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Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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Fracking Releasing Hazardous Chemicals into Local Waterways

Fracking Releasing Hazardous Chemicals into Local Waterways

Study shows two hazardous chemicals—ammonium & iodide—are being released & spilled into Pennsylvania and W.Virginia waterways from fracking operations in Marcellus shale.

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Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims

The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...

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Louisiana Whistleblower Lawsuit Revived

Louisiana Whistleblower Lawsuit Revived

A state appeals court in Louisiana has ruled that a former employee of Rapides Parish Coliseum can proceed with a whistleblower lawsuit against the Coliseum Authority.

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Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.

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Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier

In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...

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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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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

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Stryker Recalls Orthopedic Devices that May Have Been Damaged in Shipping

Medical device maker Stryker Corporation is recalling nearly 17,000 orthopedic implant devices because of potential of damage during shipping.

The Food and Drug Administration (FDA) notice lists five devices included in the recall: the rHead lateral stem and Recon radial implant, both for replacement of the proximal end of the forearm’s radius bone; the uHead ulnar implant and Sigmoid Notch radial plate, both for replacement of the distal radioulnar joint; and the Radio-Capitellum to improve elbow function, Medscape reports. Continue reading

Posted in Defective Medical Devices |

FDA Strengthens Heart Attack and Stoke Warnings for Nonsteroidal Anti-inflammatory Drugs

The Food and Drug Administration (FDA) has strengthened existing warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) Drug Facts labels to indicate that the drugs can increase the risk of a heart attack or stroke, which can lead to death.

These side effects can occur as early as the first weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Aspirin is also an NSAID, but the revised warning does not apply to aspirin.) The OTC drugs covered by the revised warning in this group are used for the temporary relief of pain and fever and the prescription drugs are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple medicines with the same active ingredient. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals |

FDA Warns of Danger of Giving Codeine Cough-and-Cold Medicines to Children

The Food and Drug Administration (FDA) is investigating the potential risks of using medicines with codeine to treat coughs and colds in children and has issued a Drug Safety Communication about such medicines. There is a potential for serious side effects, including slowed or difficult breathing.

Codeine is a type of opioid used to treat mild to moderate pain and reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines, according to the FDA. In April, the European Medicines Agency (EMA) announced that codeine must not be used to treat coughs and colds in children younger than 12. The EMA also said codeine is not recommended for children and teens between 12 and 18 who have breathing problems, such as asthma. The FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Continue reading

Posted in Health Concerns, Pharmaceuticals |

CarMax Accused of Selling Cars with Lethal Safety Defects; Senator Seeks Tighter Regulation

U.S. Sen. Richard Blumenthal has proposed new legislation to regulate the sale of used cars with unrepaired recalls with what he says can be lethal safety defects.

Blumenthal, the senior senator from Connecticut, is concerned about cars sold by CarMax. “CarMax advertises that all its vehicles must pass a rigorous ‘125 point inspection,’ but no inspection that routinely ignores outstanding safety recalls can be called ‘rigorous,'” Blumenthal said, according to television station WFSB. “Regardless of whether they are buying a new or used car, all consumers deserve to know they are buying a safe car.” Continue reading

Posted in Defective Products, Motor Vehicles, Product Recalls, Recalled Vehicles |

U.S. Representative Says CDC Withheld Data Linking MMR Vaccine and Autism

CDC Withheld Data Linking MMR Vaccine & Autism

CDC Withheld Data Linking MMR Vaccine & Autism


Florida U.S. Rep. Bill Posey recently presented evidence to Congress that the Centers for Disease Control and Prevention (CDC) destroyed data linking the MMR vaccine, (measles, mumps and Rubella) and autism.

Posey based his charges on the allegations from Dr. William Thompson, a 17-year veteran of the CDC, who became a whistleblower and charged that he was pressured to manipulate data in order to conceal possibly harmful side effects of the MMR vaccine, WND (WorldNetDaily) reports. Continue reading

Posted in Health Concerns | Tagged , , , , |

Congresswoman Calls for FDA Regulation after Veteran is Injured by Exploding E-Cigarette

Congresswoman Calls for E-Cigarette FDA Regulation

Congresswoman Calls for E-Cigarette FDA Regulation


The use of electronic cigarettes has been on the rise in their short time on the market. While they are touted as being a safer alernative to traditional cigarettes and as a cessation tool, there are still public health and safety concerns surrounding the products, especially given the lack of oversight from the U.S. Food and Drug Administration (FDA). The agency is currently planning on issuing regulations, and as that process moves forward a congresswoman is calling for the devices to be regulated the same as normal cigarettes.

According to Plymouth-Canton Patch, Michigan Congresswoman Debbie Dingell (D-Dearborn) is asking the FDA to place the same restrictions on e-cigarettes as regular cigarettes. The congresswoman was prompted by a veteran who was seriously injured by an exploding vapor pen. “Your natural thought is, is it safe to inhale? But second, is it safe to light up? Could it explode? And most people … didn’t think they had to worry about it exploding and I was actually stunned to hear of the number of incidents that have occurred across the country,” Dingell said to WWJ/CBS Detroit. Continue reading

Posted in Legal News | Tagged , , , , |

New Zealand Investigation Reveals Significant Defects in Metal-on-Metal Hip Implants

Significant Defects in Metal-on-Metal Hip Implants

Significant Defects in Metal-on-Metal Hip Implants


An investigation by the New Zealand Herald newspaper reveals significant defects in about half of the metal-on-metal (MoM) hip implants received by thousands of New Zealanders about a decade ago.

There is no official record of the injuries suffered by people who received the faulty hips because the recall and monitoring of the devices are done by medical companies and surgeons, not by the government health agency, the Herald reports. Continue reading

Posted in Defective Medical Devices, Health Concerns, Metal Hip Implants | Tagged , , , , |

Cleveland Clinic Heart & Vascular Team Warns About Food Additive Consumption

Cleveland Clinic Warns About Food Additive Consumption

Cleveland Clinic Warns About Food Additive Consumption


Many Americans spend up to 90 percent of their food budget on processed foods, which are more convenient and can be less expensive than fresh foods, but health and nutrition experts say such foods may be less healthy than fresh foods.

Dietitian Kate Patton and intern Sara Saliba of the Cleveland Clinic’s Section of Preventive Cardiology and Rehabilitation explain the concerns. “Processed food has been altered in some way from its natural state,” Patton says. Often, processed foods have additives—substances that add color, enhance flavor or increase the product’s shelf life, for example. “Additives are not necessarily bad,” Patton says. “Most foods do require additives to prevent spoilage and maintain their nutritional value.” Continue reading

Posted in Food Poisoning, Health Concerns, Toxic Substances | Tagged , , , , , |

Amgen Agrees to $71 Million Settlement in Allegations of Unlawful Promotion of Aranesp

Amgen Agrees to $71M Settlement

Amgen Agrees to $71M Settlement


Amgen Inc. has agreed to a $71 million settlement with 48 state attorneys general who accused the drug maker of unlawfully marketing its anemia drug Aranesp and plaque psoriasis drug Enbrel, for uses beyond the scope of their Food and Drug Administration’s approvals.

The Thousand Oaks, California-based drug maker agreed to a consent judgment last Tuesday, Law360 reports. New York Attorney General Eric Schneiderman and the others said Amgen has marketed Aranesp for cancer-related anemia without FDA approval and promoted Enbrel to treat mild plaque psoriasis — an auto-immune problem that causes the flaking and scaling of skin— though the drug is approved only for more serious forms of the condition, according to a statement issued by Schneiderman. Continue reading

Posted in Legal News, Pharmaceuticals | Tagged , , , |

Medical Scope Makers Warned in the Wake of Superbug Outbreaks

Scope Makers Warned in the Wake of Superbug Outbreaks

Scope Makers Warned in the Wake of Superbug Outbreaks


Three manufacturers of duodenoscopes—specialized medical scopes—have received Food and Drug Administration (FDA) warning letters because the scopes have been linked to outbreaks of a deadly “superbug.”

The FDA says the companies failed to adequately report problems with the devices and, in some instances, failed to ensure the scopes could be cleaned properly between uses, the Washington Post reports. The warning letters were sent to Olympus Medical Systems, Fujifilm Corp., and Pentax Medical. Continue reading

Posted in Defective Medical Devices, Health Concerns | Tagged , , , , , |

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