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Brown v. Johnson & Johnson

United States District Court, E.D. California

June 24, 2019

BRUCE BROWN, Plaintiff,
JOHNSON & JOHNSON., Defendant.


         I. BACKGROUND[1]

         Plaintiff, Bruce Brown, a pro se state prisoner, filed this California products liability suit against Defendant Johnson & Johnson in California state court on June 26, 2019; Defendant removed the suit to this Court on September 12, 2017. Plaintiff asserts that Defendant failed to adequately warn that its product, the pharmaceutical drug Risperdal, could cause gynecomastia and tardive dyskinesia.[2] Pending before the Court is Defendant's motion for summary judgment. (ECF No. 58) For the following reasons, the Court recommends that the motion be granted.


         As set forth below, the Court recommends summary judgment on Plaintiff's inability to provide sufficient evidence that Risperdal specifically caused his gynecomastia and tardive dyskinesia (assuming he suffered from these ailments) or that his medical providers would not have prescribed Risperdal had a different, more effective warning been in place (referred to herein as “warnings causation”). The Court declines to address Defendant's other arguments for dismissal arguments for dismissal. Therefore, facts unrelated to these grounds for dismissal are not set forth below.[3]

         Risperdal was approved by the United States Food and Drug Administration (“FDA”) in 1993 for use in “management of the manifestations of psychotic disorders” for adults with schizophrenia and other psychotic disorders. (Undisputed Material Fact “UMF” 86) The drug's original FDA-approved warning label warned of gynecomastia but characterized its occurrence as “rare.” (UMF 88, 89) In 2007, the report of gynecomastia as “rare” was removed from the label. (UMF 89) The Risperdal labels approved in 2007, 2008, and 2009, specifically warn of tardive dyskinesia and gynecomastia. (UMF 90) In 2010, the Risperdal label was revised to include gynecomastia under the same section but under a new subheading entitled “Reproductive System and Breast Disorders.” (UMF 91) The Risperdal label in effect when Plaintiff was prescribed the medication in 2016 continued to contain the same warnings for tardive dyskinesia and gynecomastia. In addition, the 2016 label contained language based on more recent clinical trials. (UMF 91)

         Plaintiff claims that he first received Risperdal at Deuel Vocational Institution (“DVI”) in dyskinesia is defined by as a “neurological disorder caused by the long-term use of neuroleptic drugs, or ani-psychotic 1997; however Plaintiff's records do not corroborate this. (UMF 1) Plaintiff was next prescribed Risperdal in mid-2007 while at Sacramento Main Jail because he was suffering from mood swings, irritability, and impulse control issues. (UMF 11) Plaintiff was then transferred to DVI and given Risperdal from mid-July 2007 through early October 2007. (UMF 12) Dr. Malet, a reception center physician at DVI, continued prescriptions for inmates transferred into the facility, including Plaintiff, until they could be seen by a psychiatrist. (UMF 13) In October 2007, psychiatrist Donald Tusel discontinued Plaintiff's Risperdal prescription. (UMF 16)

         Plaintiff's next alleged period of Risperdal use occurred while Plaintiff was incarcerated at the Alameda County facility Santa Rita jail. (UMF 18) Medical records show that Plaintiff was given Risperdal from January 2009 through September 2009. (UMF 19) In January 2009, Dr. Mcheko Graves-Matthews prescribed Risperdal for Plaintiff; she discontinued Plaintiff's prescription on September 29, 2009. (UMF 21) Dr. Graves-Matthews prescribed Risperdal “frequently” and made herself aware of the warnings and precautions in the Risperdal label before prescribing the drug. (UMF 57) Dr. Graves-Matthews was aware of the risks of gynecomastia and tardive dyskinesia before prescribing Risperdal to Plaintiff in January 2009. (UMF 58) Dr. Graves-Matthews relied on the label, as well as her own experience, when deciding whether to prescribe Risperdal to Plaintiff and believed it was the correct medication for him. (UMF 60) Plaintiff maintains that Dr. Graves-Matthews did not, however, warn him of the drug's potential side effects. (ECF 65, Plaintiff's Responses to Defendant's Undisputed Facts Number 60)

         Plaintiff's final period of Risperdal use occurred while Plaintiff was incarcerated at the CDCR's Substance Abuse Treatment Facility and State Prison. (UMF 22) According to Plaintiff's medical records, Plaintiff was given Risperdal from March 2016 to August 2016. (UMF 23).[4] Dr. Zachary Torry restarted Risperdal in February 2016. (UMF 25) Dr. Torry discontinued Plaintiff's Risperdal in April 2016. (UMF 26) Defendant contends Dr. Torry then prescribed Risperdal to Plaintiff again in May 2016, but Plaintiff does not recall this. (UMF 27; Plaintiff's Response to Defendant's Undisputed Facts number 27) Plaintiff did not restart Risperdal until mid-June 2016. (UMF 29) In August 2016, Plaintiff decided to stop taking Risperdal. (UMF 32)

         Dr. Torry prescribed Risperdal “fairly frequently, ” relying on the medication's label, medical literature and his experience. (UMF 61) Dr. Torry testified that, when he prescribed Risperdal to Plaintiff in February 2016, he discussed the “indications, risks, and benefits of Risperdal with Plaintiff, including the risks of tardive dyskinesia and gynecomastia.” (UMF 61) But Plaintiff “sincerely doubts” that this conversation occurred. (Plaintiff's Responses to Defendant's Undisputed Facts number 61)

         The first mention of Plaintiff's chest in his medical records appears in 2010, when Plaintiff requested health care services at Santa Rita Jail. (UMF 42) Plaintiff visited Medical Insights Diagnostic Center for a mammogram and ultrasound of his right breast on May 3, 2018. (UMF 43) After visiting Medical Insights Diagnostic Center, Plaintiff requested copies of Risperdal and Zoloft package inserts to determine what could have caused the changes to his breast. (UMF 44) Plaintiff began to suspect in 2010 that Risperdal might have caused the changes to his breast. (UMF 45) In April 2011, a second ultrasound was done on Plaintiff's breast, which showed “no evidence of a discrete mass.” (UMF 46) A right breast ultrasound and bilateral mammogram were performed on May 13, 2011, which found “no focal masses.” (UMF 47) Images of the right breast showed “no masses or cysts;” the ultrasound results were marked as “normal.” (UMF 47) A third ultrasound was carried out on December 20, 2017, the results of which showed an area with “probable gynecomastia; no discrete system or solid mass.” (UMF 48) The results did not mention that Plaintiff's breast issues were caused by Risperdal. (UMF 48) In April 2018, a bilateral mammogram of both breasts reported that the “breasts are fatty, ” found “no evidence of hypertrophic glandular tissue, ” and noted “no masses or abnormal calcifications.” (UMF 49) In June 2018, Plaintiff had another bilateral mammogram of both breasts and an ultrasound of his left breast. (UMF 50) The June 2018 left breast ultrasound was “negative” and found “[n]o mass, abnormal fluid collection, or abnormal calcific densities.”[5] (UMF 50)

         Plaintiff claims that Risperdal caused his alleged gynecomastia and tardive dyskinesia. There is no medical record stating that such a causal connection exists. (UMF 68) Defendant contends that no healthcare provider has ever told Plaintiff that Risperdal caused his alleged gynecomastia. However, Plaintiff states that healthcare providers have told him that Risperdal caused his “side effects.” (Plaintiff's Responses to Defendant's Undisputed Facts number 69) He refuses to give the names of these medical providers for fear that Defendant's lawyers will “terrorize” them. (Id.) Plaintiff also claims that a nurse practitioner, Laura Merritt, told him at an unspecified time that there was a “good possibility” that his Risperdal usage caused his gynecomastia, “before her alliance with the defendants [sic] lawyer.” (Plaintiff's Responses to Defendant's Undisputed Facts number 52) However, during her deposition, Nurse Merritt testified that she never told Plaintiff that Risperdal caused any abnormalities in his chest. (UMF 52) Plaintiff admitted that no healthcare provider has ever told him that he has tardive dyskinesia. (UMF 72) A diagnosis of tardive dyskinesia does not appear in Plaintiff's medical records. (UMF 73)


         On February 28, 2019, Defendant filed the instant motion for summary judgment based, in part, on the above factual background and legal arguments addressed below. (ECF No. 58) Plaintiff was given an extension of time until May 13, 2019, to oppose the motion. He filed his opposition on May 6, 2019. (ECF Nos. 65, 66) Defendant filed a reply on May 20, 2019. (ECF No. 68)

         Defendant argues that Plaintiff's case should be dismissed for the following reasons: (1) Plaintiff's inability to establish that Risperdal can cause gynecomastia and tardive dyskinesia generally (“general causation”); (2) Plaintiff's inability to establish that Risperdal caused Plaintiff's gynecomastia or tardive dyskinesia specifically (“specific causation”); (3) Plaintiff's failure to bring claims within the relevant statute of limitations; (4) Plaintiff's failure to demonstrate a deficiency in Risperdal's warning; (5) Plaintiff's inability to show warnings causation; and (6) Plaintiff's inability to show that he actually suffers from gynecomastia or tardive dyskinesia.

         As discussed below, this Court recommends granting summary judgment due to Plaintiff's lack of sufficient evidence regarding specific causation and warnings causation. Because Plaintiff's failure to warn claim cannot proceed without such evidence, the Court does not address Defendant's remaining arguments.


         a. Summary Judgment Standard

          Summary judgment is appropriate where “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). A dispute of fact is “genuine” if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party, ” and a fact is “material” if it “might affect the outcome of the suit under the governing law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Where the moving party will have the burden of proof on an issue at trial, it must “affirmatively demonstrate that no reasonable trier of fact could find other than for the moving party.” Soremkin v. Thrifty Payless, Inc., 509 F.3d 978, 984 (9th Cir. 2007). “On an issue as to which the nonmoving party will have the burden of proof, however, the movant can prevail merely by pointing out that there is an absence of evidence to support the nonmoving party's case.” Id. (citing Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986)).

         Once the moving party meets this initial burden, the nonmoving party must “go beyond the pleadings and by [his] own affidavits, or by ‘the depositions, answers to interrogatories, and admissions on file,' designate ‘specific facts showing that there is a genuine issue for trial.'” Burch v. Regents of Univ. of Cal., 433 F.Supp.2d 1110, 1125 (E.D. Cal. 2006) (quoting Celotex Corp, 477 U.S. at 324). The evidence of the nonmoving party is “to be believed, and all justifiable inferences are to be drawn in his favor.” Anderson, 477 U.S. at 255. “[T]he judge's function is not [her]self to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.” Forsberg v. Pac. Nw. Bell Tel. Co., 840 F.2d 1409, 1418 (9th Cir. 1988) (quoting Anderson, 477 U.S. at 249).

         Nevertheless, the evidence must be significantly probative to support the claims. Id. at 248-49. The nonmoving party cannot defeat summary judgment by merely demonstrating “that there is some metaphysical doubt as to the material facts.” Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). If the evidence of the nonmoving party is merely colorable or is not significantly probative, summary judgment may be granted. Anderson, 477 U.S. at 249-50.

         Plaintiff, although pro se, is not excused from the requirement of presenting admissible evidence to show a triable issue of fact in opposition to summary judgment. Franklin v. Murphy, 745 F.2d 1221, 1235 (9th Cir. 1984) (although the court must liberally construe pro se plaintiff's pleadings, on a summary judgment motion the plaintiff nonetheless “must present some ‘significant probative evidence tending to support the complaint.'”) (quoting General Business Systems v. North American Phillips Corp., 699 F.2d 965, 971 (9th Cir. 1983)). A trial court can only consider admissible evidence in ruling on a motion for summary judgment. Orr v. Bank of America, NT & SA, 285 F.3d 764, 773 (9th Cir. 2002). However, the correct focus is not on the admissibility of the evidence's form, but rather on the admissibility of the evidence's content. See Fraser v. Goodale, 342 F.3d 1032, 1036 (9th Cir. 2003) (“At the summary judgment stage we do not focus on the admissibility of the evidence's form. We instead focus on the admissibility of its contents.”)

         b. California ...

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