Nelson v. C.R. Bard, Inc.

553 F.Supp.3d 343

Dennis NELSON and Kathy Nelson, Plaintiffs

v.C.R. BARD, INC., and Bard Peripheral Vascular, Inc., Defendants

CIVIL ACTION NO. 2:19-cv-135-KS-MTP

United States District Court, S.D. Mississippi, Eastern Division.

Signed August 6, 2021

Richard Massie Martin, Jr., Lamothe Law Firm, LLC, New Orleans, LA, Julia Reed Zaic, Pro Hac Vice, Laura Smith, Pro Hac Vice, Heaviside Reed Zaic, Newport Beach, CA, Mark S. O'Connor, Pro Hac Vice, Beus Gilbert McGroder, PLLC, Phoenix, AZ, for Plaintiffs.

Elizabeth Ross Hadley, Charles Mark Stratton, Pro Hac Vice, Greenberg Traurig, LLP, Austin, TX, J. Carter Thompson, Jr., Robert Christopher White, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, Jackson, MS, C. Wade Bowden, Pro Hac Vice, Jason H. Okleshen, Pro Hac Vice, Greenberg Traurig, PA, West Palm Beach, FL, Eric W. Swanis, Pro Hac Vice, Greenberg Traurig, LLP, Las Vegas, NV, Jonathan Bass, Pro Hac Vice, Greenberg Traurig, LLP, Dallas, TX, Lori G. Cohen, Greenberg Traurig, LLP, Atlanta, GA, for Defendants.

MEMORANDUM OPINION AND ORDER

KEITH STARRETT, UNITED STATES DISTRICT JUDGE

This cause comes before the Court on both Plaintiffs’ Motion for Partial Summary Judgment [87] and Defendants’ Motion for Summary Judgment [103]. Both motions have been fully briefed, and the Court held oral argument on June 20, 2021. Having considered the parties’ submissions, argument, and the relevant legal authorities, the Court finds, for the reasons set forth herein, Plaintiffs’ Motion will be denied and Defendants’ Motion will be granted.

I. BACKGROUND AND UNDISPUTED MATERIAL FACTS

This is a products liability action involving the Recovery® Filter System (the "Recovery Filter" or "the filter"), which is designed, manufactured, marketed, and sold by the Defendants, C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. Plaintiffs, Dennis Nelson and his wife, Kathy Nelson ("Plaintiffs"), brought this action for damages related to alleged complications Mr. Nelson experienced related to the implantation of a Recovery Filter.

The Recovery Filter is a medical device that is designed for use in the inferior vena cava to prevent pulmonary embolism. [87-8]. The Recovery Filter comes with an Information for Use pamphlet ("IFU") that sets forth information related to the description, use, warnings, precautions, and potential complications, as well as instructions for use and procedure for removal. [87-8]. Under the bolded heading "Warnings ," the IFU reads, in part:

• Filter fracture is a known complication of vena cava filters. There have been reports of embolization of vena cava filter fragments resulting in retrieval of the fragment using endovascular and/or surgical techniques.

• Movement or migration of the filter is a known complication of vena cava filters.... Migration of filters to the heart or lungs have been reported in association with improper deployment, deployment into clots and/or dislodgment due to large clot burdens.

Under the bolded heading "Potential Complications ," the IFU reads:

Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with possible complications. Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to, the following:

• Movement or migration of the filter is a known complication of vena cava filters.... Migration of filters to the heart or lungs have also been reported in association with improper deployment, deployment into clots and/or dislodgment due to large clot burdens.

• Filter fracture is a known complication of vena cava filters. There have been reports of embolization of vena cava filter fragments resulting in retrieval of the fragment using endovascular and/or surgical techniques.

• Perforation or other acute or chronic damage of the IVC wall.

• Acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.

• Caval thrombosis /occlusion.

• Restriction of blood flow.

• Occlusion of small vessels.

• Distal embolization.

• Stenosis at implant site.

• All of these above complications have been associated with serious adverse events such as medical intervention and/or death. The risk/benefit ratio of any of these complications should be weighed against the inherent risk/benefit ratio for a patient who is at risk of pulmonary embolism without intervention.

[87-8] (all emphasis in original).

The Recovery Filter was designed to act as a permanent filter, but it may also be removed and was cleared through the FDA as an optional retrievable filter on July 25, 2003. [87-8]; [87-3]. The Recovery Filter was available to patients only via a physician. [87-8].

On May 16, 2005, Daniel A. DeVun, M.D. implanted a Recovery Filter in Mr. Nelson's inferior vena cava as a prophylactic measure to prevent deep venous thrombosis and pulmonary embolism prior to Mr. Nelson's temporary cessation of anticoagulation medication in anticipation of a liver transplant. [109] at p. 1. Plaintiff later underwent a successful orthotopic liver transplant on January 10, 2006. [103-1] pp. 16, 28, 62.

Medical imaging taken of Mr. Nelson in mid-2019 revealed that the Recovery Filter had fractured. [87-11] 41:4-10. Some of the struts of the filter had penetrated through the inferior vena cava wall and some had migrated to other parts of his body. [87-10]; [87-11] 40:6-19; [87-12] 31: 7-21; 44:2-47:1. He underwent three surgical procedures to remove the filter as well as fragments of the device. [87-12] at 61:3-8, 74:19-23; 91:11-14.¹ However, these surgical procedures were not completely successful, as there remains one filter fragment in Mr. Nelson's right pulmonary artery. [87-15]; [87-12] 91:11-93:23.

On December 17, 2004 Defendants’ medical director issued an internal document called a Health Hazard Evaluation (HHE) concerning the Recovery Filter, which states, "An analysis of reporting rates of serious adverse events for all inferior vena cava filters, as determined by analysis of the MAUDE and IMS databases by a consultant, revealed that reporting rates for Recovery are significantly higher than other filters" and that "[r]eports of death, filter migration (movement), IVC perforation, and filter fracture associated with Recovery Filter were seen in the MAUDE database² at reporting rates that were 4.6, 4.4, 4.1, and 5.3 higher, respectively, than reporting rates for all filters. These differences were all statistically significant." [87-22].

Earlier documentation from May 2004, including emails referencing the Recovery Filter, notes that the rate of fracture for the Recovery Filter was higher compared to other filters on the market; that the filter was tilting in a certain percentage of implantations; and that the filter had significantly higher rates of complication than other filters at a 95% confidence.³ [134-31]; [134-32]; [134-33].

Plaintiff has retained two medical experts, Dr. Darren Hurst and Dr. Derek Muehrcke, who opine that the warnings for the Recovery IFU were inadequate because they did not warn of these supposed higher rates of complications in the Recovery Filter as compared to the Simon Nitinol Filter ("SNF")⁴ and other IVC filters. [109-7] 118:14-119:9; [111] at p. 16; [134-51] 136:12-137:21.

Facts relating to the design defect claim will be discussed within the body of the analysis.

II. DISCUSSION

A. Summary Judgment Standard

Rule 56 of the Federal Rules of Civil Procedure states, in part, "The court shall grant summary judgment 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 moving party bears the initial burden of showing there is no genuine issue for trial. Skotak v. Tenneco Resins, Inc. , 953 F.2d 909, 913 (5th Cir. 1992), cert. denied , 506 U.S. 832, 113 S.Ct. 98, 121 L.Ed.2d 59 (1992) (quoting Latimer v. Smithkline & French Labs. , 919 F.2d 301, 301 (5th Cir. 1990) ). If the moving party meets this burden, the nonmoving party who will have the burden of proof at trial must come forward with summary judgment evidence establishing the existence of a genuine issue. Celotex Corp. v. Catrett , 477 U.S. 317, 321, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

At the summary judgment stage, when reviewing all evidence in the record, "the court must draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson Plumbing Prods., Inc. , 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000) (stating also that "[c]redibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge" and quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ).

B. Plaintiffs’ Remaining Claims and the Law Governing Those Claims

1. Only the failure to warn and design defect claims remain.

On September 18, 2017, this case was directly filed in the multi-district litigation ("MDL") as part of the In Re: Bard IVC Filters Products Liability Litigation , MDL No. 2641, centralized in the District of Arizona. The MDL Court entered a series of case management orders ("CMOs") and ordered the use of Short Form Complaints as a manner of efficiently managing thousands of cases for pre-trial proceedings. Plaintiff filled out a Master Short Form Complaint in compliance with the MDL procedures. On September 10, 2019, the Arizona court transferred the case to this Court via 28 U.S.C. § 1404(a), with a Second Amended Master Short Form Complaint ("Complaint") attached as the operative pleading. [18]. No further amendments have been made to Plaintiffs’ Complaint while in this Court.

In their Complaint, Plaintiffs indicate they are bringing claims for strict products liability (Counts I-III), negligence (Counts...