Case 9:11-cv RC Document 88 Filed 09/18/12 Page 1 of 22 PageID #: 4128 ** NOT FOR PRINTED PUBLICATION **

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1 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 1 of 22 PageID #: 4128 ** NOT FOR PRINTED PUBLICATION ** IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS LUFKIN DIVISION BEULAH CONKLIN, Plaintiff, v. CIVIL ACTION NO. 9:11CV-178 JUDGE RON CLARK NOVARTIS PHARMAS. CORP., Defendant. ORDER GRANTING IN PART DEFENDANT S MOTION TO STRIKE PLAINTIFF S AMENDED COMPLAINT AND GRANTING IN PART DEFENDANT S MOTION TO STRIKE DR. MARX S NOVEMBER 2010 DECLARATION Plaintiff Beulah Conklin filed suit against Defendant Novartis Pharmaceutical Corporation ( NPC ) in the United States District Court for the Eastern District of New York in March 2006, asserting claims for strict liability under both a design defect and a failure to warn theory, negligence, and breach of express and implied warranty in connection with a condition osteonecrosis of the jaw, or ONJ she allegedly developed after taking Zometa as part of her cancer treatment. In June 2006, the case was consolidated with similar cases as part of a Multi-District Litigation ( MDL ) proceeding in the United States District Court for the Middle District of Tennessee. The MDL court granted a partial summary judgment in NPC s favor on Ms. Conklin s failure to warn claim. The case was remanded to the Eastern District of New York in September 2011, and transferred to the United States District Court for the Eastern District of Texas in late October

2 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 2 of 22 PageID #: 4129 After a status conference in late November 2011, this court set a briefing schedule for any summary judgment motions. Now pending before the court are NPC s motions to strike Ms. Conklin s 1 amended Complaint and to strike the November 2010 declaration of Dr. Robert Marx. As Ms. Conklin s February 7, 2012 amended Complaint was untimely and consideration of the relevant factors favors denying leave to amend, the Clerk is directed to strike it. The only exception is that the new claim for punitive damages in Ms. Conklin s amended Complaint will be allowed. Dr. Marx s November 2010 declaration is not time-barred. However, his opinion in the November 2010 declaration that decreasing the dosage and frequency of Zometa administration would be a safe alternative design in the treatment of cancer is not admissible under Federal Rule of Evidence 702. NPC s motion to strike Ms. Conklin s amended Complaint is granted in part. NPC s motion to strike Dr. Marx s November 2010 declaration is also granted in part, to the extent that Dr. Marx s opinion in that declaration that a lower dosing/frequency regimen is a safe effective alternative design is excluded. I. BACKGROUND 2 The following facts are undisputed, unless otherwise noted. A. Ms. Conklin s illness and treatment with Zometa Ms. Conklin was diagnosed with cancer in August Shortly thereafter, she had seven 3 teeth on her bottom jaw extracted. Ms. Conklin received her first dose of Zometa in November 1 The court considers NPC s pending motion for summary judgment in a separate order. 2 To aid in analysis, the events discussed below are also set out in a time line format in Appendix A. 3 Zometa is the brand name of zoledronic acid, and is part of a class of medications called bisphosphonates. Bisphosphonates work by slowing bone breakdown, increasing bone density, 2

3 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 3 of 22 PageID #: , and received three more doses before discontinuing the treatment in February At that time, her oncologist noted that she had mouth sores and sent her to an oral surgeon for evaluation. 4 Ms. Conklin resumed bisphosphonate therapy in May 2005, and her final dose was in February Ms. Conklin developed osteonecrosis of the jaw, or ONJ, at some point during or shortly after 6 therapy. Zometa s revised packaging insert was approved by the Food and Drug Administration in February 2004, before Ms. Conklin began taking the drug. Doc. # According to the insert, [t]he recommended dose of Zometa in patients with multiple myeloma and metastatic bone lesions from solid tumors is 4 mg infused over 15 minutes every three or four weeks. The optimal duration of therapy is not known. Id. at Page ID# According to her medical records, Ms. Conklin was given Zometa within these dosage parameters 4 mg on November 2, 2004, November 30, 2004, December 23, 2004, and January 25, 2005, all administered over the course of at least 15 minutes. Doc. # 69-9 and B. Ms. Conklin s lawsuit and content of her pleadings Ms. Conklin filed suit in March 2006, and her case was transferred to MDL in June Her Complaint asserted five causes of action: (1) strict liability design defect; (2) strict and decreasing the amount of calcium released from the bones into the blood. While not cancer chemotherapy itself, Zometa can be used along with chemotherapy to treat bone damage. 4 Specifically, Ms. Conklin seems to have received pamidronate, another bisphosphonate medication which NPC sells under the brand name Aredia. 5 As discussed below, osteonecrosis of the jaw caused by bisphosphonate therapy is referred to as BIONJ. 6 The parties briefing is not clear on the precise timing of Ms. Conklin s ONJ diagnosis. 3

4 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 4 of 22 PageID #: 4131 liability failure to warn; (3) negligence; (4) breach of express warranty; and (5) breach of implied warranty. Doc. # With respect to claim (1), design defect, Ms. Conklin s pleadings stated that: 18. Zometa as designed, manufactured and sold by Defendant was defective in design or formulation in that it was unreasonably dangerous. 19. Zometa as designed, manufactured and sold by Defendant was defective in design or formulation in that its foreseeable risks exceeded the benefits associated with the design or formulation. 20. Zometa as designed, manufactured and sold by Defendant was defective due to inadequate warnings because Defendant knew or should have known that the product created a risk of harm to consumers. 21. Zometa as designed, manufactured, and sold by Defendant was defective due to inadequate testing. 22. As the proximate cause and result of the defective condition of Zometa as designed, manufactured and sold by Defendant, Plaintiff was injured. Id. at Page ID# With respect to claim (2), failure to warn, Ms. Conklin s pleadings stated that: 25. Zometa as designed, manufactured and sold by Defendant was not accompanied by proper warnings regarding possible adverse side effects. 26. Defendant knew or should have known about the possible adverse side effects of Zometa, including osteonecrosis of the jaw. 27. As the proximate cause and result of Defendant s failure to properly warn physicians and consumers, Plaintiff was injured. Id. at Page ID# With respect to claim (3), negligence, Ms. Conklin s pleadings stated in relevant part that: 31. Defendant failed to exercise reasonable care in designing, testing, developing, manufacturing, labeling, marketing, distributing and selling Zometa in that Defendant 4

5 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 5 of 22 PageID #: 4132 Id. at Page ID# knew or should have known that Zometa created an unreasonable risk of osteonecrosis of the jaw. With respect to claim (4), breach of express warranty, Ms. Conklin s pleadings stated in relevant part that: 37. Zometa did not conform to Defendant s express warranties in that it was not safe and fit for its intended use because it caused serious adverse side effects, including osteonecrosis of the jaw. Id. at Page ID# With respect to claim (5), breach of implied warranty, Ms. Conklin s pleadings stated in relevant part that: Id. 42. Zometa was not of merchantable quality or safe and fit for its intended use in that it caused serious adverse side effects, including osteonecrosis of the jaw. C. Proceedings in the MDL court The deadline to amend the pleadings in the MDL court was January 4, Doc. # 80-1 at Page ID# 3985; Doc. # 80-2 at Page ID# Ms. Conklin did not do so. In July 2008, the MDL court granted NPC s motion for partial summary judgment as to eight Texas Plaintiffs, including Ms. Conklin. Doc. # 69-1 at Page ID# This Order dismissed the eight Texas Plaintiffs, including Ms. Conklin s, claim for failure to warn based on Texas Civil Practice and Remedies Code (a). Under the MDL court s Scheduling Order, Ms. Conklin was to disclose all of her expert opinions by February 21, Doc. # and Of relevance here, she designated and 5

6 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 6 of 22 PageID #: 4133 submitted the report of Dr. Robert E. Marx, a dentist. Dr. Marx s original October 2008 report provided the following opinions: 1. Clinical experience led him to conclude that there is a causal relationship between bisphophonates and ONJ, and that bisphosphonate-induced ONJ ( BIONJ ), was a discrete pathology; 2. Bisphosphonates are an independent cause of ONJ for four main reasons; and 3. To avoid BIONJ, there should be communications between a treating oncologist and the patient s dentist or oral surgeon, followed by preventative dentistry and close monitoring of the patient. Doc. # at Page ID# In his subsequent December 2008 rebuttal report, Dr. Marx responded to reports by NPC s experts regarding patient histories and ONJ. Doc. # Nowhere in either of these reports did Dr. Marx explicitly opine that the design of Zometa or any other bisphosphonate drug was defective or that an alternative design was available. The only two places in which anything even approaching a general theory for an alternate design or administration for bisphosphonates occur are in Paragraphs 48 and 54 of Dr. Marx s original October 2008 report. Paragraph 48 states that Dr. Marx and his colleagues: collected data from our patient histories and noted the results of different prevention schemes and treatments... We also observed that the severity of cases increased with the number of doses of bisphosphonate received and that more and more cases caused by alendronate (Fosamax) in noncancer patients were being seen. Given Novartis failure to put forth any effective prevention and treatment protocols, we collected our own prevention and treatment data on 119 patients. This was assembled and coordinated with outcome measurements for a publication. This article appeared in the November 2005 issue of the Journal of Oral and Maxillofacial Surgery and represented the first comprehensive set of prevention and treatment guidelines for physicians and dentists. Marx et al Doc. # 76-2 at Page ID# Paragraph 54 states that: In another article the authors report the results of an analysis of the incidence of ONJ among a group of multiple myeloma patients treated with bisphosphonates according to two different schedules: a regular schedule (monthly administrations) and reduced (monthly 6

7 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 7 of 22 PageID #: 4134 administrations for the first year and then every 3 months). Corso et al at p The main finding of [the] study was that the incidence of ONJ was lower in patients treated with the reduced schedule than with the standard schedule of bisphosphonate administration, started after the first year of treatment. Id. Doc. # 76-2 at Page ID# Dr. Marx also submitted a declaration in connection with a summary judgment response Ms. Conklin filed in July 2011 in the MDL case. As discussed in greater detail below, this declaration purports to address whether a safe alterative design exists and cites two sources to support this idea. It is undisputed that none of the information or articles cited in the November 22, declaration regarding alternative design is explicitly in Dr. Marx s expert reports. Ms. Conklin timely designated Dr. Marx s expert reports, produced in October 2008 and as amended, in the MDL proceeding. The parties dispute whether NPC was aware of Dr. Marx s November 22, 2010 declaration as to Ms. Conklin before July On November 22, 2010, Dr. Marx s declaration was filed in the MDL case. The declaration specifically noted that: This document relates to Case Nos.:... 3:06-cv-554 (Worthington)... 3:06-cv-516 (King)... [and] 3:06-cv-388 (Wilson, J.)... I make this declaration at the request of plaintiffs Carol King, Wanda Worthington, and Jacqueline Wilson for use in their opposition to Novartis motions for summary judgment. Doc. # 76-1 at Page ID# While Dr. Marx s declaration does not specifically mention Ms. Conklin or her case number (3:06-cv-505), the court notes that Plaintiffs King, Worthington, and Wilson are, like Ms. Conklin, Texas Plaintiffs. As discussed above, the MDL court granted a combined motion for summary judgment by NPC in July 2008 as to eight Texas Plaintiffs on the 7 The information cited supra from Dr. Marx s October 2008 report in Paragraphs 48 and 54 is far more general than anything in Dr. Marx s November 2010 declaration, which specifically cites scientific articles that are absent from his October 2008 expert report. 7

8 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 8 of 22 PageID #: 4135 failure to warn claims. Four of the eight Plaintiffs were Ms. Conklin and Plaintiffs King, Worthington, and Wilson. D. Proceedings in this court In September 2011, the case was remanded from the MDL to the Eastern District of New York. It was transferred to this court on October 28, 2011, and the court held a status conference on November 28, At this status conference, Ms. Conklin s counsel stated that the case would proceed on a design defect under Texas law.... and that Dr. Marx s November 22, 2010 declaration would provide the evidence to survive a summary judgment motion. Doc. # 68 at 6:2-3 and 12:23-13:2. Ms. Conklin s counsel also stated that the Complaint would be amended to include a claim for punitive damages. Id. at 27:3-13. No other amendment was mentioned, and Ms. Conklin s counsel stated that it would take three weeks to amend the Complaint. Id. at 27:23-28:4. NPC timely filed its motions for summary judgment on the design defect claim and to strike Dr. Marx s November 2010 declaration on December 22, Docs. # 69, 70. Ms. Conklin s 8 responses were filed on February 6 and 7, Also on February 7, Ms. Conklin filed an amended Complaint against NPC which adds numerous facts regarding the dosing schedule, adds allegations regarding a new drug (Aredia), and asserts the following causes of action as to both Aredia and Zometa: (1) strict liability; (2) negligence negligent manufacture; (3) negligence failure to warn; (4) breach of express warranty; and (5) breach of implied warranty. Doc. # 75. The Complaint also alleges punitive damages. NPC 8 The original deadline was January 23, The court extended only Ms. Conklin s response deadlines, at her request, to February 6. Doc. # 72. The court was not asked to extend Ms. Conklin s deadline to amend her pleadings. 8

9 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 9 of 22 PageID #: 4136 filed a motion to strike this amended Complaint on February 21, 2012, and Ms. Conklin responded on March 7, II. NPC S MOTION TO STRIKE MS. CONKLIN S AMENDED COMPLAINT IS GRANTED IN PART A. Applicable law Fed. R. Civ. P. 16(b) governs amendment of pleadings once a scheduling order has been issued by the court. S & W Enters., LLC v. South Trust Bank of Ala., N.A., 315 F.3d 533, 536 (5th Cir. 2003). Only upon the movant s demonstration of good cause will the more liberal standard of 15(a) apply to the district court s decision to grant or deny leave. Id. The good cause standard requires the [p]arty seeking relief to show that the deadlines cannot reasonably be met despite the diligence of the party needing the extension. Id. Courts scrutinize more carefully a party s attempt to raise new theories of recovery by amendment when the opposing party has filed a motion for summary judgment. Parrish v. Frazier, 195 F.3d 761, 763 (5th Cir. 1999). When a party seeks leave after the filing of a motion for summary judgment, there is likely to be disruption to the proceedings and prejudice to the other party. See Little v. Liquid Air Corp., 952 F.2d 841, 846 (5th Cir. 1992). When determining whether leave to amend should be granted, the court should consider four factors: (1) the explanation for the failure to [timely move for leave to amend]; (2) the importance of the [amendment]; (3) potential prejudice in allowing the [amendment]; and (4) the availability of a continuance to cure such prejudice. S & W Enters, 315 F.3d at 536 (internal quotations omitted, brackets in original). 9

10 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 10 of 22 PageID #: 4137 B. Analysis Ms. Conklin makes two arguments: (1) that she was unable to file her amended Complaint within the three weeks counsel stated would be needed at the November 28, 2011 status conference, but that this is essentially irrelevant because the court granted permission to amend at the status conference, no Scheduling Order is in place in this case, and the MDL deadlines do not matter; and (2) that her Complaint does not add any new or unanticipated issues. Both arguments are incorrect. As to the first argument, Ms. Conklin s counsel stated at the November 28, 2011 status conference that an amended Complaint would be filed only to add a punitive damages claim. The court granted leave to do so, and Ms. Conklin s counsel stated that this could be accomplished in three weeks. The Complaint was not filed until February 7, No request for leave to file an amended Complaint after that deadline has ever been filed by Ms. Conklin. And while this court has not entered a Scheduling Order, that is because the MDL court previously did so. Ms. Conklin amended her pleadings more than four years after the MDL court s deadline. Ms. Conklin does not get a do over simply because this case has been remanded from the MDL. As to the second argument, Ms. Conklin concedes that she added claims that had already been disposed of on summary judgment by the MDL in order to preserve her right to appeal the MDL Court s decision. Ms. Conklin also concedes that she has asserted new claims against Aredia. She claims that she was not aware at the time of filing the original suit that she had been treated with Aredia. Given the length of time this case was pending in the MDL, the fact that the MDL court presided over both Zometa and Aredia claims, and the extensive discovery while the case was in that tribunal, this unsupported claim is not credible. 10

11 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 11 of 22 PageID #: 4138 Therefore, looking at the four factor test set out above, Ms. Conklin gives no valid reason for the failure to timely amend the Complaint. Any claimed importance of the amendment is undercut by the fact it took Ms. Conklin four years after the MDL pleadings deadline to file her amended Complaint. The potential prejudice at this point, given that NPC has already filed a summary judgment motion solely on Zometa, is significant. While a continuance is obviously possible, given the length of time Ms. Conklin s case has been pending and the discovery that has been completed, a continuance would be unreasonable. In a sense, it would always be possible to give more time to a party trying to avoid judgment. But that results in a never-ending burden on a Defendant, and the case is prolonged far beyond what is reasonable, contrary to the goals of Federal Rule of Civil Procedure 1. With the exception of her claim for punitive damages, the court will strike Ms. Conklin s February 7, 2012 amended Complaint. Ms. Conklin notified the court and NPC at the November 28 status conference that she would be adding a claim for punitive damages. Although she did not do so within the requested three weeks, there is little prejudice to NPC, as NPC was aware that the claim would be forthcoming. III. NPC S MOTION TO STRIKE DR. MARX S NOVEMBER 2010 DECLARATION IS GRANTED IN PART NPC moves to strike Dr. Marx s declaration as untimely and prejudicial. In the alternative, NPC states that the declaration should be excluded pursuant to Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmas., Inc., 509 U.S. 579, 113 S. Ct (1993), both because an oral surgeon is not qualified to render expert opinions on the proper dosage and duration of use of oncology medication and because the declaration is not reliable. 11

12 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 12 of 22 PageID #: 4139 Ms. Conklin responds that Dr. Marx s opinion was disclosed in his October 2008 original expert report, and that NPC received Dr. Marx s November 2010 declaration in November 2010, well before the close of expert discovery in this case. She argues that even assuming there is a new opinion in the declaration, the delay is harmless. Finally, Ms. Conklin states that Dr. Marx is qualified to render this opinion, and that it is sufficiently reliable under Rule 702 and Daubert. A. Under the facts of this case, timing does not bar Dr. Marx s declaration 1. Factual background The following dates are undisputed, unless otherwise noted. October 6, 2008 Dr. Marx s original expert report is provided to NPC. Doc. # May 26, 2009 July 23, 2009 August 13, 2009 November 22, 2010 February 2011 Dr. Marx s first deposition. During this deposition, he is asked about an article he cited at Paragraph 54 of his original expert report. Dr. Marx testified in response to this question that he cited the article for evidence of an alternative dosing schedule that resulted in the reduction of BIONJ. Doc. # 76-5 at 1384:3-1386:15. Dr. Marx s second deposition. He testifies that he has a background in bone and bone physiology, as well as reasonably large experience with BIONJ. Doc. # 76-7 at 136:7-10. The MDL court enters an order denying in part NPC s motion to exclude Dr. Marx s expert report. None of the areas the report touched on were an alternate design for Zometa. The Order did not deal with Dr. Marx s qualifications, but did opine that his opinions which, again, did not concern alternate designs were sufficiently reliable under Daubert. Doc. # Dr. Marx s November 22, 2010 declaration was provided to NPC as part of three of the Texas Plaintiffs response to NPC s motion for summary judgment. Ms. Conklin states that she notified NPC of her intention to rely on Dr. Marx s expert report, as supplemented in her response to a pending NPC motion. Ms. Conklin does not state that she told NPC of her intention to rely on Dr. Marx s November 2010 declaration, 12

13 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 13 of 22 PageID #: 4140 and there is, again, no evidence of any such communication between counsel to support either proposition. February 21, 2011 May 2011 June 3, 2011 July 2011 Expert designations in the MDL case are due. Expert discovery in the MDL case closes. NPC moves for summary judgment on Ms. Conklin s claims in the MDL, arguing that she failed to identify an alternate design for Zometa. Ms. Conklin responds to NPC s summary judgment motion, and 9 relies on Dr. Marx s November 2010 declaration. 2. Analysis The court agrees with NPC that until Dr. Marx s November 2010 declaration, there was no evidence that Dr. Marx was offering any opinion on an alternate and effective design for Zometa. There are vague statements in his October 2008 expert report about an article which concluded that the incidence of ONJ was lower in patients treated with fewer administrations of bisphosphonates generally, Doc. # 76-2 at Page ID# , and Dr. Marx s observation and subsequent article that in limited patient populations, ONJ was more severe when more doses of bisphosphonate were received, Doc. # 76-2 at Page ID# In other words, while Dr. Marx does generally talk about preventative measures for ONJ that involve reduction in frequency of administration, he gives little in the way of specifics. He also does not discuss reduction of the dosage amount itself, or opine in any way that an alternative dosage and/or frequency alternative design was available for Zometa, until the November 2010 declaration. 9 Shortly after Ms. Conklin s response, the MDL court remanded the case to the Eastern District of New York. NPC s motion for summary judgment does not seem to have ever been ruled on by the MDL as to Ms. Conklin. 13

14 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 14 of 22 PageID #: 4141 Similarly vague statements were made at Dr. Marx s May 2009 deposition about alternative dosing schedules. However, Dr. Marx s November 22, 2010 declaration on that was submitted to the MDL court in connection with three of the Texas Plaintiffs responses to NPC s motion for summary judgment. This is well before the February 2011 deadline for expert designations. It is true that Dr. Marx s declaration was not specifically disclosed by Ms. Conklin. However, Dr. Marx s declaration does not opine as to any particular Plaintiff s condition or medical history; rather, he makes general statements that are applicable to all of the Plaintiffs in this MDL case, who share as a common trait treatment with Zometa and/or Aredia and development of ONJ. And Ms. Conklin was previously associated with these three specific Plaintiffs in the past: they are four of the eight Texas Plaintiffs who were previously joined together in the MDL court s July 2008 ruling on NPC s summary judgment motion. The Federal Rules are not intended as traps or gotchas. Dr. Marx s declaration was disclosed timely as to certain Plaintiffs. Given that this is an MDL and the declaration was timely disclosed as to other Texas Plaintiffs, NPC cannot legitimately claim surprise when Ms. Conklin used Dr. Marx s declaration in July B. No safe alternative design is disclosed in and supported by Dr. Marx s opinion 1. Applicable law Federal Rule of Evidence 702 provides that a witness who is qualified by knowledge, skill, experience, training, or education, may provide opinion testimony if that testimony will assist the trier of fact and (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and 14

15 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 15 of 22 PageID #: 4142 methods reliably to the facts of the case. The witness must possess knowledge, skill, experience, training, or education in the relevant field in order to be qualified to express his expert opinion on the topic at issue. Id. The Supreme Court in Daubert charged trial courts with determining whether scientific expert testimony under Rule 702 is not only relevant, but reliable. Daubert v. Merrill Dow Pharmas., 509 U.S. 579, 589, 113 S. Ct. 2786, 2794 (1993); see also Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 149, 119 S. Ct. 1167, 1175 (1999) (extending Daubert to all expert testimony). The Daubert opinion lists a number of factors that a trial court may use in determining an expert s reliability. Trial courts are to consider the extent to which a given technique can be tested, whether the technique is subject to peer review and publication, and known potential rate of error, the existence and maintenance of standards governing operation of the technique, and, finally, whether the method has been generally accepted in the relevant scientific community... These factors are not mandatory or exclusive; the district court must decide whether the factors discussed in Daubert are appropriate, use them as a starting point, and then ascertain if other factors should be considered... But the existence of sufficient facts and a reliable methodology is in all instances mandatory. Without more than credentials and a subjective opinion, an expert s testimony that it is so is not admissible. Hathaway v. Bazany, 507 F.3d 312, 318 (5th Cir. 2007) (internal citations omitted). 2. Analysis Ms. Conklin cannot prevail on a design defect claim without demonstrating evidence of a safe alternative design. Brockert v. Wyeth Pharmas., Inc., 287 S.W.3d 760, 767 (Tex. App. Houston [14 Dist.] 2009, no pet.). It is a priori that something cannot be a safe alternative design 15

16 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 16 of 22 PageID #: if it substantially impairs the product s utility. Tex. Civ. Prac. & Rem. Code (b)(1). Dr. Marx s November 22 declaration purports to address whether a safe alterative design exists. Looking first at qualifications, Dr. Marx is an oral surgeon with experience in bone science and diseases of bone. Doc. # 76-2 at Page ID# He has treated over 250 patients for BIONJ over the years, and NPC itself asked Dr. Marx to be an advisor on BIONJ in 2003 and On the other hand, while Dr. Marx is undoubtedly qualified to opine on BIONJ itself, he is an oral surgeon, not an oncologist or pharmacologist. There is no evidence in the record that based on his own experience or education he is qualified to opine that a regimen with a decreased dosage and/or frequency of Zometa administration would efficaciously treat cancer-related bone damage. To the contrary, Dr. Marx s discussion of his own experience regarding treatment and avoidance of BIONJ primarily focuses on what triggers bisphosphonate osteonecrosis extraction of a tooth and how to avoid it address dental problems pre-treatment and avoid tooth extractions during bisphosphonate treatment. See, e.g., Doc. # 79-1 at 1650:2-1651:10. It is clear that Dr. Marx had to rely on studies or opinions of other experts to opine on the efficacy or utility of his safe alternative design. His declaration cites two studies. First, Dr. Marx cites a 2006 article by the Mayo Clinic relating to the use of bisphosphonates, including Zometa, in patients with multiple myeloma. The article recommended infusion of 10 Section does not apply to a drug or device, as those terms are defined by 21 U.S.C The Restatement (Second) of Torts, Section 402A, comment k states that an unavoidably unsafe product properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. Texas courts apply comment k to prescription drug claims. See, e.g., Lofton v. McNeil Consumer & Spec. Pharmas., 682 F. Supp. 2d 662, 678 (N.D. Tex. 2010), aff d 672 F.3d 372 (5th Cir. 2012). However, the court has found no prescription drug design defect case in Texas that looks to anything other than Section to define what a safe alternative design is. 16

17 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 17 of 22 PageID #: 4144 bisphosphates monthly for two years, with a decrease to once every three months after two years. 11 This is essentially what Ms. Conklin received: four doses of Zometa about once a month. Dr. Marx also cited the Mayo Clinic s preference for using Aredia over Zometa, due to Aredia s lower potency. Again, this is what happened with Ms. Conklin: she received four doses of Zometa, and was switched to either Aredia or the generic pamidronate thereafter. Nowhere does the Mayo Clinic article state that a lower dose of Zometa or Aredia, administered less frequently, would produce results similar to those seen with the higher, more frequent dose. Second, Dr. Marx also cited an article that described different studies conducted by NPC on the dosing schedules for Zometa. One study included patients who received Zometa administered monthly for the first six doses, then every three months for the next eight doses, and then every six months for the final five doses. Another study compared Zometa given every six months, then every three months. According to Dr. Marx, these studies indicated that marketed dosing schedules were in doubt and that Novartis continued to explore greater intervals between doses. Doc. # 76-1 at Page ID# ONJ is never mentioned in this article, and the article draws no real conclusions about the efficacy of one dosage/frequency regime versus another. Based on the foregoing two articles, Dr. Marx opined that the standard dosage and/or dosing schedule could be altered without reducing efficacy, and that the reduced dosage and/or frequency would result in a reduction of ONJ. Doc. # at Page ID# No explanation is given as to the source of this opinion, other than the two articles cited and described above. 11 Specifically, she was infused on: (1) November 2, 2004; (2) four weeks later on November 30, 2004; (4) three and a half weeks later on December 23, 2004; and (4) more than a month later on January 25,

18 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 18 of 22 PageID #: 4145 Expert testimony must be based on sufficient facts or data. Fed. R. Evid A court is not required to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert, and may rightfully exclude expert testimony where a court finds that an expert has extrapolated data, and there is too great an analytical gap between the data and the opinion proffered. Burleson v. Tex. Dep t of Criminal Justice, 393 F.3d 577, 587 (5th Cir. 2004) (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S. Ct. 512, 519 (1997)). The analytical gap, in Dr. Marx s opinion is demonstrated by setting out his premises and conclusions: Premise: Premise: Conclusion: Studies show that a certain regimen of Zometa helps treat cancer-related bone conditions, but may cause ONJ. Other studies show that less Zometa will result in less ONJ. A regimen using less Zometa will help treat cancer-related bone conditions. This is a classic logical fallacy an irrelevant conclusion. It is not helpful to the finder of fact for Dr. Marx to state that a drug used to fight cancerrelated diseases has a particular negative side effect, and that reducing the dosage and/or frequency of that drug will reduce the occurrence of the negative side effect. Rather, Dr. Marx must also provide some factual support that reducing the dosage and/or frequency of that drug will not only reduce the occurrence of the negative side effect, but will also be effective at fighting cancer-related diseases. Unfortunately, Dr. Marx offers no evidence as to the efficacy of a reduced Zometa regimen, and he does not explain from where he draws his naked conclusion regarding efficacy certainly, it is not in either of the articles he cites. Additionally, Dr. Marx does not explain what specific dosage and/or frequency schedule would achieve similar results for fighting cancer-related diseases. By way of analogy, studies might show that a dose of two aspirin every four hours alleviates a headache, but results in a 20% risk of 18

19 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 19 of 22 PageID #: 4146 stomach bleeding. One might hypothesize that a safe alternative design would include reducing the dosage or increasing the interval between doses. But there is a significant analytical gap between this hypothetical alterative dosage/frequency regime, and actually demonstrating that similar headache relief could be obtained. Dr. Marx s opinion that a lower dose regimen of Zometa will reduce the incidence of Zometa is not helpful. His opinion that there is a lower dose regimen that will be efficacious in fighting cancer-related diseases does not meet the requirements of Rule 702 and the Daubert line of cases. IT IS THEREFORE ORDERED that Defendant Novartis Pharmaceuticals Corp. s Motion to Strike Plaintiff s Amended Complaint [Doc. # 80] is GRANTED IN PART. Plaintiff Beulah Conklin s punitive damages claim may be asserted. The amended Complaint is struck in all other respects. IT IS FURTHER ORDERED that Defendant Novartis Pharmaceuticals Corp. s Motion to Strike the November 2010 Declaration of Dr. Robert Marx [Doc. # 70] is GRANTED IN PART. Dr. Marx s November 2010 opinion that a lower dosing/frequency regimen is a safe effective alternative declaration is excluded. 19

20 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 20 of 22 PageID #: 4147 APPENDIX A TIMELINE OF EVENTS February 2004 August 2004 November 2, 2004 November 30, 2004 December 23, 2004 January 25, 2005 Around February 2005 May 2005 February 2006 March 2006 June 2006 January 4, 2008 July 2008 October 6, 2008 December 2008 May 26, 2009 The Food and Drug Administration approves the revised Zometa packaging insert. Ms. Conklin is diagnosed with cancer. Shortly thereafter it is not clear in the record precisely when she has seven teeth removed. Ms. Conklin s first dose of Zometa. Ms. Conklin s second dose of Zometa. Ms. Conklin s third dose of Zometa. Ms. Conklin s fourth dose of Zometa. Ms. Conklin sent to her oral surgeon. Ms. Conklin resumes bisphosphonate therapy. The record is slightly unclear, but it appears that she received pamidronate, which NPC sells under the brand name Aredia. Ms. Conklin discontinues bisphosphonate therapy. Ms. Conklin files this lawsuit in the Eastern District of New York. The case is transferred to the MDL court. Pleadings deadline in the MDL court. MDL court grants NPC s motion for partial summary judgment and dismisses Ms. Conklin s failure to warn claims. Dr. Marx s original expert report is provided to NPC. Dr. Marx s rebuttal expert report is provided to NPC. Dr. Marx s first deposition. During this deposition, he is asked about an article he cited at Paragraph 54 of his original expert report. Dr. Marx testified in response to this question that he cited the article for evidence of an alternative dosing schedule that resulted in the reduction of BIONJ. Doc. # 76-5 at 1384:3-1386:15. 20

21 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 21 of 22 PageID #: 4148 July 23, 2009 August 13, 2009 November 22, 2010 February 2011 February 21, 2011 May 2011 June 3, 2011 July 2011 September 2011 October 2011 November 28, 2011 December 22, 2011 February 6-7, 2012 Dr. Marx s second deposition. He testifies that he has a background in bone and bone physiology, as well as reasonably large experience with BIONJ. Doc. # 76-7 at 136:7-10. The MDL court enters an order denying in part NPC s motion to exclude Dr. Marx s expert report. None of the areas the report touched on were an alternate design for Zometa. The Order did not deal with Dr. Marx s qualifications, but did opine that his opinions which, again, did not concern alternate designs were sufficiently reliable under Daubert. Doc. # Dr. Marx s November 22, 2010 declaration was provided to NPC as part of three of the Texas Plaintiffs response to NPC s motion for summary judgment. Ms. Conklin states that she notified NPC of her intention to rely on Dr. Marx s expert report, as supplemented in her response to a pending NPC motion. Expert designations in the MDL case are due. Expert discovery in the MDL case closes. NPC moves for summary judgment on Ms. Conklin s claims in the MDL, arguing that she failed to identify an alternate design for Zometa. Ms. Conklin responds to NPC s summary judgment motion, and relies on Dr. Marx s November 2010 declaration. The case is remanded from the MDL to the Eastern District of New York. The case is transferred to the Eastern District of Texas. This court holds a status conference. Ms. Conklin s counsel states that it will take three weeks to file an amended pleading to add a punitive damages claim. NPC files its motions for summary judgment and to strike Dr. Marx s November 22, 2010 declaration. Ms. Conklin responds to NPC s motions, and files an amended Complaint. 21

22 Case 9:11-cv RC Document 88 Filed 09/18/12 Page 22 of 22 PageID #: 4149 February 21, 2012 March 7, 2012 June 29, 2012 July 13, 2012 NPC files a motion to strike Ms. Conklin s amended Complaint. Ms. Conklin responds to NPC s motion to strike the amended Complaint. NPC files a motion for leave to file notice of supplemental authority. Ms. Conklin responds to the motion for leave to file notice of supplemental authority. 22