring complaints of AFib, as well as new and separate diagnoses of advanced coronary artery disease and symptomatic atypical atrial flutter. 9 See also Deposition of Jason Zagrodsky (“Zagrodsky Dep.”), excerpts of which are attached as Ex. L, at 37-38. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 19 of 39 13 See Wozniak Dep. at 67-68; Sanchez Dep. at 45, 48, 49, 55; Zagrodsky Dep. at 41, 45, 50. Between January 2007 and the date of his final admission on March 27, 2012, Mr. Rusk was admitted to the hospital or visited the emergency room on several occasions for cardiac symptoms. See Wozniak Dep. at 115-120, 132, 136, 146-47; Sanchez Dep. at 79. Dr. McKennon, Mr. Rusk’s attending physician during this admission, testified that Mr. Rusk was not experiencing any sort of lung disease or pulmonary toxicity, and no symptoms he would source to amiodarone. See Deposition of Dr. McKennon (“McKennon Dep.”), excerpts of which are attached as Ex. M, at 23. ii. Mr. Rusk’s Treating Physicians Could Not Exclude Other Possible Diagnoses or Confirm Amiodarone Toxicity as the Cause of His Death. On March 26, 2012, Mr. Rusk returned to the Emergency Room complaining of shortness of breath for the past two weeks. Mr. Rusk remained in the hospital until his death on May 1, 2012. March 27, 2012 Dr. McKennon Death Summary, attached as Ex. N. Dr. McKennon testified that his differential diagnoses for Mr. Rusk’s interstitial lung disease included amiodarone, burned viral pneumonia, and an autoimmune process like scleroderma. McKennon Dep. at 46. Other potential causes included alveolar cell carcinoma of the lung or drugs other than amiodarone. Id. at 48, 56. Dr. Wozniak also examined Mr. Rusk shortly after he was admitted. March 28, 2012 Dr. Wozniak Cardiology Consult, attached as Ex. O. Dr. Wozniak reported that Mr. Rusk’s “chest x- ray had changes that were concerning for congestive heart failure.” Id.; see also Wozniak Dep. at 172. As of April 1, 2012, Dr. Wozniak’s differential diagnosis of possible causes of Mr. Rusk’s symptoms included congestive heart failure, interstitial pneumonitis, and possible pulmonary toxicity. Id. at 177, 191. None of these causes or several others was subsequently ruled out by Mr. Rusk’s treating physicians. Id. at 31, 44. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 20 of 39 14 Mr. Rusk was evaluated by a pulmonologist, Dr. Cain, on March 29, 2012. March 29, 2012, Dr. Cain Consultation Notes, attached as Ex. P. His report reflects that Mr. Rusk incorrectly reported he had “initially been on 200 mg a day but, in recent years, he has been on 400 mg a day.” Id. This was not a correct picture of Mr. Rusk’s history of amiodarone use, as he was actually on 200 mg or less since July 8, 2009, except for two months between January and March 2010. Wozniak Dep. at 183. Dr. Cain testified that if Mr. Rusk was on 200 mg and not 400 mg as reported, that would make a diagnosis of pulmonary toxicity from amiodarone less likely. See Deposition of Dr. Cain (“Cain Dep.”), excerpts of which are attached as Ex. Q, at 44. Even with inaccurate dosage information, however, Dr. Cain’s pulmonology consult included several potential diagnoses other than pulmonary amiodarone toxicity. March 29, 2012 Cain Consultation Notes; Cain Dep. at 56-57. Dr. Cain likewise testified to several potential alternative diagnoses, including other forms of interstitial lung disease, congestive heart failure, alveolar hemorrhage, or neurovascular disease. March 29, 2012 Cain chest x-ray, attached as Ex. R; Cain Dep. at 59, 64-65. Dr. Cain also could not exclude Mr. Rusk’s recurrent gastrointestinal bleeding as a potential cause of death having nothing to do with amiodarone. April 20, 2012 McKennon Progress Note, attached as Ex. S; April 12, 2012 Cain Progress Note, attached as Ex. T; Cain Dep. at 163-64, 193. Consistent with the treating physicians’ testimony, numerous possible diagnoses are listed on Mr. Rusk’s hospital discharge summary, a.k.a. death summary, including: “Acute respiratory failure, interstitial pneumonia, amiodarone lung toxicity, chronic atrial fibrillation, hypertension, idiopathic encephalopathy, asystole cardiac arrest, idiopathic gastrointestinal bleed while on anticoagulation.” April 20, 2012 McKennon Progress Note. Two alternative causes of death are listed on the death certificate signed by Dr. McKennon: (1) Arteriosclerotic Heart Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 21 of 39 15 Disease; and (2) Amiodarone Induced Lung Disease. See Death Certificate, attached as Ex. U. This indicates the immediate cause of Mr. Rusk’s death was arteriosclerotic heart disease. The second potential cause of death was amiodarone induced lung disease. McKennon Dep. at 90-91. When Dr. McKennon was asked if he could say to a reasonable degree of medical probability that it was amiodarone induced lung disease, he could only say that in his opinion it was more likely than not. Id. at 93. He also said he defers to a pulmonologist as to whether Mr. Rusk actually had amiodarone induced lung disease, and notes that pulmonologists are not asked to sign death certificates. Id. at 94. Dr. Cain testified he did not consult with Dr. McKennon at all as to completing the death certificate. Cain Dep. at 192. iii. Sandoz’ Experts Concluded Mr. Rusk Did Not Have Amiodarone Induced Pulmonary Toxicity. Sandoz engaged expert physicians, including a cardiologist and pulmonologist, to evaluate Mr. Rusk’s medical history, amiodarone use, and provide an analysis and opinions to a reasonable degree of medical probability concerning Mr. Rusk’s symptoms and diagnosis, including the cause of death, if known. See Sandoz’ Designation and Disclosure of Experts (Dkt. 101). Copies of these expert reports are attached as Exhibits B & V and incorporated as if set forth fully herein. Dr. Marcus Stoddard is an expert in cardiology, arrhythmias and medical management of arrhythmias, including the use of amiodarone to treat atrial fibrillation. See Stoddard Report at 1 for additional qualifications. He explains that amiodarone induced pulmonary toxicity (“AIPT”) is a form of interstitial lung disease. Id. at 6. AIPT is a diagnosis of exclusion, as there are numerous potential causes of interstitial lung disease. Id. In order to reach a diagnosis of AIPT, other causes must be ruled out by history, examination, and testing. Id. Dr. Stoddard reviewed all of the medical records and pharmacy records of Mr. Rusk from 2006 through 2012, and Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 22 of 39 16 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. Rusk more likely than not had AIPT, as opposed to some other cause. Id. Dr. Carl Dahlberg is a pulmonologist, with expertise in the diagnosis and treatment of interstitial lung disease and its causes, including interstitial lung disease secondary to amiodarone toxicity. See Dr. Dahlberg Expert Report, Ex. V, at 1. Dr. Dahlberg also reviewed all of Mr. Rusk’s medical and pharmacy records from 2006 through 2012 and performed a differential diagnosis in his evaluation of the cause of Mr. Rusk’s interstitial lung disease. Id. Given the information present in the medical record, Dr. Dahlberg states that a diagnosis of amiodarone pulmonary toxicity cannot be established. Id. at 3. It is Dr. Dahlberg’s opinion to a reasonable degree of medical probability that amiodarone did not cause or contribute to Mr. Rusk’s alleged injuries or death. Id. Furthermore, even if amiodarone were the cause of Mr. Rusk’s pulmonary decompensation in late March 2012, because Mr. Rusk ingested amiodarone from several different manufacturers during the course of his time on amiodarone, the Sandoz amiodarone prescription cannot be shown to have caused any purported amiodarone pulmonary toxicity to a reasonable degree of medical probability. See id. Plaintiffs have not produced disclosures or reports from any expert witness or treating physician disputing these conclusions. 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. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 23 of 39 17 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 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 Court must view the evidence in a light most favorable to the non-movant. Hassan v. Lubbock Indep. Sch. Dist., 55 F.3d 1075, 1079 (5th Cir. 1995). 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 that a genuine issue as to a material fact exists.” Hicks, 989 F.Supp. at 807; see also Celotex, 477 U.S. at 324. Plaintiffs’ 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 by 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 A DUTY AND ENTITLES SANDOZ TO JUDGMENT AS A MATTER OF LAW. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 24 of 39 18 i. 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. Plaintiffs rest their sole remaining theory of liability in this case on groundless assertions regarding Defendant’s purported failure to provide the medication guides for amiodarone to Mr. Rusk. FAC ¶ 137. Plaintiffs incorrectly allege that Defendant had a duty to “provide each patient prescribed Defendant’s amiodarone with a Medication Guide.” Id. Sandoz is under no duty as a matter of law to provide a medication guide directly to patients, and Plaintiffs’ allegations thus hinge on a fundamental mischaracterization of federal law, when the undisputed facts demonstrate Sandoz fully complied with all its obligations under federal law. 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 to patients does not rest upon the manufacturer. Rather, the manufacturer of a drug product has a duty to either provide “Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers” or provide “the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers.”10 Once the authorized dispensers obtain these 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(b). 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 10 For the purpose of 21 C.F.R. § 208.24, 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. 21 CFR § 208.3. Distributor means a person who distributes a drug product. 21 CFR § 208.3. Packer means a person who packages a drug product. 21 CFR § 208.3. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 25 of 39 19 like Sandoz, which is not licensed to provide drug products by prescriptions to patients in the course of a professional practice. Thus, Sandoz owed no duty to provide a medication guide directly to Mr. Rusk. 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”). It is further undisputed that Sandoz fulfilled and indeed exceeded its duty under federal law with respect to providing sufficient numbers of medication guides or the means to produce medication guides to distributors or authorized dispensers. First, the record is wholly devoid of any evidence that Sandoz failed to provide sufficient numbers of medication guides to distributors and authorized dispensers in compliance with this regulation. To the contrary, it establishes beyond material factual dispute that Sandoz did provide medication guides in adequate numbers to authorized distributors with all shipments of amiodarone. See Stmt. of Facts § III.B.i, supra; Pitt Dec. ¶¶ 13-16. 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. Rusk’s prescriptions could possibly have originated. Pitt Dec. ¶ 17. Second, there is no material factual dispute that during the relevant time period, Sandoz made medication guides available online and through a system where dispensers could call to request medication guides. See Stmt. of Facts § III.B.i, supra; Pitt Dec. ¶ 21. 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 the authorized dispenser, who is tasked with providing the information to patients. Plaintiffs fail to address this mechanism for providing medication guides to authorized dispensers and the record is devoid of any evidence Sandoz failed to provide a means to produce medication guides. Indeed, it establishes beyond Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 26 of 39 20 material factual dispute that Sandoz did provide, both electronically and telephonically, a means to produce medication guides to authorized dispensers. Seitz Aff. ¶¶ 41-43. Even though Sandoz’ duty 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, the record in this case goes a step further. There is no dispute of material fact in this case as to whether Costco would have provided a medication guide to Mr. Rusk with his amiodarone prescription, because Costco pharmacy manager Michael Boccieri made clear at his deposition that this was Costco’s routine practice and policy and that it would have been followed in this instance. See Stmt. of Facts § III.C, supra. Plaintiffs also lack any evidence or testimony to refute that this policy and procedure was followed in this instance, with Mr. Rusk receiving a medication guide from Costco with his prescription. Thus, not only did Sandoz fulfill its duty under federal law, but its actions in fact achieved the intended result— distribution of a medication guide to Mr. Rusk. And Mr. Rusk’s doctors further alerted him to the exact same risks covered by the medication guides. See Stmt. of Facts § III.C, supra. Thus, Plaintiffs have no cognizable factual basis, in light of the undisputed factual record in this case, to substantiate their assertions that Mr. Rusk did not receive a medication guide and the warnings contained in the medication guide. ii. Plaintiffs’ 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 Plaintiffs could point to some evidence Sandoz’ violated itsfederal regulatory duties, Sandoz would still nonetheless 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), Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 27 of 39 21 held “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with the [law].” Id. at 349 n.4.11 Plaintiffs base their failure to provide medication guide claim on Sandoz’ alleged violation of the medication guide regulation, which, as discussed in the preceding section, defines the manufacturer’s duty to provide medication guides to authorized dispensers: (b) Each manufacturer who ships a container of drug product for which a Medication Guide is required under this part is responsible for ensuring that Medication Guides are available for distribution to patients by either: (1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product; or (2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Medication Guide to each patient receiving a prescription for the drug product. 21 C.F.R. § 208.24(b) (emphases added). This is strictly a federal duty arising under the FDCA, and consequently, because Plaintiffs’ medication guide claims are based solely on alleged violations of federal law, the claims are impliedly preempted under Buckman. There is no state law counterpart to Plaintiffs’ alleged violation of federal law that even arguably could permit Plaintiffs 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 intermediary’ between the manufacturer and consumer.’” Reyes v. Wyeth Labs., 498 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 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 28 of 39 22 F.2d 1264, 1276 (5th Cir.1974) (emphasis added, 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.”). The Texas Supreme Court has held there is no exception to the learned intermediary doctrine for direct-to-consumer advertising of prescription drugs. See Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 167 (Tex. 2012).12 Sandoz thus had no duty under Texas law to provide any warnings directly to Plaintiffs’ decedent, including through the medication guide. Accord 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”). And there is no record evidence to suggest that Sandoz failed to warn Mr. Rusk’s physicians of the risks associated with amiodarone. To the contrary, it is undisputed they were well aware of the risks and discussed them with Mr. Rusk. See Stmt. of Facts § III.C, supra. Texas law also imposes a duty on pharmacists, not manufacturers, to 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 or device; (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 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 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 29 of 39 23 storage; (vii) refill information; and (viii) action to be taken in the event of a missed dose. Tex. Adm. Code Rule 291.33(c)(1)(A)(i). Again, this duty runs to Mr. Rusk’s pharmacists, not Sandoz. Although Plaintiffs allege Mr. Rusk did not receive the medication guide from his pharmacies because Sandoz failed to provide them to the pharmacies, FAC ¶ 82, the undisputed evidence showsSandoz provided medication guides to authorized distributors with shipments of amiodarone, and also provided means to produce medication guides to distributors, packers, or authorized dispensers, who have the ultimate duty of providing medication guides directly to patients under federal regulations and Texas law and in fact supplied the medication guides to Mr. Rusk. See Stmt. of Facts §§ III.B-C, supra; Ex. W, Dr. Ashworth Expert Report, at 5. Simply stated, there is no evidence in the record to support Plaintiffs’ claim that Sandoz violated any duty owed to Mr. Rusk under federal law, and even if it hard the purely federal duty asserted by Plaintiffs is impliedly preempted by 21 U.S.C. §337(a) as interpreted in Buckman. C. THE UNDISPUTED EVIDENCE SHOWS THERE IS NO GENUINE ISSUE OF MATERIAL FACT AS TO CAUSATION AND ENTITLES SANDOZ TO JUDGMENT AS A MATTER OF LAW. Sandoz also is entitled to judgment as a matter of law because the record is devoid of any evidence to support Plaintiffs’ theory of causation. Plaintiffs have offered no medical evidence attributing Mr. Rusk’s alleged injuries to Sandoz’ amiodarone. In fact, the record conclusively demonstrates Mr. Rusk’s alleged injuries were not, to a reasonable degree of medical probability, caused by amiodarone manufactured by any company, let alone by Sandoz’ amiodarone. Plaintiffs bear 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. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 30 of 39 24 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). If there is no causal relationship between the product and the alleged injury, the defendant cannot be held liable on a theory of strict product liability, warranty or misrepresentation. See Petrucelli v. Bohringer & Ratzinger, 46 F.3d 1298, 1309 (3rd Cir. 1995). To prove Sandoz’ amiodarone somehow proximately caused Plaintiffs’ injury, Plaintiffs bear 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, “the vital inquiry in any case involving proximate cause is whether the negligent act set in motion a natural and unbroken chain of events that led directly and proximately to a reasonably foreseeable injury or result.” Puryear v. Porter, 262 S.W.2d 933, 936-37 (Tex. 1953); Santa Rosa Medical Center v. Robinson, 560 S.W.2d 751, 757 (Ct. App. Tex. 1997). Plaintiffs cannot meet their burden in this case because they have not disclosed any experts at all, much less experts capable of offering medical causation opinions to a reasonable degree of medical probability as required under Texas law. Proof of a causal connection between Plaintiffs’ alleged injuries and the conduct complained of must be based upon reasonable medical probability, not mere conjecture, speculation or 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 Plaintiffs’ proffered experts cannot both identify a specific defect that they allege proximately caused the injury, and also rule out other possible causes of Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 31 of 39 25 injury, Plaintiffs will not have met their burden of proof as to 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 physician expert’s specific causation opinions where expert failed to rule out other potential causes.) Here, Plaintiffs’ failure to timely designate experts leaves them with no evidence to satisfy their burden of proof on causation. Samuel, 2015 LEXIS 123482, at *13. Having missed the deadline to disclose experts, Plaintiffs have sought instead to proffer the testimony of Mr. Rusk’s treating physicians in a last-ditch attempt to raise a question of fact as to causation. There are several problems with this strategy. At the outset, expert testimony, whether from retained or non-retained witnesses, must be disclosed in accordance with Fed. R. Civ. P. 26(a)(2). In violation of this requirement, Plaintiffs may attempt to use the testimony of two treating physicians (Dr. Stewart McKennon and Dr. Harold Cain) as expert testimony, without ever having disclosed them as experts. Consequently, Plaintiffs are prohibited from relying upon Dr. McKennon or Dr. Cain to supply expert evidence at trial. See Fed. R. Civ. P. 37(c)(1). Indeed, both treating physicians testified that they were not giving their depositions with the intent of being experts in the case. McKennon Dep. at 14-15; Cain Dep. at 197. Moreover, even if the Court were inclined to consider the testimony of Dr. McKennon or Dr. Cain on the issue of causation, neither physician can supply evidence sufficient to meet Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 32 of 39 26 Plaintiffs’ burden of proving medical causation through competent expert testimony.13 Dr. McKennon’s testimony is insufficient due to the wide range of alternative diagnoses and causes that he could not properly rule out. See McKennon Dep. at 10, 49-50. Dr. McKennon not only admitted he was not a pulmonology expert, but also deferred to Dr. Cain as to the causes of Mr. Rusk’s interstitial lung disease. See id. Dr. McKennon had a list of potential alternative diagnoses that also could have caused Mr. Rusk’s lung problems and his death, rather than amiodarone.14 As for Dr. Cain, he admits amiodarone-induced pulmonary toxicity is a diagnosis of exclusion, and does not disagree with other doctors, namely Dr. McKennon, who cannot conclusively rule out other causes of interstitial lung disease. See Cain Dep. at 176, 183. Dr. Cain also acknowledged Mr. Rusk’s lack of physiological response to steroid therapy was inconsistent with an amiodarone-induced pulmonary toxicity diagnosis; once a patient ceases ingesting amiodarone and begins a course of steroids, Dr. Cain would expect improvement within a few days, but after three days of steroid use Mr. Rusk did not improve. Cain Dep. at 53-54. Dr. Cain further noted a number of possible alternative diagnoses that he also could not exclude.15 Not only do Mr. Rusk’s treating physicians fail to provide proper causation testimony, the only admissible expert opinions in this case are the expert reports served by Sandoz, which conclude Mr. Rusk did not have amiodarone-induced pulmonary toxicity. See Stmt. of Facts § 13 Sandoz filed motions to exclude the testimony of Dr. McKennon and Dr. Cain and incorporate by reference those motions herein. 14 Dr. McKennon could not rule out the following potential causes of Mr. Rusk’s interstitial lung disease: asbestos exposure, auto immune disease, occult malignancy, or viral pneumonia. McKennon Dep. at 31, 49, 51, 53-54. 15 In the comment section of his treating notes, Dr. Cain effectively lists four diagnoses that could be the source of Mr. Rusk’s lung problems. Cain Dep. at 56-57. Additionally, Mr. Rusk’s medical records are not sufficiently clear for Dr. Cain to make an acute onset amiodarone induced pulmonary toxicity diagnosis. Id. at 42. Also, Dr. Cain has only seen one other suspected case of amiodarone induced pulmonary toxicity in his career. Id. at 39. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 33 of 39 27 III.D.iii, supra.16 Thus, it is evident Plaintiffs’ cannot carry their burden to survive a motion for summary judgment as to causation. Dr. Stoddard concluded, following a review of all of Mr. Rusk’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. Rusk more likely than not had AIPT, as opposed to some other cause. Id.; see also Stoddard Rep. at 6. And Dr. Dahlberg concluded to a reasonable degree of medical probability that amiodarone did not cause or contribute to Mr. Rusk’s alleged injuries or death, and even if it were the cause, Mr. Rusk’s ingestion of amiodarone from multiple manufacturers precludes assignment of causation solely or primarily to Sandoz’ amiodarone, to a reasonable degree of medical probability. Stmt. of Facts § III.D.iii, supra; see also Dahlberg Rep. at 3. Finally, Ms. Rusk is the only witness with alleged first-hand knowledge of what Mr. Rusk received or did not receive with his Sandoz amiodarone prescriptions. Even if she were in a position to testify, her testimony would be insufficient to sustain her burden of proof on causation, without competent expert support. Samuel, 2015 LEXIS 123482, at *13. Regardless, Plaintiffs are unwilling to make her available for deposition. While Sandoz is certainly sympathetic to Ms. Rusk’s health issues, it cannot reasonably be expected to prepare for trial without the deposition of the plaintiff in this action, especially where she has identified herself as having information related to the action. See Plaintiffs’ Initial Disclosure Statement § II.A.; Plaintiffs Judy Rusk’s Answer to Defendant Sandoz Inc.’s First Interrogatories, No. 3. A 16 Dr. Dahlberg’s expert report concludes “to a reasonable degree of medical certainty that amiodarone did not cause or contribute to Mr. Rusk’s alleged injuries or death.” (Dahlberg Exp Rep. p. 3). Dr. Dahlberg reaches such a conclusion, in part, by analyzing the oxygen saturation levels from a stress test conducted relatively close in time to Mr. Rusk’s admission to the hospital on March 26, 2012. The results of the test showed Mr. Rusk did not have any significant pulmonary impairment, despite having taken amiodarone for several years prior. Dr. Stoddard reaches a similar conclusion. (Stoddard Exp Rep. p. 10.) He reaches such conclusion by noting Mr. Rusk’s chest X-rays prior to March 2012 did not show any signs of interstitial lung disease, and amiodarone induced pulmonary toxicity typically develops within a few months after ingestion—not years. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 34 of 39 28 deposition on written questions, as Plaintiffs propose, is simply no substitute for live testimony.17 This Court granted Sandoz’ motion to compel the deposition of Ms. Rusk after Plaintiffs did not oppose it (Dkt. 98), yet now Plaintiffs seek to set that Order aside. (Dkt. 120). Plaintiffs effectively seek to rely on the written testimony of Ms. Rusk while denying Sandoz the opportunity to depose her. Under these circumstances, even if Ms. Rusk could provide non- expert testimony sufficient to sustain her claim, Plaintiffs’ refusal to make Ms. Rusk available for deposition supports appropriate corrective action, up to and including dismissal of her claims. See e.g. Hubble v. Am. River Transp. Co., No. 01-2361, 2002 WL 927782, at *2 (E.D. La. May 7, 2002) (citing Durgin v. Graham, 372 F.2d 103, 131 (5th Cir. 1967)); Tabor v. E. J. Patterson, Inc., No. 98-2438, 1999 WL 52144, at *1 (E.D. La. Jan. 28, 1999). D. PLAINTIFFS CANNOT PUT FORTH THE CLEAR AND CONVINCING EVIDENCE NEEDED TO MEET THEIR HEIGHTENED BURDEN OF PROOF TO SUPPORT A CLAIM FOR GROSS NEGLIGENCE AND PUNITIVE DAMAGES. Finally, as to Plaintiffs’ gross negligence claim seeking punitive 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. Plaintiffs 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 17 Sandoz incorporates herein by reference its Response to Plaintiffs’ Motion to Reconsider its Order Granting Sandoz’ Motion to Compel (Dkt. 132.) Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 35 of 39 29 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, bad faith, or a deceptive trade practice. See Tex. Civ. Prac. & Rem. Code § 41.003(b); see also, e.g., Acosta v. Amoco Oil Co., 978 F. 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, Plaintiffs’ demand for punitive damages is based on Sandoz’ alleged gross negligence in failing to provide the “FDA-required Medication Guide.” FAC ¶ 137. “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, as discussed above, 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.i, 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 Plaintiffs were somehow able to put forth such evidence, there is nothing in Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 36 of 39 30 the record to suggest 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. Tex. Civ. Prac. & Rem. Code § 41.001(11)(B). For these reasons, Plaintiffs cannot prove by “clear and convincing evidence” that exemplary damages are warranted, and summary judgment is appropriate. V. CONCLUSION For the reasons described herein, the absence of a genuine dispute as to material facts in this case entitles Sandoz to summary judgment in its favor. First, the undisputed evidence shows Sandoz fulfilled its obligations under federal law with respect to providing medication guides, because it (1) shipped medication guides with every batch of amiodarone from which Mr. Rusk’s Sandoz prescriptions could have been filled and otherwise made the medication guide available to pharmacies; (2) the pharmacies at issue would have given Mr. Rusk the medication guide with his amiodarone; and (3) Mr. Rusk received warning information about the risks of amiodarone toxicity from his prescribing physicians and pharmacies. Moreover, Plaintiffs’ claims for violation of a purely federal duty impliedly preempted under Buckman. Second, Plaintiffs can offer no evidence to meet their burden of proof as to medical causation of Mr. Rusk’s lung injuries and death, because they have no competent experts who can so testify as required by Texas law. Finally, Plaintiffs cannot demonstrate “clear and convincing” evidence that Sandoz was grossly negligent, as is required to support a claim for punitive damages. There is simply no remaining dispute of material fact justifying proceeding to trial in this case. Sandoz therefore respectfully requests that this Court enter summary judgment in its favor and dismiss Plaintiffs’ claims with prejudice and grant Sandoz any other relief the Court deems just and proper. Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 37 of 39 31 Respectfully submitted, /s/ Sara K. Thompson Gregory J. Casas State Bar No. 00787213 E-Mail: casasg@gtlaw.com 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 * Admitted Pro Hac Vice Attorneys for Sandoz Inc. 3 Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 38 of 39 32 CERTIFICATE OF SERVICE I hereby certify this Motion for Summary Judgment and Incorporated Memorandum of Law was electronically filed with the Court and that counsel of record, who are deemed to have consented to electronic service in the above-referenced case, are being served this 15th day of November, 2016, with a copy of the above-document via the Court’s CM/ECF System per Local Rule CV-5(a)(3). /s/ Sara K. Thompson Sara K. Thompson Case 1:14-cv-00549-LY Document 134 Filed 11/15/16 Page 39 of 39