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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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Study Links Liquid in E-Cigarette to Viral Infections

Study Links Liquid in Electronic Cigarette to Increased Risk of Viral Infections

The National Jewish Health study, links the liquid used in e-cigarettes to a higher risk of respiratory viral infections, whether the liquid contains nicotine or not.

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Fracking Should be Kept 600m From Aquifers, Study Says

Fracking Should be Kept 600m From Aquifers, Study Says

New research on the safety of hydraulic fracturing (fracking) suggests new wells should not be dug within 600 meters of a water aquifer because underground fractures can extend about that far from a dug well. According to a report from UK’s The Guardian newspaper, researchers and geologists at Durham University have ...

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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FDA Class I Recall for DePuy Synthes Jaw-Stabilizing Device

Johnson & Johnson’s DePuy Synthes unit initiated a recall of its jaw-stabilizing device that the Food and Drug Administration (FDA) placed in its most serious Class I recall category. DePuy’s Craniomaxillofacial Distraction System lengthens and stabilizes bone in the lower … Continue reading

Posted in Defective Medical Devices, Depuy |

Stryker Settles Hip Implant Cases at Expected Cost of $1 Billion

Stryker, a major manufacturer of hip replacement devices, said on Monday that it had reached a settlement in thousands of lawsuits involving now-recalled all-metal hip devices. The settlement could cost the company about $1 billion. The deal would represent one … Continue reading

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

J&J Potentially Settling 1,000 Hip Implant Lawsuits for $250 Million

Johnson & Johnson may be settling another 1,000 ASR hip implant lawsuits for $250 million. J&J already settled 8,000 lawsuits filed on behalf of ASR patients who had the recalled implant removed earlier than last summer by agreeing to pay … Continue reading

Posted in Legal News |

European Scientific Committee Urges Caution on Metal-on-Metal Hips

SCENHIR, the European Union’s Scientific Committee on Emerging and Newly Identified Health Risks, has issued an opinion on the safety of metal-on-metal (MoM) joint replacement devices, with “particular focus” on hip implants. The committee examined concerns over possible exposure to … Continue reading

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

DePuy Hip Implant Lawsuits Continue to Mount as First Trial Moves Forward

As the first trial over the metal-on-metal version of the Pinnacle hip implant is underway, the number of lawsuits filed in Texas is almost 7,000. There are 6,849 Pinnacle lawsuits filed in the Dallas Division of the Northern District of … Continue reading

Posted in Legal News |

Judge Rules Jurors in DePuy Hip Implant Trial Can Hear About Other Cases in Multidistrict Litigation

On Monday, a Texas federal judge allowed the plaintiff in a bellwether trial against Johnson & Johnson’s DePuy Orthopaedics unit to tell jurors about the 6,500 other cases pending in multidistrict litigation that allege injuries caused by defects in a … Continue reading

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

DePuy Executive Questioned about Pinnacle Hip Implant Safety Studies in Bellwether Trial

On Monday, a DePuy executive was questioned about whether or not the company properly analyzed the dangers of the metal-on-metal Pinnacle hip implant. According to Reuters, Depuy worldwide vice president of clinical research Pamela Plouhar took the stand in the … Continue reading

Posted in Legal News |

Newer Joint Replacement Systems May Offer No Benefit

According to a systematic review published online September 9th in the BMJ, there is no evidence to support the use of 5 newer joint replacement devices compared to analogous products that have been on the market longer. In fact, the … Continue reading

Posted in Legal News |

DePuy Pinnacle Trial Proceeds, More DePuy Witnesses Testify

DePuy-Pinnacle-Trial-Proceeds

The DePuy Pinnacle bellwether trial continues, as DePuy witnesses continue to testify. The trial, which began on September 2nd in the U.S. District Court for the Northern District of Texas in Dallas before U.S. District Judge Ed Kinkeade, is expected … Continue reading

Posted in Legal News |

Attorney Says J&J Was Aware of Hip Implant Metal Poisoning Concern in 2001

In a lawsuit being tried in U.S. District Court in Dallas, Texas, an attorney said Johnson & Johnson knew in 2001 of concerns about metal poisoning with the DePuy Pinnacle artificial hip. Dr. Thomas Schmalzreid, a doctor who consulted with … Continue reading

Posted in Defective Medical Devices, Depuy, Legal News, Metal Hip Implants |

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