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COMMONWEALTH OF MASSACHUSETTS
MIDDLESEX, ss. SUPERIOR COURT
CIVIL ACTION NO.:
AlsicubbG
SPECIALLY ASSIGNED BOSTON
SCIENTIFIC GREENFIELD IVC FILTER
CASES-T SESSION
LEAD CASE NO. 1881CV0059
ARTHUR RUSSO JR., AN INDIVIDUAL,
JURY TRIAL DEMANDED
PLAINTIFF,
IN THE OFFICE OF THE
Cc
v. FOR THE COUNTY OF MIDDLESEX
BOSTON SCIENTIFIC CORPORATION, MAR 25: 2021
DEFENDANT.
JE 6g7o2S Cia)
COMPLAINT AND JURY DEMAND CLERK
INTRODUCTION
1 On or about January 26, 2012, Plaintiff, Arthur Russo, was surgically implanted
with a “Greenfield™ Stainless Steel Vena Cava Filter,” a medical device designed and
manufactured by Defendant Boston Scientific Corporation. Neither Mr. Russo nor his healthcare
providers were warmed that the device used in the surgery was negligently designed and
manufactured. Nor were they warned the device was unreasonably dangerous — even when used
exactly as intended by Defendant Boston Scientific Corporation. To the contrary, Defendant
Boston Scientific Corporation promoted, marketed and sold the type of inferior vena cava filter
device implanted into Mr. Russo (and thousands of other individuals like Mr. Russo), to Mr. Russo,
to healthcare providers, including Mr. Russo’s healthcare providers, and to the public at large as a
safe alternative to other medical therapy or procedures that did not incorporate Defendant Boston
Scientific Corporation’s product or no procedure or medical therapy at all. Due to being surgically
implanted with Defendant Boston Scientific Corporation’s unreasonably dangerous medical
device that was unfit for the purpose for which it was designed and sold, Mr. Russo has suffered,
and continues to suffer, debilitating injuries. Mr. Russo brings this suit for damages relating to
those injuries.
PARTIES
2 Plaintiff Arthur Russo (hereinafter “Plaintiff’) is and was, at all times relevant to
this action, a resident and citizen of the State of Louisiana.
Defendant Boston Scientific Corporation (hereinafter “Defendant BSC”) is a
Delaware corporation, with its headquarters located in Marlborough, Middlesex County,
Massachusetts. At all times relevant hereto, Defendant BSC was engaged in business and
conducted substantial business activity in Massachusetts and Louisiana. Defendant BSC has also
carried on solicitations or service activities in Massachusetts and Louisiana.
4 At all times relevant to this action, Defendant BSC designed, set specifications for,
manufactured, prepared, compounded, assembled, processed, marketed, distributed, and/or sold
the inferior vena cava filter known as the Greenfield™ Stainless Steel Vena Cava Filter to be
implanted into patients throughout the United States, including Massachusetts and Louisiana.
5 Atall times alleged herein, Defendant BSC includes and included any and all parent
companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and
organizational units of any kind, its predecessors, successors and assigns and its officers, directors,
employees, agents, representatives and any and all other persons acting on its behalf.
6 At all times herein mentioned, Defendant BSC was the agent, servant, partner,
predecessors in interest, and joint venturer of each other and were at all times operating and acting
with the purpose and scope of said agency, service, employment, partnership, joint enterprise
and/or joirit venture.
JURISDICTION AND VENUE
7 Jurisdiction is proper in this Court, because Plaintiff is seeking damages in excess
of fifty thousand dollars ($50,000) and Defendant BSC’s conduct giving rise to Plaintiff's causes
of action occurred in the State of Massachusetts. Defendant BSC is headquartered in
Massachusetts. Defendant BSC has conducted and continues to conduct substantial and systematic
business activities related to their inferior vena cava filters (hereinafter “IVC filter”), including the
Stainless Steel Greenfield™ Vena Cava Filter (hereinafter “Greenfield filter”) at issue in this case,
in this jurisdiction. Such activities include, but are not limited to: (a) sales of IVC filters, including
the Greenfield filter at issue in this case, in this jurisdiction; (b) hiring, training and deploying
employees, including managers and sales representatives in this jurisdiction; (c) advertising and
marketing of their IVC filters, including the Greenfield filter at issue in this case, in this
jurisdiction; (d) maintenance of company files and equipment relating to the Greenfield filter in
this case, in this jurisdiction; (¢) payment of employee salaries in this jurisdiction; and, (f)
maintenance of a website directed to all states, including Massachusetts and Louisiana. See G.L.
c. 223A, §§ 2 and 3.
8 Venue is properly laid in Middlesex County, as Defendant BSC is located in and
regularly conducts business in Middlesex County. See G.L. c. 223, §1.
9 Plaintiff's claims in this action are brought solely under state law. Plaintiff does
not herein bring, assert, or allege, either expressly or impliedly, any causes of action arising under
any federal law, statute, regulation, or provision, Thus, there is no federal jurisdiction in this action
on the basis of a federal question under 28 U.S.C. § 1331.
10. Furthermore, Defendant BSC is a citizen of Massachusetts and therefore the cause
of action may not be removed. See 28 U.S.C. § 1441(b)(2).
ALTERNATIVE ALLEGATIONS
ll. To the extent any allegation herein is inconsistent with any other allegation, such
inconsistent allegations are pled in the alternative pursuant to Mass. R. Civ. P. 8(e)(2). See also
Matter of Hilson, 448 Mass. 603, 613, 863 N.E.2d 483 (2007) (holding “[m]Jodern rules of pleading
permit alternative pleading.”).
CORPORATE / VICARIOUS LIABILITY
12. At all times herein mentioned, Defendant BSC and any and all parent companies,
subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of
any kind, its predecessors, successors and assigns and its officers, directors, employees, agents,
representatives and any and all other persons acting on its behalf, were agents, servants, partners,
aiders and abettors, co-conspirators and/or joint venturers, and were at-all times operating and
acting within the purpose and scope of said agency, service, employment, partnership, conspiracy,
and/or joint venture and rendered substantial assistance and encouragement to each other, knowing
that its collective conduct constituted a breach of duty owed to the Plaintiff.
13. There currently exists, and at all times herein mentioned there existed, a unity of
interest in ownership between Defendant BSC and any anid all parent companies, subsidiaries,
affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind, and
its predecessors, successors and assigns, such that any individuality and separateness between
them has ceased and these persons or entities are alter egos. Adherence to the fiction of the separate
existence of these persons or entities as being distinct and separate from each other will permit an
abuse of the corporate privilege and would sanction a fraud and/or would promote injustice.
14, At all times herein mentioned, Defendant BSC and any and all parent companies,
subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of
any kind, collectively, and each of them individually, were engaged in the business of, or were
successors in interest to entities engaged in the business of, researching, designing, formulating,
compounding, testing, manufacturing, producing, processing, assembling, inspecting, distributing,
marketing, labeling, promoting, packaging, prescribing and/or advertising for sale, and selling
products for use by the Plaintiff. As such, Defendant BSC and any and all parent companies,
subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of
any kind are individually, as well as jointly and severally, liable to the Plaintiff for his damages.
15. At all times herein mentioned, the officers, directors, employees, agents, and
representatives of Defendant BSC and any and all parent companies, subsidiaries, affiliates,
divisions, franchises, partners, joint venturers, and organizational units of any kind, and any and
all other persons acting on its behalf, participated in, authorized and/or directed the production and
promotion of the aforementioned products when they knew, or with the exercise of reasonable care
and diligence, should have known of the hazards and dangerous propensities of said products, and
thereby actively participated in the tortious conduct that resulted in the injuries suffered by the
Plaintiff.
16. “Defendant BSC” where: used hereinafter, shall refer to any and all parent
companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, organizational
units of any kind, predecessors, successors, assigns, officers, directors, employees, agents and
representatives of Defendant Boston Scientific Corporation.
FACTUAL ALLEGATIONS
17. Plaintiff brings this case for serious, life-threatening injuries he suffered as a result
of Defendant BSC’s surgically implanted medical device, the Greenfield filter, which was
implanted into Plaintiff on or about January 26, 2012, after diagnosis and treatment of a deep vein
thrombosis. The Greenfield filter was implanted by Kurt B. O’Brien, MD at Iberia Medical Center,
located at 2315 E Main St, New Iberia, LA 70560.
18. Defendant BSC designs, researches, develops, manufactures, tests, markets,
advertises, promotes, distributes, and sells products such as IVC filters that are sold to and
marketed as permanent devices to prevent, among other things, recurrent pulmonary embolism via
placement in the vena cava. One such product is the Greenfield filter.
19. Upon information and belief, on or about April 10, 1990, Defendant BSC sought
U.S. Food and Drug Administration (“FDA”) clearance to market the Greenfield filter and/or its
components under Section 510(k) of the Federal Food, Drug and Cosmetic Act, as amended by
the Medical Devices Amendments of 1976.
20. Upon information and belief, on or about November 8, 1990, Defendant BSC
obtained FDA clearance to market the Greenfield filter under Section 510(k) of the Federal Food,
Drug and Cosmetic Act, as amended by the Medical Devices Amendments of 1976.
21. Section 510(k) allows marketing of medical devices if the manufacturer claims the
device is substantially equivalent to other legally marketed predicate devices without formal
review for the safety or efficacy of said device. The device can then be cleared by the FDA under
Section 510(k).
22. An IVC filter like the Greenfield filter is a device ostensibly designed to filter blood
clots (called “thrombi”) that would otherwise travel from the lower portions of the body to the
heart and lungs. Defendant BSC’s Greenfield filters are marketed as being safely implanted
permanently within the vena cava.
23. The inferior vena cava is a vein that returns blood to the heart from the lower portion
of the body. In certain people, and for various reasons, a thrombus may travel from vessels in the
legs and pelvis, through the vena cava into the lungs. These thrombi can develop in the deep leg
veins. Such a thrombus is called a “deep vein thrombosis” or DVT. If the thrombi reach the lungs,
they are considered “pulmonary emboli” or PE.
24. An IVC filter, like the Greenfield filter, is ostensibly designed to prevent
thromboembolic events by filtering or preventing blood clots/thrombi from traveling to the heart
and/or lungs.
25. The Greenfield filter is marketed and sold as a permanent filter.
26. The Greenfield filter is made of stainless steel. The filter is preloaded into a carrier
capsule/sheath, which is introduced percutaneously via a catheter into the vena cava through either
the femoral artery or the jugular vein.
27. The Greenfield filter utilizes a conical design that is intended to capture blood clots
and/or emboli. This design consists of six (6) struts approximately 4.9 centimeters in length that,
when deployed from its carrier capsule/sheath, extend down from the filter’s apex at a slight
outward angel, resulting in a base diameter of approximately 3.2 centimeters. There is an opening
in the center of the Greenfield filter’s apex to allow passage of a guidewire.
28. The Greenfield filter has distal anchoring hooks located on each of the six (6) struts
for fixation of the filter to the vena cava wall. Four (4) of the filter’s anchoring hooks are recurved
at an angel of eighty (80) degrees and the remaining two (2) anchoring hooks are recurved
downward at an angel of one hundred twenty-five (125) degrees. The six (6) recurved anchoring
hooks are said to stabilize the filter and to protect against penetration of the filter struts through
the vena cava wall.
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29. The following illustration shows the Greenfield filter:
wenen----| Guidewire opening
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ceeeerr h
Apex of filter
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pt
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80° anchoring hooks
125° anchoring hooks
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30. On or about January 26, 2012, Plaintiff was implanted with a Defendant BSC’s
Greenfield filter. The Greenfield filter placed into Plaintiff was represented to be safe for
permanent placement.
31. On or about June 13, 2019, Plaintiff underwent a computerized tomography scan
_ scan”) of his abdomen and pelvis.
32. On or about June 13, 2019, Plaintiff was informed that his CT scan completed that
same day, revealed (1) that his Greenfield filter was tilted greater than 15 degrees with the tip
projecting on the lateral right margin of the IVC, (2) the inferior struts all penetrate the margin of
the IVC, (3) the 12:00 and 2:00 struts abut the posterior wall of the small bowel, (4) the 4:00 strut
is in close proximity to the wall of the aorta, (5) the 6:00 strut abuts the prevertebral soft tissues
and cortex of the L4 vertebral body, (6) the 8:00 strut penetrates the psoas muscle, (7) the 10:00
strut abuts a small vein and (8) mild central narrowing of the IVC is noted.
33. Plaintiff's injuries were inherently undiscoverable or objectively verifiable such
that, despite Plaintiff's reasonable diligence, he was unable to discover her injuries until on or
about June 13, 2019, when he was informed of the findings from his CT scan conducted.
34. At all times relevant hereto, the Greenfield filter was widely advertised and
promoted by Defendant BSC as a safe and effective treatment for prevention of recurrent
pulmonary embolism via placement in the vena cava.
35. At all times relevant hereto, Defendant BSC knew its permanent IVC filters were
defective and knew that the defect was attributable to the design’s failure to withstand the normal
anatomical and physiological loading cycles exerted in vivo.
36. Defendant BSC failed to disclose to physicians, patients, or Plaintiff that its
permanent IVC filters, including the Greenfield filter, were subject to breakage, collapse,
migration, and/or the appropriate degree of risk of damage to the vena cava wall.
37. At all times relevant hereto, Defendant BSC continued to promote its permanent
IVC filters, including the Greenfield filter, as safe and effective, even though the clinical trials that
had been. performed were not adequate to support long or short-term efficacy.
38. Defendant BSC concealed the known risks and failed to warn of known or
scientifically knowable dangers and risks associated with the permanent IVC filters, including the
Greenfield filter, as aforesaid.
39. Defendant BSC specifically. advertise that the Greenfield filter is “[dJesigned to
maintain normal or high flow around captured clot” and that the filter’s “[rjecurved hooks are
designed to provide protection against penetration.”
40. The failure of the Greenfield filter is attributable in part to the fact that Defendant
BSC’s permanent IVC filters, including its Greenfield filters, suffer from a design defect causing
the filters to be unable to withstand the normal anatomical and physiological loading cycles exerted
in vivo resulting in the filters tilting, penetrating through the wall of the inferior vena cava,
penetrating into other organs of the body, migrating and/or fracturing.
41. At all times relevant hereto, Defendant BSC failed to provide sufficient warnings
and instructions that would have put Plaintiff and the general public on notice of the dangers and
adverse effects caused by implantation of the Greenfield filter, including, but not limited to, the
design’s failure to withstand the normal anatomical and physiological loading cycles exerted in
vivo, the filter’s potential to penetrate through the inferior vena cava, the filter’s potential to
penetrate into other organs, the filters propensity to migrate and/or its propensity to fracture.
42. The Greenfield filter was designed, manufactured, distributed, sold, and/or supplied
by Defendant BSC, and was marketed while defective due to the inadequate warnings, instructions,
labeling, and/or inadequate testing in light of Defendant BSC’s knowledge of the product’s failure
and serious adverse events.
43. At all times relevant hereto, the officers and/or directors of Defendant BSC
participated in, authorized, and/or directed the production and promotion of the aforementioned
products when they knew or should have known of the hazardous and dangerous propensities of
said products, and thereby actively participated in the tortious conduct that resulted in the injuries
suffered by Plaintiff.
DEFENDANT’S GREENFIELD FILTER
IS A 510(k) CLEARED MEDICAL DEVICE
44, Defendant submitted premarket notification and obtained marketing clearance for
its Greenfield filter from the FDA under § 510(k) of the Federal Food, Drug, and Cosmetic Act
(“FDCA”). See 21 U.S.C. § 360 et seq.
45 . Pursuant to § 510(k)’s approval process, the FDA determined that Defendant BSC’s
Greenfield filter was “substantially equivalent” to devices that have been reclassified in
accordance with the provisions of the FDCA. Defendant BSC did not request FDA approval by
way of a Premarket Approval application (PMA).
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DISCOVERY RULE AND FRAUDULENT CONCEALMENT.
46. Plaintiff incorporates by reference the factual portion of his complaint as if fully set
forth herein and additionally, or in the alternative, if same be necessary, alleges as follows.
47. Plaintiff pleads that the discovery rule should be applied to toll the running of the
statute of limitations until Plaintiff knew, or through the exercise of reasonable care and diligence
should have known, of facts indicating that Plaintiff had been injured, the cause of the injury, and
the tortious nature of the wrongdoing that caused the injury.
48. The Greenfield filter was implanted deep within the core of the Plaintiffs body and
changes in the condition of that device or the injuries associated with the filter’s failure could only
be observed through medical imaging such as x-rays and CT Scans. Despite diligent investigation
by Plaintiff into the cause of his injuries, including consultations with Plaintiff s medical providers,
the nature of Plaintiff's injuries and damages and their relationship to the Greenfield filter and
Defendant BSC’s wrongful conduct was not discovered, and through reasonable care and due
diligence could not have been discovered, prior to June 13, 2019 a date within the applicable statute
of limitations for filing Plaintiff's claims. Therefore, under appropriate application of the
discovery rule, Plaintiffs suit was filed well within the applicable statutory limitations period.
49. Any applicable statutes of limitation have been tolled by the knowing and active
concealment and denial of material facts known by the Defendant BSC when they had a duty to
disclose those facts. Defendant BSC’s purposeful and fraudulent acts of concealment have kept
Plaintiff ignorant of vital information essential to the pursuit of his claims, without any fault or
lack of diligence on Plaintiff’s part, for the purpose of obtaining delay on Plaintiff's part in filing
his causes of action. The Defendant BSC’s fraudulent concealment did result in such delay.
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50. Defendant BSC are estopped from relying on the statute of limitations defense
because Defendant BSC failed to timely disclose, among other things, facts evidencing the
defective and unreasonably dangerous nature of the Greenfield filter.
51. Defendant BSC was, and remains, under a continuing duty to disclose the true
character, quality and nature of the device that was implanted into Plaintiff, but instead they have
concealed these facts. Defendant BSC’s conduct, as described in the complaint constitutes
purposely committed conduct, which they must have realized was dangerous, heedless, and
reckless, without regard to the consequences or the rights and safety of Plaintiff.
COUNT I
NEGLIGENCE
52. Plaintiff re-alleges and incorporates by reference each and every allegation
contained in the foregoing paragraphs as though fully set forth herein.
53. At all times relevant to this cause of action, Defendant BSC was in the business of
designing, developing, setting specifications, manufacturing, marketing, selling, and distributing
the Greenfield filter.
54, Defendant BSC designed, manufactured, marketed, inspected, labeled, promoted,
distributed and sold the Greenfield filter that was implanted into Plaintiff.
55. Defendant BSC had a duty to exercise reasonable and prudent care in the
development, testing, design, manufacture, inspection, marketing, labeling, promotion,
distribution and sale of the Greenfield filter so as to avoid exposing others to foreseeable and
unreasonable risks of harm.
56. Defendant BSC knew or reasonably should have known that the Greenfield filter
was dangerous or was likely to be dangerous when used in its intended or reasonably foreseeable
manner.
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57. At the time of manufacture and sale of the Greenfield filter (June 1995 until
Present), Defendant BSC knew or should have known that the Greenfield filter:
a. Was designed and manufactured in such a manner so as to present an
unreasonable risk of fracture of portions of the device;
Was designed and manufactured so as to present an unreasonable risk of
migration of the device and/or portions of the device;
Was designed and manufactured so as to present an unreasonable risk of the
device tilting and/or perforating the vena cava wall;
Was designed and manufactured so as to present an unreasonable risk of
causing thrombosis; and/or,
Was designed and manufactured to have unreasonable and insufficient
strength or structural integrity to withstand normal placement within the
human body.
58. At the time of manufacture and sale of the Greenfield filter (June 1995 until
Present), Defendant BSC knew or should have known that using the Greenfield filter in its intended
use or in a reasonably foreseeable manner created a significant risk of a patient suffering severe
health side effects, including, but not limited to: fracture and embolization of filter parts;
thrombosis; occlusion of the vena cava hemorrhage; cardiac/pericardial tamponade; cardiac
arrhythmia and other symptoms similar to myocardial infarction; perforation of tissues, vessels
and organs; and other severe personal injuries and diseases which are permanent in nature,
including, but not limited to, death, physical pain and mental anguish, scarring and disfigurement,
diminished enjoyment of life, continued medical care and treatment due to chronic injuries/illness
proximately caused by the device; and, the continued risk of requiring additional medical and
surgical procedures, including general anesthesia, with attendant risk of life threatening
complications.
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59. Defendant BSC knew or reasonably should have known that consumers of the
Greenfield filter would not realize the danger associated with using the device in its intended use
and/or in a reasonably foreseeable manner.
60. Defendant BSC breached its duty to exercise reasonable and prudent care in the
development, testing, design, manufacture, inspection, marketing, labeling, promotion,
distribution and sale of the Greenfield filter in, among others, the following ways:
a. Designing and distributing a product 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;
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;
Failing to use reasonable care in manufacturing the product and producing
a product that differed from its design or specifications or from other typical
units from the same production line;
Failing to use reasonable care to warn or instruct, including pre- and post-
sale, Plaintiff, Plaintiff's physicians, Plaintiffs agents or the general
healthcare community about the Greenfield filter’s substantially dangerous
condition or about facts making the product likely to be dangerous;
Failing to perform reasonable pre- and post-market testing of the Greenfield
filter to determine whether or not the product was safe for its intended use;
Failing to provide adequate instructions, guidelines, and safety precautions,
including pre- and post-sale, to those persons to whom it was reasonably
foreseeable would prescribe, use, and implant the Greenfield filter;
Advertising, marketing and recommending the use of the Greenfield filter,
while concealing and failing to disclose or warn of the dangers known by
Defendant BSC to be connected with and inherent in the use of the
Greenfield filter;
Representing that the Greenfield filter was safe for its intended use when in
fact, Defendant BSC knew and should have known the product was not safe
for its intended purpose;
Continuing to manufacture and sell the Greenfield filter with the knowledge
that the product was dangerous and not reasonably safe;
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Failing to use reasonable and prudent care in the design, research,
manufacture, and development of the Greenfield filter so as to avoid the
risk of serious harm associated with the use of the Greenfield filter;
Advertising, marketing, promoting and selling the Greenfield filter for uses
other than as approved and indicated in the product’s label;
Failing to establish an adequate quality assurance program used in the
manufacturing of the Greenfield filter; and,
Failing to establish and maintain an adequate post-market surveillance
program.
6. A reasonable manufacturer, distributor, or seller under the same or similar
circumstances would not have engaged in the aforementioned acts and omissions.
62. As a direct and proximate result of the foregoing negligent acts and omissions by
Defendant BSC, Plaintiff has suffered and will continue to suffer serious physical injuries and
sever pain, impairment, disability, economic loss, loss of enjoyment of life, expense of
hospitalization, medical care and treatment, and other losses in an amount to be determined at trial.
WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as
applicable and a trial by jury.
COUNT IT
STRICT PRODUCTS LIABILITY - FAILURE TO WARN
63. Plaintiff re-alleges and incorporates by reference each and every allegation
contained in the foregoing paragraphs as though fully set forth herein.
64. Defendant BSC designed, set specifications, manufactured, prepared, compounded,
assembled, processed, marketed, labeled, distributed, and sold the Greenfield filter, including the
one implanted into Plaintiff, ‘into the stream of commerce and in the course of same, directly
advertised and marketed the device to consumers or persons responsible for consumers.
65. At the time Defendant BSC designed, manufactured, prepared, compounded,
assembled, processed, marketed, labeled, distributed, and sold the device, placing it into the stream
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of commerce, Defendant BSC knew or should have known the device Presented an unreasonable
danger to‘users of the product when put to its intended and reasonably anticipated use.
Specifically, Defendant BSC knew or should have known at the time it manufactured, labeled,
distributed and sold the Greenfield filter, which was implanted into Plaintiff, that:the Greenfield
filter, ‘inter alia, posed a significant and higher risk than other similar devices of device failure
(fracture, migration, tilting, causing thrombosis, penetration or perforation through the vein wall
and/or penetration into other veins, arteries and organs ) and resulting serious injuries.
66. Consequently, Defendant BSC had a duty to warn of the risk of harm associated
‘
with the use of the device.and to provide adequate instructions on the safe and proper use of the
device.
67. Defendant BSC further had a duty to warn of dangers and proper safety instructions
that it became aware of even after the device was distributed and implanted into Plaintiff.
68. Despite its duties, Defendant BSC failed to adequately warn of material facts
regarding the safety and efficacy of the Greenfield filter, and further failed to adequately provide
instructions on the safe and proper use of the device.
69. No healthcare provider, including Plaintiff's, patient or patient's agent would have
used the device in the manner directed, had those facts been made known to the prescribing
healthcare providers and/or ultimate users of the device.
70. The health risks associated with the device as described herein are of such a nature
that an ordinary consumer would not have readily recognized the potential harm.
71. Plaintiff and Plaintiff's healthcare providers used the device’in a normal,
customary, intended, and foreseeable manner, namely as a surgically implanted device used to
prevent pulmonary emboli.
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72. Therefore, the Greenfield filter implanted into Plaintiff was defective and
unreasonably dangerous at the time of release into the stream of commerce due to inadequate
warnings, labeling and/or instructions accompanying the product.
2B. The Greenfield filter implanted into Plaintiff was in the same condition as when it
was manufactured, inspected, marketed, labeled, promoted, distributed and sold by Defendant
BSC.
TA. As a direct and proximate result of Defendant BSC’s lack of sufficient warning
and/or instructions, Plaintiff has suffered and will continue to suffer serious physical injuries and
sever pain, impairment, disability, economic loss, loss of enjoyment of life, expense of
hospitalization, medical care and treatment, and other losses in an amount to be determined at trial.
WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as
applicable and a trial by jury.
COUNT III
STRICT PRODUCTS LIABILITY — DESIGN DEFECT
75. Plaintiff re-alleges and incorporates by reference each and every allegation
contained in the foregoing paragraphs as though fully set forth herein.
76. At all times relevant to this action, Defendant BSC developed, tested, designed,
manufactured, inspected, labeled, promoted, sold, and distributed into the stream of commerce the
Greenfield filter, including the one implanted into Plaintiff.
77. The Greenfield filter was expected to, and did, reach its intended consumers
without substantial change in the condition it was in when it left Defendant BSC’s possession. In
the alternative, any changes that were made to Greenfield filter implanted into Plaintiff were
reasonably foreseeable to Defendant BSC.
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Bn
2B. The Greenfield filter implanted in Plaintiff was defective in design because it failed
to perform as safely as persons who ordinarily use the product would have expected at the time of
use.
79. The Greenfield filter implanted in Plaintiff was defective in design, in that its risks
of harm exceeded its claimed benefits, more specifically it penetrated/perforated through the wall
of Mr. Russo’s veins.
80. Plaintiff and Plaintiff's healthcare providers used the Greenfield filter in a manner
that was reasonably foreseeable to Defendant BSC.
81. Neither Plaintiff nor Plaintiffs healthcare providers could have, by the exercise of
reasonable care, discovered the device’s defective condition or perceived its unreasonable dangers
prior to Plaintiffs implantation with the device.
82. Defendant BSC’s permanent IVC filters, including the Plaintiff's Greenfield filter,
were defective by design as the design failed to withstand the normal anatomical and physiological
loading cycles exerted in vivo resulting in penetration of the veins and organs and fracture during
its intended use.
83. As a direct and proximate result of the Greenfield filter’s defective design, Plaintiff
has suffered and will continue to suffer serious physical injuries and sever pain, impairment,
disability, economic loss, loss of enjoyment of life, expense of hospitalization, medical care and
treatment, and other losses in an amount to be determined at trial.
WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as
applicable and a trial by jury.
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COUNT IV
STRICT PRODUCTS LIABILITY — MANUFACTURING DEFECT
84. Plaintiff re-alleges and incorporates by reference each and every allegation
contained in the foregoing paragraphs as though fully set forth herein.
85. Defendant BSC designed, set specifications, manufactured, prepared, compounded,
assembled, processed, marketed, labeled, distributed, and sold the Greenfield filter that was
implanted into Plaintiff.
86. The Greenfield filter implanted into Plaintiff contained a condition or conditions,
which Defendant BSC did not intend, at the time it left Defendant BSC’s control and possession.
87. Plaintiff and Plaintiffs healthcare providers used the device in a manner that was
reasonably foreseeable to Defendant BSC.
88. Defendant BSC’s IVC filters, including the Plaintiff's Greenfield filter, were
deigned to be permanent devices and the filter failed to withstand the normal anatomical and
physiological loading cycles exerted in vivo resulting in penetration/perforation of the Plaintiff's
veins and organs as well as the and fracturing of the filter during its intended use, if the filter is
properly designed to be a safe and effective medical device that can be permanently implanted in
a patient, but it failed during life of its user, the particular devices seems to have failed to meet it
design expectations and was manufactured in manner which rendered it defective.
89. As a result of the condition or these conditions, the product injured Plaintiff and
failed to perform as safely as the ordinary consumer would expect when used in a reasonably
foreseeable manner.
90. As a direct and proximate result of the Greenfield filter’s manufacturing defects,
Plaintiff has suffered and will continue to suffer serious physical injuries and sever pain,
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fo
impairment, disability, economic loss, loss of enjoyment of life, expense of hospitalization,
medical care and treatment, and other losses in an amount to be determined at trial.
WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as
applicable and a trial by jury.
COUNT V
BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY
91. Plaintiff re-alleges and incorporates by reference each and every allegation
contained in the foregoing paragraphs as though fully set forth herein.
92. At all times relevant to this action, Defendant BSC designed, researched,
developed, manufactured, tested, labeled, inspected, advertised, promoted, marketed, sold, and
distributed into the stream of commerce the Greenfield filter for use as a surgically implanted
device used to prevent pulmonary embolisms and for uses other than as approved and indicated in
the product’s instructions, warnings, and labels.
93. At the time and place of the sale, distribution, and supply of the Defendant BSC
Greenfield filter to Plaintiff by way of Plaintiffs healthcare providers and medical facilities,
Defendant BSC expressly represented and warranted, by labeling materials submitted with the
product, that the Greenfield filter was safe and effective for its intended and reasonably foreseeable
use,
94. Defendant BSC knew of the intended and reasonably foreseeable use of the
Greenfield filter at the time they marketed, sold, and distributed the product for use by Plaintiff,
and impliedly warranted the product to be of merchantable quality and safe and fit for its intended
use.
95. Defendant BSC impliedly represented and warranted to the healthcare community,
Plaintiff and Plaintiff's healthcare providers, that the Greenfield filter was safe, of merchantable
20
quality and fit for the ordinary purpose for which the product was intended and marketed to be
used.
96. The representations and implied warranties made by Defendant BSC were false,
misleading, and inaccurate because the Greenfield filter was defective, unsafe, unreasonably
dangerous, and not of merchantable quality, when used in its intended and/or reasonably
foreseeable manner. Specifically, at the time of Plaintiff's purchase of the Greenfield filter from
Defendant BSC, through Plaintiffs physicians and medical facilities, it was not in a merchantable
condition in that:
a. It was designed in such a manner so as to be prone to an unreasonably high
rate of failure, including fracture, migration, excessive tilting, causing
thrombosis and/or perforation of bodily organs;
It was designed in such a manner so as to result in an unreasonably high rate
of injury to the organs and anatomy; and,
It was manufactured in such a manner so that the Greenfield filter system was
inadequately, improperly and inappropriately prepared and/or finished, so as
to be prone to an unreasonably high rate of failure and/or causing the device to
fail.
97. Plaintiff and Plaintiffs healthcare providers reasonably relied on the superior skill
and judgment of Defendant BSC as the designer, researcher and manufacturer of the product, as
to whether the Greenfield filter was of merchantable quality, safe and fit for its intended use and
also relied on the implied warranty of merchantability and fitness for the particular use and purpose
for which the Greenfield filter was manufactured and sold.
98. Defendant BSC placed the Greenfield filter into the stream of commerce in a
defective, unsafe, and unreasonably dangerous condition, and the product was expected to and did
reach Plaintiff without substantial change’ in the condition in which the Greenfield filter was
manufactured and sold.
21
99. Defendant BSC breached its implied warranty because its Greenfield filter was not
fit for its intended use and purpose.
100. As a proximate result of Defendant BSC breaching its implied warranties, Plaintiff
has suffered and will continue to suffer serious physical injuries and sever pain, impairment,
disability, economic loss, loss of enjoyment of life, expense of hospitalization, medical care and
treatment, and other losses in an amount to be determined at trial.
WHEREFORE, Plaintiff demands: judgment for damages, including costs, interest as
applicable and a trial by jury.
COUNT VI
UNFAIR OR DECEPTIVE COMSUMER PRACTICES AND PUNITIVE DAMAGES
ALLEGATIONS
101. Plaintiff re-alleges and ificorporates by reference each and every allegation contained
in the foregoing paragraphs as though fully set forth herein.
102. At all times mentioned herewith the Defendant, BSC was engaged in trade or
commerce within the meaning of M.G.L. ch. 93A.
103. The carelessness, negligence and breaches of warranty of the defendant, as more
particularly set out hereinabove, constitute unfair or deceptive acts or practices within the meaning
of M.G.L. ch. 93A as defined by the regulations of the offices of Massachusetts Attorney General.
104. Plaintiff is entitled to an award of punitive and exemplary damages based upon
Defendant BSC’s carelessness, negligence, breaches of warranty, intentional, willful, knowing,
fraudulent, malicious acts, omissions, and conduct, and Defendant BSC’s unfair or deceptive acts
or practices within the meaning of M.G.L. ch. 93A §§ 9, 11 as defined by the regulations of the
offices of Massachusetts Attorney General.
105. Defendant BSC had knowledge of, and were in possession of, evidence
demonstrating that the Greenfield filter was defective, unreasonably dangerous, and had a
22
substantially higher failure rate than did other similar devices on the market. Despite their
knowledge, Defendant BSC failed to, among other purposeful acts, inform or warn Plaintiff or her
healthcare providers of the dangers, establish and maintain an adequate quality and post-market
surveillance system, and recall the Greenfield filter from the market.
106. As a direct, proximate, and legal result of Defendant BSC’s acts and omissions as
described herein, Plaintiff has suffered and will continue to suffer serious physical injuries and
severe pain, impairment, disability, economic loss, loss of earning capacity, loss of enjoyment of
life, expense of hospitalization, medical care and treatment, and other losses in an amount to be
determined at trial.
WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as
XN
applicable and a trial by jury.
COUNT VII
NEGLIGENT MISREPRESENTATION
107. Plaintiff re-alleges and incorporates by reference each and every allegation
contained in the foregoing paragraphs as though fully set forth herein.
108. At all times relevant to this cause of action, Defendant BSC was in the business of
designing, developing, setting specifications for, licensing, manufacturing, preparing, packaging,
maintaining, labeling, compounding, assembling, processing, selling, distributing, and marketing
IVC filters.
109. At the time Plaintiff was implanted with the Greenfield filter, Defendant BSC
developed, tested, designed, manufactured, inspected, labeled, promoted, sold, and distributed into
the stream of commerce the Greenfield filter, including the one implanted into Plaintiff.
110. At all times relevant to this action, Defendant BSC designed, researched,
developed, manufactured, tested, labeled, inspected, advertised, promoted, marketed, sold, and
23
distributed into the stream of commerce the Greenfield filter for use as a surgically implanted
device used to prevent pulmonary embolisms and for uses other than as approved and indicated in
the product’s instructions, warnings, a
Preview
COMMONWEALTH OF MASSACHUSETTS MIDDLESEX, ss. SUPERIOR COURT CIVIL ACTION NO.: AlsicubbG SPECIALLY ASSIGNED BOSTON SCIENTIFIC GREENFIELD IVC FILTER CASES-T SESSION LEAD CASE NO. 1881CV0059 ARTHUR RUSSO JR., AN INDIVIDUAL, JURY TRIAL DEMANDED PLAINTIFF, IN THE OFFICE OF THE Cc v. FOR THE COUNTY OF MIDDLESEX BOSTON SCIENTIFIC CORPORATION, MAR 25: 2021 DEFENDANT. JE 6g7o2S Cia) COMPLAINT AND JURY DEMAND CLERK INTRODUCTION 1 On or about January 26, 2012, Plaintiff, Arthur Russo, was surgically implanted with a “Greenfield™ Stainless Steel Vena Cava Filter,” a medical device designed and manufactured by Defendant Boston Scientific Corporation. Neither Mr. Russo nor his healthcare providers were warmed that the device used in the surgery was negligently designed and manufactured. Nor were they warned the device was unreasonably dangerous — even when used exactly as intended by Defendant Boston Scientific Corporation. To the contrary, Defendant Boston Scientific Corporation promoted, marketed and sold the type of inferior vena cava filter device implanted into Mr. Russo (and thousands of other individuals like Mr. Russo), to Mr. Russo, to healthcare providers, including Mr. Russo’s healthcare providers, and to the public at large as a safe alternative to other medical therapy or procedures that did not incorporate Defendant Boston Scientific Corporation’s product or no procedure or medical therapy at all. Due to being surgically implanted with Defendant Boston Scientific Corporation’s unreasonably dangerous medical device that was unfit for the purpose for which it was designed and sold, Mr. Russo has suffered, and continues to suffer, debilitating injuries. Mr. Russo brings this suit for damages relating to those injuries. PARTIES 2 Plaintiff Arthur Russo (hereinafter “Plaintiff’) is and was, at all times relevant to this action, a resident and citizen of the State of Louisiana. Defendant Boston Scientific Corporation (hereinafter “Defendant BSC”) is a Delaware corporation, with its headquarters located in Marlborough, Middlesex County, Massachusetts. At all times relevant hereto, Defendant BSC was engaged in business and conducted substantial business activity in Massachusetts and Louisiana. Defendant BSC has also carried on solicitations or service activities in Massachusetts and Louisiana. 4 At all times relevant to this action, Defendant BSC designed, set specifications for, manufactured, prepared, compounded, assembled, processed, marketed, distributed, and/or sold the inferior vena cava filter known as the Greenfield™ Stainless Steel Vena Cava Filter to be implanted into patients throughout the United States, including Massachusetts and Louisiana. 5 Atall times alleged herein, Defendant BSC includes and included any and all parent companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind, its predecessors, successors and assigns and its officers, directors, employees, agents, representatives and any and all other persons acting on its behalf. 6 At all times herein mentioned, Defendant BSC was the agent, servant, partner, predecessors in interest, and joint venturer of each other and were at all times operating and acting with the purpose and scope of said agency, service, employment, partnership, joint enterprise and/or joirit venture. JURISDICTION AND VENUE 7 Jurisdiction is proper in this Court, because Plaintiff is seeking damages in excess of fifty thousand dollars ($50,000) and Defendant BSC’s conduct giving rise to Plaintiff's causes of action occurred in the State of Massachusetts. Defendant BSC is headquartered in Massachusetts. Defendant BSC has conducted and continues to conduct substantial and systematic business activities related to their inferior vena cava filters (hereinafter “IVC filter”), including the Stainless Steel Greenfield™ Vena Cava Filter (hereinafter “Greenfield filter”) at issue in this case, in this jurisdiction. Such activities include, but are not limited to: (a) sales of IVC filters, including the Greenfield filter at issue in this case, in this jurisdiction; (b) hiring, training and deploying employees, including managers and sales representatives in this jurisdiction; (c) advertising and marketing of their IVC filters, including the Greenfield filter at issue in this case, in this jurisdiction; (d) maintenance of company files and equipment relating to the Greenfield filter in this case, in this jurisdiction; (¢) payment of employee salaries in this jurisdiction; and, (f) maintenance of a website directed to all states, including Massachusetts and Louisiana. See G.L. c. 223A, §§ 2 and 3. 8 Venue is properly laid in Middlesex County, as Defendant BSC is located in and regularly conducts business in Middlesex County. See G.L. c. 223, §1. 9 Plaintiff's claims in this action are brought solely under state law. Plaintiff does not herein bring, assert, or allege, either expressly or impliedly, any causes of action arising under any federal law, statute, regulation, or provision, Thus, there is no federal jurisdiction in this action on the basis of a federal question under 28 U.S.C. § 1331. 10. Furthermore, Defendant BSC is a citizen of Massachusetts and therefore the cause of action may not be removed. See 28 U.S.C. § 1441(b)(2). ALTERNATIVE ALLEGATIONS ll. To the extent any allegation herein is inconsistent with any other allegation, such inconsistent allegations are pled in the alternative pursuant to Mass. R. Civ. P. 8(e)(2). See also Matter of Hilson, 448 Mass. 603, 613, 863 N.E.2d 483 (2007) (holding “[m]Jodern rules of pleading permit alternative pleading.”). CORPORATE / VICARIOUS LIABILITY 12. At all times herein mentioned, Defendant BSC and any and all parent companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind, its predecessors, successors and assigns and its officers, directors, employees, agents, representatives and any and all other persons acting on its behalf, were agents, servants, partners, aiders and abettors, co-conspirators and/or joint venturers, and were at-all times operating and acting within the purpose and scope of said agency, service, employment, partnership, conspiracy, and/or joint venture and rendered substantial assistance and encouragement to each other, knowing that its collective conduct constituted a breach of duty owed to the Plaintiff. 13. There currently exists, and at all times herein mentioned there existed, a unity of interest in ownership between Defendant BSC and any anid all parent companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind, and its predecessors, successors and assigns, such that any individuality and separateness between them has ceased and these persons or entities are alter egos. Adherence to the fiction of the separate existence of these persons or entities as being distinct and separate from each other will permit an abuse of the corporate privilege and would sanction a fraud and/or would promote injustice. 14, At all times herein mentioned, Defendant BSC and any and all parent companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind, collectively, and each of them individually, were engaged in the business of, or were successors in interest to entities engaged in the business of, researching, designing, formulating, compounding, testing, manufacturing, producing, processing, assembling, inspecting, distributing, marketing, labeling, promoting, packaging, prescribing and/or advertising for sale, and selling products for use by the Plaintiff. As such, Defendant BSC and any and all parent companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind are individually, as well as jointly and severally, liable to the Plaintiff for his damages. 15. At all times herein mentioned, the officers, directors, employees, agents, and representatives of Defendant BSC and any and all parent companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, and organizational units of any kind, and any and all other persons acting on its behalf, participated in, authorized and/or directed the production and promotion of the aforementioned products when they knew, or with the exercise of reasonable care and diligence, should have known of the hazards and dangerous propensities of said products, and thereby actively participated in the tortious conduct that resulted in the injuries suffered by the Plaintiff. 16. “Defendant BSC” where: used hereinafter, shall refer to any and all parent companies, subsidiaries, affiliates, divisions, franchises, partners, joint venturers, organizational units of any kind, predecessors, successors, assigns, officers, directors, employees, agents and representatives of Defendant Boston Scientific Corporation. FACTUAL ALLEGATIONS 17. Plaintiff brings this case for serious, life-threatening injuries he suffered as a result of Defendant BSC’s surgically implanted medical device, the Greenfield filter, which was implanted into Plaintiff on or about January 26, 2012, after diagnosis and treatment of a deep vein thrombosis. The Greenfield filter was implanted by Kurt B. O’Brien, MD at Iberia Medical Center, located at 2315 E Main St, New Iberia, LA 70560. 18. Defendant BSC designs, researches, develops, manufactures, tests, markets, advertises, promotes, distributes, and sells products such as IVC filters that are sold to and marketed as permanent devices to prevent, among other things, recurrent pulmonary embolism via placement in the vena cava. One such product is the Greenfield filter. 19. Upon information and belief, on or about April 10, 1990, Defendant BSC sought U.S. Food and Drug Administration (“FDA”) clearance to market the Greenfield filter and/or its components under Section 510(k) of the Federal Food, Drug and Cosmetic Act, as amended by the Medical Devices Amendments of 1976. 20. Upon information and belief, on or about November 8, 1990, Defendant BSC obtained FDA clearance to market the Greenfield filter under Section 510(k) of the Federal Food, Drug and Cosmetic Act, as amended by the Medical Devices Amendments of 1976. 21. Section 510(k) allows marketing of medical devices if the manufacturer claims the device is substantially equivalent to other legally marketed predicate devices without formal review for the safety or efficacy of said device. The device can then be cleared by the FDA under Section 510(k). 22. An IVC filter like the Greenfield filter is a device ostensibly designed to filter blood clots (called “thrombi”) that would otherwise travel from the lower portions of the body to the heart and lungs. Defendant BSC’s Greenfield filters are marketed as being safely implanted permanently within the vena cava. 23. The inferior vena cava is a vein that returns blood to the heart from the lower portion of the body. In certain people, and for various reasons, a thrombus may travel from vessels in the legs and pelvis, through the vena cava into the lungs. These thrombi can develop in the deep leg veins. Such a thrombus is called a “deep vein thrombosis” or DVT. If the thrombi reach the lungs, they are considered “pulmonary emboli” or PE. 24. An IVC filter, like the Greenfield filter, is ostensibly designed to prevent thromboembolic events by filtering or preventing blood clots/thrombi from traveling to the heart and/or lungs. 25. The Greenfield filter is marketed and sold as a permanent filter. 26. The Greenfield filter is made of stainless steel. The filter is preloaded into a carrier capsule/sheath, which is introduced percutaneously via a catheter into the vena cava through either the femoral artery or the jugular vein. 27. The Greenfield filter utilizes a conical design that is intended to capture blood clots and/or emboli. This design consists of six (6) struts approximately 4.9 centimeters in length that, when deployed from its carrier capsule/sheath, extend down from the filter’s apex at a slight outward angel, resulting in a base diameter of approximately 3.2 centimeters. There is an opening in the center of the Greenfield filter’s apex to allow passage of a guidewire. 28. The Greenfield filter has distal anchoring hooks located on each of the six (6) struts for fixation of the filter to the vena cava wall. Four (4) of the filter’s anchoring hooks are recurved at an angel of eighty (80) degrees and the remaining two (2) anchoring hooks are recurved downward at an angel of one hundred twenty-five (125) degrees. The six (6) recurved anchoring hooks are said to stabilize the filter and to protect against penetration of the filter struts through the vena cava wall. oe 29. The following illustration shows the Greenfield filter: wenen----| Guidewire opening f -»? ceeeerr h Apex of filter \ \ eg pt Neeve i\0\/ 80° anchoring hooks 125° anchoring hooks wenee > eee ene nent \ Nee 30. On or about January 26, 2012, Plaintiff was implanted with a Defendant BSC’s Greenfield filter. The Greenfield filter placed into Plaintiff was represented to be safe for permanent placement. 31. On or about June 13, 2019, Plaintiff underwent a computerized tomography scan _ scan”) of his abdomen and pelvis. 32. On or about June 13, 2019, Plaintiff was informed that his CT scan completed that same day, revealed (1) that his Greenfield filter was tilted greater than 15 degrees with the tip projecting on the lateral right margin of the IVC, (2) the inferior struts all penetrate the margin of the IVC, (3) the 12:00 and 2:00 struts abut the posterior wall of the small bowel, (4) the 4:00 strut is in close proximity to the wall of the aorta, (5) the 6:00 strut abuts the prevertebral soft tissues and cortex of the L4 vertebral body, (6) the 8:00 strut penetrates the psoas muscle, (7) the 10:00 strut abuts a small vein and (8) mild central narrowing of the IVC is noted. 33. Plaintiff's injuries were inherently undiscoverable or objectively verifiable such that, despite Plaintiff's reasonable diligence, he was unable to discover her injuries until on or about June 13, 2019, when he was informed of the findings from his CT scan conducted. 34. At all times relevant hereto, the Greenfield filter was widely advertised and promoted by Defendant BSC as a safe and effective treatment for prevention of recurrent pulmonary embolism via placement in the vena cava. 35. At all times relevant hereto, Defendant BSC knew its permanent IVC filters were defective and knew that the defect was attributable to the design’s failure to withstand the normal anatomical and physiological loading cycles exerted in vivo. 36. Defendant BSC failed to disclose to physicians, patients, or Plaintiff that its permanent IVC filters, including the Greenfield filter, were subject to breakage, collapse, migration, and/or the appropriate degree of risk of damage to the vena cava wall. 37. At all times relevant hereto, Defendant BSC continued to promote its permanent IVC filters, including the Greenfield filter, as safe and effective, even though the clinical trials that had been. performed were not adequate to support long or short-term efficacy. 38. Defendant BSC concealed the known risks and failed to warn of known or scientifically knowable dangers and risks associated with the permanent IVC filters, including the Greenfield filter, as aforesaid. 39. Defendant BSC specifically. advertise that the Greenfield filter is “[dJesigned to maintain normal or high flow around captured clot” and that the filter’s “[rjecurved hooks are designed to provide protection against penetration.” 40. The failure of the Greenfield filter is attributable in part to the fact that Defendant BSC’s permanent IVC filters, including its Greenfield filters, suffer from a design defect causing the filters to be unable to withstand the normal anatomical and physiological loading cycles exerted in vivo resulting in the filters tilting, penetrating through the wall of the inferior vena cava, penetrating into other organs of the body, migrating and/or fracturing. 41. At all times relevant hereto, Defendant BSC failed to provide sufficient warnings and instructions that would have put Plaintiff and the general public on notice of the dangers and adverse effects caused by implantation of the Greenfield filter, including, but not limited to, the design’s failure to withstand the normal anatomical and physiological loading cycles exerted in vivo, the filter’s potential to penetrate through the inferior vena cava, the filter’s potential to penetrate into other organs, the filters propensity to migrate and/or its propensity to fracture. 42. The Greenfield filter was designed, manufactured, distributed, sold, and/or supplied by Defendant BSC, and was marketed while defective due to the inadequate warnings, instructions, labeling, and/or inadequate testing in light of Defendant BSC’s knowledge of the product’s failure and serious adverse events. 43. At all times relevant hereto, the officers and/or directors of Defendant BSC participated in, authorized, and/or directed the production and promotion of the aforementioned products when they knew or should have known of the hazardous and dangerous propensities of said products, and thereby actively participated in the tortious conduct that resulted in the injuries suffered by Plaintiff. DEFENDANT’S GREENFIELD FILTER IS A 510(k) CLEARED MEDICAL DEVICE 44, Defendant submitted premarket notification and obtained marketing clearance for its Greenfield filter from the FDA under § 510(k) of the Federal Food, Drug, and Cosmetic Act (“FDCA”). See 21 U.S.C. § 360 et seq. 45 . Pursuant to § 510(k)’s approval process, the FDA determined that Defendant BSC’s Greenfield filter was “substantially equivalent” to devices that have been reclassified in accordance with the provisions of the FDCA. Defendant BSC did not request FDA approval by way of a Premarket Approval application (PMA). 10 DISCOVERY RULE AND FRAUDULENT CONCEALMENT. 46. Plaintiff incorporates by reference the factual portion of his complaint as if fully set forth herein and additionally, or in the alternative, if same be necessary, alleges as follows. 47. Plaintiff pleads that the discovery rule should be applied to toll the running of the statute of limitations until Plaintiff knew, or through the exercise of reasonable care and diligence should have known, of facts indicating that Plaintiff had been injured, the cause of the injury, and the tortious nature of the wrongdoing that caused the injury. 48. The Greenfield filter was implanted deep within the core of the Plaintiffs body and changes in the condition of that device or the injuries associated with the filter’s failure could only be observed through medical imaging such as x-rays and CT Scans. Despite diligent investigation by Plaintiff into the cause of his injuries, including consultations with Plaintiff s medical providers, the nature of Plaintiff's injuries and damages and their relationship to the Greenfield filter and Defendant BSC’s wrongful conduct was not discovered, and through reasonable care and due diligence could not have been discovered, prior to June 13, 2019 a date within the applicable statute of limitations for filing Plaintiff's claims. Therefore, under appropriate application of the discovery rule, Plaintiffs suit was filed well within the applicable statutory limitations period. 49. Any applicable statutes of limitation have been tolled by the knowing and active concealment and denial of material facts known by the Defendant BSC when they had a duty to disclose those facts. Defendant BSC’s purposeful and fraudulent acts of concealment have kept Plaintiff ignorant of vital information essential to the pursuit of his claims, without any fault or lack of diligence on Plaintiff’s part, for the purpose of obtaining delay on Plaintiff's part in filing his causes of action. The Defendant BSC’s fraudulent concealment did result in such delay. 11 50. Defendant BSC are estopped from relying on the statute of limitations defense because Defendant BSC failed to timely disclose, among other things, facts evidencing the defective and unreasonably dangerous nature of the Greenfield filter. 51. Defendant BSC was, and remains, under a continuing duty to disclose the true character, quality and nature of the device that was implanted into Plaintiff, but instead they have concealed these facts. Defendant BSC’s conduct, as described in the complaint constitutes purposely committed conduct, which they must have realized was dangerous, heedless, and reckless, without regard to the consequences or the rights and safety of Plaintiff. COUNT I NEGLIGENCE 52. Plaintiff re-alleges and incorporates by reference each and every allegation contained in the foregoing paragraphs as though fully set forth herein. 53. At all times relevant to this cause of action, Defendant BSC was in the business of designing, developing, setting specifications, manufacturing, marketing, selling, and distributing the Greenfield filter. 54, Defendant BSC designed, manufactured, marketed, inspected, labeled, promoted, distributed and sold the Greenfield filter that was implanted into Plaintiff. 55. Defendant BSC had a duty to exercise reasonable and prudent care in the development, testing, design, manufacture, inspection, marketing, labeling, promotion, distribution and sale of the Greenfield filter so as to avoid exposing others to foreseeable and unreasonable risks of harm. 56. Defendant BSC knew or reasonably should have known that the Greenfield filter was dangerous or was likely to be dangerous when used in its intended or reasonably foreseeable manner. 12 57. At the time of manufacture and sale of the Greenfield filter (June 1995 until Present), Defendant BSC knew or should have known that the Greenfield filter: a. Was designed and manufactured in such a manner so as to present an unreasonable risk of fracture of portions of the device; Was designed and manufactured so as to present an unreasonable risk of migration of the device and/or portions of the device; Was designed and manufactured so as to present an unreasonable risk of the device tilting and/or perforating the vena cava wall; Was designed and manufactured so as to present an unreasonable risk of causing thrombosis; and/or, Was designed and manufactured to have unreasonable and insufficient strength or structural integrity to withstand normal placement within the human body. 58. At the time of manufacture and sale of the Greenfield filter (June 1995 until Present), Defendant BSC knew or should have known that using the Greenfield filter in its intended use or in a reasonably foreseeable manner created a significant risk of a patient suffering severe health side effects, including, but not limited to: fracture and embolization of filter parts; thrombosis; occlusion of the vena cava hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia and other symptoms similar to myocardial infarction; perforation of tissues, vessels and organs; and other severe personal injuries and diseases which are permanent in nature, including, but not limited to, death, physical pain and mental anguish, scarring and disfigurement, diminished enjoyment of life, continued medical care and treatment due to chronic injuries/illness proximately caused by the device; and, the continued risk of requiring additional medical and surgical procedures, including general anesthesia, with attendant risk of life threatening complications. 13 59. Defendant BSC knew or reasonably should have known that consumers of the Greenfield filter would not realize the danger associated with using the device in its intended use and/or in a reasonably foreseeable manner. 60. Defendant BSC breached its duty to exercise reasonable and prudent care in the development, testing, design, manufacture, inspection, marketing, labeling, promotion, distribution and sale of the Greenfield filter in, among others, the following ways: a. Designing and distributing a product 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; 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; Failing to use reasonable care in manufacturing the product and producing a product that differed from its design or specifications or from other typical units from the same production line; Failing to use reasonable care to warn or instruct, including pre- and post- sale, Plaintiff, Plaintiff's physicians, Plaintiffs agents or the general healthcare community about the Greenfield filter’s substantially dangerous condition or about facts making the product likely to be dangerous; Failing to perform reasonable pre- and post-market testing of the Greenfield filter to determine whether or not the product was safe for its intended use; Failing to provide adequate instructions, guidelines, and safety precautions, including pre- and post-sale, to those persons to whom it was reasonably foreseeable would prescribe, use, and implant the Greenfield filter; Advertising, marketing and recommending the use of the Greenfield filter, while concealing and failing to disclose or warn of the dangers known by Defendant BSC to be connected with and inherent in the use of the Greenfield filter; Representing that the Greenfield filter was safe for its intended use when in fact, Defendant BSC knew and should have known the product was not safe for its intended purpose; Continuing to manufacture and sell the Greenfield filter with the knowledge that the product was dangerous and not reasonably safe; 14 Failing to use reasonable and prudent care in the design, research, manufacture, and development of the Greenfield filter so as to avoid the risk of serious harm associated with the use of the Greenfield filter; Advertising, marketing, promoting and selling the Greenfield filter for uses other than as approved and indicated in the product’s label; Failing to establish an adequate quality assurance program used in the manufacturing of the Greenfield filter; and, Failing to establish and maintain an adequate post-market surveillance program. 6. A reasonable manufacturer, distributor, or seller under the same or similar circumstances would not have engaged in the aforementioned acts and omissions. 62. As a direct and proximate result of the foregoing negligent acts and omissions by Defendant BSC, Plaintiff has suffered and will continue to suffer serious physical injuries and sever pain, impairment, disability, economic loss, loss of enjoyment of life, expense of hospitalization, medical care and treatment, and other losses in an amount to be determined at trial. WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as applicable and a trial by jury. COUNT IT STRICT PRODUCTS LIABILITY - FAILURE TO WARN 63. Plaintiff re-alleges and incorporates by reference each and every allegation contained in the foregoing paragraphs as though fully set forth herein. 64. Defendant BSC designed, set specifications, manufactured, prepared, compounded, assembled, processed, marketed, labeled, distributed, and sold the Greenfield filter, including the one implanted into Plaintiff, ‘into the stream of commerce and in the course of same, directly advertised and marketed the device to consumers or persons responsible for consumers. 65. At the time Defendant BSC designed, manufactured, prepared, compounded, assembled, processed, marketed, labeled, distributed, and sold the device, placing it into the stream 15 of commerce, Defendant BSC knew or should have known the device Presented an unreasonable danger to‘users of the product when put to its intended and reasonably anticipated use. Specifically, Defendant BSC knew or should have known at the time it manufactured, labeled, distributed and sold the Greenfield filter, which was implanted into Plaintiff, that:the Greenfield filter, ‘inter alia, posed a significant and higher risk than other similar devices of device failure (fracture, migration, tilting, causing thrombosis, penetration or perforation through the vein wall and/or penetration into other veins, arteries and organs ) and resulting serious injuries. 66. Consequently, Defendant BSC had a duty to warn of the risk of harm associated ‘ with the use of the device.and to provide adequate instructions on the safe and proper use of the device. 67. Defendant BSC further had a duty to warn of dangers and proper safety instructions that it became aware of even after the device was distributed and implanted into Plaintiff. 68. Despite its duties, Defendant BSC failed to adequately warn of material facts regarding the safety and efficacy of the Greenfield filter, and further failed to adequately provide instructions on the safe and proper use of the device. 69. No healthcare provider, including Plaintiff's, patient or patient's agent would have used the device in the manner directed, had those facts been made known to the prescribing healthcare providers and/or ultimate users of the device. 70. The health risks associated with the device as described herein are of such a nature that an ordinary consumer would not have readily recognized the potential harm. 71. Plaintiff and Plaintiff's healthcare providers used the device’in a normal, customary, intended, and foreseeable manner, namely as a surgically implanted device used to prevent pulmonary emboli. 16 72. Therefore, the Greenfield filter implanted into Plaintiff was defective and unreasonably dangerous at the time of release into the stream of commerce due to inadequate warnings, labeling and/or instructions accompanying the product. 2B. The Greenfield filter implanted into Plaintiff was in the same condition as when it was manufactured, inspected, marketed, labeled, promoted, distributed and sold by Defendant BSC. TA. As a direct and proximate result of Defendant BSC’s lack of sufficient warning and/or instructions, Plaintiff has suffered and will continue to suffer serious physical injuries and sever pain, impairment, disability, economic loss, loss of enjoyment of life, expense of hospitalization, medical care and treatment, and other losses in an amount to be determined at trial. WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as applicable and a trial by jury. COUNT III STRICT PRODUCTS LIABILITY — DESIGN DEFECT 75. Plaintiff re-alleges and incorporates by reference each and every allegation contained in the foregoing paragraphs as though fully set forth herein. 76. At all times relevant to this action, Defendant BSC developed, tested, designed, manufactured, inspected, labeled, promoted, sold, and distributed into the stream of commerce the Greenfield filter, including the one implanted into Plaintiff. 77. The Greenfield filter was expected to, and did, reach its intended consumers without substantial change in the condition it was in when it left Defendant BSC’s possession. In the alternative, any changes that were made to Greenfield filter implanted into Plaintiff were reasonably foreseeable to Defendant BSC. 17 Bn 2B. The Greenfield filter implanted in Plaintiff was defective in design because it failed to perform as safely as persons who ordinarily use the product would have expected at the time of use. 79. The Greenfield filter implanted in Plaintiff was defective in design, in that its risks of harm exceeded its claimed benefits, more specifically it penetrated/perforated through the wall of Mr. Russo’s veins. 80. Plaintiff and Plaintiff's healthcare providers used the Greenfield filter in a manner that was reasonably foreseeable to Defendant BSC. 81. Neither Plaintiff nor Plaintiffs healthcare providers could have, by the exercise of reasonable care, discovered the device’s defective condition or perceived its unreasonable dangers prior to Plaintiffs implantation with the device. 82. Defendant BSC’s permanent IVC filters, including the Plaintiff's Greenfield filter, were defective by design as the design failed to withstand the normal anatomical and physiological loading cycles exerted in vivo resulting in penetration of the veins and organs and fracture during its intended use. 83. As a direct and proximate result of the Greenfield filter’s defective design, Plaintiff has suffered and will continue to suffer serious physical injuries and sever pain, impairment, disability, economic loss, loss of enjoyment of life, expense of hospitalization, medical care and treatment, and other losses in an amount to be determined at trial. WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as applicable and a trial by jury. 18 COUNT IV STRICT PRODUCTS LIABILITY — MANUFACTURING DEFECT 84. Plaintiff re-alleges and incorporates by reference each and every allegation contained in the foregoing paragraphs as though fully set forth herein. 85. Defendant BSC designed, set specifications, manufactured, prepared, compounded, assembled, processed, marketed, labeled, distributed, and sold the Greenfield filter that was implanted into Plaintiff. 86. The Greenfield filter implanted into Plaintiff contained a condition or conditions, which Defendant BSC did not intend, at the time it left Defendant BSC’s control and possession. 87. Plaintiff and Plaintiffs healthcare providers used the device in a manner that was reasonably foreseeable to Defendant BSC. 88. Defendant BSC’s IVC filters, including the Plaintiff's Greenfield filter, were deigned to be permanent devices and the filter failed to withstand the normal anatomical and physiological loading cycles exerted in vivo resulting in penetration/perforation of the Plaintiff's veins and organs as well as the and fracturing of the filter during its intended use, if the filter is properly designed to be a safe and effective medical device that can be permanently implanted in a patient, but it failed during life of its user, the particular devices seems to have failed to meet it design expectations and was manufactured in manner which rendered it defective. 89. As a result of the condition or these conditions, the product injured Plaintiff and failed to perform as safely as the ordinary consumer would expect when used in a reasonably foreseeable manner. 90. As a direct and proximate result of the Greenfield filter’s manufacturing defects, Plaintiff has suffered and will continue to suffer serious physical injuries and sever pain, 19 fo impairment, disability, economic loss, loss of enjoyment of life, expense of hospitalization, medical care and treatment, and other losses in an amount to be determined at trial. WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as applicable and a trial by jury. COUNT V BREACH OF IMPLIED WARRANTY OF MERCHANTABILITY 91. Plaintiff re-alleges and incorporates by reference each and every allegation contained in the foregoing paragraphs as though fully set forth herein. 92. At all times relevant to this action, Defendant BSC designed, researched, developed, manufactured, tested, labeled, inspected, advertised, promoted, marketed, sold, and distributed into the stream of commerce the Greenfield filter for use as a surgically implanted device used to prevent pulmonary embolisms and for uses other than as approved and indicated in the product’s instructions, warnings, and labels. 93. At the time and place of the sale, distribution, and supply of the Defendant BSC Greenfield filter to Plaintiff by way of Plaintiffs healthcare providers and medical facilities, Defendant BSC expressly represented and warranted, by labeling materials submitted with the product, that the Greenfield filter was safe and effective for its intended and reasonably foreseeable use, 94. Defendant BSC knew of the intended and reasonably foreseeable use of the Greenfield filter at the time they marketed, sold, and distributed the product for use by Plaintiff, and impliedly warranted the product to be of merchantable quality and safe and fit for its intended use. 95. Defendant BSC impliedly represented and warranted to the healthcare community, Plaintiff and Plaintiff's healthcare providers, that the Greenfield filter was safe, of merchantable 20 quality and fit for the ordinary purpose for which the product was intended and marketed to be used. 96. The representations and implied warranties made by Defendant BSC were false, misleading, and inaccurate because the Greenfield filter was defective, unsafe, unreasonably dangerous, and not of merchantable quality, when used in its intended and/or reasonably foreseeable manner. Specifically, at the time of Plaintiff's purchase of the Greenfield filter from Defendant BSC, through Plaintiffs physicians and medical facilities, it was not in a merchantable condition in that: a. It was designed in such a manner so as to be prone to an unreasonably high rate of failure, including fracture, migration, excessive tilting, causing thrombosis and/or perforation of bodily organs; It was designed in such a manner so as to result in an unreasonably high rate of injury to the organs and anatomy; and, It was manufactured in such a manner so that the Greenfield filter system was inadequately, improperly and inappropriately prepared and/or finished, so as to be prone to an unreasonably high rate of failure and/or causing the device to fail. 97. Plaintiff and Plaintiffs healthcare providers reasonably relied on the superior skill and judgment of Defendant BSC as the designer, researcher and manufacturer of the product, as to whether the Greenfield filter was of merchantable quality, safe and fit for its intended use and also relied on the implied warranty of merchantability and fitness for the particular use and purpose for which the Greenfield filter was manufactured and sold. 98. Defendant BSC placed the Greenfield filter into the stream of commerce in a defective, unsafe, and unreasonably dangerous condition, and the product was expected to and did reach Plaintiff without substantial change’ in the condition in which the Greenfield filter was manufactured and sold. 21 99. Defendant BSC breached its implied warranty because its Greenfield filter was not fit for its intended use and purpose. 100. As a proximate result of Defendant BSC breaching its implied warranties, Plaintiff has suffered and will continue to suffer serious physical injuries and sever pain, impairment, disability, economic loss, loss of enjoyment of life, expense of hospitalization, medical care and treatment, and other losses in an amount to be determined at trial. WHEREFORE, Plaintiff demands: judgment for damages, including costs, interest as applicable and a trial by jury. COUNT VI UNFAIR OR DECEPTIVE COMSUMER PRACTICES AND PUNITIVE DAMAGES ALLEGATIONS 101. Plaintiff re-alleges and ificorporates by reference each and every allegation contained in the foregoing paragraphs as though fully set forth herein. 102. At all times mentioned herewith the Defendant, BSC was engaged in trade or commerce within the meaning of M.G.L. ch. 93A. 103. The carelessness, negligence and breaches of warranty of the defendant, as more particularly set out hereinabove, constitute unfair or deceptive acts or practices within the meaning of M.G.L. ch. 93A as defined by the regulations of the offices of Massachusetts Attorney General. 104. Plaintiff is entitled to an award of punitive and exemplary damages based upon Defendant BSC’s carelessness, negligence, breaches of warranty, intentional, willful, knowing, fraudulent, malicious acts, omissions, and conduct, and Defendant BSC’s unfair or deceptive acts or practices within the meaning of M.G.L. ch. 93A §§ 9, 11 as defined by the regulations of the offices of Massachusetts Attorney General. 105. Defendant BSC had knowledge of, and were in possession of, evidence demonstrating that the Greenfield filter was defective, unreasonably dangerous, and had a 22 substantially higher failure rate than did other similar devices on the market. Despite their knowledge, Defendant BSC failed to, among other purposeful acts, inform or warn Plaintiff or her healthcare providers of the dangers, establish and maintain an adequate quality and post-market surveillance system, and recall the Greenfield filter from the market. 106. As a direct, proximate, and legal result of Defendant BSC’s acts and omissions as described herein, Plaintiff has suffered and will continue to suffer serious physical injuries and severe pain, impairment, disability, economic loss, loss of earning capacity, loss of enjoyment of life, expense of hospitalization, medical care and treatment, and other losses in an amount to be determined at trial. WHEREFORE, Plaintiff demands judgment for damages, including costs, interest as XN applicable and a trial by jury. COUNT VII NEGLIGENT MISREPRESENTATION 107. Plaintiff re-alleges and incorporates by reference each and every allegation contained in the foregoing paragraphs as though fully set forth herein. 108. At all times relevant to this cause of action, Defendant BSC was in the business of designing, developing, setting specifications for, licensing, manufacturing, preparing, packaging, maintaining, labeling, compounding, assembling, processing, selling, distributing, and marketing IVC filters. 109. At the time Plaintiff was implanted with the Greenfield filter, Defendant BSC developed, tested, designed, manufactured, inspected, labeled, promoted, sold, and distributed into the stream of commerce the Greenfield filter, including the one implanted into Plaintiff. 110. At all times relevant to this action, Defendant BSC designed, researched, developed, manufactured, tested, labeled, inspected, advertised, promoted, marketed, sold, and 23 distributed into the stream of commerce the Greenfield filter for use as a surgically implanted device used to prevent pulmonary embolisms and for uses other than as approved and indicated in the product’s instructions, warnings, a