Ebert v. C.R. Bard, Inc.

459 F.Supp.3d 637

Melissa EBERT, Plaintiff,

v.C.R. BARD, INC., et al., Defendants.

CIVIL ACTION NO. 12-01253

United States District Court, E.D. Pennsylvania.

May 11, 2020

Thomas WM. Arbon, Pro Hac Vice, Benny C. Martin, Martin Baughman, Pllc, Dallas, TX, Joshua M. Mankoff, Lopez McHugh LLP, Philadelphia, PA, Michael S. Katz, Lopez McHugh LLP, Moorestown, NJ, for Plaintiff.

Matthew B. Lerner, Richard B. North, Jr., Taylor Tapley Daly, Andrew J. Rosenzweig, Nelson Mullins Riley & Scarborough, LLP, Atlanta, GA, Andrew J. Trevelise, O'brien Law Firm, Phila, PA, Debra Djupman Warring, Blank Rome LLP, Philadelphia, PA, Jane T. Davis, Nelson Mullins Riley & Scarborough Chtd, Charleston, SC, Matthew E. Brown, Nelson Mullins Riley & Scarborough LLP, Boston, MA, William J. McDonough, Reed Smith LLP, Philadelphia, PA, for Defendants.

MEMORANDUM

PAPPERT, J.

Melissa Ebert's doctor implanted in her a Bard G2 inferior vena cava filter—a prescription medical device—to prevent pulmonary embolism. One of the filter's struts eventually fractured and migrated to Ebert's pulmonary artery. Both the filter and fractured strut were later removed from Ebert's body without complication. Ebert filed this lawsuit against Defendants C.R. Bard, Inc., and Bard Peripheral Vascular, Inc. (collectively as "Bard") alleging claims of negligence, breach of express warranty, negligent misrepresentation and strict liability. Bard filed a Motion for Summary Judgment on all of Ebert's claims. After thoroughly reviewing the record and hearing oral argument, the Court grants the Motion in its entirety for the reasons that follow.

I

A

Ebert was diagnosed with a deep vein thrombosis on January 7, 2008. (Defs.' Statement of Undisputed Facts ("Defs.' SOF") ¶ 6, ECF No. 132-2.) Deep vein thromboses are blood clots that can travel to the lungs, causing a pulmonary embolism. (Id. ¶ 1.) Pulmonary emboli, in turn, can cause chest pain, shortness of breath and death. (Id. ¶ 2.) Ebert's physician, Dr. Michael Ringold, treated her initially with a device called a Celect inferior vena cava (IVC) filter, which was manufactured by Cook Medical. (Id. ¶ 7.) IVC filters are designed to catch blood clots and prevent them from reaching the heart and lungs. See (G2 Information for Use ("G2 IFU") 4, Ex. C, ECF No. 132-5).¹ Shortly after Dr. Ringold implanted the Celect filter, several of its struts penetrated the wall of Ebert's IVC and one strut touched her aorta, causing inflammation. (Defs.' SOF ¶ 8.) As a result, on January 29, 2008, Dr. Ringold removed Ebert's Celect filter and replaced it with a Bard G2 filter—the device at issue in this case. (Id. ¶ 9.)

Before Dr. Ringold implanted the G2 filter in Ebert, he showed her a brochure published by Bard so that she could see what the filter looked like. (Ebert Dep. 220:5–24, Ex. V, ECF No. 138-22; Ex. I, ECF No. 132-11.) The G2 filter consists of two tiers of struts that make up its arms and legs; once deployed inside the body, the arms and legs open and anchor to the walls of the IVC. See (G2 IFU 4–5). The G2 filter is a retrievable filter, meaning it can be removed percutaneously after implantation. The device, however, was intended to be a permanent solution for Ebert's risk of deep vein thrombosis and pulmonary emboli. (G2 IFU 4; Ringold Dep. 30:23–31:15, Ex. A, ECF No. 133-1; Ex. A, ECF No. 138-1.)

Approximately three years later on March 22, 2011, Dr. Ringold removed Ebert's G2 filter and during that procedure, he discovered that one of the filter's struts had fractured and believed that it had endothelialized in the side of her IVC, meaning tissue had grown around the strut holding it in place. (Defs.' SOF ¶¶ 10–11; Ringold Dep. 47:9–25.) After weighing the risks of removing the fractured strut against the benefits of leaving it in place, Dr. Ringold left the strut inside of Ebert. (Ringold Dep. 47:9–25.)

On October 11, 2011, Ebert presented to the emergency room with severe lower back pain. (Defs.' SOF ¶ 13.) She believed that the G2 filter's strut had migrated from her IVC to somewhere near her spine. (Id. ) A CT scan of Ebert's chest revealed that the fractured strut had moved to a branch of her pulmonary artery in the left lower lobe of her lung. (Id. ¶ 14.) At that point, Ebert underwent an endovascular procedure to remove the fractured strut. (Id. ¶ 15.) In 2012, a cardiologist evaluated Ebert's heart and lungs and concluded they were functioning normally. (Id. ¶ 16.) An echocardiogram taken that year of Ebert's heart also revealed no physical damage. (Id. ¶¶ 17–18.)

B

Bard first began distributing IVC filters in 1992, when it marketed and sold the Simon Nitinol Filter (SNF)—a permanent device manufactured by Nitinol Medical Technologies. (Nitinol Medical Technologies Acquisition Proposal 3, Ex. C, ECF No. 145-2.)² After acquiring Nitinol Medical Technologies' IVC filter line, Bard developed its own modified IVC filter called the Recovery. See generally (Vena Cava Filter Overview (Glen Falls), Ex. D, EXF No. 145-3). The FDA initially approved the Recovery filter as a permanent device in November of 2002, followed by its approval as a retrievable device in July of 2003. See (Nov. 27, 2002 FDA Letter, Ex. E, ECF No. 145-4; July 25, 2003 FDA Letter, Ex. F, ECF No. 145-5). In August of 2005, Bard obtained FDA approval to market the G2 filter as a substantially equivalent device to its predicate filter, the Recovery. See (Aug. 29, 2005 FDA Letter, Ex. B, ECF No. 145-1).

All IVC filters—both Bard and non-Bard devices alike—carry well-known risks, including the possibility of fracture, migration and perforation. See generally (Grassi, Quality Improvement Guidelines for Percutaneous Permanent Inferior Vena Cava Filter Placement for the Prevention of Pulmonary Embolism ("IVC Article"), Ex. B, ECF No. 132-4; Defs.' SOF ¶¶ 20–21.) A 2003 article, for example, reported that the rate of filter fracture in all IVC filters ranged from two to ten percent. (IVC Article 4.)

The G2 filter's Information for Use (IFU) warned generally about these risks. For example, the IFU's "Warnings" and "Potential Complications" sections both cautioned that "filter fracture is a known complication" of IVC filters, and that "[t]here have been reports of embolization of vena cava filter fragments resulting in retrieval of the filter fragments using endovascular and/or surgical techniques." (G2 IFU 4–5.) It also stated that "[m]ost cases of filter fracture, however, have been reported without any adverse clinical sequelae." (Id. )

At the time Dr. Ringold implanted the G2 filter in Ebert, he was aware of the general risks associated with IVC filters. He first learned of the risks of penetration, fracture, embolization and migration as early as the 1990s during his residency and fellowship. (Ringold Dep. 15:20–16:12.) Dr. Ringold, however, testified that he never read the G2 filter's IFU in its entirety, and he could not recall whether he read the IFU at any point prior to implanting the device in Ebert. (Id. 23:25–24:7; Defs.' SOF ¶ 35.)

C

Ebert asserts the following causes of action: (1) negligence—design defect; (2) negligence—failure to warn; (3) breach of express warranty and implied warranty of merchantability; (4) negligent misrepresentation; and (5) strict liability. (Compl., ECF No. 1.) She seeks both compensatory and punitive damages. (Id. ) After Ebert filed her Complaint, the Judicial Panel on Multidistrict Litigation transferred her case to the United States District Court for the District of Arizona for consolidated pretrial proceedings. (ECF No. 117.) The case has since returned to the Eastern District of Pennsylvania (ECF No. 118), and Bard filed a Motion for Summary Judgment on all of Ebert's claims. (ECF No. 132.) In her Response, Ebert informed the Court that she no longer intends to pursue the breach of implied warranty of merchantability claim but otherwise opposes the Motion in full. (ECF Nos. 133 & 138.) The Court heard oral argument on April 27, 2020. (ECF No. 154.)

II

Summary judgment is appropriate "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) ; See Celotex Corp. v. Catrett , 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). A dispute is genuine if the evidence is such that a reasonable factfinder could return a verdict for the nonmoving party. See Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 249, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Summary judgment is granted where there is insufficient record evidence for a reasonable factfinder to find for the plaintiff. Id. at 252, 106 S.Ct. 2505. "The mere existence of a scintilla of evidence in support of the plaintiff's position will be insufficient; there must be evidence on which the jury could reasonably find for the plaintiff." Id.

When ruling on a motion for summary judgment, the court may rely only on admissible evidence. See, e.g. , Blackburn v. United Parcel Serv., Inc. , 179 F.3d 81, 94 (3d Cir. 1999). A court must view the facts and draw all reasonable inferences in favor of the nonmoving party. See In re Flat Glass Antitrust Litig. , 385 F.3d 350, 357 (3d Cir. 2004). "An inference based upon a speculation or conjecture does not create a material factual dispute sufficient to defeat entry of summary judgment." Robertson v. Allied Signal, Inc. , 914 F.2d 360, 382 n.12 (3d Cir. 1990).

III

A

Count I of Ebert's Complaint alleges negligence against Bard, and she bases her claim upon two theories of liability: design defect and failure to warn. "To prevail in a negligence action, a plaintiff ‘must show that the defendant had a duty to conform to a certain standard of conduct, that the defendant breached that duty, that such breach caused the injury in question, and actual loss or damage.’ " Berrier v. Simplicity Mfg., Inc. , 563 F.3d 38, 61 (3d Cir. 2009) (quoting Phillips v. Cricket Lighters , 576 Pa. 644, 841 A.2d 1000, 1008 (2003) ). The Court addresses the...