IN THE UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF GEORGIA

PATRICIA JONES,

 Plaintiff,

Vs.

C.R. BARD, INC., a foreign 

corporation, and BARD PERIPHERAL 

VASCULAR, INC., an Arizona 

corporiation

Case No. 

COMPLAINT FOR DAMAGES 

INTRODUCTORY ALLEGATIONS

Plaintiff brings this action for personal injuries suffered by an injured party as a direct 

and proximate result of an injured party being implanted with a defective and unreasonably 

dangerous Inferior Vena Cava (“IVC”) filter medical device manufactured by Bard. 

The subject IVC filters are part of Bard’s IVC “retrievable” filter product line and 

include the following devices: Recovery®, G2®, G2®X (G2 Express®), Eclipse®, Meridian®

and Denali® (for convenience, these devices will be referred to in this complaint under the 

generic term “Bard IVC Filters”). The term “Bard IVC Filters” also includes Bard’s 

Recovery® Cone Removal System®.

Plaintiffs’ claims for damages all relate to Bard’s design, manufacture, sale, testing, 

marketing, labeling, advertising, promotion, and/or distribution of Bard IVC Filters.

Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 1 of 44
The Bard IVC Filters that are the subject of this action all reached Plaintiff and her 

physicians without substantial change in condition from the time they left Bard’s possession.

Plaintiff and her physicians used the Bard IVC Filters in the manner in which they were 

intended. 

Bard is solely responsible for any alleged design, manufacture or informational defect 

Bard IVC Filters contain.

Bard does not allege that any other person or entity is comparatively at fault for any 

alleged design, manufacture, or informational defect Bard IVC Filters contain.

PARTIES

Plaintiff is the person and that has brought or will bring actions seeking personal injury 

damages caused by Bard IVC Filters. 

Plaintiff is the person injured and harmed by Bard IVC Filters. 

Plaintiff, PATRICIA JONES, at all times relevant to this action was and is a citizen of 

Georgia and resides in Clayton County, Georgia. On or about January 31, 2007, Plaintiff 

underwent placement of a Bard G2® Inferior Vena Cava Filter (“G2® IVC Filter”). The filter 

has failed to include the following: chest pain, migration of a strut into the right ventricle of 

the heart, perforation of the strut through the wall of the right ventricle of the heart, 

henopericardium and open vascular/sternotomy for removal of the strut. 

As a direct and proximate result of having a Bard G2® IVC Filter implanted, Plaintiff 

has suffered permanent and continuous injuries and damages. The injuries suffered and 

damages sought by Plaintiff (hereafter, “Injuries and Damages”) may include, without 

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limitation: pain and suffering; bodily injuries of any type (including, without limitation, 

perforation of organs and venous structures, thromboembolic events, and cardiovascular 

injuries); disability; impairment; scarring; disfigurement; dismemberment; physical; emotional 

and psychological trauma; anxiety; diminished capacity; loss of consortium; hedonic damages; 

past medical expenses; future medical expenses; caregiving costs; lost wages; loss of earning 

capacity; and any other form of damages under the law of any forum which governs any 

individual case. 

Defendant C.R. Bard, Inc. (“C.R. 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. 

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

prepared, compounded, assembled, processed, marketed, distributed, and sold the Recovery®, 

G2®, G2®X (G2 Express®), Eclipse®, Meridian®, and Denali® Filter Systems to be implanted 

in patients throughout the United States including the State of Arizona and Plaintiffs’ states of 

residence and/or injury. 

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

corporation of Defendant C.R. Bard, with its principal place of business at 1625 West Third 

Street, Tempe, Arizona. BPV, at all times relevant to this action, designed, set specifications 

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

sold the Recovery®, G2®, G2®X(G2 Express®), Eclipse®, Meridian®, and Denali® Filter 

Systems to be implanted in patients throughout the United States, including the State of 

Arizona and Plaintiffs’ states of residence and/or injury. 

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There exists, and at all relevant times existed, a unity of interest in ownership between 

certain defendants and other defendants such that any individuality and separateness between 

the certain defendants has ceased and those defendants are the alter ego of the other certain 

defendants, and exerted control over those defendants. 

Adherence to the fiction of the separate existence of these certain defendants as any 

entity distinct from other certain defendants would permit an abuse of the corporate privilege, 

sanction fraud, and promote injustice.

Plaintiff is informed and believes, 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 at all said times each Defendant was acting in the full course, 

scope, and authority of said agency, service, employment, and/or joint venture.

“Bard” or “Defendants” includes any and all parent companies, subsidiaries, affiliates, 

divisions, franchises, partners, joint venturers, and organizational units of any kind; their 

predecessors, successors, and assigns; their officers, directors, employees, agents, 

representatives; and any and all other persons acting on their behalf. 

At all times relevant, Bard was engaged in the business of researching, designing, 

testing, developing, manufacturing, packaging, labeling, marketing, advertising, distributing, 

promoting, warranting, and selling in interstate commerce Bard IVC Filters, either directly or 

indirectly through third parties or related entities. 

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Bard develops, manufactures, sells, and distributes medical devices and surgical 

products throughout the United States and around the world, including Bard IVC Filters for 

use in various medical applications including endovascular cardiology.

Upon information and belief, at all relevant times, Defendants expected or should have 

expected that their acts would have consequences within the United States, including in the 

State of Arizona and in the states and territories identified in each Short Form Complaint, and 

said Defendants derived and continue to derive substantial revenue therefrom.

JURISDICTION AND VENUE

This Court has subject matter jurisdiction under 28 U.S.C. § 1332 because Plaintiffs 

and Defendants are citizens of different states, the amount in controversy for each action 

exceeds seventy-five thousand dollars ($75,000.00) excluding interest and costs, and there is 

complete diversity of citizenship between each Plaintiff and Defendant.

This Court has personal jurisdiction under 28 U.S.C. § 1391, as BPV is domiciled in 

this District and all Defendants regularly conduct business in this State. Further, Defendants 

are present and doing business within this State and have continuous and systematic contacts 

in every state in the United States of America, including each Plaintiffs’ states of residence.

Pursuant to the Transfer Order filed on August 17, 2015, it was determined:

[T]he actions in this litigation involve common questions of fact, and that 

centralization in the District of Arizona will serve the convenience of the parties 

and witnesses and promote the just and efficient conduct of the litigation. All 

actions involve common factual questions arising from allegations that defects

in the design of Bard’s retrievable inferior vena cava filters (“IVC filters”) 

make them more likely to fracture, migrate, tilt, or perforate the inferior vena 

cava, causing injury. Centralization will eliminate duplicative discovery, avoid 

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inconsistent pretrial rulings (including with respect to discovery, privilege, and 

Daubert motion practice), and conserve the resources of the parties, their 

counsel and the judiciary.

Pursuant to the Transfer Order filed on August 17, 2015, cases are being transferred to 

The Honorable David G. Campbell in the United States District Court for the District of 

Arizona, Phoenix Division, as part of the IN RE: BARD IVC FILTERS PRODUCTS 

LIABILITY LITIGATION MDL 2641.

Pursuant to Case Management Order No. 2, federal cases against Bard relating to Bard 

IVC Filters may be directly filed in this District.

BACKGROUND

INFERIOR VENA CAVA FILTERS GENERALLY

IVC filters were first made commercially available to the medical community in the 

1960s. Over the years, medical device manufacturers have introduced several different 

designs of IVC filters.

An IVC filter is a device that is designed to filter or “catch” blood clots that travel from 

the lower portions of the body to the heart and lungs. IVC filters were originally designed to 

be permanently implanted in the IVC. 

The IVC is a vein that returns blood to the heart 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 

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lungs, they are considered “pulmonary emboli” or “PE.” Pulmonary emboli present risks to 

human health. 

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

example, a doctor may prescribe anticoagulant therapies such as medications like Heparin, 

Warfarin, or Lovenox to regulate the clotting factor of the blood. In some people who are at 

high risk for DVT/PE and who cannot manage their conditions with medications, physicians 

may recommend surgically implanting an IVC filter to prevent thromboembolitic events.

As stated above, IVC filters have been on the market for decades and were permanent 

implants. However, use of these filters was limited primarily to patients who were 

contraindicated for anticoagulation therapy.

In order to increase sales of these devices, Bard sought to expand the market for 

prophylactic use among nontraditional patient populations that were temporarily at risk of 

developing blood clots. 

Specifically, Bard targeted the bariatric, trauma, orthopedic and cancer patient 

population. Expansion to these new patient groups would triple sales and the first 

manufacturer to market would capture market share. 

At the same time, Bard was aware that physicians developed interest in filter devices 

that could be easily removed after the risk of clotting in these new patient populations 

subsided. This too was an opportunity to gain market share in the lucrative IVC filter market.

Other manufacturers also saw this opportunity, triggering a race to market a device that 

provided physicians the option to retrieve the filter after the clot risk subsided.

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Bard was the first medical device manufacturer to obtain FDA clearance for marketing 

a “retrievable” IVC filter (the Bard Recovery® filter) in July 2003.

This “clearance” was obtained despite lack of adequate testimony on the safety and 

efficacy of the new line of devices.

As shown below, Bard’s retrievable IVC filters have been plagued with problems – all 

created by Bard itself – most notably, the absence of any evidence that the products were 

effective in preventing pulmonary embolism (the very condition the product was indicated to 

prevent).

Years after the implantation of retrievable filters into the bodies of patients, scientists 

began to study the effectiveness of the retrievable filters – studies that Bard itself had never 

done before placing the product on the market. As recently as October 2015, an expansive 

article published in the Annals of Surgery concerning trauma patients inserted with IVC filters 

concluded that IVC filters were not effective in preventing pulmonary emboli, and instead 

actually caused thrombi to occur.

Comparing the results of over 30,000 trauma patients who had not received IVC filters 

with those who had received them, the Annals of Surgery study published its alarming results:

• Almost twice the percentage of patients with IVC filters in the study died 

compared to those that had not received them.

• Over five times the relative number of patients with IVC filters developed 

DVTs.

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• Over four times the relative percentage of patients with filters developed 

thromboemboli.

• Over twice the percentage of patients developed a pulmonary embolus – the 

very condition Bard told the FDA, physicians, and the public that its IVC 

Filters were designed to prevent.

This Annals of Surgery study – and many others referenced by it – now shows without 

any question that IVC filters are not only utterly ineffective but that they are themselves a 

health hazard.

THE G2®, RECOVERY® G2 AND G2® EXPRESS FILTERS

On or about March 2, 2005, Bard submitted a Section 510(k) premarket notification of 

intent to market the G2® filter for the prevention of recurrent pulmonary embolism via 

placement in the inferior vena cava. In doing so, Bard cited the Recovery® filter as the 

substantially equivalent predicate IVC filter, which was an inappropriate and illegal predicate 

device since it was being marketed while adulterated and misbranded for failing, among other 

things, to be as safe and effective as its predicate device, SNF. Bard stated that the only 

differences between the Recovery® filter and the G2® filter were primarily dimensional, and 

no material changes or additional components were added. It was considered by Bard the next 

generation of the Recovery® filter 

On March 30, 2005, however, the FDA rejected this application unless Bard and BPV 

included “black box” warnings that read:

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Warning: The safety and effectiveness of the Recovery® Filter System in 

morbidly obese patients has not been established. There have been fatal devicerelated adverse events reported in this population.

 [and]

[C]entral venous lines may cause the filters to move or fracture.

On April 19, 2005, prior to formally responding to the FDA’s request to add a black 

box warning, BPV CEO Timothy Ring and C.R. Bard CEO John Weiland received an 

executive summary reporting that there were at least 34 migrations and 51 fractures associated 

with Bard IVC Filters. 

This same report advised Bard executives that there were then nine deaths, six of which 

related to morbidly obese patients. Further, 18 of the 51 fractures resulted in fragments 

migrating to the heart. 

On April 20, 2005, without alerting the FDA to the alarming information Bard 

executives had the day before, Bard submitted a letter in response to the FDA’s request to add 

this black box warning stating that, “There is currently a statement in the IFU linking all of our 

complications to death.”

On August 29, 2005, the FDA cleared the G2® filter for the same intended uses as the 

Recovery® filter, except that it was not cleared for retrievable use.1

 Contrary to the FDA’s 

1 The FDA did not clear the G2® filter to be used as a retrievable filter until January 15, 2008. 

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suggestion, no black box warning was added to warn the bariatric patient population of 

fatalities associated with the use of the filter.2

In September of 2005, Bard quietly and belatedly replaced the Recovery® filter on 

hospital shelves with the G2® filter. Bard either told doctors or led them to believe that the 

G2® was a new and improved version of the Recovery® filter with the same option to retrieve 

the filter after implant. 

At the same time Bard was selling the G2® (then a permanent use filter without any 

retrievability option), Bard was also selling the SNF, which had the same indication for use 

with nearly zero adverse events.

Bard marketed the G2® filter as having “enhanced fracture resistance,” “improved 

centering,” and “increased migration resistance” without any data to back up these 

representations. Even if such data existed, Bard witnesses have testified that Bard would not 

share any such information with doctors if requested. 

Moreover, as with its predecessor Recovery® filter, Bard failed to conduct adequate 

clinical and bench testing to ensure that the G2® filter would perform safely and effectively 

once implanted in the human body. 

The G2® filter’s design causes it to be of insufficient integrity and strength to withstand 

normal stresses within the human body so as to resist fracturing, migrating, and/or tilting, 

and/or perforating the inferior vena cava. 

2 A warning was eventually added to the IFU in October of 2009.

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In addition to the same design defects as its predecessor device, the G2® filter suffers 

from the same 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 Bard IVC Filters. 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 IVC Filters.

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 Bard IVC Filters more susceptible to fatigue, failure, and migration. 

Similarly, although Bard rounded the chamfer at the edge of the cap of the G2® filter, it 

continued to fracture at that same location.

Thus, the G2® filter shares similar defects and health risks as the Recovery® filter. 

Almost immediately upon the release of the G2® filter, Bard received notice of the 

same series of adverse events of migration, fracture, tilt, and perforation causing the same type 

of harm as the Recovery® filter. This time, however, a new and different adverse event 

emerged: the G2® filter would caudally (moving against blood flow) migrate in the direction 

toward the groin. 

The G2® filter failures were again associated with reports of severe patient injuries such 

as:

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Death; 

Hemorrhage; 

Cardiac/pericardial tamponade (pressure caused by a collection of blood in the 

area around the heart); 

Cardiac arrhythmia and other symptoms similar to myocardial infarction; 

Severe and persistent pain; and

Perforations of tissue, vessels and organs.

Bard represents the fracture rate of the G2® filter to be 1.2%. 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 

frequency of fractures for the G2® filter.

As with the Recovery® filter, Bard was aware of clinical data showing that the G2® 

filter was not the substantial equivalent of its predecessor SNF device, requiring immediate 

recall of the adulterated and misbranded product.

A review of the MAUDE database from the years 2004 through 2008 demonstrates that 

the Bard IVC Filters (including the G2® Filter) are responsible for the majority of all reported 

adverse events related to IVC filters. 

On December 27, 2005, Bard’s Medical Affairs Director sent an email questioning why 

Bard was even selling the modified version of the Recovery® filter, when Bard’s SNF had 

virtually no complaints associated with it.

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This further confirms the misbranded and adulterated nature of the device, requiring 

corrective action, including recall.

On January 15, 2008, the FDA allowed a retrievable option for the G2® filter, the G2 

Express® filter. The G2 Express® filter (also known as the “G2®X”) is identical in design to 

the G2® filter except that it has a hook at the top of the filters that allows it to be retrieved by 

snares, as well as Bard’s Recovery Cone. 

The G2®X filter contained no design modifications or improvements to alleviate the 

instability, structural integrity, and perforation problems that Bard knew to exist with the 

G2®X Filter via the 510(k) process. 

ESTOPPEL FROM PLEADING STATUTES OF LIMITATIONS OR REPOSE

Plaintiff incorporates by reference all prior allegations.

Plaintiff is within the applicable statute of limitations for their claims because Plaintiff 

(and her healthcare professionals) did not discover, and could not reasonably discover, the 

defects and unreasonably dangerous condition of her Bard IVC Filter.

Plaintiff’s ignorance of the defective and unreasonably dangerous nature of the Bard 

IVC Filter, and the causal connection between these defects and Plaintiff’s injuries and 

damages, is due in large part to Bard’s acts and omissions in fraudulently concealing 

information from the public and misrepresenting and/or downplaying the serious threat to 

public safety its products present.

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In addition, Bard is estopped from relying on any statutes of limitation or repose by 

virtue of its unclean hands, acts of fraudulent concealment, affirmative misrepresentations and 

omissions. 

Such conduct includes intentional concealment from Plaintiff, Plaintiff’s prescribing 

health care professionals, and the general consuming public of material information that Bard 

IVC Filters had not been demonstrated to be safe or effective, and carried with them the risks 

and dangerous defects described above.

Bard had a duty to disclose the fact that Bard IVC Filters are not safe or effective, not 

as safe as other filters on the market, defective, and unreasonably dangerous, and that their 

implantation and use carried with it the serious risk of developing perforation, migration, 

tilting, and/or fracture.

COUNT I: STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT

Plaintiffs incorporate by reference all prior allegations.

Prior to, on, and after the date the Bard IVC Filter was implanted in Plaintiff, Bard 

designed, distributed, manufactured, sold, and marketed Bard IVC Filters for use in the United 

States. 

At all relevant times, Bard designed, distributed, manufactured, marketed, and sold 

Bard IVC Filters that were unreasonably dangerous, unsafe, and defective in manufacture 

when they left Bard’s possession.

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Upon information and belief, Bard IVC Filters contain a manufacturing defect, in that 

they differed from the manufacturer’s design or specifications, or from other typical units of 

the same product line. 

As a direct and proximate cause of Bard’s design, manufacture, marketing, and sale of 

Bard IVC Filters prior to, on, and after the date Plaintiff used the Bard IVC Filter, Plaintiff 

suffered Injuries and Damages. 

COUNT II: STRICT PRODUCTS LIABILITY – INFORMATION DEFECT

Plaintiff incorporates by reference all prior allegations.

At all relevant times, Bard engaged in the business of testing, developing, designing, 

manufacturing, packaging, labeling, marketing and/or promoting, selling and/or distributing 

Bard IVC Filters and through that conduct has knowingly and intentionally placed Bard IVC 

Filters into the stream of commerce with full knowledge that they reach consumers such as 

Plaintiffs who would become implanted with them.

Bard did in fact test, develop, design, manufacture, package, label, market and/or 

promote, sell and/or distribute Bard IVC Filters to Plaintiffs, Plaintiff’s prescribing health care 

professionals, and the consuming public. Additionally, Bard expected that the Bard IVC 

Filters they were selling, distributing, supplying, manufacturing, and/or promoting to reach, 

and did in fact reach, prescribing health care professionals and consumers, including Plaintiff 

and Plaintiff’s prescribing health care professionals, without any substantial change in the 

condition of the product from when it was initially distributed by Bard.

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The Bard IVC Filters had potential risks and side effects that were known or knowable 

to Bard by the use of scientific inquiry and information available before, at, and after the 

manufacture, distribution, and sale of the Bard IVC Filters. 

Bard knew or should have known of the defective condition, characteristics, and risks 

associated with Bard IVC Filters. These defective conditions included, but were not limited 

to: (1) Bard IVC Filters posed a significant and higher risk of failure than other similar IVC 

filters (fracture, migration, tilting, and perforation of the vena cava wall); (2) Bard IVC Filter 

failures result in serious injuries and death; and (3) certain conditions or post-implant 

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

integrity of Bard IVC Filters.

Bard IVC Filters were in a defective and unsafe condition that was unreasonably and 

substantially dangerous to any user or consumer implanted with Bard IVC Filters, such as 

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

The warnings and directions Bard provided with Bard IVC Filters failed to adequately 

warn of the potential risks and side effects of Bard IVC Filters.

These risks were known or were reasonably scientifically knowable to Bard, but not 

known or recognizable to ordinary consumers, such as Plaintiff, or to Plaintiff’s treating 

doctors. 

Bard IVC Filters were expected to and did reach Plaintiff without substantial change in 

their condition, labeling, or warnings as manufactured, distributed, and sold by Bard. 

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Additionally, Plaintiff and Plaintiff’s physicians used Bard IVC Filters in the manner in 

which they were intended to be used, making such use reasonably foreseeable to Bard. 

As a direct and proximate result of Bard’s information defects, lack of sufficient 

instructions or warnings prior to, on, and after the date Plaintiff used Bard IVC Filters, 

Plaintiff suffered Injuries and Damages.

COUNT III: STRICT PRODUCTS LIABILITY – DESIGN DEFECT

Plaintiff incorporates by reference all prior allegations.

At all relevant times, Bard designed, tested, distributed, manufactured, advertised, sold, 

marketed and otherwise placed into the stream of commerce Bard IVC Filters for use by 

consumers, such as Plaintiff, in the United States. 

Bard IVC Filters were expected to, and did, reach Bard’s intended consumers, handlers, 

and persons coming into contact with the product without substantial change in the condition 

in which they was researched, tested, developed, designed, licensed, manufactured, packaged, 

labeled, distributed, sold, and marketed by Bard.

At all times relevant, Bard IVC Filters were manufactured, designed and labeled in an 

unsafe, defective, and inherently dangerous condition which was dangerous for use by the 

public in general and Plaintiff in particular.

Bard IVC Filters, as researched, tested, developed, designed, licensed, manufactured, 

packaged, labeled, distributed, sold, and marketed by Bard were defective in design and 

formulation and unreasonably dangerous in that when they left the hands of Bard’s 

manufacturers and/or suppliers, the foreseeable risks exceeded the alleged benefits associated 

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with the use of Bard IVC Filters, and the devices were more dangerous than the ordinary 

customer would expect.

Physicians implanted Bard IVC Filters as instructed via the Instructions for Use and in 

a foreseeable manner as normally intended, recommend, promoted, and marketed by Bard. 

Plaintiff received and utilized Defendants’ IVC Filters in a foreseeable manner as 

normally intended, recommended, promoted, and marketed by Bard.

At the time Bard placed its defective and unreasonably dangerous Bard IVC Filters into 

the stream of commerce commercially, technologically, and scientifically feasible alternative 

designs were attainable and available.

These alternative designs would have prevented the harm resulting in Plaintiff’s 

Injuries and Damages without substantially impairing the reasonably anticipated or intended 

function of Bard IVC Filters.

As a direct and proximate result of the defective and unreasonably dangerous condition 

of Bard IVC Filters, Plaintiff suffered Injuries and Damages.

COUNT IV: NEGLIGENCE – DESIGN

Plaintiff incorporate by reference all prior allegations.

At the time of the design, distribution, manufacture, advertising, sale, and marketing of 

Bard IVC Filters, and their implantation in Plaintiff, Bard was aware that Bard IVC Filters 

were designed and manufactured in a manner presenting:

An unreasonable risk of fracture of portions of the filters;

An unreasonable risk of migration of the filters and/or portions of the filters;

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An unreasonable risk of filters tilting and/or perforating the vena cava wall; and 

Insufficient strength or structural integrity to withstand normal placement 

within the human body.

At the time of the design, distribution, manufacture, advertising, sale, and marketing of 

Bard IVC Filters, and their implantation in Plaintiff, Bard also was aware that Bard IVC 

Filters:

Would be used without inspection for defects;

Would be used by patients with special medical conditions such as those of the 

Plaintiff; 

Had previously caused serious bodily injury to its users with special medical 

conditions such as those of the Plaintiff;

Had no established efficacy;

Were less efficient than the predicate SNF;

Would be implanted in patients where the risk outweighed any benefit or utility 

of the filters; 

Contained instructions for use and warnings that were inadequate; and

Required retrieval (as to the Recovery® and G2® filters) by a device that was 

not approved or cleared by the FDA.

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

the design of Bard IVC Filters.

Bard breached these duties by, among other things:

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Designing and distributing a product in which it 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;

Designing and distributing a product which it knew or should have known that 

the likelihood and severity of potential harm from the product exceeded 

the likelihood of potential harm from other IVC filters available for the 

same purpose;

Failing to perform reasonable pre- and post-market testing of Bard IVC Filters 

to determine whether or not the products were safe for their intended 

use;

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

and development of Bard IVC Filters so as to avoid the risk of serious 

harm associated with the use of Bard IVC Filters;

Advertising, marketing, promoting, and selling Bard IVC Filters for uses other 

than as approved and indicated in the products’ labels; 

Failing to establish an adequate quality assurance program used in the 

manufacturing of Bard IVC Filters; and

Failing to perform adequate evaluation and testing of Bard IVC Filters when 

such evaluation and testing would have revealed the propensity of Bard 

IVC Filters to cause injuries similar to those that Plaintiffs suffered.

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As a direct and proximate result of the above-described negligence in design of Bard 

IVC Filters, Plaintiff suffered Injuries and Damages.

COUNT V: NEGLIGENCE – MANUFACTURE

Plaintiff incorporate by reference all prior allegations.

At all relevant times, Bard had a duty to exercise due care in the manufacturing of Bard 

IVC Filters.

Bard breached this duty by, among other things:

Failing to adopt manufacturing processes that would reduce the foreseeable risk 

of product failure; 

Failing to use reasonable care in manufacturing the product and by producing a 

product that differed from their design or specifications or from other 

typical units from the same production line;

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

and development of Bard IVC Filters and their manufacturing process so 

as to avoid the risk of serious harm associated with the use of Bard IVC 

Filters; and

Failing to establish an adequate quality assurance program used in the 

manufacturing of the IVC Filters.

As a direct and proximate result of the above-described negligence in manufacture of 

Bard IVC Filters, Plaintiffs suffered Injuries and Damages.

COUNT VI: NEGLIGENCE – FAILURE TO RECALL/RETROFIT

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Plaintiff incorporates by reference all prior allegations.

At this time, all Bard IVC Filters are misbranded and adulterated by virtue of them 

failing to be the substantial equivalent of their predecessor device, making them subject to 

corrective action, including recall, in the interest of patient safety.

Prior to, on, and after the date of Plaintiff’s implantation with Bard IVC Filters, and at 

all relevant times, Bard knew or reasonably should have known that Bard IVC Filters and their 

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

reasonably foreseeable manner. 

Prior to, on, and after the date of Plaintiff’s implantation with Bard IVC Filters and at 

all relevant times thereafter, Bard became aware that the defects of Bard IVC Filters resulted 

in Bard IVC Filters causing injuries similar to those Plaintiff suffered. 

Reasonable manufacturers and distributors under the same or similar circumstances 

would have recalled or retrofitted Bard IVC Filters, and would thereby have avoided and 

prevented harm to many patients, including Plaintiff.

In light of this information and Bard’s knowledge described above, Bard had a duty to 

recall and/or retrofit Bard IVC Filters. 

Bard breached its duty to recall and/or retrofit Bard IVC Filters.

As a direct and proximate result of Bard’s negligent failure to recall or retrofit, Plaintiff

suffered Injuries and Damages. 

COUNT VII: NEGLIGENCE – FAILURE TO WARN

Plaintiff incorporates by reference all prior allegations.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 23 of 44
At all relevant times, Bard knew or should have known that Bard IVC Filters were 

defective and dangerous or were likely to be dangerous when used in a reasonably foreseeable 

manner.

Such danger included the propensity of Bard IVC Filters to cause injuries and death 

similar to those suffered by Plaintiffs. 

At all relevant times, Bard also knew or reasonably should have known that the users of 

Bard IVC Filters, including Plaintiff, would not realize or discover on their own the dangers 

presented by Bard IVC Filters. 

Reasonable manufacturers and reasonable distributors, under the same or similar 

circumstances as those of Bard prior to, on, and after the date of Plaintiff’s use of Bard IVC 

Filters, would have warned of the dangers presented by Bard IVC Filters, or instructed on the 

safe use of Bard IVC Filters. 

Prior to, on, and after the date of Plaintiff’s use of the IVC Filters, Bard had a duty to 

adequately warn of the dangers presented by Bard IVC Filters and/or instruct on the safe use 

of Bard IVC Filters.

Bard breached these duties by failing to provide adequate warnings to Plaintiff 

communicating the information and dangers described above and/or providing instruction for 

safe use of Bard IVC Filters.

As a direct and proximate result of Bard’s negligent failure to warn, Plaintiff suffered 

Injuries and Damages. 

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 24 of 44
COUNT VIII: NEGLIGENT MISREPRESENTATION

Plaintiff incorporates by reference all prior allegations.

Prior to, on, and after the dates during which Plaintiff was implanted with the IVC 

Filters, Bard negligently and carelessly represented to Plaintiff, Plaintiffs’ treating physicians, 

and the general public that Bard IVC Filters were safe, fit, and effective for use. 

These representations were untrue. 

Bard owed a duty in all of its undertakings, including the dissemination of information 

concerning its IVC filters, to exercise reasonable care to ensure that it did not in those 

undertakings create unreasonable risks of personal injury to others.

Bard disseminated to health care professionals and consumers through published labels, 

labeling, marketing materials, and otherwise information concerning the properties and effects 

of Bard IVC Filters with the intention that health care professionals and consumers would rely 

upon that information in their decisions concerning whether to prescribe and use Bard IVC 

Filters.

Bard, as medical device designers, manufacturers, sellers, promoters and/or 

distributors, knew or should reasonably have known that health care professionals and 

consumers, in weighing the potential benefits and potential risks of prescribing or using Bard 

IVC Filters, would rely upon information disseminated and marketed by Bard to them 

regarding the Bard IVC Filters.

Bard failed to exercise reasonable care to ensure that the information they disseminated 

to health care professionals and consumers concerning the properties and effects of Bard IVC 

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 25 of 44
Filters was accurate, complete, and not misleading and, as a result, disseminated information 

to health care professionals and consumers that was negligently and materially inaccurate, 

misleading, false, and unreasonably dangerous to consumers such as Plaintiffs.

Bard, as designers, manufacturers, sellers, promoters, and/or distributors, also knew or 

reasonably should have known that patients receiving Bard IVC Filters as recommended by 

health care professionals in reliance upon information disseminated by Bard as the 

manufacturer/distributor of Bard IVC Filters would be placed in peril of developing the 

serious, life-threatening, and life-long injuries including, but not limited to, tilting, migration, 

perforation, fracture, lack of efficacy, and increased risk of the development of blood clots, if 

the information disseminated and relied upon was materially inaccurate, misleading, or 

otherwise false.

Bard had a duty to promptly correct material misstatements it knew others were relying 

upon in making healthcare decisions.

Bard failed in each of these duties by misrepresenting to Plaintiff and the medical 

community the safety and efficacy of Bard IVC Filters and failing to correct known 

misstatements and misrepresentations.

As a direct and proximate result of Bard’s negligent misrepresentations, Plaintiff 

suffered Injuries and Damages.

COUNT IX: NEGLIGENCE PER SE

(Violations of 21 U.S.C. §§321, 331, 352 and 21 C.F.R. §§1.21, 801, 803, 807, 820)

Plaintiff incorporates by reference all prior allegations.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 26 of 44
At all times herein mentioned, Bard was subject to a variety of federal, state, and local 

laws, rules, regulations and ordinances, including the Federal Food, Drug and Cosmetic Act 

(“FFDCA”) and its applicable regulations, concerning the manufacture, design, testing, 

production, processing, assembling, inspection, research, promotion, advertising, distribution, 

marketing, promotion, labeling, packaging, preparation for use, consulting, sale, warning, and 

post-sale warning and other communications of the risks and dangers of Bard IVC Filters. 

By reason of its conduct as alleged herein, Bard violated provisions of statutes and 

regulations, including but not limited to:

FFDCA, 21 U.S.C. §§331 and 352, by misbranding Bard IVC Filters;

FFDCA, 21 U.S.C. § 321, by making statements and/or representations via 

word, design, device, or any combination thereof failing to reveal 

material facts with respect to the consequences that may result from the 

use of Bard IVC Filters to which the labeling and advertising relates;

21 C.F.R. § 1.21, by misleading its consumers and patients by concealing 

material facts in light of representations made regarding safety and 

efficacy of its Bard IVC Filters; 

21 C.F.R. § 801, by mislabeling Bard IVC Filters as to safety and effectiveness 

of its products and by failing to update its label to reflect post-marketing 

evidence that Bard IVC Filters were associated with an increased risk of 

injuries due to tilting, fracture, migration and perforation; 

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 27 of 44
21 C.F.R. §§801.109 and 801.4 by learning that Bard IVC Filters were 

adulterated and misbranded and failing to correct and recall the devices.

21 C.F.R. § 803, by not maintaining accurate medical device reports regarding 

adverse events of tilting, fracture, migration and perforation and/or 

misreporting these adverse events maintained via the medical device 

reporting system;

21 C.F.R. § 807, by failing to notify the FDA and/or the consuming public 

when its Bard IVC Filters were no longer substantially equivalent with 

regard to safety and efficacy with regard to post-marketing adverse 

events and safety signals;

21 C.F.R. § 820, by failing to maintain adequate quality systems regulation 

including, but not limited to, instituting effective corrective and 

preventative actions;

21 CFR 201.128, by promoting each of their subject devices off-label and for 

conditions, purposes and uses beyond their labeled and intended uses; 

and

210 CFR 801.4, by their knowledge of off-label uses of their devices for 

unintended and unlabeled conditions, purposes and uses, and failing as 

required to provide adequate labeling which accords with such unlabeled 

and unintended uses.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 28 of 44
These statutes, rules and regulations, along with those listed in Count XIV, are 

designed to protect the health, safety, and well-being of consumers like Plaintiff.

Bard’s violation of these statutes, rules and regulations, as well as those detailed in 

Count XIV, constitutes negligence per se. 

As a direct and proximate result of Bard’s negligence per se, Plaintiffs suffered Injuries 

and Damages.

COUNT X: BREACH OF EXPRESS WARRANTY

Plaintiff incorporates by reference all prior allegations.

Plaintiff, though their medical providers, purchased Bard IVC Filters from Bard.

At all relevant times, Bard was a merchant of goods of the kind including medical 

devices and vena cava filters (i.e, Bard IVC Filters).

At the time and place of sale, distribution, and supply of Bard IVC Filters to Plaintiff 

(and to other consumer and the medical community), Bard expressly represented and 

warranted that Bard IVC Filters were safe; that they were well-tolerated, efficacious, fit for 

their intended purpose, and of marketable quality; that they did not produce any unwarned-of 

dangerous side effects; and that they was adequately tested. 

At the time of Plaintiff’s purchase from Defendants, Bard IVC Filters were not in a 

merchantable condition, and Bard breached its expressed warranties, in that Bard IVC Filters: 

Were designed in such a manner so as to be prone to an unreasonably high 

incidence of fracture, perforation of vessels and organs, and/or 

migration; 

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 29 of 44
Were designed in such a manner so as to result in a unreasonably high 

incidence of injury to the vessels and organs of its purchaser; 

Were manufactured in such a manner that the exterior surface of the filter was 

inadequately, improperly, and inappropriately constituted, causing the 

device to weaken and fail; 

Were unable to be removed at any time during a person’s life; 

Were not efficacious in the prevention of pulmonary emboli;

Carried a risk of use outweighed any benefit; and

Were not self-centering.

As a direct and proximate result of Bard’s breach of express warranty, Plaintiff suffered 

Injuries and Damages.

COUNT XI: BREACH OF IMPLIED WARRANTY

Plaintiff incorporate by reference all prior allegations.

Bard impliedly warranted that Bard IVC Filters were of merchantable quality and safe 

and fit for the use for which Bard intended them, and Plaintiff in fact used them. 

Bard breached its implied warranties by:

Failing to provide adequate instruction that a manufacturer exercising 

reasonable care would have provided concerning the likelihood that Bard 

IVC Filters would cause harm;

Manufacturing and/or selling Bard IVC Filters when those filters did not 

conform to representations made by Bard when they left Bard’s control;

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 30 of 44
Manufacturing and/or selling Bard IVC Filters that were more dangerous than 

an ordinary consumer would expect when used in an intended or 

reasonably foreseeable manner;

Manufacturing and/or selling Bard IVC Filters that carried foreseeable risks 

associated with the Bard IVC Filter design or formulation which 

exceeded the benefits associated with that design; 

Manufacturing and/or selling Bard IVC Filters when they deviated in a material 

way from the design specifications, formulas, or performance standards 

or from otherwise identical units manufactured to the same design 

specifications, formulas, or performance standards; and 

Impliedly representing that its filters would be effective in the prevention of 

pulmonary emboli.

As a direct and proximate result of Bard’s breach of its implied warranty, Plaintiff has

suffered Injuries and Damages. 

COUNT XII: FRAUDULENT MISREPRESENTATION

Plaintiff incorporates by reference all prior allegations.

At all times relevant to this cause, and as detailed above, Bard intentionally provided 

Plaintiff, Plaintiff’s physicians, the medical community, and the public at large with false or 

inaccurate information. Bard also omitted material information concerning Bard IVC Filters, 

including, but not limited to, misrepresentations regarding the following topics:

The safety of the Bard IVC Filters;

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The efficacy of the Bard IVC Filters;

The rate of failure of the Bard IVC Filters;

The pre-market testing of the Bard IVC Filters; 

The approved uses of the Bard IVC Filters; and

The ability to retrieve the device at any time over a person’s life.

The information Bard distributed to the public, the medical community, and Plaintiff 

was 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. 

These materials contained false and misleading material representations, which 

included: that Bard IVC Filters were safe and fit when used for their intended purpose or in a 

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

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

accurately reflected in the warnings; and that they were adequately tested to withstand normal 

placement within the human body.

Bard made the foregoing misrepresentations knowing that they were false or without 

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

was included in the package of Bard IVC Filters that were implanted in Plaintiff.

Bard’s intent and purpose in making these misrepresentations was to deceive and 

defraud the public and the medical community, including Plaintiff’s health care providers; to 

gain the confidence of the public and the medical community, including Plaintiff’s health care 

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 32 of 44
providers; to falsely assure the public and the medical community of the quality of Bard IVC 

Filters and their fitness for use; and to induce the public and the medical community, including 

Plaintiff’s healthcare providers to request, recommend, prescribe, implant, purchase, and 

continue to use Bard IVC Filters, all in reliance on Bard’s misrepresentations.

The foregoing representations and omissions by Bard were false. 

Bard IVC Filters are not safe, fit, and effective for human use in their intended and 

reasonably foreseeable manner. 

Further, the use of Bard IVC Filters is hazardous to the users’ health, and Bard IVC 

Filters have a serious propensity to cause users to suffer serious injuries, including without 

limitation the injuries Plaintiff suffered. 

Finally, Bard IVC Filters have a statistically significant higher rate of failure and injury 

than do other comparable IVC filters.

In reliance upon the false and negligent misrepresentations and omissions made by 

Bard, Plaintiffs and Plaintiff’s health care providers were induced to, and did use Bard IVC 

Filters, thereby causing Plaintiff to sustain severe and permanent personal injuries and death.

Bard knew and had reason to know that Plaintiff, Plaintiff’s health care providers, and 

the general medical community did not have the ability to determine the true facts 

intentionally and/or negligently concealed and misrepresented by Bard, and would not have 

prescribed and implanted Bard IVC Filters if the true facts regarding Bard IVC Filters had not 

been concealed and misrepresented by Bard.

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Bard had sole access to material facts concerning the defective nature of the products 

and their propensities to cause serious and dangerous side effects in the form of dangerous 

injuries and damages to persons who were implanted with Bard IVC Filters. 

At the time Bard failed to disclose and intentionally misrepresented the foregoing facts, 

and at the time Plaintiffs used Bard IVC Filters, Plaintiff and Plaintiff’s health care providers 

were unaware of Bard’s misrepresentations and omissions.

As a direct and proximate result of Bard’s fraudulent misrepresentations, Plaintiff 

suffered Injuries and Damages.

COUNT XIII: FRAUDULENT CONCEALMENT

Plaintiff incorporates by reference all prior allegations.

In marketing and selling Bard IVC Filters, Bard concealed material facts from Plaintiff

and Plaintiff’s healthcare providers. 

These concealed material facts include, but are not limited to:

Bard IVC Filters were unsafe and not fit when used for their intended purpose 

or in a reasonably foreseeable manner; 

Bard IVC Filters posed dangerous health risks in excess of those associated 

with the use of other similar IVC filters; 

That there were additional side effects related to implantation and use of Bard 

IVC Filters that were not accurately and completely reflected in the 

warnings associated with Bard IVC Filters; and 

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 34 of 44
That Bard IVC Filters were not adequately tested to withstand normal 

placement within the human body.

Plaintiff and Plaintiff’s healthcare providers were not aware of these and other facts 

concealed by Bard.

In concealing these and other facts, Bard intended to deceive Plaintiff and Plaintiff’s

healthcare providers.

Plaintiff and Plaintiff’s healthcare providers were ignorant of and could not reasonably 

discover the facts Bard fraudulently concealed and reasonably and justifiably relied on Bard’s 

representations concerning the supposed safety and efficacy of Bard IVC Filters.

As a direct and proximate result of Defendants’ fraudulent concealment of material 

facts, Plaintiff suffered Injuries and Damages.

COUNT XIV: VIOLATIONS OF APPLICABLE STATE LAW PROHIBITING 

CONSUMER FRAUD AND UNFAIR DECEPTIVE TRADE PRACTICES

Plaintiff incorporates by reference all prior allegations.

Bard had a statutory duty to refrain from unfair or deceptive acts or practices in the sale 

and promotion of Bard IVC Filters.

Bard knowingly, deliberately, willfully and/or wantonly engaged in unfair, 

unconscionable, deceptive, fraudulent, and misleading acts or practices in violation of all 

states’ consumer protection laws identified below.

Through its false, untrue, and misleading promotion of Bard IVC Filters, Bard induced 

Plaintiff to purchase and/or pay for the purchase of Bard IVC Filters.

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Bard misrepresented the alleged benefits and characteristics of Bard IVC Filters; 

suppressed, omitted, concealed, and failed to disclose material information concerning known 

adverse effects of Bard IVC Filters; misrepresented the quality and efficacy of Bard IVC 

Filters as compared to much lower-cost alternatives; misrepresented and advertised that 

Bard IVC Filters were of a particular standard, quality, or grade that they were not; 

misrepresented Bard IVC Filters in such a manner that later, on disclosure of the true facts, 

there was a likelihood that Plaintiffs would have opted for an alternative IVC filter or method 

of preventing pulmonary emboli.

Bard’s conduct created a likelihood of, and in fact caused, confusion and 

misunderstanding. 

Bard’s conduct misled, deceived, and damaged Plaintiff, and Bard’s fraudulent, 

misleading, and deceptive conduct was perpetrated with an intent that Plaintiff relies on said 

conduct by purchasing and/or paying for purchases of Bard IVC Filters. 

Moreover, Bard knowingly took advantage of Plaintiff, who were unable to protect 

their own interests due to ignorance of the harmful adverse effects of Bard IVC Filters.

Bard’s conduct was willful, outrageous, immoral, unethical, oppressive, unscrupulous, 

unconscionable, and substantially injurious to Plaintiffs and offends the public conscience.

Plaintiff purchased Bard’s IVC Filters primarily for personal, family, or household 

purposes.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 36 of 44
As a result of Bard’s violative conduct in each of the Plaintiff’s respective states, 

Plaintiff purchased and/or paid for purchases of Bard IVC Filters that were not made for 

resale.

Bard engaged in unfair competition or deceptive acts or practices in violation of Alaska 

Stat. § 45.50.471, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Ariz. 

Rev. Stat. § 44-1522, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Ark. 

Code § 4-88-101, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Cal. 

Civ. Code § 1770, et seq. (the “Consumer Legal Remedies Act”), and Cal. Bus. & Prof. Code 

§ 17200, et seq. and § 17500, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Colo. 

Rev. Stat. § 6-1-105, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Conn. 

Gen. Stat. § 42-110b, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of D.C. 

Code Ann. § 28-3901, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of 6 Del. 

Code Ann. § 2513, et seq.

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Bard engaged in unfair competition or deceptive acts or practices in violation of Fla. 

Stat. § 501.201, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Haw. 

Rev. Stat. § 480, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Idaho 

Code § 48-601, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of 815 

Illinois L.C.S. §§ 505/2, 510/2, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Ind. 

Code § 24-5-0.5, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Kan. 

Stat. Ann. § 50-623, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of KRS § 

367.170, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of 5 Me. 

Rev. Stat. Ann. § 207, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Md. 

Code, Commercial Law, § 13-301, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Mass. 

Gen. Laws Ch. 93A § 1, et seq.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 38 of 44
Bard engaged in unfair competition or deceptive acts or practices in violation of 

M.C.L.A. § 445.901, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of M.S.A. 

§ 325F.69, et seq. and M.S.A. § 325D.44, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Miss. 

Code Ann. § 75-24-5.

Bard engaged in unfair competition or deceptive acts or practices in violation of 

Missouri V.A.M.S. § 407.020, et seq. 

Bard engaged in unfair competition or deceptive acts or practices in violation of Neb. 

Rev. St. § 59-1602, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Nev. 

Rev. Stat. §§ 41.600, 598.0903, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of N.H. 

Rev. Stat. § 358-A:1, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of N.J. 

Stat. Ann. § 56:8-1, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of N.M. 

Stat. § 57-12-1, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of N.Y. 

Gen. Bus. Law § 349, et seq.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 39 of 44
Bard engaged in unfair competition or deceptive acts or practices in violation of N.C. 

Gen. Stat. Ann. § 75-1.1, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of 

N.D.C.C. § 51-15-02, et seq.

Bard has engaged in unfair competition or deceptive acts or practices in violation of 

Ohio Rev. Code. Ann. § 1345.01, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of 15 

Okla. St. Ann. §§ 751-753, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Oregon 

Revised Statutes § 646.605, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of 73 Pa. 

Stat. § 201-1, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of R.I. 

Gen. Laws § 6-13.1-1, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of S.D. 

Code Laws § 37-24-1, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Tenn. 

Code Ann. § 47-18-104, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Tex. 

Bus. & Com. Code § 17.41, et seq.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 40 of 44
Bard engaged in unfair competition or deceptive acts or practices in violation of Utah 

Code § 13-11-1, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of 9 Vt. 

Stat. § 2451, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Va. 

Code § 59.1-200, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Wash. 

Rev. Code § 19.86.010, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of W.Va. 

Code § 46A-6-101, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Wis. 

Stat. § 100.18, et seq.

Bard engaged in unfair competition or deceptive acts or practices in violation of Wy. 

Stat. § 40-12-101, et seq.

As a direct and proximate result of Bard’s violations of these statutes, Plaintiff suffered 

Injuries and Damages and seek all available damages under each state’s law.

COUNT XV: PUNITIVE DAMAGES ALLEGATIONS

Plaintiff incorporates by reference all prior allegations.

At all times material hereto, Bard knew or should have known that Bard IVC Filters 

were unreasonably dangerous with respect to the risk of tilt, fracture, migration and/or 

perforation.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 41 of 44
At all times material hereto, Bard attempted to misrepresent and did knowingly 

misrepresent facts concerning the safety of Bard IVC Filters.

Bard’s misrepresentations included knowingly withholding material information from 

the medical community and the public, including Plaintiff’s physicians, concerning the safety 

of its Bard IVC Filters. 

Bard’s conduct, alleged throughout this Master Complaint, was willful, wanton, and 

undertaken with a conscious indifference and disregard to the consequences that consumers of 

their products faced, including Plaintiff. 

At all times material hereto, Bard knew and recklessly disregarded the fact that Bard 

IVC Filters have an unreasonably high rate of tilt, fracture, migration, and/or perforation.

Notwithstanding the foregoing, Bard continued to market Bard IVC Filters aggressively 

to consumers, including Plaintiff, without disclosing the aforesaid side effects.

Bard knew of its Bard IVC Filters’ lack of warnings regarding the risk of fracture, 

migration, and/or perforation, but intentionally concealed and/or recklessly failed to disclose 

that risk and continued to market, distribute, and sell its filters without said warnings so as to 

maximize sales and profits at the expense of the health and safety of the public, including 

Plaintiff, in conscious disregard of the foreseeable harm caused by Bard IVC Filters.

Bard’s intentional and/or reckless failure to disclose information deprived Plaintiff’s

physicians of necessary information to enable them to weigh the true risks of using Bard IVC 

Filters against its benefits.

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 42 of 44
Bard’s conduct is reprehensible, evidencing an evil hand guided by an evil mind and 

was undertaken for pecuniary gain in reckless and conscious disregard for the substantial risk 

of death and physical injury to consumers, including Plaintiffs and their decedents.

Such conduct justifies an award of punitive or exemplary damages in an amount 

sufficient to punish Bard’s conduct and deter like conduct by Bard and other similarly situated 

persons and entities in the future.

PRAYER FOR RELIEF

WHEREFORE, Plaintiff demands judgment against Defendants for:

Compensatory damages, including without limitation past and future medical 

expenses; past and future pain and suffering; past and future emotional distress; past and 

future loss of enjoyment of life; past and future loss of consortium; past and future lost wages 

and loss of earning capacity; and other consequential damages as allowed by law;

Punitive damages in an amount sufficient to punish Defendants and deter similar 

conduct in the future;

Disgorgement of profits;

Restitution;

Statutory damages, where authorized;

Costs of suit; 

Reasonable attorneys’ fees, where authorized; 

Prejudgment interest as allowed by law; 

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Case 2:15-cv-02647-DGC Document 1 Filed 12/01/15 Page 43 of 44
Post-judgment interest at the highest applicable statutory or common law rate from the 

date of judgment until satisfaction of judgment; 

Any other interest recoverable under the law of any action pending in this MDL; and

Such other additional and further relief as Plaintiff may be entitled to in law or in 

equity.

Dated: November 20, 2015

Respectfully Submitted,

HENRY SPIEGEL MILLING LLP

/s/ R. Clay Milling

R. Clay Milling, Esquire

HENRY SPIEGEL MILLING LLP

Atlanta Plaza, Suite 2450

950 E. Paces Ferry Road, N.E.

Atlanta, GA 30326

(404) 832-8000

(404) 832-8050 (facsimile)

rcm@hsm-law.com

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