Author Archives: Ed Lieber

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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Bronx Teenager Killed in Hit-and-Run, Second Teen Injured

A Port Jefferson Station man was killed on Wednesday in a single-vehicle crash on the Northern State Pkwy in Dix Hills west of Exit 42. He was driving a Nissan Altima.

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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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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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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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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

In a joint statement, the American Society of Clinical Oncology and the American Association for Cancer Research have called on the federal government to move quickly to regulate e-cigarettes and increase research on their health effects. These leading research and treatment organizations asked the Food and Drug Administration (FDA) to make ...

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System for Tracking Prescription Drug Side Effects Flawed

Study Finds System for Tracking Prescription Drug Side Effects Flawed

System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.

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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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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Study Finds SSRI Antidepressant Side Effects Outweigh Their Benefits

A new study is raising more concerns about the safety of commonly used antidepressants, including selective serotonin reuptake (SSRI) inhibitor antidepressants. Investigators who conducted the study, which is published in the journal Frontiers in Psychology, posit that increased knowledge of the negative effects of SSRIs and other antidepressants could reduce ...

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Growing Movement Demands Recall of Bayer’s Essure Contraceptive Device

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The campaign for the recall of Bayer’s Essure contraceptive device is gathering strength online among women who claim the device caused them severe pain and injuries. The women have created Facebook support pages, Twitter campaigns, and petitions, and their actions … Continue reading

Posted in Legal News |

Lawsuit Filed Against Medtronic for Promoting Off-Label Use of Infuse

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A lawsuit filed this week alleges that Medtronic Inc. deliberately promoted the off-label use of its Infuse bone graft product. The complaint includes the names of 98 plaintiffs who allege that the off-label use of Medtronic caused them to incur … Continue reading

Posted in Medtonic Infuse |

Scent Device May Help in Early Detection of Bladder Cancer

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Based on earlier research findings that suggest dogs can successfully sniff out bladder cancer, researchers have built a device that can analyze gases and create a readout of the chemicals found in the urine within 30 minutes. The researchers hope … Continue reading

Posted in Legal News |

Pilot Flying J Faces Mounting Legal Pressure over Fuel Rebate Fraud Scheme

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A new lawsuit claims that Jimmy Haslam’s Pilot Flying J Travel Centers  committed rebate fraud on a fuel program it offers. The lawsuit was filed recently by an Alabama trucking company, Wright Transportation Inc., that says Flying J Travel Centers … Continue reading

Posted in Consumer Fraud |

Rise in Adverse Event Reports Prompts FDA to Investigate da Vinci Surgical Robot

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The rising number of adverse event reports (AERs) regarding Intuitive Surgical’s da Vinci Surgical System has prompted the U.S. Food and Drug Administration (FDA) to roll out an investigative survey for surgeons who use the robotic surgical systems during surgery. … Continue reading

Posted in da Vinci Surgical Robot, Defective Medical Devices |

Samsca Gets Revised Label to Reflect its Potential to Cause Serious Liver Damage

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Taking the drug Samsca (tolvaptan) for more than a month could cause serious liver injury or even death, according to federal health officials. Also at risk is anyone who has an underlying kidney problem and takes the drug. The U.S. … Continue reading

Posted in Defective Products, Pharmaceuticals |

Judge Overrules Merck’s Bid to Boot Expert Testimony from Four Doctors in Fosamax Trial

Merck and Co. was unable to stop doctors from giving expert testimony during the New Jersey-based trial, now under way, regarding osteoporosis drug Fosamax for allegedly causing atypical femur fractures. The federal judge ruled, however, that while the plaintiff’s treating … Continue reading

Posted in Fosamax, Legal News, Pharmaceuticals |

Fosamax Lawsuit Begins with Opening Remarks

Opening arguments today signaled the start of the second trial charging Merck’s Fosamax with causing femur fractures. In New Jersey federal court the focus was on the case of 58-year-old Bernadette Glynn, who says that the osteoporosis drug is part … Continue reading

Posted in Fosamax |

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