Gilliland v. Novartis Pharmaceuticals Corp.
Gilliland v. Novartis Pharmaceuticals Corp.
Opinion of the Court
ORDER
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)
I. FACTUAL AND PROCEDURAL BACKGROUND
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 osteone-crosis 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 Gilli-land’s oncologists were aware of the association between bisphosphonates
II. STANDARDS OF REVIEW
A. Daubert Motions
Novartis’s Motion to Exclude calls upon the Court to assume its role as the eviden-tiary “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
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, 113 S.Ct. 2786. 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, 113 S.Ct. 2786. 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, 113 S.Ct. 2786. 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 593-95,113 S.Ct. 2786.
B. Summary Judgment Motions
The term “summary judgment” is something of a misnomer. See D. Brock Horn-by, 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.
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.” “[Sjummary 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 Weight Watchers of Quebec, Ltd. v. Weight Watchers 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, 106 S.Ct. 2548; Anderson, 477 U.S. at 248, 106 S.Ct. 2505. 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, 106 S.Ct. 2548; Anderson, 477 U.S. at 257, 106 S.Ct. 2505. “[T]he mere existence of some alleged factual dispute between the parties will not defeat a motion for summary judgment; the requirement is that
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, 106 S.Ct. 2505 & 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. Defi’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.
. 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 Defi’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 di
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.
Furthermore, contrary to Novartis’s assertion, Dr. Sung’s reasoning in rejecting osteomyelitis, chronic sinusitis, and maxillary drainage as possible causes of Gilli-land’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 Dau-bert 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 Kuddbeck 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.”
B. Failure to Warn
Novartis seeks summary judgment on Gilliland’s failure to warn claim, advanc
1. Adequate disclosure of the risk of ONJ.
To survive summary judgment, Gil-liland 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 healthcare 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 Lability for its alleged failure to warn of the risk of ONJ. See id. Gilli-land resists, contending that there is a jury question regarding whether Novartis adequately warned her oncologists of such risk. See Pl.’s SJ Résistance Br. at 13-16. The Court agrees with Gilliland. Drs. Samer Renno (“Dr. Renno”)
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 plaintiffs 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 plaintiffs 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
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
b. Has Gilliland generated a triable issue of fact as to causation?
Even assuming that a different warning would have had no effect on Gilli-
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 Zome-ta 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 inade
E. Breach of Implied Warranty
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, 2004 WL 840561, at *8-9, 2004 U.S. Dist. LEXIS 7192, at *23-25 (S.D.Iowa Feb. 13, 2004) (internal citations omitted). It appears that Gilli-land 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
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 bis-phosph'onate,” 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.
. Novartis requests an oral argument and an evidentiary hearing on its Motion to Exclude. See Clerk's No. 79 at 2. Novartis's request for an oral argument is denied based on the Court’s conclusion that an oral argument would not substantially aid it in ruling on this Motion. See LR 7(c). The Court also concludes that an evidentiary hearing is not necessary because the parties have had ample opportunity to present their respective arguments regarding the admissibility of Dr. Sung’s testimony. See Group Health Plan, Inc. v. Philip Morris USA, Inc., 344 F.3d 753, 761 n. 3 (8th Cir. 2003) ("Although in limine hearings are generally recommended prior to Daubert determinations, ... they are not required. ... The only legal requirement is that the parties have an adequate opportunity to be heard before the district court makes its decision.” (internal citations and quotation marks omitted)). Indeed, in addition to their voluminous submissions on this issue, the parties were also allowed to further press their respective positions in supplemental filings. See Clerk's Nos. 104, 108. Therefore, the parties have had "an adequate opportunity” to be heard on the Daubert matter. See Group Health Plan, Inc., 344 F.3d at 761 n. 3.
. Novartis requests an oral argument on its Motion for Summary Judgment. See Clerk's No. 83 at 3. Because the Court has determined that an oral argument would not sub
. The Court finds that its ruling on Novartis’s Motions will not benefit from a detailed recitation of the facts in this case. If specific facts become critical to the Court's analysis, they will be set forth in Section III below.
. Zometa belongs to a class of medications known as bisphosphonates.
. Indeed, Judge Hornby, a District Court judge for the District of Maine, convincingly suggests that the name "summary judgment” should be changed to "motion for judgment without trial.” 13 Green Bag 2d at 284.
. Judge Hornby notes that over seventy years of Supreme Court jurisprudence gives no hint that the summary judgment process is unconstitutional under the Seventh Amendment. Id. at 281 (citing Parklane Hosiery Co. v. Shore, 439 U.S. 322, 336, 99 S.Ct. 645, 58 L.Ed.2d 552 (1979) and Sartor v. Arkansas Natural Gas Corp., 321 U.S. 620, 627, 64 S.Ct. 724, 88 L.Ed. 967 (1944)). While he recognizes that not much can be done to reduce the complexity of the summary judgment process, he nonetheless makes a strong.case for improvements in it, including, amongst other things, improved terminology and expectations and increased pre-summary judgment court involvement. See id. at 283-88.
. Novartis does not mount any additional challenges to Gilliland’s strict liability and breach of implied warranty claims.
. Performing a differential diagnosis is the process whereby
a physician begins by “ruling in” all scientifically plausible causes of the plaintiff's injury, ... then “rules out” the least plausible causes of injury until the most likely cause remains. The final result of a differential diagnosis is the expert's conclusion that a defendant's product caused (or did not cause) the plaintiff's injury.
Glastetter v. Novartis Pharms. Corp., 252 F.3d 986, 989 (8th Cir. 2001) (internal citation omitted).
. Novartis also moves to exclude Dr. Sung's opinion that "[t]he cumulative dose or duration of Zometa augments [his] opinion as to cause, as the incidence and severity of [ ]ONJ is related to time on bisphosphonate.” See Def.’s Daubert Br. at 14. Novartis argues that this opinion is unreliable and conclusory because Dr. Sung’s asserted bases for such opinion were common knowledge, a study involving the medication Fosamax, and his clinical experience. See id. The Court agrees that lacking from Dr. Sung’s opinion is "any data to support ... [its] reliability ..., as he only vaguely referenced potential sources of information on which he based this opinion during his deposition, and there is no indication that he used any methodology in reaching this conclusion.” See Stanley v. Novartis Pharms. Corp., No. CV 11-03191, 11 F.Supp.3d 987, 1002, 2014 WL 1316217, at *10 (C.D.Cal. Apr. 2, 2014) (internal citation omitted) (excluding an identical opinion by Dr. Sung on the relationship between bisphosphonate dosing and the incidence and severity of ONJ).
Gilliland insists, however, that Dr. Sung’s opinion regarding the relationship between bisphosphonate dosing and the incidence and severity of ONJ is admissible because it is based on the American Association of Oral and Maxillofacial Surgeons Position Paper (“Position Paper”), which reports there are studies suggesting that such a relationship exists. See Pl.’s Daubert Resistance Br. at 15;' Pl.’s App. in Supp. of Her Opp’n to Def.’s Mot. to Exclude ("PL’s Daubert App.”) (Clerk's No. 88-6) at 5 (“Recent studies have suggested that manipulation of ... bisphos-phonate dosing might be effective in ... minimizing []ONJ risk.”). To the extent Dr. Sung intends to opine, based on his personal observations, that there is a relationship between bisphosphonate dosing and ONJ, he is precluded from doing so because he has not shown that he used any methodology in reaching such conclusion. Dr. Sung may, however, testify as to the contents of the Position Paper and read passages from it into the record. See United States v. Hawley, 592 F.Supp. 1186, 1191 (D.S.D. 1984) (“[Documents governed by [Federal Rule of Evidence] 803(18) are not admissible as exhibits to go to the jury but the expert or other witnesses may testify as to these documents and read passages from them.”).
. The Court concludes that Dr. Sung has the requsite experience and knowledge to render a reliable opinion as to the cause of Gilli-land’s ONJ. Indeed, it is undisputed that Dr. Sung has not only treated multiple patients with ONJ, but has also authored publications and delivered presentations on bisphospho-
. Of course, this lawsuit presents an even stronger case for allowing Dr. Sung’s testimony because he actually provided cogent reasons — albeit in response to questions during his deposition rather than in his expert report — for excluding osteomyelitis, chronic sinusitis, and maxillary drainage as possible causes of Gilliland's ONJ.
. In the event that the Court finds Dr. Sung’s specific causation opinion admissible, Novartis argues that he should nevertheless be precluded .from testifying that Gilliland’s Zometa treatment caused her maxillary jaw problems. See Def.’s Daubert Br. at 12-14. In particular, Novartis claims that, by his own admission, Dr. Sung knew of no scientifically reliable way to exclude the possibility that Gilliland’s “draining infection” caused her exposed bone in her maxilla. See id. Therefore, Novartis argues that Dr. Sung’s opinion that Gilliland "developed ONJ from Zometa ... should be limited to the exposed bone in her mandible.” Id. at 14. Gilliland resists Novartis's argument, pointing out that Dr. Sung actually concluded that her “maxillary drainage” could not have led to the exposed bone in her maxilla. See Pl.’s Daubert Resistance Br. at 14. Because the Court finds that Dr. Sung possesses the necessary expertise to render such an opinion and because he used a methodology in reaching his conclusion, his opinion as to the causation between Gilli-land's Zometa treatment and the exposed bone in her maxilla is admissible. Novartis's objections to the testimony at issue go to its weight, not its admissibility.
. In its summary judgment brief, Novartis refers to failure to warn claims, presumably because it posits that a warning defect may give rise to both a strict liability claim and a negligence claim. See Def.’s SJ Br. at 13-14 (emphasis added). Under Iowa law, however, "[fjailure to warn claims cannot be brought under a theory of strict liability.” Nationwide Agribusiness Ins. Co. v. SMA Elevator Constr., 816 F.Supp.2d 631, 653 (N.D.Iowa 2011) (internal citation omitted).
. Dr. Renno was the first oncologist to prescribe Zometa to Gilliland. See Def.’s Resp. to Pl.'s Statement of Additional Materials Facts (Clerk's No. 102-1) at 16-17 (admitting that Dr. Renno was the first physician to prescribe Zometa).
. Gilliland was also treated by Drs. Abraham Mathews and Inaganti Shah.
.Novartis points out, however, that Drs. Renno and Verdirame were certainly aware of the association between bisphosphonates and the risk of ONJ prior to July 1, 2005 (when Gilliland was first prescribed Zometa) because in September 2004, Novartis mailed out copies of its "Dear Doctor” letter advising of the risk of ONJ to both of them. See Def.’s Resp. to Pl.’s Statement of Additional Materials Facts (Clerk’s No. 102-1) at 17; Pl.’s Suppl. App. in Supp. of Its Mot. for Summ.
. Notably, some six months later, when Gil-liland was asked to undergo a dental evaluation prior to her stem cell transplant, she complied.
. See, e.g., Terhune v. A.H. Robins Co., 90 Wash.2d 9, 577 P.2d 975, 978 (1978) ("Where a product is available only on prescription or through the services of a physician, the physician acts as a ‘learned intermediary' between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance upon that judgment.” (emphasis added)) (relied on by Luttrell v. Novartis Pharms. Corp., 555 Fed.Appx. 710, 711 (9th Cir. 2014)); Payne v. Novartis Pharms. Corp., 967 F.Supp.2d 1223, 1234-35 (E.D.Tenn. 2013) (granting summary judgment to the defendant on the plaintiff's failure to warn claim because the plaintiff presented no evidence that receiving a dental examination prior to undergoing a bisphosphonate therapy, which is what the plaintiff's treating physician would have required had he been aware of the connection between bisphospho-nates and the risk of ONJ at the time he recommended the bisphosphonate therapy to the plaintiff, would have prevented the plaintiff's injury).
. See, e.g., D'Agnese v. Novartis Pharms. Corp., 952 F.Supp.2d 880, 892 (D.Ariz. 2013) ("[Ejven after being warned of the possible risk of ONJ, Mr. D'Agnese continued to take Zometa.”); Zimmerman v. Novartis Pharms. Corp., 287 F.R.D. 357, 361 (D.Md. 2012) ("Plaintiff now relies on two ... theories to establish proximate causation: 1) If Ms. Newman's healthcare providers had known of the risk of invasive dental procedures in Aredia patients, she would have had a dental examination prior to starting Aredia and tooth #16 would have been extracted at that point; or 2) If Dr. Mennitt had known of the risk, he would not have extracted tooth # 16 in 2001 while Ms. Newman was taking Aredia.”); Ingram v. Novartis Pharms. Corp., 888 F.Supp.2d 1241, 1245 (W.D.Okla. 2012) (the plaintiff arguing that there is a genuine issue of fact as to proximate causation because his treating physician’s prescribing practices changed over time to account for the risk of ONJ as opposed to claiming that he would have refused to take bisphosphonates); Eberhart v. Novartis Pharms. Corp., 867 F.Supp.2d 1241, 1254 (N.D.Ga. 2011) (the plaintiff arguing that "had she been warned of the connection between Zometa and ONJ she would have refused the extractions of teeth 19 and 20,” which caused her ONJ, but not that she would have refused to take Zometa).
. It certainly defies common sense to argue that this premise is anything but sound. After all, patients see doctors for their unique expertise in diagnosing and treating medical conditions. It is, therefore, axiomatic that most patients rely on their doctors’ recommendations and comply with the prescribed course of treatment.
. Since no one disputes that it is up to the individual patient to decide whether to undergo a given treatment therapy, the presumption that the patient follows her doctor’s recommendations must necessarily be rebut-table.
.The theory of Gilliland’s failure to warn claim rests on the assertion that she was denied an opportunity to make an informed decision as to her multiple myeloma treatment therapy' because Novartis did not apprise the oncologists who recommended the therapy of the risk of ONJ, and the oncologists, in turn, did not inform her of such risk. As a result of this alleged warning defect, Gilliland asserts that she developed ONJ because, had she known of the relationship between bisphosphonates and the risk of ONJ, she would have rejected the Zometa treatment.
. Novartis contends that the Court should reject such testimony because, among other things, it is "hypothetical, ... [and] self-serving-" See PL's Reply in Supp. of Its Mot. for Summ. J. (Clerk’s No. 102) at 5. Although there can be no doubt that the testimony at issue is hypothetical and self-serving, so is the testimony by Gilliland's treating oncologists that they would have still prescribed Zometa to her, even if Novartis had provided a better warning of the risk of ONJ. If, as Novartis argues, the testimony of these physicians is relevant, so too must be Gilliland’s testimony in question.
. In so holding, the Court does not reject— or even undermine — the validity of the learned intermediary doctrine under Iowa law. Rather, the Court’s conclusion is merely a logical extension of its determination that, if faced with the threshold question discussed above, see supra Section III.B.2.a, the Iowa Supreme Court would decline to espouse the interpretation of the learned intermediary rule urged by Novartis. Notably, the Court is not the first tribunal to recognize that deciding whether to reject a recommended treatment therapy is solely within the purview of the patient and, accordingly, a plaintiff-patient could prevail on the causation element of a failure to warn claim if she demonstrates that she would have rejected the recommended therapy had she been warned about the risks associated with the recommended course of treatment. See Kirchman v. Novartis Pharms. Corp., 2014 WL 2158519, at *5, 2014 U.S. Dist. LEXIS 71159, at *14-15 (M.D.Fla. May 23, 2014) ("The Court concludes that genuine issues of material fact exist as to whether the allegedly inadequate warning was a proximate cause of Mr. Kirch-man's ONJ. While Dr. Byun testified that a different warning would not have changed his decision to prescribe Aredia and/or Zometa to Mr. Kirchman, Dr. Byun also testified that he now discusses the risk of ONJ with his patients, and did discuss that risk with Mr. Kirchman when recommending that he take Aredia and/or Zometa in 2007 and 2008. Thus, a reasonable juror could find that Dr. Byun, had he been adequately warned, would have changed his prescribing practices by giving different warnings or instructions to Mr. Kirchman in 2002 and 2003_On this record, a reasonable juror could infer that Mr. Kirchman, had he been given different warnings or instructions, would have declined Are-dia and/or Zometa in 2002 and 2003.” (inter
. Novartis treats Gilliland’s negligent manufacture claim as a design defect claim because it "does not believe [that] ... [Gilli-land] intends to raise a manufacturing defect claim ... [since] such a claim would not be viable as there is no evidence that any of the Zometa infusions ... [Gilliland] received departed from the design specifications for Zometa.” Def.'s SJ Br. at 17 n. 4. Novartis further argues that Gilliland "cannot maintain a design claim because, inter alia, ... [she] lacks the necessary expert testimony to establish that there is a defect in the design of Zometa, and that removing any defect from the design would have prevented ... [Gilli-land's] ONJ without compromising the benefits of Zometa.” Id. at 17. Even a cursory review of Gilliland’s Complaint, however, reveals that she intended to assert a negligent manufacture claim, not a design defect claim. See Compl. ¶¶ 28-33 (setting forth the elements of her claim and labeling it a negligent manufacture claim). Accordingly, the Court will treat Gilliland’s claim as a negligent manufacture claim. Even assuming, however, that Gilliland raised a design defect claim in this lawsuit, Novartis would also be entitled to judgment as a matter of law on such claim because she does not resist Novartis’s arguments seeking summary judgment on the design defect claim. See generally Pl.’s SJ Resistance Br.
. Even assuming that Iowa law recognized strict liability claims based on an alleged design defect, as explained above, see supra n. 22, Gilliland does not resist Novartis’s arguments seeking summary judgment on her design defect claim (assuming, of course, that she raised, such a claim in the first place). Thus, Gilliland effectively concedes that Zometa- did not suffer from a design defect.
. Novartis’s only challenge to Gilliland's breach of implied warranty claim rests on the asserted lack of specific causation evidence. See supra Section III.A. The Court, however, finds that a brief analysis of this theory of recovery would benefit the litigants, insofar as it clarifies the scope of the implied warranty claim.
.Goods are merchantable if they are “fit for the ordinary purposes for which such goods are used.’’ Iowa Code § 554.2314(2)(c). The “ordinary purposes for which ... goods are used” refers to “uses which are customarily made of the goods in question.” Id. § 554.2315 cmt. 2.
Reference
- Full Case Name
- Denise GILLILAND v. NOVARTIS PHARMACEUTICALS CORPORATION
- Cited By
- 6 cases
- Status
- Published