Trevino v. Davol Inc., C. A. PC-2018-8437

CourtSuperior Court of Rhode Island
Writing for the CourtLICHT, J.
PartiesPAUL TREVINO and EARLYNN TREVINO, Plaintiffs, v. DAVOL INC. and C.R. BARD INC., Defendants.
Docket NumberC. A. PC-2018-8437
Decision Date26 July 2022


DAVOL INC. and C.R. BARD INC., Defendants.

C. A. No. PC-2018-8437

Superior Court of Rhode Island, Providence

July 26, 2022

For Plaintiffs:

Jonathan D. Orent, Esq.

For Defendants:

Stephen M. Prignano, Esq.




Facts and Travel

Paul Trevino's (Plaintiff) case is the fourth bellwether case selected for trial from thousands of cases in this master docket litigation[1] involving injuries alleged to have been caused by hernia mesh products manufactured by the Defendants Davol Inc. and C.R. Bard Inc. (collectively Bard).

Plaintiff has a lengthy medical history. In the early 1990s, following a significant abdominal injury, Plaintiff had an exploratory laparotomy (i.e., a large open incision in his abdomen) from his mid-chest to his belt line. During the procedure, his pancreas was found cut in half and his spleen lacerated. Years after the open laparotomy, Plaintiff developed an incarcerated hernia along the midline incision site from the prior surgery. In 2007, Plaintiff underwent a primary repair of that hernia without mesh. By 2008, that primary repair failed.

On December 24, 2008, Plaintiff Trevino underwent a ventral hernia repair at Kona


Community Hospital located in Kealakekua, Hawaii. The repair was performed by Dr. Andrew Fedder, M.D., a general surgeon. Dr. Fedder implanted into Mr. Trevino a medium-sized, Ventralex Hernia Patch manufactured and distributed by Bard. The Ventralex was first cleared by the U.S. Food and Drug Administration (FDA) in 2002 and had been used extensively over the past seventeen years. See Bard's Mot. at 1. At the time, Dr. Fedder regarded the repair as "successful" and, for a period of roughly seven and a half years following the Ventralex hernia repair,[2] Plaintiff did not complain of any symptoms related to the December 2008 hernia repair. Id. at 1-2.

In October of 2017, Mr. Trevino presented to Kona Community Hospital in extreme pain. Dr. Fedder subsequently performed a laparoscopic hernia repair surgery on an unrelated hernia on October 26, 2017. However, while lysing some adhesions he discovered in Plaintiff's abdomen, Dr. Fedder inadvertently nicked the small bowel, creating an enterotomy and causing some spillage of bowel contents into the abdominal cavity. Dr. Fedder then (1) converted the laparoscopy into an open procedure; (2) explanted the Ventralex; and (3) performed a small bowel resection with anastomosis and primary repair of the New Hernia. Id. at 2. While Plaintiff did well in the days immediately following the explant surgery, he soon developed a wound infection followed by an enterocutaneous fistula (ECF) in November 2017. This resulted in a hospital stay and multiple wound revisions in December 2017 and January 2018,[3] as well as ECF closure and bowel resection in January 2018.

Plaintiff alleges that, during the October 2017 surgery, the mesh of the Ventralex patch was found to have migrated to-and eroded in-Mr. Trevino's bowel, causing adhesions, small bowel obstruction, bowel perforation, recurrent hernias, and chronic and severe pain. This compromised,


eroded mesh ultimately required a bowel resection. Further, because of the allegedly defective Ventralex, Mr. Trevino developed his ECF which, in turn, led to the need for multiple rounds of wound debridement.

Plaintiff asserts that the Ventralex is a defective product and that Bard failed to warn about the potential harms it could cause. He claims the Ventralex buckled and, caused among other injuries, adhesions to his bowel. For their part, Bard's experts contend Plaintiff's small bowel obstructions and other alleged injuries were caused by Plaintiff's adhesions and adhesive disease resulting from the severe injury Plaintiff experienced in the early 1990s and open surgical repair for the same. In the years that followed, Defendants assert that Plaintiff's adhesive disease was exacerbated by his many co-morbidities.

Plaintiff asserted numerous causes of action but only five remain: failure to warn, design defect in strict liability, general negligence, breach of implied warranty, and punitive damages. Id. at 3 (see also Bard's Ex. XX, Master Complaint (MC)). [4] All these causes of action stem from Plaintiff's lone theory of the case: that the Ventralex was defective and that its alleged defect(s) caused his injuries.

For their part, Bard contends that all of Plaintiff's causes of action fail for lack of causation, an essential element for all claims he has asserted. Specifically, Plaintiff cannot meet his burden of proving-to a reasonable degree of medical certainty or probability-that any defect or failure


in the Ventralex implanted in him caused or contributed to his alleged injuries. In addition to failing to establish causation, Bard contends that each of Plaintiff's causes of action fails for a laundry list of reasons specific to each cause. Defendant moved for Summary Judgment and on July 12, 2022, the Court heard lively argument from the parties on this motion.


Standard of Review

"Summary judgment is a drastic remedy, and a motion for summary judgment should be dealt with cautiously." Employers Mutual Casualty Co. v. Arbella Protection Insurance Co., 24 A.3d 544, 553 (R.I. 2011) (internal quotations omitted). "[S]ummary judgment is appropriate when, viewing the facts and all reasonable inferences therefrom in the light most favorable to the nonmoving party, the Court determines that there are no issues of material fact in dispute, and the moving party is entitled to judgment as a matter of law." Quest Diagnostics, LLC v. Pinnacle Consortium of Higher Education, 93 A.3d 949, 951 (R.I. 2014) (internal quotations omitted).

The moving party bears the initial burden of establishing that no such issues exist. Heflin v. Koszela, 774 A.2d 25, 29 (R.I. 2001). If the moving party can sustain its burden, then the "litigant opposing a motion for summary judgment has the burden of proving by competent evidence the existence of a disputed issue of material fact and cannot rest upon mere allegations or denials in the pleadings, mere conclusions or mere legal opinions." American Express Bank, FSB v. Johnson, 945 A.2d 297, 299 (R.I. 2008) (internal quotations omitted).

"The motion justice must refrain from weighing the evidence or passing upon issues of credibility [as] . . . [u]ltimately, the purpose of the summary judgment procedure is issue finding, not issue determination." DeMaio v. Ciccone, 59 A.3d 125, 130 (R.I. 2013) (internal quotations omitted) (emphasis added). Further, "[i]t is clear from our precedent that '[o]rdinarily the


determination of proximate cause . . . is a question of fact that should not be decided by summary judgment.'" Belmore v. Petterutti, 253 A.3d 864, 868 (R.I. 2021) (quoting Splendorio v. Bilray Demolition Co., Inc., 682 A.2d 461, 467 (R.I. 1996)).




Précis of Bard's Motion for Summary Judgment

As noted supra, Bard contends that all of Plaintiff's causes of actions fail for lack of causation. Specifically, Plaintiff cannot meet his burden of proving-to a reasonable degree of medical certainty or probability-that any defect or failure in the Ventralex caused or contributed to his alleged injuries. In addition, Bard contends that each of Plaintiff's causes of action fails for a laundry list of reasons specific to each cause.

First, Plaintiff's failure to warn claim fails because (1) Bard accurately and consistently portrayed the instructions and warnings related to the use of the device in the Ventralex Instructions for Use (IFU), and (2) there is no evidence that additional/different warnings would have affected Plaintiff's clinical outcome.[5] Second, Plaintiff cannot prevail on his design defect claims because he has not evidenced that there was, in fact, a design defect with the Ventralex, much less that it caused his injuries. Third, Plaintiff's negligence claim fails for want of expert opinion concerning breach (i.e., standard of care) and/or causation. Fourth, Plaintiff's breach of implied warranty claim fails because there is no evidence that the device was not merchantable or otherwise defective at the time of its sale. Fifth and finally, Plaintiff's punitive damages claim


fails because he cannot show-by clear and convincing evidence- that Bard acted with "malice or in bad faith," and with "intent to cause harm." Bard's Mot. at 4-5.

In response, Plaintiff counters that Bard failed to meet its burden of proving there is an absence of a question of material fact as to each remaining cause of action and, consequently, Bard's Motion should be denied in its entirety.


Bard's Comprehensive Causation Argument

Bard argues that Plaintiff cannot, through competent and reliable expert testimony, establish specific causation[6] that either: (1) a defect in the Ventralex was (to a reasonable degree of medical certainty) the proximate cause of Plaintiff's alleged injuries; or (2) that Bard breached a standard of care expected of it "with respect to the Ventralex, and that such breach was the proximate cause of Plaintiff's alleged injuries." Bard's Mot. at 20.

It is axiomatic that causation, under Rhode Island law, "is typically a question of fact for the jury." State v. Purdue Pharma L.P., No. PC-2018-4555, 2019 WL 3991963, at *10 (R.I. Super. Aug. 16, 2019).[7] However, the issue of causation is not simply a perfunctory, one-way turnstile at the pretrial motions stage. Indeed, there have been multiple occasions where our Supreme Court has ruled it proper to grant summary judgment for lack of cause (in particular, proximate cause), either because causation was wholly lacking as a matter of law and evidence, or because causation had simply become too attenuated under the circumstances.


See Russian v. Life-Cap Tire Services, Inc., 608 A.2d 1145, 1147-48 (R.I. 1992)...

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