Tag Archives: Food and Drug Administration

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Two Men Found Dead of Carbon Monoxide Poisoning

Two Men Found Dead of Carbon Monoxide Poisoning at Long Island, New York Auto Shop

Two men were found dead of apparent carbon monoxide poisoning in a Holbrook, New York, auto-detailing shop Thursday night, Suffolk County police say.

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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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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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Canadian Study Confirms Actos Bladder Cancer Risk

A new study conducted by Canadian researchers has found that users of the type 2 diabetes drug, Actos (pioglitazone), may face a higher risk of developing bladder cancer than first thought. The study, published in the British Medical Journal, found that taking Actos for two years doubles the likelihood ...

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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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Estate of Kentucky Man Alleges Wrongful Death Due to Actos Bladder Cancer

National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of diabetes drug, Actos. The lawsuit names Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, ...

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New York City Council Calls for Zadroga Act to be Renewed

New York City Council Calls for Zadroga Act to be Renewed

New York City Council members are calling for the Zadroga Act, which provides compensation and medical treatment to 9/11 victims, to be renewed.

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Death in Those Taking Bactrim with ACE Inhibitors or ARBs

Sudden Death in Those Taking Bactrim Along with ACE Inhibitors or ARBs

Association between sudden death in those given Bactrim while already taking renin-angiotensin system blockers angiotensin receptor blockers (ARBs), heart medications.

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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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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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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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