C. A. PC-2018-8437
For Plaintiffs: Jonathan D. Orent, Esq. For Defendants: Stephen M. Prignano, Esq.
Jonathan D. Orent, Esq.
Stephen M. Prignano, Esq.
Facts and Travel
Paul Trevino's (Plaintiff) case is the fourth bellwether case selected for trial from thousands of cases in this master docket litigation involving injuries alleged to have been caused by hernia mesh products manufactured by the Defendants Davol Inc. and C.R. Bard Inc. (collectively Bard).
The first case was continued and the other two settled prior to trial.
Plaintiff has a lengthy medical history. In the early 1990s, following a significant abdominal injury, Plaintiff had an exploratory laparotomy (i.e., a large open incision in his abdomen) from his mid-chest to his belt line. During the procedure, his pancreas was found cut in half and his spleen lacerated. Years after the open laparotomy, Plaintiff developed an incarcerated hernia along the midline incision site from the prior surgery. In 2007, Plaintiff underwent a primary repair of that hernia without mesh. By 2008, that primary repair failed.
On December 24, 2008, Plaintiff Trevino underwent a ventral hernia repair at Kona Community Hospital located in Kealakekua, Hawaii. The repair was performed by Dr. Andrew Fedder, M.D., a general surgeon. Dr. Fedder implanted into Mr. Trevino a medium-sized, Ventralex Hernia Patch manufactured and distributed by Bard. The Ventralex was first cleared by the U.S. Food and Drug Administration (FDA) in 2002 and had been used extensively over the past seventeen years. See Bard's Mot. at 1. At the time, Dr. Fedder regarded the repair as "successful" and, for a period of roughly seven and a half years following the Ventralex hernia repair, Plaintiff did not complain of any symptoms related to the December 2008 hernia repair. Id. at 1-2.
From December 2008 until at least June 2016.
In October of 2017, Mr. Trevino presented to Kona Community Hospital in extreme pain. Dr. Fedder subsequently performed a laparoscopic hernia repair surgery on an unrelated hernia on October 26, 2017. However, while lysing some adhesions he discovered in Plaintiff's abdomen, Dr. Fedder inadvertently nicked the small bowel, creating an enterotomy and causing some spillage of bowel contents into the abdominal cavity. Dr. Fedder then (1) converted the laparoscopy into an open procedure; (2) explanted the Ventralex; and (3) performed a small bowel resection with anastomosis and primary repair of the New Hernia. Id. at 2. While Plaintiff did well in the days immediately following the explant surgery, he soon developed a wound infection followed by an enterocutaneous fistula (ECF) in November 2017. This resulted in a hospital stay and multiple wound revisions in December 2017 and January 2018, as well as ECF closure and bowel resection in January 2018.
Totaling some forty (40) days in the hospital and an additional eight (8) surgeries under general anesthesia.
Plaintiff alleges that, during the October 2017 surgery, the mesh of the Ventralex patch was found to have migrated to-and eroded in-Mr. Trevino's bowel, causing adhesions, small bowel obstruction, bowel perforation, recurrent hernias, and chronic and severe pain. This compromised, eroded mesh ultimately required a bowel resection. Further, because of the allegedly defective Ventralex, Mr. Trevino developed his ECF which, in turn, led to the need for multiple rounds of wound debridement.
Plaintiff asserts that the Ventralex is a defective product and that Bard failed to warn about the potential harms it could cause. He claims the Ventralex buckled and, caused among other injuries, adhesions to his bowel. For their part, Bard's experts contend Plaintiff's small bowel obstructions and other alleged injuries were caused by Plaintiff's adhesions and adhesive disease resulting from the severe injury Plaintiff experienced in the early 1990s and open surgical repair for the same. In the years that followed, Defendants assert that Plaintiff's adhesive disease was exacerbated by his many co-morbidities.
Plaintiff asserted numerous causes of action but only five remain: failure to warn, design defect in strict liability, general negligence, breach of implied warranty, and punitive damages. Id. at 3 (see also Bard's Ex. XX, Master Complaint (MC)). All these causes of action stem from Plaintiff's lone theory of the case: that the Ventralex was defective and that its alleged defect(s) caused his injuries.
In his Memorandum opposing Defendants' Motion for Summary Judgment, Plaintiff stipulated to the dismissal of his Consumer Protection/Unjust Enrichment claim (Count V) and Fraud claim (Count IX) for the first time. Plaintiff had stipulated to the dismissal of several counts prior to this Motion: Strict Liability - Manufacturing Defect (Count III), Negligent Infliction of Emotional Distress (Count VII), Intentional Infliction of Emotional Distress (Count VIII), and Loss of Consortium (Count XII). This last dismissal removed Mr. Trevino's wife as a plaintiff, leaving Mr. Trevino as the only named plaintiff remaining in this action. The parties also agreed that the Discovery Rule, Equitable Tolling/Estoppel claim (Count XIII) is not an independent cause of action.
For their part, Bard contends that all of Plaintiff's causes of action fail for lack of causation, an essential element for all claims he has asserted. Specifically, Plaintiff cannot meet his burden of proving-to a reasonable degree of medical certainty or probability-that any defect or failure in the Ventralex implanted in him caused or contributed to his alleged injuries. In addition to failing to establish causation, Bard contends that each of Plaintiff's causes of action fails for a laundry list of reasons specific to each cause. Defendant moved for Summary Judgment and on July 12, 2022, the Court heard lively argument from the parties on this motion.
Standard of Review
"Summary judgment is a drastic remedy, and a motion for summary judgment should be dealt with cautiously." Employers Mutual Casualty Co. v. Arbella Protection Insurance Co., 24 A.3d 544, 553 (R.I. 2011) (internal quotations omitted). "[S]ummary judgment is appropriate when, viewing the facts and all reasonable inferences therefrom in the light most favorable to the nonmoving party, the Court determines that there are no issues of material fact in dispute, and the moving party is entitled to judgment as a matter of law." Quest Diagnostics, LLC v. Pinnacle Consortium of Higher Education, 93 A.3d 949, 951 (R.I. 2014) (internal quotations omitted).
The moving party bears the initial burden of establishing that no such issues exist. Heflin v. Koszela, 774 A.2d 25, 29 (R.I. 2001). If the moving party can sustain its burden, then the "litigant opposing a motion for summary judgment has the burden of proving by competent evidence the existence of a disputed issue of material fact and cannot rest upon mere allegations or denials in the pleadings, mere conclusions or mere legal opinions." American Express Bank, FSB v. Johnson, 945 A.2d 297, 299 (R.I. 2008) (internal quotations omitted).
"The motion justice must refrain from weighing the evidence or passing upon issues of credibility [as] . . . [u]ltimately, the purpose of the summary judgment procedure is issue finding, not issue determination." DeMaio v. Ciccone, 59 A.3d 125, 130 (R.I. 2013) (internal quotations omitted) (emphasis added). Further, "[i]t is clear from our precedent that '[o]rdinarily the determination of proximate cause . . . is a question of fact that should not be decided by summary judgment.'" Belmore v. Petterutti, 253 A.3d 864, 868 (R.I. 2021) (quoting Splendorio v. Bilray Demolition Co., Inc., 682 A.2d 461, 467 (R.I. 1996)).
Précis of Bard's Motion for Summary Judgment
As noted supra, Bard contends that all of Plaintiff's causes of actions fail for lack of causation. Specifically, Plaintiff cannot meet his burden of proving-to a reasonable degree of medical certainty or probability-that any defect or failure in the Ventralex caused or contributed to his alleged injuries. In addition, Bard contends that each of Plaintiff's causes of action fails for a laundry list of reasons specific to each cause.
First, Plaintiff's failure to warn claim fails because (1) Bard accurately and consistently portrayed the instructions and warnings related to the use of the device in the Ventralex Instructions for Use (IFU), and (2) there is no evidence that additional/different warnings would have affected Plaintiff's clinical outcome. Second, Plaintiff cannot prevail on his design defect claims because he has not evidenced that there was, in fact, a design defect with the Ventralex, much less that it caused his injuries. Third, Plaintiff's negligence claim fails for want of expert opinion concerning breach (i.e., standard of care) and/or causation. Fourth, Plaintiff's breach of implied warranty claim fails because there is no evidence that the device was not merchantable or otherwise defective at the time of its sale. Fifth and finally, Plaintiff's punitive damages claim fails because he cannot show-by clear and convincing evidence- that Bard acted with "malice or in bad faith," and with "intent to cause harm." Bard's Mot. at 4-5.
I.e., because Plaintiff's implanting surgeon did not read the IFU in deciding to implant the device and was already aware of the risks associated with the Ventralex.
In response, Plaintiff counters that Bard failed to meet its burden of proving there is an absence of a question of material fact as to each remaining cause of action and, consequently, Bard's Motion should be denied in its entirety.
Bard's Comprehensive Causation Argument
Bard argues that Plaintiff cannot, through competent and reliable expert testimony, establish specific causation that either: (1) a defect in the Ventralex was (to a reasonable degree of medical certainty) the proximate cause of Plaintiff's alleged injuries; or (2) that Bard breached a standard of care expected of it "with respect to the Ventralex, and that such breach was the proximate cause of Plaintiff's alleged injuries." Bard's Mot. at 20.
See Miranda v. Dacruz, No. PC 04-2210, 2009 WL 3515196, at *3 (R.I. Super. Oct. 26, 2009) ("General causation asks whether exposure to a substance causes harm to anyone. Specific causation asks whether exposure to a substance caused a particular plaintiff's injury.") (Emphasis added.)
It is axiomatic that causation, under Rhode Island law, "is typically a question of fact for the jury." State v. Purdue Pharma L.P., No. PC-2018-4555, 2019 WL 3991963, at *10 (R.I. Super. Aug. 16, 2019). However, the issue of causation is not simply a perfunctory, one-way turnstile at the pretrial motions stage. Indeed, there have been multiple occasions where our Supreme Court has ruled it proper to grant summary judgment for lack of cause (in particular, proximate cause), either because causation was wholly lacking as a matter of law and evidence, or because causation had simply become too attenuated under the circumstances. See Russian v. Life-Cap Tire Services, Inc., 608 A.2d 1145, 1147-48 (R.I. 1992) (trial judge's granting of summary judgment proper because Plaintiff failed to present evidence identifying actions or omissions of retailer or lessor as proximate cause of his fall, or evidence from which reasonable inference of proximate cause could be drawn).
See also Hill v. State, 121 R.I. 353, 355, 398 A.2d 1130, 1131 (1979) ("When reasonable minds could infer that causation exists, the question [of causation] must be submitted to the jury.") (Emphasis added.)
Bard reasons that because "[o]nly Dr. DeNoto and Dr. Knabe attempt to render case-specific medical opinions concerning the alleged cause of Plaintiff's  injuries [(i.e., the Ventralex)]," Plaintiff's ability to survive summary judgment rests, in whole, on "the sufficiency and admissibility of their opinions." Bard's Mot. at 21. With respect to Dr. DeNoto's ability to satisfy Plaintiff's burden of proving specific causation, Bard notes how Dr. DeNoto's theory of differential contracture generally-and his "contracture and buckle" theory of Plaintiff's Ventralex specifically-are both (i) unfounded and (ii) at odds with the testimony of Dr. Fedder, Plaintiff's implant-/explanting physician, who did not describe Mr. Trevino's Ventralex as buckled, contracted (or scalloped) in any way. See Bard's Ex. VV- DeNoto Dep. 129:21-130:5; 130:10-14, May 21, 2022; Bard's Ex. V- DeNoto Dep. 27:17-28:6, 88:19-89-2, May 22, 2022. See also Bard's Memorandum of Law in Support of Its Motion to Exclude the Testimony of Plaintiff's Causation Expert George DeNoto, III, M.D., FACS. However, having weighed Defendants' full challenge to the presence and opinions of Dr. DeNoto in their Motion to Exclude the same, this Court found the "proposed testimony of Dr. DeNoto" to be "both reliable and relevant" on the issue of causation. July 11, 2022 DECISION ON DAUBERT/DIPETRILLO MOTION FOR GEORGE DENOTO III, M.D., FACS, at 18. Furthermore, the Court ruled that Defendants' "multifaceted attack on Dr. DeNoto is best left for cross examination and the jury can decide what weight to credit his testimony." Id. See also Steinberg v. State, 427 A.2d 338, 340 (R.I. 1981) ("[I]n ruling on a motion for summary judgment, the trial justice must look for factual issues, not determine them.").
I.e., two of Plaintiff's seven disclosed expert witnesses.
To argue that Dr. DeNoto does not establish that the Ventralex caused Plaintiff's injuries with the requisite '"degree of [medical] certainty"' (Claiborne v. Duff, No. PC 10-6330, 2015 WL 3936909, at *11 (R.I. Super. June 23, 2015), Defendants must wholly ignore the plain language of Dr. DeNoto's expert report, in which he states:
(quoting Wallace v. United States, 335 F.Supp.2d 252, 262 (D.R.I. 2004)).
"it is my opinion to a reasonable degree of medical certainty that the differential contracture rates of the heavy-weight polypropylene and microporous ePTFE components of the Ventralex caused Mr. Trevino's patch to buckle. The buckling led to Mr. Trevino's bowel obstructions, mesh erosion into bowel, need for mesh removal, need bowel resection and the resultant fistula." Pl.'s Ex. EE, Expert Report of George DeNoto, M.D. at 16 (emphasis added).
Taken together, there exists a disputed "issue of material fact" and, should Plaintiff wish to proffer an expert who will testify to a theory which directly contravenes the eyewitness testimony of Plaintiff's explanting physician, then Bard should relish the opportunity to highlight this discrepancy before the trier. Delta Airlines, Inc. v. Neary, 785 A.2d 1123, 1126 (R.I. 2001).
Regarding Plaintiff's ability to use the opinions of Dr. Knabe to prove specific causation (considering her vocation as a dentist), the Court points Defendants in the instant matter to its March 29, 2021 pre-trial decision in Rudd:
See Bard's Mot. at 24-25.
"Bard argues that Dr. Knabe is not qualified to offer any specific causation opinions concerning Mr. Rudd's inflammatory response to the Bard Ventralex device, simply because she is a dentist with no experience researching or examining immune and inflammatory response to a medical hernia device. Although Dr. Knabe is technically not a licensed M.D. in the United States nor board certified in any type of medicine besides dentistry, Rhode Island courts have held that an individual need not hold a particular license, title or certificate in a specialized field to render an opinion. See Owens v. Payless Cashways, Inc., 670 A.2d 1240, 1244 (R.I. 1996). Thus, based on Dr. Knabe's education, training, employment, and prior experiences in the biomaterials field, dedicating her research on the
characterization of the cell and tissue responses, she is qualified to testify about the tissues around Mr. Rudd's polypropylene mesh implant and his inflammatory and immune response thereto." In re Timothy Rudd, PC-2018-0482, Mar. 29, 2021, at 5:22-6:16.
Likewise, the Court here concludes that Dr. Knabe is qualified to opine on the end effects of the interaction between exposed polypropylene and Mr. Trevino's bowel. Indeed, Plaintiff's expert does just that when she opines:
"with a reasonable degree of scientific certainty that in Mr. Trevino the fibrotic response to polypropylene fibers and their degradation products led to contraction of the polypropylene mesh component, which caused deformation and wrinkling of the Ventralex device, which then led to the polypropylene side of the device being exposed to the peritoneum and bowel. Collectively, this resulted in a loop of the jejunum being fixed to the abdominal wall due to adhesions, bowel erosion, partial bowel obstruction and hernia recurrence." Pl.'s Ex. CC, Expert Report of Dr. Knabe at 29.
Approaching all evidentiary disputes "from a perspective most favorable to the party opposing the motion," the Court finds that the testimony of Dr. Knabe more than demonstrates the existence of questions of material fact on the underlying issue of specific causation. Steinberg, 427 A.2d at 340. For the moment, none of Plaintiff's claims may be summarily dismissed for failure to establish the essential element of proximate causation.
Failure to Warn (Count IV)
Learned Intermediary - Rhode Island Law
Bard argues that they are entitled to summary judgment on Plaintiff's failure to warn claim (Count IV) for two reasons: first, the product warning provided to Dr. Fedder-the "learned intermediary" -was adequate as a matter of law (see Castrignano v. E.R. Squibb & Sons, 546 A.2d 775, 782 (R.I. 1988) (standard for drug manufacturers under either strict liability or negligent failure to warn claims is that they "need only warn of those dangers that are reasonably foreseeable and knowable at the time of marketing.")); and second, because Plaintiff has failed to evidence the essential element of causation. Regarding the causation prong, Defendant notes that, there is (i) no specific evidence that Dr. Fedder relied on the IFU (either generally or in connection with Plaintiff's specific hernia procedure) and, in any event, (ii) Dr. Fedder was independently aware of the risks associated with using the Ventralex based on his past training and experience and advised Plaintiff of those risks accordingly. See Bard's Ex. G at 193:22-25, 194:12-15; see also id. at 189:25-192:10, 194:7-196:7, 229:5-16, 230:7-13.
Bard cites to Hodges v. Brannon, 707 A.2d 1225, 1227-28 (R.I. 1998) for the proposition that Rhode Island has "implicitly recogniz[ed]" the "learned intermediary" doctrine; i.e., that the duty to warn runs from the manufacturer of a drug or medical device to the doctor, not the ultimate end user/patient.
See also Bard's Ex. WW at 33; Ex. UU at 16; Ventralex's IFU, Ex. C at MPPE-05946974 ("Possible complications include seroma, adhesions, hematoma, inflammation, extrusion, fistula formation and recurrence of the hernia or soft tissue defect.").
First, as it relates to Rhode Island's supposed adoption of the "learned intermediary" theory-which holds that a manufacturer's duty to warn regarding the risks associated with a product runs to a patient's treating physician (i.e., the "learned intermediary") rather than directly to the patient- our own Supreme Court, as Plaintiff correctly notes, has never expressly "adopted the learned intermediary doctrine." Pl.'s Opp'n at 12 (see also Bard's Mot. at 26-27). Rather, in Hodges v. Brannon, 707 A.2d 1225, 1227 (R.I. 1998) (the case Bard relies on in support of its proposition), the Supreme Court affirmed the jury's finding that plaintiff's death was not caused by the at-issue hypertension drug which, iso facto, "torpedoed all [of Plaintiffs'] failure-to- disclose theories of liability.". Thus, it was never necessary for the Court to reach the issue of a proper warning mechanism for prescription drugs under Rhode Island law (nor did the Court elect to do so sua sponte):
See Luna v. Atrium Medical Corp., 561 F.Supp.3d 62, 64 (D.N.H. 2021).
"[P]laintiffs contend that the jury should have been instructed that the duty to warn a patient necessitates a warning comprehensible to the average user and conveying a fair indication of the nature and extent of the danger to the mind of the reasonably prudent person. But even if plaintiffs are correct (and we express no opinion on the merits of their contentions), the jury's finding of no proximate cause moots these contentions." Id. at 1227 n.7.
Instead, this Court's Presiding Justice has stated, in no uncertain terms, that Rhode Island has not adopted th[e] ["learned intermediary"] doctrine." Providence v. Davol, Inc., No. PC 07-4701, 2011 WL 496532, at *2 (R.I. Super. Feb. 09, 2011). And while Bard cites two federal court decisions which each predict that Rhode Island will eventually adopt the learned intermediary rule, divinations from our federal counterpart do not make for Rhode Island case law. See Greaves v. Eli Lilly & Co. 503 Fed.Appx. 70, 71 (2d Cir. 2012) ("[W]e conclude that the Rhode Island Supreme Court would likely adopt the learned intermediary doctrine if faced with the question of whether to do so under circumstances similar to these"); Hogan v. Novartis Pharmaceuticals Corp., No. 06 Civ. 0260(BMC)(RER), 2011 WL 1533467, at *9 (E.D.N.Y. Apr. 24, 2011). Despite the Federal Court's assumption that Rhode Island will adopt the learned intermediary doctrine, this Court is in no position to do so.
(predicting that Rhode Island would adopt the learned intermediary rule).
Tracing of Rhode Island's "failure" to adopt the "learned intermediary" doctrine is not simply an academic exercise. Rather, it has actual relevance to summary judgment in a case such as this where (i) the question of whether Ventralex mesh eroded into Plaintiff's bowel is specifically at issue, and (ii) Plaintiff's explanting physician testified that he did not warn his patient of the risk for such an occurrence:
"Q: Would you have discussed with him the risk of erosion or extrusion?
"A: Generally not.
"Q: Would you have discussed the risk of movement of the mesh?
"A: No." Bard's Ex. G at 229:17-22.
Moreover, the Ventralex IFU is silent on the issue of "erosion" ("[Dr. Sinha: [i]f the question you're asking me is whether these instructions for use specifically say that this is -- is there a risk of erosion of this mesh into bowel, those words are not on this page."), nor is mesh erosion mentioned-save in the most general terms-in the informed consent form that Plaintiff signed prior to his December 2008 surgery. See Bard's Ex. M at PTrevino_Plaintiff Records_00849.
Pl.'s Ex. DD, Sinha Dep. at 593:2-8.
Combining Bard's failure to convey the risk of erosion (specifically, erosion into the bowel) with Plaintiff's other delineated examples of Bard failing to "accurately, clearly, and consistently portray" all of the "specific risks and injuries" relevant to this case (see Pl.'s Opp'n at 13), Plaintiff has certainly "evidence[d] the existence of a disputed issue of material fact" regarding whether Bard warned Mr. Trevino of a reasonably foreseeable danger of the Ventralex. Johnson, 945 A.2d at 299.
Yet, even if the learned intermediary doctrine applied here, Bard's self-serving history regarding its presentation of device risks to the medical community wholly ignores evidence in the record of their more questionable omissions and misrepresentations. These omissions and misrepresentations, in turn, throw into question whether Bard could have adequately warned any physician of the Ventralex's risks as a matter of law. As one example, Plaintiff proffers evidence that Defendants represented to concerned customers that their polypropylene was (i) medical grade, and (ii) safe for human implantation (i.e., biocompatible). (See Pl.'s Ex. V, MPPE-06471921, November 2014 Email from Davol Field Assurance to concerned customer). There is a genuine issue of material fact as to these assertions. See, e.g., Pl.'s Ex. K, LyondellBasell Material Safety Data Sheet for polypropylene at 4 ("This product may not be used in: . . . (ii) the manufacture of any of the following, without prior written approval by Seller . . . U.S. FDA Class II Medical Devices[.]").
Indeed, when asked whether knowledge of Bard's failure to "request permission to use th[e] polypropylene" in the Ventralex "would have affected [his] decision to use [Bard's] product[,]" Plaintiff's implanting physician, Dr. Fedder, replies in the affirmative. Pl.'s Ex. FF, Dep. of Andrew Fedder, M.D., at 50:10-23 (objections omitted). When asked to clarify 'how' it would have affected his decision to use the Ventralex in Mr. Trevino's hernia repair, Dr. Fedder testifies that he "probably would not use [the mesh] until [he] had more information that [Bard] had requested that [information]." Id. at 50:21-22. In other words, there is clearly a factual question as to whether Dr. Fedder would have used the at-issue mesh had he been warned about the history surrounding the polypropylene and its procurement. As it is "reasonably foreseeable" that mesh not blessed by its manufacturer for surgical implant into human beings could lead to the type of complications that are alleged to have occurred in the instant matter, Plaintiff has thus met his evidentiary burden to show that his injuries were "proximately caused" by Bard's inadequate warnings and instructions. See Raimbeault v. Takeuchi Manufacturing (U.S.), Ltd., 772 A.2d 1056, 1064 (R.I. 2001) (When the defendant fails to warn of "reasonably foreseeable" and knowable dangers, the defendant has breached the duty of care and "the product is rendered defective.").
And that such information was evidently "know[n]" to Bard "at the time of marketing." Castrignano, 546 A.2d at 782. See also Pl.'s Ex. K; Ex. L, Richey Expert Report at 5-8 (recounting timeline of MSDS statements made from Bard's resin suppliers, regarding Pro-Fax 6523 Polypropylene). See also Pl.'s Ex. M, Shandas Expert Report at 18-19; Ex. N, Bard Email Exchange Tricking Vendors (March 2004) (MPPE-11332014-MPPE-11332017) ("IMPORTANT": "Please do NOT mention Davol's name in any discussions with these manufacturers. In fact, I would advise purchasing the resin through a 3rd party, not the resin supplier to avoid a supply issue once the medical application is discovered."; "Once again we need to be certain that we don't contact the resin supplier directly due to the sensitivity of our implant application.") (emphasis in original).
Taken together, Plaintiff has offered such evidence as to show a genuine issue of material fact over whether (i) Bard issued a proper warning to the implanting physician and/or patient and (ii) whether such warning would have altered Dr. Fedder's decision to use the Ventralex (thus proximately causing Mr. Trevino's alleged injuries). See Schrecengost v. Coloplast Corp., 425 F.Supp.3d 448, 462 (W.D. Pa. 2019) ("To establish that a failure to warn about the risks of a medical device was a proximate cause of an injury, a plaintiff must show that had the defendant issued a proper warning to the prescribing physician, the warning would have altered the physician's behavior or treatment and the injury would have been avoided."). Therefore, Plaintiff has successfully parleyed Bard's two-pronged challenge to his Failure to Warn claim-legal adequacy of the warning and proximate causation-and summary judgment is not appropriate on Plaintiff's Count IV.
Strict Liability and Negligent Failure to Warn.
The Learned Intermediary Doctrine - Conflicts of Law Analysis
Throughout the issues presented in this trial, Hawaii and Rhode Island have substantially similar laws but the Court finds that Hawaii and Rhode Island have materially different laws concerning the applicability of the learned intermediary doctrine. Thus, the Court must engage in a conflicts of laws analysis for the acute issue of the applicability of the "learned intermediary doctrine."
First, as discussed supra, Rhode Island has not adopted the doctrine. See Providence, 2011 WL 496532, at *2 n.3.
Second, Hawaii law has adopted the learned intermediary doctrine. See Craft v. Peebles, 893 P.2d 138, 155 (Haw. 1995). The Hawaii Supreme Court agreed with the holdings in Lee v. Baxter Healthcare Corp., 721 F.Supp. 89 (D. Md.1989) and Toole v. McClintock, 999 F.2d 1430 (11th Cir. 1993) wherein those courts held that the learned intermediary rule had its genesis in the prescription drug arena, but its application should be expanded to medical devices by analogy that, in both circumstances, physicians are in a better position to assess risks than patients. Further, the courts held that the adequacy of a manufacturer's warning is measured by the effect on the physician to whom it owed a duty to warn, and not by its impact on the patient.
Bard asserts that Hawaii has an interest in this litigation as:
"Plaintiff currently resides in Hawaii, and he resided in Hawaii at all times relevant to his claims in this case. Ex. TT, Short Form Complaint ("SFC"), at TrevinoP-Complaint-00001. Indeed, Plaintiff developed his incisional hernia in Hawaii, his physician recommended and prescribed him the Ventralex in Hawaii, his implant surgery involving the Ventralex was performed in Hawaii, and the alleged injuries that Plaintiff complains of and all treatment for them occurred in Hawaii." Bard's Mot. at 16.
For his part, Plaintiff notes that this entire litigation has been conducted under Rhode Island law and, furthermore, previous hernia mesh cases in Rhode Island utilized Rhode Island substantive law after challenges from the Defendant. See Ingram v. Davol, Inc., No. PC 07-4701, 2011 WL 496532, at *5 (R.I. Super. Feb. 9, 2011) (finding Rhode Island substantive law is applicable in hernia mesh litigation with similar facts to this case); Nourse v. Davol Inc. and C. R. Bard Inc., Nos. PC20173501, 2017-02, 2019 WL 162499, at *3 (R.I. Super. Jan. 3, 2019) (reaffirming Ingram's choice of law analysis).
Bard asks this Court to rely on Ellington v. Davol, Inc., C. A. No. 007-470-ML, 2012 WL 2021908, at *3 (D.R.I. June 5, 2012) wherein Judge Lisi denied Plaintiff's motion for the application of Rhode Island law using Rhode Island's interest balancing test.
The factors that a court must weigh in determining which state's law applies are '"(1) predictability of result; (2) maintenance of interstate and international order; (3) simplification of the judicial task; (4) advancement of the forum's governmental interests; and (5) application of the better rule of law.'" Najarian v. National Amusements, Inc., 768 A.2d 1253, 1255 (R.I. 2001) (quoting Pardey v. Boulevard Billiard Club, 518 A.2d 1349, 1351 (R.I. 1986)); see also Restatement (Second) Conflict of Laws § 145(2) (1971)).
Specific to a tort case, determining the forum with the most significant relationship to the claim requires a court to evaluate the following contacts: '"(a) the place where the injury occurred, (b) the place where the conduct causing the injury occurred, (c) the domicil, residence, nationality, place of incorporation and place of business of the parties, and (d) the place where the relationship, if any, between the parties is centered.'" Id. (quoting Brown v. Church of Holy Name of Jesus, 105 R.I. 322, 326-27, 252 A.2d 176, 179 (1969)); see also Restatement (Second) Conflict of Laws § 145(2)).
While this process consists of a fact intensive analysis, Presiding Justice Gibney completed a thorough analysis of a nearly identical case (factually speaking) in Ingram. In Ingram, a doctor in Arizona implanted a Bard hernia mesh device into an Arizona plaintiff and, later on, removed the same hernia mesh in a hospital in Arizona. See Ingram, 2011 WL 496532, at *1. In the instant case, Plaintiff is a Hawaii resident whose implant and explant with a Bard hernia device occurred in Hawaii. See Ex. TT, Short Form Complaint (SFC), at TrevinoP-Complaint-00001. As such, Bard focuses their argument around the place of injury contact as discussed in Brown. Due to the substantially similar factual scenario of the instant matter and Ingram, and in conjunction with Bard's modest argument distinguishing the two, this Court need only explain Bard's inappropriate reliance on the holding predicated in Najarian, 768 A.2d at 1255 and Taylor v. Massachusetts Flora Realty, Inc., 840 A.2d 1126, 1129 (R.I. 2004) and incorporate Presiding Justice Gibney's rationale concerning the remaining factors.
Under the tort specific factors of a conflicts of law analysis, Bard misapplies Rhode Island jurisprudence and asserts that "the place of injury where the hernia patch was explanted, 'bears the most significant relationship to the event at issue and the parties.'" Bard's Mem. at 15-16. As Judge Gibney aptly stated, this is a mischaracterization of Rhode Island law.
Bard asks this Court to rely on Ellington, 2012 WL 2021908, at *1 where Judge Lisi denied Plaintiff's motion for the application of Rhode Island law using Rhode Island's interest balancing test.
As to the remaining elements of the analysis, this Court adopts the reasoning and logic of Presiding Justice Gibney as laid out in Ingram, 2011 WL 496532. Presiding Judge Gibney concluded that:
"Although the place of injury is Arizona, Rhode Island has a significant interest in this litigation because of Davol's corporate, marketing, training, and design functions in Rhode Island. Plaintiffs' complaint was brought as a result of these alleged actions. Although both Arizona and Rhode Island have an interest in this litigation, the scales tip in favor of Rhode Island because of the actions within its borders, the predictability of results, and the maintenance of interstate order. Therefore, this Court finds that the state with the 'most significant relationship' to this case is Rhode Island." Ingram, 2011 WL 496532, at *5.This was later affirmed in Nourse that substantive Rhode Island law is-and should be-applicable in this master docket action. Nourse, 2019 WL 162499, at *2.
Design Defect - Strict Liability (Count II)
As a preliminary matter, Bard argues that Plaintiff's design defect claim (strict liability) is barred by Rhode Island's adoption of Comment k to § 402A of the Restatement (Second) Torts. See Castrignano, 546 A.2d at 782 (recognizing that "some drugs . . . definitely deserve the comment k exemption."). In the alternative, however, Bard argues that Plaintiff's design defect claim must also fail for want of evidence of either a (i) design defect or (ii) proximate causation. See Ritter v. Narragansett Electric Co., 109 R.I. 176, 190-91, 283 A.2d 255, 262-63 (1971) (citing Restatement (Second) Torts § 402A cmt. g (1965)).
As with the "learned intermediary" doctrine discussed supra, Bard once again asks this (trial) Court to act as an incubator of Rhode Island case law and unilaterally expand application of Comment k to medical devices. See Bard's Mot. at 36-37 ("Indeed, courts around the country have applied comment k to prescription surgical mesh devices . . . Bard respectfully requests this Court do the same."). Bard does so despite conceding that the Supreme Court in Castrignano expressly limited its application of Comment k to prescription drugs and, even then, did so tepidly. See Castrignano, 546 A.2d at 782 ("We recognize that some drugs, like the rabies vaccine, definitely deserve the comment-k exemption.") (emphasis added). Because this Court, functioning in its gatekeeper capacity in determining whether the "unquestioned benefits" of a device "may outweigh the risk of potential harm" (i.e., whether the protection of Comment k is even accorded), recognizes that determination of that issue is far more complex (i.e., less binary) with regard to medical devices than it is with prescription drugs, the Court must respectfully decline Bard's invitation. Mills v. Ethicon, Inc., 406 F.Supp.3d 363, 380 (D.N.J. 2019).
Or, put more accurately, 'accelerator' for Rhode Island case law.
But, even if this Court were willing to extend the umbrella of Comment k over medical devices, it could not conclude, as a matter of law, that the Ventralex hernia patch would make it past step one of the Rhode Island Comment k analysis. Per our Supreme Court, step one requires the trial court make an initial risk-benefit determination:
"If a trial judge concludes that reasonable minds could not differ in deciding that a drug's benefits exceed its risks, then as a matter of law the trial judge can extend comment k's protection to that drug. If, however, the judge finds that an application of the risk-benefit analysis allows reasonable minds to differ in their conclusions, then the trial judge should submit the issue to the trier of fact." Castrignano, 546 A.2d at 782 (emphasis added).
Based on all admissible evidence in the record, the Court finds that (i) Bard has not met its burden of proving Comment k applies and, moreover, (ii) reasonable minds could indeed differ in deciding that the Ventralex's "benefits exceed its risks." Id.; see also Pl.'s Ex. EE, Expert Report of George DeNoto, M.D. at 16; Pl.'s Ex. CC, Expert Report of Dr. Knabe at 29; Pl.'s Ex. R, Expert Report of Dr. Klinge at 2, 19. This is particularly the case when the wound site left by the explanted Ventralex was "reapproximated using . . . sutures" (i.e., traditional suturing) during the closing stages of his October 2017 surgery. See Bard's Ex. E, Kona Community Hospital Post-Op Note, at 00006. As such, the issue of the device's allegedly defective state and unreasonably dangerous qualities should be submitted to the trier of fact.
"This approach burdens the defendant with proving that the benefits outweighed the risks at the time the product was prescribed for the plaintiff." Id.
Returning to the bare bones' requirements of a design defect action in strict liability sans Comment k protections, the Rhode Island Supreme Court has held that plaintiffs must "prove that (1) the product contained a defect when it left the hands of the defendant supplier, and (2) that the defect was the proximate cause of the injury for which plaintiffs are suing." Smith v. Davol Inc., No. PC-08-8307, 2016 WL 7041131, at *3 (R.I. Super. Nov. 28, 2016) (citing Romano v. Westinghouse Electric Co., 114 R.I. 451, 462, 336 A.2d 555, 561 (1975)); Ritter, 109 R.I. at 190, 283 A.2d at 262). Put another way, the specific Ventralex implanted in Plaintiff contained a defect in its design and that such defect in its design was the proximate cause of Plaintiff's injuries. Ritter, 109 R.I. at 190-91, 283 A.2d at 262-63 (quoting Restatement (Second) Torts § 402A cmt. g (1965)). This standard naturally implies that the at-issue product "is expected to and does reach the [end] user or consumer without substantial change in the condition in which it is sold." Ritter, 109 R.I. at 188, 283 A.2d at 261.
Bard nakedly claims that "Plaintiff has not presented any reliable, supportable evidence of a defect in the design of the specific Ventralex implanted in Plaintiff, nor is there testimony from any expert in this case that, to a reasonable degree of medical certainty or probability, any such design defect was the proximate cause of Plaintiff's alleged injuries." Bard's Mot. at 35 (emphasis added). Bard's contention is true only to the extent it discounts-or, more accurately, ignores-the available testimony on varying contracture rates provided by Drs. DeNoto and Knabe supra, both of whom lay the foundation for finding "medical certainty" and "proximate cause." See Pl.'s Ex. EE, Expert Report of George DeNoto, M.D. at 16; Pl.'s Ex. CC, Expert Report of Dr. Knabe at 29. Additionally, Plaintiff points to the Expert Report of Dr. Uwe Klinge (Dr. Klinge), who offers the following testimony regarding design defects with the Ventralex and its predicate devices:
"It is my opinion to a reasonable degree of medical and scientific certainty in relation to Davol/C.R. Bard's . . . Ventralex Hernia Mesh Patch the following: . . . (5) ePTFE causes scary encapsulation and shrinks excessively and a different rate than porous polypropylene meshes; . . . (9) the combination of Bard mesh with ePTFE, as well as that which incorporates additional polypropylene and PET ring(s), is a combination that results in unnecessary risks, and many of those risks could have been resolved through the use of technologies such as collagen coatings and PVDF; (10) In light of all of the scientific and medical literature, as well as the ability to conduct testing and consult with scientists, Bard did not make
its devices as safe as possible." Pl.'s Ex. R, Dr. Klinge Report at 2 (emphasis added).
Dr. Klinge's above testimony constitutes competent evidence pointing to the existence of a disputed issue of material fact regarding a design defect in Plaintiff's Ventralex. This testimony, when combined with the causal opinions of Drs. DeNoto and Knabe (both of whom opine that the Ventralex caused Plaintiff's injuries), sustains the viability of Plaintiff's claim for design defect in strict liability. See Johnson, 945 A.2d at 299.
This Court agrees with Plaintiff's contention that "no single expert is required to carry [their] case." Pl.'s Opp'n at 10, n.39. Rather, an approach in which one expert "passes the baton" to the next expert until plaintiff has evidenced the essential elements of their claim(s) (including causation) to survive summary judgment is permissible in Rhode Island. See Bay Area Mobile Medical, LLC v. Colagiovanni, No. PC 07-1782, 2010 WL 5091262, at *8 (R.I. Super. Dec. 08, 2010) (affirming that "a pattern of corroborating evidence or a mosaic of circumstantial evidence is sufficient to meet a party's burden of proof.") (internal quotation omitted); see also State of Rhode Island, by and through, Peter Neronha, Attorney General v. Purdue Pharma L.P., et al., No. PC-2018-4555, at 49 (Decision, Feb. 18, 2022) ("Ultimately, if the trier of fact finds the State's multi-expert, baton handoff-based approach so disjointed such that it cannot conclude that Defendants' allegedly false marketing proximately caused harm to the State, then it will decide accordingly.").
Finally, Defendants advance a baseless argument that because "courts in numerous other jurisdictions have ruled" that their respective consumer expectations tests classify the expectations of the "ordinary consumer" to be those of "the individual prescribing physician's, and not the plaintiff-patient's expectations[,]" that this Court should summarily find the same. Bard's Mot. at 39 (emphasis added). Defendants offer this argument despite no Rhode Island court (or Hawaiian court, for that matter) ever holding that the "consumer expectation" test's "ordinary consumer" means anything other than the ultimate end user/consumer of the product-in this case the patient implanted with the device. See Pl.'s Opp'n at 18. Ignoring for a moment that this Court is not the supreme court of the state where it sits, the Court ultimately credits Plaintiff's argument that Bard's proposed interpretation of the "consumer expectation" test runs contrary to the plain language of § 402A of the Restatement (Second) Torts. Section 402A was adopted by the Supreme Court in 1971 and applies as between "[o]ne who sells any product in a defective condition unreasonably dangerous to the user" and "the ultimate user or consumer" of that product. § 402A(1); Ritter, 109 R.I. at 188, 283 A.2d at 261 (emphasis added). Thus, there is no need for this Court to dwell on Bard's "parallel universe" scenario in which the "ordinary consumer" consists of Dr. Fedder as opposed to Mr. Trevino. It is Mr. Trevino, not Dr. Fedder, who has allegedly been injured by the Ventralex. There is no set of facts where Dr. Fedder could have been injured by Bard's product so Bard's contention that "ordinary consumer" means Dr. Fedder, in this instance, defies logic. See generally Bard's Mot. at 40-42, 45-46; Bard's Reply at 23.
"Consistent with the reasoning supporting the learned intermediary doctrine, these courts have held that, because these pharmaceuticals and medical devices are available only by prescription from a doctor, and it is the doctor who provides information concerning the product to the patient, the doctor is the ordinary consumer, not the patient." Id. at 39-40.
Based on the foregoing, Plaintiff has proffered competent evidence such to create a disputed material issue of fact over whether the Ventralex implanted in Mr. Trevino contained a design defect pursuant to Rhode Island law. See Dalo v. Thalmann, 878 A.2d 194, 197 (R.I. 2005) ("[A] party who opposes a motion for summary judgment carries the burden of proving by competent evidence the existence of a disputed material issue of fact and cannot rest on allegations or denials in the pleadings or on conclusions or legal opinions.") (internal quotations omitted). Moreover, Plaintiff has sustained his burden relating to proximate causation on this claim vis-à-vis the respective testimonies of Drs. DeNoto, Knabe, and Klinge. As such, Bard has failed to demonstrate "the absence of questions of material fact" as to Plaintiff's design defect claim, and summary judgment on Count II must be denied.
Breach of Implied Warranty (Count VI)
Since it is undisputed that Plaintiff's Ventralex implant worked effectively for at least seven-and-a-half years (from December 2008 until at least June 2016), Bard argues that (1) there is no evidence that Plaintiff's Ventralex would not "pass in trade" such that it is "unfit for the ordinary purpose for which it was intended." Thomas v. Amway Corp., 488 A.2d 716, 719 (R.I. 1985) (holding that the implied warranty of merchantability is breached "when a product of fair average quality does not pass in the trade and is unfit for the ordinary purpose for which it is used.") (See also Bard's Mot. at 49). Put differently, Plaintiff's Ventralex was "merchantable" at the time of its sale. Bard also argues that (2) Plaintiff can adduce no evidence that his injuries were caused by the "defective nature" of his Ventralex and, regardless, (3) comment k to § 402A of the Restatement (Second) Torts should serve to bar Plaintiff's breach of implied warranty claim at first instance. See Castrignano, 546 A.2d at 783 ("logic requires us to extend the [comment k] defense to implied-warranty actions.").
The elements of an action for breach of implied warranty of merchantability in Rhode Island are: '"(1) that a merchant sold goods, (2) which were not 'merchantable' at the time of sale, and (3) injury and damages to the plaintiff or his property (4) caused proximately and in fact by the defective nature of the goods, and (5) notice to seller of injury."' Electric Terminal Corp. v. Cessna Aircraft, 520 A.2d 144, 146 (R.I. 1987) (quoting James J. White and Robert S. Summers, Uniform Commercial Code § 9-6, at 343 (2d ed. 1980)).
The Court has already determined that Plaintiff has submitted sufficient evidence on the element of causation to survive summary judgment vis-à-vis the expert reports of Drs. DeNoto, Knabe, and Klinge. See Pl.'s Ex. EE, Expert Report of George DeNoto, M.D. at 16; Pl.'s Ex. CC, Expert Report of Dr. Knabe at 29; Pl.'s Ex. R, Dr. Klinge Report at 2, 19. To reiterate, the cited portions of their respective testimonies, either in isolation or in tandem, satisfactorily evidence "the causal nexus between the happening" of Plaintiff's injuries and the lack of fitness of the warranted device. Thomas, 488 A.2d at 719.
E.g., Dr. Klinge isolates a specific defect with the Ventralex patch (differential contracture rates with the component resins) and Drs. DeNoto and Knabe cite that same defect as the specific cause of Plaintiff's injuries.
Additionally, the Court has already observed that comment k to § 402A of the Restatement (Second) Torts is not the law of the land with respect to medical devices and, even if it were, reasonable minds could differ on whether the therapeutic "benefits" of the Ventralex clearly outweighed its "risks." Castrignano, 546 A.2d at 782 ("If, however, the judge finds that an application of the risk-benefit analysis allows reasonable minds to differ . . . then the trial judge should submit the issue to the trier of fact.") (emphasis added). Therefore, all that remains to be determined is whether Plaintiff can point to competent evidence that the Ventralex was not "merchantable" at the time of its sale.
To sustain his burden, Plaintiff first points to Pl.'s Ex. K at 4 (Lyondell Basell Material Safety Data Sheet for polypropylene, which states: "This product may not be used in: . . . (ii) the manufacture of any of the following, without prior written approval by Seller . . . U.S. FDA Class II Medical Devices[.]". Plaintiff next evidences that Bard had specific knowledge that the "polypropylene" it acquired "was not medical grade." Pl.'s Opp'n at 22-23 (see also Pl.'s Ex. J, MPPE-08433747, Doc. Id. 1395378; Pl.'s Ex. K, Lyondell Basell Material Safety Data Sheet for polypropylene; Ex. N, Bard Email Exchange (March 2004) (MPPE-11332014-MPPE-11332017) ("IMPORTANT": "Please do NOT mention Davol's name in any discussions with these manufacturers. In fact, I would advise purchasing the resin through a 3rd party, not the resin supplier to avoid a supply issue once the medical application is discovered."; "Once again we need to be certain that we don't contact the resin supplier directly due to the sensitivity of our implant application.") (emphasis added). Finally, Plaintiff references the Expert Report of Dr. Klinge to adduce that Bard possessed constructive knowledge that the polypropylene used in the Ventralex was shrinking in other devices before they sold the device that would later be implanted in Mr. Trevino:
The Ventralex patch is an FDA Class II Medical Device. See, e.g., Pl.'s Ex. L, Richey Expert Report at 5-8 (recounting timeline of MSDS statements made from Bard's resin suppliers, regarding Pro-Fax 6523 Polypropylene), Pl.'s Ex. Q, Email from Red Oak Sales to Bard (MPPE-12695820) (March 2015) ("Red Oak Sales Co forwarded this MSDS to Bard in August 2014 and have followed up on several occasions. While Bard has not supplied the written confirmation I requested, I understand that the MSDS will be analyzed by Bard's technical/medical personnel for any appropriate follow up. As Bard knows, Red Oak Sales is directed to purchase the specific type of resin, and that Red Oak Sales does not have the facilities or requisite knowledge base to determine if the warnings are relevant to Bard's use of the resin in mesh products.").
"Bard was aware that the Composix Kugel shrank after implant. During the design process, Bard learned that the Composix Kugel Patch would be subject to some degree of in vivo contraction. Bard's awareness of the ability of the Composix Kugel to contract only grew. In a 2007 internal document discussing mesh shrinkage and Klosterhalfen's article, Bard's sales team noted: 'there is now a broad acceptance that shrinkage is a common phenomenon after mesh implantation.' In another document, Bard employees believed that mesh buckling was due to shrinkage: 'Chris, Steve, and I, believe that the buckling is caused by the mesh contracting from the sewing process.'" Pl.'s Ex. R, Dr. Klinge Report, at 19 (emphasis added).
Plaintiff underwent his implant surgery on December 24, 2008.
A defendant's liability for breach of the implied warranty of merchantability "depends upon a plaintiff prov[ing] that the product is defective, that it was in a defective condition at the time it left the hands of the seller, and that said defect is the proximate cause of the injury." Williams v. Johnson & Johnson, C. A. No. 1:20-CV-00544-MSM-LDA, 2022 WL 157929, at *4 (D.R.I. Jan. 18, 2022) (citing Lariviere v. Dayton Safety Ladder Co., 525 A.2d 892, 896 (R.I. 1987)). A review of the proffered evidence certainly raises questions of material fact as to both (i) the existence of a defect in the Ventralex, and (ii) whether the device was in a defective condition when it left Bard's control. Moreover, as discussed supra, Plaintiff has already satisfied his burden of evidencing the "causal nexus" between the alleged defect and his alleged injury. Thomas, 488 A.2d at 719. Taken together, Bard has failed in their procedural burden with respect to Plaintiff's claim for breach of implied warranty, and summary judgement on Count VI must be denied.
Negligence (Count I)
Bard next argues that Plaintiff has not come forward with any evidence on any of the necessary elements with respect to his "generic negligence claim." Bard's Mot. at 46. First, Plaintiff has not established any applicable standards of care expected of Bard with respect to its alleged duties (including duties to inspect and test). Second, none of Plaintiff's expert witnesses have expressed opinions that Bard breached the applicable standard with respect to testing, inspection, packaging, labeling, distribution, etc., of the Ventralex. And, third, there is no evidence-nor have any of Plaintiff's expert witnesses testified-that any such alleged breach proximately caused Plaintiff's injuries. See Mills v. State Sales, Inc., 824 A.2d 461, 467-68 (R.I. 2008).
See also Bard's Ex. XX, MC ¶ 68 (alleging that Bard was negligent in how it "designed, manufactured, tested or failed to test, inspected or failed to inspect, packaged, labeled, distributed, recommended, displayed, sold, examined . . . and supplied" the Ventralex).
Rhode Island recognizes that "a plaintiff must establish a standard of care with respect to inspection and testing and the defendant's deviation from that standard." Scittarelli v. Providence Gas Co., 415 A.2d 1040, 1043 (R.I. 1980)).
As the Court has sustained several claims by Plaintiff whose elements dovetail with those of a garden variety negligence count against a medical device manufacturer, the Court need not expend significant energy on Defendants' procedural challenge to Count I. For example, the mechanics of Failing to Warn (Count IV) overlap significantly with negligent packaging, labeling, distributing, marketing, sale, etc.; Defective Design (Count II) with negligent design, testing, inspection, etc.; and Breach of Implied Warranty (Count VI) with negligent marketing, and so forth. However, out of propriety, the Court will (briefly) address each "deficiency" cited by Bard in their section on Plaintiff's negligence claims. See generally Bard's Mot. at 46-48.
Turning to Plaintiff's supposed first and second deficiency (i.e., failure to establish the applicable standard of care with respect to Bard's alleged duties; lack of expert witnesses testifying to Bard's breach of the standard of care), Bard yet again resorts to its tried and true tactic of pretending one or more of Plaintiff's expert witnesses simply does not exist. In this instance, that witness is Dr. Robin Shandas (Shandas), a tenured professor of "Bioengineering" who will opine on the "standards for designing a medical device" and relay the following opinions (among others) concerning Bard's deviation from those standards:
Or, more accurately, operating under the assumption that said expert will hopefully be eliminated during the Daubert-DiPetrillo hearings which took place after the summary judgment hearings.
1. Bard used Marlex Mesh as a predicate device and did not properly test its polypropylene and make its device as safe as possible;
2. Bard did not appropriately test its devices and by failing to do so, missed opportunities to understand its device and know whether it was safe to market;
3. Bard ignored its obligation to conform to the safest possible product(s) as new information was learned and accepted by the scientific and medical communities;
4. Bard uses source materials that were clearly labeled as not intended for human use;
5. Bard failed to identify and monitor design risks and challenges;
6. Bard altered risk profiles for the devices to minimize need for longer-term animal studies or human studies for safety and efficacy. See Pl.'s Ex. M, Shandas Expert Report at 15-23 (emphasis added).
"Bard failed the industry standard by not conducting all of the necessary testing including the requisite material stability tests such as accelerated aging, oxidative, hydrolytic and pH degradation, analytical chemistry of core and leachable materials, and mechanical evaluation of the material pre and post implant. Bard repeated this failure when it applied to the FDA for clearance of the Ventralex Patch." (Pl.'s Ex. M, Shandas Expert Report at 15).
"The Composix E/X, Composix Kugel and Ventralex patches were new devices and Bard should have tested and brought them to market as such. Since Bard did not do so, Bard failed the industry standard with respect to all three devices." Id. at 18.
Bard fails to meet the industry standard by not incorporating new materials, designs or approaches that increase safety at the same rate as growth of such knowledge in the scientific and medical communities, and by not doing so, its products lag in design. These design failures subject patients to unnecessary risks, which result in injuries such as increased inflammation, chronic pain, nerve entrapment, chronic foreign body reaction, erosion, infection, recurrence, mesh contraction, mesh folding, mesh buckling, and other major complications." Id. at 19.
"It is highly unusual for a medical device manufacturer to withhold from the materials manufacturer the intended use of the latter's product. The standard industry practice is for medical device manufacturers to work closely with the materials manufacturer to qualify the raw material for use." Id. at 20.
Taken together, Dr. Shandas' signed, Rule 26 expert report more than establishes the applicable standard of care owed to Plaintiff by Bard and, moreover, expresses how Bard negligently breached that standard with regard to its "test[ing]," "market[ing]," "label[ing]" and "warn[ing]" of the Ventralex implant. Id. As such, this case is instantly distinguishable from the one cited by Bard wherein the "District Court for the Southern District of Texas rejected the plaintiff's unsworn expert reports as competent summary judgment evidence[.]" Bard's Mot. at 47 (emphasis added) (citing Conn v. C.R. Bard Inc, Civil Action No. 4:14-CV-298, 2021 WL 2885784, at *5 (S.D. Tex. May 10, 2021)).
As to Plaintiff's third supposed "deficiency" on their negligence claim ("[T]here is no evidence-nor have any of Plaintiff's expert witnesses testified-that any such alleged breach proximately caused Plaintiff's injuries."), the Court has more than detailed how the respective testimonies of Drs. DeNoto, Knabe, Klinge-and now Dr. Shandas-establish the "causal nexus" between the allegedly negligent aspects of the device and Plaintiff's injuries. See Bay Area Mobile Medical, LLC, 2010 WL 5091262, at *5 (affirming that "a pattern of corroborating evidence or a mosaic of circumstantial evidence is sufficient to meet a party's burden of proof.") (internal quotation omitted). Finally, it is well settled in Rhode Island that '"issues of negligence are ordinarily not susceptible of summary adjudication but should be resolved by trial in the ordinary manner."' Gliottone v. Ethier, 870 A.2d 1022, 1028 (R.I. 2005) (quoting Rogers v. Peabody Coal Co., 342 F.2d 749, 751 (6th Cir. 1965)). As this Court has already determined that Plaintiff has "overcome [his] duty hurdle" on his negligence count, he is entitled to "a factual determination on each of the remaining elements: breach, causation, and damages." Ouch v. Khea, 963 A.2d 630, 633 (R.I. 2009). Summary judgment on Count I must be denied.
See also State of Rhode Island, by and through, Peter Neronha, Attorney General, No. PC-2018-4555, at 48-49 (Decision, Feb. 18, 2022)
Bard argues that since all of Plaintiff's underlying causes of action should fail as a matter of law, his claim for punitive damages also necessarily fails. See The Rhode Island Indus.-Recreational Building Authority v. Capco Endurance, LLC, No. PB 13-2069, 2014 WL 664406, at *6 (R.I. Super. Feb. 14, 2014) (dismissing cause of action for punitive damages that was premised on dismissed counts). However, assuming Plaintiff could maintain any of his claims, Bard argues that he has not established any basis for punitive damages as delineated in Palmisano v. Toth, 624 A.2d 314, 318 (R.I. 1993) ("the party seeking punitive damages has the burden of producing 'evidence of such willfulness, recklessness or wickedness . . . as amount[s] to criminality[.]"') and Albanese v. Town of Narragansett, 135 A.3d 1179, 1191 (R.I. 2016) (a plaintiff must demonstrate that "a defendant act[ed] with malice or in bad faith," and with intent to cause harm.). Instead, the record of evidence demonstrates that Bard acted reasonably and in accordance with all applicable laws, rules, regulations, and guidance, including those promulgated by the FDA, in designing, manufacturing, marketing, and selling the Ventralex. See Bard's Mot. at 58.
See Bard's Ex. XX, MC ¶¶ 145-157.
This Court has previously ruled that Summary judgment is not a proper vehicle for the denial of punitive damages. See State of Rhode Island, by and through, Peter Neronha, Attorney General, No. PC-2018-4555, at 58-59 (Decision, Feb. 18, 2022) (citing Morin v. Aetna Casualty & Surety Co., 478 A.2d 964, 967 (R.I. 1984) (As "[s]ummary judgment is not a proper vehicle for the award of punitive damages[,]" conversely, neither is the procedure a proper vehicle for the denial of punitive damages)). In a "battle of the experts" medical device trial such as this-that is expected to last three (3) to four (4) weeks-there remains extensive evidence the Court has yet to see.
Considering the scope of facts yet to be developed, the Court will defer ruling on the matter of punitive damages until the appropriate point at trial. This may be after all the evidence has been entered or after a jury verdict.
For the reasons stated herein, the Court DENIES Bard's Motion for Summary Judgment on all claims. Counsel will confer and present the appropriate order.