Posts Tagged 'DePuy'

FDA panel on hip implants seeks public input

Posted April 4, 2012 in Depuy Hip Replacements | Drug and Medical Device Lawsuits | Product News and Recalls

A federal Food and Drug Administration panel examining the safety of metal-on-metal hip implants is inviting members of the public to comment on the devices.

The FDA’s Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee has scheduled sessions for June 27 and 28 to examine the question of whether the hip implants should be subject to new testing standards and review requirements before going on the market in the U.S.

The agency is responding to thousands of complaints about ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Product News and Recalls

Tags: debris, DePuy, early failure, FDA, hip implants, lawsuits, metal-on-metal

CEO may have ties to recalled implants

Posted April 4, 2012 in Depuy Hip Replacements | Drug and Medical Device Lawsuits | Product News and Recalls | Recall | Transvaginal Mesh Lawsuit

New Johnson & Johnson CEO Alex Gorsky is already facing some questions regarding his possible involvement with a recalled line of metal-on-metal hip implants, according to a recent report in the Newark Times Ledger.

Gorsky, who started with the company in 1988, is replacing outgoing CEO William Weldon.

Weldon’s departure follows a series of recalls, including medications and devices, that were very damaging for the company. But the Times Ledger article states: “Some critics have already questioned whether Gorsky, who ran the ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Product News and Recalls, Recall, Transvaginal Mesh Lawsuit

Tags: debris, DePuy, early failure, hip implants, lawsuits, metal-on-metal, transvaginal mesh

Fatal heart attack blamed on faulty approval process

Posted April 3, 2012 in Depuy Hip Replacements | Drug and Medical Device Lawsuits | Product News and Recalls

CBS Sunday Morning did a report this week spotlighting the inadequate process by which the federal Food and Drug Administration approves medical devices.

The report, titled “When Medical Implants Fail,” examined the case of 21-year-old Joshua Oukrop, who died of a heart attack in 2005.

Oukrop suffered from a congenital heart condition, and depended on a cardiac defibrillator called an ICD that was implanted in his chest to keep him alive. But after his fatal heart attack, Oukrop’s father learned that the ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Product News and Recalls

Tags: debris, DePuy, early failure, hip implants, lawsuits, metal-on-metal

FDA schedules panel for hip implant review

Posted April 3, 2012 in Depuy Hip Replacements | Drug and Medical Device Lawsuits | Product Liability | Product News and Recalls

The U.S. Food and Drug Administration has announced an official review of all-metal hip implants, in response to growing concerns about their reported early failure rates.

According to a Reuters report, the FDA has scheduled an advisory panel for June 27 and 28, which will gather input from scientists, researchers, patients and medical practitioners. Panel members will examine the question of whether medical devices should be subject to new testing standards and review requirements before going on the market in the ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Product Liability, Product News and Recalls

Tags: debris, DePuy, early failure, hip implants, lawsuits, metal-on-metal

Consultant: Scrutiny forcing FDA to tighten standards

Posted March 30, 2012 in Depuy Hip Replacements | Drug and Medical Device Lawsuits | Product Liability | Product News and Recalls | Transvaginal Mesh Lawsuit

The federal Food and Drug Administration is becoming stricter about its process for approving medical devices, according to a consultant for regulatory affairs. Those changes are coming about in response to scrutiny and criticism over a process that allows devices to be approved based on their similarity to devices already on the market.

A recent article in the Electronic Engineering Times quotes consultant Chris Henza, who spoke at the DesignMed professional conference in California.

Henza said the 510(k) process, which employs the ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Product Liability, Product News and Recalls, Transvaginal Mesh Lawsuit

Tags: debris, DePuy, early failure, hip implants, lawsuits, metal-on-metal, transvaginal mesh

Consumer Reports: Medical device approval process deeply flawed

A new issue of Consumer Reports includes an investigation into the process by which the federal Food and Drug Administration reviews medical implants for approval.

The report concludes that most medical devices aren’t tested before being implanted in patients’ bodies. The situation amounts to what’s essentially a large-scale medical experiment carried out on unwitting test subjects, made up of members of the public.

“For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...

Categories: Depuy Hip Replacements, Drug and Medical Device Lawsuits, Legal Issues, Product Liability, Product News and Recalls, Transvaginal Mesh Lawsuit

Tags: debris, DePuy, early failure, hip implants, lawsuits, metal-on-metal, transvaginal mesh

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Posts Tagged 'DePuy'

FDA panel on hip implants seeks public input

CEO may have ties to recalled implants

Fatal heart attack blamed on faulty approval process

FDA schedules panel for hip implant review

Consultant: Scrutiny forcing FDA to tighten standards

Consumer Reports: Medical device approval process deeply flawed

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