JAMES A. TEILBORG, Senior District Judge.
Pending before the Court are: (1) Defendant's Motion for Summary Judgment on Specific Medical Causation (Doc. 110); (2) Defendant's Motion for Summary Judgment on Inadequate Warnings and Remaining Claims (Doc. 112); and (3) Defendant's Motion for Summary Judgment on Plaintiffs' Punitive Damages Claim (Doc. 114). The Court now rules on the Motions.
The Court previously set forth the Background of this case as follows:
(Doc. 139); D'Agnese v. Novartis Pharmaceuticals Corp., 2013 WL 321773, at *1 (D.Ariz. Jan. 28, 2013).
In their Second Amended Complaint, Plaintiffs assert the following claims against Defendant: (1) Strict Liability (Count I); (2) Negligence — Negligent Manufacture (Count II); (3) Negligence — Failure to Warn (Count III); (4) Breach of Express Warranty (Count IV); (5) Breach of Implied Warranty (Count V); and (6) Loss of Consortium (Count VI).
Defendant now moves for summary judgment: (1) on all of Plaintiffs' claims based on Plaintiffs' inability to prove specific medical causation; (2) on all of Plaintiffs' inadequate warning claims; and (3) on all of Plaintiffs' claims for punitive damages.
Plaintiffs filed responses to the Motions for Summary Judgment. In their Responses, Plaintiffs support their arguments with references to the "Declaration of John J. Vecchione, Esq. In Support of Plaintiffs' Opposition to Defendant's Motions to exclude Plaintiffs' Experts and for Summary Judgment in the D'Agnese Case." (Doc. 36) (the "Vecchione Declaration"). This Declaration is nine pages and the exhibits attached to it exceed 1,500 pages. Although this "Declaration" is not contemplated by the Court's local rules as responsive to a Motion for Summary Judgment,
Plaintiffs also filed "Plaintiffs' Responses to Counter-Statement of Undisputed Facts in Opposition to Defendant's Statement of Undisputed Facts in Support of Motion for Summary Judgment in the D'Agnese Case." (Doc. 126) ("Plaintiffs' Counter-Statement of Facts"). Plaintiffs' Counter-Statement of Facts is eighty-five pages and is in the Court's Record. This document is not referenced or cited to in any of Plaintiffs' Responses to the Motions for Summary Judgment.
Plaintiffs' Counter-Statement of Facts begins with the following "General Response," to Defendant's Motions for Summary Judgment:
(Doc. 126 at 2-3) (emphasis added).
Aside from the Vecchione Declaration, none of the other documents referenced are in this Court's Record. It is entirely unclear to the Court why Plaintiffs believe they may "incorporate by reference" numerous other documents that are not in this Court's Record in this case.
Further, this Court has previously informed Plaintiffs that such incorporation by reference is not permitted:
(Doc. 139 at 21-22 n. 4).
While the Court recognizes that the above-quoted Order was filed after Plaintiffs' filed their Counter-Statement of Facts, in the over six months since the Court issued that Order, Plaintiffs made
Accordingly, the Court has not considered any responses, statements of fact, or evidence that is not in its Record.
Summary judgment is appropriate when "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 party asserting that a fact cannot be or is genuinely disputed must support that assertion by... citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits, or declarations, stipulations ... admissions, interrogatory answers, or other materials," or by "showing that materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact." Id. at 56(c)(1)(A) & (B). Thus, summary judgment is mandated "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 Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
Initially, the movant bears the burden of pointing out to the Court the basis for the motion and the elements of the causes of action upon which the non-movant will be unable to establish a genuine issue of material fact. Id. at 323, 106 S.Ct. 2548. The burden then shifts to the non-movant to establish the existence of material fact. Id. The non-movant "must do more than simply show that there is some metaphysical doubt as to the material facts" by "com[ing] forward with `specific facts showing that there is a genuine issue for trial.'" Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (quoting Fed.R.Civ.P. 56(e) (1963) (amended 2010)). A dispute about a fact is "genuine" if the evidence is such that a reasonable jury could return a verdict for the non-moving party. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). In the summary judgment context, the Court construes all disputed facts in the light most favorable to the non-moving party. Ellison v. Robertson, 357 F.3d 1072, 1075 (9th Cir.2004)
Defendant argues that the Court should grant summary judgment on all of Plaintiffs' claims because: (1) Defendant warned about the association between ONJ and Aredia® /Zometa® in 2003 when the first association between bisphosphonates and ONJ was discovered, (2) Mr. D'Agnese was warned of the risk of ONJ and signed a written informed consent to continue receiving Zometa® despite being
In this case, Mr. D'Agnese began taking Aredia® in 1996. (Doc. 116 at ¶ 15; Doc. 126 at ¶ 15). On August 22, 2002, Mr. D'Agnese's former oncologist, Dr. Curley, noted that Mr. D'Agnese continued using Aredia® because of "the known incidence of increased bone events in patients who are not taking Aredia® with multiple myeloma." (Doc. 116 at ¶ 16; Doc. 126 at ¶ 16; Doc. 117-5).
Prior to September 2003, Defendant did not provide any warnings regarding a connection between bisphosphonates and ONJ. In September 2003, NPC informed the FDA that it was revising the Adverse Reactions section of the Aredia® and Zometa® labeling to include the language that:
Doc. 116 at 104.
In February 2004, the Zometa® label was revised to include language that "Although casualty cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged." (Doc. 116 at ¶ 108). On September 24, 2004, the package insert for Zometa® was revised to include the following three paragraphs in the precautions section regarding the potential risk of ONJ:
(Doc. 116 at ¶ 110).
On September 24, 2004, NPC sent a "Dear Doctor" letter to more than 17,200 hematologists, urologists, oral surgeons, and oncologists, based on the American Medical Association membership list notifying them of the label change. The letter alerted prescribing physicians to the change in the Zometa® label and reiterated its pertinent language including:
(Doc. 116 at ¶ 111).
On March 1, 2005, Dr. Olshan informed Mr. D'Agnese of potential side effects of Zometa®, including ONJ, and recommended that Mr. D'Agnese see his dentist every six months or sooner as needed. (Doc. 116 at ¶ 40). Mr. D'Agnese testified that he did not recall this conversation. (Doc. 126 at ¶ 40). Likewise, on March 1, 2005, Dr. Olshan presented Mr. D'Agnese with a written informed consent form disclosing that ONJ was a risk of continuing with Zometa® therapy. (Doc. 116 at ¶ 41, 43). Mr. D'Agnese signed the form. (Doc. 116 at ¶ 41). Mr. D'Agnese identified his signature on the form, but does not remember signing it. (Doc. 126 at ¶ 41). On December 16, 2005, Mr. D'Agnese made it clear that he wanted to continue receiving Zometa® therapy despite being informed of the risk of ONJ multiple times over the preceding months. (Doc. 116 at ¶ 49; Doc. 126 at ¶ 49). In 2005, Dr. Lines tentatively diagnosed Mr. D'Agnese with BRONJ. (Doc. 36-18 at 2).
Defendant asserts that summary judgment is appropriate on Plaintiffs' claims for strict liability (Count I), negligence — negligent manufacture (Count II), negligence
"To establish a prima facie case of products liability, at a minimum, the plaintiff must show that the product is in a defective condition and unreasonably dangerous, the defective condition [existed] at the time the product left the defendant's control, and the defective condition is the proximate cause of the plaintiff's injury." Gebhardt v. Mentor Corp., 191 F.R.D. 180, 184 (D.Ariz.1999) (citing Gosewisch v. American Honda Motor Co., Inc., 153 Ariz. 400, 737 P.2d 376, 379 (1987) (superseded on other grounds by Ariz.Rev.Stat. § 12-2506)). "Failure to prove any one of these elements is fatal." Id. (citing Gosewisch, 737 P.2d at 379).
"Three types of defects can result in an unreasonably dangerous product: (1) design defects,
In this case, Defendant argues that Plaintiffs have failed to establish a genuine issue of material fact: (1) that Aredia® and Zometa® were unreasonably dangerous because Plaintiffs cannot show that Defendant's warnings were inadequate under either strict liability or negligence theories and (2) that, even if the warnings were inadequate, that such inadequate warnings were the proximate cause of Mr. D'Agnese's injury. The Court will address each of these arguments in turn.
Under Arizona law, when a negligence claim is based on a failure-to-warn theory, the plaintiff is required to "prove
Id. (emphasis in original) (internal citation omitted).
Further, under Arizona law, "the theory of liability under implied warranty has been merged into the doctrine of strict liability," and, thus, Plaintiffs' breach of implied warranty claim has merged with their strict liability claim. Scheller v. Wilson Certified Foods, Inc., 114 Ariz. 159, 559 P.2d 1074, 1076 (Ariz.Ct.App.1976); Gebhardt v. Mentor Corp., 191 F.R.D. 180, 185 (D.Ariz.1999).
Defendant argues that it cannot be liable under strict liability or negligence theories of failure to warn because Defendant specifically warned about the association between ONJ and Aredia® /Zometa® in 2003 as soon as a possible association was first discovered and a duty to provide such a warning even arguably arose.
Defendant next argues that, even if its warnings were inadequate at any time, Plaintiffs cannot carry their burden of proving proximate cause in this case because Mr. D'Agnese's oncologist, Dr. Olshan, warned him of the risk of ONJ while obtaining his written informed consent to continue receiving Zometa® despite that risk, and Mr. D'Agnese expressly accepted that risk in order to receive the benefits of Zometa®.
"Ordinarily, what constitutes the proximate cause of any injury is a question of fact. However, the jury is not entitled to make a decision absent a proper evidentiary foundation." Gebhardt, 191 F.R.D. at 185 (citing Gosewisch, 737 P.2d at 380).
To prove causation, it is Plaintiffs burden to present evidence that, if Defendant had issued a proper warning, Mr. D'Agnese would not have taken Aredia® or Zometa®. Golonka v. General Motors Corp., 204 Ariz. 575, 65 P.3d 956, 965-966 (Ariz.Ct.App.2003); see Southwest Pet Products Inc. v. Koch Industries, Inc., 273 F.Supp.2d 1041, 1060 (D.Ariz.2003) (stating that, to make out a prima facie case of strict products liability based on an information defect, plaintiff must establish that defendant's failure to warn caused Plaintiff's injuries). In Arizona, there is heeding presumption used in strict liability information defect cases that allows "the fact-finder to presume that the person injured by product use would have heeded an adequate warning, if given." Golonka, 65 P.3d at 967. However, the heeding presumption is rebuttable and, if the manufacturer introduces evidence that would permit reasonable minds to conclude that the injured party would not have heeded an adequate warning, the presumption is destroyed as a matter of law and the existence or non-existence of the presumed fact must be determined as if the presumption
Defendant further argues that Plaintiffs are unable to carry their burden of establishing proximate cause because Mr. D'Agnese's prescribing oncologist still prescribes Zometa® to myeloma patients like Mr. D'Agnese today in the same manner and dosage and frequency as he prescribed it to Mr. D'Agnese.
Arizona courts follow the learned intermediary doctrine. Piper v. Bear Med. Sys., Inc., 180 Ariz. 170, 883 P.2d 407, 415 (Ariz.Ct.App.1993). Under the learned intermediary doctrine, a manufacturer of a prescription drug has a duty to warn physicians, and not consumers, of the risks associated with the drug. Piper, 883 P.2d at 415 n. 3. To succeed on a failure-to-warn claim, a plaintiff must establish causation by submitting evidence that the medical outcome would have been different if different warnings had been provided to the physician, i.e., that the provider would not have recommended the product, or that the patient would not have suffered the injuries. See Gebhardt v. Mentor Corp., 191 F.R.D. 180, 184-5 (D.Ariz.1999). When a prescriber is aware of the risks associated with a prescription medication and chooses to prescribe the medication in spite of these risks, or would not have modified the decision even if alternate warnings had been provided, the plaintiff has failed to establish that the manufacturer's failure to warn was the proximate cause of the plaintiff's alleged injury. See id.; Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir.2004) ("a product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician.") It is Plaintiffs' burden to establish proof that stronger warnings would have changed Mr. D'Agnese's medical treatment. Motus, 358 F.3d at 661.
Defendant argues that Plaintiffs cannot prove that the an inadequate warning was the proximate cause of Mr. D'Agnese's injury in this case because they have failed to provide any testimony that, if different warnings had been provided to Plaintiffs' prescribing physicians — namely Dr. Curley and Dr. Olshan — the providers would not have recommended Aredia® and/or Zometa® or that Mr. D'Agnese would not have suffered his injuries. The Court agrees that Plaintiffs have failed to establish proof that stronger warnings would have changed Mr. D'Agnese's medical treatment in this case.
First, Plaintiffs have failed to establish a genuine issue of material fact that Defendant's warnings were inadequate at the time Dr. Curley first prescribed Aredia® to Mr. D'Agnese in 1996. Plaintiffs argue that Defendant knew that ONJ was caused by bisphosphonates in 1996 because (1) in 1983, Dr. Jack Gotcher and Dr. W.S.S. Jee published an article explaining an experiment where rats were exposed to a bisphosphonate drug called clodronate and their findings that several of the rats had devitalized bone protruding in the oral cavities of rats treated with clodronate and (2) in 2005, after reports of links between ONJ and bisphosphonates, Defendant discovered what may have been six cases of ONJ in their original clinical trials of Aredia® in 1991.
Plaintiffs have not pointed to any evidence, including any testimony, suggesting that based on one study and six possible cases of ONJ in a clinical trial, Defendant's actions fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about. Likewise, Plaintiffs have not pointed to any evidence or testimony that, in light of this article and six possible
Even if Plaintiffs produced sufficient evidence upon which a reasonable person could conclude that the warnings were inadequate in 1996, Plaintiffs' claims also fail because Plaintiffs have offered no evidence that warnings to Dr. Curley would have changed his decision to prescribe Aredia® to Mr. D'Agnese in 1996. Although Plaintiffs appear to suggest that it is Defendant's burden to demonstrate that Dr. Curley's prescription decisions would have been different, it is Plaintiffs' burden to demonstrate proximate cause. See, e.g., Motus, 358 F.3d at 661 (finding that summary judgment was appropriate where plaintiff failed to establish proof that stronger warnings would have changed the medical treatment provided or that such warnings would have averted the injury). Although Plaintiffs may be attempting
Accordingly, on the evidence before the Court, no reasonable juror could find that Mr. D'Agnese's ONJ was caused by Defendant's allegedly inadequate warnings. This conclusion is based on the absence of any evidence that Defendant's warnings were inadequate at the time that different warnings would have prevented Mr. D'Agnese from developing ONJ, that different warnings would have changed the prescribing practices of Mr. D'Agnese's prescribing doctors or that different warnings would have prevented Mr. D'Agnese's injury, and Plaintiffs' failure to point to specific summary judgment evidence to create a genuine issue of fact as to whether Defendant's failure to warn was the proximate cause of Mr. D'Agnese's injury. As such, Defendant is entitled to summary judgment on Plaintiffs' claims for strict liability (Count I), negligence — negligent manufacture (Count II), negligence — failure to warn (Count III), and breach of implied warranty (Count V).
Defendant further argues that summary judgment must be granted on Plaintiffs' claim for breach of express warranty (Count IV) because Plaintiffs have not provided any evidence that Defendant ever made any express warranty to Mr. D'Agnese, or that Mr. D'Agnese has ever spoken with anyone associated with Defendant or received any written materials from Defendant prior to or during his use of either Aredia® or Zometa®. Under Arizona law, "[a]n express warranty claim requires a showing that the seller made an affirmation of fact or promise that became the basis of the bargain." Mills v. Bristol-Myers Squibb Co., No. CV 11-968-PHX-FJM, 2011 WL 3566131, at *3 n. 3 (D.Ariz. Aug. 12, 2011). In Response to Defendant's Motion for Summary Judgment, Plaintiffs did not address Defendant's argument that Plaintiffs have not provided any evidence of breach of an express warranty and did not otherwise provide evidence indicating the presence of an express warranty in this case. Accordingly, Plaintiffs have failed to establish the existence of a material fact on their breach of express warranty claim and, thus, summary judgment is granted in favor of Defendant on Plaintiffs' express warranty claim (Count IV).
Finally, Defendant argues that it is entitled to summary judgment on Plaintiffs' claim for loss of consortium (Count VI) because Plaintiffs have failed to establish a genuine issue of material fact on any of its underlying tort claims. Indeed, because a claim for loss of consortium is derivative of the underlying tort, "all elements of the underlying cause must be proven before the claim can exist." Barnes v. Outlaw, 192 Ariz. 283, 964 P.2d 484, 487 (1998). Accordingly, because Defendant is entitled to summary judgment on Plaintiffs' tort claims, Defendant is also entitled to summary judgment on Plaintiffs' claim for loss of consortium (Count VI).
Moreover, because the Court has granted Defendant's Motion for Summary Judgment on Inadequate Warnings and Remaining Claims, the Court need not address the remaining two motions for summary judgment and those motions are denied as moot.
Based on the foregoing,
