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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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Actos Bladder Cancer Lawsuits Continue, New Complaint Filed by Tennessee Resident

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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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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Smokers More Vulnerable to Joint Replacement Failures

Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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

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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Hip Replacement, Knee Implant Patients with Diabetes, Other Health Problems May Face Difficult Recoveries

Hip Replacement, Knee Implant Patients with Diabetes, Other Health Problems May Face Difficult Recoveries

Patients receiving hip replacement devices or knee implants may face a more complicated recovery if they are obese, or suffer from diabetes or other health woes. According to a new study published online in the journal Anesthesiology, at least 3% of all total hip or knee replacement patients will ...

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$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 |

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 |

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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