Monthly Archives: April 2014

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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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E-cigarettes Could Increase Risk of Lung Infections

E-cigarettes Could Increase Risk of Lung Infections

New research suggests the liquid used in electronic cigarettes could increase the risk of viral lung infections, regardless of whether it contains nicotine.

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Post -Tonsillectomy Morphine Life-Threatening in Children

Post -Tonsillectomy Morphine can be Life-Threatening in Children, Study Finds

A new study published in Pediatrics suggests that morphine can result in life-threatening respiratory problems when given to children after a tonsillectomy.

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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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Warning for Medtronic InterStim Neurostimulation Devices

Australian Health Agency Issues Warning for Battery Problem with Medtronic InterStim Neurostimulation Devices

Warning for Medtronic InterStim Neurostimulation DevicesTGA has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery.

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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 Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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Transvaginal Mesh Lawsuit Trial

$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial

An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...

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HeartWare’s Ventricular Assist System Recall gets Highest-Risk Class I Label

HeartWare International’s recall of their Ventricular Assist System, also known as the HeartWare Ventricular Assist Device (HVAD) has been classified as Class I by the U.S. Food and Drug Administration (FDA). The Class I designation is the agency’s most serious … Continue reading

Posted in Legal News |

Johnson & Johnson Suspends Sale of Device Used in Fibroid Surgery Over Cancer Risk

Johnson & Johnson has suspended sales worldwide of the power morcellator, a device used in uterine fibroid surgery, amid concerns over its potential to spread undetected cancer beyond the uterus. The company is suspending the sale of these devices until … Continue reading

Posted in Legal News |

Doctor Says Studies of ‘Low T’ Testosterone Treatment are Urgently Needed

Many men are being treated with testosterone when there is not enough information about its risks, says a doctor in a letter to The Lancet Diabetes and Endocrinology journal. Dr. Stephanie Page, an endocrinologist at the University of Washington and … Continue reading

Posted in Legal News |

FDA Issues Safety Alert Regarding Safety of Extra Strength Acetaminophen

The U.S. Food and Drug Administration (FDA) issued a statement regarding the safety of extra strength acetaminophen in combination prescription medications. According to the agency’s safety alert, dated January 14th, health care professionals should stop prescribing and dispensing prescription drug … Continue reading

Posted in Legal News |

FDA Proposes Reclassification of Transvaginal Mesh Devices to High-Risk Category

Today, the U.S. Food and Drug Administration (FDA) issued two proposed orders for the reclassification of transvaginal mesh devices used for repair of pelvic organ prolapse (POP). If these orders are finalized, surgical mesh devices implanted to treat POP would … Continue reading

Posted in Defective Medical Devices, Health Concerns, Legal News, Transvaginal mesh |

Mylan wants Rights to Market Generic Celebrex, Sues FDA

Mylan Inc. is suing the U.S. Food and Drug Administration (FDA) over a ruling about rights to exclusively market a generic version of Celebrex (celecoxib). Pittsburgh Business Times reports that, according to Myland, the FDA would only permit exclusive 180-day … Continue reading

Posted in Legal News |

FDA to Convene Panel on Smoking Cessation Drug, Chantix, Over Psychiatric, Behavioral Side Effect Risks

The U.S. Food and Drug Administration (FDA) announced that it plans to review Chantix, the smoking cessation drug, to determine if its quit smoking benefits exceed its psychiatric and behavioral risks, Approved in 2006, Chantix received the U.S. Food and … Continue reading

Posted in Chantix, Pharmaceuticals |

FDA Warns Firms Touting Bogus Autism Cures

The U.S. Food and Drug Administration’s (FDA) national health fraud coordinator, Gary Coody, R.Ph. says that the agency has warned various firms that they face potential legal action should they continue to issue false or misleading claims concerning products and … Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals, Toxic Substances |

Judge May Punish Lawyers for Misconduct in Actos Trial

Las Vegas district judge Kerry Earley is considering a request to punish lawyers for misconduct during a civil trial over the cancer risks associated with Takeda Pharmaceuticals’ diabetes drug Actos. On Thursday, Judge Earley heard arguments from an attorney representing … Continue reading

Posted in Actos, Health Concerns, Legal News, Pharmaceuticals |

Another Motion to Remand Granted in Medtronic Infuse Lawsuit

Another motion to remand has been granted in a Medtronic InFuse case, bringing the lawsuit back to the Circuit Court of the City of St. Louis. InFuse is a type of artificial bone graft that uses a genetically engineered, synthetic, … Continue reading

Posted in Legal News |

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