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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

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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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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Lawsuit Alleges Plavix Caused Oklahoma Man to Suffer Multiple Stomach Bleeds

Lawsuit Alleges Plavix Caused Oklahoma Man to Suffer Multiple Stomach Bleeds

Another lawsuit has been filed over adverse Plavix side effects. The lawsuit, filed by national law firm Parker Waichman LLP, alleges that the blood thinner, Plavix (clopidogrel), caused an Oklahoma man to suffer from multiple stomach bleeds.

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Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries

Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. ...

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Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products

Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.

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

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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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds

Majority of Metal-on-Metal Hip Implant Failures Occur within Two Years, Study Finds

A newly published metal-on-metal hip replacement study is reporting that the majority of failures occur early, within two years of surgery. The study, published in the journal Orthopedics, is just the latest to indicate that close follow-up of metal-on-metal hip implant patients is warranted.

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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Putting Cell Phone in Your Bra could Lead to Breast Cancer, Dr. Oz Warns

Cell-Phone-in-Your-BraDr. Mehmet Oz is warning against placing your cell phone in your bra, a habit that many women do out of convenience. “When it comes to cell phones, the bra has become the new purse,” Dr. Oz said on an episode of the Dr. Oz show that aired Aug. 26th. Continue reading

Posted in Legal News |

$18 Million Settlement Finalized over Flushmate Exploding Toilets

flushmate_explosionAn $18 million settlement is being finalized over Flushmate exploding toilets, manufactured by Sloan Valve Company. The initial lawsuit, originally filed in 2012, alleged that the Series 503 Flushmate III Pressure-Assist Flushing System manufactured by Sloan can unexpectedly explode, causing injury and property damage. Continue reading

Posted in Legal News |

Supreme Court Rejection of Pfizer RICO Case Appeal Could Unleash Cases

PfizerThe US Supreme Court’s rejection of  an appeal from drug maker Pfizer, letting stand a First Circuit ruling that the drug company improperly marketed the epilepsy drug Neurontin to Kaiser Foundation Health Plan, could unleash a flood of cases

Pfizer must pay Kaiser $142 million in damages for violating the Racketeer Influenced and Corrupt Organizations (RICO) Act and an additional $65.4 million for violating the California Unfair Competition Law (UCL). Continue reading

Posted in Health Concerns, Pharmaceuticals |

Drug Maker, Teva, Recalls Parkinson’s Disease Medication as it may be “Super Potent”

tevaTeva Pharmaceutical Industries just issued a recall of one lot of its generic Parkinson’s disease combination medication, carbidopa/levodopa, over it potentially containing too much of an active pharmaceutical ingredient.

Teva Pharmaceutical Industries indicated that the recall, which has been deemed a Class II, involved 3,881 bottles of carbidopa/levodopa 25 mg/100 mg, according to FiercePharmaManufacturing. Teva also indicated that stability testing revealed that the recalled carbidopa/levodopa may be what the drug maker described as “super potent.” The voluntary recall is for the entire United States. Continue reading

Posted in Pharmaceuticals, Product Recalls |

Researchers Study Whether Chemicals in the Environment Increase the Risk of Diabetes

Diabetes ConceptResearchers at the University of Buffalo will be studying how chemicals in the environment affect the risk of diabetes and metabolic conditions.  According to an article posted on the university’s website, the National Institute of Environmental Health Sciences has awarded a two-year $436,751 grant to Margarita L. Dubocovich, PhD and Rajendram V. Rajnarayanan, PhD to study this issue.   Continue reading

Posted in Legal News |

FDA Issues Injunction Against BioAnue Laboratories

FDA-Issues-Injunction-Against-BioAnue-LaboratoriesA federal court order demands that BioAnue Laboratories of Rochelle, Georgia stops illegally marketing its products as treatments for disease, the U.S. Food and Drug Administration (FDA) announced on its website. The court order, which was signed on July 23, 2014 in the United States District Court for the Middle District of Georgia, says that BioAnue’s products were sold as supplements but were illegally marketed as treatments for conditions such as cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease and diabetes. The FDA did not approve these products for those uses.

In February 2012, the FDA issued a warning lette Continue reading

Posted in Legal News |

Government Will Withhold Up to One Third of Payment Records in Launch of Physician Payment Database

Launch-of-Physician-Payment-DatabaseFor next month’s launch of the Open Payment database showing payments to physicians from pharmaceutical companies and medical device makers, about one-third of the records will be withheld because of data inconsistencies.

The release of payment information – intended to promote greater transparency about possible conflicts of interest in medicine – is mandated under the Physician Payment Sunshine Act, a provision of the 2010 Affordable Care Act, according to the non-profit investigative journalism group ProPublica. Continue reading

Posted in Legal News |

Court’s Discovery Order in C.R. Bard Litigation Expected to Streamline Litigation Process

Court’s-Discovery-Order-in-C-R-Bard-LitigationThe court overseeing the C.R. Bard transvaginal mesh litigation has put new discovery rules in place that are expected to streamline the discovery process in this litigation. The discovery procedures will specifically impact Collection and Preservation of Evidence in a multidistrict litigation (MDL) that was organized over C.R. Bard’s transvaginal mesh devices in the United States District Court, Southern District of West Virginia.

According to the Court, the new rules will provide that “discovery in this proceeding may involve the collection, division, storage, preservation, and production of biomaterials evidence for which special handling, division, storage, and preservation would be warranted.” The Order followed a stipulation requested by the parties involved in the MDL and involved a petition to the Court to enter an “evidence preservation protocol order,” that would be applicable for existing and future actions in the litigation. Continue reading

Posted in Defective Medical Devices, Transvaginal mesh |

DEA Announces Stricter Classification for Hydrocodone Combination Painkillers

DEA-Announces-Stricter-ClassificationThe Drug Enforcement Administration (DEA) has announced the reclassification of hydrocodone combination products from Schedule III to Schedule II under federal law. Schedule II drugs are substances known to be dangerous, prone to abuse, or could lead to severe psychological or physical dependence.

Combination hydrocodone painkiller products were previously regulated as Schedule III products under the law. Schedule III is the DEA category for substances that have accepted medical use, moderate potential for abuse, and the potential for dependency, according to the DEA definition. As a Schedule II substance, hydrocodone combination products will be subject to more stringent prescribing controls, such as bans on refills, Regulatory Affairs Professionals Society (RAPS) reports. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals |

CDC Whistleblower Exposes Data Manipulation in Vaccine and Autism Study

Data-Manipulation-in-Vaccine-and-Autism-StudyAccording to a study by Focus Autism Foundation, a whistleblower revealed the manipulation of scientific data in a 2004 study on autism and age of vaccination with  the measles, mumps, and rubella (MMR) vaccine.

A research scientist working for the Centers for Disease Control and Prevention (CDC) helped Dr. Brian Hooker of the Focus Autism Foundation uncover data manipulation by the CDC that obscured a higher incidence of autism in African-American boys who received the MMR vaccine earlier than 36 months of age.   Continue reading

Posted in Health Concerns |

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