Conn v. C.R. Bard, Inc.

Decision Date13 October 2021
Docket NumberCivil Action 4:14-CV-298
PartiesCHARLES CONN, et al, Plaintiffs, v. C.R. BARD, INC, et al, Defendants.
CourtU.S. District Court — Southern District of Texas
ORDER

Andrew S. Hanen United States District Judge.

Before the Court is a Motion for Summary Judgment filed by Defendants C.R. Bard, Inc., and Bard Peripheral Vascular Inc. (hereinafter "Bard") (Doc. No. 66). The Plaintiff Charles Conn ("Conn") responded (Doc. No 95), and Bard replied thereto (Doc. No. 109). After this Court made several summary-judgment rulings (see Docs. No. 185 & 304), Conn and Bard each filed supplemental briefing (Docs. No. 319 & 320, respectively) on the remaining issues in the Motion for Summary Judgment. Having considered the briefings and applicable law, the Court hereby GRANTS Bard's motion as to Conn's strict liability design defect claim ("Third Cause of Action," Doc. No. 1 at 29-30), and DENIES the motion as to his strict liability failure to warn claim ("Second Cause of Action," Doc. No. 1 at 28-29).

As a result, this case is set for trial by jury in accordance with the schedule already outlined by the Court. The trial will proceed in two phases, pursuant to this Court's bifurcation order (Doc. No. 116). In Phase I, the jury will determine Bard's liability under a strict liability theory of failure to warn, as well as Conn's entitlement to compensatory damages and the availability of punitive damages. Should the jury find in favor of Conn on the last issue, in Phase II the jury will determine the appropriate amount.

I. Background

This is a personal injury action involving the G2 Filter (the "Filter"), a medical device manufactured and distributed by Bard. The following factual summary is, for the most part, undisputed. On August 23, 2006, 19-year-old Conn saw his gastroenterologist for severe Crohn's disease symptoms. (Doc. No. 66-2, Ex. A at CONCC_AUSG_MDR0040-41). His doctor referred him to the emergency room due to suspicion that he had a thromboembolic disease, or, in layman's terms, problems related to blood clots. (Id.). At the South Austin Hospital emergency room, he not only presented with Crohn's-related gastrointestinal symptoms, but also with shortness of breath, high fever, worsening chest pain, and a history of weight loss. (Id. at CONCC_CSDSH_MDR00203). His doctors discovered a large free-floating caval thrombus-a blood clot in his inferior vena cava (IVC), and a possible pulmonary embolism. (Id. at CONCCCSDSHMDR00255). Several different doctors evaluated Conn's condition and recommended the filter placement to help prevent these clots from severely injuring or even killing him. Due to his already existing medical problems, Conn could not take anticoagulants (blood thinners), which are in many cases an accepted alternative treatment for blood clots and pulmonary embolisms. Anticoagulants were contraindicated due to his severe Crohn's disease. (See Id. at CONCC_CSDSH_MDR00197; MDR00205; MDR00208; MDR00255).

On August 24, 2006, Dr. Michael Gunlock performed a "suprarenal" filter placement due to the "large free-floating caval thrombus" which "precluded infrarenal cava filter placement." (Id. at CONCC_CSDSH_MDR00255). According to Dr. Gunlock, one of the reasons he used a Bard G2 filter was because, due to Conn's young age, he intended the filter to be removable. (Id; see also MDR00200). This was not the usual location for placement of an IVC filter, but Dr. Gunlock placed it there in order to avoid "the very large free floating thrombus that was present in the infrarenal cava." (Gunlock Dep. at 27:5-28:23, June 15, 2020). At the time, both the location at which Dr. Gunlock placed the filter and the use of a G2 filter as a retrievable filter were "off label," but both were done due to Conn's precarious condition. While the G2 was designed as a retrievable filter, it was not approved for that indication until after Conn's implantation. (See Doc. No. 208-5 at 6-7). Dr. Gunlock's hospital note indicates he thought the filter should be evaluated for removal in three to nine months. (Gunlock Dep. at 48:6-17, June 15, 2020).

On August 28, 2006, just four days after this procedure, Conn was re-admitted to the emergency room at South Austin Hospital because he felt sharp pain in the lower right quadrant of his abdomen and had a dull ache in his swollen right leg. (Doc. No. 66-2, Ex. A at CONCC_CSDSH_MDR00014). After a CT scan, doctors noted that the clots had moved and at least one was extending through and above the recently placed filter. "Before he only had mild extension into the right iliac with no occlusion and he now has complete occlusion of both iliac veins." (Id. at CONCC_CSDSH_MDR00015). Given the severity of his condition, the doctors decided to go ahead and put him on an anticoagulant, despite his Crohn's disease. (Id.; see also CONCC_CSDSH_MDR00010).

On October 31, 2007, Conn was again seen for Crohn's-related symptoms as well as for a check up on his filter placement. (Id. at CONNC_STDMC_MDR00667). His treating physician referred him to a different radiologist, and after imaging, the radiologist noted in Conn's medical record:

The filter is positioned considerably obliquely and appears to be well above the renal vein level. As that filler appears to be a removable type. Further evaluation of the filter position is recommended. Consider venocavogram and possible filter removal....
Addendum: Prior filter deployment images obtained from 8/24/06 demonstrate that the filter has migrated slightly into the tilted position but that it is at the approximate same axial level. View of the recent CT images suggests that the struts are well implanted into the wall of the vena cava and left renal vein, and the positioning of the struts suggests that the filter is functional. . . At this point this filter is probably not retrievable based on the time that it has been implanted and the angulation of the tip.

(Id. at CONNC_STDMC_MDR00747) (emphasis added). The referring physician conferred with the radiologist and summarized:

There was some question about the placement of the filter. Apparently it had rotated in the IVC. I reviewed this with the radiologist who after reevaluating felt that the position was adequate, it was stable and would not embolize from this position and afforded adequate protection for thromboembolic clots in the present orientation.

(Id. at CONNC_STDMC_MDR00667) (emphasis added).

In 2007 and again in 2009, Conn underwent colon and rectal surgery to mitigate the problems he was having due to his Crohn's disease. (Doc. No. 95 at 10 & Doc. No. 95, Ex. 48). On September 19, 2012, Conn again presented to the emergency department-this time at Memorial Hermann Hospital in Houston. (Id., Ex. 7). He complained of abdominal pain, nausea, vomiting, and loss of appetite, and was admitted. (Id., Ex. 3). During the hospital admission, Conn learned there was "a piece of the filter that had broken off and gone to my heart." (Id.). He followed up on October 4, 2012, when his physician described the situation as an "IVC filter barb dislodgment to heart." (Doc. No. 66-2, Ex. A at CONNC_UTP_MDR00003).

On January 28, 2017, Conn underwent a filter retrieval attempt "due to severe filter angulation." He complained of pain when the physician tried to dislodge the filter, despite being under sedation. (Doc. No. 95, Ex. 8). The attempt was unsuccessful. (Id.). On July 7, 2017, Conn underwent a second, more successful retrieval attempt at Stanford University, performed by Dr. William Kuo. The physician noted: "Today, he is aware of an old filter fragment that has migrated into his heart.... He reports intermittent episodes of chest pain/tightness which he has attributed to his filter in the past." Dr. Kuo performed a partially "successful complex retrieval of a suprarenal Bard G2 IVC filter" and a "successful complex retrieval of a fractured arm fragment," but "an old fractured arm [of the filter] fragment is seen over the right heart unchanged in position compared to prior radiographs." (Doc. No. 66-2, Ex. A at CONNC_SHC_MDR00047). In other words, a piece of the filter remains lodged in Conn's heart.

Prior to both filter retrieval attempts, Conn sued Bard on February 7, 2014 alleging negligence, failure to warn, design defects, manufacturing defect, breach of implied warranty of merchantability, negligent misrepresentation, and loss of consortium on behalf of Plaintiff Alyssa Conn, his wife. He also sought punitive damages. Alyssa Conn's claim, as well as the negligent misrepresentation, breach of warranty, and manufacturing defect claims, have been dismissed with prejudice. (Doc. Nos. 35 & 185).

Bard filed a Motion for Summary Judgment (Doc. No. 66). This Court granted in part the motion as to any claims that the Filter caused blood clot problems or any other related injuries from that time period because they are time-barred. (Doc. No. 185). In a later order, this Court granted in part the motion as to the rest of Conn's negligence claims. (Doc. No. 304).

Supplemental briefing was then filed (Docs. No. 319 & 320) on the remaining issues in the Motion for Summary Judgment. Conn's remaining causes of action for strict liability-design defect and failure to warn[1]-are the subject of this final order on summary judgment.

II. Legal Standard

Summary judgment is warranted "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ P, 56(a). "The movant bears the burden of identifying those portions of the record it believes demonstrate the absence of a genuine issue of material fact." Triple Tee Golf, Inc. v. Nike, Inc., 485 F.3d 253, 261 (5th Cir. 2007) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 ...

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