Opinion
3:20-cv-01452-AR
03-19-2024
BERENICE CAROL GLOVER, Personal Representative for the Estate of Frank Wayne Glover, Plaintiff, v. AVANOS MEDICAL, INC., doing business as Halyard Health, Inc., a Delaware Corporation, Defendant.
FINDINGS AND RECOMMENDATION
JEFF ARMISTEAD, UNITED STATES MAGISTRATE JUDGE
Plaintiff Berenice Carol Glover, representing herself, is the widow of Frank Wayne Glover (Wayne) and his estate's personal representative. Plaintiff brings this products liability action against defendant Avanos Medical, Inc., contending that a gastrostomy tube it manufactured was defective and caused Wayne's death. Around September 21, 2016, plaintiff became concerned that the gastrostomy tube that Wayne depended on for nutrition was malfunctioning because fluids were not passing into his stomach, fluids were leaking around the tube site, and the skin around the site was becoming ulcerated. Wayne was brought by ambulance to Oregon Health & Science University (OHSU) hospital emergency department, and plaintiff asked OHSU physicians to remove, reposition, or replace the gastrostomy tube. Plaintiff asserts that OHSU refused to do so, and that she had Wayne transferred to another hospital where the gastrostomy tube was removed and replaced with a nasojejunal feeding tube. Approximately two months later, Wayne died of intra-abdominal sepsis and a perforated ulcer. This lawsuit followed.
A gastrostomy tube is a thin flexible tube inserted through the wall of the abdomen directly into the stomach and is used to deliver liquid food and medicine; it may also be referred to as a percutaneous endoscopic gastrostomy (PEG) tube. Gastrostomy Tube, https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastrostomy-tube (last visited Feb. 8, 2024).
A nasojejunal feeding tube also is used to deliver liquid food and medicine, except that it is inserted through the nose, goes down the throat, through the stomach, and ends in the jejunum, a part of the small intestine. Nasojejunal Tube Feeding, https://www.cincinnatichildrens.org/health/n/nasojejunal-kangaroo (last visited Feb. 8, 2024).
Avanos now moves to exclude the testimony of plaintiff's expert witness, T. Kim Parnell, Ph.D., P.E., under Federal Rule of Evidence 702, and moves for summary judgment under Federal Rule of Civil Procedure 56. Plaintiff has responded to those motions and requests that the court hold a Daubert hearing to evaluate the admissibility of Parnell's report. As explained below, Avanos's Rule 702 and summary judgment motions should be GRANTED, plaintiff's motion for a Daubert hearing is DENIED, and the remaining motions should be DENIED AS MOOT.
Plaintiff objects to Avanos's request for oral argument because it would give Avanos an unfair advantage and asks that any oral argument on the pending motions be conducted telephonically. (Pl.'s Opp'n Mot. Summ. J. at 2, ECF No. 57.) The court determines that oral argument would not be helpful to resolution of the issues and the parties' requests are DENIED. LOCAL RULE 7-1(d). In her opposition to Avanos's summary judgment motion, plaintiff also objects to the court's pro hac vice admission of attorney Peter J. Strelitz for Avanos because she did not receive notice and he is from out of state. (Pl.'s Opp'n Mot. Summ. J. at 1-2.) Plaintiff's objection is OVERRULED. Strelitz satisfied this court's requirements for pro hac vice admission and her advance notice and permission was not required. (See ECF Nos. 47-49.)
FACTUAL AND PROCEDURAL BACKGROUND
In 1985, Wayne had several chronic, long-term medical conditions, including chronic obstructive pulmonary disease (COPD), and an anoxic brain injury that left him in a persistent vegetative state, noncommunicative, and with no central nervous system external function. He relied on a tracheostomy to breathe and a gastrostomy tube for nutrition. Wayne's longstanding conditions required that his nutrition be supplied through a gastrostomy tube for many years before his death. (Pelky Decl. Ex. 1, Martindale Dep. 13:3-16, 22:10-18, 61:1-4, ECF No. 54-1.)
The events that gave rise to this lawsuit took place in 2016. From August 5 to September 8, Wayne was treated at OHSU for “mixed hypoxic/hypercarbic respiratory failure” with chronic ventilator dependence. Around September 7, Wayne's gastrostomy tube was confirmed to be functioning properly by x-ray. (Pelkey Decl. Ex. 3 at 2, 6, ECF No 54-3.) Approximately two weeks later, on September 20, Wayne was brought to the OHSU emergency department by ambulance because plaintiff was concerned that fluids were leaking around the tube site, that the opening around the tube was enlarging, and that Wayne was unable to tolerate tube feedings for 24 hours. OHSU emergency room physicians replaced the existing gastrostomy tube (a 22 French-sized Halyard gastrostomy feeding tube manufactured by Avanos) with a different tube. They also confirmed by x-ray that fluids were not “free-leaking” into the stomach cavity and that the new feeding tube had good placement. Wayne was cleared for discharge on September 20 by Robert Martindale, M.D., one of Wayne's treating physicians, because Wayne's abdomen was “okay” from a surgical standpoint. (Pelkey Decl. Ex. 1 (Martindale Dep. 42:14-20, 43:21-44:8, 45:21-25, 46:2-10, 49:1-6), ECF No. 54-1; Pelkey Decl. Ex. 3 at 2, 6, ECF No. 54-3.)
The next day, September 21, Wayne again was brought by ambulance to the OHSU emergency department because fluids were not passing through to his stomach and “bodily fluids such as gastric juices” were pooling around the feeding tube site. Plaintiff asked that the gastrostomy tube be removed and repositioned. After waiting in the OHSU emergency department for several hours, plaintiff had Wayne transferred to a different hospital where the gastrostomy tube was removed and replaced with a nasojejunal feeding tube. Wayne was at Legacy Emmanuel Hospital from September 22 through October 24, when he was discharged and returned home. (Notice of Removal Ex. 2 ¶¶ 20-22 (attaching Complaint), ECF No. 1.) On November 23, Wayne died of intra-abdominal sepsis and a perforated ulcer, conditions that began three weeks before his death. (Pelkey Decl. Ex. 2 (attaching official death certificate), ECF No. 54-2.)
Plaintiff was represented by counsel when her complaint was filed, but counsel withdrew from representation when the matter was removed to federal court. This court appointed replacement counsel, who also later withdrew. (ECF Nos. 13, 26.) Although plaintiff's complaint is not verified as provided in 28 U.S.C. § 1746, the court recites some facts from the complaint so that it may view the facts in the light most beneficial to her as the nonmoving party.
On November 25, 2019, plaintiff filed this lawsuit in Multnomah County Circuit Court asserting one claim for product liability for a manufacturing defect against Avanos (Claim 1), and another claim for medical negligence against OHSU and twelve physicians employed by OHSU (Claim 2). Claim 2 against OSHU and its physicians was dismissed in July 2020. Avanos then transferred (removed) the lawsuit, with Claim 1 remaining, to this court. (Notice of Removal, Exs. 2, 4, ECF No. 1.)
Avanos has not objected to plaintiff continuing to pursue this action on behalf of Wayne's estate despite being self-represented and the court presumes that because no objections have been filed, there are no other beneficiaries to Wayne's estate whose interest conflicts with plaintiff's. See Simon v. Harford Life, Inc., 546 F.3d 661, 664 (9th Cir. 2008) (stating that right to represent oneself in federal court is personal to the litigant and does not extend to other parties or entities); Jones v. Corr. Med. Servs., 401 F.3d 950, 951-52 (8th Cir. 2005) (holding selfrepresented administrator of decedent's estate could not proceed pro se on behalf of estate where other beneficiaries or creditors existed). Therefore, the court resolves the pending motions on the merits.
Avanos now moves to exclude Parnell's expert report under Federal Rule of Evidence 702 and for summary judgment under Federal Rule of Civil Procedure Rule 56. The court addresses the evidentiary motion first, then the summary judgment motion.
RULE 702 MOTION
Under Rule 702, the district court applies its gatekeeping function as instructed by Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), to determine the admissibility of expert witness testimony. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 141, 147 (1999); Elosu v. Middlefork Ranch Inc., 26 F.4th 1017, 1023 (9th Cir. 2022). “[T]he trial court must assure that the expert testimony ‘both rests on a reliable foundation and is relevant to the task at hand.'” Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. 2010) (quoting Daubert, 509 U.S. at 597); see also Daubert v. Merrell Dow Pharms., Inc. (Daubert II), 43 F.3d 1311, 1313 (9th Cir. 1995).
Rule 702 provides that expert opinion evidence is admissible if (1) the witness is sufficiently qualified as an expert by knowledge, skill, experience, training, or education; (2) the expert's specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (3) the testimony is based on sufficient facts or data; (4) the testimony is the product of reliable principles and methods; and (5) the expert's opinion has reliably applied those principles and methods to the facts of the case. FED. R. EVID. 702; Elosu, 26 F.4th at 1024.
The proponent of expert testimony has the burden of showing, by a preponderance of the evidence, that the proposed testimony is admissible under Rule 702. See Cooper v. Brown, 510 F.3d 870, 942 (9th Cir. 2007). In evaluating proffered expert testimony, the trial court is “a gatekeeper, not a fact finder.” Primiano, 598 F.3d at 565. The inquiry into the admissibility of an expert opinion is a “flexible one,” where “[s]haky but admissible evidence is to be attacked by cross examination, contrary evidence, and attention to the burden of proof, not exclusion.” Id. at 564.
Plaintiff offers expert testimony from T. Kim Parnell, Ph.D., P.E., to establish that Avanos's feeding tube was defective, unreasonably dangerous, and caused Wayne's death. Parnell has degrees from Stanford and Georgia Tech universities in Mechanical Engineering. He is a Registered Professional Mechanical Engineer in California, is a member of various professional organizations, has been a consultant for more than 30 years, and is an experienced expert witness on cases involving “design, regulatory, and failure/reliability issues of a variety of medical devices, medical equipment, medical instrumentation, consumer products, and other devices[.]” (Pelkey Decl. Ex. 4 at 1, ECF No. 54-4 at 2.) Parnell's curriculum vitae lists numerous publications, presentations, and cases for which he has provided litigation support and expert testimony. (Id. Ex. 6, ECF No. 54-6.)
Turning to Parnell's export report challenged by Avanos, it is best described as anemic in its conclusions and the bases for those conclusions. Ten pages in length, it includes one page describing Parnell's background and experience; one page discussing his visual inspection of the explanted feeding tube (the tube removed from Wayne) and exemplar tube with an illustration of a properly placed gastrostomy tube; seven pages of photographs of the explanted tube and exemplar; and a signature page. (Pelkey Decl. Ex. 4, ECF No. 54-4.) To prepare his report, Parnell looked at Wayne's explanted Halyard 22 French-sized feeding tube and two new Avanos exemplar feeding tubes in sizes 20 and 18 French. He examined the explanted feeding tube under a microscope with 10-times magnification, which revealed, in Parnell's view, “an initial failure along an axial line in the cuff.” His report states that the “failure would be driven by the primary hoop stress in the cuff during inflation” and that “this type of failure is indicative of a weakness or defect in the wall of the balloon cuff from manufacture.” Based on his inspection, Parnell concluded to a “reasonable degree of scientific and engineering certainty” the following:
In my opinion, this defect in the balloon was the cause of the balloon cuff failure and the loss of the seal against the stomach wall for [Wayne]. The loss of the seal caused leakage of stomach contents and erosion and damage of the tissue surrounding the stoma. This damage and associated injury ultimately led to the death of [Wayne] on November 23, 2016.(Id. at 2.)
Parnell's threadbare conclusions did not fare any better when he was deposed by Avanos. On several occasions, Parnell stated that he did not review any records relating to the design specifications for Wayne's explanted feeding tube, did not review design specifications for feeding tubes generally, and that he has no experience with the design of feeding tubes. (Pelkey Decl. Ex. 5, Parnell Dep. at 24:2-7, 36:1-5, 45:4-7.) Parnell further acknowledged that he did not undertake any studies or testing to determine what causes balloons in feeding tubes to rupture in general, and that he did not test Wayne's explanted feeding tube or test the provided exemplars. (Id. at 36:6-11, 45:4-11.) And he agreed that he conducted no research and did not rely on any studies or literature when formulating his opinion. (Id. at 50:12-23.) Although Parnell testified that he relied on his education and experience to form his opinion, he admitted that he has no prior experience investigating the design or testing of gastrointestinal (GI) feeding tubes. (Id. at 26:5-15, 45:4-11.)
During his deposition, Parnell opined that the balloon in Wayne's feeding tube ruptured because of a manufacturing defect:
I think the most likely part is a manufacturing related defect either in the material specification, or in a physical defect associated with packaging, or something of that sort where there is a small physical defect in the balloon.(Id. at 38:9-13.) Later in the deposition, Parnell explained:
[T]he primary stress in the balloon is the hoop stress or circumferential stress, that's what drives a crack or defect that drives it in the axial direction, which is parallel to the axis of the tube. And if that's occurring under nominal inflation conditions, that it's not demonstrating any type of factor of safety in the tube against having a sufficiently high pressure, that it's occurring at . . . a nominal inflation condition, and if that occurs, I think that's associated with some type of either weakness of the tube material, inadequate strength, below what's anticipated or - and/or some type of physical defect[.](Id. at 48:11-25.) When asked if feeding tube balloons could rupture in scenarios unrelated to a manufacturing defect, including overfilling, Parnell conceded that they could. (Id. at 40:10-19.) He also acknowledged that he was not aware of any scientific studies showing that a manufacturing defect in a GI feeding tube can be assessed visually. (Id. at 65:14-19 (admitting that the exact causation of a balloon burst “cannot be determined with a visual inspection”). The sum total of the methodology used by Parnell to form his opinion concerning a manufacturing defect was his “visual inspection, visual observation, and my engineering and consulting experience.” (Id. at 50:17-51:3.)
Parnell further conceded that he was not qualified to offer an opinion on medical causation, stating the following:
Q. And you don't have any medical expertise; correct?
A. Correct.
Q. You haven't reviewed any medical records which discuss the leakage of any fluid or what type of damage or injury that might have caused; correct?
A. Correct.
Q. You would agree with me that you're not qualified as an expert to discuss any type of medical injury to Mr. Glover; correct?
A. Correct.
Q. And you also agree with me that you're not qualified as an expert to opine on the cause of death of Mr. Glover; correct?
A. Correct.(Id. at 43:10-24.)
Avanos moves to exclude his report because: (1) his opinion that the feeding tube was defective is not reliable; and (2) he is not qualified to offer an opinion on causation. (Def.'s Rule 702 Mot. at 2-3, ECF No. 50.) The court agrees with Avanos on both grounds.
Plaintiff's argument that Avanos is estopped from challenging Parnell's testimony is misplaced. (Pl.'s Opp'n Mot. Summ. J. at 6-7.) As permitted by the Federal Rules of Civil Procedure and the Federal Rules of Evidence, a party may depose an opposing party's expert and may seek to exclude that testimony on summary judgment on certain grounds, including those raised by Avanos here. FED. R. CIV. P. 26(a)(2), 30, 56(c)(4); FED. R. EVID. 702, 703. Plaintiff's motion requesting that the court conduct a Daubert hearing on Parnell's report is DENIED. Although the court has the option to hold Daubert hearing, it is not required or obligated to do so. United States v. Holguin, 51 F.4th 841, 851 (9th Cir. 2022) (“We have consistently held that Daubert hearings are not required.”). Because the court can readily conclude that Parnell's opinion concerning a defect is not reliable and that he is not qualified to offer an opinion on causation, a Daubert hearing is unnecessary here.
Reliability. As noted, expert opinion evidence is admissible under Rule 702 if, among other things, it is “the product of reliable principles and methods” and “reflects a reliable application of the principles and methods to the facts of the case.” FED. R. EVID. 702(c)-(d). “To evaluate reliability, the district court ‘must assess the expert's reasoning or methodology, using as appropriate criteria such as testability, publication in peer-reviewed literature, known or potential error rate, and general acceptance.'” Elosu, 26 F.4th at 1024 (quoting City of Pomona v.SQM N. Am. Corp., 750 F.3d 1036, 1044 (9th Cir. 2014)). Those factors, however, are not a “definitive checklist or test,” and the court has “considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable.” Kumho Tire, 526 U.S. at 152. In conducting its reliability assessment, the court has discretion to determine what Daubert factors, if any, are relevant and applicable. United States v. Valencia-Lopez, 971 F.3d 891, 898 (9th Cir. 2020); Elosu, 26 F.4th at 1024 (stating trial court has discretion “to decide how to test an expert's reliability based on the particular circumstances of the particular case” (simplified)). “[T]he party presenting the expert must show that the expert's findings are based on sound science, and this will require some objective, independent validation of the expert's methodology.” Daubert II, 43 F.3d at 1316.
Parnell's methodology in reaching his opinion that the explanted Avanos feeding tube was defective is lacking and can best be described as questionable. As Avanos argues, Parnell conducted no testing of the explanted feeding tube, the exemplar feeding tubes, or other any other feeding tubes to reach his opinion. Additionally, Parnell did not assert in his report, or state during his deposition, that his theory that a manufacturing defect may be determined visually has been peer-reviewed, and there is no evidence in the record supporting a known rate of error or general acceptance in the scientific community. Thus, none of the Daubert factors support a finding of reliability here.
Plaintiff points to no other indicia of reliability. Parnell has not conducted research “independent of the litigation” and his opinion was plainly developed for purposes of testifying. Daubert II, 43 F.3d at 1317. Additionally, Parnell's deposition testimony expressly rejected any reliance on other reliable objective sources, such as a treatise, a policy statement, or published articles, to show that he followed a scientific method “as it is practiced by (at least) a recognized minority of scientists in their field.” Id. at 1319. Aside from his “visual inspection,” Parnell's report does not appear to rely on any scientific data, information, or replicable methodology that he applied to the facts of this case to reach his conclusion. See Walker v. Conagra Brands, Inc., Case No. 8:20-cv-01679-FWS-KES, 2023 WL 8885148, at *8-9 (C.D. Cal. Sept. 21, 2023) (excluding some of expert's opinions on product safety and design as unreliable because expert did not identify data or methodology in reaching conclusion that the subject cans were defective); see also Grodzitsky v. Am. Honda Motor Co., 957 F.3d 979, 985-87 (9th Cir. 2020) (holding expert testimony unreliable in class action where there was no correlation between expert's vibration testing and failure of window regulators, and his opinion was not predicated on reliable scientific methodology); Beaty v. Ford Motor Co., Case No. C17-5201 TSZ, 2021 WL 3109661, at *7-8 (W.D. Wash. July 22, 2021), amended by 2023 WL 1879534, at *4 (Feb. 10, 2023) (determining Dr. Read's opinion that panoramic glass sunroof was defective was unreliable because he cited no industry standards, peer-reviewed literature, or other authority to support view that vehicles suffered common defect).
Furthermore, Parnell's own testimony renders his visual inspection methodology suspect. Despite basing his opinion that the tube was defective solely on his visual examination, he later admitted that the exact cause of a balloon rupture “cannot be determined with a visual inspection.” (Parnell Dep. 65:14-19). See Kumho Tire, 529 U.S. at 155 (excluding expert opinion where “the expert seemed to deny the sufficiency of his own simple visual-inspection methodology”).
Lastly, Parnell testified that he did not attempt to rule out other causes for the balloon rupture, such as user error, product age, or environment. Instead he said that “I felt that other causes of that sort were less likely. . . . I tried to provide an opinion that I felt was supported by - to a reasonable degree of engineering scientific certainty.” (Pelky Decl. Ex. 5 (Parnell Dep. 51:25-52:8.) See Kumho Tire, 526 U.S. at 153-54 (excluding opinion that tire was defective in part because expert had not reliably ruled out abuse as potential cause of tire's failure); Walsh v. LG Chem Am., Case No. CV-18-01545-PHX-SPL, 2021 WL 4859990, at *5-6 (D. Ariz. Oct. 19, 2021) (excluding expert report as unreliable because he did not exclude any other potential causes for battery short-circuiting).
Parnell also admitted that he was informed by plaintiff that the explanted feeding tube had been in place for “like one day,” as opposed to two weeks. (Parnell Dep. 46:14-25.) And he admitted that his understanding that the tube had been in place for 24 hours at the time it ruptured was “a factor certainly” in reaching his opinion that the tube was defective. (Id. 49:1318.) It appears that Parnell made no attempt to apply his theory to the facts of this case.
In sum, Parnell has not employed any reliable methodology to support his opinion that Avanos's explanted feeding tube suffered a manufacturing defect, and his expert report is excluded under Rule 702, Daubert, and its progeny. Kumho Tire, 526 U.S. at 156-57; Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997) (observing that courts should not admit an expert opinion supported only by “the ipse dixit of the expert”); Daubert II, 43 F.3d at 1315-16 (“Something doesn't become scientific knowledge just because it's uttered by a scientist.” (simplified)).
Not Qualified on Causation. As Avanos argues, Parnell is not qualified to offer an opinion on the cause of Wayne's death because he has no medical training and he admitted in his deposition that he was not qualified to opine on medical injuries and medical causation. See Thomsen v. NaphCare, Inc., Case No. 3:19-cv-00969-AR, 2023 WL 8701971, at *11 (D. Or. Dec. 15, 2023) (holding that expert with no medical training was unqualified to offer opinion about cause of death), adopted in relevant part by 2024 WL 551426 (Feb. 12, 2024); Garcia v. County of Riverside, Case No. CV 5:18-00839 SJO (ASx), 2019 WL 4282908, at *13 (C.D. Cal. June 7, 1989) (same); accord Doe v. Cutter Biological, Inc., 971 F.2d 375, 385 (9th Cir. 1992) (“Ordinarily, courts impose no requirement that an expert be a specialist in a given field, although there may be a requirement that he or she be of a certain profession, such as a doctor.”). Parnell's report is excluded concerning Wayne's medical condition and injuries, his deterioration, and cause of death.
For all these reasons, Avanos's Rule 702 Motion is GRANTED.
SUMMARY JUDGMENT
Summary judgment is appropriate when “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” FED. R. CIV. P. 56(a). A party seeking summary judgment bears the burden of establishing the absence of a genuine issue of material fact. Celotex v. Catrett, 477 U.S. 317, 323 (1986). If the moving party demonstrates that no issue of material fact exists, the nonmoving party must go beyond the pleadings and identify facts which show a genuine issue for trial. Id. at 324. A party cannot defeat a summary judgment motion by relying on the allegations set forth in the complaint, on unsupported conjecture, or on conclusory statements. Hernandez v. Spacelabs Med., Inc., 343 F.3d 1107, 1112 (9th Cir. 2003). Summary judgment thus should be entered against “a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial.” Celotex, 477 U.S. at 322.
In determining whether to grant summary judgment, the court must view the evidence in the light most favorable to the nonmoving party. Curley v. City of N. Las Vegas, 772 F.3d 629, 631 (9th Cir. 2014); Hernandez, 343 F.3d at 1112. All reasonable doubt as to the existence of a genuine issue of fact should be resolved against the moving party. Hector v. Wiens, 533 F.2d 429, 432 (9th Cir. 1976). But deference to the nonmoving party has limits. The nonmoving party must set forth “specific facts showing a genuine issue for trial.” FED. R. CIV. P. 56(e). The “mere existence of a scintilla of evidence in support of the plaintiff's position [is] insufficient.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986). Therefore, where “the record taken as a whole could not lead a rational trier of fact to find for the nonmoving party, there is no genuine issue for trial.” Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (internal quotation marks omitted). Although courts must construe liberally the pleadings of self-represented litigants, “an ordinary pro se litigant, like other litigants, must comply strictly with the summary judgment rules.” Thomas v. Ponder, 611 F.3d 1144, 1150 (9th Cir. 2010) (citation omitted).
DISCUSSION
The court begins its analysis with a preliminary argument raised by plaintiff. She contends that Avanos has mischaracterized her two claims for defective product and negligence as a single claim for “strict liability.” (Pl.'s Opp'n at 3-4, 7; Pl.'s Supp. Opp'n at 5, 7-8, ECF No. 59.) Contrary to plaintiff's suggestion, she has only a single claim against Avanos. As noted above, Claim 2 - a negligence claim against OHSU and its doctors - was dismissed before this lawsuit was removed to federal court. (See Notice of Removal, Exs. 2, 4.) Consequently, only Claim 1 remains pending in this lawsuit.
Next, under Oregon law, plaintiff may pursue a product liability action for a manufacturing defect under a strict liability theory or a negligence theory; each theory has different legal standards. See ORS § 30.920(4) (“Nothing in this section shall be construed to limit the rights and liabilities of sellers and lessors under the principles of negligence or under ORS chapter 72.”). Courts within this district have permitted plaintiffs to pursue multiple theories of potential recovery when they allege product liability claims. See, e.g., Smith v. Ethicon Inc., Case No. 3:20-cv-00851-AC, 2021 WL 3578681, at *3-4 (D. Or. May 13, 2021) (discussing that claims for negligence, fraud, and breach of express and implied warranty were not duplicative of product liability claims), adopted 2021 WL 3575099 (Aug. 12, 2021). Manufacturing defect claims under a strict liability theory are governed by statute, ORS §§ 30.900 et seq., and manufacturing defect claims under a negligence theory are governed by common-law principles.
Avanos has interpreted Claim 1 as asserting a manufacturing defect claim under a strict liability theory. In her responsive materials, plaintiff denies that she is pursuing a “strict liability” theory. However, plaintiff does not clarify that she is advancing a negligence theory; rightfully so. Her complaint contains no allegations against Avanos hinting at a negligence theory. In Claim 1, plaintiff alleges that the “feeding tube which was put in [Wayne's] abdomen and was defective and unreasonably dangerous beyond the extent contemplated by ordinary users” because it “contained a manufacturing defect which prevented it from functioning in the way it was designed,” “did not have an indication as to whether it was functioning built in to its design,” and that because of its defective condition, it “caused or was a substantial factor in [Wayne's] death.” (Compl ¶¶ 24-25.) After carefully reviewing those allegations, combined with the absence of allegations sounding in negligence - duty, breach, or foreseeability - the court agrees with Avanos that Claim 1 is asserted under a strict product liability theory.
Plaintiff explicitly disavows a strict liability theory. (Pl's Supp. Opp'n at 4 (“[N]owhere do I find ‘strict liability' nor any form of that term in [the complaint].... I have not ‘alleged' any such thing in my Complaint....The court should either disregard or strike every ‘strict liability' reference of any kind from the Motion before arriving at its final decision in this matter.”).) Plaintiff's complaint also makes no mention of a breach of warranty theory.
To establish products liability negligence under Oregon law, “a plaintiff must show that the defendant owed the plaintiff a duty, that the duty was breached, and that the breach caused the plaintiff harm.” Imhoff v. Ethicon, Inc., Case No. 3:20-cv-00380-AR, 2022 WL 4239171, at *4 (D. Or. July 15, 2022) (simplified), adopted, 2022 WL 4237145 (Sept. 14, 2022). And “[w]hen a defendant's negligence is a factual cause of harm to the plaintiff, the defendant is subject to liability to the plaintiff as long as the harm that the plaintiff suffered was a reasonably foreseeable result of the defendant's negligence.” Lasley v. Combined Transp., Inc., 351 Or. 1, 7 (2011).
Oregon law imposes strict liability on a manufacturer for injuries caused by its product if the product is both defective and unreasonably dangerous. McCathern v. Toyota Motor Corp., 332 Or. 59, 77 (2001). Through ORS § 30.920, Oregon law imposes “liability for physical harm” upon any person or entity that “sells or leases any product in a defective condition” that is “unreasonably dangerous to the user or consumer” and if the product reaches “the user or consumer without substantial change in the condition in which it is sold or leased.” ORS § 30.920(1). Dangerous products generally result from either a manufacturing defect or a design defect. See Harris v. Nw. Nat. Gas Co., 284 Or. 571, 576 (1978) (“Unreasonably dangerous defects in products come from two principal sources: (1) mismanufacture and (2) faulty design, including failure to warn as a design defect.”).
Oregon has codified the “consumer expectations” test for determining when a product is defective. McCathern, 332 Or. at 77-79 (citing ORS § 30.920 and RESTATEMENT (SECOND) OF TORTS § 402A, cmts. a to m). This test requires a plaintiff to prove that “when the product left the defendant's hands, the product was defective and dangerous to an extent beyond that which the ordinary consumer would have expected.” McCathern, 322 Or. at 79. Although the extent of a product's dangerousness is ordinarily a factual question to be determined by the jury, the trial court must still “ensure that the evidence is sufficient for the jury to make an informed decision about what ordinary consumers expect.” Id. at 77. Because ORS § 30.910 creates a rebuttable presumption that products are not defective, “a plaintiff may not rely on the bare assertion of a defect from which a jury may infer unreasonable dangerousness; rather, a party must affirmatively put forth some evidence on the issue of dangerousness before the issue may properly be submitted to a jury.” Russell v. Deere & Co., 186 Or.App. 78, 83 (2003).
“[I]n some cases, consumer expectations about how a product should perform under certain conditions will be within jurors' common experience.” McCathern, 322 Or. at 78. In other contexts, the products or factual circumstances may be beyond average jurors' expectations. In such situations, “additional evidence about the ordinary consumer's expectation is necessary.” Id.
Additionally, plaintiff must show causation. McEwen v. Ortho Pharm. Corp., 270 Or. 375, 407 (1974). When the issue of causation involves a complex medical question, a plaintiff must present expert testimony showing that there is a reasonable medical probability that the injuries were caused by the defendant. See Cleland v. Wilcox, 273 Or. 883, 887 (1975) (“Where injuries complained of are of such character as to require skilled and professional persons to determine the cause and extent thereof, the question is one of science and must necessarily be determined by testimony of skilled, professional persons.” (simplified)). “Th[is] rule prevents jurors from speculating about causation in cases where that determination requires expertise beyond the knowledge and experience of an ordinary lay person.” Baughman v. Pina, 200 Or.App. 15, 18 (2005) (citing Howerton v. Pfaff, 246 Or. 341, 347-48 (1967)).
The court has excluded Parnell's expert report and plaintiff's remaining evidence proffered to support her manufacturing defect claim rests on her subjective beliefs. Absent Parnell's report, she provides no affirmative evidence supporting her contention that the explanted tube was defective. She also presents no evidence on consumer expectations. Concerning causation, plaintiff states that Wayne did not have sepsis “on any visit in any hospital” and that he did not have sepsis on November 4, 2016. (Pl's Supp. Opp'n at 9-11, ECF No. 59.) The court understands plaintiff to be challenging Wayne's cause of death (intraabdominal sepsis and perforated ulcer) which began three weeks before, and suggesting instead that he died due to complications from Avanos's gastrostomy tube placed while he was at OHSU. Plaintiff's evidence is not sufficient here. Because Wayne suffered from several chronic, complex medical conditions, she is required to show causation through expert testimony. Cleland, 273 Or. 887-88; see also Smith v. Ethicon, Case No. 3:20-cv-00851-MO, 2022 WL 1909019, at *1 (D. Or. June 2, 2022) (discussing Oregon's causation standards in medical device product liability case). The court has excluded Parnell's report because he is not qualified to offer such an opinion, and plaintiff's subjective beliefs about Wayne's cause of death do not create an issue of fact on causation. SeeTeater v. Pfizer, Inc., No. 3:05-cv-00604-HU, 2013 WL 2455995, at *6 (D. Or. June 6, 2013) (granting defendant's motion for summary judgment on strict liability claim where plaintiff failed to provide expert testimony on medical causation).
In short, because plaintiff has not presented sufficient evidence to create an issue of fact on any element of her product liability claim, Avanos's motion for summary judgment should be GRANTED.
CONCLUSION
For the above reasons, Avanos's Rule 702 Motion (ECF No. 50) is GRANTED, Avanos's Motion for Summary Judgment (ECF No. 49) should be GRANTED, and plaintiff's Motion in Limine for a Daubert hearing (ECF No. 64) is DENIED. Any remaining pending motions should be denied as MOOT.
SCHEDULING ORDER
The Findings and Recommendation will be referred to a district judge. Objections, if any, are due within 14 days. If no objections are filed, the Findings and Recommendation will go under advisement on that date. If objections are filed, a response is due within 14 days. When the response is due or filed, whichever date is earlier, the Findings and Recommendation will go under advisement.