FDA Clearance Loophole may have let Dangerous IVC Filter on the Market

Posted by Terry Boyd on April 7, 2016 | Categories: Class Action Post

It can take awhile for a drug or medical device to gain approval through the Food and Drug Adminstration. However, there is a fast track that can be utilized. It’s called the 501(k) Clearance Loophole. This fast tracked approval process might have a role in medications and devices that have recently come under scrutiny and face class-action lawsuits. The IVC filter is one such device.

An IVC filter is a device that is designed to fit into the inferior vena cava artery. The purpose of the device is to catch and stop blood clots from the legs from making it to the heart and lungs, causing pulmonary embolism.

Many patients have experienced the filter itself migrating to other parts of their internal organs. Some even make it as far as the heart. Some become so embedded into organ tissue that removal of the filter is impossible.

The FDA recently released an edict giving doctors a time line for removing the devices. For an overwhelming majority of patients, removal has not been an option. They are forced to live with the device remaining within their body.

Various IVC filters have been the target of lawsuits. Two Canadian lawsuits involving Celect and Gunther Tulip filters have been filed. U.S. Lawsuits have been filed against the C.R. Bard IVC filter and the Bard G2 IVC filter. Some of the filters were marketed and manufactured by Cook Medical.

The Canadian lawsuits against Cook Medical maintain that the company failed to warn patients of the potential for fracture and migration of the device.

A study appearing in the April 2013 edition of JAMA suggested that only about 10% of IVC filter retrieval attempts are actually successful.

If you have suffered injury or an adverse health event due to the implantation of an IVC filter, you may be entitled to compensation. Contact the “Strong Arm” attorneys at John Foy & Associates. Our attorneys will work to get you the compensation you deserve. Contact us today.

Nearly $1 Billion in Settlements and Verdicts

$75,000 While traveling North on GA 92, our client Q.E. was struck in the rear while slowing for traffic. Our client suffered back injuries.

$100,000 Our client R.S. was a passenger in a vehicle traveling West Bound on Akers Mill Road at Powers Ferry Road when a Dodge Dakota turned left in front of the vehicle causing a collision. Our client was transported by Metro Ambulance to Southern Regional with back injuries.

$100,000 While traveling South on GA 61 South of Rock Creek Drive a truck exited the Murray County Landfill turning into the path of our client E.G. upon impact the truck spun striking our clients vehicle sending her off the left side of the roadway where she struck a guardrail with her front-end coming to an uncontrolled rest. Our client was transported by ambulance with multiple injuries where immediate surgery was necessary.

$100,000 While traveling on US Highway 80 at Ladonia Drive our client W.C. was struck by a vehicle failing to yield the right of way. Our client was transported by CARE Ambulance to Columbus Medical Center with severe injuries.

$105,000 Our client S.W. was a passenger in the rear seat of a vehicle that was traveling Northwest on North Druid Hills Road entering the intersection at LaVista Road. The driver of the vehicle veered out of its lane leaving the roadway as it was exiting the intersection the vehicle struck a traffic light pole, which spun the vehicle around coming to a final rest. Our client was seriously injured and was transported to Grady Memorial Hospital.

$125,000 While traveling North Bound on Burnt Hickory Road a van pulled into our clients J.R.’s lane causing an immediate impact. Our client was transported to Cartersville Medical Center with injuries to the lower extremities.

$128,500 While traveling East on Highway 138 an SUV turned directly in front of the vehicle in which our client D.C. was a passenger. Our client was transported by MED 5 to Atlanta Medical Center with chest, back and leg injuries.

$150,000 While stopped at a red light waiting to turn left at 10th Street and Monroe Drive our client D.W. was struck by a tractor trailer that was turning right onto Monroe Drive. The tractor trailer’s left rear side struck our clients vehicle on the right side. Our client suffered shoulder and lower back injuries.

$174,000 While traveling North on Highway 92 our client S.P. slowed down for a vehicle turning left onto Seay Road and was struck in the rear from behind by a vehicle that was traveling at a high-rate of speed. Our client S.P. was transported by MEDIC 42 to Piedmont Fayette Hospital with injuries.

$200,000 When traveling on Peachtree Industrial Boulevard our client E.A.’s vehicle broke down at the intersection of Jones Mill and Peachtree Industrial Boulevard. Our client E.A. exited the vehicle and was standing next to it when at a high rate of speed a vehicle came from behind swerving and struck our clients body. Our client was transported to GMC Lawrenceville for injuries.

$225,000 While our client C.L. was driving in the center lane a tractor trailer attempted to change lanes into the center lane striking our client. Our client was treated for injuries.

$225,000 While traveling North on Hickory Flat Highway our client J.P. stopped from traffic and was rear-ended by another vehicle. Our client suffered neck and back injuries.

$250,000 While traveling as a passenger South on Helen Highway a vehicle turned in front of the vehicle that our client B.W. was a passenger, pushing the vehicle into a stopped car. Our client was transported by ambulance to NE Georgia Medical Center with shoulder and abdominal internal injuries.

$250,000 While traveling North on Georgia 61 in the left lane our client J.H. was struck by a vehicle turning left that pulled out into his path. Our client’s vehicle rotated approximately 180 degrees counterclockwise and then backwards approximately 99’5” before traveling onto the East shoulder coming to a rest facing West. Our client was transported by Emory Life Flight with multiple internal injuries.

$265,000 While traveling on 285 North, our client K.H. was struck by a vehicle spinning out of control. Client suffered shoulder and neck injuries.

$270,000 While traveling South on GA 87, our client stopped to make a left turn. Upon stopping, a tractor trailer traveling behind was unable to stop striking our client in the rear. After impact our client came to an uncontrolled stop South of the impact area. Our client was transported by EMS Air to Macon Medical with Spinal Injuries.

$280,000 While traveling EB on Upper Riverdale Road our client was stopped at a light that had turned red. Upon stopping our client was rear-ended by a tractor trailer. Our client was transported to Southern Regional Medical Center due to head, neck and back injuries.

$300,000

Our client B.W. was driving East Bound on Honey Creek Road passing through the intersection at I-20 when a vehicle pulled out of a parking lot at the corner of the intersection and struck our client’s vehicle. Our client suffered back injuries that required surgery.

$300,000 While traveling East on I-20 in the middle lane a vehicle merged left into our client E.D.’s vehicle causing him to swerve left losing control, hit another vehicle and a guardrail. Our client was transported by Life Flight to Atlanta Medical Center with multiple injuries.

$300,000 While traveling N on SC187, our client was a passenger in a vehicle that had stopped for traffic and a vehicle that was driving too fast for conditions swerved and hit the vehicle in which our client was a passenger. Our client was transported by ambulance to AnMed Health Emergency Department with injuries to her head, neck, shoulder and ankle.

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