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Messick v Novartis Pharmaceuticals Corporation

Case No. 13-15433 (C.A. 9, Apr. 4, 2014)

We consider when a district court should exclude expert testimony at trial. Linda Messick contends that the district court erred by excluding the causation testimony offered by her expert, Dr. Richard Jackson, when it found the testimony to be irrelevant and unreliable. Examining the district court’s exclusion of expert testimony for an abuse of discretion, we conclude that Dr. Jackson’s testimony was improperly excluded, and we reverse and remand.

I



In August 2000, Linda Messick was diagnosed with breast cancer. In response to her development of osteoporosis after chemotherapy and steroid therapy, Messick was treated with the drug Zometa from May 7, 2002 to November 14, 2002. Zometa is a bisphosphonate, a class of drug commonly used to treat multiple myeloma. Such drugs are used to reduce or eliminate the possibility of skeletal-related degeneration and injuries to which cancer patients are particularly susceptible. Novartis Pharmaceuticals Corporation (“Novartis”) produces Zometa, which was approved by the FDA in 2001 and 2002 for treating hypercalcemia of malignancy and other conditions.

After Messick encountered several dental problems, two oral specialists examined her in November 2005 and discovered osteonecrosis near three of her teeth. Both doctors treated her under the assumption that she was suffering from bisphosphonate-related osteonecrosis of the jaw (“BRONJ”), a condition recognized by the American Association of Oral and Maxillofacial Surgeons (“AAOMS”). According to the AAOMS, a BRONJ diagnosis is appropriate for patients with (1) current or previous treatment with bisphosphonates, (2) exposed bone in the maxillofacial region that has lasted for more than eight weeks, and (3) no history of radiation therapy to the jaw. Other potential causes of osteonecrosis of the jaw (“ONJ”) may include: peridontal and dental disease, osteomyelitis, corticosteroid use, cancer, radiation therapy, compromised immunity, and trauma. While ONJ may be caused by many factors, the AAOMS’s diagnostic definition of BRONJ sets out its unique features: it lasts more than eight weeks and is not related to radiation therapy. Messick’s BRONJ healed between March and October 2008, about three years after diagnosis. She and her husband brought suit against Novartis for strict products liability, negligent manufacture, negligent failure to warn, breach of express and implied warranty, and loss of consortium.
 

 

Judge(s): Ronald M. Gould
Jurisdiction: U.S. Court of Appeals, Ninth Circuit
Related Categories: Expert Witness , Product Liability , Torts
 
Circuit Court Judge(s)
Morgan Christen
Raymond Fisher
Ronald Gould

 
Trial Court Judge(s)
Susan Illston

 
Plaintiff Lawyer(s) Plaintiff Law Firm(s)
John Girardi Girardi Keese
Martin Buchanan Law Offices of Martin N. Buchanan
John Vecchione Valad & Vecchione PC

 
Defendant Lawyer(s) Defendant Law Firm(s)
Katharine Latimer Hollingsworth LLP
Frank Leone Hollingsworth LLP
Rebecca Womeldorf Hollingsworth LLP

 

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jackson, when it found the testimony to be irrelevant and a witness who is qualified as an expert by february 3, 2014—seattle, washington reduce or eliminate the possibility of skeletal-related matter of weight, not admissibility. kennedy, 161 f.3d at testimony at trial. linda messick contends that the district bisphosphonate-related osteonecrosis of the jaw (“bronj”), “[e]xpert testimony . . . be both relevant and reliable,” estate excluding dr. jackson’s causation testimony when it found excluded, and we reverse and remand. argued and submitted messick v. novartis pharmaceuticals corp. 7 we recentlyacknowledged the district court’s dutyto “act has extensive experience diagnosing and treating onj, the causation testimony offered by the plaintiff’s expert, dr. novartis pharmaceuticals sufficientlycompelling proof that the agent must have caused bisphosphonate treatments. it excluded the testimony when an expert rules out a potential cause in the course the district court excluded dr. jackson’s testimony as defendant-appellee. caused by many factors, the aaoms’s diagnostic definition excluding dr. jackson’s opinion, which stated that a patient only determines that ms. messick’s onj is related to her and maxillofacial surgeons (“aaoms”). according to the messick v. novartis pharmaceuticals corp. 3 in august 2000, linda messick was diagnosed with messick v. novartis pharmaceuticals corp.4 metabolife int’l, inc., 401 f.3d 1233, 1252 (11th cir. 2005) we consider when a district court should exclude expert suggested a non-exclusive and flexible list of factors that a the panel held that the district court erred by excluding states v. vallejo, 237 f.3d 1008, 1019 (9th cir. 2001)). (b) the testimony is based on sufficient facts federal rule of evidence 702 governs expert testimony: differential diagnosis may form the basis of an expert’s i cir. 2001) (“differential diagnosis . . . is a standard scientific 464 f.3d 976, 981 (9th cir. 2006) (citations omitted). of barabin v. astenjohnson, inc., 740 f.3d 457, 463 (9th cir. causation testimony of messick’s experts and a motion appeal from the united states district court marks and citation omitted); daubert ii, 43 f.3d at 1318 the aaoms stated in a 2009 position paper that “the current for publication and transferred, the district court granted those motions, and corp., 657 f.3d 970, 982 (9th cir. 2011)). to aid courts in evidence, including whether particular evidence falls within messick v. novartis pharmaceuticals corp. 9 after messick encountered several dental problems, two that testimony to be unreliable largely because dr. jackson iii hypercalcemia of malignancy and other conditions. oral specialists examined her in november 2005 and gould, circuit judge: defendant’s conduct was “more likely than not” a substantial degeneration and injuries to which cancer patients are * evidence “logically advances a material aspect of the the scope of a given rule.” united states v. durham, court has similarly stressed that “it would be unreasonable to differential diagnosis may be admissible to prove specific causation. see does not mean that bisphosphonates caused her onj.” the v. corporation, plaintiff offered dr. richard jackson’s testimony on with the drug zometa from may 7, 2002 to november 14, barabin, 740 f.3d at 463 (quoting ellis v. costco wholesale unreliable. the panel held that dr. jackson’s testimony bisphosphonate use, and he admits that a diagnosis of bronj inc., 43 f.3d 1311, 1315 (9th cir. 1995) (“daubert ii”). records, treatment, and history. medicine partakes of art as factors at one time which of those particular risk factors is messick v. novartis pharmaceuticals corp.6 approved by the fda in 2001 and 2002 for treating ii indicated that plaintiff’s bisphosphonate use was a v. denver & rio grande w. r.r. co., 346 f.3d 987, 999 given the difficulties in establishing a medical cause and causation testimony. see clausen v. m/v new carissa, 137, 149 (1999) (citation and alterations omitted). the court 194, 202 (4th cir. 2001) (holding that an expert’s opinion 89 f.3d 594, 596–97 (9th cir. 1996). a“liberalthrust”favoringadmission, daubertv. merrelldow of the jaws.” but the paper goes on to explain that while martin n. buchanan (argued), law offices of martin n. or data; filed april 4, 2014 frank leone (argued), katharine r. latimer, rebecca a. considered to be offering “junk science.” bisphosphonates treatment and her development of onj. we hardyman v. norfolk & w. ry. co., 243 f.3d 255, 260 (6th fed. r. evid. 702. although rule 702 should be applied with underlying the testimony is scientifically valid.” daubert, explicitly stated that messick’s bisphosphonate use caused principles”). the district court abused its discretion in is often uncertain” (quoting united states v. sandoval- the appropriate use of differential diagnosis to prove specific her bronj, he did say it was at least a substantial factor in de novo. lust ex rel. lust v. merrell dow pharm., inc., mendoza, 472 f.3d 645, 655 (9th cir. 2006))). the supreme 156 f.3d 248, 253 (1st cir. 1998) (stating that “‘differential differential diagnosis. dr. jackson also relied on the before: raymond c. fisher, ronald m. gould, 550 u.s. 372, 378 (2007), and “there must be evidence on (d) the expert has reliably applied the (detailing a reliable differential diagnostic process); goebel excluded. the admissibility, correctly viewed, of dr. irrelevant because of its view that his “differential diagnosis well as science, and there is nothing wrong with a doctor causation. see saelzler v. advanced grp. 400, 23 p.3d 1143, court may consider when determining the reliabilityof expert 1 1226, 1230 (9th cir. 1998) (quoting daubert ii, 43 f.3d at no. 13-15433 effect relationship, “[c]ausation can be proved even when we messick v. novartis pharmaceuticals corp.10 vecchione, pc, fairfax, virginia, for plaintiff-appellant. underlying it has a valid connection to the pertinent inquiry.” her expert, dr. richard jackson, when it found the testimony determine a fact in issue; analysis if the expert uses reliable methods”); mcclain v. testimony was relevant. the panel also held that the relying on extensive clinical experience when making a link between her bisphosphonate treatment and later surgery in 1984. he belongs to several dental and oral this conclusion.” but dr. jackson repeatedly referred to his adoctorusingadifferentialdiagnosis groundedin significant specialized knowledge will help the trier of healing conditions. these sources form an appropriate the damage somehow.” kennedy v. collagen corp., 161 f.3d novartis. and procedures and the elimination of those hypotheses must because of that inherent uncertainty, we do not require would not develop onj lasting for years without iv primiano, 598 f.3d at 565. here, california state products principles and methods; and plaintiff-appellant, johnson & johnson, inc., 492 f.3d 901, 904 (7th cir. 2007) theory or technique; and (4) whether the theory or technique would “help the trier of fact . . . to determine a fact in issue.” treated her under the assumption that she was suffering from testimony on onj and bronj generally, and on the causal fact to understand the evidence or to basis in education and experience”). a proper differential diagnosis, is sufficiently reliable to we review the district court’s grant of summary judgement exercising this gatekeeping role, the supreme court has the substantive issue here arises under the federal rules for more than eight weeks, and (3) no history of radiation case. corporation (“novartis”) produces zometa, which was with the oxygen necessaryto start a fire. although one might to be irrelevant and unreliable. examining the district court’s as a ‘gatekeeper’ to exclude junk science that does not meet turner v. iowa fire equip. co., 229 f.3d 1202, 1208 (8th “causalitymight never be proven, emerging experimental and the fifth circuit is alone in not yet explicitly approving the use of recognized the difficulties in establishing certainty in the its discretion in concluding otherwise. see primiano, community. daubert, 509 u.s. at 592–94. based on a differential diagnosis is generally admissible); enjoys general acceptance within the relevant scientific 1982, and became board certified in oral maxillofacial seeking summary judgment. after the case was remanded education may testify in the form of an exclusion of expert testimony for an abuse of discretion, we later development of bronj. buchanan, san diego, california; john a. girardi, girardi of evidence and california state products liability law. basis in the knowledge and experience of the relevant proposing party’s case.” daubert v. merrell dow pharm., in favor ofnovartis pharmaceuticalscorporation becausethe opinion by judge gould medical sciences. id. at 565 (stating that “medical knowledge imagine more targeted testimony, dr. jackson’s testimony level of evidence does not fully support a cause-and-effect reversed and remanded. satisfy daubert.”); baker v. dalkon shield claimaints trust, breast cancer. in response to her development of osteoporosis 3:12-cv-00693-si (a) the expert’s scientific, technical, or other diagnosis’ is a standard medical technique”); ambrosini v. 2002. zometa is a bisphosphonate, a class of drug commonly condition was a substantial causative factor. the panel cir. 2000)(“[a] medicalopinion about causation, based upon relevant. federal rule of evidence 702’s reliability standards.” 1152 (cal. 2001). relevancy depends on the particular law at issue because testimony and the ensuing grant of summary judgment to (noting that “[a] differential diagnosis satisfies a daubert the district court also abused its discretion in finding dr. concluded that dr. jackson’s expert testimony created a womeldorf, hollingsworth llp, washington, d.c., for clinical experience and examination of medical records and development of bronj. dr. jackson graduated from the jackson’s expert testimonycreatesagenuineissueofmaterial that an expert be able to identify the sole cause of a medical after chemotherapy and steroid therapy, messick was treated “construction or interpretation of . . . the federal rules of factor. we hold that the district court abused its discretion in factor in her development of bronj, so his testimony is causal link between plaintiff’s bisphosphonate treatment and speculation.” clausen, 339 f.3d at 1058 (internal quotation 598f.3dat567(admittingexpert’stestimonywith “sufficient reasons for excluding potential causes, we have consistently conclude that dr. jackson’s testimony was improperly for the northern district of california therapy to the jaw. other potential causes of osteonecrosis of his opinion, as opposed to its relevancy and reliability, are a knowledge, skill, experience, training, or proceedings, novartis filed a motion to exclude the specific keese, los angeles, california; john j. vecchione, valad & her development of bronj. specifically, dr. jackson most favorable to the non-moving party, scott v. harris, osteonecrosis of the jaw generally (“bronj”), and on the opinion or otherwise if: liability law requires only that a plaintiff show that the anderson v. liberty lobby, inc., 477 u.s. 242, 252 (1986). differentialdiagnosis, aswellashis examinationofmessick’s a strong association between monthly iv bisphosphonate for rejecting alternative hypotheses using scientific methods of bronj sets out its unique features: it lasts more than eight (c) the testimony is the product of reliable 2014) (alteration and omission in original) (quoting united epidemiologic studies have established a firm foundation for link between plaintiff’s bisphosphonate treatment and her and publication; (3) the known or potential error rate of the defendant-appellee. labarraque, 101 f.3d 129, 140 (d.c. cir. 1996) (describing don’t know precisely how the damage occurred, if there is expert testimony could not “determine in a patient who has multiple risk (2) exposed bone in the maxillofacial region that has lasted messick v. novartis pharmaceuticals corp.2 relationship between bisphosphonate exposure and necrosis used to treat multiple myeloma. such drugs are used to opinion compromised immunity, and trauma. while onj may be be tested; (2) whether it has been subjected to peer review conclude that the subject of scientific testimony must be threshold requires that the expert’s testimony have “a reliable be founded on more than subjective beliefs or unsupported condition in order for his or her testimony to be reliable. it is therapy and the development of bronj.” of a differential diagnosis, the “expert must provide reasons district court applied too high a relevancy bar without causationconclusions, whichitselfpersuasivelyusesthethree discoveredosteonecrosis nearthreeof her teeth. both doctors development of osteonecrosis of the jaw. university of the pacific’s school of dentistry in 1974, discipline.” kumho tire co., ltd. v. carmichael, 526 u.s. dr. jackson’s testimony should be admitted as relevant own extensive clinical experience as the basis for his while the action was pending in multi-district litigation 509 u.s. at 592–93. (requiring explanations based on “scientifically valid messick v. novartis pharmaceuticals corp.8 messick v. novartis pharmaceuticals corp. 5 1314). viewed in this context, it is perhaps unsurprising that r. civ. p. 56(a). a court must view the evidence in the light enough that a medical condition be a substantial causative linda messick, court erred by excluding the causation testimony offered by shows “there is no genuine dispute as to any material fact and (10th cir. 2003); cooper v. smith & nephew, inc., 259 f.3d completed his oral and maxillofacial surgery residency in including onj in patients who had been treated with fact regarding the specific causal link between messick’s elements to distinguish bronj from other onj or delayed summary* causing [the onj].” such an unduly exacting standard goes the relevancy bar is low, demanding only that the judgment entirely on the fact that messick had no expert implied warranty, and loss of consortium. bisphosphonates, and he is the primary oral and maxillofacial reference to california law. while dr. jackson never principles and methods to the facts of the osteomyelitis, corticosteroid use, cancer, radiation therapy, pharm., inc., 509 u.s. 579, 588 (1993), it requires that causation testimony once all of her experts had been for the ninth circuit messick v. novartis pharmaceuticals corp. 11 testimony, including: (1) whether a theory or technique can must determine “whether the reasoning or methodology manufacture, negligent failure to warn, breach of express and opinion beyond the district court’s proper gatekeeping role. 1230–31. while the district court must act as a gatekeeper to johnson v. arkema, inc., 685 f.3d 452, 467–68 (5th cir. 2012). substantial factor in her development of bronj, so the d.c. no. messick v. novartis pharmaceuticals corp.12 1043–44 (2d cir. 1995); in re paoli r.r. yard pcd litig., indicatesthatmessick’s bisphosphonate use wasasubstantial messick appeals the exclusion of dr. jackson’s causation evidence 702(a) includes within its scope all evidence that to support her claims, messick offered dr. jackson’s we and our sister circuits have held that a reliable literature can certainly aid the trier of fact and cannot be exclude “junk science” under daubert, federal rule of weeks and is not related to radiation therapy. messick’s counsel genuine issue of material fact regarding the specific causal without cancer or exposure to radiation in the mouth area district court improperly excluded expert testimony. osteonecrosis of the jaw and bisphosphonate-related scientific basis for his opinions, and the district court abused against novartis for strict products liability, negligent particularly susceptible. novartis pharmaceuticals science.” daubert, 509 u.s. at 590. factor in causing the injury in order to prove specific jackson’s testimony to be unreliable. the reliability surgeon managing onj in the sacramento area. 598 f.3d 558, 563 (9th cir. 2010), but review de novo the aaoms, a bronj diagnosis is appropriate for patients with which the jury could reasonably find for the plaintiff,” testimony was reliable where dr. jackson testified a medical (1) current or previous treatment with bisphosphonates, a condition recognized by the american association of oral 916 f.2d 829, 862 (3d cir. 1990).1 years after diagnosis. she and her husband brought suit the movant is entitled to judgment as a matter of law.” fed. causation); mccullock v. h.b. fuller co., 61 f.3d 1038, united states court of appeals the jaw (“onj”) may include: peridontal and dental disease, technique of identifying the cause of a medical problem”); here, the district court based its grant of summary and morgan christen, circuit judges. we review a ruling on the admissibility of expert although experts must provide scientifically sound been prepared by court staff for the convenience of the reader. “[e]xpert opinion testimony is relevant if the knowledge the panel reversed the district court’s summaryjudgment susan illston, senior district judge, presiding and reliable. remaining issues regarding the correctness of because dr. jackson “never explained the scientific basis for ‘known’ to a certainty; arguably, there are no certainties in summary judgment is proper when the moving party differential diagnosis, although it suggested in a recent case that a 339 f.3d 1049, 1057 (9th cir. 2003); see also ervin v. equated messick’s use of bisphosphonates leading to bronj this summary constitutes no part of the opinion of the court. it has lectured on a variety of topics over many years. dr. jackson maxillofacial professional groups, and has published and bronj healedbetweenmarchandoctober2008,aboutthree reverse the district court’s grant of summary judgment. aaoms definition of bronj in reaching his diagnosis and testimony for an abuse of discretion, primiano v. cook,


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