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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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Do Vitamin Drinks Pose Health Risks?Do Vitamin Drinks Pose Health Risks?

Do Vitamin Drinks Pose Health Risks?

Scientists are concerned vitamin drinks are contributing to levels of vitamins and other nutrients that are not only unnecessary, but potentially harmful.

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Research Suggest Fracking Chemicals Can Pollute Aquifers

A new study suggests fluids used during the hydraulic fracturing (fracking) process could migrate through underground fractures and contaminate water aquifers.

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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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Pennsylvania Health System Proposes Comprehensive Fracking Study

A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.

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Geodon the antipsychotic drug can Cause Deadly Skin Reaction

Geodon can Cause Deadly Skin Reaction, FDA Warns

The FDA has required a new warning label for the antipsychotic drug Geodon (ziprasidone) to include the risk of a potentially fatal skin reaction.

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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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Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

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Trial over Ethicon Transvaginal Mesh Begins in California

Pelvic mesh devices have become the subject of safety concerns in recent years amidst reports that they can cause serious, sometimes permanent injuries.

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Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda

A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...

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Xarelto and Blood Thinners in its Class Linked to Internal Bleeding and Blood Clots

Blood thinners and anti-coagulation drugs sometimes lead to internal bleeding and blood clots. Established blood thinners like warfarin (Coumadin) have carefully established prescribing protocols that allow doctors to protect their patients and to deal with adverse side effects when they are taking the drug.

Xarelto (rivaroxaban), one of a newer class of blood thinners, is prescribed for patients suffering from atrial fibrillation (arrhythmia of the heart) and to prevent blood clots, deep vein thrombosis (DVT) and pulmonary embolism in patients who are undergoing knee or hip replacement surgery. Xarelto is an alternative to warfarin (Coumadin), an anticoagulant that has been on the market for more than 60 years. Continue reading

Posted in Health Concerns, Legal News, Pharmaceuticals |

FDA Warning Insufficient to Stop Fresenius Dialysis Lawsuits, Court Hears

In the U.S. District Court for the District of Massachusetts, attorneys representing plaintiffs argued that a 2012 U.S. Food and Drug Administration (FDA) warning did not bar lawsuits filed over Fresenius’ GranuFlo and NaturaLyte dialysis drugs. Plaintiffs in the litigation asserted there was no proof that patients or physicians were aware of the warning, making it an insufficient reason to prevent lawsuits from proceeding.

The FDA posted a notice regarding Fresenius’ GranuFlo and NaturaLyte on May 25, 2012. In attempting to block hundreds of lawsuits from joining a multidistrict litigation, Fresenius argued that the notice was posted beyond the three-year statute of limitations. However, plaintiffs’ attorneys told the court that this argument is invalid because there is no proof physicians or their patients knew about the notification. The warning was simply posted on the FDA website and not sent to doctors or their patients. Continue reading

Posted in Legal News |

Jury Returns $13.5 Million Verdict against Johnson & Johnson in Pelvic Mesh Trial

mesh
A Philadelphia jury has returned a $13.5 million verdict against Johnson & Johnson’s Ethicon division in a case over Ethicon’s faulty pelvic mesh implants.

The plaintiff in the case alleges that the implant left her in near constant pain and discomfort and unable to have sex, Law360 reports. The jury agreed that the Ethicon transvaginal tape (TVT) was not reasonably safe, and that the woman’s doctor would never have implanted the product had he been aware of its risks. Continue reading

Posted in Defective Medical Devices, Legal News, Transvaginal mesh | Tagged , , , , , |

Medical Center Mistakenly Tells Wrong Family Their Loved One Was Dying

notification-Protocol
In an unfortunate incident last week, a Toledo, Ohio medical center told a woman that her mother, who had come in for a routine tooth extraction, had gone into cardiac arrest and was on life support.

Andrea Stebbins brought her mother, Belinda Helton, to Mercy St. Vincent’s Medical Center on February 3, 2016 for the procedure. As she waited for her mother to get out of surgery, a doctor and a nurse came out to tell her that her mother had gone into cardiac arrest and was on life support, Omaha television station WOWT reports. They advised her to notify family members immediately.

The notification was a mistake, but before the doctor realized the error and returned to tell Stebbins, she had given the bad news to her 87-year-old grandmother. “[The doctor] came back and told me he was extremely sorry that there was a mistake made,” said Stebbins, “and that he indeed gave me information in regards to another patient.” Belinda Helton’s procedure had gone well and she was in recovery.

Mercy St. Vincent Medical Center issued a statement that said, “The compassionate and high quality care we provide to our patients and their families is of the utmost priority to all of us at Mercy. Yesterday afternoon, a family who was waiting for a loved one at Mercy St. Vincent Medical Center, was incorrectly notified about the condition of their loved one. The clinical team recognized the error within minutes and the notification was corrected.” Mercy St. Vincent offered an apology to the family and said it was “reviewing notification protocols to prevent such occurrences moving forward,” WOWT reports.

Stebbins said that her mother is recovering well from her procedure. Stebbins said she hopes that sharing what she describes as a “very traumatizing” experience, another family does not have to go through a similar situation, according to WOWT.

 

Posted in Legal News | Tagged , , |

Latest Airbag Problem May Result in Recall of up to 5 Million Vehicles

airbag
In documents filed with the National Highway Traffic Safety Administration (NHTSA) last week, Continental Automotive Systems reports a potentially dangerous problem with its airbags that can lead to the failure of the airbags to deploy or to deployment without a crash.

Continental Automotive Systems says moisture can get inside the airbag control computers, causing the power supplies to corrode and fail, The Associated Press (AP) reports. Continue reading

Posted in Accident, Defective Products, Motor Vehicles | Tagged , , , |

Flint is Not the Only City with Lead-Tainted Tap Water

water
The city of Flint, Michigan is not alone in facing drinking-water contamination issues, New York Times reports. After budget cuts led to a switch in water source, as many as 8,000 children under age 6 have been exposed to dangerously high levels of lead. According to the Centers for Disease Control and Prevention, there is no safe level of lead in children. Even in small amounts, lead exposure can lead to developmental problems.

According to NYT, issues with tainted drinking-water are not limited to Flint, which may be the site of the most serious contamination in the country. Last year, the town of Sebring, Ohio found unsafe levels of lead in the drinking water. The lead contamination stemmed from the fact that workers stopped adding a chemical that prevents corrosion in lead water pipes. City officials did not take action to protect pregnant women or children for five months. Lead contamination also occurred in Washington, D.C. after the city changed methods for disinfecting its drinking water. In 2001, tap water in homes contained as much as 20 times the federally approved level of lead. Residents did not know about the issue for three years. When they were finally notified, officials made repairs that ultimately only prolonged the lead exposure. Continue reading

Posted in Legal News | Tagged , , , , |

Fresh Express Recalls Chopped Romaine Packages that May Contain Undeclared Allergens

lettuce
Fresh Express Incorporated has recalled some 32-ounce packages of Fresh Express Chopped Romaine because they may contain undeclared allergens.

Fresh Express representatives are coordinating with stores to remove the recalled product from store shelves. No other Fresh Express products are included in this recall, according to the company’s recall announcement. No illnesses have been reported. Continue reading

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

California Coconut Oil Maker Faces Class Action over Labeling Claims

extra-virgin-coconut-oil
A proposed class action against a company that touts its coconut oil as “healthy,” claims the company misleads consumers into thinking the product is good for them when it is almost entirely made up of saturated fat.

A California woman claims that labels on Carrington Tea Co. LLC’s Carrington Farms extra virgin coconut oil and coconut cooking oil have deceived consumers since the products came on the market in 2013, Law360 reports. The label includes health claims that violate U.S. Food and Drug Administration (FDA) guidelines and the state’s False Advertising Law, Unfair Competition Law, and Consumer Legal Remedies Act, the lawsuit alleges. Continue reading

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

Man Killed by Falling Construction Crane in New York City

Crane
A construction crane with a boom nearly 600 feet high killed a 38-year-old pedestrian when it crashed onto Worth Street on Friday, February 5. David Wichs was killed on his way to work and three others were injured by the falling crane.

Workers were attempting to secure the crane’s tower during a snowstorm with winds of about 20 mph., the New York Post reports. The collapse occurred just before 8:30 a.m. Continue reading

Posted in Accident, Construction Accidents | Tagged , , , , |

Honda has Added More than 2 Million More Vehicles to Airbag Recall

Honda
Honda has added an additional 2.23 million vehicles in the U.S. to the list of vehicles recalled over Takata airbags that could explode.

On Wednesday, February 2, the automaker said that certain Honda and Acura vehicles from the 2005 to 2016 model years are being recalled to replace the Takata-manufactured driver-side front airbag inflators, USA Today reports. Continue reading

Posted in Defective Products, Motor Vehicles, Product Recalls | Tagged , , , , |

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