Tag Archives: Food and Drug Administration

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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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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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Louisiana Whistleblower Lawsuit Revived

Louisiana Whistleblower Lawsuit Revived

A state appeals court in Louisiana has ruled that a former employee of Rapides Parish Coliseum can proceed with a whistleblower lawsuit against the Coliseum Authority.

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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

The American Society of Clinical Oncology & the American Association for Cancer Research called for government regulation & research of e-cigarettes on health effects.

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New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions

Yet another study is pointing to potential dangers posed by metal-on-metal hip implants. This time, an article published in the Journal of Arthroplasty is reporting corrosion in the head taper junction was more likely to occur in patients with 36-mm diameter metal-on-metal hip replacement, compared to those with the same ...

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West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

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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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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Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent

Yet another study is confirming the association between the diabetes drug, Actos, and bladder cancer. This latest research, published today in the Canadian Medical Association Journal, found that taking Actos raised the risk of bladder cancer among diabetics by about one-fifth.

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Actos Bladder Cancer Lawsuits Continue, New Complaint Filed by Tennessee Resident

Actos bladder cancer lawsuits continue, with a new complaint filed by a resident of Tennessee. The national law firm, Parker Waichman LLP, represents the Tennessee man who alleges that Actos caused his bladder cancer.

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Hip Replacement, Knee Implant Patients with Diabetes, Other Health Problems May Face Difficult Recoveries

Patients receiving hip replacement devices or knee implants may face a more complicated recovery if they are obese, or suffer from diabetes or other health woes. According to a new study published online in the journal Anesthesiology, at least 3% of all total hip or knee replacement patients will ...

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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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