Inferior vena cava filter (IVC filter) is implanted in inferior vena cava just below the kidneys to capture blood clots, preventing them from reaching the heart and lungs, thereby safeguarding against life-threatening pulmonary emboli (PE). Patients who implanted the filter faced severe internal injuries. Currently, there are more than 9000 lawsuits filed against the manufacturers, making it one of the most defective implants of the country.
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2. What Is An IVC Filter?
Inferior Vena Cava Filter (IVC Filter) is a medical device implanted in the inferior vena cava just below
the kidneys to capture blood clots, preventing them from reaching the heart and lungs thereby,
safeguarding against life-threatening pulmonary emboli (PE). Earlier inferior vena cava filter (IVC filter)
was known as the Greenfield filter.
Interventional radiologists or vascular surgeons have the right to deploy the IVC filter. Patients who
don't have any effect of anticoagulation therapy need to use an IVC filter.
IVC filters were cleared for use through the 510(k) process since 1976. However, in 2010, the FDA
issued device safety communication after reviewing more than 900 adverse events related to the
devices over a period of five-years.
3. How Does It Work?
The blood flows past the filter when placed in the inferior vena cava. It prevents the blood
clots from reaching the heart and lungs, which prevents a pulmonary embolism.
Manufacturers Of IVC Filter
C.R. Bard
Rex Medical
Cook Medical
Boston Scientific
B. Braun Medical
Rafael Medical
Cordis Corporation
Johnson & Johnson
Argon Medical Devices
4. Devices Reported To Be Faulty
Recovery Filter
G2 Filter
G2 Express
Gunther Tulip
Greenfield Filter
Celect Filter
The complications related to IVC filters are with reference to those that occur during placement,
those problems with the filters that happen after placement, and complications during retrieval
or removal of the filter.
5. Serious Alleged Injuries Include
Device-Associated Morbidity
Device Migration
Recurrent DVT/PE
Thrombotic Complications
Insertion-Site Thrombosis
Filter Fracture
Perforation Of The Vena Cava
Filter Embolization
Vena Cava Thrombosis
Death
6. FDA Regulations
On August 9, 2010, an Advisory Letter was released by the FDA,
recommending health care providers to consider removing the temporary
filter as soon as protection from a PE is no longer needed.
The FDA received more than 6,000 adverse event reports related to inferior
vena cava filter side effects.
In 2005, the Greenfield vena cava filter produced by Boston Scientific was
recalled by the FDA, which was terminated in November 2006.
7. FDA Regulations
On May 6, 2014, the FDA recommended the removal of temporary IVC
filters within 29-54 days through the release of another Advisory letter.
In 2015, the FDA sent a warning letter to C.R. Bard Inc. for violations and
failure to warn of its IVC filter devices.
In 2013, the FDA announced a recall mentioning a labeling correction of a
retrievable IVC filter manufactured by Cordis Corporation.
9. As of October 2018, 9,000 IVC filter lawsuits have been
filed in the federal court over allegations of design and manufacturing
defects, failure to adequately warn consumers of the device-related
health hazards, breach of implied warranty on the medical device,
and negligent conduct on the part of the manufacturing
and/or marketing company.
IVC Lawsuit Status
Two MDLs have been formed for consolidated pretrial proceedings.
Allegations
MDL Status:
10. IVC Lawsuit Status
MDL No.: 2570
(IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices,
and Products Liability Litigation)
Formed in October 2014.
The plaintiffs allege defects, misrepresentation in marketing, and failure to
warn doctors and patients.
The cases are coordinated in the Southern District of Indiana and assigned
to Judge Richard L. Young and Magistrate Judge Tim A. Baker.
11. IVC Lawsuit Status
MDL No.: 2641
(IN RE: Bard IVC Filters Products Liability Litigation)
Formed in August 2015.
The plaintiffs allege negligence to warn patients and doctors about the device
defect, misrepresentation in marketing, and device fracture in their complaints.
The cases are coordinated in the U.S. District Court District of Arizona presided
by U.S. Federal Judge David G. Campbell.
Class action suits have also been filed against Bard accusing the company of negligence,
concealment, and misrepresentation of data concerning the safety of its filters.
12. Important Verdicts & Settlements
March 2018: Plaintiff Sherr-Una Booker was awarded $3.6 million by an Arizona jury on
March 30, 2018, as C.R. Bard was found liable for failing to warn doctors and public
about their Bard G2 blood filter. This was the first bellwether trial against Bard.
March 2018: The second bellwether trial against Cook in the U.S. District Court for the
Southern District of Indiana was dismissed on April 30, 2018, as the statute of limitations
expired on those claims.
May 2018: A Houston firefighter, Jeff Pavlock, was awarded more than $1.2 million by a
Texas jury for the lawsuit filed against Cook Medical LLC involving a Celect IVC filter. This
case was not part of the federal bellwether.
June 2018: The second bellwether trial involving Plaintiff Doris Jones of Georgia and C.R.
Bard's Eclipse IVC Filter ended in the defendant's favor on June 1, 2018, as the Arizona
jury found that adequate warning was provided to doctors regarding the possible ad-
verse effects of the IVC filter.
13. Important Verdicts & Settlements
December 2018: On December 5, Judge Richard L. Young granted summary judgment to
Cook Medical Inc. on failure-to-warn claims in an IVC filter bellwether case filed by Georgia
resident Tonya Brand.
February 2019: On February 1, 2019, an Indiana federal jury awarded $3 million in the
third bellwether case involving Cook Medical's Inferior Vena Cava (IVC) filter injuries,
finding that the company's product was the reason for a woman's complications.
October 2019: A Philadelphia jury awarded plaintiff Tracy Reed-Brown more than $33
million, who was injured as a result of a defectively designed blood filter.
October 2018: C.R. Bard prevailed in the fourth bellwether trial Hyde v. Bard after the
third bellwether was dismissed as the statute of limitations expired on those claims.
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