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Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions

Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...

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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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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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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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Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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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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Nestlé Drumstick Ice Cream Cones Recalled

A voluntary recall has been issued for Nestlé Drumstick Club 16 count Variety Pack and 24 count Vanilla Pack (with cones marked for easy individual sale). Nestlé USA recalled the product because contact surfaces of equipment tested positive for Listeria monocytogenes. “The products impacted by the voluntary recall were put into distribution inadvertently. No illnesses have been reported to date; the company is initiating this recall as a precautionary action to avoid any potential for consumer illness.” according to an Oct. 7 recall alert posted on the U.S. Food and Drug Administration (FDA) website.

The drumstick ice cream cones themselves did not test positive for Listeria. The recall affects 4.6 fl. oz cones. According to the announcement, the product was manufactured in Bakersfield, California and distributed nationwide. Continue reading

Posted in Legal News |

New Jersey Students Injured in School Bus Collision

A school bus accident left dozens of New Jersey high school students injured in New City, New York. State police say one school bus rear-ended another while exiting the Palisades Interstate Parkway at Exit 11. Fortunately, there were no major injuries. The school buses were carrying students who attend Northern Valley Regional High School in Demarest, New Jersey.

According to Associated Press, the accident occurred on October 17th just after 2 p.m. All injuries were considered minor, and 40 to 60 students were taken to the hospital for bumps and bruises. Continue reading

Posted in Legal News |

Deep Brain Stimulation Rechargers May Fail to Charge, Medtronic Warns

In an October 2016 “Urgent Field Safety Notice”, Medtronic warned that some rechargers for its deep brain stimulation devices may be prone to an “error state” and fail to charge. According to the letter, some of its Model 37751 rechargers may become unresponsive and fail to recharge the neurostimulator until they are reset. The company has received reports of the chargers malfunctioning, where they bleep every five seconds while displaying a blank screen.

According to the letter, the “error state” occurs in 2 percent of rechargers manufactured after November 2014 and 0.2 percent of rechargers manufactured before that date. The serial numbers on rechargers manufactured November 2014 and later begin with “NKA4” or “NKU4”. Continue reading

Posted in Legal News |

Zofran Blamed as Cause for Cleft Palate in New Lawsuit

On October 3, 2016, a mother claimed that the active ingredient in the anti-nausea drug Zofran’s caused her son to develop cleft palate and cleft lip in the womb. The woman, from Oneida, New York, filed her case in the U.S. District Court of Massachusetts, where more than 280 additional Zofran lawsuits are currently consolidated.

In 2012, researchers at Harvard and Boston University discovered that women prescribed Zofran for nausea during pregnancy were more than twice as likely to deliver children with a cleft palate. Zofran’s warning label, however, does not mention a potential increased risk for cleft palate. Continue reading

Posted in Health Concerns, Legal News, Pharmaceuticals |

Premature Battery Depletion of Defibrillator Caused Two 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 models.

A medical advisory has been released by St. Jude Medical. The FDA is investigating potential cybersecurity errors that may be responsible for the rapid battery depletion of the defibrillators. There are 398,740 affected devices sold worldwide and 841 were returned for examination. The FDA will keep the public apprised of any new information as it becomes available. Continue reading

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

Personal Panic Devices Recalled Due to Malfunction

Interlogix is recalling 67,000 personal panic devices because they may fail to operate in case of an emergency. According to a recall alert posted on the U.S. Consumer Product Safety Commission (CPSC) website, “The wireless personal panic devices can fail to operate, which could result in the device not communicating with the security system if activated in the event of an emergency.” The devices were manufactured in Mexico and sold by professional security installers and distributors across the country from May 2014 to January 2016. The personal panic devices were priced from about $35 to $60.

The wireless personal panic devices are supposed to be connected to a security system so that the wearer has a quick way to call for help in case of an emergency. This is the type of device that may be purchased for an elderly family member, for example. The recall is being issued because the panic devices may fail to communicate properly with the security system. Continue reading

Posted in Legal News |

Talcum Powder Lawsuits Continue to Pile Up

Johnson & Johnson is faced with a growing number of lawsuits from women who allege that Johnson’s Baby Powder and Shower to Shower body powder are responsible for their ovarian cancer.

The lawsuits include wrongful death lawsuits from the families of women who have died of the disease, Top Class Actions reports. Eighty-one named plaintiffs claim they or their loved ones were diagnosed with or have died from ovarian cancer resulting from years of use of talcum powder for feminine hygiene. Continue reading

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

Food Company Execs May Be Held Liable for Food Poisoning Outbreaks

Instances of food company executives receiving prison sentences and serving time over large, even deadly, food poisoning case are mounting. Now, some wonder why pharmaceutical and medical device company executives are not subject to the same punishments.

Stewart Parnell, former owner of Peanut Corporation of America (PCA) was at the center of an historic, massive peanut paste contamination and facing life imprisonment; his brother, a food broker, faced 17 years in prison. The case was the first time a food company official received a conviction on federal felony charges tied to a food contamination epidemic, according to CNN. Both men were charged with felony charges by the Department of Justice (DOJ) and a Georgia jury convicted Stewart on 72 counts of conspiracy, fraud, and the introduction of adulterated foods into interstate commerce. He was sentenced to 28 years; his brother was sentenced to 20. Continue reading

Posted in Botulism, E. Coli, Food Poisoning, Listeria, Norovirus, Salmonella, Shigella |

Lawsuit Filed Over Alleged Failure of Rex Medical Option IVC Filter

The family of a now-deceased Florida man has filed a lawsuit in Pennsylvania over the alleged failure of the Rex Medical Option Inferior Vena Cava (IVC) filter device. The lawsuit was filed in Pennsylvania.

In September 2014, the man was implanted with Rex Medical’s Option IVC filter. The implantation surgery was conducted to prevent a pulmonary embolism (PE). PEs take place when a blood clot that starts in the body’s lower extremities travel to the arteries in the lungs and block blood flow. Continue reading

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

Medtronic Recalls Thousands of Lots of Various Neurovascular Products

Medtronic PLC just recalled certain lots of four of its neurovascular products. The device maker noted that the recalled devices might lead to a thromboembolic event (blood clot) in patients. The recalled Medtronic neurovascular products are:

  • Pipeline Embolization Device (1742 lots affected)
  • Alligator Retrieval Device (171 lots affected)
  • X-Celerator Hydrophilic Guidewire (210 lots affected)
  • UltraFlow HPC Flow Directed Micro Catheters/Marathon Flow-Directed Micro Catheters (1790 lots affected)

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

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