Monthly Archives: November 2015

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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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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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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Medtronic Settles Charges Over Kickbacks To Doctors

Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a U.S. Justice Department announcement yesterday. The company was accused of seeking ...

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FDA Urged to Ban Powdered Caffeine

FDA Urged to Ban Powdered Caffeine

Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.

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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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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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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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Boston Scientific Transvaginal Mesh

Tennessee Woman Alleges Boston Scientific Transvaginal Mesh Product Caused Painful Injuries

More reports of painful injuries are being linked to transvaginal mesh. This time, a Tennessee woman has filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System.

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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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Update on FDA Evaluation of the Safety of Essure Birth Control System

FDA Evaluation of the Safety of Essure Birth Control System

The Food and Drug Administration (FDA)’s Office of Women’s Health has issued an update on the agency’s evaluation of the safety of the Essure birth control system. Essure—a form of permanent birth control (female sterilization)—is under FDA review in response … Continue reading

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

Costco Chicken Salad Tainted with E. coli, 19 People Sick

Costco Chicken Salad Tainted with E. coli, 19 People Sick

Costco’s rotisserie chicken salad has been linked to at least 19 cases of E. coli infection, the U.S. Centers for Disease Control and Prevention (CDC) announced. The outbreak has affected the following seven states: Montana, Utah, Colorado, California, Missouri, Virginia … Continue reading

Posted in E. Coli, Food Poisoning, Health Concerns, Legal News | Tagged , , , , |

FDA Orders Custom Ultrasonics to Recall AERs Used to Clean Duodenoscopes

FDA order Recall on AERs Used to Clean Duodenoscopes

The U.S. Food and Drug Administration (FDA) has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), devices used to sterilized special medical scopes such as duodenoscopes. According to a Nov. 13 announcement, the recall is being … Continue reading

Posted in Defective Medical Devices, Duodenoscope, Legal News | Tagged , , , , |

Olympus Faces Wrongful Death Lawsuit over Contaminated Duodenoscope

Olympus Faces Wrongful Death Lawsuit over Duodenoscope

A wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp. and Custom Ultrasonics has been filed over the use of an allegedly contaminated medical scope. The suit was filed on behalf of a woman whose husband died of an … Continue reading

Posted in Defective Medical Devices, Duodenoscope, Legal News | Tagged , , , , |

Researchers Call for Drug Companies to Make Public all Clinical Trial Results

Researchers Call for Drug Companies to Publicize Trial Results

In a newly published report, a group of researchers says one third of the clinical drug trial results federal regulators review in approving new drugs are not published and the researchers are pushing for all trial results to be made … Continue reading

Posted in Health Concerns, Pharmaceuticals |

FDA Warns of Possible Patient Injury if Coating Separates from Intravascular Medical Device

Coating on Medical Devices Can Cause Patient Injuries

The Food and Drug Administration (FDA) has issued a safety communication warning of the possibility of patient injury if the hydrophilic and/or hydrophobic coatings on medical devices separate—peel, flake, shed, delaminate, slough off—during use. A number of factors can cause … Continue reading

Posted in Defective Medical Devices, Health Concerns, Product Recalls | Tagged , , , , |

Tyson Foods Inc. Recalls Chicken Due to Potential Contamination

Tyson Foods Inc. Recalls Chicken Due to Contamination

After receiving customer complaints of an “off odor” scent, Tyson Foods Inc. is recalling about 52,486 pounds of fully cooked chicken wing product. According to a release posted on the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) … Continue reading

Posted in Legal News, Product Recalls | Tagged , , , , |

CPSC Says Home Depot Sold Recalled Products Even Years After Recall

CPSC Says Home Depot Sold Recalled Products After Recall

According to the Consumer Products Safety Commission (CPSC), Home Depot, and salvagers and recyclers who got items from the retailer, continued to sell 28 products that were recalled between 2012 and 2015. The products pose hazards including fire, burns, shock … Continue reading

Posted in Defective Products, Food Poisoning | Tagged , , , , |

Judge Pauses Philadelphia Risperdal Trial in Data Analysis Dispute

Judge Pauses Philadelphia Risperdal Trial in Data Dispute

Judge Kenneth Powell of the Philadelphia Court of Common Pleas has paused a trial over an adolescent boy’s breast growth allegedly caused by the antipsychotic drug Risperdal (risperidone) so that the drug maker can turn over more evidence for the … Continue reading

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

Charges Brought Against Makers of OxyElite Pro

Charges Brought Against Makers of OxyElite Pro

USPlabs LLC has been indicted on charges that it intentionally misbranded its dietary supplement products and lied to customers, the Justice Department announced. Star Advertiser reports that the company is accused of engaging in behavior intended to place its products … Continue reading

Posted in Consumer Fraud, Legal News | Tagged , , , |

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