Opinion
C. A. PC-2018-8437
03-24-2023
PAUL TREVINO and EARLYNN TREVINO, Plaintiffs, v. DAVOL INC. and C.R. BARD INC., Defendants.
For Plaintiff: Jonathan D. Orent, Esq. For Defendant: Stephen M. Prignano, Esq.
ATTORNEYS:
For Plaintiff: Jonathan D. Orent, Esq.
For Defendant: Stephen M. Prignano, Esq.
DECISION
LICHT, J.
Although the fourth bellwether case selected in this master docket for trial, Paul Trevino (Mr. Trevino) and Earlynn Trevino (Mrs. Trevino) were the first plaintiffs to have their case heard before this Court. Mr. Trevino's case was selected from thousands of cases in this master docket litigation which centers around injuries allegedly caused by hernia mesh products manufactured by Defendants, Davol Inc. and C.R. Bard Inc. (collectively referred to as Bard).
Initially, Mrs. Trevino sued for loss of consortium but subsequently voluntarily dismissed her claim.
The first selected bellwether case was continued, and the second and third bellwether cases settled prior to trial.
References to Davol Inc. (Davol), C.R. Bard Inc. (Bard), and Becton Dickinson (BD) are all made with respect to the same company, as Bard previously acquired Davol in 1980 and, more recently, BD acquired Bard in 2017.
I
Facts
Previous decisions by this Court dated July 26, 2022 denying Bard's motion for summary judgment as well as Mr. Trevino's motion for partial summary judgment set forth the pertinent facts pertaining to Mr. Trevino's lengthy medical history that begins in the early 1990s. See Trevino v. Davol Inc., No. PC-2018-8437, 2022 WL 3223845, at *1-2 (R.I. Super. July 26, 2022); see also Trevino v. Davol Inc., No. PC-2018-8437, 2022 WL 3223846, at *1-2 (R.I. Super. July 26, 2022). Nevertheless, the Court will provide a recitation of the relevant facts and procedural background herein.
After sustaining a significant abdominal injury, Mr. Trevino underwent an exploratory laparotomy (e.g., a large open incision in his abdomen) from his mid-chest to his belt line. During the procedure, Mr. Trevino's pancreas was found cut in half and his spleen was lacerated. Some years after the laparotomy, Mr. Trevino developed an incarcerated hernia along the midline incision site from the procedure and subsequently underwent a primary repair without mesh in 2007. Unfortunately, by 2008, Mr. Trevino's primary repair had failed, thus requiring a second procedure to be completed.
On December 24, 2008, Mr. Trevino underwent an additional ventral hernia repair at Kona Community Hospital located in Kealakekua, Hawaii, performed by Dr. Andrew Fedder (Dr. Fedder), a general surgeon. During the surgery, Dr. Fedder implanted a medium-sized Ventralex Hernia Patch (the Ventralex or the Ventralex Patch) manufactured and distributed by Bard. At the time of Mr. Trevino's surgery, Dr. Fedder regarded the repair as "successful" and, for a period of roughly seven and one-half years following the implantation of the Ventralex, Mr. Trevino did not complain of any symptoms related to either the device or the procedure.
The Ventralex was first cleared by the U.S. Food and Drug Administration (FDA) in 2002 and had been used extensively by treating physicians over the past seventeen years.
From December 2008 until at least June 2016.
Unfortunately, on October 26, 2017, Mr. Trevino returned to Kona Community Hospital in extreme pain, leading Dr. Fedder to perform another laparoscopic hernia repair, but on a different hernia (the New Hernia), completely unrelated to the December 2008 repair. However, while lysing some adhesions discovered in Mr. Trevino's abdomen, Dr. Fedder inadvertently nicked Mr. Trevino's small bowel, creating an enterotomy, causing the spillage of some bowel contents into the abdominal cavity. Dr. Fedder then (1) converted the laparoscopy into an open procedure; (2) explanted the Ventralex; (3) performed a small bowel resection with anastomosis; and (4) repaired the New Hernia.
An enterotomy is an "incision into the intestines." Enteretomy, Merriam-Webster.com Medical Dictionary, Merriam-Webster, https://www.merriam-webster.com/medical/enterotomy. Accessed Dec. 21, 2022.
An anastomosis is "the union of parts or branches (as of streams, blood vessels, or leaf veins) so as to intercommunicate or interconnect." Anastomosis, Merriam-Webster.com Medical Dictionary, Merriam-Webster, https://www.merriam-webster.com/medical/anastomosis. Accessed Dec. 21, 2022.
In the days immediately following the explant surgery, Mr. Trevino developed a wound infection followed by an enterocutaneous fistula (ECF) which resulted in an extended hospital stay and multiple wound revisions, to include an ECF closure and bowel resection, between December 2017 and January 2018.
An enterocutaneous fistula is "an aberrant connection between the intra-abdominal gastrointestinal tract and skin/wound." Enterocutaneous Fistula: Proven Strategies and Updates -PMC (nih.gov).
Totaling some forty days in the hospital and an additional eight surgeries under general anesthesia.
As a result of his extensive injuries, Mr. Trevino sued Bard asserting numerous causes of action, but only four remained at the time of trial: (1) strict product liability - defective design; (2) strict product liability - failure to warn; (3) general negligence; and (4) punitive damages.
The Court, over Mr. Trevino's objection, did not allow the issue of punitive damages to be presented at trial. The Court indicated that it would rule on whether there was sufficient evidence to submit the question of punitive damages to the jury after a verdict was returned. Once the jury returned its verdict, the Court ruled that while there was evidence of willfulness and recklessness, there was no evidence that amounted to criminality so the request to submit the issue of punitive damages to the jury was denied.
In July 2022, Mr. Trevino's case was tried before a jury which returned a verdict for Bard on the strict liability counts of defective design and failure to warn (Strict Liability Claims) and for Mr. Trevino on the negligence count. Consequently, the jury awarded Mr. Trevino $4.8 million in damages.
II
Travel
A
Pretrial
After extensive discovery, the parties filed a plethora of pretrial motions. Specifically, a total of forty-one motions in limine were filed-twelve by Mr. Trevino and twenty-nine by Bard.Additionally, ten Daubert/DePetrillo motions-four by Mr. Trevino and six by Bard-challenging either all or a portion of certain expert opinions were filed. This Court was also asked to decide on the applicability of an intervening superseding cause in both Bard's motion for summary judgment and Mr. Trevino's motion for partial summary judgment. Lastly, the Court reviewed, in camera, nearly 400 documents over which Bard asserted a privilege.
Fifty.
Eight of the motions were resolved without requiring a decision from the Court.
Bard withdrew one motion.
To that end, the Court received in excess of one thousand pages of memoranda relating to the parties' pretrial motions. The Court further engaged in oral argument on these motions for nine days and wrote decisions on five motions in limine, two Daubert/DePetrillo motions, and both the summary judgment and partial summary judgment motions. The remaining motions were decided by the Court from the bench. Lastly, the Court spent portions of four days ruling on objections to questions to witnesses who were testifying by video deposition.
This number excludes exhibits.
June 21-23, 27-29, July 11-13, 2022.
July 19, 21, 26, and 27, 2022.
B
Trial
The trial commenced jury selection on July 18, 2022 with the jury pool filling out a lengthy questionnaire. Voir dire began on July 20, 2022 and was completed the next day. The trial was supposed to begin on July 25, 2022 but was delayed until July 28, 2022 due to COVID-related issues. The trial lasted eighteen days. Mr. Trevino and Bard each presented nine witnesses, most with live testimony, with the exception of one witness who testified remotely and three witnesses who testified by video deposition. The jury initiated its deliberations on the afternoon of August 23, 2022 and delivered its verdict mid-day on August 29, 2022.
In reaching its verdict, the jury was asked four questions, one question for each of the remaining causes of action and one question regarding an award of damages, if applicable. The jury rendered a verdict for Bard on the questions of strict liability for design defect and failure to warn. However, the jury found that Bard was negligent and such negligence was the proximate cause of Mr. Trevino's injuries. Consequently, the jury awarded Mr. Trevino $2 million for bodily injury, $300,000 for medical expenses, $2 million for past, present, and future pain and suffering, and $500,000 for physical disfigurement.
Immediately after each of the jurors was polled on his or her verdict and returned to the jury room, Bard objected to the verdict as inconsistent and requested that the jury "be ordered back to clean [the inconsistent verdict] up." (Tr. 20:22-23, Aug. 29, 2022.) The Court denied this request.
To the extent that this Court refers to the trial transcripts, all references are to the unofficial, daily transcripts provided by the Court stenographer to the parties and not to an official trial transcript. Therefore, any citations and quotations incorporated in this decision are subject to change, either in substance or to line and page references, upon final review by the Court stenographer and the parties.
Furthermore, the Court, over Mr. Trevino's objection, did not allow the issue of punitive damages to be presented at trial; instead choosing to reserve its decision until after the verdict was returned to determine whether there was sufficient evidence to submit the question of punitive damages to the jury. After the jury returned its verdict, the Court ruled that while there was evidence of willfulness and recklessness, there was no evidence that amounted to criminality, so the request to submit the issue of punitive damages to the jury was denied and the Count was dismissed.
C
Post-Trial
On September 8, 2022, Bard filed three post-trial motions pursuant to the Superior Court Rules of Civil Procedure: (1) Rule 50(b) Renewed Motion for Judgment as a Matter of Law; (2) Rule 59(a) Motion for New Trial; and (3) Rule 59(e) Motion for Remittitur (collectively referred to as the Post-Trial Motions). At the Court's request, the Post-Trial Motions were addressed by both parties in a single memorandum, and therefore, the Court will decide all three motions herein. Pursuant to a scheduling order submitted jointly by the parties and approved by the Court, the parties submitted lengthy memoranda on the Post-Trial Motions and this Court heard oral arguments on January 18, 2023.
As Bard is the moving party on the Post-Trial Motions, the Court need not address the two Counts in which Bard successfully obtained a verdict.
Oral argument was originally scheduled for December 7, 2022, but due to illness and by agreement of the parties and the Court, the hearing was rescheduled to January 18, 2023.
Of note, there are issues raised by the parties in each individual Post-Trial Motion that overlap with one another. To the extent that this Court addresses an issue in respect to any one motion but does not address it in another motion, the reasons and bases are incorporated therein. For the reasons set forth below in Section IV, the Court denies all three motions except to the extent of a remittitur of $250,000 with respect to the damage award for bodily disfigurement.
Notably, Bard addresses (1) the learned intermediary doctrine; (2) Dr. George DeNoto's expert testimony; and (3) Mr. Trevino's damages in both its Renewed Motion for Judgment for a Matter of Law and Motion for New Trial.
III
Standard of Review
A
Rule 50(b) Renewed Motion for Judgment as a Matter of Law
Rule 50 of the Superior Court Rules of Civil Procedure governs motions for judgment as a matter of law. It provides, in pertinent part:
"If during a trial by jury a party has been fully heard on an issue and there is no legally sufficient evidentiary basis for a reasonable jury to find for that party on that issue, the court may determine the issue against that party and may grant a motion for judgment as a matter of law against that party with respect to a claim or defense that cannot under the controlling law be maintained or defeated without a favorable finding on that issue." Super. R. Civ. P. 50(a)(1) (emphasis added).
"Whenever a motion for a judgment as a matter of law made at the close of all the evidence is denied or for any reason is not granted, the court is deemed to have submitted the action to the jury subject to a later determination of the legal questions raised by the motion." Super. R. Civ. P. 50(b). This renewed motion for judgment as a matter of law must be filed and served no later than ten days after entry of judgment and may be joined with a Rule 59 motion for a new trial. Id.
When addressing a renewed motion for judgment as a matter of law, "[t]he trial justice.. .must examine 'the evidence in the light most favorable to the nonmoving party, without weighing the evidence or evaluating the credibility of [the] witnesses, and draw[] from the record all reasonable inferences that support the position of the nonmoving party.'" Lemont v. Estate of Ventura, 157 A.3d 31, 36 (R.I. 2017) (quoting Roy v. State, 139 A.3d 480, 488 (R.I. 2016)). If, after such review, "there are factual issues upon which reasonable people may have differing conclusions," the motion for judgment as a matter of law must be denied. Broadley v. State, 939 A.2d 1016, 1020 (R.I. 2008).
"However, if the only reasonable conclusion that can be drawn from the evidence is that the plaintiff is not entitled to recover, then the motion must be granted." Kenney Manufacturing Co. v. Starkweather &Shepley, Inc., 643 A.2d 203, 206 (R.I. 1994) (citing Hulton v. Phaneuf, 85 R.I. 406, 410, 132 A.2d 85, 88 (1957)). Thus, "a trial justice should enter judgment as a matter of law 'when the evidence permits only one legitimate conclusion in regard to the outcome.'" Lemont, 157 A.3d at 36 (quoting Roy, 139 A.3d at 488). In other words, for a defendant to prevail on its motion, the Court must find that no reasonable jury could have found for plaintiff based on the evidence presented. See McLaughlin v. Moura, 754 A.2d 95, 98 (R.I. 2000).
B
Rule 59(a) Motion for New Trial
After a trial by jury, "[a] new trial may be granted to all or any of the parties and on all or part of the issues for error of law occurring at the trial or for any of the reasons for which new trials have heretofore been granted in the courts of this state." Super. R. Civ. P. 59(a). It is well established that "when ruling on a motion for a new trial in a civil case tried to a jury, the trial justice acts as a superjuror and should review the evidence and exercise [the trial justice's] independent judgment in passing upon the weight of the evidence and the credibility of the witnesses." Johnston Equities Associates, LP v. Town of Johnston, 277 A.3d 716, 742 (R.I. 2022) (quoting Hough v. McKiernan, 101 A.3d 853, 856 (R.I. 2014)). In doing so, '"a trial justice sits as the super [seventh] juror and is required to independently weigh, evaluate, and assess the credibility of the trial witnesses and evidence. If the trial justice determines that the evidence is evenly balanced or is such that reasonable minds, in considering that same evidence, could come to different conclusions, then the trial justice should allow the verdict to stand.'" Martinelli v. Hopkins, 787 A.2d 1158, 1165 (R.I. 2001) (quoting Graff v. Motta, 748 A.2d 249, 255 (R.I. 2000)).
In this case, the "tenth" juror as nine jurors heard the case and the parties agreed to let all nine deliberate.
However, if after making an independent review of the evidence, "the trial justice finds that the jury's verdict is against the fair preponderance of the evidence" and fails to do substantial justice, the verdict must be set aside. Reccko v. Criss Cadillac Co., 610 A.2d 542, 545 (R.I. 1992) (citing Sarkisian v. NewPaper, Inc., 512 A.2d 831, 835 (R.I. 1986)). Even though the trial justice "need not perform an exhaustive analysis of the evidence, he or she should refer with some specificity to the facts which prompted him or her to make the decision so that the reviewing court can determine whether error was committed." Reccko, 610 A.2d at 545 (citing Zarrella v. Robinson, 460 A.2d 415, 418 (R.I. 1983)).
C
Rule 59(e) Motion for Remittitur
"'[A] remittitur may be accomplished if the trial justice concludes, after passing upon the evidence, that the plaintiff is not entitled to such an award or that the award is unreasonable in light of the evidence presented at trial.'" Hough, 101 A.3d at 856 (quoting Reccko, 610 A.2d at 546). The option of a remittitur is "designed to avoid the costs and delays that arise from relitigation of the same issues, while providing a just result for the litigants." Lennon v. Dacomed Corp., 901 A.2d 582, 590 (R.I. 2006). "'The trial justice may reject the award or order a remittitur of the award if it shocks the conscience or it clearly appears to be excessive, or to represent the passion and prejudice of the jury rather than their unbiased judgment.'" Hough, 101 A.3d at 856 (quoting Reccko, 610 A.2d at 546).
IV
Analysis A
Renewed Motion for Judgment as a Matter of Law Pursuant to Rule 50
After Mr. Trevino rested his case, Bard moved for judgment as a matter of law pursuant to Rule 50 of the Superior Court Rules of Civil Procedure noting that there was insufficient evidence to support Mr. Trevino's claims. (See Super. R. Civ. P. 50.) This Court reserved ruling on the motion. Thereafter, once Bard rested its case, it renewed its motion for judgment as a matter of law on the same grounds. Id. (See Bard's August 22, 2022 Mem. of Law in Supp. of Mot. for J. as a Matter of Law (Bard's Rule 50(a) Mot.).) The Court again reserved ruling on the motion.
Bard now renews its motion, fully incorporating the arguments made in its previous Rule 50(a) Motion, and argues that it is entitled to judgment as a matter of law because "there was no legally sufficient evidentiary basis for a reasonable jury to find for [Mr. Trevino] on his negligent failure to warn claim[.]" (Bard's Mem. of Law in Supp. of Post-Trial Mot. (Bard's Mem.) at 1.) Of note, this Court will not address any arguments made in Bard's Rule 50(a) Motion with respect to Mr. Trevino's Strict Liability Claims as the jury returned a verdict in favor of Bard on those claims.
i
Dormant Commerce Clause Challenge
Bard claims that under the Commerce Clause of the United States Constitution, or, more specifically, the "dormant commerce clause," manufacturers of prescription-only implantable medical devices, which includes Bard, are not required to provide warnings directly to patients (Commerce Clause argument). (See Bard's Mem. at 9.) (See also Bard's Rule 50(a) Mot. at 9.) At the outset, Mr. Trevino contends that Bard's failure to raise any Commerce Clause argument in its previous motion for summary judgment constitutes a waiver. (Pl.'s Resp. in Opp'n to Bard's Mem. (Pl.'s Opp'n) at 48.) Nevertheless, to the extent that this Court considers Bard's Commerce Clause argument, Mr. Trevino maintains that the argument must fail because: (1) Bard fails to explain how Rhode Island's warning requirement unconstitutionally burdens a Rhode Island corporation's interstate commerce; (2) Mr. Trevino's failure-to-warn claim is separate and distinct from his negligence claim; and (3) Bard's Commerce Clause argument depends on the learned intermediary doctrine which this Court previously refused to accept. Id. at 48, 54-58.
To the extent that Bard relies on the learned intermediary doctrine as a ground for granting the Post-Trial Motions, this Court already ruled on the applicability of the learned intermediary doctrine and reincorporates its previous arguments herein. See Trevino v. Davol Inc., No. PC-2018-8437, 2022 WL 3223845, at *5-7 (R.I. Super. July 26, 2022).
In regard to Mr. Trevino's waiver argument, this Court disagrees with the contention that Bard's failure to raise its Commerce Clause argument in its previous motion for summary judgment and/or prior to trial deems the issue waived. Id. at 48. Simply put, this Court disagrees as Bard did, in fact, raise its Commerce Clause argument during trial in its Rule 50(a) Motion. (See Bard's Rule 50(a) Mot. at 9-10.) Therefore, this Court deems that Bard's Commerce Clause argument is not waived and will address the merits of the argument herein.
Pursuant to article I, section 8, clause 3 of the United States Constitution, the Commerce Clause provides Congress with the power "[t]o regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes." (U.S. Const. art. I, § 8, cl. 3.) "'Although the Clause is framed as a positive grant of power to Congress,' [the Supreme Court of the United States] ha[s] long held that this Clause also prohibits state laws that unduly restrict interstate commerce." Tennessee Wine and Spirits Retailers Association v. Thomas, 139 S.Ct. 2449, 2459 (2019) (quoting Comptroller of Treasury of Md. v. Wynne, 575 U.S. 542, 548 (2015)). "'This 'negative' aspect of the Commerce Clause' prevents the States from adopting protectionist measures and thus preserves a national market for goods and services." Id. (quoting New Energy Co. of Ind. v. Limbach, 486 U.S. 269, 273 (1988)). Thus, "[u]nder our dormant Commerce Clause cases, if a state law discriminates against out-of-state goods or nonresident economic actors, the law can be sustained only on a showing that it is narrowly tailored to 'advanc[e] a legitimate local purpose.'" Id. at 2461 (quoting Department of Revenue of Kentucky. v. Davis, 553 U.S. 328, 338 (2008)).
There also exists a principle, commonly known as the "extraterritoriality doctrine," that is part and parcel of the dormant commerce clause and provides that "a statute that directly controls commerce occurring wholly outside the boundaries of a State exceeds the inherent limits of the enacting State's authority and is invalid regardless of whether the statute's extraterritorial reach was intended by the legislature." Healy v. Beer Institute, Inc., 491 U.S. 324, 336 (1989). Neither Bard nor Mr. Trevino contest this principle. However, Mr. Trevino contends that the doctrine is inapplicable because there is no regulation of commerce here; rather, the issue before this Court is grounded in tort and, at the most, deals with a safety issue (e.g., failure to warn). If it were considered a regulation of commerce, Mr. Trevino contends that "modern commerce clause jurisprudence instructs that commerce encompasses a stream of transactions (e.g., 'including those transactions necessary to produce a good, and those by virtue of which the good is distributed and sold to end-users')." (Pl.'s Opp'n at 57.) In other words, if at any point, part of the process occurs within the regulating state, then the extraterritoriality doctrine does not apply. Therefore, Mr. Trevino argues that because the design and marketing activities to produce the Ventralex occurred in Rhode Island, the dormant commerce clause still would not apply. Id.
The Court concurs with Mr. Trevino that a trial justice, in a tort case, in ruling on a conflicts of law issue or determining whether a legal doctrine applies is not regulating commerce. It is well established that failure to warn claims whether based on negligence or strict liability are causes of action based in tort. See Castrignano v. E.R. Squibb &Sons, Inc., 546 A.2d 775, 779 (R.I. 1988); see also Thomas v. Amway Corp., 488 A.2d 716, 722 (R.I. 1985). As such, this Court concludes that by choosing to apply Rhode Island's warning requirements to an event occurring in Hawaii, this Court is, in no way, attempting to regulate commerce.
ii
Learned Intermediary Doctrine
Bard next contends that Mr. Trevino failed to "establish that a manufacturer of a prescription-only implantable medical device has a duty under Rhode Island law to warn patients directly about the risk of those devices." (Bard's Mem. at 10.) (See Bard's Rule 50(a) Mot. at 1115.) Bard's argument is substantially based on the application of the learned intermediary doctrine which this Court previously addressed at length in its written decision on Bard's motion for summary judgment. See Trevino, 2022 WL 3223845, at *5-9. Therefore, this Court incorporates its reasons and basis from that decision herein.
iii Adequate Warnings
Assuming that this Court does not apply the learned intermediary doctrine, Bard asserts that the evidence presented at trial establishes that Bard's warnings to Dr. Fedder about the Ventralex were adequate as a matter of law. (Bard's Mem. at 10.) This Court has reviewed the evidentiary record and comes to a different conclusion; instead, finding that based on the testimony of Dr. Fedder and Dr. Uwe Klinge (Dr. Klinge), a reasonable jury could find that the warnings were inadequate.
"It is well settled that, '[t]o establish a negligence claim, a plaintiff must demonstrate a legally cognizable duty owed by a defendant to a plaintiff, a breach of that duty, proximate causation between the conduct and the resulting injury, and the actual loss or damage.'" Oliver v. Narragansett Bay Insurance Co., 205 A.3d 445, 450 (R.I. 2019) (quoting Kemp v. PJC of Rhode Island, Inc., 184 A.3d 712, 717 (R.I. 2018)). To that end, for failure to warn cases relating to products liability, our Supreme Court has held that "'[i]n negligence, the defendant only has a duty to warn if he had reason to know about the product's dangerous propensities which caused plaintiff's injuries.'" Id. (quoting Thomas, 488 A.2d at 722).
This Court is satisfied that there is evidence to support the jury's conclusion that Bard failed to provide adequate warnings of the Ventralex. Notably, Dr. Fedder himself stated that if he had known that Bard used polypropylene without the permission of the manufacturer, LyondellBasell, his decision to implant the Ventralex may have been different. (See Fedder Dep. Tr. 49:21-50:22, Mar. 11, 2022.) ("Q: If Bard did not request permission to use this polypropylene in their product, would that have affected your decision to use their product? A: Yes.I mean it -in the I guess hypothetical situation or not, it would have affected based on - you know, I probably would not use it until I had more information that they had requested that.")
To that end, testimony from Mr. Roger Darois (Mr. Darois), who previously worked for Bard as both its Vice President of Research and Advanced Technologies and Vice President of Research and Development, indicates that Bard may have been aware that LyondellBasell did not believe that its polypropylene was suitable for implantable medical devices. (See Tr. 5:17-20; 6:14, Aug. 15, 2022.) Specifically, Mr. Darois discussed an e-mail he received from Dr. Thiemo Blank (Dr. Blank), a research and development engineer at Angiomed, the division of Bard that produced cardiac stents. Id. 62:20-63:5. Mr. Darois stated that Dr. Blank expressed some interest in learning about Bard's polypropylene usage in surgical mesh because Dr. Blank wanted to know about its compatibility for cardiac stent usage. Id. 64:9-13. (See Trial Ex. P-0015.) ("I know that you have a lot of expertise with polypropylen[e]. Therefore I thought you might be able to name a vendor and brand name.. .that you would think provides the best raw material from the biocomp. point of view.") In response, Mr. Darois forwarded Dr. Blank's e-mail to one of Bard's engineers but emphasized the following to Dr. Blank:
Mr. Darois was employed as Bard's Vice President of Research and Development from 1995 through 2009. (Tr. 6:1-4, Aug. 15, 2022.) Afterwards, he became Bard's Vice President of Research and Advanced Technologies from 2009 until 2014, when he retired. Id. 5:17-20; 13:89.)
"IMPORTANT.these suppliers will likely not be interested in a medical application. We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers. Thus, it is likely that they do not know of our implant application. Please do NOT mention [Bard's] name in any discussions with these manufacturers.If you need the resin we use for samples or trials, we can get you any amount you need so you do not have to talk to the resin manufacturer." Id. (emphasis added).
Furthermore, Dr. Klinge, an expert in hernia mesh development and biomaterials, additionally testified that neither the Ventralex Instructions for Use (IFU) nor the adverse reaction section properly warn of the risks of contracture, ring buckling, ring breaking, ring fraying, or erosion. (Tr. 163:19-164:23, Aug. 4, 2022.)
For the above reasons, examining the evidence in the light most favorable to Mr. Trevino and drawing all reasonable inferences in favor of Mr. Trevino, this Court finds that a reasonable jury could have found that the warnings included in the IFU were not adequate as a matter of law. McLaughlin, 754 A.2d at 98.
iv Proximate Cause
Bard contends that George DeNoto III, M.D., F.A.C.S. (Dr. DeNoto) failed to establish that either the Ventralex itself or its warnings were the proximate cause of Mr. Trevino's injuries and, as such, Bard is entitled to judgment as a matter of law. (Bard's Mem. at 10-14.) The Court has reviewed the entire testimony of Dr. DeNoto, to include the parties' direct examination, cross- examination, and redirect, and comes to a different conclusion; instead, finding that there was ample evidence to support the jury's conclusion that the Ventralex and/or its warnings proximately caused Mr. Trevino's injuries.
Fellow of American College of Surgeons.
"In most cases, proximate cause is established by showing that but for the negligence of the tortfeasor, injury to the plaintiff would not have occurred." Skaling v. Aetna Insurance Co., 742 A.2d 282, 288 (R.I. 1999) (citing Fondedile, S.A. v. C.E. Maguire, Inc., 610 A.2d 87, 95 (R.I. 1992)). Our Supreme Court has consistently held that "'[a]lthough proximate cause may not be established by conjecture or speculation, 'proximate cause can be established by circumstantial evidence, and specific direct evidence of..proximate cause is not always necessary."" O'Connell v. Walmsley, 93 A.3d 60, 66 (R.I. 2014) (quoting Seide v. State, 875 A.2d 1259, 1268 (R.I. 2005) and Martinelli, 787 A.2d at 1169)). "A plaintiff 'is not required to demonstrate with absolute certainty each precise step in the causal chain between the tortfeasor's breach of duty and the injury.'" Gianquitti v. Atwood Medical Associates, Ltd., 973 A.2d 580, 592 (R.I. 2009) (quoting Seide, 875 A.2d at 1269)). Rather, "[w]hen inference is employed to establish causation, '[p]roof by inference need not exclude every other possible cause,. it must be based on reasonable inferences drawn from the facts in evidence.'" Id. at 592-93 (quoting Seide, 875 A.2d at 126869).
At the outset of his testimony, Dr. DeNoto provided the following opinion:
"Q: Dr. DeNoto, in short what is your opinion on whether or not the Ventralex caused Mr. Trevino's injuries?
"A: The Ventralex was responsible for all of the injuries that he incurred. It was responsible for the bowel obstruction and inflammatory process created by this mesh, obstructed the small bowel, that is one side of the mesh. The other part of the mesh and I will be able to show you this, eroded into his bowel causing erosion which set him up for the bowel resection surgery that then led to all these ensuing complications that he experienced.
"So the Ventralex mesh cause[d] the differential contracture. The Ventralex mesh started this cascade of events that led to his problems and his injuries." (Tr. 54:13-55:1, Aug. 9, 2022.)
To support his opinion, Dr. DeNoto provided a detailed explanation of this theory of differential contracture. In doing so, Dr. DeNoto first explained that the Ventralex mesh consists of two different layers of material affixed to one another: a layer of polypropylene (PPE) and a layer of expanded polytetrafluoroethylene (ePTFE). Dr. DeNoto further testified that the two different materials contract at different rates thus causing the mesh to buckle or "potato chip."
Moreover, Bard renewed its pretrial assertion that Dr. DeNoto's testimony is inadmissible as it failed to meet the requirements of Daubert or DiPetrillo. The Court rejected this argument in its eighteen page written decision filed on July 11, 2022, and it rejects it once again. The Court incorporates that decision by reference and Dr. DeNoto's trial testimony buttresses that decision.
Dr. DeNoto showed examples of differential contracture and even discussed a case study that he asserted was very similar to Mr. Trevino's case. (See Trial Ex. P-1458.) Notably, even Bard acknowledged that "composite mesh devices, especially those with permanent adhesion barriers, exhibit varying degrees of contracture post-implantation." (Trial Ex. P-0772.) To that end, Dr. DeNoto spoke of his own observations in his own practice where he observed buckling when he removed memory rings. He also testified as to various studies that showed buckling or potato chipping. On cross-examination, Dr. DeNoto did not waiver from his theory; he was asked if PPE contracted more rapidly than ePTFE and he responded, "[i]t is not a race. It contracts more than [e]PTFE." (Tr. 50:23, Aug. 10, 2022.) Although Dr. DeNoto noted that the studies differ on which material, PPE or ePTFE, contracts more or less; he emphasized that what mattered is that each contracted differently from the other.
Dr. DeNoto also showed complete familiarity with Mr. Trevino's medical records and the opinions of other witnesses, whether the witnesses were on behalf of Mr. Trevino or Bard. As to causation, Dr. DeNoto performed a differential diagnosis and ruled out the other factors which Bard's experts asserted could have been the cause of Mr. Trevino's injuries. Specifically, Dr. DeNoto concluded that, based upon his review of the CAT scans from 2013 through 2016, the Ventralex had eroded into the bowel. In reaching his opinion, Dr. DeNoto also relied on the postoperative report of Dr. Fedder which stated:
"In the midline where the hernia was too small hernias were reduced and the small bowel was adherent to the mesh in the midline. This was carefully dissected but was found to have an area of erosion of the mesh into the small bowel which was entered during the dissection with minimal spillage." (Trial Ex. P-3051-122.)
Dr. DeNoto further based his conclusion on his review of the testimony of Maria Oka(Ms. Oka), who was the operating room nurse when the Ventralex was explanted. Ms. Oka testified by way of video deposition that the mesh had eroded into the bowel. (Oka Dep. Tr. 30:1014.) When asked what Mr. Trevino's abdomen looked like she responded, "It was a complete mess. There was a lot of adhesions crumpled-up mesh with bowel and adhesive tissue kind of all stuck together." Id. 30:16-20. She also said the mesh was not lying flat. Id. 30:23-24.
Ms. Oka has an impressive list of credentials and degrees. She obtained her Associate's Degree in Nursing from Dakota Wesleyan University. She went on to obtain a Masters in Nursing from the University of Nebraska and is a Family Nurse Practitioner (M.A.F.N.). She is an Advanced Registered Nurse Practitioner (A.R.N.P.) and she attended the Wound Care Management Program at the University of Washington in Seattle and is a Certified Wound Care Nurse. (See Oka Dep. Tr. 15:5-17:6.)
Dr. DeNoto was vigorously cross-examined and yet he did not yield in his opinion. He expressed his disagreement in great detail with the pathologist who did the post-operative report after the explant surgery. While admitting that he was not a board-certified radiologist, he asserted that, as a surgeon, he constantly read radiology reports and he was very specific in why he disagreed with any report. (See Tr. 76:23-77:21; 82:2-16, Aug. 10, 2022.) Yet, he did not criticize all radiologists because with respect to one report he replied, "This radiologist nailed it." Id. 84:2.
While cross-examining Dr. DeNoto, counsel for Bard tried to undermine his testimony about what he saw on the CAT scans by pointing out that he was not a board certified radiologist, thus implying that his reading of the scans could not be as credible as the reading of a board certified radiologist. Interestingly, however, Dr. Prashant Sinha (Dr. Sinha), a witness for the defense who testified for about seven hours, is a general surgeon who currently is the Chief of Surgery at Norwell Hofstra Staten Island Hospital. While he disagreed with Dr. DeNoto's opinions, he showed great familiarity with the CAT scans and pathology reports because as a surgeon that is what he did.
Dr. DeNoto's testimony covers nearly 300 pages of the trial transcript. He was knowledgeable of the case, generally responsive, articulate, self-assured, never hesitated in his responses, thorough, and candid. He never yielded his opinions on cross-examination and he gave plausible explanations when confronted with contrary information or opinions. Therefore, this Court finds that Dr. DeNoto presented sufficient evidence that if accepted by the jury, notwithstanding contrary opinions and inconsistent opinions presented by the defense, was sufficient to establish that the Ventralex caused Mr. Trevino's injuries.
v
Damages on Past, Present, and Future Pain and Suffering
1
Past Medical Expenses
Bard claims that Mr. Trevino failed to show that his expenses "were reasonably and necessarily incurred as a result of Bard's alleged conduct." (Bard's Mem. at 4.) (See Bard's Rule 50(a) Mot. at 26.) Conversely, Mr. Trevino contends that "Mr. Trevino presented ample evidence for a reasonable jury to find that Mr. Trevino incurred reasonable medical bills stemming from medically necessary care." (Pl.'s Mem. at 60.)
Customarily, this issue does not arise because most plaintiffs avail themselves of G.L. 1956 § 9-19-27 which allows medical records and bills to be admitted "as evidence of the fair and reasonable charge for the services and/or the necessity of the services or treatments" Section 9-19-27(b). This statute is a legislative acknowledgement that it would be burdensome on medical providers to be required to testify in every case where a plaintiff seeks damages for medical expenses. See § 9-19-27(a) ("This section is enacted primarily to relieve physicians and the other medical professionals defined hereinsfrom the hardship and inconvenience of attending court as witnessess). However, the statute specifically allows "any party to the action to summon or depose any other person to testify in respect to the bill, record, and/or report or for any other purpose." Id. at (b).
Mr. Trevino did not avail himself of § 9-19-27; rather, his medical records and expenses were admitted via a joint stipulation by the parties dated August 5, 2022. (see Joint Stipulation Regarding Admission of Medical Bills dated August 5, 2022 (Joint Stipulation).) Pursuant to the language of the Joint Stipulation, the admission of Mr. Trevino's medical bills were not intended to act as evidence of either the reasonableness or necessity of the charges.
In fact, the Joint Stipulation included a provision to the contrary:
"By entering into this agreement, Defendants do not stipulate, concede, or agree, and expressly reserve all rights to contest, that the medical bills are evidence of the fair and reasonable charge for the services or treatment and/or the necessity of the services or treatment set forth therein. Nor do Defendants agree that any particular medical bills were incurred as a proximate result of any harm allegedly caused by Defendants." (Joint Stipulation ¶ 7.)
Upon a full review of the evidence, and in light of the Court's instructions, the Court finds that Mr. Trevino set forth competent evidence which would enable the jury to infer that his past medical expenses were both medically necessary and reasonably incurred.
As to whether the medical treatment was necessarily incurred, both Dr. Fedder and Dr. DeNoto testified as to the reasonableness and necessity of Mr. Trevino's explant surgery. Specifically, when Dr. Fedder was asked, "Did you believe it was medically necessary to remove Mr. Trevino's mesh when it was eroded into his bowel," he responded, "Yes." (Fedder Dep. Tr. 133:7-11, Mar. 11, 2022.) To that end, Ms. Oka further echoed Dr. Fedder's sentiment and confirmed that it was medically necessary to remove the mesh once they realized that the mesh had eroded into Mr. Trevino's bowel. Id. (See also Oka Dep. Tr. 153:7-14, Mar. 4, 2022.) In fact, even Dr. Sinha, Bard's witness, stated that the explant of the Ventralex was necessary even though he was critical of the wound care Mr. Trevino received. (Tr. 60:14-15, Aug. 19, 2022.)
Dr. DeNoto further explained the rationale behind each additional complication and subsequent procedure stemming from Mr. Trevino's Ventralex. (See Tr. 50:21-51:10, Aug. 9, 2022.) ("[T]hat started a cascade of events where [Mr. Trevino] then went [on to] develop a wound infection, an enterocutaneous fistula, wounds.that you saw.") Dr. DeNoto specifically opined that "[t]he Ventralex was responsible for all of the injuries that [Mr. Trevino] occurred." Id. 54:1555:1; 124:12-125:16. Ms. Oka further confirmed Dr. Fedder's position, explaining that Mr. Trevino's care team had to perform the additional surgeries because of the complications from Mr. Trevino's fistula, which was continuously contaminating the wound site and causing a fungal infection. (Oka Dep. Tr. 48:26-50:22; 51:7-52:11; 62:7-10, Mar. 4, 2022.)
In addition, Dr. Fedder and Ms. Oka testified extensively about the post-explant medical treatment, particularly the wound care and the eight additional operations performed during his forty-day stay. Dr. Fedder and Ms. Oka further testified as to the importance and use of a wound vac, explaining that it is often used to help speed up the healing process by draining any unwanted fluids from the wound site. See Oka Dep. Tr. 37:13-19, Mar. 4, 2022. Lastly, in response to why Mr. Trevino's wound site was left open, Ms. Oka explained that it is intended to prevent an infection. (See Oka Dep. Tr. 67:6-17; 139:13-22, Mar. 4, 2022.) ("[Wound infections are high] if it's a laparotomy incision and you're dealing with intestine or mesh or, like I said, perforation, they can be pretty high.So that's why a lot of times we leave the wound open or use staples, anticipating that something is going to get infected, and we will remove some staples." For these reasons, this Court is satisfied that sufficient evidence was presented to permit a reasonable jury to find that Mr. Trevino's medical procedures were medically necessarily. See McLaughlin, 754 A.2d at 98.
As to the issue of whether the costs were reasonable in light of the treatment received, this Court acknowledges that, except for the medical bills themselves, no other evidence regarding the reasonableness of the bills was introduced. Mr. Trevino takes the position that a jury could reasonably infer his expenses were reasonable because "the treatment itself was reasonable and necessary" and "the length of Mr. Trevino's hospitalization, the number of surgical procedures he endured, as well as the complexity and length of his wound care." (Pl.'s Opp'n at 61.)
At oral argument, Bard attempted to analogize the recovery of medical expenses to the recovery of attorney's fees, relying heavily on our Supreme Court's decision in Tri-Town Construction Co., Inc. v. Commerce Park Associates 12, LLC, 139 A.3d 467 (R.I. 2016). In that case, our Supreme Court held that in order for a party to recover attorney's fees, "testimony or [an] affidavit of an independent attorney regarding the reasonableness and necessity of" the fees is required. Id. at 480. Prior to the Tri-Town decision, the courts themselves examined the legal bills and determined the reasonableness of the requested attorney's fees. This Court is unaware of a case which requires independent expert testimony as to the reasonableness of medical expenses and instead thinks that the process discussed in Process Engineers &Constructors, Inc. v. DiGregorio Inc., 93 A.3d 1047 (R.I. 2014) is much more applicable to this case.
In Process, our Supreme Court held that "[a] plaintiff is not required to put forth expert testimony on the reasonableness of the value" of services rendered for a prima facie case of quantum meruit. Id. at 1055. In that case, the Court was tasked with evaluating a claim for quantum meruit by a subcontractor against a contractor in a breach of contract action. The Court held:
"For purposes of the prima facie case, a plaintiff need only submit evidence of the value of the services; the factfinder is permitted to infer that the charges are fair and reasonable. A plaintiff is not required to put forth expert testimony on the reasonableness of the value of the services during his or her prima facie case. If a defendant wishes to contest the fairness or reasonableness of the value asserted by a plaintiff, the burden shifts to the defendant to prove that the charges are unreasonable." Id. at 1055-56.
This Court believes the same process applies here. In the Joint Stipulation, Bard preserved its right to contest the reasonableness of Mr. Trevino's medical expenses. Mr. Trevino established his prima facie case that the treatment was necessary through the testimony of Drs. Fedder and DeNoto, Ms. Oka, and his medical records. Once Mr. Trevino presented evidence of the value of the medical care through the bills, the burden shifted to Bard to establish that the costs were unreasonable and unnecessary. As such, the only evidence that Bard introduced that might have challenged the necessity of this care was the testimony of Dr. Sinha. However, on a motion for judgment as a matter of law, the Court does not weigh the evidence. Rather, it looks at it in the light most favorable to the plaintiff.
Furthermore, § 9-19-27 is more akin to Process. The General Assembly provided that the submission of the medical bills themselves, along with an affidavit from the provider, not an independent party, is evidence of reasonableness of the care or cost. The statute then provides that any party may challenge the reasonableness which Bard failed to do even though it preserved its rights in the stipulation.
Therefore, viewing the evidence in the light most favorable to, and drawing all reasonable inferences in support of, Mr. Trevino, this Court is satisfied that the jury could reasonably find that medical expenses associated with Mr. Trevino's surgery were both medically necessarily and reasonable. See Broadley, 939 A.2d at 1020; see also McLaughlin, 754 A.2d at 98.
2 Present and Future Pain and Suffering
Bard further contends that Mr. Trevino failed to present any competent evidence to support a finding that he is either (1) presently experiencing any pain related to the Ventralex hernia repair or (2) likely to experience any pain in the future related to the Ventralex hernia repair. (Bard's Mem. at 16.) Mr. Trevino, on the other hand, maintains that his testimony adequately shows present and future suffering via his dislike of his physical appearance without a belly button, the crater in his stomach, and his fear of surgery. (Pl.'s Mem. at 61.)
This Court finds Bard's argument regarding present and future pain and suffering futile as it is unclear whether the jury awarded any damages for present and future pain and suffering. Based on the Verdict Form returned by the jury, Mr. Trevino was awarded $2 million for "past, present, and future pain and suffering." Therefore, this Court cannot discern what portion, if any, of the $2 million the jury awarded Mr. Trevino was for his future pain and suffering. However, the Court will describe in Section C, ii, 3, infra, that not only was the evidence of past and present pain and suffering sufficient to support the award, but that there was also evidence presented at trial which would support an award of future pain and suffering.
B
Motion for New Trial
Bard contends that the Court should order a new trial based on: (1) the jury's inconsistent verdict; (2) deficient and/or absent jury instructions; (3) damages being unsupported by the evidence; (4) the Court's error in admitting evidence of design defect and negligence "theories" unrelated to Mr. Trevino's alleged injuries; (5) admitting Dr. DeNoto's testimony regarding his differential contraction theory; (6) the admission of Material Safety Data Sheet (MSDS) and Technical Data Sheet (TDS) evidence; (7) admitting a document related to foreign regulatory activity and global complaints; and (8) juror misconduct. To the extent that any of Bard's arguments concern the Strict Liability Claims, the Court need not address them as the jury returned a verdict for Bard on those claims.
i
Inconsistent Verdict
1
Bard's Failure to Object to the Jury Instructions, the Verdict Form, and/or the Court's Answer to the Jury's Question Constitutes a Waiver
Bard asserts that it timely objected to the jury's inconsistent verdict and preserved that objection post-trial. (Bard's Mem. at 31.) Mr. Trevino, on the other hand, asserts that because Bard failed to object to the inconsistencies it now raises until post-trial briefing, such conduct amounts to waiver. (Pl.'s Opp'n at 64.)
First, as discussed below in greater detail, the jury instructions made it clear that there were three separate and independent counts for it to consider. Bard submitted a thirty-page memorandum objecting to the Court's instructions and further repeated those objections in a lengthy argument on the record. The Court has scoured that memorandum and transcript and while Bard objected to certain aspects of the negligence charge, the Court cannot discern an objection to negligence being a separate and distinct count.
Second, Question 4 of the Verdict Form asked: "If you answered yes to Questions 1, 2 or 3, please state the amount of money that Plaintiff has proven by the preponderance of the evidence that will fairly compensate Plaintiff for the following injuries and damages." (Verdict Form, Aug. 29, 2022.) (emphasis added). While Bard objected that there were too many damage categories and that the question did not emphasize that the damages had to be proximately caused by Bard,it never objected to the word "or" prior to the number "3."
Bard's Objections to the Court's Proposed Jury Instructions and Verdict Form at page 28 posits these objections to jury form and refers to "Question 3." However, based on the substance and context of the objection, the Court must conclude that "Question 3" is a typographical error and it should have been "Question 4."
Third, as will also be discussed below, the jury inquired if the answers to questions 1, 2, and 3 were independent of one another. The Court responded, after consultation with and without objection from the parties, that the answer to Question 3 (the negligence question) did not depend on, and was independent from, the answers to Questions 1 and 2.
This Court finds that Bard's failure to object to the relevant portions of the jury instructions, the Verdict Form, or the answer to the jury's inquiry constitutes a waiver on the merits of its contention that the verdict is inconsistent. Nevertheless, the Court will address this contention and, for the reasons stated below, finds that the verdict was not inconsistent.
2 The Law of Inconsistent Verdicts
Bard contends that there is no way to reconcile the jury's verdict in this case and, consequently, the Court should not have discharged the jury-against Bard's objection-or declined Bard's request to instruct the jury to remedy its inconsistent verdict. (Bard's Mem. at 17.) Conversely, Mr. Trevino argues that the jury's verdict is not inconsistent because under Rhode Island law, a plaintiff may "pursue negligence, design defect, and failure-to-warn claims simultaneously." (Pl.'s Opp'n at 64.)
The Rhode Island Supreme Court has only addressed the issue of inconsistent jury verdicts in the criminal context. Since this is a civil case, the Court will not only seek guidance from our Supreme Court but also from the First and Seventh Circuits, which have addressed the issue in the civil context.
It is well established that in a criminal prosecution, "'[consistency in the verdict is not necessary. Each count in an indictment is regarded as if it was a separate indictment.'" State v. Tully, 110 A.3d 1181, 1192 (R.I. 2015) (quoting State v. Allessio, 762 A.2d 1190, 1191 (R.I. 2000)). As such, courts generally hold that "'a jury must be afforded broad power to arrive at inconsistent verdicts of acquittal and conviction through its traditional power to compromise[]'" State v. Arroyo, 844 A.2d 163, 171 (R.I. 2004) (quoting State v. Romano, 456 A.2d 746, 764 (R.I. 1983)). In doing so, courts will "uphold logically inconsistent jury verdicts provided that the verdicts are legally consistent." Id. "[I]f 'the essential elements of the count[s] of which the defendant is acquitted are identical and necessary to prove the count of which the defendant is convicted,'" the verdict is deemed to be legally inconsistent. Id. (quoting Allessio, 762 A.2d at 1192).
Similarly, in the civil context, the circuit courts are generally "reluctant to order a new trial on the basis of inconsistent jury verdicts." Davignon v. Hodgson, 524 F.3d 91, 109 (1st Cir. 2008) (citing Connelley v. Hyundai Motor Co., 351 F.3d 535, 540 (1st Cir. 2003)); see Deloughery v. City of Chicago, 422 F.3d 611, 617 (7th Cir. 2005) ("A party claiming that inconsistent [jury] verdicts have been returned is not entitled to a new trial 'unless no rational jury could have brought back" the verdicts that were returned.'") (quoting Will v. Comprehensive Accounting Corp., 776 F.2d 665, 678 (7th Cir. 1985)); see also Acevedo-Diaz v. Aponte, 1 F.3d 62, 74 n.15 (1st Cir. 1993) ("A facially inconsistent verdict in a civil action-no rare phenomenon-is not an automatic ground for vacating the verdict.") (citing Fairmount Glass Works v. Cub Fork Coal Co., 287 U.S. 474, 485 (1933)). Rather, courts "'must attempt to reconcile the jury's findings, by exegesis if necessary ... before [it is] free to disregard [them].'" Id. (quoting Gallick v. Baltimore &Ohio Railroad Co., 372 U.S. 108, 119 (1963)). Although there is no "specific procedural rule to determine the existence of an inconsistency," courts will look to "whether the jury could have, consistent with its instructions, rendered the challenged verdicts." Davignon, 524 F.3d at 109 (citing Merchant v. Ruhle, 740 F.2d 86, 89 (1st Cir. 1984)). In doing so, the Court must "view the facts in the light most favorable to the verdict." Id.
3 The Jury's Finding of Negligence is Not Fatally Inconsistent as a Matter of Law
At the core of Bard's claim is that, given the Court's jury instructions, it was impossible for the jury to find that Bard was not strictly liable for design defect or failure to warn, but at the same time find that Bard was negligent. (Bard's Mem. at 23.) The fatal flaw in Bard's argument, however, is that Mr. Trevino's claim for negligence and his claims for strict liability (e.g., his claims for design defect and failure to warn) are separate, identifiable causes of action.
Before this Court goes any further and addresses the arguments made by the parties, the Court will emphasize that under Rhode Island law, a claim for negligence and a claim for strict liability are distinct from one another with each cause of action requiring separate elements. It is true that "'the elements of a strict products liability claim and a negligence claim based on a product defect overlap significantly, with the negligence claim having the additional requirement that the defendant knew or had reason to know.. .that the product was defective in any manner.'" Sweredoski v. Alfa Laval, Inc., No. PC 2011-1544, 2013 WL 1088826, at *4 (R.I. Super. Mar. 7, 2013) (quoting Guilbeault v. R.J. Reynolds Tobacco Co., 84 F.Supp.2d 263, 268 (D.R.I. 2000)) (internal quotation marks and brackets omitted) (emphasis added). However, a mere overlap in elements does not mean that negligence and strict liability are the same and that a verdict for one but not the other renders the verdict "inconsistent."
Under Rhode Island law, "'to prevail on a claim of negligence a plaintiff must establish a legally cognizable duty owed by a defendant to a plaintiff, a breach of that duty, proximate causation between the conduct and the resulting injury, and the actual loss or damage.'" Dextraze v. Bernard, 253 A.3d 411, 416 (R.I. 2021) (quoting Daniels v. Fluette, 64 A.3d 302, 304-05 (R.I. 2013)). A claim for strict liability, however, requires that the product itself be unreasonably dangerous. See Castrignano, 546 A.2d at 779; see also Restatement (Second) Torts § 402A. Thus, our Supreme Court has held that "if one of these three types of defects appears in the product and that defect renders the product unreasonably dangerous in spite of all reasonable care exercised by the manufacturer, then the manufacturer is liable for that defect." Castrignano, 546 A.2d at 779 (emphasis added) (citing Ritter v. Narragansett Electric Co., 109 R.I. 176, 190, 283 A.2d 255, 262 (1971)).
The three theories for establishing product liability include: (1) design, (2) marketing (failure to warn), or (3) manufacturing. See Guilbeault v. R.J. Reynolds Tobacco Co., 84 F.Supp.2d 263, 268 (D.R.I. 2000).
Furthermore, the notion that a claim for negligence and a claim for strict liability are distinct causes of actions is widespread. "The theories of strict liability and negligence are separate and different, and there is no inconsistency in a jury finding that there is a defect in a product but that a plaintiff has failed to prove negligence on the defendant's part." 3A Summ. Pa. Jur. 2d Torts § 41:210 (2d ed.) "Because negligence and strict liability are not mutually exclusive theories of recovery, an injury may give rise to claims that can be established under either theory, and failure to prove one theory does not preclude proving the other." Negligence and Strict Liability, Am. L. Prod. Liab. 3d § 28:14. "The key distinction between a negligence claim and strict liability claim lies in the concept of fault. In a strict liability claim, the focus is on the condition of the product. However, in a negligence claim, a defendant's fault is at issue in addition to the condition of the product." Id. Thus, "the crucial question in a negligent design case is whether the manufacturer exercised reasonable care in the design of the product." Id.
Moreover, it is not uncommon for a plaintiff to pursue both theories simultaneously. "A products liability case in which a plaintiff alleges strict liability also may be submitted to a jury on a theory of negligence; the plaintiff should not be required to elect between negligence and strict liability theories." 3A Summ. Pa. Jur. 2d Torts § 41:210 (2d ed.) "[W]ith respect to an action which may be brought as a strict liability action, the plaintiff may also proceed in negligence; when a set of facts will support both a theory of common law negligence and strict liability, a plaintiff is entitled to proceed on either theory or both." 41A Fla. Jur. 2d Products Liability § 23.
Bard relies on a plethora of caselaw from other jurisdictions in support of its argument that it cannot be found strictly liable and negligent simultaneously, as it would be considered an inconsistent jury verdict. Bard's contention, as it relates to whether the jury's verdict was inconsistent, is that "unreasonably dangerous" is synonymous with "reasonably safe." (Bard's Reply at 24.) Bard specifically relies on the fact that the drafters of Restatement (Third) Torts "substituted the phrase 'not reasonably safe' for the 'unreasonably dangerous' language in Section 402A of the Restatement (Second) of Torts." Id. at 25. Bard alleges that "[b]y choosing the phrase 'not reasonably safe,' the drafters did not intend to change the requisite proof but, rather, to frame the expected norm as a positive standard[.]" Id.
This Court finds Bard's reliance on such cases unfounded as Rhode Island law states that the elements of a negligence cause of action and strict liability cause of action do not contain the same elements. In regard to Bard's argument that the standards of "unreasonably dangerous" and "reasonably safe" are "different sides of the same coin," our Supreme Court has not yet adopted this view and still adheres to the negative formulation standard. Id. at 24, 26. Thus, this Court finds that, under the prevailing law, a defendant has the potential to be found liable for both negligence and strict liability, either cause of action, or neither.
Thus, the Court instructed the jury properly in accordance with Rhode Island law. To find for Mr. Trevino on his strict liability claims, the Court instructed the jury that they must have found that the Ventralex was unreasonably dangerous. (See Jury Instructions Nos. 14-15.) Specifically, the Court instructed the jury that in order to return a verdict in favor of Mr. Trevino for his design defect claim, the jury must find that "the Ventralex Patch was in a defective condition unreasonably dangerous when put to a reasonably anticipated use." (Jury Instruction No. 14.) (emphasis added). Similarly, the Court instructed the jury that a verdict in favor of Mr. Trevino on his failure to warn claim requires that "the Ventralex Patch was then unreasonably dangerous when put to a reasonably anticipated use without knowledge of its characteristics." (Jury Instruction No. 15.) (emphasis added). Conversely, the Court instructed the jury that to find general negligence, Mr. Trevino need only show that Bard "failed to use ordinary care to design the Ventralex Patch to be reasonably safe and/or to adequately warn of the risk of harm from the Ventralex patch." (Jury Instruction No. 16.) (emphasis added). Thus, this Court finds that the jury was properly instructed that negligence and strict liability are not identical theories of liability.
To that end, it is both possible and reasonable for the jury to have returned a verdict for Mr. Trevino on his negligence count while simultaneously returning a verdict for Bard on the strict liability counts. The First Circuit dealt with this issue in Connelly, 351 F.3d at 537-38 which dealt with an automobile accident resulting in the tragic death of a five-year-old. In Connelly, the decedent was sitting in the front seat of his parents' car when another car collided with the decedent's car, causing the airbags to deploy. Id. The decedent's estate brought claims under both a negligence theory and a strict liability against the defendant. Id. at 538. The jury returned a verdict finding that the defendant was negligent but was not strictly liable for any defective design. Id.
On appeal, the defendant argued, in part, that the jury verdict was inconsistent because "both counts required the jury to find, as an essential element, that the airbag system contained a design defect." Id. at 538-39. The First Circuit disagreed, explaining that based on the evidence presented at trial, the jury
"could have found negligence without finding Hyundai strictly liable. The jury could have rejected the strict liability count because it decided that, on balance, the benefit to the public of including the overly aggressive airbag system in the Sonata outweighed the danger caused by the airbag system (because the system saved many more lives than it took). At the same time, however, the jury could have concluded that Hyundai was negligent in failing to develop a less aggressive airbag system for the Sonata." Id. at 541.
The court concluded that a new trial was not warranted because based on the evidence presented at trial and the outcome of the verdicts, "that the jury understood that 'the focus of strict liability is on whether the design itself was unreasonably dangerous whereas in a negligence case the focus is on the conduct of the manufacturer.'" Id. at 542 (quoting Trull v. Volkswagen of America, Inc., 320 F.3d 1, 7 (1st Cir. 2002)).
Similarly, this Court finds that the jury verdict was not inconsistent as the jury could have reasonably found that Bard was negligent while simultaneously finding that the Ventralex patch was not unreasonably dangerous. For example, the jury may have found that Bard was negligent in failing to obtain permission to use the polypropylene or negligent in failing to adequately test the product prior to implantation or negligent in using large pores or negligent in using two different materials in the patch. Undoubtedly, there are other reasons to support a finding of negligence. Nevertheless, it is not for this Court to inquire into why the jury reached the verdict; rather, this Court must only determine if there was competent evidence upon which it could reach such a verdict.
4
The Jury Properly Followed the Jury Instructions
Bard next asserts that the returned verdict demonstrates that the jury failed to properly apply and follow the Court's jury instructions as well as the provided Verdict Form. (Bard's Mot. at 28, 35.) Mr. Trevino disagrees with Bard's assertion and contends that even if the jury instructions could be construed as error, Bard nevertheless "fails to show any prejudice or even the potential for prejudice that would warrant the extreme remedy of a new trial." (Pl.'s Opp'n at 71.)
The Court made clear in its jury instructions there were three separate causes of action before the Court on which the jury must deliberate. The Court instructed the jury appropriately of each element required for the causes of action:
"Plaintiff Paul Trevino contends that the Ventralex hernia patch.is defective in its design, had inadequate warnings, and that Defendant Bard was negligent.. .Bard denies that the Ventralex had a defective design or inadequate warnings, or that Bard was negligent.. .you should consider each of the claims separately." Jury Instruction No. 2 (emphasis added).
"Plaintiff must prove that it is more likely than not that the Ventralex device implanted in him was defective in its design, had inadequate warnings, and/or that the Defendant Bard was negligent." Jury Instruction No. 3 (emphasis added).
"Plaintiff has three (3) claims - design defect, failure to warn, and negligence." Jury Instruction No. 12 (emphasis added).
'"Proximate cause' is a necessary element of each of Plaintiff's three (3) claims brought against Defendant. The concept behind proximate cause is that even if a person has been negligent, or there was an alleged defect in a product or its warnings, that person will not be held responsible or liable unless that negligence conduct or the alleged defect caused actual harm to someone else." Jury Instruction No. 13 (emphasis added).
It is well established that, absent evidence indicating otherwise, courts generally "assume[] that the jury followed and understood the instructions of the trial justice." Ouellette v. Carde, 612 A.2d 687, 690-91 (R.I. 1992); see Rossi v. Hall, 430 A.2d 1072 (R.I. 1981); see also Brunswick Corp. v. Sposato, 120 R.I. 673, 389 A.2d 1251 (1978)). In this case, the Court has concrete proof that the jury read, followed, and understood the jury instructions based on the jury's detailed questions during deliberations. In response to a question submitted by the jury during deliberations, the Court made clear in its answer that the jury may consider each claim independently:
"Jury Question: "pg. 30 - Below question 3, in bold/italicized text, it states, 'If you answered 'Yes' to questions 1, 2, or 3, then answer question 4.' The juror's interpretation of this sentence is that each
of the three questions can be answered independently. We would like clarification on our interpretation..."
"The Court's Answer: "Each of questions 1-3 on the verdict form has to be answered independently of each other.[t]hose answers to questions 1 and 2 on the verdict form do not tell you how you should answer this part of question 3 on the verdict form."
This Court finds that this jury inquiry, as well as others where the jury posed questions pointing to specific pages and sentences in the instructions, provide indisputable evidence that the jury carefully read the instructions, were able to identify the issue(s) that they were tasked to answer, asked for clarification on their interpretation of the issue(s), and received an answer which allowed them to return their verdict. Therefore, this Court finds that the jury did follow the jury instructions.
ii
Improper or Missing Jury Instructions
1
Learned Intermediary
The Court addressed this issue in both Section IV, A, ii, supra, as well as in its decision on Bard's motion for summary judgment. See Trevino, 2022 WL 3223845, at *5-9. Therefore, this Court incorporates its reasons and basis from that decision herein.
2
Proximate Cause
Bard argues that the Court erroneously charged the jury by saying that to find for Mr. Trevino on his negligence claim, they must find that the "Defendant's failure to use ordinary care.proximately caused or contributed to Plaintiff's injuries." (Jury Instruction No. 16.) (Emphasis added.) However, Bard overlooks Jury Instruction 13 which states that "a cause that is a proximate cause may be the sole or only cause of an event or injury. Or, it may be one of two or more or even several causes of an event or injury." (Jury Instruction No. 13.) (Emphasis added.) If there can be more than one proximate cause for an injury, then each proximate cause "contributes" to the injury. Our Supreme Court, in recognizing that there can be more than one proximate cause, has used the word "contribute." See S.M.S. Sales Co. v. New England Motor Freight, Inc., 115 R.I. 43, 47, 340 A.2d 125,127 (1975).
Notably, the "contributed" language is also found in Bard's Proposed Instruction 36.Moreover, in Joint Proposed Instruction 2, "Bard denies that the Ventralex caused or contributed to Plaintiff's alleged injuries."
This language can also be found in Model Jury Instruction 1001.4. The Court acknowledges that the Model Jury Instructions have never been adopted as such by the Rhode Island Supreme Court. In fact, elsewhere in this opinion, the Court disagrees with one model instruction because it disagrees with established Supreme Court cases. This Court is unaware of any case that disputes Model Instruction 1001.4.
Secondly, Bard argues that the jury instructions did not tell the jury that they needed expert opinion on proximate cause. The Court disagrees that such an instruction was necessary but, in any event, as discussed in Section IV, A, iv., supra, there was sufficient testimony from Dr. DeNoto to establish causation.
Lastly, Bard argues that "the Court should have instructed the jury [that it] did not have the burden to prove the cause of Plaintiff's alleged injury or that another alternative cause was the proximate cause of that alleged injury." (Bard's Mem. at 43.) The Court is puzzled by this argument because it totally ignores the fact that prior to the commencement of voir dire, and again in the Court's opening instructions, within three minutes of the start of the trial, the jury was advised: "Keep in mind that the Defendants need not prove or disprove anything. The burden of proof is on the Plaintiff, Mr. Trevino, to prove that which he claims." (Tr. 3:13-16, July 28, 2022.) Moreover, in Jury Instruction No. 3, the Court further told the jury: "By contrast, defendant Bard is under no obligation to disprove that which the plaintiff asserts or claims." (Jury Instruction No. 3.) Since the jury was instructed on three occasions that defendants had no obligation to prove anything, to tell the jury that Bard need not prove an alternative cause is not only unnecessary but potentially confusing.
No daily transcript was ordered for voir dire so the Court cannot provide a transcript reference.
3
Independent Intervening Superseding Cause
Bard contends that the Court erred in not instructing the jury on independent intervening superseding cause. (Bard's Mem. at 36, 43-47.) Specifically, Bard argues that an intervening force is sufficient to absolve a defendant from liability. Id. at 44. This Court previously rejected this argument pretrial and does so again.
Prior to trial, Mr. Trevino sought partial summary judgment on the limited issue of Bard's ability to avail themselves of a superseding intervening cause affirmative defense. The essence of the dispute was whether the defense of superseding intervening cause requires a negligent act or merely a force. The Court addressed this argument in detail in its written decision on July 26, 2022 and incorporates its decision herein. See Trevino, 2022 WL 3223846. The essence of that decision is notwithstanding the Model Jury Instructions and Restatement (Second) Torts; the Rhode Island Supreme Court, in the cases cited in the Model Jury Instructions and in other cases has always required the intervening act to be a negligent act.
Bard contends that Dr. Sinha's testimony about the concerning aspects of Mr. Trevino's wound care was the evidence of the intervening superseding cause. (See Bard's Mem. at 44-46.) (See also Tr. 40:3-57:1, Aug. 19, 2022.) However, the Court finds that Dr. Sinha's testimony failed to establish negligence. Moreover, the Court sustained the objection to the question posed to Dr. Sinha: "in your opinion, to a reasonable degree of medical certainty, do you believe that Mr. Trevino's wound care management by Dr. Fedder and the team at the hospital fell below the standard of care." (Tr. 57:2-5, Aug. 19, 2022.) The basis for sustaining the objection was that at his deposition, the following colloquy took place:
"Q: So you've have not reviewed the standard of care and are not offering testimony that Dr. Fedder violated the standard of care.
...
"A:. . I was not asked to look at this record to make a statement about his -his overall care for Mr. Trevino. I have some concerns, as I said. And I can review that. But as to making a determination of standard of care or malpractice, I'm not prepared to do that." (Sinha Dep. Tr. 103:23-104:21, May 11, 2022.)
Thus, to have allowed Dr. Sinha to change his position at trial would have undermined the aim of discovery, which is to avoid ambush or surprise at trial.
4
State of the Art
Bard contends the Court should have instructed Bard on the state-of-the-art defense. (Bard's Mem. at 48-49.) However, the Court instructed the jury of the following: "A seller or manufacturer is under no duty to warn about product dangers that are not reasonably foreseeable at the time the product is sold." (Jury Instruction No. 15.) Moreover, the Court addressed the essence of this issue in its decision on Bard's Motion for Summary Judgment dated July 26, 2022 which is incorporated herein. See Trevino, 2022 WL 3223845.
5
Compliance with Government Regulations
Lastly, Bard wanted an instruction on compliance with government regulations. (Bard's Mem. at 49-50.) The government regulation at issue in this case is the FDA's 510(k) clearance process. Each side presented an expert witness, namely, Karen Trautman (Ms. Trautman), a former FDA employee, for Bard, and Anne Holland (Ms. Holland) for Mr. Trevino, who testified extensively about the 510(k) clearance process and Bard's application for the Ventralex. Other witnesses for both parties also testified about the FDA process and Bard's application. There was testimony which lauded the process and Bard's compliance and, as would be expected, testimony which was critical of both Bard's performance and the process itself. There was literature as well as a Congressional report critical of the 510(k) clearance process.
At the outset of the trial, the Court informed the jury briefly about the FDA and its process. (Tr. 8:13-9:6, July 28, 2022.) In its final instructions, the Court expanded on its original instruction on the FDA and concluded as follows:
"While you are free to consider the fact that the FDA cleared the Ventralex for sale in the United States, FDA clearance does not preclude you from rendering a verdict for the plaintiff. It is up to you to decide what weight, if any, to give the fact that the FDA cleared the Ventralex device." (Jury Instruction No. 8.)
The Court gave this instruction because it believed it to be fair and balanced, giving the jury the right to determine what weight to provide Bard's FDA clearance for the Ventralex. Moreover, this instruction is consistent with the Court's reasoning in deciding Bard's Motion in Limine No. 2, wherein the Court concluded that it would follow the reasoning Hrymoc v. Ethicon, Inc., 249 A.3d 191 (N.J. App. Div. 2021). The Court found Bard's proposed instruction to be onesided and thus rejected it and it still believes it was correct in so doing.
iii
Damages Unsupported by the Evidence
The Court has addressed the evidence which supports the damage award in Section IV, A, v, supra and IV, C, infra and incorporates that analysis herein.
iv
Theories Unrelated to Mr. Trevino's Alleged Negligence
Dr. DeNoto emphatically stated that the Ventralex caused Mr. Trevino's injuries. Therefore, any testimony or other evidence that indicated that the Ventralex was unreasonably dangerous or that Bard failed to exercise ordinary care in designing or warning about the Ventralex was relevant to Mr. Trevino's claims. The Court will review the evidence in Section IV, xi, infra.
v
Dr. DeNoto's Differential Contraction Theory
The Court addressed Dr. DeNoto's testimony in Section IV, A, iv, supra, and in a pretrial Daubert/DiPetrillo motion and need not revisit the admissibility of his testimony.
vi
Material Safety Data Sheet and Technical Safety Data Sheet Evidence
The Court will discuss the MSDS and TDS evidence in greater detail in Section IV, ix, infra. These documents were published by LyondellBasell, the manufacturer of the PPE resin that was the raw material from which the PPE side of the Ventralex was made. These sheets, in essence, said that the resin was not to be used in medical devices to be implanted in humans without the permission of the manufacturer. Based on a ruling on Bard's Motion in Limine No. 1, the Court gave the following instruction when the MSDS was first introduced:
"Members of the Jury.you heard counsel from both sides talk about what we call the material safety data sheet but will be talked
about throughout this as MSDS. I just want to give you a particular instruction about that. The first instruction is what I have already told you before. Everything you heard by both sides is their view of the case and how they're going to present it. None of it is evidence. Remember that.you're going to hear the witness actually talk about the MSDS.So what I want you to know is that the document that will be offered into evidence which is the polypropylene material safety data sheet known as an MSDS as well as later in the case you may see introduced something called a technical data sheet or a TDS, these documents are offered for a limited purpose. You are to consider them if you desire only in determining whether the Defendants knew or should have known of the contents of the document. You are not to consider the document as to the truth of the matter or matters asserted within the document. Neither you nor counsel should speculate as to why the resin manufacturer made any statement in the MSDS or TDS absent testimony or evidence presented as to their intent, though it's being offered for what we call notice." (Tr. 103:20-104:5; 104:13-105:4, July 28, 2022.)
The Court included a similar instruction when it charged the jury. (See Jury Instruction No. 9.) Bard repeatedly argued that its current or former employees should be able to testify that the reason for the warning was that LyondellBasell was concerned about litigation. The Court refused to allow such testimony because it was pure hearsay.
vii
Foreign Regulatory Activity
Bard believes the Court erroneously admitted Exhibit P1415-B when Dr. DeNoto was on redirect examination because it had previously ruled on a Motion in Limine that global complaints were inadmissible. Bard overlooks the fact that it opened the door when it peppered Dr. DeNoto with questions about complaint rates. The Court stands by its reasoning. (See Tr. 110:4-20, Aug. 10, 2022.)
viii
Juror Misconduct
It is well established both through caselaw and our legislative history that courts generally refrain from interfering with or reviewing the jury deliberation process after a verdict is returned. See Federal Rule of Evidence 606; see also Tanner v. United States, 483 U.S. 107, 120-21 (1987) ("[F]ull and frank discussion in the jury room, jurors' willingness to return an unpopular verdict, and the community's trust in a system that relies on the decisions of laypeople would all be undermined by a barrage of postverdict scrutiny of juror conduct.") Therefore, "[a] general rule has evolved to give substantial protection to verdict finality and to assure jurors that, once their verdict has been entered, it will not later be called into question based on the comments or conclusions they expressed during deliberations." Pena-Rodriguez v. Colorado, 580 U.S. 206, 211 (2017).
Despite this longstanding rule, which has become known as the "no-impeachment rule," Bard contends that "[a]t least three instances of juror misconduct occurred that completely undermine the verdict and substantially prejudiced Bard," thus warranting a new trial. (Bard's Mem. at 61.) Specifically, Bard relies on an affidavit (the R.G. Affidavit) which was obtained post-verdict when "a juror contacted counsel for Bard and disclosed" various concerns relating to the jury deliberation process. Id. at 61-62. (see Bard's Mem. Ex. A. (R.G. Aff.)) The R.G. Affidavit particularly identifies concerns surrounding (1) the Court's supplemental instructions; (2) the foreman's alleged one-on-one conversations with the jurors; and (3) significant bias on behalf of Juror No. 3/Seat No. 7. Id.; see also R.G. Aff. ¶¶ 3, 10.
Thus, based on the juror's allegations in the R.G. Affidavit, Bard maintains that a new trial or, in the alternative, an evidentiary hearing is warranted. (Bard's Mem. at 61.) Conversely, Mr. Trevino asserts that Bard's attempt to introduce the R.G. Affidavit into evidence "represent[s] a highly improper frontal assault on the sanctity of jury deliberations." (Pl.'s Opp'n at 96.) Furthermore, Mr. Trevino contends that not only does Rhode Island Rule of Evidence 606(b) prohibit such an investigation, even if such a review was allowed, the alleged misconduct is "legally [in]adequate to effect further inquiry into the validity of the jury verdict[.]" Id. at 99.
1
The Affidavit
Rhode Island Rule of Evidence 606(b) provides in pertinent part:
"Upon an inquiry into the validity of a verdict or indictment, a juror may not testify as to any matter or statement occurring during the course of the jury's deliberations or to the effect of anything upon his or her or any other juror's mind or emotions as influencing the juror to assent to or dissent from the verdict or indictment or concerning the juror's mental processes in connection therewith, except that a juror may testify on the question whether extraneous prejudicial information was improperly brought to the jury's attention or whether any outside influence was improperly brought to bear upon any juror." R.I. R. Evid. 606(b).
Every statement in the R.G. Affidavit deals specifically with what went on in the jury room and attempts to testify as to what influenced the jurors "to assent" "to the verdict." There is no reference in the affidavit to any "extraneous prejudicial information" or "any outside influence." As such, the Court finds the affidavit to be inadmissible. Nevertheless, the Court will proceed to address the issues raised in the affidavit.
2
Court's Supplemental Instructions
Based on the allegations made in the R.G. Affidavit, Bard asserts that the questions presented to the Court during the jury deliberation process were questions from the foreman alone, and not from the entire jury. (Bard's Mem. at 61-62.) (See R.G. Aff. at ¶¶ 3, 10.) Bard further alleges that the foreman never provided the Court's answers to the questions to the rest of the jury. Id. (see R.G. Aff. ¶ 4.) Thus, based on these allegations, Bard maintains that any of the Court's responses to the foreman's questions amount to ex parte communications, therefore, warranting a new trial. Id. at 62.
Generally, "[a] judge shall not initiate, permit, or consider ex parte communications, or consider other communications made to the judge outside the presence of the parties or their lawyers, concerning a pending or impending matter[.]" Rule 2.9 of the American Bar Association Model Code of Judicial Conduct.
Bard relies on an abundance of caselaw in which a new trial was granted or a verdict was reversed based on evidence of ex parte communications. See United States v. United States Gypsum Co., 438 U.S. 422 (1978); see also United States v. Cowan, 819 F.2d 89 (5th Cir. 1987); see also United States v. Peters, 349 F.3d 842 (5th Cir. 2003); see also Lukstas v. St. Francis Hospital &Medical Center, 583 A.2d 941 (Conn. Ct. App. 1990). However, none of the cases referenced by Bard are similar to the facts present here. Notably, in each of the referenced cases, the judge had clear, individual meetings with either the jury foreman or with the jurors themselves.
In this case, the facts are entirely different. Jury Instruction 32 provided specific instructions as to how the jury was to communicate with the Court. (See Jury Instruction No. 32.) The foreman was to write out the question, fold the paper, and deliver it to the sheriff who would give it to the Court. That is precisely what was done and, in each instance, the Court read the question to the lawyers, discussed its response, wrote it out, and delivered it to the sheriff who returned it to the foreman. Regarding the jury questions, there was no ex parte communication. Bard's counsel never objected to the process the Court followed. In fact, they participated in the process which formulated the answers. What happened in the jury room with the response is beyond the purview of the Court, and the Court can only assume that its instructions were followed.
Admittedly, the Court did communicate with the jury foreperson, once in the presence of the Court stenographer and once, on the record, with counsel. The foreperson sent a note indicating that one unidentified juror was being difficult and not participating in deliberations; thus, he inquired as to what should be done. Bard then requested that the Court declare a mistrial which it refused to do. After much discussion with counsel, the parties agreed that the difficult juror should be dismissed and that the Court, alone, in the presence of the stenographer, should ask the foreperson to identify the difficult juror. The Court did meet with the foreperson who identified the juror but added that she was now participating. The Court then brought in lead counsel for each side and asked the foreperson: "So there is no misunderstanding, you believe you can reach a verdict even with the person you described in your note earlier." The foreperson responded: "I believe there is a possibility." The Court responded: "Okay, go back to work." The Court does not believe, nor has Bard argued, that this conversation was an improper communication.
However, even if the Court's communication with the jury foreperson constituted an ex parte communication, a new trial would still not be warranted:
"[I]t is not simply the action of the judge in having the private meeting with the jury foreman, standing alone-undesirable as that procedure is-which constitutes the error; rather, it is the fact that the ex parte discussion was inadvertently allowed to drift into what amounted to a supplemental instruction to the foreman relating to the jury's obligation to return a verdict, coupled with the fact that counsel were denied any chance to correct whatever mistaken impression the foreman might have taken from this conversation, that we find most troubling. U.S. Gypsum Co., 438 U.S. at 462.
Here, there was no "drift" of the conversation and counsel was present and never indicated there might have been a "mistaken impression."
3
One-on-One Conversations between the Foreman and the Jurors
Bard further contends that in an effort to resolve deadlock, the foreman discussed with each juror privately and persuaded them to change their vote. (Bard's Mem. at 69.) (R.G. Aff. ¶ 6.) Such communications, Bard argues, were intended to influence the verdict and not only amount to extraneous information but also violated this Court's jury instructions. Id. at 70.
Bard equates this situation to People v. Alvarez, No. F054480, 2009 Cal.App. Unpub. LEXIS 4706 at *28 (June 15, 2009), an unreported case which involved a trial for attempted murder. In that case, after four days of deliberations, there were two jurors who were allegedly voting not guilty. On his way home, the foreperson called one of the holdouts, discussed the substance of the case, told the juror that she had already reported the other holdout to the judge, and threatened to report the juror on the phone to the judge if she did not convince the other juror to vote guilty. The next morning the jury returned a guilty verdict. The trial judge subsequently granted a new trial. The issue on appeal to California's intermediate appellate court was not whether there was jury misconduct, because the parties conceded that point; rather, the issue on appeal was whether the trial judge failed to consider the strength of the state's case in determining whether the misconduct was prejudicial.
This case is not equivalent to Alvarez. The conversations did not occur outside the courthouse and there are no allegations of threats or that there was specific discussion of the substance of the case. In Alvarez, there was detailed testimony of what was said by the foreman to the other juror. In the R.G. Affidavit, the only allegation is that the foreman "talked to each juror, persuading them to change their vote to 'no, no, yes,' in order to break the deadlock." (R. G. Affidavit ¶ 6.)
Even if the Court were to admit the R.G. Affidavit, it is unreliable. She contends that there was a deadlock on August 25, 2022 and that the next morning, August 26, 2022, the foreman took each juror into a separate room. The facts do not support this story. On August 26, 2022 at 1:10 p.m., the Court sent a message to the foreman asking if they could reach a verdict that day and, if necessary, the Court could arrange to have the jury stay after 4:00 p.m. The response: "At 1:20 p.m. I would say the answer to your question is No. However, I will state that there has been positive movement TODAY towards reaching a verdict. Therefore, I believe we need more time." The jury did not reach a verdict until mid-day the following Monday and this Court does not find it is not credible that the affiant would confuse the next morning with after a weekend. Interestingly, Bard, in its memorandum, glosses over this error in the R.G. Affidavit and says it was on Monday, August 29, 2022 that the foreman met one on one with the jurors. (Bard's Mem. at 69.)
As explained above, this Court is not responsible for what goes on in the jury deliberation room and it is not up to this Court to inquire. See Pena-Rodriguez, 580 U.S. at 211. For these reasons, this Court will not hold any evidentiary hearing whereby jurors are subjected to examination and cross-examination.
4
Juror No. 3/Seat No. 7 Questionnaire Responses
Lastly, Bard maintains that "Juror No.3/Seat No. 7's self-proclaimed and undisputed bias warrants a new trial." (Bard's Mem. at 71.) Bard relies on the R.G. Affidavit, which details the alleged comments and statements made by Juror No. 3/Seat No. 7 during deliberations which are purportedly contradictory to the statements made on the juror questionnaire. Id. at 71-72.
The Supreme Court of the United States recently dealt with the question of whether Federal Rule of Evidence 606(b) "precludes a party seeking a new trial from using one juror's affidavit of what another juror said in deliberations to demonstrate the other juror's dishonesty during voir dire." Warger v. Shauers, 574 U.S. 40, 42 (2014). In Warger, the petitioner, Gregory Warger (Mr. Warger), was riding his motorcycle when he was struck from behind by the respondent, subsequently requiring Mr. Warger's left leg to be amputated. Id. at 42. During voir dire, Mr. Warger's counsel asked the potential jurors whether they believed they could be fair and impartial in returning a verdict, to which all jurors, including the foreman, answered yes. Id. at 42-43.
After the jury returned a verdict against Mr. Warger, one of the jurors contacted Mr. Warger's counsel to inform them of some concerns regarding the jury foreman's conduct during deliberations. Id. at 43. Specifically, the juror explained that the foreman "had spoken during [jury] deliberations about a motor vehicle collision in which her daughter was at fault for the collision and a man died, and had related that if her daughter had been sued, it would have ruined her life." Id. (Internal quotations omitted.) Thus, based on the statements made by the juror, which was later placed in an affidavit, Mr. Warger moved for a new trial on the grounds that the foreman "deliberately lied during voir dire about her impartiality and ability to award damages." Id.
The Supreme Court of the United States concluded that the affidavit sought to be introduced by Mr. Warger was not admissible as evidence of "extraneous prejudicial information... improperly brought to the jury's attention" under Federal Rule of Evidence 606(b). Id. The Supreme Court explained that information is "'extraneous' if it derives from a source 'external' to the jury." Id. at 51. For example, "publicity and information related specifically to the case the jurors are meant to decide[.]" Id. Conversely, internal matters are "general body of experiences that jurors are understood to bring with them to the jury room." Id. Thus, the Supreme Court reasoned that although the jury foreman's daughter's accident "may... have informed her general views about negligence liability for car crashes.it did not provide either her or the rest of the jury with any specific knowledge" about the instant case. Id. at 52. As such, the Court concluded that "[w]hether a juror would have been struck from the jury because of incompetence or bias, the mere fact that a juror would have been struck does not make admissible evidence regarding that juror's conduct and statements during deliberations." Id. at 53.
Bard contends that Juror No. 3/Seat No. 7 lied about the level of her education, had "already had her mind made up since day one" about the outcome of the case and, therefore, "refused to participate in deliberations because she already knew the law." (Bard's Mem. at 71) (See R.G. Aff. ¶¶ 8-9.) This Court does not see how any of these alleged statements, even if true, amount to extraneous information that would warrant this Court to look further into the jury deliberation process. Like the jury foreman in Warger, although Juror No. 3/Seat No. 7 may have had preconceived views of products liability cases, there is nothing in the R.G. Affidavit to indicate that she had any specific knowledge of the case.
Furthermore, if Juror No. 3/Seat No. 7 demonstrated a lack of impartiality, the Court does not find that the alleged statements require a new trial. The only exception to the hesitancy to grant a new trial based on a juror's lack of impartiality recognized by the Supreme Court of the United States is evidence that indicates a juror relied on racial animus or stereotypes. See Pena-Rodriguez, 580 U.S. at 211.
Rooting its decision on public policy and this country's longstanding goal of eliminating racial bias, the Supreme Court explained:
"All forms of improper bias pose challenges to the trial process. But there is a sound basis to treat racial bias with added precaution. A constitutional rule that racial bias in the justice system must be addressed-including, in some instances, after the verdict has been
entered-is necessary to prevent a systemic loss of confidence in jury verdicts, a confidence that is a central premise of the Sixth Amendment trial right." Id. at 225.
For these reasons, the Supreme Court outlined a balancing test to determine when a juror's alleged racial bias will overcome the no-impeachment rule:
"[T]here must be a showing that one or more jurors made statements exhibiting overt racial bias that cast serious doubt on the fairness and impartiality of the jury's deliberations and resulting verdict. To qualify, the statement must tend to show that racial animus was a significant motivating factor in the juror's vote to convict. Whether that threshold showing has been satisfied is a matter committed to the substantial discretion of the trial court in light of all the circumstances, including the content and timing of the alleged statements and the reliability of the proffered evidence." Id. at 22526.
There is no question that there is no evidence to support a finding that Juror No. 3/Seat No. 7 indicated any racial bias in her deliberation process. Even if Juror No. 3/Seat No. 7 had a bias toward Bard, such bias is not sufficient to warrant a grant of a new trial. Thus, for the foregoing reasons, this Court does not find any sufficient evidence of juror misconduct.
ix Super Juror
As discussed above in the section entitled "Standard of Review," a trial justice, in deciding a motion for new trial, sits as a super juror, reviews the evidence, and makes one of three choices: (1) he or she disagrees with the verdict because there was insufficient evidence to support the outcome; (2) he or she agrees with the verdict because the "evidence is evenly balanced;" or (3) he or she determines that reasonable minds could have come to different conclusions. Johnston Equities Associates, LP, 277 A.3d at 742. If the trial justice finds insufficient evidence to support the verdict, the Court must grant a new trial. Id. Alternatively, if the trial justice either finds that the evidence is balanced or that reasonable minds could differ, the motion for new trial must be denied.
In this matter, the jury returned a verdict in favor of Bard on the Strict Liability Claims. Thus, this Court need only examine the evidence with respect to the jury's finding that Mr. Trevino proved "by a preponderance of the evidence that Bard was negligent and that such negligence was a proximate cause of plaintiff's injuries." (Verdict Form, Question 3, Aug. 29, 2022.) The Court need not conduct an exhaustive review of the evidence which, in this case, consists of over 2,700 pages of transcript and hundreds of exhibits. See Johnston Equities Associates, LP, 277 A.3d at 742. The Court will, however, refer with some specificity to the evidence which leads it to conclude that reasonable minds could have differed in reaching a verdict in this case. Thus, for the reasons described below, this Court denies Bard's Motion for New Trial.
While customarily, a trial justice, in deciding a motion for new trial, would say whether he or she agrees or disagrees with a jury's verdict, the Court will refrain from so doing. The reason is that this Court is handling this master docket litigation with thousands of cases and will be trying two bellwether cases per year. At oral argument, the Court inquired whether it would be prejudiced from future cases if it were to decide that it agreed or disagreed with the jury's verdict. While Bard's counsel replied in the negative, the Court is concerned that such a decision might give the appearance that it favored one side or the other and, therefore, will refrain from providing an opinion on whether or not it agrees or disagrees with the verdict.
1
Expert Credibility
At the outset, this case presented a classic battle of the experts. As would be expected, each expert offered testimony to support the side that engaged him or her. Nevertheless, whether testifying for Bard or Mr. Trevino, all of the retained experts were well credentialed and very knowledgeable of the facts of the case that pertained to their expertise. Despite testifying on a complex subject matter riddled with medical and scientific terminology, each expert's opinion was generally expressed with clarity and in a way that the jury and the Court could understand. Moreover, each expert was also familiar with the opposing side's expert reports and depositions of witnesses. Therefore, experts for both Bard and Mr. Trevino were prepared to articulate the reasons why different or opposite conclusions were reached. To that end, each expert also generally withstood vigorous cross-examination by opposing counsel and, in almost all cases, maintained their original positions and did not retract the testimony given on direct.
Credibility, in the sense of truthfulness, was not an issue with respect to the experts-"one assigned expert was [not] substantially better qualified or more credible and more worthy of belief than the others." Cappuccilli v. Carcieri, 174 A.3d 722, 729 (R.I. 2017). Rather, the issue this Court must address in regard to the experts is whose opinion was more persuasive, and that question goes to what weight to give each expert's opinion. The Court instructed the jury on how to view expert testimony as follows:
"The opinion of an expert is to be considered by you in the same manner as the testimony of any other witness. In other words, it is for you to determine the weight you will give such opinion and to determine its credibility in the light of all the other evidence. As with any other testimony, you may accept all of it, some of it, or none of it as you collectively deem appropriate. In addition, you should consider the factual basis for the expert's opinion." (Jury Instruction No. 11.)
The Court believes that the jury followed this instruction and that, on the issue of negligence, the jury obviously gave more weight to Mr. Trevino's experts. Nevertheless, the Court believes that reasonable minds could differ as to what weight to give the testimony of the experts and, as will be discussed below, finds that there was sufficient credible testimony from both the expert and lay witnesses to support a finding of negligence on Bard's part.
2
Negligence
As all lawyers learn in their first-year torts class, the elements of negligence are (1) duty, (2) breach of the duty, (3) damages, and (4) proximate cause. See Holley v. Argonaut Holdings, Inc., 968 A.2d 271, 274 (R.I. 2009) (citing Willis v. Omar, 954 A.2d 126, 129 (R.I. 2008) (quoting Mills v. State Sales, Inc., 824 A.2d 461, 467 (R.I. 2003))). It is undisputed that Bard owed a duty to Mr. Trevino to produce a safe product. Furthermore, although there is a dispute as to the amount of Mr. Trevino's damages, there is no dispute that he incurred and is entitled to damages. As such, the disputed issues in this case pertaining to negligence involve (1) whether Bard breached its duty to Mr. Trevino and (2) whether that breach was the proximate cause of Mr. Trevino's injuries.
The Court provided the following instruction on negligence to the jury:
"In order to recover for negligence in this case, plaintiff must prove, by a fair preponderance of the evidence, that defendant breached its duty of care to plaintiff to exercise the ordinary care expected of a reasonable medical device manufacturer in designing and/or provision of warnings for use of the Ventralex. Put another way, your verdict must be for plaintiff if you believe: First, defendant designed and labeled the Ventralex patch, and second, the Ventralex patch was defective in design and/or lacked adequate warnings, and third, defendant failed to use ordinary care to design the Ventralex patch to be reasonably safe and/or to adequately warn of the risk of harm from the Ventralex patch, and fourth, defendant's failure to use ordinary care in the design and/or warnings of the Ventralex patch proximately caused or contributed to plaintiff's injuries." (Jury Instruction No. 16.)
As there is no dispute that Bard designed and labeled the Ventralex, Bard's negligence therefore turns on the latter three elements.
As discussed above in Section IV, B, i, entitled "Inconsistent Verdict," to prevail on his claim for negligence, Mr. Trevino did not have to prove that the Ventralex was unreasonably dangerous (the strict liability standard) but rather that Bard failed to exercise ordinary care to ensure that the Ventralex was reasonably safe. Mr. Trevino argues that the evidence adduced at trial establishes that Bard failed to exercise ordinary care by: (1) overengineering the Ventralex; (2) using a resin that was not intended for use in medical devices or for implementation in the human body; (3) failing to properly test the device; and (4) having inadequate quality control. Mr. Trevino further asserts that Bard failed to use ordinary care to warn of the potential problems with the Ventralex including, but not limited to, buckling, contracting, folding, and ring breaking. Lastly, Mr. Trevino contends that he presented sufficient evidence to support his award of damages, but that discussion will be left to Section IV, C, infra, which addresses Bard's motion for a remittitur. Nevertheless, the Court incorporates the analysis from that section herein.
The Court believes that, notwithstanding Bard's evidence to refute these assertions, the jury could have reasonably accepted Mr. Trevino's evidence and thus found Bard negligent. The Court will proceed to summarize the credible evidence that supports this conclusion.
3
The FDA 510(k) process
This Court believes that a brief discussion of the FDA's 510(k) clearance process is in order as many of Bard's witnesses discussed Bard's compliance as a defense to Mr. Trevino's claims.
In 1976, Congress enacted a statute regulating medical devices "to provide for the safety and effectiveness of medical devices intended for human use." See 21 U.S.C. §§ 301-399. The FDA was tasked with issuing regulations to classify medical devices as Class I, II or III wherein the higher the classification number, the higher the risk associated with the medical device. Hernia mesh is classified as a Class II medical device. There are two ways to bring a medical device to market: (1) through pre-market approval (PMA) and (2) by establishing that the medical device is substantially equivalent to a device already on the market. PMA requires the FDA to find that the device is safe and effective and is the required method for bringing any new medical device to market post-1976 with all devices already on the market grandfathered in.
As the 510(k) clearance process does not equate with a finding of safety and efficacy, many courts have excluded evidence that a product has received FDA clearance. Bard previously moved to admit evidence about the FDA and the 510(k) clearance process in a Motion in Limine. (See Bard's Motion in Limine No. 2.) While the Court granted the motion, it required the cautionary instructions, which this Court previously discussed, to be given during the trial and in the final jury instructions. (See Tr. 5:6-43:2, July 27, 2022.) (See also Jury Instruction No. 8.)
For an excellent discussion of the history of the 510(k) process and the evidentiary approaches of various courts, this Court directs the reader's attention to Hrymoc v. Ethicon, Inc., 249 A.3d 191 (N.J. App. Div. 2021).
At trial, there was evidence that the 510(k) process has been criticized. Specifically, in 2011, the Institute of Medicine published a report identifying "challenges" of the process. (Tr. 55:3-20, Aug. 18, 2022.) The report stated, in pertinent part:
"Stimulated by reports of problems with several 510(k) devices, the public, legislatures, the Government Accountability Office, the Department of Human Health Services Office of the Inspector General, and the courts, including the Supreme Court, have all questioned the logic and value of the 510(k) clearance process being used by a federal agency charged with responsibility for protecting and promoting the public's healths.....
"In reviewing the legislative and regulatory history of the 510(k) program, the committee found that it was designed in 1976 to provide only a determination of the substantial equivalence of a new device to an already marketed predicate device. It was not designed to determine whether a new device provides a reasonable assurance
of safety and effectiveness or whether it promotes innovation." Id. at 61:1-21.
Moreover, Dr. Robin Shandas (Dr. Shandas), a biomedical engineer, discussed the role the FDA plays in developing a medical device and explained that the FDA is the one that "set[s] the rules that the medical device developers need to follow." (Tr. 96:2-4, Aug. 11, 2022.) However, Dr. Shandas noted that just because a medical device company may follow the FDA's rules, that does not guarantee a safe, effective product. Id. at 96:4-9.
Based on the foregoing, the Court finds that sufficient evidence was introduced throughout the trial that could lead a reasonable jury to conclude that FDA 510(k) clearance was not a finding that the Ventralex was safe and effective.
4
The Resin - Profax 6523
As mentioned earlier, the Ventralex is comprised of two layers, one of PPE and the other of ePTFE. The process of creating the PPE layer begins with a resin which is extruded by a subcontractor into a yarn or filament and is then woven into the mesh. To make the PPE layer of the Ventralex, Bard used the Profax 6523 resin (the Resin) manufactured by LyondellBasell. Bard never purchased the Resin directly from LyondellBasell; rather, it was bought by a third party, Red Oak Sales (Red Oak), Bard's yarn supplier. On May 8, 2006, LyondellBasell published an MSDS for the Resin which included a disclaimer stating, "Unless specifically indicated, the grades mentioned are not suitable for applications in the pharmaceutical/medical sector, particularly, (A) in any commercial or developmental application which is intended for contact with human internal body fluids or body tissues, regardless of the length of time involved ..." (Trial Ex. P-1342-002.)
As discussed earlier, this exhibit was admitted for notice only.
Bard argued that there was no evidence indicating that it ever saw this MSDS. However, in an e-mail chain in 2004, Mr. Darois responded to an inquiry by Dr. Blank about finding an appropriate PPE for cardiac stents, saying that he would turn over the request to one of his engineers. Mr. Darois added:
"We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers. Thus, it is likely that they do not know of our implant application. Please do NOT mention Davol's [Bard] 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." (Trial Ex. P-1089-004.) (Emphasis added.)
Later in the e-mail chain, the engineer responded with information about resins but further concluded: "Once again we need to be certain that we don't contact the resin supplier directly due to the sensitivity of our implant application." Id. at 002 (emphasis in the original).
Whether Bard saw the MSDS is immaterial as the evidence clearly suggests that Bard knew that LyondellBasell did not want the Resin used in medical devices that were to be implanted in humans. Bard wanted both Stephen Eldridge (Mr. Eldridge), a Research and Development manager for Bard, and Mr. Darois to testify that the reason LyondellBasell did not want the Resin used in medical devices was out of concern about lawsuits. The Court refused to admit such testimony because it is black letter law, hearsay. However, even if the Court allowed such testimony it would still be speculative as to why LyondellBasell was concerned about lawsuits. Perhaps LyondellBasell was unsure whether medical devices were an appropriate or safe use for the Resin, and thus, if someone was injured LyondellBasell could be held liable. Nevertheless, unless someone from LyondellBasell were to testify, the reason for the concern about lawsuits cannot be known.
To that end, LyondellBasell never relented on its position that the Resin should not be used in medical devices. Notably, an MSDS issued on August 12, 2008 for the Resin again stated that the Resin should not be used in a "US FDA Class III Medical Device[.]" (Trial Ex. P-0994.d_003.) Again, on December 19, 2017, the MSDS added language which said the product may not be used in "applications involving permanent implantation into the body." (Trial Ex. P-1338_012.)
In 2019, LyondellBasell discovered that one of its distributors was selling the Resin to Red Oak for a prohibited use. (See Trial Ex. P-0029.b_368.) The distributor replied, "Had we known that the customer was using Pro-fax 6523 in a prohibited medical application, we would have never sold the product to them." (Trial Ex. P-0029.b_370.) The distributor then ceased all sales to Red Oak and took back any inventory of the Resin in the possession of Red Oak. Id. Bard then submitted to LyondellBasell a Medical Request Form with documentation requesting that it be allowed to continue to use the Resin in its products. (See Trial Ex. P-0029.c.) LyondellBasell denied the request reiterating its position that hernia mesh is a prohibited application for the Resin. (See Trial Ex. P-0029.a.)
Bard argues that LyondellBasell's action in 2019 was long after Mr. Trevino's implant in 2008 and explant in 2017. Conversely, Mr. Trevino contends that this evidence demonstrates that Bard was continually aware that LyondellBasell prohibited the use of the Resin and, nevertheless, used it in the Ventralex until it was caught.
At trial, the parties argued over the term "medical grade resin." Bard asserted that no such thing existed and, certainly, there were no specifications for such material. On the other hand, Mr. Trevino produced evidence that the term "medical grade" was used in the relevant literature. (See Trial Exs. P-1057_001 and P-0296_003.) Furthermore, Scott Guelcher, a professor of chemical engineering at Vanderbilt University, who was familiar with the term, provided the following context:
"Well, medical grade implies that it's intended for implantation in the body so when I worked at Bayer, we had prohibitions on selling our industrial chemicals for biomedical use so we had these medical use prohibitions. So medical grade would generally imply that it's suitable for implantation but there isn't a technical legal definition. It tends to depend on the company." (Tr. at 115:6-12, Aug. 5, 2022.)
Obviously, by that definition, LyondellBasell did not believe the Resin was medical grade because it prohibited its use for medical devices which would be implanted in the body.
For the foregoing reasons, the Court finds that there was sufficient, credible evidence upon which the jury could reasonably find that Bard did not exercise ordinary care in selecting the Resin to be used in the Ventralex.
5 The Ventralex Design
Dr. Klinge is a surgeon at the University Hospital of the Technical University in Aachen, a small town on the border of Belgium and the Netherlands. (Tr. 13:7-10, Aug. 1, 2022.) Dr. Klinge is an expert in hernia mesh development and biomaterials, spending "more than 30 years of [his] scientific life for the investigation of hernia disease, best hernia treatment and particularly with focus of biomaterials of the meshes." Id. 13:21-24. Dr. Klinge is also a member of the German Society of Surgeons, the European Hernia Society, and the German Hernia Society. Id. 17:17-25. He has published approximately 300 articles in peer-reviewed journals-140 of which focus on surgical mesh-and has been cited over 10,000 times by other authors. Id. 23:21-24:6; 24:14-18.
Dr. Klinge testified remotely from Belgium and, because of the time zone differences, he only testified from 9:00 a.m. to 1:00 p.m. over the course of four days. On the first day of his testimony, Dr. Klinge identified three features of the Ventralex that are allegedly poorly designed: (1) the mesh itself; (2) the inclusion of ePTFE; and (3) the PET ring. (Tr. 14:7-10; 14:16-22; 16:518, Aug. 1, 2022.) To that effect, Dr. Klinge opined that three characteristics of a well-designed mesh are: (1) having the best polymer for the mesh's purpose; (2) being the appropriate strength (e.g., amount of materials); and (3) having large pores. Id. 32:18-33:22.
Dr. Klinge discussed, at length, the importance of having the appropriate amount of materials because "more material induces inflammation and scarring[.]" Id. 33:5. In the case of the Ventralex, Dr. Klinge testified that the mesh is overengineered, meaning that there "is more material than is necessary to compensate [the] force that is needed for hernia repair...." (Tr. 4:34, Aug. 2, 2022.) When reviewing a photo of an explanted Ventralex, Dr. Klinge explained that the implantation of a foreign body causes inflammation to occur which, in turn, causes "the formation of thick fibrous tissue which usually is [a] scar[.]" Id. 5:10-13.
To that effect, Dr. Klinge testified that there are scientific studies-including his own research-all of which predate the implantation of Mr. Trevino's Ventralex in 2008 that discuss the effects of overengineered mesh. (Tr. 7:21-8:22, Aug. 2, 2022.) In fact, it appears that Bard was on notice of such information based on a summary of literature on mesh products found within Bard's files. (See Trial Ex. P-1218.) Dr. Klinge was asked about each article and its corresponding summary by counsel at trial and testified that each summary supported his position and testimony regarding mesh products. (See Tr. 15:17-22:23, Aug. 2, 2022.)
In regard to Dr. Klinge's opinion on the small pore design of the Ventralex, Dr. Klinge explained that based on his research, an appropriate distance between mesh fibers should be one to two millimeters. Id. 25:3-13; 25:20-24. Dr. Klinge testified that the Ventralex has pore sizes less than .5 millimeters, which is "far below the critical value of 1 millimeters or even 2 millimeters." Id. 25:20-24. Thus, based on his expertise, Dr. Klinge opined that "[t]he polypropylene part of the Ventralex surely is a very small pore construction, and if you consider that it is even double layered so the pores are filled with more plastic material then it is really very tiny pores that are open for some tissue recovery or some tissue repair." Id. 29:24-30:3. Interestingly, it appears that Bard also knew of the benefits of a large pore mesh design based on a PowerPoint presentation entitled "Bard* Soft Mesh" created by a marketing associate. (See Trial Ex. P-1221.a.)
This Court admitted, as full, only pages 2, 8, 9, 10, and 11 of P-1221.a. (See Aug. 2, 2022 Tr. 26:4-12, 27:3-4.)
Regarding the ePTFE layer of the Ventralex, Dr. Klinge testified that ePTFE is intended to prevent adhesions which he described as "scars that form within the abdominal cavity after almost all kinds of surgery." (See Tr. 34:12-18, Aug. 2, 2022.) Specifically, Dr. Klinge described the importance of a material like ePTFE is to protect the PPE mesh from having any contact with organs, such as the bowel. Id. 34:18-35:2.
Dr. Klinge further differentiated PPE from ePTFE explaining that ePTFE does not have pores and, therefore, no tissue ingrowth can occur. Id. 35:16-21. Based on a review of various studies regarding whether ePTFE successfully stops adhesion formation, Dr. Klinge opined that "[t]he addition of the [e]PTFE cannot avoid the formation of adhesions for sure, and it cannot avoid the exposure of the polypropylene to the bowel for sure, but it increases the shrinkage of the device." Id. 36:7-10. He described the consequences of that as follows:
"It causes the film is encapsulated by this scar and because of this increased contraction on this, you have a folding of the entire device and then the part that usually lays through the abdominal wall with the polypropylene itself becomes apparent and then the bowel have [the] opportunity to stick to this polypropylene part with all the risks for bowel damage." (Tr. 36:12-18, Aug. 2, 2022.)
To that end, Dr. Klinge reviewed various animal studies, to include a 2000 study on Composix Mesh implanted into a rat, as well as another study conducted on a pig. Id. 36:1950:1. (See Trial Exs. P-0028, P-0256.) Ultimately, Dr. Klinge concluded that although "[t]hese studies are of limited value, very small amount of animals, very short period of follow-up but they all - none of it could show that the aim of the additional [e]PTFE could be reached, none of it." (Tr. 50:6-9, Aug. 2, 2022.) Furthermore, in reviewing a mesh implant study on a pig, Dr. Klinge explained that there was "similar tissue integration of the device, and in humans as predicted you can see the shrinkage, folding, you can see the exposure of the polypropylene to the bowels. So all of the risks that has been suspected have been seen in this pig experiment as well." Id. 53:712. (See Trial Ex. P-0028.) Dr. Klinge further noted that the study identified buckling and adhesions in several of the test patients which Dr. Klinge explained as "significant" because it implied that the ePTFE was not successful. Id. 53:19-54:10.
While not the Ventralex, the Composix Mesh is similar in that it has PPE and ePTFE layers.
Although the animal studies may be of limited value, Dr. Klinge discussed the pig study based on the similarities in tissue between pigs and humans. Dr. Klinge explained that because of the size of rats, "you have very, very tiny mesh particles that you implant there and the surgical trauma is too big[.]" (Tr. 52:8-10, Aug. 2, 2022.) Conversely, pigs are more similar and, moreover, the device implanted into the pig had similar properties as the Ventralex (e.g., polypropylene and ePTFE as well as a similar ring design).
Thus, based on a review of the animal studies, Dr. Klinge opined that "the [e]PTFE layer is a risk as you cannot exclude the formation of adhesions, you cannot exclude the exposure of the polypropylene to the bowels and even more [e]PTFE is well known if there is some infection in this area, you always have to remove the complete device because the body is not able to clear the infection from this device." (Tr. 50:22-51:3, Aug. 2, 2022.) As such, Dr. Klinge concluded that the risks presented by the ePTFE layer are "increased shrinkage of the device by this encapsulated scar formation, this folding and the exposure of the polypropylene to the bowels there and an increased risk for chronic infection in case of contaminated wounds." Id. 51:10-14.
Lastly, Dr. Klinge identified two additional problems with the Ventralex posed by the PET Ring: (1) it causes the device to deform, increasing the likelihood that the polypropylene will be exposed to the bowels and (2) it can degrade, causing sharp edges which can result in bowel penetration. (Tr. 4:3-21; 5:17-21, Aug. 3, 2022.)
In concluding his direct testimony, Dr. Klinge submitted:
"Each of these features increase the risk for the patients, and, therefore, for every one of these features you have clearly to show that these are necessary and reviewing all of this literature and reviewing all of these documents I didn't find any good arguments why this over-engineering is necessary, why this small pores are necessary, [why] the [e]PTFE layer is necessary or why the PET ring is necessary and thus justifies the additional risks for the patient." Id. 6:9-17.
Moreover, Dr. Klinge referred to a Danish hernia registry study, which identified the Ventralex as the worst performing mesh starting after six years. Id. 8:1-4. Conversely, the Danish study also identified the Ventralight mesh, a different product produced by Bard, as the best performer. Id. 8:4-7. Based on a comparative study between the two meshes, Dr. Klinge found the fact that the Ventralight is not over-engineered-it has a reduced amount of material, no ePTFE layer, has larger pores, uses another polymer, and it does not have a ring-determinative as all four risk features that he identified as troublesome were eliminated. Id. 8:22-9:2.
The Ventralight was not cleared for sale until 2010, sometime after Mr. Trevino's Ventralex was implanted in 2008. However, Bard's counsel, in questioning Dr. Klinge, pointed out that it takes years to bring a product to market and, therefore, someone could reasonably conclude that, prior to 2008, Bard was aware of the benefits of lightweight large pore mesh.
Dr. Klinge was cross-examined for two mornings and he never yielded his position. He was confronted by Bard's counsel with articles that came to different conclusions, and although Dr. Klinge acknowledged these studies, he merely concluded that scientists frequently disagree.
Bard further called Dr. Maureen Reitman (Dr. Reitman), a licensed mechanical engineer and polymer material scientist as its expert witness to testify regarding the Ventralex design. Dr. Reitman disputed Dr. Klinge and Dr. DeNoto's theories about buckling or contracture and additionally concluded that, based on the scientific and medical literature available, there is no evidence to support Dr. DeNoto's theory of differential contracture (e.g., that composite mesh with one side contracting at a different rate than the other causes buckling) or Dr. Klinge's opinion on buckling. (Tr. 62:1-9, 63:14-17, Aug. 12, 2022.) Dr. Reitman further maintained her ground regarding her opinion on degradation and buckling when confronted with various articles that conclude the opposite. While she acknowledged the opposing literature, which does discuss degradation, she explained that those studies likely do not account for the "controls" that she included in her own studies. Id. 129:8-130:5.
The testimony provided by Dr. DeNoto, Dr. Klinge, and Dr. Reitman simply demonstrates how scientists can disagree. Despite the differences in opinions between the experts, however, this Court finds that the evidence suggests that Bard itself was aware of the possibility of buckling. In an e-mail dated June 15, 2006, Dennis Cherok (Mr. Cherok), Bard's Program Manager for Product Development, received a description of a complaint related to an explanted Ventralex: "As you can see there is a buckle in the middle of the piece along the long axis and I don't think it's a reach to understand why patient was experiencing pain if the buclking [sic] was present while implanted." (Trial Ex. P-0366.) Mr. Cherok replied, "The buckling could be a result of tissue ingrowth and the resultant contracture of the mesh in the patch; the ring can't contract." Id.
Furthermore, Bard, as early as 2005, in its marketing materials for a different mesh product called Bard Soft Mesh touted Dr. Klinge's work: "1) Previous studies have shown lightweight and material reduced meshes to be advantageous in hernia repairs. 2) The amount and structure of an implanted mesh can affect the foreign body reaction of the patient. Reducing the amount of material in the mesh is one of the factors associated with easing this reaction." (Trial Ex. P-1217.) Additionally, Mr. Darois testified, "If there's a high degree of wound contracture, complications like infection or a seroma that impedes wound healing, the patch can form some tissue. If the tissue changes shape and contracts, the product can contract with it, of course." (Tr. 32:16-20, Aug. 16, 2022.)
The Court finds that it would have been reasonable for the jury to accept as more persuasive the testimony of Dr. Klinge, and, as such, reasonable minds could have concluded that Bard did not use ordinary care to design the Ventralex.
6
Testing the Ventralex
Dr. Shandas is a biomedical engineer with almost thirty years of experience in his field. (Tr. 65:24-25; 66:19-21, Aug. 11, 2022.) Dr. Shandas testified on Mr. Trevino's behalf as an expert in biomaterials, biomedical design, and plastics. Id. 85:20-86:2.
Before delivering his opinion, Dr. Shandas explained the importance of conducting biocompatibility testing on implantable medical devices:
"[B]iocompatibility testing is extremely important because you're designing devices, products, that go into the human body, and so as a function of that, you have to attain a standard of safety compatibility so as the term implies, biocompatibility, you want to ensure that your device and the materials that it is composed of are as safe as possible." Id. 78:1-7.
Dr. Shandas additionally provided the following opinion on why animal studies are relevant and relied upon by scientists:
"[B]enchtop testing, as I said, it provides a controlled environment. I can control certain variables and I can measure how the product and components of the product behave, but they are not biological environments so animal testing provides a really important conduit between benchtop testing and human use. Animals are biological creatures. They have obviously biological environments, and it's your responsibility as a medical device designer or developer to make sure that your device undergoes animal testing such that you understand how it responds in a biological environment." Id. 78:1323.
To that end, Dr. Shandas opined that, based on his reviews of the design files and other documents, "Bard conducted a very small number of tests. They didn't do full biocompatibility testing on the device. They didn't do any animal studies on the device and so they didn't evaluate whether the device was in fact truly safe the way they're supposed to do for medical design." Id. 96:24-97:3.
When reviewing a model of the Ventralex, Dr. Shandas explained that the Ventralex is a "very complex device." Id. 98:1. As such, Dr. Shandas submitted that with such a complex device with "multiple materials, multiple mechanical complexities, . . . it's important to fully test both the components of the device, all the different materials that we talked about and the device as a whole through the spectrum of biocompatibility[.]" Id. 101:4-9. Thus, Dr. Shandas explained that Bard "should have conducted the degradation testing on those different materials independently and then....should have conducted degradation testing on those materials as a whole." Id. 102:23103:2. In fact, Dr. Shandas said such testing, in his opinion, would have been "the minimum standard." Id. 103:2-3.
Dr. Shandas further opined that while Bard did complete testing in accordance with ISO10993 standard, other testing such as animal and degradation testing was not completed and, therefore, there was not enough testing completed to determine safety. Id. 110:11-17.
Furthermore, Dr. Shandas opined that based on various documents and publications predating 2008, Bard was on notice of some failure mechanisms such as mesh shrinkage, ring breakage, and contracture and, therefore, should have tested to determine whether those failure mechanisms applied to the Ventralex. Id. 114:9-122:3. (See Trial Exs. P-0257; P-0366; P-0292; P-0112; and P-0028.) When asked on cross-examination whether Bard complied with FDA regulations, Dr. Shandas explained that Bard did comply; however, it is "still incumbent upon you as a device manufacturer to make sure the device is safe." (Tr. 131:20-132:17, Aug. 11, 2022.)
Ms. Holland, an expert in the field of quality systems and quality assurance, further testified that Bard did not do any testing on the PPE for sensitization, genotoxicity, or implantation. Furthermore, Ms. Holland testified that Bard did not perform any original testing for cytotoxicity, sensitization, genotoxicity, or implantation. (Tr. 85:13-19, 86:3- 87:1, Aug. 1, 2022.) Instead of conducting original testing on the Ventralex device, Ms. Holland testified that Bard relied on the data from the Kugel device. Id. at 85:4-7. Ms. Holland further stated that Bard "didn't perform the density, tear resistance, and tensile test, mainly because they didn't do it before and saying they didn't do it before and you didn't have a problem with it so now we're not going to do it again." Id. at 88:20-24.
Several Bard witnesses testified about Bard's testing. However, the animal testing was on smaller animals such as rats and even when Bard did complete a validation study with surgeons, it only used three surgeons, to which the auditors Bard hired admitted "is difficult to construct a valid scientific rationale for [a] sample size of three[.] (Tr at 9:16-17, Aug. 16, 2022.)
Thus, the Court finds that reasonable minds could differ on whether Bard engaged in adequate testing before bringing the Ventralex to market.
7
Quality Control
Ms. Holland is a consultant for medical device manufacturers having worked in the industry for about thirty-five years. (Tr. 36:24-37:-3, Aug. 1, 2022.) In fact, at the time that Ms. Holland testified, she had owned her own consulting company for twenty-one years. Id. at 45:24. In reviewing the material to come to her conclusions, Ms. Holland reviewed "thousands of documents[,]" including medical device reports and 510(k) records, and she measured those documents against industry standards and regulations. Id. at 71:19-21, 73:4-11.
Ms. Holland testified that she saw a "weakness" in Bard's supplier controls. Id. at 75:710. For example, Ms. Holland pointed out that Bard did not always have contracts with key suppliers guaranteeing that Bard would be notified if a change was made to the product or component. Id. at 75:10-13. Ms. Holland further stated that FDA regulations make clear that "you need to have control of the suppliers and purchasing controls and your specifications[,]" but identified Bard's controls were weak. Id. at 75:15-17. Moreover, Ms. Holland found "very, very fishy" the e-mails discussed above in Section IV, J, iv, where Bard did not want LyondellBasell to know it was using the Resin in a medical device. Id. at 100:21-23.
Ms. Holland additionally testified that Bard's risk management systems were "really worse than weak." Id. at 75:18-19. In fact, Ms. Holland even went so far as to declare that Bard's risk management systems were "incomplete." Id. at 76:6-7. Further, Ms. Holland attested that Bard did not do any risk management reports, and Ms. Holland "found very few hazard analysis [sic]." Id. at 75:22-24.
Moreover, Ms. Holland was unimpressed with Bard's design failure mode and effect analysis (DFMEA). (Tr. 95:11-24, Aug. 2, 2022.) Ms. Holland testified that Bard's DFMEA was troublesome because 79 percent of the potential failure modes resulted in no action being taken. Id. at 95:11-18. For example, one potential failure mode or hazard was tissue adhesion to the ePTFE sewing monofilament material. Id. at 97:1-10. Ms. Holland indicated that the DFMEA rated this potential failure mode as a four on a severity scale of one to five, but the recommendation was that no action was necessary. Id
Ms. Holland was also critical of Bard's complaint handling system. Id. at 106:5-7. Ms. Holland stated that the definition of a complaint is any expression of dissatisfaction, oral or written, and that all complaints are required to be counted. (Tr. 76:10-15, Aug. 1, 2022.) However, Ms. Holland testified that Bard did not classify an expression of dissatisfaction as a complaint where they did not have the complained about product in hand. Id. at 76:15-19. Thus, Bard often did not do any analysis to review the device history record. Id. Additionally, Ms. Holland asserted that Bard's complaint handling system was not linked to its investigation system, and, therefore, there was no communication tying the complaint handling system to any control system or corrective and protective action (CAPA) system. Id. at 77:13-16.
To that end, Ms. Holland noted that Bard's complaint handling system was ineffective due to an inability to track and trend complaints. (Tr. 109:17-21, Aug. 2, 2022.) Ms. Holland further testified that Bard's CAPA system was not working well as "complaints were allowed to come in for months and months without action being taken[.]" (Tr. 83:22-25, Aug. 3, 2022.) Ms. Holland stated that there was no linkage of Bard's complaint handling system to its CAPA and investigation systems for "many years." Id. at 84:1-7. In short, Ms. Holland declared that Bard's complaint handling system was "very, very poor." (Tr. 106:5-7, Aug. 2, 2022.)
Bard additionally called Ms. Trautman, a biomedical engineer and a regulatory and end quality consultant, to testify as an expert in medical device quality management systems, quality assurance, regulatory compliance, and purchasing controls and industry standards in these areas. Ms. Trautman spent twenty-four years working at the FDA in the Office of Compliance within the Center for Devices and Radiological Health. (Tr. at 82:13-16, 85:17-21, Aug. 16, 2022.) In 2016, Ms. Trautman left the FDA and went into the consulting business. Id. at 94:18-22.
Ms. Trautman opined that Bard's quality system was "in substantial compliance" with regulatory requirements. Id. at 112:18-23. Ms. Trautman further clarified that substantial compliance "means that the quality system in place is functional. It's meeting those baseline core requirements and is constantly striving for continuous improvement and efficiency." Id. at 113:715. Specifically, Ms. Trautman testified that she found "tons of evidence that [Davol's design control] was in substantial compliance with the regulatory requirements." Id. at 113:16-25. In particular, Ms. Trautman asserted that she found the design history file for the Ventralex design to be "compliant, thorough[,]" and without any particular problems. Id. at 122:9-13. Ms. Trautman testified that Davol's purchasing and supplier controls complied with regulatory requirements. Id. at 114:1-5. Ms. Trautman pointed to the fact that Davol had an agreement with its first-tier supplier which "was laying out specific specifications." Id. at 133:11-24. Also, Ms. Trautman testified that Davol placed "some fairly strict requirements on [its] first tier supplier that they don't have the right to change any of the formulation[.]" Id. at 135:11-18. Ms. Trautman stated that it is not always possible to have such supplier agreements and manufacturers only have control of first-tier suppliers. (Tr. 55:14-22, Aug. 17, 2022 (afternoon session).) In short, Ms. Trautman opined that Davol was "diligent in its supplier controls[.]" (Tr. 136:21-24, Aug. 16, 2022.) However, this agreement was with Red Oak and not LyondellBasell.
Finally, Ms. Trautman testified that Davol's risk management system was compliant with regulatory requirements. (Tr. 65:21-66:2, Aug. 17, 2022 (afternoon session).) Specifically, Ms. Trautman testified that Davol's complaint handling system was compliant with regulatory requirements. (Tr. 114:23-115:5, Aug. 16, 2022.) On cross-examination, Ms. Trautman stated that it is not unusual for complaints to be pending for several months at a time and that "may be [a] perfect practice depending on the situation and the complaint." (Tr. 36:22-37:2, Aug. 17, 2022 (afternoon session).)
The difference in the Court's mind between Ms. Holland and Ms. Trautman is that Ms. Holland spoke of specific problems and concerns while Ms. Trautman's fallback was to simply say that Bard complied with regulatory requirements.
Contrary to Ms. Trautman's assertions, Bard engaged a company to review its quality control system which made 123 suggestions for corrective action to Bard's quality control system. (See Trial Exs. P-0635a and b.) Ms. Trautman's testimony was further undermined by a third party internal audit of Bard's complaint system based on FDA standards where it found ten deviations from regulations that could have been issued by the FDA if it did an inspection. In addition, the audit included eight which "are not necessarily deviation from FDA regulation, but corrective action or improvement should be considered in order to prevent the potential for a deviation, facilitate communication, improve business processes, improve operational efficiency, or increase robustness of the quality system." (Trial Ex. P-0515_005.)
The Court concludes that a reasonable jury could give more weight to the testimony of Ms. Holland and her opinions on quality control.
8
Warning
While the Court will never know if the jury found that Bard failed to use ordinary care in warning about the potential problems with the Ventralex, there is evidence to support that conclusion.
As discussed in Section IV, A, iii, supra, notably, Dr. Fedder himself stated that if he had known that Bard used polypropylene without permission from the manufacturer, LyondellBasell, his decision to implant the Ventralex may have been different. (See Fedder Dep. Tr. 49:21-50:22, Mar. 11, 2022.) In addition, Dr. Klinge, in addressing the Ventralex's Instructions for Use (IFU), testified that the warning section failed to mention contracture, ring buckling, ring breaking, ring fraying, or erosion. (See Tr. 163:21-164:14, Aug. 4, 2022.) (See also Trial Ex. DX-1880.) Notably, the adverse reactions section of the IFU does not mention any of these complications either. (Tr. 164:15-23, Aug. 4, 2022.)
While Bard presented testimony that IFU was adequate, the testimony of both Drs. Fedder and Klinge was credible and could have been the basis for reasonable minds to conclude that Bard did not use ordinary care in developing its warnings about the Ventralex.
9
Causation
The testimony of Dr. DeNoto on causation was discussed at length in Section IV, A, I, above and is incorporated herein.
Dr. Sinha, a witness for Bard, is a general surgeon and is currently the Chief of Surgery at Norwell Hofstra Staten Island Hospital. While Dr. Sinha has performed thousands of hernia repairs and has implanted several hundred Ventralex patches, he has neither explanted a Ventralex nor seen a Ventralex buckle or erode into the bowel. Dr. Sinha reviewed in detail Mr. Trevino's medical records and the many procedures that were performed on him from 2006 to 2018. Dr. Sinha performed a differential diagnosis and "[his] opinion is that the Ventralex did not contribute to [Mr. Trevino's] injuries and that he had a number of other factors, including the management of infection in the wound after the 2017 surgery that.. .contributed to his injuries." (Tr. at 134:14, Aug. 18, 2022.) Dr. Sinha further disagreed with Dr. DeNoto's theory of differential contracture and the conclusion of both Dr. Fedder and Dr. DeNoto that the Ventralex had eroded in the bowel.
Furthermore, Dr. Reichle, a board-certified radiologist at Mt. Auburn Hospital in Cambridge, Massachusetts, also testified for the defense. In his expert report, Dr. Reichle indicated that he thought the bowel obstruction was at the level of the mesh which was similar to Dr. DeNoto's testimony. Nevertheless, he later changed that opinion at trial and said he had made a mistake. (Tr. 64:4-24, Aug. 17, 2022, (morning session).)
Bard's last witness, Dr. Robert Babkowski (Dr. Babkowski), the Chair of Pathology at Stamford Health in Connecticut, testified that based on his review of the report of the pathologists who examined the specimens taken by Dr. Fedder after the explant, he concluded that the mesh did not erode into the bowel.
The experts all read the same medical reports and reviewed in detail the same CT scans yet came to different conclusions about erosion. Notably, Dr. Reichle even changed his opinion from his report to his testimony. The Court believes, based on his testimony alone, reasonable minds could have accepted Dr. DeNoto's view that the mesh eroded into the bowel and his conclusion is buttressed by the testimony of Dr. Klinge, Dr. Fedder, and Ms. Oka.
Moreover, Dr. Klinge testified at length about scarring and stated that the scar will eventually contract over time, causing the device to fold and become deformed. (Tr. 5:16-18, Aug.2, 2022.) When asked whether the contracture of a scar can lead to complications, Dr. Klinge explained that
"[t]he contraction of the scar, first of all, leads to a reduction of the device area, and therefore, it favors the manifestation of the recurrence at the border of these shrunk meshes. Second, it makes it a completely stiff device and it is placed in a very flexible abdominal wall so you have a miss between the flexible abdominal wall and the device and, therefore, likely to have some discomfort for the patient there. So the more the intense scar formation encapsulated all the nerves in around this area as well, and, therefore, this excessive scar formation is linked to chronic pain." Id. 5:25-6:10.
Dr. Klinge also said that extensive contraction would favor the manifestation of recurrent hernias. Id. 6:20-22. Thus, Dr. Klinge submitted that "[i]f you want to design a mesh or if you want to produce a mesh, you have to consider what are the forces of the mesh that are necessary to guarantee a good hernia repair." Id. 7:7-11.
On cross-examination, when asked about whether the specific details of a patient are necessary to determine why certain complications occurred, Dr. Klinge answered in the negative, explaining that he does not "need any specific detail to say that a mesh in use in inflammation and scarring and scarring shows and develops shrinkage. That is independent of the conditions of a specific patient there. This is a general effect that happens there and that large pores are better than small pores." (Tr. 33:22-34:3, Aug. 3, 2022.)
Moreover, Dr. Klinge reviewed photos from the animal studies and explained the significance of polypropylene being in direct contact with the bowel:
"Any direct contact of polypropylene to the bowel bears an increased risk for damage of the bowel either by breaking of the polypropylene into the bowel and forming a fistula or at least at any revisional operation, secondary operation, which comes later. Then the separation of the polypropylene with the bowels usually means that you - that damage to the bowel occurs and the need for bowel
resection is must higher if you have fistulas between polypropylene and bowel." (Tr. 56:24-57:7, Aug. 2, 2022.)
On cross-examination, Bard's counsel attempted to illicit testimony from Dr. Klinge that fistulas can happen spontaneously. (Tr. 37:13-15, Aug. 3, 2022.) Dr. Klinge submitted that although "[a] surgeon doesn't need a mesh to create a fistula . it is well known that polypropylene meshes form dense adhesions to the bowel and that is - that there is a higher risk for forming some fistula[.]" Id. 37:17-18; 38:15-17. As such, Dr. Klinge stated that "if you have a patient with an umbilical fistula, you have to check whether this is related to the underlying mesh material." Id. 38:18-20. So while he never saw Mr. Trevino's records, his opinion as to why the Ventralex was not well designed supports the testimony of Dr. DeNoto that the Ventralex was the cause of Mr. Trevino's injuries.
Only two witnesses saw Mr. Trevino's abdomen at the time of the explant-Dr. Fedder and Ms. Oka. Dr. Fedder wrote in his "Post Op Note" signed within hours of the explant surgery, "In the midline where the hernia was too [sic] small hernias were reduced and the small bowel was adherent to the mesh in the midline. This was carefully dissected but was found to have an area of erosion of the mesh into the small bowel which was entered during the dissection with minimal spillage." (Trial Ex. P-3051-122.) In a medical record prepared a few weeks later, he wrote "56-year-old male.. .presented with recurrent hernia which was fixed with removal of mesh that had entered into a loop of small bowel." (Trial Ex. P-3052.) The parties debated as to what Dr. Fedder may have said at his deposition about erosion, but the jury could have reasonably believed that his contemporaneous writings were the most accurate description of what he saw.
Furthermore, Ms. Oka said Mr. Trevino's abdomen was a mess with crumpled up mesh and adhesions. She testified:
"Q: So you just described the mesh as crumpled up. So the mesh was not laying flat?
A: Correct." (Oka Dep. Tr. 30:16-24, Mar. 4, 2022.)
"Q: Okay. And lastly, the October 26th surgery, Dr. Fedder noted that the mesh eroded into the small bowel; correct?
A: Correct.
Q: In your experience, would you ever leave an eroded piece of mesh in a bowel?
A; Not that I have seen surgeons do. They usually will remove it." Id. 153:7-14.
The Court finds that reasonable minds could differ as to whether the Ventralex was the cause of Mr. Trevino's injuries.
10
Summary
The Court has reviewed the evidence, which extends even beyond what has been mentioned herein, and it has assessed the credibility of the experts and the weight to be given their testimony. The Court concludes that reasonable minds could have come to different conclusions on whether Bard failed to use ordinary care to design the Ventralex patch to be reasonably safe and/or to adequately warn of the risk of harm from the Ventralex patch, and that failure to use ordinary care in the design and/or warnings of the Ventralex patch proximately caused or contributed to plaintiff's injuries. (See Jury Instruction No.16.) Consequently, the Court denies Bard's Motion for New Trial.
C
Remittitur
After nearly four weeks of trial, the jury returned a verdict in favor of Mr. Trevino and awarded him the following: (1) $2 million for bodily injury; (2) $300,000 for past medical expenses; (3) $2 million for past, present, and future pain and suffering; and (4) $500,000 for physical disfigurement, for a total award of $4.8 million. (See Tr. 3:10-24, Aug. 29, 2022.) Bard contends that the jury's award is "excessive and should be reduced because it was not based on evidence and/or constituted duplicative awards." (Bard's Mem. at 72.)
i
Past Medical Expenses
To the extent that Bard requests a remittitur for past medical expenses based on insufficient evidence to support the reasonableness and necessity of those expenses, this Court reincorporates its analysis from Section IV, A, v, 1, supra. To that end, in response to Bard's argument that the award is excessive and "demonstrates that the jury proceeded from a clearly erroneous belief that [Mr. Trevino]'s past medical expenses were reasonable and necessary," this Court disagrees. (Bard's Mem. at 73-74.)
Mr. Trevino presented, as evidence, the medical bills associated with the various procedures he endured as a result of the Ventralex explant. (Tr. 124:14-18, Aug. 23, 2022.) (See Tr. Exs. P-3071-3083.) As noted by Mr. Trevino's counsel in his closing argument, the medical bills totaled $291,658.14. Id. 124:21-23. This Court has no way of knowing how or why the jury reached the amount of $300,000 but it appears to be the jury's effort at rounding. Damages need not be determined by a jury with exactitude or precision. As such, this Court is unconvinced that an additional $8,341.86 or, less than 3 percent, is so conscience-shocking, so excessive, or so clearly indicative of passion or prejudice of the jury as to require a remittitur. See Hough, 101 A.3d at 856. Accordingly, this Court denies Bard's motion for remittitur on the award of past medical expenses.
ii
Bodily Injury, Pain and Suffering, and Physical Disfigurement
Bard also requests a remittitur of the jury's award for bodily injury, pain and suffering, and physical disfigurement on the grounds that (1) the awards are duplicative of one another; (2) evidence submitted at trial indicates that the Ventralex explant did not result in any new scarring; and (3) no evidence was presented to demonstrate any present or future pain or suffering as a result of the Ventralex. (Bard's Mem. at 74.)
1
Duplicative Awards
Bard first argues that "[t]he jury's three separate awards for bodily injury, pain and suffering, and physical disfigurement.. .are duplicative of one another and constitute double recovery.. .because each [damage] is an element or component of one another." Id. This Court disagrees with Bard's notion that all three categories of damages-bodily injury, pain and suffering, and physical disfigurement-are duplicative of one another; instead, finding that each is its own independent category of damages. For each individual damage category, the Court instructed the jury of the following:
"Plaintiff is entitled to be compensated for the bodily injury that he sustained as a proximate result of the accident and for any impairment that resulted from those bodily injuries. This injury to the body is different from the pain and suffering that you may find was caused by the bodily injury." Jury Instruction No. 22.
"Disfigurement, such as significant scarring, is compensable in damages. It is an aspect of bodily injury and impairment.It is an aspect of the pain and suffering that stems from bodily injury." Jury Instruction No. 24.
"Pain means physical pain, the kind resulting from a physical impact or injury. Suffering, on the other hand, can be equated with what we sometimes call the mental anguish that arises from physical
pain or injury to the body. Suffering means recognizing the pain, the danger resulting from the pain, the knowledge that the pain and treatment for it will continue. If you find that Plaintiff has proven that in addition to physical pain, he has also experienced fright, anguish, nervousness, grief, anxiety, worry, humiliation, embarrassment, or shock, then Mr. Trevino is entitled to recover for this mental suffering. Additionally, if you determine that there is medical evidence establishing to a reasonable certainty that the Plaintiff will endure pain and suffering into the future as a result of his injuries, then you may award damages for future pain and suffering." Jury Instruction No. 25 (emphasis added).
Admittedly, the Court's instruction on disfigurement states that it is an aspect of both bodily injury and pain and suffering, but the Court does not believe that language would confuse the jury or cause them to award duplicative damages. As discussed in Section IV, B, 4, this jury read the instructions carefully and when it did not understand an instruction or thought there might be an inconsistency in the instructions, they had no hesitancy in submitting a question to the Court. In this instance they did not do so.
The Court will also observe that it has, in other cases, and it is aware that its colleagues have done so as well, instructed on several categories of damages and yet the verdict form asks for total damages without itemization. No one has ever found that system duplicative or confusing.
2
Scarring
Bard further avers that "the jury's award of $500,000 for physical disfigurement is also excessive in light of the undisputed evidence that the 2017 surgery that resulted in the removal of [Mr. Trevino]'s Ventralex did not actually result in any new scars." (Bard's Mem. at 74.) It is true that Mr. Trevino did have prior scars, especially a long scar running along the midline of his chest and abdomen resulting from the mid-1990s laparotomy, and some other scars from surgeries pre-2017. (See Tr. 17:22-18:16, Aug. 10, 2022.) However, Mr. Trevino testified that, as a result of his procedure, he lost his belly button resulting in a "crater" in his stomach. (Tr. 11:3-19, Aug. 11, 2022.) (See Tr. 25:3-15, July 29, 2022.) Mr. Trevino spoke of how it impacted playfulness with his grandchildren as he lives in Hawaii where going to the beach is something he enjoys but now he will no longer take off his shirt, which he did prior to the explant even with the prior long scar. While the Court believes Mr. Trevino was entitled to recover for disfigurement, the Court finds that $500,000 is excessive and will grant a remittitur of $250,000.
3
Pain and Suffering
The Supreme Court "has not adopted a mathematical formula for the computation of damages for pain and suffering." Perry v. Alessi, 890 A.2d 463, 472 (R.I. 2006); see, e.g., Tilley v. Mather, 84 R.I. 499, 501-02, 124 A.2d 872, 874 (1956). "The establishment of the amount to be awarded for such damages has always been left, under proper instructions, to the discretion of the jury." Id. at 502, 124 A.2d at 874. "It has been our policy to allow the jury substantial latitude in computing the amount to be awarded as damages for pain and suffering and to reduce the jury's verdicts in this respect only when it appears that they are grossly excessive." Id.
"Grossly excessive means that 'a demonstrable disparity' exists between the amount awarded and the amount of pain and suffering shown to have been endured." Perry, 890 A.2d at 472-73 (quoting Tilley, 84 R.I. at 502, 124 A.2d at 874). It is "the duty of the trial justice to reduce the jury's verdict if such a disparity exists." Perry, 890 A.2d at 473. "[U]nless the verdict with respect to ... pain and suffering is such as to shock the conscience and to strongly suggest that the jury was influenced by passion or prejudice or that it proceeded upon some erroneous basis in ascertaining the amount of the award, a court will not interfere with the amount set out in the verdict." Ruggieri v. Beauregard, 110 R.I. 197, 201, 291 A.2d 413, 415 (1972).
As explained above, Bard objected to the separate awards for bodily injury, pain and suffering, and physical disfigurement. (Bard's Mem. at 74-75.) (Bard's Objections to Proposed Jury Instructions and Verdict Form dated Aug. 22, 2022 (Bard's Obj.) at 27-28.) Specifically, Bard alleged that the "brea[k] down and present[ation] to the jury [of] four different categories of damages.is unfairly suggestive to the jury on the damages that should be awarded and unfairly prejudices Bard." (Bard's Obj. at 28.) Similarly, Bard objected to the award of any present or future pain and suffering based on insufficient evidence presented at trial and, even if he had, its duplicative of the physical disfigurement award. Id. However, there is no indication by either party that the Court improperly instructed the jury on how to compute damages for pain and suffering, and the award of pain and suffering does not appear to be grossly excessive in light of the evidentiary record of Mr. Trevino's intense and increasing pain, multiple surgeries, substantial subsequent period of recovery, and continued mental anguish.
This Court has reviewed the evidentiary record, to include the transcripts from the depositions and expert witness testimony presented at trial and finds that the jury's award does not shock the conscience of this Court. Dr. DeNoto testified that the Ventralex having eroded into the bowel could cause bowel obstructions. Mr. Trevino's surgery in October 2017 was necessitated by a bowel obstruction which caused him great pain. Mr. Trevino endured forty days in the hospital and underwent eight procedures after the Ventralex was explanted. Testimony from Ms. Oka demonstrates the amount of pain Mr. Trevino had to endure following his explant surgery, to the extent of being unable to handle bedside procedures. (Oka Dep. Tr. 60:10-14, Mar. 4, 2022.) Furthermore, although not indicative of Mr. Trevino as a person, Ms. Oka testified as to the difficulties of having Mr. Trevino as a patient. Id. 81:21-82:1. ([Mr. Trevino] ...was just difficult to treat.because of the pain he was having. So the noncompliance came that he didn't want to have dressing changes at the bedside; but in his defense, it's because it was so painful, and so that's why we would go to the O.R. all the time.") Mrs. Trevino showed a video of the wound vac process. Both Dr. Fedder and Ms. Oka testified that to change the wound vac and the dressings Mr. Trevino was under general anesthesia. (See Fedder Dep. Tr. 63:21-25, Mar. 11, 2022.) (See also Oka Dep. Tr. 54:22-25; 60:11-14, Mar. 4, 2022.) He also needed a colostomy bag during this period. Lastly, with respect to long-term care and effects of living with a hernia, Ms. Oka testified that the condition can be a life-altering, disrupting, and negatively affecting the quality of person's life. (See Oka Dep. Tr. 96:5-12, Mar. 4, 2022.)
Bard further argues that there is no evidence whatsoever that establishes any future pain or suffering as a result of Mr. Trevino's explant surgery. (Bard's Mem. at 74.) To the extent that Bard asserts that such evidence can only be presented through competent expert testimony, this Court disagrees. Id. at 75. This Court found no authority that requires an expert to testify regarding the recovery of future pain and suffering damages nor does this Court think there should be. To that end, this Court believes that, based on the testimony of Mr. Trevino, the jury's award for pain and suffering is adequate.
Firstly, this Court finds it important to highlight the horror Mr. Trevino experienced after waking up and instead of seeing what used to be his body, looking down at his stomach to see a hole so big that he thought a "person could stick their hand in." (Tr. 140:20-22, Aug. 10, 2022.) The image of Mr. Trevino's body was so unnatural and so unreal that the best way he could describe it was "Frankenstein'esk." Id. 140:24. This fact, in and of itself, could lead a reasonable jury to believe that Mr. Trevino would continue to experience future anguish and suffering. Moreover, as explained above, Mr. Trevino testified as to his aversion to his physical appearance. (Tr. 11:3-19, Aug. 11, 2022.) (See Tr. 25:3-15, July 29, 2022.) Mr. Trevino further testified as to his fear of future surgeries, particularly for a current hernia (unrelated to the Ventralex) he has. (Tr. 12:19-24, Aug. 11, 2022.) Furthermore, even the act of sitting at the witness stand and explaining his story, was borderline too much for Mr. Trevino. (Tr. 130:4-6, Aug. 10, 2022.) ("[I]t is like reliving it all over again without the pain but just seeing it takes me back to a place that I don't want to be ever again.")
Lastly, Bard argues that the jury seems to have awarded Mr. Trevino nearly $4.5 million "not merely to compensate him for his harm, but also to punish Bard." (Bard's Mem. at 75.) "The jurors were likely influenced by sympathy or bias that motivated them to award an amount far in excess of what would have fairly compensated [Mr. Trevino] for his injuries. Id. In his closing argument, Mr. Trevino's counsel originally requested $8.291 million in damages. (Tr. 125:10, Aug. 23, 2022.) The fact that the jury awarded damages almost 50 percent less than the requested amount does not convince this Court that it was excessive.
Furthermore, in assessing whether the jury proceeded "upon some erroneous basis in ascertaining the amount set . . . out in the verdict," this Court has confidence in the collective intelligence of the jury to determine an appropriate amount of damages given the extensive hospitalization that Mr. Trevino had to endure. Ruggieri, 110 R.I. at 201, 291 A.2d at 415. Therefore, for the reasons explained above, this Court does not find that the damages awarded by the jury to Mr. Trevino are excessive, that they shock the conscience, or that they represent the passion and prejudice of the jury. See Hough, 101 A.3d at 856. Thus, this Court denies Bard's motion for a remittitur except as to the $250,000 remittitur for disfigurement.
v
Conclusion
For the reasons articulated above, Bard's Post-Trial Motions are denied, with the exception of a remittitur of $250,000 for physical disfigurement. Counsel shall submit the appropriate order and judgment for entry.