Cleveland v. Janssen Pharm.

DOMINGO L. CLEVELAND, SR., Plaintiff, v. JANSSEN PHARMACEUTICALS, Defendant.

No. 2:16-cv-02308 MCE AC PS

UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF CALIFORNIA

November 15, 2019

ORDER AND FINDINGS AND RECOMMENDATIONS

Plaintiff is a prisoner proceeding in this action pro se, and the case was accordingly referred to the undersigned by Local Rule 302(c)(21). This matter is before the court on a motion for summary judgment brought by defendant Janssen Pharmaceuticals. ECF No. 93. Plaintiff has opposed the motion (ECF No. 107) and defendant has filed a reply (ECF No. 108). Plaintiff has filed a motion to file a sur-reply (ECF No. 109) which defendant opposes (ECF No. 110). The undersigned will GRANT plaintiff's motion to file a sur-reply. For the reasons stated below, it is recommended that defendant's motion for summary judgment be GRANTED.

This case was filed on September 27, 2016, ECF No. 1, and proceeds on the Second Amended Complaint ("SAC"), ECF No. 12. Plaintiff alleges that he suffered the side effect of gynecomastia from taking defendant's drug Risperdal. ECF No. 12. The undersigned ordered that a settlement conference take place, and appointed counsel to represent plaintiff for the limited purpose of the settlement conference. ECF No. 36. Settlement negotiations failed and plaintiff resumed pro se status. ECF No. 54, 60. The parties proceeded through the discovery process and on July 8, 2019, defendant filed the instant motion for summary judgment. ECF No. 93. Plaintiff was given two extensions of time to oppose the motion (ECF Nos. 99 and 106), filing his opposition on October 9, 2019. ECF No. 107. The motion is fully briefed.

I. Plaintiff's Sur-Reply

On November 1, 2019, plaintiff filed a motion to file a sur-reply, which contained the proffered sur-reply and responses to defendant's statement of undisputed facts. ECF No. 109. Defendant objects to the sur-reply and asks the court to strike the filing. ECF No. 110. The decision as to whether to allow a surreply is within the court's discretion, though the discretion should only be exercised in favor of allowing the surreply when there is a valid reason for the additional briefing. Hill v. England, 2:05-cv-0869-REC-TAG, 2005 WL 3031136, at *1 (E.D. Cal. Nov. 8, 2005). Here, additional briefing is warranted because only in the surreply does plaintiff contribute to the statement of undisputed facts. Accordingly, and because it is in the interest of justice to fully consider plaintiff's case on the merits, the court exercises its discretion in favor of allowing the surreply. The filing at ECF No. 109 has been fully considered in evaluating defendant's motion for summary judgment.

II. Standard for Summary Judgment

Summary judgment is appropriate when the moving party "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). Under summary judgment practice, "[t]he moving party initially bears the burden of proving the absence of a genuine issue of material fact." In re Oracle Corp. Sec. Litig., 627 F.3d 376, 387 (9th Cir. 2010) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986)). The moving party may accomplish this by "citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials" or by showing that such materials "do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact." Fed. R. Civ. P. 56(c)(1).

Summary judgment should be entered, "after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex, 477 U.S. at 322. "[A] complete failure of proof concerning an essential element of the nonmoving party's case necessarily renders all other facts immaterial." Id. at 323. In such a circumstance, summary judgment should "be granted so long as whatever is before the district court demonstrates that the standard for the entry of summary judgment, as set forth in Rule 56(c), is satisfied." Id.

If the moving party meets its initial responsibility, the burden then shifts to the opposing party to establish that a genuine issue as to any material fact actually does exist. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87 (1986). In attempting to establish the existence of this factual dispute, the opposing party may not rely upon the allegations or denials of its pleadings but is required to tender evidence of specific facts in the form of affidavits, and/or admissible discovery material, in support of its contention that the dispute exists. See Fed. R. Civ. P. 56(c). The opposing party must demonstrate that the fact in contention is material, i.e., a fact "that might affect the outcome of the suit under the governing law," Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); T.W. Elec. Serv., Inc. v. Pac. Elec. Contractors Ass'n, 809 F.2d 626, 630 (9th Cir. 1987), and that the dispute is genuine, i.e., "the evidence is such that a reasonable jury could return a verdict for the nonmoving party," Anderson, 447 U.S. at 248.

In the endeavor to establish the existence of a factual dispute, the opposing party need not establish a material issue of fact conclusively in its favor. It is sufficient that "'the claimed factual dispute be shown to require a jury or judge to resolve the parties' differing versions of the truth at trial.'" T.W. Elec. Serv., 809 F.2d at 630 (quoting First Nat'l Bank of Ariz. v. Cities Serv. Co., 391 U.S. 253, 288-89 (1968)). Thus, the "purpose of summary judgment is to pierce the pleadings and to assess the proof in order to see whether there is a genuine need for trial." Matsushita, 475 U.S. at 587 (citation and internal quotation marks omitted).

"In evaluating the evidence to determine whether there is a genuine issue of fact, [the court] draw[s] all inferences supported by the evidence in favor of the non-moving party." Wallsv. Cent. Costa County Transit Auth., 653 F.3d 963, 966 (9th Cir. 2011) (citation omitted). It is the opposing party's obligation to produce a factual predicate from which the inference may be drawn. See Richards v. Nielsen Freight Lines, 810 F.2d 898, 902 (9th Cir. 1987). Finally, to demonstrate a genuine issue, the opposing party "must do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita, 475 U.S. at 586 (citations omitted). "Where the record taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no 'genuine issue for trial.'" Id. at 587 (quoting First Nat'l Bank, 391 U.S. at 289).

III. Statement of Undisputed Facts

Unless otherwise specified, the following facts are either expressly undisputed by the parties or have been determined by the court, upon a full review of the record, to be undisputed by competent evidence.¹

Plaintiff was first prescribed the drug Risperdal in 2005 to treat schizophrenia while at Mule Creek State Prison; the medication was prescribed because plaintiff was suffering auditory hallucinations, major depression, and recurrent bipolar disorder symptoms. Deposition of Domingo Cleveland, Sr., taken February 25, 2019, ("D. Cleveland Depo. Tr."), Ex. 1 to Barkeshli Decl. at 38:1-21; RJD Inpatient Medical Records, Ex. 29 to Barkeshli Decl. at DC:RJD:INPATIENT:000441-466. Plaintiff took Risperdal regularly from 2005 through 2018, at which point he asked to be taken off the medication. D. Cleveland Depo. Tr., Ex. 1 to Barkeshli Decl. at 40:7-12; 42:10-14. Plaintiff has alleged that defendant "never warned nor informed it [sic] consumers of the side effect of gynecomastia with taken [sic] Risperdal." ECF No. 12 at 1-2.

The drug 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 adultswith schizophrenia and other psychotic disorders, and has since been approved for various other indications, such as schizophrenia (2002), bipolar mania (2003), child and adolescent autism (2006), child and adolescent bipolar mania (2007), and adolescent schizophrenia (2007). December 1993 Risperdal package insert, at JJRIS02702629-34, Ex. 8 to Barkeshli Decl.; February 2002 Risperdal Tablets package insert, at JJRIS 02702735-46, Ex. 9 to Barkeshli Decl.; December 2003 Risperdal Tablets package insert, at JJRIS 02702787-805, Ex. 10 to Barkeshli Decl.; October 2006 Risperdal Tablets package insert, at JJRIS 02943546-53, Ex. 11 to Barkeshli Decl.; August 2007 Risperdal Tablets package insert, at JJRE 13368103-50, Ex. 12 to Barkeshli Decl. When Risperdal was initially approved in 1993, the FDA approved label included a warning regarding gynecomastia and the risk of hyperprolactinemia or elevated prolactin as follows:

Precautions

Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration.... Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients.

. . .

Endocrine Disorders: Rare: gynecomastia, male breast pain, antidiuretic hormone disorder.

December 1993 Risperdal® Tablets package insert, at JJRIS02702629-34, Ex. 8 to Barkeshli Decl.

The Risperdal label approved in 2005 also listed gynecomastia and male breast pain as potential (rare) adverse reactions under "endocrine disorders." May 2005 Risperdal Tablets Package insert, at JJRIS02943579-88,...