Tag Archives: Food and Drug Administration

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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

81-year-old Port Jefferson Station man was killed in a crash at 4:57 a.m.. He lost control of the vehicle traveling west on Northern State Pkwy, on exit 42, Dix Hills.

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Medtronic Settles Charges Over Kickbacks To Doctors

Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a U.S. Justice Department announcement yesterday. The company was accused of seeking ...

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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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Actos, Avandia May Up Risk for Diabetic Macular Edema

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda Pharmaceuticals on behalf of a West Virginia man who developed bladder cancer ...

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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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Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

A Port Jefferson Station man was killed on Wednesday due to a single-vehicle crash on the Northern State Parkway in Dix Hills. Police are investigating the accident, Newsday reports. According to Newsday, the 81-year-old man was driving a Nissan Altima west in the right lane, west of Exit 42. He ...

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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation Lawsuit

A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports.

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DeflateGate’s Effects Impact Legal Gambling and the Economy

DeflateGate’s Effects Impact Legal Gambling and the Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

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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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