Greger v. C.R. Bard, Inc.
| Decision Date | 30 September 2021 |
| Docket Number | CIVIL 4:19-CV-675-SDJ |
| Parties | MISTY GREGER v. C.R. BARD, INC., ET AL. |
| Court | U.S. District Court — Eastern District of Texas |
Plaintiff Misty Greger brought this products-liability suit as a result of injuries allegedly caused by the implantation of one of Defendants' medical products. Before the Court is Defendants C.R. Bard, Inc. and Bard Peripheral Vascular Inc.'s Motion for Summary Judgment, (Dkt. #57). For the following reasons, the Court concludes that the motion should be GRANTED.
The inferior vena cava (“IVC”) is a large vein through which blood passes to the heart from the lower body. Blood clots may develop in the IVC and travel to the heart and lungs, resulting in serious and even life-threatening medical complications such as heart attack, aneurysm, or stroke. The “IVC filter” is a medical device that can be implanted in the abdomen and is designed to prevent such blood clots from reaching the heart and lungs. IVC filters like the G2 “Recovery” Filter (“Recovery Filter” or “Filter”) manufactured and sold by Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”) are not sold directly to patients but rather are prescribed by treating physicians. The Recovery Filter consists of two levels of radially distributed Nitinol struts that are designed to anchor the Filter into the IVC and to catch any embolizing blood clots. Of the struts, two are short- commonly referred to as the “arms”-and six are long-commonly referred to as the “legs.” The arms principally serve to center the device, while the legs primarily prevent migration, i.e., the Filter's movement within the vein. Each strut converges at a single node, known as the cap, located at the top of the device.
In November 2002, the Food and Drug Administration (“FDA”) cleared Bard's Recovery Filter for permanent use. In the clearance letter, the instructions for use (“IFU”) indicate that potential complications include “[m]igration of the filter, ” “[p]erforation of the vena cava wall, ” and “[c]aval occlusion.” (Dkt. #57-5 at 1). The IFU fails to include any information on imaging follow-up or a timeline for removal. The IFU is also silent on fracture or fatigue potentiality or fragment embolization to other parts of the body, e.g., the lungs. Plaintiff Misty Greger alleges, inter alia, that the Recovery Filter's IFU insufficiently warns about the incidence (relative to other filters) and seriousness of various possible occurrences, including filter tilt, migration, and fracture, especially fracture embolization to the heart and lungs. (Dkt. #114 at 4).
At the time the FDA cleared the Recovery Filter, numerous other IVC filters were on the market, at least some of which were safer than the Recovery Filter in terms of complications, i.e., rates of fracture, perforation, and migration. See generally (Dkt. #114 at 7-8). For instance, at the time of Greger's implantation with the Recovery Filter, Bard's Simon Nitinol Filter (“SNF”), which has been consistently associated with a lower risk of medical complication than the Recovery Filter, was available on the market for permanent implantation as an IVC filter. (Dkt. #114 at 2 n.4). Further, by December 2004, Bard determined that the Recovery Filter had complication rates that exceeded alternative filters at statistically significant levels, as follows: for deaths, 4.6 times higher; for migrations, 4.4 times higher; for IVC perforation, 4.1 times higher; and for fractures, 5.3 times higher. (Dkt. #117-16 at 2). And, on August 3, 2005, Bard's Vice President of Regulatory Science reported that the Recovery Filter demonstrated a 4500% greater migration rate than the SNF and was linked to sixteen deaths, while the SNF was linked to zero. Of the sixteen deaths linked to the Recovery Filter, eleven stemmed from migrations to the heart and five stemmed from migrations to the pulmonary emboli. (Dkt. #114 at 9).[1]
In 2004, Greger sustained a fall and was diagnosed with Deep Vein Thrombosis (“DVT”), a type of blood clot, in her left leg. Greger consulted Dr. Carlos Cruz, who, in evaluating whether to recommend the implantation of an IVC filter-specifically Bard's Recovery Filter-conducted an individualized risk-benefit assessment. Dr. Cruz testified that, when making the assessment, he had read the Recovery Filter's IFU and was aware of the Filter's perforation and migration risks. However, Dr. Cruz further stated that, at the time, he was not aware of the relative risks of tilt, migration, or fracture, including fracture embolization to the heart or lungs, associated with the Recovery Filter as compared to other filters. Dr. Cruz confirmed that he would have weighed comparative complication rates associated with the Recovery Filter in his risk-benefit analysis and that, if he had known the Recovery Filter's relative rates of fracture, perforation, and migration, he likely would have recommended a different filter. (Dkt. #115 at 127:12-21, 128:4-5, 137:22-138:10). As it stands, Dr. Cruz ultimately recommended the Filter's implantation, and on November 22, 2004, Dr. Cruz implanted the Filter in Greger's abdomen.
Since then, Greger has not experienced a blood clot in her heart or lungs or the life-threatening medical complications attendant to such a clot, e.g., heart attack, stroke, or aneurysm. However, in April 2013 and November 2014, Greger underwent imaging of her torso for suspected bronchitis and a shoulder injury, respectively. Both the 2013 and 2014 imaging reflect “that a fractured arm of the Filter embolized in the right upper lobe of Ms. Greger's right lung.” (Dkt. #57 at 5) (citing (Dkt. #58-5 at 16, 26)). Significantly, however, “no mention of the fragment was made in the [2013 or 2014] radiology reports or by any of Ms. Greger's treating physicians.” (Dkt. #58-5 at 26).
In 2018, Greger began experiencing leg pain and numbness, and in May 2019, she began experiencing significant back pain. Accordingly, on August 14, 2019, Greger visited a physician and underwent imaging of her torso. Upon doing so, Greger learned that the Recovery Filter had tilted and migrated and that struts had perforated Greger's caval wall. (Dkt. #1 ¶ 72). On August 16, 2019, Greger visited Dr. James Hayhurst, a vascular surgeon, to discuss surgical options to remove the Filter. Dr. Hayhurst ordered additional imaging, determined that the Filter had migrated and pierced Greger's caval wall, and recommended an open surgery to remove the filter. Greger elected to undergo the emergency filter-removal procedure.
As a result of the displaced Filter and the procedure required to remove it, Greger alleges that she has experienced significant pain, suffering, and loss of quality of life, and that she has incurred substantial medical expenses. For instance, Greger has a twelve-inch surgery scar and continues to experience pain from nerve damage, allegedly due to the Filter, necessitating the implantation of a spinal stimulator. Greger further alleges that her earning capacity is diminished.
On September 18, 2019, Plaintiff Misty Greger filed this products-liability action for damages against Bard.[2] Specifically, Greger alleges that Bard misrepresented the safety of the Filter and, inter alia, negligently designed, developed, marketed, distributed, and sold the device as safe and effective. Greger further alleges that the Filter is susceptible to various phenomena that pose unreasonable health risks, including fracturing, migrating, excessive tilting, and perforation of the caval wall. These phenomena, Greger contends, can result in life- threatening injuries-such as hemorrhage, cardiac/pericardial tamponade, cardiac arrhythmia, and other symptoms similar to myocardial infarction, severe and persistent pain, perforation of tissue, vessels, and organs-or death, and can also result in the inability to remove the device.
Based on the foregoing factual allegations, Greger asserts the following eight causes of action against Bard: negligence (Count I), strict products liability-failure to warn (Count II), strict products liability-design defects (Count III), strict products liability-manufacturing defect (Count IV), breach of express warranty (Count V), breach of implied warranty (Count VI), fraudulent misrepresentation (Count VII), and negligent misrepresentation (Count VIII). Additionally, and consequently, Greger seeks punitive damages.
Since initiating this litigation, Greger has designated numerous expert witnesses to opine on medical, engineering, and economic questions relevant to her claims. Specifically Greger has designated four case-specific expert witnesses and eight other general experts who previously produced opinions in a multi-district litigation proceeding (“MDL”) against Bard in the District of Arizona. See In re Bard IVC Filters Prods. Liab. Litig., No. MDL-15-02641-PHX-DGC (D. Ariz. 2015) (the “Bard MDL”). The Bard MDL was formed to conduct pre-trial discovery regarding common factual and legal issues in thousands of cases as quickly and efficiently as practicable. However, before Greger learned of her injury, the Bard MDL stopped accepting new cases. Thus, Greger filed a separate action in this Court. Notably, because “general expert discovery was completed as part of the [Bard MDL], ” this Court's Scheduling Order directed the parties to conduct only “case-specific expert discovery, ” except as needed to supplement general expert discovery under Federal Rule of Civil Procedure 26(e...
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