Posts Tagged ‘ medical devices ’

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 »

New Jersey Goes After Rampant Conflicts of Interest in Medical Device Industry

May 11th, 2009. By Evelyn Pringle

On May 5, 2009, New Jersey Attorney General, Anne Milgram, announced that the State had entered into a settlement agreement with medical device maker Synthes, Inc to resolve allegations that Synthes failed to disclose financial conflicts-of-interest among doctors who conducted clinical testing on its products.

In announcing the settlement, Milgram said it is vital that the medical device industry change the way it approaches clinical testing. “We cannot allow financial conflicts-of-interest to infect the clinical trial process. It is a betrayal of the public trust, and has the potential to jeopardize patient well-being,” she said in a press release.

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Tags: conflicts of interest, medical devices
Posted in Drugs/Medical | No Comments »