Wendell et al v. Johnson & Johnson et al

Filing 368

ORDER GRANTING 319 MOTION FOR SUMMARY JUDGMENT; DENYING 355 MOTION FOR LEAVE TO FILE MOTION FOR RECONSIDERATION. ***Civil Case Terminated.*** Signed by Judge Claudia Wilken on 6/30/2014. (ndr, COURT STAFF) (Filed on 6/30/2014)

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1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE NORTHERN DISTRICT OF CALIFORNIA 3 4 STEPHEN WENDELL, et al., 5 Plaintiffs, 6 v. 7 JOHNSON & JOHNSON, et al., 8 Defendants. ________________________________/ 9 United States District Court For the Northern District of California 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ORDER GRANTING MOTION FOR SUMMARY JUDGMENT; DENYING MOTION FOR LEAVE TO FILE MOTION FOR RECONSIDERATION (Docket Nos. 257, 319, 355) Plaintiffs Stephen and Lisa Wendell brought this action as 10 11 No. C 09-4124 CW successors-in-interest to their deceased son, Maxx Wendell. They asserted claims for negligence and strict liability against Defendants Johnson & Johnson, Centocor, Inc., Abbott Laboratories, Teva Pharmaceuticals USA, GlaxoSmithKline, and Par Pharmaceutical, Inc. 1 In January 2014, Defendants Johnson & Johnson, Centocor, Abbott Labs, and Teva moved jointly for summary judgment on all claims against them; however, shortly after the Court took this motion under submission, Plaintiffs reached a settlement in principle of their claims against Johnson & Johnson, Centocor, and Abbott Labs. June 2014. The parties finalized their settlement agreements in As a result, Teva is now the only Defendant remaining in this action and the only party still seeking summary judgment. Plaintiffs oppose Teva’s motion for summary judgment. After considering the parties’ submissions and oral argument, the Court grants the motion. 26 1 27 28 Plaintiffs also initially brought suit against Gate Pharmaceuticals. However, because Gate is merely a division of Teva, rather than a separate entity, the Court construes the claims against Gate as claims against Teva. 1 BACKGROUND 2 The following facts are undisputed except where otherwise 3 4 noted. Maxx Wendell was diagnosed with inflammatory bowel disease 5 (IBD) in 1998 when he was twelve years old. 6 began receiving treatment from Dr. Edward Rich, a pediatric 7 gastroenterologist, at Kaiser Permanente in San Francisco, 8 California. 9 Soon afterward, he In June 1999, Dr. Rich prescribed a six-mercaptopurine (6MP) United States District Court For the Northern District of California 10 drug to treat Maxx’s IBD. 11 GlaxoSmithKline, then known as SmithKline Beecham, and marketed 12 under the brand name Purinethol. The drug was manufactured by 13 Three years later, in July 2002, while Maxx was still taking 14 Purinethol, Dr. Rich prescribed him an anti-tumor necrosis factor 15 (anti-TNF) drug called Remicade, which was manufactured, marketed, 16 and distributed by Centocor. 17 In July 2003, GlaxoSmithKline sold its distribution rights 18 for Purinethol to Teva and ceased distributing the drug. 19 continued to take the Teva-distributed Purinethol until July 2004 20 when he switched to a generic 6MP drug distributed by Par 21 Pharmaceutical, Inc. 22 until April 2007. 23 Maxx Maxx continued to take the generic 6MP drug In May 2006, after Maxx’s IBD symptoms had subsided, Dr. Rich 24 directed Maxx to stop taking Remicade. 25 after Maxx’s symptoms returned, Dr. Rich prescribed him another 26 anti-TNF drug called Humira. 27 is manufactured, marketed, and distributed by Abbott Labs, until 28 June 2007. In November 2006, however, Maxx continued to take Humira, which 2 1 One month later, in July 2007, Maxx was diagnosed with a 2 rare, incurable, and aggressive form of cancer known as 3 hepatosplenic T-cell lymphoma (HSTCL). 4 2007 at the age of twenty-one. 5 He passed away in December Plaintiffs initiated the present lawsuit in July 2009 and 6 filed their fourth amended complaint (4AC) in April 2011. 7 No. 165, 4AC. 8 HSTCL as a result of taking the combination of drugs that he was 9 prescribed between 2002 and 2007 -- specifically, the combination Docket In their 4AC, they alleged that Maxx had developed United States District Court For the Northern District of California 10 of 6MP and anti-TNF drugs. 11 manufacturers and distributors of those drugs failed to issue 12 adequate warnings about the risks associated with taking 6MP drugs 13 in combination with anti-TNF drugs. 14 California law for negligence and strict liability against Johnson 15 & Johnson, Centocor, Abbott Labs, GlaxoSmithKline, Par, and Teva. 16 4AC ¶¶ 62-101. 17 Plaintiffs further alleged that the They asserted claims under In 2011, Defendants Abbott Labs, GlaxoSmithKline, Teva, and 18 Par moved for summary judgment. 19 December 2011, finding that Plaintiffs had failed to produce 20 sufficient evidence to support an inference that different warning 21 labels would have changed Dr. Rich’s decision to prescribe the 22 specific combination of drugs at issue in this case. 23 based its decision, in part, on the undisputed evidence “that Dr. 24 Rich was already aware of the risk of lymphomas associated with 6– 25 MP, but still chose to prescribe the drug” to Maxx in combination 26 with an anti-TNF drug. 27 Order, at 15. The Court granted the motion in The Court Docket No. 204, Dec. 2011 Summary Judgment 28 3 Plaintiffs subsequently moved for reconsideration of the 2 December 2011 ruling after they discovered new evidence suggesting 3 that Dr. Rich may not have known about the risks associated with 4 these drugs before prescribing them. 5 the Court granted Plaintiffs’ motion for reconsideration and 6 withdrew its December 2011 summary judgment order. 7 after reviewing Plaintiffs’ new evidence, the Court denied Teva’s, 8 Par’s, and Abbott Labs’ motions for summary judgment. 9 granted summary judgment to GlaxoSmithKline, however, because it 10 United States District Court For the Northern District of California 1 found that Plaintiffs had presented “insufficient evidence for a 11 reasonable jury to find that, before July 1, 2003 when 12 [GlaxoSmithKline] discontinued distribution of Purinethol, it had 13 a duty to warn of the risk of hepatosplenic T-cell lymphoma.” 14 Docket No. 232, July 2012 Summary Judgment Order, at 27. 15 later, the Court granted Par’s unopposed motion for summary 16 judgment. 17 Based on this new evidence, In July 2012, The Court One year Docket No. 293, May 2013 Summary Judgment Order, at 1. In January 2014, the four remaining Defendants -- Johnson & 18 Johnson, Centocor, Abbott Labs, and Teva -- filed the instant 19 motion for summary judgment. 20 subsequently settled their claims against all of these Defendants 21 other than Teva. As noted above, Plaintiffs 22 LEGAL STANDARD 23 Summary judgment is properly granted when no genuine and 24 disputed issues of material fact remain, and when, viewing the 25 evidence most favorably to the non-moving party, the movant is 26 clearly entitled to prevail as a matter of law. 27 P. 56; Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986); 28 4 Fed. R. Civ. 1 Eisenberg v. Ins. Co. of N. Am., 815 F.2d 1285, 1288-89 (9th Cir. 2 1987). 3 The moving party bears the burden of showing that there is no 4 material factual dispute. 5 true the opposing party’s evidence, if supported by affidavits or 6 other evidentiary material. 7 815 F.2d at 1289. 8 in favor of the party against whom summary judgment is sought. 9 Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, Therefore, the court must regard as Celotex, 477 U.S. at 324; Eisenberg, The court must draw all reasonable inferences United States District Court For the Northern District of California 10 587 (1986); Intel Corp. v. Hartford Accident & Indem. Co., 952 11 F.2d 1551, 1558 (9th Cir. 1991). 12 Material facts which would preclude entry of summary judgment 13 are those which, under applicable substantive law, may affect the 14 outcome of the case. The substantive law will identify which 15 facts are material. Anderson v. Liberty Lobby, Inc., 477 U.S. 16 242, 248 (1986). 17 of proof on an issue at trial, the moving party may discharge its 18 burden of production by either of two methods: 19 20 21 22 23 24 25 26 27 28 Where the moving party does not bear the burden The moving party may produce evidence negating an essential element of the nonmoving party’s case, or, after suitable discovery, the moving party may show that the nonmoving party does not have enough evidence of an essential element of its claim or defense to carry its ultimate burden of persuasion at trial. Nissan Fire & Marine Ins. Co., Ltd., v. Fritz Cos., Inc., 210 F.3d 1099, 1106 (9th Cir. 2000). If the moving party discharges its burden by showing an absence of evidence to support an essential element of a claim or defense, it is not required to produce evidence showing the 5 1 absence of a material fact on such issues, or to support its 2 motion with evidence negating the non-moving party’s claim. 3 see also Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 885 (1990); 4 Bhan v. NME Hosps., Inc., 929 F.2d 1404, 1409 (9th Cir. 1991). 5 the moving party shows an absence of evidence to support the non- 6 moving party’s case, the burden then shifts to the non-moving 7 party to produce “specific evidence, through affidavits or 8 admissible discovery material, to show that the dispute exists.” 9 Bhan, 929 F.2d at 1409. United States District Court For the Northern District of California 10 Id.; If If the moving party discharges its burden by negating an 11 essential element of the non-moving party’s claim or defense, it 12 must produce affirmative evidence of such negation. 13 F.3d at 1105. 14 burden then shifts to the non-moving party to produce specific 15 evidence to show that a dispute of material fact exists. 16 Nissan, 210 If the moving party produces such evidence, the Id. If the moving party does not meet its initial burden of 17 production by either method, the non-moving party is under no 18 obligation to offer any evidence in support of its opposition. 19 Id. 20 ultimate burden of persuasion at trial. This is true even though the non-moving party bears the 21 22 Id. at 1107. DISCUSSION As previously noted, Plaintiffs assert claims against Teva 23 for negligence and strict liability. 24 claims must fail because Plaintiffs have failed to present 25 sufficient evidence to support an inference that Purinethol, 26 either alone or in combination with anti-TNF drugs, caused Maxx to 27 develop HSTCL. 28 sufficient evidence to support an inference that it had a duty to Teva contends that these Teva further contends that Plaintiffs lack 6 1 warn about the risks associated with taking Purinethol. 2 these arguments is addressed separately below. Each of 3 A. 4 “An essential element in claims for product strict liability Causation 5 and negligence is causation.” 6 1160486, at *5 (S.D. Cal.). 7 she was personally injured by a pharmaceutical product must 8 “establish that the substance at issue was capable of causing the 9 injury alleged (general causation), and that the substance caused, Cox v. Depuy Motech, Inc., 2000 WL Thus, a plaintiff claiming that he or United States District Court For the Northern District of California 10 or was a substantial factor in causing, the specific plaintiff’s 11 injury (specific causation).” 12 Trust, 633 F.3d 828, 836 (9th Cir. 2011). 13 “‘causation must be proven within a reasonable medical probability 14 based upon competent expert testimony.’” 15 Ortho Pharmaceutical Corp., 163 Cal. App. 3d 396, 402 (1985)). 16 Avila v. Willits Envtl. Remediation Under California law, Id. (citing Jones v. Here, Plaintiffs rely on the opinions of two experts to show 17 causation: Drs. Dennis Weisenburger and Andrei Shustov.2 18 Weisenburger and Shustov are both medical doctors who opined in 19 their expert reports that the combination of 6MP drugs and anti- 20 TNF drugs prescribed to Maxx increased his likelihood of 21 developing HSTCL and, ultimately, caused his death. 22 opinions are not based on sufficiently reliable scientific data, 23 they are not admissible under Federal Rule of Evidence 702 and do 24 not support an inference of causation. Drs. Because these 25 26 27 28 2 Because Plaintiffs’ third expert, Dr. David Ross, has not offered any opinions on causation, the Court does not discuss the admissibility of his opinions here. See Docket No. 337, Pls.’ Opp. 24 (“Plaintiffs are not, however, offering Dr. Ross as a medical causation expert, but as an expert on the FDA’s regulatory requirements.”). 7 1 2 3 Rule 702 permits an expert to offer opinion testimony on a subject if (a) 4 5 (b) 6 (c) 7 (d) 8 9 the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; the testimony is based on sufficient facts or data; the testimony is the product of reliable principles and methods; and the expert has reliably applied the principles and methods to the facts of the case. Fed. R. Evid. 702. In short, expert opinion testimony is only United States District Court For the Northern District of California 10 admissible if the opinion the expert seeks to offer is both 11 relevant and reliable. 12 509 U.S. 579, 589 (1993) (Daubert I); Kumho Tire Co., Ltd. v. 13 Carmichael, 526 U.S. 137, 141 (1999). 14 dispute that the opinions of Drs. Weisenburger and Shustov are 15 relevant here, it contends that they are not reliable. 16 Daubert v. Merrell Dow Pharmaceuticals, Although Teva does not To evaluate the reliability of expert opinion testimony, a 17 court must consider the factors set out in Daubert I, which 18 include “whether the theory or technique in question can be (and 19 has been) tested, whether it has been subjected to peer review and 20 publication, its known or potential error rate and the existence 21 and maintenance of standards controlling its operation, and 22 whether it has attracted widespread acceptance within a relevant 23 scientific community.” 24 reliability is ‘flexible,’ and Daubert’s list of specific factors 25 neither necessarily nor exclusively applies to all experts or in 26 every case.” 27 The focus, in other words, “must be solely on principles and 509 U.S. at 593–94. The “test of Kumho Tire, 526 U.S. at 141 (citations omitted). 28 8 1 methodology, not on the conclusions that they generate.” 2 I, 509 U.S. at 595. 3 Daubert The opinions of Drs. Weisenburger and Shustov do not meet 4 this standard. 5 independent research or published any studies on the specific 6 relationship between 6MP and anti-TNF drugs and the development of 7 HSTCL. 8 that their opinions on this subject were based on a reasonable 9 degree of medical certainty, they also conceded that their First, neither doctor has ever conducted any Although both conclusorily stated during their depositions United States District Court For the Northern District of California 10 opinions would not satisfy the standards required for publication 11 in peer-reviewed medical journals. 12 Weisenburger was asked whether his opinions in this case would be 13 publishable in a medical article, he replied that the standard for 14 publication would “probably be more rigorous” than the standard he 15 applied in forming his opinions. 16 4, Weisenburger Depo. 118:22-119:4. 17 testified that he would not be comfortable publishing his opinions 18 in this case regarding the alleged causal link between 6MP and 19 anti-TNF drugs and HSTCL. 20 The fact that both of Plaintiffs’ causation experts are reluctant 21 to publish their opinions -- and appear to have developed their 22 opinions specifically for the purposes of this litigation -- casts 23 doubt the reliability of their methodologies under Rule 702. 24 Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1317 (9th Cir. 25 1995) (Daubert II) (“One very significant fact to be considered 26 [under Rule 702] is whether the experts are proposing to testify 27 about matters growing naturally and directly out of research they For instance, when Dr. See Docket No. 320, Defs.’ Ex. Similarly, Dr. Shustov Defs.’ Ex. 6, Shustov Depo. 74:4-75:9. 28 9 See 1 have conducted independent of the litigation, or whether they have 2 developed their opinions expressly for purposes of testifying.”). 3 So, too, does their failure to identify any animal studies or 4 epidemiological studies showing a causal link between HSTCL and 5 the combination of 6MP and anti-TNF drugs prescribed to Maxx. 6 Plaintiffs admit that they have not identified any such studies, 7 arguing instead that such studies are impossible to conduct 8 because HSTCL is an “exceedingly rare” disease. 9 349, March 13, 2014 Hrg. Tr. 16:18-:22 (“If it were possible to do See Docket No. United States District Court For the Northern District of California 10 the kind of epidemiological study that the Defendants insist is 11 required here, that would have been done a long time ago. 12 has done it.”). 13 however, does not relieve Plaintiffs of their obligation to 14 present evidence of causation. 15 is especially important here in light of the fact that more than 16 seventy percent of observed HSTCL cases are idiopathic, meaning 17 that they have no known cause. 18 Shustov Depo. 106:5-:24. 19 cases, Plaintiffs cannot reasonably eliminate other potential 20 causes of Maxx’s HSTCL without some reliable evidence of a 21 positive link between the drugs at issue and the disease. 22 II, 43 F.3d at 1319 (finding expert testimony inadmissible under 23 Rule 702 where expert offered “no tested or testable theory to 24 explain how, from [] limited information, he was able to eliminate 25 all other potential causes”). 26 Nobody The difficulty of conducting these studies, Indeed, the need for such evidence Weisenburger Depo. 174:4-:15; Given this high rate of idiopathic Daubert This is precisely why courts often exclude expert medical 27 testimony under Rule 702 when the expert fails to cite any 28 specific epidemiological studies suggesting that a given drug 10 1 caused a disease with a high rate of idiopathic cases. 2 v. Wyeth-Ayerst Labs., for instance, this Court excluded the 3 testimony of a medical expert under Rule 702 because his testimony 4 was not based on reliable epidemiological evidence and failed to 5 “eliminate all other potential causes” of the plaintiff’s 6 condition. 7 (9th Cir. 1998). 8 rule out other possible causes of the plaintiff’s Guillain–Barre 9 Syndrome (GBS) was “particularly troubling in light of [the In Lopez 1996 WL 784566, at *3 (N.D. Cal.), aff’d, 139 F.3d 905 The Court found that the expert’s failure to United States District Court For the Northern District of California 10 expert]’s statement that 30 to 40% of the GBS cases have 11 idiopathic or unknown causes.” 12 noted that the defendant’s expert had presented “uncontroverted 13 testimony that there has been no epidemiological study showing 14 increased incidence of GBS in persons receiving a non-swine flu 15 vaccine,” like the one that the plaintiff alleged had caused him 16 to develop GBS. 17 present case from Lopez nor from any of the other cases where 18 courts have excluded expert medical evidence under Rule 702 for 19 failing to eliminate potential alternative causes of the 20 plaintiff’s harm.3 21 605 F. Supp. 2d 1142, 1163 (E.D. Wash. 2009) (“[B]ecause [the 22 expert]’s methodology employed fails to adequately account for the 23 possibility that [plaintiff]’s AML was idiopathic, the court finds 24 that his conclusion that prolonged exposure to benzene in gasoline 25 was the cause of his AML is unreliable and therefore Id. Id. The Court also specifically Plaintiffs have not distinguished the See, e.g., Henricksen v. ConocoPhillips Co., 26 3 27 28 Plaintiffs failed to discuss Lopez in their briefs and, when asked to distinguish the case at the hearing, noted simply that Lopez was decided “a long time ago.” March 13, 2014 Hrg. Tr. 35:3-:13. This is not a relevant distinction. 11 1 inadmissible.”); Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 2 434, 567 (W.D. Pa. 2003) (excluding expert testimony under Rule 3 702 because it did not “reliably rule out reasonable alternative 4 causes of [the plaintiff’s condition] or idiopathic causes”). 5 Although Plaintiffs cite a handful of studies and case 6 reports discussing possible causes of HSTCL, none of these 7 purports to show that the specific combination of drugs prescribed 8 to Maxx actually causes HSTCL. 9 of which are actually cited in Plaintiffs’ expert reports Rather, the studies -- only some 4 -- United States District Court For the Northern District of California 10 contain statistics about the incidence of HSTCL among different 11 patient populations, including patients with IBD. 12 contend that these statistics, viewed as a whole, show that 13 patients exposed to a combination of 6MP and anti-TNF drugs are 14 more likely to develop HSTCL than other patients. 15 Plaintiffs have not shown that all of the observed differences in 16 these incidence rates are statistically significant or that they 17 account for plausible alternative causes of HSTCL, such as IBD 18 itself. 19 deposition that the studies he reviewed failed to control for IBD 20 as a possible risk factor. 21 he and Dr. Weisenberger both stated that they do not believe IBD 22 is a risk factor for HSTCL, they have not presented any scientific 23 evidence to support that opinion. 24 Inc., 167 F.3d 146, 156 (3d Cir. 1999) (“‘[W]here a defendant 25 points to a plausible alternative cause and the doctor offers no Plaintiffs However, Indeed, Dr. Shustov himself acknowledged during his Shustov Depo. 25:19-26:12. Although See Heller v. Shaw Indus., 26 27 28 4 Neither Dr. Weisenberger nor Dr. Shustov appears to have cited the 2010 letter-to-the-editor written by David Kotlyar et al. or the 2013 article written by Prakkal Deepak et al. 12 1 explanation for why he or she has concluded that was not the sole 2 cause, that doctor’s methodology is unreliable.’” (quoting In re 3 Paoli Railroad Yard PCB Litig., 35 F.3d 717, 759 n.27 (3d Cir. 4 1994))); Casey v. Ohio Med. Products, 877 F. Supp. 1380, 1385 5 (N.D. Cal. 1995) (explaining that “case reports are not reliable 6 scientific evidence of causation, because they simply describe[] 7 reported phenomena without comparison to the rate at which the 8 phenomena occur in the general population or in a defined control 9 group” and “do not isolate and exclude potentially alternative United States District Court For the Northern District of California 10 11 causes”). In sum, the opinions of Drs. Weisenburger and Shustov do not 12 provide sufficiently reliable evidence of causation and must be 13 excluded under Rule 702. 14 admissible evidence sufficient to support an inference of “a 15 reasonable causal connection” between the combination of 16 Purinethol and anti-TNF drugs and the development of Maxx’s HSTCL. 17 Jones, 163 Cal. App. 3d at 399, 402 (recognizing that causation 18 “must be proven within a reasonable medical probability based upon 19 competent expert testimony” and that “[m]ere possibility alone is 20 insufficient to establish a prima facie case”); see also Avila, 21 633 F.3d at 836 (quoting same). 22 summary judgment on all of Plaintiffs’ remaining claims against it 23 for negligence and strict liability. Plaintiffs have not presented any other Accordingly, Teva is entitled to 24 B. 25 Plaintiffs’ failure to produce any admissible evidence of Duty to Warn 26 causation is sufficient to preclude them from prevailing on any of 27 their claims under a failure-to-warn theory. 28 Searle & Co., 35 Cal. 3d 691, 701 (1984) (“The strength of the 13 See Finn v. G. D. 1 causal link thus is relevant both to the issue of whether a 2 warning should be given at all, and, if one is required, what form 3 it should take.”). 4 on Plaintiffs’ claims under this theory for another, independent 5 reason: specifically, because they have not adduced any evidence 6 to suggest that Dr. Rich actually relied on Teva’s warning labels 7 before prescribing Purinethol to Maxx. 8 9 But Teva is also entitled to summary judgment Dr. Rich testified during his deposition that he cannot recall reading the Purinethol label in making his decision to United States District Court For the Northern District of California 10 prescribe the drug and that it is “not [his] regular practice to 11 look at drug labeling.” 12 283:13-:15 (“I don’t remember specifically reading the label for 13 Purinethol 6-MP or generic [sic] at any particular time.”). 14 Plaintiffs have not identified any evidence to contradict this 15 testimony or otherwise suggest that Dr. Rich actually relied on 16 the Purinethol warning label. 17 their negligence claim under a failure-to-warn theory. 18 Wyeth, Inc., 168 Cal. App. 4th 89, 112 (2008) (“There can be no 19 proximate cause where, as in this case, the prescribing physician 20 did not read or rely upon the allegedly inadequate warnings 21 promulgated by a defendant about a product.”); Motus v. Pfizer 22 Inc., 358 F.3d 659, 661 (9th Cir. 2004) (“Because the doctor 23 testified that he did not read the warning label that accompanied 24 Zoloft or rely on information provided by Pfizer’s detail men 25 before prescribing the drug to [plaintiff], the adequacy of 26 Pfizer’s warnings is irrelevant to the disposition of this 27 case.”). 28 against Teva for negligent misrepresentation, that claim fails for Defs.’ Ex. 1, Rich Depo. 192:6-:7; id. Accordingly, they cannot prevail on Conte v. To the extent that Plaintiffs have asserted a claim 14 1 the same reason. 2 Partners, LLC, 158 Cal. App. 4th 226, 243 (2007) (recognizing that 3 one of the “elements of negligent misrepresentation” is 4 “justifiable reliance on the misrepresentation”). 5 therefore entitled to summary judgment on all of Plaintiffs’ 6 claims based on a failure-to-warn theory. Apollo Capital Fund, LLC v. Roth Capital 7 8 9 5 Teva is CONCLUSION For the reasons set forth above, Teva’s motion for summary judgment (Docket No. 319) is GRANTED. Plaintiffs’ request to United States District Court For the Northern District of California 10 strike the supplemental declarations of Teva’s experts, Drs. 11 Robert Valuck and Andrew Place, is DENIED as moot as the Court did 12 not rely on either of these supplemental declarations in reaching 13 its decision. 14 In addition, Plaintiffs’ motion for leave to file 15 supplemental material (Docket No. 355) is DENIED. 16 failed to establish that the March 2014 statements and documents 17 issued by Health Canada and Teva Canada, neither of which is a 18 party in this action, are admissible. 19 statements and documents were admissible, they would not alter the 20 outcome of this case. 21 government under an unidentified regulatory standard is not 22 sufficient to support an inference of causation here, particularly 23 when the warning notice only pertains to Purinethol, rather than 24 the full combination of drugs at issue in this case. Plaintiffs have Furthermore, even if the A warning notice issued by a foreign 25 26 5 27 28 Plaintiffs conceded at the hearing that they cannot prevail on their strict liability claims against Teva under a failure-to-warn theory. March 13, 2014 Hrg. Tr. 50:24-:25 (Plaintiffs’ Counsel: “What I agree is we can’t hold Teva liable under strict liab[ility].”). 15 1 Finally, Plaintiffs’ motion for leave to file a motion for 2 reconsideration of the Court’s July 2012 order granting summary 3 judgment to GlaxoSmithKline (Docket No. 257) is DENIED as moot. 4 Plaintiffs cannot prevail on their claims against GlaxoSmithKline 5 for the same reasons they cannot prevail on their claims against 6 Teva: once again, they have not presented sufficient evidence to 7 support an inference of (1) a causal link between the combination 8 of 6MP and anti-TNF drugs and HSTCL; nor (2) actual reliance by 9 Dr. Rich on the warning label for Purinethol. Maxx’s untimely United States District Court For the Northern District of California 10 death was tragic but, without this evidence, Teva cannot be held 11 liable as its cause. 12 13 14 The clerk shall close the file and the parties shall bear their own costs. IT IS SO ORDERED. 15 16 17 Dated: 6/30/2014 CLAUDIA WILKEN United States District Judge 18 19 20 21 22 23 24 25 26 27 28 16

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