Couturier v. Bard Peripheral Vascular, Inc.

Decision Date08 July 2021
Docket NumberCIVIL ACTION NO. 19-12497
Parties Craig COUTURIER v. BARD PERIPHERAL VASCULAR, INC. and C.R. Bard, Inc.
CourtU.S. District Court — Eastern District of Louisiana

Ben C. Martin, Pro Hac Vice, Jason Voelke, Pro Hac Vice, Laura J. Baughman, Pro Hac Vice, Cameron Earl Dean, Pro Hac Vice, Martin Baughman, PLLC, Dallas, TX, Joseph R. Joy, III, Pro Hac Vice, Joseph Joy & Associates, Lafayette, LA, Nelson W. Wagar, III, Sarah W. Hickman, Wagar Hickman, LLC, Mandeville, LA, for Craig Couturier.

Kim E. Moore, Alison A. Spindler, Brian Gerard Reaney, II, David Michael Melancon, Kelly Juneau Rookard, Irwin Fritchie Urquhart & Moore, LLC, New Orleans, LA, Charles Wade Bowden, Pro Hac Vice, Greenberg Traurig, P.A., West Palm Beach, FL, Charles Mark Stratton, Pro Hac Vice, Greenberg Traurig, P.A., Austin, TX, Joseph Patrick Griffith, Pro Hac Vice, Greenberg Traurig, P.A., Dallas, TX, Lori Gail Cohen, Pro Hac Vice, Sean Jessee, Pro Hac Vice, Greenberg Traurig, LLP, Atlanta, GA, Sabrina R. Gallo, Pro Hac Vice, Greenberg Traurig, LLP, Miami, FL, Sylvia Ester Simson, Greenberg Traurig, LLP, New York, NY, Timothy E. Di Domenico, Pro Hac Vice, Greenberg Traurig, LLP, White Plains, NY, for Bard Peripheral Vascular, Inc., C.R. Bard, Inc.

SECTION: "B"(2)

ORDER AND REASONS

IVAN L.R. LEMELLE, SENIOR UNITED STATES DISTRICT JUDGE

Before the Court are defendantsmotion for summary judgment on all claims (Rec. Docs. 122, 141) and plaintiff's motion for partial summary judgment on defendants’ affirmative defenses (Rec. Docs. 102, 124).

After reviewing the motions, supplemental briefings, and oral arguments, IT IS ORDERED that the defendantsmotion for summary judgment on all claims is GRANTED IN PART and DENIED IN PART.

IT IS FURTHER ORDERED that the plaintiff's motion for partial summary judgment on defendants’ affirmative defenses is DENIED.

I. FACTS AND PROCEDURAL HISTORY

This is a products liability action that was remanded to this Court from the multidistrict litigation captioned In re: Bard IVC Filters Products Liability Litigation , MDL 2641, in the United States District Court for the District of Arizona. (the "MDL"). The parties agreed that voluminous and comprehensive fact and expert discovery was undertaken in the MDL and that general fact and expert discovery has been completed and is closed, with two narrow exceptions: (1) any new medical literature published since 2017 may be added to the reliance lists of general experts, and the general experts may expand their trial testimony from the MDL to include a discussion of such new literature1 , and (2) defendants shall supplement their disclosures of adverse event data2 . No further general fact or expert discovery shall be pursued.

Plaintiff brings this action for personal injuries suffered after being implanted with an Inferior Vena Cava ("IVC") filter medical device manufactured by defendants. Rec. Doc. 6-9 at 25. An IVC filter is a device that is designed to filter or "catch" blood clots

that travel from the lower portions of the body to the heart and lungs. Id. at 30. IVC filters were originally designed to be permanently implanted in the IVC.3

Id. The IVC is a vein that returns blood to the heart from the lower portions of the body. Id. In certain people, blood clots travel from the vessels in the legs and pelvis, through the vena cava and into the lungs. Deep vein thrombosis ("DVT") occurs when the blood clots develop in the deep leg veins and once these clots reach the lungs, they are considered pulmonary emboli ("PE")—presenting risk to human health, including death. Id. IVC filters have been on the market for decades but were limited to patients who could not manage their DVT/PE with prescribed medications. Id. at 31. Defendants were the first medical device manufacturer to obtain FDA clearance for marketing a "retrievable" IVC filter in July 2003. Id. at 31.

Plaintiff Craig Couturier presented to the emergency room on May 6, 2011 with complaints of "headaches, nausea and vomiting. Rec. Doc. 141-1 at 2. He was diagnosed with severe ear infections and meningitis

and underwent surgery to treat the ear infections. Id. Following surgery, plaintiff "showed an upper gastrointestinal bleed

from a Mallory-Weiss tear4 ." Id. Plaintiff required multiple transfusions and was anemic. Id. at 3. On May, 2011, a scan of his lungs showed plaintiff had pulmonary emboli in his left lower lobe. Id. Because of his anemia and transfusions, plaintiff could not be placed on blood thinners, but needed to be protected from further PE. Id.

Dr. Jose Mena5 , a board-certified vascular and cardiothoracic surgeon, discussed potentially implanting an IVC filter with plaintiff as a form of treatment.6 Id. Dr. Mena explained the risks and benefits to plaintiff and his wife and they "voiced understanding and wished to proceed." Id. at 7. Plaintiff's wife signed a consent form (that included various risks associated with IVC implant procedures, including "heart problems" and "displacement of device requiring retrieval") on plaintiff's behalf following Dr. Mena's consultation. Id. at 9-10. Dr. Mena then implanted an Eclipse® IVC filter7 in plaintiff under what plaintiff's wife described as "emergent conditions" because it was the only IVC filter available at the hospital. Id. at 11-12.

Medical device manufacturers, like defendant, provide an "Instructions for Use" document ("IFU") in the same box with the device. Rec. Doc. 141-1 at 13. According to the Eclipse® filter's IFU, it is a venous interruption device "designed to prevent pulmonary embolism

" and is "designated to act as a permanent filter," but "when clinically indicated, ... may be percutaneously removed after implantation according to the instructions provided under the Optional Removal Procedure." Id. 13-14. The IFU includes several indications for use, warnings, and potential complications such as:

Filter fractures are a known complication of vena cava filters

. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.

Movement, migration or tilt of the filter are known complications of vena cava filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal migration of the filter. Migration may be caused by placement in IVCs with diameters exceeding the appropriate labeled dimensions specified in this IFU. Migration may also be caused by improper deployment, deployment into clots and/or dislodgment

due to large clot burdens. Rec. Doc. 141-1 at 15 (emphasis included).
Possible complications include, but are not limited to ... [p]erforation or other acute or chronic damage of the IVC wall ... [d]istal [e]mbolization ... and [o]rgan [i]njury. Id. at 17 (internal quotes omitted).

Notably, the parties are contentious about whether Dr. Mena read the IFU prior to implanting the filter in plaintiff; Dr. Mena could not recall whether he read it or not because of the elapsed time between treating plaintiff and his deposition. Rec. Doc. 141-1 at 19. Moreover, the parties argue whether Dr. Mena properly deployed the filter and to what extent did plaintiff follow up with Dr. Mena post-implantation. Id. at 23-25.

In October 2016, plaintiff presented at the emergency room and a CT showed that a "linear metallic foreign body" was found in plaintiff's right ventricle of his heart. One was found in his lung in November 2016. Rec. Doc. 141 at 5. Plaintiff consulted with Dr. Mena and a cardiologist, Dr. Ghiath Mikdadi, and both agreed that at that time the fragment in plaintiff's heart was stable and advised plaintiff to "leave it alone." Rec. Doc. 122-2 at 7. Subsequent scans have shown that the fragment is unchanged in position and is stable. Id. However, as of December 2019, plaintiff's IVC has been perforated in eight places and he continues to suffer from shortness of breath, irregular heartbeat, and hip pain. Id. Because of this, plaintiff alleges he is at risk of the filter further penetrating adjacent organs such as his spine, duodenum, and aorta, which could result in symptomatic or life-threatening hemorrhage, infection, bowel perforation

, bowel obstruction, leg pain, or back pain. Rec. Doc. 141 at 5. Plaintiff further alleges that he is at risk of deadly cardiac complications and further penetration may lead to pericardial tamponade8 , arrythmia and infection. Id.

Plaintiff filed his master short complaint for damages in the United States Court for the District of Arizona on July 13, 2017. Rec. Doc. 1 at 4. His short form complaint asserts thirteen causes of action against defendants including strict liability and negligent manufacturing defect (Counts I, V), design defect (Counts III, IV), and failure to warn (Counts II, VII), negligent misrepresentation (Count VIII), negligence per se (Count IX), breach of express and implied warranty (Counts X, XI), fraudulent misrepresentation and concealment (Counts XII, XIII), and violation of state consumer laws (Count XIV). Rec. Doc. 1 at 3. Plaintiff also alleges punitive damages. Id. at 4. The case was then transferred to this court on September 9, 2019. Rec. Doc. 5.

II. LAW AND ANALYSIS

Under Federal Rule of Civil Procedure 56, summary judgment is appropriate when "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Celotex Corp. v. Catrett , 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) (quoting Fed. R. Civ. P. 56(c) ). See also TIG Ins. Co. v. Sedgwick James of Wash. , 276 F.3d 754, 759 (5th Cir. 2002). A genuine issue of material fact exists if the evidence would allow a reasonable jury to return a verdict for the nonmoving party. Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 248, 106 S.Ct. 2505, 91...

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