Articles Posted in Medical Devices

epipen injury lawsuit

While the purpose of medical devices is to prevent injury and save lives, mistakes continue to be made, and patients become hurt. On Tuesday, March 24, the Food and Drug Administration let out a swift warning that the EpiPen 0.03mg (epinephrine auto-injector) and EpiPen Jr 0.15mg are malfunctioning and causing serious problems that could cause death and injuries to users. EpiPens are emergency devices used to stop or delay severe allergic reactions from things like foods and insect bites in both children and adults. It’s a popular brand used by families especially because the device has become widely accepted and standard throughout U.S. schools. When in use, EpiPens are forced against the thigh of the user and meant to automatically inject the hormone epinephrine to stop a dangerous allergic reaction.

The FDA issued the warning after global biopharmaceutical companies Pfizer and Mylan spoke with medical providers reporting malfunction issues with the device could cause death or serious injuries to their patients. Pfizer is the manufacturer of the EpiPens in question, and Mylan is the company selling them. It’s estimated that EpiPens impact the lives of 15 million U.S. patients (6 million kids and 9 million adults) each year.

What is Malfunctioning?

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Top 10 Patient Safety Concerns for 2020

Each year, the nonprofit ECRI Institute puts out a “Top 10 Patient Safety Concern Executive Brief” aimed to bring a heightened awareness for a better continuum of care and stronger accountability for U.S. health care systems. The annual top 10 report ranks patient safety concerns in all health care settings and designed to help organizations identify dangerous patient safety challenges and offers suggestions and resources for addressing them.

The list for 2020 includes:

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URGENT/11: Medical Products Are Vulnerable to Cybersecurity Threats

Healthcare organizations, IT professionals, device manufacturers and patients are being warned of cybersecurity vulnerabilities. The U.S. Food and Drug Administration issued a safety communication alert on October 1 explaining the serious safety and security risks due to URGENT/11 and a third-party software system called IPnet.

“Security researchers, manufacturers and the FDA are aware that the following operating systems are affected, but the vulnerability may not be included in all versions of these operating systems,” said FDA officials in a released statement which included a warning involving six different operating systems.

breathing tubes

Breathing Tube Removal Mistakes Can Be Deadly for Hospital Patients 

During sedation or illness, many hospital patients may require breathing assistance through intubation. The device used in this procedure is called an endotracheal tube (ET) which is placed through a patient’s mouth and then into the airway so that a breath can be delivered when used with a ventilator. The sensitive intervention can be especially necessary for patients with respiratory failure in both hospital intensive care units (ICU) and pediatric intensive care units (PICU).

Unplanned extubation (UE) is the uncontrolled and dangerous removal of this life-sustaining breathing tube. Sometimes the removal is self-induced by a patient, but healthcare providers also make deadly mistakes during the repair of a tube, suctioning, weighing, or replacing a ventilator circuit. Sadly, UE is a complication that occurs in more than 121,000 adult patients every year in the U.S. and kills 33,000 American adults, as noted in a recent article published in MedPage Today, authored by Art Kanowitz, MD, FACEP.

When we are sick we often require treatments and procedures that assist in the diagnosis of our medical problem. In one recent case, a woman died after a medical testing procedure was allegedly administered improperly. The woman’s estate administrator filed a lawsuit stating that the hospital and doctors were negligent by failing to provide proper care to the woman and thereby causing or contributing to her death.

Endoscopic Procedures

Endoscopies are generally safe procedures that are completed to view and diagnose internal medical problems throughout the digestive tract. In this case, the woman underwent an esophagogastroduodenoscopy, EGD. The procedure is exploratory and is performed using a scope with a camera which is used to view the inside of the esophagus and stomach. The procedure is not supposed to be invasive. The procedure may be completed as outpatient surgery or can be completed in the ICU or emergency room using special portable equipment.
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A woman has filed a medical malpractice lawsuit in Cook County against a hospital, medical group, and two doctors alleging negligence during surgery caused serious injuries. The woman was a patient at St. Alexius Medical Center where she underwent a surgical procedure. The procedure was not performed properly, according to the woman, and she was injured as a result. The lawsuit seeks damages of more than $50,000.

Failure to Properly Perform Procedure

The lawsuit indicates that the woman underwent a surgical procedure through Suburban Surgical Care Specialists, S.C. although the exact operation was not disclosed. After the procedure, the woman complained of extreme physical pain and also suffered from vomiting. The woman claims that the doctors did not perform the procedure properly and that caused her to suffer injuries along with pain.

Negligence

Negligence occurs when a responsible party fails to provide proper care or take proper precautions to keep someone safe. Particularly, in the case of a doctor, negligence may happen due to a mistake or the failure to do something that should have been done to prevent injuries. Negligence by a doctor is often the same as medical malpractice. Doctors and other medical professionals must provide a high standard of care. Failure to do so could result in medical malpractice if the patient suffers a serious injury or dies as a result.

Surgical Procedures
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A malpractice lawsuit filed in Cook County alleges that negligent care at a Chicago hospital caused the death of a man in 2013. According to the lawsuit, the man underwent triple bypass surgery at the University of Chicago Medical Center. After surgery, the man was utilizing an extracorporeal membrane oxygenation machine (EMCO) which supplies oxygen directly into the femoral artery. In order to prevent bedsores, the man required regular turning which was performed by hospital staff. The EMCO became dislodged due to turning the man, causing him to suffer massive blood loss and ultimately death.

Negligent Care at Hospitals
Negligent care by a doctor or medical professional is also called medical malpractice. Proper care is expected when someone is a patient at a hospital. In this case, the care providers were negligent because they did not use proper care when turning the man and did not ensure that the EMCO device was still in place after moving him. Further, the lawsuit in this case indicates that the providers did not observe the man’s vital signs, and they were not notated on the man’s chart. Had the caregivers noticed that the man was bleeding medical action could have prevented his death. The man’s death in this instance was clearly caused directly by the substantial blood loss.
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When we go under the knife we trust that our surgeon and medical team will provide the best possible care during the procedures. That wasn’t the case for a Vernon Hills woman. The woman underwent a surgical procedure at Hoffman Estates Surgery Center in 2014. According to the lawsuit, during the surgery a Bovie cautery pad was placed onto the woman’s leg causing a third-degree burn on her thigh. The burn was serious and purportedly left her with a scar and permanent disfigurement. The lawsuit was filed in Cook County court, alleging medical negligence.

Surgical Procedures

Many tools and various types of equipment and implements are utilized during surgery. These must be properly accounted for and taken care of throughout the procedure. Many incidents involving misuse of surgical implements have resulted in injuries or death to patients. Common problems include leaving sponges and other items inside the patient, improper sterilization of implements, and general mistakes made during the procedure. These issues are preventable and are generally considered medical malpractice.
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Medical malpractice is a common occurrence in today’s world. Doctors and other medical professionals often make mistakes that cause harm to their patients. Of course, not every error results in a medical malpractice lawsuit. The laws regarding malpractice are complex and require the expertise of a skilled malpractice attorney. When a doctor or nurse has provided inappropriate treatment, the patient likely suffers both physically and emotionally. The result can range from minor medical problems that are quickly resolved, to long-term physical problems, and even could cause death.

Standard of Care
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Power morcellators are essentially small power tools that can be used to remove fibroids in the uterus by cutting uterine tissue during surgery. They are manufactured by several companies, including Olympus, Karl Storz, Blue Endo, and Ethicon (a subsidiary of Johnson & Johnson).

However, there is a concern that, in the process of cutting the tissue, they could end up spreading tumor parts to other areas of the body if that tissue contains cancerous cells, resulting in leiomyosarcoma, myelosarcoma, and uterine sarcoma.
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