Aug 01 by GJEL

DePuy Hip Implants Cited in Report on FDA Medical Device Approval Process

The past few years have been marked by a shocking number of high-profile recalls of medical devices that were previously approved by the Food and Drug Administration’s abbreviated investigation process, dubbed 510(k). Last summer’s DePuy Orthopedics hip implant recall, for example, followed an abnormally high number of revision surgeries caused by thousands of artificial hips. Late last week, the journal Institute of Medicine released a report criticizing the FDA’s loopholes that allow medical devices to go to market if they are “substantially equivalent” to other models that have been approved in a complete FDA review.

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Jun 08 by GJEL

California Hip Implant Recall Lawsuits Continue to Target DePuy Orthopedics

It’s been nine months since DePuy Orthopedics issued a recall for its popular brand of metal-on-metal hip implant models, designed for younger patients in need of artificial hips. This week, the Sacramento Bee reports that hip implant recall lawsuits continue to pile up against the Johnson and Johnson subsidiary from patients claiming pain in the wake of hip surgeries. That’s not surprising, as hundreds of patients here in California have reported complications in the form of hip pain and metal particles leaking into their blood stream.

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Mar 09 by GJEL

DePuy Orthopedics President Resigns Following Hip Implant Recall Lawsuits

Since DePuy Orthopedics announced that it would recall its ASR hip implants last July, the Johnson & Johnson subsidiary as been barraged by bad news and even worse public perception. The metal-on-metal hip implant models were designed to be more sturdy, and were marketed toward a younger audience. But in reality, the hip implant’s metal construction was found to have an astronomical 13 percent failure rate, as many patients complained of chronic pain and abnormal levels of cobalt and chromium in their blood streams. Facing more than 500 state and federal hip implant lawsuits, J&J announced this week that DePuy’s president David Floyd will step down later this month.

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Mar 04 by GJEL

California DePuy Hip Implant Lawsuits May Come to San Francisco

Since DePuy Orthopedics announced a recall of one of its popular hip implant models last August, lawsuits have piled up against the Johnson & Johnson subsidiary. Most recently, it looks like a large number of these DePuy hip implant lawsuits are coming to San Francisco, as Superior Court Complex Litigation Judge Richard Kramer said San Francisco would be the best setting for state lawsuits against DePuy, reports the San Francisco Daily Journal. On favoring San Francisco over the larger Los Angeles court system, Kramer said “I wouldn’t assign something to San Francisco if I thought I couldn’t do it.”

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Feb 22 by GJEL

DePuy Hip Implant Short Approval Process Faulted for Major Recalls

Even after a heavy year for medical product recalls, medical device companies have vamped up their criticism of government regulation, and are actively seeking to undermine efforts to make safer products. Last week, for example, the New York Times mentioned DePuy faulty hip implants in an article about companies who say the safety regulations will send business overseas. But a study released this week has shown that the Food and Drug Administration used an abbreviated approval process for more than 70 percent of the products that were recalled over the past five years. For good reason, this study is likely to dampen any hopes for decreased FDA scrutiny.

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Feb 14 by GJEL

Medical Companies Seek Lax Regulation on Devices Like DePuy’s Faulty Hip Implants

It’s true: regulation is often not good for business. The American food industry no doubt took a hit when the government decided to test products for poisons before they hit grocery stores. But we accept those regulations because we know it’s best for public safety. Last week, the New York Times name-checked DePuy Orthopedics and its faulty hip implants in a report on medical device companies that are increasingly critical of government regulation of their products. These companies say US regulation will cause the industry to lag behind nations with more relaxed laws, with little mention of the dangerous side effects associated with lesser regulation.

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