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News Archives

May 26, 2016: Hummi Micro-Draw Device Bleeding Risk Leads to Recall

Hummi Micro-Draw Device Bleeding Risk Hummingbird Med Devices Inc. is recalling the Hummi Micro-Draw Blood Transfer Device due to the risk of blood or fluid leakage. This error may occur if the Y-shaped connector and the yellow tube disconnect from each other prior to or during use, resulting in blood or fluid loss. This dangerous scenario could lead to serious adverse health consequences, including death. Hummi Micro-Draw Device Use The Hummi Micro-Draw Blood Transfer Device is a blood collection device with a Y-shaped connector attached to a yellow cannula hub (tube). It connects to a catheter to collect small volume blood samples from infants, including premature ones. The collected blood is transferred from the device to a syringe or other container for transport and processing. The device is primarily used in hospitals. OBTAIN A FREE MEDICAL DEVICE LAWSUIT EVALUATION If Read More

May 10, 2016: FDA Warns Of Olanzapine Serious Skin Reactions

Olanzapine Serious Skin Reactions On May 10, 2016, the U.S. Food and Drug Administration (FDA) issued a Safety Communication regarding a dangerous side effect associated with olanzapine-containing products. The FDA will require the addition of a new warning to olanzapine labeling indicating that the medication may cause a serious skin condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). What is olanzapine? Olanzapine is an antipsychotic medication used to treat mental health disorders schizophrenia and bipolar disorder. It can decrease hallucinations, in which people hear or see things that do not exist, and other psychotic symptoms such as disorganized thinking. Olanzapine is available under the brand names Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, and also as generics. What is DRESS? According to the FDA, DRESS may start as a rash that can spread to all parts of the Read More

May 5, 2016: Three Patients Died in Huntington Hospital Duodenoscope Outbreak

Huntington Hospital Duodenoscope Outbreak As revealed by the LA Times in a “newly discovered regulatory report,” another duodenoscope outbreak occurred in 2015 at Huntington Hospital in Pasadena, resulting in the death of at least three patients. The hospital has yet to release the number of patients who had been exposed to the infected duodenoscope. After undergoing a procedure with a duodenoscope, the three deceased patients had been infected with sepsis. According to the CDC, sepsis is the body’s overwhelming and life-threatening response to infection which can lead to tissue damage, organ failure, and death. It is difficult to predict, diagnose, and treat. Patients who develop sepsis have an increased risk of complications and death and face higher healthcare costs and longer treatment. Call the Weinberg Law Firm For Duodenoscope Lawsuit Help The Law Firm of Eric H. Weinberg is assisting Read More

April 22, 2016: FDA Proposes Electric Stimulation Devices Ban

Electric Stimulation Devices Ban The US Food and Drug Administration (FDA) has resolved to ban electrical stimulation devices used to treat aggressive and self-injurious behaviors, according to an April 22 New Release. According to FDA, Electric Stimulation Devices are only used at a single US facility, the Judge Rotenberg Educational Center in Canton, MA. The Judge Rotenberg Educational Center is a special-needs school which uses Electric Stimulation Devices as a behavior modification method. This proposed ban came to be because the FDA assertion that Electric Stimulation Devices pose a “substantial and unreasonable” risk to patients. Additionally, the FDA was unconvinced that the benefits of such treatment outweigh the risks. FDA Finds Insufficient Evidence of Effectiveness, Seeks Electric Stimulation Devices Ban Electric Stimulation Devices were originally classified as medical devices in as aversion conditioning devices “used to administer an electric shock Read More

April 20, 2016: Medtronic Recalls for Battery Pack in Patient Monitors

Medtronic Monitor Battery Recall By means of the U.S. Food and Drug Administration (FDA), Medtronic issued a recall of the battery pack found in their Covidien Oridion labeled Capnostream™20 and Capnostream™20p Patient Monitors. A capnostream monitor is an external medical device used to monitor a patients’ respiratory status. Due to a defect in the battery manufacturing, the device suffers an increased risk of thermal damage. Defect in Manufacturing May Lead to Thermal Damage So far, out of the 9,817 battery packs impacted by this recall, Medtronic has received seven reports of thermal damage, one of which involved a fire resulting in smoke inhalation and minor burns. Medical Device Lawsuit Help The Weinberg Law Firm is currently assisting individuals injured by medical devices, including vaginal mesh, power morcellators, IVC filters, and endoscopes/duodenoscopes as well as other devices. Mr. Weinberg also serves Read More

March 29, 2016: “Do Not Use” OxySure Portable Emergency Oxygen System, Warns FDA

Emergency Oxygen System Recall According to the U.S. Food and Drug Administration’s (FDA) March 29, 2016, Press Release, the OxySure Portable Emergency Oxygen System, Model 615 suffers several device malfunctions, including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to explode. Due to these dangerous risks, the FDA recommends that consumers, businesses, schools, and health care providers stop using the device immediately. OxySure Portable Emergency Oxygen System is intended to produce oxygen for emergency use. These devices may be purchased without a prescription and can be used in businesses, schools, and other public places. FDA Release Severe Warning Against Use of the OxySure Portable Emergency Oxygen System, Calls for Emergency Oxygen System Recall “Due to adverse event reports to the FDA and the company’s failure to address the device’s safety issues noted during inspections and Read More

April 1, 2016: B. Braun Dialysis Systems Recall Due Defective Conductivity Sensors

Dialysis Systems Recall The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the B. Braun Medical Inc Dialog+ Hemodialysis Systems due to defective conductivity sensors. A Class I recall is the most serious type of recall; use of these devices may cause serious injuries or death. The recall was warranted by defective, cracked conductivity sensors, which could “allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood,” according to the FDA. If air adulterates the dialysis fluid, this may lead to improper blood filtration. This error could cause serious adverse health consequences, including death. Dialog+ Hemodialysis Systems Conductivity Sensors Dialog+ Hemodialysis Systems Conductivity Sensors are used to treat patients with chronic kidney disease. The device is used for the clinical purification of Read More

March 11, 2016: Teleflex Heart Catheter Recall Due to Risk of Fatal Blood Loss

Teleflex Heart Catheter Recall Teleflex Incorporated of Wayne, PA, recalled its ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits as the U.S. Food and Drug Administration (FDA) branded the risk as a “Class I Recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” According to the Teleflex Heart Catheter Recall press release, the Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits are inserted in the aorta and provides mechanical circulatory support for cardiac patients. This is achieved by inflating and deflating the balloon at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart. Teleflex Heart Catheter Recall and Dangerous Adverse Effects The Teleflex Heart Catheter Recall was initiated due to the risk Read More

February 29, 2016: FDA Orders Studies OF Essure Complications, and New Patient Warnings

Essure Complications On February 29, 2016, due to a growing number of adverse event reports, the U.S. Food and Drug Administration (FDA) issued a plan to investigate the safety of Essure, a female sterilization device. Essure Adverse Events The FDA’s actions were spurred by several serious adverse event reports, including: • persistent pain, • perforation of the uterus and/or fallopian tubes, • intra-abdominal or pelvic device migration, • abnormal or irregular bleeding, • allergy or hypersensitivity reactions. Due to these events, some women have had surgical procedures to remove the Essure, and in other cases Essure failure has occurred due to incomplete patient follow-up, leading to unintended pregnancies. CALL THE WEINBERG LAW FIRM FOR ESSURE COMPLICATIONS LAWSUIT HELP If you are a loved one has been seriously injured by Essure complications, and you have a question concerning a potential Essure Read More

Febuary 26, 2016: FDA Warns of Surgical Skull Clamps Device Slippage

Surgical Skull Clamps Device Slippage After having received over 1,000 medical device reports, the U.S. Food and Drug Administration issued a Safety Communication warning of the risk of skull clamps (also known as “neurosurgical head holders”) to slip off of the patient’s head during or before surgery. From January 2009 to January 2016, this error resulted in more than 700 injuries. What are skull clamps? A skull clamp is part of a neurological head holder system used to hold the patient’s head position during surgical procedures, and may also include a head holder frame that attaches to the operating table, neurosurgical head hold stabilization components, or skull pins. Call the Weinberg Law Firm For a Free Surgical Skull Clamps Device Slippage Lawsuit Evaluation If you are a loved one has been seriously injured by a medical device, and you have Read More

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