Featured Stories

U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims

The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...

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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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System for Tracking Prescription Drug Side Effects Flawed

Study Finds System for Tracking Prescription Drug Side Effects Flawed

System for keeping track of dangerous side effects of prescription drugs is flawed because drug makers are submitting incomplete information about problems to the FDA.

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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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Decision on Pradaxa Bleeding Lawsuit Multidistrict Litigation Expected Soon

Victims of alleged Pradaxa injuries are awaiting word on whether their lawsuits will be consolidated in a multidistrict litigation. According to a report from The Madison Record, so far just over two dozen Pradaxa bleeding lawsuits have been filed in federal courts throughout the U.S.

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Dozens Receive Nonsterile Simulated Saline Solution

Dozens-Receive-Nonsterile-Simulated-Saline-Solution

The FDA said last week that more than 40 patients had received intravenous simulated saline that was not sterile and was not intended for human use.

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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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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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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Increased Risk of Bone Fractures with Invokana and Invokamet XR

Despite a multitude of warnings for a drug taken for treatment of type 2 diabetes, the U.S. Food and Drug Administration (FDA) has expanded indications for Invokamet (canagliflozin and metformin). Invokamet along with Invokana (canagliflozin), carry warnings for adverse reactions including an increased risk for lower limb amputations, kidney failure, diabetic ketoacidosis, and cardiovascular injuries.

Invokamet was initially approved by the FDA in 2014. Invokamet XR was given the FDA’s green light as an extended-release drug for the treatment of type 2 diabetes. “Invokamet XR offers the convenience of once-daily dosing and provides physicians needed flexibility for tailoring treatment to the needs of type 2 diabetes patients, especially those with higher A1c levels,” said John Anderson, M.D., with the Frist Clinic in Nashville, Tennessee, in a published statement on behalf of Invokamet XR manufacturer Janssen Pharmaceuticals. Continue reading

Posted in Health Concerns, Pharmaceuticals |

Endo Agrees to Additional $775M Settlement for a Total of $2.6B

As of August 7, 2017, Endo International has agreed to set aside an additional $775 million to resolve the company’s remaining mesh lawsuits’ allegations related to the Transvaginal Mesh (TVM) Multidistrict (MDL) Litigation pending in the U.S. district Court of West Virginia. These claims involve Endo’s vaginal-mesh implants that allegedly eroded in some women, leaving them incontinent and in pain.

The agreement to fund settlement of the remaining 22,000 mesh suits notes the company has now set aside over $2.6 billion to finalize the litigation claims related to the American Medical Systems (AMS) faulty medical devices, according to document filed with the U.S. Securities and Exchange Commission (SEC). American Medical Systems, a subsidiary of Endo was sold to Boston Scientific in 2015. Continue reading

Posted in Defective Medical Devices, Defective Products, Health Concerns, Product Recalls, Recalled Vehicles, Transvaginal mesh |

General Motors Recalls 800,000 Trucks due to Power Steering Defects

Nearly 800,000 pickup trucks are being recalled by General Motors because they may suddenly lose power steering while the truck is being driven, and the sudden steering jolt may cause drivers to lose control of the vehicle, reports Fortune.

About 690,685 Chevy Silverado and GMC Sierra 1500s in the United States, as well as 80,000 in Canada and 25,000 in other counties are the pickups that have been affected. The Silverados were manufactured between January 30, 2013, and September 4, 2014, and the Sierras between January 29, 2013, and September 4, 2014, reports the Daily Hornet. Continue reading

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

Mixed Metals are Focus of Stryker LFIT V40 Hip Implant Litigation

The Stryker Corporation is facing parallel litigations in Boston and New Jersey defending its LFIT Anatomic CoCr V40 Femoral Head (Cobalt Chromium V40) with allegations that the metal-on-metal ball and joint hip implant has a design defect causing it to fail prematurely. The giant medical device manufacturer sells its products worldwide in over 100 countries.

The alleged design defect is the junction between the femoral head and the femoral stem. The stems are normally titanium alloys and the heads are cobalt chromium and that is crux of the problem. Some hip implants of this type use a ceramic head. The current litigation revolves around the cobalt chromium heads combined with the titanium stems. It is alleged that the mixed metal can “fret” and corrode over time with everyday repetitive motion of the hip. Continue reading

Posted in Defective Medical Devices, Depuy, Health Concerns, Metal Hip Implants, Recalled Medical Devices |

Popular Heartburn Medications Linked to Increased Risk of Death

Drugs to relieve heartburn and acid-reflux are among the best selling drugs in the country, used by millions of Americans annually in both prescription and non-prescription strength.

Excess acid can cause stomach ulcers and damage to the esophagus. A reduction in stomach acid reduces irritation of the stomach lining and allows ulcers and irritation of the esophagus to heal, according to WebMD. Continue reading

Posted in Health Concerns, Pharmaceuticals, Proton Pump Inhibitors |

Stryker Hip Implant Failure Lawsuits Update

State-Based Stryker Lawsuits Consolidated in New Jersey

The New Jersey Supreme Court recently approved consolidation of all pending and future state-based hip replacement implant failure lawsuits brought against Stryker Corp. subsidiary, Howmedica Osteonics Corp.. within a multicounty legislation. The medical device products involved are the LFIT Anatomic Cobalt Chromium (CoCr) V40 femoral heads. The case is In re: Stryker LFIT Anatomic CoCr V40 Femoral Heads Litigation, Case No. 624, in the Superior Court of the State of New Jersey, County of Bergen.

The LFIT V40 Femoral Head is a hip replacement component that was recalled in 2016 over reports of taper lock failure. The alleged hip replacement implant failure involves corrosion at the point in which the head and neck intersect. The corrosion may cause the femoral head to break apart from the stem neck. This device failure would require immediate revision surgery. Continue reading

Posted in Defective Medical Devices, Metal Hip Implants |

Retired FDNY Firefighter Died Following Fight with 9/11-Related Cancer

Injured FDNY Member Fought Long and Hard for Zadroga Act and its Reauthorization

Ray Pfeifer, 59, a retired 27-year veteran of the Fire Department of New York (FDNY) died of cancer associated with his selfless work at the September 11th terrorist attacks in New York City. Pfeifer long fought his cancer that was attributed to his work at Ground Zero as he was also lobbying Congress to fund health care for his fellow first responders, officials said, Newsday reported.

Pfeifer worked approximately eight months on the pile of dangerous debris in lower Manhattan and also made more than one-dozen trips to Washington, D.C., to convince hesitant lawmakers to pass the James L. Zadroga 9/11 Health & Compensation Act. The Act is named to honor another 9/11 hero, a New York Police Department (NYPD) officer who died of respiratory disease contracted at Ground Zero, according to Newsday. Continue reading

Posted in Accident |

Takata Recalls an Additional 2.7 Million Air Bag Inflators

Takata has announced yet another air bag recall as part of the largest automotive recalls in United States history, this time involving 2.7 million air bag inflators made between 2005 and 2012. The cars involved are Ford, Nissan, and Mazda sold in the U.S. Some 42,000,000 vehicles are affected by the Takata air bag recalls as of January 19, 2017, according to the National Highway Traffic Safety Administration (NHTSA).

Reason for Current Recall

This most recent air bag inflator recall is triggered by test results that are foreseeing future air bag explosions, said the NHTSA in a statement. Takata reported that it is not aware of any ruptures having taken place, but is issuing the recall out of “an abundance of caution,” notes the NHTSA. This recall concerns the earliest generation of Takata airbag inflators, which use calcium sulfate as a desiccant (drying agent), and were put in driver-side airbags installed in vehicles sold by Mazda North American Operations, Nissan North America Inc., and Ford Motor Co., reports the NHTSA. Continue reading

Posted in Defective Products, Motor Vehicles |

Soliris Vaccination Raises Risk for Meningococcal Disease

People who have received eculizumab (brand name Soliris) are at high risk (1,000 to 2,000-fold greater), for invasive meningococcal disease compared to the general United States population. Life-threatening and fatal infections have occurred in some patients treated with Soliris. These infections may become rapidly deadly if not recognized and treated promptly, according to RxList.

What is Soliris?

Soliris is used to treat two rare blood disorders, paroxysmal nocturnal hemoglobinuria (PNH) that can cause a decrease in red blood cells (anemia). Soliris helps to block the decrease in red blood cells and can improve the symptoms of anemia such as tiredness, shortness of breath, and can decrease the need for blood transfusions. Continue reading

Posted in Health Concerns, Pharmaceuticals |

Oscor Recalls Defective Cables for External Pacemakers and Diagnostic Machines

On July 6, 2017, Oscor, Inc. issued a nationwide recall of Atar Reusable Extension Cables and Atar Disposable Extension Cables, which connect to external cardiac pacemakers or diagnostic machines.

During use, some Atar extension cables separated from the connector at the proximal end (the end nearer to the center of the body), the U.S. Food and Drug Administration (FDA) reports. Continue reading

Posted in Defective Medical Devices |

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