Drug and Medical Device Lawsuits

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

Study: Conflicts of interest no concern for many doctors

Posted April 3, 2012 in Drug and Medical Device Lawsuits | Product News and Recalls | Yaz

A recent study found that about 35 percent of physicians do not completely agree that they should tell patients about their financial relationships with drug and medical device companies, according to Medscape Today News.

The study, published in the February issue of Health Affairs, drew on a 2009 survey of almost 1900 physicians.

The article quotes medical ethicist Linda Emanuel, MD, PhD, of Northwestern University in Evanston, Illinois, as saying: “We need to do some serious interventions to return to our ethical ...

Categories: Drug and Medical Device Lawsuits, Product News and Recalls, Yaz

Tags: Bayer, Beyaz, blood clots, drospirenone, lawsuit, Ocella, pulmonary embolism, Yasmin, Yaz

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

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Drug and Medical Device Lawsuits

FDA panel on hip implants seeks public input

CEO may have ties to recalled implants

Fatal heart attack blamed on faulty approval process

Study: Conflicts of interest no concern for many doctors

FDA schedules panel for hip implant review

Consultant: Scrutiny forcing FDA to tighten standards

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