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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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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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Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

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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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Actos Side Effects Lawyers Says Whistleblower Revelations Could Boost Bladder Cancer, Heart Failure Lawsuits

An attorney with a prominent personal injury law firm says an Actos whistleblower lawsuit filed earlier this year could strengthen legal claims alleging the type 2 diabetes medication caused some users to develop bladder cancer and heart failure.

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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...

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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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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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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Bard Alleged to Have Mishandled Risks with Recovery IVC Filter

A year-long investigation by NBC Nightly News raises questions about the C.R. Bard’s handling of the Recovery IVC filter product, a device implanted in the inferior vena cava to block blood clots from traveling to the lungs.

In the first part of the series, aired on September 2, NBC News reported that more than 300 adverse events, including at least 27 fatalities, have been associated with the Recovery device. Continue reading

Posted in Bard IVC Filter Injuries, Defective Medical Devices, Health Concerns |

Texas Man Blames Fracking for Well Explosion that Injured His Family

Cody Murray, a former oil field services supervisor, blames hydraulic fracturing—fracking—for an explosion on his property that injured him and members of his family.

The water well on Murray’s property exploded in August 2014, burning Murray, his father, wife and daughter. The family has filed a lawsuit alleging that a nearby oil and gas drilling operation contaminated the water with the methane that caused the explosion, the Houston Chronicle (chron.com) reports. Continue reading

Posted in Accident, Hydraulic Fracturing / Fracking |

Lawsuit Alleges Pentax was Negligent with Scope Design, Liable for Patient Death

A lawsuit has been filed in state court in Cook County, Illinois alleging that Pentax Medical, a division of Pentax of America, is liable for the death of a woman who died of a superbug infection after underoing a procedure with a duodenoscope. The August 31 lawsuit alleges that the scope was defectively designed, making it difficulty to sterilize. Duodenoscopes are snaked down the esophagus and into the small intestine to diagnose and treat gastrointestinal conditions. The devices have come under scrutiny following several outbreaks of infection from antibiotic-resistant bacteria.

The lawsuit was filed on behalf of the estate of a woman who died of infection with carbapenem-resistant Enterobacteriaceae (CRE) after undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) at Advocate Lutheran General Hospital in the Chicago suburb of Park Ridge, Illinois. The suit alleges that the hospital failed to adequately clean the scopes, leading to infections in 43 other patients. Continue reading

Posted in Legal News |

Covidien Bennett 980 Ventilator System under FDA Class 1 Recall

A number Covidien Puritan Bennett 980 Ventilator System units have been recalled because a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician.

Lots with product codes 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, and 980N3ENDIUUS are affected by the recall. These ventilators were manufactured March 2014 to June 2015 and were distributed from March 1, 2014 to June 17, 2015. A total of 657 ventilators were recalled in the U.S. Continue reading

Posted in Defective Medical Devices, Health Concerns |

Judge Issues Order in Conserve Hip Implant Bellwether Case

The first of the consolidated multidistrict litigation (MDL) cases over Wright Medical Conserve metal-on-metal hip implants continues to move forward. United States District Judge William S. Duffrey, Jr. issued a 123-page order in the case on August 31. Wright Medical had claimed that the design-defect claims were preempted by the Medical Device Amendment to the Food Drug & Cosmetic Act, but this argument was rejected by the Court. The Court also denied motion for summary judgement related to the plaintiff’s claims for defective design, fraudulent misrepresentation, concealment and punitive damages.

Plaintiffs in the MDL allege that Wright’s Conserve hip implant caused serious injuries as a result of its metal-on-metal design. All-metal hip implants have come under increased scrutiny in recent years in light of multiple recalls and high failure rates. The devices were first marketed as being more suitable for younger, more active patients. However, the implants have a risk of shedding or fretting metal particles into the bloodstream and nearby tissues when the surfaces of the implant rub together. This can lead to a host of complications, including metal poisoning. In some patients, it was necessary to perform a revision surgery to remove and replace the implant. Continue reading

Posted in Legal News |

Knee or Hip Replacement Increases Risk of Heart Attack and Blood Clots

A team of researchers based in Boston found that osteoarthritis patients who had total knee or hip joint replacement surgery (arthroplasty) were at increased risk of heart attack (myocardial infarction) in the early post-operative period.

The findings, published this week in Arthritis & Rheumatology, a journal of the American College of Rheumatology (ACR), indicate that long-term risk of heart attack did not persist, but the risk for venous thromboembolism—blood clot in veins and lungs—remained years after the procedure, News-Medical.net reports. Continue reading

Posted in Defective Medical Devices, Health Concerns |

FDA Renews Warnings of the Dangers of Pure Powdered Caffeine

Because pure powdered caffeine products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers,” the Food and Drug Administration (FDA) issued warning letters to five distributors of pure powdered caffeine and the agency has renewed warnings to consumers about this substance.

A teaspoon of pure caffeine is roughly equal to 28 cups of coffee. A tablespoon of pure caffeine can be lethal. A 100-gram package (which is about 3.5 ounces) can have as much caffeine as 400 “tall” cups of Starbucks coffee, 1,250 cans of Red Bull or 3,000 cans of Coke, the New York Times reports. In 2014, two otherwise healthy young men died after using too much pure caffeine, prompting the FDA to issue a safety warning. Continue reading

Posted in Health Concerns |

FDA Allows Sales of 700 Generic Medicines Banned by European Medicines Agency

FDA Allows Sales of 700 Generic Medicines Banned by Europe

FDA Allows Sales of 700 Generic Medicines Banned by Europe


The European Medicines Agency (EMA) instituted a ban on about 700 generic medicines that were approved based in part on what were said to be flawed clinical studies conducted at GVK BioSciences, a contract research organization based in Hyderabad, India.

The U.S. Food and Drug Administration (FDA) said it found no systemic issues affecting the safety or efficacy of generic drugs tested at GVK BioSciences, but the FDA said it supports Europe’s ban, according to Outsourcing-Pharma.com. The banned medicines include different formulations and strengths. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals | Tagged , , , , , |

FDA Warns of Diabetes Drugs that Can Cause Disabling Joint Pain

FDA Warns of Diabetes Drug that Causes Disabling Joint Pain

FDA Warns of Diabetes Drug that Causes Disabling Joint Pain


On Friday, the Food and Drug Administration (FDA) warned diabetes patients that an entire class of diabetes drugs can cause severe and disabling joint pain.

The drugs include Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). They are all in the same class and work by making more insulin available to the body. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals | Tagged , , , , |

FDA is Using Whole Genome Sequencing to Stop Foodborne Illnesses

FDA is Using Whole Genome Sequencing to Stop Illnesses

FDA is Using Whole Genome Sequencing to Stop Illnesses


The U.S. Food and Drug Administration (FDA) is implementing whole genome sequencing to quickly detect and stop the spread of foodborne illnesses, Business Insider reports. The process offers huge advantages over the previous method, where samples from sick patients were tested to see if infections were caused by the same pathogen. Once enough matches appeared, the sick individuals were interviewed by epidemiologists to see if a common food was responsible for the outbreak. This method, however, does not conclusively find the cause and is time-consuming. “While all of this was going on, more contaminated product was getting out into the public,” said Dr. Steven Musser, deputy director for scientific operations at the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition, according to Business Insider.

The FDA is now having state and federal labs map out the exact genome of strains of foodborne pathogens such as Listeria and Salmonella. The National Institutes of Health houses a public database, known as GenomeTrakr where all the sequences are uploaded. Whole genome sequences allows scientists to distinguish a pathogen from related species, as well as slight mutations within the same strain. Continue reading

Posted in Legal News | Tagged , , , , |

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