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Gilliland v. Novartis Pharms. Corp.

United States District Court, S.D. Iowa, Western Division

July 25, 2014

DENISE GILLILAND, Plaintiff,
v.
NOVARTIS PHARMACEUTICALS CORPORATION, Defendant

For Denise Gilliland, Plaintiff: Cheryl P Robertson, John A Girardi, Molly B Weber-Girardi, PRO HAC VICE, GIRARDI KEESE, Los Angeles, CA; J Barton Goplerud, HUDSON MALLANEY SHINDLER & ANDERSON PC, WEST DES MOINES, IA.

For Novartis Pharmaceuticals Corporation, Defendant: Ross W Johnson, LEAD ATTORNEY, FAEGRE BAKER DANIELS, LLP (IA), Des Moines, IA; Christine R.M. Kain, PRO HAC VICE, FAEGRE BAKER DANIELS LLP (MN), MINNEAPOLIS, MN; Donald W. Fowler, James M. Sullivan, John Michael Kalas, Katharine R. Latimer, Peter J Skalaban , Jr., PRO HAC VICE, HOLLINGSWORTH LLP, Washington, DC.

Page 961

ORDER

ROBERT W. PRATT, U.S. DISTRICT JUDGE.

Before the Court are the following two motions by Novartis Pharmaceuticals Corporation (" Novartis" ), both filed May 15, 2014: (1) Motion to Exclude Testimony of Dr. Eric Sung, D.D.S. (" Dr. Sung" ) (" Motion to Exclude" ) (Clerk's No. 79)[1]; and (2) Motion for Summary Judgment (Clerk's No. 83)[2] (collectively " Novartis's Motions" ).

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Denise Gilliland (" Gilliland" ) responded to each Motion on June 16, 2014. Clerk's Nos. 88, 93. Novartis replied on June 30, 2014. Clerk's Nos. 100, 102. On July 3, 2014, Novartis filed a Notice of Supplemental Authorities in Support of Its Motion for Summary Judgement, Motion to Exclude, and Motion to Exclude Testimony of Plaintiff's Non-Retained Experts (" Notice of Supplemental Authorities" ). Clerk's No. 104. Gilliland responded to Novartis's Notice of Supplemental Authorities on July 10, 2014. Clerk's No. 108. The Motions are fully submitted.

I. FACTUAL AND PROCEDURAL BACKGROUND [3]

On June 17, 2005, Gilliland was diagnosed with multiple myeloma. As a part of her treatment regimen, she received Zometa infusions from July 1, 2005 until May 1, 2009, when she independently decided to discontinue her Zometa treatment. She was not seen by a dentist prior to receiving her first dose of Zometa. On February 7, 2006, Gilliland underwent a stem cell transplant. On the advice of the physician who performed the transplant, she saw a dentist on January 10, 2006, prior to undergoing the transplant. On April 15, 2010, Dr. Valmont Desa, an oral surgeon, diagnosed Gilliland with osteonecrosis of the jaw (" ONJ" ).

On April 16, 2012, Gilliland filed this lawsuit in the United States District Court for the Central District of California, asserting the following five claims: (1) strict liability; (2) negligent manufacture; (3) negligent failure to warn; (4) breach of express warranty; and (5) breach of implied warranty. See Compl. (Clerk's No. 1) ¶ ¶ 20-49. On October 24, 2012, however, the case was transferred to this Court pursuant to the parties' stipulation. See Clerk's Nos. 10-11. The primary dispute in this lawsuit centers on whether Gilliland's oncologists were aware of the association between bisphosphonates [4] and the risk of ONJ at the time they recommended and prescribed the Zometa treatment to her.

II. STANDARDS OF REVIEW

A. Daubert Motions

Novartis's Motion to Exclude calls upon the Court to assume its role as the evidentiary " gatekeeper" and to determine whether to admit the testimony of Dr. Sung, one of Gilliland's proffered expert witnesses. Federal Rule of Evidence 702 provides:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the produce of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

In Daubert v. Merrell Dow Pharmaceuticals, Inc., the United States Supreme Court explained that when trial courts are faced with a proffer of expert scientific testimony, the Court must determine at

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the outset " whether the expert is proposing to testify to (1) scientific knowledge that (2) will assist the trier of fact to understand or determine a fact in issue." 509 U.S. 579, 592, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Making such a determination " entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and whether that reasoning or methodology properly can be applied to the facts in issue." Id. at 592-93. In Kumho Tire Co. v. Carmichael, the Supreme Court expanded the general holding of Daubert, which established the district court's role as a gatekeeper, to include all expert testimony based on technical or scientific knowledge. 526 U.S. 137, 141, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999).

Under the Daubert test, the Court's task is to " ensure that any and all scientific evidence is not only relevant, but reliable." Daubert, 509 U.S. at 589. The Court must, therefore, perform a two-step inquiry into the reliability and relevance of the proffered expert testimony. Under the first prong of the test, reliability, the Court must determine whether the expert testimony is based on scientific knowledge and derived from, and validated by, the scientific method. Id. at 590. To aid the trial court in making this determination, the Daubert Court listed four potentially relevant factors, but the Court stressed that it was not setting forth a definitive checklist or test. Id. at 593. The identified factors include: (1) whether the theory or technique " can be (or has been) tested" ; (2) " whether the theory or technique has been subjected to peer review and publication" ; (3) the " known or potential rate of error" ; and (4) whether the theory or technique has gained general acceptance within the scientific community. Id. at 593-95.

B. Summary Judgment Motions

The term " summary judgment" is something of a misnomer. See D. Brock Hornby, Summary Judgment Without Illusions, 13 Green Bag 2d 273 (Spring 2010). It " suggests a judicial process that is simple, abbreviated, and inexpensive," while in reality, the process is complicated, time-consuming, and expensive.[5] Id. at 273, 281. The complexity of the process, however, reflects the " complexity of law and life." Id. at 281. " Since the constitutional right to jury trial is at stake," judges must engage in a " paper-intensive and often tedious" process to " assiduously avoid deciding disputed facts or inferences" in a quest to determine whether a record contains genuine factual disputes that necessitate a trial. Id. at 281-82. Despite the seeming inaptness of the name, and the desire for some in the plaintiffs' bar to be rid of it, the summary judgment process is well-accepted and appears " here to stay." [6] Id. at 281. Indeed, " judges are duty-bound to

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resolve legal disputes, no matter how close the call." Id. at 287.

Federal Rule of Civil Procedure 56(a) provides that " [a] party may move for summary judgment, identifying each claim or defense--or the part of each claim or defense--on which summary judgment is sought." " [S]ummary judgment is an extreme remedy, and one which is not to be granted unless the movant has established his right to a judgment with such clarity as to leave no room for controversy and that the other party is not entitled to recover under any discernible circumstances." Robert Johnson Grain Co. v. Chem. Interchange Co., 541 F.2d 207, 209 (8th Cir. 1976) (citing Windsor v. Bethesda Gen. Hosp., 523 F.2d 891, 893 n.5 (8th Cir. 1975)). The purpose of summary judgment is not " to cut litigants off from their right of trial by jury if they really have issues to try." Poller v. Columbia Broad. Sys., Inc., 368 U.S. 464, 467, 82 S.Ct. 486, 7 L.Ed.2d 458 (1962) (quoting Sartor v. Ark. Natural Gas Corp., 321 U.S. 620, 627, 64 S.Ct. 724, 88 L.Ed. 967 (1944)). Rather, it is designed to avoid " useless, expensive and time-consuming trials where there is actually no genuine, factual issue remaining to be tried." Anderson v. Viking Pump Div., Houdaille Indus., Inc., 545 F.2d 1127, 1129 (8th Cir. 1976) (citing Lyons v. Bd. of Educ., 523 F.2d 340, 347 (8th Cir. 1975)). Summary judgment can be entered against a party if that party fails to make a showing sufficient to establish the existence of an element essential to its case, and on which that party will bear the burden of proof at trial. See Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

Federal Rule of Civil Procedure 56 mandates the entry of summary judgment upon motion after there has been adequate time for discovery. Summary judgment is appropriately granted when the record, viewed in the light most favorable to the nonmoving party and giving that party the benefit of all reasonable inferences, shows that there is no genuine issue of material fact, and that the moving party is therefore entitled to judgment as a matter of law. See Fed.R.Civ.P. 56(a); Harlston v. McDonnell Douglas Corp., 37 F.3d 379, 382 (8th Cir. 1994). The Court does not weigh the evidence, nor does it make credibility determinations. The Court only determines whether there are any disputed issues and, if so, whether those issues are both genuine and material. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); Wilson v. Myers, 823 F.2d 253, 256 (8th Cir. 1987) (" Summary judgment is not designed to weed out dubious claims, but to eliminate those claims with no basis in material fact." ) (citing Weightwatchers of Quebec, Ltd. v. Weightwatchers Int'l, Inc., 398 F.Supp. 1047, 1055 (E.D.N.Y. 1975)).

In a summary judgment motion, the moving party bears the initial burden of demonstrating the absence of a genuine issue of material fact based on the pleadings, depositions, answers to interrogatories, admissions on file, and affidavits, if any. See Celotex, 477 U.S. at 323; Anderson, 477 U.S. at 248. If the moving party has carried its burden, the nonmoving party must then go beyond its original pleadings and designate specific facts showing that there remains a genuine issue of material fact that needs to be resolved by a trial. See Fed.R.Civ.P. 56(c). This additional showing can be by affidavits, depositions, answers to interrogatories, or the admissions on file. Id. ; Celotex, 477 U.S. at 322-23; Anderson, 477 U.S. at 257. " [T]he mere existence of some alleged factual dispute between the parties will not defeat a motion for summary judgment; the requirement is that

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there be no genuine issue of material fact." Anderson, 477 U.S. at 247-48. An issue is " genuine" if the evidence is sufficient to persuade a reasonable jury to return a verdict for the nonmoving party. See id. at 248. " As to materiality, the substantive law will identify which facts are material . . . . Factual disputes that are irrelevant or unnecessary will not be counted." Id.

Courts do not treat summary judgment as if it were a paper trial. Therefore, a " district court's role in deciding the motion is not to sift through the evidence, pondering the nuances and inconsistencies, and decide whom to believe." Waldridge v. Am. Hoechst Corp., 24 F.3d 918, 920 (7th Cir. 1994). In a motion for summary judgment, the Court's job is only to decide, based on the evidentiary record that accompanies the moving and resistance filings of the parties, whether there really is any material dispute of fact that still requires a trial. See id. (citing Anderson, 477 U.S. at 249 & 10 Wright & Miller, Federal Practice & Procedure § 2712 (3d ed. 1998)).

III. ANALYSIS

Novartis moves for summary judgment on all of Gilliland's claims, advancing a two-part argument. First, Novartis contends that summary judgment on all of Gilliland's claims is proper because she cannot, as a matter of law, generate a jury question as to specific causation, i.e., that Gilliland's Zometa infusions caused her ONJ. Def.'s Mem. in Supp. of Its Mot. for Summ. J. (" Def.'s SJ Br." ) (Clerk's No. 84) at 12. Second, in the event that its specific causation argument fails, Novartis contends that it is nevertheless entitled to summary judgment on Gilliland's failure to warn, negligent manufacture, and breach of express warranty claims.[7] See id. at 13-19. In particular, Novartis maintains that Gilliland's failure to warn claim must fail because the warning provided was adequate as a matter of law and because there can be no genuine factual dispute as to whether a different " warning would have prevented . . . [Gilliland] from developing ONJ." See id. at 13-17. As for Gilliland's negligent manufacture cause of action, Novartis argues that she has not presented any evidence sufficient to raise a triable issue of fact regarding whether the specific Zometa infusions that Gilliland received deviated from the medication's intended design. See id. at 17-18. Finally, Novartis contends that the breach of express warranty claim fails because Gilliland cannot, as a matter of law, demonstrate that Novartis made any affirmations to her or that she relied on such affirmations. See id. at 18-19.

A. Specific Causation

The parties agree that to generate a jury question on this issue, the testimony of Dr. Sung, Gilliland's only designated specific causation expert, must be admissible. Compare Def.'s SJ Br. at 12-13 with generally Pl.'s Resp. in Opp'n to Def.'s Mot. for Summ. J. (" Pl.'s SJ Resistance Br." ) (Clerk's No. 93) & Pl.'s Opp'n to Def.'s Mot. to Exclude (" Pl.'s Daubert Resistance Br." ). Thus, the success of Novartis's Motion for Summary Judgment--to the extent it is based on the asserted lack of specific causation--depends solely on the success of its Motion to Exclude. Novartis raises the following three challenges to the admissibility of Dr. Sung's testimony: (1) he lacks the necessary expertise to render a reliable differential diagnosis [8]

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by ruling out other possible causes of Gilliland's ONJ because he is not an expert on osteomyelitis, which is the main alternate cause of her ONJ; (2) his differential diagnosis is unreliable because he did not rule out osteomyelitis, chronic sinusitis, and maxillary drainage as possible causes of Gilliland's ONJ; (3) to the extent he ruled out these other potential causes, his stated rationale for doing so is " unduly conclusory." [9] Def.'s Mem. in Supp. of Mot. to Exclude (" Def.'s Daubert Br." ) (Clerk's No. 79-1) at 8-12. Although Novartis challenges Dr. Sung's testimony on these three purportedly separate grounds, its arguments boil down to the assertion that he did not conduct a proper differential diagnosis. Gilliland disagrees, arguing that Dr. Sung is qualified to and did in fact perform a sound differential diagnosis by, inter alia, excluding osteomyelitis, chronic sinusitis, and maxillary drainage as possible causes of her ONJ. Pl.'s Daubert Resistance Br. at 8-14.

For reasons that follow, the Court concludes that Dr. Sung completed a scientifically sound differential diagnosis, and, accordingly, is not precluded from testifying that Gilliland's Zometa treatment caused her ONJ.[10] See Glastetter v. Novartis Pharms. Corp.,

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252 F.3d 986, 989 (8th Cir. 2001) (" Because a differential diagnosis is presumptively admissible, a district court may exercise its gatekeeping function to exclude only those diagnoses that are scientifically invalid." (internal citation omitted)). Indeed, there is no doubt that despite Novartis's assertion to the contrary, Dr. Sung considered but rejected the possibility that Gilliland's osteomyelitis, chronic sinusitis, and maxillary drainage caused her ONJ. Pl.'s Daubert App. (Clerk's No. 88-3) at 35-36 (Dr. Sung Dep. at 136:11-138:21) (Dr. Sung explaining why he ruled out osteomyelitis, chronic sinusitis, and maxillary drainage as potential causes of Gilliland's ONJ). True, Dr. Sung's expert report makes no mention of osteomyelitis, chronic sinusitis, or maxillary drainage, see generally id. (Clerk's No. 88-9) ¶ ¶ 12-25, but, during his deposition, he was explicitly asked whether it was plausible that one of those conditions had caused Gilliland's ONJ, and he answered in the negative. Moreover, even assuming that Dr. Sung could offer no cogent explanation for ruling out osteomyelitis, chronic sinusitis, and maxillary drainage as potential causes of Gilliland's ONJ, his testimony would still be admissible because Eighth Circuit precedent does not require the exclusion of expert testimony merely because the expert has not ruled out every possible alternative cause for the plaintiff's medical condition.[11] See Lauzon v. Senco Prods., 270 F.3d 681, 693-94 (8th Cir. 2001) (" Another factor commonly applied to the determination of admissibility of an expert opinion is the ability to rule out other possibilities. Yet, this requirement cannot be carried to a quixotic extreme. . . . [A]n expert's causation conclusion should not be excluded because he or she has failed to rule out every possible alternative cause.. . . The doctor's explanations as to conclusions not ruled out went to weight and not admissibility." (emphasis added) (internal citations omitted)); see also Wilson v. TASER Int'l, Inc., 303 F.App'x 708, 714 (11th Cir. Dec. 16, 2008) (" [A] medical expert need not rule out every possible alternative in order to form an opinion on causation . . . ." ); Goebel v. Denver & Rio Grande W. R.R., 346 F.3d 987, 999 (10th Cir. 2003) (affirming the district court's conclusion that the medical expert's differential diagnosis was reliable because, inter alia, " he adequately considered and ruled out some alternative explanations [for the plaintiff's medical condition] even if he did not explicitly rule out depression" ); Westberry v. Gislaved Gummi AB, 178 F.3d 257, 265 (4th Cir. 1999) (" [A] medical expert's causation conclusion should not be excluded because he or she has failed to rule out every possible alternative

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cause of a plaintiff's illness. The alternative causes suggested by a defendant affect the weight that the jury should give the expert's testimony and not the admissibility of that testimony, unless the expert can offer no explanation for why she has concluded [an alternative cause offered by the opposing party] was not the sole cause." (internal citations and quotation marks omitted) (alteration in original)); Heller v. Shaw Indus., Inc., 167 F.3d 146, 156 (3d Cir. 1999) (" A medical expert's causation conclusion should not be excluded because he or she has failed to rule out every possible alternative cause of a plaintiff's illness." ).

Furthermore, contrary to Novartis's assertion, Dr. Sung's reasoning in rejecting osteomyelitis, chronic sinusitis, and maxillary drainage as possible causes of Gilliland's ONJ is not ipse dixit. See Def.'s Daubert Br. at 10-11. His decision was based on his knowledge and experience with ONJ and his review of Gilliland's medical and dental histories. See Pl.'s Daubert App. (Clerk's No. 88-9) ¶ ¶ 3, 5-7, 11. In essence, Novartis's challenge to the soundness of Dr. Sung's differential diagnosis amounts to an argument that he should have done more testing and more thorough patient evaluations before concluding that Gilliland's ONJ was caused by her Zometa treatment. See Def.'s Daubert Br. at 11 (pointing out that Dr. Sung did not examine Gilliland or " perform[] any tests on her, . . . did not rely upon any of her dental x-rays in forming his opinions . . . , [and did] [n]o biopsy testing, culture testing, or other testing of the alleged ONJ . . . to evaluate for osteomyelitis" ). Such arguments, however, go to the weight of the challenged testimony, not its admissibility. See Kudabeck v. Kroger Co., 338 F.3d 856, 861 (8th Cir. 2003) (" Kroger's attacks regarding the completeness of Dr. Reilly's methodology go to the weight and not the admissibility of his testimony." (internal citation omitted)). Thus, Novartis's " remedy is not exclusion, but instead cross-examination, the presentation of contrary evidence, and careful instruction on the burden of proof." [12] See Martin v. Apex Tool Group, L.L.C., 961 F.Supp.2d 954, 961 (N.D. Iowa 2013) (internal citation omitted).

B. Failure to Warn[13]

Novartis seeks summary judgment on Gilliland's failure to warn claim, advancing

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a two-fold argument. First, Novartis claims that, at the time Gilliland was prescribed Zometa, the risk of ONJ had been adequately disclosed, and, therefore, no reasonable jury could conclude that Novartis's warning was defective in that regard. See Def.'s SJ Br. at 13-14. Second, Novartis maintains that Gilliland's failure to warn claim should fail because she cannot, as a matter of law, demonstrate that the alleged warning defect caused her ONJ, i.e., " [she] has no evidence that different warnings regarding Zometa would have prevented . . . [her] from developing ONJ." Id. at 14 (capitalization modified from original).

1. Adequate disclosure of the risk of ONJ.

To survive summary judgment, Gilliland must demonstrate a genuine fact issue as to whether Novartis adequately warned her oncologists-- not her --of the connection between bisphosphonates and the risk of ONJ. See Daughetee v. CHR. Hansen, Inc., 960 F.Supp.2d 849, 870 (N.D. Iowa 2013) (explaining that the " intermediary defense is still viable under Iowa law" and that a seller of a product can escape liability on a failure to warn claim if the seller shows that it adequately warned an intermediary that, in turn, has a duty to warn the end user (internal citations and quotation marks omitted)); see also In re Aredia & Zometa Prods. Liab. Litig., No. 3:06-MD-1760, 2009 WL 8638121, at *1 (M.D. Tenn. Aug. 13, 2009) (" Under the learned intermediary doctrine, manufacturers of prescription drugs escape liability for failure to instruct and warn consumers so long as they adequately instruct and warn physicians responsible for prescribing the medication." (internal citation omitted)); Restatement (Third) of Torts: Products Liability (" Third Products Restatement" ) § 6 cmt. d (" The traditional rule, often referred to as the 'learned intermediary rule,' holds that manufacturers of prescription drugs discharge their duty of care to patients by warning the health-care providers who prescribe and use the drugs to treat them." ). Novartis argues that by July 1, 2005--when Zometa was first prescribed to Gilliland--the association between ONJ and bisphosphonates was widely recognized in the medical community and known to her oncologists. See Def.'s SJ Br. at 13-14. Therefore, Novartis asserts that, as a matter of law, it cannot face liability for its alleged failure to warn of the risk of ONJ. See id. Gilliland resists, contending that there is a jury question regarding whether Novartis adequately warned her oncologists of such risk. See Pl.'s SJ Resistance Br. at 13-16. The Court agrees with Gilliland. Drs. Samer Renno (" Dr. Renno" )[14] and Joseph Verdirame (" Dr. Verdirame" ), two of Gilliland's oncologists [15] who prescribed Zometa to her, testified that they could not recall when they first became aware of the association between Zometa and the risk of ONJ.[16] See Pl.'s SJ App. at 183 (Dr.

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Renno Dep. at 43:17-25), 191 (Dr. Verdirame Dep. at 36:2-15). Dr. Verdirame testified, however, that as soon as such association became known, all the physicians in his practice had a meeting and decided to require that every patient undergo a dental evaluation before starting Zometa infusions. See id. at 192 (Dr. Verdirame Dep. at 40:10-24). It is, however, undisputed that Gilliland did not see a dentist before starting her Zometa infusions. Therefore, a reasonable jury could infer that neither Dr. Renno nor Dr. Verdirame was aware of the risk of ONJ when they prescribed Zometa to Gilliland because had they been aware of such risk, they would have required that Gilliland undergo a dental evaluation prior to starting the Zometa therapy, and she would have complied.[17]

2. Causation.

The gist of Novartis's argument is that Gilliland has presented no evidence that a different warning would have caused her prescribing physicians to alter her recommended course of treatment in such a way that Gilliland's ONJ would have been avoided. See Def.'s SJ Br. at 14-15. In support, Novartis highlights the testimony of Gilliland's treating oncologists stating that they would have prescribed Zometa even if Novartis had included a different warning concerning the risk of ONJ because the benefits of Zometa far outweigh its risks. Id. As Gilliland notes, however, Novartis's " focus on the prescribing physician completely ignores the fact that ultimately it is up to the patient to decide whether to take a recommended therapy." Pl.'s SJ Resistance Br. at 17. The Court finds this argument persuasive. Prior to deciding whether Gilliland has raised a triable issue of fact as to causation, however, the Court must resolve a threshold issue: whether, under Iowa law, a defendant-drug manufacturer is entitled to a judgment as a matter of law on the causation element of the plaintiff-patient's negligent failure to warn claim if the defendant demonstrates that the plaintiff's doctor would not have changed her prescribing practices even if the defendant had provided a better warning or that any change in the prescribing practices would not have prevented the plaintiff's medical condition.

a. The threshold question.

Novartis espouses--and urges the Court to adopt--the following position shared by many courts throughout the country: that whether the plaintiff-patient would have refused treatment if a better warning had been provided is irrelevant. See Def.'s SJ Br. at 15-17 (collecting cases from various jurisdictions for this proposition); Def.'s Reply in Supp. of Its Mot. for Summ. J. (Clerk's No. 102) at 5 (Novartis arguing that Gilliland's assertion she would have refused the Zometa treatment had she been apprised of the associated risks is

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irrelevant to the causation issue because all that matters is whether her oncologists would have prescribed Zometa even if they knew of the risk of ONJ). Rather, Novartis claims that summary judgment to the defendant-drug manufacturer is proper so long as the plaintiff-patient's treating physicians testify that even if the defendant-drug manufacturer had provided a better warning, they would not have changed their prescribing practices or if the plaintiff-patient lacks evidence that any change in such prescribing practices would have prevented her disease or condition. See Def.'s SJ Br. at 15-17. Although instructive, neither of the cases cited by Novartis in support of this argument is binding on the Court. Indeed, the cases Novartis relies on and urges the Court to follow have effectively endorsed an extension of the learned intermediary rule that presents an issue of first impression in Iowa. Because the Iowa Supreme Court has yet to make a pronouncement, the Court must predict how Iowa's highest court would resolve this threshold question. See Gage v. HSM Elec. Prot. Servs., 655 F.3d 821, 825 (8th Cir. 2011) (internal citations omitted). With this task in mind, the Court turns to analyzing the cases, upon which Novartis relies.

The cases cited by Novartis fall into two categories: (1) those that necessarily rely on the premise that patients generally follow their treating physicians' recommendations [18]; and (2) those that do not appear to involve a statement by the plaintiff that she would have refused the recommended treatment had she been better advised of the associated risks.[19] Because Gilliland states that she would have refused the

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Zometa treatment had she known of the risk of ONJ, the latter category of cases is inapposite, and the Court, accordingly, focuses its attention on the first group of cases. Even assuming that the premise upon which those cases rely is sound,[20] the legal effect of such premise should, at most, raise a rebuttable presumption [21] that plaintiff-patients can attempt to overcome. Therefore, assuming that the Iowa Supreme Court would adopt the premise at issue, Iowa's learned intermediary jurisprudence suggests that the State's highest court would conclude that the legal effect of such premise is, at most, to raise a rebuttable presumption. Indeed, to conclude otherwise, i.e., that patients should always be deemed to undergo the treatment therapy recommended by their physicians, regardless of the risks associated with such therapy, would frustrate the purpose of the learned intermediary rule, which is to enable patients to make informed and intelligent decisions whether to undergo a recommended therapy by balancing the probable risks against the probable benefits of the course of treatment proposed by their physicians. See Third Products Restatement § 6(d) cmt. b (" The rationale supporting this 'learned intermediary' rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy." ). The learned intermediary doctrine certainly does not allow health care professionals to substitute their judgment for that of their patients. Nor does it obviate the need to consider whether the plaintiff-patient's decision concerning her recommended course of treatment would have been different, assuming that the warning at issue had been more adequate. Rather, the " learned intermediary" rule merely recognizes that only health care professionals are able to fully understand and appreciate the risks associated with a given prescription medication. Accordingly, the law makes it their duty to provide to their patients whatever information they deem pertinent so that the patients can make informed decisions.[22] See Third Products Restatement § 6(d) cmt. b (stating that health care providers have a duty " to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy" ).

b. Has Gilliland generated a triable issue of fact as to causation?

Even assuming that a different warning would have had no effect on Gilliland's

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oncologists' decision to recommend Zometa infusions as a course of treatment for her multiple myeloma, the record contains sufficient evidence for a reasonable jury to conclude that Gilliland would have rejected the Zometa treatment had she been apprised of the risk of developing ONJ. Indeed, Gilliland testified in her deposition that had she been aware of Zometa's risks, she would have rejected the treatment.[23] See Pl.'s SJ App. at 173 (Gilliland Dep. at 69:11-13), 178 (Gilliland Dep. at 121:5-24). The record further supports such inference because Gilliland requested a reduction of her Zometa dose and ultimately decided to discontinue the infusions altogether, see id. at 173 (Gilliland Dep. at 69:22-70:5), 175 (Gilliland Dep. at 71:11-25), even though by that time she was aware of Zometa's benefits, having lived more than six months, which is the average life expectancy for patients with multiple myeloma, if left untreated, see Pl.'s Resp. to Def.'s Statement of Material Facts (Clerk's No. 93-1) ¶ 3; see also Sheffer v. Novartis Pharms. Corp., No. 3:12-cv-238, 2013 WL 5276558, at *13 (S.D. Ohio Sept. 18, 2013) (" Sheffer testified that even though Dr. Haluschak recommended that she undergo radiation treatment, she opted not to follow his advice because of the potential for liver damage. . . . It can be inferred that, having rejected Dr. Haluschak's advice on that particular matter after being fully informed of the risks, she would have no qualms about doing so again." ). Accordingly, the Court finds that a reasonable fact-finder, viewing the evidence in the light most favorable to Gilliland, could conclude that she would have refused the Zometa treatment had she been warned about the risks associated with bisphosphonate therapy, including the possibility of developing ONJ.[24]

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C. Negligent Manufacture [25] and Breach of Express Warranty

Novartis claims that it is entitled to summary judgment on Gilliland's negligent manufacture claim because she has presented " no evidence that any of the Zometa infusions . . . [she] received departed from the design specifications for Zometa." See Def.'s SJ Br. at 17 n.4. As for the breach of express warranty claim, Novartis points out that Gilliland " has offered nothing to show that [Novartis] made any affirmations of fact to her . . . , and [t]here is no evidence under this record that [she] read or relied on any of [Novartis's] informational material." Id. at 18 (internal citations and quotation marks omitted) (alterations in original). Since Gilliland does not respond to these arguments, see generally Pl.'s SJ Resistance Br., Novartis is entitled to summary judgment on her negligent manufacture and breach of express warranty claims. See L.R. 56(b)(1) (" A party resisting a motion for summary judgment must . . . file contemporaneously . . . [a] brief . . . in which the resisting party responds to each of the grounds asserted in the motion for summary judgment." ); C. Line, Inc. v. City of Davenport, 957 F.Supp.2d 1012, 1032 (S.D. Iowa 2013) (granting summary judgment to the defendant on the takings and substantive due process claims where the plaintiff did not resist the defendant's request for summary judgment on those claims).

D. Strict Liability

There are three types of product defects--manufacturing, design, and warning. See Third Products Restatement § 2 (adopted by the Iowa Supreme Court in Wright v. Brooke Group Ltd., 652 N.W.2d 159 (Iowa 2002)). Gilliland's strict liability claim asserts that Zometa suffers from all three. See Compl. ¶ 25 (alleging that Zometa is " a product unreasonably dangerous for normal use due to its defective design, defective manufacture, and . . . [Novartis's] misrepresentations and inadequate

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facts disclosed to Ms. Gilliland and her health care providers" ). Under Iowa law, however, " [f]ailure to warn claims cannot be brought under a theory of strict liability." Scott v. Dutton-Lainson Co., 774 N.W.2d 501, 504 (Iowa 2009) (internal citation omitted). As for claims based on the remaining two types of defects, " [t]he Third Products Restatement recognizes that 'strict liability is appropriate in manufacturing defect cases, but negligence principles are more suitable for . . . [design defect [26]] cases.'" Id. (quoting Wright, 652 N.W.2d at 168); accord Huck v. Wyeth, Inc., No. 12-0596, 850 N.W.2d 353, (Iowa July 11, 2014) (" [T]he Restatement (Third) of Torts: Products Liability had, in addressing claims of design defect, abandoned the consumer-expectations test traditionally employed in strict liability analyses in favor of a risk-utility test typically found in negligence analyses." (internal citation omitted)). Thus, in light of Gilliland's assertions in this case, her strict liability cause of action can only rest on allegations of a manufacturing defect, i.e. that the Zometa infusions Gilliland received deviated from Zometa's intended design. See id. As noted above, however, see supra Section III.C, Gilliland has apparently chosen not to defend her negligent manufacture claim, thus effectively conceding that the Zometa infusions she received did not suffer from a manufacturing defect. Therefore, pursuant to Federal Rule of Civil Procedure 56(f)(1), no later than August 1, 2014, Gilliland shall file a brief explaining why the Court should not enter summary judgment for Novartis on her strict liability claim. If Gilliland decides to abandon this claim, she shall notify the Court of such decision as soon as practicable, but in any event, no later than August 1, 2014. Failure to timely comply with this Order shall result in the entry of summary judgment--without further notice--in favor of Novartis.

E. Breach of Implied Warranty [27]

For reasons that follow, the present ruling does not preclude recovery by Gilliland under an implied warranty theory. Under Iowa law, claims for breach of implied warranty of fitness for a particular purpose are distinct from claims for breach of implied warranty of merchantability. See Employers Mut. Cas. Co. v. Collins & Aikman Floor Coverings, Inc., No. 4:02-cv-30467, at *23-25 (S.D. Iowa Feb. 13, 2004) (internal citations omitted). It appears that Gilliland asserts the latter type of implied warranty claim because she alleges that the Zometa infusions she received were not merchantable, i.e., fit for their ordinary purpose. See Compl. ¶ 48 (alleging that Zometa was not " safe for its intended use . . . [and was not] of merchantable [28] quality" ).

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To prevail on such claim, Gilliland must persuade the jury that the Zometa infusions she received suffered from some defect, as defined by § 2 of the Third Products Restatement. See Conveyor Co. v. SunSource Tech. Servs., 398 F.Supp.2d 992, 1004 (N.D. Iowa 2005) (" Conduct that gives rise to a warranty claim based on fitness for ordinary purposes mirrors conduct that gives rise to tort liability for a defective product. Thus, warranty liability under section 554.2314(2)(c) requires proof of a product defect as defined in [the Third] Products Restatement section 2." (quoting Wright, 652 N.W.2d at 182)). As noted above, however, see supra Section III.C, Gilliland has apparently chosen not to defend either her negligent manufacture claim or her design defect claim (assuming, of course, that she asserted such a claim), thus effectively conceding that Zometa did not suffer from any design or manufacturing defects. Accordingly, Gilliland's breach of implied warranty claim may only rest on allegations of a warning defect. See Wright, 652 N.W.2d at 182 (concluding that, even though the plaintiffs could not maintain a breach of implied warranty claim based on an alleged manufacturing defect, they could nevertheless seek " recovery under an implied warranty theory where the defect alleged ar[o]se[] from a defective design or inadequate instructions or warnings" ). As the Court has already determined, see supra Section III.B.1, a reasonable jury could conclude that Zometa suffered from a warning defect. Therefore, Gilliland's breach of implied warranty claim remains viable.

IV. CONCLUSION

For the foregoing reasons, Novartis's Motion to Exclude (Clerk's No. 79) is GRANTED IN PART and DENIED IN PART. In particular, Dr. Sung is precluded from opining, based on his personal observations, that " the incidence and severity of []ONJ is related to time on bisphosphonate," but he is allowed to testify that Gilliland's Zometa infusions caused her ONJ. Novartis's Motion for Summary Judgment (Clerk's No. 83) is also GRANTED IN PART and DENIED IN PART. Specifically, the Court grants Novartis's Motion with respect to Gilliland's negligent manufacture and breach of express warranty claims, as well as her design defect claim (assuming Gilliland asserted such claim), and denies it with regard to her negligent failure to warn and breach of implied warranty claims. The Court reserves ruling as to the propriety of entering summary judgment in favor of Novartis on Gilliland's strict liability claim until she briefs the issue or the time for doing so has expired.

IT IS SO ORDERED.


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