Posts Tagged ‘ Medtronic ’

Medtronic CD Horizon Spinal System: Buyer Beware

September 28th, 2009. By LucyC

MedTronic's spinal implant recall was lesson learned We’re approaching the two year anniversary of the FDA recall of all lots of the MedTronic CD Horizon Spinal System Agile Dynamic Stabilization Device. So why bring it up? Well, in light of the seemingly endless number of defective products that make their way onto the market every year, the CD Horizon provides a cautionary tale.

The device was developed to relieve spinal pain, and was surgically implanted. Sadly, the CD Horizon spinal system was prone to failure, causing patients more pain rather than less.

The device was approved on the strength of risk analyses by Medtronic which allegedly claimed

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Tags: CD Horizon Spinal System, Medtronic
Posted in Drugs/Medical | No Comments »

Calls for End to Medical Device Maker Immunity

May 13th, 2009. By Evelyn Pringle

On May 12, 2009, the House Energy and Commerce Subcommittee on Health held a hearing on the Medical Device Safety Act of 2009. HR 1346 would overturn the February 2008 Supreme Court decision that, for the first time, denied patients the right to sue device makers for compensation when injured by certain medical devices.

In the case of Riegel v Medtronic, the court ruled that a device maker cannot be sued under state law by patients alleginginjury from a device that received marketing approval from theFDA.

“The Court’s decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings,” according to a March 5, 2009 press release by Representatives Frank Pallone, Jr (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, issued when introducing the Medical Device Safety Act of 2009.

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Tags: immunity, medical devices, Medtronic
Posted in Defective Products | No Comments »