Keen v. C.R. Bard, Inc.

480 F.Supp.3d 624

Harry KEEN, III, Plaintiff

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

CIVIL ACTION No. 13-5361

United States District Court, E.D. Pennsylvania.

Signed August 17, 2020

Filed August 19, 2020

Ashley C. Crowell, Paul L. Stoller, Dalimonte Rueb Stoller, LLP, Phoenix, AZ, John A. Dalimonte, Dalimonte Rueb Stoller LLP, Boston, MA, Joshua D. Miller, Teresa C. Toriseva, Toriseva Law, Wheeling, WV, Michael E. Gallant, Dalimonte Rueb Stoller, LLP, Washington, DC, Michael S. Katz, Lopez McHugh LLP, Moorestown, NJ, Michael Joseph Ryan, Obermayer, Rebman, Maxwell & Hippel, Philadelphia, PA, for Plaintiff.

Matthew B. Lerner, Richard B. North, Jr., Nelson Mullins Riley & Scarborough, LLP, Atlanta, GA, Andrew J. Trevelise, O'Brien Law Firm, William J. McDonough, Reed Smith LLP, Philadelphia, PA, Matthew E. Brown, Nelson Mullins Riley & Scarborough LLP, Boston, MA, for Defendant C.R. Bard, Inc.

Matthew B. Lerner, Richard B. North, Jr., Nelson Mullins Riley & Scarborough, LLP, Atlanta, GA, Andrew J. Trevelise, O'Brien Law Firm, Debra Djupman Warring, Blank Rome LLP, William J. McDonough, Reed Smith LLP, Philadelphia, PA, Matthew E. Brown, Nelson Mullins Riley & Scarborough LLP, Boston, MA, for Defendant Bard Peripheral Vascular, Inc.

MEMORANDUM

Pratter, United States District Judge

Harry Keen, III received a G2X inferior vena cava (IVC) filter—a prescription-based medical device placed in the largest vein leading to the heart in order to prevent blood clots—manufactured by C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.¹ Approximately a year and three months after implantation, Mr. Keen's filter fractured, necessitating removal. Although a physician was unable to retrieve the fractured filter on the first attempt, all but two pieces of the filter which remain in a stable position were eventually retrieved. Mr. Keen brings this product liability action, alleging that Bard defectively designed and manufactured the G2X filter that was implanted in him and failed to provide adequate warning of the filter's complications. Bard moves for summary judgment in its favor as to all of the claims.

For the reasons detailed below, the Court grants summary judgment in favor of Bard as to the strict liability and breach of implied warranty of merchantability claims, denies summary judgment as to the negligence and negligence misrepresentation claims, and reserves its determination as to punitive damages for a later date.

BACKGROUND

I. Procedural Background

Bard's entire product line of retrievable IVC filters has been the subject of a multidistrict litigation created in 2015 and presided over by Judge David Campbell of the District of Arizona. See in re Bard IVC Filters Prods. Liab. Litig. , MDL No. 15-2641, 2016 WL 3970338 (D. Ariz.). This particular case was transferred to the multidistrict litigation in 2015 and returned to this Court in 2019. Mr. Keen brings negligence and strict products liability claims based on manufacturing, design, and failure-to-warn theories, a breach of implied warranty of merchantability claim, a negligent misrepresentation claim, and he also seeks punitive damages, among other damages.

Now, Bard requests the Court to grant summary judgment in its favor as to all of Mr. Keen's claims. In addition to reviewing the parties’ briefing and substantial evidentiary submissions pertaining to Bard's motion, the Court also ordered supplemental briefing concerning the admissibility of facts and evidence Mr. Keen "incorporated by reference," and held oral argument on the motion, following which the Court permitted the parties to submit supplemental briefing.

II. Factual Background

A. General Information About IVC Filters and the G2X Filter

The Bard G2X filter is a prescription medical device implanted in the IVC. The IVC is "the main vessel returning blood from the lower half of the body to the heart." Cason v. C.R. Bard, Inc. , No. 12-1288, 2015 WL 9913809, at *1 (N.D. Ga. Feb. 9, 2015). Generally, trauma patients face the risk of developing deep vein thromboses, which can result in a patient suffering from a potentially life-threatening pulmonary embolism. IVC filters are intended to help prevent blood clots from reaching the lungs and causing a pulmonary embolism. After implantation, all IVC filters, including the G2X filter, carry risks of tilt, migration, puncture, fracture, and irretrievability.

B. Mr. Keen's Experience with the G2X Filter Implanted in his IVC

Mr. Keen was involved in a motorcycle accident on June 14, 2020, and, as a result, suffered multiple skull fractures and severe traumatic brain injury. Eight days later, Mr. Keen's physician, Dr. David Sacks, placed a Bard G2X filter in Mr. Keen's IVC as a prophylactic measure to prevent a pulmonary embolism. Dr. Sacks chose to use the G2X filter for Mr. Keen based on his clinical experience with the filter and his assessment of Mr. Keen's condition. Dr. Sacks intended that the G2X filter implanted in Mr. Keen would be used temporarily and retrieved in the future. Because it was unclear how long Mr. Keen would need the filter, Dr. Sacks thought that the G2X filter was preferable to the Gunther Tulip filter, the Greenfield filter, and the Simon Nitinol filter.²

On September 15, 2011, Dr. Karekin Cunningham performed a percutaneous procedure³ in an attempt to retrieve the G2X filter implanted in Mr. Keen. During this retrieval procedure, Dr. Cunningham discovered that two of the filter struts had fractured and that the filter was tilted. Dr. Cunningham was unable to retrieve the filter on this date "secondary to lack of appropriate inventory and retrieval techniques." Reading Hosp. Med. Records, Ex. B (Doc. No. 60-2).

On October 21, 2014, Dr. Frank Lynch performed a second percutaneous procedure on October 21, 2014 to retrieve the G2X filter. Dr. Lynch retrieved the filter and most of the fractured components except for a "leg foot process" and "half of a filter leg," both of which were embedded in the wall of Mr. Keen's IVC. Penn State Hershey Med. Center Med. Records, Ex. F (Doc. No. 60-6).

Mr. Keen alleges that he suffered from various complications, including filter fracture, tilt, perforation, and irretrievability of the fragments. Between the time Mr. Keen's filter was explanted in 2014 and the date of his last deposition in November 2019, he has not seen any doctors due to abdominal, back, or chest pain for an evaluation of the filter struts retained in his body. It appears that no doctor has recommended image monitoring of the filter struts still in his body. Mr. Keen understands that the filter struts are in stable position.

C. The Evolution of Bard IVC Filters

Bard distributed the Simon Nitinol filter for Nitinol Medical Technologies in the United States from at least as early as 1992 to 2001, when Bard purchased all the rights for the Simon Nitinol filter. In conjunction with Nitinol Medical Technologies, Bard developed a modified design of the Simon Nitinol filter known as the Recovery filter. The Recovery filter was intended to be removed, optionally, from the body. Bard obtained clearance from the Food and Drug Administration to market the Recovery filter through the 510(k) process as a permanent device in November 2002, and for optional retrieval in July 2003. The FDA grants 510(k) clearance "where the device is as safe and effective as a [predicate device] and does not raise different questions of safety and efficacy than the predicate device." In re Bard IVC Filters Prods. Liab. Litig. , 289 F. Supp.3d 1045, 1048 (D. Ariz. 2018) (citation omitted).

Bard modified the Recovery filter to develop the G2 filter. Bard developed an entire line of G2 filters, which includes the G2, G2 Express, and G2X filters. The FDA granted 510(k) clearance for retrievable use of the G2 filter in January 2008. The FDA also cleared the G2X filter through the 510(k) process.⁴ The only difference between the G2 filter and the G2X filter is a snare retrievable hook that Bard added to the G2X filer. Bard then developed the Eclipse filter, which is an electropolished⁵ version of the G2X filter. The FDA cleared the Eclipse filter in January 2010 through the 510(k) process, approximately six months prior to the date that the G2X filter was implanted in Mr. Keen.

Mr. Keen submits a considerable amount of evidence concerning the various problems and complications associated with multiple Bard filters and Bard's apparent knowledge of such issues. In sum, Mr. Keen stresses that Bard's design and manufacturing of IVC filters were defective, including the G2X filter, which purportedly fracture, migrate, tilt, and perforate in patients’ IVCs at rates significantly higher than other IVC filters. He also claims Bard failed to provide adequate warning of these complications. For the sake of brevity, the Court focuses on the evidence Mr. Keen relies upon in his briefing as they are, in turn, also addressed in defense of his claims from the challenge by Bard in its motion.

D. Information Bard Provided to Dr. Sacks

Dr. Sacks testified that he relies on "the manufacturer to tell [him] as much information as [it] ha[s] available that would be relevant to [his] placing the filter[,]" Sacks Dep. at 96:23-97:1 (Doc. No. 97-3), and that he expects the manufacturer to provide information concerning known adverse events with a product, Id. at 97:17-20. Bard provided both written and oral communications to Dr. Sacks concerning the G2X filter implanted in Mr. Keen.

Concerning the written communication, the G2X filter implanted in Mr. Keen was accompanied by an "Instructions for Use" document. Under the two bolded headings "Warnings" and "Potential Complications," the Instructions for Use warned physicians that:

"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

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