Tag Archives: Food and Drug Administration

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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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FDA Gives 7 Companies Go Ahead To Market Generic Plavix

The U.S. Food & Drug Administration (FDA) just gave seven companies the go-ahead to market generic Plavix. Plavix is a blood thinner prescribed for the prevention of blood clots, heart attacks, and which has been linked to serious side effects such as the heart attacks and strokes it is supposed to ...

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Pennsylvania Health System Proposes Comprehensive Fracking Study

A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.

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Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP

The manufacturer of Plavix continues to be named in lawsuits alleging the blood thinner caused some patients to suffer from serious bleeding side effects. Most recently, the national law firm of Parker Waichman LLP filed nine Plavix bleeding lawsuits in state court in New York.

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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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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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Do Vitamin Drinks Pose Health Risks?Do Vitamin Drinks Pose Health Risks?

Do Vitamin Drinks Pose Health Risks?

Scientists are concerned vitamin drinks are contributing to levels of vitamins and other nutrients that are not only unnecessary, but potentially harmful.

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Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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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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Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

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FDA Investigation Finds Underreporting of Medical Device Problems

FDA Finds Underreporting of Medical Device Problems

Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA), but an FDA investigation has revealed that many hospitals are likely underreporting these events. This reporting helps the FDA identify … Continue reading

Posted in Defective Medical Devices, Duodenoscope | Tagged , , , , |

Teleflex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Use

Teleflex Medical Recalls Tracheostomy Tube Set

Teleflex Medical has issued a recall for the Willy Rusch Tracheostomy Tube Set because the connector may disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, the … Continue reading

Posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices | Tagged , , , , |

Federal Regulators Issue Warning Letter to Teva Pharmaceuticals

Federal Regulators Issue Warning to Teva Pharmaceuticals

Teva Pharmaceuticals just received a “Warning Letter” from the U.S. Food and Drug Administration (FDA) due to the agency’s Current Good Manufacturing Practices (CGMP) inspection of Teva’s Gödöllő, Hungary’s manufacturing facility. Teva was also placed on Import Alert 66-40 on … Continue reading

Posted in Health Concerns, Pharmaceuticals | Tagged , , , , |

Premature Battery Depletion of Defibrillator Caused Two Deaths

Premature Battery Depletion of Defibrillator Caused 2 Deaths

On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued a safety warning for premature battery depletion of the St. Jude Medical Implanted Defibrillator. The St. Jude products in question were manufactured before May 2015 and are ICD and CRT-D … Continue reading

Posted in Defective Medical Devices, Health Concerns, St. Jude Defibrillators | Tagged , , , , |

Fresh Express American Salad Voluntarily Recalled

Fresh Express American Salad Voluntarily Recalled

A voluntary precautionary recall has been issued by Fresh Express Incorporated of 480 cases of 11-oz. Fresh Express American Salad with a Product Code of G264A12A and a Use-by-Date of October 5, 2016. The reason for the removal of the … Continue reading

Posted in Food Products, Health Concerns, Product Recalls, Recalled Food Products | Tagged , , , , |

Hepatitis B Reactivation in Certain Patients Taking Hepatitis C Drugs

epatitis B Reactivation in Patients Using Hepatitis C Drugs

The U.S. Food and Drug Administration (FDA) has mandated that its most serious warning, the so-called “black box,” be placed on nine brand name hepatitis C virus (HCV) drugs. The call for the black box followed 24 reported cases of … Continue reading

Posted in Pharmaceuticals | Tagged , , , , |

GAO Says FDA Information Systems Riddled with Cybersecurity Flaws

GAO Says FDA Info. Systems Riddled with Cybersecurity Flaws

The Government Accountability Office (GAO) has found that the U.S. Food and Drug Administration’s (FDA) online information system has a number of weaknesses that make it vulnerable to cyberattacks. After conducting a review, GAO said it found over 80 weaknesses … Continue reading

Posted in Health Concerns, Legal News | Tagged , , , , , |

DePuy Pinnacle MDL Status Update: Jury Selected, Motion to Quash Denied

DePuy Pinnacle Update: Jury Selected, Motion to Quash Denied

A jury was selected last week in a case in the DePuy Pinnacle multidistrict litigation (MDL). The MDL—IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation—(MDL 2244) is being heard in the Northern District Court, Northern District of … Continue reading

Posted in Defective Medical Devices, Depuy | Tagged , , , , |

Final Rule for Antibacterial Soap Efficacy and Safety Released by Federal Regulators

Final Rule for Antibacterial Soap Efficacy and Safety

Officials with the U.S. Food and Drug Administration (FDA) just released the agency’s final rule concerning over-the-counter (OTC) consumer antiseptic hand soap products that are made with specific active ingredients, including triclocarban and triclosan. These soaps are no longer marketable … Continue reading

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

In Xarelto MDL, Judge Extends Deadline to File Complaints

In Xarelto MDL, Judge Extends Deadline to File Complaints

Certain groups of plaintiffs in the Xarelto multidistrict litigation (MDL) have more time to file a lawsuit against manufacturers Janssen Pharmaceuticals and Bayer Healthcare. According to a recent order issued by Judge Eldon Fallon, who is overseeing the MDL in … Continue reading

Posted in Pharmaceuticals | Tagged , , , , , , , |

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