Wendell et al v. Johnson & Johnson et al

Filing 204

ORDER by Judge Claudia Wilken GRANTING 177 , 179 , 183 , 185 MOTIONS FOR SUMMARY JUDGMENT. (ndr, COURT STAFF) (Filed on 12/15/2011)

Download PDF
1 2 3 IN THE UNITED STATES DISTRICT COURT 4 FOR THE NORTHERN DISTRICT OF CALIFORNIA 5 6 7 STEPHEN WENDELL and LISA WENDELL, as successors in interest to MAXX WENDELL, deceased, 8 9 United States District Court For the Northern District of California 10 11 12 13 14 15 Plaintiffs, v. No. C 09-04124 CW ORDER GRANTING MOTIONS FOR SUMMARY JUDGMENT (Docket Nos. 177, 179, 183 and 185) JOHNSON & JOHNSON; CENTOCOR, INC.; ABBOTT LABORATORIES; SMITHKLINE BEECHAM d/b/a GLAXOSMITHKLINE; TEVA PHARMACEUTICALS USA; GATE PHARMACEUTICALS, a division of TEVA PHARMACEUTICALS USA; PAR PHARMACEUTICAL, INC., Defendants. ________________________________/ 16 17 This is a pharmaceutical product liability case in which 18 Plaintiffs Stephen and Lisa Wendell have sued as successors-in- 19 interest to their son, Maxx Wendell, the decedent. 20 allege claims for negligence and strict liability, asserting that 21 Defendants Abbott Laboratories, GlaxoSmithKline LLC (GSK),1 TEVA The Wendells 22 Pharmaceuticals USA, Gate Pharmaceuticals, a division of TEVA 23 24 Pharmaceuticals, and PAR Pharmaceuticals, Inc. failed adequately 25 to warn about certain risks posed by their products, specifically 26 two prescription drugs: Humira and mercaptopurine (also known as 27 28 1 GSK was formerly known as and erroneously served and sued in this action as SmithKline Beecham d/b/a GlaxoSmithKline. 1 6-mercaptopurine, 6-MP and Purinethol). 2 each separately moved for summary judgment, arguing that the 3 Wendells cannot show evidence of proximate causation necessary to 4 establish liability for failure to warn. 5 183 and 185. 6 These Defendants have Docket Nos. 177, 179, Having considered all of the parties' submissions and oral argument, the Court GRANTS the motions. 7 BACKGROUND 8 9 Abbott is the alleged manufacturer, marketer and distributor United States District Court For the Northern District of California 10 of Humira in California. GSK and TEVA are purportedly the 11 manufacturers, and the California marketers and distributors of 6- 12 MP, sold under the brand name Purinethol. 13 manufacturer, marketer and distributor of 6-MP in California. 14 Wendells have also sued Johnson & Johnson and its wholly owned PAR is allegedly a The 15 subsidiary, Centocor, Inc., both of which are allegedly involved 16 in the manufacture, marketing, sale and distribution of Remicade. 17 18 Johnson & Johnson and Centocor have not moved for summary 19 judgment. 20 In the fall of 1998, Maxx was diagnosed with inflammatory 21 bowel disease (IBD), and began receiving treatment from Dr. Edward 22 Rich, a pediatric gastroenterologist at Kaiser Permanente in San 23 Francisco. Rich Dep. at 50:5-10, 59:22-60:1, 74:23-25.2 24 25 26 27 28 Dr. Rich testified that it was not his "regular practice to look at drug labeling." Id. at 192:6-7. 2 He received information The complete transcript of the deposition is located at Docket No. 199. 2 1 on medications from multiple sources, including meetings, other 2 professionals in the field, articles and occasional meetings with 3 drug representatives. 4 I'm looking at drug labeling or the PDR in medicines that I'm less 5 familiar with." 6 Id. at 192:7-14. He explained, "Generally Dr. Rich could not remember whether he ever relied on labeling information for 6-MP before prescribing it to 7 patients. Id. at 282:2-283:2. 8 9 With respect to the impact of drug labeling on his decisions United States District Court For the Northern District of California 10 regarding treatment, Dr. Rich testified, "Drug labeling is 11 sometimes something I rely on when making decisions on drug use 12 for patients." 13 labeling, it's one of the things that is part of my decision- 14 making process. Id. at 190:21-23. He stated, "When I read the Id. at 191:20-22. 15 Initially, Dr. Rich prescribed Prednisone, a steroid, and 16 Asacol, an aspirin, anti-inflammatory drug, to treat Maxx's IBD. 17 18 Id. at 75:8-12, 79:22-25, 82:6-8. 19 sought to wean Maxx from Prednisone, due to the significant side 20 effects and the weakness of the drug as a long-term therapy, 21 replacing it with 6-MP, an immunosuppressive therapy. 22 82:9-83:16, 86:16-22. 23 After several months, Dr. Rich In June 1999, Maxx began taking 6-MP. Id. at Id. at 105:14-15. 24 Rich prescribed varying dosages of 6-MP, while attempting to 25 26 eliminate gradually Maxx's need for Prednisone. However, as of 27 May 2002, Maxx was still taking Prednisone and 6-MP. 28 117:4-11. 3 Id. at Dr. 1 At the time Dr. Rich prescribed 6-MP he was aware of a paper 2 reporting the occurrence of lymphoma in adults taking the drug. 3 Id. at 89:12-90:17. 4 lymphoma occurrences reported in the study was one in one hundred 5 adult patients taking 6-MP. 6 According to Dr. Rich, the frequency of Id. at 89:23-90:4. Dr. Rich found this "significant," prompting him to warn patients of a "small but 7 non-zero increased risk of serious infections or malignancies" 8 9 when discussing 6-MP treatment with patients. Id. at 89:2-90:17. United States District Court For the Northern District of California 10 Dr. Rich testified that he may or may not have included the word 11 "lymphoma" when providing the warning. 12 Id. at 89:7-12. At an appointment with Maxx on May 8, 2002, Dr. Rich 13 discussed in detail prescribing Remicade. 14 Again, the goal in changing Maxx's medication at this time was to Id. at 117:4-118:1. 15 take him off steroids. Id. at 151:17-152:9. On July 10, 2002, 16 Maxx received his first infusion of Remicade. Id. at 147:24- 17 18 148:16. 19 three months, in combination with 6-MP. 20 170:12-21. 21 22 23 Maxx received infusions of Remicade approximately every Id. at 155:4-12, 157:9, Dr. Rich considered Remicade, as well as Humira, part of a class of anti-tumor necrosis factor drugs, also known as "anti-TNF drugs" and "TNF inhibitors." Id. at 175:10-14, 176:9-17, 264:24- 24 25, 265:2-3. He testified that he "virtually always" informed his 25 26 patients of a "nonzero increased risk" of serious infections and 27 malignancies related to "immunosuppressives and anti-tumor 28 necrosis factor drugs." Id. at 123:6-10. 4 Dr. Rich's notes did 1 not mention specific warnings as to malignancies and lymphomas, 2 but he testified that such discussions "might not be documented." 3 Id. at 214:5-9. 4 Maxx of side effects. 5 6 Other notations indicate that he had informed It is not entirely clear when Dr. Rich began warning his patients about a “nonzero increased risk” of malignancies 7 connection with Remicade. According to Dr. Rich, at a point in 8 9 time he could not recall, he became aware of a study involving United States District Court For the Northern District of California 10 approximately 700 patients on Remicade therapy, a majority of whom 11 had rheumatoid arthritis and a minority of whom had Crohn's 12 disease. 13 serious infections and malignancies, including lymphomas, within 14 that patient population. Id. at 125:13-19. The study reported incidences of Id. at 125:20-126:1. An entry regarding 15 Remicade in the 2002 Physicians' Desk Reference included mention 16 of a clinical study involving 771 patients, seven of whom 17 18 developed new or recurrent malignancies, including lymphoma. 19 at 133:2-12. 20 rates and incidents [of these malignancies] were similar to those 21 expected for the population." 22 Rich, in 2002 there were no reports on the risk of therapies 23 Id. However, the PDR also stated that "the observed combining Remicade and 6-MP. Id. at 133:10-12. According to Dr. Id. at 132:10-12. 24 In about November 2005, Dr. Rich began to consider 25 26 discontinuing Maxx's Remicade treatment and discussed Humira with 27 him. Id. at 170:24-173:5. 28 2005" he became aware of a "complication" associated with Dr. Rich also testified that in "late 5 1 Remicade, namely the occurrence of hepatosplenic T-cell lymphoma 2 in adolescent and young adult patients taking Remicade with 6-MP. 3 Id. at 204:21-205:22, 215:3-4. 4 knowledge about "this complication" led him to consider taking 5 Maxx off Remicade. 6 Dr. Rich did not testify that new Maxx received an infusion of Remicade in November 2005 and 7 then his final dose of Remicade in March 2006. Id. at 182:15-14; 8 9 197:16-199:7. In May 2006, Maxx underwent a colonoscopy that Id. at 198:1-199:14. According to Dr. United States District Court For the Northern District of California 10 revealed no signs of IBD. 11 Rich, a decision to discontinue Remicade or use an alternative 12 medication would have been made at the time of the colonoscopy, 13 based on the results of the examination. 14 received no further infusions of Remicade. Id. at 172:10-12. Maxx 15 Also in May 2006, the FDA approved Remicade for an additional 16 indication for the treatment of pediatric Crohn's disease, but 17 18 required a black box warning about the drug. 19 The warning alert physicians to the following: 24 RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL LYMPHOMA HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG ADULT PATIENTS WITH CROHN'S DISEASE TREATED WITH REMICADE. THIS TYPE OF T-CELL LYMPHOMA HAS A VERY AGGRESSIVE DISEASE COURSE AND IS USUALLY FATAL. ALL OF THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT WITH AZATHIOPRINE OR 6-MERCAPTOPURINE. 25 Declaration of Kevin Haverty in Support of Plaintiffs' Opposition 26 to GSK's Motion for Summary Judgment, Ex. 3. 20 21 22 23 27 28 6 1 Dr. Rich testified that he would have received this black box 2 warning in the form of a letter or other notification at about the 3 time it was issued. 4 noted that he had learned of this "complication" earlier, in late 5 2005, as previously stated. 6 Rich Dep. at 214:23-215:3. However, he also By November 2006, Maxx experienced a relapse. On November 7 22, 2006, he received his first prescription for Humira, taking 8 9 the drug in combination with 6-MP. Id. at 217:14-16. Dr. Rich United States District Court For the Northern District of California 10 testified that he first treated patients with Humira in early 2005 11 or 2006 when two sixteen year old female patients with IBD 12 received the drug. 13 a rheumatologist, wrote Maxx's first prescription for Humira 14 because, when Humira was first placed on the Kaiser formulary, it Id. at 193:3-7; 173:19-25. Dr. Aileen Dillon, 15 was placed under limited release, only through rheumatologists. 16 Id. at 217:14-218:6. Dr. Rich testified that when he first began 17 18 prescribing Humira to his patients, he warned them of a "nonzero 19 but increased risk of serious infections and malignancies." 20 at 193:23-194:11. 21 literature he had reviewed and discussions he had had with other 22 physicians. 23 His awareness of this risk was based on Id. at 194:12-18. When asked why he did not treat Maxx with Remicade in 24 November 2006, Dr. Rich responded, 25 26 27 28 Id. So in November '06, we had been aware for some time of complication of hepatosplenic T-cell lymphoma, so that would have been part of my discussion with the family. Ease of therapy is always a discussion with Humira versus Remicade. 7 1 2 Id. at 218:13-23. Dr. Rich explained that Humira may be administered by the patient or a family member at home through 3 subcutaneous injections, while Remicade requires a patient to 4 5 6 7 visit a facility for two to three hour infusions. Id. at 174:15- 19, 267:5-23. When asked whether he opted for Humira because of the black 8 box warning concerning Remicade, Dr. Rich testified, "I think that 9 the concern of hepatosplenic T-cell lymphoma would have been part United States District Court For the Northern District of California 10 of my discussion with the family and it would have been part of my 11 thinking about the use of this disease (verbatim)." Id. at 12 13 219:16-22. Dr. Rich did not recall any similar warning regarding 14 Humira's use in combination with 6-MP and hepatosplenic T-cell 15 lymphoma. 16 would have forgone prescribing Humira in November 2006, had he 17 learned of a black box warning or similar alert regarding the use 18 of Humira, alone or in combination with 6-MP, and the occurrence 19 Id. at 219:23-220:2. Dr. Rich did not state that he of hepatosplenic T-cell lymphoma. 20 In deposition, Dr. Rich was asked whether his drug 21 22 recommendation was informed by the fact that one drug had a black 23 box warning about a rare, aggressive cancer, while the other drug 24 did not. 25 26 27 28 Dr. Rich responded, I don't think the black box would have been a primary driving point in the use of medicine, just as FDA indication or not is not a driving point, as FDA doesn't indicate very much of anything in pediatrics. Id. at 220:1-15. 8 1 Later, Dr. Rich was asked again whether information that he 2 had about the cases of hepatosplenic T-cell lymphoma associated 3 with Remicade and 6-MP combination use informed in any way his 4 recommendation that Maxx start Humira in November 2006. 5 answered, 6 7 8 9 United States District Court For the Northern District of California 10 He The occurrence of hepatosplenic T-cell lymphomas and the information and knowledge about that would have been part of many things that would have gone into my own thinking on how to use this--these medications and my discussion with the patients on how to use these medications. Id. at 225:7-113. 11 In addressing whether all anti-TNF drugs carry the same 12 13 risks, Dr. Rich testified that Humira was "entirely humanized," 14 whereas Remicade was "75 percent humanized and 25 percent mouse." 15 Id. at 194:24-25. 16 counsel, 17 18 19 20 21 22 Dr. Rich engaged in the following exchange with A: So I presented [anti-TNF] medications always as having an increased but nonzero increased risk. And if I was asked by a patient, "Why do you use one versus the other," or why we were considering Humira, it may have come up in discussions that Humira was fully humanized and may have--my statement would have --would have been, "It may have a better safety profile." 23 Q: What was the basis of your thinking that it may have a better safety profile? 24 A: That it was fully humanized. 25 Q: What-- 26 A: That there are allergy side effects to these medicines. 27 28 9 1 2 Q: Okay. Other than allergies, did the fact that Humira was fully humanized, monoclonal antibody, as opposed to Remicade, affect, in your mind, the risk of malignancies? 3 4 5 6 7 8 9 United States District Court For the Northern District of California 10 A: I can't recall whether I thought that or not. The fact that there--I'm not an immunologist, and I'm not sure they can answer that question. But the fact that there is no mouse suggests that it might have been a consideration in my thinking, that it's a possibility. Id. at 195:13-196:12. Based on Dr. Rich's recommendation, Maxx took Humira for at least eight months. In mid-July 2007, Maxx was diagnosed with hepatosplenic T-cell lymphoma. In December 2007, he passed away. 11 After Maxx's death and as part of this litigation, Ms. 12 13 Wendell testified, "I didn't know that there had been a black box 14 warning on Remicade . . . [W]e were not informed of that and there 15 would have been no reason for [Dr. Rich] to inform us of that 16 because [Maxx] wasn't taking Remicade at the time." 17 Ex. 2, Lisa Wendell Dep. at 77:4-8. 18 Rich told her that Humira offered the convenience of self- 19 Haverty Dec., Ms. Wendell recalled that Dr. injection and had a better safety profile. Id. at 77:9-13. The 20 issue of convenience was considered because Maxx was moving to 21 22 Davis to attend college. Id. at 76:20-24. She answered 23 affirmatively when asked whether she would have discontinued the 24 use of any of the medications if she had been told that there was 25 a risk of hepatosplenic T-cell lymphoma. 26 27 Id. at 75:8-12. During 2007 Dr. Rich continued to treat patients using therapies combining anti-TNF drugs with 6-MP, although he could 28 10 1 not recall whether the "combination therapy" consisted of 6-MP 2 combined with Remicade or 6-MP combined with Humira or both. 3 Dep. at 208:11-209:5. 4 using "mono-therapy," treating patients with an anti-TNF drug 5 alone without concomitant use of 6-MP. 6 16. Rich Most likely in 2008, Dr. Rich switched to Id. at 208:16-17, 288:13- Maxx's case played an "important role" in influencing Dr. 7 Rich's decision to use monotherapy as opposed to combination 8 9 therapy. Id. at 230:16-20. Dr. Rich reported that the majority United States District Court For the Northern District of California 10 of practitioners, including many pediatric gastroenterologists, 11 use combination therapy, although that is no longer his practice. 12 Id. at 230:12-15. 13 LEGAL STANDARD 14 Summary judgment is properly granted when no genuine and 15 disputed issues of material fact remain, and when, viewing the 16 evidence most favorably to the non-moving party, the movant is 17 18 clearly entitled to prevail as a matter of law. 19 56. 20 Eisenberg v. Ins. Co. of N. Am., 815 F.2d 1285, 1289 (9th Cir. 21 1987). 22 the party against whom summary judgment is sought. 23 Fed. R. Civ. P. Celotex Corp v. Catrett, 477 U.S. 317, 322-23 (1986); The court must draw all reasonable inferences in favor of Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); 24 Intel Corp. v. Hartford Accident & Indem. Co., 952 F.2d 1551, 1558 25 26 27 28 (9th Cir. 1991). Material facts which would preclude entry of summary judgment are those which, under applicable substantive law, may affect the 11 1 outcome of the case. The substantive law will identify which 2 facts are material. Anderson v. Liberty Lobby, Inc., 477 U.S. 3 242, 248 (1986). 4 DISCUSSION 5 6 Under the learned intermediary doctrine, a manufacturer of a prescription drug is obliged to warn doctors, not patients, of 7 potential side-effects associated with its pharmaceutical 8 9 products. Carlin v. Superior Court, 13 Cal. 4th 1104, 1116 United States District Court For the Northern District of California 10 (1996). A plaintiff asserting causes of action for failure to 11 warn must prove not only that no warning was provided or that the 12 warning was inadequate, but also that the inadequacy or absence of 13 a warning caused the plaintiff's injury. 14 Laboratories, 819 F.2d 349, 358 (2d Cir. 1987) (applying Plummer v. Lederle 15 California law). 16 Under Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir. 17 18 2004), "a product defect claim based on insufficient warnings 19 cannot survive summary judgment if stronger warnings would not 20 have altered the conduct of the prescribing physician." 21 the treating physician testified unequivocally that he neglected 22 to read the published warnings and did not rely on information 23 In Motus from Pfizer's detail men before prescribing the drug that 24 allegedly induced the decedent to commit suicide. 385 F.3d at 25 26 661. On this basis, the plaintiff could not establish a causal 27 connection between the representations or omissions that 28 accompanied the product and the plaintiff's injury. 12 1 The present action is distinguishable from Motus because Dr. 2 Rich testified that he sometimes read drug labeling, in particular 3 when dealing with unfamiliar drugs. 4 6-MP during his training, there is evidence that Humira was 5 relatively new to Dr. Rich as a treatment for IBD when he 6 Although Dr. Rich learned of prescribed it to Maxx. 7 However, even assuming that Dr. Rich would have read a 8 9 warning on the labels of Humira and 6-MP, summary judgment in In Plummer, the Second Circuit, United States District Court For the Northern District of California 10 favor of Movants is warranted. 11 applying California law, found that judgment should have been 12 entered for the defendant, because the physician knew of the risk 13 for which the plaintiff sought a warning, and yet the physician 14 still failed to warn the patient's mother about the risk. 819 15 F.2d at 358-59. Plummer, citing Rosburg v. Minnesota Mining & 16 Mfg. Co., 181 Cal. App. 3d 726, 730 (1986), concluded that "no 17 18 harm could have been caused by failure to warn of a risk already 19 known." 20 risk of malignancies associated with 6-MP and Humira, but still 21 prescribed the medication. 22 to create a material dispute of fact as to whether the warnings 23 819 F.2d at 359. As in Plummer, Dr. Rich knew of the Thus, there is insufficient evidence that Plaintiffs contend should have been given would have changed 24 Maxx's treatment. 25 26 A. 6-MP 27 The Wendells assert that GSK, TEVA and PAR, allegedly 28 involved in the manufacture, marketing and distribution of 6-MP, 13 1 negligently failed to discover and/or provide an adequate warning 2 about the risk of hepatosplenic T-cell lymphoma posed by 6-MP when 3 used singly or in combination with Remicade or Humira. 4 however, was already aware of a significant risk of lymphomas 5 associated with 6-MP treatment. 6 drug. Dr. Rich, Yet he continued to prescribe the It appears that Dr. Rich's knowledge of this risk prompted 7 him to warn his pediatric patients about the nonzero increased 8 9 risk of developing malignancies or lymphomas while taking the United States District Court For the Northern District of California 10 medication, but there is no evidence that the risk persuaded him 11 to cease recommending or prescribing the drug. 12 Moreover, there is insufficient evidence for a jury to infer 13 that Dr. Rich ceased treating Maxx with Remicade because of the 14 May 2006 black box warning regarding the risk of lymphoma 15 associated with therapy combining Remicade and 6-MP. Dr. Rich 16 began considering taking Maxx off Remicade in November 2005, 17 18 before the black box warning was issued. 19 testified that black box warnings were not the driving force in 20 making decisions about the prescription of medication. 21 Remicade black box warning does not provide a basis from which to 22 infer that, had Dr. Rich received a similar warning regarding 23 In addition, he Thus, the Humira and 6-MP prescribed in combination, he would have ceased 24 treating Maxx with that combination of drugs. 25 26 Nor is there evidence that a warning specific to pediatric 27 patients or specific to treatments combining 6-MP with TNF- 28 blockers would have led Dr. Rich to stop prescribing 6-MP alone or 14 1 in combination with Remicade or Humira. 2 contention, evidence that Dr. Rich ceased prescribing TNF-blockers 3 in combination with 6-MP after Maxx was diagnosed with 4 hepatosplenic lymphoma does not prove that he would have changed 5 his prescription practices based on the warning they suggest. 6 Contrary to the Wendells' A warning about rare occurrences of hepatosplenic lymphoma 7 associated with therapy combining 6-MP and Remicade is bound to 8 9 United States District Court For the Northern District of California 10 11 have less persuasive power than an instance of the disease affecting a doctor's own patient followed that therapy. Because there is insufficient evidence for a reasonable jury 12 to find that the failure to warn of the risk of hepatosplenic T- 13 cell lymphoma posed by 6-MP when used singly or in combination 14 with Remicade or Humira proximately caused Maxx's death, summary 15 judgment is granted in favor of GSK, TEVA and PAR. 16 The Wendells also argue that it is premature to grant summary 17 18 judgment in favor of GSK because further discovery may reveal that 19 Dr. Rich relied on information from GSK concerning the risks 20 associated with 6-MP. 21 response to a request for documents, and the Wendells had not had 22 time to sift through the discovery. 23 Apparently, GSK served a voluminous However, the Wendells have not demonstrated how documents from GSK could prove proximate 24 causation in this case, where the undisputed fact is that Dr. Rich 25 26 was already aware of the risk of lymphomas associated with 6-MP, 27 but still chose to prescribe the drug. 28 lack evidence that any further warning regarding the use of 6-MP, 15 Furthermore, Plaintiffs 1 such as a warning about its use in combination with Humira, would 2 have changed the manner in which Dr. Rich treated Maxx. 3 judgment is not premature. Summary 4 B. Humira 5 The Wendells claim that Abbott should have provided a label 6 warning Dr. Rich about the risk of hepatosplenic T-cell lymphoma 7 associated with treatment combining Humira and 6-MP. However, 8 9 none of the evidence that the Wendells point to is sufficient to United States District Court For the Northern District of California 10 create a dispute of fact as to whether the warning would have 11 altered Dr. Rich's decision to treat Maxx with Humira and 6-MP. 12 First, for the reasons already explained above, Dr. Rich's 13 subsequent decision to prescribe anti-TNF drugs alone, rather than 14 in combination with 6-MP, is not probative of whether a warning 15 about risks associated with Humira, used singly or in combination 16 with 6-MP, would have altered Maxx's treatment. 17 18 Next, Dr. Rich's testimony regarding Humira's comparatively 19 better safety profile is not helpful to the Wendells' case. 20 read in context, Dr. Rich's testimony indicates that he believed 21 that Humira may have had a better safety profile based on the fact 22 that it was fully humanized and, thus, had fewer allergy side 23 When effects. 24 Evidence that Dr. Rich did not warn Maxx about the risk of 25 26 combination therapy is not sufficient to establish proximate 27 causation with respect to Humira. 28 black box warnings were not the primary driver for his decisions 16 Rather, Dr. Rich testified that 1 regarding medication. 2 discontinue treating Maxx with Remicade is not evidence that a 3 black box warning as to Humira would have changed the course of 4 Maxx's treatment. 5 discontinue Maxx's Remicade treatment before the black box warning 6 The timing of Dr. Rich's decision to Dr. Rich began considering whether to issued in May 2006. These grounds are insufficient to raise a 7 dispute of fact that a warning would have made a difference in 8 9 Maxx's treatment. That Dr. Rich did not suspect Humira as a cause of Max's United States District Court For the Northern District of California 10 11 lymphoma after his diagnosis fails to establish that a warning 12 about Humira would have persuaded him to stop prescribing the 13 medication. 14 risk with Humira while the warning had not yet been announced does In other words, that Dr. Rich did not associate a 15 not mean that, had the warning been provided, Dr. Rich would have 16 associated such a strong risk with Humira that he would have 17 18 decided against prescribing the drug. 19 Furthermore, Ms. Wendell's testimony that the family would 20 have discontinued the drug treatment if they had been warned is 21 insufficient. 22 received Humira in November 2006, he was twenty years old. 23 Maxx was born on August 20, 1986. At the time Maxx There is no evidence that Ms. Wendell made health care decisions for 24 Maxx. Ms. Wendell's statement as to what Maxx would have done 25 26 lacks foundation. 27 // 28 // 17 1 Because the Wendells have failed to provide sufficient 2 evidence to raise a dispute of fact as to the element of proximate 3 causation, summary judgment in favor of Abbott is warranted. 4 5 6 CONCLUSION The Wendells' loss of their son is tragic. However, because they have failed to provide sufficient evidence of proximate 7 causation by GSK, TEVA, PAR and Abbott, the motions for summary 8 9 judgment submitted by these Defendants are granted. In the event United States District Court For the Northern District of California 10 that the Wendells or remaining Defendants move for summary 11 judgment, the motions shall be noticed for January 26, 2012. 12 IT IS SO ORDERED. 13 14 15 Dated: 12/15/2011 CLAUDIA WILKEN United States District Judge 16 17 18 19 20 21 22 23 24 25 26 27 28 18

Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.

Why Is My Information Online?