Inferior
Vena Cava (IVC) filters are popularly used for the treatment of
patients who suffer from pulmonary embolism. Patients with hip and knee
replacement surgeries have been popularly treated with this implant
surgery however, there have been reports which shows how they are linked
with various health complications.
The
first FDA warning was issued in 2010 against Bard IVC Filters which
notified the medical professionals as well as the public about the
possible filter injuries. At that time, there were 921 adverse event
reports about the injuries or death in between a span of 2005 and 2010.
What are the major complications that are discussed in ivc filter lawsuit settlements?
- Hemorrhage
- Internal organ damage
- Acute pain
- Punctured blood vessels
- Death
- Embolization
The
risks associated with IVC filter migration have been a serious worry
for the physicians. As these filters are flexible with temperature
changes, body temperature fluctuations can adapt the device's design and
ultimately cause it to separate. The struts are carried along with the
blood flow, which then perforates the organ or the nerve walls along its
path.
- Organ or nerve perforation
The
filter can cause life risking situations during implantation, general
presence, and removal of the IVC filter. Retroperitoneal hematoma,
gastrointestinal bleeding, sepsis and air embolism are some of the major
health risks associated with the perforation.
- IVC Filter Thrombosis
Pulmonary
embolism, lower back pain, inflammation, painful swellings in thighs
and legs and fever are the associated signs of filter thrombosis.
What do the attorneys claim for?
In the ivc filter lawsuit settlements, the attorneys fight for their claimants to get the following:
- Ongoing and future medical costs which caused injuries
- Past and future expenses required in the treatment and recovery process
- Loss of wage
- Inability or reduced capability to earn in future
- Degradation in the regular quality of life
- Punitive damages, if the court finds appropriate
The
risks associated with IVC filter migration has been always cited in the
FDA warnings. The 2014 FDA Bard IVC filter warning provides information
on the safety and effectiveness of the implant. Bard’s retrievable IVC
filters were passed through a fast track approval process known as 510k
in 2002.
In 2015, Bard was hit by a warning letter from the FDA citing how it completely violated the protocols by:
- misbranding
- quality system violations
- quality system regulation violation
- MDR violations (that is failing to rely to the reports to the FDA regarding device failure, injury, death)
Cook
Medical and Bard, the two major manufcturers of the IVC filter have
faced thousands of lawsuits in the federal court. Most recently, a jury
awarded $3.6 million to a victim who claimed her IVC filter broke and
injured her.
The multidistrict litigation filed through the ivc filter lawsuit settlements accuse the device makers of the following:
- severity of injuries caused with the IVC filter implant surgery
- quality of filter used in implantation
- check if the injuries resulted in permanent disability
- economic damages incurred for hospitalization, treatment, as well as lost income
- projected rehabilitation expenses such as those of in-home nursing care, future corrective surgeries or if they require any other recurring medical treatments
- punitive damages as found by the judge
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