IN THE UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF TEXAS

MAGDALENA MACIAS, an individual,

and JANELLE O’BRIEN, an individual

Plaintiffs,

v.

C.R. BARD, INC., a New Jersey 

corporation; BARD PERIPHERAL 

VASCULAR, INC., an Arizona corporation, 

and DOES 1 through 10,

Defendants.

Case No. 20-574

COMPLAINT

(JURY TRIAL DEMANDED)

Plaintiffs, Magdalena Macias (hereinafter “Plaintiff Macias” or “Ms. Macias”) and 

Janelle O’Brien (hereinafter “Plaintiff O’Brien” or “Ms. O’Brien”), allege for their

Complaint against the Defendants as follows:

INTRODUCTORY ALLEGATIONS

1. This is a product-liability action against Defendants arising out of the 

malfunction and resulting injuries to Plaintiff Macias from a Bard Eclipse inferior vena 

cava (“IVC”) filter (the “Filter”) that was implanted in Plaintiff Macias on or about April 

25, 2011 at San Antonio, Texas, and to Plaintiff O’Brien from a Bard Denali filter on or 

about May 8, 2015 in Columbus, Ohio.

2. An IVC filter is an implantable medical device that is placed in the IVC—

the body’s largest vein that carries blood to the heart and lungs—purportedly to catch 

blood clots before they reach the heart and lungs.
2

3. In the early 2000s, Defendant Bard Peripheral Vascular (collectively with 

Defendant C.R. Bard, Inc. “Bard”) was one of several manufacturers in the IVC filter 

market that saw an opportunity to expand the existing market and to increase its own 

share of that market by developing an IVC filter that could be retrieved after 

implantation. Prior to that time, IVC filters were permanent-only devices, implanted for 

the lifetime of a patient and not capable of removal without major surgery. The existing, 

permanent devices were designed to be sturdy so they could be permanently implanted in 

a patient’s IVC without tilting, migrating, or breaking. Bard sold a permanent IVC filter 

called the Simon Nitinol Filter (“SNF”) that, like most permanent filters, had a long 

history of extremely low complication rates.

4. Bard believed that it could Bard substantially increase its share of the U.S. 

IVC filter market and, thus, its profits by introducing a retrievable filter. Bard knew that 

other competing medical device manufacturers were also working on retrievable IVC 

filters, and the company that would win the race to the market by introducing its product 

first would reap most of the rewards. Bard concluded that it could overcome the 

“absence of solid clinical history” for its new retrievable filter through “aggressive 

marketing.” And, as a result, it began to design and develop an IVC filter that could be 

retrieved after implant. 

5. To win the race to market, Bard took shortcuts in both (1) designing and 

testing of its permanent-but-retrievable IVC filters and (2) obtaining regulatory clearance 

from the FDA to sell the filter. Significantly, though Bard marketed and sold its 

retrievable filters as permanent devices that could be safely retrieved after implant, Bard 
3

never designed or tested the filters for permanent implantation. For its first-generation 

device, the Recovery filter, Bard conducted a single human clinical trial that was not a 

safety or effectiveness study; rather, it was a short-term study as to whether the device 

could be safely retrieved shortly after implantation. For its second-generation device, the 

G2 (originally named the Recovery G2), Bard conducted a 100-patient retrievability 

study. Both studies demonstrated significant incidence of device malfunctions, including 

a fracture and migration of the Recovery in just 33 patients; in the G2 study, Bard learned 

that the filter was tilting, perforating, and migrating at rates significantly higher than 

expected and significantly higher than Bard’s predicate device for the retrievable filters: 

the SNF. Despite these results, Bard never did any studies nor any trials of the filters to 

determine if they were safe and effective as a permanent filter. Bard did not call off its 

release of the filters; instead, Bard charged forward and sold the filter to doctors and 

patients across the country, including Plaintiff. Significantly, Bard sold the filters as 

“permanent” devices with the “option” of retrieval—representing first and foremost that 

the devices were safe to be implanted for a lifetime.

6. To be able to sell the filters, Bard made misrepresentations to the FDA to 

obtain “clearance” for the sale of the filter. Clearance comes under the FDA’s far less 

restrictive 510(k) process—a streamlined path in which a company represents that its 

product is so substantially similar to a product that has already been approved by the 

FDA to be on the market (substantially equivalent) that there is no need to fully vet and 

test whether the product is safe and effective. Bard promised the FDA that its new 

retrievable filter was “substantially equivalent” to the SNF, and that the filter was just as 
4

safe and effective when permanently left in the human body. But Bard had absolutely no 

proof that was the case. Indeed, its actual testing of its filters demonstrated precisely to 

the contrary.

7. Unsurprisingly, almost immediately, patients began experiencing major 

complications with Bard’s retrievable filter—it was breaking/fracturing and migrating to 

the heart at rates not previously seen with IVC filters. In the first 10 months after full 

market release, there were nine patient deaths from Bard’s Recovery filter. Bard was 

unable to determine the root cause for those deaths, but, rather than pull the product from 

the market, it continued to market and sell the filter to doctors and patients, assuring them 

that there was no real problem, while at the same time forming a team to respond to what 

it called a crisis.

8. Further, Bard found that the filter was failing and causing death at rates 

many times higher than other IVC filters, including its own SNF, the predicate device. 

Still, Bard did not pull the filter from the market. Rather, while it continued to sell the 

Recovery and without understanding why the Recovery was failing at such high rates, 

Bard designed a second generation (G2) filter on the fly. And, again, rather than test its 

safety and efficacy (particularly as a permanent device), Bard sold that second-generation 

filter to doctors and patients with little to no idea how it would perform long term. As a 

result, the G2 created new problems and risks for patients. By 2006, just months after 

release, an internal investigation at Bard determined the G2 had an “unacceptable risk” of 

complications. But Bard did not recall or place a hold on the product, warn doctors and 
5

patients of what it knew internally about the dangers of the device, nor take any action to 

protect people like Plaintiffs. 

9. In subsequent generations, Bard (a) added a hook (G2X), (b) polished the 

filter and changed its name to “avoid baggage” (Eclipse), and (c) added caudal anchors

(Meridian). It made these changes to hold its market share, while looking at new ways to 

design a safer IVC filter. But none of these minor changes fixed the significant problems 

with the filter.

10. At the same time, Bard developed another version of the filter that it called 

the Denali, which retained the essential design elements of all the iterations of its 

permanent-but-retrievable IVC filters.

11. Bard defectively designed the Filter because its risks outweigh its benefits 

and it fails to meet the reasonable expectations of consumers. Indeed, developing science 

suggests that all IVC filters, including the Filter, provide no benefit whatsoever to 

patients. The design choices that Bard made in designing all of its permanent-butretrievable filters, including the Filter, rendered the filter defectively designed. There are 

reasonable alternative designs of IVC filters both on the market and that include 

additional safety features, such as design elements to reduce the risk of fracture and 

improvements to the anchoring mechanism to prevent tilting, movement (migration), and 

perforation, all failure modes that also increase the risk of fracture. Bard was similarly 

negligent in its design of the Filter.

12. Further, Bard failed to provide adequate warnings regarding the risks of all 

of its permanent-but retrievable filters, including the Filter. Bard knew that the Filter 
6

presented significantly increased risks of failures, including fracture, migration, tilt, and 

perforation as compared to other available IVC filters, including its own SNF. 

Nonetheless, it failed to warn doctors and patients of these significantly increased risks 

and the risks specific to its IVC filters. Still, Bard actively marketed the Filter as being 

safer than or at least as safe as other devices. Bard was similarly negligent in its 

warnings and failure to provide adequate warnings regarding the Filter. 

13. Bard was negligent in their testing of the Filter prior to release. Bard failed 

to conduct worst-case scenario testing as required by standards of reasonable engineering 

and the federal Food and Drug Administration (“FDA”) guidance documents. 

14. Bard was negligent in its post-market monitoring of the Filter because it 

was aware that the risks posed by the device exceeded the burden of taking available 

safety measures that would have reduced the risk of harm. These safety measures include 

the failure to warn and the failure to incorporate additional safety features.

15. Bard was negligent in failing to recall or to stop marketing the Filter once it

realized that its IVC filters were not performing as expected, and the Filter was

significantly more likely to fail and cause injury than other available devices. The filters

risks exceeded their benefits, and they were not the substantial equivalent of the predicate 

device—Bard’s own SNF filter. 

16. Bard also engaged in fraud, deceit and concealment in that Bard knowingly 

misrepresented the benefits of the Filter by concealing and downplaying the risks so as to 

maintain sales and stock prices, and to keep consumers and victims like the Plaintiffs

ignorant of the defect in the Filter. Despite knowing that the Filter was substantially 
7

more likely to fracture, migrate, tilt, and cause death than other filters, Bard marketed the 

filter as being safer and more effective than all other filters. Despite information 

demonstrating a lack of safety and efficacy, Bard failed to warn Plaintiffs or physicians 

that the device should be promptly removed after the acute risk of clotting passed.

17. Bard misrepresented the safety and effectiveness of its permanent-butretrievable IVC filters, including the Filter. Bard sold all of its IVC filters as permanent 

devices; specifically identifying each filter as indicated for use “via permanent 

placement” in the IVC. But, Bard did not do adequate testing to ensure that the filters 

were safe for permanent implantation in the human body; and Bard knew, from the 

testing it did perform, that its permanent-but-retrievable filters were not the substantial 

equivalent of, and not as safe as, its permanent-only filter, the SNF. 

18. Here, Plaintiff Macias has suffered damages as a result of Bard’s actions. 

In particular, Plaintiff Macias’ filter perforated the IVC into adjacent organs, including

abutting the aorta and L4 vertebral body. As a result, Ms. Macias has suffered pain, 

emotional distress, and loss of enjoyment of life. As a direct and proximate result of these 

malfunctions and Bard’s actions, Ms. Macias suffered significant injuries and damages 

and required extensive medical care and treatment. As a further proximate result, Ms. 

Macias has suffered and will continue to suffer significant medical expenses and pain and 

suffering, along with other damages.

19. Here, Plaintiff O’Brien has suffered damages as a result of Bard’s actions. 

In particular, Plaintiff O’Brien’s filter perforated the IVC. As a result, Ms. O’Brien has 

suffered pain, emotional distress, and loss of enjoyment of life. As a direct and proximate 
8

result of these malfunctions and Bard’s actions, Ms. O’Brien suffered significant injuries 

and damages and required extensive medical care and treatment. As a further proximate 

result, Ms. O’Brien has suffered and will continue to suffer significant medical expenses 

and pain and suffering, along with other damages.

PARTIES

20. Plaintiff Macias is a citizen of and resident in the City of Marfa, Texas.

21. Plaintiff O’Brien is a citizen of and resident in the City of San Antonio, 

Texas.

22. Defendant C.R. Bard, Inc. (“CR Bard”) is a corporation duly organized and 

existing under the laws of the state of Delaware and has its principal place of business in 

New Jersey.

23. Bard, at all times relevant to this action, designed, set specifications for, 

manufactured, prepared, compounded, assembled, processed, marketed, distributed, and 

sold its permanent but retrievable filters, including the Filter, to be implanted in patients 

throughout the United States, including Texas.

24. Defendant Bard Peripheral Vascular, Inc. (“BPV”) is a wholly owned 

subsidiary corporation of Defendant Bard, with its principal place of business at 1625 

West Third Street, Tempe, Arizona.

25. BPV, at all times relevant to this action, designed, set specifications for, 

manufactured, prepared, compounded, assembled, processed, marketed, distributed, and 

sold its permanent but retrievable filters, including the Filter, to be implanted in patients 

throughout the United States, including Texas.
9

26. Plaintiffs are informed and believe, and thereon allege, that at all times 

herein mentioned, each of the Defendants were the agent, servant, employee and/or joint 

venturer of the other co-Defendants, and each of them, and at all said times each 

Defendant was acting in the full course, scope, and authority of said agency, service, 

employment and/or joint venture.

27. Plaintiffs are informed and believe, and thereon allege, that at all times 

mentioned herein, Defendants, and each of them, were also known as, formerly known 

as, and/or were the successors and/or predecessors in interest/business/product line/or a 

portion thereof, assigns, a parent, a subsidiary (wholly or partially owned by, or the 

whole or partial owner), affiliate, partner, co-venturer, merged company, alter egos, 

agents, equitable trustees and/or fiduciaries of and/or were members in an entity or 

entities engaged in the funding, researching, studying, manufacturing, fabricating, 

designing, developing, labeling, assembling, distributing, supplying, leasing, buying, 

offering for sale, selling, inspecting, servicing, contracting others for marketing, 

warranting, rebranding, manufacturing for others, packaging, and advertising the Filter. 

28. Defendants, and each of them, are liable for the acts, omissions and tortious 

conduct of their successors and/or predecessors in interest/business/product line/or a 

portion thereof, assigns, parent, subsidiary, affiliate, partner, co-venturer, merged 

company, alter ego, agent, equitable trustee, fiduciary and/or their alternate entities in that 

Defendants, and each of them, enjoy the goodwill originally attached to each such 

alternate entity, acquired the assets or product line (or a portion thereof), and in that there 

has been a virtual destruction of Plaintiffs’ remedy against each such alternate entity, and 
10

that each such Defendant has the ability to assume the risk-spreading role of each such 

alternate entity.

29. Plaintiffs are informed and believes, and thereon alleges that, at all times 

herein mentioned, Defendants, and each of them, were and are authorized to do and are 

doing business in the State of Texas and regularly conducted business in the State of 

Texas.

30. Upon information and belief, at all relevant times, Defendants, and each of 

them, were engaged in the business of researching, developing, designing, licensing, 

manufacturing, distributing, selling, marketing, and/or introducing into interstate 

commerce and into the State of Texas, either directly or indirectly through third parties or 

related entities, its products, including the Filter.

31. At all relevant times, Defendants, and each of them, conducted regular and 

sustained business and engaged in substantial commerce and business activity in the State 

of Texas, which included but was not limited to researching, developing, selling, 

marketing, and distributing their products, including the Filter, in the State of Texas.

32. Upon information and belief, at all relevant times, Defendants, and each of 

them, expected or should have expected that their acts would have consequences within 

the United States including in the State of Texas, and said Defendants derived and 

continue to derive substantial revenue therefrom.

JURISDICTION AND VENUE

33. Plaintiffs have suffered damages in an amount that exceeds the minimum 

jurisdictional limits of this Court. In particular, Plaintiffs have suffered bodily injury as 
11

set forth below and has incurred pain and suffering. Plaintiffs further seek punitive 

damages against Defendants based on their conduct at issue in this suit.

34. This Court has jurisdiction over this case because Defendants committed 

acts in this jurisdiction giving rise to the claims that are the subject of this action.

35. Venue is proper in this Court pursuant to 28 U.S.C. § 1391(b)(2) because a 

substantial part of the event or omissions giving rise to the claim occurred in this District.

GENERAL ALLEGATIONS

Inferior Vena Cava Filters Generally

36. IVC filters first came on to the medical market in the 1960s. Over the 

years, medical device manufacturers have introduced several different designs of IVC 

filters.

37. An IVC filter is a device that is intended to filter or “catch” blood clots that 

travel from the lower portions of the body to the heart and lungs. IVC filters are designed 

to be implanted, either permanently or temporarily, in the IVC.

38. The IVC is a vein that returns blood to the heart and lungs from the lower 

portions of the body. In certain people, for various reasons, blood clots travel from the 

vessels in the legs and pelvis, through the vena cava and into the lungs. Oftentimes, these 

blood clots develop in the deep leg veins, a condition called “deep vein thrombosis” or 

“DVT.” Once blood clots reach the lungs, they are considered “pulmonary emboli” or 

“PE.” Pulmonary emboli present risks to human health. 

39. People at risk for DVT/PE can undergo medical treatment to manage the 

risk. For example, a doctor may prescribe medications like Heparin, Warfarin, or 
12

Lovenox to regulate the clotting factor of the blood. In some people who are at high risk 

for DVT/PE, or who cannot manage their conditions with medications, physicians may 

recommend surgically implanting an IVC filter to prevent thromboembolitic events.

40. The first IVC filters sold were permanent filters. These devices were 

designed to be left in a patient’s IVC permanently and have long-term follow-up data (of 

up to 20 years and longer) demonstrating their risks and the frequency of occurrence of 

such risks, which is relatively low. 

41. Beginning in 2003, manufacturers also began marketing what are known as 

“optional” or “retrievable” filters. These filters were designed so that, in theory, they can 

be surgically removed from a patient after implantation, presumably after the risk of PE 

has subsided. These optional or retrievable filters are sold as permanent filters with an 

option to remove them, in some cases within a window; in the case of Bard’s filters, it 

claims there is no window limiting retrieval. 

42. But, while Bard sells its “retrievable” filters as permanent devices with 

unlimited retrieval windows, Bard never designed or properly tested the filters for safety 

as permanent devices and, over time, they demonstrate both a significantly increased risk 

of failure and becoming irretrievable.

The Recovery Filter

43. In the early 2000s, Bard began development of its first generation 

“retrievable” filter, called the Recovery filter (hereafter “Recovery” or “Recovery 

Filter”).
13

44. The Recovery Filter consists of two (2) levels of six (6) radially distributed 

Nitinol struts that are designed to anchor the filter into the inferior vena cava and to catch 

any embolizing clots. There are six short struts, which are commonly referred to as the 

arms, and six long struts, which are commonly referred to as the legs. Each strut is held 

together by a single connection to a cap located at the top of the device. According to the 

Patent filed for this device, the short struts are primarily for “centering” or “positioning” 

with the vena cava, and the long struts with attached hooks are designed primarily to 

prevent the device from migrating in response to “normal respiratory movement” or 

“pulmonary embolism.”

45. The Recovery filter is made out of “Nitinol”, an acronym for Nickel 

Titanium Naval Ordinance Laboratory. “Nitinol” possesses “shape memory,” meaning it 

will change shape according to changes in temperature, and then, retake its prior shape 

after returning to its initial temperature. When placed in saline, therefore, the Nitinol 

struts become soft and can be straightened to allow delivery through a small diameter 

catheter. The metal struts then reassume their original shape when warmed to body 

temperature in the vena cava.

46. An IVC filter is typically implanted in the IVC via a catheter that is guided 

by a physician (normally an interventional radiologist) through a blood vessel into the 

IVC. The implanting physician normally reviews an imaging study prior to placement to 

determine size of IVC, renal vein location, and to identify any venous anomalies or clots 

in the vena cava. Following placement, the physician will normally use an imaging study 
14

to confirm successful placement. The Recovery filter was designed to be retrieved in a 

similar fashion. 

47. In its design and development stage, Bard conducted a small clinical trial 

(involving human patients) to evaluate the retrievability of the Recovery filter. In a 

short-term setting involving less than 40 patients, the Recovery filter experience three 

significant failures: the first was that a filter moved substantially (migrated) from it 

location of implant toward the patient’s heart; the second was that one filter broke 

(fractured) in two different places, resulting in pieces of the filter breaking apart and 

separating from the filter so that they could freely travel to the heart. Despite those 

problems, Bard took no action to redesign the filter or to stop the process toward sale.

48. In 2002, Bard submitted a notification of intent to the FDA to market the 

“Recovery Filter System” for the prevention of recurrent pulmonary embolism by 

placement in the IVC.

1 Bard identified the SNF as one of the Recovery’s predicate 

devices, representing to the FDA that the Recovery was the substantial equivalent in 

terms of safety performance and efficacy as the SNF. On November 27, 2002, the FDA 

cleared the Recovery filter for marketing and use in the prevention of recurrent 

1 Bard submitted the notification under Section 510(k) of the United States Food, Drug and 

Cosmetic Act (“Act”) of 1976 (21 U.S.C. 321 et seq.). The 510(k)-review process requires 

any entity engaged in the design, manufacture, distribution or marketing of a device 

intended for human use to notify the FDA 90 days before it intends to market the device 

and to establish that the device is substantially equivalent to a legally marketed predicate 

device. (21 C.F.R. §§ 807.81, 807.92(a)(3).) Substantial equivalence means that the new 

device has the same intended use and technological characteristics as the predicate device. 

This approval process allows a manufacturer to bypass the rigorous safety scrutiny required 

by the pre-market approval process. 
15

pulmonary embolism via permanent placement in the vena cava in the following 

situations:

a. Pulmonary thromboembolism when anticoagulants are 

contraindicated;

b. Failure of anticoagulant therapy for thromboembolic disease;

c. Emergency treatment following massive pulmonary embolism where 

anticipated benefits of conventional therapy are reduced;

d. Chronic, recurrent pulmonary embolism where anticoagulant therapy 

has failed or is contraindicated.

49. In April 2003, Bard and BPV submitted a Section 510(k) premarket 

notification of intent to market the Recovery Filter for the additional intended use of 

optional retrieval. The FDA cleared this additional intended use on July 25, 2003. 

50. Bard and BPV began actually marketing the device in April 2003, but full 

market release did not occur until January 2004. 

51. Prior to full market release, Bard failed to adequately test the Recovery 

filter for safety as a permanent filter. In particular, it failed to test the filter to determine 

that it was reasonably safe under foreseeable worst-case scenario conditions, including 

how likely it was that the filter would tilt and what would happen to the filter if it were 

tilted.

52. Further, Bard’s lab tests to simulate migration resistance consistently 

demonstrated that the Recovery was the worst IVC filter available at resisting migration 

and significantly worse than the SNF. Thus, contrary to Bard’s representation to the 

FDA, the Recovery was not the substantial equivalent of that device. 
16

53. Moreover, after an internal special design review committee raised 

questions as to the safety of the Recovery, and particularly its ability to resist migration, 

in December 2003, Bard did not stop its full market release of the filter or even answer 

the significant safety questions raised by the committee prior to release. Rather, Bard 

proceeded to full market release and conducted some (but not all) of the requested testing 

after the product was already one the market. And, then, the Recovery failed the tests, 

failing to meet the safety threshold that Bard established for migration resistance.

54. Shortly after full market release, Bard began receiving reports of significant 

filter failures, including migrations to the heart and deaths. 

55. The Recovery Filter is prone to an unreasonably high risk of failure and 

patient injury following placement in the human body. Multiple studies report Bard’s 

Recovery Filter to have a fracture and migration rate ranging from 21% to 31.7%.2

 When 

such failures occur, shards of the device or the entire device can travel to the heart, as 

seen here, where it can cause cardiac tamponade, perforation of the atrial wall, 

myocardial infarction and death. These fractured shards may also become too embedded 

in tissue or migrate to locations, such as the heart and lungs, where those shards are too 

dangerous to remove. These patients, like Plaintiff, are exposed to a lifetime of future 

risks due to the high failure and complication rates with this device. 

2 See e.g., Hull JE, Robertson SW. Bard Recovery Filter: Evaluation and Management of 

Vena Cava Limb Perforation, Fracture and Migration. J Vasc Interv Radiol. 

2009;20(1):52-60; Nicholson W, et al. Prevalence of Fracture and Fragment Embolization 

of the Bard Recovery and Bard G2 Cava Filters and Clinical Implications Including 

Cardiac Perforation and Tamponade. Arch. Int. Med. 2010 Nov.; 170:1827-31.
17

56. The Recovery Filter similarly poses a high risk of tilting and perforating the 

vena cava walls. When such failures occur, the device can perforate the aorta,

duodenum, small bowel, ureter, pancreas, spine, and other organs/structures/vessels -

which may lead to numerous significant problems including death. Further, given the 

risks of injury in attempting to remove devices that have perforated the vena cava, the 

device may be irremovable. Thus, these patients are faced not only with an injury that 

cannot be fixed but with a lifetime of future additional risk due to the high failure and 

complication rates with this device. 

57. The Recovery filter failures described above occur at a substantially higher 

rate than with other IVC filters. 

58. Soon after the Recovery filter’s introduction to the market, Bard began 

receiving large numbers of adverse event reports from healthcare providers. The adverse 

event reports (“AERs”) associated with IVC filter devices demonstrates that Bard’s IVC 

filters are far more prone to device failure then are other similar devices. A review of the 

FDA MAUDE database from the years 2004-2008 reveals data to establish that Bard’s 

IVC filters are responsible for the following percentages of all AERs:

a. 50% of all adverse events

b. 64% of all occurrences of migration of the device

c. 69% of all occurrences of vena cava wall perforation

d. 70% of all occurrences of filter fracture. 
18

59. These failures are attributable, in part, to the fact that the Recovery filter 

was not adequately designed to be able to withstand the normal anatomical and 

physiological loading cycles exerted in vivo.

60. In addition to design defects, the Recovery filter suffers from 

manufacturing defects. These manufacturing defects include, but are not limited to, the 

existence of “draw markings” and circumferential grinding markings on the exterior of 

the surface of the device. The presence of these draw markings and/or circumferential 

grinding markings further compromises the structural integrity of the device while in 

vivo. In particular, the Recovery filter is prone to fail at or near the location of draw 

markings/circumferential grinding markings on the struts of the device. Put simply, the 

Recovery filter is not of sufficient strength to withstand normal placement within the 

human body. The presence of the aforementioned exterior manufacturing defects makes 

the device more susceptible to failure.

61. Bard knew that no clinical testing, such as animal studies or simulated use 

tests, was conducted to determine whether the Recovery filter would perform safely once 

implanted in the human body and subjected to normal in vivo stresses. 

62. Soon after the Recovery filter’s introduction to the market in 2003, Bard 

began receiving large numbers of AERs from healthcare providers reporting that the 

Recovery filter was fracturing post-implantation and that fractured pieces and/or the 

entire device were migrating throughout the human body, including to the heart and 

lungs. Bard also received large numbers of AERs reporting that the Recovery filter was 

found to have excessively tilted and/or perforated the inferior vena cava post-
19

implantation. These failures were often associated with reports of severe patient injuries 

such as:

a. Death; 

b. Hemorrhage; 

c. Cardiac/pericardial tamponade (pressure caused by a collection of 

blood in the area around the heart); 

d. Cardiac arrhythmia and other symptoms similar to myocardial 

infarction; 

e. Severe and persistent pain; 

f. Thrombosis and occlusion of the IVC; and 

g. Perforations of tissue, vessels and organs.

63. Within the first year of full market release of the Recovery filter, Bard and 

BPV received at least 32 AERs reporting that the Recovery Filter had fractured in vivo 

and at least 22 AERs reporting that the entire device had migrated in vivo. Of the 22 

reported migration failures, at least nine (9) were reported to have been associated with a 

patient death.

64. From 2003 through September 2005, Bard received ever growing numbers 

of AERs reporting the above described failures and patient injuries. Bard knew or should 

have known that the failure rates associated with the Recovery filter were substantially 

higher than other similar products on the market, yet Bard failed to warn consumers of 

this unreasonably dangerous device.

65. Bard began investigating these failures in 2004, creating Failure 

Investigation Reports and Remedial Action Plans, but each time Bard reviewed a 
20

migration, fracture, or death, it was unable to determine the root cause. Thus, it never 

understood how or why these failures were happening.

66. Nonetheless, in late 2004 or early 2005 Bard, without knowing why the 

failures were happening (and thus what design changes were necessary to prevent them) 

and without notifying consumers of the design and manufacturing flaws inherent in the 

Recovery filter, began to make design changes to the Recovery in an attempt to correct 

those flaws. But, as with its design of the Recovery filter, Bard failed to appreciate how 

the failures were caused and how to create a design to reduce or eliminate them; further, 

Bard again failed to adequately test the remodeled Recovery to ensure that it was safe for 

permanent implantation. 

67. The second generation of Bard’s filter is known as the G2 filter; G2 is 

shorthand for “second generation” Recovery filter. Once Bard obtained FDA approval to 

market the G2 in or around August 2005, Bard and BPV quietly stopped marketing the 

Recovery filter. Bard failed, however, to make any effort to notify consumers of the risk 

inherent in the use of the Recovery filter or to recall the remaining devices on hospital 

shelves.
21

The G2 and G2 Express Filters

68. In 2005, Bard made several design changes to its first-generation 

retrievable filter, Recovery Filter, in an attempt to fix its design flaws. The secondgeneration Recovery filter is called the G2. 

69. As with the Recovery filter, Bard’s design and testing of the G2 was 

significantly inadequate. For example, Bard substantially widened the base of the filter. 

This change was an immediate and reactionary response to the migrations of the 

Recovery filter to patients’ hearts and related deaths. But, Bard failed to do any testing to 

determine what impact that change would have on the filter’s safety and performance. 

Particularly, Bard failed to test to determine if the change would impact the filter’s 

likelihood of tilting, perforating the IVC, or fracturing. Similarly, it again failed to test to 

determine how the filter would perform under foreseeable worst-case conditions. 

70. And, when the filter failed some of Bard’s internal test standards, including 

that it perform as well as or better than the SNF, Bard lowered the standard (to be better 

than the poor performing Recovery) rather than fix the issue and improve the G2’s actual 

performance.

71. On August 10, 2005, Bard submitted a Section 510(k) premarket 

notification of intent to market the G2 filter for the prevention of recurrent pulmonary

embolism via permanent placement in the inferior vena cava. Bard cited the Recovery 

filter as the substantially equivalent predicate device, substantially lowering the bar from 

the SNF, which had served as the Recovery’s predicate. Bard stated that the differences 

between the Recovery filter and the G2 filter were primarily dimensional and no material 
22

changes or additional components were added. On August 29, 2005, the FDA cleared the 

G2 filter for the same intended uses as the Recovery filter, except that the G2 was not 

cleared for retrievable use.3

72. Even after the redesigned G2 filter was cleared for use, Bard failed to take 

any steps to recall the Recovery filter and/or to notify consumers that the failure rates 

associated with the Recovery filter were substantially higher than other similar products 

on the market. 

73. Bard marketed the G2 Filter as having “enhanced fracture resistance,” 

“improved centering,” and “increased migration resistance.” Despite these claims, 

however, Bard failed to ensure that the changes made to the G2 filter were sufficient to 

cure the defective and unreasonably dangerous nature of the device. As a result, the G2 

filter shares the same defects and health risks as its predicate device. 

74. The G2 filter’s design causes it to be of insufficient integrity and strength to 

withstand normal in vivo body stresses within the human body so as to resist fracturing, 

migrating, tilting, and/or perforating the IVC. 

75. After its full market release, Bard conducted a clinical trial of the G2 filter. 

Like the Recovery trial, this was not a trial designed to determine the filter’s long-term 

safety and effectiveness. Instead, the study was designed to determine the ability to 

retrieve the G2 in order to obtain a retrievability indication for the then permanent-only 

device. In that study, the G2, like the Recovery, suffered significant device failures, 

3 The FDA did not clear the G2 filter to be used as a retrievable filter until January 15, 

2008. 
23

including migration, fracture, tilt, and perforation, in a limited patient pool of 83 patients. 

And, the filter demonstrated a new failure: migrating away from the heart.

76. Also, like its predecessor, in addition to design defects, the G2 filter suffers 

from manufacturing defects. These manufacturing defects include, but are not limited to, 

the existence of “draw markings” and circumferential grinding markings on the exterior 

of the surface of the device. The presence of these draw markings and/or circumferential 

grinding markings further compromises the structural integrity of the G2 filter while in 

vivo. In particular, the G2 filter is prone to fail at or near the location of draw markings/ 

circumferential grinding markings on the struts of the device. Put simply, the G2 filter is 

not of sufficient strength to withstand normal placement within the human body. The 

presence of the aforementioned exterior manufacturing defects makes the device more 

susceptible to fatigue failure.

77. As with the Recovery filter, after full market release, Bard immediately 

began receiving large numbers of AERs reporting that the G2 filter was, inter alia, 

fracturing, migrating, excessively tilting, and perforating the vena cava once implanted. 

These failures were again often associated with reports of severe patient injuries such as:

a. death; 

b. hemorrhage;

c. cardiac/pericardial tamponade (pressure caused by a collection of 

blood in the area around the heart);

d. cardiac arrhythmia and other symptoms similar to myocardial 

infarction;

e. severe and persistent pain;
24

f. thrombosis and occlusion of the IVC; and

g. perforations of tissue, vessels and organs.

78. Bard represents the fracture rate of the G2 filter to be 1.2 percent. Based 

upon a review of the data available in the public domain (including the FDA MAUDE 

database statistics and the published medical literature), this representation does not 

accurately reflect the true fracture rate for the G2 Filter.

79. A review of the MAUDE database from the years 2004-2008 reveals data 

to establish that the Bard’s IVC filters (including the G2 Filter) are responsible for the

majority of all IVC-filter reported adverse events.

80. Bard’s next iteration of its permanent-but-retrievable filter was the G2 

Express filter. The only design change from the G2 filter to the G2 Express filter was the 

addition of a snare tip at the apex of the filter to assist in its retrieval. The change had no 

substantive change to the performance or safety of the filter. Again, Bard failed to test 

the G2 Express for long-term (permanent) safety 

81. The FDA cleared the G2 Express filter on July 30, 2008. The only 

significant difference between this filter and the G2 was a new snare tip which was 

designed in an effort to optimize retrieval. Bard launched and began marketing the G2 

Express in August 2008. The G2 and the G2 Express are the same filter, from a design 

standpoint, and share the same defects and complications.

82. The G2x filter was cleared by the FDA on October 31, 2008. As with the 

G2 Express, the G2x had no significant design difference between it and the G2 filter (or 

G2 Express). Bard launched the G2x filter in January 2009. The G2, G2 Express, and 
25

the G2x are the same filter, from a design standpoint, and share the same defects and 

complications.

83. Upon information and belief, Plaintiffs allege that as early as 2003, Bard 

was aware and had knowledge of the fact that the Recovery filter was defective and 

unreasonably dangerous and was causing injury and death to patients who had received it. 

Similarly, Bard was aware as early as 2005 that the G2 filter family was defective and 

unreasonably dangerous and was causing injury and death to patients who had received it. 

And due to the similarities in design, Bard should have known that the G2 Express and 

G2x were just as dangerous and defective. 

84. Data establishes that the failure rate of the G2, G2 Express, and G2x filters 

was/is exceedingly higher than the rate that Bard have in the past, and currently continue 

to publish to the medical community, members of the public. Further, Bard and BPV are 

aware or should have been aware that the G2, G2 Express, and G2x filters have a 

substantially higher failure rate than other similar products on the market, yet they have 

failed to warn consumers of this fact. 

85. Upon information and belief, from the time the G2 filter became available 

on the market, the Bard embarked on an aggressive campaign of “off label marketing” 

concerning the G2 filter. This included representations made to physicians, healthcare 

professionals, and other members of the medical community that the G2 filter was safe 

and effective for retrievable use prior to the FDA approving the G2 filter for retrievable 

use.
26

86. Despite having knowledge as early as 2005 of the unreasonably dangerous 

and defective nature of the product, Bard consciously disregarded the known risks and 

continued to actively market and offer for sale the G2, G2 Express, and G2x filters.

The Eclipse Filter

87. In response to the complications associated with the G2, G2 Express, and 

G2x filters along with a negative image in the marketplace for those filters, Bard decided 

to electropolish the filter and change its name to the Eclipse filter.

88. Bard recognized that electropolishing was fairly standard in the medicaldevice market and by making purely cosmetic changes to the G2X filter, it could rename 

and market the filter to avoid the “baggage” associated with the G2 filter.

89. The Eclipse filter was cleared by the FDA on January 14, 2010. The Eclipse 

filter was identical to the G2/G2X filters except that the filter was electropolished and 

tinted blue. The Eclipse filter continued to share the same design defects and complications 

associated with the Recovery, G2, G2 Express, and G2x filters due to the fact that the 

Eclipse design was based on its predecessors.

90. Bard launched the Eclipse filter in 2010. Soon thereafter, Bard began 

receiving similar complaints associated with the Eclipse filter as it had with the predecessor 

filters. Because the Eclipse is based on Bard’s previous filter designs, the Eclipse filter 

shares the same or similar design and manufacturing defects as Bard’s previous filters and 

suffers from the same complications and defects.

91. Bard was aware of the defective nature of the Eclipse filter before it hit the 

market, but did not discontinue sales until 2015.
27

The Meridian Filter

92. In an effort to address one recurring failure of the G2/G2X/Eclipse filters, 

Bard added “caudal” anchors to the filter and renamed it the Meridian. Caudal anchors are 

hooks added to the legs that point downward in an effort to keep the filter from moving 

93. The Meridian filter was cleared by the FDA on August 24, 2011. The 

Meridian filter has the same defective design platform as Bard’s predecessor filters, but 

added, in pertinent part, caudal migration anchors. The Meridian filter was the first Bard 

filter to add caudal anchors, despite Bard being aware since late 2005 of the need for caudal 

anchors to decrease tilt, caudal migration, perforation, and fracture. Despite awareness of 

the need to correct the problems its filters had with stability in the IVC and caudal 

migration, Bard waited 5 years before attempting to correct this issue with the Meridian 

filter.

94. The Meridian filter continued to share the same design defects and 

complications associated with the Recovery and G2/G2X/Eclipse filters due to the fact that 

the Meridian was the same filter with the same core design. Soon after launching the 

Meridian, Bard began receiving similar complaints associated with the Meridian filter as it 

had with the predecessor filters. Because the Meridian is the same as Bard’s previous filter 

designs, the Meridian filter shares the same or similar design and manufacturing defects as 

Bard’s previous filters and causes the same complications and defects. 

95. Bard was aware of the defective nature of the Meridian before it hit the 

market.
28

The Denali Filter

96. Bard began developing another design of the permanent-but-retrievable IVC 

filter in 2009—at the same time it was rebranding the G2/G2X as the Eclipse and Meridian. 

Bard called that filter “Denali” and purported to make it to address the ongoing failures of 

the Recovery/G2/G2X/Eclipse/Meridian filter. Unfortunately, the “new” design of the 

Denali was essentially the same design as the Recovery/G2/G2X/Eclipse/Meridian filter: 

a conical design with six arm struts and six leg struts that connect to the IVC. Thus, 

although the angles are a bit different at different points, the design of the Denali is the 

same as Bard’s permanent-but-retrievable filters.

97. The Denali filter is also made of NITINOL, is electropolished like the 

Eclipse, and has caudal anchors like the Meridian. The one significant change that Bard 

made was that the NITINOL wires used in the Denali filter are electropolished prior to 

forming the filter. 

98. Bard represented to the FDA that the Denali was the substantial equivalent 

of the Eclipse filter, again bypassing formal pre-market FDA approval and instead utilizing 

the 510(k) process.

99. Based on Bard’s representations, the FDA cleared the Denali filter for sale 

in the U.S. on May 15, 2013. 

100. As with each earlier iteration of Bard’s permanent-but-retrievable filter, soon 

after its introduction to the market, Bard received reports that the Denali filters were 

fracturing, perforating, migrating, causing extreme thrombosis and/or tilting in the patients 

in which they were implanted.
29

101. The Denali filter was likewise plagued with the same manufacturing and 

design defects that were causing damage to the general public in Bard’s predecessor 

retrievable filter family.

102. At all times material hereto from the design phase, testing and manufacture 

of the iterations of the filter (Recovery through Denali), Bard lacked a thorough 

understanding of dynamics of caval anatomy that impacted testing methods.

103. At this time, all Bard IVC filters contain the same or substantially similar 

defects resulting in the same or substantially similar mechanism of injury to patients and 

their decedents.

104. At this time, all Bard IVC filters are misbranded and adulterated by virtue of 

them failing to be the substantial equivalent of their predecessor devices, all of which were 

required to be as safe and effective as the original predicate device, the SNF, and none 

were/are, making them subject to corrective action, including recall, in the interest of 

patient safety. The use of each of these subject devices was inappropriate and illegal since 

each was being marketed while adulterated and misbranded for failing, among other things, 

to be as safe and effective as the originating predicate device, SNF.

105. At all relevant times, safer and more efficacious designs exist for this product 

as well as reasonable treatment alternatives.

Outrageous Conduct

106. Bard’s conduct as alleged in this Complaint constitutes willful, wanton, 

gross, and outrageous corporate conduct that demonstrates a conscious disregard for the 
30

safety of Plaintiffs and the community at large. Bard had actual knowledge of the 

dangers presented by the Filter, yet consciously failed to act reasonably to:

a. Inform or warn Plaintiffs, Plaintiffs’ physicians, or the public at 

large of these dangers;

b. Establish and maintain an adequate quality and post-market 

surveillance system; and 

c. Recall the Filter from the market.

107. Plaintiffs further allege that Bard acted in willful, wanton, gross, and total 

disregard for the health and safety of the users or consumers of the Filter, when acting to 

serve its own interests, it knowingly and consciously disregarded the substantial risk that 

its product might kill or significantly harm patients, by consciously pursuing a course of 

conduct knowing it created a substantial risk of significant harm to other persons.

108. The failures of the Filter are attributable, in part, to the fact that the Filter

was designed so as to be unable to withstand the normal long-term anatomical and 

physiological loading cycles exerted in vivo.

What Happens When An IVC Filter Fails?

109. The failure (fracture, migration, perforation, irretrievability, extreme 

thrombosis, etc.) of the Filter leads to a number of different, and potentially fatal, 

complications. These complications include, but are not limited to:

a. Death;

b. Hemorrhage;

c. Cardiac/pericardial tamponade (pressure caused by a collection of 

blood in the area around the heart);

d. Severe and persistent pain;
31

e. Extreme lower body clotting and thrombosis;

f. Perforation of tissue, vessels and organs; and

g. Embolization.

Specific Factual Allegations As To Plaintiff

110. On or about April 25, 2011, Plaintiff Macias underwent placement of a 

permanent-but-retrievable Bard Eclipse filter. The Filter subsequently malfunctioned by 

perforating through her IVC with struts abutting the aorta and L4 vertebral body. As a 

result, the Filter caused injury and damages to Ms. Macias. Plaintiff Macias has suffered 

pain, emotional distress, and loss of enjoyment of life.

111. On or about May 8, 2015, Plaintiff O’Brien underwent placement of a 

permanent-but-retrievable Bard Denali filter. The Filter subsequently malfunctioned by 

perforating through her IVC. As a result, the Filter caused injury and damages to Ms. 

O’Brien. Plaintiff O’Brien has suffered pain, emotional distress, and loss of enjoyment 

of life. 

112. The Filter was designed, manufactured, prepared, compounded, assembled, 

processed, marketed, distributed, and sold by Bard.

113. Plaintiffs have incurred significant medical expenses and has endured pain 

and suffering, anxiety, loss of enjoyment of life, and other losses, some of which are 

permanent in nature. 

FIRST CAUSE OF ACTION

[Strict Products Liability]

114. Plaintiffs incorporate by reference all preceding paragraphs. 
32

115. Prior to, on, and after the date the Filter was implanted in Plaintiffs and at 

all relevant times, Defendants designed, distributed, manufactured, sold, and marketed 

the Filter for use in the United States. 

116. At all times herein mentioned, Defendants designed, distributed, 

manufactured, marketed, and sold the Filter such that it was dangerous, unsafe, and 

defective due to design, manufacture, and lack of adequate warnings.

117. The Filter contained all of these defects when it left Defendants’ 

possession.

118. Plaintiffs is informed and believes, and on that basis alleges, that the Filter

contained a manufacturing defect in that it differed from the manufacturer’s design or 

specifications, or from other typical units of the same product line. 

119. Prior to the dates on which the Filter was implanted in Plaintiffs, 

Defendants manufactured, distributed, and sold the Filter. 

120. The Filter had potential risks and side effects that were known or knowable 

to Defendants by the use of scientific knowledge available before, at, and after the 

manufacture, distribution, and sale of the Filter. 

121. Defendants knew or should have known of the defective condition, 

characteristics, and risks associated with the Filter, as previously set forth herein. 

122. Said defective conditions included, but were not limited to, the Filter

posing a significant and higher risk than other similar devices of device failure (fracture, 

migration, tilting, extreme clotting and thrombosis, and perforation of the vena cava wall) 

resulting in death and/or serious injuries and that certain conditions or post-implant 
33

procedures, such as morbid obesity or open abdominal procedures, could affect the safety 

and integrity of the device, among other things.

123. The Filter was in a defective condition that was unreasonably and 

substantially dangerous to any user or ordinary consumer implanted with the Filter, such 

as Plaintiffs when used in an intended or reasonably foreseeable way. 

124. Such ordinary consumers, including Plaintiffs, would not and could not 

have recognized or discovered the potential risks and side effects of the Filter, as set forth 

herein. 

125. The warnings and directions provided with the Filter by Defendants failed 

to adequately warn of the potential risks and side effects of the Filter, which risks were 

known or were reasonably scientifically knowable to Defendants, but not known or 

recognizable to ordinary consumers, such as Plaintiffs or their treating doctors. 

126. The Filter was expected to and did reach Plaintiffs without substantial 

change in its condition, labeling, or warnings as manufactured, distributed, and sold by 

Defendants. 

127. Plaintiffs and Plaintiffs’ physicians used the Filter in the manner in which it 

was intended to be used, making such use reasonably foreseeable to Defendants. 

128. Defendants’ lack of sufficient instructions or warnings prior to, on, and 

after the date Plaintiffs were implanted with the Filter was a substantial factor in causing 

Plaintiff’s injuries and damages.

129. Defendants’ design, manufacture, marketing, promotion, and sale of the 

Filter were a substantial factor in causing Plaintiffs’ injuries and damages.
34

130. As a direct and proximate result of Defendants’ defective design, 

manufacture, marketing, and sale of the Filter prior to and on the date Plaintiffs used the 

Filter, Plaintiffs suffered damages herein described. 

SECOND CAUSE OF ACTION

[Negligence—Design, Manufacture, Sale]

131. Plaintiffs incorporate by reference all preceding paragraphs.

132. Prior to, on, and after the date the Filter was implanted in Plaintiffs, and at 

all relevant times, Defendants designed, tested, distributed, manufactured, advertised, 

sold, and marketed the Filter for use by consumers, such as Plaintiffs, in the United 

States. 

133. Prior to, on, and after the date the Filter was implanted in Plaintiffs, 

Defendants had a duty to exercise due care and avoid unreasonable risk of harm in and 

about their design, testing, distribution, manufacture, advertising, sale, and marketing of 

the Filter. 

134. At the time of design, distribution, manufacture, advertising, sale, 

marketing, and implantation of the Filter in Plaintiffs, Defendants were aware of the 

following facts:

a. The Filter was designed and manufactured in such a manner so as to 

present an unreasonable risk of fracture of portions of the Filter;

b. The Filter was designed and manufactured so as to present an

unreasonable risk of migration of the device and/or portions of the 

device;

c. The Filter was designed and manufactured so as to present an

unreasonable risk of the device tilting and/or perforating the vena 

cava wall; 
35

d. The Filter was designed and manufactured to have unreasonable and 

insufficient strength or structural integrity to withstand normal 

placement within the human body;

e. The Filter was designed and manufactured to present an

unreasonable risk of extreme clotting and IVC thrombosis;

f. The Filter would be used without inspection for defects;

g. The Filter would be used by patients with special medical conditions 

such as those of Plaintiffs; and

h. The Filter had previously caused serious bodily injury to its users 

with special medical conditions such as those of Plaintiffs.

135. Prior to and on the date of Plaintiffs’ implantation with the Filter, 

Defendants breached their duty of care by, but not limited to, the following:

a. Designing and distributing a product in which they knew or should 

have known that the likelihood and severity of potential harm from 

the product exceeded the burden of taking safety measures to reduce 

or avoid harm;

b. Designing and distributing a product in which they knew or should 

have known that the likelihood and severity of potential harm from 

the product exceeded the likelihood of potential harm from other 

devices available for the same purpose;

c. Failing to use reasonable care in manufacturing the product and 

producing a product that differed from their design or specifications 

or from other typical units from the same production line;

d. Failing to use reasonable care to warn or instruct Plaintiff, Plaintiff’s 

physicians, or the general healthcare community about the Filter’s 

substantially dangerous condition or about facts making the product 

likely to be dangerous;

e. Failing to perform reasonable pre- and post-market testing of the 

Filter to determine whether or not the product was safe for its 

intended use;

f. Failing to provide adequate instructions, guidelines, and safety 

precautions to those persons to whom it was reasonably foreseeable 

would prescribe, use, and implant the Filter; 
36

g. Advertising, marketing, and recommending the use of the Filter, 

while concealing and failing to disclose or to warn of the dangers 

known by Defendants to be connected with and inherent in the use 

of the Filter;

h. Representing that the Filter was safe for its intended use when, in 

fact, Defendants knew or should have known the product was not 

safe for its intended purpose;

i. Continuing manufacture and sale of the Filter with the knowledge 

that said product was dangerous and not reasonably safe, and failing 

to comply with FDA good manufacturing regulations and policy;

j. Failing to use reasonable and prudent care in the design, research, 

manufacture, and development of the Filter so as to avoid the risk of 

serious harm associated with the use of the Filter;

k. Advertising, marketing, promoting and selling the Filter for uses 

other than as approved and indicated in the product’s label; 

l. Failing to establish an adequate quality assurance program used in 

the manufacturing of the Filter; and

m. Failing to perform adequate evaluation and testing of the Filter

where such evaluation and testing would have revealed the 

propensity of the Filter to cause injuries and death as described 

herein.

136. Defendants’ conduct also violates Federal and other laws, regulations, and 

policies, all of which are designed to protect consumers like Plaintiffs. 

137. These laws include, without limitation, 18 U.S.C. §§ 2, 1001, 333(b), and 

1341; 21 U.S.C. §331(a). 

138. Defendants’ violation of these safety statutes proscribing specific conduct 

constitutes negligence per se.
37

139. As a direct and legal result of the above-described negligence in design, 

testing, distribution, manufacture, advertising, sales, and marketing, Plaintiffs sustained 

the injuries and damages described above.

THIRD CAUSE OF ACTION

[Negligence—Failure to Recall/Retrofit]

140. Plaintiffs incorporate by reference all preceding paragraphs. 

141. Prior to, on, and after the date of Plaintiffs’ implantation with the Filter, and 

at all relevant times, Defendants designed, distributed, manufactured, sold, and marketed 

the Filter for use by consumers such as Plaintiffs in the United States.

142. Prior to, on, and after the date of Plaintiffs’ implantation with the Filter, and 

at all relevant times, Defendants knew or reasonably should have known that the Filter

and its warnings were dangerous or were likely to be dangerous when used in a 

reasonably foreseeable manner. 

143. Prior to, on, and after the date of Plaintiffs’ implantation with the Filter, and 

at all relevant times, Defendants became aware that the defects of the Filter resulted in 

the Filter causing injuries similar to those Plaintiffs suffered. 

144. Defendants negligently and carelessly failed to recall, to retrofit, or to warn 

patients or physicians about the danger of the Filter prior to, on, and after the date of 

Plaintiffs’ implantation with the Filter and continue to fail to recall the device up until the 

present time. 
38

145. Reasonable manufacturers and distributors under the same or similar 

circumstances would have recalled or retrofitted the Filter and would thereby have 

avoided and prevented harm to many patients, including Plaintiffs.

146. As a direct and legal result of the above-described negligent failure to recall 

or retrofit, Plaintiffs suffered the injuries described above.

FOURTH CAUSE OF ACTION

[Negligence—Failure to Warn]

147. Plaintiffs incorporate by reference all preceding paragraphs. 

148. Prior to, on, and after the date of Plaintiffs’ implantation with the Filter, and 

at all relevant times, Defendants designed, distributed, manufactured, sold, and marketed 

the Filter for use by consumers, such as Plaintiffs, in the United States.

149. Prior to, on, and after the date of Plaintiffs’ implantation with the Filter, and 

at all relevant times, Defendants knew or should have known that the Filter was 

dangerous or was likely to be dangerous when used in a reasonably foreseeable manner. 

Such danger included the propensity of the Filter to cause injuries similar to those 

suffered by Plaintiffs. 

150. Prior to, on and after the date of Plaintiffs’ implantation with the Filter, 

Defendants knew or reasonably should have known that the users of the device, including 

Plaintiffs and Plaintiffs’ physicians, would not realize the dangers presented by the Filter. 

151. Prior to, on, and after the date of Plaintiffs’ use of the Filter, Defendants 

negligently and carelessly failed to adequately warn of the dangers presented by the Filter

and/or failed to instruct on the safe use of the Filter. 
39

152. Reasonable manufacturers and reasonable distributors, under the same or 

similar circumstances as those of Defendants prior to, on, and after the date of Plaintiffs’

use of the Filter, would have warned of the dangers presented by the Filter, or instructed 

on the safe use of the Filter. 

153. Prior to the date of Plaintiffs’ use of the Filter, the Filter had already caused 

numerous instances of injuries similar to those suffered by Plaintiffs, as well as death, as 

alleged herein. Defendants deliberately failed to warn of the Filter’s increased propensity 

to cause these serious complications, or of the signs and symptoms of these 

complications.

154. As a direct and proximate result of Defendants’ failure to warn, Plaintiffs

sustained the injuries and damages described above.

FIFTH CAUSE OF ACTION

[Negligence—Misrepresentation]

155. Plaintiffs incorporate by reference all preceding paragraphs.

156. Prior to, on, and after the dates during which Plaintiffs were implanted with 

the Filter, Defendants negligently and carelessly represented to Plaintiffs, Plaintiffs’

physicians, and the general public that an important fact was true, namely that the Filter

was safe, fit, and effective for use. 

157. Prior to, on, and after the dates during which Plaintiffs purchased and used 

the Filter, said representations were not true, and there was no reasonable ground for 

believing said representations to be true at the times said representations were made. 
40

158. Prior to, on, and after the dates during which Plaintiffs purchased and used 

the Filter, Defendants intended that Plaintiffs, their treating physicians, and the general 

public would rely on said representations, which Plaintiffs did reasonably do at said 

times.

159. As a direct and proximate result of Defendants’ negligent 

misrepresentation, Plaintiffs sustained the injuries and damages described above.

SIXTH CAUSE OF ACTION

[Breach of Express Warranty]

160. Plaintiffs incorporate by reference all preceding paragraphs.

161. Prior to, on, and after the dates during which Plaintiffs were implanted with 

the Filter, and at all relevant times, Defendants, and each of them, had knowledge of the 

purpose for which the Filter was to be used, and represented it to be in all respects safe, 

effective, and proper for such purpose.

162. Said warranties and representations were made to consumers, such as 

Plaintiffs, their treating physicians and medical professionals. 

163. Plaintiffs and their treating physicians relied on said warranties and 

representations in deciding to use the Filter. 

164. Defendants, and each of them, breached the above-described express 

warranties and representations in that the Filter did not conform to these express 

warranties and representations, as the Filter was and is not safe or effective and it 

produces serious side effects including, among other things, the injuries sustained by the 

Plaintiffs. 
41

165. Prior to, on, and after the dates during which Plaintiffs purchased and used 

the Filter, Defendants, and each of them, were put on notice of the Filter’s inability to 

conform to these express warranties. 

166. As a direct and proximate cause of Defendants’ breach of express warranty, 

Plaintiffs sustained the injuries and damages described above.

SEVENTH CAUSE OF ACTION

[Breach of Implied Warranty of Fitness for Particular Purpose]

167. Plaintiffs incorporate by reference all preceding paragraphs.

168. At all relevant times, Defendants were in the business of selling the Filter.

169. At all relevant times, Defendants, and each of them, knew or had reason to 

know that Plaintiffs intended to use the Filter for a particular purpose, namely prevention 

of injury caused by PE.

170. Prior to, on, and after the dates during which Plaintiffs purchased and were

implanted with the Filter, Defendants, and each of them, knew or had reason to know that 

Plaintiffs and their treating physicians were relying on their skill and judgment to select 

or to furnish medical devices that were suitable for a relevant particular purpose, namely 

the prevention of injury caused by PE.

171. Prior to, on, and after the dates during which Plaintiffs purchased and were

implanted with the Filter, Plaintiffs and their treating physicians justifiably relied on 

Defendants’ skill and judgment. 
42

172. Prior to, on, and after the dates during which Plaintiffs purchased and were

implanted with the Filter, it was in fact not suitable for the relevant particular purpose, 

namely prevention of injury caused by PE. 

173. Prior to, on, and after the dates during which Plaintiffs purchased and were

implanted with the Filter, Defendants, and each of them, were put on notice of the Filter’s 

inability to conform to these warranties. 

174. Prior to, on, and after the dates during which Plaintiffs purchased and were

implanted with the Filter, Defendants, and each of them, were put on notice of the Filter’s 

tendency to cause extreme clotting and IVC thrombosis – the very injury it was designed 

to prevent.

175. As a direct and proximate cause of Defendants’ breach of said implied 

warranty of fitness for a particular purpose, Plaintiffs sustained the injuries and damages 

described above.

EIGHTH CAUSE OF ACTION

[Breach of Implied Warranty of Merchantability]

176. Plaintiffs incorporate by reference all preceding paragraphs.

177. Prior to implantation with the Filter, Plaintiffs purchased the Filter from 

Defendants.

178. Prior to, on, and after the dates during which Plaintiffs purchased and were

implanted with the Filter, Defendants, and each of them, were in the business of selling 

medical devices, such as IVC filters. 
43

179. Prior to, on, and after the dates during which Plaintiffs purchased and were

implanted with the Filter, the Filter was, among other things: not of the same quality as 

those other, similar IVC filters generally acceptable in the trade; not fit for the ordinary 

purpose for which such IVC filters are generally used; and did not conform to the quality 

established by the usage of the trade. 

180. Prior to, on, and after the dates during which Plaintiffs purchased and were

implanted with the Filter, Defendants, and each of them, were put on notice of the Filter’s 

inability to conform to these warranties. 

181. As a direct and proximate result of Defendants’ breach of said implied 

warranty of merchantability, Plaintiffs sustained the injuries and damages described 

above.

NINTH CAUSE OF ACTION

[Fraud—Misrepresentation]

182. Plaintiffs incorporate by reference all preceding paragraphs.

183. At all times relevant to this cause, and as detailed above, Defendants 

intentionally provided Plaintiffs, Plaintiffs physicians, and the medical community, as 

well as the public at large, with false or inaccurate information, and/or omitted material 

information concerning the Filter, including, but not limited to, misrepresentations 

regarding the following topics:

a. The safety of the Filter;

b. The efficacy of the Filter;

c. The rate of failure of the Filter;
44

d. The pre-market testing of the Filter; and

e. The approved uses of the Filter.

184. The information distributed by Defendants to the public, the medical 

community, and Plaintiffs were in the form of reports, press releases, advertising 

campaigns, labeling materials, print advertisements, commercial media containing 

material representations, and instructions for use, as well as through their officers, 

directors, agents, and representatives.

185. These materials contained false and misleading material representations, 

which included: that the Filter was safe and fit when used for its intended purpose or in a 

reasonably foreseeable manner; that it did not pose dangerous health risks in excess of 

those associated with the use of other similar devices; that any and all side effects were 

accurately reflected in the warnings; and that it was adequately tested to withstand 

normal placement within the human body.

186. Defendants made the foregoing misrepresentations knowing that they were 

false or without reasonable basis.

187. These materials included instructions for use and a warning document that 

was included in the package of the Filter that was implanted in Plaintiffs.

188. Defendants’ intent and purpose in making these misrepresentations was to 

deceive and to defraud the public and the medical community, including Plaintiffs’

healthcare providers; to gain the confidence of the public and the medical community, 

including Plaintiff’s healthcare providers; to falsely assure them of the quality of the 

Filter and its fitness for use; and to induce the public and the medical community, 
45

including Plaintiffs’ healthcare providers, to request, recommend, prescribe, implant, 

purchase, and continue to use the Filter, all in reliance on Defendants’ 

misrepresentations.

189. The foregoing representations and omissions by Defendants were in fact 

false. The Filter is not safe, fit, or effective for human use in its intended and reasonably 

foreseeable manner. The use of the Filter is hazardous to the user’s health, and said 

device has a serious propensity to cause users to suffer serious injuries, including without 

limitation, the injuries Plaintiffs suffered. Further, the Filter has a high rate of failure and 

injury when compared to similar devices.

190. In reliance upon the false and negligent misrepresentations and omissions 

made by Defendants, Plaintiffs and their healthcare providers were induced to use, and 

did use, the Filter, thereby causing Plaintiffs’ injuries.

191. Defendants knew and had reason to know that Plaintiffs, Plaintiffs’

healthcare providers, and the general medical community did not have the ability to 

determine the true facts intentionally and/or negligently concealed and misrepresented by 

Defendants, and would not have prescribed and implanted same, if the true facts 

regarding the Filter had not been concealed and misrepresented by Defendants.

192. Defendants had sole access to material facts concerning the defective nature 

of the product and its propensity to cause death and serious injuries and damages to 

persons who are implanted with the Filter. 

193. At the time Defendants failed to disclose and intentionally misrepresented 

the foregoing facts, and at the time Plaintiffs used the Filter, Plaintiffs and their
46

healthcare providers were unaware of said Defendants’ negligent misrepresentations and 

omissions.

194. Plaintiffs, Plaintiffs’ healthcare providers, and the general medical 

community reasonably relied upon misrepresentations and omissions made by 

Defendants where the concealed and misrepresented facts were critical to understanding 

the true dangers inherent in the use of the Filter.

195. As a direct and proximate result of Defendants’ fraudulent 

misrepresentations, Plaintiffs sustained the injuries and damages described above.

TENTH CAUSE OF ACTION

[Fraud—Concealment]

196. Plaintiffs incorporate by reference all preceding paragraphs. 

197. In marketing and selling the Filter, Defendants concealed material facts 

from Plaintiffs and Plaintiffs’ healthcare providers. 

198. Defendants’ concealed material facts include, but are not limited to, the 

following:

a. That the Filter was unsafe and not fit when used for its intended 

purpose or in a reasonably foreseeable manner; 

b. That the Filter posed dangerous health risks in excess of those 

associated with the use of other similar devices;

c. That there were additional side effects related to implantation and 

use of the Filter that were not accurately and completely reflected in 

the warnings associated with the Filter; and

d. That the Filter was not adequately tested to withstand normal 

placement within the human body.
47

199. Plaintiffs and Plaintiffs’ healthcare providers were not aware of these and 

other facts concealed by Defendants.

200. In concealing these and other facts, Defendants intended to deceive 

Plaintiffs and Plaintiffs’ healthcare providers.

201. Plaintiffs and Plaintiffs’ healthcare providers reasonably and justifiably 

relied on Defendants’ representations.

202. As a direct and proximate result of Defendants’ concealment, Plaintiffs

sustained the injuries and damages described above.

Punitive Damages Allegations

203. Plaintiffs hereby incorporate by reference all preceding paragraphs.

204. Upon information and belief, Plaintiffs allege that, as early as 2003, Bard 

was aware and had knowledge of the fact that the predicates to the Filter, including the 

Recovery filter, were defective and unreasonably dangerous and were causing injury and 

death to patients who had received it. 

205. Data establishes that the failure rates of the Filter and its precursors are and 

were much higher than the rate Bard had in the past and currently continue to publish to 

the medical community and members of the public. Defendants knew this and continued 

to sell the Filter.

206. Bard also was aware or should have been aware that the Filter and its 

precursors had a substantially higher failure rate than other similar products on the 

market, yet Defendants have failed to warn consumers about the Filter. 
48

207. The conduct of Bard as alleged in this Complaint constitutes willful, 

wanton, gross, and outrageous corporate conduct that demonstrates a conscious disregard 

for the safety of Plaintiffs. 

208. Bard had actual knowledge of the dangers presented by the Filter, yet 

consciously failed to act reasonably to:

a. Inform or warn Plaintiffs, Plaintiffs’ physicians, or the public at 

large of these dangers; to remove the Filter from the inventory of the 

facility where Plaintiffs were implanted; and,

b. Establish and maintain an adequate quality and post-market 

surveillance system.

209. Despite having knowledge of the unreasonably dangerous and defective 

nature of the Filter, Bard consciously disregarded the known and substantial risks of 

death and injury and continued to actively market and offer for sale the Filter.

210. Plaintiffs further allege that Defendants acted in willful, wanton, gross, and 

total disregard for the health and safety of the users or consumers of the Filter, acted to 

serve their own interests (some of them pecuniary), and consciously disregarded the 

substantial risk that their product might kill or significantly harm patients, or significantly 

injure the rights of others.

211. As a result, Plaintiffs are entitled to an award of punitive damages to punish 

Defendants and deter similar conduct in the future.

PRAYER FOR RELIEF

WHEREFORE, Plaintiffs demand judgment against the Defendants as follows: 
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1. For general (non-economic) damages according to proof at the time of trial, 

including pain and suffering;

2. For special (economic) damages according to proof at the time of trial, 

including payment of past and future medical expenses, lost wages and loss of income 

potential;

3. For punitive damages, sufficient to punish and deter Defendants;

4. For prejudgment interest as permitted by law;

5. For costs of suit incurred herein as permitted by law; and 

6. For such other and further relief as this Court may deem proper.
50

DATED this 8th day of May 2020. Respectfully Submitted,

/s/ Ben C. Martin

Ben C. Martin

Texas Bar No. 13052400

Bmartin@martinbaughman.com

Kristi Wood

Texas Bar No. 24076784

kwood@martinbaughman.com

3710 Rawlins Street, Suite 1230

Dallas, Texas 75219

(214)-761-6614 Phone

(214) 744-7590 Fax

Attorneys for Plaintiff

CERTIFICATE OF SERVICE 

I hereby certify that on this 8th day of May, 2020, a copy of the foregoing was 

served electronically and notice of the service of this document will be sent to all parties 

by operation of the Court’s electronic filing system to CM/ECF participants registered to 

receive service in this matter. Parties may access this filing through the Court’s system. 

/s/ Ben C. Martin

Ben C. Martin