Daily Archives: June 25, 2005

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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Cancer Groups Call for E-cigarettes Regulation/Research

Two-Leading-Cancer-Groups-Issue-Call-for-Regulation-of-E-cigarettes-and-Research-on-Health-Risks

The American Society of Clinical Oncology & the American Association for Cancer Research called for government regulation & research of e-cigarettes on health effects.

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Exposure to Common Pesticide May Increase ADHD Risk

Exposure to Common Pesticide May Increase ADHD Risk

A new study has found that exposure to a common household pesticide may increase the risk of attention deficit hyperactivity disorder (ADHD) in children.

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Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.

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Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions

Yet another study is pointing to potential dangers posed by metal-on-metal hip implants. This time, an article published in the Journal of Arthroplasty is reporting corrosion in the head taper junction was more likely to occur in patients with 36-mm diameter metal-on-metal hip replacement, compared to those with the same ...

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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British Recall of Smith & Nephew Renasys Wound Care System

British Recall of Smith & Nephew Renasys Wound Care System for Infection Risk

The MHRA announced the recall of Smith & Nephew Renasys wound care devices - risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds.

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THE PROBLEM OF BOGUS DRUGS BECOMING A SERIOUS HEALTH THREAT AS CANADIAN AUTHORITIES INVESTIGATE FIVE DEATHS LINKED TO FAKE DRUGS DISPENSED BY PHARMACY IN HAMILTON, ONTARIO

As previously reported, the FDA and federal law enforcement authorities are becoming increasingly concerned with the sale of counterfeit drugs over the Internet and at pharmacies in Mexican border towns. Although the operators of several Internet (and mail-order) operations have … Continue reading

Posted in Legal News |

FDA NOTIFIES PUBLIC OF NATIONWIDE RECALL OF ENCLOSED BED SYSTEMS FROM VAIL PRODUCTS INC. FOR ASPHYXIATION RISK

On Friday, the FDA issued a public notification that Vail Products, Inc., Toledo, Ohio, has initiated a nationwide recall of approximately 5,000 "enclosed" bed systems. The enclosed bed systems have been found to cause patient entrapments, resulting in severe neurological … Continue reading

Posted in Defective Products |

THE CONSUMER PRODUCT SAFETY COMMISSION (CPSC) AND POLARIS INDUSTRIES ANNOUNCE EXPANDED RECALL OF SELECT MODEL YEAR 2004.5 AND 2005 ATVs FOR FIRE HAZARD

The CPSC and Polaris Industries of Medina, Minnesota, announced the voluntary product safety recall of an additional 45,000 Polaris All Terrain Vehicles made in the United States. Customers should stop using the product immediately. This expansion of the 15,000 Polaris ATV … Continue reading

Posted in Defective Products |

THE NEWS KEEPS GETTING WORSE FOR GUIDANT AS IT ANNOUNCES AN ADDITIONAL 46,000 DEFIBRILLATORS HAVE POTENTIALLY SERIOUS ELECTRICAL DEFECTS

On May 24, Guidant disclosed it had waited three years before disclosing it had been aware of an electrical problem that had caused some 28 of 28,900 Ventak Prizm 2 DR defibrillators to malfunction. One death that of a 21-year-old … Continue reading

Posted in Defective Products |

FDA NOTIFIES PUBLIC OF NATIONWIDE RECALL OF ENCLOSED BED SYSTEMS FROM VAIL PRODUCTS INC. FOR ASPHYXIATION RISK

On Friday, the FDA issued a public notification that Vail Products, Inc., Toledo, Ohio, has initiated a nationwide recall of approximately 5,000 "enclosed" bed systems. The enclosed bed systems have been found to cause patient entrapments, resulting in severe neurological … Continue reading

Posted in Defective Products |

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