Senator Al Franken Weighs in on Medtronic/FDA Problems

Posted by Terry Boyd on April 19, 2016 | Categories: Auto Accidents

The Medtronic company has been in some hot water lately. A recently published article in the Minneapolis Star Tribune failed to report adverse events attributed to the use of their Infuse Bone Graft device to the FDA. Now, a United States senator is questioning the company and the Food and Drug Administration about the events.

U.S. Senator Al Franken recently asked Medtronic Inc for more detailed information about the adverse events reported by patients after being implanted with their device.

In the article for the Minneapolis Star Tribune, the author claimed that the company studied the outcomes of some 3,600 patients who received the bone graft. The study returned more than 1,000 adverse events.

Manufacturers of medical devices and medications are required to report adverse events to the FDA within 30 days. The article alleges that Medtronic hid the results of the study and did not release them until 5 years later.

Officials for Medtronic told the Star Tribune that the report had been misfiled internally. They additionally stated that it was reported to the FDA once it was discovered.

Franken, who is a senator from Minneapolis, has asked Medtronics to produce information about what they reported to the FDA and when. He also inquired as to how staff are trained to report adverse events.

In response to the article published in the Star Tribune, Medtronic stated that they concluded that the adverse events seen in the report were consistent with already known outcomes.

Franken also involved the FDA. He asked FDA commissioner Dr. Robert Califf to provide more data on the types of injuries captured in the previously unsubmitted data.

Franken was also curious as to whether the injuries were attributed to approved uses versus non-approved uses of the Infuse bone graft.

If you have experienced complications or injury due to the use of an Infuse bone graft, you may be entitled to compensation. Contact the law offices of John Foy & Associates. The “Strong Arm” attorneys will work to get you the compensation you deserve. Contact us today.

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$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 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.

$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.

$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 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.

$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.

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